Information From Foreign Regions Applying for Recognition of Animal Health Status, 81404-81408 [2011-33206]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 76, Number 249 (Wednesday, December 28, 2011)]
[Proposed Rules]
[Pages 81404-81408]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33206]


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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: Proposed rule.

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SUMMARY: We are proposing to amend the regulations that govern the 
importation of animals and animal products by revising the list of 
factors APHIS considers when evaluating the animal health status of a 
foreign region. Additionally, we are proposing criteria for considering 
a region to be historically free of a specific disease. These changes 
would make clearer the type of information APHIS needs from a 
requesting region to most expeditiously conduct an evaluation.

DATES: We will consider all comments that we receive on or before 
February 27, 2012.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2007-0158-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2007-0158, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2007-
0158 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.

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) 734-4356.

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. Currently, the 
provisions in paragraph (b) of Sec.  92.2 state that each request must 
include the following information, which APHIS commonly refers to as 
``the 11 factors'':
     The authority, organization, and infrastructure of the 
veterinary services organization in the region.
     Disease status, i.e., is the restricted disease agent 
known to exist in the region? If ``yes,'' at what prevalence? If 
``no,'' when was the most recent diagnosis?
     The status of adjacent regions with respect to the agent.
     The extent of an active disease control program, if any, 
if the agent is known to exist in the region.
     The vaccination status of the region. When was the last 
vaccination? What is the extent of vaccination if it is currently used, 
and what vaccine is being used?
     The degree to which the region is separated from adjacent 
regions of higher risk through physical or other barriers.
     The extent to which movement of animals and animal 
products is controlled from regions of higher risk, and the level of 
biosecurity regarding such movements.
     Livestock demographics and marketing practices in the 
region.
     The type and extent of disease surveillance in the region, 
e.g., is it passive and/or active; what is the quantity and quality of 
sampling and testing?
     Diagnostic laboratory capabilities.
     Policies and infrastructure for animal disease control in 
the region, i.e., emergency response capacity.
    Current paragraph (e) of Sec.  92.2 provides that if, after 
evaluating the information submitted, APHIS believes the action being 
requested can be safely taken, the Agency will publish a proposed rule 
in the Federal Register proposing to take such action and will provide 
a period of time during which the public may comment on the proposal. 
Current paragraph (f) of Sec.  92.2 provides that, during the comment 
period, the public will have access both to the information upon which 
APHIS based its analysis of risk and the analysis itself. Once APHIS 
reviews and considers all comments received, it makes a final decision 
regarding the request and publishes that decision in the Federal 
Register.
    In order to conduct a valid evaluation of a region's animal health 
status and any risk that might be associated with the action requested, 
it is important that APHIS have complete and pertinent information 
regarding the region, its disease history, its animal health practices 
and capabilities, and any effect its import practices or relationship 
to adjacent regions might have on disease risk.
    The 11 factors listed in Sec.  92.2(b) specify the types of 
information APHIS needs to accomplish its evaluation. To assist foreign 
governments making a request under Sec.  92.2, APHIS also makes 
available on its Web site detailed guidance as to the types of 
information required. This guidance is forth in a document titled 
``Clarification of Information Requested for Recognition of a Region,'' 
which can be viewed at https://www.aphis.usda.gov/import_export/downloads/info_request.pdf.
    Each year, APHIS receives a number of requests to evaluate the 
animal health status of foreign regions. However, the evaluation 
process is often hindered because, even with the assistance of the

[[Page 81405]]

guidance, the initial information sent to APHIS is incomplete and 
requires APHIS to contact the requesting government for additional 
information.
    Based on our experience, we believe it is advisable to clarify 
further what information is necessary for APHIS to initiate an 
evaluation of risk. Therefore, we are proposing to revise the list of 
factors in Sec.  92.2(b) and to make available more detailed guidance 
as to the specific types of information encompassed by each factor.
    Our experience dealing with requests from foreign governments 
indicates that the list of 11 factors can be confusing because the 
information requested in some of the factors overlaps with information 
requested in other factors. For instance, one of the factors asks for 
information regarding the degree to which the region is separated from 
adjacent regions of higher risk through physical or other barriers. A 
separate factor asks for information regarding the extent to which 
movement of animals and animal products is controlled from regions of 
higher risk and the level of biosecurity regarding such movements.
    To eliminate such overlap, we propose to consolidate the 11 factors 
into 8 factors, listed as follows:
     Scope of the evaluation being requested;
     Veterinary control and oversight;
     Disease history and vaccination practices;
     Livestock demographics and traceability;
     Epidemiological separation from potential sources of 
infection;
     Diagnostic laboratory capabilities;
     Surveillance practices; and
     Emergency preparedness and response.
    The type of information required would not change substantively 
from what we currently require to conduct an evaluation. It would 
simply be described in what we believe is a more helpful way. More 
detailed guidance as to the specific types of information encompassed 
by each factor would be set forth in a guidance document available on 
the APHIS Web site or by contacting APHIS. Instructions for accessing 
or obtaining the guidance document would be set forth in Sec.  92.2(b) 
of the regulations. The revised guidance document, ``Clarification of 
Information Requested for Recognition of a Region,'' is available for 
review and comment as part of this rulemaking and may be viewed on the 
Regulations.gov Web site or in our reading room. Instructions for 
accessing Regulations.gov and information on the location and hours of 
the reading room are provided under the heading ADDRESSES at the 
beginning of this proposed rule. In addition, a copy may be obtained by 
calling or writing to the individual listed under FOR FURTHER 
INFORMATION CONTACT.
    An overview of the information required for each of the factors, as 
explained in the guidance document, is as follows:
    1. Scope of the evaluation being requested. This factor would 
require identification of the disease(s) for which an APHIS evaluation 
is requested; a detailed description of the region, including maps; 
identification of the animal commodities proposed for export to the 
United States; and an estimate of the projected annual volume of export 
for each commodity. Although this type of information is not 
specifically referenced in the current regulations and guidance 
document, it is standard practice for APHIS to require such information 
from a requesting region before beginning an evaluation.
    2. Veterinary control and oversight. This factor would require 
sufficient information for APHIS to assess the infrastructure of the 
official veterinary services in the region and the ability of the 
veterinary services to oversee animal health activities, monitor for 
disease, and implement disease control measures.
    3. Disease history and vaccination practices. This factor would 
require sufficient information to enable APHIS to understand the 
history of the disease(s) being evaluated in the region, including 
prior control measures, revisions to those measures as applicable, and 
the vaccination status and history in the region.
    4. Livestock demographics and traceability. This factor would 
require sufficient information for APHIS to assess the geographic 
distribution of livestock and wildlife species that are susceptible to 
the disease(s) under evaluation, patterns of livestock movement within 
the region, and the ability of the official veterinary services of the 
region to trace livestock movements in the event of a disease outbreak.
    5. Epidemiological separation from potential sources of infection. 
This factor would require sufficient information to enable APHIS to 
evaluate the ability of the region to prevent incursions of the 
disease(s) under evaluation. Relevant risk factors that we would 
evaluate include the presence of the disease(s) in adjacent regions or 
in regions with epidemiological links to the requesting region, natural 
and manmade barriers to disease introduction, trading practices, and 
inspection practices.
    6. Surveillance. This factor would require sufficient information 
to enable APHIS to determine whether the surveillance system in the 
region is sufficient to ensure early detection of the disease(s) under 
evaluation. Countries would need to submit information regarding active 
and/or passive surveillance as applicable.\1\ Documentation regarding 
collection and analysis of disease and infection data must be 
sufficient to provide confidence in the disease status of the region.
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    \1\ Active surveillance is defined in Sec.  92.1 of the 
regulations as sample collection using a systematic or statistically 
designed survey methodology to actively seek out and find cases of 
animals with a restricted disease agent, or to determine the 
prevalence of the restricted disease agent in the population. 
Passive surveillance is defined as a surveillance system that does 
not depend on active participation by the responsible agency to seek 
out and monitor a restricted disease agent. The definition explains, 
further, that such a system relies on mandatory reporting, a pool of 
trained investigators, diagnostic submission procedures and 
laboratory support, and periodic public information and continuing 
education programs on diseases.
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    7. Diagnostic laboratory capabilities. This factor would require 
sufficient information to enable APHIS to determine whether the animal 
health laboratory system, diagnostic procedures, and quality assurance 
measures in the region are sufficient to effectively support 
surveillance for the disease(s) under evaluation.
    8. Emergency preparedness and response. This factor would require 
information sufficient for APHIS to assess emergency preparedness 
measures and response capabilities in the region, as well as procedures 
in place to notify trading partners and other international entities of 
a disease outbreak.

Regions Historically Free of a Disease

    In regions in which a significant period of time has elapsed since 
a particular disease or infection has occurred, if it has ever 
occurred, certain information required as part of the eight factors 
listed above would not be applicable or necessary. An example of this 
would be some of the information on surveillance, particularly active 
pathogen-specific surveillance. In the guidance document for the eight 
factors above, APHIS asks for detailed information regarding 
surveillance specific to the pathogen under consideration, including 
the following: Target populations, targeted prevalence for detection 
and estimated confidence level, sampling plan, types of samples 
collected, frequency of sampling, and the targeted and actual numbers 
of samples collected and the results of screening and confirmatory 
testing for the past 3 years.

[[Page 81406]]

    However, if a particular disease or infection has not occurred in a 
region for many years, the benefit of active surveillance specifically 
targeting that pathogen would be minimal. In such a case, it would not 
be necessary for APHIS to receive detailed information from the region 
regarding active pathogen-specific surveillance. However, to be 
recognized as free of a disease, it would still be necessary for the 
region to demonstrate an effective early detection system for the 
disease(s) under evaluation, as described below.
    The World Organization for Animal Health (OIE), of which the United 
States is a Member country, is the internationally recognized standard-
setting body that develops science-based recommendations for the safe 
trade of animals and animal products. The World Trade Organization has 
recognized the OIE as the international forum for setting animal health 
standards, reporting global animal disease events, and presenting 
guidelines and recommendations on sanitary measures relating to animal 
health. The OIE recommends criteria for recognizing a country or zone 
free of a disease based on a significant period of time having elapsed 
since the disease was last reported, if it was ever reported.\2\ Such 
an area is described by the OIE as being historically free of a 
disease.
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    \2\ When discussing areas with regard to animal diseases, OIE's 
use of the terms ``country'' and ``zone'' is equivalent to APHIS' 
use of the term ``region.'' In Sec.  92.1, a region is defined as 
any of the following: (1) A national entity (country); (2) part of a 
national entity (zone, county, department, municipality, parish, 
Province, State, etc.; (3) parts of several national entities 
combined into an area; or (4) a group of national entities combined 
into a single area.
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    In its Terrestrial Animal Health Code (Code), the OIE recommends 
that a region may be recognized as historically free of a disease if 
the disease has never occurred in the region or has not occurred for at 
least the past 25 years, provided the following conditions have been 
met for at least the past 10 years:
     The disease has been a notifiable disease; \3\
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    \3\ The Code defines a notifiable disease as one listed by the 
Veterinary Authority in a region that, as soon as it is detected or 
suspected, must be brought to the attention of the Veterinary 
Authority in accordance with national regulations.
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     An early detection system has been in place for all 
relevant species;
     Measures to prevent disease/infection introduction have 
been in place and no vaccination against the disease has been carried 
out unless otherwise provided in the Code; and
     There has been no evidence of infection in wildlife in the 
region.
    Based on APHIS' experience evaluating the animal health status of 
foreign regions, we concur with the OIE's recommended criteria for 
being recognized as historically free of a disease, and we are 
proposing to add a new paragraph (c) in Sec.  92.2 of the regulations 
that would list the factors we will consider in evaluating whether to 
recognize a region as historically free. Much of the information is the 
same as that required for the eight factors discussed above. However, 
consistent with OIE guidelines, APHIS' evaluations for historically 
free status will focus on verifying an effective early detection system 
for the disease(s) under consideration, disease reporting requirements, 
and measures in place to prevent introduction. Therefore, certain 
information encompassed by the eight factors would not be required.
    In evaluating whether a region can be considered historically free 
of a disease, we would consider the following six factors:
     Scope of the evaluation being requested;
     Veterinary control and oversight;
     Disease history and vaccination practices;
     Disease reporting;
     Disease detection; and
     Barriers to disease introduction.
    As with the eight factors discussed earlier in this document, more 
detailed guidance as to the specific types of information encompassed 
by each factor for regions historically free of a disease would be set 
forth in a guidance document available on the APHIS Web site or by 
contacting APHIS. Instructions for accessing or obtaining the guidance 
document would be set forth in Sec.  92.2(c) of the regulations. The 
guidance document, ``Clarification of Information Requested for 
Recognition of a Historically Free Region,'' is available for review 
and comment as part of this rulemaking and may be viewed on the 
Regulations.gov Web site or in our reading room.
    Consistent with the OIE guidelines, proposed Sec.  92.2(c) would 
indicate that, for a region to be considered historically free of a 
disease, the disease must not have occurred 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. An overview of the information required 
for each of the factors, as explained in the guidance document, is as 
follows.
    1. Scope of the evaluation being requested. The information we 
would require for this factor is the same as that described for the 
eight factors, above.
    2. Veterinary control and oversight. This factor would require 
sufficient information to enable APHIS to determine whether the 
veterinary services in the region have had and continue to have 
sufficient legal authority, organization, and infrastructure to 
effectively investigate, diagnose, and report the disease(s) under 
evaluation, if detected.
    3. Disease history and vaccination practices. For this factor, the 
requesting authority would need to indicate when each disease under 
evaluation was last reported, if ever, in domestic livestock and 
wildlife in the region. Additionally, if vaccination against the 
disease(s) has occurred within the past 10 years, the request must 
include information indicating the reasons for vaccination, the source 
and type of vaccines used, target populations, recordkeeping 
requirements, and procedures to distinguish vaccinated animals.
    4. Disease reporting. This factor would require sufficient 
information to enable APHIS to determine whether each disease under 
evaluation has been legally notifiable in the region for at least the 
past 10 years.
    5. Disease detection. This factor would require sufficient 
information for APHIS to determine whether an effective early detection 
system has been in place for at least the past 10 years for the 
disease(s) under evaluation. An effective early detection system would 
include, among other things, representative coverage of susceptible 
animal populations by field services, a training program for detecting 
and reporting unusual animal health incidents, the ability to undertake 
effective disease investigation and reporting, and access to 
laboratories capable of diagnosing and differentiating relevant 
diseases.
    6. Barriers to disease introduction. This factor would require 
sufficient information for APHIS to determine whether measures have 
been in place for at least the past 10 years to prevent introduction of 
the disease(s) under evaluation.

Initiation of an Evaluation

    Historically, the evaluations APHIS has conducted in accordance 
with part 92 have been at the request of a representative of a foreign 
jurisdiction. We expect that to continue to be the case the great 
majority of the time. However, there might be instances where APHIS 
initiates an evaluation on its own initiative. As with evaluations done 
at the request of a foreign region, we would consider the factors set 
forth in this proposed rule and, if our intent is to recognize the 
health status of the region, would give notice in the Federal Register 
of that intent, make the

[[Page 81407]]

relevant information and data and our evaluation available to the 
public, and accept public comment regarding our intent. After reviewing 
and considering any comments received, we would give notice to the 
public of our final determination. In this proposed rule, we include a 
footnote to Sec.  92.2(a) that references such situations.

Information Received With Requests

    Current Sec.  92.2(d) states that the information sent to APHIS 
with requests submitted in accordance with part 92 will be made 
available to the public prior to initiation by APHIS of any rulemaking 
action on the request. Current Sec.  92.2(f) provides that, in cases 
where APHIS does publish a proposed rule based on a request, the public 
will be provided a period of time to comment on the proposal and that, 
during the comment period, the public will have access to the 
information upon which APHIS based its analysis supporting the 
proposal, as well as its methodology in conducting the analysis.
    We believe that the wording of current Sec.  92.2(d) can be 
confusing. The intent of that paragraph is to give notice to the public 
that, at the time a proposal is published, information supporting the 
proposal will have been made available to the public. Such information 
is posted on the APHIS Web site. However, the wording of current Sec.  
92.2(d) does not indicate how early in the process such information 
will be made available to the public. It has been APHIS' practice to 
make such information available immediately before publication of a 
proposed rule. APHIS does not begin an evaluation until it has 
sufficient information to conduct a valid analysis of a request, and 
does not take the further action of publishing a proposed rule in the 
Federal Register unless it believes the results of the evaluation 
support the action being requested. We believe that, until a proposed 
rule is ready for publication, it can be confusing and misleading for 
the public to review what APHIS considers partial information or 
information with regard to which further action may not be taken. 
However, we believe it could be useful to the public to know which 
foreign regions have requested APHIS' recognition of their animal 
health status. Therefore, in this document, we are proposing to remove 
the statement in Sec.  92.2(d) that supporting information will be made 
available to the public prior to initiation of rulemaking and to 
replace it with the statement that a list of regions that have 
requested recognition of their animal health status is available to the 
public. We will continue to make available to the public by the time 
APHIS publishes a proposal in the Federal Register any relevant 
information received from a requesting country.

Miscellaneous

    As noted above, current paragraph (e) of Sec.  92.2 provides that 
if, after evaluating the information submitted with a region's request 
for APHIS' recognition of its animal health status, APHIS believes the 
action being requested can be safely taken, the Agency will publish a 
proposed rule in the Federal Register proposing to take such action and 
will provide a period of time during which the public may comment on 
the proposal. However, recent rulemaking by APHIS has made it incorrect 
to say that a proposed rule will be used in all cases to give notice of 
APHIS' intent. On January 24, 2011, we published in the Federal 
Register an interim rule (76 FR 4046-4056, Docket No. APHIS-2006-0074) 
concerning highly pathogenic avian influenza (HPAI) as it applies to 
the importation of live birds and poultry and the products of birds and 
poultry. In that interim rule, we provide for a method of notifying the 
public of APHIS' intent regarding the HPAI status of a region that 
differs somewhat from the method currently provided for in Sec.  
92.2(e). Instead of publishing a proposed rule, as provided for in 
current Sec.  92.2(e), the HPAI interim rule indicates that a region 
will be removed from the list of regions where HPAI is considered to 
exist only after APHIS makes its evaluation available for public 
comment through a notice published in the Federal Register. The interim 
rule provides that, following the close of the comment period, APHIS 
will publish another notice responding to comments and announcing 
APHIS' decision.
    In order to account for such situations where a notice, rather than 
proposed rule, will be used to solicit comment regarding APHIS' 
evaluation of the animal health status of a foreign region, we are 
proposing to revise paragraph (e) of Sec.  92.2 to provide that, if 
APHIS believes a request from a foreign region for APHIS' recognition 
of its animal health status 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. Paragraph (f) of Sec.  
92.2 would indicate that, during the comment period, the public will 
have access to the information upon which APHIS based its evaluation, 
as well as the evaluation itself, and that, once APHIS has reviewed all 
comments received, it will make a final determination regarding the 
request and will publish that determination in the Federal Register.
    Additionally, in this document, we are clarifying which requests 
are governed by Sec.  92.2. The scope of Sec.  92.2 is reflected in its 
heading, which reads ``Application for recognition of the animal health 
status of a region.'' Requests submitted to APHIS in accordance with 
part 92 are evaluated by the Regionalization Evaluation Services staff 
of APHIS' Veterinary Services. However, the wording in paragraphs (b), 
(c), and (e) of current Sec.  92.2 indicates that the section also 
governs requests for approval to export a particular type of animal or 
animal product to the United States from a foreign region. Although the 
evaluations conducted by the Regionalization Evaluation Services staff 
can ultimately affect which commodities are allowed importation into 
the United States and under what conditions, requests to import 
specific types of animals or animal products are governed by parts in 9 
CFR other than part 92. To clarify the scope of part 92, we are 
proposing to remove from that part the references to exportation of a 
particular type of animal or animal product to the United States from a 
foreign region.
    Currently, Sec.  92.2(c) indicates where requests for recognition 
of a region, and information supporting such a request, should be sent. 
That paragraph also requests that, where possible, a copy of the 
request and supporting information be submitted on a 3.5-inch floppy 
disk in ASCII or a word processing format. In this proposal, we include 
the address to which requests and supporting information should be sent 
in Sec.  92.2(a) instead of Sec.  92.2(c) and propose to remove the 
request for submission on a 3.5-inch floppy disk. Such disks are no 
longer commonly used. In proposed Sec.  92.2(a), we request that, where 
possible, a copy of the request and accompanying information be 
included in electronic format.
    We are also proposing several nonsubstantive wording changes to 
Sec.  92.2 for the sake of clarity.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed 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 action. The 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

[[Page 81408]]

reduction in time it would take under this proposal for APHIS to 
initiate and complete an evaluation of the animal disease status of a 
region. Based on the information presented in the analysis, we expect 
that decreasing the amount of time and APHIS resources required to 
initiate and complete such an evaluation would not have a significant 
economic effect on the entities affected. We invite comment on our 
economic analysis, which is posted with this proposed rule on the 
Regulations.gov Web site (see ADDRESSES above for instructions for 
accessing Regulations.gov) and may also be obtained from the person 
listed under FOR FURTHER INFORMATION CONTACT.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent with this rule 
will be preempted; (2) no retroactive effect will be given to this 
rule; and (3) administrative proceedings will not be required before 
parties may file suit in court challenging this rule.

Paperwork Reduction Act

    This proposed 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 propose to amend 9 CFR part 92 as follows:

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

    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.

    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.)
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    \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.
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    (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 [address to be 
added in final rule] 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 [address to be added in final rule] 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 is available at [address to be added in 
final rule].
    (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 the request and 
will publish that determination in the Federal Register.
* * * * *

    Done in Washington, DC, this 19th day of December 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-33206 Filed 12-27-11; 8:45 am]
BILLING CODE 3410-34-P