```

[Federal Register Volume 77, Number 145 (Friday, July 27, 2012)]
[Rules and Regulations]
[Pages 44107-44110]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18324]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
week.

========================================================================


Federal Register / Vol. 77, No. 145 / Friday, July 27, 2012 / Rules 
and Regulations

[[Page 44107]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 92

[Docket No. APHIS-2007-0158]
RIN 0579-AD30

Information From Foreign Regions Applying for Recognition of 
Animal Health Status

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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

SUMMARY: We are amending the regulations that govern the importation of 
animals and animal products by consolidating the list of factors APHIS 
considers when evaluating the animal health status of a foreign region 
and by setting out new factors APHIS will consider when evaluating a 
region as historically free of a specific disease. These changes will 
make clearer the types of information APHIS needs from a requesting 
region in order to conduct an evaluation.

DATES: Effective Date: August 27, 2012.

FOR FURTHER INFORMATION CONTACT: Dr. Kelly Rhodes, Regionalization 
Evaluation Services, Sanitary Trade Issues Team, National Center for 
Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 
20737-1231; (301) 851-3300.

SUPPLEMENTARY INFORMATION: 

Background

    The regulations in 9 CFR part 92, ``Importation of Animals and 
Animal Products; Procedures for Requesting Recognition of Regions'' 
(referred to below as the regulations), set forth the process by which 
a foreign government may request recognition of the animal health 
status of a region.
    Section 92.2 of the regulations requires that such requests be 
accompanied by information regarding the region that will enable the 
Animal and Plant Health Inspection Service (APHIS) of the U.S. 
Department of Agriculture to evaluate the request.
    On December 28, 2011, we published in the Federal Register (76 FR 
81404-81408, Docket No. APHIS-2007-0158) a proposal \1\ to amend the 
regulations by consolidating the 11 factors listed in Sec.  92.2(b) 
that APHIS considers when evaluating the animal health status of a 
foreign region into 8 factors. We also proposed to establish criteria 
for recognizing a region as historically free of a specific disease. 
Our intent was to make clearer the types of information APHIS needs 
from a requesting region to conduct an evaluation. Additionally, 
although our regulations focus on requests from foreign regions, we 
noted that APHIS could initiate an evaluation of the disease status of 
a foreign region and, if we did, would conduct the evaluation using 
these same factors. We also proposed to remove a statement in Sec.  
92.2(d) that supporting information submitted with country requests 
will be made available to the public prior to initiation of rulemaking. 
We proposed to replace it with a statement that a list of regions that 
have requested recognition of their animal health status will be 
available to the public, and to leave in place a statement in Sec.  
92.2(f) that when APHIS makes its evaluation available for public 
comment, the public will have access to the information upon which 
APHIS based its evaluation, as well as the evaluation itself.
---------------------------------------------------------------------------

    \1\ To view the proposed rule and the comments we received, go 
to http://www.regulations.gov/#!docketDetail;D=APHIS-2007-0158.
---------------------------------------------------------------------------

    We solicited comments concerning our proposal for 60 days ending 
February 27, 2012. We received 12 comments (including two from the same 
person) by that date. They were from an organization representing pork 
producers, an organization representing cattle farmers and ranchers, an 
organization representing U.S. consumers, a wildlife conservation 
society, a State board of animal health, foreign governments, and 
individuals.
    Six commenters supported the proposed changes.
    Three commenters objected to the proposed rule. Two of the three 
said that they oppose the concept of regionalization for animal health 
status. Two also said they were concerned about APHIS' ability to 
predict outbreaks or detect disease threats under the current 11 
factors and oppose finalizing a rule predicated on those factors. They 
cited several instances where regions APHIS had recognized as free of a 
disease had subsequently experienced an outbreak of that disease. One 
commenter also said that APHIS should not adopt international criteria 
for evaluating a region as historically free of a disease until we have 
conducted a scientific study to determine whether such recommendations 
are, in fact, capable of adequately assessing whether a country is 
historically free of a disease.
    We are making no changes to the proposed rule in response to these 
comments. Regionalization is an important principle of the World Trade 
Organization Agreement on the Application of Sanitary and Phytosanitary 
Measures (WTO-SPS Agreement). Regionalization is based on recognition 
that pest and disease conditions may vary across a country as a result 
of ecological, environmental, and epidemiological factors, and on the 
premise that these differences should be taken into account in 
developing science-based regulatory measures. The United States has 
successfully applied the concept for decades in domestic disease 
control and eradication programs, and regionalization of the United 
States for bluetongue and other diseases has facilitated exports.
    Our evaluations of regions for animal health closely consider a 
broad range of factors widely accepted by the international community 
for assessing the disease risks associated with a region. As discussed 
above, we provide an opportunity for the public to view and comment on 
our evaluations and the information upon which they are based prior to 
making a final determination. Finding that a region is free of a 
disease based on such an evaluation does not guarantee, however, that 
the region will always remain free of that disease. Our evaluations 
enable us to determine whether a disease is present in a region at a 
given time, ensure that the region has safeguards in place to protect 
against introduction of the disease, and ensure that the region is 
capable of detecting and containing

[[Page 44108]]

the disease should it be introduced despite these measures.
    Two commenters did not speak for or against the specific changes, 
but raised other issues, as follows.
    One expressed concern that the reason for the changes was to 
expedite the evaluations for animal health status. The commenter stated 
that this should not be done at the expense of preventing foreign 
animal disease introductions into the United States.
    We agree and point out that we are not changing the way we conduct 
evaluations. Our goal is to expedite the process of a region supplying 
us with the necessary information to conduct an evaluation.
    One commenter expressed concern that APHIS emphasizes geographic, 
or zonal, freedom from disease over other approaches to trade in animal 
products that effectively mitigate disease risks. He mentioned 
compartmentalization and commodity-based trade as two alternatives. As 
examples of the latter, he cited the international standards for trade 
in fresh beef from regions that vaccinate for foot-and-mouth disease 
and the international standards for trade in milk and deboned beef from 
regions where the risk of bovine spongiform encephalopathy is neither 
negligible nor controlled. He stated that eradication of livestock 
diseases may not always be realistic or feasible, especially in places 
like Africa, where the means for achieving zone freedom (fences, for 
example) can conflict with wildlife preservation efforts (e.g., 
ensuring wildlife have space and freedom to roam).
    We are making no changes to the proposed rule in response to this 
comment. While this rulemaking addresses factors we consider when 
assessing the disease status of a geographic area, APHIS' regulations 
also include commodity-based requirements that allow for the 
importation of a variety of products from regions not considered free 
of diseases of concern. These requirements are contained largely in 9 
CFR part 94. Inquiries regarding these requirements or requests for 
approval of new requirements may be directed to the National Center for 
Import and Export: Telephone (301) 851-3300 or email 
AskNCIE.Products@aphis.usda.gov.
    Additionally, several of the commenters addressed specific 
provisions of the proposal.
    One commenter objected to the proposal to allow APHIS to initiate 
an evaluation of a foreign country's disease status in the absence of a 
request from that foreign country, stating that multinational meat 
packers might lobby APHIS to conduct such evaluations in order to 
source meat and livestock.
    We are making no changes to the proposed rule in response to this 
comment. If there is a U.S. market for meat or livestock from a foreign 
region but APHIS has not yet evaluated its disease risk, the foreign 
government of that region will likely request an evaluation because of 
the value those exports would have for the foreign region. In any case, 
as stated in the proposed rule, APHIS anticipates that most evaluations 
will be done at the request of a foreign country. There may be 
instances, however, when it will be beneficial for APHIS to initiate an 
evaluation, and we reserve the right to do so. Even in such cases, we 
could not conduct the evaluation without the cooperation of the foreign 
government, which would need to supply information and allow access for 
any necessary site visits. As with any evaluation, there would be 
opportunity for the public to review and comment on the evaluation and 
proposed disease status.
    One commenter objected to our proposal to remove the statement in 
Sec.  92.2(d) that supporting information submitted with country 
requests will be made available to the public prior to initiation of 
rulemaking. The commenter stated withholding such information will 
severely limit APHIS' transparency. Another commenter expressed concern 
that this change would reduce the amount of time that supporting 
information regarding a country's disease status is available to the 
public.
    We are making no change in response to these comments. The intent 
of this statement was to assure the public that they will have access 
to, and opportunity to comment on, the information upon which APHIS 
bases its evaluation, as well as the evaluation itself. As discussed in 
the proposed rule, this has been our practice, and it will continue to 
be our practice. Moreover, there will be no change in when we make the 
supporting information available. We will continue to make both the 
supporting information and the evaluation available when we announce 
our intention to recognize the animal health status of a region and 
open the public comment period. We were concerned that the statement we 
proposed to remove suggested that the supporting information might be 
made available sooner, perhaps at the time of the initial submission of 
the request, when the information may be incomplete or inadequate. 
Additionally, this is not the only information APHIS relies upon to 
make its determination. In addition to information provided by the 
requesting country, we also gather information from literature, 
reports, and site visits and consider all of this in preparing our 
evaluation. We believe that the public should consider all of the 
information together, and that it could be confusing or misleading to 
release it in stages.
    One commenter requested that, when we make available to the public 
a list of regions that have requested recognition of their animal 
health status, we include an indication of the animal species and 
diseases under evaluation with respect to each region. Another 
commenter recommended that we encourage foreign jurisdictions to 
specify the type of animal or product they wish to export and that we 
also make that information available to the public when we have it.
    We agree with the suggestions. Paragraph Sec.  92.2(d) in this 
final rule provides that APHIS will list on its Web site each region 
that has requested APHIS recognition of its animal health status, the 
disease(s) under evaluation, and, if the information is available, the 
animal(s) or product(s) the region wishes to export.
    One commenter said that while the proposed changes would facilitate 
the work of foreign governments in submitting information, he remains 
concerned about the length of time it can take to complete assessments. 
The commenter referenced provisions in Annex C of the WTO-SPS Agreement 
that recommend that Members publish the standard processing period for 
evaluation requests or communicate the anticipated processing period to 
the applicant upon request.
    We are making no changes to the proposed rule in response to this 
comment. Because the time required for each evaluation varies, 
estimates must be made on a case-by-case basis, which APHIS will 
communicate with the applicant upon request, consistent with Annex C.
    One commenter asked what we mean by the wording ``safely granted'' 
in proposed Sec.  92.2(e), which says: ``If, after review and 
evaluation of the information submitted in accordance with paragraph 
(b) or (c) of this section, APHIS believes the request can be safely 
granted, APHIS will indicate its intent and make its evaluation 
available for public comment through a document published in the 
Federal Register.''
    We mean that APHIS has determined that imports from the region 
would present a low risk of introducing a particular disease into the 
United States and may be safely imported.
    A few commenters also made suggestions or raised issues not 
directly

[[Page 44109]]

related to the changes we proposed, including expanding APHIS' 
oversight of other animals, including rodents; data sharing among 
regulatory agencies; conducting post-mortem examinations of a 
representative sample of imported livestock to rule out ``potential 
disease''; and the agreement between the European Commission and the 
United States on sanitary measures. Because these matters are outside 
the scope of this rulemaking, we are not addressing them here.
    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 
change discussed above.

Executive Order 12866 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.
    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on small entities. The 
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.
    The economic analysis identifies importers and producers of animals 
and animal products as the small entities most likely to be affected by 
this action and considers the reduction in time between receipt of a 
request by APHIS and initiation of an evaluation.
    Based on the information presented in the analysis, we expect that 
decreasing the amount of time and APHIS resources required to conduct 
such an evaluation would not have a significant economic effect on the 
entities affected.
    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 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 inconsistent 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.

Paperwork Reduction Act

    This final rule contains no new information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

List of Subjects in 9 CFR Part 92

    Animal diseases, Imports, Livestock, Poultry and poultry products, 
Region, Reporting and recordkeeping requirements.

    Accordingly, we are amending 9 CFR part 92 as follows:

PART 92--IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS; PROCEDURES FOR 
REQUESTING RECOGNITION OF REGIONS

0
1. The authority citation for part 92 continues to read as follows:

    Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

0
2. In Sec.  92.2, paragraphs (a) through (f) are revised to read as 
follows:

Sec.  92.2  Application for recognition of the animal health status of 
a region.

    (a) The representative of the national government(s) of any country 
or countries who has the authority to make such a request may request 
that APHIS recognize the animal health status of a region.\1\ Such 
requests must be made in English and must be sent to the Administrator, 
c/o National Center for Import and Export, VS, APHIS, 4700 River Road 
Unit 38, Riverdale, MD 20737-1231. (Where possible, include a copy of 
the request and accompanying information in electronic format.)
---------------------------------------------------------------------------

    \1\ Additionally, APHIS may choose to initiate an evaluation of 
the animal health status of a foreign region on its own initiative. 
In such cases, APHIS will follow the same evaluation and 
notification procedures set forth in this section.
---------------------------------------------------------------------------

    (b) Requests for recognition of the animal health status of a 
region, other than requests submitted in accordance with paragraph (c) 
of this section, must include, in English, the following information 
about the region. More detailed information regarding the specific 
types of information that will enable APHIS to most expeditiously 
conduct an evaluation of the request is available at http://www.aphis.usda.gov/import_export/animals/reg_request.shtml or by 
contacting the Director, Sanitary Trade Issues Team, National Center 
for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, 
MD 20737.
    (1) Scope of the evaluation being requested.
    (2) Veterinary control and oversight.
    (3) Disease history and vaccination practices.
    (4) Livestock demographics and traceability.
    (5) Epidemiological separation from potential sources of infection.
    (6) Surveillance.
    (7) Diagnostic laboratory capabilities.
    (8) Emergency preparedness and response.
    (c) Requests for recognition that a region is historically free of 
a disease based on the amount of time that has elapsed since the 
disease last occurred in a region, if it has ever occurred, must 
include, in English, the following information about the region. More 
detailed information regarding the specific types of information that 
will enable APHIS to most expeditiously conduct an evaluation of the 
request is available at http://www.aphis.usda.gov/import_export/animals/reg_request.shtml or by contacting the Director, Sanitary 
Trade Issues Team, National Center for Import and Export, VS, APHIS, 
4700 River Road Unit 38, Riverdale, MD 20737. For a region to be 
considered historically free of a disease, the disease must not have 
been reported in domestic livestock for at least the past 25 years and 
must not have been reported in wildlife for at least the past 10 years.
    (1) Scope of the evaluation being requested.
    (2) Veterinary control and oversight.
    (3) Disease history and vaccination practices
    (4) Disease notification.
    (5) Disease detection.
    (6) Barriers to disease introduction.
    (d) A list of those regions that have requested APHIS' recognition 
of their animal health status, the disease(s) under evaluation, and, if 
available, the animal(s) or product(s) the region wishes to export, is 
available at http://www.aphis.usda.gov/import_export/animals/reg_request.shtml.
    (e) If, after review and evaluation of the information submitted in 
accordance with paragraph (b) or (c) of this section, APHIS believes 
the request can be safely granted, APHIS will indicate its intent and 
make its evaluation available for public comment through a document 
published in the Federal Register.
    (f) APHIS will provide a period of time during which the public may 
comment on its evaluation. During the comment period, the public will 
have access to the information upon which APHIS based its evaluation, 
as well as the evaluation itself. Once APHIS has reviewed all comments 
received, it will make a final determination regarding

[[Page 44110]]

the request and will publish that determination in the Federal 
Register.
* * * * *

    Done in Washington, DC, this 23rd day of July 2012.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2012-18324 Filed 7-26-12; 8:45 am]
BILLING CODE 3410-34-P
```