[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Notices]
[Pages 32235-32237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12666]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2012-0041]
Availability of Compliance Guide for Residue Prevention and
Response to Comments
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice of availability.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
the availability of the final revision of the compliance guide for the
prevention of violative residues in livestock slaughter establishments.
In addition, this notice summarizes and responds to comments received
on the guide and residue testing issues that FSIS raised previously in
the Federal Register.
ADDRESSES: A downloadable version of the revised compliance guide is
available to view and print at http://www.fsis.usda.gov/PDF/Residue_Prevention_Comp_Guide.pdf. No hard copies of the compliance guide
have been published.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant
Administrator, Office of Policy and Program Development, at Telephone:
(202) 205-0495, or by Fax: (202) 720-2025.
SUPPLEMENTARY INFORMATION:
I. Background
On April 25, 2012, FSIS announced the availability of a compliance
guide for residue prevention (77 FR 24671) and requested comment on the
guide. FSIS explained that the 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 violative residues. Similarly, the guidance recommends
that establishments notify producers in writing if their animals are
found to have residues that are detectable but that do not exceed the
tolerance or action levels established by the Food and Drug
Administration (FDA) and the Environmental Protection Agency.
FSIS also explained that the compliance guide discusses the
Agency's Residue Repeat Violator List. In addition, FSIS explained
recent changes to the list, including that the list now includes only
producers who have provided more than one animal with a violative
residue during the past 12 months, and asked for comment on recent
revisions to the list.
FSIS also announced that it 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. Finally, FSIS also
announced it intended to increase testing for residues in animals from
producers who are under an injunction obtained by the FDA because of
drug use practices that have led to residue violations.
In response to the comments it received, FSIS has updated the
guidance document by substituting ``residue free'' and ``drug free''
with the phrase ``free from violative residues.'' In addition, FSIS has
included a discussion of means of livestock identification other than
those discussed in the initial guidance that should be considered by
livestock slaughter establishments when back tags are lost or prove
ineffective in maintaining the identity of the animals.
The guide includes recommendations rather than regulatory
requirements. FSIS encourages livestock slaughter establishments to
follow this final guide.
As for increased testing of animals from producers under an
injunction obtained by FDA, FSIS and FDA continue to discuss how this
testing can best be done. FSIS did not receive any comments on this
issue. FSIS advises
[[Page 32236]]
that it does intend to implement this increased testing.
FSIS also did not receive any comments on recent increases in
testing of carcasses for residues.
II. Comments and Responses
FSIS received a total of 12 comment letters in response to the
April 2012 notice from professional veterinary associations, national
trade organizations, private citizens, and an animal welfare advocacy
organization. Following is a summary of the comments and FSIS's
responses.
Comment: Several comments stated that only a small percentage of
livestock receiving a back tag at the livestock market or sale barn
actually retain those tags all the way to slaughter. One comment
estimated that 80 percent of back tags placed on swine fall off before
the animals are presented for slaughter. Several comments conjectured
that if processors refuse to purchase animals without identification as
recommended by FSIS, owners of animals that unwittingly lose their back
tags while in transit or holding pens will be denied market access. As
an alternative to back tags, two comments requested that FSIS mandate
the use of permanent ear identification tags in swine.
Response: FSIS acknowledges that incidental loss of back tags does
occur while livestock are in transport and holding areas. However, FSIS
believes, in some cases, back tags prove to be an acceptable form of
identification. If back tags do not work in certain situations, FSIS
recommends that establishments use other means of identification, like
producer ear tags, feedlot identification tags, tattoos, and calf-hood
tags (``bangs''). FSIS has modified the guide to address animal
identification options for establishments to consider when incidental
loss of back tags occurs.
FSIS has limited authority to mandate the use of specific
identification devices, permanent or otherwise, on livestock presented
for slaughter. Therefore, FSIS does not intend to propose changes to
its regulations to require specific identification devices at this
time.
Comment: Several comments opposed FSIS's recommendation that
slaughter establishments notify animal producers if their animals are
found to have non-violative levels of a drug residue because the
information will likely confuse producers.
Response: On November 28, 2000, FSIS informed establishments that
if their HACCP plans included residue controls that incorporate the
best available preventive practices for slaughter establishments, if
they implement those controls effectively, and if they supply FSIS with
information about violators, then the Agency will not treat violative
residue findings by the establishment that are followed by appropriate
corrective actions as noncompliance (65 FR 70809). The Federal Register
notice went on to recommend that slaughter establishments notify animal
producers in writing of both violative and non-violative residue
findings as one of several ``best preventive practices.'' As reaffirmed
in the compliance guide, FSIS believes that such an approach will
result in a decrease in violative residue findings because evidence of
non-violative residues is an indication of lack of care in drug use by
that producer.
Comment: Several comments requested that FSIS resume publishing the
Residue Violator List in addition to the revised Residue Repeat
Violator List. According to the comments, information contained within
the discontinued Residue Violator List was used by certain trade
organizations to target outreach on residue avoidance to reduce the
probability that a repeat violation would occur.
Response: In 2011, to avoid confusion, FSIS stopped publishing the
monthly Residue Violator (Alert) List that included the names of any
producer, including first-time offenders, with a residue violation in
the previous 12 months. FSIS replaced that list with the Residue Repeat
Violator List. Published weekly, the Residue Repeat Violator List
identifies producers who repeatedly (i.e., on more than one occasion)
within a 12-month period have sold animals for slaughter whose
carcasses were found by FSIS to contain a violative level of a chemical
residue.
FSIS recognizes that posting the name of a livestock producer to a
publicly-available list of residue violators may potentially result in
significant economic harm to that producer. Moreover, the incentive of
removal of the producer's name from the Residue Repeat Violator List,
which motivates repeat violators to improve their operations to prevent
violative residues, will be weakened if producers with only one
violation are listed on the Web site. Finally, FSIS notes that many
first-time residue violators do not go on to become repeat violators
within the designated 12-month period. Therefore, FSIS does not intend
to resume publishing names of producers with a single violation within
a 12-month period.
Comment: Because producers or suppliers can sell livestock to
multiple Federal establishments, one comment suggested that FSIS
consolidate residue test results from the supplier or producer and set
an acceptance level of non-violative samples that would trigger removal
of a producer from the Residue Repeat Violator List rather than use a
hard 12-month timeframe.
Response: FSIS would need to evaluate existing data to set a level
of acceptable non-violative residue sample results that would trigger
removal of a producer from the Residue Repeat Violator List. Given the
time and resources that it would take to perform this evaluation, FSIS
finds that the passage of time without a violation remains the
appropriate criterion for removal from the list and is not making any
changes to the Residue Repeat Violator list at this time.
Comment: Two comments requested that FSIS amend the compliance
guide by substituting ``residue-free'' and ``drug residue free'' with
the phrase ``free from violative residues''.
Response: FSIS agrees with the suggested changes and has modified
the compliance guide accordingly.
Comment: Two comments expressed various concerns about drug
residues in horses destined to be slaughtered for human consumption.
Response: In January 2010, the USDA Office of Inspector General
determined in its review of the FSIS National Residue Program for
Cattle that cull dairy cows and bob veal account for 90 percent of the
residues found in animals presented for slaughter. Therefore, the guide
focuses primarily on establishments that slaughter these livestock.
However, this guide will be useful to any establishments that slaughter
horses under Federal inspection in the future. By following the
recommendations in the guidance, horse slaughter establishments would
employ practices that help them avoid receiving horses with residues.
USDA Nondiscrimination Statement
The U.S. Department of Agriculture (USDA) prohibits discrimination
in all its programs and activities on the basis of race, color,
national origin, gender, religion, age, disability, political beliefs,
sexual orientation, and marital or family status. (Not all prohibited
bases apply to all programs.)
Persons with disabilities who require alternative means for
communication of program information (Braille, large print, audiotape,
etc.) should contact USDA's Target Center at 202-720-2600 (voice and
TTY). To file a written complaint of discrimination, write USDA, Office
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and
[[Page 32237]]
TTY). USDA is an equal opportunity provider and employer.
Additional Public Notification
FSIS will announce this notice online through the FSIS Web page
located at http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/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. 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://www.fsis.usda.gov/News_&_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: May 20, 2013.
Alfred V. Almanza,
Administrator.
[FR Doc. 2013-12666 Filed 5-28-13; 8:45 am]
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