Highly Pathogenic Avian Influenza, 70997-71007 [2014-28244]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 79, Number 230 (Monday, December 1, 2014)]
[Rules and Regulations]
[Pages 70997-71007]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28244]


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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: Final rule.

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SUMMARY: We are adopting as a final rule, with changes, an interim rule 
that amended the regulations concerning the importation of animals and 
animal products to prohibit or restrict the importation of live birds 
and poultry (including hatching eggs) and bird and poultry products 
from regions where any subtype of highly pathogenic avian influenza 
(HPAI) is considered to exist. The interim rule also added restrictions 
concerning importation of live birds and poultry that have been moved 
through regions where HPAI is considered to exist, or that have been 
vaccinated for certain types of avian influenza. This final rule amends 
the interim rule to allow the importation of live zoological birds and 
poultry that have been vaccinated for avian influenza as part of an 
official program and under specific conditions as determined by the 
Administrator and to allow the importation of HPAI-resistant pigeons, 
doves, and other Columbiform species under certain conditions from 
regions where HPAI is considered to exist. This action will provide for 
the importation of certain zoological birds and poultry under specified 
conditions designed to minimize the risk of introducing HPAI into the 
United States.

DATES: Effective December 1, 2014.

FOR FURTHER INFORMATION CONTACT: Mr. Javier Vargas, Case Manager, 
National Import Export Services, Animal Health Policy and Programs, VS, 
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737; (301) 851-3300.

SUPPLEMENTARY INFORMATION:

Background

    In an interim rule \1\ effective and published in the Federal 
Register on January 24, 2011 (76 FR 4046-4056, Docket No. APHIS-2006-
0074), we amended the regulations in 9 CFR parts 93, 94, and 95 \2\ 
concerning the importation of animals and animal products to prohibit 
or restrict the importation of bird and poultry products from regions 
where highly pathogenic avian influenza (HPAI) is considered to exist 
by applying mitigations similar to those we use for Newcastle 
disease.\3\ The interim rule included restrictions concerning 
importation of live birds and poultry (including hatching eggs) that 
have been vaccinated for certain types of avian influenza or that have 
been moved through regions where HPAI is considered to exist. In 
addition, the interim rule updated cooking requirements to specifically 
include carcasses, parts, or products of poultry or other birds from 
regions where HPAI is considered to exist. These actions were necessary 
to prevent the introduction of HPAI into the United States.
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    \1\ To view the interim rule, supporting documents, the May 2011 
and June 2012 documents reopening the comment period, and the 
comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2006-0074.
    \2\ On December 4, 2013, we published another rulemaking, 
``Bovine Spongiform Encephalopathy; Importation of Bovines and 
Bovine Products'' (78 FR 72980-73008) that redesignated the sections 
we amended in part 95 in the interim rule. These redesignations are 
reflected in this final rule.
    \3\ The interim rule used the term ``exotic Newcastle disease'' 
or ``END.'' In this document, we have removed the word ``exotic'' 
from the term to reflect changes made to the regulations in a final 
rule published March 29, 2013 (78 FR 19080-19085).
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    We solicited comments concerning the interim rule for 60 days 
ending March 25, 2011. We reopened the comment period \4\ for 15 days 
ending May 18, 2011, to give commenters more time to respond. We 
reopened the

[[Page 70998]]

comment period a second time \5\ for 30 days ending July 12, 2012, to 
solicit comments on allowing the importation of pigeons, doves, and 
other Columbiform species from regions considered to have HPAI after 
establishing that importation of these species poses a low risk of 
introducing HPAI into the United States.
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    \4\ Federal Register, May 3, 2011 (76 FR 24793, Docket No. 
APHIS-2006-0074).
    \5\ Federal Register, June 12, 2012 (77 FR 34783-34784, Docket 
No. APHIS-2006-0074).
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    We received a total of 19 comments during those three comment 
periods. Commenters included a State veterinary official, a foreign 
government official, veterinarians, associations representing U.S. zoos 
and zoo veterinarians, an ornithological research organization, egg 
industry representatives, a restaurant chain, and the general public. A 
consumer food safety organization commented by submitting a letter with 
17,540 copies signed by members of the public.
    We have carefully considered the comments we received. Three 
commenters expressed concerns about the risk of HPAI but did not 
substantively address any specifics of the interim rule. The remaining 
comments are discussed below by topic.

General Comments

    One commenter objected to our issuing an interim rule instead of a 
proposed rule, noting that we made effective the action to prohibit or 
restrict the importation of live birds and poultry, and bird and 
poultry products, from regions where HPAI is considered to exist 
without first soliciting public comments.
    Immediate action was necessary to prevent the introduction of HPAI 
into the United States. Under those circumstances, we determined that 
prior notice and opportunity for public comment were contrary to the 
public interest and that there was good cause under 5 U.S.C. 553(b)(B) 
for making the interim rule effective upon publication in the Federal 
Register.
    In the interim rule, we requested comment on whether the list of 
regions considered to be free of Newcastle disease in 9 CFR 94.6(a)(1) 
should be removed from the regulations and posted on the Animal and 
Plant Health Inspection Service (APHIS) Web site, as we have done with 
similar lists of regions.
    Two commenters agreed with the idea and no commenters objected.
    Accordingly, this final rule amends the regulations to remove the 
list of regions considered to be free of Newcastle disease from 9 CFR 
94.6(a)(1)(i) and adds text referring readers to the list on the APHIS 
Web site.\6\
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    \6\ https://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml.
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    A region will be removed from the list of regions considered to be 
free of Newcastle disease whenever we receive reliable reports of 
disease outbreaks in commercial birds and poultry from veterinary 
officials of the national government of the region and/or the World 
Organization for Animal Health (OIE). The Administrator of APHIS may 
also remove a region from the list based on outbreak reports of 
Newcastle disease that he or she receives from other reliable sources, 
such as APHIS inspectors based in foreign countries. This approach will 
allow us to quickly update the list on the Web site whenever necessary 
without needing to amend the CFR, which can take much more time to do.
    A region removed from the list of regions considered to be free of 
Newcastle disease on the APHIS Web site may be reinstated to the list 
in accordance with the procedures for reestablishing a region's 
disease-free status set forth in 9 CFR 92.4 of the regulations.

Importation of Live Birds and Poultry

    The importation into the United States of live birds and poultry, 
including eggs for hatching, is subject to the regulations in part 93, 
Subpart A--Birds (Sec. Sec.  93.100-93.107) and Subpart B--Poultry 
(Sec. Sec.  93.200-93.220).
    A commenter requested that APHIS provide an exception to its 
prohibition on live birds and poultry from regions where HPAI is 
considered to exist by permitting the entry of birds and poultry that 
have been quarantined and tested prior to export to the United States 
in a manner consistent with our own post-import quarantine and testing 
procedures.
    We are taking no action in response to this request. Our 
established import quarantine procedures have been proven to be 
effective and offer a predictable measure of assurance supported by 
testing in approved laboratories using appropriate diagnostic methods. 
Quarantine and testing procedures conducted overseas may not always 
adequately address APHIS requirements and would be impractical and 
resource-intensive.
    However, we have determined that it is necessary to amend the live 
bird and poultry regulations in the interim rule to reflect changes we 
made in another rulemaking. In a March 2013 final rule that recognized 
25 Member States of the European Union (EU) as the APHIS-defined EU 
poultry trade region,\7\ we amended the regulations to allow the 
importation of hatching eggs that have transited a zone restricted for 
HPAI within that region. To make the regulations consistent with this 
change, we are amending the general prohibitions in 9 CFR 93.101(a) for 
birds and hatching eggs of birds, and 9 CFR 93.201(a) for poultry and 
hatching eggs of poultry, to indicate that unless specifically 
indicated otherwise in the regulations,\8\ no live birds or poultry, 
and no hatching eggs from birds or poultry, shall be imported into the 
United States if the birds or poultry (or the flocks of origin in the 
case of hatching eggs) originated from or transited a region identified 
in accordance with 9 CFR 94.6(a) as a region where any form of HPAI or 
Newcastle disease is considered to exist. As 9 CFR 93.201(a) prohibits 
importation of hatching eggs of poultry that have originated in or 
transited regions where these diseases exist other than the APHIS-
defined EU poultry trade region, we are also amending 9 CFR 93.205(b) 
to require that the import certificate state that the hatching eggs 
have not been moved through a region identified in accordance with 
Sec.  94.6(a) as a region where any form of HPAI exists. This statement 
is already required on certificates for live poultry in 9 CFR 
93.205(a).
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    \7\ Federal Register, March 29, 2013 (78 FR 19080-19085, Docket 
No. APHIS-2009-0094): https://www.regulations.gov/#!docketDetail;D=APHIS-2009-0094.
    \8\ The Administrator, under 9 CFR 93.101(a), may also allow pet 
or other birds to transit regions where any form of HPAI is 
considered to exist, under stipulated conditions provided in a 
permit, when a determination is made that such importations will not 
endanger livestock or poultry health in the United States.
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    We are also amending paragraphs (b)(7), (c)(11), and (d)(7) of the 
certification requirements for importing live birds in 9 CFR 93.104 to 
replace ``previously unused containers'' with ``new or appropriately 
sanitized packaging materials.'' Similarly, we are amending paragraphs 
(a) and (b) of 9 CFR 93.205 to make this same change in the 
certification requirements for importing live poultry and hatching eggs 
of poultry. This change allows for more flexible packaging options and 
provides additional risk mitigation for imported poultry and hatching 
eggs.
    Finally, to emphasize that testing for avian influenza is currently 
a part of our routine health certification and quarantine requirements 
for imported birds, we are amending these requirements in 9 CFR 93.101, 
93.104, and 93.106 to include references to avian influenza.

[[Page 70999]]

Importation of Columbiform Species From Regions Where HPAI Is 
Considered To Exist

    As noted above, we reopened the comment period on the interim rule 
for 30 days \9\ to solicit comments on a change that would allow live 
pigeons, doves, and other Columbiform species to be imported under 
certain conditions to approved establishments from regions where HPAI 
is considered to exist. We considered this change because peer-reviewed 
scientific studies \10\ have come to our attention since the 
publication of the interim rule establishing that Columbiform species 
have a very low risk of being infected by HPAI viruses. We have 
carefully reviewed these studies and concluded that importation of such 
species to approved establishments would constitute a low risk of 
introducing and spreading HPAI viruses in birds and poultry.
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    \9\ See footnote 5.
    \10\ Infectious and Lethal Doses of H5N1 Highly Pathogenic Avian 
Influenza Virus for House Sparrows (Passer Domesticus) and Rock 
Pigeons (Columbia Livia) J VET Diagn Invest July 2009 21: 437-445. 
Pathogenesis and pathobiology of avian influenza virus infection in 
birds, M. J. Pantin-Jackwood and D. E. Swayne, Southeast Poultry 
Research Laboratory, Agricultural Research Service, USDA, Athens, GA 
30605.
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    One commenter, a State veterinary official, stated that there 
appear to be no restrictions in the rule on how Columbiform species are 
to be housed and transported within a zone where HPAI is considered to 
exist. The commenter stated that non-Columbiform species of birds and 
poultry could be crated next to Columbiform species during transport 
and be on- and off-loaded from or within the zones of infection. The 
commenter added that even though Columbiform species from HPAI-affected 
regions have a low risk of becoming infected, those species and their 
crates could serve as fomites and transmit the virus to more 
susceptible species of avians if commingled with them at any point 
during importation or quarantine. For this reason, the commenter 
requested that we not allow importation of any Columbiform species that 
have been moved through regions where HPAI is considered to exist.
    While it is possible that Columbiform species could transmit the 
HPAI virus to non-Columbiform species via fomites, we consider our 
existing risk mitigations regarding fomites and commingling sufficient 
to allow importation of Columbiform species that have been moved 
through regions with HPAI. Title 9 CFR 93.204 establishes that for the 
importer to obtain a permit, he or she must provide information that 
includes the species, breed, and number of poultry to be imported and 
the region of origin, as well as the mode of transportation and the 
route of travel. APHIS would not issue an import permit if the 
conditions of importation were such that Columbiform species (and their 
fomites) from regions considered to have HPAI were commingled, 
quarantined, or otherwise directly or indirectly exposed at any point 
with non-Columbiform species.
    However, we acknowledge the commenter's concern about commingling 
and are adding a provision to the certificate requirement to 9 CFR 
93.205(a) for Columbiform species that have been moved through regions 
considered to have HPAI. Except for the requirement prohibiting 
movement through such regions, Columbiform species intended for 
importation into the United States are subject to all other certificate 
requirements listed in 9 CFR 93.205(a) as amended by this document. The 
certificate requirement we are adding to 9 CFR 93.205(a) states that 
pigeons, doves, and other Columbiform species that have originated from 
or been moved through regions where HPAI is considered to exist were 
moved and handled under conditions specified on an import permit 
ensuring that their movement and handling involved no direct or 
indirect exposure to other animals, birds, and poultry.

Prohibition on Day-Old Chicks and Hatching Eggs Transiting Regions 
Where HPAI Is Considered To Exist

    Three commenters opposed the prohibition in the interim rule on the 
importation into the United States of day-old chicks and hatching eggs 
that have transited regions where HPAI of any subtype is considered to 
exist.
    One commenter stated that day-old chicks are commonly flown in 
sealed containers between continents and expressed concern about 
whether such chicks would still be eligible for importation into the 
United States if the flight touched down briefly at an airport in a 
region considered to have HPAI. Another commenter noted that EU 
regulations allow transit of live poultry, including day-old chicks and 
hatching eggs, through zones under restrictions for HPAI on the 
condition that transport takes place on roads or rail without unloading 
or stopping. The commenter stated that if the day-old chicks are moved 
under strictly controlled, biosecured, and air-conditioned 
circumstances, with no need to provide feed and water during transport, 
the risk of their exposure to HPAI is minimal.
    We disagree with the commenters with regard to importing day-old 
chicks that have transited regions where HPAI is considered to exist. 
Unlike Columbiform species, day-old chicks of other poultry species are 
highly susceptible to contracting HPAI and therefore more likely to 
harbor and transmit the virus to other birds or poultry. Water or feed 
present during transit may also become contaminated. Scientific 
evidence indicates that secondary spread of avian influenza viruses 
mainly occurs through mechanical transfer of feces from infected birds, 
in which the virus may be present at high concentrations and may 
survive for considerable periods, and that the virus may be spread by 
birds, poultry, or other animals not themselves susceptible to 
infection becoming contaminated in transit through contact with 
infected birds and poultry \11\ (which is why, as a condition of entry, 
Columbiform species will not be allowed to be commingled with birds of 
any other species during transport). Consequently, there is a 
significant risk of day-old chicks contracting HPAI if they are moved 
through regions where HPAI is considered to exist en route to the 
United States.
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    \11\ 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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    While we consider movement of day-old chicks through regions 
affected by HPAI to pose an unacceptable import risk, we acknowledge 
that hatching eggs can be moved through regions affected by HPAI at a 
sufficiently low level of risk if we determine that the controlling 
authority of that region has instituted sufficient risk mitigation 
measures. Accordingly, in a March 2013 final rule \12\ that recognized 
25 Member States of the EU as the APHIS-defined EU poultry trade 
region, we amended the regulations to allow the importation of hatching 
eggs that have transited a zone restricted for HPAI within that region. 
Given the control measures that are uniformly and effectively enforced 
by the EU, the risk of exposure of hatching eggs to HPAI while 
transiting zones within the APHIS-defined EU poultry trade region is 
very low as long as all measures in the import permit issued by APHIS 
are followed and the shipment is sealed by the veterinary competent 
authority. All hatching eggs must be quarantined from time of arrival 
at the port of entry until hatched as required in 9 CFR 93.209, and the 
poultry from such eggs will remain quarantined for not less than 30 
days following hatching. During their quarantine, eggs for hatching and 
poultry from such eggs will be subject to any inspections,

[[Page 71000]]

disinfections, and tests as may be required by APHIS to determine their 
freedom from HPAI and other communicable diseases of poultry. 
Otherwise, hatching eggs that have originated from any region affected 
with HPAI will remain prohibited from importation to the United States.
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    \12\ See footnote 7.
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Prohibitions on Birds Vaccinated for Avian Influenza

    The interim rule prohibited imports of live poultry that have been 
vaccinated for H5 or H7 subtypes of avian influenza, as well as imports 
of day-old chicks and hatching eggs that have been vaccinated or have 
originated from birds or poultry vaccinated with those subtypes.
    Several commenters opposed the import prohibitions we placed on 
HPAI-vaccinated poultry and hatching eggs.
    Two commenters representing the domestic egg industry stated that 
vaccination for HPAI can be part of an effective disease control 
program and, for this reason, requested that we reconsider our 
prohibition on importation of egg layer hatching eggs from vaccinated 
poultry.
    We are making no changes to our prohibition on importation of 
hatching eggs from poultry vaccinated for HPAI. We noted in the interim 
rule that vaccination could mask the presence of infection in imported 
poultry and that vaccinated poultry and hatching eggs would have 
antibodies to serotypes H5 or H7 detectable during quarantine or 
routine surveillance. The presence of antibodies in imported poultry 
and hatching eggs could result in uncertainty as to whether the 
antibodies originated from vaccination or exposure to HPAI serotypes.
    Another commenter stated that diagnostic testing could distinguish 
antibodies in vaccinated poultry from those acquired from exposure to 
the HPAI virus, thus eliminating uncertainty as to whether the poultry 
acquired avian influenza antibodies through vaccination or through 
natural exposure to the virus.
    We are making no changes in response to the comment. We acknowledge 
that diagnostic methods exist that can distinguish those antibodies 
created by natural exposure to the virus from those created through 
vaccination. However, this process, known as DIVA (differentiation of 
infected from vaccinated animals), has not been sufficiently validated 
in the field or across avian species.
    Another commenter suggested that prohibiting the importation of 
hatching eggs from vaccinated poultry is unnecessary because embryos 
infected with lethal strains of HPAI typically die prior to hatching.
    We are making no changes based on this information. It is true that 
transmission of lethal strains of avian influenza via hatching eggs to 
other birds would be unlikely if the embryos die and fail to hatch. 
However, broken, contaminated eggs may possibly infect chicks inside 
the incubator because live virus can be recovered from the eggshell and 
internal egg contents.
    Another commenter opposing the vaccination prohibitions on poultry 
and hatching eggs noted that other countries sometimes use vaccination 
to help control H5 and H7 strains of low pathogenic avian influenza 
(LPAI). The commenter added that APHIS approved use of such vaccines to 
control a 2002 outbreak of H7N2 LPAI in Virginia.
    We are making no changes based on this comment. Emergency 
vaccination for some avian influenza subtypes may be necessary to 
control outbreaks if administered under specific conditions and under 
direct control of veterinary authorities. However, we would not likely 
allow the export of such emergency vaccinated poultry from the United 
States, nor would we allow the importation of poultry vaccinated for 
avian influenza due to the vaccination-related issues discussed above. 
Only if we were to incorporate the use of vaccinations for H5 and H7 
subtypes of avian influenza as routine practice would we reconsider 
modifying restrictions on the importation of most classes of poultry 
that have been vaccinated.
    Two commenters representing organizations affiliated with U.S. zoos 
indicated that they import live birds and hatching eggs from throughout 
the world for the purposes of species preservation and scientific 
study. They stated that the import prohibition on live birds and 
hatching eggs vaccinated for avian influenza would adversely affect 
their ability to import live, zoological birds from other countries. 
The commenters noted that some foreign zoos already vaccinate 
zoological birds with avian influenza vaccines as part of their own 
government programs. The commenters added, however, that their member 
zoos and other facilities maintain extensive biosecurity and quarantine 
protocols to ensure that any animal entering their collections is 
examined and kept in secure facilities to contain any potential disease 
threat. They stated that, as a result, the risk of introducing HPAI 
into the United States through such birds is low and asked that we 
allow importation of zoological birds under such protocols.
    We agree with these commenters and are amending 9 CFR 93.104(b)(4) 
in this final rule to allow live, zoological avians (including some 
species we define as `poultry') that have been vaccinated for H5 or H7 
subtypes of avian influenza to be imported to approved facilities. In 
this limited exception, such avians may be imported under specific 
permit restrictions if they are part of an official program using 
vaccine products approved and used under the supervision of the 
veterinary authorities of the exporting country and under specific 
conditions as determined by the Administrator and included in the 
import permit. The avians will also be required to be exported with 
permanent individual identification and meet other certification or 
entry requirements, including official testing and quarantine on 
arrival to the United States.

Restrictions on Imports of Bird and Poultry Carcasses, Meat, and 
Products From Regions Where HPAI Is Considered To Exist

    In the interim rule, most of the Newcastle disease-related 
provisions in 9 CFR 94.6(b) governing importation of bird and poultry 
carcasses, and parts or products of carcasses, were also applied to 
importation of those items from regions where HPAI is considered to 
exist. Historically, nearly all foreign regions where HPAI is 
considered to exist have also been regions where Newcastle disease has 
existed, so until the interim rule was published, the provisions for 
Newcastle disease were being applied de facto to HPAI. In the interim 
rule, we specifically revised those provisions to cover HPAI 
independent of Newcastle disease. The increasing number of outbreaks of 
HPAI worldwide has increased the likelihood that the disease could 
emerge in a region where Newcastle disease has never existed and pose a 
risk to the United States through the importation of birds, poultry, or 
bird or poultry products from that region.
    While the interim rule specifically applied most of the import 
provisions for Newcastle disease to HPAI, it did not apply those in 9 
CFR 94.6(b)(1) regarding game birds, which state that carcasses of game 
birds, if eviscerated with heads and feet removed, may be imported from 
regions where Newcastle disease is considered to exist. We stated in 
the interim rule that we would consider comments on whether we should 
apply the same conditions to importation of carcasses of game birds 
from regions with HPAI.
    A commenter stated that the interim rule fails to provide science-
based information to show that the restrictions

[[Page 71001]]

in the regulations sufficiently mitigate either Newcastle disease or 
HPAI in game birds. The commenter noted that Newcastle disease virus 
can be found in all parts of the carcass, and that removal of the head, 
feet, and viscera is insufficient to prevent introduction of the virus 
into the United States. The commenter suggested that we remove the 
Newcastle disease-based game bird provisions from the existing 
regulations and not extend those provisions to apply to game birds from 
HPAI regions.
    We are making no changes based on the comment. Our experience has 
shown the disease risk to domestic birds and poultry to be minimal from 
allowing entry of hunter-harvested carcasses of game birds, intended 
only for personal consumption and with head, feet, and viscera removed, 
from regions where Newcastle disease is considered to exist.\13\ The 
number of carcasses imported from such regions historically has been 
very small and the carcasses are prohibited from entering into 
commercial channels. However, we continue to evaluate the potential 
risk to domestic birds and poultry from allowing entry of hunter-
harvested carcasses of game birds from regions where HPAI is considered 
to exist. If we determine that entry of such carcasses from regions 
with HPAI can occur with sufficient mitigation of risk, we will publish 
our determination in a future rulemaking. We note that we consider game 
bird carcasses for personal consumption to be distinct from game bird 
trophies, which unlike carcasses are allowed entry into the United 
States from regions affected by HPAI because we require the trophies to 
be consigned directly under official seal to approved establishments 
for processing.\14\
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    \13\ Importation of such carcasses is also subject to 
verification of the import documentation by a U.S. Fish and Wildlife 
Service (FWS) officer. Information on FWS requirements for bringing 
game birds can be found at: https://www.fws.gov/le/hunting.html.
    \14\ Requirements for importing bird trophies from regions where 
Newcastle disease or HPAI is considered to exist are addressed in 9 
CFR 95.17. Such trophies do not require an import permit but are 
required to be moved under official seal to approved establishments. 
Entry requirements for bird trophies imported from regions free of 
Newcastle disease and HPAI are addressed in 9 CFR 95.16.
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    An organization representing scientists and others who import 
ornithological specimens for scientific study opposed our decision to 
restrict the importation of bird and poultry carcasses, parts, and 
products from regions where HPAI is considered to exist. The commenter 
stated that some strains of avian influenza considered to be highly 
pathogenic based on their molecular characteristics do not present 
signs of virulence in infected poultry. The commenter suggested that 
restrictions could be lifted from an HPAI-affected region if diagnostic 
tests of the avian influenza strain show no signs of virulence.
    We are making no changes to this final rule in response to the 
comment. It is our determination that virulence cannot be adequately 
ruled out through testing or a lack of observed symptoms in a 
population of birds or poultry. H5 and H7 strains of avian influenza 
can have widely varying pathogenic effects on different populations of 
birds or poultry and are subject to mutations that can change them into 
virulent strains. However, we note that provisions exist for the 
importation of ornithological specimens for scientific study. Paragraph 
(b)(2) of Sec.  94.6 allows carcasses, or parts or products of 
carcasses, of poultry, game birds, and other birds to 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 Newcastle disease or HPAI into the United States, 
and which is approved by the Administrator.
    A consumer safety organization objected to the interim rule, 
stating that it was concerned that the rule lifts import restrictions 
APHIS had placed on all poultry products from regions where HPAI is 
considered to exist, particularly the People's Republic of China.
    The interim rule did not lift import restrictions on poultry 
products from any region where HPAI is considered to exist. On the 
contrary, the interim rule applied the restrictions in 9 CFR 94.6(b) 
for unprocessed carcasses and parts or products of unprocessed 
carcasses of poultry or other birds from regions where Newcastle 
disease is considered to exist to regions where HPAI is considered to 
exist. These items are not eligible for import except when deemed 
appropriate by APHIS for scientific, educational, or research purposes, 
and must undergo processing conditions that ensure destruction of these 
viruses, if present. Carcasses of poultry or other birds that 
originated in a region considered to be free of Newcastle disease and 
HPAI, but that are processed (cut, packaged, or other processing) in a 
region where Newcastle disease or HPAI is considered to exist, are only 
eligible for import if they have been cooked or otherwise processed in 
such a way as to ensure destruction of Newcastle disease and avian 
influenza viruses, and if the processing establishments from which they 
come satisfy all the requirements in 9 CFR 94.6(b)(5). In deciding 
whether to approve a processing establishment, we determine the 
establishment's compliance with APHIS animal health requirements and 
the United States Department of Agriculture (USDA) Food Safety and 
Inspection Service (FSIS) evaluates the exporting region's processing 
methods for products for human consumption under the Poultry Products 
Inspection Act. If the processing establishments of any country or 
region do not meet both APHIS and FSIS requirements, those 
establishments are not permitted to export bird and poultry meat and 
products to the United States.

Cooking and Egg Pasteurization Requirements

    Prior to the interim rule, we required in 9 CFR 94.6(b) that cooked 
carcasses, parts, or products of poultry or other birds from regions 
considered to have Newcastle disease ``have a thoroughly cooked 
appearance throughout.'' Based on our review of OIE recommendations, we 
revised our cooking requirements to be more effective against both HPAI 
and Newcastle disease viruses. Accordingly, in the interim rule, we 
amended 9 CFR 94.6(b)(4) to establish a single standard stating that 
the articles must be cooked to a minimum internal temperature 
throughout of 74 [deg]C (165 [deg]F). This requirement replaced the 
previous standard that required confirmation by an inspector that the 
poultry appeared to be thoroughly cooked.
    Four commenters disagreed with our establishment of a single 
cooking standard. One stated that application of any of the appropriate 
OIE cooking standards will result in products with negligible disease 
risk. Another commenter agreed, adding that cooking with the intention 
of eliminating avian influenza viruses is dependent on both cooking 
temperature and time. Another commenter noted that there may be certain 
products where heating to 74 [deg]C is not sufficient and that for 
those products additional cooking standards might need to be 
considered. A commenter also requested that APHIS apply the cooking 
requirement only to imported bird and poultry products intended for 
consumption and not to products imported for scientific purposes, which 
have their own heat treatment requirements.
    The cooking regulations we established in the interim rule are 
intended to simplify the cooking

[[Page 71002]]

process by mitigating the risks of HPAI and Newcastle disease viruses 
in cooked poultry products under a single standard. We have determined 
that a cooking temperature of 74 [deg]C is sufficient to mitigate both 
viruses. If we determine that the regulations need to be amended to 
allow alternative processing standards in products intended for 
consumption or scientific purposes, we will consider that change in a 
future rulemaking. We will also consider alternative cooking and heat 
treatment approaches that are scientifically supportable and meet 
international standards. We will work with industry and researchers to 
validate other standards and welcome specific information to help us 
develop such standards. We will also harmonize procedures with FSIS to 
verify that their public health standards are also suitable for 
inactivating HPAI and Newcastle disease viruses.
    Two commenters asked that we also include OIE egg pasteurization 
standards in the regulations.
    We do not consider it necessary to include such standards in the 
regulations. As with poultry meat and products, APHIS currently applies 
international standards for egg products that are validated by USDA 
researchers and harmonizes its procedures with FSIS whenever possible.

Cooked Poultry Meat in Passenger Baggage

    One commenter noted that the changes to the interim rule do not 
provide clear guidance on the importation requirements for cooked 
poultry meat entering the United States in passenger baggage. The 
commenter stated that if APHIS intends to apply the cooking requirement 
that we included in the interim rule, then we should specify whether 
this requirement applies only to commercially imported poultry meat and 
poultry products, including table eggs, or whether it also extends to 
cooked poultry meat in passenger baggage.
    On the same subject, another commenter disagreed with how we 
implemented the change in the interim rule to the cooking regulations, 
which requires official certification stating that the proper cooking 
temperature had been applied to accompany all cooked carcasses, parts, 
or products of poultry or other birds entering the United States from 
regions where Newcastle disease or HPAI is considered to exist. The 
commenter stated that we did not adequately inform Department of 
Homeland Security, Customs Border and Protection (CBP) inspectors or 
the traveling public about this change, resulting in disruptions at 
ports of entry as CBP officials were not adequately prepared to manage 
the large quantity of uncertified cooked poultry meat and eggs seized 
in passenger baggage as a result of enforcement of the interim rule. To 
address this situation, a commenter representing an international 
restaurant chain requested that we amend the cooking regulations in 9 
CFR 94.6(b)(6) to include an exception for perishable cooked poultry 
products intended for personal consumption in passenger baggage.
    After we published the new cooking regulations, we recognized that 
it was impractical to require passengers entering the country to 
produce a cooking certificate for non-commercial quantities of 
perishable, thoroughly cooked poultry intended for personal 
consumption. We determined from experience that such importations pose 
an insignificant risk to domestic birds and poultry. Accordingly, we 
published in the APHIS Animal Products Manual a directive \15\ that CBP 
inspectors may permit entry of cooked and perishable poultry products 
for personal consumption if, in the view of the inspector, the products 
appear to be thoroughly cooked throughout. If the products do not 
appear in the inspector's determination to be thoroughly cooked or 
intended for personal consumption, entry of the product will be denied. 
We believe that this directive is reliable since we allow inspectors in 
other cases to draw on their experience and judgment to determine 
whether a product is sufficiently processed to minimize risk. 
Accordingly, we will proceed with this directive but we plan to include 
this exception for cooked poultry in the regulations in the future.
---------------------------------------------------------------------------

    \15\ https://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/apm.pdf. See footnote 1, Table A-1-10.
---------------------------------------------------------------------------

Table Eggs From Regions Where HPAI Is Considered To Exist

    One commenter noted that while the interim rule clearly explained 
how we changed the regulations for importing poultry products and 
byproducts from regions where HPAI is considered to exist, the 
regulations provide no clear guidance as to whether this change applies 
to table eggs and egg products (other than hatching eggs) from such 
regions.
    In the interim rule, we made no changes to 9 CFR 94.6(c), which 
lists import requirements for table eggs from regions where Newcastle 
disease is considered to exist. We solicited comments in the interim 
rule on whether a targeted testing program for HPAI in egg flocks in 
foreign regions is advisable and how such a program might be designed 
to provide a statistically valid testing regimen. We noted that those 
who wish to comment on this issue should also review a final rule we 
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 amended 9 CFR 
94.6(c) to include a protocol for targeted Newcastle disease testing of 
a statistically valid sample of dead, dying, and cull birds. 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. In the future, we intend to use the same process to develop 
regulations for importation of table eggs from HPAI regions, beginning 
with a risk assessment that reviews the testing options. This 
assessment would be made available for public comment.
    However, we are adding language to Sec.  94.6 (c) to clarify that 
table eggs from HPAI regions are prohibited from importation, except by 
APHIS permit to approved establishments for breaking and 
pasteurization, for scientific, educational, or research purposes, or 
for other purposes determined by the Administrator, provided that the 
eggs have been cooked, processed, or otherwise handled in a manner that 
will prevent the introduction of both Newcastle disease and HPAI into 
the United States.
    Three commenters recommended that APHIS consider adopting 
provisions of the Secure Egg Supply (SES) plan for imports of poultry 
and egg products to the United States, and one commenter recommended 
that we modify 9 CFR 94.6(c) to require exporting countries to 
implement systems equivalent to the SES plan as a condition for 
continuing exports to the United States should those countries have 
HPAI outbreaks. The SES plan implements levels of heightened 
biosecurity, additional testing, and other emergency measures during a 
disease outbreak.
    We believe that the adoption of such broad emergency measures in 
this context is not necessary. Incorporating provisions of the SES plan 
into general guidance under normal trade conditions is unnecessary and 
would be potentially burdensome to domestic egg producers.

Additional Treatments for Research Specimens

    A commenter interested in the scientific study of birds asked that 
we

[[Page 71003]]

make it easier to access approved treatment methods that are currently 
established as conditions for obtaining an import permit and requested 
that we make such information available on the APHIS Web site.
    For specific information regarding approved treatment methods, 
please contact National Import Export Services at (301) 851-3300, or 
send an email to AskNCIE.Products@aphis.usda.gov. A search engine 
listing approved establishments where such treatment methods are 
administered is available online at: https://vsapps.aphis.usda.gov/vsps/public/AESearch.do?method=unspecified.
    The same commenter requested that we also consider another process 
for importing untreated material of avian origin, noting that current 
treatment requirements somewhat degrade materials intended for research 
and asked that we consider establishing a procedure for pre-import 
testing of the material in a laboratory and with methods equivalent to 
those used by USDA labs.
    We welcome scientific information that supports other processes for 
testing, handling, and importing untreated avian material in such a 
manner that minimizes the risk of introducing HPAI or other avian 
diseases. Other procedures will be considered in the future on a case-
by-case basis.

Regionalization

    Two commenters, including an official representing the EU, stated 
that APHIS uses the term ``region'' to refer only to the whole 
territory of a country and not to a part of a country, and recommended 
that we include regionalization as part of our regulations to be in 
line with OIE recommendations.
    We currently recognize regions that span countries and parts of 
countries for animal disease control purposes and which are based on 
geographic considerations instead of national boundaries, as 
recommended by the OIE. In the past, APHIS has removed from that list 
several subnational regions consisting of either single or several 
administrative units or groups within the EU that were affected by HPAI 
H5N1.\16\
---------------------------------------------------------------------------

    \16\ The subnational regions removed include areas within 
Denmark and France (July 21, 2008); Germany (June 5, 2009 and 
September 23, 2009); Poland (June 5, 2009); United Kingdom 
(September 23, 2009); Hungary (September 24, 2009); and the Czech 
Republic and Sweden (November 10, 2010).
---------------------------------------------------------------------------

Disease Terms

    A commenter questioned our use of the term ``exotic'' in 
conjunction with ``Newcastle disease,'' noting that it does not conform 
to OIE usage, and also requested that we replace the term ``European 
fowl plague'' with ``highly pathogenic avian influenza'' in our 
regulations, noting that the latter term is more in line with 
international usage.
    APHIS agrees with the commenter's suggestions. In another 
rulemaking,\17\ we have since removed the word ``exotic'' from 
references to Newcastle disease and replaced the terms ``fowl pest'' 
and ``fowl plague'' with ``highly pathogenic avian influenza.'' The 
word ``exotic'' is no longer a useful description of Newcastle disease, 
and the terms ``fowl pest'' and ``fowl plague'' predate identification 
of the avian influenza virus and are no longer commonly used in 
scientific discourse. This change is consistent with our previous 
efforts to replace these outdated terms in other parts of our 
regulations and reflects OIE terminology.
---------------------------------------------------------------------------

    \17\ See footnote 7.
---------------------------------------------------------------------------

Other Changes

    We are making other changes to the regulations to provide readers 
with additional information about terms we use in the regulations. We 
are adding a definition of approved establishment to 9 CFR 94.0. This 
term refers to establishments authorized by APHIS for the receipt and 
handling of restricted imported animal carcasses, trophies, products, 
and byproducts. We are adding this term in order to distinguish such 
establishments from ``processing establishments'' that process meat, 
fish, and poultry intended for human consumption. We are also adding a 
definition of commercial birds to 9 CFR 94.0 in order to distinguish 
birds imported for resale, breeding, public display, or any other 
purpose from birds imported for zoological or research purposes, 
performing or theatrical purposes, and as pets. In addition, we are 
adding a similar definition for commercial poultry to 9 CFR 93.200 and 
94.0 to distinguish such poultry from other types recognized in the 
regulations. We are also revising the definition of highly pathogenic 
avian influenza in 9 CFR 94.0 to harmonize it with OIE standards and 
adding that definition to 9 CFR 93.100, 93.200, and 95.1, as we now use 
that term in those regulations. We are adding a definition of 
quarantine facility to 9 CFR 93.100 of Subpart A--Birds and 9 CFR 
93.200 of Subpart B--Poultry because we include requirements for 
quarantine facilities in those subparts but provide no definition of 
the term.
    We are also amending the list of disease agents (anthrax, foot-and-
mouth disease, and rinderpest) in 9 CFR 95.3 to clarify that 
importation of byproducts taken or removed from any animal affected 
with Newcastle disease or HPAI are specifically prohibited. Under 
amended 9 CFR 95.17 we will allow products such as bird trophies from 
HPAI regions to be consigned directly to an approved establishment, as 
is currently the case with bird trophies from regions with Newcastle 
disease. Such trophies consigned directly to an approved establishment 
do not require an import permit. Therefore, we are removing 9 CFR 95.41 
from the regulations because the import permit required in that section 
specifically for bird trophies from HPAI regions is no longer 
necessary.
    Finally, we are correcting an incorrect reference in Sec.  94.6. 
Currently, paragraph (c)(3) states the requirements for the importation 
of eggs for scientific, educational, or research purposes and that the 
eggs must be accompanied by a permit obtained from APHIS in accordance 
with paragraph (f) of that section. Paragraph (f) was removed in a 
prior rulemaking and the instructions for obtaining a permit are 
currently contained in paragraph (d). We are correcting that reference.

Addition of Bhutan to the List of Regions in Which HPAI Is Considered 
To Exist

    We are also announcing that we have added Bhutan to the list of 
regions referenced in 9 CFR 94.6(a)(2)(i) in which HPAI is considered 
to exist because we have determined that HPAI exists in commercial 
birds or poultry in the country based on veterinary reports of disease 
outbreaks.
    Therefore, for the reasons given in the interim rule and in this 
document, we are adopting the interim rule as a final rule, with the 
changes discussed in this document.

Effective Date

    Pursuant to the administrative procedure provisions in 5 U.S.C. 
553, we find good cause for making this rule effective less than 30 
days after publication in the Federal Register. The interim rule 
adopted as final by this rule became effective on January 24, 2011. 
This rule relieves a restriction in the interim rule that prohibits the 
import of birds vaccinated for avian influenza subtypes H5 or H7 by 
permitting the import of vaccinated zoological birds to approved 
facilities under controlled conditions. This rule also relieves a 
restriction that prohibits the importation of HPAI-resistant pigeons, 
doves, and other Columbiform species by permitting the import of such 
species,

[[Page 71004]]

under permit and controlled conditions, from regions where HPAI is 
considered to exist. Therefore, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this rule should be 
effective upon publication in the Federal Register.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been determined to be not significant for the 
purposes of Executive Order 12866 and, therefore, has not been reviewed 
by the Office of Management and Budget.
    We have prepared an economic analysis for this rule. The economic 
analysis, which is summarized below, examines the potential economic 
effects of this rule on small entities, as required by the Regulatory 
Flexibility Act. Copies of the full analysis are available on the 
Regulations.gov Web site (see footnote 1 in this document for a link to 
Regulations.gov) or by contacting the person listed under FOR FURTHER 
INFORMATION CONTACT.
    To prevent the introduction of HPAI into the United States, APHIS 
published an interim rule that amended the regulations in 9 CFR parts 
93, 94, and 95 to prohibit or restrict the importation of birds and 
poultry products from regions where HPAI exists. APHIS is adopting the 
rule with changes: The final rule will allow the importation of live 
zoological birds vaccinated for HPAI under controlled conditions to 
approved facilities and allow the importation of pigeons, doves, and 
other Columbiform species resistant to HPAI under permit and controlled 
conditions from regions where HPAI is considered to exist.
    Because of the substantial overlap between existing restrictions to 
prevent the importation of articles that could introduce Newcastle 
disease and the new restrictions to prevent the importation of articles 
that could introduce HPAI, this final rule is not expected to have 
significant economic impacts on small entities. The rule will benefit 
U.S. poultry and egg producers by protecting domestic flocks against 
the introduction of HPAI. Consumers and importers will not be 
significantly affected by any changes in imports that may result 
because of the rule, as poultry and poultry product imports are minor 
compared to domestic production. Compliance costs will be incurred only 
with respect to imports from regions where HPAI is discovered and there 
are no existing restrictions for HPAI or Newcastle disease.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12988

    This 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 the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501 et seq.), the information collection or recordkeeping requirements 
included in this rule have been approved by the Office of Management 
and Budget (OMB) under OMB control number 0579-0245 (formerly 0579-
0367).

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 rule, please contact Ms. Kimberly Hardy, 
APHIS' Information Collection Coordinator, at (301) 851-2727.

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, the interim rule amending 9 CFR parts 93, 94, and 95 
that was published at 76 FR 4046-4056 on January 24, 2011, is adopted 
as a final rule with the following changes:

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 93.100 is amended by adding, in alphabetical order, 
definitions of highly pathogenic avian influenza (HPAI) and quarantine 
facility to read as follows:


Sec.  93.100  Definitions.

* * * * *
    Highly pathogenic avian influenza (HPAI). Highly pathogenic avian 
influenza is defined as follows:
    (1) Any influenza virus that kills at least 75 percent of eight 4- 
to 6-week-old susceptible chickens within 10 days following intravenous 
inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, 
infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-
week-old chickens resulting in an intravenous pathogenicity index 
(IVPI) of greater than 1.2;
    (2) Any H5 or H7 virus that does not meet the criteria in paragraph 
(1) of this definition, but has an amino acid sequence at the 
haemagglutinin cleavage site that is compatible with highly pathogenic 
avian influenza viruses; or
    (3) Any influenza virus that is not an H5 or H7 subtype and that 
kills one to five out of eight inoculated chickens and grows in cell 
culture in the absence of trypsin within 10 days.
* * * * *
    Quarantine facility. A USDA facility, or a private facility 
approved by APHIS, for the secure housing of imported birds, poultry, 
or other animals for specified periods.
* * * * *

0
3. Section 93.101 is amended as follows:
0
a. In paragraph (a), by revising the last sentence;
0
b. In paragraph (c)(4)(i), by adding the words ``highly pathogenic 
avian influenza,'' before the words ``Newcastle disease'';
0
c. In paragraph (g)(2), by adding the words ``highly pathogenic avian 
influenza and'' before the words ``Newcastle disease'';
0
d. By revising footnote 7;
0
e. In paragraph (g)(3), by adding the words ``highly pathogenic avian 
influenza and'' before the words

[[Page 71005]]

``Newcastle disease'' the first and second time they appear, and by 
adding the words ``highly pathogenic avian influenza or'' before the 
words ``Newcastle disease'' the third and fourth time they appear; and
0
f. In paragraph (g)(4), by adding the words ``highly pathogenic avian 
influenza and'' before the words ``Newcastle disease''.
    The revisions read as follows:


Sec.  93.101  General prohibitions; exceptions.

    (a) * * * Unless otherwise indicated in the regulations, no live 
birds, and no hatching eggs from birds, shall be imported into the 
United States if the birds have originated from a region referenced in 
Sec.  94.6(a) of this subchapter where highly pathogenic avian 
influenza or Newcastle disease is known to exist in commercial poultry 
populations, have transited highly pathogenic avian influenza- or 
Newcastle disease-affected regions, or have been vaccinated for the H5 
or H7 subtype of avian influenza.
* * * * *
    \7\ Such tests are conducted according to protocols for highly 
pathogenic avian influenza and Newcastle disease which are available 
upon request from the Administrator.


0
4. Section 93.104 is amended as follows:
0
a. In paragraphs (b)(2) and (b)(3), by adding the words ``highly 
pathogenic avian influenza,'' before the word ``chlamydiosis'';
0
b. By revising paragraph (b)(4);
0
c. In paragraph (b)(5), by adding the words ``highly pathogenic avian 
influenza or'' before the words ``Newcastle disease'';
0
d. In paragraph (b)(6), by adding the words ``originated from or'' 
before the words ``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;'';
0
e. In paragraph (b)(7), by removing the words ``previously unused 
containers'' and adding the words ``new or appropriately sanitized 
packaging materials'' in their place;
0
f. In paragraphs (c)(3) and (c)(4), by adding the words ``highly 
pathogenic avian influenza,'' before the word ``chlamydiosis'';
0
g. In paragraph (c)(6), by adding the words ``highly pathogenic avian 
influenza or'' before the words ``Newcastle disease'';
0
h. In paragraph (c)(7), by adding the words ``originated from or'' 
before the words ``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;'';
0
i. In paragraph (c)(11), by removing the words ``previously unused 
containers'' and adding the words ``new or appropriately sanitized 
packaging materials'' in their place;
0
j. In paragraphs (d)(3) and (d)(4), by adding the words ``highly 
pathogenic avian influenza,'' before the word ``chlamydiosis'';
0
k. In paragraph (d)(5), by adding the words ``highly pathogenic avian 
influenza or'' before the words ``Newcastle disease''; and
0
l. In paragraph (d)(7), by removing the words ``previously unused 
containers'' and adding the words ``new or appropriately sanitized 
packaging materials'' in their place.
    The revision reads as follows:


Sec.  93.104  Certificate for pet birds, commercial birds, zoological 
birds, and research birds.

* * * * *
    (b) * * *
    (4) That the birds have not been vaccinated with a vaccine for the 
H5 or H7 subtype of avian influenza; however, zoological birds that 
have been vaccinated for avian influenza subtypes H5 or H7 as part of 
an official program, using vaccine products approved and used under 
supervision by the veterinary authorities of the exporting country, may 
be imported under specific conditions as determined by the 
Administrator and specified in an import permit. Such birds must be 
exported with permanent individual identification and meet the other 
requirements for entry under this part, and will be subject to official 
testing and quarantine on arrival to the United States.
* * * * *

0
5. Section 93.106 is amended as follows:
0
a. In paragraph (b)(3), by adding the words ``highly pathogenic avian 
influenza and'' before the words ``Newcastle disease'';
0
b. In paragraph (c)(3)(ii)(E), by revising the last sentence;
0
c. In paragraphs (c)(5)(iii)(A)(14) and (c)(5)(iii)(A)(17), by adding 
the words ``highly pathogenic avian influenza or'' before the words 
``Newcastle disease''; and
0
d. In paragraphs (c)(5)(iii)(B)(4) and (c)(5)(iii)(B)(5), by adding the 
words ``highly pathogenic avian influenza or'' before the words 
``Newcastle disease''.
    The revision reads as follows:


Sec.  93.106  Quarantine requirements.

* * * * *
    (c) * * *
    (3) * * *
    (ii) * * *
    (E) * * * If Newcastle disease or highly pathogenic avian influenza 
is found or detected among any birds in quarantine, all birds in the 
facility shall be destroyed or refused entry and the entire facility 
shall be thoroughly cleaned and then disinfected as directed under the 
supervision of an inspector.
* * * * *

0
6. Section 93.200 is amended by adding, in alphabetical order, 
definitions of commercial poultry, highly pathogenic avian influenza 
(HPAI), and quarantine facility to read as follows:


Sec.  93.200  Definitions.

* * * * *
    Commercial poultry. Chickens, doves, ducks, geese, grouse, guinea 
fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and 
turkeys (including eggs for hatching) which are imported for resale, 
breeding, public display, or any other commercial purpose.
* * * * *
    Highly pathogenic avian influenza (HPAI). Highly pathogenic avian 
influenza is defined as follows:
    (1) Any influenza virus that kills at least 75 percent of eight 4- 
to 6-week-old susceptible chickens within 10 days following intravenous 
inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, 
infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-
week-old chickens resulting in an intravenous pathogenicity index 
(IVPI) of greater than 1.2;
    (2) Any H5 or H7 virus that does not meet the criteria in paragraph 
(1) of this definition, but has an amino acid sequence at the 
haemagglutinin cleavage site that is compatible with highly pathogenic 
avian influenza viruses; or
    (3) Any influenza virus that is not an H5 or H7 subtype and that 
kills one to five out of eight inoculated chickens and grows in cell 
culture in the absence of trypsin within 10 days.
* * * * *
    Quarantine facility. A USDA facility, or a private facility 
approved by APHIS, for the secure housing of imported birds, poultry, 
or other animals for specified periods.
* * * * *

0
7. Section 93.201 is amended as follows:
0
a. In paragraph (a), by revising the last sentence of the paragraph; 
and
0
b. By adding paragraph (e).
    The revision and addition read as follows:

[[Page 71006]]

Sec.  93.201  General prohibitions; exceptions.

    (a) * * * Unless otherwise indicated in the regulations, no live 
poultry, and no hatching eggs from poultry, shall be imported into the 
United States if the poultry have originated from a region referenced 
in Sec.  94.6(a) of this subchapter where highly pathogenic avian 
influenza or Newcastle disease is known to exist in commercial poultry 
populations, have transited highly pathogenic avian influenza- or 
Newcastle disease-affected regions, or have been vaccinated for the H5 
or H7 subtype of avian influenza.
* * * * *
    (e) Pigeons, doves, and other Columbiform species that have 
originated from or transited regions where highly pathogenic avian 
influenza is considered to exist may be imported into the United States 
under permit and controlled conditions to approved establishments 
subject to all applicable requirements in this part.
* * * * *

0
8. Paragraphs (a) and (b) of Sec.  93.205 are revised to read as 
follows:


Sec.  93.205  Certificate for live poultry and hatching eggs.

    (a) Live poultry. (1) 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 originated from or have been moved through a region referenced in 
Sec.  94.6(a) of this subchapter as a region where any form of highly 
pathogenic influenza exists, and that, as far as it has been possible 
to determine, no case of highly pathogenic avian influenza or Newcastle 
disease occurred on the premises where such poultry were kept, or on 
adjoining premises, during that 90-day period. The certificate must 
also state that the birds were placed into new or appropriately 
sanitized packaging materials at the premises from which the birds were 
to be exported.
    (2) Live poultry certificates accompanying pigeons, doves, and 
other Columbiform species that have originated from or been moved 
through regions where highly pathogenic avian influenza is considered 
to exist must additionally state that the Columbiform species have been 
moved and handled under conditions specified on the import permit 
ensuring that their movement and handling involved no direct or 
indirect exposure to other animals, birds, and poultry.
    (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, that during the 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, and that the hatching eggs and the flock or 
flocks of origin have not originated in or been moved through a region 
referenced in accordance with Sec.  94.6(a) of this subchapter as a 
region where any form of highly pathogenic avian influenza exists. The 
certificate must also state that the hatching eggs were placed into new 
or appropriately sanitized packaging materials at the premises from 
which the hatching eggs were to be exported.
* * * * *

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

0
9. 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.


0
10. Section 94.0 is amended as follows:
0
a. By adding, in alphabetical order, definitions of approved 
establishment, commercial birds, and commercial poultry; and
0
b. By revising the definition of highly pathogenic avian influenza.
    The additions and revision read as follows:


Sec.  94.0  Definitions.

* * * * *
    Approved establishment means an establishment authorized by 
Veterinary Services for the receipt and handling of restricted imported 
animal carcasses, products, and byproducts.
* * * * *
    Commercial birds. Birds that are imported for resale, breeding, 
public display, or any other purpose, except pet birds, zoological 
birds, research birds, or performing or theatrical birds.
    Commercial poultry. Chickens, doves, ducks, geese, grouse, guinea 
fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and 
turkeys (including eggs for hatching) which are imported for resale, 
breeding, public display, or any other commercial purpose.
* * * * *
    Highly pathogenic avian influenza (HPAI). Highly pathogenic avian 
influenza is defined as follows:
    (1) Any influenza virus that kills at least 75 percent of eight 4- 
to 6-week-old susceptible chickens within 10 days following intravenous 
inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, 
infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-
week-old chickens resulting in an intravenous pathogenicity index 
(IVPI) of greater than 1.2;
    (2) Any H5 or H7 virus that does not meet the criteria in paragraph 
(1) of this definition, but has an amino acid sequence at the 
haemagglutinin cleavage site that is compatible with highly pathogenic 
avian influenza viruses; or
    (3) Any influenza virus that is not an H5 or H7 subtype and that 
kills one to five out of eight inoculated chickens and grows in cell 
culture in the absence of trypsin within 10 days.
* * * * *

0
11. Section 94.6 is amended as follows:
0
a. By revising paragraph (a)(1)(i);
0
b. In paragraph (a)(1)(ii), in the first sentence, by adding the word 
``referenced'' after the word ``list'';
0
c. In paragraph (b)(2), by adding the words ``from regions where 
Newcastle disease or HPAI are considered to exist'' after the words 
``and other birds'';
0
d. In the heading and introductory text of paragraph (c), by adding the 
words ``or HPAI'' after the words ``Newcastle disease'' each time they 
occur;

[[Page 71007]]

0
e. In paragraphs (c)(1)(ix) introductory text, (c)(1)(ix)(A), and 
(c)(1)(ix)(B), by adding the words ``or HPAI'' after the words 
``Newcastle disease'' each time they occur;
0
f. In paragraph (c)(1)(ix)(C), in the first sentence, by adding the 
words ``region free of HPAI, or from a'' before the words ``flock of 
origin'';
0
g. In paragraph (c)(2), by adding the words ``and HPAI'' after the 
words ``Newcastle disease'';
0
h. In paragraph (c)(3), by adding the words ``and HPAI'' after the 
words ``Newcastle disease'' each time they occur, and by removing the 
words ``paragraph (f)'' and adding the words ``paragraph (d)'' in their 
place; and
0
i. In paragraph (c)(4), by removing the words ``paragraph (f)'' and 
adding the words ``paragraph (d)'' in their place.
    The revision reads as follows:


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 Newcastle disease or highly pathogenic 
avian influenza is considered to exist.

    (a) * * *
    (1) * * *
    (i) A list of such regions is maintained on the APHIS National 
Import Export Services Web site at https://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml. Copies of the list 
will also be available upon request to Regional Evaluation Services, 
National Import Export Services, Veterinary Services, Animal and Plant 
Health Inspection Service, 4700 River Road Unit 38, Riverdale, Maryland 
20737; fax: (301) 851-3300; email: AskNCIE.Products@aphis.usda.gov.
* * * * *

PART 95--SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS), 
AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES

0
12. 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.


0
13. Section 95.1 is amended by adding, in alphabetical order, the 
definition of highly pathogenic avian influenza (HPAI) to read as 
follows:


Sec.  95.1  Definitions.

* * * * *
    Highly pathogenic avian influenza (HPAI). Highly pathogenic avian 
influenza is defined as follows:
    (1) Any influenza virus that kills at least 75 percent of eight 4- 
to 6-week-old susceptible chickens within 10 days following intravenous 
inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, 
infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-
week-old chickens resulting in an intravenous pathogenicity index 
(IVPI) of greater than 1.2;
    (2) Any H5 or H7 virus that does not meet the criteria in paragraph 
(1) of this definition, but has an amino acid sequence at the 
haemagglutinin cleavage site that is compatible with highly pathogenic 
avian influenza viruses; or
    (3) Any influenza virus that is not an H5 or H7 subtype and that 
kills one to five out of eight inoculated chickens and grows in cell 
culture in the absence of trypsin within 10 days.
* * * * *


Sec.  95.3  [Amended]

0
14. Section 95.3 is amended by adding the words ``highly pathogenic 
avian influenza, Newcastle disease,'' after the words ``foot-and-mouth 
disease,''.


Sec.  95.16  [Amended]

0
15. Section 95.16 is amended as follows:
0
a. In the introductory text, by removing the citation ``Sec.  95.6'' 
and adding the citation ``Sec.  95.17'' in its place; and
0
b. In footnote 1, by removing the citation ``Sec.  95.41'' and adding 
the citation ``Sec.  95.17'' in its place.


Sec.  95.17  [Amended]

0
16. In Sec.  95.17, paragraph (c) is amended by adding the word 
``highly pathogenic avian influenza,'' after the words ``African swine 
fever,''.


Sec.  95.23  [Amended]

0
17. In Sec.  95.23, paragraph (c) is amended by removing the word 
``and'' after the words ``foot-and-mouth disease,'' and by adding the 
words ``highly pathogenic avian influenza, and Newcastle disease,'' 
after the word ``rinderpest,''.


Sec.  95.41  [Removed]

0
18. Section 95.41 is removed.

    Done in Washington, DC, this 25th day of November 2014.
Jere L. Dick,
Associate Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-28244 Filed 11-28-14; 8:45 am]
BILLING CODE 3410-34-P