[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Pages 32235-32237]
From the Federal Register Online via the Government Printing Office
[FR Doc No: 2013-12666]



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.


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.

Administrator, Office of Policy and Program Development, at Telephone: 
(202) 205-0495, or by Fax: (202) 720-2025.


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 
    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 
    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 
    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,
[FR Doc. 2013-12666 Filed 5-28-13; 8:45 am]