[Federal Register Volume 76, Number 15 (Monday, January 24, 2011)]
[Rules and Regulations]
[Pages 4046-4056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1289]
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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.
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(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