[Federal Register Volume 66, Number 151 (Monday, August 6, 2001)]
[Notices]
[Pages 40965-40967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19596]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. 00-051N]


Residue Testing Procedures

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is changing the 
action it will take when livestock or poultry are presented for 
slaughter at official establishments that come from producers and 
others who have previously marketed such animals with violative levels 
of drug, pesticide, or other chemical residues (``chemical residues''). 
FSIS will no longer test livestock and poultry carcasses at official 
establishments for chemical residues until a specific number of the 
carcasses consecutively test negative for violative chemical residues 
(i.e., FSIS ``5/15'' policy). Instead, FSIS will post on its website 
the names and addresses of the sellers of livestock and poultry who the 
Food and Drug Administration has determined are responsible for the 
repeated sale of livestock or poultry that contain violative levels of 
chemical residues. FSIS believes that this action will help better 
ensure that meat and poultry products distributed in commerce are not 
adulterated with violative residues. FSIS is taking this action partly 
in response to a request from certain industry groups.

DATES: The new procedures will be effective September 5, 2001.

FOR FURTHER INFORMATION CONTACT: Daniel L. Lazenby, Acting Director, 
Technical Analysis Staff, Office of Policy, Program Development, and 
Evaluation, FSIS, U.S. Department of Agriculture, Room 409, Cotton 
Annex, 300 12th Street, SW., Washington, DC 20250, (202) 205-0210.

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. 
This program among other things helps to prevent the distribution in 
commerce 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, meat and 
poultry products that are capable of use as human food that are 
adulterated (21 U.S.C. 458(a)(2)(A) and 610(c)(1)). Meat and poultry 
products are considered adulterated under the FMIA and PPIA if they 
bear or contain illegal amounts of drugs, pesticides, and other 
chemicals (21 U.S.C. 453(g)(1), (g)(2), and (g)(3) and 601(m)(1), 
(m)(2), and (m)(3)).
    Both the FMIA and the PPIA include requirements for Federal 
inspection. They prohibit the sale, transportation, offer for sale or 
transportation, or receipt for transportation, in commerce, of meat and 
poultry products that are required to be inspected unless they have 
been inspected and passed (21 U.S.C. 458(a)(2)(B) and 610(c)(2)).
    Meat and poultry products prepared at establishments that operate 
solely within a State are effectively subject to the same inspection 
requirements and

[[Page 40966]]

adulteration prohibitions discussed above. These requirements and 
prohibitions are imposed pursuant to a State inspection program or by 
the FMIA and PPIA as a result of the designation of a State for Federal 
inspection (21 U.S.C. 454(c)(1) and 661(c)(1)).
    Since the 1960's, the public and private sectors have tried to meet 
the challenges presented by various types of product adulteration that 
organoleptic examination generally cannot detect. The control of 
chemical residues in meat and poultry products is a particularly 
appropriate subject for an improved regulatory 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.). FDA and EPA 
establish, respectively, what, if any, levels of animal drug and 
pesticide residues in food are safe, and thus can legally remain in the 
tissue of livestock and poultry. EPA also may make recommendations 
regarding what level, if any, of other chemical hazards that may be 
associated with substances that occur in meat and poultry products as a 
result of environmental contamination are safe. These levels are known 
as action or tolerance levels. FSIS enforces the tolerance and action 
levels set by the EPA and FDA to ensure that meat and poultry products 
do not contain levels of animal drugs, pesticides, or other chemicals 
above the level that is considered safe.
    At slaughter, FSIS looks for indications of illegal chemical use or 
exposure and collects livestock and poultry carcass samples for residue 
analysis. The analytical components of the Agency's residue control 
activities are collectively known as the ``National Residue 
Program''(NRP). 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. 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.)
    The prevention of illegal chemical residues in the food supply is 
an integral aspect of maintaining a high level of food safety. As part 
of FSIS's inspection program to screen for violative levels of chemical 
residues in livestock and poultry carcasses to ensure that meat and 
poultry products are not adulterated, Agency inspection program 
personnel sample meat and poultry carcasses at official establishments 
and submit the samples for testing to determine whether they contain 
violative drug, pesticide, or other chemical residues.
    If it is confirmed that a carcass contains a violative drug, 
pesticide, or other chemical residue, the Slaughter Operations Staff at 
FSIS' Technical Service Center (TSC) opens a case file about this 
matter and initiates an investigation to determine who is the violator. 
A violator is defined as a firm or person, (e.g., farmer, hauler, 
auction market) who sells livestock or poultry for slaughter that 
contains violative levels of drugs, pesticides, or other chemical 
residues. If the TSC staff is able to obtain from the official 
establishment the name of the producer (e.g. farmer) of the livestock 
or poultry, the TSC sends an ``FSIS Violation Notification Letter'' to 
this person. The letter provides the results of the residue tests taken 
and requests that the producer submit five animals to FSIS for residue 
testing at a designated official establishment.
    The TSC staff informs the appropriate FSIS personnel at the 
designated official establishment to sample the carcasses of animals 
presented for slaughter by the producer. There is no specific time 
period in which these carcasses must be presented. The case file 
remains open until five consecutive carcasses from animals presented 
for slaughter by the producer test negative for violative residues.
    If the TSC staff is not able to obtain the name of the producer who 
supplied the violative livestock or poultry carcass to the official 
establishment, then inspection program personnel are instructed to 
sample 15 carcasses from animals provided by the auction, market, or 
buyer that had previously supplied livestock or poultry to the official 
establishment that had been found to contain violative chemical 
residues. Inspection program personnel will select carcasses from three 
or more different lots for sampling and testing. There is no specific 
time period in which these carcasses must be presented. The case file 
remains open until 15 consecutive carcasses from animals presented for 
slaughter test negative for violative residues.
    The sampling and testing undertaken at official establishments of a 
specified consecutive number of carcasses of livestock or poultry that 
contained violative chemical residues is known as FSIS' ``5/15'' 
residue policy.
    Under an October 1984, Memorandum of Understanding with FDA, when 
FSIS finds violative drug, pesticide, or other chemical residues in 
livestock or poultry, FSIS transmits to FDA information, including the 
name of the official establishment where the livestock or poultry that 
was presented for slaughter was confirmed positive for violative 
chemical residues and information about the violator. This information 
is transmitted via the Residue Violation Information System (RVIS). 
RVIS is a nationwide interagency computer information system that was 
designed by FSIS in cooperation with FDA to handle pertinent regulatory 
information related to residue violations.
    FDA uses the information it receives from RVIS to conduct an 
investigation of the violator to determine whether the violator is a 
repeat violator. A repeat violator is an individual or firm who sells 
an animal for slaughter whose carcass is found to contain a violative 
level of a drug, pesticide, or other chemical residue within a 12-month 
period after having received a FSIS Violation Notification Letter.
    On July 27, 2000, the American Meat Institute, the Livestock 
Marketing Association, the National Livestock Producers Association, 
the National Cattleman's Beef Association, and the National Meat 
Association wrote to FSIS and requested that the Agency make certain 
changes in how it responded to residue violations by sellers of 
livestock. The associations stated that they were particularly 
interested in reducing the sales of market cattle that contained 
violative levels of animal drug residues. The associations requested 
that FSIS terminate its ``5/15'' policy ``in favor of a more meaningful 
cooperative program with FDA.'' They contended that FSIS' ``5/15'' 
policy was not an effective deterrent for firms or persons who 
knowingly and repeatedly sold medicated livestock.
    In place of FSIS' ``5/15'' policy, the associations requested that 
FSIS publish and disseminate a list that contains the names and 
addresses of the sellers of livestock that FDA has investigated and 
determined to be responsible for more than one residue violation in a 
12-month period (repeat violators). The associations recommended that 
these violators remain on the published list

[[Page 40967]]

for a period of one year following a ``responsible party'' designation 
by FDA, and that this time period be extended another twelve months for 
each subsequent residue violation for which the seller was determined 
to be responsible.
    FSIS has reviewed the associations' request. FSIS has determined 
that the list requested may more effectively prevent, than its current 
``5/15'' policy does, the distribution of meat products that are 
adulterated with violative levels of chemical residues. FSIS has also 
determined that this type of list may also more effectively prevent, 
than the current ``5/15'' policy does, the distribution of poultry 
products that contain violative chemical residues. FSIS believes that 
its current ``5/15'' policy may not be the best way to deter the 
repeated sale of livestock and poultry with violative chemical residues 
because, once a producer is notified about a residue violation, it is 
not difficult for a seller of livestock and poultry to temporarily 
present animals for slaughter that do not contain violative drug, 
pesticide, or other chemical residue levels. FSIS also believes that 
the suggested approach is more consistent with the approach embodied in 
HACCP than is the ``5/15'' policy.
    Therefore, FSIS will implement the change requested by the 
associations not only in regard to persons who have marketed livestock 
with violative chemical residues, but also in regard to persons who 
have marketed poultry that contain violative chemical residues. In 
cooperation with FDA, FSIS will make a list of repeat chemical residue 
violators publicly available by posting a list of repeat violators on 
the FSIS Homepage (www.fsis.usda.gov). The list will contain the names 
and addresses of the sellers of livestock and poultry that FDA has 
investigated and determined to be responsible for more than one drug, 
pesticide or other chemical residue violation in a 12-month period. The 
names and addresses of violators will remain on the list for a year 
from the time of being listed. For any subsequent violation, the time 
period will be extended by a year from the time of that subsequent 
violation.

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 webpage 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. 01-19596 Filed 8-3-01; 8:45 am]
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