[Federal Register Volume 65, Number 229 (Tuesday, November 28, 2000)]
[Proposed Rules]
[Pages 70809-70815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30309]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 /
Proposed Rules
[[Page 70809]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 309, 310, 311, 314, 318, 320, 325, 327, 331, 381, 416,
and 417
[Docket No. 00-043N]
Residue Control in a HACCP Environment
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Conceptual framework for program changes; notice of
availability of documents and public meeting.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing
this document to advise the public of its intent to adapt its approach
to the control of chemical residues in or on meat and poultry products
in light of the implementation of the regulations in the Agency's
Pathogen Reduction-Hazard Analysis and Critical Control Point Systems
(PR/HACCP) final rule. The Agency is providing an opportunity for
public participation in this effort. FSIS hopes that a wide variety of
interested members of the public will consider how HACCP should affect
the Agency's approach to preventing illegal chemical residues in or on
FSIS-regulated products and will provide comments for improving
consumer protection through a well-integrated, federal farm-to-table
food safety strategy. Therefore, FSIS is providing a conceptual
framework that sets out issues that the Agency wants to consider during
its program review and in making decisions about how it should modify
its approach to the control of chemical residues. FSIS is also making
relevant materials available to the public. The Agency is soliciting
written comments on the issues raised in this document, including those
raised in the materials it references, and is seeking comments that
contain additional information or raise additional issues. The Agency
will hold a public meeting to discuss the issues presented in this
document and the issues raised by the comments submitted.
DATES: The public meeting will be held on December 11, 2000, from 9
a.m. to 5 p.m. Members of the public who wish to provide information or
raise issues for discussion at the meeting should submit written
comments before December 4, 2000.
ADDRESSES: Submit one original and two copies of written comments to
FSIS Docket Clerk, Docket No. 00-43N, U.S. Department of Agriculture,
Food Safety and Inspection Service, Room 102 Cotton Annex Building, 300
12th Street, SW, Washington, DC 20250-3700. All comments submitted and
documents referred to below will be available for public inspection in
the Docket Clerk's office between 8:30 a.m. and 4:30 p.m., Monday
through Friday. The public meeting will be held at the Washington Plaza
Hotel, 10 Thomas Circle NW, Washington, DC 20005.
FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy
Administrator, Regulations and Inspection Methods, Food Safety and
Inspection Service, Washington, DC 20250-3700; (202) 205-0699.
SUPPLEMENTARY INFORMATION:
Background
The Food Safety and Inspection Service (FSIS) administers a
regulatory program under the Federal Meat Inspection Act (FMIA) (21
U.S.C. 601 et seq.) and the Poultry Products Inspection Act (PPIA) (21
U.S.C. 451 et seq.) to protect the health and welfare of consumers by,
among other things, preventing the distribution of adulterated products
of livestock and poultry. Under the FMIA and the PPIA, it is illegal to
sell or transport, offer for sale or transportation, or receive for
transportation, in commerce, products that are capable of use as human
food that are adulterated (21 U.S.C. 458(a)(2)(A) and 610(c)(1)).
Both the FMIA and the PPIA include requirements for federal
inspection, and they prohibit selling or transporting, offering for
sale or transportation, or receiving for transportation, in commerce,
products required to be inspected unless they have been inspected and
passed (21 U.S.C. 458(a)(2)(B) and 610(c)(2)). Intrastate operations
and transactions are effectively subject to the same requirements and
prohibitions, pursuant to a State inspection program or the designation
of the State for federal inspection (21 U.S.C. 454(c)(1) and
661(c)(1)).
FSIS laid the foundation for modernizing its system of food safety
regulation in July 1996, when it issued the PR/HACCP final rule (61 FR
38806). The Agency's regulations (9 CFR chapter III) now require
federally inspected establishments to take preventive and corrective
measures at each stage of the food production process where food safety
hazards can occur. The amended regulations also establish an approach
to food safety regulation that relies less on after-the-fact detection
of problems and more on verification of the effectiveness of an
establishment's process controls that are designed to ensure food
safety. In particular, the regulations on HACCP systems (part 417)
require that an establishment-specific hazard analysis consider food
safety hazards that can occur before, during, or after entry into the
establishment, and they require the implementation of a HACCP plan
that, for each production process, addresses the food safety hazard or
hazards that are reasonably likely to occur (Sec. 417.2(a)(1), (b)(1),
and (c)).
Under the HACCP system regulations, a food safety hazard is any
biological, chemical, or physical property that may cause a food to be
unsafe for human consumption (Sec. 417.1). The possible sources from
which food safety hazards might be expected to arise specifically
include chemical contamination, pesticides, and drug residues
(Sec. 417.2(a)(3)(iii), (a)(3)(iv), and (a)(3)(v)).
The standard for determining whether a food safety hazard is
reasonably likely to occur in the production process is if either (1)
the hazard historically has occurred, or (2) there is a reasonable
possibility that the hazard will occur in the particular type of
product being produced in the absence of preventive measures to control
it (Sec. 417.2(a)(1)). For each hazard that is reasonably likely to
occur, a HACCP plan must identify the preventive measures that the
establishment will apply to control the hazard. These include critical
control points (CCPs), the critical limits to be met at each CCP,
procedures for (and documentation of) the monitoring of CCPs,
corrective actions to be followed in response to any deviation from a
[[Page 70810]]
critical limit at a CCP, and verification procedures (Secs. 417.2(c),
417.3(a), and 417.4(a)).
A HACCP plan's CCPs are the points, steps, and procedures in a food
process at which the establishment can apply control and, as a result,
prevent, eliminate, or reduce to acceptable levels food safety hazards
that could be introduced in the establishment and food safety hazards
introduced outside the establishment (including hazards that occur
before, during, and after entry into the establishment) (Secs. 417.1
and 417.2(c)(2)). A plan's critical limits must be designed, at a
minimum, to ensure that applicable targets or performance standards
established by FSIS, and any other requirement in the Agency's
regulations pertaining to the specific process or product, are met
(Sec. 417.2(c)(3)).
FSIS phased in the applicability of part 417 requirements over a
two year period, based on establishment size, beginning with large
establishments (those with 500 or more employees) on January 26, 1998,
and ending with very small establishments (those with fewer than 10
employees or annual sales of less than $2.5 million) on January 25,
2000. The Agency is evaluating the results of HACCP implementation to
date and is considering what further steps to take to increase the
effectiveness of the HACCP approach to food safety--including steps
that would better ensure the adequacy of industry members' HACCP plans
and advance the ongoing transformation of the Agency's regulatory
system (see `` 417.8). One focus of the Agency during this process will
be its consideration of what approach should be taken to control
chemical residues in light of the PR/HACCP final rule.
Residue Control
FSIS-regulated products may be adulterated because they bear or
contain residues of drugs, pesticides, and other chemicals used in
animal production or present in the animals' environment (see 21 U.S.C.
453(g)(1), (g)(2), and (g)(3) and 601(m)(1), (m)(2), and (m)(3)). FSIS
has not yet modified its regulatory requirements and program activities
dealing with residues to reflect the implementation of HACCP plans at
official establishments. Some companies have had difficulty
understanding their responsibilities under the HACCP system regulations
and integrating their residue control responsibilities with other
regulatory requirements.
Since the 1960's, the public and private sectors have tried to meet
the challenges presented by various types of adulteration that
organoleptic examination generally cannot detect. Residue control is a
particularly appropriate candidate for an improved approach that
involves a well-integrated and seamless, prevention-oriented farm-to-
table strategy.
At the federal regulatory level, efforts to prevent residue-related
food safety problems principally involve, in addition to FSIS, the Food
and Drug Administration (FDA), acting under the Federal Food, Drug, and
Cosmetic Act (FFDCA) (21 U.S.C. 321 et seq.), and the Environmental
Protection Agency (EPA), acting under the FFDCA, the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135 et seq.), and
the Toxic Substances Control Act (15 U.S.C. 2601 et seq.). In their
premarket approval programs, FDA and EPA consider what, if any, levels
of drug and pesticide residues should be viewed as safe, and they
evaluate potential exposure to toxic substances that may contaminate
food. FDA also has federal regulatory responsibility for animal feeds
and food producing animals.
At slaughter, FSIS looks for indications of illegal chemical use or
exposure and collects carcass samples for residue analysis. The
analytical components of the Agency's residue control activities are
collectively known as the ``National Residue Program'' (NRP). The most
recent NRP reports are the ``1999 FSIS National Residue Program'' and
the ``Domestic Residue Data Book National Residue Program 1998''
(referred to informally as the ``Blue Book'' and the ``Red Book'',
respectively.)
Initiated more than 30 years ago, the NRP has generally been a
success. It has been instrumental in reducing the incidence of such
residue violations as sulfamethazine in market hogs and in improving
analytical capabilities for detecting chemical residues, including
significantly increasing the number of compounds for which analyses can
be performed. Additionally, FSIS has been instrumental in the
development of screening tests that make more efficient use of
resources and that facilitate residue detection. Other improvements
include the development of sophisticated information exchange systems
that aid communication both within the public sector and with
interested private sector parties, and the development of collaborative
educational efforts with producers that are supported by other USDA
agencies. In recent years, FSIS' Animal Production Food Safety Staff
has worked with States, producer groups, and others to develop and
enhance producers' residue avoidance activities and to help ensure that
only nonviolative animals are presented for slaughter.
FSIS regulations directed at residue control and the Agency's
implementing directives have grown more pointed during the past 30
years. In general, the regulations have become more detailed, have
reflected a growing dependence on residue testing as the preferred
means of control, and have increased FSIS' responsibility for this
control function.\1\ At the same time, communication and coordination
among the agencies involved in residue control have improved, with
multiple interagency committees and contacts.\2\
Despite these arrangements, more testing, and more government
control, the outcome has not been optimal. Significant residue control
issues have persisted. For example, certain market classes of domestic
animals continue to have unacceptably high rates of residue
violations.\3\
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\2\ Reference 1 is a list of FSIS regulations, directives, and
notices.
\1\ Reference 2 describes the interagency infrastructure.
\3\ NRP results indicate that, over time, the majority of
residue violations have involved illegal levels of animal drugs,
particularly sulfonamides and antibiotics, apparently due to the
failure of producers of a relatively small percentage of livestock
and poultry to follow prescribed withdrawal times--that is, to use
these drugs in accordance with the FDA regulations.
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Discussed below is additional information about the basic design of
the NRP, the relationship between residue control and HACCP, and
practical considerations that need to be taken into account when
reconsidering the approach to residue control. The document then
discusses the resolution of a practical problem that arose during HACCP
implementation that FSIS believes can serve as a first step in
rethinking what ought to be the approach to residue control in a HACCP
environment. Finally, other issues that FSIS believes need to be
considered in order to determine what approach will best lead to
optimal residue control in a HACCP environment are discussed.
FSIS hopes that a wide variety of interested members of the public
will consider how developments described in this document should affect
the Agency's approach to preventing illegal chemical residues in or on
FSIS-regulated products and the approach to providing improved consumer
protection through a well-integrated, federal farm-to-table food safety
strategy. The Agency is soliciting written comments, including the
submission of additional information, and it will hold a public meeting
to discuss broad policy and program
[[Page 70811]]
concerns, including the issues raised in this document and in the
comments submitted.
FSIS intends to organize the public meeting so that a number of
groups that include a variety of constituents consider one or more of
the issues identified in this document. The materials referenced in
this document (see footnotes) are available in the Docket Clerk's
office, and they also will be available at the meeting. A variety of
people with knowledge and experience about the particular topics to be
considered will facilitate the groups. At the end of the day, the
facilitator will report to the attendees at the general meeting on the
comments of the participants in each group. This information will be
considered in the development of policy and program activities for
residue controls.
Basic Program Design
Although NRP testing is planned and conducted using several
sampling schemes, there are essentially two broad purposes for all NRP
residue sampling. They are:
(1) Prevalence sampling: sampling to estimate the prevalence of
residues of certain chemical compounds in the tissues of specific
market classes of livestock and birds after they have been inspected
and passed at slaughter; and
(2) Verification sampling: sampling to determine whether one or
more processes to control residues have been successful.
Prevalence sampling has encompassed national, annual testing of
specific market class/compound pairs of livestock and birds (e.g.,
market hogs/sulfonamides) to determine whether a compound is a problem
in that market class of animals; regional, seasonal, or market class
specific testing, often in response to suspected problems of a more
limited nature; and special testing programs initiated to meet the
concerns of non-USDA entities, often international groups or countries
that receive meat or poultry products. Prevalence sampling programs
generally occur at one of four levels: 460 samples/year; 300 samples/
year; 230 samples/year; or 90 samples/year. The 300 samples/year scheme
provides a 95 percent confidence level that a problem occurring in 1
percent of the market class will be detected. The assumption that a
greater than 1 percent violation rate will be discovered 95 percent of
the time rests on the premise that normal-appearing inspected and
passed carcasses constitute a sufficiently homogeneous population that
this size sample can provide a national picture.
Currently, verification sampling of domestic products occurs after
there has been a violation detected in carcasses from a particular
producer. Typically, in such a case, subsequent livestock from the same
producer are subjected to verification sampling until findings
demonstrate that the production problem has been corrected.
Verification sampling can also be generated by inspector observations,
either ante-mortem or post-mortem, that suggest that a violative
residue may be present. Verification sampling is also done on imports.
FSIS samples products shipped to the United States from countries whose
inspection systems, including their residue control programs, have been
determined by FSIS to be equivalent.
Relationship Between Residue Control and HACCP
The PR/HACCP final rule established various requirements for
inspected facilities producing meat and poultry products. These
requirements include the following: (1) That establishments develop,
implement, maintain, and keep records of their standard operating
procedures for sanitation (Sanitation SOPs) (part 416), (2) that
slaughter establishments implement generic E. coli testing and record
and analyze results as a means of verifying the effectiveness of their
slaughter and sanitary dressing process in preventing and removing
fecal contamination from carcasses (Secs. 310.25(a) and 381.94(a)), and
(3) that establishments develop and implement HACCP plans to prevent,
eliminate, or reduce to an acceptable level the food safety hazards
reasonably likely to occur in their meat and poultry product production
processes (part 417).
These requirements were designed to improve the safety of meat and
poultry products, thereby reducing the incidence of foodborne illness
attributable to these products. These requirements also assist the
Agency in meeting one of its other regulatory objectives: to separate
and clarify the roles of the government inspection force and the
regulated industry.
Sanitation SOP implementation was a vitally important first step in
getting the inspection force out of the role of functioning as the
quality control department for plants. Key features of part 417
requirements reinforced this objective: the requirement that
establishments, not FSIS, conduct (or have conducted for them) a hazard
analysis (Sec. 417.2(a)(1)), the absence of HACCP plan approval by
FSIS, the lack of FSIS-specified CCPs, the requirement that
establishments validate the adequacy of their HACCP plans
(Secs. 417.4(a)), and the specification of consequences for incomplete
corrective actions (Secs. 417.2(e) and 417.6). All of these emphasize
the distinctly different roles of FSIS and the establishment. These
regulations underscore the companies' responsibility for producing meat
and poultry products that are safe, and make clear that the Agency will
hold them accountable for failing to do so.
The preamble to the PR/HACCP final rule discussed other important
features of the Agency's overall food safety strategy, including
regulatory reform, that provide flexibility and encourage company
innovation and a farm-to-table approach that extends beyond the
slaughter and processing establishments where most FSIS activities have
occurred (61 FR 38810-11). FSIS is aware that the command-and-control
nature of many of its regulations may discourage or impede
establishments from taking full responsibility for the production of
safe, complying products. In some cases, these regulations dictate to
establishments exactly how something must be done; in other cases, FSIS
carries out the activity itself and does not accept results from other
sources. To address this problem, FSIS is converting many of its
regulatory requirements into performance standards that allow an
establishment to determine how it will meet a requirement, while still
ensuring that appropriate requirements are in place.
FSIS is also aware that food safety problems may arise at many
points along the farm-to-table continuum, not just in inspected
establishments. Invisible hazards may be introduced at the production,
distribution, or consumption levels. Therefore, FSIS has committed
itself to working cooperatively with others concerned with food safety
to encourage hazard prevention and control at every step in the process
where a problem could arise.
As explained above, part 417 makes clear that violative residues
present food safety hazards that may be reasonably likely to occur,
and, therefore, slaughter establishments must consider the likelihood
of their occurrence in developing HACCP plans. Nevertheless, some
companies have found it difficult to integrate part 417 requirements
with other FSIS regulations, including those that address residue
control, even though Sec. 417.2(c)(3) directly addresses the need to
design critical limits to ensure that regulatory requirements are met.
Part 417 also addresses FSIS activities with respect to establishments'
HACCP systems and makes clear that FSIS will conduct activities to
verify the
[[Page 70812]]
adequacy of HACCP plans, including records review, direct observation
or measurement at a CCP, and sample collection and analysis
(Sec. 417.8).
FSIS believes that it is appropriate now to rethink the current
approach to residue control. On the one hand, industry must develop
more effective systems of residue control. On the other, FSIS will need
to shift its focus to verification testing to ensure residue
requirements are met, so that only safe meat and poultry products reach
the public. The Agency believes that this will result in a more
effective residue control program and a more efficient use of its
resources.
Full HACCP implementation gives FSIS and its constituents the
opportunity to consider what approach is best to resolve problems of
residue control by plants and what approach is best to accomplish
effective integration of HACCP and residue control requirements.
Practical Considerations
(1) Historically, residue control programs have engendered
controversies. There may be several underlying reasons, including
persistent consumer concerns about the hazards they cannot see and
cannot readily manage themselves. Obviously, chemical hazards in meat
and poultry products cannot be managed by the individual consumer
through usual techniques such as cooking or careful handling. The Food
Marketing Institute (FMI) has conducted surveys of consumer attitudes
and actions with regard to food safety. Even after many years of
documented improvement of residue control in domestic meat and poultry
products, and even with the increasing availability of data about the
success of residue control, annual FMI surveys reveal that consumers
continue to be concerned about residues.\4\
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\4\ Reference 3 is ``Trends in the United States: Consumer
Attitudes and the Supermarket,'' 2000, Food Marketing Institute.
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(2) Management of the hazards presented by chemical residues
depends on persons with several different, but highly technical,
scientific qualifications: toxicologists, chemists, epidemiologists,
veterinarians, microbiologists, statisticians, and others who sometimes
have not regarded open communication with the less expert public as a
critical task. Additionally, in the United States and most countries,
the scientists who are involved in the management of the hazards
presented by chemical residues are not all employed by the same
government agency and naturally develop different perspectives and
concerns. Thus, a program that encompasses the kind of coordination and
communication that is included in the United States' system is
necessary. Communication about that system, and public involvement in
shaping it, however, can be improved.
FSIS does not contemplate changes to residue control that would
significantly alter the involvement in it of different types of highly
skilled professionals or the close coordination that exists among food
safety agencies in regard to it. FSIS does, however, contemplate
changes that would make it even clearer that inspected establishments
are responsible for analyzing the hazards from chemical residues and
for taking measures to control those hazards that are reasonably likely
to occur.
(3) The public health hazards presented by violative residues may
be underestimated by the public whose attention is currently drawn to
health hazards associated with pathogens in meat and poultry products.
Two possible reasons for this may be a sense of security about the
effectiveness of the current residue program and the usually longer-
term consequences of residue control failures when compared to the
immediate consequences of failures to control pathogenic organisms.
Although there is competition for finite resources, FSIS does not
contemplate changes to its residue control program that would reduce
its effectiveness or its importance. In fact, FSIS expects that the
environment established by full HACCP implementation should lead to
more efficient and effective residue control.
(4) Residue control activities have been the subject of well-
publicized international controversies. The United States is a major
exporter and importer of meat and poultry products. In addition, its
agricultural production systems for meat and poultry products are
substantially different from those of the many countries with which it
trades. Determining whether such different systems impose equivalent
requirements has not been an easy task.
FSIS does not contemplate changes that would undermine the
exportation of meat and poultry products, but it is likely to ask that
producers and processors take more responsibility for ensuring that
residue violations are prevented. If producers and processors do so,
FSIS will be able to assume a true verification role, as contemplated
by HACCP.
Rethinking the Approach to Residue Control--Best Available
Practices
FSIS believes that efforts to solve a practical problem that arose
during HACCP implementation provide the initial steps for rethinking
the approach to residue control in a HACCP environment. An
establishment that slaughters principally cull dairy cows, a market
class of livestock with an historically high incidence of drug residue
violations, had not included any residue controls in its HACCP plan
because it assumed that FSIS would continue to take the lead
responsibility in this area. Findings of violative levels of drug
residues in carcasses of animals slaughtered at the establishment
resulted in the issuance of FSIS Noncompliance Records (NRs). (The NR,
FSIS Form 5400.5-4, is the Agency's official record of noncompliance
and serves as notification to an establishment of its failure to comply
with one or more regulatory requirements. See FSIS Directive 5400.5.)
In response to this situation, a coalition of industry members and
trade associations and other interested parties met with the Agency.
They expressed a number of concerns. They were concerned about the high
number of NRs issued at some establishments because of repeated
violations in cull dairy cows. They also were concerned about the lack
of consistency regarding the taking of screening samples for residues
of certain antibiotics in similar types of establishments. They
requested that the Agency clarify its instructions to its supervisory
veterinary medical officers (SVMOs) regarding the taking of screening
samples for residues of certain antibiotics. They also requested
assistance in obtaining rapid laboratory results so that the
appropriate disposition of carcasses could be determined quickly.
The coalition offered to share information that the large majority
of establishments had that slaughter cull dairy cows, including the
identification of suppliers of residue-violative animals, and
notifications issued by a slaughtering establishment to such suppliers
of a violative residue finding that might indicate that future
purchases would be restricted. Coalition members suggested that, over
time, such an approach might result in an actual decrease in violative
residue findings in cull dairy cows.
Since the initial discussions, there have been several important
developments:
--FSIS reviewed its instructions to SVMOs about the post-mortem
observations that should trigger performance of a screening test for
residues of certain antibiotics, and it found that there was a
discrepancy between the Agency's training of
[[Page 70813]]
SVMOs and the instructions they received on the job for this matter.
FSIS remedied this situation by issuing a new notice that is consistent
with the training given to SVMOs.\5\ The notice is expected to result
in more screening tests being performed.
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\5\ Reference 4 is FSIS Notice 24-00.
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--FSIS determined that it could accomplish its laboratory confirmation
analyses of screening positive results within a short timeframe.
--FSIS has told establishments that if their HACCP plans include
residue controls that constitute the best available preventive
practices for slaughter establishments, if they implement those
controls effectively, and if they supply FSIS with information about
violators, then the Agency will not treat violative residue findings by
the establishment that are followed by appropriate corrective actions
as noncompliance (see Sec. 417.3(a)).
In response to these modest shifts in the Agency's approach,
several establishments are exploring what might be considered to be the
best preventive practices available to slaughterers. These include:
ensuring that all animals brought into an establishment
for slaughter are identified, so that they can be traced back to the
producers of them, with receiving as a CCP;
Notifying animal producers in writing of both violative
and high, but not violative, residue findings, with such notification
including a discussion of the issues involved, the company's future
expectations, and an indication that repeat violators will not be
future suppliers;
Exploring the possibilities for the establishment of
state-certified, and possibly USDA Cooperative State Research,
Education, and Extension Service-verified, voluntary residue avoidance
programs comparable to those developed by major producer trade
organizations, so that slaughter establishments could add to their
purchase specifications a requirement that suppliers participate in
such programs and supply certifications to that effect; and
Exploring the possibilities for live animal testing, so
that slaughter establishments could have a rapid, convenient
verification tool.
FSIS notes that there is a considerable methods development agenda
that must be accomplished before the potential for live animal testing
can be fully realized, but some existing efforts may aid this process.
For example, the European Union (EU) expects testing at the producer
level,\6\ and thereby has created a demand for such methods.\7\ In
addition, there are efforts underway to facilitate the timely
recognition and acceptance of test kit methods by providing
independent, third-party scientific validation and accreditation of
test kit performance claims.\8\
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\6\ Reference 5 is Council Directive 96/23/EC.
\7\ Reference 6 is a list of live animal test methods.
\8\ Reference 7 is general information describing the AOAC
Institute and its activities.
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There may be models in Europe for other forms of public-private
cooperation in residue control. In the Netherlands, there is a National
Plan for Residues implemented by two ministries. Analyses for drug and
pesticide residues in meat, poultry, and eggs are performed on a
variety of sample types (muscle, fat, liver, kidney, and urine) taken
from animals at slaughterhouses and on farms. There is also a private
sector quality assurance group that provides support to producer groups
that use its seal in marketing. The laboratory for the quality
assurance group uses the same analytical methods as the government
laboratories, and its results are considered to be equivalent to those
of the government laboratories, including as a basis for action against
producers of violative animals.
It is likely that additional models in use in other countries could
provide concepts for the United States to consider as it reviews
residue control in a HACCP environment.
Residue Control in a HACCP Environment--Issues To Be Considered
Almost fifteen years ago, the National Academy of Sciences (NAS)
issued the first of several reports commissioned by FSIS that analyzed
and commented upon the status and future of the nation's meat and
poultry inspection system. The July 1985 report, titled ``Meat and
Poultry Inspection System, The Scientific Basis of the Nation's
Program,'' paid particular attention to the NRP because it was a
principal means through which chemical hazards were addressed.\9\ The
report provides a useful framework for reconsidering the management of
chemical hazards because it is HACCP oriented, and because most of the
elements on which it focused still appear relevant today.
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\9\ Reference 8 is the chapter of the 1985 NAS report (Chapter
4) that addressed control of chemical hazards.
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The areas addressed by NAS include the 10 discussed below. They are
addressed here in order to raise issues that need consideration in the
course of reconsidering the Agency's approach to residue control.
(1) Public Protection as the Primary Objective
The 1985 report determined that public protection was the primary
objective of the NRP, and it remains the primary objective today. One
issue that needs to be considered now is what full HACCP implementation
adds to the potential for public health protection against chemical
hazards. The Agency believes that it explicitly adds responsibility for
establishments, through the hazard analysis, to determine whether
chemical contamination, pesticides, or drug residues are food safety
hazards reasonably likely to occur, and if so, it adds the
responsibility for the establishment to control them through the HACCP
system. Industry's enhanced role in this area will enable FSIS to
optimize its effectiveness by allowing it to focus upon verifying that
safe and wholesome product enters commerce.
If public protection is to be the primary focus of the Agency's
residue control program, a question remains as to how the Agency should
respond to requests by receiving countries to test for compounds that
this country's risk analysis has not determined to be of public health
significance. Where additional testing is requested, current FSIS
policy is to not use federal funds for it; rather, the expense is borne
by the exporter. For example, meat and poultry products exported from
the United States to the EU are subjected to additional residue testing
for some compounds that are banned in the EU but that may be used, in
accordance with FDA regulations, in the United States. They also are
tested for compounds that are approved for use in both the EU and the
United States, but for which the EU mandates testing and for which the
current U.S. program does not conduct tests. Only product eligible for
export to the EU is being sampled for these compounds, and the analyses
are performed in independent laboratories at industry expense.\10\ In
light of HACCP, an issue that needs to be considered is what other
possible approaches might be developed for this matter.
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\10\ Reference 9 is extra residue requirements for the EU.
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(2) Focus on Prevention
The July 1985 NAS report indicated that the NRP was improved, but
that it was nevertheless still deficient in its focus on prevention. An
issue that needs to be examined in this area is what full
implementation of HACCP has added to the capacity of the government
[[Page 70814]]
to enhance residue control programs' focus on prevention.
As articulated in the preamble to the PR/HACCP final rule (61 FR
38807-08), HACCP is a science-based system of process control, designed
to prevent food safety problems during the processing of food rather
than to detect them after they have occurred. This raises the question
of what producers and processors should be doing to identify and
promote the acceptance of validated preventive measures.
In 1985, NAS suggested that the NRP was handicapped by the lack of
traceback capabilities as well as by the low numbers of samples for
residue testing. NAS also suggested that analysis of test results
needed to produce a better characterization of the hazards, rather than
just an enumeration of them across market class/compound dimensions.
This raises the issue of how full HACCP implementation contributes to
addressing these deficiencies.
(3) Clear Tolerance Levels Available on All Important Substances
In 1985, NAS identified this feature as improved, but still needing
more progress. The process of setting tolerances has changed
significantly since 1985. Tolerance setting is a function performed by
FDA and EPA and, thus, minimally affected by FSIS program changes.
Therefore, FSIS considers this issue to be minimally affected by full
HACCP implementation.
(4) Sampling Scheme Adequate for Prevention
In 1985, NAS was critical of the NRP's monolithic sampling
strategy. NAS suggested that the strategy ought to be revised to
provide for more sampling, true probability sampling, and sampling
designed to adequately characterize the nature and distribution of
contaminants. NAS also suggested that random sampling schemes other
than simple random sampling should be considered and that substantial
technical advice from experts on sample surveys should be obtained.
There are certainly alternative sampling strategies that could be
used in the residue control effort. FSIS might choose to sample certain
historically problematic market classes intensively to define baseline
conditions; from those baseline conditions, the Agency could consider
promulgating performance standards for some market class/compound
combinations that have been historically troublesome. Alternatively,
FSIS could propose performance standards based on historical results
from its own program.\11\ In either case, establishments would be
responsible for achieving these standards. FSIS would verify whether
they were meeting the standards, and failure to meet the standards
would have HACCP system consequences.
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\11\ Reference 10 summarizes recent FSIS data that could serve
as the basis for performance standards.
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The Agency could also consider an approach that takes into account
the amount of establishment sampling being done in determining the
amount of FSIS testing that is appropriate. In fact, if FSIS verifies
that an establishment has included residue control in its HACCP plan
and is following corrective action procedures after any violative
finding, with records available for Agency personnel to review, it
would logically be expected that FSIS would consider limiting its
residue testing.
Another alternative sampling strategy could involve adding
marketbasket testing to FSIS activities and combining all FSIS results
with any available test results from industry--animal producers as well
as processors. Analysis of such a body of data might be possible and
might provide a more comprehensive picture of residue control. Other
countries may have experience with approaches that combine public and
private testing.
Other issues that need to be considered here are what new
approaches that combine producer, processor, and government activities
into a multifaceted and more comprehensive residue control approach can
and should be implemented now that HACCP has been fully implemented,
and what needs to be done to accomplish this.
(5) Risk Assessment
NAS recommended that risk assessment play a prominent role in each
of the first four areas discussed above. FSIS experience with risk
assessment in the realm of microbial hazards is somewhat limited,
although growing. FSIS has completed a risk assessment for Salmonella
enteritidis in shell eggs and egg products, and it soon will complete a
risk assessment for E. coli O157:H7 in ground beef and a Listeria
monocytogenes risk ranking with FDA. Some people believe that risk
assessment is less difficult in the realm of chemical hazards. The
interagency Surveillance Advisory Team recently completed a significant
change in the way compounds are selected for analysis any given
year.\12\
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\12\ Reference 11, sections 5 and 6 of the current Blue Book,
describes the new approach.
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FSIS believes the following issues need to be considered in this
area: How should the Agency establish an agenda for risk assessment in
the realm of controlling chemical hazards; how should the Agency
allocate resources for its growing risk assessment needs; is the Animal
and Plant Health Inspection Service's approach--which involves setting
standards for risk assessments, and then permitting outside parties who
meet those standards to perform risk assessments--useful; and what does
full HACCP implementation bring in terms of these risk assessments?
(6) Adequate Analytical Tools and Testing Capacity
The Agency and its partners, such as FDA, have made great strides
in the development of methods for residue testing and in the capability
of laboratories to conduct analyses for residues (which even in 1985
were recognized as greatly improved). However, full implementation of
HACCP may bring opportunities for greater progress, because it could
create new markets for high quality laboratory work or new analytical
methods.
Issues that need to be considered include the following: What are
the needs for laboratory capacity, and what new analytical methods are
needed; should the Agency consider recognizing test results for
residues from State and private laboratories that have appropriate
accreditation; and how can the Agency facilitate the development of new
testing methods, particularly for live animals?
(7) A Trained Inspection Force
Issues that need to be considered in this area include the
following: What training does the FSIS inspection force need regarding
residue control in a full HACCP implementation situation; and what
training do those in the regulated industries and others need regarding
residue control in a full HACCP implementation situation?
(8) Close Links to Regulatory Enforcement
Much has changed since 1985, including a major FSIS reorganization
and implementation of the PR/HACCP final rule. An issue that needs to
be considered is what opportunities do the Agency's realignment and
other activities in support of full HACCP implementation create for
linkage between residue control and enforcement.
FSIS intends to proceed with its regulatory reform agenda and to
apply the principles that guide it to complete its agenda, which
includes residue control reform. (See the Agency's advance notice of
proposed rulemaking,
[[Page 70815]]
``FSIS Agenda for Change: Regulatory Review'' (60 FR 67469, December
29, 1995), and Reference 1.) In this regard, issues that need to be
considered include the following: What amendments to the regulations
and other materials that cover residue control are needed; are
additional efforts at interagency coordination regarding residue
control necessary, and if so, what should they be?
FSIS has adopted the practice of supplementing its regulations with
guidance material for industry. Issues that need to be considered
include the following: What new or improved guidance materials are
needed regarding residue control; what improvements in these materials
can be made to ensure that industry members obtain the greatest benefit
possible from them?
(9) Useful Information Systems
Implementation of HACCP has significantly modified most of the
Agency's information system needs. Considering residue control alone,
what are the critical information system needs in this area?
FSIS knows that EPA and FDA both need information regarding
residues. The following issues need to be considered here: Who else
needs information regarding residues, and who has the needed
information; what are the constraints on sharing information regarding
residues; how can obstacles to the sharing of information be overcome;
and what resources are available for obtaining and sharing information?
(10) Priorities Are Set Through an Open Process
The NAS strongly suggested that an open process, readily available
to a wide spectrum of constituents, be used to establish priorities for
the control of chemical hazards in the meat and poultry supply. The
upcoming public meeting is a first step in an effort to meet that goal.
FSIS would like to know what other efforts might be useful in opening
up the process.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to better ensure
that minorities, women, and persons with disabilities are aware of this
rule, FSIS will announce the publication of this document in the FSIS
Constituent Update. FSIS provides a weekly FSIS Constituent Update,
which is communicated via fax to over 300 organizations and
individuals. In addition, the update is available on line through the
FSIS web page located at http://www.fsis.usda.gov. The update is used
to provide information regarding FSIS policies, procedures,
regulations, Federal Register notices, FSIS public meetings, recalls,
and any other types of information that could affect or will be of
interest to our constituents/stakeholders. The constituent fax list
consists of industry, trade, and farm groups, consumer interest groups,
allied health professionals, scientific professionals, and other
individuals that have requested to be included. Through these various
channels, FSIS is able to provide information to a much broader, more
diverse audience. For more information and to be added to the
constituent fax list, fax your request to the Congressional and Public
Affairs Office, at (202) 720-5704.
Done at Washington, DC, on November 22, 2000.
Thomas J. Billy,
Administrator.
[FR Doc. 00-30309 Filed 11-27-00; 8:45 am]
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