[Federal Register Volume 74, Number 76 (Wednesday, April 22, 2009)]
[Rules and Regulations]
[Pages 18285-18288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-9102]



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Rules and Regulations
                                                Federal Register
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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.

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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.
---------------------------------------------------------------------------

    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