[Federal Register Volume 69, Number 89 (Friday, May 7, 2004)]
[Notices]
[Pages 25539-25542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10443]



[[Page 25539]]

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. 00-026N]


Residue Policy; Response to Comments

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is implementing 
the modified approach to the testing of meat carcasses for the presence 
of violative new animal drug residues, and disposition of product 
thereafter, as was announced in an August 6, 2001, Federal Register 
notice (66 FR 40964). This action will make FSIS' testing and 
disposition procedures consistent with the target tissue/marker residue 
policy of the Food and Drug Administration (FDA). FSIS is modifying its 
approach to ensure that meat containing unsafe levels of animal drug 
residues is not released into commerce.

DATES: Effective Date: June 7, 2004.

FOR FURTHER INFORMATION CONTACT: Carole Thomas, Technical Analysis 
Staff, Office of Policy and Program Development, FSIS, U.S. Department 
of Agriculture, 1400 Independence Avenue, SW., Room 405, Cotton Annex, 
Washington, DC 20250-3700, (202) 205-0210.

SUPPLEMENTARY INFORMATION:

Background

    Under the Federal Food, Drug, and Cosmetic Act, FDA determines 
whether new animal drugs proposed for use in food producing animals are 
safe for those animals, and establishes tolerances for residues of such 
drugs that remain in the edible tissues of treated animals. The term 
``new animal drug'' is defined in FDA's regulation in Title 21 of the 
Code of Federal Regulations (21 CFR 510.3(g). For new animal drugs 
approved prior to 1976, FDA established residue tolerances for each 
edible tissue of food producing animals. Since 1976, however, FDA has 
been establishing tolerances for new animal drugs using a marker 
residue. In a guideline published by FDA's Center for Veterinary 
Medicine (CVM), ``General Principles for Evaluating the Safety of 
Compounds Used in Food-Producing Animals'' (CVM Guideline 3, 
http://www.fda.gov/cvm/guidance/guideline3toc.html), the term ``marker 
residue'' is defined as 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.
    Marker residues serve as sentinels for levels of residues of 
toxicological concern associated with a drug (parent and metabolites) 
in edible tissues of a food producing animal. In more general terms, a 
marker residue is the residue that reflects the depletion of animal 
drug residues in edible tissues. A target tissue (typically the liver 
or kidney or, more rarely, the muscle or fat) is the edible tissue from 
which residues deplete most slowly, and the tissue used for regulatory 
surveillance. When the concentration of the marker residue in the 
target tissue is equal to or less than the target tissue tolerance, the 
residue concentration reached in each edible tissue will be at a safe 
concentration.
    If FSIS inspection personnel identify an animal as suspect for any 
condition where animal drug misuse is possible, and a suitable in-plant 
test is available, an initial screen test is performed at the federal 
establishment to determine whether the animal drug is present. If the 
screen test is positive, the target tissue of the animal is analyzed in 
a FSIS laboratory to verify that the drug is present, as well as to 
quantify the amount of the drug that is present. If the target tissue 
contains violative levels of the animal drug, FSIS tests the muscle 
tissue of the animal to determine whether it also contains a violative 
residue level. If the target tissue is found to contain a violative 
residue level, but the muscle tissue is not found to contain a 
violative residue level, FSIS condemns only the target tissue and 
releases the muscle tissue for human consumption. Likewise, if the 
target tissue does not contain violative levels of residue, but the 
muscle tissue does, only the muscle tissue is condemned.
    On August 6, 2001, FSIS issued a Federal Register notice (66 FR 
40964) that announced its intent to harmonize its procedures with those 
of FDA with respect to applying FDA's target tissue/marker residue 
policy regarding the testing of meat carcasses for residues of new 
animal drugs and disposition of tissues thereafter. In the notice, FSIS 
stated that it had reviewed its approach regarding the testing of meat 
carcasses for new animal drug residues and the disposition of meat 
carcasses containing violative residues and had determined that it was 
not consistent with FDA's approach. FSIS is now implementing the 
approach discussed in its August 2001 notice.
    For the new animal drugs for which FDA has established a marker 
residue tolerance in a specific target tissue without also establishing 
a tolerance for a residue in muscle tissue or an official analytical 
method for muscle residues, FSIS will only test the target tissue that 
is identified in FDA's regulations (21 CFR Part 556 Subpart B--Specific 
Tolerances for Residues of New Animal Drugs). If the residue 
concentration in the target tissue exceeds the FDA's established 
tolerance, FSIS will consider the entire carcass to be adulterated, and 
condemn it, and not allow it to be distributed for human food purposes. 
If, however, FDA has established an animal drug residue tolerance in 
muscle tissue and an official analytical method for detecting muscle 
residues, FSIS will test the muscle tissue using the official 
analytical method to determine whether the concentration of residue in 
the muscle is at or below the established muscle tolerance. If the 
residue concentration in the muscle does not exceed the tolerance, FSIS 
will release the muscle tissue and allow it to be distributed in 
commerce for human consumption.
    For the new animal drugs where tolerances have been established for 
all edible tissues, but for which a target tissue has not been 
identified, FSIS will continue to collect and monitor multiple edible 
tissues and allow those that have animal drug residue levels equal to 
or less than the established tolerances to be distributed in commerce 
for human consumption.
    FSIS received several comments about the intended change that it 
announced on August 6, 2001. FSIS has carefully considered the comments 
and is now responding to them.
    Several commenters asked whether the intended change had a 
scientific rationale. They stated that it was important that the change 
be based on public health concerns, and that FSIS not discard safe 
tissues or place unnecessary burdens on producers and processors. 
Others stated that the change would not enhance public health.
    FDA's Center for Veterinary Medicine (CVM) has the primary 
responsibility for establishing and codifying tolerances for new animal 
drugs. In establishing tolerances, FDA relies on human food safety 
studies, including analysis of toxicological, total residue depletion, 
and metabolic data submitted by individual new animal drug sponsors. In 
a letter from the Office of New Animal Drug Evaluation (NADE), Center 
for Veterinary Medicine, CVM states that a tolerance represents the 
concentration of an indicator (marker residue) of the total residues in 
all edible tissue below which FDA has a reasonable certainty that no 
harm will

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occur to a consumer through daily exposure to the residues in food over 
a lifetime. Thus, all of the animal drug tolerances established in 21 
CFR part 556 are based on human safety considerations. When the 
tolerance in the target tissue is exceeded, FDA considers the entire 
carcass to be adulterated because the residue in the target tissue is 
imputed to the rest of the animal.\1\
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    \1\ Dr. S.D. Vaughn, Director, Office of New Animal Drug 
Evaluation, Center for Veterinary Medicine, June 2003.
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    FSIS does not establish animal drug tolerances. However, it does 
have authority over a food animal once it is presented for slaughter at 
an official federal establishment. FSIS conducts ante-mortem 
inspections of animals. The ante-mortem inspections screen for visible 
diseases and pathological conditions in an animal that could pose a 
public health risk if the meat from the animal entered the food supply. 
FSIS also conducts post-mortem inspection of animals. On post-mortem 
inspection, FSIS inspectors check an animal carcass for indications of 
animal drug use, including examining the carcass for injection sites, 
septicemia, endocarditis, mastitis, pneumonia, or other conditions that 
may indicate the animal was medicated. If such conditions are 
identified, the carcass and parts of the animal are retained, and 
appropriate tissue samples are submitted to a FSIS Food Service 
Laboratory for further testing. FSIS believes that these procedures, 
and the modifications it is now implementing, will ensure that meat 
containing unsafe levels of chemical residues are not being released 
into commerce.
    Many commenters asked why FSIS does not use the ``maximum residue 
limit'' (MRL) established by CODEX for the drugs that do not have 
established tolerances for muscle tissue. They stated that FSIS should 
harmonize its procedures with CODEX.
    FDA has the authority to regulate veterinary drugs and to establish 
and codify animal drug tolerance levels. FDA has determined that its 
method for establishing tolerance levels for muscle tissue is more 
reflective of consumption patterns in the U.S. than the MRLs 
established by CODEX. FSIS does not establish or codify animal drug 
tolerance levels. FSIS enforces the tolerances established by FDA and 
relies upon FDA's determination of what are appropriate tolerance 
levels.
    One commenter stated that it is important that FSIS develop beef 
muscle residue testing methods since the European Union is requiring 
testing of beef for violative residues before entry into the European 
beef market.
    FSIS does not itself develop residue testing methods. The Agency 
does not believe that it needs to develop them itself since there are 
validated methods available for its use. The tests for beef muscle 
residues that are used by FSIS are based on the testing methods 
developed by drug sponsors as part of the FDA approval process. These 
methods are used for tissue residue determinations once the FDA method 
trial has validated their use for this purpose.
    A commenter stated that imported beef should be subjected to a 
limited amount of residue testing to verify that the beef is free of 
violative residues.
    Through its National Residue Program (NRP), FSIS tests meat and 
poultry products imported into the United States for violative 
residues. In addition, every country that exports meat or poultry to 
the United States is required to have a residue control program that is 
equivalent to that of the United States. This program needs to include 
laws and regulations that control the use of animal drugs, pesticides, 
and environmental contaminants and an organizational structure to 
implement those requirements; a residue sampling and testing program 
equivalent to the United States' residue program (the National Residue 
Program); and the ability to take enforcement actions when residue 
violations are detected.
    A few commenters suggested that muscle tissue should be tested to 
see if it contains residues that exceed the science-based standards set 
by FDA. They argued that if the muscle tissue is not tested, or if FDA 
has not established an official analytical method for testing, a 
``blanket'' condemnation of carcasses could occur.
    Muscle tissue will be tested if there is an FDA established 
tolerance for muscle tissue and an analytical method for detection 
established by FDA. If not, action on the carcass will be based on the 
marker residue findings in the target tissue. Carcasses will be 
condemned only if the residue in the target tissue exceeds the 
applicable tolerance. This is an appropriate outcome because if a 
violative animal drug residue level is found in a target tissue for a 
drug for which there is no muscle tolerance established, FSIS cannot 
determine that the carcass is not adulterated.
    FSIS does not believe that its approach will result in a blanket 
condemnation of carcasses. FSIS has reviewed the potential impact of 
its modified testing approach and has concluded that the percentage of 
carcass condemnation as a result of this change will be only 2% (see 
economic review). Additionally, there are only seven commonly used 
veterinary drugs that do not have established muscle tolerances or an 
analytical method for detection.
    One commenter stated that FSIS' current procedure of testing muscle 
tissue meets FSIS statutory obligations.
    FSIS has tried to maintain an equitable residue program. While the 
Agency considered its approach appropriate, the Agency has now 
determined that the better, more scientific approach is to harmonize 
its residue policy procedures with those of FDA with respect to target 
tissue/marker residues.
    One commenter expressed concerns about the downstream discovery of 
residues after slaughter and the lack of responsibility and traceback.
    In a November 28, 2000, Federal Register notice (65 FR 70809), FSIS 
discussed meetings that it had held with a coalition of industry 
members, trade associations, and other interested parties to discuss 
concerns related to residue violations and laboratory reporting 
procedures. As a result of those meetings and FSIS' response, several 
slaughter establishments indicated that they would begin to explore how 
to effectively institute the best preventive practices available to 
slaughterers. These included ensuring, through the use of a receiving 
critical control point in their HACCP Plans, that all animals brought 
into an establishment for slaughter were identified so they would be 
traced back to the producer; notifying animal producers in writing of 
violative levels of residue findings, making clear the issues involved, 
the purchaser's expectations, and the fact that repeat violators would 
not be future suppliers; exploring the possibility of establishing 
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, and requiring suppliers to participate in such programs 
and to supply certifications to that effect; and exploring the 
possibility of live animal testing. FSIS believes that adoption of 
these types of practices by packers will facilitate accountability and 
traceback.
    Two commenters suggested that if a tolerance and analytical 
methodology for muscle have been developed for one species, it should 
be used for other species when there are no tolerances or detection 
methods developed for them.
    Tolerance levels are derived from an evaluation of residue and 
metabolism studies for each species for which data

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are provided to FDA. Because there are significant differences among 
species, applying a tolerance level established for one species to 
another species without metabolic studies would be inappropriate.
    One commenter suggested that it is premature to change existing 
rules until other tasks have been completed.
    FSIS is not changing any rules in this proceeding. Rather, it is 
announcing a change in how it will determine whether a product is not 
adulterated and thus eligible to bear the mark of inspection.
    One commenter asked whether FSIS will issue a directive or provide 
additional training to all inspectors.
    FSIS will issue a new directive to its inspectors that clearly 
explains this procedural change and their responsibilities.
    Two commenters requested that the procedural change be implemented 
at a later time. One argued that it needed sufficient time to discuss 
the feasibility of muscle tolerances for certain compounds with a 
pharmaceutical company and FDA. Another stated that there is a lack of 
a strategy within FDA for establishing tolerances for drugs for which 
muscle tolerances are currently not established.
    In the August 6, 2001, Federal Register notice (66 FR 40964; 
confirmed 68 FR 540 (1/6/03)), FSIS asked for comments on its intent to 
change its current procedures to be consistent with FDA's marker 
residue/target tissue policy for new animal drugs. In a November 8, 
2001, Federal Register notice (66 FR 56533), FSIS reopened the comment 
period on this issue for an additional thirty days. More than two years 
have passed since FSIS published its initial notice. FSIS believes that 
it has allowed adequate time for comments on, and consideration of, 
this change. Therefore, FSIS will begin operating in accordance with 
the marker residue/target tissue policy on June 7, 2004.
    One commenter stated that FSIS' changed approach does not give 
producers an incentive to stop inappropriately administering veterinary 
drugs, while it continues to punish the packer. Another commenter 
stated that packers do not have the option of buying food animals that 
have been pre-screened for veterinary drugs.
    On August 6, 2001, FSIS published ``Residue Testing Procedures; 
Response to Comments'' (66 FR 40965), which announced its policy 
effective as of September 5, 2001, on repeat chemical residue violators 
and announced the public availability of the list of repeat violators 
on the Agency's Web site (http://www.fsis.usda.gov). This list will 
enable slaughter establishments to incorporate into their purchasing 
practices control measures that are designed to decrease the likelihood 
of purchasing animals from producers and sellers that violate the 
Federal law by inappropriately administering veterinary drugs.
    FSIS received a comment from the Small Business Administration 
(SBA) that raised four specific concerns. First, SBA asserted that 
FSIS' August 6, 2001, residue policy notice (66 FR 40964) did not 
simply announce a change in FSIS' procedures but in fact was a 
rulemaking action that FSIS needed to publish in the Federal Register 
and give interested persons an opportunity to comment upon, in 
accordance with the Administrative Procedure Act (APA). Second, SBA 
stated that FSIS had to comply with the Regulatory Flexibility Act 
(RFA) and certify, as well as provide a factual basis for the 
certification, that the procedural changes would not have a significant 
economic impact on a substantial number of small entities. Third, based 
on their calculations, SBA contended that FSIS'' intended action had a 
potential to be economically significant under Executive Order 12866, 
and that FSIS needed to prepare a Regulatory Impact Analysis. Lastly, 
SBA stated that it believed FSIS should suspend the August 6, 2001, 
notice and republish it as a proposed rule.
    FSIS does not agree with any of SBA's statements. The action 
announced in the August 6, 2001, Federal Register notice is not a 
rulemaking. It does not impose any regulatory requirements on industry. 
FSIS' residue policy notice simply provides information on the 
procedures the Agency will use to ensure that meat establishments do 
not distribute meat containing unsafe levels of animal drug residues. 
Thus, there is no reason for FSIS to republish its August 6, 2001, 
notice as a proposed rule. Further, although not required, FSIS has, in 
fact, employed a notice and comment procedure in adopting its residue 
policy. The policy was not implemented when it was announced in August 
of 2001. Rather, at that time, the Agency simply announced how it 
intended to proceed. It is only now after FSIS solicited, received, and 
has responded to comments that the announced policy is being 
implemented. In regard to SBA's RFA and E.O. 12866 concerns about the 
economic impact of the procedural changes FSIS is implementing, FSIS 
does not expect its action will have a significant economic impact on a 
substantial number of small entities or will be economically 
significant.

Economic Review

    Of the veterinary drugs commonly used in swine and cattle there are 
only seven for which the FDA has established a marker residue tolerance 
in a specific target tissue without also establishing a tolerance for 
the residue of the drug in the muscle tissue or an analytical method 
for detecting muscle animal drug residues. These seven drugs are: 
apramycin, carbadox, fenbendazole, melengestrol acetate, morantel 
tartrate, oxfendazole, and tiamulin. Four of these are ones that the 
FDA has established and codified tolerances for the liver; two are ones 
for which the FDA has established and codified tolerances for the 
kidney; and one is one for which the FDA has established and codified 
tolerances for fat (See Tables 1 and 2).

                 Table 1.--Veterinary Drugs and Unavoidable Contaminants With a Tolerance in Both Organ and/or Muscle for Cattle \1\ \2\
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              Substance                          Liver                        Kidney                       Muscle                        Fat
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Apramycin...........................  None.......................  None.......................  None.......................  None.
Carbadox............................  None.......................  None.......................  None.......................  None.
Fenbendazole........................  Yes (0.8)..................  None.......................  None.......................  None.
Melengestrol acetate................  None.......................  None.......................  None.......................  Yes (0.025).
Morantel tartrate...................  Yes (0.7)..................  None.......................  None.......................  None.
Oxfendazole.........................  Yes (0.8)..................  None.......................  None.......................  None.
Tiamulin............................  None.......................  None.......................  None.......................  None.
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\1\ Tolerances are expressed in parts per billion (ppm).
\2\ Source: 2000 FSIS Red Book.


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    Thus, the modified testing procedure FSIS is implementing would be 
utilized for only a very small number of meat carcasses. In turn, only 
very small amount of meat carcasses would be expected to be condemned 
as a result of any findings of violative drug residues.

                 Table 2.--Veterinary Drugs and Unavoidable Contaminants With a Tolerance in Both Organ and/or Muscle for Swine \1\ \2\
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              Substance                          Liver                        Kidney                       Muscle                        Fat
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Apramycin...........................  None.......................  Yes (0.1)..................  None.......................  None.
Carbadox............................  None.......................  Yes (0.03).................  None.......................  None.
Fenbendazole........................  None.......................  None.......................  None.......................  None.
Melengestrol acetate................  None.......................  None.......................  None.......................  None.
Morantel tartrate...................  None.......................  None.......................  None.......................  None.
Oxfendazole.........................  None.......................  None.......................  None.......................  None.
Tiamulin............................  Yes (0.6)..................  None.......................  None.......................  None.
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\1\ Tolerances are expressed in parts per billion (ppm).
\2\ Source: 2000 FSIS Red Book.

    This fact is supported by two results of FSIS'' drug residue 
testing in prior years. In these prior years, 2000-2002, as is the case 
each year, FSIS only tests for residues of certain animal drugs based 
on risk analysis and past experiences. In the years 2000-2001, FSIS 
conducted residue testing for only two of the seven drugs, 
melengesterol acetate and carbadox, for which FSIS is implementing a 
modified testing approach. In 2002, FSIS only tested for melengesterol 
acetate. All of FSIS' test results (29) for this drug in 2002 indicated 
that there were no violative residue levels for the drug. In the 
previous two years (2000 and 2001), only 19 of 925 tests for 
melengestrol acetate resulted in a finding of violative drug residues. 
During that same time period, 2000-2001, FSIS also conducted tests for 
carbadox. Only one of the 322 carbadox tests conducted resulted in a 
finding of a violative drug residue. Thus, between 2000 and 2002, only 
20 of the 1,276 tests conducted for drug residues resulted in a finding 
of violative animal drug residues. Therefore, only 2 percent of the 
meat carcasses prepared at establishments during the years 2000 through 
2002 would have been condemned under FSIS'' modified procedures, as a 
result of a finding of a violative level of animal drug residue. 
Therefore, FSIS believes no significant economic impact upon small 
entities or any other entities can be expected to be generated by the 
issuance of this notice.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to better ensure 
that the public, and in particular minorities, women, and persons with 
disabilities, are aware of this notice, FSIS will announce it on-line 
through the FSIS Web page located at http://www.fsis.usda.gov.
    The Regulations.gov Web site is the central online rulemaking 
portal of the United States government. It is being offered as a public 
service to increase participation in the Federal government's 
regulatory activities. FSIS participates in Regulations.gov and will 
accept comments on documents published on the site. The site allows 
visitors to search by keyword or Department or Agency for rulemakings 
that allow for public comment. Each entry provides a quick link to a 
comment form so that visitors can type in their comments and submit 
them to FSIS. The Web site is located at http://www.regulations.gov.
    FSIS also will make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, recalls, and other types of 
information that could affect or would be of interest to our 
constituents and stakeholders. The update is communicated via Listserv, 
a free e-mail subscription service consisting of industry, trade, and 
farm groups, consumer interest groups, allied health professionals, 
scientific professionals, and other individuals who have requested to 
be included. The update also is available on the FSIS web page. Through 
Listserv and the web page, FSIS is able to provide information to a 
much broader, more diverse audience.
    For more information contact the Congressional and Public Affairs 
Office, at (202) 720-9113. To be added to the free e-mail subscription 
service (Listserv) go to the ``Constituent Update'' page on the FSIS 
Web site at http://www.fsis.usda.gov/oa/update/update.htm. Click on the 
``Subscribe to the Constituent Update Listserv'' link, then fill out 
and submit the form.

    Done at Washington, on May 3, 2004.
Barbara Masters,
Acting Administrator.
[FR Doc. 04-10443 Filed 5-6-04; 8:45 am]
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