[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Pages 24671-24673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-9797]



Food Safety and Inspection Service

[Docket No. FSIS-2011-0008]

Compliance Guide for Residue Prevention and Agency Testing Policy 
for Residues

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability and opportunity for comments.


SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of a compliance guide for the prevention of violative 
residues in livestock slaughter establishments. FSIS has posted this 
compliance guide on its Web page and it may be used immediately. FSIS 
also welcomes comments on this compliance guide, which will be revised 
as needed. This notice also discusses changes to the FSIS Residue 
Repeat Violator List and announces the Agency's intention to subject to 
increased testing animals from producers who are under an injunction 
obtained by the Food and Drug Administration because of drug use 
practices that have led to residue violations.

DATES: Submit written comments by June 25, 2012.

ADDRESSES: FSIS invites interested persons to submit comments on this 
notice and the compliance guide, which can be accessed at http://www.fsis.usda.gov/Regulations_&_Policies/Compliance_Guides_Index/index.asp. Comments may be submitted by either of the following 
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the online instructions at that site for 
submitting comments.
     Mail, including floppy disks or CD-ROMs, and hand- or 
courier-delivered items: Send to U.S. Department of Agriculture (USDA), 
FSIS, Docket Clerk, Patriots Plaza 3, 1400 Independence Avenue SW., 
Room 8-163A, Mailstop 3782, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-

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2011-0008. Comments received in response to this docket will be made 
available for public inspection and posted without change, including 
any personal information, to http://www.regulations.gov.
    Docket: For access to background documents or to comments received, 
go to the FSIS Docket Room at the address listed above between 8:30 
a.m. and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Ph.D., Assistant 
Administrator for Office of Policy and Program Development, FSIS, U.S. 
Department of Agriculture, Room 349-E, Jamie Whitten Building, 14th and 
Independence, SW., Washington DC 20250-3700; telephone (202) 205-0495, 
fax (202) 720-2025; [email protected].



    The U.S. National Residue Program (NRP) is administered by FSIS to 
collect data on chemical residues in domestic and imported meat, 
poultry, and egg products and to keep products that are adulterated 
because of illegal residues out of commerce. FSIS collects samples of 
meat, poultry, and egg products at federally inspected establishments 
and analyzes the samples at FSIS laboratories for chemical residues of 
veterinary drugs, pesticides, and environmental contaminants. With the 
implementation of the Hazard Analysis and Critical Control Points 
(HACCP) inspection system, another important component of the NRP is to 
provide verification of residue control in HACCP systems. As part of 
the HACCP regulation under 9 CFR part 417, establishments are required 
to conduct a hazard analysis and to consider the food safety hazards 
that can be expected to arise from drug and other chemical residues.
    The USDA Office of Inspector General (OIG) report of January 29, 
2010, reflecting its review of the NRP with regard to cattle, 
identified as a contributing factor to violative residue problems the 
practice of slaughter establishments continuing to purchase livestock 
from repeat residue violators. OIG also noted that there is often 
insufficient information at slaughter establishments to identify the 
producers responsible for the violative residues. The OIG review also 
underscored the fact that there are two slaughter classes of livestock, 
dairy cows and bob veal, that account for 90 percent of the residues 
found in animals presented for slaughter, pointing to the need for the 
Agency to continue to focus compliance efforts on cull dairy cows and 
bob veal.
    This Compliance Guide emphasizes that establishments, especially 
those that slaughter dairy cows and bob veal calves, should apply five 
basic measures to reduce or prevent the occurrence of violative 
residues. The guide recommends that establishments should: (1) Confirm 
producer history; (2) buy animals from producers who have a history of 
providing residue-free animals and have effective residue prevention 
programs; (3) ensure that animals are adequately identified to enable 
traceback; (4) supply information to FSIS at ante-mortem inspection 
showing that animals in the lot did not come from repeat violators; and 
(5) notify producers in writing if their animals are found to have 
either violative residues or detectable levels that do not exceed the 
tolerance levels established by FDA and FSIS. Persistent non-violative 
levels residues may indicate a pattern of usage that could result in a 
violation at some point.
    The Compliance Guide discusses the Agency's revised Residue Repeat 
Violator List, which has been streamlined for greater ease of use. The 
List now includes only producers who have provided more than one animal 
with a violative residue during the past 12 months. The List is also 
now presented in two differing forms. ``Part I'' is intended for use by 
Agency inspection personnel and contains comprehensive information on 
the individual residue findings (e.g., tissue identified with the 
violation, chemical compound identified, concentration), organized 
alphabetically by state and firm name. ``Part II'' is intended for use 
by industry and lists producers that have been the source of multiple 
animals with residue violations and does not provide the technical 
information contained in Part I. The Agency invites comments on these 
recent revisions to the List, especially comments related to the List's 
utility and ease of use. Should the Agency be providing additional 
information on producers who supply animals with violative residues?
    The Compliance Guide explains that establishments that do not use 
the information in the Residue Repeat Violator List, either directly or 
through a letter or certification, would not be taking advantage of a 
tool to identify livestock from known repeat violators. If an 
establishment does not follow this guide, and FSIS finds violative 
residues, the establishment's HACCP system may be inadequate under 9 
CFR 417.6.
    FSIS has also been asked recently whether producers could be 
removed from the Residue Repeat Violator List in less than 12 months in 
certain circumstances, e.g., if a producer goes three consecutive 
months without any new violations. The Agency is evaluating this issue 
and invites comments on it.
    FSIS recently increased testing for residues of carcasses in 
establishments with violations associated with the same producer or at 
establishments that fail to apply the residue control measures 
described in the Compliance Guide. The notices with instructions to 
FSIS personnel concerning increased testing for residues are available 
at http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/21-11.pdf andhttp://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/12-11.pdf.
    In addition, FSIS intends to increase its testing for residues in 
animals from producers who are under an injunction obtained by the Food 
and Drug Administration because of drug use practices that have led to 
residue violations. This action is consistent with FSIS's policy of 
increasing testing of carcasses at slaughter establishments that are 
attributable to producers with multiple residue violations.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that 
minorities, women, and persons with disabilities are aware of this 
notice, FSIS will announce it online through the FSIS Web page located 
at http://www.fsis.usda.gov/regulations_&_policies/2010_Notices_
    FSIS will also 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, and other types of information 
that could affect or would be of interest to constituents and 
stakeholders. The Update is communicated via Listserv, a free 
electronic mail subscription service for industry, trade groups, 
consumer interest groups, health professionals, and other individuals 
who have asked to be included. The Update is also available on the FSIS 
Web page. Through the Listserv and Web page, FSIS is able to provide 
information to a much broader and more diverse audience. In addition, 
FSIS offers an electronic mail subscription service which provides 
automatic and customized access to selected food safety news and 
information. This service is available at http://

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www.fsis.usda.gov/news--and--events/email--subscription/. Options range 
from recalls to export information to regulations, directives and 
notices. Customers can add or delete subscriptions themselves, and have 
the option to password protect their accounts.

    Done at Washington, DC, on April 18, 2012.
Alfred V. Almanza,
[FR Doc. 2012-9797 Filed 4-19-12; 4:15 pm]