4046 Federal Register / Vol. 76, No. 15 / Monday, January 24, 2011 / Rules and Regulations 

interest in land, NRCS will provide 

written notice by certified mail, return 

receipt requested, to the eligible entity 

at the eligible entity’s last known 

address. The notice will set forth the 

nature of the noncompliance by the 

eligible entity and a 60-day period to 

cure. If the eligible entity fails to cure 

within the 60-day period, NRCS will 

take the action specified under the 

notice. NRCS reserves the right to 

decline to provide a period to cure if 

NRCS determines that imminent harm 

may result to the conservation values or 

other interest in land it seeks to protect. 

§ 1491.31 Appeals. 

(a) A person or eligible entity which 

has submitted an FRPP proposal and is 

therefore participating in FRPP, may 

obtain a review of any administrative 

determination concerning eligibility for 

participation utilizing the 

administrative appeal regulations 

provided in 7 CFR part 614. 

(b) Before a person or eligible entity 

may seek judicial review of any 

administrative action taken under this 

part, the person or eligible entity must 

exhaust all administrative appeal 

procedures set forth in paragraph (a) of 

this section, and for the purposes of 

judicial review, no decision will be a 

final agency action except a decision of 

the Chief under these provisions. 

(c) Enforcement action undertaken by 

NRCS in furtherance of its vested 

property rights are under the 

jurisdiction of the Federal District Court 

and not subject to review under 

administrative appeal regulations. 

§ 1491.32 Scheme or device. 

(a) If it is determined by NRCS that a 

eligible entity has employed a scheme 

or device to defeat the purposes of this 

part, any part of any program payment 

otherwise due or paid to such an 

eligible entity during the applicable 

period may be withheld or be required 

to be refunded, with interest, as 

determined appropriate by NRCS on 

behalf of the CCC. 

(b) A scheme or device includes, but 

is not limited to, coercion, fraud, 

misrepresentation, and depriving any 

other person or entity of payments for 

easements for the purpose of obtaining 

a payment to which a person would 

otherwise not be entitled. 

Signed this 11th day of January, 2011 in 

Washington, DC. 

Dave White, 

Vice-President, Commodity Credit 

Corporation and Chief, Natural Resources 

Conservation Service. 

[FR Doc. 2011–1212 Filed 1–21–11; 8:45 am] 

BILLING CODE 3410–16–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Parts 93, 94, and 95 

[Docket No. APHIS–2006–0074] 

RIN 0579–AC36 

Highly Pathogenic Avian Influenza 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Interim rule and request for 

comments. 

SUMMARY: We are amending the 

regulations concerning the importation 

of animals and animal products to 

prohibit or restrict the importation of 

bird and poultry products from regions 

where any subtype of highly pathogenic 

avian influenza is considered to exist. 

We are also adding restrictions 

concerning importation of live poultry 

and birds that have been vaccinated for 

certain types of avian influenza, or that 

have moved through regions where any 

subtype of highly pathogenic avian 

influenza is considered to exist. These 

restrictions supplement or replace 

existing restrictions on the importation 

of live birds and poultry, and bird and 

poultry products and byproducts from 

regions where exotic Newcastle disease 

or highly pathogenic avian influenza 

subtype H5N1 are considered to exist. 

They are necessary to prevent the 

introduction of highly pathogenic avian 

influenza into the United States. 

DATES: This interim rule is effective on 

January 24, 2011. We will consider all 

comments that we receive on or before 

March 25, 2011. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/fdmspublic/

component/main?main=Docket

Detail&d=APHIS-2006-0074 to submit 

or view comments and to view 

supporting and related materials 

available electronically. 

• Postal Mail/Commercial Delivery: 

Please send one copy of your comment 

to Docket No. APHIS–2006–0074, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A–03.8, 4700 

River Road, Unit 118, Riverdale, MD 

20737–1238. Please state that your 

comment refers to Docket No. APHIS– 

2006–0074. 

Reading Room: You may read any 

comments that we receive on this 

docket in our reading room. The reading 

room 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. 

Other Information: Additional 

information about APHIS and its 

programs is available on the Internet at 

http://www.aphis.usda.gov. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Julia Punderson, Senior Staff 

Veterinarian, National Center for Import 

and Export, Animal Health Policy and 

Programs, VS, APHIS, 4700 River Road, 

Unit 38, Riverdale, MD 20737; (301) 

734–4356. 

SUPPLEMENTARY INFORMATION: 

Background 

The Animal and Plant Health 

Inspection Service (APHIS) regulations 

in title 9 of the Code of Federal 

Regulations (CFR), parts 93, 94, and 95 

(referred to below as the regulations), 

govern the importation into the United 

States of specified animals and animal 

products and byproducts to prevent the 

introduction of various animal diseases, 

including exotic Newcastle disease 

(END) and highly pathogenic avian 

influenza subtype H5N1. 

END is a contagious disease of birds 

and poultry caused by a paramyxovirus. 

END is one of most infectious diseases 

of poultry in the world. A death rate of 

almost 100 percent can occur in 

unvaccinated poultry flocks. END can 

also infect and cause death even in 

vaccinated birds and poultry. 

Avian influenza is caused by a 

orthomyxovirus, the same family that 

includes viruses that cause human 

influenza. Worldwide, there are many 

strains of avian influenza (AI) virus that 

can cause varying amounts of clinical 

illness in birds and poultry. AI viruses 

can infect chickens, turkeys, pheasants, 

quail, ducks, geese and guinea fowl, as 

well as a wide variety of other birds. 

Migratory waterfowl have proved to be 

a natural reservoir for the less virulent 

strains of the disease known as lowpathogenicity avian influenza. 

Classification of AI viruses is based 

on both biological and molecular 

characteristics of the virus. AI viruses 

are identified by a combination of two 

groups of surface proteins; the 

hemagglutinin or H proteins and the 

neuraminidase or N proteins. AI viruses 

also are characterized as low pathogenic 

(LP) or highly pathogenic (HP) by their 

ability to produce disease or by 

molecular characteristics. The ability to 

cause clinical signs may depend on the 

species of bird infected and may change 

over time, becoming more or less 


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1Hatching eggs are eggs intended and used for 

hatching, and do not include embryonated eggs for 

consumption, such as balut eggs. 

2See, e.g., World Organization for Animal Health, 

Draft Report of the Meeting of the OIE Ad Hoc 

Group on Avian Influenza, Paris, 12–14 November 

2003. 

pathogenic. Highly pathogenic avian 

influenza (HPAI) is an extremely 

infectious and potentially fatal form of 

the disease in birds and poultry that, 

once established, can spread rapidly 

from flock to flock. 

In general, AI viruses of H5 and H7 

subtypes are considered to be of greatest 

concern. The H5N1 subtype of HPAI 

(referred to below as HPAI subtype 

H5N1) that has caused outbreaks in 

birds and poultry in Asia, Africa, 

Europe, and other foreign regions has 

never been found in the United States. 

Other forms of HPAI have been detected 

in 1924, 1983 and 2004 in domestic 

poultry in this country. The 2004 

outbreak was confined to a single flock 

and rapidly eradicated. There were no 

human illnesses reported in connection 

with these outbreaks; however, HPAI 

subtype H5N1 has caused human illness 

and death in other countries where 

people have handled or been in close 

contact with infected birds or poultry. 

Live Birds and Poultry 

The regulations in part 93, subparts A 

and B, require that most birds and 

poultry imported into the United States 

be accompanied by a permit and health 

certificate and be quarantined upon 

arrival for a minimum of 30 days to 

ensure the birds’ or poultry’s freedom 

from END, HPAI subtype H5N1, and 

other communicable diseases, including 

other subtypes of HPAI. Pet birds of U.S. 

origin that are returning to the United 

States and that have not been in any 

region where HPAI subtype H5N1 exists 

have been exempt from quarantine if 

they have been outside the country for 

less than 60 days. Such pet birds have 

been allowed to be maintained in 

confinement at the owner’s residence, 

rather than in a USDA quarantine 

facility, if they have been outside the 

country for 60 days or more. Any U.S. 

origin pet birds or performing or 

theatrical birds or poultry that are 

returning to the United States and that 

have been in any region where HPAI 

subtype H5N1 exists have been required 

to undergo quarantine in a USDA 

facility, and may only be imported 

through certain ports (Los Angeles, CA, 

Miami, FL, or New York, NY). The 

regulations have also prohibited the 

importation of birds that have been 

vaccinated against Newcastle virus. 

While the regulations do not explicitly 

prohibit the importation of live birds or 

poultry from countries where END or 

HPAI is considered to exist, APHIS has 

been effectively prohibiting such 

imports by denying import permits 

under § 93.103(a)(2)(i) and 

§ 93.204(a)(2), which allow a permit to 

be denied based on communicable 

disease conditions in the area or region 

of origin. 

Changes Affecting the Importation of 

Live Birds and Poultry 

This interim rule makes several 

changes to the requirements for 

importing live birds and poultry to 

improve protection against the 

introduction of all subtypes of HPAI. 

First, we are prohibiting the entry of 

live birds or poultry that have been 

vaccinated for any H5 or H7 subtype of 

avian influenza. The prohibition will 

also apply to hatching eggs 1 that were 

laid by birds or poultry vaccinated for 

the H5 or H7 subtypes of avian 

influenza. The current prohibition in 

the regulations applies only to birds 

(including hatching eggs) that have been 

vaccinated for Newcastle disease. 

The changes we are making are based 

on our emergency preparedness plans 

for HPAI and the experience we gained 

following the 2004 outbreak of H5N2 in 

Gonzales County, TX. The preparedness 

plan is based on the best available 

science and developed in consultation 

with academic and industry experts. We 

have adopted a policy that reserves the 

use of H5 or H7 AI vaccines for control 

of HPAI outbreaks with the intent to 

implement vaccination on a strategic 

basis and under the supervision or 

control of USDA as part of an official 

USDA animal disease control program. 

The regulations in § 93.106 and 

§ 93.209 require that birds and poultry 

be quarantined in an approved facility 

for at least 30 days after importation 

into the United States and tested during 

quarantine for communicable diseases 

of poultry. Such testing now includes 

testing for all subtypes of avian 

influenza. Vaccination for H5 or H7 

strains of avian influenza could mask 

the presence of infection in imported 

birds, and vaccinated birds would have 

antibodies to H5 or H7 that would be 

detected during quarantine or routine 

surveillance, resulting in the birds being 

handled as if they were infected. 

Therefore, we are adding two new 

requirements addressing vaccination to 

Subpart A—Birds and Subpart B— 

Poultry in part 93. There is currently a 

statement in paragraph (b)(4) of 

§ 93.104, ‘‘Certificate for pet birds, 

commercial birds, zoological birds, and 

research birds,’’ that requires that the 

certificate accompanying such birds 

state that ‘‘the birds have not been 

vaccinated with Newcastle disease 

vaccine.’’ We are removing the 

requirement that birds are not 

vaccinated against Newcastle virus 

because it is standard practice in the 

United States. We are changing that 

required statement to ‘‘the birds have 

not been vaccinated with a vaccine for 

any H5 or H7 subtype of avian 

influenza.’’ We are also changing the 

similar statement contained in the 

parallel certificate requirement for 

ratites in § 93.104(c)(5) to read ‘‘the 

ratites have not been vaccinated with a 

vaccine for any H5 or H7 subtype of 

avian influenza.’’ We are also adding a 

statement to § 93.205, ‘‘Certificate for 

poultry,’’ to read ‘‘The certificate shall 

also state that the poultry have not been 

vaccinated with a vaccine for any H5 or 

H7 subtype of avian influenza.’’ A 

complementary sentence is added to 

§ 93.205(b) addressing poultry hatching 

eggs, requiring that the certificate 

accompanying them to state that ‘‘the 

hatching eggs are from poultry that have 

not been vaccinated with a vaccine for 

any H5 or H7 subtype of avian 

influenza.’’ These new certificate 

statement requirements are expected to 

add a recordkeeping burden of about 30 

minutes for each of the approximately 

718 certificates obtained each year, or a 

total burden of about 358 hours. These 

changes will effectively prohibit the 

importation of any live birds or live 

poultry that have been vaccinated for 

any H5 or H7 subtype of avian 

influenza, including hatching eggs from 

such birds. 

Second, we are prohibiting the 

importation into the United States of 

live birds or poultry that transit regions 

where HPAI of any subtype is 

considered to exist. Live birds and 

poultry cannot be kept in completely 

sealed containers or otherwise protected 

from contamination during shipment to 

the United States. The World 

Organization for Animal Health (the 

OIE) has found that secondary spread of 

avian influenza viruses is mainly by 

mechanical transfer of infective faeces, 

in which virus may be present at high 

concentrations and may survive for 

considerable periods and that the virus 

may be spread by birds or other animals 

that are not themselves susceptible to 

infection that become contaminated 

through contact with infected birds in 

transit.2 Water or feed present during 

transit may also become contaminated. 

In some cases caretakers, farm owners 

and staff, and trucks and drivers moving 

birds or delivering food have been 

implicated in the spread of virus. 

Consequently, there are significant risks 


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4048 Federal Register / Vol. 76, No. 15 / Monday, January 24, 2011 / Rules and Regulations 

of live birds or poultry contracting HPAI 

if allowed to move through regions 

where HPAI is considered to exist en 

route to the United States. 

We are making this change in 

§ 93.104, ‘‘Certificate for pet birds, 

commercial birds, zoological birds, and 

research birds,’’ which describes the 

certificate requirements for live poultry, 

live birds, and hatching eggs imported 

into the United States, and in § 93.205, 

‘‘Certificate for poultry,’’ which 

describes the certificate requirements 

for imported live poultry and hatching 

eggs. We are adding language to 

paragraphs (b)(6) and (c)(7) of § 93.104, 

and to paragraphs (a) and (b) of § 93.205 

to require that the certificate must state 

that the live poultry or birds it applies 

to have not been moved through a 

region identified in accordance with 

§ 94.6(a) as a region where any form of 

highly pathogenic avian influenza 

exists. 

Third, we are redescribing the 

applicability of the requirements in 

§ 93.101(c)(3) and (f)(3) for importing 

pet and theatrical birds. These 

paragraphs currently require 

importation only through certain ports 

and quarantine for any U.S. origin pet 

birds or performing or theatrical birds or 

poultry that are returning to the United 

States and that have been in any region 

where HPAI subtype H5N1 exists. This 

requirement will now apply to such 

birds that have been in any region 

where HPAI of any subtype exists. This 

change is consistent with the other 

changes in this rule that apply 

requirements equally whether HPAI 

subtype H5N1 or other subtypes are 

involved. 

Bird and Poultry Products and 

Byproducts 

Prior to this interim rule, the 

regulations in part 94, § 94.6, restricted 

the importation of carcasses, parts of 

products of carcasses, and eggs (other 

than hatching eggs) of poultry, game 

birds, and other birds, from regions 

where END or HPAI subtype H5N1 are 

considered to exist. 

Paragraph (a)(1) of § 94.6 stated that 

END is considered to exist in all regions 

of the world except those listed in 

paragraph (a)(2) of that section. 

Paragraph (a)(2) listed regions 

considered to be free of END, based on 

evaluations by APHIS. 

Paragraph (b) of § 94.6 contained 

requirements for importations from 

regions where END is considered to 

exist. Paragraph (b) provided that 

(except for game birds, which are 

eligible for importation if eviscerated, 

with heads and feet removed) carcasses 

and parts or products of carcasses may 

be imported only for consignment to an 

approved establishment, or if they are 

packed in hermetically sealed 

containers and cooked by a commercial 

method after such packing such that 

they are shelf stable without 

refrigeration, or if they have been 

thoroughly cooked. Paragraph (b) also 

contained provisions for the importation 

of poultry carcasses or parts or products 

of carcasses that originate in a region 

free of END and are then processed in 

a region where END is considered to 

exist. Additionally, paragraph (b) 

contained provisions for the importation 

under permit of carcasses or parts or 

products of carcasses of poultry, game 

birds, or other birds that do not 

otherwise meet the requirements of 

paragraph (b), when the Administrator 

determines that such importation will 

not constitute a risk of introducing or 

disseminating END into the United 

States. 

Paragraph (c) of 94.6 contained 

requirements for importing eggs (other 

than hatching eggs) from poultry, game 

birds, or other birds if the birds or 

poultry were raised in any region where 

END is considered to exist, if the eggs 

are imported from any region where 

END is considered to exist, or if the eggs 

are moved into or through any region 

where END is considered to exist at any 

time before importation or during 

shipment to the United States. 

Paragraph (c) provided that the eggs 

may be imported with a certificate that 

contains information documenting that 

the eggs do not present a risk of 

introducing END; or the eggs may be 

imported into an approved 

establishment for breaking and 

pasteurization; or the eggs may be 

imported into an approved 

establishment for scientific, educational, 

or research purposes. Additionally, 

paragraph (c) contained provisions for 

the importation under permit of eggs 

(other than hatching eggs) that do not 

otherwise meet the requirements of 

paragraph (c), when the Administrator 

determines that such importation will 

not constitute a risk of introducing END 

into the United States. 

Paragraph (d) of § 94.6 listed regions 

where HPAI subtype H5N1 is 

considered to exist. Paragraph (e) of 

§ 94.6 contained requirements for 

importing unprocessed carcasses and 

parts or products of unprocessed 

carcasses of poultry, game birds, or 

other birds from regions where HPAI 

subtype H5N1 is considered to exist. 

Paragraph (e) provided that such 

unprocessed products could only be 

imported under permit for scientific, 

educational, or research purposes and if 

the Administrator had determined that 

such importation could be made under 

conditions that will prevent the 

introduction of HPAI subtype H5N1. 

Such conditions are specified in the 

permit. 

Although prior to this interim rule, 

§ 94.6(b) applied only to carcasses and 

parts or products of carcasses of poultry, 

game birds, or other birds from regions 

where END is considered to exist, 

similar restrictions have been in general 

use among nations engaged in 

international trade of poultry products 

to prevent the introduction of both END 

and HPAI. Moreover, to date, all foreign 

regions where HPAI is considered to 

exist are also regions where END is 

considered to exist, so the restrictions 

have been applied de facto with regard 

to both diseases. 

However, APHIS expects that, over 

time, additional regions will be 

determined to be free from END, and 

some regions where END was 

considered to exist may successfully 

eradicate the disease and then be 

determined free from END. In such 

cases, import restrictions based on the 

presence of END would no longer apply 

to the regions, and, thus, would no 

longer protect against HPAI if it exists 

in the region. There is also a recent 

apparent increase in HPAI outbreaks 

worldwide and HPAI may become 

established in a region where END has 

never existed, resulting in an increasing 

threat of introducing HPAI into the 

United States through imported poultry 

or poultry products. Although we could 

take immediate action as outbreaks 

occur to issue Federal emergency action 

orders to prohibit the importation of 

birds and poultry and bird and poultry 

carcasses, or parts or products of 

carcasses, from such regions under the 

Animal Health Protection Act (7 U.S.C. 

8301 et seq.), we have determined that 

we need to establish regulatory 

safeguards that will be triggered by the 

discovery of an outbreak of any form of 

HPAI in commercial birds or poultry in 

a region, irrespective of whether END 

exists in the region. 

Changes Affecting the Importation of 

Bird and Poultry Products and 

Byproducts 

This interim rule explicitly applies 

the END provisions in current 

§ 94.6(b)(3), (b)(4), and (b)(5) that apply 

to bird and poultry carcasses, and parts 

or products of carcasses, from regions 

where END exists to regions where any 

subtype of HPAI is considered to exist. 

Paragraphs (b)(3) and (b)(4) of § 94.6 

require the products to be cooked in a 

manner that destroys the HPAI virus. 

Paragraph (b)(5) addresses products that 

originate in a region free of END and are 


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3OIE, Terrestrial Animal Health Code 2007, 

Appendix 3.6.5, ‘‘Guidelines for the Inactivation of 

the Avian Influenza Virus’’; http://www.oie.int/eng/ 

normes/mcode/code2007/en_chapitre_3.6.5.htm. 

4E.g., Thomas, C., King, D.J., Swayne, D.E. 2008. 

Thermal inactivation of avian influenza and 

Newcastle disease viruses in chicken meat. Journal 

of Food Protection. 71(6):1214–1222. 

then processed in a region not 

considered free of the disease. It allows 

products from free regions to be 

processed in regions not considered free 

under conditions designed to prevent 

contamination of the products. 

This interim rule does not apply the 

END provisions in § 94.6(b)(1) regarding 

game birds to HPAI regions. This 

paragraph states that carcasses of game 

birds may be imported from an END 

region if eviscerated, with heads and 

feet removed. We do not believe we 

have enough information at this time to 

conclude that this END-based restriction 

would also control HPAI. As discussed 

later in this document, we are 

requesting public comment on this 

issue. To make it clear that this interim 

rule paragraph does not allow 

importation of carcasses of game birds 

from regions where HPAI exists, it adds 

the following sentence to § 94.6(b)(1): 

‘‘Carcasses of game birds may not be 

imported from regions where HPAI is 

considered to exist.’’ 

In connection with the changes 

related to HPAI, we are establishing a 

list of regions where HPAI of any 

subtype exists. This list is discussed in 

more detail below under the heading 

‘‘The Lists of Regions.’’ Note that we are 

creating a single list of regions where 

any subtype of HPAI is considered to 

exist because we are applying the same 

conditions to importations from regions 

where HPAI subtype is considered to 

exist, regardless of the subtype of HPAI. 

Processed Carcasses, and Parts or 

Products of Carcasses 

In addition to applying certain 

requirements in § 94.6(b), ‘‘Carcasses, 

and parts or products of carcasses, from 

regions where END is considered to 

exist,’’ to HPAI as well as END, we are 

making one substantive change, 

concerning cooking, to these 

requirements. 

Prior to this interim rule, paragraph 

(b)(4) of § 94.6 required that cooked 

carcasses, parts, or products of poultry 

or other birds from END regions ‘‘have 

a thoroughly cooked appearance 

throughout.’’ In adapting this 

requirement to apply to both END and 

HPAI, we are changing the requirement 

to read that the articles must be ‘‘cooked 

to reach a minimum internal 

temperature throughout of 74 °C (165 

°F).’’ 

To protect against both END and 

HPAI, cooking must be sufficient to 

inactivate the viruses in poultry meat 

that cause these diseases. The former 

recommendation by the OIE was for 

cooking that achieves an internal 

temperature of 70 °C (158 °F) for 5 

seconds, but the 2007 Terrestrial 

Animal Health Code indicates that a 

standard of 73.9 °C (165 °F) for 0.51 

seconds is equally or more effective.3

Based on this OIE recommendation and 

the research supporting it, APHIS is 

applying this revised cooking standard 

with regard to both HPAI and END. We 

are rounding the temperature up from 

73.9 °C to 74 °C, to make it more 

practical for commercial treatment 

situations, and are eliminating the ‘‘for 

0.51 seconds’’ part of the standard 

because experience monitoring such 

cooking has shown that if the articles 

reach any given internal temperature, 

the temperature will endure for more 

than half a second. The cooking 

temperature of 74 °C (165 °F) is based 

on scientific data regarding the 

temperature required to inactivate both 

types of viruses, but also includes a 

small margin of error with regard to 

END to allow for the wide variety of 

commercial cooking practices around 

the world. Although studies indicate 

that END can be inactivated at a slightly 

lower temperature than HPAI, 

approximately 72 °C (162 °F), having a 

single standard will make the 

regulations easier to apply and enforce 

and will ensure that products from 

regions where either or both diseases 

exist do not present a risk of introducing 

either disease. Setting the same 

temperature requirement with regard to 

both diseases also reduces the 

possibility for processing error that 

could occur if cooking operations 

needed to frequently switch between, 

for instance, the former 70 °C (158 °F) 

OIE standard still used by some 

countries, a 72 °C (162 °F) requirement 

for END, and a 74 °C (165 °F) 

requirement for HPAI. 

The cooking temperatures required to 

inactivate these viruses are a matter of 

both regulatory and commercial 

concern. If the standard is set too low, 

there is a risk that significant amounts 

of infectious material may survive 

cooking. If the standard is set 

unnecessarily high, it increases the cost 

for producers and may degrade some 

products. We do not expect the new 

standard will significantly increase the 

cost of required cooking. Various 

scientific studies 4 are underway to 

further examine the optimal cooking 

standards to inactivate END or HPAI 

viruses in products, and APHIS may 

revisit this standard if new information 

indicates a need to do so. Therefore, we 

particularly invite public comment on 

this issue. 

The Lists of Regions 

Prior to this interim rule, § 94.6(a)(1) 

and (a)(2) identified regions where END 

is considered to exist and regions that 

are considered to be free of END, 

respectively. 

We are consolidating paragraphs (a)(1) 

and (a)(2) into a single paragraph (a)(1). 

We are also taking this opportunity to 

add to § 94.6(a)(1) a sentence explaining 

that a region on this list that is removed 

due to an outbreak of END may be 

returned to the list in accordance with 

the procedures for reestablishment of a 

region’s disease-free status in § 92.4. 

This information does not add any new 

requirements regarding END; it merely 

refers to another section of the 

regulations that is relevant to 

determining a region’s disease status. 

We are also adding a new paragraph 

(a)(2) that establishes a list of regions in 

which HPAI of any subtype is 

considered to exist. This list will 

include all regions where we consider 

HPAI subtype H5N1 to exist: 

Afghanistan, Albania, Azerbaijan, 

Bangladesh, Benin, Burkina Faso, 

Cambodia, Cameroon, China, Djibouti, 

Egypt, Ghana, Hong Kong, India, 

Indonesia, Iran, Iraq, Israel, Ivory Coast 

(Coˆte d’Ivoire), Japan, Jordan, 

Kazakhstan, Kuwait, Laos, Malaysia, 

Myanmar, Nepal, Niger, Nigeria, 

Pakistan, Palestinian Autonomous 

Territories, Romania, Russia, Saudi 

Arabia, South Korea, Sudan, Thailand, 

Togo, Turkey, Ukraine, and Vietnam. 

We are removing the list of regions 

where HPAI subtype H5N1 is 

considered to exist in § 94.6(d) because 

it is no longer needed. These changes 

consolidate into § 94.6(a) all the listings 

of the disease status of regions for END 

and HPAI, making § 94.6 easier to 

follow. 

Unlike paragraph (a)(1), which 

maintains a list of regions in the CFR, 

new paragraph (a)(2) for HPAI of any 

subtype will refer to a list that APHIS 

will maintain on its Web site. Copies of 

the list will also be available via postal 

mail, fax, or e-mail upon request to 

APHIS, Veterinary Services, National 

Center for Import and Export. Paragraph 

(a)(2)(ii) describes the procedures for 

adding regions to and removing regions 

from the list. The public will have the 

opportunity to comment on any changes 

to the list. 

The purpose of maintaining the list on 

the Web site is to maintain the most 

accurate, up-to-date list possible in a 

location where affected parties can 

easily view recent changes. The Web 


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site list should be particularly useful 

when a new region is added to the list, 

which occurs immediately after APHIS 

receives reliable reports of a new 

outbreak. Changes to lists maintained in 

the CFR are typically not published 

until days or even weeks after APHIS 

determines a region should be added to 

the list. As discussed in more detail 

below under the heading ‘‘Related Issues 

on Which APHIS is Seeking Comment,’’ 

we particularly invite commenters to 

address whether this approach should 

also be used not only for the new HPAI 

list of regions, but also with regard to 

the END list of regions in § 94.6(a)(1). 

A region will be added to the list of 

regions where HPAI exists when APHIS 

receives reports of outbreaks of the 

disease in commercial birds or poultry 

in the region from veterinary officials of 

the national government of the region 

and/or the World Organization for 

Animal Health (the OIE). The 

Administrator of APHIS may also add a 

region to the list based on outbreak 

reports he or she receives from other 

sources the Administrator determines to 

be reliable; e.g., reports from APHIS 

inspectors based in foreign countries. 

This last means of adding regions to the 

list allows APHIS to take prompt action 

as soon as it reliably learns of an 

outbreak, even before reports have been 

received and referred by the exporting 

country’s animal health agency or the 

OIE. This is the same basis APHIS has 

used to remove regions from the list of 

regions considered free of END, and to 

add regions to the list of regions where 

HPAI subtype H5N1 is considered to 

exist. The principle is the same for all 

such lists—the lists are changed as soon 

as APHIS has reliable reports of an 

outbreak of the relevant disease in the 

region. 

A region will be removed from the list 

of regions where HPAI is considered to 

exist only after APHIS completes an 

evaluation and makes it available for 

public comment through a notice 

published in the Federal Register. 

Following the close of the comment 

period, we will publish another notice 

responding to comments and 

announcing APHIS’ decision. 

In assessing the region’s disease 

status, APHIS takes into consideration 

our regulations in Part 92, ‘‘Importation 

of Animals and Animal Products: 

Procedures For Requesting Recognition 

of Regions,’’ as well as the standards of 

the OIE for disease-free status and all 

relevant information obtained from 

veterinary authorities in the region and 

through public comments. Additional 

information about the information 

APHIS will review can be found on the 

APHIS National Center for Import and 

Export Web site at http:// 

www.aphis.usda.gov/import_export/ 

animals/animal_disease_status.shtml. 

Prior to this interim rule, the 

regulations in § 95.30 provided that 

products and byproducts of poultry, 

game birds, or other birds from regions 

where HPAI subtype H5N1 is 

considered to exist could only be 

imported under permit and in 

accordance with conditions specified in 

the permit to prevent the introduction of 

HPAI subtype H5N1 into the United 

States. This section covers feathers, 

birds’ nests, bird trophies, and other 

products and byproducts not suitable 

for human consumption, whereas the 

regulations in part 94 generally cover 

meat and other products suitable for 

human consumption. This interim rule 

applies the regulatory requirements in 

this section to all subtypes of HPAI. 

Approved Establishments 

Paragraph (b)(5) of § 94.6 concerns 

processing of products in foreign 

regions. A footnote to that paragraph 

(footnote 5 prior to this interim rule, 

and renumbered in this interim rule as 

footnote 7) states that, as a condition of 

entry into the United States, products 

must be prepared only in what the 

footnote calls ‘‘approved 

establishments.’’ Prior to this interim 

rule, the term ‘‘approved 

establishments’’ in this footnote referred 

to establishments approved under the 

Poultry Products Inspection Act (PPIA, 

21 U.S.C. 451 et seq.) to prepare food 

products in accordance with regulations 

of USDA’s Food Safety and Inspection 

Service (FSIS). To avoid confusion with 

other uses of the term ‘‘approved 

establishment’’ in the regulations, we are 

changing the term that refers to 

establishments operating under the 

PPIA to ‘‘processing establishment.’’ We 

believe this change will prevent 

possible confusion due to the use of the 

term ‘‘approved establishment’’ in two 

other paragraphs in § 94.6. In a footnote 

to § 94.6(b)(2) (footnote 4 prior to this 

interim rule, and renumbered in this 

interim rule as footnote 5), the term 

refers to museums, educational 

institutions, or other establishments that 

are approved to receive bird or poultry 

carcasses for educational purposes. In 

§ 94.6(c)(2), the term refers to 

establishments that are approved by 

FSIS for breaking and pasteurization of 

eggs in a manner that will prevent the 

spread of disease. 

Products 

We are consolidating into one 

paragraph the requirements for 

carcasses and products with regard to 

both END and HPAI. Paragraph (b) of 

§ 94.6 is therefore retitled ‘‘Carcasses, 

and parts or products of carcasses, 

including meat, from regions where 

END or HPAI is considered to exist.’’ As 

part of this consolidation we are moving 

the requirements addressing products 

from a region where HPAI subtype 

H5N1 is considered to exist from 

§ 94.6(e) into § 94.6(b)(2), which applies 

to all subtypes of HPAI. Those 

requirements state that articles from 

such regions may only be consigned to 

certain types of establishments 

approved by the Administrator, must be 

accompanied by a permit, and must be 

moved and handled as specified on the 

permit. We are also removing § 94.6(e), 

because the requirements of this 

paragraph have been incorporated into 

§ 94.6(b)(2). 

We are adding the word ‘‘meat’’ in 

several places in § 94.6 where the text 

has said only ‘‘carcasses and parts or 

products of carcasses.’’ The phrase 

‘‘carcasses and parts or products of 

carcasses’’ includes meat in its meaning, 

but adding the word makes that clearer. 

We are also adding text and footnotes to 

refer readers to part 95 for regulations 

covering products not intended for 

human consumption. 

Corresponding Changes in Other Parts 

of Title 9, Subchapter D 

Finally, in conjunction with the 

changes to § 94.6 discussed above, we 

are making several changes to parts 93, 

94, and 95 that refer to § 94.6. All but 

three of these changes simply correct 

references to § 94.6(d)—the former 

location of the list of regions in which 

HPAI subtype H5N1 is considered to 

exist—to instead read ‘‘§ 94.6(a)(2).’’ 

One of the remaining changes is to 

§ 93.205, which contains certificate 

requirements for live poultry and 

hatching eggs. We are making 

nonsubstantive changes to § 93.205 to 

simplify it slightly and divide it into 

three subordinate paragraphs for ease in 

reading. 

The remaining two changes address 

requirements in §§ 93.209(b) and 94.26 

that have applied to regions where END 

is considered to exist. These 

requirements must now apply to regions 

where either END or HPAI exist. In 

§ 93.209(b), the relevant requirement is 

that poultry hatching eggs must be 

quarantined upon arrival in the United 

States for at least 30 days, unless they 

are from a region considered free of END 

and HPAI. Section 94.26 now requires 

an additional certification statement and 

other requirements to import live 

poultry and other products from certain 

regions that supplement their meat 

supply from, or have a common land 


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border with, regions considered to have 

either END or HPAI. 

Related Issues on Which APHIS Is 

Seeking Comment 

There are several additional issues 

related to HPAI and END for which we 

are seeking public comment. This 

interim rule does not make any of the 

possible changes discussed below, 

because there are no immediate risks 

associated with them that would justify 

immediate action. However, we believe 

the following changes would improve 

the effectiveness of our programs to 

prevent the introduction of HPAI, END, 

and other poultry diseases. 

As discussed above, the new list of 

regions considered to have HPAI of any 

subtype will be maintained on the 

APHIS Web site, not in the CFR. We are 

also considering listing the regions 

where END is considered to exist on the 

Web rather than in the CFR, and we are 

soliciting public comment on this issue. 

This change would help us maintain the 

most accurate, up-to-date list possible in 

a location where affected parties can 

easily view recent changes. We would 

continue to provide an opportunity for 

public comment on changes to the list. 

As now, when APHIS determines that a 

disease is present in a region that 

presents a potential threat to animal 

health in the United States, we would 

take immediate action to restrict imports 

from that region. However, we would 

not follow that action with an interim 

rule in the Federal Register (which is 

necessary to change text in the CFR, 

where the lists are currently located). 

Instead, we would list the region on the 

APHIS Web site, and announce the 

listing through a notice, rather than a 

rule, in the Federal Register, with an 

opportunity for public comment. As 

explained previously with respect to the 

process for adding or removing a region 

from the Web list for HPAI, we would 

consider END to exist in a region when 

APHIS receives reports of outbreaks of 

the disease in commercial birds or 

poultry in the region from veterinary 

officials of the national government of 

the region and/or the World 

Organization for Animal Health (the 

OIE), or receives reports of an outbreak 

from another source that the 

Administrator determines to be reliable; 

e.g., APHIS inspectors based in foreign 

countries. 

We would add a region to the list of 

those considered to be free of END only 

after completing an evaluation and 

making it available for public comment. 

We would do this through a notice in 

the Federal Register. Following the 

close of the comment period, we would 

publish another notice responding to 

comments and announcing APHIS’ 

decision. 

In assessing the region’s disease 

status, APHIS would take into 

consideration the same information it 

does now—our region recognition 

standards in part 92, the standards of 

the OIE for disease-free status, and all 

relevant information obtained from 

veterinary authorities in the region and 

through public comments. Additional 

information about the factors APHIS 

reviews to determine a region’s END 

and HPAI statuses may be found on the 

APHIS National Center for Import and 

Export Web site at http:// 

www.aphis.usda.gov/import_export/ 

animals/animal_disease_status.shtml. 

After evaluating public comments 

received on this issue in response to this 

interim rule, we may publish a final rule 

to establish a Web site list of regions’ 

disease status for END. That final rule 

would also remove the END list from 

§ 94.6(a)(1). We would at that time also 

name the regions included in the END 

Web site list, including any regions that 

have been added based on reports of 

END outbreaks since the last time the 

list was amended in the CFR. 

We also seek public comment on 

whether and how to change paragraph 

(c) of § 94.6 to address risks associated 

with importing table eggs from regions 

where HPAI is considered to exist. 

Paragraph 94.6(c) addresses importation 

of eggs (other than hatching eggs, which 

are regulated by part 93) from regions 

where END is considered to exist. It 

currently authorizes four ways such 

eggs may be imported, one of which is 

with a certificate stating that the flocks 

meet certain disease monitoring and 

testing requirements. These 

requirements involve placing sentinel 

birds in the flock and later testing them 

for END, or alternatively testing the 

carcasses of any poultry that die in the 

flock and also testing at least 10 percent 

of live birds. We are considering adding 

HPAI to the coverage of this paragraph, 

and requiring the appropriate tests and 

flock surveillance for HPAI where such 

tests and surveillance are already 

required for END. 

This document does not make any 

changes to § 94.6(c) related to HPAI 

because APHIS is still considering 

issues concerning the importation of 

table eggs from regions where HPAI is 

considered to exist, and we are 

soliciting public comment on the issues. 

In particular, we seek comments on 

whether a targeted testing program for 

HPAI in egg flocks in foreign regions is 

advisable, and how it could be designed 

to provide a statistically valid testing 

regimen. Any comments we receive on 

this subject will be considered if and 

when APHIS develops a rule on the 

subject. Those who wish to comment on 

this issue should also review a final rule 

APHIS published in the Federal 

Register on April 22, 2009 (‘‘Importation 

of Table Eggs from Regions Where 

Exotic Newcastle Disease Exists,’’ 

Docket No. APHIS–2007–0014; 74 FR 

18285–18288). That document changed 

§ 94.6(c) to create a protocol for targeted 

END testing of a statistically valid 

sample of dead, dying, and cull birds. 

We believe it would also be possible to 

create such a targeted testing program 

for HPAI, although the sample sizes, 

type of tests, and other technical details 

would vary. 

We also seek public comment on 

whether and how the requirements in 

§ 94.6(b)(1) for importing carcasses of 

game birds from regions where END 

exists should be changed. This 

paragraph primarily affects hunters 

returning to the United States with game 

birds they have shot. It allows carcasses 

of game birds to be imported from 

regions where END exists if they have 

been eviscerated and the heads and feet 

removed. The viscera, heads, and feet 

may not be imported into the United 

States. We are seeking comment on 

whether we should apply the same 

conditions to importation of carcasses of 

game birds from regions with HPAI. We 

further seek comment on whether 

different requirements should apply to 

carcasses of game birds depending on 

whether they are imported from a region 

with HPAI subtype H5N1, or from a 

region with another subtype of HPAI. In 

your comments, please address how any 

such requirement would address the 

risks of spreading HPAI associated with 

importing carcasses of game birds. 

Immediate Action 

This action is necessary to ensure 

continuing protection against the 

introduction of HPAI into the United 

States. All subtypes of HPAI are threats 

to U.S. poultry industries, and current 

regulations do not directly address all 

subtypes of HPAI, relying instead on the 

overlapped protection afforded by END 

restrictions. However, continuing rapid 

changes in world trade patterns make it 

likely that eventually poultry products 

may be imported from a region with 

HPAI but without END. Under these 

circumstances, the Administrator has 

determined that prior notice and 

opportunity for public comment are 

contrary to the public interest and that 

there is good cause under 5 U.S.C. 553 

for making this action effective less than 

30 days after publication in the Federal 

Register. 

We will consider comments we 

receive during the comment period for 


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this interim rule (see DATES above). 

After the comment period closes, we 

will publish another document in the 

Federal Register. The document will 

include a discussion of any comments 

we receive and any amendments we are 

making to the rule. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This rule has been determined to be 

significant for the purposes of Executive 

Order 12866 and, therefore, has been 

reviewed by the Office of Management 

and Budget. 

We have prepared an economic 

analysis for this rule. The economic 

analysis provides a cost-benefit analysis, 

as required by Executive Order 12866, 

and an initial regulatory flexibility 

analysis that examines the potential 

economic effects of this interim rule on 

small entities, as required by the 

Regulatory Flexibility Act. The 

economic analysis is summarized 

below. Copies of the full analysis are 

available by contacting the person listed 

under FOR FURTHER INFORMATION

CONTACT or on the Regulations.gov Web 

site (see ADDRESSES above for 

instructions for accessing 

Regulations.gov). The economic analysis 

is also available for review in our 

reading room (information on the 

location and hours of the reading room 

is listed under the heading ADDRESSES at 

the beginning of this document). 

This rule amends the regulations 

concerning the importation of animals 

and animal products to prohibit or 

restrict the importation of live birds and 

poultry and bird and poultry products 

from regions where any subtype of 

highly pathogenic avian influenza is 

considered to exist. The rule also adds 

restrictions concerning importation of 

live poultry and birds that have been 

vaccinated for the H5 and H7 subtypes 

of avian influenza, or that have moved 

through regions where any subtype of 

HPAI is considered to exist. These 

restrictions supplement existing 

restrictions on the importation of live 

birds and poultry, and bird and poultry 

products and byproducts from regions 

where exotic Newcastle disease or HPAI 

subtype H5N1 are considered to exist. 

They are necessary to prevent the 

introduction of HPAI into the United 

States. 

Because of the current substantial 

overlap between existing restrictions to 

prevent the importation of articles that 

could introduce END and the new 

restrictions to prevent the importation 

of articles that could spread HPAI, this 

rule is not expected to cause significant 

economic effects. The effects it does 

have benefit domestic poultry producers 

and the associated costs should be borne 

largely by importers of poultry and 

poultry products. 

Based on the domestic production 

and trade volumes, the interim rule is 

likely to benefit producers by protecting 

domestic flocks against the introduction 

of HPAI, while effects on consumers are 

expected to be negligible. The costs of 

complying with the requirements of the 

rule will largely be borne by persons 

importing poultry and poultry products 

into the United States. We do not expect 

small entities to be significantly affected 

by the interim rule, other than to benefit 

from the reduced risk of introduction 

into the United States of HPAI. Overall, 

the restrictions placed on imports of 

birds, poultry, and bird and poultry 

products will closely follow those 

already in place for END. The only 

substantive change will affect certain 

cooked poultry products with a 

requirement that cooked poultry 

carcasses or parts or products of 

carcasses be heated to a minimum 

internal temperature of 74 °C (165 °F) 

before shipment to the United States. 

Executive Order 12988 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. This rule: (1) Has no retroactive 

effect and (2) does not require 

administrative proceedings before 

parties may file suit in court challenging 

this rule. 

Paperwork Reduction Act 

In accordance with section 3507(j) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), the information 

collection and recordkeeping 

requirements included in this interim 

rule have been submitted for emergency 

approval to the Office of Management 

and Budget (OMB). OMB has assigned 

control number 0579–0367 to the 

information collection and 

recordkeeping requirements. 

We plan to request continuation of 

that approval for 3 years. Please send 

written comments on the 3-year 

approval request to the following 

addresses: (1) Office of Information and 

Regulatory Affairs, OMB, Attention: 

Desk Officer for APHIS, Washington, DC 

20503; and (2) Docket No. APHIS–2006– 

0074, Regulatory Analysis and 

Development, PPD, APHIS, Station 

3A–03.8, 4700 River Road Unit 118, 

Riverdale, MD 20737–1238. Please state 

that your comments refer to Docket No. 

APHIS–2006–0074 and send your 

comments within 60 days of publication 

of this rule. 

This interim rule affects the 

importation of birds and poultry and 

bird and poultry products from regions 

where any subtype of HPAI is 

considered to exist. The rule includes 

information collection activities. In 

many cases the information collection 

activities with regard to HPAI are 

already occurring because the countries 

involved have END. New information 

collections will generally occur only 

when products are imported from a 

country where HPAI is considered to 

exist but END is not considered to exist. 

Such cases should be rare, but when 

they do occur the information 

collections are associated with 

certificates and with recordkeeping 

required for processing facilities. 

In addition, this rule requires an 

additional statement on the certificate 

already required by § 93.104 for 

imported live birds and by § 93.205 for 

imported live poultry. That certificate 

must now contain an additional 

statement that the poultry it applies to 

have not been moved through a region 

considered to have any subtype of 

HPAI. Also, the certificate currently 

required by § 94.26 to import live 

poultry and other products from certain 

regions that supplement their meat 

supply from, or have a common land 

border with, regions considered to have 

END will now also be required for 

imports from regions considered to have 

HPAI. 

We are soliciting comments from the 

public (as well as affected agencies) 

concerning our information collection 

and recordkeeping requirements. These 

comments will help us: 

(1) Evaluate whether the information 

collection is necessary for the proper 

performance of our agency’s functions, 

including whether the information will 

have practical utility; 

(2) Evaluate the accuracy of our 

estimate of the burden of the 

information collection, including the 

validity of the methodology and 

assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

information collection on those who are 

to respond (such as through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology; e.g., permitting 

electronic submission of responses). 

Estimate of burden: Public reporting 

burden for this collection of information 

is estimated to average 0.4986072 hours 

per response. 

Respondents: U.S. importers, owners 

or operators of establishments that 

handle restricted or controlled 

materials, and foreign animal health 

authorities. 


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Estimated annual number of 

respondents: 416. 

Estimated annual number of 

responses per respondent: 1.7259615. 

Estimated annual number of 

responses: 718. 

Estimated total annual burden on 

respondents: 358 hours. (Due to 

averaging, the total annual burden hours 

may not equal the product of the annual 

number of responses multiplied by the 

reporting burden per response.) 

Copies of this information collection 

can be obtained from Mrs. Celeste 

Sickles, APHIS’ Information Collection 

Coordinator, at (301) 851–2908. 

E-Government Act Compliance 

The Animal and Plant Health 

Inspection Service is committed to 

compliance with the E-Government Act 

to promote the use of the Internet and 

other information technologies, to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. For information pertinent to 

E-Government Act compliance related 

to this interim rule, please contact Mrs. 

Celeste Sickles, APHIS’ Information 

Collection Coordinator, at (301) 851– 

2908. 

List of Subjects 

9 CFR Part 93 

Animal diseases, Imports, Livestock, 

Poultry and poultry products, 

Quarantine, Reporting and 

recordkeeping requirements. 

9 CFR Part 94 

Animal diseases, Imports, Livestock, 

Meat and meat products, Milk, Poultry 

and poultry products, Reporting and 

recordkeeping requirements. 

9 CFR Part 95 

Animal feeds, Hay, Imports, 

Livestock, Reporting and recordkeeping 

requirements, Straw, Transportation. 

Accordingly, we are amending 9 CFR 

parts 93, 94, and 95 as follows: 

PART 93—IMPORTATION OF CERTAIN 

ANIMALS, BIRDS, FISH, AND 

POULTRY, AND CERTAIN ANIMAL, 

BIRD, AND POULTRY PRODUCTS; 

REQUIREMENTS FOR MEANS OF 

CONVEYANCE AND SHIPPING 

CONTAINERS 

■ 1. The authority citation for part 93 

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. Section 93.101 is amended as 

follows: 

■ a. In paragraph (a), by adding a new 

sentence at the end of the paragraph to 

read as set forth below. 

■ b. In paragraphs (c)(2)(i) introductory 

text, (c)(2)(ii) introductory text, and 

(c)(2)(ii)(E)(2)(ii), by removing the words 

‘‘subtype H5N1’’ each time they appear. 

■ c. In paragraph (c)(3), by removing the 

words ‘‘listed in § 94.6(d) of this 

subchapter as a region where highly 

pathogenic avian influenza subtype 

H5N1’’ and adding the words ‘‘identified 

in accordance with § 94.6(a)(2) of this 

subchapter as a region where highly 

pathogenic avian influenza’’ in their 

place. 

■ d. In paragraphs (f)(2) introductory 

text and (f)(2)(iii)(B)(2), by removing the 

words ‘‘subtype H5N1’’ each time they 

appear. 

■ e. In paragraph (f)(3), by removing the 

words ‘‘listed in § 94.6(d) of this 

subchapter as a region where highly 

pathogenic avian influenza subtype 

H5N1’’ and adding the words ‘‘identified 

in accordance with § 94.6(a)(2) of this 

subchapter as a region where highly 

pathogenic avian influenza’’ in their 

place. 

§ 93.101 General prohibitions; exceptions. 

(a) * * * No live birds, and no 

hatching eggs from birds, shall be 

imported into the United States if the 

birds have been vaccinated for the H5 or 

H7 subtype of avian influenza. 

* * * * * 

§ 93.104 [Amended] 

■ 3. Section 93.104 is amended as 

follows: 

■ a. In paragraph (b)(4), by removing the 

words ‘‘Newcastle disease vaccine’’ and 

adding the words ‘‘with a vaccine for the 

H5 or H7 subtype of avian influenza’’ in 

their place. 

■ b. In paragraph (b)(6), by adding the 

words ‘‘, and that the birds have not 

been moved through a region identified 

in accordance with § 94.6(a) of this 

subchapter as a region where highly 

pathogenic avian influenza exists’’ 

immediately after the words 

‘‘exportation of the birds’’. 

■ c. In paragraph (c)(5), by adding the 

words ‘‘or with a vaccine for the H5 or 

H7 subtype of avian influenza’’ 

immediately after the word ‘‘vaccine’’. 

■ d. In paragraph (c)(7), by adding the 

words ‘‘, and that the ratites have not 

been moved through a region identified 

in accordance with § 94.6(a) of this 

subchapter as a region where highly 

pathogenic avian influenza exists’’ 

immediately after the word 

‘‘exportation’’. 

■ 4. Section 93.201 is amended as 

follows: 

■ a. In paragraph (a), by adding a new 

sentence at the end of the paragraph to 

read as set forth below. 

■ b. In paragraphs (c)(2) and (c)(3), by 

removing the words ‘‘subtype H5N1’’ 

each time they appear. 

§ 93.201 General prohibitions; exceptions. 

(a) * * * No live poultry, and no 

hatching eggs from poultry, shall be 

imported into the United States if the 

poultry have been vaccinated for the H5 

or H7 subtype of avian influenza. 

* * * * * 

■ 5. Section 93.205 is revised to read as 

follows: 

§ 93.205 Certificate for live poultry and 

hatching eggs. 

(a) Live poultry. All live poultry, 

except eggs for hatching, offered for 

importation from any region of the 

world shall be accompanied by a 

certificate stating that such poultry and 

their flock or flocks of origin were 

inspected on the premises of origin 

immediately before the date of 

movement from such region and that 

they were then found to be free of 

evidence of communicable diseases of 

poultry. The certificate shall also state 

that, as far as it has been possible to 

determine, during the 90 days prior to 

movement, the poultry were not 

exposed to communicable diseases of 

poultry and the premises were not in 

any area under quarantine. The 

certificate shall also state that the 

poultry have not been vaccinated with 

a vaccine for the H5 or H7 subtype of 

avian influenza. The certificate shall 

also state that the poultry have been 

kept in the region from which they are 

offered for importation since they were 

hatched, or for at least 90 days 

immediately preceding the date of 

movement, that the poultry have not 

been moved through a region identified 

in accordance with § 94.6(a) of this 

subchapter as a region where any form 

of highly pathogenic avian influenza 

exists, and that, as far as it has been 

possible to determine, no case of 

European fowl pest (fowl plague) or 

Newcastle disease occurred on the 

premises where such poultry were kept, 

or on adjoining premises, during that 

90-day period. 

(b) Hatching eggs. All eggs for 

hatching offered for importation from 

any part of the world shall be 

accompanied by a certificate stating that 

the flock or flocks of origin were found 

upon inspection to be free from 

evidence of communicable diseases of 

poultry, the hatching eggs are from 

poultry that have not been vaccinated 

with a vaccine for the H5 or H7 subtype 

of avian influenza and that during the 


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4Animal byproducts are regulated under part 95 

of this subchapter. 

5The names and addresses of approved 

establishments may be obtained from, and requests 

for approval may be made to the National Center 

for Import-Export, Veterinary Services, APHIS, 4700 

River Road, Unit 38, Riverdale, Maryland 20737– 

1231. 

90 days prior to movement, the flock or 

flocks of origin were not exposed to 

communicable diseases of poultry and 

the premises were not in any area under 

quarantine. 

(c) Nature of certificate. The 

certificate required by this section shall 

be issued by a salaried veterinary officer 

of the national government of the region 

of origin, or if the articles are exported 

from Mexico, may alternatively be 

issued by a veterinarian accredited by 

the National Government of Mexico and 

endorsed by a full-time salaried 

veterinary officer of the National 

Government of Mexico, thereby 

representing that the veterinarian 

issuing the certificate was authorized to 

do so. 

§ 93.209 [Amended] 

■ 6. In § 93.209, paragraph (b) is 

amended by removing the words 

‘‘designated in § 94.6(a)(2) of this 

subchapter as free of exotic Newcastle 

disease’’ and adding the words 

‘‘designated in § 94.6(a) of this 

subchapter as free of exotic Newcastle 

disease and highly pathogenic avian 

influenza’’ in their place. 

PART 94—RINDERPEST, FOOT-ANDMOUTH DISEASE, EXOTIC 

NEWCASTLE DISEASE, AFRICAN 

SWINE FEVER, CLASSICAL SWINE 

FEVER, SWINE VESICULAR DISEASE, 

AND BOVINE SPONGIFORM 

ENCEPHALOPATHY: PROHIBITED 

AND RESTRICTED IMPORTATIONS 

■ 7. The authority citation for part 94 

continues to read as follows: 

Authority: 7 U.S.C. 450, 7701–7772, 7781– 

7786, and 8301–8317; 21 U.S.C. 136 and 

136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 

371.4. 

§§ 94.8, 94.9, 94.12, 94.16, 94.17, 94.18, and 

94.24 [Amended] 

■ 8. Sections 94.8, 94.9, 94.12, 94.16, 

94.17, 94.18, and 94.24 are amended by 

redesignating footnotes 7 through 20 as 

footnotes 8 through 21, respectively. 

■ 9. Section 94.6 is amended as follows: 

■ a. By revising the section heading to 

read as set forth below. 

■ b. In paragraph (b), by removing 

footnotes 4 and 5. 

■ c. In paragraph (c), by redesignating 

footnote 6 as footnote 7. 

■ d. By revising paragraphs (a) and (b) 

to read as set forth below. 

■ e. By removing paragraphs (d) and (e) 

and redesignating paragraph (f) as 

paragraph (d). 

■ f. By revising the OMB citation at the 

end of the section to read as set forth 

below. 

§ 94.6 Carcasses, meat, parts or products 

of carcasses, and eggs (other than hatching 

eggs) of poultry, game birds, or other birds; 

importations from regions where exotic 

Newcastle disease or highly pathogenic 

avian influenza is considered to exist. 

(a) Disease status of regions for exotic 

Newcastle disease (END) and highly 

pathogenic avian influenza (HPAI). 

(1) Regions in which END is not 

considered to exist. (i) END is 

considered to exist in all the regions of 

the world except the following: 

Argentina, Australia, Canada, Chile, 

Costa Rica, Denmark, Fiji, Finland, 

France, Great Britain (England, 

Scotland, Wales, and the Isle of Man), 

Greece, Iceland, Luxembourg, Mexico 

(States of Campeche, Quintana Roo, and 

Yucatan), New Zealand, Republic of 

Ireland, Spain, Sweden, and 

Switzerland. APHIS has evaluated these 

regions for the presence of END. Regions 

not listed may have END, or may not 

have been evaluated for END status. 

(ii) APHIS will remove a region from 

the list in paragraph (a)(1)(i) of this 

section upon determining that END 

exists there based on reports APHIS 

receives of outbreaks of the disease in 

commercial birds or poultry from 

veterinary officials of the exporting 

country, from the World Organization 

for Animal Health (OIE), or from other 

sources the Administrator determines to 

be reliable. APHIS will add a region to 

this list after it conducts an evaluation 

of the region and finds that END is not 

likely to be present in its commercial 

bird or poultry populations. In the case 

of a region formerly on this list that is 

removed due to an outbreak, the region 

may be returned to the list in 

accordance with the procedures for 

reestablishment of a region’s diseasefree status in § 92.4 of this subchapter. 

(2) Regions in which HPAI is 

considered to exist. (i) A list of such 

regions is maintained on the APHIS 

National Center for Import and Export 

Web site at http://www.aphis.usda.gov/ 

import_export/animals/ 

animal_disease_status.shtml. Copies of 

the list will also be available via postal 

mail, fax, or e-mail upon request to 

Sanitary Trade Issue Team, National 

Center for Import and Export, Veterinary 

Services, Animal and Plant Health 

Inspection Service, 4700 River Road, 

Unit 38, Riverdale, Maryland 20737. 

(ii) APHIS will consider a region to 

have HPAI and add it to this list 

referenced in paragraph (a)(2)(i) of this 

section upon determining that HPAI 

exists in commercial birds or poultry in 

the region based on reports APHIS 

receives of outbreaks of the disease from 

veterinary officials of the exporting 

country, from the OIE, or from other 

sources the Administrator determines to 

be reliable. APHIS will remove a region 

from this list only after it conducts an 

evaluation of the region and finds that 

HPAI is not likely to be present in its 

commercial bird or poultry populations. 

(b) Carcasses, and parts or products of 

carcasses, including meat, from regions 

where END or HPAI is considered to 

exist. This paragraph applies to 

carcasses, and parts or products of 

carcasses,4 including meat, of poultry, 

game birds, or other birds that were 

raised or slaughtered in any region 

where END or any subtype of HPAI is 

considered to exist (see paragraph (a) of 

this section); are imported from any 

such region; or are moved into or 

through any such region at any time 

before importation or during shipment 

to the United States. 

(1) Carcasses of game birds, if 

eviscerated with heads and feet 

removed, may be imported from regions 

where END is considered to exist. 

Carcasses of game birds may not be 

imported from regions where any 

subtype of HPAI is considered to exist. 

Viscera, heads, and feet removed from 

game birds in any of these regions are 

ineligible for entry into the United 

States. 

(2) Carcasses, or parts or products of 

carcasses, of poultry, game birds, and 

other birds may be imported for 

consignment to any museum, 

educational institution or other 

establishment which has provided the 

Administrator with evidence that it has 

the equipment, facilities, and 

capabilities to store, handle, process, or 

disinfect such articles so as to prevent 

the introduction or dissemination of 

END or HPAI into the United States, and 

which is approved by the 

Administrator.5

(3) Carcasses, or parts or products of 

carcasses, including meat, of poultry, 

game birds, or other birds, may be 

imported if packed in hermetically 

sealed containers and if cooked by a 

commercial method after such packing 

to produce articles that are shelf stable 

without refrigeration. 

(4) Carcasses and parts or products of 

carcasses, including meat, of poultry, 

game birds, or other birds, may be 

imported if they are accompanied by a 

certificate that is signed by a full-time, 

salaried veterinarian of the government 

agency responsible for animal health in 


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6As a condition of entry into the United States, 

poultry species and poultry products addressed by 

the Poultry Products Inspection Act (PPIA, 21 

U.S.C. 451 et seq.) and regulations thereunder (9 

CFR, chapter III, part 381), must also meet all of the 

requirements of the PPIA and part 381, including 

requirements that the poultry or poultry products 

be prepared only in establishments approved by 

FSIS. Species subject to these requirements include 

chickens, turkeys, ducks, geese, guineas, ratites, or 

squabs. 

the region and that specifies that the 

articles were cooked throughout to 

reach a minimum internal temperature 

of 74 °C (165 °F). 

(5) Carcasses, and parts or products of 

carcasses, including meat, of poultry, 

game birds, or other birds, that 

originated in a region considered to be 

free of END and any subtype of HPAI, 

and that are processed (cut, packaged, or 

other processing) in a region where END 

or HPAI is considered to exist, may be 

imported under the following 

conditions: 

(i) Shipment to processing 

establishments. All poultry, game bird, 

or other bird products from such regions 

shall be shipped from the END and 

HPAI-free region where they originated 

to a processing establishment 6 in the 

region where END or HPAI is 

considered to exist in closed containers 

sealed with serially numbered seals 

applied by an official of the national 

government of that region. They must be 

accompanied by a certificate that is 

signed by a full-time, salaried 

veterinarian of the government agency 

responsible for animal health in the 

region and that specifies the products’ 

region of origin, the processing 

establishment to which the carcasses or 

parts or products are consigned, and the 

numbers of the seals applied to the 

shipping containers. 

(A) The poultry, game bird, or other 

bird carcasses or parts or products may 

be removed from containers at the 

processing establishment in the region 

where END or HPAI is considered to 

exist only after an official of the national 

government has determined that the 

seals are intact and free of any evidence 

of tampering. The official must attest to 

this fact by signing the certificate 

accompanying the shipment. 

(B) [Reserved] 

(ii) Handling of poultry, game bird, or 

other bird carcasses or parts or 

products. Establishments in regions 

where END or HPAI is considered to 

exist that process poultry, game bird, or 

other bird carcasses or parts or products 

for export to the United States: 

(A) May not receive or handle any live 

poultry or birds. 

(B) Must keep any records required by 

this section on file at the facility for a 

period of at least 2 years after export of 

processed products to the United States, 

and must make those records available 

to USDA inspectors during inspections. 

(C) May process carcasses or parts or 

products that originate in any region, 

provided that: 

(1) All areas, utensils, and equipment 

likely to contact the carcasses or parts 

or products to be processed, including 

skinning, deboning, cutting, and 

packing areas, are cleaned and 

disinfected between processing 

carcasses or parts or products from 

regions where END or HPAI is 

considered to exist and processing those 

from END and HPAI-free regions. 

(2) Carcasses or parts or products 

intended for export to the United States 

are not handled, cut, or otherwise 

processed at the same time as any 

carcasses or parts or products not 

eligible for export to the United States. 

(3) Carcasses or parts or products 

intended for export to the United States 

are packed in clean new packaging that 

is clearly distinguishable from that 

containing any carcasses or parts or 

products not eligible for export to the 

United States. 

(4) Carcasses or parts or products are 

stored in a manner that ensures that no 

cross-contamination occurs. 

(iii) Cooperative service agreement. 

Operators of processing establishments 

must enter into a cooperative service 

agreement with APHIS to pay all 

expenses incurred by APHIS in 

inspecting the establishment. APHIS 

anticipates that such inspections will 

occur once a year. The cooperative 

service account must always contain a 

balance that is at least equal to the cost 

of one inspection. APHIS will charge 

the cooperative service account for 

travel, salary, and subsistence of APHIS 

employees, as well as administrative 

overhead and other incidental expenses 

(including excess baggage charges up to 

150 pounds). 

(iv) Shipment to the United States. 

Poultry, game bird, or other bird 

carcasses or parts or products to be 

imported into the United States must be 

shipped from the region where they 

were processed in closed containers 

sealed with serially numbered seals 

applied by an official of the national 

government of that region. The 

shipments must be accompanied by a 

certificate signed by an official of the 

national government of the region where 

articles were processed that lists the 

numbers of the seals applied and states 

that all of the conditions of this section 

have been met. A copy of this certificate 

must be kept on file at the processing 

establishment for at least 2 years. 

(6) Poultry, game bird, or other bird 

carcasses or parts or products that do 

not otherwise qualify for importation 

under paragraphs (b)(1) through (5) of 

this section may be imported only if the 

importer applies to, and is granted a 

permit by, the Administrator, 

authorizing such importation. A permit 

will be given only when the 

Administrator determines that such 

importation will not constitute a risk of 

introduction or dissemination of END or 

HPAI into the United States. 

Application for a permit may be made 

in accordance with paragraph (d) of this 

section. 

* * * * * 

(Approved by the Office of Management and 

Budget under control numbers 0579–0015, 

0579–0245, 0579–0328, and 0579–0367) 

§ 94.9 [Amended] 

■ 10. Section 94.9 is amended by 

revising newly redesignated footnote 12 

to paragraph (e)(2) introductory text to 

read ‘‘ 12 See footnote 9.’’ 

§ 94.12 [Amended] 

■ 11. Section 94.12 is amended by 

revising newly redesignated footnote 14 

to paragraph (b)(3) to read ‘‘ 14 See 

footnote 11.’’ 

§ 94.17 [Amended] 

■ 12. Section 94.17 is amended by 

revising newly redesignated footnote 17 

to paragraph (p)(1) introductory text to 

read ‘‘ 17 See footnote 16.’’ 

§ 94.26 [Amended] 

■ 13. Section 94.26 is amended as 

follows: 

■ a. In the introductory text, by 

removing the citation ‘‘§ 94.6(a)(2)’’ and 

adding the citation ‘‘§ 94.6(a)(1)’’ in its 

place. 

■ b. In paragraph (b) introductory text, 

(c)(1), and (c)(4), by removing the words 

‘‘§ 94.6 as free of END’’ each time they 

appear and adding the words ‘‘§ 94.6(a) 

as free of END and highly pathogenic 

avian influenza’’ in their place. 

PART 95—SANITARY CONTROL OF 

ANIMAL BYPRODUCTS (EXCEPT 

CASINGS), AND HAY AND STRAW, 

OFFERED FOR ENTRY INTO THE 

UNITED STATES 

■ 14. The authority citation for part 95 

continues to read as follows: 

Authority: 7 U.S.C. 8301–8317; 21 U.S.C. 

136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 

2.80, and 371.4. 

§ 95.30 [Amended] 

■ 15. Section 95.30 is amended as 

follows: 

■ a. In the section heading and 

paragraph (a), by removing the words 

‘‘subtype H5N1’’ each time they appear. 


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4056 Federal Register / Vol. 76, No. 15 / Monday, January 24, 2011 / Rules and Regulations 

■ b. In paragraph (a), by removing the 

words ‘‘listed in § 94.6(d)’’ and adding 

the words ‘‘identified in accordance 

with § 94.6(a)(2)’’ in their place. 

Done in Washington, DC this 12th day of 

January 2011. 

Edward M. Avalos, 

Under Secretary for Marketing and Regulatory 

Programs. 

[FR Doc. 2011–1289 Filed 1–21–11; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2011–0054; Directorate 

Identifier 2010–CE–070–AD; Amendment 

39–16582; AD 2011–01–53] 

RIN 2120–AA64 

Airworthiness Directives; PIAGGIO 

AERO INDUSTRIES S.p.A Model 

PIAGGIO P–180 Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; request for 

comments. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for the 

products listed above. This emergency 

AD was sent previously to all known 

U.S. owners and operators of these 

airplanes. This AD supersedes 

Emergency AD 2011–01–51, requires an 

immediate functional test of the fuselage 

drain holes, and requires sending a 

report of the results to the FAA. This 

AD also allows, with noted exceptions, 

for the return/position of the airplane to 

a home base, hangar, maintenance 

facility, etc. This AD was prompted by 

reports of water accumulation in the 

belly of the fuselage that froze and 

caused the flight controls to jam. We are 

issuing this AD to prevent water or fluid 

from accumulating in the belly of the 

fuselage and freezing when the aircraft 

reaches and holds altitudes where the 

temperature is below the freezing point. 

This condition could cause the flight 

controls to jam with consequent loss of 

control. 

DATES: This AD is effective January 24, 

2011 to all persons except those persons 

to whom it was made immediately 

effective by Emergency AD 2011–01–53, 

issued on December 20, 2010, which 

contained the requirements of this 

amendment. 

We must receive comments on this 

AD by March 10, 2011. 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Portal: Go to 

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

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, 

M–30, West Building Ground Floor, 

Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590. 

• Hand Delivery: Deliver to Mail 

address above between 9 a.m. and 

5 p.m., Monday through Friday, except 

Federal holidays. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http:// 

www.regulations.gov; or in person at the 

Docket Operations Office between 

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

Friday, except Federal holidays. The AD 

docket contains this AD, the regulatory 

evaluation, any comments received, and 

other information. The street address for 

the Docket Operations Office (phone: 

800–647–5527) is in the ADDRESSES

section. Comments will be available in 

the AD docket shortly after receipt. 

FOR FURTHER INFORMATION CONTACT: 

Mike Kiesov, Aerospace Engineer, Small 

Airplane Directorate, FAA, 901 Locust, 

Kansas City, MO 64106; phone: (816) 

329–4144; fax: (816) 329–4090; e-mail: 

mike.kiesov@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Discussion 

The European Aviation Safety Agency 

(EASA), which is the Technical Agent 

for the Member States of the European 

Community, is considered the State of 

Design for PIAGGIO AERO 

INDUSTRIES S.p.A Model PIAGGIO P– 

180 airplanes. A reported occurrence of 

the flight controls jamming on a Model 

PIAGGIO P–180 airplane prompted 

EASA to issue AD No. 2007–0025, dated 

February 1, 2007. This prompted the 

FAA to issue AD 2007–24–15, 

Amendment 39–15281 (72 FR 67843, 

December 3, 2007). AD 2007–24–15 

requires correcting the fuselage drain 

system and ensuring that the drain lines 

of the environmental unit condenser are 

not clogged. 

Since AD 2007–24–15 became 

effective, we received reports of two 

additional incidences of water 

accumulating in the belly of the fuselage 

that froze and caused the flight controls 

to jam on Model PIAGGIO P–180 

airplanes. These reports prompted us to 

issue Emergency AD 2011–01–51 on 

December 18, 2010, to require an 

immediate functional test of the fuselage 

drain holes and submitting a report of 

the results to the FAA. It also allows, 

with noted exceptions, for the return/ 

position of the airplane to a home base, 

hangar, maintenance facility, etc. 

After we issued Emergency AD 2011– 

01–51, we realized that we 

inadvertently omitted figure 2 in 

Appendix 1. This prompted us to 

supersede Emergency AD 2011–01–51 

and issue Emergency AD 2011–01–53. 

This condition, if not corrected, could 

result in water or fluid accumulating in 

the belly of the fuselage and freezing 

when the aircraft reaches and holds 

altitudes where the temperature is 

below the freezing point, which could 

cause the flight controls to jam with 

consequent loss of control. 

FAA’s Determination 

We are issuing this AD because we 

evaluated all the relevant information 

and determined the unsafe condition 

described previously is likely to exist or 

develop in other products of the same 

type design. 

AD Requirements 

We are superseding Emergency AD 

2011–01–51 with a new AD, which was 

issued as Emergency AD 2011–01–53 on 

December 20, 2010. This AD retains the 

actions from Emergency AD 2011–01– 

51, adds figure 2 to Appendix 1, and 

corrects other minor typographical 

errors. 

Interim Action 

We consider this AD interim action. 

The FAA is working with EASA and 

PIAGGIO on this unsafe condition. Due 

to the nature of the immediate safety of 

flight situation, the FAA is working this 

AD concurrently with EASA instead of 

waiting for EASA, as the State of Design, 

to issue an AD. Thus, this action is 

considered unilateral AD action. 

FAA’s Determination of the Effective 

Date 

An unsafe condition exists that 

requires the immediate adoption of this 

AD. The FAA has found that the risk to 

the flying public justifies waiving notice 

and comment prior to adoption of this 

rule because water or fluid 

accumulating in the belly of the fuselage 

and freezing could cause the flight 

controls to jam with consequent loss of 

control. Therefore, we find that notice 

and opportunity for prior public 

comment are impracticable and that 

good cause exists for making this 

amendment effective in less than 30 

days. 

Comments Invited 

This AD is a final rule that involves 

requirements affecting flight safety and 

was not preceded by notice and an 

opportunity for public comment. 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1