[Federal Register Volume 66, Number 157 (Tuesday, August 14, 2001)]
[Rules and Regulations]
[Pages 42595-42601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20399]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 94 and 95
[Docket No. 00-121-1]
RIN 0579-AB26
Importation Prohibitions Because of Bovine Spongiform
Encephalopathy
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Interim rule and request for comments.
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SUMMARY: We are amending the regulations to prohibit, with limited
exceptions, the importation of certain animal materials and their
derivatives, and any products they are used in, from regions considered
to present an unacceptable risk of introducing bovine spongiform
encephalopathy into the United States. Additionally, we are requiring
that those materials, when imported from regions not considered at risk
for bovine spongiform encephalopathy, be accompanied by government
certification regarding the species, region of origin, processing, and
handling of the materials and the animals from which they were derived.
These actions are necessary to ensure that materials containing the
bovine spongiform encephalopathy agent are not imported into the United
States.
DATES: This rule is effective retroactively to December 7, 2000, except
for Sec. 95.29, which is effective August 14, 2001. We invite you to
comment on this docket. We will consider all comments that we receive
by October 15, 2001.
ADDRESSES: Please send four copies of your comment (an original and
three copies) to: Docket No. 00-121-1, Regulatory Analysis and
Development, PPD, APHIS, Suite 3C03, 4700 River Road, Unit 118,
Riverdale, MD 20737-1238
Please state that your comment refers to Docket No. 00-121-1.
You may read any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Donna Malloy, Senior Staff
Veterinarian, Technical Trade Services, National Center for Import and
Export, VS, APHIS, 4700 River Road, Riverdale, MD 20737-1231; (301)
734-3277.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR parts 93, 94, 95, and 96 (referred to
below as the regulations) govern the importation of certain animals,
birds, poultry, meat, other animal products and byproducts, hay, and
straw into the United States in order to prevent the introduction of
various animal diseases, including bovine spongiform encephalopathy
(BSE).
BSE is a neurological disease of bovine animals and possibly other
ruminants and is not known to exist in the United States.
[[Page 42596]]
It appears that BSE is primarily spread through the use of ruminant
feed containing certain protein products from ruminants infected with
BSE. Currently, the U.S. Food and Drug Administration (FDA) regulations
at 21 CFR 589.2000 prohibit the feeding of protein products that
contain or may contain certain protein derived from mammalian tissues
to cattle and other ruminants. However, BSE could be introduced into
the United States if foreign-source protein materials carrying the BSE
agent, such as meat, animal products, animal byproducts, and related
materials are imported into the United States from regions where BSE
exists, or from regions that present an undue risk of introducing BSE
into the United States, and are ingested by cattle or other ruminants
in the United States. BSE could also be introduced into the United
States if ruminants from regions where BSE exists, or ruminants from
regions that present an undue risk of introducing BSE into the United
States, are imported into the United States.
Sections 94.18, 95.4, and 96.2 of the regulations prohibit or
restrict the importation of certain meat and other animal products and
byproducts from ruminants that have been in regions where BSE exists or
regions that present an undue risk of introducing BSE into the United
States.
In Sec. 94.18, paragraph (a)(1) contains a list of regions where
BSE exists, while paragraph (a)(2) contains a list of regions that,
because of import requirements less restrictive than those that would
be acceptable for importation into the United States and/or because of
inadequate surveillance, present an undue risk of introducing BSE into
the United States. Together, the lists in Sec. 94.18(a)(1) and (a)(2)
consist of all the countries of Europe and the country of Oman.
Section 94.18 also prohibits the importation into the United States
of certain products. Specifically, Sec. 94.18(b) prohibits the
importation of fresh (chilled or frozen) meat, meat products, and
edible products other than meat (excluding milk and milk products and,
under certain conditions, gelatin) from ruminants that have been in any
of the regions listed in Sec. 94.18(a).
Section 95.4(a) of the regulations prohibits the importation of
certain other products because of BSE. These products include--with
certain exceptions for materials used in cosmetics and for materials
transiting the United States for immediate export--bone meal, blood
meal, meat meal, tankage, offal, fat, and glands from ruminants that
have been in any region listed in Sec. 94.18(a). In this interim rule,
we are adding materials to the list of prohibited products in
Sec. 95.4(a). These amendments to the list in Sec. 95.4(a) are
effective retroactively to December 7, 2000.
Additions to List of Prohibited Items
With limited exceptions described below, the importation of the
following materials, if derived from an animal that has been in any
region listed in Sec. 94.18(a), is prohibited:
1. Processed animal protein, offal, tankage, processed fats and
oils, and tallow other than tallow derivatives, unless, in the opinion
of the Administrator of the Animal and Plant Health Inspection Service
(APHIS), the tallow cannot be used in feed, regardless of the animal
species from which such materials are derived; and glands and
unprocessed fat tissue derived from ruminants.
2. Derivatives of processed animal protein, offal, and tankage,
regardless of the species of origin; processed fats and oils,
regardless of the species of origin; and derivatives of glands from
ruminants.
3. Products containing any of the materials included in items 1 or
2 above.
Additionally, we are prohibiting the importation of any of the
types of materials included in items 1, 2, and 3 above, if the
material:
Originates in, or is stored, rendered, or otherwise
processed in, a region listed in Sec. 94.18(a) as a region where BSE
exists or that presents an undue risk of introducing BSE into the
United States;
Is otherwise associated with a facility located in a
region listed in Sec. 94.18(a); or
Is otherwise associated with any of the materials included
in items 1, 2, or 3 above that have been in a region listed in
Sec. 94.18(a).
As noted above, the only regions currently listed in Sec. 94.18(a)
are Oman and the countries of Europe.
In this interim rule, we have also added a definition of processed
animal protein to Sec. 95.1. We have defined that term to mean meat
meal, bone meal, meat and bone meal, blood meal, dried plasma and other
blood products, hydrolyzed proteins, poultry meal, feather meal, fish
meal, and any other similar products.
Reasons for Additional Prohibitions
We consider it necessary to expand the importation prohibitions in
Sec. 95.4(a) to include certain products derived from animals other
than ruminants because of the possibility that those products may have
been cross-contaminated by products derived from ruminants.
A ban on the feeding of ruminant products to other ruminants was
enacted in the United Kingdom in 1988 and in certain other European
countries in the early 1990's. A ban on the feeding of all mammalian
products to ruminants was enacted in the European Union (EU) in 1994.
However, several EU countries have identified cases of BSE in animals
born after these bans were imposed. This has led to the conclusion
among experts studying these cases that feed that was not prohibited by
the bans was cross-contaminated by feed of ruminant origin. It appears
likely that such cross-contamination occurred at facilities that
process both prohibited and nonprohibited products.
Opinions issued in July and November 2000 by the European
Commission's (EC's) Scientific Steering Committee stated that such
cross-contamination has prolonged the BSE epidemic in Europe. In
December 2000, the EC announced a temporary prohibition on the feeding
of processed animal protein to all farmed animals. This prohibition
became effective on January 1, 2001.
Because of the possibility that animal-based feeds or other
processed animal proteins have been cross-contaminated by ruminant
material, we have established (effective as of December 7, 2000) the
prohibitions set forth in this interim rule to prohibit, with certain
limited exceptions, the importation of the products described above
under the heading ``Additions to List of Prohibited Items.'' We are
taking this action on an emergency basis to help ensure that the BSE
agent is not introduced into the United States. If, as further
information becomes available to us, we determine that any of the
prohibited products can be brought into the United States without risk
of introducing the BSE agent into this country, we will initiate
rulemaking to amend the regulations to allow the importation of those
products, along with any conditions necessary to reduce the disease
risk associated with such importations to a negligible level.
Tallow
Prior to this interim rule, the regulations in Sec. 95.4 prohibited
the importation of fat from ruminants that have been in any region
listed in Sec. 94.18(a). We are clarifying in this interim rule that
tallow--which, according to standard dictionary definition, is rendered
fat--is included among the materials to which the prohibitions of
Sec. 95.4 apply. However, we are excluding tallow derivatives from this
prohibition, because such
[[Page 42597]]
products are so highly processed that it is highly unlikely they
contain any protein. Further, we are not prohibiting all tallow, but
only that tallow that is in a form that can be incorporated into feed,
such as, but not limited to, bulk tallow. Generally, tallow is used for
many industrial purposes, such as in soaps, candles, and lubricants for
industrial equipment. These products would pose no risk of infecting
animals in the United States with the BSE agent, and tallow in such
forms will not be prohibited importation into the United States.
However, we consider it necessary to prohibit the tallow if it could be
used in feed of any type, because of the risk that tallow used in feed
for animals other than ruminants might be diverted for use as ruminant
feed.
Fat Tissue and Glands
The prohibitions in this interim rule regarding the importation of
glands and unprocessed fat tissue apply only if such materials are
derived from ruminants; they do not apply to glands and unprocessed fat
tissue derived from any other animal species. We do not consider it
necessary to prohibit the importation of glands and unprocessed fat
tissue from animal species other than ruminants because those articles
are, by standard collection methods, not combined with any other
materials. However, the prohibitions in this rule do apply to fat from
any animal species if the fat has been processed in any way, because
processed fat from various species may be commingled with or cross-
contaminated by processed fat from ruminants.
Exceptions for Materials From Certain Facilities
With certain exceptions discussed in this supplementary
information, we are applying the prohibitions contained in Sec. 95.4 to
materials derived from all animal species because of the risk the
materials could become cross-contaminated by materials derived from
ruminants. However, in certain situations, we consider there to be a
negligible risk that materials that would otherwise be prohibited
importation by this interim rule will be cross-contaminated by
materials derived from ruminants. In those situations, we do not
consider it necessary to prohibit the importation of such materials.
Specifically, the importation prohibition will not apply to
materials if, prior to importation, the following conditions have been
met:
1. The materials are derived from a nonruminant species, or from a
ruminant species if the ruminants have never been in any region listed
in Sec. 94.18(a) of the regulations.
2. All steps of processing and storing the material are carried out
in a foreign facility that has not been used for the processing and
storage of materials derived from ruminants that have been in any
region listed in Sec. 94.18(a) of the regulations.
3. The facility has demonstrated to APHIS that the materials
intended for exportation to the United States were transported to and
from the facility in a manner that would prevent cross-contamination by
or commingling with prohibited materials.
4. If the facility processes or handles any materials derived from
mammals, the facility has entered into a cooperative service agreement
executed by the operator of the facility and APHIS. Under that
cooperative service agreement, the facility is current in paying all
costs for a veterinarian of APHIS to inspect the facility (we
anticipate that such inspections will occur approximately once per
year), including travel, salary, subsistence, administrative overhead,
and other incidental expenses (including excess baggage provisions of
up to 150 pounds). Additionally, the facility has on deposit with APHIS
an unobligated amount equal to the cost for APHIS personnel to conduct
one inspection. As funds from that amount are obligated, a bill for
costs incurred based on official accounting records will be issued to
restore the deposit to the original level, revised as necessary to
allow for inflation or other changes in estimated costs. To be current,
bills must be paid within 14 days of receipt.
5. The foreign facility allows periodic APHIS inspection of its
facilities, records, and operations.
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 export
certifying that conditions 1, 2, and 3, above, have been met.
7. The person importing the shipment has applied for and obtained
from APHIS a United States Veterinary Permit for Importation and
Transportation of Controlled Materials and Organisms and Vectors by
filing a permit application on VS form 16-3. (VS Form 16-3 may be
obtained from APHIS, Veterinary Services, National Center for Import-
Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or
electronically at http://www.aphis.usda.gov/ncie.)
Materials Used for Cosmetics and Insulin for Personal Use
Animal-derived materials that are used for cosmetics will continue
to be allowed importation into the United States under the existing
conditions in Sec. 94.5, because such use should not allow the
materials to come into contact with animals. For the same reason, we
are adding a new Sec. 95.4(e), so as not to prohibit under Sec. 95.4(a)
the importation of insulin for the personal medical use of the person
importing it (i.e., small quantities of ready-to-administer insulin).
(Please note: We have determined that insulin for personal medical use
that is imported in accordance with the regulations should not pose a
risk to livestock. This does not imply endorsement of the safety of
such insulin for human use. Further, importation of insulin for
personal medical use may be prohibited by other Federal laws, including
the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., which
is administered by the FDA.) A permit will continue to be required for
the importation of materials to be used for cosmetics, and will also be
required for the importation of insulin for personal medical use.
Certification Requirements
We are also adding a new Sec. 95.29 to help ensure that products
that are prohibited from being imported into the United States under
Sec. 95.4(a) due to their origin are not moved to a country not listed
in Sec. 94.18(a) and then to the United States. We are providing in new
Sec. 95.29 that each shipment of the following material from any region
not listed in Sec. 94.18(a) must be accompanied by an original
certificate signed by a full-time salaried veterinarian of the agency
responsible for animal health in the exporting region:
1. Processed animal protein, offal, tankage, processed fats and
oils, and tallow other than tallow derivatives, unless, in the opinion
of the Administrator, the tallow cannot be used in feed, regardless of
the animal species from which such materials are derived; and glands
and unprocessed fat tissue derived from ruminants.
2. Derivatives of processed animal protein, offal, and tankage,
regardless of the animal species from which the material is derived;
and derivatives of glands from ruminants.
3. Products containing any of the materials included in items 1 or
2 above.
The certification would have to include the following information:
The animal species from which the material was derived;
[[Page 42598]]
The region where any facility in which the material was
processed is located;
That the material was derived only from animals that have
never been in any region listed in Sec. 94.18(a);
That the material did not originate in, and was never
stored, rendered, or otherwise processed in, a region listed in
Sec. 94.18(a);
That the material was not otherwise associated with a
facility located in a region listed in Sec. 94.18(a), or with any
materials included in items 1, 2, or 3, above, that have been in a
region listed in Sec. 94.18(a).
As part of our ongoing efforts to ensure that the BSE agent is not
introduced into the United States, we are in the process of obtaining
data from each of our trading partners regarding all of the factors
that could contribute to the risk that a country or other region might
contain animals or products contaminated with the BSE agent. If this
information demonstrates that a particular country or region poses an
unacceptable risk of introducing BSE into the United States, we will
take action to restrict or prohibit animals and animal products from
that country or region.
Among the requirements that might be considered for imports would
be certification by the exporting country that ruminant material
imported into the United States comes from ruminants that have never
been fed ruminant material from BSE-affected regions. At this time,
evidence does not exist to indicate that countries from which imports
are currently not restricted due to BSE pose enough of a risk to make
such a certification requirement an effective or justifiable mitigation
measure for exports from these countries. However, as part of our
ongoing BSE-prevention program, we welcome comment from the public on
the need for or effectiveness of such measures, as well as on any other
issues related to mitigating the risk of the introduction of the BSE
agent into the United States.
Nonsubstantive Changes
We are making a nonsubstantive change to the definition of Animal
and Plant Health Inspection Service in Sec. 95.1 to indicate that the
acronym ``APHIS'' can be used in the regulations in place of the full
name of the agency.
Additionally, we are clarifying in Sec. 94.18(b) that the term
``fresh meat'' as used in that paragraph means chilled or frozen meat.
This clarification makes the wording in Sec. 94.18(b) consistent with
the wording used elsewhere in part 94.
Emergency Action
This rulemaking is necessary on an emergency basis to ensure that
materials that contain the BSE agent are not imported into the United
States. Under these circumstances, the Administrator has determined
that prior notice and opportunity for public comment are contrary to
the public interest and that there is good cause under 5 U.S.C. 553 for
making this rule effective less than 30 days after publication in the
Federal Register. We are making this action effective retroactively to
December 7, 2000, except for the certification requirement of
Sec. 95.29, which is effective upon publication. December 7, 2000, is
the date APHIS issued a policy stating it had stopped issuing import
permits for, and would prohibit the importation of, the materials
covered by this interim rule. These effective dates are necessary to
ensure that animal products containing the BSE agent are not imported
into the United States.
We will consider comments that are received within 60 days of
publication of this rule in the Federal Register. After the comment
period closes, we will publish another document in the Federal
Register. The document will include a discussion of any comments we
receive and any amendments we are making to the rule as a result of the
comments.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be significant for the purposes of Executive
Order 12866 and, therefore, has been reviewed by the Office of
Management and Budget.
We are amending the regulations to prohibit, with limited
exceptions, the importation into the United States of certain animal
materials and their derivatives, and any products they are used in, if,
because of origin, processing, or other handling, the item intended for
importation presents an unacceptable risk of containing the BSE agent.
The types of prohibited materials include: Processed animal protein
(including poultry meal and fish meal), offal, tankage, processed fats
and oils, and tallow (other than tallow derivatives), unless the tallow
cannot be used in feed, regardless of the animal species from which
such materials are derived; and glands and unprocessed fat tissue
derived from ruminants.
The following economic analysis provides a cost-benefit analysis as
required by Executive Order 12866 and an analysis of the potential
economic effects on small entities as required by the Regulatory
Flexibility Act.
As one major exception to the prohibitions imposed by this rule, we
will allow the importation of materials derived from nonruminant
species, or from ruminant species if the ruminants have never been in
any region listed in Sec. 94.18(a) of the regulations, if all steps of
processing and storing the material are carried out in a foreign
facility that has not been used for the processing and storage of
materials derived from ruminants that have been in any region listed in
Sec. 94.18(a) of the regulations.
Additionally, we are requiring that such materials imported from
regions other than those in which BSE exists or that present an undue
risk of introducing BSE into the United States be accompanied by
government certification regarding the animal species of origin,
processing, handling, and region of origin of the animals from which
the materials were derived.
Information on import levels is more readily available for some
materials affected by this rule than for others. Our discussion of
potential imports is based on data for the principal commodity
categories expected to be affected. Additionally, we identify other
potentially affected commodity categories.
The principal commodity categories of prohibited items for which an
assessment of imports from Europe is possible (none of these categories
of commodities is imported from Oman) are the following: Powder and
waste of bones; lard and other fat; flours, meals, and pellets
containing meat or meat offal; flours, meals, and pellets containing
fish or crustaceans; dog or cat food; and animal feed preparations
other than dog or cat food. For each of these commodity categories
except animal feed preparations other than dog or cat food, the
percentage of U.S. imports supplied by Europe is minor--about 1 percent
or less for lard and for flours, meals, and pellets made of meat or
meat offal, and of fish or crustaceans; about 6 percent for powder and
waste of bones and for dog or cat food. The average annual value, from
1997 to 1999, of animal feed preparations other than dog or cat food
that were supplied by Europe was about $49 million, and represented
about 22 percent of such imports.
About 18 percent of animal feed preparations imported by the United
States, by value, is composed of prepared poultry and swine feed. These
types of feed comprise about one-third of the animal feed preparations
imported from Europe. (Other products used in animal feed preparations
[[Page 42599]]
include egg, milk, or vegetable products.)
The United States is a net exporter of all of the above categories
of commodities. For dog or cat food and for animal feed preparations
other than dog or cat food--the two categories with the highest import
volumes--annual import values were about 22 and 40 percent of export
values, respectively.
The relatively small value of dog or cat food and of other animal
feed preparations imported from Europe is apparent when compared to the
value of annual U.S. exports of these products. Imports from Europe
comprise only about 0.1 percent of the value of U.S. exports of dog or
cat food. For other animal feed preparations, imports from Europe are
less than 0.3 percent of the value of U.S. exports.
In addition to the principal commodity categories discussed above,
it is possible there will be other items whose importation will be
prohibited by this interim rule, such as certain other animal fat
products and certain animal-derived substances used in medicament
preparations. We are unable to identify affected products under these
headings, nor the value of any such products supplied by Europe.
The Regulatory Flexibility Act requires that agencies assess the
potential economic effects of rules on small entities. Whether affected
entities within a particular industry are considered small by the U.S.
Small Business Association depends either on the number of employees or
annual gross receipts. Two industries that will likely be affected are
``dog and cat food manufacturing'' and ``other animal food
manufacturing,'' for both of which the criterion for being considered a
small entity is whether the establishment has 500 or fewer employees.
The 1997 ``Economic Census'' reports that 186 of the 188 dog and cat
food manufacturing establishments in the United States had 500 or fewer
employees, and that all of the 1,514 establishments categorized as
``other animal food manufacturing establishments'' had 500 or fewer
employees.
Other entities that may be affected by this rule are livestock
producers who use nonruminant animal feed preparations that have been
imported from Europe. U.S. dairy, beef, and hog producers are
predominantly small entities, based on the criterion of having annual
gross receipts of $500,000 or less. Cattle feedlot operations that
could also be affected are predominantly small entities, based on the
criterion of having annual gross receipts of $1.5 million or less.
Although manufacturing establishments and agricultural firms that
could be affected by this rule are predominantly small entities, the
fact that very small volumes of the items prohibited under this interim
rule are imported from Europe suggests that any effects will be
similarly small. For manufacturers of dog or cat food and other animal
feed preparations, imports from Europe are but a fraction of 1 percent
of industry sales. Nonruminant lard imports and imports of animal feed
preparations from Europe are also small compared to overall import
levels. Additionally, although we are unable to assess at this time the
possible effects of the provisions in this interim rule with regard to
certain exceptions to the general prohibitions (e.g., for nonmammalian
materials processed in a plant dedicated to processing only
nonmammalian animal species), they can be expected to reduce any
economic effects of this rule even further.
For the commodities examined, some U.S. small entities are likely
to be affected by this rule. However, the volumes imported from Europe
suggest that a substantial number of entities will not be affected, and
that those that are will not be affected significantly.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12988
This 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 retroactive
effect to December 7, 2000; and (3) does not require administrative
proceedings before parties may file suit in court challenging this
rule.
Paperwork Reduction Act
In accordance with section 3507(j) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection and
recordkeeping requirements included in this interim rule have been
submitted for emergency approval to the Office of Management and Budget
(OMB). OMB has assigned control number 0579-0183 to the information
collection and recordkeeping requirements.
We plan to request continuation of that approval for 3 years.
Please send written comments on the 3-year approval request to the
following addresses: (1) Office of Information and Regulatory Affairs,
OMB, Attention: Desk Officer for APHIS, Washington, DC 20503; and (2)
Docket No. 00-121-1, Regulatory Analysis and Development, PPD, APHIS,
suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please
state that your comments refer to Docket No. 00-121-1 and send your
comments within 60 days of publication of this rule.
This interim rule prohibits the importation of certain animal
materials into the United States because of the risk of the
introduction of BSE into this country. Additionally, it requires that
certain animal materials imported into the United States be accompanied
by certification by the veterinary authorities of the national
government of the country from which the materials are shipped
regarding the origin and processing of the products. We are soliciting
comments from the public, as well as affected agencies, concerning our
information collection and recordkeeping requirements. These comments
will help us:
(1) Evaluate whether the information collection is necessary for
the proper performance of our agency's functions, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
information collection, including the validity of the methodology and
assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology; e.g., permitting electronic
submission of responses).
Estimate of burden: Public reporting burden for this collection of
information is estimated to average 10 minutes per response.
Respondents: Producers and importers of certain animal products.
Estimated annual number of respondents: 1,000.
Estimated annual number of responses per respondent: 9.
Estimated annual number of responses: 9,000.
Estimated total annual burden on respondents: 1,500 hours.
Copies of this information collection can be obtained from Mrs.
Celeste Sickles, APHIS' Information Collection Coordinator, at (301)
734-7477.
List of Subjects
9 CFR Part 94
Animal diseases, Imports, Livestock, Poultry and poultry products,
[[Page 42600]]
Quarantine, Reporting and recordkeeping requirements.
9 CFR Part 95
Animal feeds, Hay, Imports, Livestock, Reporting and recordkeeping
requirements, Straw, Transportation.
Accordingly, we are amending 9 CFR parts 94 and 95 as follows:
PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, HOG
CHOLERA, AND BOVINE SPONGIFORM ENCEPHALOPATHY; PROHIBITED AND
RESTRICTED IMPORTATIONS
1. The authority citation for part 94 continues to read as follows:
Authority: 7 U.S.C. 450, 7711, 7712, 7713, 7714, 7751, and 7754;
19 U.S.C. 1306; 21 U.S.C. 111, 114a, 134a, 134b, 134c, 134f, 136,
and 136a; 31 U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80,
and 371.4.
Sec. 94.18 [Amended]
2. In Sec. 94.18, paragraph (b) is amended by removing the words
``fresh, frozen, and chilled'' and adding in their place the words
``fresh (chilled or frozen)''.
PART 95--SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS),
AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES
3. The authority citation for part 95 continues to read as follows:
Authority: 21 U.S.C. 111, 136, and 136a; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.4.
4. In Sec. 95.1, the definition of Animal and Plant Health
Inspection Service is revised and a new definition of processed animal
protein is added, in alphabetical order, to read as follows:
Sec. 95.1 Definitions.
* * * * *
Animal and Plant Health Inspection Service (APHIS) means the Animal
and Plant Health Inspection Service of the United States Department of
Agriculture.
* * * * *
Processed animal protein means meat meal, bone meal, meat and bone
meal, blood meal, dried plasma and other blood products, hydrolyzed
proteins, hoof meal, horn meal, poultry meal, feather meal, fish meal,
and any other similar products.
* * * * *
5. Section 95.4 is revised to read as follow:
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.
(a) Except as provided in paragraphs (c) through (f) of this
section, the importation of the following is prohibited:
(1) Any of the materials listed in paragraphs (a)(1)(i) through
(a)(1)(iv) of this section that have been derived from animals that
have been in any region listed in Sec. 94.18(a) of this chapter:
(i) Processed animal protein, tankage, offal, and tallow other than
tallow derivatives, unless, in the opinion of the Administrator, the
tallow cannot be used in feed, regardless of the animal species from
which the material was derived;
(ii) Glands and unprocessed fat tissue derived from ruminants;
(iii) Processed fats and oils, and derivatives of processed animal
protein, tankage, and offal, regardless of the animal species from
which the material was derived; and
(iv) Derivatives of glands from ruminants.
(2) Any of the materials listed in paragraphs (a)(2)(i) through
(a)(2)(iv) of this section that have been stored, rendered, or
otherwise processed in a region listed in Sec. 94.18(a) of this
chapter, or that have otherwise been associated with a facility in a
region listed in Sec. 94.18(a) of this chapter or with any material
listed in paragraph (a)(1) through (a)(3) of this section:
(i) Processed animal protein, tankage, offal, and tallow other than
tallow derivatives, unless, in the opinion of the Administrator, the
tallow cannot be used in feed, regardless of the animal species from
which the material was derived;
(ii) Glands and unprocessed fat tissue derived from ruminants;
(iii) Processed fats and oils, and derivatives of processed animal
protein, tankage, and offal, regardless of the animal species from
which the material was derived; and
(iv) Derivatives of glands from ruminants.
(3) Products containing any of the items listed in paragraphs
(a)(1) and (a)(2) of this section.
(b) Except as provided in paragraphs (d) and (f) of this section,
the importation of serum from ruminants that have been in any region
listed in Sec. 94.18(a) of this chapter is prohibited, except that
serum from ruminants may be imported for scientific, educational, or
research purposes if the Administrator determines that the importation
can be made under conditions that will prevent the introduction of
bovine spongiform encephalopathy into the United States. Serum from
ruminants imported in accordance with this paragraph must be
accompanied by a permit issued by APHIS in accordance with Sec. 104.4
of this chapter, and must be moved and handled as specified on the
permit.
(c) Materials that are otherwise prohibited importation into the
United States under paragraph (a) of this section may be imported into
the United States if the following conditions are met prior to
importation:
(1) The material is derived from a nonruminant species, or from a
ruminant species if the ruminants have never been in any region listed
in Sec. 94.18(a) of this chapter.
(2) All steps of processing and storing the material are carried
out in a foreign facility that has not been used for the processing and
storage of materials derived from ruminants that have been in any
region listed in Sec. 94.18(a) of this chapter.
(3) The facility demonstrates to APHIS that the materials intended
for exportation to the United States were transported to and from the
facility in a manner that would prevent cross-contamination by or
commingling with prohibited materials.
(4) 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 accordance with
the cooperative service agreement, the facility must be current in
paying all costs for a veterinarian of APHIS to inspect the facility
(it is anticipated that such inspections will occur approximately once
per year), including travel, salary, subsistence, administrative
overhead, and other incidental expenses (including excess baggage
provisions up to 150 pounds). In addition, the facility must have on
deposit with APHIS an unobligated amount equal to the cost for APHIS
personnel to conduct one inspection. As funds from that amount are
obligated, a bill for costs incurred based on official accounting
records will be issued to restore the deposit to the original level,
revised as necessary to allow for inflation or other changes in
estimated costs. To be current, bills must be paid within 14 days of
receipt.
(5) The facility allows periodic APHIS inspection of its
facilities, records, and operations.
(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
[[Page 42601]]
region of export certifying that the conditions of paragraphs (c)(1)
through (c)(3) of this section have been met.
(7) The person importing the shipment has applied for and obtained
from APHIS a United States Veterinary Permit for Importation and
Transportation of Controlled Materials and Organisms and Vectors by
filing a permit application on VS form 16-3. (VS Form 16-3 may be
obtained from APHIS, Veterinary Services, National Center for Import-
Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or
electronically at http://www.aphis.usda.gov/ncie.)
(d) The importation of serum albumin, serocolostrum, amniotic
liquids or extracts, and placental liquids derived from ruminants that
have been in any region listed in Sec. 94.18(a) of this chapter, and of
collagen and collagen products that meet any of the conditions listed
in paragraphs (a)(1) through (a)(3) of this section, is prohibited
unless the following conditions have been met:
(1) The article is imported for use as an ingredient in cosmetics;
(2) The person importing the article has obtained a United States
Veterinary Permit for Importation and Transportation of Controlled
Materials and Organisms and Vectors by filing a permit application on
VS form 16-3 (VS Form 16-3 may be obtained from APHIS, Veterinary
Services, National Center for Import-Export, 4700 River Road Unit 38,
Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/ncie.); and
(3) The permit application states the intended use of the article
and the name and address of the consignee in the United States.
(e) Insulin otherwise prohibited from importation into the United
States under paragraph (a) of this section is not prohibited from
importation under that paragraph if the insulin is for the personal
medical use of the person importing it and if the person importing the
shipment has applied for and obtained from APHIS a United States
Veterinary Permit for Importation and Transportation of Controlled
Materials and Organisms and Vectors by filing a permit application on
VS form 16-3. (VS Form 16-3 may be obtained from APHIS, Veterinary
Services, National Center for Import-Export, 4700 River Road Unit 38,
Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/ncie. Note: Insulin that is not prohibited from
importation under this paragraph may be prohibited from importation
under other Federal laws, including the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C, 321 et seq.)
(f) Articles that are prohibited importation into the United States
in accordance with this section may transit the United States for
immediate export if the following conditions are met:
(1) The person moving the articles has obtained from APHIS a United
States Veterinary Permit for Importation and Transportation of
Controlled Materials and Organisms and Vectors by filing a permit
application on VS form 16-3. (VS Form 16-3 may be obtained from APHIS,
Veterinary Services, National Center for Import-Export, 4700 River Road
Unit 38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/ncie.)
(2) The articles are sealed in leakproof containers bearing serial
numbers during transit. Each container remains sealed during the entire
time that it is in the United States.
(3) The person moving the articles notifies, in writing, the Plant
Protection and Quarantine Officer at both the place in the United
States where the articles will arrive and the port of export prior to
such transit. The notification includes the:
(i) United States Veterinary Permit for Importation and
Transportation of Controlled Materials and Organisms and Vectors permit
number;
(ii) Times and dates of arrival in the United States;
(iii) Times and dates of exportation from the United States;
(iv) Mode of transportation; and
(v) Serial numbers of the sealed containers.
(4) The articles transit the United States in Customs bond.
(Approved by the Office of Management and Budget under control
numbers 0579-0015 and 0579-0183)
6. A new Sec. 95.29 is added to read as follows:
Sec. 95.29 Certification for certain materials.
(a) In addition to meeting any other certification or permit
requirements of this chapter, the following articles may be imported
into the United States from any region not listed in Sec. 94.18(a) only
if they are accompanied by a certificate, as described in paragraph (b)
of this section:
(1) Processed animal protein, tankage, offal, and tallow other than
tallow derivatives, unless, in the opinion of the Administrator, the
tallow cannot be used in feed, regardless of the animal species from
which the material is derived;
(2) Glands and unprocessed fat tissue derived from ruminants;
(3) Processed fats and oils, and derivatives of processed animal
protein, tankage, and offal, regardless of the animal species from
which the material is derived;
(4) Derivatives of glands from ruminants; and
(5) Any product containing any of the materials listed in
paragraphs (a)(1) through (a)(4) of this section.
(b) The certificate required by paragraph (a) of this section must
be an original official certificate, signed by a full-time, salaried
veterinarian of the agency responsible for animal health in the
exporting region, that states the following:
(1) The animal species from which the material was derived;
(2) The region in which any facility where the material was
processed is located;
(3) That the material was derived only from animals that have never
been in any region listed in Sec. 94.18(a) of this chapter, with the
regions listed in Sec. 94.18(a) specifically named;
(4) That the material did not originate in, and was never stored
in, rendered or processed in, or otherwise associated with a facility
in a region listed in Sec. 94.18(a); and
(5) The material was never associated with any of the materials
listed in paragraph (a) of this section that have been in a region
listed in Sec. 94.18(a).
(c) The certification required by paragraph (a) of this section
must clearly correspond to the shipment by means of an invoice number,
shipping marks, lot number, or other method of identification.
(Approved by the Office of Management and Budget under control
number 0579-0183)
Done in Washington, DC, this 8th day of August 2001.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 01-20399 Filed 8-13-01; 8:45 am]
BILLING CODE 3410-34-P