[Federal Register Volume 74, Number 76 (Wednesday, April 22, 2009)]
[Rules and Regulations]
[Pages 18285-18288]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9102]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
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Federal Register / Vol. 74, No. 76 / Wednesday, April 22, 2009 /
Rules and Regulations
[[Page 18285]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 53, 82, and 94
[Docket No. APHIS-2007-0014]
RIN 0579-AC47
Importation of Table Eggs From Regions Where Exotic Newcastle
Disease Exists
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the regulations to modify the requirements
concerning the importation of eggs (other than hatching eggs) from
regions where exotic Newcastle disease (END) exists. This action is
necessary to provide a more efficient and equally effective testing
option for determining the END status of flocks producing eggs (other
than hatching eggs) for export to the United States.
DATES: Effective Date: May 22, 2009.
FOR FURTHER INFORMATION CONTACT: Dr. Christopher Robinson, Senior Staff
Veterinarian, Technical Trade Services, National Center for Import and
Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 20737-1231;
(301) 734-7837.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 94 prohibit or restrict the
importation of certain animals and animal and poultry products into the
United States to prevent the introduction of dangerous and destructive
diseases of livestock and poultry. Section 94.6 contains requirements
that apply to the importation of carcasses, parts or products of
carcasses, and eggs (other than hatching eggs) of poultry, game birds,
or other birds from regions where exotic Newcastle disease (END) or
highly pathogenic avian influenza subtype H5N1 is considered to exist.
On August 13, 2007, we published in the Federal Register (72 FR
45177-45181, Docket No. APHIS-2007-0014) a proposal \1\ to modify the
requirements concerning the importation of eggs (other than hatching
eggs) from regions where END exists. We proposed this action to provide
for a more efficient and effective testing option for determining the
END status of flocks producing table eggs for export to the United
States.
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\1\ To view the proposed rule and the comments we received, go
to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0014.
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We solicited comments concerning our proposal for 60 days ending
October 12, 2007. We received four comments by that date. They were
from a private citizen, State agricultural agencies, and another agency
in the U.S. Department of Agriculture (USDA). They are discussed below.
One commenter stated that commercial poultry farming methods were
responsible for diseases in poultry. The commenter suggested that the
abolition of these methods would remove the need to regulate movement
of eggs and poultry.
We disagree. Poultry become infected with END when they are exposed
to Newcastle disease virus (NDV), which can be spread by pet and wild
birds as well as domestic poultry. For example, a 1971 outbreak of END
started in pet birds in California and spread to commercial flocks.
Wild double-crested cormorants were the source of an END outbreak in
North Dakota in 1992. The 2002-2003 END outbreak in several western
States was first detected in backyard poultry flocks in California,
from whence it spread to commercial poultry houses. We are making no
changes in response to this comment.
One commenter expressed concern that the proposed testing protocols
would increase the risk to human health.
There is no public health risk from END. Human infection with NDV
is rare and usually occurs only in people who have close direct contact
with infected birds, such as veterinarians or laboratory staff. The
resulting disease is usually limited to conjunctivitis, and recovery is
usually rapid. There are no known instances of NDV transmission to
humans through handling or consumption of poultry products. In any
case, as discussed in the proposed rule, the testing requirements in
this final rule are as effective at detecting END as the requirements
that were previously in place.
One commenter expressed concern that some countries may not have
laboratories that can perform virus isolation testing and APHIS did not
include provisions to ensure that the samples be transported and
handled appropriately. Another commenter asked for assurance that the
cull birds for sampling will be selected, and that the samples
themselves will be collected, by a government salaried veterinarian.
The commenter also stated that the samples should be from birds that
died, not birds that were killed.
As we explained in the proposed rule, and as is true in the current
regulations, the laboratory performing the testing must be in the
region of origin of the eggs and must be approved by the veterinary
services organization of the national government of the region. If a
region lacks the necessary veterinary infrastructure to perform the
appropriate tests and to transport and handle samples appropriately, it
would not be eligible to export eggs to the United States. While there
is always a risk of improperly handled samples returning a false
negative, we will require that the samples be collected from cull birds
chosen by a salaried veterinary officer of the national government of
the region of origin or by a veterinarian accredited by the national
government of Mexico. We are confident that these measures will ensure
the appropriate handling of the samples.
It was our intent that samples be collected from sick birds or
birds that died, not healthy birds that were killed. We have clarified
this in the final rule. In addition, to be consistent with the other
proposed changes, we have also made a minor change in our proposed
regulatory text in paragraph (c)(1)(ix)(C) of Sec. 94.6 by replacing
the words ``an accredited veterinarian'' with the words ``a
veterinarian accredited by the national government of Mexico''. We
proposed to recognize only accreditation by the national government of
Mexico, so the more specific form is appropriate.
[[Page 18286]]
Two commenters stated that the level of confidence associated with
the proposed sampling rate was too low. One asked why we were not
requiring a sampling rate that would detect low-level infection with 98
percent confidence.
As we explained in the proposed rule, the level of confidence
associated with the proposed sampling rate is 95 percent. This is the
same level of confidence associated with the current requirements under
which 10 percent of the flock must be sampled. Our intent is to replace
the current testing regimen with one that will be both timelier and
more efficient while maintaining the same level of effectiveness.
We proposed to allow either hemagglutination inhibition (HI) or
embryonated egg inoculation testing to be used. One commenter stated
that in 9 CFR 53.1, END is defined as ``any velogenic Newcastle
disease,'' and that this implies that lentogenic and mesogenic strains
of NDV do not cause END. The commenter expressed concern that HI tests
conducted on blood samples from sick birds would only identify whether
or not a sample was positive or negative for NDV, since there is no
serological test to detect specific strains of the END virus.
We agree with the commenter's concerns. While the current
regulations allow for HI testing of sentinel birds, this is appropriate
because sentinel birds are not vaccinated against END. For flocks that
have been vaccinated against END, HI testing is not appropriate because
it will not be able to distinguish between a bird that has been
vaccinated against END and a bird that has died from disease. We have
revised the risk assessment accordingly and will remove references to
HI testing from the final rule. Embryonated egg inoculation testing,
one of the options available under the current regulations, is an
accepted diagnostic procedure for detecting NDV and will be effective
for detecting the virus without additional HI testing. The revised risk
assessment, titled ``Justification for the changes to the regulations
governing the importation of table eggs from regions where exotic
Newcastle disease exists into the United States,'' may be viewed on the
Regulations.gov Web site (see footnote 1 in this document for a link to
Regulations.gov). In addition, copies may be obtained by calling or
writing to the individual listed under FOR FURTHER INFORMATION CONTACT.
The commenter also noted that with new knowledge of NDV the
classification and terminology of END has evolved; in fact, in a
proposed rule published in the Federal Register on August 28, 2007 (72
FR 49231-49236, Docket No. APHIS-2007-0033), we had proposed to change
the definition of END in the select agent regulations in 9 CFR part 121
to replace the word ``velogenic'' with the word ``virulent.'' We
published a final rule adding this change to 9 CFR part 121 on October
16, 2008 (73 FR 61325-61332). The commenter stated that if the new
wording were adopted the definition in 9 CFR part 53 would have to be
amended as well.
We agree with the commenter that amending the END definition to be
consistent with our select agent regulations and with the World
Organization for Animal Health (OIE) definition is appropriate.
Therefore, we are amending the definition of ``exotic Newcastle
disease'' in Sec. 53.1, the definition of ``END'' in Sec. 82.1, and
the definition of ``exotic Newcastle disease (END)'' in Sec. 94.0 to
replace the word ``velogenic'' with the word ``virulent.'' This will
bring those definitions in line with the definition of END in our
select agents regulations in 9 CFR part 121 and the OIE definition of
END.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The 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.
The Regulatory Flexibility Act requires agencies to evaluate the
potential effects of rules on small businesses, small organizations,
and small governmental jurisdictions. Section 605 of the Act allows the
head of an agency to certify that a rule will not, if promulgated, have
a significant economic impact on a substantial number of small
entities. Following is the factual basis for such certification of this
final rule.
We are amending the regulations concerning the importation of eggs
(other than hatching eggs) from regions where exotic Newcastle disease
(END) exists. This action will provide a more efficient testing
protocol for determining the END status of flocks producing eggs (other
than hatching eggs) for export to the United States.
The goal of this rule is to make our testing requirements more
efficient and equally effective while continuing to protect domestic
poultry from END. One procedure by which foreign producers located in
regions affected with END can currently export table eggs into the
United States is to place sentinel birds within their flocks and then
test these birds for presence of the disease. As many of these foreign
producers vaccinate their flocks for END, sentinel birds may produce
false-positive results when tested for END, necessitating further
testing to differentiate a vaccine-induced response from an actual
infection. The second procedure currently authorized, testing 10
percent of the flock, is viewed by foreign egg producers as excessive.
This final rule will replace the current options for flock testing with
a less costly protocol that targets the birds most likely to be
infected.
U.S. Table Egg Production and Imports
The United States is the world's largest producer of poultry meat
and the second largest egg producer after China. Table egg production
during the year ending November 30, 2007, totaled 77.3 billion eggs.\2\
The largest table egg-producing States are Indiana, Iowa, and
Pennsylvania.\3\
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\2\ USDA, Chickens and Eggs 2007 Summary. Washington, DC:
National Agricultural Statistics Service, Table: Eggs; Production
During the Month by Type 2006-2007, pg. 8. February 2008.
\3\ Production statistics for Alaska, Arizona, Delaware, Kansas,
North Dakota, New Mexico, Nevada, and Rhode Island are not
separately reported to avoid disclosing information on individual
operations. http://usda.mannlib.cornell.edu/usda/current/ChickEgg/ChickEgg-02-28-2008.pdf.
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The cost of complying with flock testing requirements for foreign
suppliers of table eggs from regions where END exists will likely
decrease due to the lower number of birds required to be tested to
demonstrate flock freedom from END. This reduction in cost could result
in a small increase in the volume of table egg imports by the United
States from END-affected regions. In 2007, table eggs were imported
from two countries free of END, Canada and New Zealand. These imports
totaled 94,241 dozen and were valued at $345,000. The only other
country from which table eggs were imported in 2007 was China, where
END is considered to exist. These imports totaled 7,740 dozen and were
valued at $12,000.\4\ Between January and August of 2008, the United
States' only table eggs imports were from Canada (60,700 dozen valued
at $80,020) and New Zealand (21,888
[[Page 18287]]
dozen valued at $148,991); no table eggs were imported from China or
any other country where END is considered to exist. The 7,740 dozen
table eggs imported from China in 2007 was a negligible quantity
compared to the number produced domestically (less than 100,000,
compared to 77.3 billion). Any increase in the U.S. supply of table
eggs attributable to this final rule will likely be insignificant.
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\4\ USDA, Harmonized System 10-Digit Imports. Washington, DC:
Foreign Agricultural Service, 2008. Import quantities and cash value
estimates of table eggs for regions where END is considered to exist
were approximated by subtracting the quantity and value of imports
from regions free of END from the ``world total'' query.
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Impact on Small Entities
Companies engaged in chicken egg production are classified under
the North American Industry Classification System code 112310. The
Small Business Administration (SBA) defines a chicken egg-producing
entity as small if it has annual receipts of not more than $11.5
million per year. The 2002 Census of Agriculture reported that there
were 83,381 domestic poultry and egg farms. While their size
distribution is unknown, the census indicates that 29,393 of those
poultry operations had annual sales of $50,000 or more. Thus, the
majority of operations engaged in table egg production are small
entities by SBA standards.
As described, recent imports of table eggs from regions where END
exists have come only from China and constitute an extremely small
share of the U.S. supply. While this rule provides a more efficient and
effective testing protocol for determining the END status of flocks
producing table eggs for the United States, any effects on the supply
of imported eggs will be minimal.
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 final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) 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 0579-0328.
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 Mrs. Celeste Sickles,
APHIS' Information Collection Coordinator, at (301) 851-2908.
Lists of Subjects
9 CFR Part 53
Animal diseases, Indemnity payments, Livestock, Poultry and poultry
products.
9 CFR Part 82
Animal diseases, Poultry and poultry products, Quarantine,
Reporting and recordkeeping requirements, Transportation.
9 CFR Part 94
Animal diseases, Imports, Livestock, Meat and meat products, Milk,
Poultry and poultry products, Reporting and recordkeeping requirements.
0
Accordingly, we are amending 9 CFR parts 53, 82, and 94 as follows:
PART 53--FOOT-AND-MOUTH DISEASE, PLEUROPNEUMONIA, RINDERPEST, AND
CERTAIN OTHER COMMUNICABLE DISEASES OF LIVESTOCK OR POULTRY
0
1. The authority citation for part 53 continues to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
Sec. 53.1 [Amended]
0
2. In Sec. 53.1, the definition for ``Exotic Newcastle Disease (END)''
is amended by removing the word ``velogenic'' and adding the word
``virulent'' in its place.
PART 82--EXOTIC NEWCASTLE DISEASE (END) AND CHLAMYDIOSIS
0
3. The authority citation for part 82 continues to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
Sec. 82.1 [Amended]
0
4. In Sec. 82.1, the definition for ``END'' is amended by removing the
word ``velogenic'' and adding the word ``virulent'' in its 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
5. 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
6. The heading of part 94 is revised to read as set forth above.
Sec. 94.0 [Amended]
0
7. In Sec. 94.0, the definition of ``Exotic Newcastle disease (END)''
is amended by removing the word ``velogenic'' and adding the word
``virulent'' in its place.
0
8. In Sec. 94.6, the introductory text of paragraph (c)(1), paragraph
(c)(1)(v), paragraph (c)(1)(viii), the introductory text of paragraph
(c)(1)(ix), paragraph (c)(1)(ix)(C), and the OMB citation at the end of
the section are revised, and a new paragraph (c)(1)(ix)(D) is added to
read as follows:
Sec. 94.6 Carcasses, 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 subtype H5N1 is considered to exist.
* * * * *
(c) * * *
(1) With a certificate. The eggs may be imported if they are
accompanied by a certificate signed by a salaried veterinary officer of
the national government of the region of origin or, if exported from
Mexico, accompanied either by such a certificate or by a certificate
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, and:
* * * * *
(v) The certificate states that no more than 90 days before the
certificate was signed, a salaried veterinary officer of the national
government of the region of origin or, if exported from Mexico, by a
veterinarian accredited by the national government of Mexico, inspected
the flock of origin and found no evidence of communicable diseases of
poultry.
* * * * *
(viii) Before leaving the premises of origin, the cases in which
the eggs were
[[Page 18288]]
packed were sealed with a seal of the national government of the region
of origin by the salaried veterinarian of the national government of
the region of origin who signed the certificate or, if exported from
Mexico, by the veterinarian accredited by the national government of
Mexico who signed the certificate.
(ix) In addition, if the eggs were laid in any region where END is
considered to exist (see paragraph (a) of this section), the
certificate must also state:
* * * * *
(C) The eggs are from a flock of origin found free of END as
follows: On the seventh and fourteenth days of the 21-day period before
the certificate is signed, at least 1 cull bird (a sick or dead bird,
not a healthy bird that was killed) for each 10,000 live birds
occupying each poultry house certified for exporting table eggs was
tested for END virus using embryonated egg inoculation technique. The
weekly cull rate of birds of every exporting poultry house within the
exporting farm does not exceed 0.1 percent. The tests present no
clinical or immunological evidence of END by embryonated egg
inoculation technique from tissues of birds that were culled and have
been collected by a salaried veterinary officer of the national
government of the region of origin or by a veterinarian accredited by
the national government of Mexico. All examinations and embryonated egg
inoculation tests were conducted in a laboratory located in the region
of origin, and the laboratory was approved to conduct the examinations
and tests by the veterinary services organization of the national
government of that region. All results were negative for END.
(D) Egg drop syndrome is notifiable in the region of origin and
there have been no reports of egg drop syndrome in the flocks of origin
of the eggs, or within a 50 kilometer radius of the flock of origin,
for the 90 days prior to the issuance of the certificate.
* * * * *
(Approved by the Office of Management and Budget under control numbers
0579-0015, 0579-0245, and 0579-0328)
Sec. 94.8 [Amended]
0
9. In Sec. 94.8 in the introductory text and paragraph (a)(4)
introductory text footnotes 8 and 9 are redesignated as footnotes 7 and
8 respectively.
Sec. 94.9 [Amended]
0
10. In Sec. 94.9 (a), (c)(3), and (e)(2) introductory text footnotes
10 through 12 are redesignated as footnotes 9 through 11 respectively.
0
11. Section 94.12 is amended as follows:
0
a. In paragraph (b)(1)(iii)(B), by redesignating footnote 13 as
footnote 12.
0
b. In paragraph (b)(3), by redesignating footnote 14 as footnote 13 and
revising newly redesignated footnote 13 to read as set forth below.
Sec. 94.12 Pork and pork products from regions where swine vesicular
disease exists.
* * * * *
(b) * * *
(3) * * * \13\
\13\ See footnote 9 in Sec. 94.9.
Sec. 94.16 [Amended]
0
12. In Sec. 94.16 (b)(2) footnote 15 is redesignated as footnote 14.
0
13. Section 94.17 is amended as follows:
0
a. In paragraph (e), by redesignating footnote 16 as footnote 15.
0
b. In paragraph (p)(1)(i), by redesignating footnote 17 as footnote 16
and revising newly redesignated footnote 16 to read as set forth below.
Sec. 94.17 Dry-cured pork products from regions where foot-and-mouth
disease, rinderpest, African swine fever, classical swine fever, or
swine vesicular disease exists.
* * * * *
(p) * * *
(1) * * *
(i) * * * \16\
\16\ See footnote 15 in paragraph (e) of this section.
Sec. 94.18 [Amended]
0
14. In Sec. 94.18 in paragraphs (c)(2) and (d)(1) footnotes 18 and 19
are redesignated as footnotes (17) and (18) respectively.
Sec. 94.24 [Amended]
0
15. In Sec. 94.24 in paragraphs (a)(5) and (b)(6) footnotes 20 and 21
are redesignated as footnotes 19 and 20 respectively.
Done in Washington, DC, this 15th day of April 2009.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E9-9102 Filed 4-21-09; 8:45 am]
BILLING CODE 3410-34-P