81404 Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules 

and adults of the order Lepidoptera, 

with irradiation in accordance with 

§ 305.9 of this chapter. Treatment must 

be conducted prior to importation of the 

fruits into the United States. 

(c) Each shipment of litchi must be 

accompanied by a phytosanitary 

certificate of inspection issued by the 

NPPO of Australia with an additional 

declaration stating that the litchi were 

treated with irradiation as described in 

the Plant Protection and Quarantine 

Treatment Manual. 

(d) In addition to meeting the labeling 

requirements in Part 305 of this chapter, 

cartons in which litchi are packed must 

be stamped ‘‘Not for importation into or 

distribution in FL.’’ 

(e) The litchi may be imported in 

commercial consignments only. 

Done in Washington, DC, this 19th day of 

December 2011. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2011–33201 Filed 12–27–11; 8:45 am] 

BILLING CODE 3410–34–P 

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. 

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 

http://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 http:// 

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 § 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 § 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 § 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 § 92.2(b) 

specify the types of information APHIS 

needs to accomplish its evaluation. To 

assist foreign governments making a 

request under § 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 

http://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 

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1Active surveillance is defined in § 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. 

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 § 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 § 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. 

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. 

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2When 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 § 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. 

3The 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. 

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 standardsetting 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. 

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

• 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 § 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 § 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 § 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 

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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 § 92.2(a) that 

references such situations. 

Information Received With Requests 

Current § 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 § 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 § 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 

§ 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 

§ 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 § 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 § 92.2(e). 

Instead of publishing a proposed rule, as 

provided for in current § 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 § 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 § 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 § 92.2. The scope of § 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 

§ 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, § 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 § 92.2(a) 

instead of § 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 

§ 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 

§ 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 

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81408 Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules 

1Additionally, 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. 

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 § 92.2, paragraphs (a) through (f) 

are revised to read as follows: 

§ 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.) 

(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 

DEPARTMENT OF ENERGY 

10 CFR Part 719 

48 CFR Parts 931, 952 and 970 

RIN 1990–AA37 

Contractor Legal Management 

Requirements; Acquisition 

Regulations 

AGENCY: Office of General Counsel, 

Department of Energy. 

ACTION: Notice of proposed rulemaking 

and opportunity for public comment. 

SUMMARY: The Department of Energy 

(DOE or Department) is proposing to 

revise existing regulations covering 

contractor legal management 

requirements. Conforming amendments 

are also proposed to the Department of 

Energy Acquisition Regulation (DEAR). 

The proposed regulations will provide 

rules for handling of legal matters and 

associated costs by certain contractors 

whose contracts exceed $100,000,000 as 

well as legal counsel retained directly 

by the Department for matters in which 

costs exceed $100,000. 

DATES: DOE will accept comments, data, 

and information regarding this notice of 

mstockstill on DSK4VPTVN1PROD with PROPOSALS