[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Notices]
[Pages 24671-24673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-9797]
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DEPARTMENT OF AGRICULTURE
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.
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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
methods:
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-
[[Page 24672]]
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].
SUPPLEMENTARY INFORMATION:
Background
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_
Index/index.asp.
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://
[[Page 24673]]
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,
Administrator.
[FR Doc. 2012-9797 Filed 4-19-12; 4:15 pm]
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