[Federal Register: January 6, 2003 (Volume 68, Number 3)]
[Notices]               
[Page 540-542]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ja03-40]                         


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DEPARTMENT OF AGRICULTURE


Food Safety and Inspection Service


[Docket No. 02-014N]


 
Residue Testing Procedures; 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 issuing this 
notice to address comments that it received on its August 6, 2001 
Federal Register notice, ``Residue Testing Procedures.'' That notice 
announced that FSIS was changing the action that it would take when 
livestock or poultry that are presented for slaughter come from 
producers and others who have previously marketed such animals that 
contain violative levels of chemical residues. FSIS will now post on 
its website, the names and addresses of the sellers of livestock and 
poultry who the Food and Drug Administration (FDA) has determined are 
responsible for the repeated sale of livestock or poultry that contain 
violative levels of chemical residues. FSIS instituted this action 
partly in response to a petition submitted by a number of trade 
associations. The repeat violators alert list (RVAL) may be found at http://www.fsis.usda.gov/.


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


SUPPLEMENTARY INFORMATION:


Background


    FSIS conducts both ante-mortem and post-mortem inspection of all 
livestock and poultry presented for slaughter at each official 
establishment. As part of ante-mortem inspection, FSIS personnel 
inspect animals to determine whether they exhibit behaviors or 
conditions that are indicative of illegal chemical use. If such 
behaviors or symptoms are exhibited the animals are tagged ``U.S. 
Suspect'' and are further examined at post-mortem inspection.
    During post-mortem inspection, FSIS veterinarians examine carcasses 
and their organs to determine whether the animals they came from had 
pathological diseases or other conditions that could have warranted the 
use of drugs or other chemicals and whether there are any indications 
of illegal chemical use. In addition, FSIS conducts laboratory analysis 
of sample organ tissues that have been taken from carcasses that have 
pathologies or other conditions indicative of chemical use to determine 
whether they contain violative chemical residues.
    On August 6, 2001, FSIS issued a Federal Register notice entitled, 
``Residue Testing Procedures'' (66 FR 40965). The notice announced 
that, in cooperation with FDA, FSIS would make publicly available a 
list of repeat chemical residue violators by posting the list on the 
FSIS Homepage {http://www.fsis.usda.gov/}. The Agency stated that the 
list would contain the names and addresses of the sellers of livestock 
and poultry that FDA had investigated and determined to be responsible 
for more than one 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 that the violation is confirmed by FDA. For any 
subsequent violation, the time period would be extended for a year from 
the date that the violation is confirmed by FDA.
    This new procedure replaces FSIS' previous policy of testing 
livestock and poultry carcasses derived from animals marketed by 
producers or sellers who were previously the source of an animal with a 
violative chemical residue at an official establishment (i.e., FSIS 
``5/15'' policy).
    FSIS received several comments about the policy change that it made 
effective on September 5, 2001. FSIS has carefully considered the 
comments and is now responding to them.
    One commenter asked FSIS to evaluate the role that livestock 
markets play in the marketing chain and to provide the necessary 
resources to ensure that only the actual violator is identified.
    FSIS will work closely with the Food and Drug Administration, 
Center for Veterinary Medicine, to identify the source of an animal 
that contains a violative chemical residue. If testing shows that a 
carcass contains a violative chemical residue, the Slaughter Operations 
Staff at FSIS' Technical Service Center (TSC) will open a case file and 
attempt to determine the source of the livestock or poultry. The source 
is the farmer, hauler, or auction market that sold the animal for 
slaughter.
    The TSC staff will try to obtain from the official establishment 
the name of the seller (e.g., farmer, hauler, producer or auction 
house) of the livestock or poultry. If the source of the animal is 
identified, FSIS will send an ``FSIS Violation Notification Letter'' to 
the identified entity. The letter will provide the results of the 
residue tests taken.
    Additionally, pursuant to an October 1984, Memorandum of 
Understanding, FSIS will transmit to FDA information about the 
violative chemical residue found, including the name of the official 
establishment where the livestock or poultry was presented for 
slaughter. Transmission to FDA is through the Residue Violation 
Information System (RVIS).
    FDA uses the information that it receives from RVIS to conduct an 
investigation to confirm a violation and to determine whether the 
source of the violative livestock or poultry is a repeat


[[Page 541]]


violator. A repeat violator is an individual or firm who repeatedly 
(i.e., on more than one occasion) within a 12-month period sells an 
animal for slaughter whose carcass is found to contain a violative 
level of a drug, pesticide, or other chemical residue.
    One commenter requested that FSIS work closely with the U.S. Animal 
Health Association to develop a quality assurance and food safety 
certification program that could be used by federal and state agencies 
to assist producers in developing certification and compliance 
procedures. The commenter also requested that FSIS develop and 
implement a national animal identification program to facilitate rapid 
traceback for animal disease and food safety issues.
    FSIS believes that quality assurance programs can have significant 
value. Thus, through its Animal and Egg Production Food Safety Staff, 
it encourages States and private groups like the U.S. Animal Health and 
Education Association to develop them. Moreover, packers may want to 
require that their suppliers provide food safety certifications to 
ensure that the packers do not receive animals with violative residues.
    FSIS, in February 2002, issued a notice, FSIS Notice 5-02, to its 
field personnel that emphasized the importance of animal identification 
and current regulatory requirements (9 CFR 310.2) on this subject. 
Section 310.2 requires that establishments handle severed parts of a 
carcass that are to be used in the preparation of meat food products in 
a manner that identifies them with the rest of the carcass and as being 
derived from the particular animal involved until the post mortem 
examination of the carcass and its parts have been completed. Thus, 
establishments are required to remove and present to FSIS program 
personnel, ear tags, backtags, implants, and other identifying devices 
in a manner that will provide a ready means of identifying a specific 
carcass until post-mortem examination has been completed, or to have 
alternative measures in place that accomplish the required 
identification. Additionally, 9 CFR 310.2(b)(5)(i) and (ii) require 
inspection program personnel to collect all IDs associated with animals 
to obtain the traceback information necessary for the proper 
disposition of an animal or carcass.
    Two commenters asked whether FSIS has conducted studies that 
correlate target tissue collection with the actual source of the sample 
or correct carcass identification.
    FSIS is not aware of any problems with its collection practices for 
target tissue samples and carcass identification. Thus, it has not 
conducted a study of the type described in the comment.
    Some commenters asked whether FSIS would issue instructions or 
conduct training for all inspectors. They suggested that the 
instructions or training address such issues as standardized sample 
collection procedures for both monitoring and enforcement residue 
testing, and a standardized protocol for what tissue samples should be 
collected from each carcass to be tested.
    FSIS conducts training for its personnel. The training for sample 
collection and sample identification that FSIS personnel receive is 
sufficient and provides the proper collection and sample identification 
methodologies. FSIS' Center for Learning conducts training for FSIS 
personnel that are responsible for sample collection, particularly on 
aseptic techniques and tissue collection for chemical residue testing. 
The TSC has provided hands-on, in-plant correlation training sessions 
with FSIS personnel that are responsible for sample collection and 
identification. Additionally, a computer-based training program is 
available to assist the in-plant inspection team on sample collection 
procedures.
    Several commenters raised questions concerning the FSIS Web site 
presentation of the list of repeat violators, the residue violators 
alert list (RVAL). Questions included who has the responsibility for 
updating the list on the Web site, and how frequently FSIS will update 
it. Commenters also asked when the 12-month identification period on 
the RVAL begins if a seller is found to be a repeat violator.
    The 12-month listing period on the RVAL will begin once a second 
violation has been confirmed by FDA. FDA, or a state government acting 
under FDA's authority, will conduct an on-site investigation. If FDA 
finds that a seller is responsible for a second violative sample, it 
will notify FSIS. The TSC will then notify the FSIS Webmaster to post 
the name and address of the repeat violator on the FSIS Web site. The 
Web site will be updated as violations are confirmed, and the names of 
the violators will be deleted once the 12-month period has passed. For 
subsequent violations, the time period will be extended by a year from 
the time the additional violation is confirmed by FDA.
    One commenter asked whether there was an appeal process available 
to a producer who is assigned the responsibility of a violation.
    An appeal can be made to FSIS and, if necessary, FSIS will consult 
with FDA about the appeal.
    Two commenters asked what type of economic impact there would be on 
the average pork producer and on current marketing practices from the 
posting of repeat violators on the FSIS Web site.
    FSIS cannot anticipate what precise economic impact might be for 
pork producers. FSIS anticipates, however, that the impact will be 
minimal because, historically, FSIS has found few chemical residue 
violations in pork products. Also, if drugs are used properly and the 
proper withdrawal time is followed, there will be no residue violation.
    One commenter suggested that FSIS change the number of violations 
to five instead of two. The commenter argued that a repeat violation by 
a livestock market is not the same as a repeat violation by a single, 
individual producer.
    FSIS believes that when there is a second chemical residue 
violation, regardless of who is responsible for it, there is just cause 
to make information about the violation available to help better ensure 
that meat and poultry products distributed in commerce are not 
adulterated with violative chemical residues.


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 on the Internet at http://www.fsis.usda.gov.
 The update is used to provide information regarding 
FSIS policies, procedures, regulations, Federal Register notices, 
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, farm groups, and 
consumer interest groups, allied health professionals, scientific 
professionals, and other individuals that have requested to be included 
on the list. Through these various channels, FSIS is able to provide 
information to a much broader, more diverse audience.


[[Page 542]]


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: December 30, 2002.
Garry L. McKee,
Administrator.
[FR Doc. 03-212 Filed 1-3-03; 8:45 am]