[Federal Register Volume 70, Number 20 (Tuesday, February 1, 2005)]
[Rules and Regulations]
[Pages 5043-5044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1796]



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 Rules and Regulations
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  Federal Register / Vol. 70, No. 20 / Tuesday, February 1, 2005 / 
Rules and Regulations  

[[Page 5043]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. 04-091-1]


Add Malaysia to List of Regions in Which Highly Pathogenic Avian 
Influenza Subtype H5N1 Is Considered To Exist

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 by adding Malaysia to the list of regions 
in which highly pathogenic avian influenza (HPAI) subtype H5N1 is 
considered to exist. We are taking this action because there has been 
an outbreak of HPAI subtype H5N1 in Malaysia. This action is necessary 
to prevent the introduction of HPAI subtype H5N1 into the United 
States.

DATES: This interim rule was effective August 7, 2004. We will consider 
all comments that we receive on or before April 4, 2005.

ADDRESSES: You may submit comments by any of the following methods:
     EDOCKET: Go to http://www.epa.gov/feddocket to submit or 
view public comments, access the index listing of the contents of the 
official public docket, and to access those documents in the public 
docket that are available electronically. Once you have entered 
EDOCKET, click on the ``View Open APHIS Dockets'' link to locate this 
document.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. 04-091-1, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your 
comment refers to Docket No. 04-091-1.
     E-mail: Address your comment to 
[email protected]. Your comment must be contained in the body 
of your message; do not send attached files. Please include your name 
and address in your message and ``Docket No. 04-091-1'' on the subject 
line.
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for locating this 
docket and submitting comments.
    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: You may view APHIS documents published in the 
Federal Register and related information, including the names of groups 
and individuals who have commented on APHIS dockets, on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Julie Garnier, Staff Veterinarian, 
Technical Trade Issues Team, National Center for Import and Export, VS, 
APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231; (301) 734-
5677.

SUPPLEMENTARY INFORMATION:

Background

    The Animal and Plant Health Inspection Service (APHIS) of the 
United States Department of Agriculture (USDA or the Department) 
regulates the importation of animals and animal products into the 
United States to guard against the introduction of animal diseases. The 
regulations in 9 CFR parts 93, 94, and 95 (referred to below as the 
regulations) govern the importation of certain animals, birds, poultry, 
meat, other animal products and byproducts, hay, and straw into the 
United States in order to prevent the introduction of various animal 
diseases, including avian influenza (AI).
    There are many strains of AI virus that can cause varying degrees 
of clinical illness in poultry such as chickens, turkeys, pheasants, 
quail, ducks, geese, and guinea fowl, as well as a wide variety of 
other birds. AI viruses can be classified into low pathogenic (LPAI) 
and highly pathogenic (HPAI) forms based on the severity of the illness 
they cause. Most AI virus strains are LPAI and typically cause little 
or no clinical signs in infected birds. However, some LPAI virus 
strains are capable of mutating under field conditions into HPAI 
viruses.
    HPAI is an extremely infectious and fatal form of the disease for 
chickens. HPAI can strike poultry quickly without any infection warning 
signs and, once established, the disease can spread rapidly from flock 
to flock. HPAI viruses can also be spread by manure, equipment, 
vehicles, egg flats, crates, and people whose clothing or shoes have 
come in contact with the virus. HPAI viruses can remain viable at 
moderate temperatures for long periods in the environment and can 
survive indefinitely in frozen material. One gram of contaminated 
manure can contain enough virus to infect 1 million birds.
    In some instances, strains of HPAI viruses can be infectious to 
people. Human infections with AI viruses under natural conditions have 
been documented in recent years. Since December 2003, a growing number 
of Southeast Asian countries have reported outbreaks of HPAI 
responsible for the deaths of millions of birds and at least 22 humans.
    The rapid spread of HPAI, with outbreaks occurring at the same time 
in a number of regions, is historically unprecedented and of growing 
concern for human and animal health. According to the World Health 
Organization, particularly alarming is the HPAI strain of most of these 
outbreaks, H5N1, which has crossed the species barrier and caused 
severe disease, with high mortality, in humans. The current AI 
outbreaks have caused significant concern among health authorities 
worldwide because of the potential for the human and avian flu viruses 
to swap genes, creating a new virus to which humans would have little 
or no immunity.

[[Page 5044]]

    On May 10, 2004 (69 FR 25820-25826, Docket No. 04-011-1), we 
published an interim rule that amended the regulations to, among other 
things, establish additional restrictions on the importation of birds 
and poultry and unprocessed bird and poultry products from regions 
where HPAI subtype H5N1 is considered to exist. The interim rule also 
added to the regulations a list of regions (Cambodia, China, Indonesia, 
Japan, Laos, South Korea, Thailand, and Vietnam) in which HPAI subtype 
H5N1 is considered to exist.
    On August 19, 2004, Malaysia alerted the World Organization for 
Animal Health and the United States that an outbreak of HPAI subtype 
H5N1 had occurred in that country. The outbreak occurred in the 
northeastern State of Kelantan, close to the border with Thailand, a 
country where the presence of the disease has already been confirmed. 
Currently, control measures for the disease in Malaysia include 
depopulation of all poultry and birds within a 1-kilometer radius of 
the infected flock, quarantine within 10 kilometers of the infected 
flock, movement restrictions, and clinical surveillance in the State of 
Kelantan.
    Therefore, in order to prevent the introduction of HPAI subtype 
H5N1 into the United States, we are amending the regulations by adding 
Malaysia to the list in Sec.  94.6(d) of regions where HPAI subtype 
H5N1 exists. We are making this action effective retroactively to 
August 7, 2004, which is the date that Malaysian veterinary authorities 
estimate to be the date of primary infection. As a result of this 
action, the importation into the United States of birds, poultry, and 
unprocessed bird and poultry products from Malaysia is restricted and 
U.S. origin pet birds and performing or theatrical birds and poultry 
returning to the United States from Malaysia will be subject to 
additional permit and quarantine requirements.

Emergency Action

    This rulemaking is necessary on an emergency basis to prevent the 
introduction of HPAI subtype H5N1 into the United States. 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 rule 
effective less than 30 days after publication in the Federal Register.
    We will consider comments we receive during the comment period for 
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 reviewed under Executive Order 12866. For this 
action, the Office of Management and Budget has waived its review under 
Executive Order 12866.
    This rule amends the regulations by adding Malaysia to the list of 
regions in which HPAI subtype H5N1 is considered to exist. This action 
is necessary on an emergency basis to prevent the introduction of HPAI, 
subtype H5N1 into the United States.
    The U.S. does not recognize Malaysia as free of exotic Newcastle 
disease, thus the importation of poultry and non-processed poultry 
products from Malaysia is restricted. The United States, Canada, and 
Mexico imported no live poultry, poultry meat, eggs, or feathers from 
Malaysia in 2003/2004. The only exception was two commercial shipments, 
consisting of 6,791 and 9,646 pet birds, respectively, which were 
imported from Malaysia in October 2003 and February 2004. Both 
shipments consisted of assorted finches. Live birds are quarantined in 
U.S. ports prior to clearance for entry into the country, during which 
time testing for infectious diseases, including AI, takes place.
    Since no live poultry or poultry products are imported from 
Malaysia at this time, it is unlikely that this interim rule will have 
any substantial effects on trade, or on small or large businesses. 
APHIS also does not anticipate significant changes in program 
operations, or effects on other Federal agencies, State governments, or 
local governments.
    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) Preempts all State and local laws and 
regulations that are in conflict with this rule; (2) has retroactive 
effect to August 7, 2004; and (3) does not require administrative 
proceedings before parties may file suit in court challenging this 
rule.

Paperwork Reduction Act

    This rule contains no new information collection or recordkeeping 
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.).

List of Subjects in 9 CFR Part 94

    Animal diseases, Imports, Livestock, Meat and meat products, Milk, 
Poultry and poultry products, Reporting and recordkeeping requirements.

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL 
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL 
SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND 
RESTRICTED IMPORTATIONS

0
1. The authority citation for part 94 continues to read as follows:

    Authority: 7 U.S.C. 450, 7701-7772, 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.  94.6  [Amended]

0
2. In Sec.  94.6, paragraph (d) is amended by adding the word 
``Malaysia,'' after the word ``Laos,''.

    Done in Washington, DC, this 26th day of January 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-1796 Filed 1-31-05; 8:45 am]
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