[Federal Register Volume 70, Number 2 (Tuesday, January 4, 2005)]
[Rules and Regulations]
[Pages 460-553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28593]
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Part III
Department of Agriculture
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Animal and Plant Health Inspection Service
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9 CFR Parts 93, 94, 95, and 96
Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation
of Commodities; Final Rule and Notice
Federal Register / Vol. 70, No. 2 / Tuesday, January 4, 2005 / Rules
and Regulations
[[Page 460]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 93, 94, 95, and 96
[Docket No. 03-080-3]
RIN 0579-AB73
Bovine Spongiform Encephalopathy; Minimal-Risk Regions and
Importation of Commodities
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the regulations regarding the importation of
animals and animal products to establish a category of regions that
present a minimal risk of introducing bovine spongiform encephalopathy
(BSE) into the United States via live ruminants and ruminant products
and byproducts, and we are adding Canada to this category. We are also
establishing conditions for the importation of certain live ruminants
and ruminant products and byproducts from such regions. These actions
will continue to protect against the introduction of BSE into the
United States while removing unnecessary prohibitions on the
importation of certain commodities from minimal-risk regions for BSE,
currently only Canada.
EFFECTIVE DATE: March 7, 2005.
FOR FURTHER INFORMATION CONTACT: For information concerning ruminant
products, contact Dr. Karen James-Preston, Director, Technical Trade
Services, National Center for Import and Export, VS, APHIS, 4700 River
Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356.
For information concerning live ruminants, contact Lee Ann Thomas,
Director, Technical Trade Services, Animals, Organisms and Vectors, and
Select Agents, National Center for Import and Export, VS, APHIS, 4700
River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356.
For other information concerning this rule, contact Dr. Gary
Colgrove, Director, Sanitary Trade Issues Team, National Center for
Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD
20737-1231; (301) 734-4356.
SUPPLEMENTARY INFORMATION:
I. Purpose
This document makes final, with changes, a proposed rule that the
Animal and Plant Health Inspection Service (APHIS) of the U.S.
Department of Agriculture (USDA or the Department) published in the
Federal Register on November 4, 2003 (68 FR 62386-62405, Docket No. 03-
080-1). In that document, we proposed to establish a category of
regions that present a minimal risk of introducing bovine spongiform
encephalopathy (BSE) into the United States via live ruminants and
ruminant products and byproducts, and to add Canada to this category.
The proposal also set forth conditions for the importation of certain
live ruminants and ruminant products and byproducts from BSE minimal-
risk regions. We solicited public comment on the proposed rule and its
underlying risk analysis and other supporting analyses for 60 days
ending on January 5, 2004. At the time the proposed rule was published,
BSE had never been detected in a native animal in the United States and
only a single case in a native animal had been reported in Canada (in
Alberta in May 2003). In December 2003, BSE was detected in an imported
dairy cow in Washington State. This document describes the course of
this rulemaking before and after the detection in Washington State,
including how the rulemaking was affected by additional BSE-related
safeguards imposed by USDA's Food Safety and Inspection Service (FSIS)
in January 2004. It also responds to public comments received on the
proposed rule and its underlying risk analysis and other supporting
analyses, both before the original closing date on January 5, 2004, and
during an extended comment period that closed on April 7, 2004, and
explains the changes we are making in this final rule.
II. Summary of Changes Made in This Final Rule
Based on our continued analysis of the issues and on information
provided by commenters, we have made certain changes in this final rule
from the provisions we proposed in November 2003, as supplemented by
our March 2003 notice of the extension of the comment period. Those
changes, summarized in the list below, are discussed in detail in our
responses to comments.
1. For bovines imported from a BSE minimal-risk region for feeding
and then slaughter (referred to as feeder cattle), we are making the
following changes:
We are requiring that feeder cattle be permanently marked
before entry as to country of origin with a brand or other means of
identification approved by the Administrator, rather than by an ear
tattoo as proposed. Feeder cattle imported from Canada must be marked
with ``C[and]N.''
We are requiring that feeder cattle be individually
identified before entry by an eartag that allows the animal to be
traced back to the premises of origin and are specifying that the
eartag may not be removed until the animal is slaughtered.
We are requiring that the animal health certification
currently required under existing Sec. 93.405 for certain live animals
imported into the United States include, for feeder cattle imported
from a BSE minimal-risk region, additional information relating to
animal identification, origin, destination, and responsible parties.
We are requiring that feeder cattle be moved from the port
of entry to a feedlot in a sealed means of conveyance and then from the
feedlot to a recognized slaughtering establishment in a sealed means of
conveyance. The cattle may not be moved to more than one feedlot.
When referring to the destination of feeder cattle
imported into the United States, we are using the terminology ``the
feedlot identified on the APHIS Form VS 17-130'' rather than
``designated feedlot.''
We are specifying that the physical location of the
feedlot of destination and the person responsible for movement of the
cattle be identified on the documentation required for movement from
the port of entry to the feedlot.
2. For sheep and goats imported from a BSE minimal-risk region for
feeding and then slaughter (referred to as ``feeder sheep and goats'')
we are making the following changes:
As with cattle, we are requiring that feeder sheep and
goats be permanently marked before entry as to country of origin (with
the requirements for marking modified as appropriate for sheep and
goats). Feeder sheep and goats imported from Canada must be marked with
``C.''
As with cattle, we are requiring that feeder sheep and
goats be individually identified before entry by an eartag that allows
the animal to be traced back to the premises of origin and are
specifying that the eartag may not be removed until the animal is
slaughtered.
We are continuing to refer to the feedlot of destination
for feeder sheep and goats as a ``designated feedlot'' and are adding
criteria for such feedlots. The sheep and goats may not be moved to
more than one designated feedlot.
We are requiring the same additional information on the
health certification required under Sec. 93.405 as described above for
feeder cattle.
We are requiring that feeder sheep and goats be moved from
the port of entry to a designated feedlot as a group in a sealed means
of conveyance, not be
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commingled with any sheep or goats that are not being moved directly to
slaughter from the designated feedlot at less than 12 months of age,
and be moved from the designated feedlot to a recognized slaughtering
establishment in a sealed means of conveyance.
3. For sheep and goats imported from a BSE minimal-risk region for
immediate slaughter, we are prohibiting the importation of sheep and
goats that are positive, suspect, or susceptible for TSEs.
4. We are moving the provisions for the importation of feeder sheep
and goats from Canada from proposed Sec. 93.436 to Sec. 93.405 and
Sec. 93.419.
5. We are moving the provisions for the importation of sheep and
goats from Canada for immediate slaughter from proposed Sec. 93.436 to
Sec. 93.419 and Sec. 93.420.
6. We are clarifying in Sec. 93.420 that all ruminants imported
from Canada for immediate slaughter must be moved to a recognized
slaughtering establishment in a sealed means of conveyance.
7. We are not specifying in our regulations that the intestines
from bovines imported from Canada be removed at slaughter in the United
States and be disposed of in a manner approved by the Administrator.
8. We are not including any import restrictions because of BSE for
live cervids (e.g., deer, elk) and cervid products from a BSE minimal-
risk region.
9. We are specifying that there are no import restrictions because
of BSE for camelids (i.e., llamas, alpacas, guanacos, and vicunas) from
a BSE minimal-risk region.
10. We are also providing in Sec. 94.18 for the overland
transiting of products derived from bovines, sheep, and goats from a
BSE minimal-risk region that are eligible for entry into the United
States. Additionally, we are clarifying that the existing provisions in
Sec. 94.18 for the transiting of ruminant products from regions in
which BSE exists or that pose an undue risk of BSE apply only to
transiting at air or sea ports.
11. We are requiring that bovines, sheep, and goats imported from a
BSE minimal-risk region be subject to a ruminant feed ban equivalent to
requirements established by Food and Drug Administration (FDA) of the
U.S. Department of Health and Human Services at 21 CFR 589.2000. This
is a change from our proposal that the ruminants ``are not known to
have been fed ruminant protein, other than milk protein.''
12. In the definition of bovine spongiform encephalopathy (BSE)
minimal-risk region, we are rewording the factor that said a BSE
minimal-risk region is one that has ``a ban on the feeding of ruminant
protein to ruminants that appears to be an effective barrier to the
dissemination of the BSE infectious agent, with no evidence of
significant noncompliance with the ban'' to say instead that the region
is one in which ``a ruminant-to-ruminant feed ban is in place and is
effectively enforced.''
13. We are providing that meat, meat byproducts, and meat food
products derived from bovines from a BSE minimal-risk region may not be
imported into the United States unless an air-injected stunning process
was not used at slaughter and unless the specified risk materials
(SRMs) and the small intestine were removed in the exporting region,
consistent with the FSIS regulations at 9 CFR 313.15 and 310.22 for
stunning and processing in the United States. We are defining SRMs as
those materials designated as such by FSIS in 9 CFR 310.22, to include
the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral
column (excluding the vertebrae of the tail, the transverse process of
the thoracic and lumbar vertebrae, and the wings of the sacrum), and
dorsal root ganglia of cattle 30 months of age and older, and the
tonsils and distal ileum of the small intestine of all cattle.
14. We are removing the proposed requirement that imported meat
derived from bovines from BSE minimal-risk regions be derived only from
animals less than 30 months of age when slaughtered.
15. We are removing the proposed requirement that meat derived from
bovines in a BSE minimal-risk region that are slaughtered in that
region come from animals slaughtered at a facility that either
slaughters only bovines less than 30 months of age or complies with an
approved segregation process.
16. We are clarifying that the final rule applies to ``meat,''
``meat byproducts,'' and ``meat food products'' as defined by FSIS.
17. We are removing the requirement that hunter-harvested meat be
accompanied by a certificate of the national government of Canada.
18. We are clarifying the type of ruminant offal from a BSE
minimal-risk region that is allowed importation into the United States.
19. We are providing that tallow may be imported from a BSE
minimal-risk region provided the tallow is composed of less than 0.15
percent insoluble impurities and is not commingled with any other
material of animal origin.
20. We are providing that, except for gelatin allowed importation
under Sec. 94.18(c), gelatin imported from a BSE minimal-risk region
must be derived from the bones of bovines that were subject to a
ruminant feed ban equivalent to the requirements established by FDA at
21 CFR 589.2000 and from which SRMs were removed.
21. We are providing that sheep casings may be imported from a BSE
minimal-risk region provided the sheep from which the casings were
derived were less than 12 months of age when slaughtered and were
subject to a ruminant feed ban equivalent to that of FDA at 21 CFR
589.2000.
22. We are adding and revising definitions in this final rule to
clarify the meaning of certain terms used in the rule.
III. Background
A. Bovine Spongiform Encephalopathy
APHIS regulates the importation of animals and animal products into
the United States to guard against the introduction of various animal
diseases, including BSE. The regulations are contained in 9 CFR parts
92, 93, 94, 95, and 96.
BSE is a progressive and fatal neurological disorder of cattle that
results from an unconventional transmissible agent. BSE belongs to the
family of diseases known as transmissible spongiform encephalopathies
(TSEs). In addition to BSE, TSEs include, among other diseases, scrapie
in sheep and goats, chronic wasting disease (CWD) in deer and elk, and
variant Creutzfeldt-Jakob disease in humans. The agent that causes BSE
and other TSEs has yet to be fully characterized. The theory that is
most accepted in the scientific community is that the agent is a prion,
which is an abnormal form of a normal protein known as cellular prion
protein. The BSE agent does not evoke any demonstrated immune response
or inflammatory reaction in host animals. BSE is confirmed by
postmortem microscopic examination of an animal's brain tissue or by
detection of the abnormal form of the prion protein in an animal's
brain tissues. The pathogenic form of the protein is both less soluble
and more resistant to degradation than the normal form. The BSE agent
is extremely resistant to heat and to normal sterilization processes.
BSE is spread to cattle primarily through the consumption of animal
feed containing protein from ruminants infected with BSE.
BSE was first diagnosed in 1986 in the United Kingdom. Since then,
there have been more than 187,000 confirmed cases of BSE in cattle
worldwide. The disease
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has been confirmed in native-born cattle in 20 European countries in
addition to the United Kingdom, and in some non-European countries,
including Japan, Israel, and Canada. Over 95 percent of all BSE cases
have occurred in the United Kingdom, where the epidemic peaked in 1992/
1993. Agricultural officials in the United Kingdom have taken a series
of actions to mitigate BSE, including making it a reportable disease,
banning mammalian meat-and-bone meal in feed for all food-producing
animals, prohibiting the inclusion of animals more than 30 months of
age in the animal and human food chains, and destroying all animals
showing signs of BSE and other potentially exposed animals at high risk
of developing the disease. As a result of these actions, most notably
the feed bans, the annual incidence of BSE in the United Kingdom has
fallen dramatically. The figure below illustrates the downward trend in
BSE cases among cattle born after implementation of the feed ban.
[GRAPHIC] [TIFF OMITTED] TR04JA05.010
Variant Creutzfeld-Jakob disease (vCJD), a chronic and fatal
neurodegenerative disease of humans, has been linked via scientific and
epidemiological studies to exposure to the BSE agent, most likely
through consumption of cattle products contaminated with the BSE agent.
To date, since vCJD was first identified in 1996, approximately 150
probable and confirmed cases of vCJD have been identified. The majority
of these cases have either been identified in the United Kingdom or
were linked to exposure that occurred in the United Kingdom, and all
cases have been linked to exposure in countries with native cases of
BSE. Some studies estimate that more than 1 million cattle may have
been infected with BSE throughout the epidemic in the United Kingdom.
This number of infected cattle could have introduced a significant
amount of infectivity into the human food supply. Yet, the number of
cases of vCJD identified to date suggest a substantial species barrier
that may protect humans from widespread illness due to BSE.
B. APHIS' Regulatory Approach to BSE: Past and Present
Since 1989 APHIS has prohibited the importation of live cattle and
other ruminants and certain ruminant products, including most rendered
protein products, into the United States from countries where BSE is
known to exist. In 1997, due to concerns about widespread risk factors
and inadequate surveillance for BSE in many European countries, APHIS
added an additional classification of countries as regions of undue
risk for BSE and extended importation restrictions on ruminants and
ruminant products to all of the countries in Europe. In December 2000,
APHIS expanded its prohibitions on imports of rendered ruminant protein
products from BSE-restricted regions to include rendered protein
products of any animal species, due to concern that cattle feed
supposedly free of ruminant protein may have been cross-contaminated
with the BSE agent. The same importation restrictions apply to regions
where BSE has been confirmed in a native animal and regions that
present an undue risk of BSE because of import requirements less
restrictive than those that would be acceptable for import into the
United States and/or because of inadequate surveillance (9 CFR 94.18).
In effect then, until implementation of this final rule, countries
have fallen into one of three categories with regard to BSE:
Regions in which BSE is known to exist;
Regions that present an undue risk of BSE because of
import requirements less restrictive than those that would be
acceptable for import into the United States and/or because of
inadequate surveillance; and
Regions that do not fall into either of the above two
categories.
This regulatory framework recognized only two risk situations--
those regions considered free of BSE and those regions considered to
present a BSE risk--and prohibited the importation of live ruminants
and most ruminant products from those regions considered to present a
BSE risk.
In our November 2003 proposed rule, we explained that we believed
it was appropriate to establish an additional category of regions with
regard to BSE--the BSE minimal-risk region. We stated that regions that
could be eligible for a minimal-risk classification would be (1) those
regions in which a BSE-infected animal has been diagnosed, but in which
measures have been taken that make it unlikely that BSE would be
introduced from that region into the United States, and (2) those
regions that cannot be considered BSE-free even though BSE has not been
detected, but that have taken sufficient measures to be
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considered minimal risk. We proposed to add Canada to the new BSE
minimal-risk category and also proposed conditions for the importation
of certain live ruminants and ruminant products and byproducts from BSE
minimal-risk regions.
Our proposed definition of BSE minimal-risk regions included the
standards we would use to evaluate the BSE risk from a region and to
classify a region as one of minimal risk for BSE. To qualify as a BSE
minimal-risk region, we proposed that a region be one that meets the
following standards:
1. The region maintains and, in the case of regions where BSE was
detected, had in place prior to the detection of BSE, risk mitigation
measures adequate to prevent widespread exposure and/or establishment
of the disease. Such measures include the following:
Restrictions on the importation of animals sufficient to
minimize the possibility of infected ruminants being imported into the
region, and on the importation of animal products and animal feed
containing ruminant protein sufficient to minimize the possibility of
ruminants in the region being exposed to BSE;
Surveillance for BSE at levels that meet or exceed
recommendations of the Office International des Epizooties (OIE, also
now referred to as the World Organisation for Animal Health) for
surveillance for BSE; and
A ban on the feeding of ruminant protein to ruminants that
appears to be an effective barrier to the dissemination of the BSE
agent, with no evidence of significant noncompliance with the ban.
2. In regions where BSE was detected, the region conducted an
epidemiological investigation following detection of BSE sufficient to
confirm the adequacy of measures to prevent the further introduction or
spread of BSE, and continues to take such measures.
3. In regions where BSE was detected, the region took additional
risk mitigation measures, as necessary, following the BSE outbreak
based on risk analysis of the outbreak, and continues to take such
measures.
We stated in our proposal that we would use these standards as a
combined and integrated evaluation tool, basing a BSE minimal-risk
classification on the overall effectiveness of control mechanisms in
place (e.g., surveillance, import controls, and a ban on the feeding of
ruminant protein to ruminants). We noted that this approach would
differ from some of the numerical guidelines specified by OIE in its
recommendations for a BSE minimal-risk country or zone (discussed
below).
Basis for Focused Regulatory Restrictions
Our proposed rule was based on a number of considerations. A
significant amount of research has been conducted on BSE since the
disease was initially identified and since we first established our
regulatory framework to protect against the introduction of BSE.
(Please note: In this final rule, we use the term ``importation'' to
mean the movement of animals or products into the United States or
another country and the term ``introduction'' to mean the movement of a
disease agent into the United States or another country.)
While there are many unanswered questions, both research studies
and field epidemiological experience have demonstrated effective
control measures to prevent spread of this disease. Ongoing studies
have identified specific tissues where the majority of infectivity
appears to reside, so that these tissues can be removed from the food
chain. Early epidemiological work identified contaminated feed as the
primary method of spread of the disease between animals. Continued
monitoring and surveillance in Europe--where the exposure is assumed to
be the highest--have demonstrated the effectiveness of control measures
that have been enacted, such as feed bans that prevent the recycling of
the agent. This increased body of knowledge provides a sound and
compelling scientific basis for more focused regulatory restrictions
with regard to BSE than those we have been operating under.
A more focused approach is also supported by the international
community, as evidenced by the evolution of BSE guidelines adopted by
the OIE (Ref 1). The OIE is recognized by the World Trade Organization
(WTO) as the international organization responsible for development and
periodic review of standards, guidelines, and recommendations with
respect to animal health and zoonoses (diseases that are transmissible
from animals to humans). The OIE guidelines for trade in terrestrial
animals (mammals, birds, and bees) are detailed in the Terrestrial
Animal Health Code (Ref 2). The OIE guidelines on BSE, contained in
Chapter 2.3.13 of the Terrestrial Animal Health Code, and supplemented
by Appendix 3.8.4 of the Code, currently provide for five possible BSE
classifications for regions. For each classification, the guidelines
recommend different export conditions for live animals and products,
based on the risk presented by the region. This framework not only
recognizes different levels of risk among regions, but provides for
trade in live animals and products under certain conditions even from
regions considered high-risk under the OIE guidelines.
As a member of the OIE, the United States, represented by APHIS,
has been actively involved in the development of OIE guidelines and
fully supports the OIE position that gradations in BSE risk among
regions should be recognized and that trade should be commensurate with
risk. Although APHIS did not incorporate the text of OIE's BSE
guidelines into its proposed rule, the agency based its standards on
these guidelines. The standards contain the same basic factors for
assessing a region's BSE status as the OIE guidelines (e.g., import
requirements, incidence, surveillance, feed restrictions, etc.). APHIS
also considered the OIE guidelines, in conjunction with other relevant
factors and available information, when evaluating Canada as a BSE
minimal-risk region, and will do so in the future in evaluating other
countries that may apply for minimal-risk status under our regulations.
It is in this context that APHIS' standards and the OIE guidelines
should be viewed.
We believe it is important to explain the relationship of our
standards to the OIE guidelines because a number of commenters
questioned why we did not adopt the OIE guidelines outright and/or
assumed that differences in text meant that APHIS had rejected the OIE
guidelines. While there are differences between the APHIS standards and
the OIE guidelines, these differences reflect the different purposes
and uses of the OIE guidelines and our standards.
The OIE guidelines are designed to provide a science-based
reference document for international trade in animals and animal
products. To this end, the OIE Terrestrial Animal Health Standards
Commission draws upon the expertise of internationally renowned
specialists to draft new and revised articles of the Terrestrial Code
in light of advances in veterinary science. Draft texts are circulated
to member countries for review and comment and, as a general rule, are
adopted based on consensus of the OIE membership. Articles adopted by
the membership provide guidance for use by veterinary authorities,
import/export services, epidemiologists and all those involved in
international trade. OIE guidelines are not intended to be
prescriptive; each member nation may determine its own appropriate
level of protection and, therefore, establish its own import
requirements. (In accordance with Article 5 of the WTO ``Agreement on
the Application of Sanitary and
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Phytosanitary Measures'' (WTO-SPS Agreement), WTO members are obligated
to base their import requirements on an assessment of risk, taking into
account the standards, guidelines, and recommendations, and the risk
assessment techniques developed by the relevant international
organizations.)
Regulations, which may be based on the OIE guidelines, are
prescriptive, as they are intended to be enforced as written and are
not designed to be a point of reference. Furthermore, because
rulemaking may take considerable time, the most successful regulations
must also be flexible enough to allow a country to consider individual
circumstances among its trading partners, as well as changes in
science, without undergoing constant revisions. One reason that APHIS
has decided not to simply adopt the OIE guidelines as regulations is
that they are constantly evolving and subject to change. Some chapters,
in fact, such as the one on BSE, are continually being updated as new
information becomes available. For example, the OIE is currently
considering proposing a three-tier country classification system for
BSE as an alternative to the existing five-tier system. In 2004, the
OIE changed the recommended reported incidence rate for minimal-risk
regions from less than 1 case per million during each of the last four
consecutive 12-month periods within the cattle population over 24
months of age to less than 2 cases per million during that time period
within that cattle population. This example of a numeric threshold
points to another reason that APHIS chose not to adopt the OIE
guidelines as regulations. In some cases, holding a country to a rigid
criterion without consideration of compensatory risk reduction measures
may not be scientifically justified and unfairly discriminate against
regions where the overall conditions indicate equivalence with minimal
BSE risk. In other cases, rigidly applying a numeric criterion without
a thorough consideration and evaluation of relevant factors (e.g., the
quality of a country's surveillance program and the supporting
veterinary infrastructure) could result in trade with a region that may
meet OIE guidelines but, nonetheless, present, in our view, an undue
risk of BSE introduction. Therefore, rather than incorporate the text
of the OIE guidelines into our regulations, APHIS chose to base its
evaluation on OIE guidelines in a way that allows us to consider an
individual country's specific situation and to analyze risk based on
the overall effectiveness of actions taken by the country to prevent
the introduction and spread of BSE.
As stated above, APHIS considered the OIE guidelines in evaluating
whether Canada met our proposed standards, and we plan to consider them
in assessing whether other countries that may apply for minimal-risk
classification meet our standards. To illustrate how we would use the
OIE guidelines for minimal-risk regions in applying our own standards,
we can look to our evaluation of the incidence of BSE with respect to
Canada. Although APHIS' standards do not include a numerical threshold
for incidence, our standards provide that a region must have in place
risk mitigation measures adequate to prevent widespread exposure and/or
establishment of the disease. In concluding that measures taken in
Canada had prevented widespread exposure and/or establishment, we
compared Canada's incidence rate of two infected cattle in 2003 out of
a population of 5.5 million cattle over 24 months of age with OIE's
recommendation of less than two infected cattle per million during each
of the last four consecutive 12-month periods within the cattle
population over 24 months of age. Canada's incidence rate (0.4 per
million head of adult cattle) is well below the current OIE
recommendation regarding incidence in minimal-risk regions. We also
considered that the reported rate of disease cannot be considered
independently from either the level and quality of disease surveillance
or from the position on the epidemic curve. In this regard, we note
that Canada exceeds the OIE recommended level of testing. We also
consider Canada's surveillance program for BSE in cattle to be of high
quality because it includes active surveillance for BSE in cattle that
is appropriately targeted based on known risk factors. Also, because
Canada implemented import restrictions and a feed ban before detection
of BSE in any indigenous animals, it is more likely that the incidence
of BSE in Canada is decreasing (on the down slope of the epidemic
curve), rather than increasing (on the up slope).
The November 2003 Proposed Rule
As explained above, our proposed standards for minimal-risk regions
were based on the OIE guidelines for BSE minimal-risk regions, using
those guidelines as a reference. We based our proposed classification
of Canada as a minimal-risk region, as well as our proposed mitigation
measures for live ruminants and ruminant products and byproducts from
Canada, on an analysis of risk APHIS prepared entitled, ``Risk
Analysis: BSE Risk from Importation of Designated Ruminants and
Ruminant Products from Canada into the United States.'' The analysis
drew on a number of sources of information, including scientific
literature, results of epidemiological investigations, data provided by
the Canadian Government, a quantitative analysis (i.e., uses numerical
values) of the risk of BSE in Canada prepared by the Canadian Food
Inspection Agency (CFIA), and quantitative analyses of the consequences
of BSE being introduced into the United States prepared by the Harvard
Center for Risk Analysis at Harvard University (HCRA) and the Center
for Computational Epidemiology at Tuskegee University (Ref 3)
(discussed in more detail below under the heading ``Harvard-Tuskegee
Investigation of BSE Risk in the United States''). This analysis was
made available to the public when the proposed rule was published in
November 2003.
We solicited public comment on the proposed rule and its underlying
risk analysis and other supporting analyses for 60 days ending on
January 5, 2004. As noted, at the time the proposed rule was published,
BSE had never been detected in a native animal in the United States,
and only a single case in a native animal had been reported in Canada
(in Alberta in May 2003).
The Reopening of the Comment Period and Explanatory Note
On December 23, 2003, less than 2 weeks before the close of the
comment period for our proposed rule, USDA announced a presumptive
positive case of BSE in a dairy cow in Washington State. Samples had
been taken from the cow on December 9 as part of USDA's BSE
surveillance program. The BSE diagnosis was made on December 22 and 23
by histopathology and immunohistochemical testing at the National
Veterinary Services Laboratories in Ames, IA, and was verified on
December 25 by the international reference laboratory, the Veterinary
Laboratories Agency in Weybridge, England.
Upon detection of the BSE-positive cow in Washington State, USDA,
FDA, and other Federal and State agencies, along with CFIA, immediately
began working together to perform an epidemiological investigation (Ref
4), trace any potentially infected cattle, trace potentially
contaminated rendered product, increase BSE surveillance, and take
additional measures to address human and animal health.
[[Page 465]]
The epidemiological investigation and DNA test results confirmed
that the infected cow was not indigenous to the United States, but
rather was born and most likely became infected in Alberta, Canada,
before Canada's 1997 implementation of a ban on feeding mammalian
protein to ruminants.
Following detection of the imported BSE-infected cow in Washington
State in December 2003, further safeguards on human and animal health
were implemented in the United States by FDA and FSIS. These actions
are described in more detail below under the headings ``Measures
Implemented by FSIS'' and ``Measures Implemented by FDA.''
In response to comments from the public requesting an extension of
the comment period and in order to give the public an additional
opportunity to comment on the proposed rule in light of these
developments, on March 8, 2004, we published a notice in the Federal
Register (69 FR 10633-10636, Docket No. 03-080-2) reopening and
extending the comment period until April 7, 2004. The notice also
announced the availability of a document titled ``Explanatory Note''
that discussed each component of the original risk analysis and related
information in light of the new BSE case. (You may view the Explanatory
Note document on the Internet by accessing the APHIS Web site at http://www.aphis.usda.gov/lpa/issues/bse/bse.html. Click on the document
titled ``Analysis of Risk--Update for the Final Rule: Bovine Spongiform
Encephalopathy; Minimal Risk Regions and Importation of Commodities,
December 2004.'')
The Explanatory Note stated that APHIS did not consider the
detection of a second BSE case to have an effect on the conclusions of
the original risk analysis and explained why. The original risk
analysis addressed the likelihood that animals might have been infected
before Canada implemented its feed ban in 1997 and also concluded that
compliance with the feed ban in Canada would have minimized the
likelihood of infectivity from these animals spreading to other
ruminants in Canada.
As noted above, the epidemiological investigation and DNA test
results indicated that the infected cow most likely became infected
before Canada's 1997 implementation of a ban on feeding mammalian
protein to ruminants. Both animals diagnosed with BSE were older than
30 months of age. The cow found to have BSE in December 2003 also was
imported into the United States when it was older than 30 months; the
proposed rule would not have allowed the importation of cattle 30
months of age or older.
The Explanatory Note observed further that, although an additional
animal of Canadian origin had been diagnosed with BSE since the time
APHIS published its November 2003 proposed rule and risk analysis, the
fact remained that only two cases of BSE had been detected in animals
born in Canada. The Explanatory Note also discussed the additional BSE
control measures taken by Canada after BSE had been detected in that
country.
The March 2004 notice that reopened and extended the comment period
on our proposed rule also proposed allowing the importation of beef
from Canada, regardless of the age of the cattle from which it was
derived, provided other specified mitigating conditions were met, and
invited comment on this change from our November 2003 proposal. The
original proposal would have required the beef to come from cattle that
were less than 30 months of age at the time of slaughter.
We explained in the notice that the change in our thinking was
based on the changes FSIS made in its regulations in January 2004, and
the fact that Canada had also implemented the changes made by FSIS.
Among other things, FSIS required that cattle tissues considered at
particular risk of containing the BSE agent in infected animals
(referred to as ``specified risk materials'' or SRMs) be removed from
cattle at slaughter and prohibited their use in human food. FSIS
designated as SRMs the brain, skull, eyes, trigeminal ganglia, spinal
cord, vertebral column (excluding the vertebrae of the tail, the
transverse process of the thoracic and lumbar vertebrae, and the wings
of the sacrum), and dorsal root ganglia of cattle 30 months of age and
older, and the tonsils and distal ileum of the small intestine of all
cattle. To ensure effective removal of the distal ileum, FSIS also
required that the entire small intestine be removed and be disposed of
as inedible. FSIS did not restrict the age of cattle eligible for
slaughter, because the removal of SRMs effectively mitigates the BSE
risk to humans associated with cattle that pass both ante-mortem and
post-mortem inspections (i.e., apparently healthy cattle); FSIS and FDA
regulations prohibit the use of other cattle in human food. The
Canadian Government had already established equivalent safeguards in
Canada in July 2003. In addition, because regions wishing to export
meat and meat products to the United States must follow processing
practices equivalent to those of FSIS, the FSIS requirements
effectively require removal of SRMs from all cattle slaughtered outside
the United States when meat derived from those cattle is intended for
export to the United States, which would prevent such materials from
entering the food chain in the United States. Additionally, FDA's feed
ban prohibits ruminant protein from entering the ruminant feed chain.
Therefore, we stated in our notice that we did not believe it was
necessary to require that beef imported from BSE minimal-risk regions
be derived from cattle under 30 months of age, provided measures
equivalent to those of FSIS regarding SRM removal are in place in the
exporting region and provided such other measures as are necessary
(e.g., a prohibition on the use of air injection stunning devices,
controls to prevent cross-contamination) are in place.
We received a total of 3,379 comments on the proposed rule from the
public by the close of the comment period on April 7, 2004.
C. Background Information for APHIS' Response to Comments
Before discussing the comments received, we consider it useful to
discuss a number of documents and actions that contributed to the basis
for our establishment of a BSE minimal-risk region category and our
inclusion of Canada in that category. These include: Measures
implemented by FSIS and FDA to further reduce BSE risk in the United
States; the Harvard-Tuskegee investigations of BSE risk in the United
States; a memorandum from Joshua Cohen and George Gray of the HCRA;
measures taken in Canada in response to BSE risk prior to May 2003; a
2002 Canadian assessment of BSE risk in that country; the
epidemiological investigation and a report by an international review
team following the diagnosis of BSE in a cow in Canada in May 2003;
additional measures taken in Canada; and an update to the APHIS
analysis of the risk of allowing the importation of ruminants and
ruminant products and byproducts from Canada.
Roles of Different Agencies
Protecting human and animal health from the risks of BSE is carried
out on the Federal level primarily by APHIS regarding animal health and
FSIS regarding food safety, in coordination with the following FDA
Centers: The Center for Veterinary Medicine regarding animal feed; the
Center for Food Safety and Applied Nutrition regarding foods other than
meat, poultry, and egg products; and other Centers regarding drugs,
biologics, and
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devices containing bovine material. These agencies collaborate, issuing
regulations under their respective authorities, to implement a
coordinated U.S. response to BSE.
APHIS is promulgating this final rule under the authority of the
Animal Health Protection Act, which gives the Secretary broad
discretion to regulate the importation of animals and animal products
when he or she determines it to be necessary. As discussed below, FSIS
and FDA have recently published regulations regarding BSE to protect
human health. Because of the specific focus of each of these three
agencies, provisions for similar products may sometimes differ slightly
in the agencies' respective regulations as appropriate based on the
intended consumer.
Measures Implemented by FSIS
FSIS, in a series of three interim final rules that were published
and made effective on January 12, 2004, took additional measures to
prevent the BSE agent from entering the human food supply. In its
interim final rule titled, ``Prohibition on the Use of Specified Risk
Materials for Human Food and Requirements for the Disposition of Non-
Ambulatory Disabled Cattle'' (FSIS Docket No. 03-025IF; 69 FR 1861),
and referred to below as the SRM rule, FSIS designated certain cattle
tissues as SRMs and prohibited their use in human food. As noted
earlier, FSIS designated as SRMs the brain, skull, eyes, trigeminal
ganglia, spinal cord, vertebral column (excluding the vertebrae of the
tail, the transverse process of the thoracic and lumbar vertebrae, and
the wings of the sacrum), and dorsal root ganglia of cattle 30 months
of age and older, and the tonsils and distal ileum of the small
intestine of all cattle as SRMs. FSIS also required removal of the
entire small intestine and disposal of it as inedible to ensure
effective removal of the distal ileum.
To facilitate enforcement of the SRM rule, FSIS has developed
procedures to verify the approximate age of cattle that are slaughtered
in official establishments. Such procedures, based on records or
examination of teeth, are intended to ensure that SRMs from cattle 30
months of age and older are effectively segregated from edible
materials (Ref 5).
As provided by the SRM rule, materials designated as SRMs if they
are from cattle 30 months of age and older will be deemed to be SRMs
unless the establishment can demonstrate that they are from an animal
that was younger than 30 months of age at the time of slaughter.
Further, FSIS developed procedures to verify that cross-
contamination of edible tissue with SRMs is reduced to the maximum
extent practical in facilities that slaughter cattle or process
carcasses or parts of carcasses of cattle, for cattle both younger than
30 months of age and 30 months of age and older (Ref 5).
The SRM rule also declared mechanically separated beef (MS(beef))
to be inedible and prohibited its use for human food. Additionally, the
SRM rule prohibited all non-ambulatory disabled cattle for use as human
food.
The second interim final rule, titled ``Meat Produced by Advanced
Meat/Bone Separation Machinery and Meat Recovery (AMR) Systems'' (FSIS
Docket No. 03-038IF; 69 FR 1874-1885), prohibited products produced by
advanced meat recovery (AMR) systems from being labeled as ``meat'' if,
among other things, they contain central nervous system (CNS) tissue.
AMR is a technology that enables processors to remove the attached
skeletal muscle tissue from livestock bones without incorporating
significant amounts of bone and bone products into the final meat
product. FSIS had previously established and enforced regulations that
prohibited spinal cord from being included in products labeled
``meat.'' The interim final rule expanded that prohibition to include
dorsal root ganglia (DRG)--clusters of CNS tissue connected to the
spinal cord along the vertebral column. In addition, because the
vertebral column and skull of cattle 30 months of age and older have
been designated as SRMs, they cannot be used for AMR. Because they are
not SRMs, the skull and vertebral column from cattle younger than 30
months of age are allowed to be used in AMR systems. However,
establishments that use skulls and vertebral columns in the production
of beef AMR product must be able to demonstrate that such materials are
from cattle younger than 30 months of age.
The third interim final rule, titled ``Prohibition on the Use of
Certain Stunning Devices Used to Immobilize Cattle During Slaughter''
(FSIS Docket No. 01-0331IF; 69 FR 1885-1891), prohibited the use of
penetrative captive bolt stunning devices that deliberately inject air
into the cranial cavity of cattle, because the use of such devices may
force large fragments of CNS tissue into the circulatory system of
stunned cattle where the fragments may become lodged in edible tissues.
Also on January 12, 2004, FSIS published a notice, ``Bovine
Spongiform Encephalopathy Surveillance Program,'' announcing it would
no longer pass and apply the mark of inspection to carcasses and parts
of cattle selected for BSE testing by APHIS until the sample testing
has been completed, and the result is negative (FSIS Docket No. 03-
048N; 69 FR 1892).
Measures Implemented by FDA
FDA, like FSIS, has taken additional measures to prevent the BSE
agent from entering the human food supply. In an interim final rule
published in the Federal Register on July 14, 2004, ``Use of Materials
Derived from Cattle in Human Food and Cosmetics,'' FDA prohibited SRMs
(the same as defined by FSIS), the small intestine of all cattle,
material from non-ambulatory disabled cattle, material from cattle not
inspected and passed for human consumption, and MS(beef) from use in
FDA-regulated human food, including dietary supplements, and cosmetics
(69 FR 42255; FDA Docket No. 2004N-0081).
In an advance notice of proposed rulemaking issued jointly by FDA,
FSIS, and APHIS on July 14, 2004, ``Federal Measures to Mitigate BSE
Risks: Considerations for Further Action'' (69 FR 42288-42300, FDA
Docket No. 2004N-0264, FSIS Docket No. 04-021ANPR, APHIS Docket No. 04-
047-1), FDA requested additional information to help it determine the
best course of action to reduce the already small risk of BSE spread
through animal feed. (We refer to the advance notice of proposed
rulemaking below as the ``USDA/FDA joint notice.'')
FDA continues to conduct inspections to monitor compliance of
domestic feed mills, renderers, and protein blenders with regulations
it put in place in 1997 to prevent recycling of potentially infectious
cattle tissue through ruminant feed. (FDA regulations at 21 CFR
589.2000 prohibit the feeding of most mammalian protein to ruminants in
the United States.) FDA also has expanded the scope of its inspections
to include other segments of animal feed production and use, such as
transportation firms, farms that raise cattle, and animal feed salvage
operations. Compliance with the feed ban by U.S. feed mills, renderers,
and protein blenders is currently very high. As of July 2004,
conditions or practices warranting regulatory sanctions had been found
in less than 1 percent of inspected facilities (Ref 6).
Harvard-Tuskegee Investigation of BSE Risk in the United States
In April 1998, USDA commissioned the HCRA at Harvard University and
the Center for Computational Epidemiology at Tuskegee University to
conduct a comprehensive investigation of BSE risk
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in the United States. The report was completed in 2001 and released by
the USDA. Following a peer review of the Harvard-Tuskegee Study in 2002
(Ref 7), the authors responded to the peer review comments (Ref 8) and
released a revised risk assessment in 2003 (Ref 3). The report, widely
referred to as the Harvard Risk Assessment or the Harvard Study, is
referred to in this document as the Harvard-Tuskegee Study.
The Harvard-Tuskegee Study reviewed available scientific
information related to BSE and other TSEs, assessed pathways by which
BSE could potentially occur in the United States, and identified
measures that could be taken to protect human and animal health in the
United States. The assessment concluded that the United States is
highly resistant to any amplification of BSE or similar disease and
that measures taken by the U.S. Government and industry make the United
States robust against the spread of BSE to animals or humans should it
be introduced into this country.
The Harvard-Tuskegee Study concluded that the most effective
measures for preventing the potential spread of BSE are: (1) The ban
placed by APHIS on the importation of live ruminants and ruminant meat-
and-bone meal from the United Kingdom since 1989 and all of Europe
since 1997; and (2) the feed ban instituted in 1997 by FDA. The
Harvard-Tuskegee Study further indicated that, if introduction of BSE
had occurred via importation of live animals from the United Kingdom
before 1989, mitigation measures in place in the United States at the
time the Study was conducted would have minimized exposure and worked
to eliminate the disease from the U.S. cattle population.
The Harvard-Tuskegee Study also identified three practices that
could create a pathway for human exposure to the BSE agent or the
spread of BSE should it be introduced into the United States: (1) Non-
compliance with FDA's regulations prohibiting the use of certain
proteins in feed for cattle and other ruminants; (2) rendering of
animals that die on the farm and use (through illegal diversion or
cross-contamination) of the rendered product in ruminant feed; and (3)
the inclusion of high-risk tissues from cattle, such as brain and
spinal cord, in products for human consumption.
The Harvard-Tuskegee Study's independent evaluation of the
potential risk mitigation measures predicts that a prohibition against
rendering of animals that die on the farm would reduce the number of
potential cases of BSE in cattle following hypothetical exposure by 82
percent as compared to the base case scenario, and that a ban on SRMs
(which included, according to the evaluation, the brain, spinal cord
and vertebral column, ``gut,'' and eyes) from inclusion in human and
animal food would reduce potential BSE cases in cattle by 88 percent
and potential human exposure to BSE by 95 percent as compared to the
base case scenario (Ref 9).
In 2003, following the identification of BSE in a native-born cow
in Canada, USDA, working with HCRA, evaluated the implications of a
then-hypothetical introduction of BSE into the United States from
Canada, using the same simulation model developed for the initial
Harvard-Tuskegee Study. This assessment, titled ``Evaluation of the
Potential Spread of BSE in Cattle and Possible Human Exposure Following
Introduction of Infectivity into the United States from Canada'' (Ref
10), confirmed the conclusions of the earlier Harvard-Tuskegee Study--
namely, that a very low risk exists of BSE becoming established or
spreading should it be introduced into the United States.
Cohen and Gray Memorandum
Following receipt of comments from the public on its November 2003
proposed rule, APHIS requested the HCRA to respond to comments that
pertained to the Harvard-Tuskegee Study. The HCRA's response to the
comments, authored by Joshua Cohen and George Gray, was reported to
APHIS in a June 18, 2004, memorandum, referred to below as ``the Cohen
and Gray memorandum.'' The memorandum also updates the model used in
the Harvard-Tuskegee Study with new data from the FDA addressing two
critical model parameters--mislabeling of products containing
prohibited ruminant protein and contamination of nonprohibited protein
with prohibited protein. You may view the memorandum on the Internet by
accessing the APHIS Web site at http://www.aphis.usda.gov/lpa/issues/bse/bse.html. Click on the document titled ``Analysis of Risk--Update
for the Final Rule: Bovine Spongiform Encephalopathy; Minimal Risk
Regions and Importation of Commodities, December 2004.''
Measures Taken in Canada in Response to BSE Risk Prior to May 2003
Import restrictions. Canada imposed import restrictions to guard
against the introduction of BSE, starting in 1990. In that year, Canada
prohibited the importation of live cattle from the United Kingdom and
the Republic of Ireland. In 1994, an import ban was imposed on all
countries where BSE had been detected in native cattle. In 1996, Canada
made this policy even more restrictive and prohibited the importation
of live ruminants from any country that had not been recognized as free
of BSE following a comprehensive risk assessment. Some animals were
imported into Canada from high-risk countries prior to the imposition
of these import restrictions. A total of 182 cattle were imported into
Canada from the United Kingdom between 1982 and 1990. Similar to
actions taken in the United States, efforts were made in Canada to
trace these animals. In late 1993, after Canada identified a case of
BSE in one of the imported bovines, all cattle imported from the United
Kingdom or the Republic of Ireland that remained alive at that time
were killed.
Canada has also restricted the importation of ruminant products,
including meat-and-bone meal, since 1978. In general, Canada has
prohibited the importation of most meat-and-bone meal from countries
other than the United States, Australia, and New Zealand. Limited
amounts of specialty products of porcine or poultry origin have been
allowed to be imported into Canada under permit for use in aquaculture
feed products. No meat-and-bone meal for livestock feed-associated uses
has been imported, except from the United States, Australia, and New
Zealand.
Feed ban. A crucial element in preventing the spread and
establishment of BSE in a country is the implementation of a ruminant-
to-ruminant feed ban. Canada implemented a feed ban in 1997 that
prohibits the feeding of most mammalian protein to ruminants. Under the
ban in Canada, mammalian protein may not be fed to ruminants, with
certain exceptions. These exceptions include pure porcine or equine
protein, blood, milk, and gelatin. The feed ban is equivalent to the
feed ban in place in the United States, with the addition that Canada
prohibits the feeding of plate waste and poultry litter to ruminants.
Canada has provided information, including statistics on
compliance, demonstrating that an effective feed ban is in place in the
rendering, feed manufacturing, and livestock raising industries. Few
cattle born before implementation of the Canadian feed ban are alive
today, given that most male cattle are slaughtered before 24 months of
age and given the normal cull rates for beef and dairy cows. It is
estimated that 39.4 percent of the beef cattle born in 1996 are alive
today. It is estimated that 5.8 percent of the dairy cattle born in
1996 are alive today.
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Infected animals typically exhibit clinical signs of BSE 4 to 6 years
after infection, and 95 percent of infected cattle exhibit clinical
signs in less than 7 years. Since cattle born before the feed ban would
now be 7 years of age or older, any remaining infected cattle, if
present, would likely be showing clinical signs of BSE that would allow
their detection through Canada's BSE surveillance system.
Canadian Government authorities inspect rendering facilities, feed
manufacturers, and feed retailers to ensure compliance with the feed
ban. Rendering facilities are regulated under an annual permit system,
and compliance with the regulations is verified through at least one
inspection each year. Feed manufacturers or mills, feed retailers, and
farms have been inspected on a routine basis. These inspections have
shown a high level of compliance. CFIA indicates that, with respect to
the inedible rendering sector, full compliance with the feed ban
requirements has been consistently achieved, and that, with respect to
the Canadian commercial feed industry, CFIA has identified
noncompliance of ``immediate concern'' in fewer than 2 percent of feed
mills inspected during 2003-2004. Those instances of noncompliance of
``immediate concern'' are dealt with when identified. According to
CFIA, noncompliance of immediate concern includes situations where
direct contamination of ruminant feed with prohibited materials has
occurred, as identified through inspections of production documents or
visual observation, and where a lack of appropriate written procedures,
records, or product labeling by feed manufacturers may expose ruminants
to prohibited animal proteins (Ref 11).
Surveillance. Canada has an adult cattle population of
approximately 5.5 million cattle older than 24 months of age. The
current OIE Code, Appendix 3.8.4, references adult cattle populations
as those greater than 30 months and recommends examining at least 300
samples per year from high-risk animals in a country with an adult
cattle population of 5 million, or 336 samples per year in a country
with an adult cattle population of 7 million. Even though the adult
cattle population in Canada is defined as greater than 24 months of age
and OIE defines it as greater than 30 months of age, Canada has met or
exceeded this level of surveillance for the past 7 years, thus
exceeding the OIE guidelines. Active targeted surveillance was begun in
Canada in 1992, with numbers of annual samples ranging from 225 in 1992
to current levels of over 15,800 per year. This surveillance has
continued to be targeted surveillance, with samples obtained from adult
animals exhibiting some type of clinical signs or considered high risk
for other reasons that could be considered consistent with BSE. During
the time Canada has been conducting surveillance for BSE, BSE has been
detected in only two cattle indigenous to Canada--the cows diagnosed
with BSE in May and December 2003.
Canadian 2002 BSE Risk Assessment
In December 2002, CFIA issued an assessment of the risk of BSE in
Canada. The assessment evaluated BSE risk factors and correlating risk
mitigation measures being taken in Canada, as well as surveillance
being conducted in that country to detect any BSE-infected animals. The
risk assessment analyzed the possibility that BSE infectivity was
introduced into Canada through 665 cattle imported into Canada from
Europe between 1979 and 1997, when Canada implemented its feed ban. The
analysis indicated a low potential for cumulative introduction of
infectivity into Canada via these cattle and further suggested that the
likelihood of the spread and establishment of BSE in Canada, both
before and after the 1997 feed ban, was negligible (Ref 12).
Epidemiological Investigation and a Report by an International Review
Team
On May 20, 2003, CFIA reported a case of BSE in a beef cow in
northern Alberta. Following the detection of the BSE-infected cow,
Canada conducted an epidemiological investigation of the BSE
occurrence, working with, among others, APHIS representatives. The
epidemiological investigation showed that the animal was born before
implementation of the feed ban in 1997, and that exposure likely
occurred prior to or near the time of the imposition of the feed
regulations. Although a specific source of infection was not
identified, the most likely source of exposure was feed that contained
protein from an infected animal imported from the United Kingdom
between 1982 to 1989.
Additionally, the epidemiological investigation focused on rendered
material or feed that could have been derived from the carcass of the
infected cow. As part of that investigation, a survey was conducted of
approximately 1,800 sites that were at some risk of having received
such rendered material or feed. The survey suggested that 99 percent of
the sites surveyed experienced either no exposure of cattle to the feed
(96 percent of the sites) or only incidental exposure (3 percent of the
sites). The remaining 1 percent represented limited exposures, such as
cattle breaking into feed piles, sheep reaching through a fence to
access feed, and a goat with possible access to a feed bag.
Depopulation of Canadian herds possibly exposed to the feed in question
was carried out by the Canadian Government. Canadian officials
conducted a wide-ranging investigation of possible exposure to the feed
in question and carried out depopulation of Canadian herds possibly
exposed to the feed. On each of those farms where the investigation
could not rule out the possibility of exposure to feed that may have
contained rendered protein from the infected animal, the herds were
slaughtered and tested. All of those animals tested negative for BSE
and their carcasses were disposed of in ways, such as disposal in
landfills, to ensure that they did not go into the animal food chain
(Ref 13).
In June 2003, an international review team (IRT) of animal disease
experts assessed the CFIA's investigation of the May 2003 case of BSE
and Canada's overall protective measures. The IRT noted the quality of
the Canadian investigation and the effectiveness of protective measures
in place in Canada. The IRT recommended a number of actions to further
enhance the safety of human and animal health, including putting in
place a national requirement that SRMs be removed from products
destined for consumption; a review of animal feed restrictions;
strengthened tracking and tracing systems; improved disease testing and
surveillance; and additional efforts to improve disease awareness among
producers, veterinarians, and the public (Ref 14).
Additional Measures Taken in Canada
Response to the IRT Report. Subsequent to the IRT report, in July
2003 Canada implemented the requirement that SRMs be removed from
cattle at slaughter (Ref 15). Additionally, Canada implemented enhanced
measures for identification and for tracking and tracing, as well as
for increased BSE surveillance and testing. We discuss the increased
surveillance and testing in greater detail below. (Ref 16).
Epidemiological Investigation of the Case in Washington State. As
noted above, in December 2003, BSE was detected in a Canadian-origin
cow in Washington State. Canada, along with the United States,
conducted a rigorous epidemiological investigation. As with the May
2003 case, the epidemiological investigation showed that the animal was
born in Canada before implementation of the feed ban in 1997 and, in
all likelihood, was exposed to
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BSE before or near the time the Canadian feed ban was imposed. As with
the May 2003 case, although a specific source of infection was not
identified, the investigation indicated that the most likely source of
exposure was feed that contained protein from an infected animal
imported from the United Kingdom between 1982 to 1989. Again, the
investigation resulted in the destruction and testing of a large number
of potentially exposed cattle, and testing resulted in no further
evidence of infection.
Increased Surveillance. In January 2004, the Canadian Government
announced that it would increase its level of BSE testing. As of
December 1, 2004, Canada had tested more than 15,800 animals for BSE in
2004, all with negative results, and has announced its goal of testing
at least 30,000 animals in 2005. The surveillance program focuses on
testing high-risk cattle: dead, dying, diseased, and down cattle over
30 months of age and cattle showing neurological symptoms consistent
with BSE. This level of testing represents a significant increase over
previous testing levels; surveillance levels in Canada have increased
to current levels from under 500 animals per year in 1996.
Update to APHIS' Risk Analysis and Summary of Mitigation Measures and
Their Applicability to Canada as a BSE Minimal-Risk Region
In order to add transparency to APHIS' basis for establishing a BSE
minimal-risk category and including Canada in that category, we are
making available a separate update of factors and measures that
mitigate the risk of BSE and their applicability to imports from
Canada. This update, titled ``Analysis of Risk-Update for the Final
Rule: Bovine Spongiform Encephalopathy; Minimal Risk Regions and
Importation of Commodities, December 2004,'' can be viewed on the
Internet at http://www.aphis.usda.gov/lpa/issues/bse/bse.html. Click on
the document titled ``Analysis of Risk-Update for the Final Rule:
Bovine Spongiform Encephalopathy; Minimal Risk Regions and Importation
of Commodities, December 2004.''
The update extends the discussions APHIS provided previously in its
risk analysis, explanatory note, proposed rule, and notice extending
the comment period. In the update, we summarize the APHIS standards for
a BSE minimal-risk region and the factors considered in our evaluation
of such a region. We expand on our considerations of Canada as a
minimal-risk region in the context of those standards. In accordance
with OIE guidelines (Chapter 1.3.2), the original analysis had four
major components: (1) Release assessment; (2) exposure assessment; (3)
consequence assessment; and (4) risk estimation. In the update, we
discuss in detail two of these four components--the release assessment
and exposure assessment--and provide, in more depth, data relevant to
our consideration of BSE risk. Finally, the update addresses
information that has become available subsequent to our original
analysis.
IV. Comments From the Public
As noted above, we received a total of 3,379 comments from the
public by the close of the comment period on April 7, 2004. They were
from members of Congress, representatives of State and local
governments, livestock producers, importers and exporters,
organizations representing livestock producers, organizations
representing processors and distributors of animal products and
byproducts, individual companies, representative of foreign
governments, a national animal health association, human health
associations, the academic community, and other members of the public.
Subjects of Comments Received
A number of commenters supported the rule and recommended no
changes to the proposed provisions. Other commenters supported the rule
in general but recommended certain changes to the proposed provisions.
Others comments consisted only of recommended changes, objections to
the rule in general or to specific provisions, or requests for
clarification. In general, the comments we received on the proposed
rule can be categorized as follows:
Comments on the proposed standards for BSE minimal-risk
regions;
omments on whether Canada should be recognized as a
minimal-risk region;
Comments on the proposed risk mitigation measures for the
importation of live ruminants from Canada;
Comments on the proposed risk mitigation measures for the
importation of ruminant meat and meat products derived from animals in
Canada;
Comments on the risk analysis;
Comments on the economic analysis;
Comments on the environmental analysis;
Comments advocating that we delay implementation of this
rule or withdraw the proposal;
Comments on miscellaneous issues related to the proposed
rule.
We discuss these comments by topic below.
Clarification
We note that, in order to clarify our intent in this final rule, we
are making a change to the proposed minimal-risk standards that was not
addressed by commenters. One of the standards we proposed to evaluate
for a BSE minimal-risk region was whether the region maintains, and, in
the case of regions where BSE was detected, had in place prior to the
detection of BSE, risk mitigation measures adequate to prevent
widespread exposure and/or establishment of the disease. In this final
rule, we are clarifying that the BSE detection referred to in that
factor is detection in an animal indigenous to the region, consistent
with the OIE guidelines for BSE. We are making this change to
distinguish between the risk of BSE from detection in indigenous
animals and imported animals. In this regard, detection of the disease
in an indigenous animal suggests that transmission of the agent has
occurred in the region, whereas an imported case does not.
In this final rule, we are making several other clarifications of
our regulations. These additional clarifications are discussed below,
following the discussion of comments, under the heading ``V. Additional
Clarifications.''
A. Proposed Standards for BSE Minimal-Risk Regions
Some of the comments we received on our proposed rule agreed with
the standards proposed for a BSE minimal-risk region and supported our
proposed classification of Canada as such a region. However, a number
of other commenters questioned the clarity of and basis for the BSE
minimal-risk standards. Others disagreed that Canada should be
considered such a region.
Proposed Minimal-Risk Standards in General
Issue: One commenter requested that APHIS reconsider the approach
of establishing a category of BSE minimal-risk region. The commenter
stated that, because OIE already lists a category very similar to
APHIS' BSE minimal-risk category, referring to ``minimal risk'' in the
proposal is an unnecessary duplication of definitions and could lead to
confusion. The commenter also suggested that APHIS link definitions and
the consequent treatment of animals and meat products to the OIE Code.
Several commenters said that APHIS should not adopt criteria for BSE
minimal-risk regions that differ from
[[Page 470]]
OIE guidelines for BSE minimal-risk regions or questioned APHIS' basis
for doing so. One of these commenters stated that OIE guidelines have
highly detailed and specific criteria that allow the identification of
minimal-risk regions and said that APHIS did not provide sufficient
analysis in the proposed rule to support the creation of a new minimal-
risk category. Some others said that APHIS did not adequately describe
the scientific basis for deviating from the OIE guidelines,
particularly with respect to time during which ruminant feed
restrictions have been in place.
Response: We are making no changes based on these comments. We
consider the definition of BSE minimal-risk region in this rule to be
clear. We have explained our reasoning in detail for adopting
performance standards for the critical factors, and discussed at some
length our conclusion that some regulatory flexibility is essential. We
noted the that the OIE guidelines are fluid, and discussed above in
section III. B., under the heading ``APHIS' Regulatory Approach to BSE:
Past and Present,'' that OIE may revise its BSE classifications in the
near future.
As discussed above in section III. B. under the heading ``More
Focused Regulatory Restrictions,'' although APHIS did not incorporate
the text of OIE's BSE guidelines into its proposed rule, the agency
based its standards on those guidelines, and the APHIS standards
contain the same essential factors for assessing a region's BSE status
as the OIE guidelines (e.g., import requirements, incidence,
surveillance, feed restrictions, etc.). The proposed rule and
associated risk analysis explain where APHIS' proposed standards for
minimal-risk regions departed from OIE guidelines. The preamble to the
proposed rule discussed how we would use those standards to evaluate
the BSE risk of a region. We said we would use the standards as a
combined and integrated evaluation tool in evaluating a region,
focusing on the overall effectiveness of all control mechanisms in
place (e.g., surveillance, import controls, and a ban on the feeding of
ruminant protein to ruminants). We further explained that, in regions
where BSE had been diagnosed, we would base our evaluation on the
overall effectiveness of all control mechanisms in place at the time
BSE was diagnosed in the region, and on actions taken after the
diagnosis (e.g., the epidemiological investigation of the occurrence).
We agree that this approach differs from the OIE's in that it does not
adhere to specific numerical recommendations specified in some of the
OIE guidelines, but, as discussed earlier, the OIE guidelines are in
flux and are meant to be a reference document. Further,
disqualification of a region for failure to precisely meet one OIE
recommendation would not account for a region's potential to present an
overall minimal risk for BSE by exceeding other OIE recommendations or
other relevant factors bearing on a risk to animal health.
We discussed in the proposed rule's preamble how we applied our
standards for minimal risk to an evaluation of Canada's BSE risk. For
example, we stated that, although Canada has had a feed ban in place
for only 7 years (1 year less than provided for by OIE), this time
period may be conservative because of the variability in the incubation
period for BSE. Based on an analysis of data collected in the United
Kingdom, the Harvard-Tuskegee Study (Ref 17) estimates that the
variability distribution for the BSE incubation period in cattle has a
median (50th percentile) of approximately 4 years and a 95th percentile
of approximately 7 years. Based on the best-fit parameter values
provided in the Harvard-Tuskegee Study (Ref 18), the mean (expected
value) of the incubation period distribution is estimated at 4.2 years,
and 7.5 years (August 1997 through January 2005) represents the
estimated 97.5th percentile of the incubation period. We determined
that the duration of the feed ban in Canada adequately addresses the
expected BSE incubation period, taking into consideration all of the
actions Canada has taken to prevent the introduction and control the
spread of BSE (e.g., import controls, level and quality of
surveillance, effectiveness of feed ban, epidemiological investigation
of detected cases, and depopulation of herds possibly exposed to
suspected feed sources). We, therefore, concluded that a feed ban of
less than 8 years' duration was appropriate for Canada. Canada, in
fact, meets all OIE guidelines for a minimal-risk region, except for
the duration of its feed ban.
We also note that OIE's guidelines for BSE include not just
guidelines for classifying regions according to risk, but corresponding
guidelines for trade in cattle, meat, and meat products from regions,
according to the region's BSE risk classification. Our rule is
consistent with this two-part OIE approach of considering a region's
overall BSE risk status in combination with appropriate import
restrictions for specific commodities.
Issue: A few commenters said that adopting criteria less stringent
than OIE guidelines could result in other countries' perceiving the
United States as having a greater BSE risk status and, therefore,
prohibiting or restricting imports of cattle and beef from the United
States. One commenter observed that OIE has five risk classifications
for regions and said that, while some countries may choose to trade
with high-risk regions, the United States should trade only with
countries determined to be free of BSE.
Response: We are working diligently on an international level to
ensure that BSE-related trade restrictions are based on sound science
and a realistic understanding of the risks presented by the commodities
we are proposing for trade. We do not believe it is appropriate to
limit trade in cattle, meat, and meat products only to regions
determined to be free of BSE if there are measures that can be applied
to mitigate the risk of those commodities introducing BSE into the
United States. There are such mitigation measures, consistent with
those we have proposed. In fact, OIE guidelines provide for trade in
cattle of any age, as well as beef and many other cattle products, even
from countries that are considered high risk for BSE.
Issue: One commenter said that he was not opposed to APHIS'
adopting criteria for minimal-risk regions that differ from OIE
guidelines, but that APHIS' criteria put too much emphasis on import
controls and epidemiological investigations and not enough on risk
management measures in a country under consideration. The commenter
mentioned a variety of risk mitigation measures in place in the
European Union, including removal of SRMs; a ban on the feeding of
mammalian meat-and-bone meal (MBM) to cattle, sheep, and goats; a
suspension on the use of processed animal protein in feeds for any
animals farmed for the production of food since January 2001, with the
exception of fish meal for pigs and poultry; high processing standards
for the treatment of ruminant animal waste; surveillance measures in
accordance with the OIE Code; an ongoing awareness program for
veterinarians; compulsory notification of all cattle showing clinical
signs of BSE; testing of risk animals (fallen stock, emergency
slaughtered animals, and animals with clinical signs at post-mortem
inspection) over 24 months of age and healthy slaughtered animals over
30 months of age; culling policy for animals with a high probability of
receiving the same potentially infected feed as a BSE case and
offspring of female BSE cases; approval of rapid tests with the same
sensitivity as the confirmatory methods.
[[Page 471]]
Response: We agree with the commenter regarding the effectiveness
of an integrated BSE risk management approach, and APHIS' standards for
minimal-risk regions consider risk management measures such as those
mentioned by the commenter. As discussed above, the standards we
proposed for a BSE minimal-risk region included the need for risk
mitigation measures to have been in place even before detection of BSE.
These would be considered under the broad criteria that form our
definition of minimal-risk region. Specifically, those standards
include: (1) Having in place risk mitigation measures adequate to
prevent widespread exposure and/or establishment of the disease,
including import restrictions, surveillance for BSE at levels that meet
or exceed OIE recommendations, and a ban on the feeding of ruminant
protein to ruminants; (2) conducting, in regions where BSE has been
detected, an epidemiological investigation sufficient to confirm the
adequacy of measures to prevent the further introduction or spread of
BSE; and (3) taking additional risk mitigation measures, as necessary,
in regions where BSE has been detected.
We emphasize, in this final rule, import controls as actions to
avoid the introduction of the BSE infectious agent, and epidemiological
investigations as action to promptly determine the extent of
introduction. However, we also place value on risk management actions
that were already in place in cases where BSE is detected.
Issue: Several commenters stated that APHIS' proposed standards for
a minimal-risk region were relatively ambiguous compared to the
corresponding provisions of the OIE Code. One such commenter stated
this is partly because the proposal did not have an objective
acceptable threshold regarding the extent of BSE infection in the
country and a minimum enforcement period of effective measures,
including a feed ban. Consequently, recommended the commenter, the
United States should either: (1) Prepare objective guidelines that
would allow exporting countries to determine their status with a
certain level of predictability; or (2) investigate and approve more
than one country. The commenter stated that the latter option would
give other countries a much clearer idea of what is acceptable.
Response: As explained previously, while there are differences
between the APHIS standards and the OIE guidelines, these differences
reflect the different purposes and uses of the OIE guidelines and our
standards. The OIE guidelines are designed to provide a science-based
reference document for international trade in animals and animal
products. Articles adopted by the OIE membership provide guidance for
use by veterinary authorities, import/export services, epidemiologists
and all those involved in international trade. OIE guidelines are not,
however, intended to be prescriptive; each member nation may determine
its own appropriate level of protection and, therefore, establish its
own import requirements.
In contrast, regulations, which may be based on the OIE guidelines,
are prescriptive, as they are intended to be enforced through an
appropriate enforcement and compliance program. Furthermore, as
rulemaking may take considerable time, the most successful regulations
must also be flexible enough to allow a country to consider individual
circumstances among its existing and potential trading partners, as
well as advances in science, without undergoing constant revisions.
As explained previously, specific numeric recommendations in the
OIE guidelines have changed over time and can be expected to change
further in the future. Rigid adherence to each specific standard would
disqualify some regions that present an overall minimal risk for BSE,
despite not quite meeting one standard, as a result of exceeding
certain other guidelines. We do not consider the suggested approach to
provide a sufficient level of flexibility to allow consideration of the
nature of BSE and the need to acknowledge and address varying
permutations of risk among different regions on a case-by-case basis.
Under the Animal Health Protection Act (AHPA) (7 U.S.C. 8301-8317),
``the Secretary may prohibit or restrict the importation or entry of
any animal, article, or means of conveyance * * * if the Secretary
determines that the prohibition or restriction is necessary to prevent
the introduction into or dissemination within the United States of any
pest or disease of livestock'' (7 U.S.C. 8303(a)). However, neither the
AHPA nor the Secretary (or officials delegated by the Secretary) has
delineated through regulations all the specific conditions that might
be considered necessary to protect against the introduction of animal
diseases or pests. This flexibility is necessary for APHIS to evaluate
situations involving specific animal diseases or pests of concern and
impose specific importation conditions necessary to mitigate the risk
of the introduction of such diseases and pests.
The use of rigid criteria may limit the scope of acceptable
alternatives for mitigating risk. This is particularly critical for
trade-related issues. The situations in individual regions differ
significantly, and each region defines its own particular spectrum of
control measures. An equivalent level of risk might be reached using
various combinations of different control measures. In this context, it
is quite possible that a region that does not meet a particular numeric
standard could compensate for any risk with other control measures. A
case in point is Canada. Although Canada does not precisely meet the
OIE guideline for duration of a feed ban, its control measures in other
areas (such as surveillance and import restrictions) more than
compensate for this. In some cases, holding a country to a rigid
criterion without consideration of compensatory risk reduction measures
may inappropriately discriminate against regions where the overall
conditions indicate minimal BSE risk. In other cases, uniformly
applying a numeric criterion without a thorough consideration of
qualitative factors (e.g., the quality of a country's surveillance
program and the supporting veterinary infrastructure) could result in
trade with a region that presents an undue risk of BSE introduction. In
order to make rational decisions, APHIS needs the flexibility to make
case-by-case determinations regarding the animal health status of
particular regions. In fact, the OIE guidelines state that risk
assessment should be flexible, in order to deal with the complexity of
real-life situations. Specifically, the OIE Code states that risk
assessment must be able to accommodate the variety of animal
commodities, the multiple hazards that may be identified with an
importation, the specificity of each disease, detection and
surveillance systems, exposure scenarios, and types and amounts of data
and information (Ref 19).
With regard to investigating and recognizing additional countries
as BSE minimal-risk regions, that process begins with a request by the
country interested in being considered, along with submission by that
country of the necessary information. Several countries, in fact,
submitted data in conjunction with their comments on our proposed rule.
In those cases where the information exchange between the requesting
country and the United States is at a very preliminary stage, it will
likely be some time before we have all of the information needed and
can complete our evaluation. Once an evaluation is completed, we will
provide an opportunity for public comment through a proposed rule to
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add the region to our list of minimal-risk regions for BSE.
Issue: Two commenters questioned why we did not include the
preparation of a risk analysis as a criterion for minimal-risk status,
pointing out that a risk analysis is a basic requirement for OIE
country classification for BSE under the OIE guidelines. One of these
commenters said that the OIE guidelines regarding BSE minimal-risk
require that a risk analysis be conducted and appropriate measures be
taken to manage any risk identified. In contrast, said the commenter,
instead of focusing on a region's total risk analysis process (as the
OIE guideline does), APHIS focuses only on whether the region's risk
mitigation strategies are adequate to prevent ``widespread exposure
and/or establishment of the disease.'' The commenter questioned whether
this approach would allow a region's potential BSE risk to be
adequately assessed and addressed before the region was considered
minimal-risk.
Response: We consider an analysis of risk to be an inherent and
integral component of the evaluation of a particular region with regard
to BSE. Further, such an analysis is required under the WTO-SPS
Agreement and the North American Free Trade Agreement. We encourage any
region proposing trade to conduct such a risk analysis and include it
with the documentation and data that APHIS requires. However, we did
not include the preparation of a risk analysis by a region in our
standards for minimal-risk status because APHIS itself intends to
assess the BSE risk of a region using the criteria that were listed.
APHIS routinely performs a risk analysis when proposing to allow
imports, not just regarding BSE, but also with regard to other diseases
of concern. A case in point is the risk analysis we prepared for this
rulemaking. The standard mentioned by the commenter-whether a region's
risk mitigation strategies are adequate to prevent widespread exposure
and/or establishment of the disease--is only one factor that will be
considered in the risk analysis. That factor itself has subsets
concerning import restrictions, surveillance for BSE at levels that
meet or exceed OIE guidelines, and a ban on the feeding of ruminant
protein to ruminants. In addition, our risk analysis would assess
whether, in regions where BSE has been detected, the region: (1) Had
conducted an epidemiological investigation sufficient to confirm the
adequacy of measures to prevent the further introduction or spread of
BSE and (2) had taken, and was continuing to take, additional risk
mitigation measures, as necessary, such as, for example, increased
surveillance. With regard to Canada, our risk analysis assessed both
the risk mitigation measures in place before the diagnosis of BSE in
that country and the actions Canada took after the detection.
Issue: Two commenters recommended that we provide more specificity
about how APHIS would evaluate whether a region meets the criteria for
minimal-risk status. One of the commenters called the proposed
standards for minimal-risk regions ``a series of ill-defined factors''
and complained that no mechanisms for enumerating or weighing these
factors were set forth in the proposal. The other commenter agreed with
the approach of evaluating a region for minimal-risk status using a
combined and integrated evaluation tool, rather than basing the
evaluation on single-factor values such as OIE recommendations on
feeding. However, the commenter suggested that how a region meets
APHIS' standards should be quantitatively as well as qualitatively
evaluated and that the results should be measured in terms of the
relative importance to the combined and integrated overall evaluation
(e.g., surveillance might need to be different from the OIE
recommendation and weighted more heavily than some other standards).
The commenter suggested further that, in evaluating regions beyond
Canada, APHIS should publish for public comment detailed risk
assessments, as well as the results of the combined and integrated
evaluation of the factors used to determine risk for establishing any
BSE minimal-risk region.
Response: We consider it necessary and appropriate not to specify
in the regulations mechanisms for enumerating or weighing the standards
for a minimal-risk region. As discussed above under the heading ``More
Focused Regulatory Restrictions,'' holding a country to a rigid
criterion without consideration of compensatory risk reduction measures
may, in some cases, unfairly discriminate against regions where the
overall conditions indicate equivalence with minimal BSE risk. In other
cases, uniformly applying a numeric criterion without a thorough
consideration of qualitative factors (e.g., the quality of a country's
surveillance program and the supporting veterinary infrastructure)
could result in trade with a region that presents an undue risk of BSE
introduction.
Application of Standards to Other Countries
Issue: A number of commenters raised questions regarding how the
proposed standards for BSE minimal-risk regions would be applied to
countries other than Canada. Some commenters stated it appeared the
standards were tailored to meet the situation in Canada. Several
commenters proposed additional countries for classification as BSE
minimal risk and suggested that those countries be included in this
rulemaking. One commenter requested that APHIS publish for public
comment evaluations done for regions beyond Canada. One commenter
recommended that applications for BSE minimal-risk recognition from
regions with similar status as Canada be rejected. Conversely, another
commenter recommended that any countries that currently have standards
that equal or exceed those of Canada should be included as BSE minimal-
risk regions in this final rule.
Response: We stated in our proposed rule that we would consider
requests from other countries for recognition as minimal-risk regions
once the regulatory framework defining a BSE minimal-risk region had
been established through this rulemaking. We will evaluate other
countries using the same standards we used for evaluating Canada.
Countries wishing to be recognized as minimal-risk regions by APHIS
need to apply for such recognition by following the procedures set
forth in 9 CFR part 92, ``Importation of Animals and Animal Products:
Procedures for Requesting Recognition of Regions.'' Although the 11
factors listed in part 92 are not the same as the standards listed in
this rule for BSE minimal-risk regions, they are broadly applicable to
any change in disease status and are compatible with the BSE minimal-
risk standards in this rule. As noted above, several countries
submitted data in conjunction with their comments on our proposed rule.
Once all of the necessary information is received, we will conduct an
evaluation of the request and, if a proposal appears warranted, provide
an opportunity for public comment through a proposed rule to add the
region to our list of minimal-risk regions for BSE. A final rule based
on the proposed rule would need to be issued before imports could
begin.
Issue: One of the standards for minimal-risk status was that a
region in which BSE has been detected must have had in place, prior to
the detection of BSE in the region, risk mitigation measures adequate
to prevent widespread exposure to and/or establishment of the disease.
Several commenters asked how, according to that criterion, countries
that reported cases of BSE before scientific studies had determined
appropriate risk
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mitigation requirements would be able to be considered BSE minimal-risk
regions.
Response: We agree that countries that were among the first to
diagnose BSE will, under the standards in this rule, not qualify as BSE
minimal-risk regions. Because of the lengthy incubation period of the
disease, by the time BSE was diagnosed in such countries and control
measures were implemented, the chances that the disease had
significantly spread were great. However, individual regions may apply
to APHIS to be able to export to the United States specific products
under conditions that could differ from those in our current
regulations. Such applications should be submitted in accordance with 9
CFR part 92 and will be considered when received by APHIS.
Measures to Prevent Widespread Exposure or Establishment
Issue: In our proposed definition of BSE minimal-risk region in
Sec. 94.0, we provided that such a region must maintain, and, in the
case of regions where BSE was detected, must have had in place prior to
the detection of BSE, risk mitigation measures adequate to prevent
widespread exposure and/or establishment of the disease. One commenter
asked the following questions: (1) What exactly are the risks to be
addressed and mitigated by the country seeking minimal-risk status; (2)
what risk mitigation measures are deemed adequate; and (3) what are the
standards to be used to judge whether the measures are adequate?
Response: As discussed in the preamble to our proposed rule, in
evaluating whether a country had in a place risk mitigation measures
adequate to prevent widespread exposure or establishment of BSE, we
would consider whether the country had in place:
Restrictions on the importation of animals sufficient to
minimize the possibility of infected ruminants being imported into the
region, and on the importation of animal products and animal feed
containing ruminant protein sufficient to minimize the possibility of
ruminants in the region being exposed to BSE;
Surveillance for BSE at levels that meet or exceed OIE
recommendations for surveillance for BSE; and
A ban on the feeding of ruminant protein to ruminants that
appears to be an effective barrier to the dissemination of the BSE
infectious agent, with no evidence of significant noncompliance with
the ban.
We provided, further, that, in regions where BSE was detected, a
minimal-risk region must have conducted an epidemiological
investigation following detection of BSE sufficient to confirm the
adequacy of measures to prevent the further introduction or spread of
BSE, and must continue to take such measures. Additionally, the region
must have taken additional risk mitigation measures, as necessary,
following the BSE outbreak based on risk analysis of the outbreak, and
continue to take such measures.
We did not specify numeric thresholds for each of the above
criteria. As discussed above, because rulemaking may take considerable
time, the most successful regulations must also be flexible enough to
allow a country to consider individual circumstances among its trading
partners, as well as changes in science, without undergoing constant
revisions. Further, in some cases, holding a country to a rigid
criterion without consideration of compensatory risk reduction measures
may not be scientifically justified and may unfairly discriminate
against regions where the overall conditions indicate minimal BSE risk.
In other cases, rigidly applying a numeric criterion without a thorough
consideration and evaluation of relevant factors (e.g., the quality of
a country's surveillance program and the supporting veterinary
infrastructure) could result in trade with a region that may meet
numeric criteria but, nonetheless, present, in our view, an undue risk
of BSE introduction. Therefore, APHIS chose to base its evaluation on
OIE guidelines in a way that allows us to consider an individual
country's specific situation and to analyze risk based on the overall
effectiveness of actions taken by the country to prevent the
introduction and spread of BSE.
Issue: As noted above, one of the proposed standards for a BSE
minimal-risk region was that, in regions where BSE was detected, the
region ``had in place prior to the detection of BSE, risk mitigation
measures adequate to prevent widespread exposure and/or establishment
of the disease.'' One commenter asked for clarification of the meaning
of ``widespread exposure or establishment,'' of whether moderate
exposure or establishment is acceptable, and of how many cases are
acceptable in both humans and animals. Another commenter stated that
the wording in the definition could create disagreements with regions
applying for BSE minimal-risk status as to whether the disease is
widespread in a particular region.
Response: APHIS has set no specific thresholds for an acceptable
number of cases in humans or animals. Rather, the Agency will conduct
an evaluation of the BSE situation in a region according to the factors
in that region and define mitigations appropriate for the conditions.
APHIS would consider in its evaluations OIE recommendations regarding
the recommended maximum number of BSE cases per million at different
BSE risk levels.
As an example, APHIS considers the situation that existed in the
United Kingdom and certain other European countries in the 1990s to be
clearly an example of widespread exposure or establishment, and also
one that would clearly contribute to a high-risk categorization under
OIE guidelines (Ref 1). Widespread BSE exposure in the United Kingdom
was at its peak in the early 1990's, as reflected by the finding of
more than 30,000 cases per year in 1992-1993. The situation has
improved dramatically with the stringent control measures that have
been imposed in the United Kingdom. This has also been the case in
other European countries that have had what we consider ``widespread
exposure.'' It is important to note that, in each of these situations,
BSE was detected and control measures were then instituted, resulting
in some delay until the effects of the control measures could become
apparent. These situations were very different, for example, from the
situation in Canada, where: (1) Control measures were in place before
the detection of the disease; (2) only two animals of Canadian origin
have been confirmed with BSE; (3) both were born before implementation
of Canada's feed ban; and (4) Canada has maintained other protective
measures (including import restrictions) that would help preclude a
significant level of infectivity from being transmitted to the cattle
population.
Surveillance
Issue: One commenter stated that the premise in the proposed rule
that prevalence of BSE will be lower in regions with adequate
prevention and control measures does not take into account that the
level of determined prevalence is dependent on the quality and level of
surveillance in each region. The commenter expressed concern that,
although a country may say it has low prevalence, its surveillance may
be inadequate to accurately measure the prevalence.
Response: We agree with the commenter concerning the importance of
a valid and effective surveillance program. One of the first
evaluations we make regarding a country or other region seeking a
particular animal health status is the effectiveness and
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reliability of its veterinary infrastructure, including its
surveillance programs.
Issue: One commenter recommended that the specific content of
adequate surveillance systems be detailed in the regulations.
Response: In this rulemaking, we require that a region seeking BSE
minimal-risk status conduct surveillance for BSE at levels that meet or
exceed OIE recommendations for surveillance for the disease. As noted
above, in establishing its guidelines, the OIE Terrestrial Animal
Health Standards Commission draws upon the expertise of internationally
renowned specialists to draft new and revised articles of the
Terrestrial Code in light of advances in veterinary science. Therefore,
the OIE guidelines are constantly evolving and subject to change. In
order to make our regulations flexible enough to allow us to
accommodate internationally recognized changes in science without
making constant revisions to the regulations, we are basing our
requirements for surveillance on OIE recommendations, but are not
specifying numeric thresholds in this rule.
Feed Restrictions
Issue: One of the standards we proposed for a BSE minimal-risk was
that the region have ``a ban on the feeding of ruminant protein to
ruminants that appears to be an effective barrier to the dissemination
of the BSE infectious agent, with no evidence of significant
noncompliance with the ban.'' Several commenters took issue with this
factor. The commenters stated that the absence of evidence of
noncompliance is not evidence of compliance and that this standard
could be met by countries with no or minimal compliance monitoring. The
commenters stated that the feed ban should be enforced by an inspection
program, including sampling and testing of feed, as recommended by the
IRT. Another commenter took issue with the words ``appears to be,''
recommending instead that the factor should address whether a feed ban
is or is not an effective barrier in a particular region. One commenter
stated that specific guidelines for compliance, including on-farm
compliance, should be provided.
Response: We concur that the lack of evidence of noncompliance may
not be evidence of compliance. We did not intend for the proposed rule
to produce or allow for the result described by the commenter. For this
reason, we are changing the wording of the factor referred to by the
commenter to provide instead that ``a ruminant-to-ruminant feed ban is
in place and effectively enforced.'' It was, and continues to be, our
intent to evaluate all relevant factors thoroughly. Determining whether
a feed ban has been effectively enforced will involve a review by APHIS
of a number of interrelated factors, including: The existence of a
program to gather compliance information and statistics; whether
appropriate regulations are in place in the region; the adequacy of
enforcement activities (e.g., whether sufficient resources and
commitment is dedicated to enforcing compliance); a high level of
facility inspections and compliance; accountability of both inspectors
and inspected facilities; and adequate recordkeeping. Our individual
evaluation of the BSE status of a region will assess these factors and
evaluate any contribution to risk.
Issue: Several commenters expressed concern regarding a U.S.
recommendation to the OIE that the OIE feed ban duration standard be
reduced from 8 to 5 years. One commenter recommended that USDA champion
a continuation of the current OIE standard. Commenters stated that
shortening the standard from an 8-year feed ban was inadvisable because
it is possible some residual ruminant protein feed in some countries
would be fed for several years after a feed ban went into effect.
Response: The APHIS recommendation that the OIE standard for the
minimum duration of a feed ban be reduced from 8 years to 5 years was
based on the estimated average incubation period of the BSE agent in
cattle. As discussed above, the Harvard-Tuskegee Study (Ref 17)
estimates that the variability distribution for the BSE incubation
period in cattle has a median (50th percentile) of approximately 4
years. Based on the best-fit parameter values provided in the Harvard-
Tuskegee Study (Ref 18), the mean (expected value) of the incubation
period distribution is estimated at 4.2 years. However, the OIE decided
not to change the standard.
Epidemiological Investigation
Issue: A commenter expressed concern with the proposed factor for a
BSE minimal-risk region related to an epidemiological investigation.
This factor stated that, in regions where BSE has been detected, a
minimal-risk region must have ``conducted an epidemiological
investigation following detection of BSE sufficient to confirm the
adequacy of measures to prevent the further introduction or spread of
BSE, and continues to take such measures.'' The commenter stated that
the standard focuses on the conduct of an investigation and not whether
there were definitive findings resulting from such an investigation.
The commenter also took issue with our explanation in the preamble that
``an investigation following a detected case would include, among other
things, an investigation to determine the most likely source of the
animal's exposure to BSE,'' saying that the ``most likely source'' is
not a definitive finding.
Response: Certainly, the quality of the investigation and its
results and findings must be carefully evaluated. However, definitive
findings are not always possible or necessary in an epidemiological or
scientific investigation. If a region is able to explain the approach
it has taken in its investigation and produce adequate information
regarding the most likely source of infection, the lack of a definitive
finding can be within normal scientific parameters. Uncertainty may, in
many instances, be compensated for in other areas, such as through
appropriate mitigations. Depending on the quality of the
epidemiological investigation, the absence of definitive findings may
be less important than whether there are adequate measures in place to
address disease risk.
Additional Measures
Issue: One commenter expressed concern with the proposed factor for
a BSE minimal-risk region that requires that, in regions where BSE was
detected, the minimal-risk region ``took additional measures, as
necessary, following the BSE outbreak based on risk analysis of the
outbreak, and continues to take such measures.'' The commenter objected
to our explanation in the preamble that additional risk mitigation
measures could include ``a broad eradication program, increased
surveillance, or additional import restrictions,'' expressing concern
that the statement indicates that additional measures either could or
could not include those listed by APHIS.
Response: We intended the additional mitigation measures that were
listed by the commenter (a broad eradication program, increased
surveillance, and additional import restrictions) to be examples of
possible additional measures that might be necessary. In pointing to
those measures, we did not intend to provide a definitive list of
additional mitigation measures we might consider; rather, the examples
were intended to provide a sense of the types of measures we might
consider. Indeed, in the discussion of OIE standards in the updated
risk analysis,
[[Page 475]]
we provide several more examples of additional mitigation measures we
are considering, e.g., an ongoing awareness program for veterinarians,
farmers, and workers involved in transportation, marketing, and
slaughter of cattle; compulsory notification and investigation of all
suspected cases of BSE; and examination in an approved laboratory of
brain and other tissues collected within the framework of the
surveillance and monitoring system. As we stated in the preamble of our
proposal, measures will be required that are appropriate depending on
the conclusions of the risk analysis that is required following a BSE
diagnosis.
Human Health Risks
Issue: Several commenters recommended that the definition of BSE
minimal-risk region specifically list actions taken to minimize human
health risks, which the commenter said should be equal to or more
stringent than those in the United States. The commenters stated that
the definition should require, for example, that minimal-risk regions
do the following: (1) Ban use of non-ambulatory cattle; (2) hold
product/carcass until negative results are obtained; (3) prohibit air-
injected stunning; (4) remove high-risk tissues; and (5) prevent the
inclusion of central nervous system tissue in ``meat'' products.
Response: The issues raised by the commenters relate to the
equivalency of standards for the production of meat in countries that
export to the United States. The FSIS regulations in 9 CFR 327.2
provide that, to be eligible to export meat and meat products to the
United States, a foreign country must be able to certify that it
applies to its own meat processing establishments requirements
equivalent to those in the United States. Under those regulations,
exporting countries are required to provide documentation supporting
how their meat inspection system is equivalent to that of the United
States. FSIS determines whether the systems are equivalent. The FSIS
procedures for evaluating such equivalency are discussed below in more
detail, under the heading ``Verification of Compliance in the Exporting
Region.'' Each of the requirements recommended by the commenter are
currently required of meat processing establishments in the United
States and, therefore, are applicable to establishments in foreign
countries that wish to export meat and meat products to the United
States.
Tracking and Labeling
Issue: One commenter recommended that requirements for a minimal-
risk region include existence of a national animal identification and
tracking program, adequate and active testing and monitoring programs
for all OIE List A animal diseases, and product labeling to enable
tracking of the product.
Response: Although the standards for a BSE minimal-risk region in
this rule do not specifically require a national animal identification
and tracking program, they do include a requirement for an effective
epidemiological investigation and the ability of authorities in the
region to conduct traceback and trace-forward of animal feed or
rendered material. An evaluation of these capabilities will include
consideration of animal identification. Although we acknowledge the
importance of adequate testing and monitoring for OIE List A diseases
with regard to whether and under what conditions animals and animal
products should be allowed importation from a particular region, those
diseases are already addressed individually in the regulations in 9 CFR
92, 93, 94, 95, 96, and 98. Further, we do not consider List A diseases
to fall under the scope of this rulemaking. List A diseases are defined
by OIE as transmissible diseases that: (1) Have the potential for very
serious and rapid spread, irrespective of national borders; (2) are of
serious socioeconomic and/or public health consequences; and (3) are of
major importance in the international trade of animals and animal
products. BSE is not included as an OIE List A disease but, instead, is
categorized as a List B disease. List B diseases are considered to be
(1) of socioeconomic and/or public health importance within countries
and (2) significant in the international trade of animals and animal
products.
With regard to product labeling in the exporting region, it is not
clear to us from the comment what type of labeling the commenter is
referring to.
Testing of Ruminants
Issue: One commenter stated that, if BSE is diagnosed in a country,
the United States should not accept ruminants and ruminant products
from that country until the country tests all cattle over 20 months of
age at slaughter. Other comments recommended that we require that all
cattle slaughtered in such a country be tested for BSE. Some commenters
recommended that such testing be carried out by USDA representatives in
Canada.
Response: We understand the interest expressed by some commenters
in testing certain cattle for slaughter. However, no live animal tests
exist for BSE and the currently available postmortem tests, although
useful for disease surveillance (i.e., in determining the rate of
disease in the cattle population), are not appropriate as food safety
indicators. We know that the earliest point at which current testing
methods can detect a positive case of BSE is 2 to 3 months before the
animal begins to demonstrate clinical signs. We also know that the
incubation period for this disease--the time between initial infection
and the manifestation of clinical signs--is generally very long, on the
average of about 5 years. Accordingly, we know there is a long period
during which, using the current methodology, testing an infected animal
that has not demonstrated clinical signs of the disease would,
incorrectly, produce negative results. If, however, the infected animal
is already exhibiting some type of clinical signs that could be
consistent with BSE, then the test is not likely to produce false
negative results.
Development of reliable food safety indicators will require
improved understanding of the pathogenesis of the disease and improved
laboratory methods. However, if BSE is present in a country's cattle
population, various mitigation measures, such as feed bans and removal
of SRMs, are available to prevent the spread of BSE in cattle and to
prevent human exposure to the BSE agent. The United States and Canada
have already implemented such measures. The results of an enhanced
animal surveillance program for BSE, announced by the Secretary on
March 15, 2004 (Ref 20), and currently underway, which will help
determine the prevalence of BSE in the United States, should the
disease exist, and will provide information that will indicate whether
these measures should be adjusted. But measures such as SRM removal and
the prohibition of the use of non-ambulatory cattle in human food will
ensure a safe meat supply. Testing of individual animals, especially if
it is performed on clinically normal animals at slaughter, is not in
itself an effective risk mitigation measure for protecting public
health. The purpose of a surveillance program is to gauge the level of
BSE prevalence. This can be achieved through targeted sampling, as is
being carried out in the United States and Canada.
For these reasons, we do not consider the testing at slaughter of
every bovine over 20 months of age, or the testing of every bovine at
slaughter, to be scientifically justified or meaningful in the context
of either human or animal health. Making this a criterion for minimal-
risk regions would not contribute to human or animal health protection
beyond the protection
[[Page 476]]
achieved by a statistically and epidemiologically valid surveillance
plan, coupled with the risk mitigations specified in this rule.
B. Recognition of Canada as a Minimal Risk Region
Issue: A number of commenters questioned whether Canada has made
improvements to its systems (e.g., surveillance infrastructure,
surveillance levels, removal of SRMs, feed ban compliance) sufficient
to warrant the resumption of exports of ruminants and ruminant products
to the United States. Other commenters contended that Canada has not
effectively enforced its feed ban and that further investigation and
enforcement is necessary.
Response: Enhancements Canada has made to its surveillance levels
are discussed above in section III. B. under the heading ``Additional
Measures Taken in Canada'' (Ref 16). Additionally, Canada has added a
rapid test as a routine screening tool and has expanded the number of
laboratories approved to run BSE tests. These steps should shorten the
interval between collection of samples and diagnosis. In July 2003, the
Canadian Government issued requirements for the removal,
identification, control, and disposition of SRMs (Ref 15). The Canadian
SRM requirements for products eligible for importation into the United
States are equivalent to requirements in the United States.
Based on the information available to us, including communication
with and visits to Canada, we have concluded that Canada has
effectively enforced its feed ban. Canada implemented a feed ban in
1997 that prohibits the feeding of most mammalian protein to ruminants.
The Canadian feed ban is essentially the same as the feed ban in place
in the United States. Canadian Government authorities inspect rendering
facilities, feed manufacturers, and feed retailers to ensure compliance
with the feed ban. Procedures to reduce the likelihood of cross-
contamination are in place at all feed mills that handle both
prohibited and nonprohibited feeds. As discussed below under the
heading ``Prevalence of BSE in Canada,'' CFIA indicates that compliance
with the feed ban is very high.
Issue: Several commenters expressed concern about the 4 months that
passed between the death of the BSE-infected Canadian cow in January
2003 and the diagnosis of BSE in May 2003. The commenters stated that
this delay in diagnosis indicates that disease surveillance and
laboratory disease diagnostic capabilities in Canada are not equal to
those in the United States.
Response: It is true that the May 2003 case of BSE in Canada was
not confirmed until 4 months after the death of the animal. This delay
was due to a combination of factors, primarily the fact that the sample
was not identified as ``suspect'' for BSE. Samples were taken from the
cow at slaughter because it was non-ambulatory. The animal passed ante-
mortem inspection but was condemned on post-mortem inspection for
pneumonia. Because the cow did not display classic clinical signs of
BSE, samples were tested as they would be for any routine surveillance
sample. Also, because the sample was identified as part of routine
surveillance, the laboratory did not place a high priority on it for
testing. In order to address the delay, Canada has changed its
surveillance approach, primarily by using rapid screening tests for
BSE. We consider BSE surveillance and diagnostic capabilities in Canada
to be equivalent to and as effective as those in the United States.
Issue: One of the standards we proposed for qualification as a BSE
minimal-risk region was that a region conduct surveillance for BSE at
levels that meet or exceed OIE guidelines. One commenter objected to
that standard with regard to Canada, stating OIE surveillance
recommendations are intended for countries that have not diagnosed a
case of BSE in native cattle. A number of commenters stated that Canada
should not be considered a BSE minimal-risk region until that country
increases its surveillance levels for BSE, so that the disease
situation in Canada is better understood. Some commenters raised
concerns that Canada's proposed level of testing was much lower than
what the United States has proposed for U.S. testing. One commenter
recommended that a surveillance program test all high-risk cattle in
Canada during a period of at least 12 to 18 months.
Response: The commenter's suggestion that OIE surveillance
recommendations are intended for countries that have not diagnosed a
case of BSE in native cattle is incorrect. The OIE testing guidelines
apply to any country or zone, whether or not BSE has been diagnosed in
a native animal. As discussed above, Canada has an adult cattle
population of approximately 5.5 million cattle older than 24 months of
age. The current OIE Code, Appendix 3.8.4, references adult cattle
populations as those greater than 30 months and recommends examining at
least 300 samples per year from high-risk animals in a country with an
adult cattle population of 5 million, or 336 samples per year in a
country with an adult cattle population of 7 million. Even though the
adult cattle population in Canada is defined as greater than 24 months
of age and OIE defines it as greater than 30 months of age, Canada has
met or exceeded this level of surveillance for the past 7 years, thus
exceeding the OIE guidelines. Additionally, OIE recommends sampling of
target cattle that display clinical signs compatible with BSE and
cattle that have died or been killed for reasons other than routine
slaughter. Canada again exceeds OIE guidelines by conducting active
targeted surveillance that, in addition to sampling animals that
display clinical signs that could be considered consistent with BSE,
includes sampling animals with risk factors for BSE.
Also, in May 2004, the Canadian Government initiated enhancements
of its BSE surveillance program. This enhanced surveillance program
focuses on determining a maximum prevalence of BSE in Canada and will
allow the Canadian Government to improve further, if necessary, the
effectiveness of Canada's BSE risk management measures. Under the plan,
Canada is progressively increasing the number of animals tested
annually to be able to detect BSE at a level as low as 1 in 1 million
animals. During 2004, through December 1, a total of more than 15,800
samples had been obtained. Testing may reach 30,000 animals in 2005.
This level of testing represents a significant increase over previous
testing levels; surveillance levels in Canada have increased to current
levels from under 500 animals per year in 1996. Canada's testing
program, like that in the United States, focuses on those animals most
at risk of BSE. Because the cattle population in Canada is much smaller
than the cattle population in the United States, Canada does not need
to test the same number of animals as the United States (where testing
of over 200,000 animals has been announced) to reach high levels.
Surveillance testing of 30,000 animals in Canada is equivalent to the
U.S. target of sampling 240,000 to 300,000 animals. With the import
requirements APHIS is establishing for live animals and products from
Canada, there is simply no scientific basis to wait until Canada has
completed 12 to 18 months of enhanced surveillance before allowing
imports from that country.
Issue: In the preamble to our proposed rule, we discussed the
epidemiological investigation that Canada conducted after the diagnosis
of a BSE-infected cow in Canada in May 2003. Among other things, the
investigation focused on rendered material or feed that could
[[Page 477]]
have been derived from the carcass of the infected cow. CFIA traced the
potential movement of material from the infected cow to rendering
facilities and then to feed mills and determined that the risk of the
material having been mislabeled as ruminant feed was extremely low. As
noted below under the heading ``Other Comments Related to the Risk
Basis for the Rule,'' as part of that investigation, a survey was
conducted of approximately 1,800 sites that were at some risk of having
received such rendered material or feed. The survey suggested that 99
percent of the sites surveyed experienced either no exposure of cattle
to the feed (96 percent of the sites) or only incidental exposure (3
percent of the sites). We stated in our proposal that the remaining 1
percent represented limited exposures, such as cattle breaking into
feed piles, sheep reaching through a fence to access feed, and a goat
with possible access to a feed bag. One commenter recommended that all
cattle that were part of the 1 percent limited exposures be slaughtered
before Canada is classified as a BSE minimal-risk region.
Response: As discussed above, depopulation of Canadian herds
possibly exposed to the feed or in question was carried out by the
Canadian Government, which conducted a wide-ranging investigation of
possible exposure to the feed in question and carried out depopulation
of Canadian herds possibly exposed to the feed. On each of those farms
where the investigation could not rule out the possibility of exposure
to feed that may have contained rendered protein from the infected
animal, the herds were slaughtered and tested, in each case with
negative results.
Issue: One commenter asked whether APHIS consulted with or sought
the opinion of leading international scientific experts with regard to
the proposed mitigation measures and, if so, whether those experts
considered those risk mitigation measures adequate.
Response: The risk mitigation measures in this rulemaking are
equivalent to those measures considered appropriate by the OIE, which
are guidelines developed by teams of international veterinary and other
scientific experts. Additionally, following the diagnosis of BSE in
Canada in May 2003, a review team of international experts evaluated
the situation and reported favorably on the measures being taken in
that country with regard to BSE. Those measures are equivalent to those
set forth in this rulemaking.
Issue: One commenter asked whether the epidemiological
investigation conducted by Canada following the diagnosis of BSE in May
2003 was the only information from Canada used in developing the
proposed rule.
Response: As we note above, APHIS was able to effectively evaluate
the animal disease situation in Canada and risk mitigation measures
taken by that country based on information such as the 2002 Canadian
assessment of BSE risk in that country, the epidemiological
investigation that Canada conducted following the diagnose of BSE in
Canada in May 2003, and on continuing exchanges on multiple animal
health issues, as well as on a long history of trade with Canada and
close and continued interaction and communication with Canadian
authorities. As discussed above in section II. C., under the heading
``Update to APHIS'' Risk Analysis and Summary of Mitigation Measures
and Their Applicability to Canada as a BSE Minimal-Risk Region,'' APHIS
has developed an update to the risk analysis that APHIS conducted for
the November 2003 proposed rule. The update elaborates on the available
scientific information and on the analysis supporting the rule. It is
also designed to make the process APHIS followed in evaluating the risk
of imports from Canada more transparent (Ref 21).
C. Risk Mitigation Measures for Importation of Ruminants
How the Rule Applies to Camelids, Cervids, Bison, and Water Buffalo
Alpacas and Other Camelids
Issue: In Sec. 93.436 of our proposed rule, we provided that the
importation of any ruminant from a BSE minimal-risk region would be
prohibited unless the animal met the conditions we proposed for various
types of live ruminants from the region. The types of ruminants for
which we provided import conditions in Sec. 93.436 were bovines,
ovines (sheep and goats), and cervids (e.g., deer, elk). The proposed
provisions did not include conditions for the importation of camelids
(llamas, alpacas, guanacos, and vicunas).
A number of commenters stated that prohibiting the importation of
camelids because of BSE was not justifiable. The commenters cited a
number of reasons why camelids should be allowed importation from BSE
minimal-risk regions, including, said the commenters, the following:
Camelids are physiologically distinct from ruminants and
are not true ruminants. For instance, camelids have a three-compartment
stomach, whereas other animals considered ruminants have a four-
compartment stomach;
Camelids are traditionally used for fiber, recreation, and
show, rather than for food;
Purebred registries for camelids ensure the animals'
health and identification;
Camelids are not fed high-protein feeds;
Camelids are resistant to the BSE agent and do not
transmit the disease to other camelids or any other species; and, in
fact, no camelid has been diagnosed with a TSE;
Prohibiting camelids from a BSE minimal-risk region would
not be consistent with OIE guidelines, both because the OIE guidelines
on BSE relate only to bovines, and because OIE recommends that an
importing country not be more trade-restrictive than necessary to
achieve the desired level of protection.
Other commenters recommended ways of tracking the location of
camelids in the United States if they were allowed importation from BSE
minimal-risk regions. One commenter requested that camelids that had
been exported from the United States to Canada for breeding purposes
before the May 2003 diagnosis of BSE in Canada be allowed to be
returned to their original U.S. premises.
Response: Although we agree that taxonomic differences exist
between camelids and ruminants such as cattle, sheep, and goats, we do
not consider those differences to be sufficient to exclude camelids
from being regulated as ruminants with regard to most diseases of
concern. Regardless of their taxonomic classification, camelids meet
the definition of ruminants and are susceptible to ruminant diseases,
including foot-and-mouth disease and tuberculosis. However, with regard
to BSE, we agree it is not necessary to prohibit the importation of
camelids from minimal-risk regions. Although we recognize there are
unknowns with regard to susceptibility to BSE, given the mitigation
measures that must be in place for a region to be recognized as minimal
risk for BSE, and the facts that there have been no diagnosed cases of
BSE in camelids and that camelids are not typically fed ruminant
byproducts, we agree it would be highly unlikely BSE would be
introduced into the United States through the importation of camelids
from BSE minimal-risk regions.
Therefore, in this final rule, we are providing in Sec. 93.436(f)
that camelids from a BSE minimal-risk region may be imported into the
United States without any restrictions related to BSE. However, such
animals will continue to be subject to all other applicable import
[[Page 478]]
requirements in part 93, subpart D, for ruminants imported into the
United States. We are also amending Sec. 93.400 of the regulations to
add a definition of camelid to mean all species in the family
Camelidae, including camels, llamas, alpacas, guanacos, and vicunas.
Issue: One commenter questioned why we proposed restricting the
importation of alpacas because of BSE but not the importation of mink,
felines, and mice, which are also susceptible to certain TSEs. Another
commenter questioned why the restrictions regarding BSE in the
regulations apply only to four-stomached animals, despite the fact that
certain single-stomached animals have been be shown to be susceptible
to BSE and that certain other animals, such as horses, also eat animal
byproducts. One commenter asked whether the occurrence of the disease
in single-stomached animals suggests that the root cause of BSE may be
the environment and that the disease has not been adequately defined.
Response: Although BSE belongs to the family of diseases known as
TSEs, and certain species other than those classified as ruminants have
been known to be infected with some form of TSE, natural infections of
BSE have been confirmed only in cattle, other bovines, some zoo animals
including exotic felines, and domestic cats. Experimental infections of
BSE can be induced in certain other species, such as mice and sheep.
Animals that have been experimentally inoculated with BSE are
prohibited entry into the United States except for entry under permit
for research. Zoological animals are restricted to entry under permit
to recognized zoological parks. Research indicates that BSE spreads
primarily through the ingestion of ruminant feed containing protein and
other products from ruminants infected with BSE. Because domestic
felines (1) are rarely infected with BSE, even in BSE high-risk
regions, (2) are generally not rendered for animal feed, and, (3) if
rendered, are precluded from ruminant feed by the FDA feed ban, the
importation of domestic felines from BSE-affected regions is not
considered a significant risk. We do not have any evidence to suggest
that it is necessary to establish prohibitions or restrictions on the
importation of non-ruminant animals because of BSE.
Cervids
Issue: In our proposed rule, we included provisions for the
importation of live cervids from a BSE minimal-risk region, but only if
such cervids were to be moved directly to slaughter in the United
States and met other conditions, including that the cervids not be
known to have been fed ruminant protein, other than milk protein,
during their lifetime. One commenter stated that it would be impossible
to verify the feeding practices for cervids. Conversely, a number of
commenters stated that our proposed provisions regarding cervids were
too stringent. A number of commenters stated that live cervids should
be allowed importation for any reason from BSE minimal-risk regions.
Several pointed out that BSE has not been identified in cervids.
Several commenters recommended specific conditions for the importation
of live cervids for any reason from a BSE minimal-risk region. One
recommended that the cervids be farmed animals originating from herds
that have participated for at least 3 years in a CWD surveillance
program. Another commenter recommended that it be required that the
cervids were born after implementation of the required feed ban, were
not known to have been fed ruminant proteins prohibited under the feed
ban, are identified by permanent identification enabling tracing of the
animal back to the herd and dam of origin, and were members of a herd
that participates in a TSE surveillance program and that is not known
to have been affected with a TSE.
Response: In this final rule, we are not including restrictions on
the importation of cervids from a BSE minimal-risk region for reasons
relating to BSE. The import restrictions we proposed took a
conservative approach in that they were based on evidence of cervid
susceptibility to CWD, rather than susceptibility to BSE. We
extrapolated from CWD susceptibility of cervids to predict a
theoretical risk that cervids might also be susceptible to BSE.
However, APHIS, like many of the commenters, is aware of no
epidemiological data indicating cervids are naturally susceptible to
the BSE agent. Published observations indicate that, during the height
of the BSE outbreak in 1992 and 1993 in the United Kingdom, exotic
ruminants of the Bovidae family in zoos were affected with BSE, while
cervids, which are members of the Cervidae family, were not (Ref 22).
Therefore, even in regions that have high levels of circulating
infectivity and that should be considered high risk for BSE, BSE
susceptibility in cervids was not observed.
Although specific challenge studies have not been conducted to
evaluate the experimental infectivity of BSE in cervids, natural
infection has not been observed. At least some of the certification
requirements for cervids in the proposed rule were focused on TSEs in
general rather than BSE specifically. For example, the proposed
requirements included certification that the cervids had been members
of a herd that was subject to TSE surveillance and that was not known
to be infected with or exposed to a TSE. Upon reconsideration, APHIS
concluded that restrictions relating to general TSE-related factors in
the absence of demonstrated BSE in cervids would be outside the scope
of this regulation, which was intended to focus on BSE.
In addition, it should be noted that Canada, as a BSE minimal-risk
region, is not likely to have high circulating levels of the infectious
agent. Since no infected cervids were observed in captive zoo cervids
(unlike in other bovine species) in the United Kingdom at a time when
there were high levels of circulating infectivity, it is unlikely that
infected cervids will be detected in a BSE minimal-risk region.
Therefore, the available information suggests that importation of
cervids from Canada does not pose a risk of importing BSE into the
United States.
APHIS considers these observations to be evidence suggesting that
cervids from BSE minimal-risk regions should not be restricted for BSE,
even in view of the fact that no controlled studies have been conducted
on cervid susceptibility to BSE. Although APHIS is not restricting
cervids for BSE, it will maintain requirements related to cervids for
other diseases, including CWD. General surveillance for CWD will detect
any TSE exposure, thus providing additional assurances.
We are adding a definition of cervid to Sec. 93.400 to mean all
members of the family Cervidae and hybrids, including deer, elk, moose,
caribou, reindeer, and related species. This definition is the same as
the definition of cervid used in 9 CFR part 55 with regard to CWD.
Additionally, we are amending the definition of cervid in Sec. 94.0 to
also be consistent with the definition in Sec. 55.1.
Issue: One commenter recommended that the regulations require that
all cervids imported into the United States from Canada be tested for
TSEs such as CWD.
Response: We are making no changes based on the comment. There is
no evidence that cervids affected with CWD pose a risk for BSE and we
do not consider such testing warranted.
Bison and Water Buffalo
Issue: Many of the provisions in our proposed rule had to do with
the importation of bovines and bovine products from a BSE minimal-risk
region. Several commenters asked that
[[Page 479]]
the regulations include a definition of bovine and that such a
definition make it clear whether ``bovine'' includes bison and water
buffalo.
Response: We are adding a definition of bovine to the definitions
in Sec. Sec. 93.400, 94.0, and 95.1 to mean Bos taurus (domestic
cattle), Bos indicus (zebu cattle), and Bison bison (American bison).
These types of bovines were those for which our risk assessment
determined whether the proposed risk mitigation measures would be
appropriate. Water buffalo may not be imported into the United States
under this rule.
Issue: Several commenters recommended that the restrictions and
prohibitions for bovines in this rule not apply to bison because of
husbandry and feeding practices within the bison industry. At the
least, said the commenters, bison should be allowed entry into the
United States from Canada if they were born after the required feed ban
and were fed no ruminant protein. The commenters stated that, among
other factors, there has never been a reported case of BSE in bison in
North America, farmed bison are not fed high-levels of protein and are
not fed animal byproducts under industry association codes, and bison
in Canada have been under a disease surveillance program since 1992.
Response: We are making no changes based on these comments. The
reference to bovines in the proposed rule included bison. As such, live
bison may be imported from BSE minimal-risk regions subject to the same
conditions as other bovines. Published information from the United
Kingdom (Ref 22) indicates that, along with other bovines, bison are
susceptible to BSE. Because such susceptibility has been demonstrated,
we do not consider it prudent to assume that voluntary industry
practices will be sufficient safeguards against the disease.
Issue: Another commenter wanted to eliminate obstacles to importing
wood bison from Canada for conservation and restoration projects in
Alaska.
Response: We will consider this comment in developing our planned
rulemaking regarding the importation from BSE minimal-risk regions of
live bovines other than those addressed in our November 2003 proposed
rule.
Identification of Bovines, Sheep, and Goats From BSE Minimal-Risk
Regions
Issue: In Sec. 93.436(b)(3) and (d)(3) of our proposed rule, we
included the requirement that for bovines, sheep, and goats imported
from a BSE minimal-risk region for feeding and then slaughter, the
inside of one ear on each animal be permanently and legibly tattooed
with letters identifying the exporting country, and that animals
exported from Canada be tattooed with the letters ``CAN.'' Several
commenters said tattoos were not sufficient to permanently identify
animals because such markings can become illegible over time and cannot
be effectively monitored without restraining the animal. Other
commenters stated that ear tattoos can be obscured by dirt and hair,
are not readily visible--particularly on animals with dark-skinned
ears--and are difficult to apply under winter conditions. A number of
commenters recommended that identification of country of origin by hot
iron branding be required for cattle imported for feeding from BSE
minimal-risk regions.
Response: We agree that tattoos might not provide effective,
readily visible, permanent identification of the country of origin of
bovines. Therefore, we are requiring in Sec. 93.436(b)(3) that bovines
imported for feeding and then slaughter from a BSE minimal-risk region
be permanently and humanely identified before arrival at the port of
entry with a distinct and legible mark identifying the exporting
country, properly applied with a freeze brand, hot iron, or other
method, and easily visible on the live animal and on the carcass prior
to skinning, unless the bovine is imported for immediate slaughter in
accordance with Sec. 93.429. The mark must not be less than 2 inches
or more than 3 inches high, and must be applied to each animal's right
hip, high on the tail-head (over the junction of the sacral and first
cocygeal vertebrae). Animals exported from Canada must be so marked
with ``CAN''.
We are also requiring in this final rule that a brand or other
specified form of permanent identification be used to mark sheep and
goats that are imported for feeding and then slaughter. We are
providing in Sec. 93.419(d)(1) that sheep and goats imported for
feeding and then slaughter from a BSE minimal-risk region be
permanently identified before arrival at the port of entry. We will
require humane identification with a distinct, permanent, and legible
mark identifying the exporting country, properly applied with a freeze
brand, hot iron, or other method before arrival at the port of entry,
and easily visible on the live animal and on the carcass prior to
skinning. The mark must be not less than 1 inch or more than 1\1/4\
inches high. In all cases, the permanent identification must identify
the country of export. Animals exported from Canada must be so marked
with ``C''.
Additionally, we are providing that other means of permanent
identification may be used upon request if deemed by the APHIS
Administrator as adequate to humanely identify the animal in a distinct
and legible way as having been imported from the BSE minimal-risk
region.
Issue: One commenter recommended that the regulations provide that
cattle requiring the identifying mark be branded on the left cheek.
Response: Although we agree that branding should be required for
cattle imported for feeding from a BSE minimal-risk region, we disagree
it is necessary to require that the brand be applied to the cheek of
the animal. Facial branding is more stressful for cattle than branding
the hind quarters. We consider a brand on the right hip to be adequate
for quick identification of the animal as an export from a BSE minimal-
risk region.
Issue: Several commenters recommended that all live cattle that
have been imported into the United States from Canada be permanently
identified with a hot iron brand.
Response: We do not consider the action requested by the commenters
necessary. Canada, like the United States, was proactive in
implementing a BSE prevention program. Canada has had a ruminant feed
regulation in place since 1997. Canada prohibited the importation of
live cattle from the United Kingdom and the Republic of Ireland
starting in 1990, and subsequently applied the same prohibitions to
additional countries as those countries identified native cases of BSE.
In 1996, Canada made this policy even more restrictive and prohibited
the importation of live ruminants from any country that had not been
recognized as free of BSE. Canada has also conducted surveillance in
high-risk cattle to monitor the effectiveness of these measures. The
combination of these factors makes Canadian-origin cattle currently
located in the United States a very low risk for infection with BSE
and, in combination with the safeguards in place in the United States,
makes them very unlikely to cause the amplification of BSE in U.S.
cattle or pose a health risk to U.S. consumers.
The identification recommended by the commenters would require the
use of significant resources of time, personnel, and funding, and would
provide in return information that is of minimal value. The question
that must be answered is whether BSE is present in the U.S. cattle
population. This can be done only through the extensive targeted
surveillance program underway in the United States. Canadian-origin
animals will be included in targeted
[[Page 480]]
surveillance efforts being carried out in this country. Attempting to
track Canadian imports--animals that are not contributing significantly
to increased risk at this time--will serve only to draw resources away
from the targeted surveillance efforts.
Issue: One commenter recommended that the regulations require that
cattle imported from a BSE minimal-risk region for immediate slaughter
be electronically identified as part of a recognized national system.
Response: We are making no changes based on this comment. We
consider the sealing requirements for the means of conveyance
transporting the animals adequate to ensure immediate slaughter of the
animals.
Issue: One commenter stated that the requirement for permanently
identifying sheep and goats probably violates international agreements
that forbid a country from applying health or food safety standards to
foreign products that are not met by domestically produced products.
The commenter stated that, because the BSE statuses of Canada and
United States are now similar, similar standards should be adopted.
Response: We are making no changes based on the comment. BSE has
been detected in two cows indigenous to Canada, whereas a BSE-infected
animal indigenous to the United States has not be detected to date. The
domestic animal health regulations that govern interstate movement in
the United States are based on differences in disease status among
States. Because the United States makes no distinctions among States
with regard to BSE, a tattoo requirement would be meaningless for
interstate movements.
Issue: One commenter recommended that permanent marking with a
brand or tattoo be required for all livestock imported into the United
States, unless the animals are moved in a sealed conveyance to
immediate slaughter.
Response: We do not consider it necessary to apply the permanent
marking requirements of this rule to all livestock imported into the
United States. The purpose of the branding requirement in this rule for
cattle, sheep, and goats is to allow for quick and easy identification
of the animals as having been imported from a BSE minimal-risk region,
not to track the animals.
Issue: A number of commenters recommended that, to be able to more
effectively maintain identity of animals imported from a BSE minimal-
risk region for feeding and then slaughter, and to be able to trace the
animals back to the premises of origin, some form of individual
identification should be required, such as an eartag. Some commenters
stated that the identification should allow for tracing back to the
animal's dam.
Response: We agree that it is important to be able to trace cattle,
sheep, and goats that are imported from a BSE minimal-risk region for
feeding and then slaughter back to the animals' premises of origin, and
concur that an eartag can be an effective method of individual animal
identification. Therefore, we are requiring in Sec. 93.436(b)(4) for
bovines and in Sec. 93.419(d)(2) for sheep and goats that an eartag of
the country of origin that is determined by the Administrator to meet
the standards for official eartags in the United States and to be
traceable to the premises of origin (which we are defining in Sec.
93.400 as the premises where the animal was born) be applied to
bovines, sheep, and goats imported for feeding and then slaughter,
before the animals' entry into the United States. We do not, however,
consider it necessary to require that the eartag make it possible to
trace the animal back to its dam. If an infected animal is diagnosed,
epidemiological investigation and, if necessary, depopulation will
involve all animals of potential concern in the herd of origin.
Issue: Several commenters recommended that we require maintenance
of individual identification of imported animals throughout the
lifetime of each animal.
Response: We agree that removal of the animal's individual
identification would prevent USDA from reconciling the required APHIS
movement forms to confirm that all animals are slaughtered as required.
Therefore we are requiring in Sec. 93.436(b)(4) for feeder bovines,
and Sec. 93.419(d)(2) for feeder sheep and goats, that no person may
alter, deface, remove, or otherwise tamper with the individual
identification placed on each animal that is in the United States or
moving into or through the United States and that such identification
may be removed only at slaughter.
Issue: One commenter recommended that APHIS require electronic
identification for cattle, sheep, and goats, in addition to the
permanent identification.
Response: As discussed above, we are requiring individual
identification of bovines, sheep, and goats imported from BSE minimal-
risk regions for feeding and then slaughter. However, the national
animal identification plan announced by the Secretary of Agriculture on
March 15, 2004, does not mandate the use of any particular technology,
including electronic identification, and we are not requiring that the
individual identification under this rule be electronic. Further, there
is little infrastructure for reading electronic identification devices
in the United States. Therefore, individual identifications would still
require visual reading.
Issue: One commenter recommended that, for bovines less than 30
months of age, we require eartags that allow traceback to the producer
of origin with verification for ownership history, movement history,
and compliance with the ruminant feed ban. This commenter and other
commenters recommended that we require that the eartags be a form of
electronic identification.
Response: As we discussed above for cattle imported into the United
States from a BSE minimal-risk region for feeding and then slaughter,
we are requiring that an official eartag of the country of origin that
is determined by the Administrator to meet the standards for official
eartags in the United States and to be traceable to the premises of
origin be applied to the animal before its entry into the United
States. With regard to cattle from Canada, since January 1, 2001,
Canada has required all cattle to be identified with machine-readable
eartags (radio frequency identification or bar coded) that would allow
them to be traced to their herd of origin within Canada. With regard to
verification of feed ban compliance, this rule requires that such
verification accompany cattle exported to the United States in the form
of a certificate issued either by a full-time salaried veterinary
officer of the national government of the region of origin, or by a
veterinarian designated or accredited by the national government of the
region of origin and endorsed by a full-time salaried veterinary
officer of the national government of the region of origin. We do not
consider it necessary or practical for the individual animal
identification to also be a means of verifying individual on-farm
compliance with the feed ban regulations. As discussed above, we also
do not consider it practical at this time to require that the
identification be electronic, due to the fact that such identification
would require availability and general use of readers, which is
currently not the case.
Issue: Several commenters requested that the proposed requirement
for an ear tattoo be replaced in the case of bison with a requirement
for an electronic eartag.
Response: As discussed above, we agree with the need for an eartag
as a means of tracing animals to their premises of origin. However, we
consider it necessary that the animal also be marked in some permanent
and
[[Page 481]]
easily visible way as having been imported from a BSE minimal-risk
region. In the case of bison from Canada, this would be a brand or
other permanent ``CAN'' mark on the right hip. The hip brand is
necessary so that bovines from a BSE minimal-risk region that are not
imported for immediate slaughter can be easily identified as such in
feedlots and at slaughter or if they are illegally diverted from the
feeder/slaughter chain. The purpose of the mark is to provide permanent
identification and eartags cannot be relied upon to be permanent
identification.
Issue: Several commenters recommended that APHIS allow the use of
forms of individual identification other than those specified in the
regulations, provided such means of identification are deemed
acceptable by the APHIS Administrator. One commenter stated that APHIS
should not limit the use of acceptable technologies to identify animals
from BSE minimal-risk regions. Instead, APHIS should establish
standards for animal identification and traceability systems.
Response: We agree that there may be acceptable means of
identifying animals in addition to those we are specifying and, as
stated above, have provided for approval by the Administrator of other
adequate means of identification. At this time, U.S. standards for
animal identification and traceability are under development and will
be made available for public comment in future rulemaking.
Issue: One commenter stated that we should allow retinal vascular
imaging as a form of animal identification.
Response: At this time, we do not consider retinal scanning alone
to provide adequate identification of animals because the scans cannot
be performed more than a few hours after death. Due to tissue
deterioration, it is extremely difficult to obtain a valid scan.
Movement to Feedlots and Then to Slaughter
Issue: We proposed to require that bovines, sheep, and goats
imported from a BSE minimal-risk region for feeding and then slaughter
be moved directly from the port of entry to a designated feedlot. We
proposed to define designated feedlot in Sec. 93.400 as ``a feedlot
indicated on the declaration required under Sec. 93.407 as the
destination of the ruminants imported into the United States.''
Paragraph (b) of Sec. 93.407 requires presentation by the importer of
a declaration for imported ruminants that includes, among other
information, the name of the person to whom the ruminants will be
delivered and the location of the place to which such delivery will be
made. Several commenters asked how APHIS will verify that imported
cattle moved to a feedlot were not moved from the feedlot other than to
slaughter. Many commenters requested that the regulations include
criteria for approval of a feedlot as a designated feedlot. A number of
commenters recommended specific criteria for such approval.
Response: Based on these comments, we consider it necessary to
clarify our intent as to what we meant by a designated feedlot in the
proposal and where and how we are using that term in this final rule.
In this final rule, we are still requiring, as proposed, that
cattle from a BSE minimal-risk region imported into the United States
for feeding and then slaughter (which we refer to as feeder cattle)
must be moved from the port of entry to an identified feedlot, but we
are not calling that feedlot a ``designated feedlot.'' In our proposal,
it was our intent that a feedlot for cattle be ``designated'' only in
the sense that it was identified as the location to which the cattle
would be moved for feeding and then movement to slaughter. We did not
specify criteria for designated feedlots for either cattle or sheep and
goats and did not require that cattle from BSE minimal-risk regions be
segregated from other cattle at feedlots. Because there has been no
demonstrated lateral transmission of BSE from bovine to bovine (the
most likely cause or transmission in bovines appears to be through
ingestion of infected ruminant protein), we considered it sufficient to
ensure that the imported cattle be clearly marked as to country of
origin.
FSIS's January 2004 SRM rule, discussed above under the heading
``Measures Implemented by FSIS,'' which requires that SRMs be removed
from all cattle at slaughter--both from cattle born and raised in the
United States and from imported cattle--further supports the conclusion
that it is not necessary to require segregation of imported feeder
cattle from U.S. feeder cattle while at a feedlot before slaughter.
Individual identification, permanent marking indicating the country of
origin, and movement only under an APHIS-issued movement permit (the
physical destination of the cattle must be identified on all documents
described in Sec. 93.407 and on APHIS Form VS 17-130) will allow
monitoring and tracking of the imported cattle as they move from the
port of entry to the identified feedlot and then to a recognized
slaughtering establishment. This process is as follows.
Movement of cattle to feedlots and then to slaughter. Means of
conveyance containing cattle for feeding and then slaughter will be
presented to an APHIS port veterinarian at a border port listed in
Sec. 93.403(b) or as provided in Sec. 93.403(f). These cattle must be
accompanied by the health certificate from the region of origin (in
this case Canada) that is required under Sec. 93.405. The health
certificate must list the eartag number of each of the animals in the
shipment. Additionally, the animals must be accompanied by the
certification required from the country of origin under Sec.
93.436(b)(5) regarding the age, feeding history, and identification of
the cattle. The means of conveyance must have been sealed in the region
of origin with seals of the national government of the region of
origin. (The requirement for sealing of the vehicle is discussed below
under the heading ``Sealed Means of Conveyance.'')
The APHIS port veterinarian will review the paperwork and inspect
the shipment to ensure that it is being imported in compliance with the
regulations. The APHIS port veterinarian will then complete and sign
APHIS Form VS 17-30, ``Report of Animals, Poultry, or Eggs Offered for
Importation.'' (This is a standard form completed by APHIS port
veterinarians as certification of the inspection and release of animals
offered for importation from any region.) The APHIS port veterinarian
will also complete and sign APHIS VS Form 17-130, ``Permit for Movement
of Restricted Animals,'' which will authorize the movement of the
animals to a feedlot. The APHIS VS Form 17-130, which must identify the
physical location of the feedlot and the individual responsible for the
movement of the animal, must also be signed by the owner or the shipper
of the animals, to certify that the livestock will be delivered to the
consignee without diversion.
The cattle must be moved as a group to the feedlot indicated on the
APHIS VS Form 17-130. When the cattle arrive at the feedlot, the seal
must be broken only by an accredited veterinarian or by a State or USDA
representative or his or her designee. The person breaking the seal
will indicate on the APHIS VS Form 17-130 where and when the animals
were received and the number of animals received, as well as the date
and time the seal was broken. The form will be signed by the person
breaking the seal and a copy sent to the APHIS Area Office or Regional
Office. APHIS or
[[Page 482]]
State officials may spot-check this process at the feedlot. (In this
final rule, we are adding a definition of State representative to the
definitions in Sec. 93.400 to mean a veterinarian or other person
employed in livestock sanitary work of a State or a political
subdivision of a State who is authorized by such State or political
subdivision of a State to perform the function involved under a
memorandum of understanding with APHIS. This definition is consistent
with the definition of State representative as used elsewhere in the
APHIS regulations. Section 93.400 already includes a definition of
accredited veterinarian.)
Once at the feedlot designated on the import documents and the
movement permit, the cattle must remain there until transported to a
recognized slaughtering establishment and must not be moved to
different feedlots, onto range, or to cattle sales. As provided in
Sec. 93.436(b)(4) regarding individual identification by eartag of
each animal, the eartag required under this rule must not be removed
from any of the animals. The feedlot operator must be able to account
for all incoming cattle from BSE minimal-risk regions--those sent to
slaughter and those that die at the feedlot.
When the cattle are to be sent to slaughter, an accredited
veterinarian or a State or USDA employee must complete APHIS VS Form 1-
27 at the feedlot and seal the means of conveyance. The APHIS VS Form
1-27, which must identify the physical location of the recognized
slaughtering establishment and the individual responsible for the
movement of the animal, must also be signed by the owner or the shipper
of the animals, certifying that the livestock will be delivered to the
consignee without diversion. This APHIS Form VS 1-27 must accompany the
cattle to the slaughtering establishment, along with a copy of the
APHIS VS Form 17-130 and the health certificate that accompanied the
animals from the port of entry to the feedlot. Upon arrival of the
means of conveyance at the slaughtering establishment, a USDA
representative will break the seal, complete the APHIS VS Form 1-27,
and return all the paperwork that accompanied the animals to either the
APHIS Area Office or Regional Office. Although we acknowledge that this
process will involve time and costs for the importer and the feedlot
owner, it will provide APHIS with a means of monitoring the movement of
these shipments. However, following implementation of the National
Animal Identification System currently under development, we will
evaluate the effectiveness of tracking these shipments by the national
identification system compared to tracking by means of the documents
required by this rule. In recognition of the possibility that
alternative effective means of monitoring movement may be developed, we
are providing in this final rule that the animals shipped must be
accompanied by the movement documentation described above or other
movement documentation deemed acceptable by the Administrator.
Movement of sheep and goats to feedlots and then to slaughter. The
requirements in this final rule for the movement of feeder sheep and
goats from a BSE minimal-risk region from the port of entry to a
feedlot and then to slaughter are the same as those described above for
the movement of cattle. However, provisions regarding the feedlots
themselves for sheep and goats are more detailed than those for cattle,
due to the fact that transmission of BSE among sheep and goats could
potentially differ from transmission among bovines. In this final rule,
we are using the term ``designated feedlot'' for the feedlot of
destination of the sheep and goats. We discuss the criteria and
rationale for designated feedlots for sheep and goats below under the
heading ``Designated Feedlots for Sheep and Goats.''
Issue: With regard to ruminants moved to a U.S. feedlot and then to
slaughter, one commenter asked whether APHIS or FSIS would verify that
the animals are properly permanently identified.
Response: The accredited veterinarian who issues the APHIS VS Form
1-27 for movement to slaughter will verify that the required
identification is on the animal and record it on the form.
Issue: Several commenters recommended that the regulations require
that means of conveyance carrying livestock from BSE minimal-risk
regions to feedlots (i.e., feeder cattle) in the United States be
sealed at the border. Several commenters questioned why cattle for
immediate slaughter must be moved as a group, but those going to a
designated feedlot will be allowed to be moved to slaughter at varying
times and to different slaughter facilities. The commenters said this
defeats the purpose of control over and traceback of imported animals.
Another recommended that the rule clarify how bovines from BSE minimal-
risk regions sent to designated feedlots will be kept separate from
U.S. bovines. Several commenters expressed concern that the potential
diversion of feeder cattle would result in their being over 30 months
of age when slaughtered. A number of commenters recommended that the
possibility of the diversion of feeder cattle for breeding use could be
eliminated by requiring that feeder cattle from BSE minimal-risk
regions be neutered before importation. Other commenters recommended
that feeder cattle from Canada be required to be moved to quarantined
feedlots.
Response: All of the above comments were in response to our
proposal to allow feeder cattle to be imported from BSE minimal-risk
regions provided they were moved to a designated feedlot as a group,
then were moved directly to slaughter. These comments were made based
on the premise that, to be in accord with the proposed requirements,
Canadian feeder cattle needed to be segregated from U.S. feeder cattle.
However, because of the identification and movement requirements
discussed above and the recent FSIS requirements for the removal of
SRMs from all cattle at slaughter in the United States, we do not
consider it necessary to segregate Canadian and U.S. feeder cattle.
However, as an added safeguard that the animals are moved directly
from the port of entry to a feedlot and from the feedlot to a
recognized slaughtering establishment, we are requiring in this final
rule that means of conveyance carrying feeder cattle from the U.S. port
of entry to a feedlot have been sealed in the region of origin with
seals of the national government of the region of origin. We are
providing that such seals must be broken only at port of entry by the
APHIS port veterinarian or at the feedlot by an accredited veterinarian
or a State or USDA representative or his or her designee. If the seals
are broken by the APHIS port veterinarian at the port of entry, the
means of conveyance must be resealed with seals of the U.S. Government
before being moved to the feedlot. We are also requiring that means of
conveyance carrying cattle from the feedlot to a slaughtering
establishment be sealed with seals of the U.S. Government before
leaving the feedlot.
Issue: One commenter stated that neutered male animals should be
allowed to utilize range resources without having to go directly to
confined feedlots.
Response: This rule requires that the physical location of the
cattle be identified. Because of the inherent difficulties involved in
identifying and gathering those cattle on range that were imported from
a BSE minimal-risk region and must be slaughtered before they are 30
months of age, we are not providing that feeder cattle imported from a
BSE minimal-risk region may be placed on range. They must be put into
[[Page 483]]
the feedlot identified on the APHIS movement permit and other
accompanying documentation to help ensure they are slaughtered in a
timely manner.
Maximum Age of Cattle, Sheep, and Goats Imported From a BSE Minimal-
Risk Region
Issue: APHIS proposed to limit live cattle imported from a BSE
minimal-risk region to those that would be less than 30 months of age
at slaughter. A number of commenters expressed concerns regarding that
maximum age. The commenters stated that, because there have been
multiple detections of BSE in cattle less than 30 months of age in
Europe and Japan, APHIS should decrease the maximum age for imports.
Recommended maximums ranged from 18 to 28 months of age. Several
commenters requested that APHIS more comprehensively state and validate
the scientific basis for determining that cattle in the 20 to 30 month
age range do not present a risk of BSE. Another commenter cited
evidence from Britain that the commenter said indicates some cattle may
be fast incubators of the disease and, therefore, have the potential to
introduce detectable levels of BSE into the food chain. One commenter
expressed concern that, because bulls are routinely slaughtered at 19
to 22 months old, they may be too young to test positive for the
disease, even though those animals may be infected with BSE. One
commenter stated that with prion diseases, the incubation time tends to
become shorter the longer a specific prion has been circulating within
a species.
Response: As discussed in our proposal, pathogenesis studies--where
tissues obtained from orally infected calves were assayed for
infectivity--have illustrated that levels of infectious BSE agent in
certain tissues vary with the age of an animal. Infectivity was not
detected in most tissues in cattle until at least 32 months post-
exposure. The exception to this is the distal ileum (a part of the
intestines), where infectivity was confirmed in the experimentally
infected cattle as early as 6 months post-exposure, and the tonsils,
where infectivity was confirmed at 10 months post-exposure.
Research demonstrates that the incubation period for BSE in cattle
is linked to the infectious dose received--i.e., the larger the
infectious dose received, the shorter the incubation period. While some
cases of BSE have been found in cattle less than 30 months of age,
these are relatively few and have occurred in countries with
significant levels of circulating infectivity (i.e., where infected
ruminants are used for feed for other ruminants, which in turn become
infected).
In our proposal, we set out a list of standards we will use to
evaluate the BSE risk from a region and determine whether it is
appropriate to classify that region as a region of minimal-risk for
BSE. We stated that we would use these standards as a combined and
integrated evaluation tool, basing a BSE minimal-risk classification on
the overall effectiveness of control mechanisms in place (e.g.,
surveillance, import controls, and a ban on the feeding of ruminant
protein to ruminants). Given the low level of circulating infectivity
in minimal-risk regions, we proposed a 30-month age limit for cattle
and proposed that the intestines be removed from those imported cattle.
As discussed already, following the detection of a BSE-positive cow in
Washington State in December 2003, FSIS implemented additional measures
to protect the human food supply in the United States--including a
requirement that SRMs be removed from all cattle--and prohibited the
use of SRMs in human food.
Under these circumstances, we continue to consider 30 months of age
to be the appropriate age threshold for removal of most SRMs. We are
evaluating whether cattle over 30 months of age could be safely
imported into the United States from a BSE minimal-risk region under
the same conditions as younger cattle, since SRM removal is now
standard operating procedure for all cattle 30 months of age and older
that go to slaughter in the United States. However, we are not making a
change with regard to live cattle over 30 months of age in this final
rule, because, as stated in our March 8, 2004, notice, we are currently
evaluating the appropriate approach regarding live cattle other than
those specified in our proposal and intend to address that issue in a
supplemental rulemaking proposal in the Federal Register.
Issue: Several commenters asked why we proposed that live sheep and
goats 12 months of age and older would not be allowed importation into
the United States. One commenter noted that we said in our proposal
that we would allow cattle less than 30 months of age to be imported
from BSE minimal-risk regions because BSE infectivity was not detected
in most tissues in cattle until at least 32-months post-exposure to the
agent. In contrast, said the commenter, although we stated BSE
infectivity has not been demonstrated in most tissues in sheep and
goats until 16 months post-exposure, we proposed to prohibit the
importation of live sheep and goats 12 months of age or older from a
BSE minimal-risk region. The commenter noted that APHIS was
establishing a safety margin of 2 months for cattle (6.25 percent) (32
months/30 months), but 4 months (25 percent) for sheep and goats. The
commenter requested that APHIS provide the scientific basis for
determining whether this distinction is significant.
Response: As noted above, research has indicated that the levels of
infectious agent in certain tissues vary with the age of an animal.
Infectivity in cattle was not detected in most tissues until the animal
was at least 32 months post-exposure. In sheep and goats, infectivity
has not been demonstrated in most tissues until 16 months of age post-
exposure. The 30-month age limit for cattle imported from minimal-risk
regions is accepted internationally in BSE standards set by various
countries and is consistent with OIE guidelines and target surveillance
(Ref 23). We proposed a 12-month age limit for sheep and goats based on
the research regarding infectivity in such animals and, practically
speaking, because 12 months is consistent with the age at which lambs
are generally sent to slaughter.
Issue: Several commenters recommended that, rather than using the
age of an animal as a risk mitigation measure, APHIS should follow OIE
guidelines that allow the movement of cattle born after an effective
feed ban was implemented, provided appropriate risk mitigation measures
are applied during slaughter and processing.
Response: The import conditions proposed by APHIS for importation
of bovines for immediate slaughter from BSE minimal-risk regions
included several restrictions, including both age of the animal and the
requirement that the animal not be known to have been fed ruminant
protein. Those conditions were analyzed together in our risk analysis,
which did not differentiate among the efficacy of the alternative risk
mitigation options. Based on that analysis of risk, we are including
both conditions in this final rule.
Issue: One commenter asked if, since the May 2003 diagnosis of a
BSE infected cow, CFIA has tested a statistically ``responsible''
number of brains of cattle less than 30 months of age in order to state
with confidence that the region does not have younger animals that
would test positive, as has happened in the United Kingdom and Japan.
Response: APHIS published a risk assessment in November 2003 that
discussed the risks and identified
[[Page 484]]
mitigation measures necessary for the import of certain live cattle and
products from minimal-risk countries, and does not consider such
testing on the part of Canada to be necessary before importation of
these commodities. Experience in the United Kingdom and other parts of
Europe in dealing with widespread BSE outbreaks, unlike the limited
number of infections in Canada, has shown that testing cattle that are
non-ambulatory, dead on the farm, or showing clinical signs consistent
with BSE is the method most likely to disclose BSE if it is present in
the cattle population. If BSE is not detected through testing of such
``high-risk'' animals, there is little or no benefit to testing other
cattle populations. It should be noted that CFIA, like APHIS, has
conducted active surveillance since 1992 and implemented an expanded
surveillance program on June 1, 2004. As of December 1, 2004, a total
of more than 15,800 samples had been obtained in Canada, all with
negative results for BSE.
Verification and Enforcement of Age Limits
Issue: For ruminants entering the United States from a BSE minimal-
risk region for immediate slaughter, one commenter recommended that
U.S. border officials and the receiving slaughtering establishment
accept the age verification prepared by accredited Canadian
veterinarians in order to expedite movement of the animals from the
source feedlot to the slaughtering establishment. The commenter stated
that such expeditious movement is important both from an animal welfare
perspective and a product quality perspective. Conversely, another
commenter indicated that USDA veterinarians should have the option of
refusing entry to any cattle that appear to be 30 months of age or
older.
Response: As with the importation of all livestock into the United
States, APHIS port veterinarians will be responsible for assuring that
shipments of animals presented for import fulfill all necessary import
requirements before their release from the border port. However we
agree with the commenter who stated that verification of the animals'
age can be made based on review of the certificate that is required by
this rule to accompany the shipment of live bovines, sheep, and goats
from BSE minimal-risk regions. Further, we agree that verification by
means of the certificate will expedite movement of the animals to their
destination.
Therefore, instead of requiring, as we proposed in Sec.
93.436(a)(4) and (c)(4) for bovines and sheep and goats, respectively,
that means of conveyance that are used to move the animals to immediate
slaughter be sealed with seals of the U.S. Government at the port of
entry, we are requiring in Sec. 93.436(a)(4) for bovines and Sec.
93.420(a) for other ruminants that the means of conveyance be sealed in
the region of origin with seals of the national government of the
region of origin. Such animals will undergo visual inspection by U.S.
inspectors at the port of entry while they are in the means of
conveyance. However, we are also providing in those sections that if
U.S. inspectors at the port of entry consider it necessary to unseal
the means of conveyance, the means of conveyance must be resealed with
seals of the U.S. Government.
Also, as discussed below under the heading ``Sealed Means of
Conveyance,'' we are requiring that bovines, sheep, and goats imported
from a BSE minimal-risk region for movement to a feedlot be moved in a
means of conveyance that is sealed with seals of the national
government of the region of origin. As with animals imported for
immediate slaughter, such animals will undergo visual inspection by
U.S. inspectors at the port of entry while they are in the means of
conveyance and, as with animals imported for immediate slaughter, if
U.S. inspectors at the port of entry consider it necessary to unseal
the means of conveyance, the means of conveyance must be resealed with
seals of the U.S. Government.
Issue: Several commenters stated that determining the age of
animals is not an exact science and that USDA should more clearly set
out how it expects to enforce the 30-month age limit for slaughter.
Response: Under this rule, cattle imported from a BSE minimal-risk
region must be accompanied by certification by an authorized veterinary
representative of the region of origin that the animals entering the
United States are less than 30 months of age. In its January 2004 SRM
rule, FSIS explained that the Agency's inspection program personnel
will confirm the age of cattle, both of U.S. and foreign origin, that
are slaughtered in official establishments, by means of documentation
that identifies the age of the animal and, where necessary, by
examination of the dentition of the animal to determine whether at
least one of the second set of permanent incisors has erupted (the
permanent incisors of cattle erupt from 24 to 30 months of age).
Issue: A number of commenters asked what will be done with imported
feeder cattle if they are determined to be over 30 months of age when
received for slaughter.
Response: If FSIS concludes the animals are 30 months of age or
older, or if it cannot be determined that the animals are less than 30
months of age, all SRMs will be removed, which would include brain and
central nervous system tissue, along with the animal's tonsils and the
distal ileum of the small intestine. FSIS will notify APHIS when such
situations arise and APHIS will initiate enforcement action as
appropriate. As we noted in APHIS'' March 2004 notice reopening the
comment period on the proposed rule, APHIS is currently evaluating the
appropriate approach regarding live cattle 30 months of age and older
and intends to address that issue in a supplemental rulemaking in the
Federal Register. (Please note: Although the wording we used in our
notice did not specifically state the live animals we would evaluate
for potential future rulemaking would be cattle and other animals other
than those already included in the proposal, we consider our intent to
have been clear in the context of the issues discussed in that notice.)
Importation of Cattle Other Than Those Going to Slaughter
Issue: Our proposed rule provided that all ruminants would be
prohibited importation from a BSE minimal-risk region, except for those
imported in accordance with the provisions of the proposed rule. The
only bovines for which conditions for importation were included in the
proposed rule were those being moved either directly to slaughter or to
a designated feedlot for further feeding before slaughter. In both
cases, the proposed provisions limited importation to bovines that
would be less than 30 months of age at slaughter. Similar provisions
were proposed for sheep and goats that would be less than 12 months of
age at slaughter. In effect, this provided for the continued
prohibition on the importation of breeding cattle, sheep, and goats
from Canada that APHIS imposed following the diagnosis of a BSE-
infected cow in that country in May 2003.
Several commenters supported a continued prohibition on the
importation of breeding cattle from Canada. One commenter stated that
such animals should not be allowed into the United States from Canada
until the year 2012, 15 years after the implementation of the feed ban
in that country.
Many commenters, however, stated that the regulations should allow
the importation from a BSE minimal-risk
[[Page 485]]
region of cattle intended for other than immediate slaughter or
slaughter after further feeding. One commenter recommended that APHIS
open the border to breeding stock under 36 months of age. Another
commenter recommended that cattle born after 2000 be allowed
importation. A number of commenters stated that live cattle born after
implementation of the feed ban in the BSE minimal-risk region should be
allowed importation. Others said that cattle that were born before
implementation of the feed ban, but other than in a high-risk area of
the BSE minimal-risk region, should be allowed importation. Several
commenters stated that no importation measures over and above the
exporting country's being a BSE minimal-risk region would be necessary
if the United States requires the removal of all SRMs upon slaughter in
this country.
A number of commenters recommended more specific conditions under
which breeding cattle should be allowed importation from BSE minimal-
risk regions generally or from Canada specifically. One commenter
requested that the importation be allowed for cattle that are
temporarily brought to the United States for livestock expositions.
Some of the other conditions recommended by commenters are the same
ones we proposed to apply to the importation of ``feeder'' or ``fed''
cattle, such as that the animal was born after implementation of the
feed ban and was not known to have been fed prohibited ruminant
protein. In addition, several commenters recommended that the animal
have permanent identification traceable back to the dam and herd of
origin and not be progeny of a BSE suspect or confirmed animal. One
commenter recommended that identification be in the form of an
electronic eartag. Another commenter expressed confidence that breeding
cattle imported from a BSE minimal-risk region could be adequately
monitored using a permit process along with health certification before
importation and by requiring recordkeeping by importers of animal
transfers or disposal, including use in the food chain.
Another commenter requested that the regulations allow the
importation of registered cattle that were born in the United States
and were taken to Canada at least 1 year following implementation of
the ruminant feed ban in Canada, and also their offspring. The
commenter provided suggested means of verifying the origin of the
animal, including a tattoo of the breed registration number and
accompaniment by the animal's registration certificate. Another
commenter requested that U.S. origin cattle that are stranded in Canada
be allowed to return to the United States if accompanied by a
certification by the Government of Canada that, in accordance with
Canada's feed ban, the animals have been not been fed ruminant protein
while in that country.
One commenter recommended that cattle over 30 months of age be
allowed importation if the animals have tested negative for BSE. One
commenter recommended allowing the importation of breeding stock that
are found to be negative to a new BSE test.
One commenter stated that pregnant heifers should be allowed
importation if, after calving in the United States, the heifers are
slaughtered before reaching 30 months of age. One commenter recommended
allowing the importation of breeding cattle under 30 months of age or,
alternatively, donor dams born in the United States and owned by U.S.
producers. At the minimum, stated the commenter, such donor dams should
be eligible to be returned to the herd of the owner, along with
offspring resulting from embryo transfer.
One commenter stated that, because BSE is not transmitted
horizontally, the regulations should allow for the temporary
importation of cattle into the United States for purposes such as
livestock shows and rodeos, breeding, and semen collection, as long as
the animal has permanent identification and tracking is carried out
that the Administrator deems appropriate to ensure that the animal is
returned to its country of origin.
Response: We have carefully reviewed and considered the commenters'
requests to allow the importation of cattle other than cattle less than
30 months of age for immediate slaughter and cattle imported for
feeding and then slaughter at less than 30 months of age. As we stated
in our March 8, 2004, notice, we are currently evaluating the
appropriate approach regarding other live cattle and intend to address
that issue in a separate proposed rule in the Federal Register. We are
taking the information provided by commenters into consideration in
conducting the evaluation. However, at this time, we are making no
changes in this final rule to allow the importation of cattle from BSE
minimal-risk regions other than those for immediate slaughter, or for
feeding then and slaughter, at less than 30 months of age.
There is no BSE test for live animals at this time. The risk
assessment made available by APHIS in conjunction with the November
2003 proposed rule assessed the risk of resuming trade in designated
ruminants and ruminant products from Canada. The analysis was conducted
primarily in the context of feeder animals imported for slaughter.
Special circumstances that might relate to breeding animals were not
addressed. The analysis considered various risk factors associated with
feeder animals for slaughter and mitigations of those risks. The age of
the animal and the effect of a feed ban were two of the most
significant factors. APHIS determined that cattle that are less than 30
months of age are unlikely to have infectious levels of the BSE agent
and that animals born after the feed ban was implemented are unlikely
to have been exposed to the infectious agent. The combination of these
factors caused us to conclude that we could safely import cattle for
feeding and slaughter or for immediate slaughter that (1) were less
than 30 months of age; (2) were subject to a ruminant feed ban; (3)
were imported through designated ports of entry and, if moved directly
to slaughter, were moved in a sealed means of conveyance; (4) were
accompanied from the port of entry to a recognized slaughtering
establishment by VS Form 17-33, or were accompanied by an APHIS Form VS
17-130 for movement to the feedlot designated on the import documents
and by APHIS Form VS 1-27 for movement from the feedlot; (5) were moved
as a group to either a designated feed lot or recognized slaughtering
establishment and (6) had their intestines removed at slaughter.
The assessment did not consider the effects of these risk
mitigation measures individually. Because we did evaluate the
individual effects of these mitigation measures and the fact that we
did not address the special circumstances related to breeding animals
in our risk analysis, at this time we are not providing for the
importation of such animals from BSE minimal-risk regions.
Request for Bans on Imports of Live Animals
Issue: Several commenters expressed concern regarding the
importation of any live cattle from Canada and requested that the
importation of such animals continue to be prohibited. One commenter
questioned how we can be certain that live animals from Canada are not
affected by BSE, given there is currently no method available for
testing live animals for the disease.
Response: We acknowledge there are currently no approved live
animal tests for BSE. However, our comprehensive analysis and
evaluation leads firmly to the conclusion that the conditions specified
in this rule for the importation of ruminants and ruminant products
from BSE minimal-risk regions will be
[[Page 486]]
effective and will protect against the introduction of BSE into the
United States. In our proposal, we set out a list of standards we would
use to evaluate the BSE risk from a region and determine whether it is
appropriate to classify that region as a region of minimal-risk for
BSE. We stated that we would use these standards as a combined and
integrated evaluation tool, basing a BSE minimal-risk classification on
the overall effectiveness of control mechanisms in place (e.g.,
surveillance, import controls, and a ban on the feeding of ruminant
protein to ruminants).
In addition, we proposed individual risk mitigation measures for
specific commodities, including live animals intended for importation
from BSE minimal-risk regions, to further protect against the
introduction and transmission of BSE in the United States. For live
animals, such measures include: Maximum age requirements, movement
restrictions and use within the United States, identification
requirements, and removal of SRMs. As noted, our proposed rule
specified removal of the intestines. However, FSIS has since issued
regulations regarding SRM removal in all cattle slaughtered in the
United States, including the removal of the tonsils and distal ileum in
cattle of any age.
Canada has implemented strong measures to guard against the
introduction, establishment, and spread of BSE among cattle in that
country, to detect infected animals through surveillance, and to
protect the Canadian animal and human food supplies. Among other
things, Canada has taken the following actions: Maintenance of
stringent import restrictions since 1990; prohibition of the
importation of live ruminants and most ruminant products from countries
that have not been recognized as free of BSE; surveillance for BSE
since 1992; implementation of a feed ban in 1997 that prohibits the
feeding of most mammalian protein to ruminants; and extensive
epidemiological investigations after the case of BSE in May 2003 and
the Canadian origin case in Washington State in December 2003. Given
these and other measures taken by Canada (e.g., requirements for
removal of SRMs), and the conditions in this rule for the importation
of ruminants and ruminant products from BSE minimal-risk regions, it is
highly unlikely BSE would be introduced through the importation of live
cattle for immediate slaughter or for feeding and slaughter under this
rule.
Issue: One commenter stated that, because every infected cow in
North America has been a Holstein cow from Canada, APHIS should
specifically prohibit the importation of dairy (in general, Holstein)
cows. Another commenter stated that the differences between the risk
profiles of dairy and beef cattle should be taken into account; that
the feeding practices of dairies are more risky than those used by beef
producers. The commenter requested that APHIS increase BSE testing for
dairy cattle.
Response: We are making no changes based on these comments. (It
should be noted that, contrary to the commenter's statement, the cow
that was diagnosed as BSE-infected in Alberta Canada in May 2003 was a
beef cow and not a Holstein cow.) BSE is spread primarily through the
use of ruminant feed containing protein and other products from
ruminants infected with BSE. In cattle, oral ingestion of feed
contaminated with the BSE is the only documented route of field
transmission of the disease (Ref 24). Although there is no evidence to
indicate that the breed of cattle is a risk factor for BSE, there is
some evidence that the use of BSE-contaminated ruminant protein results
in an increased risk of BSE in dairy cattle compared to beef cattle.
However, this is most likely due to the differences in feeding
practices between dairy and beef producers, because dairy cattle
routinely receive high-protein feeds during milk production. In regions
with an effective feed ban on ruminant protein, the differences in
feeding practices should not significantly increase the level of risk,
given that no ruminant protein is fed to either beef or dairy cattle.
Issue: One commenter stated that APHIS should prohibit the
importation for slaughter of any foreign animal born before the feed
ban that is intended for human consumption or rendering. Another
commenter stated the cattle born in Canada in a high-risk area before
implementation of that country's feed ban should be prohibited
importation.
Response: From the context of the first comment, it appears the
commenter is referring only to the importation of bovines. Practically
speaking, the guidelines of both commenters will be met by the
combination of the required feed ban and the provision limiting the
importation of bovines to those less than 30 months of age.
Importation of Cattle for Subsequent Export of Meat
Issue: One commenter stated that we should allow the importation of
live cattle for slaughter through eastern U.S./Canadian border ports
and allow the meat to be exported to Canada for use at fast food
outlets.
Response: We are making no changes based on the comment. We
consider it necessary to apply the same risk mitigation measures
regarding the importation of cattle from Canada for slaughter
regardless of the intended destination of the meat derived from the
animals. With regard to exportation of beef to Canada, this rule does
not place any restrictions on the export to Canada of meat from cattle
slaughtered in the United States. Those meat commodities that can be
exported to Canada from the United States can be found at http://www.inspection.gc.ca.
Cattle Importations From Any Region
Issue: One commenter stated that all beef cows imported into the
United States from any country should be processed as a group.
Response: Our proposal concerned the importation of live ruminants
and ruminant products from regions that present a minimal risk of
introducing BSE into the United States. Requirements regarding the
importation of beef cows from elsewhere in the world are beyond the
scope of this rulemaking.
Importation of Veal Calves
Issue: Several commenters recommended that veal calves not be
subject to the ban on the importation of live ruminants from Canada
that the United States established in May 2003, because veal calves are
a low-risk commodity due to their diet and their age at slaughter.
Response: Veal calves are eligible for importation into the United
States under this rule.
Basis for Restrictions on Sheep and Goats
Issue: In Sec. 93.436(b) and (c) of our proposed rule, we proposed
to allow the importation of sheep and goats from a BSE minimal-risk
region for either immediate slaughter or for feeding and then
slaughter, provided specified conditions were met. These conditions
included, among others, the requirements that the sheep or goats be
less then 12 months of age when slaughtered and not have been known to
have been fed ruminant protein, other than milk protein, during their
lifetime. Additionally, we proposed to require that sheep and goats
imported for feeding and then slaughter be moved directly from the port
of entry to a designated feedlot and then to slaughter.
A number of commenters recommended that, because the OIE guidelines
do not specifically address
[[Page 487]]
sheep or goats with regard to BSE, the importation of sheep and goats
from BSE minimal-risk regions not be restricted.
Response: We are making no changes based on this comment. Of the
family of TSE diseases, one that has been known to occur naturally in
sheep and goats is scrapie. With regard to sheep and goats and scrapie,
the OIE guidelines recommend that all animal TSEs be considered when
doing a risk assessment for the scrapie status of a country. There is
currently less than complete understanding of the exact nature of TSEs
and, in particular, their capability to cross species lines or adapt to
new species; however, one theory is that BSE originated from scrapie
(Ref 25). The OIE Terrestrial Animal Health Code (the OIE Code)
discourages the importation of breeding animals from countries with
scrapie or risk factors for TSEs in small ruminants, unless the animal
originated from a scrapie-free flock. Because Canada is not free of
TSEs, it is appropriate under the OIE Code to restrict the importation
of breeding sheep and goats from Canada or any region that is not free
of TSEs in sheep and goats or that has not conducted adequate
surveillance to establish freedom. It is also appropriate to establish
measures to prevent the diversion of imported feeder sheep or goats
into breeding flocks in the United States. Since natural scrapie and
the TSE in sheep caused experimentally by the BSE agent can't be
differentiated by current routine diagnostic tests, APHIS intends to
develop proposed rulemaking that would regulate for all TSEs in sheep
and goats in this manner. In order to reestablish trade in low-risk
sheep and goat commodities from BSE minimal-risk regions in a timely
manner, we are addressing sheep and goats imported for immediate
slaughter and for feeding and then slaughter in this rulemaking.
Issue: A number of commenters recommended that breeding, feeder,
and slaughter sheep and/or goats of any age, or feeder sheep and/or
goats of any age be allowed unrestricted entry from a BSE minimum-risk
region. Other commenters recommended that such animals be allowed entry
if they were born after the implementation of a ruminant feed ban in
the region, were not known to have been fed protein prohibited by the
required feed ban, and are permanently identified in such a way that
would allow tracing back to the dam and flock of origin. Several
commenters recommended that breeding sheep and goats under 12 months of
age be allowed importation. One commenter recommended that any sheep
from a scrapie-monitored premises or sheep of any age that have been
genotyped for scrapie resistance be allowed entry into the United
States from a BSE minimal-risk region.
Response: Sheep and goats over 12 months of age, such as breeding
sheep and goats, were addressed in our risk assessment as animals with
the potential to have infectious levels of the BSE agent. We consider
it necessary to require risk mitigation measures to ensure that such
animals do not introduce BSE into the United States. We are currently
evaluating the type of mitigation measures needed to control risks
associated with these animals and may conduct rulemaking in the future
regarding the requirements necessary for the safe importation from BSE
minimal-risk regions of such animals.
Issue: One commenter questioned the advisability of allowing the
importation from BSE minimal-risk regions of live sheep and goats
younger than 12 months of age, stating that BSE infectivity has been
shown to be more widely distributed in sheep tissue than in that of
cattle.
Response: Although the commenter is correct that results from
experimental infections of sheep have shown that the BSE prion is more
widely distributed in sheep tissues than in cattle, infectivity could
not be demonstrated in most tissues until at least 16 months post-
exposure to the agent.
Sheep and Goats and Other TSEs
Issue: Several commenters questioned how the proposed requirements
for the importation of sheep and goats from BSE minimal-risk regions
relate to other sections of APHIS animal import regulations,
particularly those with regard to scrapie, a TSE for which there are
import restrictions in part 93 and for which an eradication program
exists in the United States. One commenter recommended that Canada be
required to implement a country-wide scrapie eradication program
identical to the U.S. system, along with an active surveillance system
that meets or exceeds U.S. criteria and numbers. The commenter stated
that such an eradication and surveillance system would reduce risk and
eventually eradicate scrapie in the Canada, as well as any other
variant TSE expressed in a manner clinically similar to scrapie,
thereby reducing the risk of BSE entering the United States through the
importation of sheep from Canada.
Response: We agree with the commenter that a strong scrapie program
in Canada will mitigate scrapie and possibly BSE risks for the United
States. Historically, the United States has not significantly
restricted the movement of sheep and goats into the United States from
Canada with regard to TSEs because our ongoing bilateral trade
relationship made it likely that our countries shared the same scrapie
types and because both countries have maintained similar control and
eradication programs for scrapie and prevention programs for BSE. Since
the occurrence of BSE in two native Canadian cows, there is a now a
very small risk that Canadian sheep and goats might have been exposed
to BSE in feed and that BSE or a variant scrapie type may have been
transmitted to sheep or goats, and an even more remote risk that BSE or
a variant of BSE has become established through lateral transmission to
other sheep and goats. We note that strong, although not mandatory,
programs exist in Canada for surveillance and certification of sheep
and goats with regard to scrapie. Although the proposed rule did not
address the possible relationship of these programs in Canada to
requirements for importing sheep and goats from minimal-risk regions
for BSE, we consider it appropriate to restrict the importation of
sheep and goats from BSE minimal-risk regions if certain conditions
exist for those animals with regard to BSE or scrapie.
Because of the differing nature of the BSE risk in sheep and goats
as compared to that in bovines, we have reconsidered placing the import
conditions for live sheep and goats from BSE minimal-risk regions in
Sec. 93.436 as proposed (``Ruminants from regions of minimal risk for
BSE''). The parallel construction of that section--two paragraphs
addressing requirements for bovines, followed by two paragraphs
addressing requirements for sheep and goats--may give the impression
that sheep, goats, and bovines all present the same risk profile and
require exactly parallel restrictions. In fact, the risks associated
with importing sheep and goats include a very small risk that some
sheep and goats may have naturally contracted, and might theoretically
laterally spread, BSE or a variant of BSE, and a somewhat larger risk
that sheep and goats affected by scrapie variants may spread these
diseases. The primary risks presented by sheep and goats are related to
scrapie and laterally transmissible variants that may or may not be
related to BSE, not classic BSE.
To correct this erroneous impression, we are moving the
requirements for sheep and goats out of Sec. 93.436 and into other
sections of the CFR that more generally address importation of sheep
and goats (Sec. Sec. 93.419 and 93.420). While these changes will
implement the
[[Page 488]]
requirements necessary for the current situation, because Canada is the
only listed BSE minimal-risk region in Sec. 94.18(a)(3), we will need
to reexamine these changes in the future if other countries are added
to the list.
One of the other changes we are making in this final rule is to
amend Sec. 93.405, which has exempted sheep and goats from Canada that
are not imported for immediate slaughter from restrictions that apply
to sheep and goats from most regions of the world due to scrapie. Under
this final rule, those restrictions will also apply to feeder sheep and
goats from Canada.
We are amending Sec. Sec. 93.419 and 93.420. Under the existing
regulations, Sec. 93.419 has included provisions specifically for the
importation of sheep and goats from Canada, other than those for
immediate slaughter. In this final rule, we are including in Sec.
93.419 most of the conditions for the importation of sheep and goats
from Canada that we set forth in Sec. 93.436 of our proposal. However,
those conditions that apply exclusively to sheep and goats from Canada
for immediate slaughter, as opposed to feeding and then slaughter, we
are including in Sec. 93.420, which currently includes conditions for
the importation of ruminants from Canada for immediate slaughter.
The existing provisions in Sec. 93.420 for the importation of
ruminants from Canada for immediate slaughter require that the
ruminants be consigned from the port of entry directly to a recognized
slaughtering establishment and there be slaughtered within 2 weeks from
the date of entry. Additionally, Sec. 93.420 provides that such
ruminants will be inspected at the port of entry. In this final rule,
we are retaining those provisions in Sec. 93.420 and are adding in
that section the requirements we proposed for sheep and goats from BSE
minimal-risk regions for immediate slaughter that the ruminants be
moved as a group to the slaughtering establishment in sealed means of
conveyance. However, as discussed above under the heading
``Verification and Enforcement of Age Limit of Ruminants,'' we are
requiring that the means of conveyance be sealed in the region of
origin. As we proposed for sheep and goats for immediate slaughter, we
are also specifying that the seals may be broken at the recognized
slaughtering establishment only by a USDA representative. The shipment
must be accompanied from the port of entry to the recognized
slaughtering establishment by APHIS Form VS 17-33, which shall include
the location of the recognized slaughtering establishment. By including
these provisions in Sec. 93.420, they will be applied to sheep, goats,
and other ruminants from Canada. This change to Sec. 93.420 represents
a codification of conditions that APHIS has already been requiring by
policy. (Please note: These same provisions with regard to bovines for
immediate slaughter from BSE minimal-risk regions, including Canada,
are included in Sec. 93.436 as proposed.)
Additionally, we are providing in Sec. 93.420 that sheep and goats
may not be imported from Canada for immediate slaughter if any one of
the following conditions exists:
The animals have tested positive for or are suspect for a
TSE;
The animals have resided in a flock or herd that has been
diagnosed with BSE; or
The animals' movement is restricted within Canada as a
result of exposure to a TSE.
These prohibitions preclude the entry of sheep and goats most
likely to pose a risk for TSE transmission. For the reasons described
above, we are also requiring in Sec. 94.19(c) and (d) of this final
rule that meat, meat byproducts, meat food products, and carcasses of
ovines and caprines from BSE minimal-risk regions not be derived from
animals that were positive, suspect, or susceptible for TSEs. We are
adding definitions of positive for a transmissible spongiform
encephalopathy and suspect for a transmissible spongiform
encephalopathy to Sec. Sec. 93.400 and 94.0.
Designated Feedlots for Sheep and Goats
Issue: One commenter recommended that we include in the regulations
specific criteria for designated feedlots for sheep and goats and
methods and criteria according to which inventory control and
traceability can be achieved once feeder lambs are imported.
Response: Because of the uncertainty regarding BSE infectivity and
transmissibility in sheep and goats, we concur that it is appropriate
to establish criteria for designated feedlots for sheep and goats from
BSE minimal-risk regions to ensure that such animals from are not
commingled with U.S. sheep and goats not going to slaughter or U.S.
sheep and goats older than those eligible for entry from a BSE minimal-
risk region. Scrapie, the best-studied TSE in sheep and goats, is
laterally transmitted from sheep/goats to sheep/goats (most frequently
either through exposure to an infected placenta or placental fluids or
to environments contaminated with these tissues and fluids). Because
experimental BSE in sheep has a tissue distribution that closely mimics
that of scrapie in sheep, it is reasonable to conclude that BSE, if
transmitted to sheep in feed, might be laterally transmitted. Until the
risk of lateral transmission is better defined, we consider it prudent
to ensure that sheep and goats of unknown TSE status are not commingled
with U.S. sheep and goats not being moved to slaughter.
Therefore, in Sec. 93.400, we are adding a definition of
designated feedlot to mean a feedlot that has been designated by the
Administrator as one that is eligible to receive sheep and goats
imported from a BSE minimal-risk region and whose owner or legally
responsible representative has signed an agreement to adhere to, and is
in compliance with, the requirements for a designated feedlot. We are
also adding specific requirements for a designated feedlot to Sec.
93.419, ``Sheep and goats from Canada.'' Under these requirements:
The owner of the designated feedlot or the owner's
representative must monitor sheep and goats entering the feedlot to
insure that all sheep and goats imported from a BSE minimal-risk region
have the required ``C'' brand.
Records must be kept at the feedlot of the acquisition and
disposition of all sheep and goats imported from a BSE minimal-risk
region that enter the feedlot. Such records must include the official
eartag and all other identifying information; the date the animal was
acquired by the feedlot and the animal's age at the time; the date the
animal was shipped to slaughter and the animal's age at the time; and
the plant where the animal was slaughtered. For sheep and goats
imported from a BSE minimal-risk region that die in the feedlot, the
eartag must be removed and be kept on file at the feedlot, along with a
record of the disposition of the carcass.
Copies must be maintained at the feedlot of the VS 17-130
forms that indicate the official identification number of the animal
and that accompany the animal to the feedlot and then to slaughter.
Inventory and other records must be kept at the feedlot
for at least 5 years.
The feedlot must allow inspection by and provide inventory
records to State and Federal animal health officials upon their
request.
Eartags on animals entering the feedlot must not be
removed unless such removal is necessary for medical reasons. In such
cases, and in cases where eartags are otherwise detached from the
animal, an official scrapie program eartag assigned to the feedlot for
this purpose or another form of official identification must be applied
to the animals from which the eartags were
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removed and must be cross-referenced in the designated feedlot's
records to enable matching with the original eartag.
Either the entire feedlot or designated pens within the
lot must be terminal for sheep and goats to be moved directly to
slaughter at less than 12 months of age.
If the inventory cannot be reconciled or if animals are
not moved to slaughter as required, the feedlot's status as a
designated feedlot will be withdrawn by the Administrator.
Distribution of BSE Agent in Goats
Issue: In our proposed rule, we stated that, in the absence of data
regarding distribution of the BSE agent in goats, it is assumed that
such distribution would be similar to distribution of the agent in
sheep tissues. One commenter stated that in the absence of scientific
data such an assumption should not be made.
Response: We disagree. Because distribution of the TSE scrapie is
similar in sheep and goats, we consider it more logical to assume
similarity of potential BSE distribution in sheep and goats than
dissimilarity.
Ovine Embryos and Semen
Issue: One commenter stated that because ovine embryos and semen
have not demonstrated BSE infectivity, they should be allowed
importation from a BSE minimal-risk region.
Response: We are making no changes based on this comment. Under the
existing regulations, semen from sheep and goats is currently not
prohibited importation from regions listed in Sec. 94.18(a) as being
affected with or at undue risk of BSE and will not be prohibited
importation from BSE minimal-risk regions. However, we consider it
necessary to prohibit the importation of ovine and caprine embryos from
BSE minimal-risk regions. No studies have been conducted to date with
regard to the BSE risk of ovine and caprine embryos. In the absence of
an assessment of risk from such materials, we consider it prudent to
continue to prohibit the importation of ovine and caprine embryos from
regions listed in Sec. 94.18(a), which will include, under this rule,
BSE minimal-risk regions.
Determining Age by Break Joint Technique
Issue: One commenter recommended that instead of using less than 12
months as the age of eligibility for sheep imported from a BSE minimal-
risk region, the maximum age for sheep should be determined by the
``break joint'' technique that is used by FSIS to classify lamb.
Response: We are making no changes based on this comment. The break
joint in young lambs and goats is a cartilaginous area of the cannon
bone that is not ossified. This joint ossifies with age to become what
is called a spool joint. The break joint (or spool joint) method for
establishing the maturity of a lamb or goat is not a FSIS regulation,
but is instead contained in a guideline pamphlet published by the
Agricultural Marketing Service (AMS) entitled ``Official United States
Standards for Grades of Slaughter Lambs, Yearlings and Sheep'' (Ref
26). This method was never presented as a truly reliable method for
identifying animals of less than 12 months age, but instead was
intended to provide general marketing methods and practices for
agricultural commodities so that consumers could obtain the quality of
product they desire.
The break joint method is not sufficiently accurate to determine
the age of sheep or goats for the risk mitigation purposes of this
rule. Also, the break joint can not be readily determined in live
animals and is therefore not useful in determining the age of slaughter
sheep. Therefore, we are making no changes based on this comment.
Sealed Conveyances and Movement to Immediate Slaughter
Issue: In Sec. 93.436 of our proposed rule, we included
requirements that bovines, sheep and goats, and cervids imported from a
BSE minimal-risk region for immediate slaughter be moved from the port
of entry to a recognized slaughtering establishment in conveyances
sealed at the port of entry with seals of the U.S. Government. We
proposed, further, that the seals could be broken only at the
recognized slaughtering establishment by a USDA representative. (As
discussed above, we are requiring in this final rule that the means of
conveyance be sealed in the region of origin.) One commenter asked what
procedures will be followed with regard to the animals if broken seals
or missing cattle are discovered at the slaughter plant and what
procedures APHIS will follow if a truck cannot be adequately sealed at
the port. The commenter also stated that USDA representatives should
not include employees of the slaughtering establishment. Another
commenter asked what the verification process would be concerning APHIS
documents and sealed conveyances.
Response: APHIS has provisions whereby the Agency enters into
compliance agreements with the management of approved slaughtering
establishments. These have proven to be exceptionally effective across
a range of programs. We will work in accordance with these agreements
and in close cooperation with FSIS to ensure that animals are accounted
for and will take appropriate remedial measures as necessary.
We do not expect, as a practical matter, to encounter situations
where a means of conveyance cannot be adequately sealed at the port. As
noted, we are requiring in this final rule that the means of conveyance
be sealed in the region of origin before reaching the U.S. port of
entry. If for some reason the APHIS inspector at the port needs to
break the seal, resealing a means of conveyance that had previously
been sealed is not expected to be a problem and there are several types
of seals that can be used.
Immediate Slaughter
Issue: In our proposal, we noted that, under the definition of
immediate slaughter in Sec. 93.400, ruminants imported into the United
States for immediate slaughter must be slaughtered within 2 weeks of
the date of entry into the United States. Several commenters
recommended that, in order to better control the movement of the cattle
in the United States, the regulations not allow 2 weeks for slaughter,.
Another commenter asked which government official will oversee and
verify that all animals are sent to slaughter within the 2 weeks
following entry into the United States. Other commenters wanted to know
what steps will be taken if the cattle are not slaughtered within the
required time period.
Response: We continue to consider it appropriate to define
immediate slaughter as slaughter within 2 weeks after entry into the
United States. Animals imported for immediate slaughter must be moved
directly from the port of arrival to the slaughter facility. However,
cattle moved into the United States for slaughter are not always
slaughtered as soon as they arrive at the slaughtering establishment.
Because of the effects of stress and shrinkage during shipment, they
are often held at the slaughtering establishment to improve body
condition. Also, the date the animals are slaughtered is dependent on
the workload at the slaughtering establishment. The 2-week period was
established to allow time for arrival, processing, conditioning and
slaughter of the animals in a reasonable amount of time. Because
recognized
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slaughtering establishments must have full-time Federal or State
veterinary inspectors on the premises, official government oversight of
the arrival and penning of the animals is available. APHIS Form VS 17-
33 accompanies every shipment of animals imported for immediate
slaughter and must be returned to the APHIS veterinarian at the port of
entry after the animals are slaughtered. Any establishment that fails
to comply with its agreement with APHIS will have its approval to
receive further shipments of restricted animals for slaughter
suspended.
Methods of Disposal
Issue: Paragraphs (a)(6) and (b)(10) of Sec. 93.436 of our
proposed rule included the requirement that the intestines of bovines
imported from a BSE minimal-risk region be removed at slaughter in the
United States. Paragraphs (a)(7) and (b)(11) of Sec. 93.436 of the
proposed rule required that the intestines be disposed of in a manner
approved by the Administrator. Several commenters asked for
clarification regarding who we were referring to as the
``Administrator.''
Response: In APHIS'' regulations, including the definitions in
Sec. 93.400 regarding the importation of ruminants into the United
States, ``Administrator,'' unless otherwise identified, is defined as
``The Administrator of the Animal and Plant Health Inspection Service
or any other employee of the Animal and Plant Health Inspection
Service, United States Department of Agriculture, to whom authority has
been or may be delegated to act in the Administrator's stead.''
However, in this final rule, we are not specifying that SRMs and
other tissues removed at slaughter in the United States from bovines
imported from a BSE minimal-risk region be disposed of in a manner
approved by the Administrator. FSIS regulations governing disposal
already exist in that Agency's regulations at 9 CFR 310.22, 314.1 and
314.3, and we consider it appropriate that the FSIS provisions be
followed with regard to disposal.
Issue: A number of commenters stated that we should specify the
potential means of disposal of removed intestines and verification of
such disposal. Several commenters stated that materials requiring
disposal under the regulations should be rendered by a licensed
rendering company, with materials resulting from rendering being
subject to FDA feed rules. In all cases, stated commenters, rendering
should be the main option, and any other method must have to conform to
the transportation, traceability, and pathogenic reduction requirements
currently imposed on the rendering industry. Several commenters stated
that disposal options should include only rendering, incineration, or
alkaline digestion at an approved and licensed facility. Other
commenters stated that burial, landfilling, composting, or burning
should not be disposal options. Several commenters asked what FSIS will
require of slaughtering establishments to ensure that the intestines
are removed and disposed of properly.
Response: In its SRM rule, FSIS established provisions regarding
disposal of SRMs. In the explanatory information to that rule, FSIS
stated: ``In this interim final rule, FSIS is requiring that
establishments that slaughter cattle and establishments that process
the carcasses or parts of cattle develop, implement, and maintain
written procedures for the removal, segregation, and disposition of
SRMs....'' FSIS provided further that the establishments must address
their control procedures in their Hazard Analysis and Critical Control
Point (HACCP) plans, sanitation standard operating procedures, or other
prerequisite programs, and that FSIS will ensure the adequacy and
effectiveness of the establishment's procedures. The FSIS SRM rule also
requires that establishments that slaughter cattle and establishments
that process the carcasses or parts of cattle maintain daily records
that document the implementation and monitoring of their procedures for
the removal, segregation, and disposition of SRMs. The rule provided in
9 CFR 310.22(c) that SRMs must be disposed of in accordance with the
FSIS requirements for disposal in 9 CFR 314.1 and 314.3. Those
regulations provide that allowable means of disposing of the materials
include tanking (inedible rendering), or-in those establishments that
do not have facilities for tanking-incineration or denaturing.
The comment period for the SRM rule closed on May 7, 2004. FSIS is
assessing the comments it received on the rule, including those
regarding the issue of disposal, and will determine whether to maintain
or modify the requirements of the rule. In determining whether to
approve a manner of disposal, FSIS will consult with FDA and the U.S.
Environmental Protection Agency.
Issue: Some commenters stated that, in addition to being prohibited
from the food chain, SRMs should also be prohibited from being
rendered.
Response: FSIS considers SRMs to be unfit for human food.
Therefore, such materials may be rendered only as inedible (not for
human consumption). As discussed above, the allowable means of
disposing of the materials include tanking (inedible rendering) or-in
those establishments that do not have facilities for tanking-
incineration or denaturing.
Issue: Several commenters asked whether proper disposal of
intestines includes utilizing intestines in a meat-and-bone meal
product that is used as a feed ingredient for nonruminant animals. The
commenters stated that the distal ileum should be allowed to be
processed into meat-and-bone meal for feeding to nonruminant animals
because there is a high level of compliance with mandatory feed
restrictions in United States.
Response: We are making no changes based on these comments. FDA
regulates the ingredients used in animal feed, including SRMs.
Testing at Slaughter
Issue: A number of commenters recommended testing increased numbers
of cattle for BSE at slaughter in the United States. Some commenters
stated that determining which cattle are to be tested should depend on
the animals' ages. Guidelines ranged from testing all cattle over 24
months of age to all cattle over 30 months of age. One commenter
recommended testing all cattle imported from a BSE minimal-risk region
that were born before 2000. Some commenters recommended testing all
cattle from Canada. Others recommended testing of all cattle sent to
slaughter in the United States or all cattle that die in any location.
One commenter recommended that the importer be required to have each
imported animal that dies other than by slaughter tested at an
accredited veterinary diagnostic laboratory.
Response: APHIS, in cooperation with FSIS and FDA, has developed an
intensive national BSE surveillance plan. The goal of this plan is to
test as many cattle in the targeted high-risk population as possible in
a 12-to 18-month period. Experience in the United Kingdom and other
parts of Europe has shown that testing cattle that are non-ambulatory,
dead on the farm, or showing clinical signs consistent with BSE is the
method most likely to disclose BSE if it is present in the cattle
population. This enhanced surveillance was begun on June 1, 2004. As of
December 7, 2004, 136,153 cattle had been tested, all with negative
results.
Over a period of 12-18 months, APHIS will test as many cattle as
possible in the targeted high-risk population. Data obtained in this
effort will demonstrate whether BSE is actually present in the U.S.
adult cattle
[[Page 491]]
population and, if so, help provide estimates of the level of the
disease. This data will also help determine whether risk management
policies need to be adjusted. The key to surveillance is to look at the
population of animals where the disease is likely to occur. Thus, if
BSE is present in the U.S. cattle population, there is a significantly
better chance of finding the BSE within this targeted high-risk cattle
population than within the general cattle population.
Non-Ambulatory Disabled (Downer) Animals
Issue: Many commenters stated that no beef derived from non-
ambulatory (``downer'') animals should be allowed either to enter the
United States or enter the U.S. food supply. Other commenters stated
that meat from any downer animal should be held until the animal is
tested for BSE, and should be allowed into the food supply only if the
animal tests negative. Some commenters stated that downer animals
should be allowed to go to custom slaughtering for the owner's personal
use.
Response: The issues raised by the commenters concern the safety
for human consumption of beef slaughtered in the United States, which
USDA addresses through its food safety agency, FSIS. As discussed above
under the heading ``Measures Implemented by FSIS,'' that agency has
determined that the carcasses of non-ambulatory disabled cattle are
unfit for human food under section 1(m)(3) of the Federal Meat
Inspection Act (FMIA), and that all non-ambulatory disabled cattle that
are presented for slaughter will be condemned (i.e., not passed for
human consumption). With regard to Canada specifically, that country is
not allowing non-ambulatory animals to be slaughtered for export.
Issue: One commenter expressed concern that Canada has not adopted
the same BSE risk mitigation measures adopted by the United States,
such as not prohibiting downer animals from entering the human food
chain.
Response: As noted above, Canada is not allowing non-ambulatory
animals to be slaughtered for export. All of the FSIS requirements
imposed on the U.S. domestic beef supply as a consequence of that
agency's January 12, 2004, rulemakings also apply to foreign countries
that are eligible to export beef to the United States. The foreign
country's inspection program must be deemed by FSIS to be equivalent to
the U.S. inspection program before the country can ship beef to the
United States. This means that SRMs must have been properly removed in
the exporting country consistent with the U.S. requirements, and that
non-ambulatory disabled cattle be prohibited for human food purposes.
FSIS has an on-going verification system to assess the effectiveness of
the equivalency determination made for each foreign country deemed
eligible to export meat to the United States, as discussed below under
the heading ``Verification of Compliance in the Exporting Region.''
Issue: Several commenters expressed concern that if non-ambulatory
animals are excluded from slaughter in the United States, the current
targeted surveillance systems will miss the chance to test these
animals.
Response: We disagree with the commenter that non-ambulatory
animals will not be tested under the U.S. targeted surveillance system.
Even before the FSIS determination that all non-ambulatory disabled
cattle that are presented for slaughter will be condemned, these types
of animals have often moved through channels other than for human
consumption. A comparison of testing records before and after the FSIS
determination indicates that this category of animals was being tested
before that determination and continues to be tested.
Use of Blood in Ruminant Feed
Issue: Several commenters stated that we should continue to
prohibit the importation of live cattle from Canada because, according
to the commenters, that country allows the feeding of blood and certain
other ruminant products to cattle that are banned in the United States.
Another commenter expressed concern that the proposal did not contain
adequate verification that cattle imported from Canada are not fed
animal blood.
Response: The CFIA feed ban was implemented in 1997 to prevent BSE
from entering the food chain. The CFIA's feed ban, equivalent to the
FDA prohibition on the feeding of most mammalian protein to ruminants,
prohibits materials that are comprised of protein, including meat-and-
bone meal, derived from mammals such as cattle, sheep and other
ruminants, as well as salvaged pet food, plate waste and poultry
litter. Products exempt from CFIA's feed ban include pure porcine and
equine proteins, poultry and fish proteins, milk, blood, and gelatin,
and non-protein animal products such as rendered animal fats (e.g.,
beef tallow, lard, poultry fat). These are products that are also
exempt from the FDA prohibition. (Please note, however, that as
discussed above in section III. C. under the heading ``Measures
Implemented by FDA,'' in an advance notice of proposed rulemaking
issued jointly by FDA, FSIS, and APHIS on July 14, 2004, FDA requested
additional information to help it determine the best course of action
regarding the feed ban.)
In 2001, the EU Scientific Steering Committee (SSC), a scientific
advisory committee for the EU, considered the amount and distribution
of BSE infectivity in a typical case of BSE and estimated that, in an
animal with clinical disease, the brain contains 64.1 percent of the
total infectivity in the animal and the spinal cord contains 25.6
percent. Thus, the brain and spinal cord of cattle with clinical BSE
are estimated to contain nearly 90 percent of the total infectivity in
the animal. According to the EU SSC, the remaining proportion of
infectivity in a typical animal with clinical BSE is found in the
distal ileum (3.3 percent), the dorsal root ganglia (2.6 percent), the
spleen (0.3 percent), and the eyes (0.04 percent). Similar conclusions
on the relative infectivity of specific tissues from an infected cow
have been reached by Comer and Huntley in their evaluation of the
available literature (Ref 27).
We have noted that recent scientific studies have indicated that
blood may carry some infectivity for BSE; however, those studies have
concerned blood transfusions in animals. Additional research is
necessary to determine which animals may become infected with BSE via
blood, as well as the amount of infectivity contained in blood. We
continue to consider it appropriate to recognize Canada as a minimal-
risk region because that country has taken a number of measures that
would make it unlikely that BSE would be introduced from that country
into the United States. The measures include a feed ban equivalent to
that in effect in the United States.
In addition to CFIA's feed ban on ruminant protein, Canada has
taken additional measures to protect against the importation and
possible spread of BSE. Such measures include: Import restrictions on
live ruminants and ruminant products from countries that have not been
recognized as free of BSE, surveillance and monitoring for BSE, and
epidemiological investigation following the detection of BSE sufficient
to confirm the adequacy of measures to prevent the further introduction
and spread of the disease. Because of the mitigation measures taken by
Canada to guard against the introduction and spread of BSE, we consider
there to be minimal risk of infected blood entering the food chain from
that region. However, to ensure the adequacy of feed restrictions for
ruminants imported from Canada and other regions that may be
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recognized as minimal-risk regions for BSE in the future, we require in
this rule that ruminants must have been subject to a ruminant feed ban
that is equivalent to the requirements established by the U.S. Food and
Drug Administration. That provision replaces the condition in our
proposal that required that ruminants not be fed ruminant protein,
other than milk protein, during their lifetime.
Animal Inventories
Issue: One commenter recommended that the regulations require that
cattle and other ruminants imported from a BSE minimal-risk region be
accompanied by certification of the exact number of animals being
shipped and the individual identification of the animals.
Response: Section 93.407 of the existing regulations requires a
declaration of, among other information, the number of ruminants
presented for import. Additionally, on a working basis, we have
interpreted the requirement in Sec. 93.405 that ruminants imported
into the United States from Canada for other than immediate slaughter
be accompanied by certification to include official identification of
the ruminants. However, in order to make clear our intent, we are
amending Sec. 93.405 by adding a new paragraph (a)(4) to specify that
the information on the certificate required by that section must
include the following: (1) The name and address of the importer; (2)
the species, breed, number or quantity of ruminants or ruminant test
specimens to be imported; (3) the purpose of the importation; (4)
individual ruminant identification, which includes the eartag required
by this final rule and any other identification present on the animal,
including registration number, if any; (5) a description of the
ruminant, including name, age, color, and markings, if any; (6) region
of origin; (7) the address of or other means of identifying the
premises of the herd of origin and any other premises where the
ruminants resided immediately prior to export, including the State or
its equivalent, the municipality or nearest city, or an equivalent
method, approved by the Administrator, of identifying the location of
the premises, and the specific physical location/destination of the
feedlot where the ruminants are to be moved after importation; (8) the
name and address of the exporter; (9) the port of embarkation in the
foreign region; and (10) the mode of transportation, route of travel,
and port of entry in the United States.
We are also specifying in Sec. 93.436 that an official
identification and any other identification on bovines imported for
feeding and then slaughter from a BSE minimal-risk region must be
listed on the APHIS Form VS 17-130 that must accompany the animals from
the port of entry and on the APHIS Form VS 1-27 that must accompany the
animals to slaughter. For sheep and goats, that requirement is in Sec.
93.419. With regard to ruminants imported from a BSE minimal-risk
region for immediate slaughter, the requirement that the animals be
accompanied to slaughter by APHIS Form VS 17-33 for movement to
slaughter will enable tracking of the animals following importation.
Additionally, ruminants moved directly to slaughter must be moved in
means of conveyance that was sealed in the region of origin and that is
opened only by a USDA representative. We consider these requirements
adequate to ensure immediate slaughter of such ruminants.
Transiting of Live Ruminants Through the United States
Issue: One commenter stated that there would be little risk in
allowing the transiting through the United States of products and live
animals that have been recognized as low-risk by another country and in
accordance with OIE standards. Several commenters expressed concern
that the current prohibition on the importation of sheep and goats from
Canada has unnecessarily eliminated the transiting of sheep and goats
from Canada through the United States to Mexico and other Latin
American countries. The commenters noted that the regulations as
proposed would allow live sheep and goats imported from a BSE minimal-
risk region to be moved to designated feedlots in other than a sealed
means of conveyance, and that, therefore, the regulations should also
allow the transiting of lambs to Mexico.
Response: We agree that the issue of the transiting of live sheep,
goats, and bovines through the United States from a BSE minimal-risk
region should be considered. As we noted in our March 2004 notice
reopening the comment period on the proposed rule, we are currently
evaluating, and intend to address in a supplemental rulemaking in the
Federal Register, the importation of live animals under conditions
other than those specified in our proposed rule.
Issue: One commenter asked how APHIS will ensure that cattle are
not exported from Canada to Mexico, then re-exported from Mexico into
the United States.
Response: As noted above, in this final rule we are codifying our
interpretation that, under the requirements of Sec. 93.405, live
cattle imported into the United States, including cattle from Mexico,
must be accompanied by a certificate that includes, among other
information, the region of origin of the animals.
Movement Forms
Issue: One commenter stated that FSIS policies need to be
established to ensure that agency's inspectors return the VS Form 17-33
(which must accompany imported livestock to immediate slaughter) to the
APHIS Port Veterinarian in a timely manner.
Response: We agree that close collaboration and timely coordination
between APHIS and FSIS is necessary, and both agencies are committed to
establishing the most appropriate mechanism to achieve that result.
APHIS is in the process of developing written instructions for FSIS
personnel at approved slaughtering establishments and will submit those
instructions to FSIS before this rule is implemented.
Issue: One commenter recommended that the rule not be implemented
until certain Veterinary Services forms and a memorandum are updated.
Response: The documents referred to by the commenter are
periodically reviewed and updated. As currently written, the forms
provide sufficient information regarding the number and species of
animal, as well as the seal numbers that are applied to the means of
conveyances.
Issue: Several commenters recommended that importers be required to
account for all cattle, whether dead or sold.
Response: The necessary accountability regarding the location,
movement and disposition of animals will be provided by the requirement
that movement permit APHIS Form VS 17-130, which identifies the
physical destination of the animals and the person responsible for the
movement of the animals, accompany all movements in the United States
of feeder cattle imported from BSE minimal-risk regions.
Age and Feed Verifications
Issue: Several commenters asked whether FSIS will verify the
following information: (1) That animals are less than 30 months of age
at slaughter; (2) that CFIA is using the same procedure for determining
animal age as FSIS; and (3) that ruminants imported from BSE minimal-
risk regions for slaughter were not fed ruminant protein.
[[Page 493]]
Response: Countries eligible to export meat to the United States
must have a meat inspection system equivalent to the U.S. meat
inspection system (as discussed below in section IV. D. under the
heading ``Verification of Compliance in the Exporting Region''),
including a system for verifying that SRMs are properly identified and
removed from the human food supply. FSIS has an ongoing verification
system to assess the effectiveness of the equivalency determination
made for each foreign country deemed eligible to export meat to the
United States. For live cattle, the FSIS-inspected slaughtering
establishment is required by FSIS to implement procedures to determine
the age of cattle in order to properly deal with SRMs. FSIS verifies
that the establishment is meeting the regulatory requirements. Any
cattle deemed to be 30 months of age and older must have those tissues
that are considered SRMs in such animals, as well as the small
intestine, removed and disposed of as inedible material.
Regarding verification procedures for ensuring that an animal has
not been fed ruminant protein during its lifetime, APHIS will not
recognize a region as a BSE minimal-risk region unless APHIS has first
determined that the region has in place and is effectively enforcing a
ruminant-to-ruminant feed ban and that the region has a reliable
veterinary infrastructure that can certify that the requirements of
this rule with regard to individual shipments have been met. For FSIS,
part of that agency's equivalency determination is based on the total
system for ensuring that the BSE-infective agent is appropriately
controlled. FSIS would rely upon certifications made by the government
of the exporting country in order to assess compliance with these
requirements.
Certification of Feed Ban Compliance
Issue: Several commenters requested that the regulations require
that the owner of ruminants imported from BSE minimal-risk regions be
responsible for certifying that their animals have not been fed
ruminant protein. One commenter further recommended that all imported
cattle, regardless of their region of origin, be accompanied by an
affidavit stating the animals have not been fed ruminant-derived
protein.
Response: One of the requirements in this rule regarding the
importation of feeder and slaughter cattle from a BSE minimal-risk
region is that they have been fed in compliance with the ruminant feed
ban of the region of origin and, further, that the ruminant feed ban is
equivalent to the requirements established by the FDA. That provision
will replace the requirement in our proposal that such animals not have
been fed ruminant protein, other than milk protein, during their
lifetime. Certification for import must be provided by the government
of the exporting country--in this case, CFIA. For the purposes of
international trade, the country of export is required to issue the
official health certification required by the importing country.
We do not consider it necessary to require that all imported
cattle, regardless of their region of origin, be accompanied by an
affidavit stating the animals have not been fed ruminant-derived
protein. Cattle are not permitted importation from those regions listed
in Sec. 94.18(a)(1) as regions in which BSE exists, nor are they
permitted importation from regions listed in Sec. 94.18(a)(2) as those
that pose an undue risk of BSE. For regions that are included in
neither of these categories, except for those regions listed in Sec.
94.18(a)(3) as BSE minimal-risk regions, we do not consider it
warranted based on risk to require certification that ruminants
imported into the United States were subject to a feed ban.
Issue: One commenter recommended that, because the United States
already considered the scope and application of a feed ban in Canada
before proposing to designate that country as a BSE minimal-risk
region, the required certification for live ruminants and ruminant
products from Canada not include a statement concerning compliance with
the feed ban for individual commodities. The commenter requested that
the certification be required to address only any additional measures
taken to prevent against the introduction of BSE into the United
States, such as verification of age for live animals and removal of
SRMs for beef. Another commenter stated that a broad certification
addressing the feed ban established in the region of origin would be
more appropriate than certification based solely on the knowledge of
the certifying officer.
Response: We are making no changes based on these comments. We
consider it necessary for possible traceback efforts that the
verification statement regarding compliance with the feed ban
requirements be included on the documentation that is provided when
animals or commodities are presented for entry at U.S. border stations.
Such certification for individual commodities will require that the
certifying individual have knowledge of the origin of the commodities.
Border Stations
Issue: Several commenters expressed concern that cattle are being
imported into the United States illegally after dark on back roads. One
commenter stated that border ports should be open 24 hours a day, 7
days per week. Another commenter asked whether APHIS or FSIS will
verify CFIA procedures to ensure that cattle were imported into the
United States through an APHIS-designated port of entry.
Response: U.S. Customs and Border Protection (CBP), Department of
Homeland Security, monitors every port of entry with officers, 24 hours
per day, 7 days per week, to ensure security at America's borders and
ports of entry and, among other things, protect our agricultural and
economic interests from harmful pests and diseases. Because CBP
monitors every port of entry around the clock, we are confident that
all shipments of live animals entered through those ports, including
cattle imported from Canada, will be referred to APHIS and meet all
applicable laws and regulations before importation into the United
States. The issue of attempts at illegal smuggling is one that must be
dealt with at any country's borders. APHIS' regulations in Sec. 93.408
explicitly require that all live cattle imported into the United States
be inspected by APHIS' Veterinary Services at designated ports of
entry. Any individual who violates the regulations is subject to civil
and criminal penalties in accordance with the AHPA.
Issue: Several commenters expressed concern that our proposal did
not designate a sufficient number of U.S./Canadian land border ports
for the importation of live ruminants and ruminant products from Canada
and requested that we establish additional land border ports in
Minnesota, Montana, and North Dakota. Commenters specifically requested
that we designate Dunseith, ND, as a port of entry. One commenter said
that if our proposal were made final, a significant portion of renewed
trade from Canada would be in the form of live animals. The commenter
expressed concern that, because the proposal listed only three
designated ports of entry convenient to the Canadian prairie Provinces,
any delays at the ports of entry could become a serious animal welfare
issue.
Response: Section 93.403(b) of the regulations lists 20 designated
ports of entry for the importation of live ruminants from Canada. Seven
of those ports are in either Minnesota, Montana, or North Dakota.
Dunseith, ND, is listed as a designated port of entry for live
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ruminants. The remainder of the designated ports are in Idaho, Maine,
New York, Vermont, and Washington.
With regard to meat and edible products derived from ruminants in
Canada, we proposed that such commodities from Canada could be imported
into the United States from Canada only through the border ports we
listed in Sec. 94.19(k) of our proposal. Proposed Sec. 94.19(k)
listed fewer ports of entry for meat and edible products from Canada
than are listed in Sec. 93.403(b) for the importation of live animals.
This is because the number of ports designated for meat and edible
products is limited by the availability of facilities for FSIS
personnel trained in the inspection of such commodities to conduct
their required inspections.
We do not have any evidence to suggest that the land border ports
listed in Sec. Sec. 93.403(b) and 94.19(g) (redesignated from Sec.
94.19(k) of the proposal) will be inadequate to provide inspection and
import-related services for ruminant products and live ruminants
entering the United States from Canada. Therefore, we are not making
any changes in response to the comments. However, if, in the future, we
add other countries to the list of BSE minimal-risk regions, or if the
volume of imported commodities warrants it, we will adjust the list of
designated ports accordingly.
Timing of Health Inspections
Issue: One commenter recommended that the regulations require that
animals intended for importation into the United States be inspected by
an accredited veterinarian within 24 hours before shipment and be
accompanied with a certificate of veterinary inspection.
Response: We are making no changes based on this comment. The
regulations in Sec. 93.408 explicitly require that all live cattle
imported into the United States from Canada be inspected at the port of
entry. Animals imported into the United States under this rule will be
visually inspected by a U.S. inspector while on the means of conveyance
at the port of entry. (Also, as noted above under the heading
``Verification and Enforcement of Age Limit of Ruminants,'' U.S.
inspectors at the port of entry will, if they consider it necessary,
unseal the means of conveyance at the port of entry.) Section 93.418
requires certificates of veterinary inspection for cattle other than
for immediate slaughter. Requiring that such inspection be conducted
within 24 hours of export would not be consistent with our current
requirements for health certificates that require issuance of such
certificates by the exporting region within 30 days of export, and
would be unnecessary because the animals would be reinspected at the
border 24 hours or less after inspection in the exporting region. From
the standpoint of ensuring animal health and detecting disease, it is
preferable to have two inspections up to 30 days apart.
D. Risk Mitigation Measures for Importation of Ruminant Products and
Byproducts
Age of Animals From Which Meat Is Derived
Issue: In Sec. 94.19 of our proposed rule, we provided that meat
derived from bovines slaughtered in a BSE minimal-risk region could be
imported into the United States under certain conditions. One of the
conditions was that the meat be derived from bovines that were less
than 30 months of age when slaughtered. One commenter stated that the
OIE and Canada prohibit the importation of meat products and carcasses
from bovines less than 30 months of age; therefore, the United States
should do the same. Conversely, a number of commenters stated that,
provided all SRMS were removed from the animals, it was unnecessary to
require that the animals from which the meat was derived were less than
30 months of age at slaughter. With the removal of the SRMs, said the
commenters, the risk of BSE would be sufficiently mitigated.
Response: We consider the commenters' recommendation to allow the
importation of meat from bovines of any age under certain conditions to
have merit. As we discussed in our March 8, 2004, extension of the
comment period on our November 2003 proposed rule, and as we discuss
above in section III. C. under the heading ``Measures Implemented by
FSIS,'' the FSIS SRM rule designated the following tissues in cattle as
SRMs and prohibited their use in human food: The brain, skull, eyes,
trigeminal ganglia, spinal cord, vertebral column (excluding the
vertebrae of the tail, the transverse processes of the thoracic and
lumbar vertebrae, and the wings of the sacrum) and dorsal root ganglia
of cattle 30 months of age and older, and the tonsils and distal ileum
of the small intestine of all cattle. To ensure effective removal of
the distal ileum, FSIS requires removal of the entire small intestine
and prohibits its use in human food.
These prohibitions do not restrict the slaughter of cattle in the
United States based on age. The only role the age of the cattle plays
in FSIS actions is in determining whether certain tissues (e.g.,
central nervous system tissues) in the animal should be considered SRMs
due to the animal's age.
Under FSIS regulations, meat inspection systems and processing
requirements in Canada and in any country authorized to export meat and
meat products to the United States must be equivalent to those in the
United States in order for meat and meat products to be eligible for
importation. Under these circumstances, we no longer consider it
necessary to require that meat from bovines that is imported from a BSE
minimal-risk region be derived only from animals less than 30 months of
age, or that the animals were slaughtered in a facility that either
slaughters only bovines less than 30 months of age or has in place a
process adequate to segregate the meat from other meat slaughtered at
the facility.
With regard to meat from sheep, goats, and other ovines and
caprines, neither the proposed rule nor this final rule identifies SRMs
in ovines and caprines that could be removed to eliminate any potential
infectivity from products derived from the animals. Therefore, this
final rule will require, as proposed, that meat from sheep or goats or
other ovines or caprines from a BSE minimal-risk region be derived from
animals that were less than 12 months of age when slaughtered, and we
are adding the same condition for the importation of meat byproducts
and meat food products derived from ovines or caprines. We discuss the
issue of meat byproducts and meat food products below.
We disagree with the commenter who stated that international
guidelines preclude the importation of meat products and carcasses from
bovines less than 30 months of age from countries that OIE would
consider to be minimal risk for BSE. The OIE guidelines recommend
allowing the importation of meat from cattle of any age from such
minimal-risk regions, provided the necessary risk mitigation measures
are taken (e.g., the meat contains no part of the brain, eyes, spinal
cord, skull or vertebral column, or protein products derived from such
materials).
What Constitutes Meat
Issue: In our proposed rule, we stated that, to be considered meat
that is eligible for importation into the United States from a BSE
minimal-risk region, a product would have to meet the FSIS definition
of meat in 9 CFR 301.2. The FSIS regulations provided that, to be
considered meat, product that undergoes mechanical separation and meat
recovery from the bones of livestock must be processed in such a way
that the processing does not crush,
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grind, or pulverize bones, so that bones emerge comparable to those
resulting from hand-deboning and the meat itself meets the criteria of
no more than 0.15 percent or 150 mg/100 gm of product for calcium (as a
measure of bone solids content) within a tolerance of 0.03 or 30 mg. We
noted in the preamble of our proposal that, except where the FSIS
definition of meat was specifically referenced in our proposal, when we
used ``meat'' we meant the standard dictionary definition of the term.
One commenter stated that ``meat,'' as defined according to its common
usage, could mean several different things. The commenter recommended
that how we intend to use the term in the regulations should be
specific to its purpose.
Response: In order to avoid confusion, in this final rule we are
using the term ``meat'' in all cases to mean meat as defined by FSIS.
In its AMR rule, FSIS revised the definition of meat in 9 CFR 301.2 to
mean, ``The part of the muscle of any cattle, sheep, swine, or goats
that is skeletal or that is found in the tongue, diaphragm, heart, or
esophagus, with or without the accompanying and overlying fat, and the
portions of bone (in bone-in product such as T-bone or porterhouse
steak), skin, sinew, nerve, and blood vessels that normally accompany
the muscle tissue and that are not separated from it in the process of
dressing. * * *'' FSIS provided further that meat does not include the
muscle found in the lips, snout, or ears, and that meat may not include
significant portions of bone, including hard bone and related
components, such as bone marrow, or any amount of brain, trigeminal
ganglia, spinal cord, or dorsal root ganglia.
Additionally, in this final rule, we are clarifying that meat, meat
byproducts, and meat food products from bison qualify as meat, meat
food products, and meat byproducts under this rule, even though such
commodities derived from bison are not included under the FSIS
definitions.
Meat Byproducts and Meat Food Products
Proposed Sec. 94.19 prohibited the importation of fresh (chilled
or frozen) meat, meat products, and edible products other than meat
(excluding gelatin, milk, and milk products) from ruminants that have
been in a BSE minimal-risk region, unless conditions allowing for the
importation of a specified commodity were included in that section or
in Sec. 94.18. In Sec. 94.19, we proposed conditions for the
importation of the following commodities: Fresh (chilled or frozen)
bovine whole or half carcasses or other meat; fresh (chilled or frozen)
bovine liver; fresh (chilled or frozen) bovine tongues; fresh (chilled
or frozen) carcasses or other meat of ovines and caprines; fresh
(chilled or frozen) meat or dressed carcasses of hunter-harvested wild
sheep, goats, cervids, or other ruminants; fresh (chilled or frozen)
meat of cervids either farm-raised or harvested on a game farm or
similar facility; fresh (chilled or frozen) meat from specified wild-
harvested musk ox, caribou or other cervids; and gelatin.
Issue: A number of commenters expressed concern that the proposed
rule did not specifically include conditions for the importation of
processed meat products. The commenters stated that products processed
for edible use from boneless cuts of beef and other parts of the
carcass from cattle of any age should be allowed importation, provided
SRMs were removed from the cattle from which the products were derived.
One commenter stated that, by incorporating FSIS's regulatory
description of meat from 9 CFR 301.2, APHIS excluded from importation
from a BSE minimal-risk region meat food products that are separately
defined by FSIS as ``any article capable of use as human food which is
made wholly or in part from any meat or other portion of the carcass of
any cattle.'' The commenter stated that this prohibits the importation
of a wide range of products for which there is no discernible risk
factor.
Response: We agree it is not necessary to prohibit the importation
of processed meat products and byproducts from ruminants that meet the
conditions in this rule for the importation of meat. Therefore, we are
providing in Sec. 94.19 of this final rule that, along with meat as
defined by FSIS, the importation conditions in this rule also apply to
those products that are included in the FSIS definitions of meat food
product and meat byproduct in 9 CFR 301.2.
In those definitions, meat byproduct is defined as ``any part
capable of use as human food, other than meat, which has been derived
from one or more cattle, sheep, swine, or goats. * * *'' Meat food
product is defined as ``any article capable of use as human food which
is made wholly or in part from any meat or other portion of the carcass
of any cattle, sheep, swine, or goats, except those exempted from
definition as a meat food product by the [FSIS] Administrator in
specific cases or by the regulations in * * * [9 CFR part 317], upon a
determination that they contain meat or other portions of such
carcasses only in a relatively small proportion or historically have
not been considered by consumers as products of the meat food industry,
and provided that they comply with any requirements that are imposed in
such cases or regulations as conditions of such exemptions as to assure
that the meat or other portions of such carcasses contained in such
articles are not adulterated and that such articles are not represented
as meat food products. * * *''
Additionally, we are not specifying in this final rule that the
meat and meat commodities imported into the United States under this
rule must be chilled or frozen. Chilling or freezing meat and meat
products does not affect the BSE risk from those commodities.
Cervid Products
Issue: A number of commenters addressed the issue of the
importation of products derived from cervids, including meat, antlers,
trophies, and urine. One commenter objected in general to the
importation of any hunter-harvested wild ruminant products. Most of the
other commenters who addressed the issue of cervid products recommended
that they be eligible for importation from a BSE minimal-risk region.
Some commenters said such products should be eligible for importation
without restriction. Others suggested specific conditions for importing
such products. Several commenters recommended that we prohibit the
importation of offal derived from cervids from BSE minimal-risk
regions, because of the susceptibility of cervids to CWD.
Response: As we discuss above under the heading ``Cervids,'' in
this final rule we are not prohibiting or restricting the importation
of cervids from BSE minimal-risk regions because of BSE. APHIS is aware
of no epidemiological data indicating that cervids are naturally
susceptible to the BSE agent. Published observations indicate that,
during the height of the BSE outbreak in 1992 and 1993 in the United
Kingdom, exotic ruminants of the Bovidae family in zoos were affected
with BSE, while cervids, which are members of the Cervidae family, were
not (Ref 22). Therefore, even in regions that have high levels of
circulating infectivity and that should be considered high risk for
BSE, BSE susceptibility in cervids was not observed. Therefore, in this
final rule, we are not imposing any restrictions on cervid products
from BSE minimal-risk regions because of BSE.
Issue: Several comments recommended that products from wild
cervids, especially from the United Kingdom, be allowed importation
into the United States regardless of the exporting region's BSE status.
The commenters stated that wild deer by
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their nature are not fed ruminant protein, that no TSE has ever been
recorded in the deer population in the United Kingdom, and that
surveillance of wild deer is ongoing in the United Kingdom, with no
evidence of prion.
Response: We are making no changes based on the comments, other
than those we are making in this final rule with regard to cervid
products from BSE minimal-risk regions. The provisions we proposed, and
the risk analysis we conducted in conjunction with this rulemaking,
concerned ruminant imports from BSE minimal-risk regions. We consider
the issue of the importation of ruminant products from BSE-affected
regions to be outside the scope of this rulemaking.
What SRMs Should Be Removed
Issue: One commenter stated that we said in our proposal that a
region we might classify as minimal risk for BSE could, strictly
speaking, be classified as a moderate-risk country or zone under OIE
guidelines. The commenter stated that OIE recommends, for moderate-risk
countries or zones, that meat and meat products for export not contain
brain, eyes, spinal cord, distal ileum or mechanically separated meat
from skull and vertebral column from cattle over 6 months of age. The
commenter expressed concern that, for cattle under 30 months of age
from BSE minimal-risk regions, we proposed to require only the removal
of the intestines at slaughter.
Response: In our proposal, we did not make a general statement that
BSE minimal-risk regions by our guidelines might be classified as BSE
moderate-risk countries by OIE guidelines. Our discussion was
particular to the situation in Canada. Our evaluations concluded that,
according to our proposed standards, Canada qualified as a BSE minimal-
risk region. We indicated that, although a strict reading of the OIE
standards relative to the duration of a feed ban would classify Canada
as a moderate-risk country until 2005, our integrated approach to
evaluating the BSE status of a country considers the length of a feed
ban within the context of all control measures in place. Further, 7
years represents the 95th percentile of the incubation period
distribution; therefore, there is a rational basis for departing from
the OIE guideline of 8 years. We considered the sum total of the
control mechanisms in place at the time of diagnosis (e.g.,
effectiveness of surveillance, import controls, and feed ban) and the
actions taken after it (e.g., epidemiological investigations,
depopulation), thereby allowing the actions CFIA took in other elements
to compensate for a shorter feed ban duration than recommended by OIE.
Consistent with OIE guidelines, we consider the 30-month age standard
for SRMs-except for tonsils and the distal ileum, as discussed below-to
be adequate for regions such as Canada that we consider to be minimal-
risk for BSE. If countries (or other regions) other than Canada apply
for a BSE minimal-risk designation under this rule, we will evaluate
such requests on a case-by-case basis, and consider, as we did for
Canada, the combination of factors affecting the risk of BSE being
introduced into the United States from such countries or other regions.
According to OIE guidelines, in a minimal-risk region, all of the
tissues listed by the commenter except the distal ileum need be removed
only from cattle over 30 months of age. The distal ileum need not be
removed from cattle of any age. FSIS regulations define tonsils and the
distal ileum as SRMs regardless of the age of cattle and require their
removal. These definitions are applicable to meat from cattle
slaughtered in the United States, as well as to meat imported from
eligible foreign sources. To be consistent with the FSIS requirements,
we are requiring in Sec. 94.19(a)(2) and (b)(2) that meat and other
bovine products imported into the United States from a BSE minimal-risk
region be derived from cattle that have had SRMs and the small
intestine removed in accordance with the FSIS regulations.
Issue: Several commenters recommended that not just intestines, but
also brains, eyes and spinal tissue be prohibited from the food chain
or rendering.
Response: As discussed above in section III. C. under the heading
``Measures Implemented by FSIS,'' that agency's SRM rule applies to
meat from cattle slaughtered in the United States, as well as to meat
from eligible foreign sources. As noted, we are requiring that meat and
other bovine products from a BSE minimal-risk region be derived from
animals that have had SRMs removed in accordance with the FSIS
regulations.
Removal of SRMs
Issue: One commenter stated that an exporting region would
generally be unable to accurately certify that ``SRMs have been
removed,'' and that APHIS should require instead certification that ``a
majority of the known SRMs have been removed.'' For example, said the
commenter, when a carcass-splitting band saw is used to split a carcass
through the spinal cord, bone dust mixed with spinal cord tissue is
left on the exposed cut surfaces of the vertebral column before removal
of the spinal cord. Also, said the commenter, captive bolt pistols,
when penetrating the skull during the stunning procedure, provide a
source of hematogenous spread of central nervous system tissue to the
carcass, although not as much as when air stunning devices are used.
The commenter also stated that if BSE is anything like scrapie, perhaps
steam is not an adequate means of sterilizing equipment after being
used on BSE-contaminated tissues, given the heat-resistant nature of
the scrapie agent. Another commenter raised similar issues, stating
that the U.S. Government should discontinue contamination of beef with
prions from the central nervous system and change allowable methods of
slaughter and processing. The commenter recommended that captive bolt
stunning be replaced by electrical stunning, that immobilization of the
animal by a pithing rod be prohibited, and that no sawing through the
spinal cord be permitted.
Response: On January 12, 2004, FSIS published an interim final rule
prohibiting the use of penetrative captive bolt devices that
deliberately inject air into the cranial cavity of cattle, because that
method of stunning has been found to force visible pieces of central
nervous system tissue ( known as macro-emboli) into the circulatory
system of stunned cattle. The comment period on that interim final rule
closed on May 7, 2004, and FSIS is assessing the comments on this
issue. At this time, FSIS considers the current stunning methods
allowable for use in the United States to be practical and effective,
based on a review of published studies on stunning methods.
Regarding the cross-contamination issues identified by the
commenter, FSIS has developed procedures to verify that cross-
contamination of edible tissue with SRMs is reduced to the maximum
extent practical in facilities that slaughter cattle or process
carcasses or parts of carcasses of cattle, both animals younger than 30
months of age and 30 months of age and older. If an establishment uses
dedicated equipment to cut through SRMs, or if it segregates cattle 30
months of age and older from cattle younger than 30 months of age, then
the establishment may use routine operational sanitation procedures
(i.e., no special sanitation procedures are required). If the
establishment does not segregate cattle 30 months of age and older from
younger cattle, equipment used to cut through SRMs must be cleaned and
sanitized before it is used on carcasses or parts from cattle less than
30 months of age. FSIS believes
[[Page 497]]
that, due to the multiple risk mitigation measures implemented in the
United States to prevent the spread of BSE, these procedures will
reduce to the extent possible cross-contamination of carcasses with
high-risk tissues. However, to assist in determining whether it should
strengthen the measures required of establishments, on March 31, 2004,
FSIS issued a press release during the comment period for its SRM rule
that specifically requested public comment on methods to prevent cross-
contamination of carcasses with SRMs. The type of measures described
above have also been implemented in Canada.
Advanced Meat Recovery Systems
Issue: Several commenters stated that AMR systems (a technology
that enables processors to remove the attached skeletal muscle tissue
from livestock bones without incorporating significant amounts of bone
and bone products into the final meat product) are notorious for
containing tissue derived from the dorsal root ganglia (an SRM) in the
final product, and recommended that the use of AMR be prohibited in the
United States when slaughtering animals of Canadian origin.
Additionally, the commenters recommended that products that contain AMR
meat should not be allowed into the United States from BSE minimal-risk
regions.
Response: In its AMR rule, FSIS amended its description of meat to
make it clear that, to be considered meat, AMR product may not include
significant portions of bone or related components, such as bone
marrow, or any amount of central nervous system-type tissues.
Additionally, FSIS'' AMR rule provided that AMR systems may not use
bones classified as SRM (vertebral column and skull of cattle 30 months
of age and older). The AMR rule states that, if skulls or vertebral
column bones from cattle 30 months of age and older are used in AMR
systems, the product exiting the AMR system is adulterated, and the
product and the spent bone materials are inedible and must not be used
for human food. FSIS stated that the potential for human exposure to
the BSE-infective agent is prevented in products prepared from cattle
30 months of age and older using AMR systems because the AMR product
cannot include source materials from the skull or vertebral column or
contain any amount of brain, trigeminal ganglia, spinal cord or dorsal
root ganglia. AMR systems can be used to prepare meat from the skull
and vertebral column of cattle under 30 months of age. However, these
source materials from cattle under 30 months of age are not designated
as SRMs. The FSIS requirements are applicable to domestic beef as well
as to beef from a foreign country deemed eligible for export to the
United States.
Request for Clarification of Intent
Issue: One commenter stated that the proposed rule seemed to allow
the importation of some products containing bone or even SRMs. The
commenter requested that APHIS clarify whether this was the intent,
and, if so, provide the scientific justification for that decision.
Response: It is not clear to us what provisions in the proposed
rule the commenter is referring to. It is not APHIS' intent to allow
the importation of any SRMs from BSE minimal-risk regions. SRMs must be
removed from imported cattle at slaughter in the United States and must
have been removed from cattle in the exporting country from which meat
and meat products are derived. The skull and vertebral bones are
included in the definition of SRMs (both according to the Canadian
regulations and those of the United States because of the possibility
that those bones might contain dorsal root ganglia) so ``bones of
concern'' as far as BSE are concerned are not allowed importation.
Other bones have not been shown to pose a risk of BSE infectivity.
Tonsils and Third Eyelid
Under our proposed rule, intestines would have been the only
tissues required to be removed at slaughter from cattle less than 30
months of age from a BSE minimal-risk region. We also proposed that
beef imported from a BSE minimal-risk region be derived only from
bovines less than 30 months of age from which the intestines had been
removed.
Issue: One commenter stated that the EU SSC recommends also that
tonsils of bovines of any age be regarded as a BSE risk. Several other
commenters stated that, although our proposed rule required removal of
only the intestines, Canada requires removal of all SRMs from animals
at slaughter, and that U.S. citizens should be afforded the same level
of protection as Canadian citizens. The commenters stated that because
tonsils and third eyelid lymphoid tissue have been demonstrated to have
possible BSE infectivity in animals as early as 10 months post-
inoculation, USDA should not only require removal of all SRMs from
animals and products imported from minimal-risk regions, but also from
all cattle slaughtered in the United States.
Response: We are assuming that the commenters who referred to
``animals'' in these comments were referring to bovines and bovine
products from BSE minimal-risk regions. As discussed above in this
document under the heading ``Age of Animals from Which Meat is
Derived,'' requirements for removal of SRMs in Canada for meat and meat
products eligible to be imported and U.S. requirements are currently
equivalent. All of the requirements that were imposed by FSIS'' SRM
rule on cattle slaughtered in the United States also apply to meat
imported into the United States from foreign countries eligible to
export the beef to the United States. FSIS'' SRM rule identified
tonsils as SRMs. Tonsils of all cattle, regardless of age, must be
removed. Based on FSIS's requirements, all regions intending to import
meat and meat products into the United States will also have to remove
the tonsils from cattle of all ages from which the meat and meat
products are derived. As noted, we are providing in this rule that we
consider SRMs to be those identified as such by FSIS.
With regard to the third eyelid, there is no evidence that the
third eyelid lymphoid tissue is a tissue at risk of infectivity for BSE
in bovines. The only TSE agents that have been found in the third
eyelid are scrapie in sheep and CWD in deer and elk. PrPres
(the pathological form of the prion protein) has not been found in the
third eyelid of cattle. There have been no reports of its presence in
goats. Therefore, neither FSIS nor APHIS considers the third eyelid to
be an SRM.
Distal Ileum
Issue: A number of commenters took issue with the requirement in
our proposal that the intestines be removed from cattle less than 30
months of age from BSE minimal-risk regions, even though we stated in
the explanatory information of our proposal that the distal ileum (a
part of the small intestine) is the only part of the intestine that is
likely to have infectious levels of the BSE agent. Several comments
stated that we were incorrect in stating in our March 8, 2004, notice
reopening the proposed rule comment period that FSIS classifies the
small intestine of cattle of all ages as an SRM. The commenters stated
that the FSIS rule classifies only the distal ileum as SRM, but
requires removal of the entire small intestine as a means of ensuring
the removal of the distal ileum. The commenters stated that APHIS
should recommend removal only of the distal ileum. Other commenters
stated that, at most, APHIS should require removal of the small
intestine. One commenter recommended removal of the last 70
[[Page 498]]
inches of the small intestine, rather than the entire small intestine.
Another commenter provided an anatomical description of the bovine
small intestine that the commenter said could be used to develop a
model of certification for the removal and disposal of the distal
ileum.
Response: The commenters are correct that FSIS classified the
distal ileum from cattle of all ages as an SRM and not the entire small
intestine. FSIS requires removal of the entire small intestine to
ensure effective removal of the distal ileum. Canada has the same
requirements. This final rule on BSE minimal-risk regions adopts FSIS''
requirements regarding removal of SRMs and the small intestine. In its
SRM rule, however, FSIS acknowledged that methods might exist for
processors to effectively remove the distal ileum without removing the
entire small intestine and requested comments on that issue. The
comment period for the FSIS interim final rule closed on May 7, 2004.
Issue: One commenter stated that, although beef casings are
currently allowed into the United States from countries not listed as
BSE-affected or posing an undue risk of BSE, the FSIS rule requires the
removal of the entire small intestine from all cattle of all regions
regardless of BSE status. In addition, stated the commenter, the FSIS
rule has prevented the importation of the entire intestines of cattle
from regions where no BSE exists if the exporting country cannot
certify removal of the small intestine. The commenter recommended that
exporting countries that do not fall into any of the U.S. BSE risk
categories should not be required to remove any SRM, much less certify
the removal of the entire small intestine.
Response: In addressing FSIS' application of its regulations to
countries other than BSE minimal-risk regions, the commenter is raising
an issue that goes beyond the scope of the APHIS rulemaking. In both
its SRM rule and the USDA/FDA joint notice, FSIS specifically requested
comment on the issue of removal of the distal ileum.
Tongue and Liver
Issue: In Sec. 94.19(d) of our proposed rule, we provided that
bovine tongues could be imported from BSE minimal-risk regions if the
tongues were derived from bovines that were born after the region
implemented an effective ban on the feeding of ruminant protein to
ruminants, that are not known to have been fed ruminant protein other
than milk protein during their lifetime, and from which the tonsils
were removed at slaughter. Several commenters stated that the
regulations should prohibit either the importation of all tongues from
bovines from BSE minimal-risk regions, or the importation of tongues
from bovines 30 months or older. Some of the commenters stated that the
risk from tongues is unacceptable because the tongue is attached to the
tonsils, which are likely to contain the BSE infectious agent in an
infected animal.
Response: We do not consider it necessary to prohibit the
importation of bovine tongues from a BSE minimal-risk region, provided
the conditions set forth in this rule are met. As we stated above under
the heading ``What Constitutes Meat?,'' the tongue (but not the
peripheral glandular material) is a muscle included in the FSIS
definition of meat, and, to date, BSE infectivity has not been detected
in muscle meat of cattle. In this final rule, we are not including a
separate paragraph that includes the conditions for importing tongues
from BSE minimal-risk regions. Tongues will be subject to the same
requirements as other meat.
We do acknowledge, however, as we did in our proposed rule, that it
is necessary to ensure that the tongues come from bovines from which
the tonsils have been removed. As we discuss above under the heading
``Age of Animals from Which Meat is Derived'' and elsewhere, we
believe, from an animal health perspective, to consider as SRMs those
tissues listed by FSIS as SRMs. Under that listing, tonsils of all
cattle, regardless of age, must be removed. Several procedures exist
for removal of tongues so that they are effectively separated from the
tonsils, including cutting of the tongue at its base and cutting the
hyoid bones and associated structures to liberate the tongue from the
tonsils.
Issue: Several commenters stated that the proposed rule did not
make clear why APHIS would require that bovine tongues or tallow from a
BSE minimal-risk region be derived from animals that were born after
the implementation of an effective feed ban, while the same requirement
was not proposed for liver. Similarly, another commenter questioned why
the age of an animal should be a factor regarding some products from a
BSE minimal-risk region, such as meat, and not others, such as tongue
and liver. Several commenters recommended that the regulations require
that bovine liver from BSE minimal-risk regions be from cattle under 30
months of age and that certification be required that this and any
other requirements for liver have been met.
Response: Under this rule, tongues, which, as we noted, are
included in the FSIS definition of meat in 9 CFR 301.2, will be subject
to the same requirements as other meat, including the requirement that
the tongues be derived from bovines that were subject to a ruminant
feed ban during their lifetime equivalent to the requirements
established by FDA. Thus it is unnecessary for us to retain the
separate conditions for tongues that appeared in Sec. 94.19 of the
proposed rule, including the condition that the tongues be derived from
bovines that were born after the region implemented an effective ban on
the feeding of ruminant protein to ruminants. Also, as discussed in
this document under the heading ``Age of Animals from which Meat is
Derived,'' we are not including the requirement we proposed that meat
from bovines from BSE minimal-risk regions be derived from animals that
were less than 30 months of age when slaughtered. Liver, which falls
under the FSIS definition in 9 CFR 301.2 of meat byproducts, will be
subject to the same importation requirements in our rule as meat.
With regard to certification, Sec. 94.19 as proposed and as set
forth in this final rule already requires certification that the
requirements for liver and other commodities regulated under that
section have been met.
Issue: One commenter asked how APHIS could conclude that the
intestines of cattle are not safe, but the tongue and liver are.
Response: Our proposed requirement that the intestines of cattle
from BSE minimal-risk regions be removed was based on evidence that BSE
infectivity could exist in the distal ileum of bovines as young as 6
months of age. Similar infectivity has not been demonstrated in the
tongue or liver of bovines of that age.
Milk and BSE Risk
Issue: One commenter stated that milk was a dangerous prion carrier
and that milk protein is an unacceptable risk.
Response: At this time, there is no scientific evidence that milk
and milk products are sources of BSE infectivity that would pose any
BSE risk to public or animal health. Milk and milk products are
regulated by the FDA and the safety of milk is discussed in ``BSE
Questions and Answers'' that can be accessed on that agency's Web site
at http://www.cfsan.fda.gov/comm/bsefaq.html.
[[Page 499]]
Verification of Compliance in the Exporting Region
Issue: A number of commenters stated that USDA should conduct
monitoring to ensure that imported products meet the FSIS definition of
meat. One commenter recommended that APHIS specify the methods that
will be used to conduct such verification. Several commenters asked
whether APHIS or FSIS will verify the CFIA procedures necessary to
ensure compliance with this rule. Other commenters questioned whether
USDA can verify the practices of Canadian producers and the meat
industry in that country. One commenter stated that verification should
include the presence of USDA personnel in Canadian beef processing
plants.
Response: As required under the FMIA, FSIS ensures that imported
meat in the U.S. marketplace is safe, wholesome, unadulterated, and
properly labeled by (1) determining if foreign countries and their
establishments have implemented food safety system and inspection
requirements equivalent to those in the United States and (2)
reinspecting imported meat and poultry products from those countries
through random sampling of shipments. Countries eligible to export meat
to the United States must have a meat inspection system determined by
FSIS to be equivalent to the U.S. meat inspection system, including a
system for verifying that SRMs are properly identified, segregated, and
removed from meat that is exported to the United States. FSIS has a
system to verify the ongoing equivalence of each foreign country deemed
eligible to export beef to the United States. The FSIS equivalency
determination is based on the country's inspection system for
appropriately controlling the BSE-infective agent.
FSIS conducts annual system equivalence audits, as required by the
FMIA, to verify that the foreign country's inspection system remains
equivalent to that required in the United States. This audit includes a
sampling of export-certified foreign establishments. FSIS's audit
system focuses on two essential components of safe food production that
must be present in a foreign food regulatory system: (1) Industry
process control, which is executed by establishments through sanitary
procedures such as sanitation, HACCP and quality assurance systems, and
microbial/chemical testing programs; and (2) government inspection,
verification, and enforcement activities exercised in a form and at an
intensity appropriate to ensure the effectiveness of industry process
controls and detect noncompliance. Foreign food regulatory system
audits are conducted in four phases: Planning, execution, evaluation,
and feedback. Each of these phases is discussed below:
1. Planning. FSIS prepares a consolidated annual plan to audit each
country that exports meat, poultry, or egg products to the United
States. Individual country audit plans are based, in large part, upon
prior experience with the exporting country. For example, all previous
FSIS audit reports are reviewed to identify issues for inclusion in the
current audit. Port-of-entry reinspection data are also reviewed at
this time to determine trends and identify areas of special interest
for audit. These documents and data are used by FSIS to develop an
audit plan that is customized for each country. The plan includes a
list of foreign establishments selected for centralized records review.
A subset of these establishments is further selected for on-site audit.
FSIS uses a statistical method for establishment selection. Additional
establishments may be added for cause.
2. Execution. An auditor (or in some cases an audit team) is
dispatched to the exporting country's inspection headquarters and/or to
sub-offices as agreed in the audit protocol. Opening discussions are
held with exporting country officials to determine if the national
system of inspection, verification, and enforcement is being
implemented as documented, and to identify significant trends or
changes in operations. The FSIS auditor examines a sample of program
records that provide evidence of the exporting country's regulatory
activities and accompanies officials of the exporting country on field
visits to a representative sample of establishments eligible to export
to the United States. Exporting country officials conduct a review to
verify that each selected establishment continues to achieve the U.S.
level of sanitary protection. Particular attention is paid to how
eligible establishments address food safety hazards, some of which may
be different from those encountered in the United States. FSIS auditors
observe establishment activities and correlate review findings made by
exporting country officials. Selected microbiological and chemical
laboratories are also reviewed, and a farm or feedlot is visited to
verify animal drug controls. In a closing meeting, the FSIS auditor
provides exporting country officials with an overview of conditions
observed and ensures that audit observations are clearly understood.
3. Evaluation. FSIS conducts a post-audit evaluation of all data
collected on-site. When evaluating audit data, FSIS considers how
sanitary measures of the foreign food regulatory system compare to
those used in the United States and determines whether the foreign
system cumulatively provides the same level of protection.
4. Feedback. FSIS then sends the exporting country a draft audit
report and provides the country an opportunity to respond to the
audit's findings. After consideration of comments from the country, a
final report is prepared. An action plan is mutually developed to
address any issues raised by the audit. These issues are tracked by
FSIS until resolution and are automatically included as items of
special interest in the next audit.
All reports of initial equivalence audits and equivalence
verification audits are posted on the FSIS Web site (http://www.fsis.usda.gov/regulations/foreign_audit_reports_past/index.asp) when they are final, which is immediately after the final
version is delivered to the audited country.
Meat From Beef vs. Dairy Cattle
Issue: One commenter suggested distinguishing meat obtained from
beef cattle from meat obtained from dairy cattle.
Response: We are making no changes based on this comment. We are
not aware of any benefits in addressing BSE mitigations or risk that
would be derived from identifying meat as having come from beef or
dairy cattle.
Request for Import Bans
Issue: A number of commenters requested bans on certain commodities
from Canada or other countries. Commenters stated that APHIS should not
allow the importation of Canadian beef. Other commenters requested that
APHIS not allow the importation of beef (some commenters specified
ground beef) or animal feedstuffs from any country. None of these
commenters provided data or other information to support their
requests.
Response: We are making no changes based on these comments. Under
the Animal Health Protection Act, the Secretary of Agriculture (or
official delegated in accordance with 7 CFR 2.22 and 2.80) may prohibit
or restrict articles if the Secretary determines such prohibition or
restriction is necessary to prevent the introduction or dissemination
within the United States of any pest or disease of livestock. The
Secretary has determined that the
[[Page 500]]
measures in place in Canada relative to BSE, together with the import
risk mitigations required by this rule, would be effective in
preventing the introduction of BSE into the United States via meat and
meat products imported from Canada. Further, the United States, as part
of the World Trade Organization, cannot set up arbitrary barriers to
trade that would prohibit the importation of animal products if the
risk of such products introducing livestock diseases or pests into the
United States can be mitigated.
Animal feed containing animal products may currently be imported
into the United States under an import permit that sets out the
conditions for such importation. Feed containing ruminant protein other
than milk protein is prohibited importation into the United States from
any region listed in Sec. 94.18(a), which lists regions in which BSE
exists, those that pose an undue risk of BSE, and, under this final
rule, those that are considered BSE minimal-risk regions.
Offal
Issue: The regulations prior to this rule prohibited the
importation of offal from any region listed in Sec. 94.18(a). Prior to
this rule, the only regions listed in Sec. 94.18(a) were those in
which BSE exists and those that present an undue risk of introducing
BSE into the United States. As noted, however, in this final rule, we
are including in Sec. 94.18(a)(3) a list of BSE minimal-risk regions.
Paragraphs (a) and (a)(1) of the regulations in Sec. 95.4--which
deal with restrictions due to BSE on the importation of processed
animal protein, offal, tankage, fat, glands, certain tallow other than
tallow derivatives, and serum--prohibit the importation of specified
materials from regions listed in Sec. 94.18(a), unless the materials
meet conditions set forth in Sec. 95.4.
In Sec. 95.4(g) of our proposal, we set forth risk mitigation
measures under which offal derived from cervids from BSE minimal-risk
regions could be imported into the United States. However, we did not
include provisions in our proposed rule for the importation of offal
from ruminants other than cervids. The proposal was limited to cervid
offal because cervid offal was among the most commonly imported low-
risk commodities from BSE minimal-risk regions. We proposed to define
offal in Sec. 95.1 to mean the parts of a butchered animal that are
removed in dressing, consisting largely of the viscera and trimmings,
which may include, but are not limited to, brains, thymus, pancreas,
liver, heart, and kidney.
A number of commenters addressed the importation of offal other
than cervid offal for edible and inedible purposes. One commenter
recommended that the only requirement for the importation of offal from
Canada should be certification from the Canadian Government that the
fresh offal and other edible by-products are derived from bovines that
were slaughtered and processed in a facility approved and inspected by
the Government of Canada, and from which SRMs had been removed. Other
commenters expressed concern that the proposed definition of offal in
Sec. 95.1 would preclude the importation of hearts and kidneys from
cattle from BSE minimal-risk regions and recommended that such organs
be allowed importation provided they do not come in contact with SRMs.
Several commenters noted that, although the proposed regulations and
definition of offal in part 95 would prohibit the importation of liver
from cattle from BSE minimal-risk regions, the provisions in proposed
Sec. 94.19(c) provided for the importation of bovine liver from BSE
minimal-risk regions if no air-injected stunning was used at slaughter.
One commenter stated that it was not clear whether our proposed
definition of offal applied to cervids. The commenter also recommended
that the word ``trimmings'' be removed from the proposed definition of
offal because its inclusion could be construed to prohibit the
importation of meat trimmings. One commenter stated that the import
prohibitions in part 95 should apply only to tissues that have been
proven to potentially harbor the BSE infective agent.
Response: We agree with the commenters that there is no scientific
reason to limit the importation of offal from BSE minimal-risk regions
to offal derived from cervids and that the criterion for whether
products, including offal, derived from ruminants are allowed
importation into the United States should be whether those products
pose a risk of introducing BSE into the United States. Consequently, in
this final rule, we are defining offal to mean ``the parts of an animal
that are removed in dressing, including meat, meat byproducts, and
organs,'' and, for clarity's sake, are specifying in Sec. 95.4(g) the
conditions for the importation of offal from BSE minimal-risk regions.
The conditions for importation of offal from ruminants from BSE
minimal-risk regions are the same as those set forth in Sec. 94.19 of
this final rule for the importation of meat, meat byproducts, and meat
food products. We are providing in Sec. 95.4(g) that offal derived
from ruminants from BSE minimal-risk regions is allowed importation
into the United States if the offal is derived from cervids or if the
offal is derived from bovines, ovines, or caprines and the following
conditions are met:
1. If the offal is derived from bovines, the offal:
Contains no SRMs and is derived from bovines from which
the SRMs were removed;
Is derived from bovines for which an air-injected stunning
process was not used at slaughter; and
Is derived from bovines that were subject to a ruminant
feed ban equivalent to the requirements established by FDA.
2. If the offal is derived from ovines or caprines, the offal is
derived from animals that:
Have not tested positive for and are not suspect for a TSE
(we are adding definitions of positive for a transmissible spongiform
encephalopathy and suspect for a transmissible spongiform
encephalopathy to Sec. 95.1 of the regulations);
Were less than 12 months of age when slaughtered and that
are from a flock or herd subject to a ruminant feed ban equivalent to
the requirements established by FDA;
Have resided in a flock or herd that has not been
diagnosed with BSE; and
Have not had their movement restricted in the BSE minimal-
risk region as a result of exposure to a TSE.
As required for meat, meat byproducts, and meat food products in
Sec. 94.19, we are requiring certification from the country of origin
that the offal meets the above requirements and are requiring that the
offal, if arriving at a U.S. land border port, arrives at a port listed
in Sec. 94.19(g).
Tallow
Issue: One commenter stated that it does not make sense to prohibit
the importation of tallow from Canada but allow the importation of
Canadian beef and veal.
Response: The proposed rule did not prohibit the importation of
tallow from BSE minimal-risk regions. We provided in proposed Sec.
95.4(f) that tallow could be imported from a BSE minimal-risk region if
the tallow is composed of less than 0.15 percent protein and meets
certain other conditions specified in the proposal.
Issue: One commenter said there is no scientific basis for
requiring that tallow eligible for importation contain no more than
0.15 percent impurities. The commenter stated that research
[[Page 501]]
conducted by Dr. D.M. Taylor, et al., of the Animal Health Institute,
Edinburgh Scotland, failed to find an association between the
occurrence of BSE and the consumption of tallow by cattle, and that in
studies using BSE-spiked tallow, no infectivity was found in crude,
unfiltered tallow extracted from rendered meat-and-bone meal. The
commenter stated that the study was validated by injecting spiked BSE
tallow intracerebrally into experimental mice without resulting
demonstrated changes associated with TSEs. The commenter stated further
that, in 1991, the World Health Organization (WHO) assembled
consultants who determined tallow not to be a risk to animal or human
health. Additionally, stated the commenter, the Harvard-Tuskegee Study
refers to the safety of tallow.
Response: The research referenced by the commenter documents the
results of mouse assays. We are unaware of any studies that have been
performed using cattle experimentally fed tallow infected with BSE with
resulting absence of infectivity. Based on the scientific evidence
currently available, it is not possible to dismiss the possibility that
ingestion of tallow infected with BSE creates a risk of the
transmission of BSE. This conclusion is consistent with the OIE Code,
Article 2.3.13.1., which recommends that one of the conditions for the
importation of tallow from any country, regardless of its BSE status,
be that the tallow is protein-free (i.e., have a maximum level of
insoluble impurities of 0.15 percent in weight).
While WHO concluded that because of the proteinaceous nature of TSE
agents, they will tend to remain with the cellular residues of meat-
and-bone meal during the extraction process rather than being extracted
with the lipids of tallow, the EU SSC considers that possible TSE risks
associated with tallow will result from protein impurities that may be
present in the end product, because it is expected that TSE agents, if
present in the product, would be associated with those impurities (Ref
28).
Issue: One commenter specifically supported the proposed provisions
regarding edible tallow. Another commenter supported the proposed
conditions except for the requirement that the intestines of the bovine
had been removed at slaughter and the requirement that the bovine not
have been fed ruminant protein other than milk protein. Instead, said
the commenter, the requirement regarding feeding should refer instead
to adherence to the CFIA and FDA feed bans. Another commenter stated
that importation of all tallow should be prohibited. Several commenters
stated that tallow should be accepted from BSE minimal-risk regions
only if all SRMs were removed from the bovines from which the tallow
was derived, segregation of the tallow from potentially risky materials
is carried out in the region of origin, and the tallow is accompanied
by certification by the owner of the animal from which the animal was
derived that the animal was not fed ruminant protein. Other commenters
recommended that there be no restrictions on the importation of tallow
from BSE minimal-risk regions. One commenter stated that it was not
scientifically defensible to require that tallow not be derived from an
animal that died otherwise than by slaughter. Several commenters stated
that, under the OIE Code, tallow is considered protein-free if it
contains no more than 0.15 percent impurities, and that protein-free
tallow should be allowed importation without further restriction.
Several commenters said such tallow should be allowed importation no
matter what the BSE status of the region of origin. The commenters
stated further that, even if tallow intended for food, feed,
fertilizers, cosmetics, pharmaceuticals including biologicals, or
medical devices is not protein-free, it should be allowed importation
if (1) it came from bovines that were subject to ante-mortem inspection
with favorable results, and (2) had not been prepared using SRMs. One
commenter also recommended that derivatives of non-protein-free tallow
intended for the uses listed above be allowed importation without
restriction.
Response: In this rule, we are making some changes to the
requirements we proposed regarding the importation of tallow from BSE
minimal-risk regions. We agree that protein-free tallow will not pose a
risk of introducing BSE into the United States. As noted above, this
conclusion is consistent with the recommendation in the OIE Code that
protein-free tallow (maximum level of insoluble impurities of 0.15
percent in weight) be considered a commodity that may be imported
without restriction, regardless of the BSE status of the exporting
country. Therefore, we are removing the restrictions we proposed for
the importation of protein-free tallow from BSE minimal-risk regions
that could be used in animal feed, except for the requirements that the
tallow be accompanied by certification that it is protein-free and, if
arriving at a land border port, that it arrive at a port listed Sec.
94.19(g). Additionally, with the commenter who recommended segregation
of the tallow from any other risky products for BSE. We are also adding
language to Sec. 95.4(f) to indicate that the listed importation
requirements for tallow are for tallow imported into the United States
from BSE minimal-risk regions as listed in Sec. 94.18(a)(3).
Therefore, in this final rule, Sec. 95.4(f) authorizes the
importation of tallow from BSE minimal-risk regions that could be used
in animal feed, provided the tallow is accompanied by official
documentation certifying that: (1) The tallow is protein-free tallow
(maximum level of insoluble impurities of 0.15 percent in weight); and
(2) after processing, the tallow was not exposed to or commingled with
any other animal origin material. The requirements of our proposal
pertaining to the port of arrival of the shipment and the requirement
that each shipment be accompanied by an original certificate will
remain. We intend to address the importation of tallow from regions
other than BSE minimal-risk regions in future rulemaking.
Under the existing regulations in Sec. 95.4, tallow derivatives
are allowed importation from regions listed in Sec. 94.18(a) as
regions affected with BSE or that pose an undue risk of BSE. Likewise,
under this rule, tallow derivatives from BSE minimal-risk regions will
be eligible for importation into the United States.
Tallow and Offal Testing and Inspection
Issue: One commenter requested that our rule include the methods
that will be used to test or inspect at the border any tallow or offal
intended for importation into the United States from a BSE minimal-risk
region to ensure that BSE-contaminated tallow or offal does not enter
this country.
Response: For tallow or offal subject to the FMIA to enter the
United States, it must originate from a country where the inspection
system has been determined by FSIS to be equivalent to the U.S. meat
inspection system. As part of its equivalence determination, FSIS
requires that certified establishments in foreign countries eligible to
export meat product to the United States develop, implement, and
maintain written procedures for the removal, segregation, and
disposition of materials identified by FSIS as SRMs, to ensure that
such materials are not used for human food. Thus, the use of SRMs in
the production of edible tallow and offal imported into the United
States is prohibited. When shipments reach the U.S. border, they are
subject to reinspection by FSIS. Such reinspection can include review
of documentation, product examination, and laboratory testing. If the
product is not covered under the FMIA, FDA
[[Page 502]]
enforces its import restrictions applicable to those products.
Issue: One commenter recommended that the importation of any organ
meat into the United States from a BSE minimal-risk region be
prohibited.
Response: We are making no changes based on this comment. Some
bovine tissues have demonstrated infectivity, whereas others have not.
Tissues that have demonstrated infectivity are designated as SRMs and
must be removed and disposed of as inedible. The small intestine of all
cattle must also be removed and disposed of as inedible to ensure
effective removal of the distal ileum. There is no BSE basis for
prohibiting the importation of other tissue, including other tissue
that is organ meat.
Sheep Casings
Issue: As discussed above, in this rule we are adding the category
of BSE minimal-risk regions to the existing categories in Sec.
94.18(a) of regions where BSE exists or that present an undue risk of
BSE. Several commenters stated that, although our proposed rule would
allow the importation of live sheep from BSE minimal-risk regions under
certain conditions, there was no mention of amending part 96, which,
among other things, prohibits the importation of casings (bovine or
other ruminant casings) from any region listed in Sec. 94.18(a).
Because BSE minimal-risk regions will be listed in Sec. 94.18(a), said
the commenters, this will preclude the importation of sheep casings
from BSE minimal-risk regions. The commenters stated that APHIS should
address this inconsistency by amending Sec. 96.2(b) to allow the
importation of casings from BSE minimal-risk regions such as Canada.
Response: The commenters are correct that we did not address the
importation of sheep casings from BSE minimal-risk regions in the
proposed rule. We agree that sheep casings imported from a BSE minimal-
risk region that are derived from sheep that were less than 12 months
of age when slaughtered and that were from a flock subject to a
ruminant feed ban equivalent to the requirements of FDA pose no more of
a BSE risk than live sheep that meet the same conditions imported from
such a region. Therefore, we are providing in Sec. 96.2(b) that sheep
casings from a BSE minimal-risk region that are derived from animals
less than 12 months of age when slaughtered and that were from a flock
subject to a feed ban equivalent to FDA's may be imported into the
United States from a BSE minimal-risk region, provided the casings are
accompanied by an original certificate stating those conditions have
been met. The certificate must be written in English. The certificate
must be issued by an individual authorized to issue such a certificate
under the provisions of current Sec. 96.3, which contains provisions
for the issuance of certificates of animal casings from any foreign
region. Upon arrival of the sheep casings in the United States, the
certificate must be presented to an authorized inspector at the port of
arrival. We are also adding a new paragraph (d) to Sec. 96.3 to
provide that the required certification for sheep casing imported from
BSE minimal-risk regions must be included on the certification required
by that section.
Bile
Issue: One commenter expressed concern that our proposed rule did
not include provisions for the importation of bile from BSE minimal-
risk regions. The commenter stated that bile is synthesized in the
liver and recycled from the intestines back to the liver before being
stored in the gall bladder. In addition, said the commenter, bile has
very low protein content, has never been found to contain any BSE
agent, and has been classified by the EU in the same low-risk category
as milk and liver. The commenter stated that if APHIS will allow the
importation of bovine liver without regard to the age of the animal
from which it was derived, then the importation of bile should also be
allowed, because the process of collecting bile includes removing the
gall bladder from the liver before emptying it.
Response: The opinion of the European Union Scientific Steering
Committee (Ref 29) includes bile in category IV--no detectible
infectivity in a BSE-infected animal. However, because we did not
address the importation of bile from a BSE minimal-risk region in our
risk analysis for the proposed rule, we are not including bile in this
final rule as a product eligible for importation from a BSE minimal-
risk region. However, we intend to address the importation of ruminant
bile from such regions in separate rulemaking.
Blood Products
Issue: One commenter recommended that APHIS allow the importation
of blood products, including serum and products derived from serum,
from a BSE minimal-risk region, provided the product is accompanied by
certification by the exporting country that the blood was collected at
the time of slaughter in a hygienic manner from either (1) a fetus or
an animal that is less than 30 months of age; or (2) an animal older
than 30 months of age that was either a live animal or stunned with a
non-penetrating stunning device. The commenter noted that APHIS stated
in its proposed rule that infectivity has not been detected in bovine
tissues apart from the distal ileum until at least 32 months post-
exposure. As a result, said the commenter, the probability that blood
collected from animals less than 30 months of age at slaughter might be
contaminated with BSE is negligible. The commenter stated that, for
animals older than 30 months, the potential that blood might be
contaminated with BSE infectivity following stunning can be effectively
mitigated by ensuring that blood is collected either from animals
slaughtered with a non-penetrating stunning device or from live
animals.
Response: We did not address the importation of blood and blood
products from BSE minimal-risk regions in the risk analysis we
conducted for this rulemaking. Currently, conclusive science is lacking
regarding the risk of BSE transmission by blood and blood products.
Scientific studies researching TSE infectivity and blood have to date
been limited to mouse bioassay. In those studies, infectivity in mice
was not demonstrated (Ref 30). However, in studies with sheep, TSE
infectivity in blood was demonstrated. To date, there are no known
cattle studies researching TSE/BSE infectivity and blood.
Fetal Bovine Serum
Issue: A number of commenters recommended that APHIS allow the
importation of fetal bovine serum (FBS) from BSE minimal-risk regions.
Commenters stated that FBS is collected from fetuses, which, if allowed
to develop into calves, would meet the under-30-months-of-age criterion
of our proposal. Further, it is collected under a controlled system
that ensures that it is not exposed to SRMs. One commenter stated that
there have been no documented cases of transmission of BSE from cow to
fetus during pregnancy.
Response: We are making no changes based on the comments. There is
no conclusive data to indicate whether BSE is transmitted by blood or
blood products such as FBS. The commenters did not identify the uses to
which FBS would be applied. Were serum to contain infectious levels of
the BSE agent, it might pose a risk for livestock if used in certain
applications such as bovine vaccine production or bovine embryo
transfer, or for other products brought into direct exposure with
ruminants. Unless and until there is conclusive data to demonstrate
that BSE is not transmitted by blood and would
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not be a contaminant of FBS, we consider it necessary to prohibit the
importation of FBS from BSE minimal-risk regions. However, we realize
that more information is necessary on this subject, and we are working
with FDA to assess the risk from FBS and related materials and their
various uses.
Issue: One commenter recommended that, because of the need for FBS
and the potential serious consequences of BSE in FBS, APHIS should
pursue rulemaking to allow the importation of FBS under certain
conditions from countries affected with foot-and-mouth-disease.
Response: We have taken the commenter's guideline under
consideration, but consider it outside the scope of this rulemaking,
and are making no changes based on the comment in this final rule.
Gelatin and Collagen
Issue: In Sec. 94.19(j) of our proposal, we proposed to allow the
importation of gelatin from BSE minimal-risk regions, provided the
gelatin was derived from the bones of bovines that were less than 30
months of age when slaughtered and that were not known to have been fed
ruminant protein other than milk protein during their lifetime. One
commenter stated that those restrictions on the importation of gelatin
were unnecessary and that the only requirement for the importation of
gelatin from a BSE minimal-risk region should be that the bones used in
the production of gelatin did not include the skull or vertebral
columns from animals older than 30 months of age.
Response: Consistent with the changes we discuss above under the
heading ``Age of Animals from which Meat is Derived'' regarding the
effectiveness of the removal of SRMs in mitigating BSE risk, we are
removing the proposed requirement that the gelatin be derived from the
bones of bovines less than 30 months of age when slaughtered and are
requiring instead that the gelatin be derived from the bones of bovines
from which the SRMs were removed. Also, consistent with the changes we
discuss above under the heading ``Certification of Feed Ban
Compliance,'' we are revising our provisions regarding gelatin from BSE
minimal-risk regions to require that the bovines from which the gelatin
was derived were subject to a ruminant feed ban equivalent to that
established by FDA.
We are also adding language to the regulations to clarify how the
provisions regarding gelatin in Sec. 94.19(f) of this final rule
differ from the existing provisions regarding gelatin in Sec. 94.18.
The existing provisions in Sec. 94.18 have allowed the importation of
gelatin under import permit from regions in which BSE exists or that
pose an undue risk of BSE. APHIS issues such a permit only after
determining that the gelatin will be imported only for use in human
food, human pharmaceutical products, photography, or some other use
that will not result in the gelatin coming in contact with ruminants in
the United States. We are making no changes to those provisions. The
provisions in Sec. 94.19(f) of this final rule regarding gelatin from
BSE minimal-risk regions allow for the importation of certain gelatin
over and above that eligible for importation under Sec. 94.18(c)--
i.e., if the gelatin from a BSE minimal-risk region meets the
conditions of Sec. 94.19(f), it will not be limited to uses that will
not result in the gelatin coming in contact with ruminants in the
United States. To clarify this, we are identifying the gelatin
addressed in this final rule in Sec. 94.19(f) as gelatin not allowed
importation under Sec. 94.18(c). Additionally, we are making a
nonsubstantive wording change to Sec. 94.18(b) to clarify that the
only gelatin derived from ruminants from regions listed in Sec.
94.18(a)(1) or (a)(2) as regions in which BSE exists or that pose an
undue risk of BSE that is eligible for importation is gelatin that
meets the requirements of Sec. 94.18(c).
Issue: One commenter recommended that collagen also be addressed in
the regulations and be allowed importation from a BSE minimal-risk
region under the same conditions as gelatin.
Response: Collagen derived from hides is not considered a risk
(hides are exempt from most restrictions). However, collagen can be
derived from bones. In addition, collagen is not subjected to the same
extreme conditions of processing as is gelatin. We believe there is a
need for more research regarding the risk from bone-derived products
that have the potential for direct exposure to ruminants and are making
no changes based on the comment.
Issue: One commenter requested that this final rule confirm there
will be no restrictions on the importation of gelatin and collagen from
hides or skins.
Response: According to the OIE guidelines, hide-derived products
should be allowed unrestricted entry because they do not pose a BSE
risk. At this time, we allow the importation of hide-derived gelatin
and collagen under permit.
Issue: One commenter stated that all gelatin derived from the bones
of bovines should be prohibited importation into the United States
because there have been instances of people contracting vCJD from
gardening with bone meal.
Response: We are making no changes based on this comment. We assume
the commenter linked gelatin and bone meal because both products are
derived from bones.
In this rule, we are allowing the importation of gelatin from a BSE
minimal-risk region only if the gelatin is derived from bovines from
which SRMs have been removed in the exporting region, and, further,
that the bovines from which the gelatin was derived were subject to a
ruminant feed ban equivalent to the requirements established by the
U.S. Food and Drug Administration.
To date, there is no known link between bone-derived gelatin and
vCJD and we are unaware of any evidence that shows that handling bone
meal can cause vCJD. Additionally, on January 9, 2004, the Centers for
Disease Control issued a Morbidity and Mortality Weekly Report (Ref 31)
that confirms that since 1996, surveillance efforts have not detected
any cases of indigenous vCJD in the United States.
Importation of Animal Feed From Canada
Issue: Several commenters stated that the importation of feed that
contains animal byproducts from Canada should be prohibited. Another
commenter addressed the requirements in part 95 of the regulations
regarding certification for the importation of products used in animal
feed into the United States. The commenter stated that, because
obtaining original certifications for each load of feed can be time-
consuming and expensive for feed mills not located close to government
veterinary certification services, the Canadian regulations allow faxed
copies of veterinary certificates to accompany loads of feed, with the
understanding that the feed mill will keep a copy of the original on
file once it arrives at the mill. The commenter requested that APHIS
honor this form of certification for feed containing animal protein,
or, at a minimum, for feeds containing only vitamins and minerals as
the only animal source of ingredients in the feed.
Response: We are making no changes based on these comments. We did
not propose any changes to the provisions in 9 CFR part 95 regarding
the importation of meat meal and bone meal for animal feed and consider
the comments to be outside the scope of the proposal.
Issue: One commenter recommended a prohibition on the importation
of feed and feed byproducts from either of the
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two Canadian feed mills that have been associated with BSE-infection in
that country, unless such feed is submitted to routine FDA inspection.
Response: We do not consider it practical or necessary to place
restrictions on individual feed mills that may have handled high-risk
material more than 5 years ago. We consider current USDA and FDA import
restrictions on processed animal proteins from BSE countries, including
minimal-risk countries, adequate to provide the necessary protection to
public and animal health.
Plate Waste and Poultry Litter
Issue: One commenter stated that plate waste and poultry litter
have the potential of exposing ruminants to BSE infection and should be
among the materials prohibited in feed for ruminants.
Response: This final rule requires that the ruminant feed ban in
BSE minimal-risk regions be equivalent to that of FDA in the United
States. As discussed above in section III. C. under the heading
``Measures Implemented by FDA,'' in an advance notice of proposed
rulemaking issued jointly by FDA, FSIS, and APHIS on July 14, 2004, FDA
requested information to help it determine the best course of action
with regard to the ruminant feed ban.
Cooperative Service Agreements
Issue: Although Sec. 95.4 restricts the importation of animal
protein, tankage, fat, glands, tallow other than tallow derivatives,
and serum from regions where BSE is known to exist or that present an
undue risk of BSE, Sec. 95.4(c) exempts certain materials from the
restrictions under certain conditions. One of the conditions for such
an exemption is that the facility where the materials are processed and
stored have entered into a cooperative service agreement with APHIS to
pay for the costs of an APHIS veterinarian to make annual inspections
of the facility. In our proposed rule, we proposed that, for facilities
in a BSE minimal-risk region, in lieu of annual APHIS inspections of
the facility, such inspections could be carried out by the government
agency responsible for animal health in the region, although APHIS
would reserve the right to inspect as necessary. One commenter stated
that cooperative service agreements should be required for all
countries in order to maintain uniformity.
Response: We are making no changes based on the comment. In order
for APHIS to consider a region eligible for BSE minimal-risk status,
APHIS would have evaluated the region's veterinary infrastructure as
well as the risk of BSE in the region. This rule requires that
equivalent inspections be performed by the veterinary authorities of
such minimal-risk regions, thereby relieving the need for cooperative
service agreement cost recovery mechanisms for APHIS to conduct the
site inspections. As noted, however, APHIS reserves the right to
conduct site inspections as needed.
Issue: Several commenters addressed the fact that the FDA ban on
feeding ruminant products to ruminants in this country has included an
exemption allowing mammalian blood and blood products to be used in
ruminant feed. One commenter, referring to the APHIS proposed
requirement that ruminants imported into the United States not have
been feed ruminant protein other than milk protein, asked how APHIS
will handle cattle that were fed blood meal before FDA announced in
January 2004 that it will eliminate the blood and blood product
exemption. Another commenter stated that the proposed rule contained
inadequate verification that a similar tightening of restrictions will
be taken by Canada.
Response: At this time, both the United States and Canada allow the
use of bovine blood and blood products in ruminant feed. Therefore, the
feeding requirements for ruminants in Canada are currently equivalent
to those here in the United States. We are requiring in this final rule
that bovines imported from a BSE minimal-risk region have been fed in
accordance with the feed requirements that were in effect in the United
States at that time. Therefore, herd owners in minimal-risk regions
will have to meet any new U.S. feed requirements in order for their
animals to be eligible for export to the United States. As discussed
above in section III. C. under the heading ``Measures Implemented by
FDA,'' FDA has requested additional information to help it determine
the best course of action regarding the feed ban.
Importation Based on Origin of Meat
Issue: One commenter recommended that APHIS should allow the
importation of (1) meat that originated in the United States and was
processed in a BSE minimal-risk region, and (2) meat that originated in
a region not listed in Sec. 94.18 (a)(1) or (2) as a BSE-affected or
undue-risk region.
Response: Even before this final rule, the regulations in Sec.
94.18 allowed for the situations described by the commenter by allowing
the importation into the United States of meat, meat byproducts, and
meat food products derived from ruminants that had never been in a
region listed in Sec. 94.18(a). That provision would allow the
importation of U.S. origin meat that was processed in a BSE minimal-
risk region. However, the commodities must meet all other applicable
importation conditions in part 94 of the regulations.
E. Risk Basis for the Classification of Canada
Of the 3,379 comments that APHIS received on the proposed rule,
approximately 15 questioned the risk basis for the proposed
classification of Canada as a minimal-risk region for BSE. These
comments focused largely on the nature of our risk analysis; APHIS' use
of the Harvard-Tuskegee Study; whether the risk analysis provided
sufficient data and adequately considered uncertainties; the prevalence
of BSE in Canada; and whether existing regulations should be
maintained. The issues raised by these commenters are discussed below
by topic.
Nature of the Risk Analysis
Issue: One commenter stated that USDA has not presented an
appropriate risk analysis that supports the proposed action to allow
the importation of ruminants and ruminant products from Canada. The
commenter said that the risk analysis presents opinions, judgments, and
conjectures rather than relevant data and the results of transparent
and sound quantitative analysis.
Response: We disagree with the comments. We believe that our risk
analysis provides a solid basis for action by the Secretary under the
Animal Health Protection Act (7 U.S.C. 8301-8317), USDA's statutory
authority for animal health regulations, and that it meets Federal
guidelines and requirements related to rulemaking, including the
Administrative Procedure Act (5 U.S.C. 551 et seq.) and Executive Order
12866, Regulatory Planning and Review.
Experts in the field of risk analysis generally agree that
different methods of risk assessment are appropriate in different
circumstances. OIE Guidelines for Import Risk Analysis involving trade
in animals and animal products (Ref 19), for example, recognize both
qualitative and quantitative risk assessment methods as valid.
Likewise, Codex Alimentarius (Ref 32), the international standard-
setting organization for food safety, encourages the use of
quantitative information in risk analysis to the extent possible, but
provides that food safety risk analysis may be either qualitative or
quantitative.
APHIS' risk analysis, which relied on both qualitative and
quantitative
[[Page 505]]
information, including the Harvard-Tuskegee Study's quantitative
analysis of the risk of BSE spreading if introduced into the United
States (Ref 3), provided the information necessary to make informed,
scientifically sound, well-reasoned decisions for our action with
respect to Canada.
Issue: The same commenter maintained that APHIS' risk analysis
fails to answer questions about the impacts of the proposed rule on
human health, including: What is the probable change to human health
risk (i.e., frequency and severity) that would be caused by each
alternative risk management option considered (e.g., reopening the
border to less restricted imports, importing under different types of
restrictions, keeping the status quo), and how certain is the change in
health risk caused by each proposed action? Specifically, the commenter
stated that the risk analysis does not provide ``any quantitative or
substantive qualitative estimation of the frequency and severity of
adverse health effects from the different decision alternatives, beyond
undefined adjectives such as `low,' offered without any clear explicit
interpretation or any explicit verifiable derivation from data.''
The commenter stated that these questions, and analogous questions
for animal health, are usually considered essential components of a
health risk assessment. For example, said the commenter, a Joint United
Nations Food and Agricultural Organization/World Health Organization
Expert Consultation ``defines risk characterization (corresponding
approximately to what USDA terms `risk estimation') as the `integration
of hazard identification, hazard characterization [i.e., dose-response
or exposure-response relation] and exposure assessment into an
estimation of the adverse effects likely to occur in a given
population, including attendant uncertainties.' '' The commenter also
pointed to a similar definition used by the Codex Alimentarius
Commission: ``The qualitative and/or quantitative estimation, including
attendant uncertainties, of the probability of occurrence and severity
of known or potential adverse health effects in a given population
based on hazard identification, hazard characterization, and exposure
assessment.'' The commenter asserted that ``qualitative reassurances do
not constitute an adequate risk analysis.''
The commenter also stated that the Harvard-Tuskegee Study found
``available information inadequate'' to assess the risk of U.S.
consumers developing vCJD from cows or meat. The commenter said that
when maintaining the status quo will have no adverse impact on public
health, and a proposed change could have a negative impact on public
health, sound public policy dictates that the change not be made until
all information needed to adequately assess the public health risk is
available.
Response: The commenter suggested that the risk analysis for the
rulemaking answer very specific questions about the precise impacts of
the rule on human health. As the Harvard-Tuskegee Study noted, the
information necessary to quantitatively assess the risk of humans
contracting vCJD as a result of consuming BSE-contaminated food
products is not available (Ref 33). Thus, the Harvard-Tuskegee Study
quantified potential human exposure, but did not estimate how many
people might contract vCJD from such exposure. That does not mean,
however, that there is insufficient information about the potential
impacts of the rule on human health. The Harvard-Tuskegee Study
concluded that only a small amount of potentially infective tissues
would likely reach the human food supply and be available for human
consumption. As explained above, that amount was based on conditions as
they existed in 2001, before safeguards implemented recently by FSIS
and FDA, including prohibitions on the use of air injection stunning
devices at slaughter and prohibitions on the use of nonambulatory
cattle and SRMs in human food. These newly implemented safeguards, as
well as additional information that indicates that compliance with feed
restrictions in the United States is better than had been estimated,
makes it far less likely that even small amounts of infective tissue
would reach the human food supply and be available for human
consumption. Further, we know that, despite estimates that more than 1
million cattle may have been infected with BSE during the course of the
epidemic in the United Kingdom, which could have introduced a
significant amount of infectivity into the human food supply, only 150
probable and confirmed cases of vCJD have been identified worldwide.
This data suggests a substantial species barrier that may protect
humans from widespread illness due to ingesting BSE-contaminated meat.
This barrier suggests that it is unlikely that there would be any
measurable effects on human health from small amounts of infectivity
entering the food chain. We believe that this information allows an
appropriate assessment of the effects of this rulemaking on human
health.
Regarding the commenter's assertion that our risk analysis lacked
essential components and provides only qualitative assurances, we
disagree. As explained earlier, APHIS analyzed the risk of BSE being
introduced into the United States through the importation of live
ruminants and ruminant products and byproducts from Canada under the
proposed rule. In doing so, we drew on a number of sources of
information, including the Harvard-Tuskegee Study, which, as noted,
specifically and quantitatively assessed the consequences of an
introduction of BSE.
APHIS' risk analysis began with identifying the hazard as ``the BSE
risk that might be posed by importation of designated commodities and
animals into the United States from Canada.'' Carefully scrutinizing
both qualitative and quantitative information, we characterized the
hazards to animal health, public health, the environment, and trade and
evaluated the likelihood that U.S. livestock would be exposed to
infectious levels of BSE from any of the commodities that would be
allowed into the United States under the proposed rule.
Based on the hazard identification, hazard characterization
(referred to in our risk analysis using the OIE terminology, ``release
assessment''), and exposure assessment, APHIS' risk analysis then
estimated the adverse effects likely to occur--that is, we
characterized the risk. The hazard identification, release assessment,
and exposure assessment clearly indicated that it is unlikely that
infectious levels of BSE would be introduced into the United States
from Canada with any of the commodities included in the assessment, and
that, even if the BSE agent were introduced into the United States, it
would be extremely unlikely to enter commercial animal feed and thereby
infect U.S. cattle or to result in human exposure to the BSE agent.
This conclusion was based on multiple factors, each of which
reduces risk. These factors include the low number of infected animals
or products that might conceivably be imported into the United States
from Canada even without the mitigations applied by this rule, given
the import and feed restrictions in place in Canada; the low reported
incidence rate in that country coupled with Canada's active
surveillance program--both of which satisfy and exceed the OIE
guideline for a minimal BSE risk country or zone; the further reduction
in risk associated with imports as a result of the mitigation measures
imposed by this rule; the very
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low likelihood of tissue from an infected animal entering the U.S.
animal feed chain or the human food chain as a result of past and
recent safeguards imposed by USDA and FDA on slaughter practices, the
prohibitions of nonambulatory cattle and SRMs in human food, and animal
feed restrictions, both in Canada and the United States; and the very
low likelihood that any such tissue would contain infectious levels of
the BSE agent, and be present in sufficient quantities in feed consumed
by susceptible animals to cause infection.
Issue: The same commenter stated that the Secretary's own advisory
committee cautioned against making BSE-related regulatory decisions
until a more thorough scientific risk analysis is completed. The
commenter cited the Report of the Secretary's Advisory Committee on
Foreign Animal Diseases, Measures Related to Bovine Spongiform
Encephalopathy in the United States, February 13, 2004.
Response: The February 13 report to the Secretary cited by the
commenter (Ref 34) discusses a report prepared by an international
review team (IRT) that, at the Secretary's request, reviewed the U.S.
response to the case of BSE in Washington State and recommended
measures that could be taken to provide additional public or animal
health benefits. The IRT, which was established as a subcommittee of
the Secretary's Advisory Committee, delivered its report to the
Secretary's Advisory Committee on February 4, 2004. The IRT report was
titled ``Measures Relating to BSE in the United States'' (Ref 35). The
February 13 report said that the IRT's conclusions about the level of
BSE likely to be circulating in the United States and North American
cattle populations were different from those of the Harvard-Tuskegee
Study. The February 13 report stated, ``The Committee must have this
issue of risk resolved prior to completing its recommendations to the
Secretary. It is imperative that the Secretary has the best available
science and more precise risk assessments in order to make appropriate
regulatory decisions.'' The regulatory decisions referred to in the
report involve decisions by the Secretary about whether and how to
respond to recommendations of the IRT, particularly those related to
exclusion of SRMs and non-ambulatory cattle from human and animal food
supplies in the United States. The IRT also made recommendations
related to surveillance of U.S. cattle for BSE, laboratory diagnosis of
samples taken for surveillance purposes, animal identification, and
other domestic measures, such as educational programs, that could
provide additional public or animal health benefits. None of the IRT's
recommendations pertained to import restrictions. Accordingly, the
specific statement cited by the commenter is not relevant to this
rulemaking. We have responded to and are in the process of evaluating
the balance of the committee's recommendations. We, of course, agree
that sound regulatory decisions must be based on a scientifically sound
risk assessment and the best available science, and we believe we have
adhered to that standard in this rule.
APHIS' Use of the Harvard-Tuskegee Study
Issue: The same commenter maintained that the Harvard-Tuskegee
Study was prepared for purposes other than to serve as support for a
decision to allow the importation of live ruminants and ruminant
products from Canada. Moreover, said the commenter, it was prepared
before the BSE cases in 2003 and, even though the authors have updated
their analysis, none of the simulation runs or analyses were
specifically appropriate for the action that USDA propose, and none
claimed to model the current situation in Canada. The commenter said
that USDA does not explain how the Harvard-Tuskegee Study, which did
not use Canadian data, can even be used as an analytic tool to support
reclassifying Canada's risk status. At best, said the commenter, the
Harvard-Tuskegee Study should be viewed as a first-cut ``screening''
risk analysis, whose conclusions suggest the need for additional
refined risk analyses.
Response: We agree that the Harvard-Tuskegee model is not
appropriate for modeling the situation in Canada. We did not employ the
model to that end. Rather, we used the model to evaluate the likelihood
that BSE would spread if introduced into the United States from Canada.
As explained previously, the Harvard-Tuskegee Study analyzed the risk
that BSE would spread if introduced into the United States. The
Harvard-Tuskegee model doesn't specify the external source of the
infectivity, only its size and timing. Therefore, it is relevant to
evaluating the consequences of introducing BSE into the United States
from any country. In fact, because of the similarities between the
measures in place in Canada and the United States, when CFIA conducted
its assessment of the risk of BSE in Canada, it used the Harvard-
Tuskegee model as a base.
APHIS conducted a separate analysis to determine the risk of BSE
being introduced into the United States through live ruminants or
ruminant products or byproducts imported from Canada, and concluded
that it is unlikely that infectious levels of BSE would be introduced
into the United States from Canada as under the proposed rule. Drawing
on the Harvard-Tuskegee Study, then, APHIS also concluded that, even if
the BSE agent were introduced into the United States, it would be
extremely unlikely to enter commercial animal feed and thereby infect
U.S. cattle, or to result in human exposure to the BSE agent. This is
where the Harvard-Tuskegee Study is useful and directly applicable to
this rulemaking.
As discussed above, USDA commissioned the HCRA and the Center for
Computational Epidemiology at Tuskegee University to conduct what we
now refer to as the Harvard-Tuskegee Study in 1998. The objective of
the Harvard-Tuskegee Study was to analyze and evaluate the measures
implemented by the U.S. Government to prevent the spread of BSE in the
United States and to reduce the potential exposure of Americans to the
BSE agent. The Harvard-Tuskegee Study reviewed available scientific
information related to BSE and other TSEs, assessed pathways by which
BSE could potentially spread in the United States, and identified
measures that could be taken to protect human and animal health in the
United States.
The Harvard-Tuskegee Study evaluated the potential for the
establishment and spread of BSE in this country if 10 infected cows
were introduced into the United States. The Harvard-Tuskegee Study
concluded that, if introduced, BSE is extremely unlikely to become
established in the United States (Ref 36). This conclusion was based on
the estimation that ``the disease is virtually certain to be eliminated
from the country within 20 years after its introduction'' under the
model's base case assumptions (i.e., the most likely scenario) assuming
10 infected cattle were introduced into the United States. The study's
conclusions also were based on the preventive measures already in place
in the United States at the time the study was conducted. The Harvard-
Tuskegee Study also concluded that, should BSE enter the United States,
only a small amount of potentially infective tissues would likely reach
the human food supply and be available for human consumption. For the
purpose of quantifying both animal and human exposure to the BSE agent,
the Harvard-Tuskegee Study expressed the amount of infectivity in terms
of cattle oral
[[Page 507]]
ID50s. A cattle oral ID50 is the amount of
infectious tissue that would be expected to cause 50 percent of exposed
cattle to develop BSE. By tracking cattle oral ID50s in the
tissues of cattle through slaughter, processing, rendering, animal
feeding, and human consumption, the model can evaluate the human
exposures and animal health consequences of introducing BSE in imported
animals or meat.
The Harvard-Tuskegee Study concluded that, based on conditions as
they existed in 2001, the three practices that could contribute most to
either human exposure or the spread of BSE, should it be introduced
into the United States, were noncompliance with FDA's feed
restrictions, rendering of animals that die on the farm and illegal
diversion or cross-contamination of the rendered product in ruminant
food, and inclusion of high-risk tissue, such as brain and spinal cord,
in human food. As noted earlier in section III. C. in the discussion of
Federal actions since December 2003, FSIS and FDA have implemented
comprehensive safeguards that both agencies have concluded provide
exceptionally effective protection to both human and animal health, and
a higher level of protection than contemplated in 2001.
Even without these additional safeguards, however, the Harvard-
Tuskegee Study concluded that, based on conditions as they existed in
2001, if 10 infected cows were introduced into the United States, only
five new cases of BSE in cattle would be expected. In fact, the
Harvard-Tuskegee Study predicted that there was at least a 50 percent
chance that there would be no new cases at all. The extreme case (95th
percentile of distribution) predicted 16 new cases of BSE in cattle and
180 cattle oral ID50s available for potential human exposure
over 20 years. Even the highest of these predictions indicate a small
number of cases of BSE and extremely small potential for human
exposure. With the additional safeguards implemented in the United
States in 2004 (i.e., the FSIS requirement that SRMs be removed from
all cattle at slaughter and the condemnation of non-ambulatory disabled
cattle presented for slaughter), this already small potential is
reduced even further. This outcome is dramatically different from the
experience in the United Kingdom, where it is estimated that there were
nearly 1 million infected animals and millions of cattle oral
ID50s were available for potential human exposure (Ref 36).
In all cases, even the most extreme, the Harvard-Tuskegee Study
concluded that the United States is highly resistant to the spread of
BSE or a similar disease and that BSE is extremely unlikely to become
established in the United States (where establishment is defined as
continued occurrence after 20 years). Thus, APHIS' statement that the
Harvard-Tuskegee Study found that, even if BSE were to enter the United
States, it would be unlikely to spread, is an accurate representation
of the Study's findings. Again, it must be emphasized that the Harvard-
Tuskegee Study did not factor in the additional safeguards in place in
the United States today.
As mentioned earlier in connection with our revised risk analysis,
the HCRA recently updated its model using updated estimates for some of
the model parameters, based on new data about compliance with feed
restrictions. The results are even lower estimates of risk than
previously predicted. This recent revision is discussed in more detail
in the response to the next comment.
Issue: The same commenter maintained that APHIS' risk analysis
represented the Harvard-Tuskegee Study as being more definitive and
reassuring than it really is by stating that the Study found, even if
BSE were to enter the United States, that it would be unlikely to
spread. The commenter said that APHIS gave inadequate consideration to
worst case scenarios, which the commenter referred to as ``low-
frequency, potentially high health consequence events,'' and to the
sensitivity analysis in the Harvard-Tuskegee Study.
The commenter stated that the Harvard-Tuskegee Study reports that
its sensitivity analysis indicates that the predicted number of
additional cattle infected is particularly sensitive to the assumed
proportion of ruminant meat-and-bone meal (MBM) that is mislabeled and
the assumed proportion of properly labeled MBM that is incorrectly fed
to cattle. The commenter stated that the predicted human exposure is
likewise sensitive to these parameters. The commenter stated that
assigning worst case values to even two of the three sets of parameters
(demographic assumptions and MBM production; feed production; and feed
practice) is sufficient to shift the conclusion based on the base case
scenario that ``imported BSE cases will probably die out'' to
``imported cases will probably start an epidemic.'' The commenter
further stated that, even if a subset of the key drivers were assigned
values within its allowed uncertainty range, spread of BSE is highly
likely, which suggests the need for a much more thorough risk analysis.
The commenter stated that the findings of the Harvard-Tuskegee Study
should have driven USDA to commission additional refined data
gathering, development of more refined models, and consequent refined
risk analysis.
Response: APHIS is confident that it appropriately represented the
Harvard-Tuskegee Study as demonstrating that BSE would be unlikely to
spread even if it were to be introduced into the United States.
Sensitivity analysis evaluates the degree to which changes in the
data used in a model affect the model's results. The Harvard-Tuskegee
Study used a sensitivity analysis to mathematically evaluate the extent
to which variations in input data affected the modeled results,
including the likelihood that BSE would spread if introduced, rather
than die out. The Harvard-Tuskegee Study evaluated the effects of
changes when one model parameter was assigned a worst case value but
other model parameters were held at values assigned in the base case,
as well as the effects of assigning worst case values to multiple model
parameters at the same time. (The base case values represent the
Harvard-Tuskegee Study's, and USDA's, best estimates of what is likely
to be representative of conditions in the United States. Extreme case
scenarios are those in which some or all model parameters are given
worst case values; in the worst of the extreme case scenarios, all
model parameters are simultaneously assigned worst case values.)
We evaluated the Harvard-Tuskegee Study's sensitivity analysis and
extreme case scenarios and used the results as a key factor in reaching
our conclusion that the risk from importing Canadian animals and
products is very low.
According to the Harvard-Tuskegee Study, changing the value
assigned to most model parameters had only a limited influence on
results. That is, even when they were assigned their worst case values,
the results were not substantially different from what was predicted
when all model parameters were assigned their base case values.
The model parameters that had the most significant effects on the
Harvard-Tuskegee model results were: (1) The misfeeding rate
(proportion of correctly labeled prohibited feed that is incorrectly
administered to cattle); (2) the feed mislabeling rate (proportion of
prohibited feed incorrectly labeled as nonprohibited); and (3) the
render reduction factor (amount by which the rendering treatment
reduces the amount of BSE infectivity).
When Harvard-Tuskegee conducted its original analysis in 2001,
[[Page 508]]
establishing realistic bounds for the values of some of these model
parameters was complicated by the limited amount of available
information. For example, data on feed ban compliance indicated the
fraction of facilities out of compliance with the feed ban regulations,
but not the fraction of all prohibited material passing through
noncompliant facilities. Second, the data did not differentiate between
technical violations (e.g., incorrect paperwork) and substantive
violations. Harvard-Tuskegee therefore estimated the frequency of
violations indirectly (Ref 36).
Simultaneously assigning estimated worst case values to the model's
demographic model parameters (i.e., proportion of animals that die on
farm that are rendered, relative susceptibility vs. age for BSE in
cattle, and the incubation period for BSE in cattle) and all MBM
production, feed production, and feed administration model parameters
at the same time resulted in a 75 percent chance that BSE would not
become established in the United States. The ``upper tail of the
distribution'' (i.e., the 25 percent chance that BSE would spread in
the worst of the worst case scenarios) is what concerned the commenter.
To reduce uncertainty about the importance of extreme case
scenarios, we requested, as the commenter suggested, additional data
gathering and refinement of the analysis. Specifically, we asked Joshua
Cohen and George Gray at the HCRA in 2004 to refine its risk analysis
to incorporate additional, more recent data on the mislabeling of
products containing prohibited ruminant protein and the contamination
of nonprohibited feeds with ruminant protein. Cohen and Gray ran the
model using updated worst case values for model parameters related to
ruminant MBM production and feed production. No new information on the
rate of misfeeding was available, so Cohen and Gray continued to use
the same value for misfeeding as had been used previously. However,
because the misfeeding rate has the greatest influence on the predicted
number of infected cattle following the introduction of BSE into the
United States, Cohen and Gray ran multiple sets of simulations to
determine how its value influenced the predicted results. Values tested
included the original worst case value of 15 percent, as well as a
range of values below that, from 0 percent to 12.5 percent.
Cohen and Gray used the most recent FDA data to estimate
probabilities for mislabeling and contamination in MBM production
(rendering) facilities and feed production facilities. Mislabeling
occurs when a producer fails to label a product with prohibited
material (e.g., ruminant material) as ``Do not feed to cattle or other
ruminants.'' Contamination may occur when a prohibited product is
incorporated into a nonprohibited product, or when prohibited and
nonprohibited products are handled by the same facility without proper
segregation or cleaning and disinfection.
Since the publication of the 2001 Harvard-Tuskegee Study, FDA has
collected and distributed additional information on compliance with its
feed restrictions that quantifies the number of facilities out of
compliance and provides information on the nature of violations
discovered. With respect to the number of noncompliant facilities,
FDA's databases do not report the size of the facilities (i.e., amount
of material produced), so Cohen and Gray conservatively estimated that
noncompliant facilities were the same size on average as compliant
facilities. With respect to data on the nature of violations
discovered, Cohen and Gray relied on data collected by FDA before
September 2003, because it provides better detail on the nature of
violations than data collected afterward. Data collected before
September 2003 is reported as the total number of firms with at least
one violation and designates each violation as a case in which (1)
products were not labeled as required; (2) the facility did not have
adequate systems to prevent commingling, or (3) the facility did not
adequately follow recordkeeping regulations. More recent data do not
provide this level of detail.
Cohen and Gray reported their results in a June 18, 2004,
memorandum to the Agency (Ref 37). The following table (Table 2 in the
analysis) shows the original and revised assumptions for rates of
contamination and mislabeling at MBM production (rendering) facilities
and feed production facilities.
Assumptions for Mislabeling and Contamination
----------------------------------------------------------------------------------------------------------------
MBM production Feed production
-----------------------------------------------------------------------
Revised Revised
Parameter Base case Worst case worst case Base case Worst case worst case
2003 \a\ 2003 \a\ \b\ 2003 \a\ 2003 \a\ \b\
(percent) (percent) (percent) (percent) (percent) (percent)
----------------------------------------------------------------------------------------------------------------
Probability of contamination............ 14 25 1.8 16 16 1.9
Proportion of prohibited material 0.1 1 1 0.1 1 1
transferred to nonprohibited material
per contamination event................
Mislabeling probability................. 5 10 2.3 5 33 4
----------------------------------------------------------------------------------------------------------------
\a\ Values from Cohen et al. (2003)
\b\ Values developed for the 2004 assessment.
This table shows that, not only are the revised worst case
estimates for certain of the model parameters much lower than the
original worst case estimates, they are also lower than the base case
estimates.
The predicted results based on the revised estimates show, with 95
percent confidence, that BSE will not spread if the misfeeding rate is
7.5 percent or less. Even when higher misfeeding rates are assumed,
however, the results indicate that BSE spread would be very slow.
Using the terminology of the model, the value of R0
determines whether the number of BSE infected cattle will increase or
decrease over time and how rapidly. R0 is calculated based
on information put into the model, including information on the number
of infected animals slaughtered, the amount of infectivity remaining
after rendering, and the quantity of ruminant MBM that is consumed by
cattle. Values of R0 greater than 1 indicate an outcome
where the number of infected animals will increase; values less than 1
indicate an outcome where the disease will decrease and eventually
disappear. The degree to which R0 is greater than or less
than 1 is a measure of the rapidity with
[[Page 509]]
which the disease will increase or decrease.
Using even the highest estimated misfeeding rate of 15 percent,
Cohen and Gray found that the value of R0 is 1.23, only
slightly higher than 1, which indicates a very slow rate of spread in
the worst case. HCRA noted in its 2004 analysis that data to
characterize the misfeed rate would be very useful and might make it
possible to judge whether a misfeed rate of more than 7.5 percent is
even plausible. Regardless, the risk of BSE spreading at even a very
slow rate when the highest estimated misfeeding rate is used assumes
that no further mitigation measures are taken that could prevent the
disease from spreading in the cattle population. As mentioned
previously, FDA continues to conduct inspections to monitor compliance
of feed mills, renderers, and protein blenders with the 1997 feed ban
rule and has expanded the scope of its inspections to monitor
compliance with the 1997 feed ban rule.
Issue: The same commenter stated further that the Harvard-Tuskegee
Study noted that a ``true validation of the simulation model * * * is
not possible'' due to lack of direct, real world experience with
importing BSE-infected cattle.
Response: Although the Harvard-Tuskegee model is not amenable to
formal validation through controlled experiments that monitor and
measure the consequences of introducing BSE into a country, Harvard-
Tuskegee did test its model using a real world situation. As a test of
the model's plausibility, Harvard-Tuskegee modeled the small BSE
outbreak identified in Switzerland following the introduction of BSE
infectivity from the United Kingdom. Working with experts in
Switzerland, the authors identified appropriate values for model
parameters necessary to appropriately characterize that country's
practices and procedures and then simulated the introduction of BSE
infectivity. The simulation took into account risk management actions,
such as feed bans instituted by the Swiss. HCRA found that the model's
predictions were ``reasonably close to empirical observations (Ref
38),'' providing confidence in the model's structure and approach.
Issue: The same commenter stated that the need for more refined
quantitative risk analysis is further increased by the fact that the
Harvard-Tuskegee Study did not thoroughly model spatial (or other)
heterogeneity of BSE risks. In other words, the Study did not, in the
commenter's words, consider the extent to which some herds are
particularly susceptible, or if other rare conjunctions of unfavorable
conditions occur in a small fraction (e.g., less than 1 percent of
cases) of a large number of replicates (e.g., farms, processing runs,
etc.) each year in the United States, then, by chance, combinations of
worst case conditions may occur several times per year at random
locations, leading to sporadic adverse animal and human health events.
The commenter further stated that the Harvard-Tuskegee Study authors
noted something similar, stating, ``Many of the simulation results are
`right skewed, meaning that the average value often exceeds the median
(50th percentile) and can sometimes exceed even the 95th percentile.'
'' The commenter stated that while the average case is reassuring, the
extreme cases are not, and said that extreme cases need to be better
quantified. Such analysis of low frequency, potentially high health
consequence events from removing current restrictions on Canadian beef
imports appears to have been omitted entirely from any of USDA's risk
analyses, and is not fully addressed by the Harvard-Tuskegee Study,
which indicates the possibility of such events but does not address
them specifically for the Canadian situation, which was not the focus
of that study.
In summary, the commenter stated, it is not concern about the
average case or base case alone that should inform the risk analysis
component of decision making in this case, but concern about the less
likely but high consequence events and the upper tail of the risk
distribution that should be the focus of substantive analysis. Unless
some credible information is provided about how frequently adverse
events are expected to occur with and without the proposed changes, it
is impossible to make an informed judgment about whether the economic
benefits outweigh the human and animal health risks.
Response: We disagree that the Harvard-Tuskegee Study did not model
the heterogeneity of BSE risks sufficiently to allow it to provide
meaningful information for decisions about this rulemaking. We believe
that our risk analysis does provide sufficient information about the
potential for adverse events.
Specifically, the Harvard-Tuskegee Study considered differential
susceptibility of cattle with respect to age, as well as differential
infectivity by duration of infection and differential exposure by usage
type and age. In their June 18, 2004, memorandum Cohen and Gray
conclude ``There is no evidence that susceptibility differs
substantially among animals of the same age * * * [E]ven if
susceptibility does vary * * *, there is no reason to believe the
Harvard-Tuskegee model would substantially * * * underestimate the
degree to which the disease would spread * * *'' (Ref 37).
The Harvard-Tuskegee Study did not consider heterogeneity in
virulence of BSE strains, clustering of rare events within geographic
areas or affected populations, or varying susceptibility between breeds
of cattle. The commenter did not provide any evidence or data to show
that such heterogeneities exist, and we are unaware of any such data or
evidence that would allow the modeling suggested by the commenter. To
our knowledge, there is nothing in the scientific literature that
concludes that one herd or breed is more susceptible to BSE than
another. Cohen and Gray concur (Ref 37). We also note that, while
samples from a few cattle in Japan and Italy have recently demonstrated
some unusual patterns on Western blot tests, which suggests a
possibility that different strains of BSE may exist, the evidence is
far from conclusive and could be explained by other factors (Ref 39).
Thus, there is no information at this point about the existence of
different strains, much less about differences in virulence among
strains, that could be modeled. In the absence of such data or
evidence, any consideration of the potential impacts of these
heterogeneities would be purely hypothetical and speculative, and would
not provide an appropriate basis for making regulatory decisions.
However, we continue to monitor the latest scientific research, and
will certainly consider any significant information that becomes
available.
APHIS' risk analysis evaluated known BSE risks and provided a
rational, scientific basis for our classification of Canada as a BSE
minimal-risk region and for determination that the application of
specified mitigation measures would allow for the safe importation of
certain animals and products from Canada. Further, our assessment of
actions taken by the Canadian Government lead us to place Canada on the
list of BSE minimal-risk regions.
Data and Uncertainties
Issue: The same commenter asserted that USDA's recent re-analysis
(the Explanatory Note) was not adequately sensitive to data and did not
attempt to address uncertainties and that its conclusions are,
therefore, unsupportable.
Specifically, the commenter said that APHIS' conclusion and
supporting reasoning that the second case does not alter the risk
estimate ``violates
[[Page 510]]
principles of sound statistical inference and risk assessment, which
teach that observing a second adverse event in a monitored population
in a comparatively short period of time after the first observation is
informative and should significantly inform (i.e., update) data-driven
risk estimates, especially when there is a high prior uncertainty about
model parameters.''
Codex Alimentarius and other sources, said the commenter, specify
that a risk analysis should include uncertainty analysis. The commenter
said that major technical questions and uncertainties that should be
addressed and modeled include: the roles of horizontal and vertical
transmission (if any); susceptibility distribution within cattle of the
same age; variability of virulence of different new BSE cases;
proportion of infected animals in Canada (``low'' we are told, but how
long, on what basis, and with what confidence); detection probability
per case (and hence the number of true cases per observed case); the
age distribution at first infection; the latency period (and its
distribution) until expression; the potential for clustering of rate
events within geographic areas, processing plants, affected
populations, etc.; the status and extent of current and future
compliance and attendant consequences of noncompliance (such as
mislabeling, etc.) in Canada and the United States; and differences in
the likelihood of spread of BSE in different geographic areas or for
different strains of BSE, different types of cattle, etc. The commenter
maintained that these and other sources of uncertainty make initial
perceptions about risk sufficiently uncertain that the number of cases
of BSE actually detected should shape updated beliefs. When the
observed rate increases from one to two detected cases in the past
year, said the commenter, estimated risks should increase
correspondingly. (In Bayesian terms, noted the commenter, the prior
should be sufficiently diffuse or noninformative, given the above
uncertainties, so that the posterior is heavily driven by the data,
rather than by the prior * * *).
Response: We disagree with the suggestion that a second infected
cow of Canadian origin should have altered the conclusions of our risk
analysis--namely, that the BSE risk associated with importing ruminants
and ruminant products and byproducts from Canada as proposed would be
very low. Our Explanatory Note explained that a comprehensive
investigation conducted by APHIS in coordination with Canadian
authorities indicated that the second BSE-positive animal, found in
Washington State, most likely became infected in Canada before Canada's
feed ban was put in place in 1997. The apparent or reported rate of
disease is meaningful when considered in conjunction with the level and
quality of disease surveillance and from the position on the epidemic
curve. Canada is well below the reported incidence rate that the OIE
recommends for minimal-risk status (i.e., 2 detected cases per million
animals during the last 4 consecutive 12-month periods) and, with over
15,800 animals tested as of December 1, 2004, Canada far exceeds the
OIE surveillance guidelines for BSE. Further, Canada implemented import
restrictions and a feed ban prior to detection of BSE in any indigenous
animals. The downward pressure exerted by a feed ban--which the early
experience in the United Kingdom demonstrated to be substantial even if
only partially implemented--and the time of controls before detection
of the disease indicate that it is more likely that the incidence of
BSE is decreasing in Canada rather than increasing. Although the
reported or apparent incidence of BSE in Canada has increased since May
2003, we are also aware that infected animals born before the feed ban
in 1997 have entered the age when they are more likely to be detected,
given the incubation period, and that surveillance for BSE in North
America has increased. APHIS' designation of Canada or any country as a
BSE minimal-risk region is based on the sum total of a country's
prevention and control mechanisms for the disease. These include import
restrictions, surveillance, feed restrictions, epidemiological
investigations, and other measures. It is our view that these factors,
evaluated together, provide a better indication of a country's BSE risk
than any single numeric threshold criterion for BSE incidence.
Therefore, while the discovery of a second infected cow alters Canada's
reported incidence rate, the change does not affect the conclusions of
our risk analysis. Similarly, it would not have affected Canada's
categorization or classification as a BSE minimal-risk region according
to OIE guidelines. We note in particular that this rule will not allow
the importation of cattle born before Canada implemented its feed ban.
In its decisionmaking, APHIS considered both qualitative and
quantitative information. With regard to uncertainty analysis, although
APHIS' risk analysis for the proposed rule did not include a separate
section entitled ``Uncertainty Analysis,'' the analysis did, in fact,
address uncertainty throughout.
For example, in its analysis of BSE risk from imports from Canada,
APHIS' risk analysis documented and described the current state of
knowledge of BSE epidemiology based on the outbreaks in the United
Kingdom and other parts of Europe. While the analysis indicates that
BSE transmission occurs primarily through contaminated feed, it also
states that uncertainty exists as to whether this is the only mechanism
by which the disease may be spread. Having considered this lack of
certainty, APHIS errs on the side of caution by requiring further risk
mitigation measures, as discussed in the risk analysis, such as age
limitations on live animals imported into the United States. The risk
analysis states, ``* * * [A]lthough risk factors can be identified with
some certainty, individual risk mitigation measures may be difficult to
apply precisely. For example * * * it has not been established with
certainty that contaminated feed is the only pathway. Furthermore, it
cannot be assumed that there is complete compliance with a feed ban,
which is the most effective mitigation for contaminated feed.
Therefore, [APHIS] considered it necessary to mitigate risk arising
from alternate pathways or lack of compliance with a feed ban.''
The Harvard-Tuskegee Study (Ref 3), referred to in the context of
APHIS' risk analysis, uses probability distributions. That Study
includes probability distributions for many of the model's parameters,
including the age at which animals first become infected, the
incubation period of BSE, and the level of compliance with a feed ban.
Use of these probabilistic input parameters allows the results of the
Harvard-Tuskegee Study to be expressed probabilistically, thereby being
explicit about the implications of several key sources of uncertainty
inherent in the model.
We did not attempt to estimate the number of BSE-infected animals
that might be imported into the United States under this rule. We have
confidence in Canada's BSE control measures and the rule's required
mitigation measures and note, further, that BSE incidence and
surveillance in Canada are well within the OIE guidelines for BSE
minimal risk. We note further that the Harvard-Tuskegee Study concluded
that, even if a small quantity of infectivity were introduced into the
United States, it is not likely to cause the establishment of BSE.
With respect to the commenter's assertion that there is so much
uncertainty about the situation in
[[Page 511]]
Canada that detection of the second infected cow should be given
significant weight in shaping our beliefs, we disagree that we failed
to adequately consider the data or to give appropriate weight to the
detection of BSE in a second cow of Canadian origin.
Although the commenter suggests that APHIS should have used a
Bayesian technique in estimating the prevalence of BSE in Canada, such
a technique would have started with the same information base-it would
have been informed by the available historical surveillance data,
including that acquired since implementation of the Canadian feed ban
and import restrictions, which would be relevant to the current
prevalence estimate. The projected trajectory of the disease is down,
because of the downward pressures the measures have been shown to exert
on the incidence of disease in such a region. We know that Canada had
two indigenous cases of BSE in an adult cattle population of 5.5
million (a reported incidence rate that is well within the OIE
guidelines for a minimal-risk country). Even before the discovery of
two Canadian-origin animals with BSE, we had information from both
active and passive surveillance about the prevalence of BSE in Canada
and we would have used that information to construct a prior
distribution. Finally, we note Canada has tested thousands of animals
for BSE, and Canadian surveillance since the most recent detected case
has increased significantly. As of December 1, 2004, Canada had tested
over 15,800 animals in 2004 with no additional BSE cases found.
Issue: The same commenter stated that USDA should conduct a risk
analysis that, in addition to addressing the uncertainties already
listed in the comment concerning the second case, addresses the
following:
Exposure
What is the probable prevalence of BSE in Canada now and
in the future under the proposed conditions. The modeling should
explicitly document the data and assumptions used to answer it,
specifically including compliance rates with any existing or future
management strategies such as feed bans.
What is (and has been) the likely age distribution of BSE
infections among Canadian ruminants over time? A variety of models from
the United Kingdom and Japan address the issue of ``hidden''
(unobserved) prevalence and the age distribution of unobserved cases.
Exposure-Response
What is the probability distribution for R0
(R0 being the likelihood that the disease will amplify or
diminish over time)?
What is the frequency distribution of R0 in
different herds/locations/populations in the United States where
Canadian ruminants might be imported?
Risk Characterization
How much would the probability of a U.S. epidemic in the
next 10 years increase if Canadian ruminants are imported under the
proposed conditions? (This is driven by the probability that
R0 > 1 and the expected time until the first BSE import
starts an epidemic.)
If R0 < 1, then how would the equilibrium level
of sporadic outbreaks or cases in the United States increase if
Canadian ruminants are imported? What is the total harm per outbreak?
Putting these two together, what is the increment (mean and variance)
in flow of harm per unit time from allowing the imports?
Response: A thorough discussion of why it is not necessary to
determine a precise numeric measurement of prevalence of BSE in the
Canadian cattle population follows, under the heading ``Prevalence of
BSE in Canada.''
The commenter's other points seek to determine the likelihood of
different scenarios occurring, given changes in variables. As explained
previously, APHIS largely based its conclusions about the likelihood of
BSE spreading if introduced into the United States on the Harvard-
Tuskegee Study. The Harvard-Tuskegee Study evaluated the effects of
changes when one model parameter was assigned a worst case value but
other model parameters were assigned base case values, as well as the
effects of assigning worst case values to multiple model parameters at
the same time. We are confident that the extreme scenarios presented by
Harvard-Tuskegee are extremely unlikely to occur and that the base case
represents the most likely scenario given the available information.
Cohen and Gray's memorandum (Ref 37), discussed in response to a
previous comment, substantiates this. Second, we are confident that,
even if the most extreme case occurred, few cases of BSE would result
and even fewer cases of vCJD. Again, this is substantiated by Cohen and
Gray's memorandum, which indicates that even in the most extreme case,
the disease will still spread very slowly, leaving time to intervene.
Neither the Harvard-Tuskegee Study nor the Cohen and Gray memorandum
considered recently strengthened safeguards on slaughter practices,
including a ban on the use of air injection stunning devices,
requirements for removal of SRMs, and a ban on the use of nonambulatory
cattle in human food, that would provide further increases in
protection for human and animal health.
Issue: The same commenter stated that APHIS' assertion that it is
unlikely that BSE would be introduced from Canada under the proposed
rule is not the result of any rational analysis based on independently
verifiable, explicit calculations from data. In fact, said the
commenter, applying the methods of the Harvard-Tuskegee Study, some BSE
imports would be expected under the proposed rule if the age
distribution of BSE in beef and the probability of erroneous labeling
or routing put at least some positive probability, even if only 0.0001
percent per animal, on such an import.
Response: We disagree with the comment and with the assumption
inherent in it. Our decision and the critical evaluation and analyses
on which it is based are scientifically sound and entirely consistent
with our statutory authority. APHIS, and indeed all regulatory
agencies, are called upon each day to make informed and reasonable
decisions without numerical calculations. APHIS has made such decisions
for years. Although rigorous experimental research, which forms the
scientific basis for determining which tissues harbor the BSE agent in
infected cattle, can be fed into computer modeling, it is not necessary
in all cases to base decisions on numerical calculations. There is a
wide body of independently verifiable scientific evidence regarding
BSE, including how to control and eliminate the disease. Based on
qualitative and quantitative evidence, we have concluded that the risk
associated with imports under this rulemaking is very low. Regarding
the commenter's second point, we did not assert that there is zero
probability that BSE would be introduced from Canada under the
conditions we proposed. Rather, we concluded that such imports are
unlikely. Furthermore, the Harvard-Tuskegee Study demonstrated that,
even if a small amount of infectivity were introduced into the United
States, it would be unlikely to spread and result in the establishment
of BSE. In accordance with the Animal Health Protection Act, the
Secretary has concluded quite reasonably that restrictions on the
importation of ruminant meat and meat products from Canada, but not
prohibition of those
[[Page 512]]
commodities, is necessary to prevent the introduction of BSE from
Canada.
APHIS carries out an array of animal and plant health regulatory
programs, governing both domestic and imported commodities. In none of
these programs, many of which have been in place for years, is it
possible to assure that there is zero risk. Indeed, were we to make
trade dependent on zero risk, foreign, as well as interstate, trade in
animals and animal products would cease to exist.
Issue: The same commenter quoted APHIS as stating that,
``[a]lthough the BSE-infected cow in Washington State was more than 30
months of age when diagnosed, it was obviously not imported under the
conditions of the yet-to-be-implemented proposed rule and would not
have been allowed to be imported under the proposed rule.'' The
commenter said that USDA has not shown it is impossible for BSE to
occur in some cattle less than 30 months of age or that some cattle
older than 30 months of age might be inadvertently imported.
Response: As discussed above, the epidemiological investigation
conducted by APHIS and others following the detection of BSE in a cow
in Washington State in December 2003 indicated that the cow was born in
Canada early in 1997 before Canada initiated a feed ban. This animal
and all others born before Canada's feed ban would now be at least 7
years old. Because the rule requires that all cattle imported into the
United States from Canada be less than 30 months old, no animals born
before Canada's feed ban will be allowed to enter the United States
under this rule. Furthermore, the rule also requires that cattle
imported from Canada be slaughtered before they are 30 months of age.
In actual practice, because cattle imported into the United States from
Canada will be coming in for slaughter or for feeding and slaughter,
the large majority will be less than 24 months of age (most male cattle
are slaughtered before 24 months of age). FSIS has established
procedures for checking an animal's age at slaughter through records
and/or dentition. These procedures apply to both domestic and imported
cattle and we are confident they are effective in determining age. The
appropriate SRMs based on age will be removed from any cattle that are
determined to be 30 months of age or older based on those procedures,
and APHIS will take enforcement action as necessary.
With regard to the possibility that BSE could occur in cattle
younger than 30 months of age, research demonstrates that the shorter
incubation period (i.e., infection developing in less than 30 months)
is apparently linked to younger animals receiving a relatively large
infectious dose (Ref 40). The younger cases have occurred primarily in
countries with significant levels of circulating infectivity.
Specifically, BSE was found in animals less than 30 months of age in
the United Kingdom in the late 1980's to early 1990's, when the
incidence of BSE was extremely high. This research also suggests that a
calf must receive an oral dose of 100 grams of infected brain material
containing high levels of the infectious agent to produce disease
within a minimum of approximately 30 months (Ref 40). All available
evidence leads to the conclusion that the level of infectivity in the
Canadian cattle population is low and that compliance with the feed ban
is high. Further, infectivity in animals younger than 30 months has in
most cases been confined to tonsils and distal ileum, both of which
would be removed at slaughter in the United States.
Prevalence of BSE in Canada
Issue: The same commenter specifically argued that APHIS should
present quantitative evidence of the true prevalence of BSE in Canada
and that the risk analysis for the rule should take this into account.
The commenter said that the risk analysis only discusses the prevalence
of BSE in Canada in vague, subjective terms such as ``very low'' and
``unlikely'' to generate cases in the United States, but that recent
history now suggests that figure is 100 percent. The commenter asserted
that more quantitative information is needed on the likely prevalence
of BSE infections in Canadian ruminants and ruminant products that
would be imported under the proposed rule (true prevalence, not just
detected or qualitatively perceived). How likely is it, asked the
commenter, that BSE prevalence in Canada could be 0.01 percent or 0.1
percent, or 1 percent, given current and prior testing? The commenter
stated the belief that available data could help provide useful upper
bounds.
Response: We disagree with the comment. Precise measurement of true
prevalence of BSE is difficult to achieve, given the constraints of
current testing methods available. It should be noted that no country
in the world is attempting to officially define the true prevalence of
BSE in its entire cattle population. Reports of incidence rates are
indications of detectable levels of disease. Current testing
methodology can only detect BSE, at the earliest, a few months before
an animal exhibits clinical signs and, therefore, limits the ability to
measure true prevalence in the entire cattle population. Data obtained
through targeted surveillance can be extrapolated to make inferences
about prevalence in broader populations as necessary. However, a
specific calculation of true prevalence of BSE is not necessary to
determine whether risk management policies or control policies are
appropriate or need to be changed, and the importance of determining an
exact prevalence rate should not be overstated.
We also disagree with the commenter's assertion that APHIS needs to
establish a more precise estimate of the true prevalence of BSE in
Canada for this rulemaking. Our risk analysis presented compelling
evidence that the prevalence of BSE in Canada is low. The absence of a
precise numeric measurement of prevalence of BSE in the Canadian cattle
population is not an absence of information to inform estimates. As we
have stated, we will use a combined and integrated approach that
examines the overall effectiveness of control mechanisms in place when
evaluating a country for BSE minimal risk. We believe that such an
evaluation will provide a better indication of a country's BSE risk
than simply a numeric threshold for BSE incidence or prevalence.
The threshold for incidence set by OIE for BSE minimal-risk regions
is less than 2 cases per million cattle over 24 months of age during
each of the last four consecutive 12-month periods. There have been two
cases of BSE in Canadian-origin cattle since May 2003 out of an adult
(over 24 months of age) cattle population of 5.5 million (0.4 per
million) and no cases before May 2003. While we recognize that the
number of detected cases does not, by itself, allow for a determination
of prevalence, the number may be taken as a strong indication in
countries with active surveillance that the mitigation measures in
place to prevent the introduction and spread of BSE are working, thus
prevalence is likely to be low. As we have discussed elsewhere, this is
the case in Canada, which has had strict import controls in place since
1978 and instituted its feed ban, equivalent to that of the United
States, on the same date as the United States in August 1997. Canada
has also conducted surveillance for BSE since 1992 and has met or
exceeded OIE guidelines for surveillance since 1995. It should be noted
that OIE guidelines refer to the reported incidence of BSE infection or
levels of detectable disease.
The commenter is incorrect in asserting that recent history
suggests that Canadian imports are 100 percent likely to generate cases
of BSE in the United States. While our risk analysis
[[Page 513]]
evaluated whether an infected ruminant or ruminant product from Canada
might be imported, and concluded that the risk was considered ``low,''
that risk was considered in the context of the proposed mitigation
measures. In addition, the risk analysis considered the likelihood that
such an animal or product would spread the disease to other animals
within the United States; in other words, whether the imported source
of infectivity would generate new cases within the United States.
Issue: The same commenter asserted that the HCRA's ``Evaluation of
the Potential Spread of BSE in Cattle and Possible Human Exposure
Following Introduction of Infectivity into the United States from
Canada'' (Ref 10) (referred to below as the Canada Study) contradicts
the statement in APHIS' risk analysis that the prevalence of BSE in
Canada is ``low.'' According to the commenter, the Canada Study states
that the prevalence of BSE in Canada cannot be determined because of
the absence of strong evidence about the prevalence of BSE in the
Canadian herd. The commenter also took issue with a statement we made
that, although a second case of BSE was detected in an animal of
Canadian origin, the total number of diagnosed cases attributed to that
country remains low. According to the commenter, this statement is
irrelevant and misleading. The commenter said that what matters for
risk assessment purposes is the occurrence rate per unit time, not the
total (cumulative) number ever diagnosed, and that two diagnosed cases
in less than 1 year is not self-evidently a ``low'' rate.
Response: APHIS' assessment of the prevalence of BSE in Canada was
related to the small number of cases detected through an active
surveillance program, and was not contingent upon there being only one
case. The statement from the Canada Study that the prevalence of BSE in
Canada cannot be determined is taken out of context and used by the
commenter to imply that no judgment about the prevalence of BSE in
Canada may be made. The Canada Study actually stated that, in the
absence of strong evidence about the prevalence of BSE in the Canadian
herd, the authors chose to posit a hypothetical introduction of five
BSE-positive bulls into the United States instead of calculating a
probability of such an introduction. The model used by the HCRA was not
set up to gauge the probability of the introduction of BSE into the
United States, but rather to calculate the outcome if the BSE agent
were introduced. Moreover, the unavailability of precise data for a
quantitative estimate of the prevalence of BSE in Canada does not
preclude an evaluation and judgment about the prevalence of BSE in
Canada. APHIS proposed to classify Canada as a minimal-risk region
after considering substantial evidence about the BSE situation in that
country, including information on the incidence of cases of BSE and
level of surveillance, as well as other relevant factors such as the
quality of Canada's BSE surveillance program and its veterinary
infrastructure.
Issue: The same commenter stated that, until the source of
contaminated feed for the two cows is determined, it is not possible to
determine whether infectivity occurred before or after the feed ban was
implemented in Canada because of the animals' ages and the 2-8 year
incubation period for BSE. The commenter asserted that, if the
infectivity occurred after the feed ban was implemented, this suggests
a continuing risk of BSE in younger Canadian cattle. The commenter
therefore maintained that APHIS must determine the source of the
contaminated feed or test more representative samples of Canadian
cattle to conclude that the prevalence of BSE in Canada is low.
Specifically, said the commenter, Canada plans to test 8,000 head in
the next 12 months under limited surveillance; it should be required to
test all cattle over 24 months of age for 2 years. The United States
should not relax restrictions for countries of unknown prevalence.
Response: As discussed previously, we disagree that Canada is a
country of unknown prevalence for BSE or that a precise measurement of
prevalence must be made before cattle from Canada are allowed to be
imported into the United States. As determined by the epidemiological
investigations conducted after their detections, both the May and
December 2003 cases of BSE involved cows born before Canada implemented
its feed restrictions. Both cows were most likely to have become
infected by consuming contaminated feed at very early ages, most likely
before the feed ban was implemented.
Animals born before Canada's feed ban would now be at least 7 years
old. At this stage of the incubation period, most remaining cattle
infected before the feed ban was implemented would be symptomatic. In
light of the active surveillance program in Canada, as well as
restrictions on the slaughter of animals with symptoms compatible with
BSE, any such infected cattle are likely to be detected and to be
eliminated from the food chain. Because this rule requires that all
cattle imported into the United States from Canada be less than 30
months old at the time of importation and slaughter, no animals born
before Canada's feed ban will be allowed to enter the United States
under this rule. The age of cattle can also be verified at the time of
slaughter through records and/or dentition. As noted above, the
appropriate SRMs based on age will be removed from any cattle that are
determined to be or suspected of being 30 months of age or older and
enforcement action will be taken as necessary by APHIS. Further, as
noted in response to a previous comment concerning the possibility that
BSE could occur in cattle younger than 30 months of age, infectivity in
such young animals has been associated with a high incidence of
infectivity in the cattle population where the animal originates. This
is not the case with Canada. Further, infectivity in animals younger
than 30 months has in most cases been confined to tonsils and distal
ileum, both of which would be removed at slaughter in the United States
and Canada.
Issue: One commenter stated that the APHIS risk analysis builds
upon the Harvard-Tuskegee Study's conclusion that the introduction of
BSE into the United States would be an unlikely event. However, the
fact that the remains of the December 2003 cow are known to have
entered the food chain renders APHIS' risk analysis relative to human
health issues nonapplicable and outdated.
Response: We disagree. The Harvard-Tuskegee Study did not address
the likelihood of the introduction of BSE infectivity into the United
States. However, the Harvard-Tuskegee study did conclude that, even if
a small amount of BSE infectivity were introduced into the United
States, the disease is unlikely to spread and become established. We
are confident that the incidence of BSE in U.S. cattle, if any, is and
will remain extremely low.
The epidemiological investigation that was conducted following
detection of an imported cow in Washington State (Ref 4) determined
that the animals was born before implementation of a ban in Canada on
feeding mammalian protein to ruminants and was most likely to have
become infected before that feed ban was implemented. Additionally, the
investigation determined that the animal was imported into the United
States in 2001 at approximately 4 years of age, was more than 30 months
of age when diagnosed, and clearly would not have qualified for
importation under the provisions of this final rule.
To date, BSE has never been confirmed in indigenous U.S. cattle. We
cannot state with certainty that BSE will
[[Page 514]]
never occur in indigenous animals or that material from BSE-infected
animals will never enter the human or bovine food supply. We note,
however, that an interim rule published by FSIS on January 12, 2004,
excludes all non-ambulatory disabled cattle and all SRMs, regardless of
the health status of the animal from which they are taken, from the
human food supply. In addition, FDA has banned any material from non-
ambulatory cattle and SRMs from all cattle from FDA-regulated human
food, including dietary supplements, and cosmetics. These rules and
other Federal measures described previously ensure stringent protection
of the U.S. food supply.
Issue: One commenter said that the term ``isolated cases'' used in
the March 4 request for comment is very subjective and asked how we
could use the word ``isolated'' when we do not know the prevalence of
the disease in the Canadian national herd. The commenter stated that we
should clarify what we meant so that appropriate comment could be
provided on whether to allow high-risk, over 30-month-old, animals into
the United States. The commenter stated further that USDA should not
relieve restrictions on imports from Canada until Canada tests a
significant percentage of its cull animals, with a major emphasis on
the highest risk animals, over the next 2-5 years, without any
significant positive findings.
Response: The terms ``isolated cases'' and ``isolated'' were not
used in the March 2004 notice or the Explanatory Note., nor did APHIS
propose to allow the importation of any live cattle over 30 months of
age from Canada.
Finally, as discussed in response to several comments, we do not
believe it is necessary to wait to relieve restrictions on imports from
Canada until such testing as the commenter suggests has been conducted.
Although active surveillance must be conducted to ensure that
prevention and control measures implemented by a country are providing
adequate protection, there is sufficient evidence already, based on
nearly a decade of active surveillance in Canada at levels that have
met or exceeded OIE guidelines, for us to conclude that Canada's
prevention and control measures have been effective.
Issue: One commenter said that the discovery of a Canadian cow with
BSE in Washington State, coupled with the previous finding of a BSE cow
in Alberta, indicates that the Canadian feed supply was contaminated as
late as 1997. The commenter stated that the infected cattle were from
two different herds and utilized different feed sources and concluded
that other infected cattle undoubtedly exist. The commenter also
concluded that since both the United States and Canada have been doing
surveillance for several years without a diagnosed case, these cases
must be considered as the first cases to appear on the epidemiological
curve. The commenter stated further that the epidemiological curve for
BSE is an extended one and must be considered at this time likely to
continue for several more years, perhaps 5 to 10, and that no Canadian
cattle should be allowed to enter the United States until sufficient
time has elapsed for any remaining infected cattle to be identified and
removed from the Canadian cattle population.
Response: We disagree with the comment. While it is possible that
additional BSE-infected cattle may exist in Canada, we have confidence
that if such cattle do exist the number is small. First, Canada has not
imported ruminant MBM from any country with BSE since 1978 (Ref 12).
Second, Canada has prohibited the feeding of ruminant MBM to ruminants
since August 1997, and CFIA has verified high levels of compliance with
the feed ban by routine inspections of both renderers and feed mills
(Ref 12). Third, Canada has traced and destroyed all remaining cattle
imported from the United Kingdom (Ref 12). Fourth, Canada has traced
and destroyed the majority of the cattle that comprised the birth
cohorts of the two Canadian BSE cases (Ref 11 and 13). Fifth, Canada
has conducted surveillance for BSE since 1992 and has conducted
targeted surveillance at levels that have met or exceeded OIE
guidelines since 1995 (Ref 12 and 13).
Even if BSE-infected cattle do remain in Canada, they are likely to
be older animals that were exposed before Canada's feed ban in 1997.
Because this rule requires that imported animals be less than 30 months
old, such animals could not legally enter the United States under this
rule. Even if an infected cow did enter the United States, the Harvard-
Tuskegee Study indicates it would be unlikely to lead to the spread of
BSE in cattle or to human exposure to the BSE agent.
Regarding the suggestion that the two BSE-infected Canadian cows
must be considered as the first cases to appear on the epidemiological
curve, we disagree. The evidence strongly indicates that the two
Canadian cases do not represent the beginning of a multi-year,
exponentially expanding outbreak such as occurred in the United
Kingdom. In the United Kingdom, where BSE was first detected, measures
to prevent and control the spread of the disease were implemented only
after the disease had reached epidemic proportions. In countries such
as Canada, where effective measures were implemented before detection
of any case of BSE, and well before detection in any indigenous animal,
the situation is quite different. The best scientific evidence from the
United Kingdom and other countries is that BSE is spread primarily by
contaminated feed and that prohibiting the feeding of ruminant-origin
protein to ruminants prevents disease spread. Canada has had such a
feed ban for over 7 years. While a few older animals born before Canada
initiated its feed ban may have been exposed to BSE and may yet develop
clinical signs, Canada has taken every necessary step to prevent an
epidemic. While additional cases may occur in cattle born before
implementation of Canada's feed ban, the epidemiological evidence
indicates the number of new cases, if any, will be limited by the
downward pressure of the comprehensive mitigations in place.
Issue: One commenter stated that, because the source of infection
has not been identified for either BSE-positive cow of Canadian origin,
the possibility exists that more asymptomatic cases may be present in
Canadian herds, and that additional BSE-positive cattle have already
gone to slaughter. The commenter stated that APHIS should not relieve
restrictions on importations from Canada in the midst of an outbreak of
uncertain size. Another commenter expressed concern that Canada
admitted to identifying two feed mills not in compliance with the
mandate to cease mixing mammalian tissue into cattle feed. The
commenter stated that these mills were the source of the feed that led
to the two identified cases of BSE in Canadian cattle.
Response: As we stated in the March 2004 Explanatory Note to our
risk assessment, epidemiological evidence indicates that both of the
BSE-infected animals of Canadian origin were born before implementation
in that country of a ban on the feeding of ruminant protein to
ruminants, that they were most likely exposed to the BSE agent through
consumption of contaminated feed, and that epidemiological follow-up
has identified the feed mills where the contaminated feed most likely
originated.
From an epidemiological standpoint, it would be virtually
impossible to definitively pinpoint a ``source of infection'' that
occurred over 7 years ago. Canada has, however, evaluated the various
potential sources of infection and has concluded that the source of
[[Page 515]]
infection was most likely a bovine imported from the United Kingdom in
the 1980's.
We agree it is possible there may be other asymptomatic BSE-
infected animals in Canada. However, because the two BSE-infected
animals were born before the feed ban, there is no evidence to suggest
that the feed ban is ineffective. The feed mills identified as having
provided possibly infected feed most likely distributed that feed
before the ban was implemented. The feed mills complied with CFIA feed
ban regulations after they were implemented and have a good compliance
record based on CFIA inspections. CFIA indicates that with respect to
the inedible rendering sector, full compliance with the feed ban
requirements has been consistently achieved, and that with respect to
the Canadian commercial feed industry, non-compliance of ``immediate
concern'' has been identified in fewer than two percent of feed mills
inspected during the period April 1, 2003, to March 31, 2004. Those
instances of noncompliance of ``immediate concern'' are dealt with when
identified (Ref 11). According to CFIA, non-compliance of immediate
concern includes situations where direct contamination of ruminant feed
with prohibited materials has occurred, as identified through
inspections of production documents or visual observation, and where a
lack of appropriate written procedures, records, or product labeling by
feed manufacturers may expose ruminants to prohibited animal proteins.
An effective feed ban is an important part of the mitigation
measures proposed for the importation of ruminants and ruminant
products from a BSE minimal-risk region. However, the feed ban is not
the sole mitigation in this rule. In addition to the risk-mitigating
effect of the feed ban, importations of cattle and cattle products will
also be subject to the import restrictions described in this rule.
Those restrictions are based on the scientifically demonstrated
likelihood of the BSE agent residing selectively in various tissues of
animals of specified species and ages. Based on our analysis of the
risk of such importations, it is highly unlikely that the BSE agent
will be transmitted to the cattle population of the United States or
into the U.S. human food supply through ruminants or ruminant products
or byproducts imported into the United States under this rule.
Additionally, the rule prohibits the importation of any cattle 30
months of age or older, which includes cattle born before Canada
implemented its feed ban. This age restriction was not in place when
the cow that was detected as positive for BSE in December 2003 was
imported into the United States.
Issue: One commenter expressed concern that some cattle under 30
months of age and, therefore, eligible for importation from Canada
under the proposed rule, might be offspring of cattle born before the
feed ban (and thus offspring of potentially infected cattle). The
commenter noted that Canadian officials indicated that 68 British
cattle that died or were slaughtered in Canada more than 10 years ago
are the probable source of the original BSE infection in Canada. The
commenter stated that current OIE guidelines do not recommend the
immediate culling of offspring in the case of index or cohort animals,
provided they are excluded from food and feed chains at the end of
their lives. The commenter stated that until all animals born in Canada
before the feed ban have been properly identified, as well as their
offspring, the risk of importing one of these animals into the United
States remains a risk that USDA has not adequately recognized. Other
commenters also stated that there are likely additional undetected
cases of BSE in Canada resulting from exposure to contaminated feed and
that we should not relieve import restrictions at this time. One
commenter stated that there are still breeding cattle alive in Canada
that may have been exposed to the similar infectious material as the
two BSE-positive cows identified in Alberta, Canada, and Washington
State.
Response: We disagree that the possible presence of additional
animals in Canada, infected before implementation of the Canadian feed
ban, present risks that have not been addressed for this rulemaking. As
stated in responses to several other comments, it is possible that
cattle born before Canada initiated its feed ban in August of 1997 may
still exist in Canada. Because these cattle are now 7 years old or
older, this rule will not allow them to be imported into the United
States. Offspring of such cattle, which may be eligible for
importation, are not likely to be infected with BSE. Although some
evidence suggesting maternal transmission exists, such transmission has
not been proven and, if it occurs at all, it occurs at very low levels
not sufficient to sustain an epidemic (Ref 41). Canada has conducted
extensive investigations of both of the two known BSE-infected animals
in Canada and culled all of those animals' herdmates and offspring, all
of which tested negative for BSE. Based on the low prevalence of BSE in
Canadian cattle combined with the unlikely occurrence of maternal
transmission, we concluded that cattle eligible for importation from
Canada under this rule are highly unlikely to have BSE. Breeding cattle
of any age may not be imported into the United States from Canada under
this rule.
Issue: One commenter stated that Canada has offered no scientific
proof that it has either contained or eradicated BSE from its cattle
herd, and that the two BSE-infected cattle detected were discovered
despite a very limited testing program in effect in both the United
States and Canada at the time.
Response: We disagree. We believe Canada has established through
import restrictions, a rigorous feed ban and ongoing surveillance that
BSE is contained and that the necessary mitigation measures are in
place to detect and prevent the dissemination of BSE infected material
and eradicate the disease. Our rule is not predicated on eradication of
BSE from a region. Canada meets our requirements for a minimal-risk
region in part because the country has had an active, targeted
surveillance program since 1992, and has exceeded OIE guidelines for
BSE surveillance for more than the past 7 years. Additionally, as
discussed above, Canada has significantly broadened that surveillance
program.
Issue: One commenter stated that, because BSE has a long latency
period, it is not possible to know at present the exact disease status
of Canada.
Response: We concur that at present it is not possible to know with
certainty whether any additional cows in Canada are infected with BSE.
However, as documented in our risk analysis, we have concluded that the
surveillance, prevention, and control measures implemented by Canada,
in combination with the import restrictions imposed by this rule, will
comprehensively mitigate the risk of introducing BSE into the United
States through imported Canadian-origin animals and animal products.
Whether Existing Regulations Should be Maintained
Issue: One commenter stated that APHIS has not demonstrated that
the current regulations applicable to regions where BSE exists are not
necessary in all cases. According to the commenter, the Harvard-
Tuskegee Study said import restrictions and the feed ban in the United
States were the two most important reasons the United States was
unlikely to have BSE. The commenter maintained that these regulations
are essential now that BSE has ``crossed the Atlantic'' and pointed out
that most
[[Page 516]]
countries that have reported a single case of BSE in a native animal
have had additional cases either the following year or within the next
several years. The commenter further stated that, according to the
Harvard-Tuskegee Study, if BSE were introduced into the United States,
it would be eliminated within 20 years, but only if the conditions
affecting the spread of BSE remained unchanged for the 20 years
following its introduction. The commenter maintained that time frame is
not acceptable. The commenter stated that the regulations should not be
relaxed without a comprehensive scientific evaluation of the
implications of such relaxation. The commenter further recommended that
APHIS immediately upgrade its present safeguards and restrictions for
all imported beef and cattle and mobilize all its available resources
to vigorously enforce these restrictions. One other commenter also
noted the Harvard-Tuskegee Study's statement that the ban on the
importation of live ruminants and ruminant MBM is the most effective
measure for reducing the spread of BSE and maintained that USDA should
``follow this recommendation from its own funded study.''
Response: As discussed above, we have determined that it is
appropriate, based on science, to use our standards for minimal-risk
regions as a combined and integrated evaluation tool, focusing on the
overall effectiveness of control mechanisms in place (e.g.,
surveillance, import controls, and a ban on the feeding of ruminant
protein to ruminants).
The commenters' paraphrasing of the Harvard-Tuskegee study is
misleading. What the study actually said was, ``Measures in the U.S.
that are most effective at reducing the spread of BSE include the ban
on the import of live ruminants and ruminant MBM from the [United
Kingdom] (since 1989) and all of Europe (since 1997) by USDA/APHIS, and
the feed ban instituted by the Food and Drug Administration in 1997 to
prevent recycling of potentially infectious cattle tissues.'' APHIS'
restrictions on imports from regions listed in Sec. 94.18(a)(1) and
(a)(2) are very restrictive and APHIS is not reducing those
restrictions.
As noted, since our proposed rule was published, FSIS and FDA have
both strengthened their requirements concerning slaughter practices and
food restrictions. The Harvard-Tuskegee Study's predictions that, if
BSE entered the United States in as many as 10 cattle, few new cases of
BSE would result and the disease would be eliminated within 20 years,
at most, were based on the control measures existing in 2001. The
Harvard-Tuskegee Study did not take into account recent regulatory
changes concerning the use of rendered ruminant origin materials or
active measures, such as culling and testing, that would be taken in
response to an outbreak and for the purpose of eradication. If BSE were
detected in a cow native to the United States, APHIS would work with
other Federal agencies and State governments to eradicate preventable
disease as quickly as possible. In combination with the recent changes
in Federal regulations, we are confident that BSE would be eradicated
in substantially less than 20 years.
Regarding the possibility of additional cases being discovered in
Canada, for reasons given in response to other comments on this issue,
we would expect that number, if any, to be very low. This is based on
the fact that Canada has had comprehensive BSE prevention and control
measures in place for many years, and that the two animals found in
2003 with BSE were older animals likely to have been exposed to
contaminated feed before implementation of the feed ban.
Remove Import Restrictions
Issue: Several commenters stated that, because BSE is considered a
North American problem, the APHIS risk analysis and the proposed
mitigation measures should be revisited, and restrictions on movement
from Canada should be removed.
Response: APHIS does not agree that the restrictions included in
this rule should be removed. Based on our risk analysis, we consider
these restrictions appropriate at this time to protect the United
States from the introduction of BSE from minimal-risk regions such as
Canada. BSE has been detected in two cows indigenous to Canada and, at
this time, BSE has not been detected in any ruminant indigenous to the
United States.
Other Comments Related to the Risk Basis for the Rule
Issue: One commenter stated that APHIS has not properly analyzed
the risk associated with Canada's inability to identify the source of
the BSE case discovered on May 20, 2003. The commenter stated that,
because the cow diagnosed with BSE in May 2003 could have consumed
contaminated feed after the feed ban was in place and up to the age of
3, and because Canada cannot definitively say that the cow's remains
did not enter the ruminant feed chain, other Canadian cattle are likely
to be infected. APHIS did not present the full range of risk
possibilities associated with this scenario and, instead, presented
only a best case scenario. Therefore, we should not relieve
restrictions on imports.
Response: The CFIA in May 2003 confirmed BSE in a cow from northern
Alberta that was slaughtered in January 2003. In response, CFIA
immediately started an exhaustive epidemiological investigation. U.S.
representatives worked in conjunction with Canada during the
investigation, the results of which are available on the CFIA Web site
(Ref 13). The investigation considered a wide range of possible sources
of infection, including two possible routes of MBM exposure, maternal
transmission, exposure to chronic wasting disease via domestic or
sylvatic cervids, exposure to scrapie, and the possibility that the
infected animal may have originated in the United States. CFIA
concluded, consistent with scientific knowledge from the United Kingdom
and Europe, that the most likely source of BSE for the infected cow
would have been the consumption of feed containing MBM of ruminant
origin contaminated with the BSE prion before the United States and
Canada implemented a feed ban in August 1997. CFIA also concluded that
the original source of the BSE prion in MBM is likely to have been from
a limited number of cattle imported directly into either Canada or the
United States from the United Kingdom in the 1980s, before BSE was
detected in that country.
Proving the source of an infection is rarely easy, particularly
when the infection occurred, as in this case, 6 or 7 years earlier.
CFIA's epidemiological investigation was thorough and complete and its
conclusions consistent with scientific knowledge about BSE and the
facts associated with this case. CFIA did identify the source of the
infection with as much certainty as is reasonable to expect. APHIS is
confident that CFIA's conclusions are accurate.
As discussed above, the epidemiological investigation additionally
focused on rendered material or feed that could have been derived from
the carcass of the infected cow. As part of that investigation, a
survey was conducted of approximately 1,800 sites that were at some
risk of having received such rendered material or feed. The survey
suggested that 99 percent of the sites surveyed experienced either no
exposure of cattle to the feed (96 percent of the sites) or only
incidental exposure (3 percent of the sites). The remaining 1 percent
represented limited exposures, such as cattle breaking into feed piles,
sheep
[[Page 517]]
reaching through a fence to access feed, and a goat with possible
access to a feed bag. Depopulation of Canadian herds possibly exposed
to the feed in question was carried out by the Canadian Government.
Canadian officials conducted a wide-ranging investigation of possible
exposure to the feed in question and carried out depopulation of
Canadian herds possibly exposed to the feed. On each of those farms
where the investigation could not rule out the possibility of exposure
to feed that may have contained rendered protein from the infected
animal, the herds were slaughtered and tested. All of those animals
tested negative for BSE and their carcasses were disposed of in ways,
such as disposal in landfills, to ensure that they did not go into the
animal food chain.
Issue: One commenter, in light of the detection of two BSE-positive
cows of Canadian origin, criticized the Canadian risk assessment for
having concluded that ``993 times out of a thousand, there would be no
BSE infection in Canada as the result of importation of cattle from the
UK and Europe from 1979 to 1997.''
Response: Canada's risk assessment concluded that there is a very
small probability that BSE was introduced into Canada as a result of
the importation of cattle from the United Kingdom or elsewhere in
Europe from 1979 to 1997. The estimated probability of at least one
infection of BSE occurring before 1997 was 7.3 x 10 -3 or,
as the commenter noted, that 993 times out of a thousand, there would
be no BSE infection in Canada as the result of importation of cattle
from the UK and Europe from 1979 to 1997'' (Ref 12). However, the
Canadian risk assessment did not conclude that no infected animal would
ever be found. Both Canada and the United States have conducted
aggressive surveillance for BSE designed to detect the disease should
it exist in our cattle populations. Other controls are in place to
ensure that the disease does not spread and amplify in the cattle
populations or result in human exposure.
Issue: One commenter stated that the United States has a zero
tolerance policy for fecal, ingesta, or milk contamination on livestock
carcasses or meat products. The commenter said that these contaminants
can result in diseases that are treatable, even though they may cause
severe illness and death, but stated that BSE causes a disease in
humans that invariably causes death and asked why we could find an
acceptable risk for BSE, which is always terminal, when we have zero
tolerance for contaminants, which may cause diseases which are
treatable.
Response: The comment suggests an inconsistency that is not
present. The policy of zero tolerance is consistent for adulterants
whether the adulterant is E. coli O157:H7 or the BSE agent. Under FMIA,
a meat food product is adulterated if, among other circumstances, it
bears or contains any poisonous or deleterious substance that may
render it injurious to health (21 U.S.C. 601 (m)(3)). FMIA requires
that FSIS inspect the carcasses, parts of carcasses, and meat food
products of amenable species to ensure that such articles are not
adulterated (21 U.S.C. 604, 606). FMIA gives FSIS broad authority to
promulgate such rules and regulations as are necessary to carry out the
provision of the Act (21 U.S.C. 621).
FSIS recognizes the agent that causes BSE as an adulterant under
FMIA (Ref 42). The infective agent that causes BSE, however, is not
fully characterized or easily identified. USDA's Agricultural Research
Service is currently conducting research to further characterize the
agent that causes BSE. Pathogenesis studies have confirmed that certain
tissues of cattle (i.e., the brain, skull, eyes, trigeminal ganglia,
spinal cord, vertebral column--excluding the vertebrae of the tail, the
transverse processes of the thoracic and lumbar vertebrae, and the
wings of the sacrum, and dorsal root ganglia of cattle 30 months of age
and older, and the tonsils and distal ileum of all cattle) are
predisposed to harboring the infective agent that leads to BSE. FSIS,
as part of its January 12, 2004, rulemaking, designated these tissues
as SRMs, declaring that they are inedible, and prohibited their use for
human food. For these BSE rules, FSIS also used the adulteration
provision, which relies upon the determination that certain cattle and
parts are unfit for human food because of the uncertainty associated
with onset of the disease and the value of the testing results.
E. coli O157:H7 is well characterized and recognized by industry as
associated with fecal contamination that is transferred from hide or
digestive tract onto carcass during dehiding. As a result, industry
recognizes that sanitary dressing is a critical step in the production
of safe beef, particularly regarding E. coli O157:H7. In contrast, the
infective agent for BSE cannot be easily identified and removed in the
same way as fecal content. As a result, FSIS has a zero tolerance for
SRMs (i.e., any evidence that SRMs were not properly controlled as
inedible will result in the product being considered as adulterated)
that scientific studies confirmed as associated with the BSE agent.
Furthermore, FSIS excludes non-ambulatory cattle from the human food
supply because European surveillance data have shown a higher incidence
of BSE in non-ambulatory disabled cattle than in healthy slaughter
cattle. Therefore, the inconsistency in tolerance suggested by the
commenter does not exist.
The FMIA requires that FSIS inspect the carcasses, parts of
carcasses, and meat food product of all cattle, sheep, swine, goats,
horses, mules, or other equines that are capable for use as human food
to ensure that such articles are not adulterated (21 U.S.C. 604, 606).
If the carcasses, parts of carcasses, and meat food products are found,
upon inspection, to be not adulterated, FSIS marks them as ``Inspected
and passed'' (21 U.S.C. 604, 606, 607).
F. Economic Analysis for the Rulemaking
In accordance with Executive Order 12866 and the Regulatory
Flexibility Act, we assessed the potential economic costs and benefits
of our November 2003 proposed rule and its potential effects on small
entities. We included a summary of our economic analysis in the
proposed rule and indicated how the public could obtain a copy of the
full economic analysis.
A number of commenters addressed the potential economic effects of
the proposed rule. Some of the comments focused on the rule in general
or specific provisions of the rule, while others addressed our analysis
of the potential economic effects of the rule. We discuss below each of
the issues raised by commenters. Because some of the comments were
technical in nature, we have tried to use the commenters' wording where
practicable. Therefore, the manner in which we characterize each of the
issues reflects the commenters' viewpoint.
The issues are grouped into eight sections:
Economic modeling;
Prices and quantities;
Social welfare changes;
Consumer demand;
Feeder animal movement and feedlot requirements;
U.S. beef exports;
Effects on small entities; and
Other.
1. Economic Modeling
Issue: The APHIS economic analysis of the potential impact of the
proposed rule falls short of estimating the larger economic impacts
this rule could have on the U.S. economy. It provides only a limited
analysis of the effect of imports of Canadian cattle and beef on prices
in the United States and ignores
[[Page 518]]
the impacts this rule will have on associated industries and their
productive output, as well as on employment.
Response: The commenter provides his own analysis of impacts, using
multipliers to demonstrate economy-wide effects. (Multipliers measure
total change throughout the economy resulting from one unit change for
a given sector.) Effects can be described as direct, indirect, or
induced. Direct effects represent the initial change in the industry in
question. Indirect effects are changes in inter-industry transactions
as supplying industries respond to increased demands from the directly
affected industries. Induced effects reflect changes in local spending
that result from income changes in the directly and indirectly affected
industry sectors (Ref 43).
We acknowledge that the rule will have effects that reach beyond
the cattle producing and processing sectors. However, the analysis
presented by the commenter estimates only the negative impacts to the
wider economy while ignoring the positive impacts. The commenter
calculates that a reduction in U.S.-supplied feeder cattle of 283,182
head reduces sales by $181.2 million and causes a $701.2 million loss
to the economy, assuming a multiplier of 3.87. However, the analysis
for the proposed rule also showed an increase in the total number of
feeder cattle fed in the United States of 221,318 head. When valued at
$938 per head, the resulting additional fed cattle generate $207.6
million in additional sales for U.S. feedlot operators. Applying the
commenter's choice of a 3.87 multiplier yields an economic gain of
$803.4 million from feeding these additional feeder cattle. The result
is a net gain to the U.S. economy of $102.2 million for importing the
504,500 feeder cattle from Canada. The same type of analysis would also
apply to slaughter cattle and carcass beef.
However, the multipliers the commenter chose for his analysis are
Type II, which include direct, indirect, and induced effects. We
consider the use of Type I multipliers (only the direct and indirect
effects) more appropriate for the calculation of impacts of changes in
cattle supplies as well as changes in exports. Income loss and reduced
consumer spending that might occur in one part of the cattle industry
due to this rule need to be balanced against the growth in income and
spending that can be expected to occur in other parts of the industry.
In recognition of the commenter's observation that the rule will have
impacts on associated industries, we include in the analysis for this
final rule a multi-sector model of feed inputs, animal production, and
animal product processing for a number of agricultural sub-sectors
besides cattle and beef. Using this model, we estimate effects of
reestablished imports from Canada in terms of changes in gross revenue.
For the cattle sector, gross revenues are simulated to decline in 2005
by between 3.85 percent and 4.81 percent and for the beef processing
sector, by between 1.26 percent and 1.59 percent. This model does not
provide measures of change in welfare for the United States because of
the rule; however, welfare changes would be smaller than the change in
gross revenue identified by the model.
Issue: The decrease in the quantity of cattle supplied by the
United States is a longer-term effect than the analysis suggests.
Because the calf-crop that will produce beef in 2005 has already been
conceived, this reduction will not occur until at least 2006. If the
decrease in quantities supplied by U.S. entities is a short-term
consequence (such as cattle held on feed for longer periods), then the
longer-term price impact of holding supplies should be calculated.
Response: The model used to estimate effects of the proposed rule
did not specify the period of time over which U.S. cattle producers
would reduce herd size in response to price declines following
resumption of imports from Canada. We expect that the resumption of
cattle imports from Canada will have effects both in the near term
(adjustment of the length of time animals are fed) and longer term
(adjustment of calf retention and breeding decisions). We acknowledge
that the comparative statics model abstracts from the problem of what
becomes of the cattle that are already in the system, ready to be
marketed in the near term; however, we believe the net benefits
identified by the model are robust to this abstraction.
Holding cattle longer on feed depends mainly on feed prices
relative to expected slaughter prices. Favorable forage conditions are
expected to result in more cattle being placed on winter pasture and
then moved to feedlots after the grazing season ends. Record-high
feeder cattle prices in the United States will continue to pull more
heifers into the feedlots than are retained for breeding. Effects
described by the analysis should be viewed as including both near-term
and longer-term effects.
Issue: Calculating results on a weekly rather than an annual basis
allows the ``surge effect'' to be more clearly reflected. Annual
averages smooth the price impacts. Weekly surges have been shown to
exhibit a powerful effect, both fundamentally and psychologically on
cattle and beef markets.
Response: The commenter's reference to surge effects concerns
weekly price swings that can affect cattle and beef markets. While we
understand that market disruptions can occur within a short time
period, we are unable to model expected impacts of the rule on a weekly
basis, as we are unaware of any data with sufficient depth and
precision to model weekly effects. Annual data used in the analysis of
welfare impacts generally capture the very short-term market events
that may occur, even if they are not described in detail. In the
analysis for this final rule, price effects are estimated over the one
or two quarters that the backlog of Canadian fed and feeder cattle are
expected to be imported.
Issue: The entire model is heavily dependent on elasticities
calculated in 1996. The current situation in U.S. beef supply and
demand is very different from that year's; there have been shifts in
demand since 1996.
Response: The elasticities used in the analysis for this final rule
have been revised from those used for the proposed rule. The revised
elasticities are provided by USDA Economic Research Service, based on
historical price and quantity data. The price elasticities of supply
and demand, respectively, are 0.61 and -0.76 for fed cattle, 0.40 and -
0.89 for feeder cattle, and 0.84 and -0.80 for wholesale beef. For
comparison in our consideration of near-term price effects during
importation of the cattle backlog in the analysis for the final rule,
we calculate the results using supply and demand elasticities reduced
by one-half. Buyers and suppliers of cattle can reasonably be expected
to be less responsive to price changes in one or two quarters than over
a year.
2. Prices and Quantities
Issue: In its economic analysis, APHIS estimated that reestablished
slaughter cattle imports from Canada of 840,000 head would result in a
price decline for such animals of $1.30 per cwt. With regard to feeder
cattle, APHIS estimated that reestablished feeder cattle imports from
Canada totaling 504,500 head would result in a price decline of 72
cents per cwt. However, if you affect the price of a 1,200-pound
finished steer by $1.70 per cwt, then you have to change the price of
an 800-pound feeder steer by more than 80 cents per cwt.
Response: The commenter apparently confused the $1.30 per cwt drop
in price with the percentage decline it represents, i.e., 1.7 percent.
In the economic analysis for this final rule, we
[[Page 519]]
find the decline in prices for fed cattle in 2005 to range from $1.95
to $2.72 per cwt. For feeder cattle, the decline in prices ranges from
$0.61 to $1.22 per cwt.
Issue: With constant demand, if you increase supply by 1 percent,
you affect the price by 3 to 5 percent. Before the May 2003 ban on
ruminant imports into the United States, Canada shipped about 3 percent
of its cattle to the United States, both feeder and finished.
Accordingly, with finished cattle bringing about $100 per cwt, the
estimated effect on the U.S. market should be at least $9 per cwt.
Response: The commenter describes a change that graphically can be
portrayed as movement to a lower price on a vertical (constant) demand
curve, due to an outward supply shift. In reference to the percentage
of cattle shipped from Canada, we believe the commenter did not mean to
write ``3 percent of their cattle,'' but rather 3 percent of cattle
marketed in the United States. With this change and a fixed demand, the
percentages set forth by the commenter would lead as stated to at least
a $9 per cwt drop in price.
However, this projected price decline is too large for several
reasons. While demand for feeder and finished cattle is inelastic, it
is not perfectly inelastic. Demand will increase as price falls,
moderating the price decline. The own price elasticities of demand
(percentage change in demand for a given percentage change in price)
used in the analysis for this final rule are -0.89 for feeder cattle
and -0.76 for fed cattle. These are considered short-run elasticities.
In addition, the increase in overall supply will be less than the
number of cattle imported from Canada. The imports will partly result
in an increase in the total supply of cattle sold in the United States,
but also partly displace U.S.-produced cattle. Lastly, while the
percentages and prices used by the commenter are not specific,
inaccuracies do spuriously contribute to the commenter's conclusion.
Cattle under 30 months of age imported from Canada in 2002 comprised
about 2 percent of the U.S. market for such animals, not 3 percent.
Annual 2005 prices forecasted in November 2004 for choice steers
(Nebraska, Direct, 1100-1300 lbs), according to USDA World Agricultural
Supply and Demand Estimates, range from $82 to $88 per cwt, not $100
per cwt.
Issue: With the loss of other foreign markets for Canadian beef,
Canada will probably send more cattle to the United States.
Response: We agree that because of the closure of foreign markets
for Canadian beef, there are additional cattle in Canada that are
likely to be shipped to the United States with the resumption of
imports. This backlog of Canadian cattle is included in the analysis
for this final rule.
Issue: A thorough analysis detailing the entire scale of impacts on
exports due to the proposed rule is warranted. For example, the
economic analysis shows the proposed price effect of importing 840,800
slaughter cattle from Canada. It indicates an increase in the number
slaughtered in the United States of only 66,350 and a decrease in the
number supplied by the United States of 474,450, yielding a price
decrease of $1.30 per cwt. What calculations were used to arrive at
these numbers?
Response: Impacts on U.S. exports were addressed in the economic
analysis for the proposed rule by considering a range for possible
foreign market losses if importing countries do not agree with the U.S.
categorization of Canada as a BSE minimal-risk region. Reestablished
imports from Canada of 840,800 head of slaughter cattle were estimated
to result in an increase of 366,350 head in the total number of cattle
slaughtered and displacement of 474,450 head that would have been
supplied by U.S. entities. These calculations are based on the partial
equilibrium model referenced in footnote 4 of the economic analysis,
and a price-quantity baseline as shown in table 2 of the analysis. The
same model, but with more current baseline data and estimates on
expected cattle imports from Canada, is used in the analysis for this
final rule.
Issue: The calculation used to determine the annual number of
feeder cattle fed at U.S. feedlots assumes inventory turnover of three
times per year, an average of 120 days on feed. This assumes that all
feedlots are 100 percent full each day of the year. Due to seasonal
supply shortages (e.g., there were 11 percent less cattle on feed
during the third quarter of 2003 than the first quarter of that year)
and an average of 150 days on feed, industry turnover averages are much
closer to 2.5 times per year. Using 2.5 inventory turns per year, the
number of feeder cattle fed in U.S. feedlots becomes 27,273,750 head
per year. This is 5,454,750 head (17 percent) less than the 32,728,500
calculated using three inventory turns per year. An overstated
inventory number understates the price impact related to resumption of
cattle imports.
Response: We concur that we may have used too large a number of
inventory turns per year in calculating the number of feeder cattle fed
at U.S. feedlots. The baseline number of feeder cattle marketed in
2005, for feedlots with capacities greater than 1,000 head, is assumed
to be 22,125,000 head, as provided by the USDA Office of the Chief
Economist.
Issue: The baseline slaughter cattle information table uses a
slaughter cattle price of $78.16 per cwt, the average price of choice
steers for the first two quarters of 2003. The market has been over
$100 per cwt this fall [the fall of 2003] and Cattle-Fax [a member-
owned information organization serving producers in all segments of the
cattle industry] forecasts a price of $87 per cwt for the second
quarter of 2004. Due to the non-typical price structure that is
forecast well into 2004, the price of $78.16 per cwt clearly translates
into understated market damages.
Response: In the analysis for this final rule, we use a price range
for fed cattle of $82 to $88 per cwt, based on the annual forecast for
2005, as of November 2004 (USDA World Agricultural Supply and Demand
Estimates). This price range takes into consideration continued high
U.S. demand for beef and present restrictions on U.S. beef exports.
Issue: If the scenarios described in the proposed rule regarding
the potential loss of export markets assume an eventual recovery of
these lost markets, costs need to be estimated representing recovery
efforts. If the assumption is a terminal loss of markets, then a long-
term accumulated loss value should be estimated and reported.
Response: We do not assume a permanent loss of export markets.
Since publication of the proposed rule, many countries have established
restrictions on U.S. cattle and beef due to the Washington State BSE
discovery. It is not clear to us what is meant by ``recovery efforts,''
but we believe it is likely the commenter is referring to negotiations
between the United States and its trading partners for the resumption
of cattle and beef imports from the United States. In the analysis for
this final rule, we consider how the rule may influence these
countries' future decisions with respect to the lifting of the import
restrictions.
Issue: The cost/benefit analysis of the proposed rule shows little
if any benefit and underestimated cost to U.S. producers, feeders and
packers. It should also be noted that the benefits are limited, as the
December prices of Alberta feeder cattle were 10 to 18 percent higher
than those of December 2002 and the prices of Alberta slaughter cattle
were 7 to 9 percent higher than those of December 2002.
Response: The analysis for the proposed rule estimated price
declines
[[Page 520]]
for feeder and fed cattle, given a resumption of imports from Canada.
As a group, U.S. entities in competition with firms exporting the
Canadian cattle can be expected to experience reduced earnings. They
will sell fewer cattle at lower average prices. Entities buying feeder
and fed cattle at lower average prices due to the increased supply from
Canada can be expected to experience increased earnings. Quantities of
cattle assumed to be imported from Canada are based on the backlog that
has built up because of current restrictions and on historic import
levels. Once the backlog has cleared in 2005, prices for feeder and fed
cattle in Canada relative to prices in the United States will influence
the number of Canadian cattle sold in the United States and, therefore,
the ultimate price effects as well.
Issue: With the December 2003 BSE discovery in Washington State, we
have a very clear example of negative price impact from losing our
export markets. The only export market currently closed that we
estimate would remain open under the least favorable reaction to the
APHIS proposal is Mexico. The January Live Cattle contract fell from
$90.80 per cwt to $73.50 per cwt, or approximately 19 percent. This
negative price impact has not only deflated fed-cattle prices, but is
also discounting feeder cattle and calf prices. Every animal
slaughtered will take discounts each time it is sold, resulting in
heavy cumulative discounts. The APHIS proposal shows potential losses
from a 32 percent reduction in beef exports (approximately Japan's
portion) to range from $1.65 to $1.93 per cwt on a live weight basis.
Another very clear example of the significance of Japan as an export
market is demonstrated by the loss of 44 percent of the volume of beef
and beef variety meat exports to Japan in 2001-2002 due to the
discovery of BSE in Japan. Industry economists estimated the sharp
decline in exports to Japan negatively impacts fed cattle prices in the
United States by $2.50 per cwt to as much as $4.00 per cwt. Nor was the
impact confined to the beef industry--shockwaves rippled through the
grain and oilseed sectors, as well as the shipping industry. It is
important to realize that this impact was felt from only a 44 percent
loss of the Japan market * * *[I]t took nine months to make significant
progress and full recovery had not occurred in the trade sector after
one year. Determining the actual price impact of lost export markets
appears much more amplified than the APHIS proposal suggests.
Response: Although prices for cattle did decline sharply
immediately following the Washington State BSE discovery in December
2003, they quickly rebounded. Forecasted annual 2005 prices for feeder
cattle, as of October 2004, are $94 to $100 per cwt. This is one of the
baseline price ranges used in the analysis for this final rule. Beef
prices are also forecasted to remain high despite export restrictions.
A wholesale light Choice boxed beef price for 2005 of $141 to $147 per
cwt is used in the analysis. In the discussion of possible effects of
this rule on U.S. exports, we acknowledge the premium earnings foregone
due to closed foreign markets.
Issue: The economic analysis assumes a scenario where U.S. markets
are unaffected with BSE--a scenario that is no longer true. In
addition, it accepts as justification, in part, for the economic risks,
the high prices received by cattle producers and feeders in recent
months. However, if you adjust dollars for inflation, producers
received less for cattle than they did 40 years earlier.
Response: The analysis for this final rule takes into consideration
existing conditions for the U.S. cattle and beef markets. Today's
cattle prices, adjusted for inflation, may well be lower than 40 years
ago, but this fact is not pertinent in considering expected benefits
and costs of the rule.
Issue: Annual imports of beef into the United States rose from 3.6
billion pounds in 1995 to 5.5 billion pounds in 2000. In addition,
other factors, such as the declining share of the retail dollar passed
on to U.S. producers, have already injured the U.S. cattle industry. To
open the border will accentuate this problem. Opening the border to
live cattle imports combined with Canadian beef imports will result in
supplies being increased by 9 percent and will result in an 18 to 20
percent decline in prices. When the Canadian border was opened to beef
imports into the United States, our cattle prices declined 20 percent.
Response: The economic analysis performed for the proposed rule did
not indicate the cattle and beef increases suggested by the commenter.
The analysis showed that with resumption of imports from Canada, the
number of fed cattle may increase by about 3 percent, the number of
feeder cattle by less than 2 percent, and beef supplies by less than 1
percent (given ongoing boneless beef imports). We expect a decline in
prices due to these increased supplies, but not an 18 percent to 20
percent decline. With the resumption of beef imports from Canada in
2003, there was an increase in cattle prices (choice steers, Nebraska,
1100-1300 lbs) from $78.49 per cwt in the second quarter, to $83.07 per
cwt in the third quarter, to $99.38 per cwt in the fourth quarter (USDA
World Agricultural Supply and Demand Estimates). The analysis for this
final rule indicates a decline in cattle prices for 2005 of roughly
between 0.63 percent and 3.2 percent due to reestablishment of imports
from Canada, depending on the category of cattle frame and underlying
import assumptions.
Issue: The beef analysis for the proposed rule used two different
baseline prices for beef, $3.00 and $3.50 per pound. It should be noted
that these values for beef may be low. USDA's Economic Research Service
(ERS) quotes beef prices at $4.32 per pound in November 2003, a record
high.
Response: In the economic analysis for the proposed rule, we noted
that $3.00 and $3.50 per pound were used as baseline prices to take
into consideration affected beef products lower in value than choice
cuts. In the analysis for this final rule, we use a wholesale beef
price range of $141 to $147 per cwt (light Choice boxed beef), a
forecasted annual 2005 price provided by USDA Economic Research
Service.
3. Social Welfare Changes
Issue: Despite APHIS' assertions that price decreases associated
with the renewal of trade of feeder and slaughter cattle with Canada
would not significantly affect buyers or sellers of slaughter cattle,
APHIS must recognize that these costs would be borne entirely by
relatively few small businesses, whereas the consumer surplus (in the
form of reduced beef prices) would be spread out among millions of
consumers.
Response: We acknowledge that consumers who benefit from the
expected price decreases will outnumber U.S. livestock producers and
other entities harmed by the same price decreases. The economic
analysis indicates that the net change in welfare due to these impacts
within the United States will be positive.
Issue: Three scenarios in the analysis for the proposed rule are
used to evaluate reestablished cattle and beef imports from Canada,
assuming (1) no loss, (2) 32 percent loss, and (3) 64 percent of U.S.
beef export markets. Based on the APHIS analysis, producers and feeders
lose under all three scenarios. Packers gain only if export markets are
maintained while live cattle imports resume. Benefits to retailers/
consumers are positive under each assumption. The only net benefit
scenario for all sectors occurs if live cattle imports resume and
export markets are maintained.
[[Page 521]]
Response: The commenter is correct in concluding that the economic
analysis for the proposed rule indicated that loss of export markets
due to the rule could result in an overall negative impact for the
United States. The analysis was clear in stating that we do not know
how other countries would react to reestablished imports from Canada.
Since publication of the proposed rule, many countries have established
import restrictions on U.S. cattle and beef because of the Washington
State BSE discovery. In the analysis for this final rule, we consider
how the rule may influence these countries' future decisions with
respect to lifting of the import restrictions. Possible trade effects
of the rule cannot be discussed with the same confidence as expected
domestic impacts.
Issue: APHIS' use of ``consumer surplus'' is theoretically
questionable. By making a direct offset between the ``consumer
surplus'' of public and the ``producer surplus'' of the industry, APHIS
assumes that these surpluses are both measurable and comparable between
producers and consumers. The concentration of the negative impacts on a
relatively small number of industry participants and the wide diffusion
of benefits across millions of consumers suggests that the true impact
is much more negative than the analysis suggests.
Response: Benefit-cost analysis, the approach used for analyzing
Federal regulations, determines whether benefits to society as a whole
outweigh costs to society as a whole. Costs and benefits are not borne
equally by all groups in a society. When measured in monetary units,
comparing changes in consumer and producer surplus is well within
standard economic theory, regardless of whether the number of entities
differs across producers and consumers. This standard application of
economic theory, moreover, is recommended in OMB guidance (Ref 44).
Issue: An impact that is particularly germane is that of other
countries shutting their borders to U.S. exports based on the proposed
rule. Although this has been addressed in the analysis, it depends upon
increased ``consumer surplus'' to offer generous offsets to the
crippling losses on the beef industry.
Response: APHIS' economic analysis for the proposed rule found that
the net effect of the resumption of cattle imports from Canada would be
positive for both feeder cattle and slaughter cattle--that is, the
action would benefit U.S. buyers more than it would harm U.S. sellers.
The analysis for this final rule also shows net positive effects. This
is not surprising, as it is a standard result of microeconomic theory
that opening a formerly restricted market benefits consumers in that
market more than it hurts producers participating in the market when it
was closed. Prior to the Washington State BSE discovery, exports of
U.S. beef and ruminant products were earning 7.5 billion annually.
Immediately afer the discovery, these export earnings fell by 64
percent. As of November 2004, the export decline had been reduced to 41
percent of pre-BSE levels. (Source: USDA Transcript, Release No.
0497.04, November 9, 2003.)
Issue: Serious concerns exist about the analytical framework that
finds offsets for every producer loss as a gain in consumer surplus.
Response: We disagree. It is a standard result of microeconomic
theory that expanding the supply in a formerly restricted market causes
both an increase in consumer surplus and a decrease in producer surplus
among producers participating in the market before it was opened. The
analysis would cause more concern if this were not the case.
Issue: In its economic analysis for the proposed rule, APHIS'
states that estimated price declines for producers/suppliers and
consumers/buyers of slaughter cattle, feeder cattle, and beef due to
allowing imports of live cattle from Canada would largely reflect a
return to the more normal market conditions that prevailed before
Canada's BSE discovery. APHIS' economic analysis states that these
``more normal'' market conditions would come at an annual decrease of
$448.7 million for sellers of cattle. APHIS' analysis also claims a
``net benefit'' from reopening the border that presumably is based on
consumers' savings through lower beef prices. APHIS needs to reevaluate
its economic analysis in light of the current situation and in light of
other trends in the beef industry, taking into account the economic
situation of cattle farmers and ranchers.
Response: APHIS used the phrase ``more normal market conditions''
in reference to our nation's long history of trade with Canada in
cattle and beef and has omitted this wording in the analysis for the
final rule to avoid any misunderstanding. The net benefits estimated in
the analysis result from the gains for consumers and other purchasing
entities (due to the price declines) exceeding the losses for producers
and other parties whose products will compete with the imports from
Canada.
Issue: Do normal conditions suggest livestock values that reflect
negative margins for U.S. producers? If so, that is science that must
be considered in the rule, because producers operating at a loss are
less able to invest in disease prevention, surveillance, and response.
Response: The rule is expected to result in price declines, but
such declines do not equate to negative margins for U.S. producers.
Clearly, those producers with smallest net revenues will be the most
affected. Given current prices, it is not expected that the rule will
cause producers to reduce their investments in disease prevention,
surveillance, and response.
Issue: The APHIS analysis shows no benefit to the U.S. live cattle
industry or consumers for assuming greater risk. How will reopening the
border benefit consumers? How will reopening the border benefit
producers?
Response: The economic analysis for the proposed rule showed that
beef consumers could be expected to benefit due to lower prices.
Producers, if in competition with fed and feeder cattle that would be
imported from Canada, are not expected to benefit because of the
reestablished imports. However, owners of slaughter facilities, for
example, are expected to benefit because of the additional supply of
fed cattle. The analysis showed that gains to consumers would exceed
losses to producers, for a net gain overall. These same conclusions are
reached in the analysis for this final rule.
Issue: Since the United States closed its border to the importation
of Canadian cattle under 30 months of age, the beef processing industry
in Weld County, Colorado, which is the largest contributor to the local
economy there, has been experiencing significant financial losses and
is at risk of losing the entire beef industry in that area. The risk
from the importation of beef, with its limited inspections, far exceeds
the potential problems associated with importation of live cattle from
Canada.
Response: As shown in the economic analysis for the proposed rule,
buyers of feeder cattle can be expected to benefit from resumption of
imports from Canada. Communities such as that identified by the
commenter that are dependent on processing industries will gain from
the reestablished trade. Removal of SRMs at slaughter and other
required risk-mitigating measures of this rule will ensure that beef
entering the United States from Canada satisfies animal health criteria
the same as or equivalent to those required in the United States.
Issue: In the analysis for the proposed rule, expected effects of
the rule on the
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fed and feeder cattle markets were examined in separate scenarios. The
results of these two scenarios indicate that when fed cattle imports
are resumed, producers' surplus declines by $448 million. When feeder
cattle imports are resumed, producers' surplus declines by $182
million. APHIS concludes that these impacts would be independent and
that increased imports of feeder cattle would benefit feedlot owners.
Lower prices for feeder cattle are more likely, however, to pass
through the market channel to consumers, and feedlot producers are not
likely to realize significant benefits from the lower prices for feeder
cattle. This suggests that the impacts of these events [reestablished
fed cattle and feeder cattle imports from Canada] would be additive,
implying that opening the border to trade with Canada on fed cattle and
feeder cattle would likely have an effect of more than $630 million.
Response: Benefits from lower prices for feeder cattle and fed
cattle may be at least partially realized by entities further down the
marketing chain, including consumers. Revenue margins for feedlot
operators may be characterized by greater rigidity than is implied in
the analysis for the proposed rule. This possibility is acknowledged in
the analysis for this final rule. Impacts described from reestablishing
fed and feeder cattle imports from Canada would be additive. Their
addition does not negate the fact that expected benefits outweigh
expected costs of resumption of imports.
4. Consumer Demand
Issue: A significant negative reaction by importing countries
regarding the safety of Canadian beef may very well translate into a
U.S. consumer backlash should U.S. beef and beef products be perceived
as unsafe. What are the long-term costs and implications of domestic
market share loss to other protein sources?
Response: According to Cattle-Fax, U.S. domestic beef sales and
demand remained strong after the discovery of a single cow diagnosed
with BSE in the state of Washington. Three months after Canada
announced a case of BSE, limited trade resumed with the United States,
and imports of Canadian boneless meat from animals less than 30 months
of age at slaughter began entering the United States. There has been no
evidence that domestic consumers substituted other protein sources due
to either the BSE discovery in Washington State, or in response to
resumed imports of Canadian boneless meat. There is no indication that
domestic consumers had a negative reaction to resumed imports of
Canadian boneless meat. Rather, all market reports indicate that
consumer demand for beef remains strong, even in light of over 70
countries imposing import bans on U.S. cattle and beef products in
response to the BSE case in Washington. In fact, the National
Cattleman's Beef Association, along with the Cattlemen's Beef Board,
administered checkoff surveys of U.S. consumers in January 2004 that
indicated that 97 percent of consumers were aware of BSE and a record
89 percent were confident in the safety of domestic beef on the market.
That confidence level increased to 91 percent in February surveys.
Because there were no discernible losses in consumer confidence or
demand for domestic beef, and likewise no domestic market share loss to
other protein sources in response to a single case of BSE in Washington
State or in response to resumed imports of Canadian boneless meat, we
would not expect this climate to change in light of increased imports
of associated Canadian commodities.
Issue: Even if U.S. practices are adequate to avoid amplification
of BSE after it is imported in Canadian animals, it is clearly wrong to
assume, as APHIS does, that a limited number of U.S. cases associated
with Canadian-born animals will not materially injure the U.S. industry
and consuming public. The fallout over the Washington State BSE case
has shown that quite clearly. Cattle prices are dropping on the basis
of a single Canadian-born cow slaughtered in the United States. The
loss of economic confidence in the beef supply has clear negative
impacts on producer revenue. In APHIS' analytical approach, it should
also have clear negative impacts on ``consumer surplus,'' since the
downward shifting of the demand curve reflects the reduced potential
for enjoyment of beef by a shaken public. Assurances--such as we had in
December of 2003--of overall safety of the U.S. beef supply will help
mitigate this impact. However, the economic impacts are large even if
``it is highly unlikely that such an introduction would pose a major
animal health or public health threat.''
Response: U.S. beef consumers have not reduced beef consumption
since the discovery of BSE in an imported cow in the United States, nor
are there indications of a long-term impact of the discovery on the
domestic demand for beef. Following the BSE discovery in Washington
State in December 2003, a sudden price decline was short-lived. Prices
today have largely recovered, with the projected 2004 price range for
choice steers (Nebraska, 1100-1300 lbs) ranging from $84 to $88 per
cwt, compared to prices of $67.04 and $84.69 for 2002 and 2003,
respectively (USDA World Agricultural Supply and Demand Estimates).
U.S. cattle and beef markets since the single BSE occurrence in
Washington State have, if anything, reflected the strength and
resilience of these industries and the high level of confidence
consumers hold with respect to the health and safety of U.S. cattle and
beef. We do not expect the rule to result in an increase in risk of BSE
in the United States. Removal of SRMs at slaughter and other risk-
mitigating measures of the rule will ensure that beef entering from
Canada satisfies animal health criteria that are the same as or
equivalent to those required in the United States.
Issue: The most serious problem with the economic analysis for the
proposed rule is the failure to take seriously the costs to both the
producer and the consumer as a result of loss in confidence associated
with even a very limited incidence of BSE in the United States.
Response: Consumer confidence is an issue of concern for APHIS;
however U.S. consumers do not appear to have reacted to the case of BSE
reported in Washington State in a way that demonstrates profound loss
of confidence. There were short-term price effects in U.S. markets for
cattle and beef, but there do not appear to have been longer-term
decreases in the demand for beef or increases in the demand for
substitute protein sources such as chicken and pork. In this respect,
U.S. consumers' reaction appears to differ from the reaction of
consumers in countries like Germany, Japan, and the United Kingdom
following BSE discoveries in those countries.
Issue: The economic analysis for the proposed rule is no longer
applicable to current cattle market conditions, due to the Washington
State BSE discovery.
Response: The economic analysis for this final rule takes into
consideration market changes that have occurred since the initial
analysis was done. The Washington State BSE discovery has had a
significant effect on U.S. beef exports, but it has had little effect
on domestic demand, as reflected in continuing high price levels for
beef and cattle.
Issue: Once animals are allowed in, if boneless cuts are the only
exports allowed, what will happen to the remaining cuts? Are they going
to be dumped into our markets?
Response: Beef imported from Canada, like beef from cattle of U.S.
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origin, will be consumed domestically or exported to another country
depending on prices, trade arrangements, and the numerous other factors
influencing the beef market. APHIS cannot predict the eventual use,
other than to note current restrictions on U.S. beef exports.
Issue: The most important impact of APHIS' proposed rulemaking is
the potential for BSE cases in the United States caused by the
importation of Canadian cattle. This is dismissed almost offhandedly in
the published analysis. This conclusion has already been proven wrong
and is the most glaring deficiency in the economic analysis of the
proposed rule. Additionally, the proposed rule ignores the potential
economic impact should Canada discover additional cases of BSE while
the United States is known to be importing Canadian beef and cattle.
Response: The risk mitigation measures included in the proposed
rule were developed to ensure that ruminants and ruminant products
imported from Canada pose a minimal BSE risk to the United States.
Under the conditions of this final rule, the cow of Canadian origin
that was diagnosed with BSE in Washington State would not have been
eligible for importation into the United States. We do not expect the
rule to result in an increased risk of BSE in the United States, given
the risk-mitigating measures put in place in Canada and the monitoring
of the movement of imported cattle that will be required. Removal of
SRMs at slaughter and other risk-mitigating measures of the rule will
ensure that beef entering from Canada satisfies animal health criteria
the same as or equivalent to those required in the United States.
Issue: The APHIS analysis ignores the cost the rule would have if a
second BSE event occurred on U.S. soil due to the transmission, or
market and consumer perception of transmission, resulting from this
rule, or even the increased risk that producers and consumers would
incur from trade with Canada when there is risk of introduction of BSE.
A BSE outbreak would cause demand for beef to decline and an increase
in human health concerns. Estimates of the cost of the 1986 outbreak on
the British economy, with a herd size of 12.04 million head, are $5.8
billion. Given that the U.S. herd size is 8 times larger, a worst-case
scenario suggests the impacts on the United States could be as large as
$46.4 billion.
Response: U.S. consumers have not appeared to reduce beef
consumption in response to the BSE case found in Washington State. The
commenter refers to the economic impact of BSE in the United Kingdom,
applying it to the North American situation. It is important to note,
as reported by Mathews and Buzby, that the total number of confirmed
cases of BSE in the United Kingdom has exceeded 175,000 on over 35,000
farms, compared to the 2 confirmed cases in native North American
cattle (Ref 45). We do not expect the rule to result in an increased
risk of BSE in the United States.
5. Feeder Animal Movement and Feedlot Requirements
Issue: APHIS did not consider in its economic analysis the costs of
ensuring compliance with risk mitigation measures. Such verification
(e.g., determination of animal age through dentition and the auditing
of health certificates) will be burdensome and costly. Simply
obtaining, tracking, and recording the necessary information will be
time-consuming and take an undeterminable amount of man-hours.
Response: We acknowledge there will be additional costs to U.S.
cattle feeding and packing operations that decide to import Canadian
cattle. The additional costs will include, but not be limited to, those
associated with increased recordkeeping requirements. These costs will
vary by operation. In the analysis for the final rule, we approximate
the cost of inspection and certification for movement of Canadian
feeder cattle from the port of entry to a feedlot and ultimately to a
slaughter facility. As with other business expenditures, affected U.S.
firms will include additional recordkeeping costs associated with
importing Canadian cattle in their cost calculations, and will purchase
Canadian cattle only if the expected returns of doing so outweigh the
costs.
Issue: Designated feedlots and slaughter facilities will need to
develop a sound segregation plan for Canadian cattle. This adds another
level of regulation, cost, and complexity. Without a national animal
identification system, which is at least 2 years away, the only way for
U.S. feedlots to keep segregation integrity with regard to U.S. and
Canadian cattle would be to keep cattle in country-specific pens. This
in itself would make it extremely difficult for feedlots to effectively
manage cattle health care and feed costs, costing the industry millions
of dollars annually. The only way to comply would be for feedlots to
establish ``Canadian regions'' within each facility and construct
separate hospital treatment facilities. This would also include the
tracking of individual animal movements within designated feeding
facilities, segregated transportation schedules and staged slaughter
times--which requires a more efficient and effective communication link
than current industry standards.
Response: In this final rule, there are no requirements for
designated feedlots with regard to feeder cattle imported from Canada.
Further, the rule does not require feedlots or slaughter facilities to
develop segregation plans for live cattle from Canada. Canadian feeder
cattle, and feeder sheep and goats, moved from the port of entry to a
feedlot and from the feedlot to slaughter must be accompanied by an
APHIS Form VS 17-130 to the feedlot and from the feedlot to slaughter
by an APHIS Form VS 1-27. These forms will list all animals moved. This
final rule will also require that feeder cattle be individually
identified before entry by an eartag that allows the animal to be
traced back to the premises of origin. The eartag may not be removed
until the animal is slaughtered.
Issue: The costs of segregating Canadian cattle from U.S. cattle
include additional downtime and changeover time (between processing
imported Canadian cattle versus others), increased quality control and
regulatory inspection, and a doubling of sku [stock keeping unit]
inventory requirements (for ``export only'' sales under the Bovine
Export Verification (BEV) program). Furthermore, these costs will
definitely place smaller Northern tier single-plants at a disadvantage
compared to those in other regions.
Response: Segregation/tracking of Canadian-origin product at the
processing stage and beyond will not be necessary to ensure that the
products are safe. We address issues concerning the BEV program in our
responses to other comments.
Issue: The proposed rule requires that sheep and goats imported
from a BSE minimal-risk region be less than 12 months of age if
imported for immediate slaughter or for feeding and then slaughter. Was
the cost of managing and maintaining imported Canadian sheep and goats
as a separate group included in the economic analysis?
Response: The cost of managing and maintaining imported Canadian
sheep and goats as a separate group was not included in the economic
analysis for the proposed rule. Whether individual feedlot operations
consider it worthwhile to handle imports from Canada--i.e., whether the
expected additional revenue exceeds the costs associated with feedlot
designation--will be an individual choice and will be voluntary on the
part of feedlots.
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In this final rule, we specify that sheep and goats not for
immediate slaughter will be required to be moved to designated
feedlots. Criteria for designated feedlots include a written agreement
between the feedlot's representative and APHIS that the feedlot will
not remove eartags from animals unless medically necessary and cross-
reference with the original eartag any eartag that must be replaced on
an animal, will create and maintain acquisition and disposition records
for at least 5 years, will maintain copies of APHIS movement permits,
will allow Federal and State health officials to inspect the premises
and animals upon request, and will designate either the entire feedlot
or designated pens within the feedlot as terminal for sheep and goats
to be moved only directly to slaughter at less than 12 months of age.
Issue: The record high prices for cattle that farmers and ranchers
received during the summer and fall of 2003 have given way to limit[ed]
down drops in live and future cattle prices. In addition, the market
analysis done for the proposed rule ignores recent changes in
Americans' diets and cattle herd culling due to extended drought
conditions throughout the United States. The economic analysis also
ignores that Canadian cattle were captive supplies for cattle that may
have been used to manipulate United States cattle markets. These
factors were not considered by APHIS in weighing the costs and benefits
of the proposed rule.
Response: Record high prices for cattle during the summer and fall
of 2003 primarily resulted from tight cattle supplies due to weather
conditions and the ban on imports from Canada. With resumption of
imports from Canada and improved forage conditions, there will be an
increase in the cattle supply, causing downward pressure on prices
received by domestic producers. APHIS, of course, does not have
authority under statutory mandate to regulate marketing practices such
as packer ownership of captive cattle, and any issues presented by
packer ownership of cattle supplies is outside the scope of this rule.
The economic analysis does not consider captive cattle supplies in
examining the costs and benefits of this regulation.
6. U.S. Beef Exports
Issue: The economic analysis does not estimate the impact on the
U.S. beef cattle industry as a result of trading partner discomfort
with the lessening of restrictions on the importation of ruminants and
their products from Canada. APHIS must rework the economic analysis to
take this significant impact into consideration.
Response: In the economic analysis for the proposed rule, we
addressed possible impacts of the rule on U.S. cattle and beef exports.
Consideration was given to the possibility that importing countries may
not agree with the United States' categorization of Canada as a region
of minimal risk. That part of the analysis, regarding possible
restrictions on cattle and beef imports from the United States by other
countries because of the rule, addressed possible impacts due to
``trading partner discomfort.'' The analysis for this final rule takes
into consideration current restrictions on U.S. beef exports and
addresses the question of how the rule may affect these restrictions.
Issue: The negative trade scenarios outlined in the cost-benefit
analysis of the proposed rule are based upon there continuing to be
very few countries in the world that fully adopt or embrace the
recommendations of the OIE regarding imports from BSE-affected
countries. Such an underlying assumption is rapidly changing. The
possibility that the United States would face lasting negative trade
effects as a result of implementation of the proposed rule seems
increasingly remote.
Response: In the economic analysis for the proposed rule, we did
not assume there would be lasting negative trade effects. However,
neither could we assume that negative trade reactions might not result
if importing countries did not accept the U.S. categorization of Canada
as a BSE minimal-risk region. We now have a different situation, with
beef imports from the United States prohibited by a number of
countries. It is possible that, because of the rule, these countries
may either delay lifting current restrictions on cattle and beef
imports from the United States or become more open to reestablishment
of the imports. The analysis for this final rule addresses these
possible impacts for U.S. beef exports.
Issue: In its cost-benefit analysis, APHIS does not appear to have
considered the recent U.S. experience with the cost of segregating U.S.
origin meat from Canadian meat to meet Japan's demand that we ship to
that country only U.S. born and slaughtered meat. To the extent there
are data or estimates available regarding the cost to the U.S. industry
to meet Japanese demands, this should be considered in APHIS' analysis.
Response: We believe that the commenter is referring to the
voluntary BEV program. Under the BEV program, USDA's Agricultural
Marketing Service certifies through compliance audits that beef and
other products exported by an eligible supplier are derived from cattle
slaughtered in the United States. The BEV program, while ongoing for
Canada and Mexico, has been terminated for Japan pending resumption of
U.S. beef exports to that country. The BEV program will not be affected
by this rule.
Issue: Even if BEV-compliant slaughter facilities do not import
Canadian live cattle, they will have to comply and certify they are not
receiving Canadian-origin cattle from feedlots and adopt new BEV
regulations.
Response: As noted above, the BEV is a program, not a regulation,
and is not covered by this rule. Slaughter facilities, if necessary,
will be able to identify Canadian-origin cattle by the animal
identification requirements included in the rule.
Issue: The proposed analysis calculated the price effect from lost
export markets by using elasticities and price information. A large
factor that was not analyzed was the loss in premiums that the U.S.
beef industry gains by ``upgrading'' cuts with a low value in the
United States by sending them to markets that pay a much higher price
for them. Japan is the main premium market for U.S. beef and beef
variety meats. Based on 2000 research conducted by the United States
Meat Export Federation, the extra value achieved by U.S. beef exports
is $1.2 billion per year (Ref 46). The loss of export markets will
directly pass those markets' portions of this loss of value back to the
U.S. beef industry. These losses are in addition to the losses caused
by an increased supply of beef on the U.S. market. The extent to which
export premiums support prices of domestic beef should be further
analyzed.
Response: In the economic analysis accompanying the proposed rule,
we stated that we were unsure how other countries would react to a
resumption of ruminants and ruminant products from Canada. Because of
the Washington State BSE discovery, most U.S. beef exports are now
restricted. The question has become how the rule might affect current
restrictions. In addressing this issue, we acknowledge the premium
earnings foregone due to closed foreign markets.
Issue: The proposed rule fails to take into account the value of
the entire animal to the industry. The rule appears to look at muscle
cuts, but ignores the ``drop value'' of products such as variety meats,
rendered products and goods that utilize such items as a base
ingredient (i.e., pet foods). No analysis was done for the potential
loss of variety meat exports, both in terms of increased
[[Page 525]]
supply in the United States and lost premiums. Beef variety meat (BVM)
exports to Japan averaged 149,388 metric tons from 2000-2002 and
averaged $309 million in value. Japan is the number two market for BVM,
while Korea is number four with an average of 22,949 metric tons valued
at an average $36.5 million from 2000-2002. The Livestock Marketing
Information Center states ``The byproduct value can have a considerable
impact on current slaughter cattle prices.'' In mid-November, the
byproduct (drop credit) value surpassed $10 per cwt on a live weight
basis. This is a significant proportion (ten percent) of the entire
animal value. What are the costs of losing these variety meat markets?
Response: In response to the single case of BSE in Washington
State, many export markets placed bans on imports from the United
States. As the commenter states, Japan was the second largest market
for U.S. BVM. Exports of BVM to Japan, January to March for 2003 and
2004, illustrate the significance of lost sales. During these three
months in 2003, 18,988 metric tons of BVM valued at over $41 million
were exported to Japan. During the same months in 2004, only 154 metric
tons of BVM with a value of $1.4 million were exported. A question
addressed in the analysis for the final rule is whether the rule, in
itself, can be expected to affect the restrictions on U.S. beef exports
and therefore the continued loss of premium earnings on beef variety
meat.
Issue: It is assumed, although not stated in the proposed rule,
that beef and variety meats would be segregated through processing
beyond slaughter. If this is not done, all economic advantages of prior
animal segregation are lost, while the associated costs of segregation
are incurred by the industry with no benefit accruing to the domestic
or international consumer.
Response: This final rule does not impose any requirements vis-a-
vis labeling, segregation, or preservation of identity of the product
of Canadian feeder or slaughter cattle. Once imported Canadian cattle
are moved to slaughter, the application of FSIS rules for the removal
and disposal of SRMs will prevent adverse consequences related to BSE.
Issue: Costs of plant segregation lines were not included in the
analysis. Assuming that the proposed rule allows the reestablishment of
Canadian beef and cattle imports, and our export markets, mainly Japan
and Korea, require that no Canadian beef be exported to them, the costs
of animal and beef segregation would become a direct cost to the U.S.
beef industry.
Response: APHIS agrees that there could be operational and
recordkeeping costs associated with exporting U.S. beef to Asian
markets once they reopen, if the importing countries require that the
products be derived from cattle of U.S. origin. However, if such
requirements were placed on U.S. exports, the effects would be
attributable to the policies of the importing countries, not to this
rule.
Issue: The APHIS analysis fails to address the likelihood that U.S.
beef export customers would reject the proposed actions.
Response: In the economic analysis for the proposed rule, APHIS
addressed possible effects of the rule on U.S. cattle and beef exports.
Consideration was given to the possibility that importing countries
might not agree with the U.S. categorization of Canada as a region of
minimal risk. In the analysis for this final rule, we consider whether
the rule may influence other countries' decisions with regard to
lifting of current restrictions on U.S. beef.
7. Effects on Small Entities
Issue: With regard to potential effects of the rule on small
entities, economies of scale dictate that larger entities will be
better able to absorb increased fixed costs on a per-unit basis.
Segregation costs in packing and processing sectors will have a larger
impact on smaller entities. It is believed that larger entities are
better situated to absorb market volatility than smaller firms. The
history of production agriculture has shown that smaller producers have
higher costs of production and face higher risks associated with lower
market prices. The economic analysis as proposed by USDA would have
harsher consequences on smaller enterprises.
Response: APHIS agrees that larger entities will be better able to
absorb costs associated with the rule than smaller entities, such as
costs of segregating sheep and goats less than 12 months of age at
designated feedlots. We expect entities that envisage a profit by doing
so to make the capital investments and plan for the operating outlays
that may be required to import such ruminants from Canada.
Issue: The claim that the impacts on small business cannot be
estimated due to lack of data is not correct. There is considerable
data available from USDA's National Agricultural Statistics Service
(NASS) on livestock inventories by operation size. There is clearly
adequate data to define small business impact. APHIS should complete a
more thorough economic analysis of these impacts, particularly in light
of the events of December 2003. Such an analysis should be made
available for public comment before consideration of adoption of the
proposed rule.
Response: APHIS showed in table 19 of the economic analysis for the
proposed rule that the great majority of entities in industries
expected to be directly affected by the rule are small, based on NASS
data and Economic Census data. It is understood that effects of the
rule will differ among entities, depending on specific business
circumstances. APHIS does not have data that would allow a
comprehensive analysis of potential economic effects for small entities
beyond the price declines and welfare gains and losses that are
described generally. We are unaware of NASS data or additional data
available from the producer segment of the livestock industry that can
be used to more finely examine these variations in impact. However, we
do provide as an example possible effects of the rule on earnings by
small beef cow operations.
Issue: Any resumption of Canadian live cattle imports should be
carefully studied to ensure there is no negative impact on the U.S.
cattle market. Such analysis should focus on specific geographic areas,
especially Idaho and the Pacific Northwest.
Response: The various price and welfare effects described in the
analysis are for the nation as a whole, because reestablished imports
from Canada will not be restricted by region. However, it is recognized
that regions of the United States that historically have been more
closely associated with cattle imports from Canada can be expected to
be more heavily affected by the rule. An example of possible effects on
northern U.S. packing plants is referred to in the analysis of impacts
of small entities.
8. Other
Issue: Costs of removing intestines are not included in the
analysis. This would be a requirement of cattle imported from Canada
and associated costs should be outlined. Associated costs include the
costs of removal as well as the loss of the intestine as a product as
opposed to removal of only the distal ileum. The intestines are a
significant product for international markets.
Response: The FSIS SRM rule requires removal of the small intestine
from all cattle slaughtered in the United States. For illustrative
purposes, the FSIS Regulatory Impact Analysis estimates small intestine
disposal costs to be $0.22 per animal, the value of the small intestine
(casings and trepas) to be $12.21 per animal, and the value of
alternative industrial uses of small intestine to be $0.33 per animal.
[[Page 526]]
G. Environmental Assessment for the Rulemaking
Consistent with the National Environmental Policy Act of 1969
(NEPA), as amended (42 U.S.C. 4321 et seq.), and regulations of the
Council on Environmental Quality (CEQ) for implementing the procedural
provisions of NEPA (40 CFR parts 1500-1508), we prepared an
environmental assessment (EA) regarding the potential impact on the
quality of the human environment due to the importation of ruminants
and ruminant products and byproducts from Canada under the conditions
specified in our proposed rule. In December 2004, we revised the EA to
address the detection of a BSE-infected cow in Washington State in
December 2003 and actions subsequently taken by Federal agencies to
further protect the U.S. food supply from potential BSE infection.
Other revisions to the EA include the addition of more detail about the
available disposal methods of BSE-infected carcasses and information
regarding disposal requirements for SRMs of cattle that are now
required to be removed in the United States when establishments
slaughter cattle or process cattle carcasses or cattle parts. The EA
may be viewed on the Internet at http://www.aphis.usda.gov/lpa/issues/bse/bse.html.
Issue: One commenter asked whether APHIS considered the appropriate
disposal of intestines in its EA.
Response: The revised EA gave an overview of the four methods that
would be approved for disposal of diseased carcasses and discussed the
FSIS SRM rule, which required slaughter establishments and
establishments that process the carcasses or parts of cattle to
develop, implement, and maintain written procedures for the removal,
segregation, and disposition of SRMs. In its SRM rule, FSIS discussed
the need for establishments to have the flexibility to choose the
disposal method or methods most appropriate for them; however, general
disposal procedures are found in 9 CFR 314.1 and 314.3.
Issue: One commenter stated that APHIS should work with FSIS to
develop an environmental impact statement (EIS) for this rulemaking.
The commenter suggested that the proposed rulemaking would have
potentially significant environmental effects and establishes a
precedent for future actions with potentially significant environmental
effects.
Response: The commenter is distinguishing between an EA such as the
one we have prepared for this rulemaking and an EIS. An EA is a concise
public document by which a Federal agency briefly provides its analysis
for determining whether to prepare an EIS or a finding of no
significant impact (CEQ NEPA Implementing Regulations, 40 CFR 1508.9).
An EA identifies and assesses the significance of potential impacts on
the environment of the proposed action. Its purpose is to provide any
agency with the appropriate environmental information to make an
informed decision about the proposed action and assist the agency in
deciding whether an EIS is needed. An EIS is a more extensive
environmental analysis that seeks to compare potential positive and
negative environmental effects and weigh negative environmental effects
against an action's other objectives. As discussed above, APHIS has
prepared an EA that analyzes the potential environmental effects of the
proposed rule. (Instructions for obtaining or viewing the revised EA
are included below under the heading ``National Environmental Policy
Act.) The revised EA provides additional information on the anticipated
nature and extent of environmental consequences and the relevance of
preventive actions to protect public health and safety. Based on the
known cause of BSE; on the risk information cited to and referenced in
the EA; on the preventive actions set forth in this rulemaking and on
other mitigation requirements imposed by FSIS, FDA, and the U.S.
Environmental Protection Agency; and on the history of BSE in this
country, this rulemaking should not significantly affect the quality of
the human environment. The CEQ NEPA Implementing Regulations define
significance in terms of intensity, including the degree to which the
action may establish a precedent for future actions with significant
effects or that it represents a decision in principle about a future
consideration (40 CFR 1508.27(b)(6)). This section of the CEQ
regulations does not apply to this rulemaking because: (1) The EA
concludes that the effects are not significant, (2) there is no
evidence that any effects in the rulemaking would be cumulative or
cumulatively significant, and (3) any future importations from other
countries that might eventually be designated BSE minimal-risk regions
under this rulemaking will be considered in separate NEPA analyses.
H. Withdraw or Delay Implementation of Rule
Withdraw or Delay Rule for Economic Reasons
Issue: A number of commenters recommended that APHIS withdraw,
delay, or restrict implementation of the rule because of its potential
negative economic effects on the U.S. livestock and livestock product
industry, due to the potential significant influx of cattle from Canada
over a short period of time. Additionally, said the commenters, the
rule could harm the U.S. export market and its BSE status in the eyes
of other countries if trade is allowed with Canada or if requirements
less stringent than OIE recommendations are adopted. Further,
commenters recommended that APHIS delay implementation of the rule
until Canada removes its unfair restrictions on exports from the United
States, and delay the rule until all U.S. export markets that were
closed due to the December 2003 detection in an imported cow in
Washington State are reopened. According to the commenters, if the rule
is implemented, APHIS should do one or more of the following to
minimize market disruptions:
Offer an extended window for implementation that closely
corresponds with the cattle industry's standard feeding period of 135
to 150 days;
Resume imports of live cattle in small increments and
build up over a 3 to 5 year period;
Do not allow cattle for immediate slaughter to be imported
before feeder cattle;
Establish a monthly quota for imported cattle until the
backlog of cattle from Canada is reduced;
Stagger resumption of imports of live cattle according to
the feeding and weight of the animals;
Restrict tonnage of imports to the amount that was being
imported before restrictions on Canadian imports were established.
Response: APHIS does not have authority to restrict trade based on
its potential economic impact, market access effects, or quantity of
products. Under its statutory authority, APHIS may prohibit or restrict
the importation or entry of any animal or article when the agency
determines it is necessary to prevent the introduction or dissemination
of a pest or disease of livestock. However, APHIS is actively
negotiating with trading partners to reestablish our export markets.
Issue: One commenter stated that the importation of live cattle
from Canada should not be resumed until Canada is able to verify that
actions equivalent to those imposed by FDA have been in place for at
least 30 months before such importation begins.
Response: As stated above, we consider the feed ban in Canada to be
equivalent to the one established and enforced by FDA in the United
States,
[[Page 527]]
and we consider the feed ban to have been equivalent for more than the
30 months recommended by the commenter.
Issue: One commenter referred to an announcement by CFIA of its
intention to conduct further inquiry into the importation of cattle
into Canada between 1982 and 1989, their herds of origin in the United
Kingdom, and the resulting use of rendered materials and feed
distribution from 1986 until 1993. The commenter stated that the
information from this phase of CFIA's investigation is vital to
determining the risks of allowing further imports from Canada.
Response: We acknowledge the potential value of further inquiry by
CFIA in understanding the origin and nature of BSE in North America.
However, the epidemiological investigations into both BSE cases (the
BSE cow detected in Canada in May 2003 and the BSE cow imported into
the United States from Canada and later slaughtered in Washington
State) have indicated that it is likely the infected cows were born in
Canada before implementation of the feed ban and thus were likely to
have been infected under risk conditions that no longer exist. Under
this rule, in combination with safeguards in place in Canada and in the
United States, we consider the risk that BSE-infected or contaminated
animals or animal products will enter the United States from Canada and
expose U.S. livestock through feeding of infected materials to
susceptible animals to be extremely low. Consequently, we do not
consider it necessary to delay implementation of this rule until CFIA
completes its inquiry.
Request for Public Meetings
Issue: Several commenters requested that public meetings be held
before this rule is made final. One of the commenters requested that
USDA convene a meeting of beef producers and consumers to develop a
strategy to protect our beef industry and consumers.
Response: We do not believe that public meetings at this time would
identify any issues that have not already been raised in the comments
received on our proposed rule. As discussed above, we initially
provided a 60-day comment period on our November 4, 2003, proposed
rule, which closed on January 5, 2004. On March 8, 2004, we reopened
the comment period for an additional 30 days until April 7, 2004.
Additionally, we gave notice we would consider any comments on the
proposed rule we had received between January 6, 2004 (the day after
the close of the original comment period) and March 8, 2004. We
received a total of 3,379 comments during the 5-month period between
November 4, 2003 and April 7, 2004, and do not consider it necessary to
hold public meetings before proceeding with this final rule.
Issue: A number of commenters requested the delay of this
rulemaking until the investigation of the December 2003 detection of
BSE in a cow in Washington State was completed. Several commenters
requested that APHIS wait until all appropriate domestic measures to
reduce BSE risk are in place before allowing the importation of
ruminant products from regions that have had a BSE case. Another
commenter requested that APHIS not implement the proposed rule until
the advance notice of proposed rulemaking published by APHIS in the
Federal Register on January 21, 2003 (``Risk Reduction Strategies for
Potential BSE Pathways Involving Downer Cattle and Dead Stock of Cattle
and Other Species'' (68 FR 2703-2711, Docket No. 01-068-1)), and the
advance notice of proposed rulemaking published by FDA in the Federal
Register on November 6, 2002 (Ref 47) are followed by proposed and
final actions. Several commenters requested that the final rule not be
implemented until USDA has expanded BSE surveillance, testing, and
prevention efforts and has increased funding for BSE research,
education, and development of rapid tests to detect the disease in live
animals.
Response: We do not consider it necessary to delay implementation
of this final rule. As discussed above in section III. B. under the
heading ``Reopening of the Comment Period and Explanatory Note,'' an
extensive investigation of the detection of the BSE-infected cow in
Washington State has been completed. Since publication of the proposed
rule and following the detection of the imported BSE case in Washington
State, the United States has redirected resources towards planning,
implementation, and enforcement of national policy measures to enhance
BSE surveillance and protect human and animal health. In that regard,
both USDA and FDA have initiated additional food and feed safety
measures, discussed previously in this document. In addition, USDA has
initiated an enhanced BSE surveillance program that targets cattle from
populations considered at highest risk for BSE, Also, FSIS public
health veterinarians have begun assisting in APHIS' BSE animal
surveillance efforts by collecting brain samples from all cattle
condemned during ante-mortem inspection at Federally inspected
establishments. This will allow APHIS to focus on sample collection at
locations other than Federally inspected establishments, such as
rendering operations and farms. Details of the BSE surveillance plan
are available at: http://www.aphis.usda.gov/lpa/issues/bse/BSE_Surveil_Plan03-15-04.pdf.
Strengthening of the passive surveillance system for BSE through
outreach and education is an integral part of the USDA surveillance
plan. In this regard, APHIS has developed plans to enhance existing
educational materials and processes in conjunction with other Federal
and State agencies. These outreach efforts will inform veterinarians,
producers, and affiliated industries of the USDA surveillance goals and
the sometimes subtle clinical signs of BSE, and will encourage
reporting of suspect or targeted cattle on-farm and elsewhere. One of
the tools for reporting high-risk cattle, announced on June 8, 2004, is
a toll-free number (1-866-536-7593).
To help cover additional costs incurred by industries participating
in the surveillance plan, and to help encourage reporting and
collection of targeted samples, USDA may provide payments for certain
transportation, disposal, cold storage, and other costs.
In addition, increased funding has been requested for USDA's
Agricultural Research Service (ARS) to further study BSE. Examples of
research projects ARS is actively engaged in include: Development of
information and methods to characterize and differentiate among the
known prion diseases of ruminant livestock and cervids, including BSE;
development and validation of diagnostic and surveillance tests for BSE
and CWD and development of intervention strategies for these diseases;
development of biological and biochemical methods for detection of the
transmissible agent in animal tissues and in the environment;
identification and development of new methods and collaborative
arrangements with other institutions for detecting animal proteins,
especially prion proteins (PrP), in fields, barns, abattoirs, animal
feed, feed additives or other animal products; and development of novel
techniques for destruction of prion molecules.
It is important to note that all of the above measures are
specifically designed to further minimize risks of BSE to animal and
human health in the United States that were already low, as
characterized by the Harvard-Tuskegee Study, even before the measures
taken since December 2003. Because APHIS' risk analysis was based on
the controls in place before these improvements, we
[[Page 528]]
consider it unnecessary to delay the implementation of this rule until
additional measures are in place.
General information and links to relevant APHIS documents are
available at http://www.aphis.usda.gov/lpa/issues/bse/bse.html. General
information and links to relevant FSIS documents are available at
http://www.fsis.usda.gov/oa/news/2004/bseregs.htm. General information
and links to relevant FDA documents are available at http://www.fda.gov/cvm/index/bse/bsetoc.html. In addition, the joint APHIS-
FSIS-FDA advance notice of proposed rulemaking published on July 14,
2004, provides an overview of all Federal actions taken related to BSE
and requests comment on additional measures under consideration.
Issue: A number of commenters recommended not only that APHIS
follow OIE guidelines for BSE minimal-risk status, but that the Agency
also delay any rulemaking action until new guidelines regarding BSE
risk have been set by OIE. Commenters noted that APHIS was involved in
discussions with the international community regarding such guidelines.
One commenter stated that OIE is only in the process of developing
guidelines that would be consistent with the standards for minimal-risk
regions in the proposal.
Response: OIE guidelines have continually evolved and are likely to
continue evolving, which is one reason that APHIS has decided not to
simply adopt the OIE guidelines as regulations. The United States and
other countries routinely propose revisions of the OIE BSE chapter (and
other animal disease chapters) and make comments on draft OIE
guidelines through official channels. These comments reflect technical
and scientific issues relevant to the United States. The
recommendations are reviewed by an ad hoc committee. As appropriate,
the ad hoc committee issues a report suggesting revisions to existing
OIE chapters. These are presented for adoption at the next General
Session of the International Committee.
For instance, in April 2004, the OIE ad hoc committee issued a
report proposing an example of a simplified BSE classification scheme.
This report followed a meeting held in Paris on April 15 and 16, 2004,
which resulted from OIE discussions in 2003 regarding the OIE's desire
to simplify the BSE risk categorization system while retaining its
scientific base. The report included an example of a simplified BSE
categorization scheme. It is planned that a simplified scheme will be
proposed for possible adoption in 2005.
OIE experts proposed a revision of the risk categories and a
reduction in their number from five (``free,'' ``provisionally free,''
``minimal risk,'' ``moderate risk,'' and ``high risk'') to three
(``negligible risk,'' ``controlled risk,'' or ``undetermined risk'').
The report stated that the three-category system offered the best
science-based practicable approach to the epidemiology of BSE in
combination with an emphasis on the safety of commodities for trade
rather than on a classification of country status. This overall
approach, currently under consideration by OIE, is a scientifically
sound approach consistent with APHIS' approach in this final rule,
which evaluated in an integrated way the risk conditions existent in
the exporting region in combination with risk mitigation measures for
commodities. These proposed OIE changes, as well as current OIE
guidelines, reinforce the validity of the approach APHIS adopted, which
also includes an evaluation of risk in regions seeking to be
categorized as minimal risk, coupled with an intense focus on commodity
mitigations.
Issue: Several commenters made various statements to the effect
that we should not proceed with the rulemaking at this time because of
a lack of certainty about the prevalence of BSE in Canada. Several
commenters stated that the December 2003 find means that Canada no
longer has a single case, and that Canada cannot now be considered a
minimal-risk for BSE. One other commenter specifically disagreed with
APHIS' conclusion that the additional case of BSE of Canadian origin
does not significantly alter the original risk estimate. Another
commenter stated that, based on the respective cattle populations, the
detection of BSE in 2 cows of Canadian origin is the equivalent of 15
positive cases in the United States in less than a year and that,
therefore, the risk of BSE from Canada is too high to resume imports.
Several commenters asked whether the finding of a second BSE cow of
Canadian origin will preclude Canada from consideration as a BSE
minimal-risk region.
Response: The diagnosis of BSE in a cow of Canadian origin in
Washington State in December 2003 does not preclude Canada from being
considered a BSE minimal-risk region. Under this rule, a determination
of minimal-risk status is based on an evaluation of all of a country's
BSE prevention and control measures and not on any single criterion,
such as the number of reported cases of BSE or any numerical threshold
for prevalence. While we did not quantitatively estimate the true
prevalence of BSE in Canada, we did evaluate the evidence involving the
reported incidence of BSE and the nature and level of BSE surveillance
for minimal risk regions in general and for Canada in particular. There
is ample evidence to support the conclusion that the prevalence in
Canada is very low and that Canada has implemented BSE prevention and
control measures adequate to prevent widespread exposure and/or
establishment of the disease.
Further, and, we believe, very importantly, the epidemiological
evidence obtained shows that both animals referred to by the commenters
were likely to have been infected before implementation of the Canadian
feed ban. As noted, cattle born before the 1997 feed ban are not
eligible for importation under this rule. Therefore, the detection of
BSE in the two animals does not reflect the current risk conditions in
Canada and the U.S. import conditions addressed in the analysis and
proposed rule. In addition to the measures currently in place in Canada
that make it unlikely that new cases are developing, the import
restrictions in this rule and safeguards in place in the United States
make it highly unlikely that the BSE agent will be introduced into the
United States from Canada, spread to the U.S. cattle population, or
enter the U.S. human food supply through ruminants or ruminant products
or byproducts imported into the United States from Canada.
Issue: A number of commenters recommended that APHIS not allow the
importation of cattle, beef, or beef products from Canada until more
time has passed. The periods of time suggested by commenters ranged
from 2 years to 12 years. Commenters provided various reasons for their
recommendations. While some commenters recommended a delay only in
allowing the importation of cattle, others requested a moratorium on
all imports of live cattle, fresh beef, pre-cooked beef, and beef
products until a specified period of time has elapsed or until
exporters can prove the commodities are BSE-free. Some stated generally
either that it requires a substantial amount of time until a region can
be considered to present no risk or that more information is necessary
on Canada's BSE prevention efforts. One commenter recommended that the
importation of live cattle from Canada not be resumed until USDA can
assure the U.S. beef industry and the public that it has done a
complete analysis of the Canadian livestock production system to ensure
that
[[Page 529]]
potential exporters are in full compliance with U.S. regulations that
seek to prevent the introduction and spread of BSE in the United
States. Others said that APHIS should follow WHO guidelines, which
various commenters said recommend waiting periods of from 4 to 12 years
from the date of detection of BSE. Several commenters recommended that
the importation of beef and live cattle from Canada be prohibited until
30 months from May 20, 2003, the date a BSE-infected cow in Alberta,
Canada was diagnosed.
Response: We do not consider it necessary to delay implementation
of this final rule. We have evaluated the BSE risk mitigation measures
for ruminants and ruminant products in place in Canada and consider
them equivalent to the measures that are in place in the United States.
These measures are discussed in more detail in this document under the
headings ``Reopening of the Comment Period and Explanatory Note''
(section III. B), ``Measures Implemented by FSIS'' (section III. C.),
``Verification of Compliance in the Exporting Region'' (section IV.
D.), ``Measures Taken in Canada in Response to BSE Risk Prior to May
2003'' (section III. C.), and ``Epidemiological Investigation and a
Report by an International Review Team'' (section III. C.). As noted
above, APHIS conducted a risk analysis for this rulemaking. The risk
analysis took into account the Canadian measures already in place, as
well as our proposed mitigation measures for importation. Based on our
analysis of risk, we concluded that any BSE-risk was thoroughly
mitigated under the proposed import restrictions. Additional measures
implemented since that time, both in the United States and Canada,
further reduce risks.
With regard to the reference to WHO guidelines for waiting periods,
we are unaware of WHO standards regarding the time periods the
commenters' recommended for delay of this rule. The most recent WHO
guidelines (Ref 48) reference OIE guidelines for trade, which include
provisions for trade of live cattle and meat and meat products under
certain conditions even from countries that would be considered high
risk for BSE under OIE guidelines.
In addition, it is very important to note again the point made in
the technical discussion in the risk analysis that certain commodities,
such as muscle meat, are a BSE low-risk commodity in and of themselves.
In that discussion, we pointed out that even cattle carrying the BSE
infectious agent are unlikely to carry that agent in tissues that have
not had demonstrated infectivity (e.g., muscle, liver, skin, hide,
milk, embryos) or products derived from these tissues.
Require Certification From All Countries
Issue: One commenter requested that APHIS not implement this rule
with regard to Canada until the Agency requires certification regarding
livestock feed production from all U.S. trading partners, similar to
that required by this rule for minimal-risk regions, and requires them
to allow the United States to perform random investigations and testing
of their production facilities as a condition of market access.
Response: We do not consider it necessary to postpone
implementation of this rule for the reason recommended by the
commenter. APHIS evaluates regions on an individual basis to assess the
risk of importing animals and animal products into the United States.
When supported by such an evaluation, restrictions are imposed as
necessary on imports from exporting regions. As part of the evaluation
related to BSE, we evaluate the livestock feed practices. We impose
import restrictions necessary to ensure that the practices are
appropriate. In addition, we have the authority to and will, of course,
re-evaluate regions when necessary (Sec. 92.2(g)). We consider the
requirements spelled out in this rule to be comprehensive and
sufficient to mitigate the risk of BSE introduction into the United
States.
Tracking of Animals
Issue: Several commenters stated that a national tracking system
compatible with the Canadian system should be established in the United
States before importations occur. One commenter recommended methods for
efficiently administering such an identification system.
Response: We do not consider it necessary to delay implementation
of this rule until a national animal identification system is
implemented in the United States. The animals that will be allowed
importation under this rule will either be moved directly to slaughter
or be officially and permanently identified and moved within a short
period of time under APHIS movement permit to slaughter once in the
United States.
Issue: A number of commenters requested that importation of
ruminants and ruminant products from Canada not be resumed until more
research on BSE is done. Another commenter mentioned that the science
of prions is in its infancy and disputed the notion that prions appear
only in older animals and not in milk or muscle.
Response: We do not consider it necessary to wait until more
research is conducted or more information from Canada is available
before implementing this rule. We consider the BSE research upon which
we based the proposed rule and this final rule to be very substantial,
and consider the mitigation measures in this rule to be very well
supported by the research. We discussed the research upon which we
based this rulemaking in the risk documents we made available with our
November 2003 proposed rule and March 2004 notice of extension of the
comment period. Additionally, in the update to our risk analysis
described above in section II. C. under the heading ``Update to APHIS'
Risk Analysis and Summary of Mitigation Measures and Their
Applicability to Canada as a BSE Minimal-Risk Region,'' we describe the
sequential risk barriers that Canadian imports will be subjected to.
The commenter who disputed whether prions appear only in older animals
and not in milk or muscle did not provide any data to support that
contention and we are unaware of any reports that demonstrate BSE
infectivity in ruminant milk and skeletal muscles.
I. Miscellaneous
Consider Regionalizing Parts of Canada
Issue: Some commenters suggested that APHIS regionalize Canada to
differentiate Canadian provinces where BSE-infected cattle have been
detected from provinces that have not had a BSE case.
Response: We are making no changes based on the comments. The
information currently available to us does not suggest a difference in
risk factors between provinces in Canada to the extent that would be
necessary to justify such regionalization. Consequently, APHIS is
categorizing all of Canada as a BSE minimal-risk region.
Effectiveness of Existing Regulations
Issue: One commenter stated that the detection of BSE in a cow
slaughtered in Washington State indicates that even the existing
regulations are not sufficiently robust to protect the U.S. cattle
industry and the consumer from the introduction of BSE.
Response: From the time of the diagnosis of a BSE-infected cow in
Canada in May 2003 until implementation of this final rule, the
importation of live ruminants from Canada has been prohibited. As we
discussed in the Explanatory Note to our risk analysis and in section
III. B.
[[Page 530]]
above under the heading ``Reopening of the Comment Period and
Explanatory Note,'' the epidemiological investigation of the imported
BSE-positive cow slaughtered in Washington State shows that the
infected cow was not indigenous to the United States and most likely
became infected in Canada before that country's implementation of a
feed ban, and, therefore does not reflect current risk conditions.
Furthermore, all cattle identified in the United States as possibly
having been from the Canadian source herd of the infected cow were
euthanized and tested for BSE, and all of the animals tested negative.
Because there is a small probability that BSE can be transmitted
maternally, the two live offspring of the infected cow were also
euthanized. A third had died at birth in October 2001. All carcasses
were properly disposed of in accordance with Federal, State, and local
regulations. Also, in conjunction with USDA's investigation, FDA
conducted an extensive feed investigation. By December 27, 2003, FDA
had located all potentially infectious product rendered from the BSE-
positive cow in Washington State. The product was disposed of in a
landfill in accordance with Federal, State, and local regulations. This
rule by its terms requires that any cattle imported into the United
States from Canada were born after the implementation of that country's
feed ban.
Enforcement of Current Regulations
Issue: One commenter suggested that USDA focus its limited
resources on effectively enforcing current BSE regulations, rather than
subjecting the U.S. industry and consumers to what the commenter viewed
as an increased BSE risk. The commenter stated that import data
obtained through reports from the Economic Research Service (ERS) in
2001 and the Foreign Agricultural Service (FAS) show that several BSE-
affected countries have exported beef to the United States. Also, the
commenter said Japan should have been listed as an ``undue risk''
country because it did not implement internationally recommended feed
import restrictions and because its import requirements were less
restrictive than those acceptable for import by the United States.
Response: APHIS has examined U.S. import statistics reported by ERS
and FAS that the commenter stated indicated the importation of products
from countries with cases of BSE in violation of current APHIS import
rules. In many cases, these reports have turned out to be erroneous. In
the import databases, several commodities--including those that are
restricted from importation and those that are not--may be included in
a given category of imports, so the data are subject to
misinterpretation. In addition, we have identified certain errors in
the reports, such as the miscoding of imports that actually came from
Australia as having originated in Austria. Further, import codes are
based on tariff needs rather than on animal health needs, which makes
it difficult to use the reports to determine compliance with animal
health based trade restrictions. We are satisfied that our current
import requirements are being properly enforced.
With regard to imports from Japan, following the finding of the
first case of BSE in Japan in 2001, APHIS immediately banned the
importation of live ruminants and ruminant products and byproducts from
that country, and codified that ban by publishing an interim rule in
the Federal Register on October 16, 2001 (66 FR 52483-52484, Docket No.
01-094-1), that added Japan to the list in Sec. 94.18(a) of regions in
which BSE exists. Before detection of BSE in Japan, that country was
not listed as a region that posed an undue risk of BSE. At the time the
``undue risk'' category was developed, the focus was on trading
practices among Member States of the European Union, because the
European Union was where BSE was first detected and its Member States
largely follow uniform trade practices. It is not clear to us from the
comment what import practices in Japan are being referred to. The lack
of a feed ban was not specifically part of the rationale for
establishing the ``undue risk'' category.
Follow-Up to Washington State Detection
Issue: Following detection of BSE in an imported cow in Washington
State in December 2003, one commenter recommended that a group of USDA
stakeholders be assembled to work with the Secretary of Agriculture's
BSE advisory group to address all issues arising out of the
epidemiological investigation, emergency response, and mitigating
measures announced by the Secretary on December 30, 2003.
Response: Following detection of BSE in December 2003 in an
imported dairy cow in Washington State, USDA and other Federal and
State agencies worked together closely to perform an epidemiological
investigation, trace any potentially infected cattle, trace potentially
contaminated rendered product, increase BSE surveillance, and take
additional measures to protect human and animal health. USDA worked in
collaboration with the CFIA in conducting the investigations.
Additionally, an international team of scientific experts (the IRT)
convened by the Secretary of Agriculture as a subcommittee of the
Secretary's Advisory Committee on Foreign Animal and Poultry Diseases
(SACFADP) reviewed the U.S. response and recommended actions that could
provide additional meaningful human or animal health benefits in light
of the North American experience. Both the IRT and the full SACFADP
include governmental and nongovernmental representatives who made
recommendations for enhancements of the national BSE response program
in the United States (Ref 34 and 35).
Imports From Canada Before May 2003
Issue: Several commenters recommended that BSE surveillance in the
United States be targeted at cattle imported from Canada into the
United States before May 2003.
Response: This recommendation does not directly apply to this
rulemaking but, rather, to our animal surveillance program for BSE.
Nevertheless, to address the potential risk posed by these earlier
imports, USDA and the U.S. Department of Health and Human Services have
opted to focus resources on activities that offer the most direct
protection of animal and public health. These included applying SRM
removal requirements, enforcing the feed ban, and very aggressively
increasing overall surveillance in the United States. The Departments
have determined that focusing on these measures will be very effective
and will do far more to lessen the possibility of BSE-infected material
affecting animal health or reaching the public than devoting resources
to the exceptionally difficult task of tracing Canadian-origin animals
and conducting a surveillance program focused on such Canadian-origin
animals.
Possible Causes of BSE Infection
Issue: One commenter asked whether it is known conclusively that
cattle can become infected with BSE through eating contaminated
materials.
Response: Oral ingestion of feed contaminated with the abnormal BSE
prion protein is the only documented route of field transmission of BSE
(Ref 49) although other routes have been considered. Thus, the primary
source of BSE infection appears to be commercial feed contaminated with
the infectious agent. The scientific evidence shows that feed
contamination results from the incorporation of ingredients that
contain ruminant protein derived from infected
[[Page 531]]
animals. Standard rendering processes do not completely inactivate the
BSE agent. Therefore, rendered protein such as meat-and-bone meal
derived from infected animals may contain the infectious agent and can
result in the infection of other animals that consume the material.
Canadian Prohibition of Imports
Issue: One commenter noted that in 1996 Canada prohibited imports
of live ruminants from any country not recognized as free of BSE, and
asked why, now that BSE has been detected in cattle indigenous to
Canada, the United States would take a different approach than Canada
did and allow imports from that country.
Response: The BSE situation addressed by Canada in 1996 was
significantly different from the BSE situation in that country today.
Actions taken now can be based on scientific research and information
that was not available in 1996. In 1996, BSE concerns were focused on
the United Kingdom and other countries with a high incidence of the
disease. In addition, significant concern existed regarding the risks
of possible human exposure to the BSE agent if the importation of live
cattle from those regions were allowed. At that time, the apparent link
between BSE and vCJD had just been announced, and predictions were
being made of huge numbers of cases of vCJD. Since 1996, understanding
of the disease has increased significantly, as has our knowledge of and
experience with measures that can be taken to mitigate the risk. In
addition, the predictions related to numbers of human cases have been
scaled down dramatically, reflecting a better understanding of the true
exposure that might have occurred. Today, effective import conditions
can be designed to address specific risk issues.
U.S. Approach to BSE as Compared to Other Diseases
Issue: Several commenters expressed concern that APHIS' import
policy with regard to BSE seems to differ from its general policy with
regard to other foreign animal diseases. One commenter stated that,
with most diseases, APHIS does not allow importation until adequate
surveillance has been done to prove freedom from the disease. However,
with regard to BSE, stated the commenter, APHIS allows imports from a
region until a case of BSE is identified in that region. The commenter
stated that APHIS should define standards for all levels of trade with
various countries concerning BSE. Another commenter said that a country
should be classified into one of the BSE established categories before
trade in ruminant and ruminant products can be established.
Response: With regard to trade from BSE-affected countries, in
Sec. 94.18(a)(1) APHIS currently maintains a list of regions where BSE
is known to exist. Additionally, Sec. 94.18(a)(2) lists regions that
present an undue risk of BSE because their import requirements are less
restrictive than those that would be acceptable for import into the
United States and/or because the regions have inadequate surveillance
for BSE. APHIS prohibits the importation of live ruminants and certain
ruminant products and byproducts both from regions where BSE is known
to exist (and that are not considered BSE minimal-risk regions) and
from regions of undue risk, even though BSE has not been diagnosed in a
native animal in the latter regions.
As a newly discovered disease, BSE was limited in its geographic
distribution to the United Kingdom and certain other countries in
Europe. There was no evidence to suggest the disease existed elsewhere
in the world. This situation lent itself to the policy of adding
regions to lists of BSE-affected regions or regions that present an
undue risk of BSE based on evidence of the disease's existence in those
regions or on evidence that there was an undue risk of the disease
existing in those regions, rather than assuming that BSE exists in
every country of the world unless proven otherwise. This is consistent
with our approach to other diseases, such as African horse sickness,
which has never been shown to exist in countries other than in Africa
and some countries on the Arabian Peninsula. Also, in contrast to
infectious diseases that can be diagnosed relatively quickly, BSE has
an extremely long incubation period.
If the commenter who discussed the need to conduct adequate
surveillance to prove freedom from a disease before allowing
importations was referring to the proposed provisions that would allow
the importation of ruminants and ruminant products from Canada, it
should be noted that we did not propose to consider Canada as a region
free of BSE. Rather, in this rule we are creating a new category of
regions that present a minimal risk of introducing BSE into the United
States via imported ruminants and ruminant products and byproducts.
This category is in addition to the categories of regions where BSE
exists and regions that present an undue risk for BSE. We are adding
conditions to allow the importation of certain live ruminants and
ruminant products and byproducts from BSE minimal-risk regions (at this
time, only Canada). As discussed in our proposed rule and in this
Supplementary Information section, we will evaluate other regions as
potential BSE minimal-risk regions upon their request and submission of
the necessary information.
We described in the proposed rule and the risk analysis conducted
for this rulemaking that Canada has conducted BSE surveillance since
1992. For the past 7 years, Canada has tested more than the minimum
number of samples recommended by OIE. Additionally, we consider Canada
to have exceeded the OIE guideline for surveillance by conducting
active targeted surveillance, as has been done in the United States. We
concluded that Canada's level of surveillance is adequate for that
country to be recognized as a BSE minimal-risk region.
Change in BSE Status
Issue: One commenter stated that this rule should include criteria
for determining when the BSE minimal-risk status of a region will be
changed to a status of higher or lower risk, and should include how
criteria for such a change in classification will be reviewed and
evaluated.
Response: We acknowledge that there may be situations where the BSE
minimal-risk status of a region should be changed to a status of higher
or lower risk. As proposed, however, this rulemaking was intended to
establish and address standards for recognizing a region as a BSE
minimal-risk region, along with mitigation measures for the importation
of susceptible animals and animal products from such regions. We have
taken the commenter's recommendation under review, and, if we determine
that standards for movement to a higher or lower risk status should be
promulgated, we will propose those standards in a separate rulemaking.
The provisions in Sec. 92.2(g) recognize the need to conduct ongoing
monitoring of a region's animal health status and provide that a region
that has been granted animal health status under the APHIS regulations
may be required to submit additional information pertaining to animal
health status or allow APHIS to conduct additional information
collection activities in order for that region to maintain its status.
WHO Guidelines
Issue: One commenter stated that the WHO does not recognize
``minimal-risk BSE countries'' and that WHO policy is not to allow
imports of beef or cattle from BSE countries. Therefore, said the
commenter, the import of beef and cattle from Canada should not be
allowed.
[[Page 532]]
Response: As discussed above under the heading ``Withdraw or Delay
Implementation of Rule,'' we are not aware of any WHO guidelines that
reference specific trade policies. It is the OIE guidelines (Ref 2)
that are relevant in this regard, and OIE guidelines include provisions
for trade in live cattle and meat and meat products from countries in
all categories--including those at high risk for BSE.
Indemnity for U.S. Producers
Issue: One commenter asked whether USDA will indemnify U.S.
producers if our trading partners question movement and identification
controls for cattle imported from Canada and Canadian feeder cattle
become unmarketable.
Response: APHIS will not indemnify U.S. producers for the actions
of trading partners.
Recognize Isolated Donor Herds
Issue: Several commenters requested that the regulations allow
ruminant products to be collected from isolated herds that have been
controlled to be free from exposure to contaminated feed and animal
diseases, and that APHIS work with companies that currently have such
herds to established harmonized standards for BSE freedom.
Response: We are making no changes based on these comments. There
are currently no procedures in place for classifying herds as BSE free,
and it would not be appropriate to add such criteria in this final
rule. However, APHIS welcomes information from interested parties on
recommended criteria for BSE-free herds.
Feed Ban and Processing Compliance in the United States
Issue: One commenter recommended that we check more rigorously for
violations of the ban on ruminant products in ruminant feed in the
United States. Another commenter stated that FDA data from 2000 and
2002 indicate low compliance with the ban on feeding ruminant protein
to ruminants in the United States.
Response: The United States, through the FDA, implemented a feed
ban prohibiting the use of most mammalian protein in feeds for ruminant
animals, effective August 4, 1997. This prohibition appears in 21 CFR
part 589.2000. Compliance with the 1997 FDA feed ban is currently very
high. Current compliance numbers are not readily comparable with
numbers that were published in 2000 and 2002. The two sets of
compliance numbers were drawn from different databases and used
different presentation formats. Current numbers differentiate between
serious and minor violations of the feed rule, the latter of which
generally consist of minor recordkeeping deviations. Previous
compliance numbers included those minor recordkeeping as part of the
total number of violations. A level of high compliance by feed mills,
renderers, and protein blenders has been noted for a number of years.
BSE inspection results are accessible on the Internet at http://www.fda.gov/cvm/index/bse/RuminantFeedInspections.htm.
Animal Feed Restrictions
Issue: Several commenters requested that no animal protein and fat
be allowed in feed for farm animals, so as to prevent the possibility
of cross-contamination of concentrate feed in mills and accidental
misfeeding on farms that contain different species of animals. Several
commenters requested that SRMs be banned from use in all animal feed.
Response: As noted, the FDA enforces a feed ban prohibiting the use
of most mammalian protein in feeds for ruminant animals and compliance
with this feed ban is currently very high. In the joint FDA-FSIS-APHIS
advance notice of proposed rulemaking published July 14, 2004, FDA
requested additional information to help it determine the best course
of action with regard to the feed ban. As discussed above under the
heading ``Measures Implemented by FSIS,'' FSIS bans the use of SRMs in
human food.
Products for Human Consumption
Issue: One commenter stated that USDA should act to ensure that no
central nervous system tissue (CNS) is found in meat destined for human
consumption. The commenter said that a survey conducted by FSIS in 2002
regarding the use of advanced meat recovery (AMR) systems in the United
States indicated that 74 percent of establishments surveyed tested
positive for CNS tissue contamination. (AMR is a technology that
enables processors to remove the attached skeletal muscle tissue from
livestock bones without incorporating significant amounts of bone and
bone products into the final meat product.)
Response: With regard to beef product derived from an AMR system,
FSIS reported that their 2002 survey indicates that approximately 76
percent (25 of 34) of the establishments whose AMR product was tested
had positive laboratory results for spinal cord, dorsal root ganglia
(clusters of nerve cells connected to the spinal cord along the
vertebral column), or both in their final beef AMR products. However,
as discussed in this Supplementary Information section under the
heading ``Measures Implemented by FSIS,'' in an interim final rule
published and made effective on January 12, 2004, FSIS expanded the
previous prohibition against spinal cord tissue being present in meat
derived from AMR systems to include all CNS tissue. In addition, in its
January rulemaking, FSIS prohibited the manufacture of mechanically
separated beef, as well as the production of AMR using SRMs.
Issue: A number of commenters stated that APHIS should make final
its proposed rule only if the United States bans all rendered products
from the human food supply.
Response: FSIS has identified those tissues that are unfit for
human consumption regardless of whether cattle exhibit signs of BSE. As
a result, all SRMs, as well as the small intestine, are prohibited from
entering the human food supply, and if rendered, may be used only in
inedible rendering.
Issue: As discussed above under the heading ``Measures Implemented
by FDA,'' FDA has prohibited SRMs, the small intestine of all cattle,
material from non-ambulatory disabled cattle, material from cattle not
inspected and passed for human consumption, and MS(beef) from use in
FDA-regulated human food, including dietary supplements, and cosmetics.
One commenter stated that the APHIS was silent on whether Canada plans
to adopt those new FDA restrictions.
Response: FDA applies any restrictions it establishes on the use of
products in the United States to products imported into the United
States and will enforce those restrictions with regard to imports from
Canada accordingly.
Restrictions on Product Use Due to Clinical Signs of BSE
Issue: One commenter stated that, to avoid consumer problems,
Federal agencies should provide that any animals exhibiting symptoms of
BSE may be used only for pet food.
Response: All cattle slaughtered in Federally inspected
establishments in the United States are subject to inspection. FSIS
inspectors examine cattle to identify any symptoms of disease,
including signs of central nervous system impairment. Cattle that are
suspect for any reason are examined by an FSIS veterinarian to
determine whether the animals are eligible for slaughter. Cattle that
show signs of systemic illness and disease are condemned and are not
allowed into the human food supply. As noted, FDA currently prohibits
the feeding of most
[[Page 533]]
mammalian protein (other than that from horses and pigs) to ruminants,
and is developing a proposed rule to further strengthen the feed ban.
Uniform Standards
Issue: Several commenters requested that this rule not be
implemented until a uniform set of BSE standards has been agreed upon
among the United States, Canada, and Mexico. The commenters stated that
particular relevance should be placed on a ban on the inclusion of
blood meal in ruminant feed and on the segregation of lines in feed
mills, as FDA announced it was planning to propose.
Response: The United States has been discussing a North American
approach to the BSE issue for a number of years. Officials from the
United States hold annual meetings with Canadian and Mexican technical
experts from counterpart agencies that cover animal health, public
health, diagnostics, and research. These meetings have contributed to
greater understanding and harmonization of BSE control and prevention
policies among the three countries. In fact, the United States, Canada,
and Mexico have an agreement to recognize BSE region evaluations
conducted by any of the three countries, using the same standards.
Currently, the United States is working with Canada and Mexico to
develop a joint North American BSE strategy that promotes international
guidelines protecting public and animal health, while encouraging the
use of science- and risk-based trade measures in order to maintain
sound disease surveillance and transparent reporting. Some of the
preliminary results from those discussions are reflected in this final
rule, such as the changes from our proposed provisions regarding the
importation of live cervids into the United States (discussed above
under the heading ``Cervids'').
Issue: One commenter recommended that implementation of this rule
be delayed until there is a clear consensus among trading partners as
to what constitutes SRMs.
Response: As noted above, the United States is working with Canada
and Mexico to develop a joint North American BSE strategy and those
three countries agree on what constitutes SRMs. APHIS is also
interested in maintaining consistency with OIE guidelines regarding
SRMs, although in certain cases the USDA considers it prudent to exceed
the guidelines currently recommended by OIE.
Country-of-Origin Labeling
Issue: A number of commenters recommended that country-of-origin
labeling be required in the United States so that beef imported from
Canada would be so labeled. Some commenters suggested APHIS postpone
implementation of this rule until such labeling is in place in this
country. Several commenters raised concerns about how the United States
would be able to certify U.S.-produced material as free of Canadian-
sourced material.
Response: Under the Farm and Security and Rural Investment Act of
2002 and the 2002 Supplemental Appropriations Act, USDA is required to
implement a mandatory country of origin labeling program (COOL) (Ref
50). USDA's Agricultural Marketing Service (AMS) published a proposed
rule on the COOL program on October 30, 2003 (68 FR 61944-61985, Docket
No. LS-03-04). Under the proposal, retailers would be required to
notify their customers of the country of origin of all beef (including
veal), lamb, pork, fish, and selected other perishable commodities
being marketed in their stores. In addition, the AMS proposal
identified criteria that these commodities must meet to be considered
of U.S. origin. In January 2004, President Bush signed Public Law 108-
199, which includes a provision to delay until September 2006 the
implementation of mandatory COOL for all covered commodities except
wild and farm-raised fish and shellfish. The COOL program, when
implemented, will address the labeling concerns raised by commenters
with regard to APHIS'' proposed rule. APHIS does not consider it
necessary to delay implementation of this rule until those labeling
provisions are implemented. In its October 30, 2004 proposal, AMS
noted, in discussing Section 10816 of Public Law 107-171 (7 U.S.C.
1638-1638d) regarding COOL that the ``intent of the law is to provide
consumers with additional information on which to base their purchasing
decisions. It is not a food safety or animal health measure. COOL is a
retail labeling program and as such does not address food safety or
animal health concerns.''
Jurisdiction
Issue: One commenter expressed the need for elimination of what the
commenter termed conflicts of jurisdiction between the agencies of the
Federal Government that oversee public health and safety. As an
example, stated the commenter, the November 2003 APHIS proposed rule
gives APHIS precedence over FSIS in determining whether an animal or
its food products are safe to import, even though APHIS does not have
authority to regulate food derived from the animal. One commenter
stated that this rulemaking should be under the control of a human
health agency because USDA has no expertise in the subject area.
Another commenter suggested as a possible solution to what the
commenter viewed as overlapping agency authorities the development of a
single food agency in the United States to oversee all aspects of the
food product safety system.
Response: We disagree with the commenters' assessments. The issues
of protecting human and animal health from the risks of BSE are
sufficiently diverse to require involvement of multiple agencies acting
under their respective authorities. This work is carried out primarily
through the USDA agencies of APHIS for animal health and FSIS for food
safety, along with FDA. USDA has the statutory authority to protect
both animal agriculture (AHPA) and public health (the Federal Meat
Inspection Act, the Poultry Products Inspection Act of 1968, and the
Egg Products Inspection Act).
APHIS regulates the importation of animals and animal products into
the United States to guard against the introduction of animal diseases,
including BSE. FSIS is responsible for ensuring the nation's commercial
supply of meat, poultry, and egg products is safe, wholesome, and
correctly labeled and packaged, whether produced domestically or
imported. To ensure the safety of imported products, FSIS maintains a
comprehensive system of import inspection and controls, which includes
audits of a region's foreign inspection system, port-of-entry
reinspection, and annual review of inspection systems of foreign
countries eligible to export meat and poultry to the United States.
These two USDA agencies, under their respective authorities, act
together in the prevention, monitoring, and control of BSE in the U.S.
livestock and meat and meat products food supply.
USDA agencies coordinate their responsibilities with FDA's Center
for Veterinary Medicine regarding safety of animal feed. Likewise, such
coordination is carried out with the FDA's Center for Food Safety and
Applied Nutrition regarding the safety of all foods other than meat,
poultry, and egg products, and with other FDA Centers having
responsibility for drugs, biologics, and devices containing bovine
material. These agencies collaborate, issuing regulations under their
respective, to implement a coordinated U.S. response to BSE.
[[Page 534]]
Private Testing for BSE
Issue: Several commenters recommended that private companies be
provided the opportunity to do their own testing for BSE.
Response: APHIS has considered carefully the possibility of
allowing private companies to conduct their own BSE testing, and
remains convinced that allowing such testing for private marketing
programs is inconsistent with USDA's mandate to ensure effective,
scientifically sound testing for significant animal diseases and to
maintain domestic and international confidence in U.S. cattle and beef
products. As we continue to deal with the complexities of BSE, we
consider it important to maintain clarity with regard to the purpose of
USDA's BSE testing and the results such testing yields. As explained
previously, currently available post-mortem tests, although useful for
disease surveillance, are not appropriate as food safety indicators.
User Fees
Issue: One commenter stated that the $94.00 fee for a permit to
import animals and products into the United States is unfair to private
individuals and that there should be a minimal or no fee for permits.
Response: The issue raised by the commenter pertains to general
import procedures and is not within the scope of this rulemaking.
However, with regard to the general issue of user fees, under APHIS'
regulations, user fees are charged for the services APHIS provides
related to the importation, entry, or exportation of animals and animal
products. As provided in 9 CFR part 130, APHIS charges all individuals
a $94.00 fee for processing an application for a permit to import live
animals, animal products or byproducts, organisms, vectors, or
germplasm (embryos or semen) or to transport organisms or vectors.
These charges are necessary for APHIS to recover the costs of providing
these services. APHIS does not receive funds appropriated by Congress
for these activities, and Congress has directed APHIS to charge user
fees to recover its costs. The $94.00 cost for APHIS'' processing of
applications for permits to import products was set in August 2001 (66
FR 39628-39632, Docket No. 99-060-2) based on the average of the actual
volumes of each type of application processed in fiscal years 1998 and
1999. The user fee amount includes cost components for the salaries of
employees involved in the processing applications, along with costs of
billings and collections, rent, equipment (such as computer
technologies), Agency overhead, and departmental charges.
Flexibility and BSE Research Advances
Issue: One commenter recommended that this rule explicitly provide
administrative flexibility to the Administrator, with the understanding
that the flexibility granted to the Administrator would be applied on
the basis of risk assessment and sound science. The commenter stated
that such an approach would provide for transparent and predictable
application of the rule, while accommodating the evolution of
scientific knowledge and risk mitigation processes, new product
development, market demand, and revisions to OIE standards or WHO
guidance. Another commenter requested that USDA review the provisions
in this final rule 2 years after publication to see if technology and
research advances warrant changes in the regulations. Another commenter
requested that APHIS reassess the rule in 5 or 10 years.
Response: We are making no changes based on these comments. In
developing this rule, we considered the best current BSE research
available to us and designed the standards for minimal-risk regions to
provide for some flexibility. We continually evaluate our regulations
to consider advancement in knowledge and science.
Zero Risk
Issue: Several commenters disagreed that importations of ruminants
and ruminant products should be allowed under certain conditions from
regions that APHIS considers minimal risk for BSE. Some commenters said
that countries exporting such commodities to the United States should
present a ``zero risk'' of BSE, not a minimal risk. Even with a zero
risk standard, said one of these commenters, it would be incorrect to
say any region is BSE free and that the most that can be said is
testing has not been conducted for BSE in that region.
Response: Zero risk is virtually, if not completely, impossible to
achieve. As noted above, if we were to make trade dependent on zero
risk, foreign, as well as interstate, trade in animals and animal
products would cease to exist. APHIS agrees with the conclusion
expressed in international trade agreements, such as the WTO-SPS
Agreement and NAFTA, that trade should be commensurate with risk. Under
these agreements, participating nations, including the United States
and U.S. trading partners, have agreed to base conditions for
importations on risk assessment and international standards. Regarding
the risk associated with regions that have no or inadequate
surveillance for BSE, we do not currently accept live ruminants or
ruminant products from these regions, either because they are listed in
Sec. 94.18 as a BSE-restricted region or because they have not applied
for status necessary to trade in ruminants or ruminant products with
the United States, which would involve an evaluation by APHIS of the
region for other diseases, such as foot-and-mouth disease and
rinderpest, as well as for BSE.
The Harvard-Tuskegee Study
Issue: One commenter asked why USDA requested Harvard to conduct a
risk analysis to evaluate the effectiveness of the U.S. system with the
presence of Canadian products in U.S. channels, instead of requesting
that Canada conduct a similar risk assessment of its system.
Response: As discussed above under the heading ``Harvard-Tuskegee
Investigation of BSE Risk in the United States,'' in April 1998, USDA
commissioned Harvard and Tuskegee Universities to conduct a
comprehensive investigation of BSE risk in the United States. The
purpose of the Harvard-Tuskegee Study was to assess the effectiveness
of the U.S. domestic system with regard to BSE. The initial study did
not specifically address the risk of BSE being introduced into the
United States from Canada. The study was completed in 2001 and released
by the USDA. Following a peer review of the Harvard-Tuskegee Study in
2002, the authors responded to the peer review comments and released a
revised risk assessment in 2003 (Ref 2).
In 2003, using the same simulation model developed for the initial
study, the HCRA evaluated the implications of a then-hypothetical
introduction of BSE into the United States from Canada (Ref 10). Again,
this was an assessment of the internal system in the United States,
rather than an assessment of the risk of BSE in Canada. This assessment
confirmed the conclusions of the earlier study-namely, that a very low
risk exists of BSE becoming established or spreading should it be
introduced into the United States. In December 2002, the CFIA, Science
Branch, issued a risk assessment that evaluated the risk for BSE in
Canada. (Ref 12).
J-List
Issue: One commenter stated that, when the border is opened, we
should remove Canadian cattle from the ``J-list.''
[[Page 535]]
Response: The ``J-list'' referred to by the commenter is a list of
commodities that the Secretary of the Treasury has exempted from the
general requirement in 19 U.S.C. 1304(a) that all products that are
imported into the United States be marked as to country of origin.
Among the commodities excepted by the Secretary of Treasury from this
requirement are live livestock. The commenter's request is beyond the
scope of this rulemaking, which does not address U.S. Department of
Treasury requirements. However, we note that, under this rule, all
cattle, sheep, and goats imported from Canada for other than immediate
slaughter must be permanently identified before exportation to the
United States as being of Canadian origin.
Comments on Issues Outside the Scope of This Rulemaking
A number of comments raised issues addressed topics outside the
scope of the provisions of the proposed rule. These comments included
the following issues: Concern regarding the effect of regulations in
general on the cost of raising cattle; concern regarding the inhumane
treatment and shipment of animals; recommendations regarding the
terminology to use when referring to the euthanization of animals;
requests for meetings with APHIS officials to discuss product
development; concern that APHIS appears to be giving the issue of BSE
minimal-risk regions a higher priority than domestic cattle disease
programs; prohibiting the lambing of U.S. sheep on pastures where
scrapie might be a problem; a recommendation that we require cattle
exported from the United States to Canada to have a USDA identification
tag and be marked with a brand; a recommendation that all livestock be
allowed to live out their lives; a recommendation that cattle not be
slaughtered before 30 months of age and that sheep and goats not be
slaughtered before 12 months of age; and requests that the Canadian
government pay U.S. cattle producers for economic and administrative
losses due to the detection of a BSE-infected cow in Washington State.
V. Additional Clarifications
Transiting of Ruminant Products Through the United States
We are providing in Sec. 94.18(d) that meat, and edible products
other than meat, that are eligible for entry into the United States
from a BSE minimal-risk region may, under certain conditions, be
transited overland through the United States for export to another
country.
The existing regulations in Sec. 94.18(d) have allowed the
transiting through the United States for immediate export, under
certain conditions, of meat, and edible products other than meat, that
are otherwise prohibited importation into the United States because
they are derived from ruminants that have been in a region listed in
Sec. 94.18(a) as a region either in which BSE exists or that poses an
undue risk of BSE. Before our listing Canada in this rule in Sec.
94.18(a)(3) as a BSE minimal-risk region, the only regions listed in
Sec. 94.18(a) were countries from which transport of ruminant products
to and through the United States would necessarily involve shipment by
air or sea. Therefore, we have interpreted the existing provisions for
transiting the United States in Sec. 94.18(d) to apply only to such
transiting at air or sea ports in the United States for export to
another country. The increased risk from overland shipment would have
required mitigation measures in addition to those listed in existing
Sec. 94.18(d).
Now that BSE has been detected in a country (Canada) from which
overland shipment of ruminant products is feasible, we consider it
necessary to clarify our intent with regard to the existing transiting
provisions in Sec. 94.18(d) to make it clear that transiting of
shipments otherwise prohibited importation into the United States
because of a region's BSE status may be done only at air or sea ports
in the United States. We are revising the wording in Sec. 94.18(d) to
make this clear.
However, because we consider Canada to be a region of minimal risk
for BSE, we are adding provisions to this final rule that will allow
the overland transiting through the United States of products from BSE
minimal-risk regions that are derived from bovines, sheep, or goats.
These conditions appear in Sec. 94.18(d) of this final rule and
require that, in addition to meeting the existing transiting conditions
in Sec. 94.18(d), such shipments must meet additional conditions that
are set forth in Sec. 94.18(d)(5), which provide that the shipment
must be exported from the United States within 7 days of its entry, the
commodities must not be transloaded while in the United States, and a
copy of the import permit required under the transiting conditions must
be presented to the Federal inspector at the port of arrival and the
port of export in the United States.
A reasonable question would be: ``If products are eligible for
entry into the United States from a BSE minimal-risk region, why is it
necessary to establish conditions for their transiting through the
United States?'' The reason for restricting overland transiting to low-
risk products from BSE minimal-risk regions is that shipments for
controlled transit are not intended for ultimate entry into the United
States and generally do not need the same manner of border inspection
as shipments intended for U.S. entry. In recognition of this, we are
combining the existing transiting requirements and those of this final
rule with limitations on the type of products eligible for transiting
to further ensure that such products do not present a risk of
introducing BSE into the United States.
Part 95, which deals with the importation of inedible products, has
provisions in Sec. 95.4(f) that are similar to those in Sec. 94.18(d)
regarding transiting of products. In this final rule, we are making the
same changes to Sec. 95.4 as those discussed above with regard to
Sec. 94.18(d).
Definition of Inspector
Sections 93.400 and 95.2 each contain a definition of inspector.
Section 94.0 contains a definition of authorized inspector. These
definitions refer to an individual responsible for certain functions at
a port of arrival or export in the United States. Each of the
definitions refers to an individual either employed by APHIS or
authorized by the Administrator to enforce the regulations. However,
these definitions do not reflect the reassignment of certain
responsibilities from APHIS to the Department of Homeland Security's
Bureau of Customs and Border Protection by the Homeland Security Act of
2002. Therefore, we are replacing the definitions of inspector and
authorized inspector in those sections with new definitions that read
as follows: ``Any individual authorized by the Administrator of APHIS
or the Commissioner of Customs and Border Protection, Department of
Homeland Security, to enforce the regulations in this part.''
Similarly, we are updating Sec. Sec. 94.18(d)(3) and 95.4(f)(3) (which
is redesignated as Sec. 95.4(h)(3) in this final rule), which have
required notification of the APHIS Plant Protection and Quarantine
Officer at ports of arrival and export, to refer instead to
notification of the inspector. We are also adding the definition of
authorized inspector to Sec. 96.1 to clarify the use of that term in
part 96 of the regulations.
Definition of Flock
Before this final rule, the term flock was defined in Sec. 93.400
to mean ``a herd.'' However, 9 CFR part 93, subpart D, includes
provisions that refer to a ``flock or herd.'' To eliminate this
redundancy and to clarify our intent, we
[[Page 536]]
are a making a nonsubstantive change to Sec. 93.400 to define flock as
``a group of one or more sheep maintained on common ground; or two or
more groups of sheep under common ownership or supervision on two or
more premises that are geographically separated, but among with there
is an interchange or movement of animals.'' This definition is the same
as the existing definition of herd in Sec. 93.400, except that the
revised definition of flock refers specifically to sheep.
Wording Clarification
We are also amending Sec. 94.18(a)(1) to make it clear that
imports of ruminants and ruminant products from Canada are not subject
to the restrictions of that paragraph.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be economically significant for the purposes of
Executive Order 12866 and, therefore, has been reviewed by the Office
of Management and Budget.
Under the Animal Health Protection Act of 2002 (7 U.S.C. 8301 et
seq.) the Secretary of Agriculture is authorized to promulgate
regulations to prevent the introduction into the United States or
dissemination of any pest or disease of livestock.
The regulations in 9 CFR parts 93 to 96 include provisions that
prohibit the importation of ruminants and most ruminant products (meat
and certain other products and byproducts) from (1) regions where BSE
exists and (2) regions that present an undue risk of introducing BSE
into the United States because of import requirements less restrictive
than those that would be acceptable for import into the United States
or because of inadequate surveillance.
In this rule, APHIS is establishing an additional category of
regions that present a minimal risk of introducing BSE into the United
States. This category will include (1) those regions in which a BSE-
infected animal has been diagnosed but in which measures have been
taken that reduce the risk of BSE being introduced into the United
States, and (2) those regions in which BSE has not been detected, but
that cannot be considered BSE-free. In this rule, APHIS (1) sets forth
the standards the Agency will consider before listing a region as one
of minimal risk for BSE, (2) lists Canada as the only BSE minimal-risk
region at this time, and (3) establishes measures to mitigate any risk
that BSE would be introduced into the United States through the
importation of ruminants and ruminant products from a BSE minimal-risk
region. Future requests received from other regions to be considered
BSE minimal-risk regions will be evaluated.
On May 20, 2003, CFIA reported a case of BSE in a beef cow in
northern Alberta. To prevent the introduction of this disease into the
United States, APHIS issued an interim rule that listed Canada as a
region where BSE exists, thereby prohibiting the importation of
ruminants and most ruminant products from Canada, effective May 20,
2003.
Following the discovery of the BSE-infected cow, Canada conducted
an epidemiological investigation of the BSE occurrence, and took action
to guard against any spread of the disease, including the quarantining
and depopulation of herds and animals determined to be possibly at risk
for BSE. Subsequently, Canada asked APHIS to consider resumption of
ruminant and ruminant product imports into the United States, based on
information regarding the following: Canada's veterinary
infrastructure; disease history; practices for preventing widespread
introduction, exposure, and/or establishment of BSE; and measures taken
following detection of the disease.
The prohibition was modified on August 8, 2003, to allow the
importation of certain ruminant-derived products from Canada under
APHIS Veterinary Services permit. The most important commodity that can
enter by permit is boneless bovine meat from cattle less than 30 months
of age.
This study analyzes ruminant and ruminant product imports from
Canada that will be allowed to resume because of this rule. Expected
benefits and costs are examined in accordance with requirements of the
Office of Management and Budget for benefit-cost analysis as described
in Circular A-4, ``Regulatory Analysis,'' which provides guidance for
agencies on the analysis of economically significant rulemakings as
defined by Executive Order 12866. Effects on small entities are also
considered, as required by the Regulatory Flexibility Act.
Although not addressed in the analysis, Canadian producers and
suppliers of ruminants and ruminant products will clearly benefit from
the resumption of exports to the United States. In 2002, about 90
percent of Canadian beef exports and virtually all (99.6 percent) of
Canada's cattle exports were shipped to the United States. Canada's
cattle producers reportedly had one million more head of cattle on
their farms on July 1, 2004, than they did one year earlier. This
increase is largely due to the collapse of Canadian cattle exports.
Below is a summary of our economic analysis. A copy of the full
economic analysis is available by contacting the individual listed
under FOR FURTHER INFORMATION CONTACT. You may also view the economic
analysis on the Internet by accessing the APHIS Web site at http://www.aphis.usda.gov/lpa/issues/bse/bse.html. Click on the listing for
``Economic Analysis, Final Rule, Bovine Spongiform Encephalopathy:
Minimal-Risk Regions and Importation of Commodities (APHIS Docket No.
03-080-3.)''
The commodities that will be allowed to be imported from Canada
under specified conditions under this final rule can be summarized as:
Bovines, as long as they are slaughtered at less than 30
months of age, and as long as those bovines not imported for immediate
slaughter are moved to a single feedlot before slaughter;
Sheep and goats (ovines and caprines), as long as they are
slaughtered at less than 12 months of age, and provided sheep and goats
not imported for immediate slaughter are moved to a single designated
feedlot before slaughter;
Cervids of any age;
Camelids (i.e., llamas, alpacas, guanacos, and vicunas);
Meat from bovines, ovines, and caprines; and
Certain other products and byproducts, including bovine
livers and tongues, gelatin, and tallow.
Model and Assumptions
Cattle and beef imports comprise 99 percent of the value of
commodities that will be allowed entry from Canada because of this
rulemaking, and they are therefore the focus of the analysis. The model
used is a net trade partial equilibrium welfare model. Net trade is
defined as the absolute value of the difference between exports and
imports. Individual country trade with the United States is not
modeled. Non-spatial means that price and quantity effects resulting
from geographic differences in market locations are not included.
Therefore, price and quantity effects obtained from the model are
assumed to be the average of effects across geographically separated
markets. Partial equilibrium means that the model results are based on
maintaining a commodity-price equilibrium in a limited portion of the
overall economy.
Economic sectors not explicitly included in the model are assumed
to have a negligible effect on the model
[[Page 537]]
results. Welfare refers to benefits or losses to society, as measured
by changes in consumers' willingness to pay for commodities beyond
their actual price (a measure of utility known as consumer surplus) and
changes in producers' revenue beyond their variable costs (a measure of
returns to fixed investment known as producer surplus).
This quantitative economic modeling approach is appropriate because
the rule changes are specific to the U.S. cattle and beef sectors, are
focused in extent, and have only limited extensions into non-
agricultural sectors of the economy. A disadvantage of the model is the
lack of linkages between the cattle production and beef processing
sectors. This disadvantage is addressed through the presentation of
results from an agricultural multi-sector model that recognizes such
linkages.
We estimate effects of additional supplies to the United States of
fed cattle and feeder cattle, due to resumption of imports from Canada.
The additional quantities of cattle, all things equal, will cause
prices to fall. The model indicates the expected price decline and the
increase in quantity demanded and decrease in domestic production/
supply that will occur in response to the fall in price. Summing
welfare gains for consumers/buyers and losses for producers/ suppliers
(changes in consumer and producer surplus) yields estimated net
benefits for the United States. For beef, we expect a small decline in
imports from Canada with the rule due to the replacement of beef
produced from fed cattle by beef produced from cows, as explained
below. Estimated effects for beef are in the opposite direction from
those for cattle, with losses for U.S. consumers/buyers outweighing
gains for U.S. producers/suppliers. The effects for beef are much
smaller than the effects for cattle.
Cattle imports from Canada. There are three components to the
number of cattle under 30 months of age that are expected to be
imported from Canada: A quantity that would be imported normally, a
quantity that would have entered if cattle imports from Canada were not
prohibited (termed the backlog); and a quantity of fed cattle that
would be expected to be displaced from slaughter in Canada by increased
cow slaughter for the export of processing beef to the United States.
For the first component, the quantities of fed and feeder cattle
that would enter normally are based on average imports for 2001 and
2002: About 652,400 fed cattle and about 311,400 feeder cattle in 2005,
with somewhat lesser quantities in years 2006-2009 because of assumed
expanded slaughter capacity in Canada.
The backlog is the additional Canadian cattle that may have
accumulated due to the closing of the border to live ruminant imports
in May 2003. Importation of the backlog or some fraction of it would
begin as soon as the rule is in effect, with most of these fed and
feeder cattle expected to enter in 3 to 6 months.
Calculation of the size of the backlog is based on the change in
Canada's cattle inventory from July 2003 to July 2004. The backlog may
include about 394,500 fed cattle under 30 months of age and about
204,000 feeder cattle. The backlog of cattle over 30 months of age (not
eligible for importation under the rule) numbers about 462,500 head.
The third component of expected cattle imports, an additional
supply of fed cattle derives from another change included in the rule-
namely, removal of the requirement that beef imported from Canada come
from cattle slaughtered at less than 30 months of age. We expect this
change to result in a large increase in cow slaughter in Canada for the
export of processing beef to the United States. We discuss these
expected effects here in greater detail.
Our assumptions regarding (1) the shift in Canada from slaughter of
fed cattle under 30 months of age to slaughter of cattle (principally
cows) over 30 months of age, for the export of processing beef to the
United States, and (2) the shipment to the United States of the fed
cattle under 30 months of age not slaughtering in Canada, are based on
relative prices and margins in the two countries for fed cattle, cows,
fed beef, and processing beef. As of mid-November 2004, a Canadian
packer could buy a cow for about US$17 per cwt and sell the processing-
grade beef for about US$123 per cwt. The packer also could buy a fed
steer or heifer at about US$67 per cwt and sell the beef for about
US$132 per cwt. In the United States, the cow would cost a packer about
$55 per cwt and the beef would sell for about $125 per cwt; a fed steer
or heifer would cost about $85 per cwt and the beef would sell for
about $135 per cwt.
Although differences in weights and dressing percentages do not
permit the direct comparison of live animals to dressed meat, the
difference between the relative purchase prices to sales prices
indicate that the margin buying cows and selling processing beef is
much larger for a Canadian packer than it is for a U.S. packer.
Canadian packers are prevented from taking greater advantage of this
large margin by Canada's relatively small market for cow beef. Canadian
production of processing beef has already displaced much of Canada's
imported product. Without a larger demand, increased production would
cause the Canadian price of processing beef to decline sharply.
The United States is already providing Canada with additional
demand for beef from fed cattle, through the importation of boneless
beef under permit from cattle slaughtered at less than 30 months of
age. The United States, in a sense, is currently importing Canada's
surplus production of fed beef. Allowing the United States to import
Canadian beef from cattle slaughtered at more than 30 months of age
would enable Canada to produce and sell much larger quantities of
processing beef without fearing the significant price collapse that
would likely occur if the entire additional product were only for the
Canadian market.
This is not to say that the price of processing beef or cow prices
in the United States would not decline from their current levels due to
the supply from Canada, but we would not expect a sharp decline. Two
facts concerning the U.S. supply of processing beef underlie this
reasoning. First, U.S. cow slaughter is forecast to decline in 2005, as
producers begin to rebuild herds that have been characterized by
diminishing cow inventories for several years. Second, cow retention
for herd rebuilding is also expected to take place in Australia and New
Zealand, major sources of processing beef for the United States. Their
beef exports are forecast to remain largely unchanged in 2005. As long
as principal Asian markets continue to prohibit entry of U.S. beef, any
increase in imports of beef from Australia and New Zealand by these
markets may limit the supply of beef from Australia and New Zealand
into the United States.
With the rule, entry of Canadian steers and heifers is expected to
result in steer and heifer prices in the two countries becoming more
similar. For example, in 2002, fed steer prices in Alberta averaged
about US$63 per cwt, while in the United States, the Nebraska Direct
Choice steer price averaged about $67 per cwt. Given the difference in
mid-November 2004 prices for fed cattle, $67 per cwt in Canada and $85
per cwt in the United States, shipment of fed cattle to the United
States will be an attractive alternative for Canadian producers, at
least until Canadian prices rise to the level of U.S. prices (adjusted
for grade differentials and minus transportation and transaction
costs).
Prices for slaughter cows in the two countries are expected to
continue to differ because Canadian cattle more
[[Page 538]]
than 30 months of age will not be allowed entry by the rule, despite a
ready market for them at slaughter facilities located in the Northern
United States. Thus, in the absence of trade in those cattle, the
backlog of cattle over 30 months of age will remain until increased cow
slaughter in Canada reduces their inventory. We would expect the price
of cows in Canada to increase as slaughter increases in response to
opportunities to export beef from cattle more than 30 months of age to
the United States. However, the margin earned from slaughtering cows in
Canada and exporting the processing beef to the United States is likely
to remain favorable (though decreasingly so as Canada's backlog of
cattle more than 30 months of age is reduced).
It is assumed that the Canadian slaughter sector is operating at
full capacity. Key to assumptions underlying this analysis is the
willingness of Canadian slaughter facilities to add cow slaughter
shifts or days to their operations at the expense of steer and heifer
slaughter. We believe they would want to do so, given the price
differentials in Canada and the United States and the opportunity for
Canadian beef exports to the United States from cattle slaughtered at
more than 30 months of age. With the rule, beef imported from Canada
would no longer be required to come from a slaughter facility that
either slaughters only cattle less than 30 months of age or complies
with an approved segregation process, which may permit increased
flexibility in scheduling cow slaughter.
In 2005, APHIS expects this shift by Canada to exports of
processing beef and additional fed cattle to the United States to take
place throughout the year, not during one or two quarters as assumed
for the backlog of steers and heifers under 30 months of age. Beyond
2005, additions to Canadian slaughter capacity are expected to allow
increased slaughter of cattle of all ages. Canada has been able to
increase its slaughter numbers during the past year, but the opening of
new plants and major expansion of current processing facilities to
accommodate increased cow slaughter will likely take some years. The
lack of excess slaughter capacity in Canada and the described price
differentials are the basis for the assumed shift to increased cow
slaughter in Canada for the production of processing beef for export to
the United States, and the assumed additional imports of Canadian fed
cattle.
In 2005, the maximum number of imported fed cattle displaced from
Canadian slaughter may equal the backlog of cattle over 30 months of
age (assumed to be slaughtered for the export of processing beef to the
United States), about 460,000 head. For years 2006-2009, we assume the
number of fed cattle displaced from slaughter in Canada and exported to
the United States to decline, as Canada's slaughter capacity increases
and Canada's cow prices trend upward. However, all things equal, as
long as live cattle imports from Canada are limited to animals less
than 30 months of age and the U.S. demand for processing beef is high,
beef imports from Canadian cow slaughter may be favored.
Uncertainty surrounds both the assumed backlog quantities and the
quantity of fed cattle expected to be displaced by cows slaughtered in
Canada and exported to the United States. We acknowledge these
uncertainties by also conducting the analysis using one-half of the
assumed backlog and one-half of the assumed number of displaced fed
cattle.
After the backlog of cattle has been imported, imports of cattle
under 30 months of age from Canada are expected to continue at historic
levels elevated by the importation of the fed cattle displaced from
Canadian slaughter by the slaughter of cows. We therefore expect the
largest impact of the rule to occur during the first 3 to 6 months that
the rule is in effect. In order to assess these very near-term price
impacts, we estimate effects of the rule for the first and second
quarters of 2005, in addition to the five-year analysis of welfare
effects. As in the analysis of welfare impacts, we acknowledge
uncertainty about the quantity of cattle what will enter from Canada by
conducting a sensitivity analysis of near-term price effects using one-
half of the assumed backlog and one-half of the assumed number of
displaced fed cattle.
Beef imports from Canada. Boneless beef entering from Canada under
permit represents a large share of historic beef imports from Canada.
Before the Alberta BSE discovery, Canada's share of U.S. beef imports
was about 41 percent (90 percent of fresh/chilled beef imports and 4
percent of frozen beef imports). Currently, Canada's share of U.S. beef
imports is about 32 percent (fresh/chilled beef, 85 percent; frozen, 3
percent). For this reason alone, the effect of the rule for beef
imports will be much smaller than the effect for cattle imports.
Canadian beef entering the United States by permit is included in the
baseline for the analysis.
As described, we expect Canadian cows to be slaughtered in place of
fed cattle for the export of processing beef to the United States,
given Canada's limited capability to increase its slaughter capacity in
the short term. A cow that is slaughtered produces less meat than a fed
steer or heifer due to a lighter weight and lower dressing percentage.
Recent statistics from Canada indicate an average difference in beef
produced from one steer/heifer and one cow of 150 pounds. In 2005,
assuming Canada is fully utilizing all available slaughter capacity,
the decrease in beef production would total about 69 million pounds if
the backlog of about 460,000 cattle over 30 months of age is
slaughtered in place of steers and heifers. To take into consideration
possible declines in Canada's domestic consumption of beef as beef
prices rise slightly relative to other meats, and therefore movement of
beef from the domestic to export markets, we reduce the decline of 69
million pounds by one-third, to 46 million pounds.
The forecast for Canada's beef exports worldwide in 2005 is 570,000
metric tons. U.S. imports of beef from Canada are forecast to equal
about 86 percent of Canada's total beef exports, or about 490,200
metric tons. The 490,200 metric tons is equivalent to 1,081 million
pounds. In other words, Canada's beef exports to the United States,
compared to what would have been exported without this rule, can be
expected to decline in 2005 by 4.3 percent (46 million pounds divided
by 1,080 million pounds) because of the displacement of steer/heifer
slaughter by cow slaughter in Canada. The decrease in Canadian beef
exports to the United States because of this displacement is assumed to
diminish in years 2006-2009, as Canada's slaughter capacity expands.
Processing-grade beef is not perfectly substitutable for fed beef.
The two commodities compete in different but closely related markets.
This distinction is not included in the analysis because the model is
based on aggregate beef price ranges and elasticities. Increased
supplies of processing beef are expected to compete with fed beef in
the same fashion as other close substitutes. Thus, allowing imports of
beef from cattle slaughtered at over 30 months of age, together with
fed cattle imports augmented by the cattle displaced from Canadian
slaughter, is expected to result in lower prices for U.S. steers and
heifers.
As with the assumed backlog and displaced fed cattle imports, there
is uncertainty as to the amount of beef from Canadian cow slaughter
that will be imported by the United States. Accordingly, we include in
the sensitivity analysis a reduction by one-
[[Page 539]]
half of the assumed change in beef imports from Canada. In 2005, for
example, this reduced amount would represent a decrease in beef imports
from Canada of 2.1 percent from what would have been imported without
the rule.
Welfare and Near-term Price Effects of the Rule for Cattle and Beef
Welfare effects. Welfare effects of the rule for cattle and beef
are summarized in Table 1. Present values and annualized values of
welfare gains and losses over the five-year period 2005-2009, are
determined using 3 percent and 7 percent discount rates, in both 2005
and 2001 dollars.
Table 1.--Present and Annualized Value Estimations of Effects of the Rule for Fed Cattle, Feeder Cattle, and
Beef, Discounted at 3 Percent and 7 Percent, in 2005 and 2001 Dollars, 2005-2009
----------------------------------------------------------------------------------------------------------------
Changes in welfare (per thousand
Discount dollars)
Value rate -----------------------------------------
(percent) Consumer Producer Net
----------------------------------------------------------------------------------------------------------------
Present, 2005 dollars.................................... 3 $2,982,088 -$2,907,462 $74,626
7 2,592,201 -2,525,852 66,349
Present, 2001 dollars.................................... 3 2,810,618 -2,740,283 70,335
7 2,443,150 -2,380,616 62,534
Annualized, 2005 dollars................................. 3 651,153 -634,858 16,295
7 632,214 -616,032 16,182
Annualized, 2001 dollars................................. 3 613,711 -598,353 15,358
7 595,861 -580,610 15,251
----------------------------------------------------------------------------------------------------------------
Note: The present and annualized values are taken from Appendix H, based on assumed import of the backlog,
import of fed cattle displaced from slaughter in Canada by increased cow slaughter for the export of
processing beef to the United States, and beef imports from cows slaughtered in place of fed cattle.
The present value of the net benefit of the rule for cattle and
beef is estimated to range in 2005 dollars between $66.3 million and
$74.6 million, depending on the discount rate used. Over the five-year
period, the annualized value of the net benefit in 2005 dollars,
depending on the discount rate, ranges between $16.2 million and $16.3
million.
The largest effects for cattle are expected to occur in 2005, when
the backlog would be imported and the displacement of fed cattle
slaughter by cow slaughter would be largest. The impact for fed cattle
would be greater than for feeder cattle because of the larger number of
fed cattle expected to be imported. For fed cattle, the annual price
declines may range from an average of 3.2 percent in 2005 to 1.3
percent in 2009. For feeder cattle, the price declines range from an
average of 1.3 percent in 2005 to 0.6 percent in 2009.
Estimated net benefits in 2005 for fed cattle are estimated to
range from $25.0 million to $26.9 million, and for feeder cattle, from
$10.4 million to $11.0 million. In each successive year, the net
benefits are expected to become smaller, such that by 2009 they may
range for fed cattle from $3.8 million to $4.3 million, and for feeder
cattle, from $4.3 million to $4.8 million.
Effects of the rule for beef attributable to the change in beef
imports from Canada are expected to be much smaller than those for
cattle. For example, the expected 2005 net welfare loss (because of the
decline in imports due to cow slaughter replacing fed cattle slaughter)
in 2005 dollars is estimated to range between $94,000 and $98,000.
Average percentage increases in price may range from 0.09 percent in
2005 to 0.01 percent in 2009, suggesting nearly negligible impacts. If
the beef-equivalent of the fed and feeder cattle imported from Canada
is considered, the supply of beef in the United States increases and
the price of beef decreases by 1 to 2 percent from 2005 baseline
levels. Smaller decreases from baseline projections would occur after
2005 because the volume of imported animals declines.
Effects may be even smaller for U.S. producers than these
percentages indicate, given that nearly all U.S. beef imports from
countries other than Canada consist of processing beef. Demand for
imported processing beef has increased drastically as ground beef sales
continue at a robust pace. At the same time, U.S. production of
processing beef has fallen to record lows because of the cyclical
decline in cow slaughter.
Table 2 shows the results of the sensitivity analysis, assuming
importation of one-half of the backlog, one-half of the fed cattle
expected to be displaced from slaughter in Canada, and one-half of the
expected replacement of fed cattle beef imports derived from fed cattle
by beef imports derived from cows. The present value of the net benefit
for cattle and beef in this case is estimated to range in 2005 dollars
between $48.9 million and $56.1 million, depending on the discount rate
used. Over the five-year period, the annualized value of the net
benefit in 2005 dollars, depending on the discount rate, may range
between $11.9 million and $12.3 million--that is, about three-fourths
of the expected annualized net benefit with the rule.
Table 2.--Sensitivity Analysis Based on Reduced Import Quantities: Present and Annualized Value Estimations of
Effects of the Rule for Fed Cattle, Feeder Cattle, and Beef, Discounted at 3 Percent and 7 Percent, in 2005 and
2001 Dollars, 2005-2009
----------------------------------------------------------------------------------------------------------------
Discount Changes in welfare (per thousand dollars)
Value rate --------------------------------------------
(percent) Consumer Producer Net
----------------------------------------------------------------------------------------------------------------
Present, 2005 dollars................................. 3 $2,571,323 -$2,515,180 $56,144
7 2,211,115 -2,162,168 48,947
Present, 2001 dollars................................. 3 2,423,472 -2,370,557 52,915
7 2,083,976 -2,037,844 46,132
[[Page 540]]
Annualized, 2005 dollars.............................. 3 561,460 -549,201 12,259
7 539,270 -527,333 11,938
Annualized, 2001 dollars.............................. 3 529,176 -517,622 11,554
7 508,262 -497,011 11,251
----------------------------------------------------------------------------------------------------------------
Note: The present and annualized values are midpoints taken from Appendix I, based on assumed imports of one-
half of the backlog, one-half of the fed cattle numbers, and one half of the replacement of fed cattle beef
imports by cow beef imports.
In this scenario, the impact in 2005, in particular, would be
smaller because of the fewer cattle imported. For fed cattle, the
annual price declines may range from 2.3 percent in 2005 to 1.2 percent
in 2009. For feeder cattle, the price declines over the five-year
period may average 0.7 percent. Estimated net benefits in 2005 for fed
cattle may range from $12.9 million to $13.9 million, and for feeder
cattle, from $8.0 million to $8.5 million. In each successive year, the
net benefits are expected to become smaller, such that by 2009 they may
range for fed cattle from $3.5 million to $3.9 million, and for feeder
cattle from $4.3 million to $4.8 million.
The estimated percentage decrease in the price of fed cattle, if
one-half of the backlog and one-half of the fed cattle expected to be
displaced from slaughter in Canada were imported, would be about 1
percent less than when we assume importation of the full backlog and
full quantity of displaced fed cattle (2.3 percent decrease compared to
a 3.2 percent decrease). For feeder cattle, the difference in the
effect is smaller in absolute terms, but larger in relative terms (0.6
percent decrease compared to a 1.3 percent decrease). In both cases the
effects are expected to diminish over the five-year period.
Near-term price effects. As expected, price effects are larger when
the backlog is assumed to enter in one quarter rather than two
quarters, and are larger for fed cattle than for feeder cattle, given
the larger number of fed cattle expected to be imported. For example,
for fed cattle, the decrease in price when the backlog is assumed to
enter entirely within one quarter is estimated to be 5.4 percent,
assuming a price elasticity of supply of 0.61 and a price elasticity of
demand of -0.76. When the backlog of fed cattle is assumed to enter
over two quarters using the same price elasticities, the decline in
price is estimated to be 3.8 percent. Entry of the backlog of feeder
cattle over the two quarters could result in price declines of 1.9
percent, for the same elasticities, compared to a possible price drop
of 3.3 percent when the enter entirely within one quarter.
The less elastic the price elasticities (the less responsive
sellers and buyers are to price changes), the larger the expected
percentage changes in price. When the supply and demand elasticities
are halved (supply elasticity of 0.30 and demand elasticity of -0.38),
for example, and fed cattle are assumed to enter within two quarters,
the decrease in price could be 4.8 percent, compared to a price
decrease of 3.8 percent when a supply elasticity of 0.61 and demand
elasticity of -0.76 are used.
When the assumed backlog and assumed number of imported fed cattle
displaced from Canadian slaughter are halved as a sensitivity analysis,
the near-term price effects are found to be smaller overall, with the
smaller elasticities again yielding larger price decreases. For
example, the percentage decrease in price for fed cattle entering over
two quarters is estimated to be 2.5 percent for a supply elasticity of
0.61 and a demand elasticity of -0.76 (compared to a 3.8 percent price
decline when the full backlog and number of displaced fed cattle are
imported). If the supply elasticity were 0.30 and the demand elasticity
were -0.38, the price decline is estimated to be 3.2 percent (compared
to 4.8 percent for the full cattle import numbers). Similarly, smaller
percentage price declines are observed for feeder cattle when in the
sensitivity analysis the backlog and the number of imported fed cattle
displaced from Canadian slaughter are halved.
Other Impacts of the Rule
We consider other effects of the rule besides those estimated for
cattle and beef, including: The results of an agricultural multi-sector
analysis; costs that may be incurred in monitoring the movement of
imported Canadian feeder ruminants; effects for ruminant products other
than cattle and beef; and possible effects of the rule on U.S. exports.
Multi-sector analysis. Some commenters on the analysis for the
proposed rule emphasized the integrated structure of the cattle and
beef processing industries, and noted potential effects of the rule on
other sectors of the economy. APHIS agrees that a multi-sector analysis
can capture industry interactions that are missing from single-sector
analyses. We therefore report the results of an analysis based on a
model that includes the animal feed, animal production, and animal
product processing sectors.
While the major vertically linked marketing channels are included
in this model, effects of the rule farther downstream in the economy
are not modeled. For example, economic benefits to surrounding
communities of increased employment in slaughter plants receiving
greater supplies of cattle due to reopening of the Canadian border are
not captured by the model, nor are similar economic losses resulting
from reduced spending in communities by cattle producers due to
reductions in their returns. These effects are believed to be very
small on a national basis, but may show some geographic concentration.
The multi-sector analysis simulates percentage changes in prices
and gross revenues (price multiplied by the quantity sold) using the
assumed 2005 range of imported Canadian cattle (roughly 1.5 million to
2 million head, fed and feeder cattle combined). The results of the
analysis show for the combined livestock, feed, and grain sectors, a
possible decline in gross revenues of 1.4 percent to 1.7 percent. For
the beef and cattle sectors, the gross revenue declines may range from
1.3 percent to 1.6 percent, and from 3.9 percent to 4.8 percent,
respectively.
With respect to the change in the price of cattle in 2005, the
multi-sector analysis indicates a possible decline of between 3.3
percent and 4.1 percent, compared to 2005 price declines estimated in
the single-sector analyses of between 0.6 percent and 1.3 percent
[[Page 541]]
for feeder cattle, and between 2.3 percent and 3.2 percent for fed
cattle. To the extent that sector interactions result in expanded
effects as indicated by these relative price declines, welfare gains
and losses will be larger than are indicated in Table 1. The multi-
sector model simulates price and revenue changes, but does not yield
measures of welfare change. However, this model does indicate a decline
in consumer expenditures by about 1 percent, a finding that supports
the estimated consumer welfare gains attributable to the rule.
The multi-sector analysis also examines possible effects if beef
consumption in the United States were to decline by 2 percent because
of consumers' perception of increased risk of BSE with the rule.
Compared to the assumption of no consumer response, this scenario shows
that there would be a decline in beef and cattle prices by an
additional 0.2 percent to 0.4 percent, causing gross revenues for the
beef and cattle sectors to fall by an additional 0.2 percent to 0.5
percent.
A third scenario considered in the multi-sector analysis is partial
restoration of beef exports to Japan, such that U.S. beef exports in
2005 would double, from an expected 0.3 million metric tons to 0.6
million metric tons. In this instance, gross revenue for the cattle
sector (assuming 1.5 million head of Canadian cattle are imported)
could decline by 1.7 percent, compared to a possible decrease of 3.9
percent assuming no change in U.S. beef exports. For the beef sector,
gross revenue losses of 1.3 percent may become gains of 2.2 percent
because of the exports to Japan. For both sectors, increased U.S.
exports could moderate by at least one-half the price declines due to
resumption of cattle imports from Canada.
Monitoring the movement of feeder cattle. Movement within the
United States of feeder cattle (and feeder lambs and goats) imported
from a BSE minimal-risk region such as Canada--from the U.S. port of
entry to a feedlot and from the feedlot to slaughter--will require that
certain inspection and record keeping safeguards be satisfied. The
increased cost of these requirements is considered a cost to this
rulemaking. These include certification of each animal's identification
(by eartag and branding), age, and feeding history. Feeder cattle will
be listed on the APHIS Form VS 17-130 that accompanies the animals from
the port of entry and on the APHIS Form VS 1-27 that accompanies the
animals to slaughter.
Costs of the process can be approximated by considering the time
Federal or State officials or their designees would spend monitoring
the movement of these cattle. We approximate the cost of performing the
inspections and related tasks to be $10 per animal, based on direct
salary, personnel benefits, administrative support costs, agency
overhead, and departmental charges, and using a simplified example
developed by APHIS Veterinary Services. Given the number of feeder
cattle that may enter because of the rule, the overall cost in 2005
would be between $4.1 million and $5.2 million
Commodities other than cattle and beef. Other, less major
commodities that will be allowed entry under the rule and for which we
have data are sheep, goats, and farmed cervids; meat from these
ruminants; and bovine tongues and livers. In all cases, reestablished
imports from Canada will have small effects on the U.S. supply of these
commodities and the welfare of U.S. entities. Feeder lambs and goats
will be required to be moved to designated feedlots. As with feeder
cattle from Canada, movement of feeder lambs and goats from the port of
entry to feedlot and from feedlot to slaughter will be monitored, which
will lead to a small cost.
U.S. exports. The rule, of course, will have no immediate effect
for U.S. exports to countries that currently prohibit beef imports from
the United States. It could influence these countries' future decisions
regarding resumption of beef imports from the United States. A country
may consider the rule to lend justification to a decision to continue
to prohibit entry of U.S. beef because of concern about BSE risks posed
by Canadian cattle, even though there would be no scientific basis. In
such a case, there would be continued premium losses over and above the
domestic value of the products, especially for beef variety meats. On
the other hand, resumption of U.S. imports from Canada may help
convince other countries of the sanitary safety of both U.S. and
Canadian beef. Any effects the rule may have for future U.S. beef
exports may vary from one trading partner to another.
Alternatives to the Rule
Alternatives to the rule would be to leave the regulations
unchanged--that is, continue to prohibit entry of ruminants and most
ruminant products from regions of minimal BSE risk (other than products
allowed entry under permit), or modify the commodities and/or import
requirements specified in the rule. By maintaining current import
restrictions, the net benefits of reestablishing imports from Canada of
fed and feeder cattle, and beef not by permit, and other affected
commodities would not be realized. Two possible modifications would be
to (i) require that imported beef come from cattle slaughtered at less
than 30 months of age, or (ii) continue to prohibit the entry of live
ruminants.
Beef only from cattle less than 30 months of age. The proposed rule
would have required beef imports from Canada to come from cattle
slaughtered at less than 30 months of age. In a notice that reopened
the comment period for the proposed rule, APHIS stated that it no
longer believed that it would be necessary to require that beef
imported from BSE minimal-risk regions be derived only from cattle less
than 30 months of age, provided measures are in place to ensure that
SRMs are removed when the animals are slaughtered, and that such other
measures as are necessary are in place. Canada is removing SRMs at
slaughter and fulfilling other required measures.
Requiring that beef come only from cattle slaughtered at less than
30 months of age would continue the prohibition on Canadian cows and
bulls as source animals, and eliminate effects of the rule for beef.
Continuing to limit imports from Canada to veal from calves and beef
from steers and heifers would cause Canada's cow and bull inventories
to continue to grow and exert downward pressure on Canada's cow prices,
which are already well below U.S. price levels. Canadian suppliers
would be prevented from participating in the current high-demand market
in the United States for processing beef, and U.S. processors would not
benefit from the additional source of supply during a time when U.S.
cow slaughter is cyclically low.
This alternative would maintain the status quo in terms of beef
imports, other than removing permit requirements and broadening the
commodities allowed to be imported beyond boneless beef. In terms of
the quantity of beef imported, we expect that these changes would have
a very small effect, given the large share of Canada's historic exports
that enter currently.
This alternative would affect cattle imports from Canada by
removing the incentive for Canadian cows to be slaughtered in place of
fed cattle, since the processing beef would not be allowed to be
imported by the United States; there would not be the displaced fed
cattle assumed to be available for import under the rule. The number of
fed cattle imports would be fewer than
[[Page 542]]
with the rule, especially in 2005, and price and welfare impacts,
including net benefits, would be smaller.
Welfare effects of this alternative for cattle and beef are
summarized in Table 3. Present values and annualized values of welfare
gains and losses over the five-year period 2005-2009 are determined
using 3 percent and 7 percent discount rates in both 2005 and 2001
dollars.
Table 3.--Alternative of Canadian Beef Imports Only From Cattle Less Than 30 Months of Age: Present and
Annualized Value Estimations of the Effects of the Rule for Fed Cattle, Feeder Cattle, and Beef, Discounted at 3
Percent and 7 Percent, in 2005 and 2001 Dollars 2005-2009
----------------------------------------------------------------------------------------------------------------
Discount Changes in welfare (per thousand dollars)
Value rate --------------------------------------------
(percent) Consumer Producer Net
----------------------------------------------------------------------------------------------------------------
Present, 2005 dollars................................. 3 $2,399,299 -$2,345,160 $54,139
7 2,064,181 -2,016,794 47,387
Present, 2001 dollars................................. 3 2,261,339 -2,210,314 51,026
7 1,945,490 -1,900,828 44,662
Annualized, 2005 dollars.............................. 3 523,898 -512,076 11,821
7 503,434 -491,877 11,557
Annualized, 2001 dollars.............................. 3 493,774 -482,632 11,142
7 474,487 -463,594 10,893
----------------------------------------------------------------------------------------------------------------
Note: The present and annualized values are midpoints taken from Appendix U, based on the assumed backlog
imports.
The present value of the net benefit of the alternative for cattle
and beef is estimated to range in 2005 dollars between $47.4 million
and $54.1 million, depending on the discount rate used (with the rule:
Between $66.3 million and $74.6 million). Over the five-year period,
the annualized value of the net benefit in 2005 dollars, depending on
the discount rate, may range between $11.6 million and $11.8 million
(with the rule: Between $16.2 million and $16.3 million).
The largest effects for cattle are expected to occur in 2005, when
the backlog is imported. Since allowing Canadian beef imports only from
cattle slaughtered at less than 30 months of age would not affect the
number of feeder cattle expected to be imported, effects for feeder
cattle would be the same as with the rule.
Possible effects of this alternative for future U.S. exports would
differ from possible effects with the rule only if other countries
perceived BSE-risks associated with Canadian beef produced from cattle
slaughtered at less than 30 months of age as different from those
associated with Canadian beef produced from cattle slaughtered at more
than 30 months of age.
There would be no known reduction in risk of BSE introduction under
this alternative. Removal of SRMs at slaughter and other required risk-
mitigating measures of the rule will ensure that beef entering from
Canada satisfies animal health criteria the same as or equivalent to
those required in the United States.
Near-term price effects of this alternative would be similar to
those of this rule. For example, for fed cattle the decrease in price
when the backlog is assumed to enter entirely within one quarter is
estimated to be 4.4 percent (with the rule: 5.4 percent), assuming a
price elasticity of supply of 0.61 and a price elasticity of demand of
-0.76. When the backlog of fed cattle is assumed to enter over two
quarters using the same price elasticities, the decline in price is
estimated to be 2.8 percent (with the rule: 3.8 percent). Entry of the
backlog of feeder cattle over the two quarters could result in a price
decline of 1.9 percent under this alternative and using the same
elasticities, compared to a possible price drop of 3.3 percent when the
backlog is assumed to enter entirely within one quarter. The expected
effects are the same for feeder cattle under this alternative and with
the rule because their number is assumed to be unaffected by whether
Canadian beef imports are restricted to being derived from cattle less
than 30 months of age. When the supply and demand elasticities are
halved (supply elasticity of 0.30, and demand elasticity of -0.38, for
example, and fed cattle are assumed to enter within two quarters, the
decrease in price is estimated to be 3.6 percent (with the rule, 4.8
percent), compared to a decrease of 2.8 percent (with the rule, 3.8
percent) when a supply elasticity of 0.61 and demand elasticity of -
0.76 are used.
No live ruminants. Direct effects of this alternative would be
equivalent to expected effects of the rule only for ruminant products.
We would expect the same effect for beef as with the rule; imports of
beef from cows would replace imports of beef from fed cattle, yielding,
for the five-year period 2005-2009, present value losses for consumers
of between $73.9 million and $78.8 million, gains for producers of
between $73.7 million and $78.5 million, and net welfare losses of
between $264,000 and $283,000, compared to the baseline (3 percent
discount rate, 2005 dollars). There would also be net benefits forgone
by the continued prohibition on the importation of sheep and goats.
Possible effects of this alternative on future U.S. exports would
likely be small, since it would maintain the current prohibition on
imports of live ruminants from Canada.
In sum, the rule is preferable in terms of expected net benefits to
the status quo (continuing to prohibit the entry of Canadian ruminants,
and the entry of Canadian ruminant products other than those allowed by
permit), and to the two alternatives discussed: Limiting beef imports
to cattle slaughtered at less than 30 months of age or allowing entry
of ruminant products but not live ruminants. Risks of BSE introduction
would not be reduced to any known degree by selecting one of the
alternatives in place of the rule. We believe that listing Canada as a
minimal-risk region subject to the required risk-mitigating measures is
a balanced response, based on scientific evidence, to Canada's request
that certain ruminant and ruminant product imports by the United States
be allowed to resume.
Final Regulatory Flexibility Analysis
As a part of the rulemaking process, APHIS evaluates whether
regulations are likely to have a significant economic impact on a
substantial number of small entities. The resumption of ruminant and
ruminant product imports from Canada will most importantly affect the
cattle industry, reducing prices and increasing supplies. Entry of fed
cattle
[[Page 543]]
(and fed sheep and goats) will benefit U.S. slaughtering
establishments, and entry of feeder cattle (and feeder sheep and goats)
will benefit feedlots. Also, entry of beef from cattle slaughtered at
over 30 months of age will benefit some U.S. meat and meat product
wholesalers and packers by providing an additional source of processing
beef. At the same time, these imports will increase the competition for
U.S. and foreign suppliers of these commodities.
The main industries expected to be affected by the rule are
composed predominantly of small entities, as indicated by the 1997
Economic Census, the 2002 Census of Agriculture, and USDA's ``Cattle on
Feed'' (February 20, 2004). The small entities number in the hundreds
of thousands, with cattle producers comprising the largest number. For
beef cattle ranching and farming, the 2002 Census of Agriculture
indicates a total of about 657,000 operations, of which nearly 656,000
are considered small entities. For cattle feedlots, more than 91,000 of
the approximately 93,200 total operations are small entities. For sheep
and goat farming, 44,000 out of about 44,200 operations are considered
small entities. Small entities similarly dominate, in terms of
percentage operations, other affected industries, including animal
slaughtering, meat and meat byproduct processing, and meat and meat
product wholesaling.
Notwithstanding the prevalence of small entities, the concentrated
structure of affected industries is well-documented. In the U.S.
meatpacking industry, for example, four firms handle nearly 80 percent
of all steer and heifer slaughter. The cattle feedlot industry is also
highly concentrated. Data from 2003 show that only 2 percent of
feedlots have capacities greater than 1,000 head, and yet these larger
feedlots market 85 percent of fed cattle.
Imports from Canada that will be allowed to resume are expected to
have a larger effect on the fed cattle market than on the feeder cattle
market. Prices and welfare of producers and suppliers will decline
because of the additional supply and the welfare of consumers and
buyers will increase. Net benefits of the rule will be positive.
The analysis provides an estimation of possible price effects for
small-entity and other producers and processors during the first 3 to 6
months that the rule is in effect, when impacts may be greatest due to
the expected importation of the backlog. Depending on the assumed
elasticities of supply and demand and the period over which the backlog
enters, the estimated price declines could range from 1.9 percent to
4.4 percent for feeder cattle and from 3.8 percent to 6.9 percent for
fed cattle. For the year 2005, the model indicates a possible decline
in feeder cattle prices of 1.3 percent and a possible decline in fed
cattle prices of 3.2 percent.
To give these average percentage price decline some perspective, we
consider as an example their effect on earnings by small U.S. beef cow
herds. Based on data from the 2002 Census of Agriculture, the average
value of sales of cattle and calves by small-entity beef cow operations
was about $26,700. Given the forecast feeder cattle baseline price for
2005 of between $94 and $100 per cwt, the 2005 estimated price decline
of 1.3 percent would be equivalent to a decrease of between $1.22 to
$1.30 per cwt, or a decrease in annual revenue of between $326 and
$347, assuming no reduction in the number of cattle marketed. This
example abstracts from the wide range in size for small beef cow herds,
but gives an indication of a possible average price effect of the rule
for these operators in 2005. It should be recognized that while the
decline in price would be a loss for producers, it would represent a
gain for small-entity feedlot operators.
Beyond the net welfare gains as summarized in Table 1, there will
likely be regional impacts not captured in the analysis. Among comments
received on the proposed rule were ones that pointed out the historical
reliance of some northern U.S. meat processing plants (and the
communities they support) on cattle imports from Canada to maintain
necessary throughput volumes. Historical dependence of these processing
facilities on cattle imports from Canada exemplifies economic ties with
Canadian entities that existed prior to the prohibition on ruminant
imports. Resumption of imports will enable trade relationships
involving small-entity operations to be reestablished.
Alternatives to the rule, whether leaving the regulations unchanged
or modifying the commodities and/or import requirements specified in
the rule, would benefit certain categories of small entities while
harming others. For example, a continued prohibition on the importation
of Canadian feeder cattle would benefit small-entity suppliers of
feeder cattle, but at the expense of small-entity feedlot operators.
Estimated price declines, particularly in the near term, will cause
economic losses for some entities and at the same time benefit other
entities. Overall, the analysis indicates the rule will have a net
positive effect for the United States.
Small Business Regulatory Enforcement Fairness Act of 1996
This rule has been designated by the Administrator, Office of
Information and Regulatory Affairs, Office of Management and Budget, as
a major rule under the Small Business Regulatory Enforcement Fairness
Act of 1996 (5 U.S.C. 801-808). Accordingly, the effective date of this
rule has been delayed the required 60 days pending congressional
review.
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
National Environmental Policy Act
In October 2003, APHIS prepared an environmental assessment to
consider potential impacts to the human environment from implementation
of the proposed rulemaking. During the comment period for the proposed
rulemaking, comments were received from the public regarding the
environmental assessment. As a result of those comments, APHIS revised
the environmental assessment to discuss in more detail the potential
impacts of concern for the human environment.
The environmental assessment was prepared in accordance with: (1)
The National Environmental Policy Act of 1969 (NEPA), as amended (42
U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental
Quality for implementing the procedural provisions of NEPA (40 CFR
parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part
1), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).
APHIS sent copies of the revised environmental assessment to those
who commented on the October 2003 environmental assessment, in
accordance with 7 CFR 372.9(a)(3). In a separate notice in today's
issue of the Federal Register, APHIS is announcing the availability of
the revised assessment and is requesting comments on the revised
assessment for 30 days.
Paperwork Reduction Act
This final rule includes certain regulatory provisions that differ
from those included in the November 2003 proposed rule. Some of those
provisions involve changes from the information collection requirements
set out in the proposed rule. These changes include
[[Page 544]]
the following regarding ruminants from Canada:
Bovines, sheep, and goats moved from a U.S. port of entry
to a feedlot before being moved to slaughter must be accompanied by an
APHIS Form VS 17-130, rather than an APHIS Form VS 1-27 as proposed.
Those animals moved to a feedlot before being moved to
slaughter must be permanently identified in Canada as being of Canadian
origin with a distinct and legible mark, properly and humanely applied
with a freeze brand, hot iron, or other method. This is a change from
the proposed requirement that permanent identification be done by
tattooing the animal.
Those animals moved to a feedlot must be individually
identified in Canada by an official Canadian eartag. This requirement
was not in the proposed rule.
The owners of feedlots wishing to be considered designated
feedlots must sign an agreement with APHIS. This requirement was not in
the proposed rule.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this rule have been approved by the Office of Management
and Budget (OMB) under OMB control number 0579-0234.
Government Paperwork Elimination Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the Government Paperwork Elimination Act (GPEA), which
requires Government agencies in general to provide the public the
option of submitting information or transacting business electronically
to the maximum extent possible. For information pertinent to GPEA
compliance related to this rule, please contact Mrs. Celeste Sickles,
APHIS' Information Collection Coordinator, at 301-734-7477.
References
1. Office International des Epizooties, Terrestrial Animal Health
Code, ``Bovine Spongiform Encephalopathy,'' Chapter 2.3.13, available
at http://www.oie.int.
2. Office International des Epizooties, Terrestrial Animal Health
Code, available at http://www.oie.int.
3. Harvard Center for Risk Analysis--Harvard School of Public
Health, and Center for Computational Epidemiology--College of
Veterinary Medicine, Tuskegee University, ``Evaluation of the Potential
for Bovine Spongiform Encephalopathy in the United States,'' (2001),
available at http://www.aphis.usda.gov/lpa/issues/bse/risk_assessment/mainreporttext.pdf; Harvard Center for Risk Analysis, Harvard School of
Public Health, and Center for Computational Epidemiology, College of
Veterinary Medicine, Tuskegee University, ``Evaluation of the Potential
for Bovine Spongiform Encephalopathy in the United States'' (2003),
available at http://www.aphis.usda.gov/lpa/issues/bse/madcow.pdf.
4. USDA and FDA, ``A Case of Bovine Spongiform Encephalopathy (BSE)
in the United States'' (March 2004), available at http://www.aphis.usda.gov/lpa/issues/bse/BSE_tr_ban%20_ltr_enc_1.pdf.
5. USDA, FSIS Notice 5-04, ``Interim Guidance for Non-Ambulatory
Disabled Cattle and Age Determination'' (January 12, 2004), available
at http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/oppde/rdad/fsisnotices/5-04.pdf; USDA, FSIS Notice 7-04, ``Questions and Answers
for FSIS Notice 4-04 Regarding FSIS BSE Regulations'' (January14,
2004), available at http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/oppde/rdad/fsisnotices/7-04.pdf; USDA, FSIS
Notice 9-04, ``Verification Instructions for the Interim Final Rule
Regarding Specified Risk Materials (SRMs) in Cattle'' (January 23,
2004), available at http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/oppde/rdad/fsisnotices/9-04.pdf; USDA, FSIS
Notice 10-04, ``Questions and Answers, Regarding the Age Determination
of Cattle and Sanitation'' (January 29, 2004), available at http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/oppde/rdad/fsisnotices/10-04.pdf
6. FDA, ``CVM Update: July 2004 Update on Ruminant Feed (BSE)
Enforcement Activities,'' (July 29, 2004), available at http://www.fda.gov/cvm/index/updates/bse72004up.htm.
7. Research Triangle Institute, ``Review of the Evaluation of the
Potential for Bovine Spongiform Encephalopathy in the United States''
(October 31, 2002), available at http://www.aphis.usda.gov/lpa/issues/bse/BSE_Peer_Review.pdf.
8. Joshua T. Cohen and George M. Gray, Harvard Center for Risk
Analysis, Harvard School of Public Health, ``Evaluation of the
Potential for Bovine Spongiform Encephalopathy in the United States:
Response to Reviewer Comments submitted by Research Triangle Institute
(RTI project number 07182.024)'' (October 31, 2003), available at
http://www.hcra.harvard.edu/pdf/ResponsetoComments.pdf.
9. Harvard Center for Risk Analysis, Harvard School of Public
Health, and Center for Computational Epidemiology, College of
Veterinary Medicine, Tuskegee University, ``Evaluation of the Potential
for Bovine Spongiform Encephalopathy in the United States,'' pg. 111
(2003), available at http://www.hcra.harvard.edu/pdf/madcow.pdf.
10. Joshua T. Cohen and George M. Gray, Harvard Center for Risk
Analysis--Harvard School of Public Health, ``Evaluation of the
Potential Spread of BSE in Cattle and Possible Human Exposure Following
Introduction of Infectivity into the United States from Canada'' (2003)
available at http://www.aphis.usda.gov/lpa/issues/bse/harvard_10-3/text_wrefs.pdf.
11. Evans, Brian, Chief Veterinary Officer, Memo to Dr. John
Clifford, Deputy Administrator at APHIS (July 30, 2004).
12. Morley, R.S., S. Chen, and N. Rheault, ``Assessment of the Risk
Factors Related to Bovine Spongiform Encephalopathy,'' Revue
Scientifique et Techique Office International des Epizooties 22(1):157-
78 (2003), available at http://www.oie.int/eng/publicat/rt/2201/10.%20Morley.pdf; Canadian Food Inspection Agency, Science Branch,
Animal Health Risk Analysis, ``Risk Assessment on Bovine Spongiform
Encephalopathy in Cattle in Canada'' (2002), available at http://www.inspection.gc.ca/english/sci/ahra/bseris/bserise.shtml.
13. Canadian Food Inspection Agency, ``Summary of the Report of the
Investigation of Bovine Spongiform Encephalopathy (BSE) in Alberta
Canada'' (2003), available at http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/evalsume.shtml.
14. International Review Team, ``Report on Actions Taken by Canada
in Response to the Confirmation of an Indigenous Case of BSE'' (2003),
available at http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/internate.shtml. See also Government of Canada, ``News Release:
Minister's Comment on International Report on BSE'' (June 26, 2003),
available at http://www.inspection.gc.ca/english/corpaffr/newcom/2003/20030626e.shtml.
15. Canadian Food Inspection Agency, ``BSE in North America;
Specified Risk Materials,'' http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/srmmrse.shtml.
[[Page 545]]
16. Canadian Food Inspection Agency, ``BSE in North America;
Surveillance and Animal Tracking,'' http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/surv/protecte.shtml.
17. Harvard Center for Risk Analysis, Harvard School of Public
Health, and Center for Computational Epidemiology, College of
Veterinary Medicine, Tuskegee University, ``Evaluation of the Potential
for Bovine Spongiform Encephalopathy in the United States'' (2003), pg.
53, available at http://www.aphis.usda.gov/lpa/issues/bse/madcow.pdf.
18. Harvard Center for Risk Analysis, Harvard School of Public
Health, and Center for Computational Epidemiology, College of
Veterinary Medicine, Tuskegee University, ``Evaluation of the Potential
for Bovine Spongiform Encephalopathy in the United States'' (2003),
Appendix 1, pg. 29, available at http://www.aphis.usda.gov/lpa/issues/bse/harvard_10-3/appendix_1.pdf.
19. Office International des Epizooties, Terrestrial Animal Health
Code, ``Guidelines for Risk Analysis,'' Chap. 1.3.2, Art. 1.3.2.3,
available at http://www.oie.int.
20. USDA, ``News Release: Veneman Announces Expanded BSE
Surveillance Program'' (March 15, 2004), available at http://www.usda.gov/Newsroom/0105.04.html.
21. USDA, APHIS, Veterinary Services, ``Analysis of Risk--Update
for the Final Rule: Bovine Spongiform Encephalopathy; Minimal Risk
Regions and Importation of Commodities, December 2004,'' available at
http://www.aphis.usda.gov/lpa/issues/bse/bse.html.
22. Kirkwood, J. K. and A. A. Cunningham, ``Epidemiological
Observations on Spongiform Encephalopathies in Captive Wild Animals in
the British Isles,'' Veterinary Record 135:296-303 (1994).
23. Office International des Epizooties, Terrestrial Animal Health
Code, ``Bovine Spongiform Encephalopathy,'' Chap. 2.3.13, Art.
2.3.13.15 and Art. 2.3.13.19, available at http://www.oie.int.
24. Prince, M.J., et. al., ``Bovine Spongiform Encephalopathy,''
Revue Scientifique et Techique, Office International des Epizooties
22(1):37-60 (2003).
25. Brown, Paul, et. al., ``Bovine Spongiform Encephalopathy and
Variant Creutzfeldt-Jakob Disease: Background, Evolution, and Current
Concerns,'' Emerging Infectious Diseases 7(1):6-16 (2001), available at
http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm.
26. USDA, ``Official United States Standards for Grades of
Slaughter Lambs, Yearlings and Sheep'' (1992), available at http://www.ams.usda.gov/lsg/stand/standards/sl-lamb.pdf. See also, e.g.,
``Labeling Standards for Ovine Carcasses, Parts of Carcasses, Meat and
Meat Food Products,'' Docket No. 97-030A, November 21, 1997; 62 FR
62271-62273.
27. Comer, P.J. and P.J. Huntley, ``Exposure of the Human
Population to BSE Infectivity over the Course of the BSE Epidemic in
Great Britain and the Impact of Changes to the Over Thirty Month
Rule,'' Over Thirty Month Rule (OTMR) Review Paper (June 2003),
available at http://www.food.gov.uk/multimedia/pdfs/otmcomer.pdf.
28. European Union Scientific Steering Committee, ``Revised Opinion
and Report on: The Safety of Tallow Obtained from Ruminant Slaughter
By-Products'' (adopted June 28-29, 2001), available at http://europa.eu.int/comm/food/fs/sc/ssc/out228_en.pdf.
29. European Union Scientific Steering Committee, ``Listing of
Specified Risk Materials: A Scheme for Assessing Relative Risks to
Man'' (adopted December 9, 1997), available at http://europa.eu.int/comm/food/fs/sc/ssc/out22_en.pdf.
30. Brown, P., R. G. Rohwer, B. C. Dunstan, C. MacAuley, D. C.
Gajdusek, and W. N. Drohan, ``The Distribution of Infectivity in Blood
Components and Plasma Derivatives in Experimental Models of
Transmissible Spongiform Encephalopathy,'' Transfusion 38:810-816
(1998); Manuelidis, E. E., E.J. Gorgacz, L. Manuelidis, ``Transmission
Creutzfeldt-Jakob Disease with Scrapie-Like Syndromes to Mice,'' Nature
271:778-779 (1978).
31. Center for Disease Control, ``Bovine Spongiform Encephalopathy
in a Dairy Cow-- Washington State, 2003,'' MMWR Weekly 52(53):1280-1285
(2004).
32. Codex Alimentarius Commission, ``Principles and Guidelines for
the Conduct of Microbiological Risk Assessment,'' Section 4--Guidelines
for Application, CAC/GL-30 (1999), available at http://www.codexalimentarius.net/web/standard_list.do?lang=en.
33. Harvard Center for Risk Analysis, Harvard School of Public
Health, and Center for Computational Epidemiology, College of
Veterinary Medicine, Tuskegee University, ``Evaluation of the Potential
for Bovine Spongiform Encephalopathy in the United States'' (2003), pg.
2, available at http://www.aphis.usda.gov/lpa/issues/bse/madcow.pdf.
34. USDA, ``Report of the Secretary's Advisory Committee on Foreign
Animal and Poultry Diseases: Measures Relating to Bovine Spongiform
Encephalopathy in the United States'' (February 13, 2004), available at
http://cofcs66.aphis.usda.gov/lpa/issues/bse/bse_sec_adv_comm.pdf.
35. The Secretary's Foreign Animal and Poultry Disease Advisory
Committee's Subcommittee on the United States' Response to the
Detection of a Case of Bovine Spongiform Encephalopathy or
International Review Team (IRT), ``Report on Measures Relating to
Bovine Spongiform Encephalopathy (BSE) in the United States'' (2004),
available at http://www.aphis.usda.gov/lpa/issues/bse/BSE_tr_ban_ltr%20_enc_2.pdf.
36. Harvard Center for Risk Analysis, Harvard School of Public
Health, and Center for Computational Epidemiology, College of
Veterinary Medicine, Tuskegee University, ``Evaluation of the Potential
for Bovine Spongiform Encephalopathy in the United States,'' pg. vii-
viii (2003), available at http://www.aphis.usda.gov/lpa/issues/bse/madcow.pdf.
37. Gray, G. Cohen, J., Harvard Center for Risk Analysis, Harvard
School of Public Health, ``Response to Comments Submitted in Response
to USDA's Proposed Rule on Importing Beef and Beef Products from
Canada'' (June 18, 2004).
38. Harvard Center for Risk Analysis, Harvard School of Public
Health, and Center for Computational Epidemiology, College of
Veterinary Medicine, Tuskegee University, ``Evaluation of the Potential
for Bovine Spongiform Encephalopathy in the United States,'' Section
4.4.1--Switzerland (2003), available at http://www.aphis.usda.gov/lpa/issues/bse/madcow.pdf.
39. Yamakawa, Y., K. Hagiwara, K. Nohtomi, et al, ``For the Expert
Committee for BSE Diagnosis, Ministry of Health, Labour and Welfare of
Japan: Atypical Proteinase K-Resistant Prion Protein (PrPres) Observed
in an Apparently Healthy 23-Month-Old Holstein Steer,'' Jpn J Infect
Dis 56:221-222 (2003), available at http://www.nih.go.jp/JJID/56/221.pdf and Casalone, C., G. Zanusso, PL. Acutis, et al,
``Identification of a Novel Molecular and Neuropathological BSE
Phenotype in Italy: International Conference on Prion Disease: From
Basic Research to Intervention Concepts,'' 8-10 (October, 2003).
40. Scientific Steering Committee, ``Opinion on TSE Infectivity
Distribution in Ruminant Tissues (State of Knowledge, December 2001)''
(Adopted January 10-11, 2002),
[[Page 546]]
available at http://europa.eu.int/comm/food/fs/sc/ssc/out241_en.pdf.
41. Wilesmith, JW et. al., ``A Cohort Study to Examine Maternally-
Associated Risk Factors for Bovine Spongiform Encephalopathy,''
Veterinary Record 141:239-243 (1997).
42. FSIS, ``Prohibition of the Use of Specified Risk Materials for
Human Food and Requirements for the Disposition of Non-Ambulatory
Disabled Cattle; Meat Produced by Advanced Meat/Bone Separation
Machinery and Meat Recovery (AMR) Systems; Prohibition of the Use of
Certain Stunning Devices Used To Immobilize Cattle During Slaughter;
Bovine Spongiform Encephalopathy Surveillance Program; Interim Final
Rules and Notice,'' Docket No 03-025IF, 69 FR 1861-1874 (January 12,
2004).
43. Mulkey, David and Alan W. Hodges, ``Using IMPLAN to Assess
Local Economic Impacts,'' (last visited December 6, 2004), available at
http://hortbusiness.ifas.ufl.edu/usingimplan.pdf.
44. OMB, ``Circular A-4: Regulatory Analysis'' (September 17,
2003).
45. USDA Economic Research Service, ``Dissecting the Challenges of
Mad Cow and Foot-and-Mouth Disease,'' Agricultural Outlook 4-5 (Aug.
2001), available at http://www.ers.usda.gov/publications/AgOutlook/aug2001/AO283c.pdf.
46. United States Meat Export Federation,--Methodology and Results
of the Value of Beef Exports,'' pp. 8-9 (2002), available at http://www.cattle-fax.com/special/files/beefvalue_method_02.pdf.
47. FDA, ``Substances Prohibited From Use in Animal Food or Feed;
Animal Proteins Prohibited in Ruminant Feed,'' Docket No 02N-0273, 67
FR 67572-67573 (November 6, 2002).
48. The guidelines are discussed in WHO, ``Joint WHO/FAO/OIE
Technical Consultation on BSE: Public Health, Animal Health and Trade''
(June 11-14, 2001), available at http://www.who.int/emc-documents/tse/docs/whocdscsraph20018.pdf.
49. Prince, M.J., et. al., ``Bovine Spongiform Encephalopathy,''
Revue scientifique et technique, Office International des Epizooties
22(1) 37-60 (2003); Wilesmith, J.W., ``The Epidemiology of Bovine
Spongiform Encephalopathy,'' Seminars in Virology 2:239-45 (1991);
Wilesmith, J.W., et. al., ``Bovine Spongiform Encephalopathy:
Epidemiological Studies,'' Veterinary Record 123:638-644 (1988).
50. AMS USDA, ``Country of Origin Labeling--Current Status of
Country of Origin Labeling,'' available at http://www.ams.usda.gov/cool/status.htm.
List of Subjects
9 CFR Part 93
Animal diseases, Imports, Livestock, Poultry and poultry products,
Quarantine, Reporting and recordkeeping requirements.
9 CFR Part 94
Animal diseases, Imports, Livestock, Meat and meat products, Milk,
Poultry and poultry products, Reporting and recordkeeping requirements.
9 CFR Part 95
Animal feeds, Hay, Imports, Livestock, Reporting and recordkeeping
requirements, Straw, Transportation.
9 CFR Part 96
Imports, Livestock, Reporting and recordkeeping requirements.
0
Accordingly, we are amending 9 CFR parts 93, 94, 95, and 96 as follows:
PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, AND POULTRY, AND
CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR MEANS
OF CONVEYANCE AND SHIPPING CONTAINERS
0
1. The authority citation for part 93 continues to read as follows:
Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
0
2. Section 93.400 is amended by revising the definitions of flock and
inspector and adding definitions of as a group, bovine, bovine
spongiform encephalopathy (BSE) minimal risk region, camelid, cervid,
designated feedlot, positive for a transmissible spongiform
encephalopathy, premises of origin, State representative, suspect for a
transmissible spongiform encephalopathy, and USDA representative, in
alphabetical order, to read as follows:
Sec. 93.400 Definitions.
* * * * *
As a group. Collectively, in such a manner that the identity of the
animals as a unique group is maintained.
Bovine. Bos taurus, Bos indicus, and Bison bison.
Bovine spongiform encephalopathy (BSE) minimal risk region. A
region listed in Sec. 94.18(a)(3) of this subchapter.
* * * * *
Camelid. All species of the family Camelidae, including camels,
llamas, alpacas, and vicunas.
* * * * *
Cervid. All members of the family Cervidae and hybrids, including
deer, elk, moose, caribou, reindeer, and related species.
* * * * *
Designated feedlot. A feedlot that has been designated by the
Administrator as one that is eligible to receive sheep and goats
imported from a BSE minimal-risk region and whose owner or legally
responsible representative has signed an agreement in accordance with
Sec. 93.419(d)(8) of this subpart to adhere to, and is in compliance
with, the requirements for a designated feedlot.
* * * * *
Flock. Any group of one or more sheep maintained on common ground;
or two or more groups of sheep under common ownership or supervision on
two or more premises that are geographically separated, but among which
there is an interchange or movement of animals.
* * * * *
Inspector. Any individual authorized by the Administrator of APHIS
or the Commissioner of Customs and Border Protection, Department of
Homeland Security, to enforce the regulations in this subpart.
* * * * *
Positive for a transmissible spongiform encephalopathy. A sheep or
goat for which a diagnosis of a transmissible spongiform encephalopathy
has been made.
Premises of origin. Except as otherwise used in Sec. 93.423 of
this subpart, the premises where the animal was born.
* * * * *
State representative. A veterinarian or other person employed in
livestock sanitary work by a State or political subdivision of a State
who is authorized by such State or political subdivision of a State to
perform the function involved under a memorandum of understanding with
APHIS.
Suspect for a transmissible spongiform encephalopathy. (1) A sheep
or goat that has tested positive for a transmissible spongiform
encephalopathy or for the proteinase resistant protein associated with
a transmissible spongiform encephalopathy, unless the animal is
designated as positive for a transmissible spongiform encephalopathy;
or
(2) A sheep or goat that exhibits any of the following signs and
that has been determined to be suspicious for a transmissible
spongiform encephalopathy by a veterinarian: Weight loss despite
retention of appetite; behavior abnormalities; pruritus (itching); wool
pulling; biting at legs or side; lip smacking; motor
[[Page 547]]
abnormalities such as incoordination, high stepping gait of forelimbs,
bunny hop movement of rear legs, or swaying of back end; increased
sensitivity to noise and sudden movement; tremor, ``star gazing,'' head
pressing, recumbency, or other signs of neurological disease or chronic
wasting.
* * * * *
USDA representative. A veterinarian or other individual employed by
the United States Department of Agriculture who is authorized to
perform the services required by this part.
* * * * *
0
3. Section 93.405 is amended as follows:
0
a. A new paragraph (a)(4) is added to read as set forth below.
0
b. In paragraphs (b)(2) introductory text, (c)(2), and (c)(3) the
phrase ``Australia, Canada, and New Zealand'' is removed and the phrase
``Australia and New Zealand'' is inserted in its place.
0
c. In paragraph (c)(3), the phrase ``Australia, Canada, New Zealand, or
the United States'' is removed and the phrase ``Australia, New Zealand,
or the United States'' is added in its place.
0
d. The Office of Management and Budget citation at the end of the
section is revised to read as set forth below.
Sec. 93.405 Certificate for ruminants.
(a) * * *
(4) If the ruminants are bovines, sheep, or goats from regions
listed as BSE minimal-risk regions in Sec. 94.18(a)(3) of this
subchapter, the certificate must also include the name and address of
the importer; the species, breed, and number or quantity of ruminants
to be imported; the purpose of the importation; individual ruminant
identification, which includes the eartag required under Sec.
93.419(d)(2) or Sec. 93.436(b)(4) of this subchapter, and any other
identification present on the animal, including registration number, if
any; a description of the ruminant, including name, age, color, and
markings, if any; region of origin; the address of or other means of
identifying the premises of origin and any other premises where the
ruminants resided immediately prior to export, including the State or
its equivalent, the municipality or nearest city, or an equivalent
method, approved by the Administrator, of identifying the location of
the premises, and the specific physical location of the feedlot where
the ruminants are to be moved after importation; the name and address
of the exporter; the port of embarkation in the foreign region; and the
mode of transportation, route of travel, and port of entry in the
United States.
* * * * *
(Approved by the Office of Management and Budget under control
numbers 0579-0040, 0579-0165, and 0579-0234)
0
4. In Sec. 93.419, new paragraphs (c) and (d) are added to read as
follows:
Sec. 93.419 Sheep and goats from Canada.
* * * * *
(c) Any sheep or goats imported from Canada must be less than 12
months of age when imported into the United States and when
slaughtered, and must be from a flock or herd subject to a ruminant
feed ban equivalent to the requirements established by the U.S. Food
and Drug Administration at 21 CFR 589.2000. The animals must be
accompanied by a certificate issued or endorsed by a salaried
veterinarian of the Canadian Government that states that the conditions
of this paragraph have been met. Additionally, for sheep and goats
imported for other than immediate slaughter, the certificate must state
that the conditions of paragraphs (d)(1) and (d)(2) of this section
have been met. For sheep and goats imported for immediate slaughter,
the certificate must also state that:
(1) The animals have not tested positive for and are not suspect
for a transmissible spongiform encephalopathy.
(2) The animals have not resided in a flock or herd that has been
diagnosed with BSE; and
(3) The animals' movement is not restricted within Canada as a
result of exposure to a transmissible spongiform encephalopathy.
(d) Imported for feeding. Any sheep or goats imported from Canada
for feeding at a feedlot must be imported only through a port of entry
listed in Sec. 93.403(b) or as provided for in Sec. 93.403(f) in a
means of conveyance sealed in the region of origin with seals of the
national government of the region of origin, must be moved directly as
a group from the port of entry to a designated feedlot, must not be
commingled with any sheep or goats that are not being moved directly to
slaughter from the designated feedlot at less than 12 months of age,
and must meet the following conditions:
(1) The sheep and goats must be permanently and humanely identified
before arrival at the port of entry with a distinct and legible ``C''
mark, properly applied with a freeze brand, hot iron, or other method,
and easily visible on the live animal and on the carcass before
skinning. The mark must be not less than 1 inch or more than 1\1/4\
inches high. Other means of permanent identification may be used upon
request if deemed adequate by the Administrator to humanely identify
the animal in a distinct and legible way as having been imported from
Canada;
(2) Each sheep and goat must be individually identified by an
official Canadian Food Inspection Agency eartag, applied before the
animal's arrival at the port of entry into the United States, that is
determined by the Administrator to meet standards equivalent to those
for official eartags in the United States as defined in Sec. 71.1 of
this chapter and to be traceable to the premises of origin of the
animal. No person may alter, deface, remove, or otherwise tamper with
the individual identification while the animal is in the United States
or moving into or through the United States, except that the
identification may be removed at the time of slaughter;
(3) The animals may be moved from the port of entry only to a
feedlot designated in accordance with paragraph (d)(8) of this section
and must be accompanied from the port of entry to the designated
feedlot by APHIS Form VS 17-130 or other movement documentation deemed
acceptable by the Administrator, which must identify the physical
location of the feedlot, the individual responsible for the movement of
the animals, and the individual identification of each animal, which
includes the eartag required under paragraph (d)(2) of this section and
any other identification present on the animal, including registration
number, if any;
(4) The seals of the national government of Canada must be broken
only at the port of entry by the APHIS port veterinarian or at the
designated feedlot by an accredited veterinarian or a State or USDA
representative or his or her designee. If the seals are broken by the
APHIS port veterinarian at the port of entry, the means of conveyance
must be resealed with seals of the U.S. Government before being moved
to the designated feedlot;
(5) The animals must remain at the designated feedlot until
transported to a recognized slaughtering establishment. The animals
must be moved directly to the recognized slaughtering establishment in
a means of conveyance sealed with seals of the U.S. Government by an
accredited veterinarian or a State or USDA representative. The seals
must be broken only at the recognized slaughtering establishment by a
USDA representative;
[[Page 548]]
(6) The animals must be accompanied to the recognized slaughtering
establishment by APHIS Form VS 1-27 or other documentation deemed
acceptable by the Administrator, which must identify the physical
location of the recognized slaughtering establishment, the individual
responsible for the movement of the animals, and the individual
identification of each animal, which includes the eartag required under
paragraph (d)(2) of this section and any other identification present
on the animal, including registration number, if any;
(7) The animals must be less than 12 months of age when
slaughtered;
(8) To be approved to receive sheep or goats imported for feeding,
a feedlot must have signed a written agreement with the Administrator
stating that the feedlot:
(i) Will not remove eartags from animals unless medically
necessary, in which case another eartag or other form of official
identification, as defined in Sec. 79.1 of this chapter, will be
applied and cross referenced in the records;
(ii) Will monitor all incoming imported feeder animals to ensure
that they have the required ``C'' brand;
(iii) Will maintain records of the acquisition and disposition of
all imported sheep and goats entering the feedlot, including the
Canadian Food Inspection Agency tag number and all other identifying
information, the age of each animal, the date each animal was acquired
and the date each animal was shipped to slaughter, and the name and
location of the plant where each animal was slaughtered. For Canadian
animals that die in the feedlot, the feedlot will remove its eartag and
place it in a file along with a record of the disposition of the
carcass;
(iv) Will maintain copies of the APHIS Forms VS 17-130 and VS 1-27
or other movement documentation deemed acceptable by the Administrator
that have been issued for incoming animals and for animals moved to
slaughter and that list the official identification of each animal;
(v) Will allow State and Federal animal health officials access to
inspect its premises and animals and to review inventory records and
other required files upon request;
(vi) Will keep required records for at least 5 years;
(vii) Will designate either the entire feedlot or pens within the
feedlot as terminal for sheep and goats to be moved only directly to
slaughter at less than 12 months of age, and
(viii) Agrees that if inventory cannot be reconciled or if animals
are not moved to slaughter as required the approval of the feedlot will
be immediately withdrawn.
(Approved by the Office of Management and Budget under control
numbers 0579-0040 and 0579-0234)
0
5. Section 93.420 is revised to read as follows:
Sec. 93.420 Ruminants from Canada for immediate slaughter.
(a) Ruminants imported from Canada for immediate slaughter must be
imported only through a port of entry listed in Sec. 93.403(b) or as
provided for in Sec. 93.403(f) in a means of conveyance sealed in
Canada with seals of the Canadian Government, and must be moved
directly as a group from the port of entry to a recognized slaughtering
establishment for slaughter as a group. The seals must be broken only
at the port of entry by the APHIS port veterinarian or at the
recognized slaughtering establishment by an accredited veterinarian or
a State or USDA representative or his or her designee. If the seals are
broken by the APHIS port veterinarian at the port of entry, the means
of conveyance must be resealed with seals of the U.S. Government before
being moved to the recognized slaughtering establishment. The shipment
must be accompanied from the port of entry to the recognized
slaughtering establishment by APHIS Form VS 17-33, which shall include
the location of the recognized slaughtering establishment. Such
ruminants shall be inspected at the port of entry and otherwise handled
in accordance with Sec. 93.408.
(b) In addition to meeting the requirements of paragraph (a) of
this section, sheep and goats imported from Canada for immediate
slaughter must meet the requirements of Sec. 93.419(c) as well as the
following conditions:
(1) The animals have not tested positive for and are not suspect
for a transmissible spongiform encephalopathy;
(2) The animals have not resided in a flock or herd that has been
diagnosed with BSE; and
(3) The animals' movement is not restricted within Canada as a
result of exposure to a transmissible spongiform encephalopathy.
0
6. An undesignated center heading ``Additional General Provisions'' is
added preceding reserved Sec. 93.430.
0
6a. A new Sec. 93.436 is added to subpart D to read as follows:
Sec. 93.436 Ruminants from regions of minimal risk for BSE.
The importation of ruminants from regions listed in Sec.
94.18(a)(3) of this subchapter is prohibited, unless the conditions of
this section and any other applicable conditions of this part are met.
Once the ruminants are imported, if they do not meet the conditions of
this section, they must be disposed of as the Administrator may direct.
(a) Bovines for immediate slaughter. Bovines from a region listed
in Sec. 94.18(a)(3) of this subchapter may be imported for immediate
slaughter under the following conditions:
(1) The bovines must be less than 30 months of age when imported
into the United States and when slaughtered;
(2) The bovines must have been subject to a ruminant feed ban
equivalent to the requirements established by the U.S. Food and Drug
Administration at 21 CFR 589.2000;
(3) The bovines must be accompanied by a certificate issued by a
full-time salaried veterinary officer of the national government of the
region of origin, or issued by a veterinarian designated or accredited
by the national government of the region of origin and endorsed by a
full-time salaried veterinary officer of the national government of the
region of origin, representing that the veterinarian issuing the
certificate was authorized to do so, and the certificate states that
the conditions of paragraphs (a)(1) and (a)(2) of this section have
been met;
(4) The bovines must be imported only through a port of entry
listed in Sec. 93.403(b) or as provided for in Sec. 93.403(f) in a
means of conveyance sealed in the region of origin with seals of the
national government of the region of origin, and must be moved directly
as a group from the port of entry to a recognized slaughtering
establishment. The seals must be broken only at the port of entry by
the APHIS port veterinarian or at the recognized slaughtering
establishment by a USDA representative. If the seals are broken by the
APHIS port veterinarian at the port of entry, the means of conveyance
must be resealed with seals of the U.S. Government before being moved
to the recognized slaughtering establishment;
(5) The bovines must be accompanied from the port of entry to the
recognized slaughtering establishment by APHIS Form VS 17-33; and
(6) At the recognized slaughtering establishment, the bovines must
be slaughtered as a group.
(b) Bovines for feeding. Bovines from a region listed in Sec.
94.18(a)(3) of this subchapter may be imported for movement to a
feedlot and then to slaughter under the following conditions:
[[Page 549]]
(1) The bovines must be less than 30 months of age when imported
into the United States;
(2) The bovines must have been subject to a ruminant feed ban
equivalent to the requirements established by the U.S. Food and Drug
Administration at 21 CFR 589.2000;
(3) The bovines must be permanently and humanely identified before
arrival at the port of entry with a distinct and legible mark
identifying the exporting country, properly applied with a freeze
brand, hot iron, or other method, and easily visible on the live animal
and on the carcass before skinning. The mark must be not less than 2
inches nor more than 3 inches high, and must be applied to each
animal's right hip, high on the tail-head (over the junction of the
sacral and first cocygeal vertebrae). Other means of permanent
identification may be used upon request if deemed adequate by the
Administrator to humanely identify the animal in a distinct and legible
way as having been imported from the BSE minimal-risk exporting region.
Bovines exported from Canada must be so marked with ``C[Lambda]N;''
(4) Each bovine must be individually identified by an official
eartag of the country of origin, applied before the animal's arrival at
the port of entry into the United States, that is determined by the
Administrator to meet standards equivalent to those for official
eartags in the United States as defined in Sec. 71.1 of this chapter
and to be traceable to the premises of origin of the animal. No person
may alter, deface, remove, or otherwise tamper with the individual
identification while the animal is in the United States or moving into
or through the United States, except that the identification may be
removed at the time of slaughter;
(5) The bovines must be accompanied by a certificate issued in
accordance with Sec. 93.405 that states, in addition to the statements
required by Sec. 93.405, that the conditions of paragraphs (b)(1)
through (b)(4) of this section have been met;
(6) The bovines must be imported only through a port of entry
listed in Sec. 93.403(b) or as provided for in Sec. 93.403(f) in a
means of conveyance sealed in the region of origin with seals of the
national government of the region of origin, and must be moved directly
from the port of entry as a group to the feedlot identified on the
APHIS VS Form 17-130 or other movement documentation required under
paragraph (b)(8) of this section;
(7) The seals of the national government of the region of origin
must be broken only at the port of entry by the APHIS port veterinarian
or at the feedlot by an accredited veterinarian or a State or USDA
representative or his or her designee. If the seals are broken by the
APHIS port veterinarian at the port of entry, the means of conveyance
must be resealed with seals of the U.S. Government before being moved
to the feedlot;
(8) The bovines must be accompanied from the port of entry to the
feedlot by APHIS Form VS 17-130 or other movement documentation deemed
acceptable by the Administrator, which must identify the physical
location of the feedlot, the individual responsible for the movement of
the animals, and the individual identification of each animal, which
includes the eartag required under paragraph (b)(4) of this section and
any other identification present on the animal, including registration
number, if any;
(9) The bovines must remain at the feedlot until transported from
the feedlot to a recognized slaughtering establishment for slaughter;
(10) The bovines must be moved directly from the feedlot identified
on APHIS Form VS 17-130 to a recognized slaughtering establishment in
conveyances that must be sealed at the feedlot with seals of the U.S.
Government by an accredited veterinarian or a State or USDA
representative. The seals may be broken only at the recognized
slaughtering establishment by a USDA representative.
(11) The bovines must be accompanied from the feedlot to the
recognized slaughtering establishment by APHIS Form VS 1-27 or other
movement documentation deemed acceptable by the Administrator, which
must identify the physical location of the recognized slaughtering
establishment, the individual responsible for the movement of the
animals, and the individual identification of each animal, which
includes the eartag required under paragraph (b)(4) of this section and
any other identification present on the animal, including registration
number, if any; and
(12) The bovines must be less than 30 months of age when
slaughtered.
(c) Sheep and goats for immediate slaughter. Sheep and goats from a
region listed in Sec. 94.18(a)(3) of this subchapter may be imported
for immediate slaughter under the conditions set forth in this subpart
for such sheep and goats. The conditions for the importation of sheep
and goats from Canada for immediate slaughter are set forth in
Sec. Sec. 93.419(c) and 93.420.
(d) Sheep and goats for feeding. Sheep and goats from a region
listed in Sec. 94.18(a)(3) of this subchapter may be imported for
other than immediate slaughter under the conditions set forth in this
subpart for such sheep and goats. The conditions for the importation of
sheep and goats from Canada for other than immediate slaughter are set
forth in Sec. Sec. 93.405 and 93.419.
(e) Cervids. There are no BSE-related restrictions on the
importation of cervids from a region listed in Sec. 94.18(a)(3) of
this subchapter.
(f) Camelids. There are no BSE-related restrictions on the
importation of camelids from a region listed in Sec. 94.18(a)(3) of
this subchapter. (Approved by the Office of Management and Budget under
control number 0579-0234)
PART 94-RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL
SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND
RESTRICTED IMPORTATIONS
0
7. The authority citation for part 94 continues to read as follows:
Authority: 7 U.S.C. 450, 7701-7772, and 8301-8317; 21 U.S.C. 136
and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
0
8. Section 94.0 is amended by revising the definitions of authorized
inspector and cervid and adding new definitions of bovine, bovine
spongiform encephalopathy (BSE) minimal-risk region, Food Safety and
Inspection Service, personal use, positive for a transmissible
spongiform encephalopathy, specified risk materials (SRMs), and suspect
for a transmissible spongiform encephalopathy, in alphabetical order,
to read as follows:
Sec. 94.0 Definitions.
* * * * *
Authorized inspector. Any individual authorized by the
Administrator of APHIS or the Commissioner of Customs and Border
Protection, Department of Homeland Security, to enforce the regulations
in this part.
* * * * *
Bovine. Bos taurus, Bos indicus, and Bison bison.
Bovine spongiform encephalopathy (BSE) minimal-risk region. A
region that:
(1) Maintains, and, in the case of regions where BSE was detected,
had in place prior to the detection of BSE in an indigenous ruminant,
risk mitigation measures adequate to prevent widespread exposure and/or
establishment of the disease. Such measures include the following:
[[Page 550]]
(i) Restrictions on the importation of animals sufficient to
minimize the possibility of infected ruminants being imported into the
region, and on the importation of animal products and animal feed
containing ruminant protein sufficient to minimize the possibility of
ruminants in the region being exposed to BSE;
(ii) Surveillance for BSE at levels that meet or exceed
recommendations of the World Organization for Animal Health (Office
International des Epizooties) for surveillance for BSE; and
(iii) A ruminant-to-ruminant feed ban that is in place and is
effectively enforced.
(2) In regions where BSE was detected, conducted an epidemiological
investigation following detection of BSE sufficient to confirm the
adequacy of measures to prevent the further introduction or spread of
BSE, and continues to take such measures.
(3) In regions where BSE was detected, took additional risk
mitigation measures, as necessary, following the BSE outbreak based on
risk analysis of the outbreak, and continues to take such measures.
Cervid. All members of the family Cervidae and hybrids, including
deer, elk, moose, caribou, reindeer, and related species.
* * * * *
Food Safety and Inspection Service. The Food Safety and Inspection
Service (FSIS) of the United States Department of Agriculture.
* * * * *
Personal use. Only for personal consumption or display and not
distributed further or sold.
* * * * *
Positive for a transmissible spongiform encephalopathy. A sheep or
goat for which a diagnosis of a transmissible spongiform encephalopathy
has been made.
* * * * *
Specified risk materials (SRMs). Those bovine parts considered to
be at particular risk of containing the bovine spongiform
encephalopathy (BSE) agent in infected animals, as listed in the FSIS
regulations at 9 CFR 310.22(a).
Suspect for a transmissible spongiform encephalopathy. (1) A sheep
or goat that has tested positive for a transmissible spongiform
encephalopathy or for the proteinase resistant protein associated with
a transmissible spongiform encephalopathy, unless the animal is
designated as positive for a transmissible spongiform encephalopathy;
or
(2) A sheep or goat that exhibits any of the following signs and
that has been determined to be suspicious for a transmissible
spongiform encephalopathy by a veterinarian: Weight loss despite
retention of appetite; behavior abnormalities; pruritus (itching); wool
pulling; biting at legs or side; lip smacking; motor abnormalities such
as incoordination, high stepping gait of forelimbs, bunny hop movement
of rear legs, or swaying of back end; increased sensitivity to noise
and sudden movement; tremor, ``star gazing,'' head pressing,
recumbency, or other signs of neurological disease or chronic wasting.
* * * * *
Sec. 94.1 [Amended]
0
9. In Sec. 94.1, paragraph (b)(4) and the introductory text to
paragraph (d) are amended by removing the reference to ``Sec. 94.21''
each time it appears and adding in its place a reference to ``Sec.
94.22''.
0
10. Section 94.18 is amended as follows:
0
a. In paragraph (a)(1), the word ``Canada,'' is removed.
0
b. Paragraph (a)(3) is redesignated as paragraph (a)(4) and newly
redesignated paragraph (a)(4) is revised to read as set forth below.
0
c. A new paragraph (a)(3) is added, and paragraph (b) and the
introductory text of paragraph (c) are revised, to read as set forth
below.
0
d. In paragraph (d), the introductory text and paragraph (d)(3) are
revised and a new paragraph (d)(5) is added to read as set forth below.
Sec. 94.18 Restrictions on importation of meat and edible products
from ruminants due to bovine spongiform encephalopathy.
(a) * * *
(3) The following are minimal-risk regions with regard to bovine
spongiform encephalopathy: Canada.
(4) A region may request at any time that the Administrator
consider its removal from a list in paragraphs (a)(1) or (a)(2) of this
section, or its addition to or removal from the list in paragraph
(a)(3) of this section, by following the procedures in part 92 of this
subchapter.
(b) Except as provided in paragraph (d) of this section or in Sec.
94.19, the importation of meat, meat products, and edible products
other than meat (except for gelatin as provided in paragraph (c) of
this section, milk, and milk products) from ruminants that have been in
any of the regions listed in paragraph (a) of this section is
prohibited.
(c) Gelatin. The importation of gelatin derived from ruminants that
have been in any region listed in paragraph (a) of this section is
prohibited unless the following conditions or the conditions of Sec.
94.19(f) have been met:
* * * * *
(d) Transit shipment of articles. Meat, meat products, and edible
products other than meat that are prohibited importation into the
United States in accordance with this section may transit air and ocean
ports in the United States for immediate export if the conditions of
paragraph (d)(1) through (d)(4) of this section are met. If such
commodities are derived from bovines, sheep, or goats from a region
listed in paragraph (a)(3) of this section, they are eligible to
transit the United States by overland transportation if the
requirements of paragraphs (d)(1) through (d)(5) of this section are
met:
* * * * *
(3) The person moving the articles must notify, in writing, the
inspector at both the place in the United States where the articles
will arrive and the port of export before such transit. The
notification must include the:
* * * * *
(5) The commodities must be eligible to enter the United States in
accordance with Sec. 94.19 and must be accompanied by the
certification required by that section. Additionally, the following
conditions must be met:
(i) The shipment must be exported from the United States within 7
days of its entry;
(ii) The commodities must not be transloaded while in the United
States;
(iii) A copy of the import permit required under paragraph (d)(1)
of this section must be presented to the inspector at the port of
arrival and the port of export in the United States.
* * * * *
Sec. Sec. 94.19 through 94.25 [Redesignated as Sec. Sec. 94.20
through 94.26]
0
11. Sections 94.19 through 94.24 are redesignated as Sec. Sec. 94.20
through 94.26, respectively.
0
12. A new Sec. 94.19 is added to read as follows:
Sec. 94.19 Restrictions on importation from BSE minimal-risk regions
of meat and edible products from ruminants.
Except as provided in Sec. 94.18 and this section, the importation
of meat, meat products, and edible products other than meat (excluding
gelatin that meets the conditions of Sec. 94.18(c), milk, and milk
products), from bovines, sheep, or goats that have been in any of the
regions listed in Sec. 94.18(a)(3) is prohibited. The commodities
listed in paragraphs (a) through (f) of this section may be imported
from a region listed in
[[Page 551]]
Sec. 94.18(a)(3) if the conditions of this section are met; if (except
for commodities described in paragraph (e) of this section) the
commodities are accompanied by an original certificate of such
compliance issued by a full-time salaried veterinary officer of the
national government of the region of origin, or issued by a
veterinarian designated or accredited by the national government of the
region of origin and endorsed by a full-time salaried veterinary
officer of the national government of the region of origin,
representing that the veterinarian issuing the certificate was
authorized to do so; and if all other applicable requirements of this
part are met.
(a) Meat, meat byproducts, and meat food products from bovines. The
meat, meat byproduct, or meat food product, as defined by FSIS in 9 CFR
301.2--that those terms as applied to bison shall have a meaning
comparable to those provided in 9 CFR 301.2 with respect to cattle,
sheep, and goats--is derived from bovines that have been subject to a
ruminant feed ban equivalent to the requirements established by the
U.S. Food and Drug Administration at 21 CFR 589.2000 and meets the
following conditions:
(1) The meat, meat byproduct, or meat food product is derived from
bovines for which an air-injected stunning process was not used at
slaughter; and
(2) The SRMs and small intestine of the bovines were removed at
slaughter.
(b) Whole or half carcasses of bovines. The carcasses are derived
from bovines for which an air-injected stunning process was not used at
slaughter and that meet the following conditions:
(1) The bovines are subject to a ruminant feed ban equivalent to
the requirements established by the U.S. Food and Drug Administration
at 21 CFR 589.2000; and
(2) The SRMs and small intestine of the bovines were removed at
slaughter.
(c) Meat, meat byproducts, and meat food products from sheep or
goats or other ovines or caprines. The meat, meat byproduct, or meat
food product, as defined by FSIS in 9 CFR 301.2, is derived from ovines
or caprines that are from a flock or herd subject to a ruminant feed
ban equivalent to the requirements established by the U.S. Food and
Drug Administration at 21 CFR 589.2000, that were less than 12 months
of age when slaughtered, and that meet the following conditions:
(1) The animals were slaughtered at a facility that either
slaughters only sheep and/or goats or other ovines and caprines less
than 12 months of age or complies with a segregation process approved
by the national veterinary authority of the region of origin and the
Administrator as adequate to prevent contamination or commingling of
the meat with products not eligible for importation into the United
States;
(2) The animals did not test positive for and were not suspect for
a transmissible spongiform encephalopathy;
(3) The animals have not resided in a flock or herd that has been
diagnosed with BSE; and
(4) The animals' movement is not restricted within Canada as a
result of exposure to a transmissible spongiform encephalopathy.
(d) Carcasses of ovines and caprines. The carcasses are derived
from ovines or caprines that are from a flock or herd subject to a
ruminant feed ban equivalent to the requirements established by the
U.S. Food and Drug Administration at 21 CFR 589.2000, that were less
than 12 months of age when slaughtered, and that meet the following
conditions:
(1) The animals were slaughtered at a facility that either
slaughters only sheep and/or goats or other ovines and caprines less
than 12 months of age or complies with a segregation process approved
by the national veterinary authority of the region of origin and the
Administrator as adequate to prevent contamination or commingling of
the meat with products not eligible for importation into the United
States;
(2) The animals did not test positive for and were not suspect for
a transmissible spongiform encephalopathy;
(3) The animals have not resided in a flock or herd that has been
diagnosed with BSE; and
(4) The animals' movement is not restricted within Canada as a
result of exposure to a transmissible spongiform encephalopathy.
(e) Meat or dressed carcasses of hunter-harvested wild sheep,
goats, or other ruminants other than cervids. The meat or dressed
carcass (eviscerated and the head is removed) is derived from a wild
sheep, goat, or other ruminant other than a cervid and meets the
following conditions:
(1) The meat or dressed carcass is derived from an animal that has
been legally harvested in the wild, as verified by proof such as a
hunting license, tag, or the equivalent that the hunter must show to
the United States Customs and Border Protection official; and
(2) The animal from which the meat is derived was harvested within
a jurisdiction specified by the Administrator for which the game and
wildlife service of the jurisdiction has informed the Administrator
either that the jurisdiction conducts no type of game feeding program,
or has complied with, and continues to comply with, a ruminant feed ban
equivalent to the requirements established by the U.S. Food and Drug
Administration at 21 CFR 589.2000.
(f) Gelatin other than that allowed importation under Sec.
94.18(c). The gelatin is derived from the bones of bovines subject to a
ruminant feed ban equivalent to the requirements established by the
U.S. Food and Drug Administration at 21 CFR 589.2000 and from which
SRMs and small intestine were removed.
(g) Ports. All products to be brought into the United States under
this section must, if arriving at a land border port, arrive at one of
the following ports: Eastport, ID; Houlton, ME; Detroit (Ambassador
Bridge), Port Huron, and Sault St. Marie, MI; International Falls, MN;
Sweetgrass, MT; Alexandria Bay, Buffalo (Lewiston Bridge and Peace
Bridge), and Champlain, NY; Pembina and Portal, ND; Derby Line and
Highgate Springs, VT; and Blaine (Pacific Highway and Cargo Ops),
Lynden, Oroville, and Sumas (Cargo), WA.
PART 95--SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS),
AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES
0
13. The authority citation for part 95 continues to read as follows:
Authority: 7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C.
9701; 7 CFR 2.22, 2.80, and 371.4.
0
14. Section 95.1 is amended by revising the definition of inspector and
adding new definitions of bovine, bovine spongiform encephalopathy
(BSE) minimal-risk region, offal, positive for a transmissible
spongiform encephalopathy, specified risk materials (SRMs), and suspect
for a transmissible spongiform encephalopathy, in alphabetical order,
to read as follows:
Sec. 95.1 Definitions.
* * * * *
Bovine. Bos taurus, Bos indicus, and Bison bison.
Bovine spongiform encephalopathy (BSE) minimal-risk region. A
region listed in Sec. 94.18(a)(3) of this subchapter.
* * * * *
Inspector. Any individual authorized by the Administrator of APHIS
or the Commissioner of Customs and Border Protection, Department of
Homeland
[[Page 552]]
Security, to enforce the regulations in this part.
* * * * *
Offal. The inedible parts of a butchered animal that are removed in
dressing, consisting largely of the viscera and the trimmings, which
may include, but are not limited to, brains, thymus, pancreas, liver,
heart, kidney.
Positive for a transmissible spongiform encephalopathy. A sheep or
goat for which a diagnosis of a transmissible spongiform encephalopathy
has been made.
* * * * *
Specified risk materials (SRMs). Those bovine parts considered to
be at particular risk of containing the bovine spongiform
encephalopathy (BSE) agent in infected animals, as listed in the FSIS
regulations at 9 CFR 310.22(a).
Suspect for a transmissible spongiform encephalopathy. (1) A sheep
or goat that has tested positive for a transmissible spongiform
encephalopathy or for the proteinase resistant protein associated with
a transmissible spongiform encephalopathy, unless the animal is
designated as positive for a transmissible spongiform encephalopathy;
or
(2) A sheep or goat that exhibits any of the following signs and
that has been determined to be suspicious for a transmissible
spongiform encephalopathy by a veterinarian: Weight loss despite
retention of appetite; behavior abnormalities; pruritus (itching); wool
pulling; biting at legs or side; lip smacking; motor abnormalities such
as incoordination, high stepping gait of forelimbs, bunny hop movement
of rear legs, or swaying of back end; increased sensitivity to noise
and sudden movement; tremor, ``star gazing,'' head pressing,
recumbency, or other signs of neurological disease or chronic wasting.
* * * * *
0
15. Section 95.4 is amended as follows:
0
a. In paragraph (a) introductory text, the words ``paragraphs (c)
through (f)'' are removed and the words ``paragraphs (c) through (h)''
are added in their place.
0
b. In paragraph (b), the words ``paragraphs (d) and (f)'' are removed
and the words ``paragraphs (d) and (h)'' are added in their place.
0
c. In paragraph (c)(4), the first sentence is revised and a new
sentence is added after the final sentence to read as set forth below.
0
d. Paragraph (c)(6) is revised to read as set forth below.
0
e. Paragraph (f) is redesignated as paragraph (h).
0
f. New paragraphs (f) and (g) are added to read as set forth below.
0
g. In newly redesignated paragraph (h), the introductory text,
paragraph (h)(3) introductory text, and paragraph (h)(4) are revised to
read as set forth below.
Sec. 95.4 Restrictions on the importation of processed animal
protein, offal, tankage, fat, glands, certain tallow other than tallow
derivatives, and serum due to bovine spongiform encephalopathy.
* * * * *
(c) * * *
(4) Except for facilities in regions listed in Sec. 94.18(a)(3) of
this subchapter, if the facility processes or handles any material
derived from mammals, the facility has entered into a cooperative
service agreement executed by the operator of the facility and APHIS. *
* * In facilities in regions listed in Sec. 94.18(a)(3) of this
subchapter, the inspections that would otherwise be conducted by APHIS
must be conducted at least annually by a representative of the
government agency responsible for animal health in the region.
* * * * *
(6) Each shipment to the United States is accompanied by an
original certificate signed by a full-time, salaried veterinarian of
the government agency responsible for animal health in the region of
origin certifying that the conditions of paragraph (c)(1) through
(c)(3) of this section have been met, except that, for shipments of
animal feed from a region listed in Sec. 94.18(a)(3) of this
subchapter, the certificate may be signed by a person authorized to
issue such certificates by the veterinary services of the national
government of the region of origin.
* * * * *
(f) Tallow otherwise prohibited importation under paragraph (a)(1)
of this section may be imported into the United States if it meets the
following conditions:
(1) The tallow is derived from bovines that have not been in a
region listed in Sec. 94.18(a)(1) or (a)(2) of this subchapter;
(2) The tallow is composed of less than 0.15 percent insoluble
impurities;
(3) After processing, the tallow was not exposed to or commingled
with any other animal origin material; and
(4) Each shipment to the United States is accompanied by an
original certificate signed by a full-time salaried veterinary officer
of the national government of the region of origin, or issued by a
veterinarian designated by or accredited by the national government of
the region of origin and endorsed by a full-time salaried veterinary
officer of the national government of the region of origin,
representing that the veterinarian issuing the certificate was
authorized to do so. The certificate must state that the requirements
of paragraphs (f)(1) through (f)(3) of this section have been met; and
(5) The shipment, if arriving at a U.S. land border port, arrives
at a port listed in Sec. 94.19(g) of this subchapter.
(g) Offal that is otherwise prohibited importation under paragraph
(a)(1) of this section may be imported if the offal is derived from
cervids or the offal is derived from bovines, ovines, or caprines from
a region listed in Sec. 94.18(a)(3) of this subchapter that have not
been in a region listed in Sec. 94.18(a)(1) or (a)(2) of this
subchapter, and the following conditions are met:
(1) If the offal is derived from bovines, the offal:
(i) Contains no SRMs and is derived from bovines from which the
SRMs and small intestine were removed;
(ii) Is derived from bovines for which an air-injected stunning
process was not used at slaughter; and
(iii) Is derived from bovines that are subject to a ruminant feed
ban equivalent to the requirements established by the U.S. Food and
Drug Administration at 21 CFR 589.2000;
(2) If the offal is derived from ovines or caprines, the offal:
(i) Is derived from ovines or caprines that were less than 12
months of age when slaughtered and that are from a flock or herd
subject to a ruminant feed ban equivalent to the requirements
established by the U.S. Food and Drug Administration at 21 CFR
589.2000;
(ii) Is not derived from ovines or caprines that have tested
positive for or are suspect for a transmissible spongiform
encephalopathy;
(iii) Is not derived from animals that have resided in a flock or
herd that has been diagnosed with BSE; and
(iv) Is derived from ovines or caprines whose movement was not
restricted in the BSE minimal-risk region as a result of exposure to a
transmissible spongiform encephalopathy.
(3) Each shipment to the United States is accompanied by an
original certificate signed by a full-time salaried veterinary officer
of the national government of the region of origin, or issued by a
veterinarian designated by or accredited by the national government of
the region of origin and endorsed by a full-time salaried veterinary
officer of the national government of the region of origin,
representing that the veterinarian issuing the certificate was
authorized to do so. The certificate must state that the requirements
of paragraph (g)(1) or (g)(2) of this section have been met; and
[[Page 553]]
(4) The shipment, if arriving at a U.S. land border port, arrives
at a port listed in Sec. 94.19(g) of this subchapter.
(h) Transit shipment of articles. Articles that are prohibited
importation into the United States in accordance with this section may
transit air and ocean ports in the United States for immediate export
if the conditions of paragraphs (h)(1) through (h)(3) of this section
are met. If such commodities are derived from bovines, sheep, or goats
from a region listed inSec. 94.18(a)(3) of this subchapter, they are
eligible to transit the United States by overland transportation if the
requirements of paragraphs (h)(1) through (h)(4) of this section are
met:
* * * * *
(3) The person moving the articles notifies, in writing, the
inspector at both the place in the United States where the articles
will arrive and the port of export before such transit. The
notification includes the following:
* * * * *
(4) The articles are eligible to enter the United States in
accordance with this section and are accompanied by the certification
required by this section. Additionally, the following conditions must
be met:
(i) The shipment is exported from the United States within 7 days
of its entry;
(ii) The commodities are not transloaded while in the United
States;
(iii) A copy of the import permit required under paragraph (h)(2)
of this section is presented to the inspector at the port of arrival
and the port of export in the United States.
* * * * *
PART 96--RESTRICTION OF IMPORTATIONS OF FOREIGN ANIMAL CASINGS
OFFERED FOR ENTRY INTO THE UNITED STATES
0
16. The authority citation for part 96 continues to read as follows:
Authority: 7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 7 CFR
2.22, 2.80, and 371.4.
0
17. In Sec. 96.1, a definition of authorized inspector is added in
alphabetical order to read as follows:
Sec. 96.1 Definitions.
* * * * *
Authorized inspector. Any individual authorized by the
Administrator of APHIS or the Commissioner of Customs and Border
Protection, Department of Homeland Security, to enforce the regulations
in this subpart.
* * * * *
0
18. In Sec. 96.2, paragraph (b) is revised to read as follows:
Sec. 96.2 Prohibition of casings due to African swine fever and
bovine spongiform encephalopathy.
* * * * *
(b) Bovine or other ruminant casings. The importation of casings,
except stomachs, from bovines and other ruminants that originated in or
were processed in any region listed in Sec. 94.18(a) this subchapter
is prohibited, except that casings derived from sheep that were
slaughtered in a region listed in Sec. 94.18(a)(3) of this subchapter
at less than 12 months of age and that were from a flock subject to a
ruminant feed ban equivalent to the requirements established by the
U.S. Food and Drug Administration at 21 CFR 589.2000 may be imported,
provided the casings are accompanied by a certificate that states that
the casings were derived from sheep that met the conditions of this
paragraph and that meets the following conditions:
(1) The certificate is written in English;
(2) The certificate is signed by an individual eligible to issue
the certificate required under Sec. 96.3; and
(3) The certificate is presented to an authorized inspector at the
port of arrival.
* * * * *
0
19. In Sec. 96.3, a new paragraph (d) is added to read as follows:
Sec. 96.3 Certificate for Animal Casings.
* * * * *
(d) In addition to meeting the other requirements of this section,
the certificate accompanying sheep casings from a region listed in
Sec. 94.18(a)(3) of this subchapter must state that the sheep from
which the casings were derived were less than 12 months of age when
slaughtered and were subject to a ruminant feed ban equivalent to the
requirements established by the U.S. Food and Drug Administration at 21
CFR 589.2000.
* * * * *
Done in Washington, DC, this 27th day of December 2004 .
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 04-28593 Filed 12-29-04; 3:00 pm]
BILLING CODE 3410-34-P