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[Federal Register: January 24, 2011 (Volume 76, Number 15)]
[Rules and Regulations]               
[Page 4046-4056]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ja11-2]                         

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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.

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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=DocketDetail&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 
low-pathogenicity 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

[[Page 4047]]

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 
Sec.  93.103(a)(2)(i) and Sec.  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.
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    \1\ Hatching eggs are eggs intended and used for hatching, and 
do not include embryonated eggs for consumption, such as balut eggs.
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    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 Sec.  93.106 and Sec.  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 Sec.  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 Sec.  
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 Sec.  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 Sec.  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

[[Page 4048]]

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.
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    \2\ See, 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.
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    We are making this change in Sec.  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 Sec.  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 Sec.  93.104, and to 
paragraphs (a) and (b) of Sec.  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 Sec.  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 
Sec.  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, Sec.  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 Sec.  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 Sec.  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 Sec.  94.6 listed regions where HPAI subtype H5N1 
is considered to exist. Paragraph (e) of Sec.  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, Sec.  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 
Sec.  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 Sec.  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

[[Page 4049]]

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 Sec.  
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 Sec.  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 Sec.  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 Sec.  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 [deg]C (165 
[deg]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 [deg]C (158 [deg]F) for 5 seconds, but the 
2007 Terrestrial Animal Health Code indicates that a standard of 73.9 
[deg]C (165 [deg]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 [deg]C to 74 [deg]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 [deg]C (165 [deg]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 [deg]C (162 [deg]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 [deg]C 
(158 [deg]F) OIE standard still used by some countries, a 72 [deg]C 
(162 [deg]F) requirement for END, and a 74 [deg]C (165 [deg]F) 
requirement for HPAI.
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    \3\ OIE, 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.
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    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.
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    \4\ E.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.
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The Lists of Regions

    Prior to this interim rule, Sec.  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 Sec.  
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 Sec.  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 (C[ocirc]te 
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 Sec.  94.6(d) because it is 
no longer needed. These changes consolidate into Sec.  94.6(a) all the 
listings of the disease status of regions for END and HPAI, making 
Sec.  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

[[Page 4050]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  94.6. In a footnote to 
Sec.  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 Sec.  
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 Sec.  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 Sec.  94.6(e) into Sec.  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 Sec.  94.6(e), because the requirements of this 
paragraph have been incorporated into Sec.  94.6(b)(2).
    We are adding the word ``meat'' in several places in Sec.  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 Sec.  94.6 discussed 
above, we are making several changes to parts 93, 94, and 95 that refer 
to Sec.  94.6. All but three of these changes simply correct references 
to Sec.  94.6(d)--the former location of the list of regions in which 
HPAI subtype H5N1 is considered to exist--to instead read ``Sec.  
94.6(a)(2).''
    One of the remaining changes is to Sec.  93.205, which contains 
certificate requirements for live poultry and hatching eggs. We are 
making nonsubstantive changes to Sec.  93.205 to simplify it slightly 
and divide it into three subordinate paragraphs for ease in reading.
    The remaining two changes address requirements in Sec. Sec.  
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 Sec.  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

[[Page 4051]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 
Sec.  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

[[Page 4052]]

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 [deg]C (165 [deg]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 Sec.  93.104 for imported live birds 
and by Sec.  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 Sec.  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.

[[Page 4053]]

    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

0
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.

0
2. Section 93.101 is amended as follows:
0
a. In paragraph (a), by adding a new sentence at the end of the 
paragraph to read as set forth below.
0
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.
0
c. In paragraph (c)(3), by removing the words ``listed in Sec.  94.6(d) 
of this subchapter as a region where highly pathogenic avian influenza 
subtype H5N1'' and adding the words ``identified in accordance with 
Sec.  94.6(a)(2) of this subchapter as a region where highly pathogenic 
avian influenza'' in their place.
0
d. In paragraphs (f)(2) introductory text and (f)(2)(iii)(B)(2), by 
removing the words ``subtype H5N1'' each time they appear.
0
e. In paragraph (f)(3), by removing the words ``listed in Sec.  94.6(d) 
of this subchapter as a region where highly pathogenic avian influenza 
subtype H5N1'' and adding the words ``identified in accordance with 
Sec.  94.6(a)(2) of this subchapter as a region where highly pathogenic 
avian influenza'' in their place.

Sec.  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.
* * * * *

Sec.  93.104  [Amended]

0
3. Section 93.104 is amended as follows:
0
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.
0
b. In paragraph (b)(6), by adding the words ``, and that the birds have 
not been moved through a region identified in accordance with Sec.  
94.6(a) of this subchapter as a region where highly pathogenic avian 
influenza exists'' immediately after the words ``exportation of the 
birds''.
0
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''.
0
d. In paragraph (c)(7), by adding the words ``, and that the ratites 
have not been moved through a region identified in accordance with 
Sec.  94.6(a) of this subchapter as a region where highly pathogenic 
avian influenza exists'' immediately after the word ``exportation''.

0
4. Section 93.201 is amended as follows:
0
a. In paragraph (a), by adding a new sentence at the end of the 
paragraph to read as set forth below.
0
b. In paragraphs (c)(2) and (c)(3), by removing the words ``subtype 
H5N1'' each time they appear.

Sec.  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.
* * * * *

0
5. Section 93.205 is revised to read as follows:

Sec.  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 Sec.  
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

[[Page 4054]]

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.

Sec.  93.209  [Amended]

0
6. In Sec.  93.209, paragraph (b) is amended by removing the words 
``designated in Sec.  94.6(a)(2) of this subchapter as free of exotic 
Newcastle disease'' and adding the words ``designated in Sec.  94.6(a) 
of this subchapter as free of exotic Newcastle disease and highly 
pathogenic avian influenza'' in their place.

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, EXOTIC NEWCASTLE 
DISEASE, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, SWINE 
VESICULAR DISEASE, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED 
AND RESTRICTED IMPORTATIONS

0
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.

Sec. Sec.  94.8, 94.9, 94.12, 94.16, 94.17, 94.18, and 94.24  [Amended]

0
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.
0
9. Section 94.6 is amended as follows:
0
a. By revising the section heading to read as set forth below.
0
b. In paragraph (b), by removing footnotes 4 and 5.
0
c. In paragraph (c), by redesignating footnote 6 as footnote 7.
0
d. By revising paragraphs (a) and (b) to read as set forth below.
0
e. By removing paragraphs (d) and (e) and redesignating paragraph (f) 
as paragraph (d).
0
f. By revising the OMB citation at the end of the section to read as 
set forth below.

Sec.  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 
disease-free status in Sec.  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.
---------------------------------------------------------------------------

    \4\ Animal byproducts are regulated under part 95 of this 
subchapter.
---------------------------------------------------------------------------

    (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\
---------------------------------------------------------------------------

    \5\ The 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.
---------------------------------------------------------------------------

    (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

[[Page 4055]]

the region and that specifies that the articles were cooked throughout 
to reach a minimum internal temperature of 74 [deg]C (165 [deg]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.
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    \6\ As 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.
---------------------------------------------------------------------------

    (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)

Sec.  94.9  [Amended]

0
10. Section 94.9 is amended by revising newly redesignated footnote 12 
to paragraph (e)(2) introductory text to read `` \12\ See footnote 9.''

Sec.  94.12  [Amended]

0
11. Section 94.12 is amended by revising newly redesignated footnote 14 
to paragraph (b)(3) to read `` \14\ See footnote 11.''

Sec.  94.17  [Amended]

0
12. Section 94.17 is amended by revising newly redesignated footnote 17 
to paragraph (p)(1) introductory text to read `` \17\ See footnote 
16.''

Sec.  94.26  [Amended]

0
13. Section 94.26 is amended as follows:
0
a. In the introductory text, by removing the citation ``Sec.  
94.6(a)(2)'' and adding the citation ``Sec.  94.6(a)(1)'' in its place.
0
b. In paragraph (b) introductory text, (c)(1), and (c)(4), by removing 
the words ``Sec.  94.6 as free of END'' each time they appear and 
adding the words ``Sec.  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

0
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.

Sec.  95.30  [Amended]

0
15. Section 95.30 is amended as follows:
0
a. In the section heading and paragraph (a), by removing the words 
``subtype H5N1'' each time they appear.

[[Page 4056]]

0
b. In paragraph (a), by removing the words ``listed in Sec.  94.6(d)'' 
and adding the words ``identified in accordance with Sec.  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
```