[Federal Register Volume 78, Number 88 (Tuesday, May 7, 2013)]
[Rules and Regulations]
[Pages 26486-26489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10825]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 71
[Docket No. APHIS-2007-0039]
RIN 0579-AC61
Recordkeeping for Approved Livestock Facilities and Slaughtering
and Rendering Establishments
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the regulations regarding the interstate
movement of livestock to require approved livestock facilities and
listed slaughtering and rendering establishments to maintain certain
records for 5 years. Currently, approved livestock facilities are
required to retain certain records for 2 years, and there are no record
retention provisions that apply to listed slaughtering and rendering
establishments. Requiring the retention of certain records for 5 years
will allow us to trace the prior movements of diseased livestock
further into the past than is currently possible, thus providing the
opportunity to locate potentially infected or exposed livestock that
might otherwise remain unidentified. We are also requiring the
operators of slaughtering and rendering establishments to sign listing
agreements to document their agreement to comply with the requirements
of the regulations for listed slaughtering and rendering
establishments. Such agreements are currently required for approved
livestock facilities, but not for slaughtering and rendering
facilities. This change will eliminate that inconsistency.
[[Page 26487]]
DATES: Effective Date: June 6, 2013.
FOR FURTHER INFORMATION CONTACT: Dr. Debra C. Cox, Senior Staff
Veterinarian, National Surveillance Unit, Centers for Epidemiology and
Animal Health, VS, APHIS, 4700 River Road Unit 200, Riverdale, MD
20737; 301-851-3504.
SUPPLEMENTARY INFORMATION:
Background
The regulations in subchapter C of chapter I, title 9, of the Code
of Federal Regulations contain provisions designed to prevent the
dissemination of livestock or poultry diseases in the United States and
to facilitate the control and eradication of such diseases. The
regulations in 9 CFR part 71 (referred to below as the regulations)
include general prohibitions on the interstate movement of animals that
could spread livestock or poultry diseases.
The regulations in Sec. 71.20 contain provisions under which
livestock facilities may acquire and retain status as an approved
facility. To obtain approval, facilities must enter into an agreement
with the Animal and Plant Health Inspection Service (APHIS) in which
they agree to follow certain procedures when handling livestock
entering the facility. Part of this agreement states that documents
such as weight tickets, sales slips, and records of origin,
identification, and destination that relate to livestock that are in,
or that have been in, the facility shall be maintained by the facility
for a period of 2 years. Such records would be critical in the event
that APHIS or State animal health officials needed to conduct a disease
traceback investigation.
On July 7, 2008, we published in the Federal Register a proposed
rule \1\ (73 FR 38343-38346, Docket No. APHIS-2007-0039) to amend the
regulations to require approved livestock facilities and listed
slaughtering and rendering establishments to maintain certain records
for 5 years. We also proposed to require the operators of slaughtering
and rendering establishments to sign listing agreements to document
their agreement to comply with the requirements of the regulations for
listed slaughtering and rendering establishments.
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\1\ To view the proposed rule and the comments we received, go
to http://www.regulations.gov/#!docketDetail;D=APHIS-2007-0039.
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We solicited comments for 60 days ending September 5, 2008. We
received four comments by that date. They were from two private
citizens (one of whom submitted two comments) and a rendering industry
association. Two of the commenters expressed concerns about farm animal
welfare and general dissatisfaction with the United States Department
of Agriculture, but did not address the specific provisions of the
proposed rule. The third commenter raised a number of specific concerns
regarding the proposed rule. They are discussed below.
The commenter stated that we were incorrect to say that there are
no recordkeeping requirements for rendering establishments, noting that
the Food and Drug Administration (FDA) requires rendering
establishments to keep records. The commenter questioned why rendering
establishments should be subject to more stringent recordkeeping
requirements by APHIS than by FDA and stated that the agencies should
better coordinate their recordkeeping requirements.
The commenter is correct that the FDA has recordkeeping
requirements in 21 CFR part 589 that apply to rendering establishments;
however, those regulations require records to be kept for 1 year only.
In our proposed rule, we noted that there are currently no APHIS
requirements for recordkeeping by rendering establishments. APHIS
attempts to coordinate its recordkeeping requirements with other
agencies whenever possible, and we do not expect rendering
establishments to keep different categories of records from what they
already keep under FDA requirements. However, some animal diseases have
incubation periods of several years, and an animal disease
investigation may require tracing animals that were exposed to an
infected animal several years before the outbreak occurred. If exposed
animals have been slaughtered or died and been sent to a rendering
establishment, we need to be able to confirm that they reached these
terminal points. For this reason, we need the records to be kept for
longer than 1 year. We are making no changes to the final rule in
response to this comment.
The same commenter stated that, because of increased costs
associated with the 2008 FDA ruminant feed ban rule, there may be an
increased number of carcasses disposed of illegally. The commenter
asked why APHIS has not addressed the issue of carcass disposal.
In its final rule prohibiting the use of certain cattle origin
materials in the food or feed of all animals, published in the Federal
Register on April 25, 2008 (73 FR 22720-22758, Docket No. 2002N-0273),
FDA responded to comments that expressed the same concern regarding the
impact the FDA rule could have on the availability and cost of disposal
of cattle material prohibited in animal feed and dead stock cattle. In
its response, FDA acknowledged that carcass disposal problems exist in
certain States or regions and that developing and implementing adequate
solutions to these problems is challenging. On April 24, 2009, FDA
published a document confirming the effective date of the April 2008
final rule (74 FR 18626-18628, Docket No. FDA-2002-N-0031) and
announced that it would delay compliance with the provisions of the
April 2008 final rule until October 26, 2009, stating that a delay in
the compliance date would allow the significant number of stakeholders
affected by the April 2008 final rule more time to comply with the new
regulations or adjust to the loss of rendering service. In that notice,
FDA also acknowledged that it might be particularly challenging to
address such disposal problems by the compliance date. FDA issued a
revision of the Small Entities Compliance Guide for Renderers on May 6,
2009, and has stated its intent to engage in further outreach to the
rendering industry, pertinent State agencies, and others affected by
the rule. APHIS has been working and will continue to work with FDA to
address any animal disease issues associated with implementation of the
feed ban rule, and will revisit the issue of carcass disposal if
necessary. We are making no changes to the rule in response to this
comment.
The commenter stated that APHIS's animal disease traceability
program does not address animal identification beyond death unless the
animal is slaughtered in a federally inspected slaughter facility. The
commenter expressed concern that without stronger identification
requirements for animals and carcasses, additional recordkeeping
requirements for renderers will have no benefit for animal health.
The commenter is correct that APHIS' animal disease traceability
program focuses on the identification of live animals rather than of
carcasses. We did not propose to require renderers to keep traceability
information for carcasses they collect, or to establish new categories
of records, but only to keep the records they do have for a longer
period of time. We acknowledge that there may be an animal disease risk
from products produced by rendering an animal that has died of disease;
however, primary authority for regulating rendered products falls to
the Food Safety and Inspection Service and FDA. APHIS has worked and
will continue to work with these agencies to ensure that any animal
disease issues associated with these products are
[[Page 26488]]
addressed. We are making no changes in response to this comment,
however.
It is necessary for us to make a change in this rule so that its
provisions are consistent with those of our final rule on animal
disease traceability (see 78 FR 2040-2075, Docket No. APHIS-2009-0091).
Specifically, in that final rule we acknowledge, in responding to
comments, that the lifespans of poultry and swine are relatively short
compared with those of other species of livestock, and that records for
those animals do not, therefore, need to be kept as longs as records
for other animals. Hence, in that final rule, we provided for the
retention of records for poultry and swine to 2 years rather than 5. To
be consistent, this final rule keeps the recordkeeping period for
poultry and swine at 2 years. Records for cattle, bison, sheep, goats,
cervids, and equines will still be required to be kept for 5 years.
In addition, we are making a change to Sec. 71.20(a)(8) to add a
reference to 9 CFR part 86 to the list of regulations under which
livestock must be identified at the time of, or prior to, entry into a
livestock facility. This change should have been included in the animal
disease traceability final rule but was inadvertently omitted.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Executive Orders 12866 and 13563 and Regulatory Flexibility Act
This final rule has been determined to be not significant for the
purposes of Executive Order 12866 and, therefore, has not been reviewed
by the Office of Management and Budget.
We have prepared an economic analysis for this rule. The economic
analysis provides a cost-benefit analysis, as required by Executive
Orders 12866 and 13563, which direct agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, and equity). Executive Order 13563 emphasizes the importance
of quantifying both costs and benefits, of reducing costs, of
harmonizing rules, and of promoting flexibility. The economic analysis
also examines the potential economic effects of this rule on small
entities, as required by the Regulatory Flexibility Act. The economic
analysis is summarized below. Copies of the full analysis are available
on the Regulations.gov Web site (see footnote 1 in this document for a
link to Regulations.gov) or by contacting the person listed under FOR
FURTHER INFORMATION CONTACT.
This rule amends the regulations regarding the interstate movement
of livestock to require approved livestock facilities and listed
slaughtering and rendering establishments to maintain certain records
for 5 years. Currently, approved livestock facilities are required to
retain certain records for 2 years. No record retention provisions
currently apply to listed slaughtering and rendering establishments.
For some livestock diseases, the incubation period (the time from
when an animal becomes infected until the disease is evident) can last
for years before clinical or behavioral signs become apparent. A prime
example is bovine tuberculosis, a contagious disease of both animals
and humans caused by specific types of bacteria that are part of the
Mycobacterium group. The incubation period for bovine tuberculosis can
range from months to years. By requiring record retention for 5 years,
the rule will benefit APHIS and State animal health authorities, the
operators of livestock, slaughtering, and rendering facilities, and
livestock producers, generally, in the event that a traceback is
required to locate the source herd of an animal discovered to have a
disease such as bovine tuberculosis.
The rule is not expected to result in significant costs for the
affected entities. An analysis of similar recordkeeping costs expected
to be incurred in connection with a May 2012 Food Safety and Inspection
Service rulemaking (75 FR 14361-14368, Docket No. FSIS-2008-0025) found
the costs to be minimal. For approved livestock facilities that are
already required to retain records for 2 years, and rendering
facilities that are currently maintaining relevant records per FDA's
requirements, the costs will be smaller still.
The alternative to the rule would be to leave the regulations
unchanged. In doing so, possible reductions in losses associated with
animal diseases that have long incubation periods would not be
realized. The rule is preferred to the current regulations, given the
relatively minor recordkeeping costs that would be incurred to achieve
improved traceback capabilities.
The benefits of the rule will justify its costs. There were no
comments received on the economic analysis prepared for the proposed
rule, nor were other significant economic issues raised. While the
majority of approved livestock facilities, slaughtering establishments,
and rendering establishments are small entities, costs incurred because
of the rule are also expected to be small.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are in conflict with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Executive Order 13175
This rule has been reviewed in accordance with the requirements of
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments. The review reveals that this regulation will not have
substantial and direct effects on Tribal governments and will not have
significant Tribal implications.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this final rule, which were
filed under 0579-0342, have been submitted for approval to the Office
of Management and Budget (OMB). When OMB notifies us of its decision,
if approval is denied, we will publish a document in the Federal
Register providing notice of what action we plan to take.
E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the E-Government Act to promote the use of the Internet
and other information technologies, to provide increased opportunities
for citizen access to Government information and services, and for
other purposes. For information pertinent to E-Government Act
compliance related to this rule, please contact Mrs. Celeste
[[Page 26489]]
Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.
List of Subjects in 9 CFR Part 71
Animal diseases, Livestock, Poultry and poultry products,
Quarantine, Reporting and recordkeeping requirements, Transportation.
Accordingly, we are amending 9 CFR part 71 as follows:
PART 71--GENERAL PROVISIONS
0
1. The authority citation for part 71 continues to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
0
2. Section 71.20 is amended as follows:
0
a. By revising paragraph (a)(7) to read set forth below.
0
b. In paragraph (a)(8), by removing the words ``and 85'' and adding the
words ``85, and 86'' in their place.
0
c. In the OMB citation at the end of the section, by removing the words
``number 0579-0258'' and adding the words ``numbers 0579-0258 and 0579-
0342'' in their place.
Sec. 71.20 Approval of livestock facilities.
(a) * * *
(7) Documents such as weight tickets, sales slips, and records of
origin, identification, and destination that related to livestock that
are in, or that have been in, the facility shall be maintained by the
facility. For poultry and swine, such documents must be kept for at
least 2 years, and for cattle and bison, sheep and goats, cervids, and
equines, for at least 5 years. APHIS representatives and State
representatives shall be permitted to review and copy those documents
during normal business hours.
* * * * *
0
3. Section 71.21 is amended as follows:
0
a. By redesignating paragraphs (a)(l), (a)(2), and (a)(3) as paragraphs
(a)(2), (a)(3), and (a)(4), respectively, and by adding a new paragraph
(a)(l) to read as set forth below.
0
b. By adding a new paragraph (a)(5) to read as set forth below.
0
c. In the OMB citation at the end of the section, by removing the words
``number 0579-0212'' and adding the words ``numbers 0579-0212 and 0579-
0342'' in their place.
Sec. 71.21 Tissue and blood testing at slaughter.
(a) * * *
(1) The owner or operator of the establishment must agree, in
writing, to meet the requirements for a listed facility under this
section by signing a listing agreement.
* * * * *
(5) The management of the slaughtering or rendering establishment
agrees that weight tickets, sales slips, and records of origin,
identification, and destination that relate to livestock that are in,
or have been in, the establishment will be maintained by the
establishment. For poultry and swine, such documents must be kept for
at least 2 years, and for cattle and bison, sheep and goats, cervids,
and equines, for at least 5 years. APHIS, APHIS contractors, and State
animal health representatives will be permitted to review and copy or
scan these documents during normal business hours.
* * * * *
Done in Washington, DC, this 2nd day of May 2013.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-10825 Filed 5-6-13; 8:45 am]
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