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Rules and Regulations Federal Register

44107 

Vol. 77, No. 145 

Friday, July 27, 2012 

1To view the proposed rule and the comments 

we received, go to http://www.regulations.gov/ 

#!docketDetail;D=APHIS-2007-0158. 

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 

§ 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 

§ 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 § 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. 

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 


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44108 Federal Register / Vol. 77, No. 145 / Friday, July 27, 2012 / Rules and Regulations 

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 

§ 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 § 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 § 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 


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Federal Register / Vol. 77, No. 145 / Friday, July 27, 2012 / Rules and Regulations 44109 

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. 

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 

■ 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 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 


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44110 Federal Register / Vol. 77, No. 145 / Friday, July 27, 2012 / Rules and Regulations 

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 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 29 

[Docket No. FAA–2012–0785; Special 

Conditions No. 29–027–SC] 

Special Conditions: Agusta S.p.A. 

Model AW139 and AB139 Helicopter, 

Installation of a Search and Rescue 

(SAR) Automatic Flight Control System 

(AFCS) 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final special conditions; request 

for comments. 

SUMMARY: These special conditions are 

issued for the Agusta S.p.A. (Agusta) 

Model AW139 and AB139 helicopters. 

These model helicopters, as modified by 

Agusta, will have novel or unusual 

design features associated with 

installing an optional SAR AFCS. The 

applicable airworthiness standards do 

not contain adequate or appropriate 

safety standards for this design feature. 

These special conditions contain the 

additional safety standards the 

Administrator considers necessary to 

show a level of safety equivalent to that 

established by the existing 

airworthiness standards. 

DATES: The effective date of these 

special conditions is July 18, 2012. We 

must receive your comments by 

September 25, 2012. 

ADDRESSES: Send comments identified 

by docket number [FAA–2012–0785] 

using any of the following methods: 

• Federal eRegulations Portal: Go to 

http://www.regulations.gov and follow 

the online instructions for sending your 

comments electronically. 

• Mail: Send comments to Docket 

Operations, M–30, U.S. Department of 

Transportation (DOT), 1200 New Jersey 

Avenue SE., Room W12–140, West 

Building Ground Floor, Washington, DC 

20590–0001. 

• Hand Delivery of Courier: Deliver 

comments to the ‘‘Mail’’ address 

between 9 a.m., and 5 p.m., Monday 

through Friday, except Federal holidays. 

• Fax: Fax comments to Docket 

Operations at 202–493–2251. 

Privacy: The FAA will post all 

comments it receives, without change, 

to http://regulations.gov, including any 

personal information the commenter 

provides. Using the search function of 

the docket Web site, anyone can find 

and read the electronic form of all 

comments received into any FAA 

docket, including the name of the 

individual sending the comment (or 

signing the comment for an association, 

business, labor union, etc.). DOT’s 

complete Privacy Act Statement can be 

found in the Federal Register published 

on April 11, 2000 (65 FR 19477–19478), 

as well as at http://DocketsInfo.dot.gov. 

Docket: You can read the background 

documents or comments received at 

http://www.regulations.gov. Follow the 

online instructions for accessing the 

docket or go to the Docket Operations in 

Room @12–140 of the West Building 

Ground Floor at 1200 New Jersey 

Avenue SE., Washington, DC, between 

9 a.m., and 5 p.m., Monday through 

Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

FAA, Aircraft Certification Service, 

Rotorcraft Directorate, Regulations and 

Policy Group (ASW–111), Attn: Stephen 

Barbini, 2601 Meacham Blvd., Fort 

Worth, Texas 76137; telephone (817) 

222–5196; facsimile (817) 222–5961. 

SUPPLEMENTARY INFORMATION: 

Reason for No Prior Notice and 

Comment Before Adoption 

The substance of these special 

conditions has been subjected to the 

notice and comment period previously 

and has been derived without 

substantive change from those 

previously issued. It is unlikely that 

prior public comment would result in a 

significant change from the substance 

contained herein. Further, a delay in the 

effective date of these special conditions 

would significantly delay issuance of 

the design approval and thus delivery of 

the helicopter, which is imminent. 

Therefore, the FAA has determined that 

prior public notice and comment are 

unnecessary, impracticable, and 

contrary to the public interest, and finds 

good cause exists for adopting these 

special conditions upon issuance. The 

FAA is requesting comments to allow 

interested persons to submit views that 

may not have been submitted in 

response to the prior opportunities for 

comment. 

Comments Invited 

While we did not precede this with a 

notice of proposed special conditions, 

we invite interested people to take part 

in this action by sending written 

comments, data, or views. The most 

helpful comments reference a specific 

portion of the special conditions, 

explain the reason for any 

recommended change, and include 

supporting data. 

We will consider all comments we 

receive by the closing date for 

comments. We will consider comments 

filed late if it is possible to do so 

without incurring additional expense or 

delay. We may change these special 

conditions based on the comments we 

receive. 

Background and Discussion 

On November 11, 2008, Agusta 

applied for a change to Type Certificate 

(TC) No. R00002RD to install an 

optional SAR AFCS in the Model AB139 

and AW139 helicopters. The AB139 and 

AW139 models are transport category 

helicopters certificated to Category A 

and Category B requirements, and 

instrument flight certificated under the 

requirements of Appendix B to 14 CFR 

part 29, Amendment 29–40. 

There is a need to use dedicated 

AFCS upper modes, in which a fully 

coupled autopilot provides operational 

SAR profiles, for SAR operations 

conducted over water in offshore areas 

clear of obstructions. The SAR modes 

enable the helicopter pilot to fly fully 

coupled maneuvers, to include 

predefined search patterns during cruise 

flight, and to transition from cruise 

flight to a stabilized hover and 

departure (transition from hover to 

cruise flight). The SAR AFCS also 

includes an auxiliary crew control that 

allows another crewmember (such as a 

hoist operator) to have limited authority 

to control the helicopter’s longitudinal 

and lateral position during hover 

operations. 

Flight operations conducted over 

water at night may have an extremely 

limited visual horizon with little visual 

reference to the surface even when 

conducted under Visual Meteorological 

Conditions. Consequently, the 

certification requirements for SAR 

modes must meet Appendix B to 14 CFR 

part 29 for helicopter instrument flight. 

While this appendix prescribes 

airworthiness criteria for instrument 

flight, it does not consider operations 

below instrument flight minimum speed 

(VMINI), whereas the SAR modes allow 

for coupled operations at low speed, allazimuth flight to zero airspeed (hover). 

Since SAR operations have 

traditionally been a public use mission, 

the use of SAR modes in civil 

operations requires special 

airworthiness standards (special 

conditions) to maintain a level of safety 


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