[Federal Register: August 6, 2001 (Volume 66, Number 151)]
[Notices]
[Page 40964-40965]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au01-51]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. 00-026N]
Residue Policy
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice; request for comment.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
its intention to harmonize its procedures with those of the Food and
Drug Administration (FDA) with respect to the target tissue/marker
residue policy in testing animal tissues for residues of new animal
drugs. FSIS has reviewed its approach regarding the disposition of
carcasses containing residues and has determined that its approach is
not consistent with FDA's approach. To ensure that meat containing
unsafe levels of chemical residues is not being released into commerce,
FSIS intends to modify its approach to testing and disposition of
carcasses for violative residues to be more consistent with FDA's
target tissue/marker residue policy.
DATES: Comments may be submitted by no later than September 5, 2001.
FSIS will review comments and address them in another notice. That
notice will announce when the procedural changes addressed in this
notice are effective.
ADDRESSES: Submit one original and two copies of written comments to:
FSIS Docket Clerk, Docket # 00-026N, Room 102, Cotton Annex Building,
300 12th Street, SW., Washington, DC 20250-3700. All comments received
in response to this notice will be considered part of the public record
and will be available for viewing in the FSIS Docket Room between 8:30
a.m. and 4:30 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Daniel L. Lazenby, Acting Director,
Technical Analysis Staff, Office Policy, Program Development and
Evaluation; (202) 205-0210.
SUPPLEMENTARY INFORMATION:
Background
When a new animal drug is given to an animal, some of the parent
drug and resulting metabolites remain in the animal as residues. A new
animal drug is defined under 21 CFR 510.3(g) and examples of
``newness'' are specified in 21 CFR 510.3(i).
For new animal drugs approved prior to 1976, tolerances were
assigned for each of the edible tissues. Collection and testing of
multiple tissues is routine for these new animal drugs. As each tissue
is tested, it is either released or condemned, depending on whether it
is found to have an acceptable level of residue.
Since 1976, FDA has been establishing tolerance levels for new
animal drugs using a ``marker residue.'' The term ``marker residue'' is
defined in the Food and Drug Administration's (FDA) Center for
Veterinary Medicine's Guideline, ``General Principles for Evaluating
the Safety of Compounds Used in Food-Producing Animals,'' (CVM
Guideline #3, http://www.fda.gov/cvm/guidance/guideline3toc.html) as
being the residue selected for assay whose concentration is in a known
relationship to the total residue of toxicological concern in the last
tissue to deplete to its permitted concentration.
These marker residues serve as a sentinel for the levels of all
residues associated with that drug (parent and metabolites) in all
edible tissues of the food animal. CVM's Guideline 3 defines
target tissue as being the edible tissue selected to monitor for
residues in the target animals, including, where appropriate, milk or
eggs. When the FDA-approved conditions of use for a new animal drug are
followed, the concentration of marker residue in the target tissue
should be below the target tissue tolerance when the animal is sent to
slaughter. To establish an appropriate tolerance for the marker
residue, FDA must know the relationship between the concentration of
the marker residue in the target tissue and the concentrations of total
residues in each of the edible tissues (CVM Guideline 3). FDA
obtains this information from the drug's sponsor who, in submitting a
New Animal Drug Application (NADA), includes total residue depletion
and metabolism studies with radiolabeled compound in species for which
approval is sought (CVM's Guideline #3). The target tissue is usually
liver, kidney, or fat because residues generally deplete from these
tissues more slowly than from other tissues, i.e., muscle tissue.
In those cases where FDA has established a marker residue tolerance
in target tissue, when the marker residue in the target tissue depletes
to a concentration equal to or less than the target tissue
tolerance(based on the total residue depletion and metabolite data),it
can be reliably anticipated that the concentration of total residue in
each edible tissue has reached its respective permitted safe
concentration. In other words, when the concentration of the marker
residue is at or below its tolerance in the target tissue, the entire
carcass is considered safe to eat, without additional testing of the
individual edible parts of the animal carcass. Similarly, if the level
of the marker residue in the target tissue exceeds the tolerance, FDA
will consider the entire carcass to be adulterated, because the residue
in the target tissue is imputed to the rest of the animal.
In addition, for 15 new animal drugs FDA has specifically
established tolerances for residues found in muscle tissue and
analytical methods for detecting those residues. Therefore, the muscle
tissue may be released for human consumption if it meets the muscle
residue tolerance level. This is true even when the marker residue
tolerance in the target tissue has been exceeded. The target tissue,
however, would be condemned. In this situation, documenting that the
drug residues in muscle are less than the muscle tolerance will only
demonstrate that the muscle tissue is safe, and does not imply that any
other part of the animal carcass is safe, except in those few instances
where muscle has been designated to be the target tissue.
FSIS Practice
FSIS regulations regarding residues state that ``* * *Animal drug
residues are permitted in meat and meat food products if such residues
are from drugs which have been approved by the Food
[[Page 40965]]
and Drug Administration and any such drug residues are within tolerance
levels approved by the Food and Drug Administration * * *''(9 CFR
318.20). FSIS has not strictly applied FDA's marker residue/target
tissue approach in determining whether drug residues are within
tolerance levels.
Specifically, FSIS has condemned only the organ with a violative
residue level and has conducted a laboratory analysis of the muscle
tissue to determine whether the muscle portion of the carcass can be
salvaged. This has been the practice even for residues of those new
animal drugs for which FDA has not established a tolerance or testing
methodology for the muscle tissue. Historically, if no drug residue was
detected in the muscle, FSIS released the muscle portion of the carcass
for human consumption.
FSIS's practice has generated on-going questions regarding whether
or not the muscle or other organs are safe. FSIS has referred these
questions to FDA, which addresses them on an ad hoc basis.
FSIS needs to modify its procedures to be consistent with the
determinations that underlie FDA's approach. Therefore, for those new
animal drugs for which FDA has established a marker residue tolerance
in a specified target tissue without establishing a tolerance for a
residue in muscle and an official analytical method for muscle
residues, FSIS will only test the target tissue that is identified in
FDA regulations. If the residues found in the target tissue exceed the
FDA tolerances, FSIS will condemn the entire carcass. If FDA has also
established a tolerance for a residue in muscle and an official
analytical method for muscle residues, FSIS will test the muscle using
the official methodology to determine whether the concentration of
residues in the muscle is at or below the muscle tolerance. If
acceptable, FSIS will permit the release of the muscle. For those new
animal drugs for which a marker residue tolerance in a specified target
tissue has not been identified, FSIS will continue to collect and
monitor multiple edible tissues.
FSIS is aware that the change in its procedures announced in this
notice will affect the industry. To ensure that animals do not have
violative amounts of residues, establishments may change their
purchasing practices. Establishments should consider incorporating
controls into their HACCP plans to avoid exceeding residue tolerances.
Exceeding residue tolerances may result in the condemnation of more
product than is currently being condemned. FSIS invites comment on this
impact and will welcome any cost data. FSIS will consider these data
and consider in what ways it may lessen the impact.
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
notice, FSIS will announce it and provide copies of this Federal
Register publication 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 would 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: July 31, 2001.
Thomas J. Billy,
Administrator.
[FR Doc. 01-19597 Filed 8-3-01; 8:45 am]
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