```

[Federal Register Volume 78, Number 88 (Tuesday, May 7, 2013)]
[Rules and Regulations]
[Pages 26486-26489]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10825]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \1\ To view the proposed rule and the comments we received, go 
to http://www.regulations.gov/#!docketDetail;D=APHIS-2007-0039.
---------------------------------------------------------------------------

    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]
BILLING CODE 3410-34-P
```