[Federal Register: May 28, 2008 (Volume 73, Number 103)]
[Proposed Rules]
[Page 30528-30543]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28my08-19]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 145, 146, and 147
[Docket No. APHIS-2007-0042]
RIN 0579-AC78
National Poultry Improvement Plan and Auxiliary Provisions
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend the National Poultry Improvement
Plan (the Plan) and its auxiliary provisions by providing new or
modified sampling and testing procedures for Plan participants and
participating flocks. The proposed changes were voted on and approved
by the voting delegates at the Plan's 2006 National Plan Conference.
These changes would keep the provisions of the Plan current with
changes in the poultry industry and provide for the use of new sampling
and testing procedures.
DATES: We will consider all comments that we receive on or before July
28, 2008.
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-2007-0042 to submit or view comments and
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send two copies of
your comment to Docket No. APHIS-2007-0042, 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-2007-0042.
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,
[[Page 30529]]
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: Mr. Andrew R. Rhorer, Senior
Coordinator, Poultry Improvement Staff, National Poultry Improvement
Plan, Veterinary Services, APHIS, USDA, 1498 Klondike Road, Suite 101,
Conyers, GA 30094-5104; (770) 922-3496.
SUPPLEMENTARY INFORMATION:
Background
The National Poultry Improvement Plan (NPIP, also referred to below
as ``the Plan'') is a cooperative Federal-State-industry mechanism for
controlling certain poultry diseases. The Plan consists of a variety of
programs intended to prevent and control poultry diseases.
Participation in all Plan programs is voluntary, but breeding flocks,
hatcheries, and dealers must first qualify as ``U.S. Pullorum-Typhoid
Clean'' as a condition for participating in the other Plan programs.
The Plan identifies States, flocks, hatcheries, dealers, and
slaughter plants that meet certain disease control standards specified
in the Plan's various programs. As a result, customers can buy poultry
that has tested clean of certain diseases or that has been produced
under disease-prevention conditions.
The regulations in 9 CFR parts 145, 146, and 147 (referred to below
as the regulations) contain the provisions of the Plan. The Animal and
Plant Health Inspection Service (APHIS, also referred to as ``the
Service'') of the U.S. Department of Agriculture (USDA, also referred
to as ``the Department'') amends these provisions from time to time to
incorporate new scientific information and technologies within the
Plan.
The proposed amendments discussed in this document are consistent
with the recommendations approved by the voting delegates to the
National Plan Conference that was held from September 7 to September 9,
2006. Participants in the 2006 National Plan Conference represented
flockowners, breeders, hatcherymen, slaughter plants, and Official
State Agencies from all cooperating States. The proposed amendments are
discussed in detail below.
Definitions
We are proposing to amend the definition of equivalent or
equivalent requirements in Sec. 145.1 and the definition of equivalent
in Sec. 146.1. The definition for both these terms currently reads:
``Requirements which are equal to the program, conditions, criteria, or
classifications with which compared, as determined by the Official
State Agency and with the concurrence of the Service.'' We would add
the words ``or exceed'' after the words ``equal to,'' in order to
indicate that the requirements may also be more stringent or
restrictive than the requirements with which they are being compared
and still be considered equivalent. We would also add the words ``they
are'' after the words ``with which'' for clarity.
We are also proposing to add to the regulations definitions of a
body within the NPIP, the NPIP Technical Committee, and a position
within the NPIP, the Senior Coordinator.
The NPIP Technical Committee would be defined in Sec. 145.1 as:
``A committee made up of technical experts on poultry health,
biosecurity, surveillance, and diagnostics. The committee consists of
representatives from the poultry and egg industries, universities, and
State and Federal governments and is appointed by the Senior
Coordinator and approved by the General Conference Committee.'' The
NPIP Technical Committee is currently referred to in the regulations in
Sec. 145.15; adding this definition will clarify what we mean by that
term.
The regulations in Sec. 147.43(d)(1) refer to the Senior
Coordinator and his staff administering the provisions of the plan. The
definition of Senior Coordinator that we are proposing to add to Sec.
145.1 would indicate what roles the Senior Coordinator plays in
administering the plan. The Senior Coordinator's duties might include,
but would not necessarily be limited to:
Serving as executive secretary of the General Conference
Committee;
Serving as chairperson of the Plan Conference described in
Sec. 147.47;
Planning, organizing, and conducting the Plan Conference;
Reviewing NPIP authorized laboratories as described in
proposed Sec. 147.51 (see the section headed ``Authorized
Laboratories'' later in this document);
Coordinating the State administration of the NPIP through
periodic reviews of the administrative procedures of the Official State
Agencies, according to the applicable provisions of the Plan and the
Memorandum of Understanding required in Sec. Sec. 145.2(a) and
146.2(a);
Coordinating rulemaking to incorporate the proposed
changes of the provisions approved at the Plan conference into the
regulations in 9 CFR parts 145, 146, and 147;
Directing the production of official NPIP publications;
Proposing an annual budget for plan activities and the
General Conference Committee; and
Providing overall administration of the NPIP.
Contact Representatives
The regulations in Sec. Sec. 145.2(a) and 146.2(a) state that the
Department cooperates through a Memorandum of Understanding with the
Official State Agency in the administration of the Plan. One key
component of the Memorandum of Understanding is the Official State
Agency's designation of a contact representative to serve as a liaison
between the Service and the Official State Agency. The contact
representative facilitates communication between the two organizations.
While we have requested that Official State Agencies designate
contact representatives in their Memoranda of Understanding, we
currently do not require them to do so in the regulations. However,
because this position is crucial to the effective operation of the
NPIP, we are proposing to make the designation of a contact
representative by the Official State Agency a requirement. To
accomplish this, we would add a sentence to the end of Sec. Sec.
145.2(a) and 146.2(a) that would read as follows: ``In the Memorandum
of Understanding, the Official State Agency must designate a contact
representative to serve as a liaison between the Service and the
Official State Agency.''
Official Tests for Avian Influenza
The regulations in Sec. Sec. 145.14(d) and 146.13(b) set out the
NPIP approved tests for avian influenza in breeding poultry and
commercial poultry, respectively. These paragraphs provide for the use
of the agar gel immunodiffusion (AGID) test, under the procedures set
forth in Sec. 147.9, and the enzyme-linked immunosorbent assay
(ELISA). The AGID test must be conducted on all ELISA-positive samples.
Positive tests by AGID or ELISA must be further tested by Federal
Reference Laboratories. Final judgment may be based upon further
sampling or culture results. In addition, the tests must be conducted
using antigens or test kits approved by the Service. Test kits for
ELISA must be licensed by the Service and approved by the Official
State Agency, and tests must be performed in accordance with the
recommendations of the producer or manufacturer.
[[Page 30530]]
Paragraph (b) of Sec. 146.13 further requires that the official
determination of a flock as positive for the H5 or H7 subtypes of low
pathogenic avian influenza may be made only by the Service's National
Veterinary Services Laboratories (NVSL). This paragraph also states
that the AGID and ELISA tests may be performed either on egg yolk or
blood samples. Otherwise, Sec. Sec. 145.14(d) and 146.13(b) are
substantively identical.
We are proposing to amend Sec. Sec. 145.14(d) and 146.13(b) to
include two agent detection tests in addition to the AGID and ELISA
antibody detection tests. To accommodate the addition of the agent
detection tests, we would reorganize Sec. Sec. 145.14(d) and 146.13(b)
by splitting each of those paragraphs into two subparagraphs. The
requirements related to the antibody detection tests would then appear
under the heading ``Antibody detection tests'' in Sec. Sec.
145.13(d)(1) and 146.13(b)(1), respectively. We would indicate in both
paragraphs that the AGID test must be conducted using reagents approved
by the Department and the Official State Agency, and that it can be
performed on egg yolk or blood samples. (The ELISA could still be
performed on egg yolk or blood samples as long as it is performed in
accordance with the recommendations of the producer or manufacturer.)
We are also proposing to add the new provisions for agent detection
tests in Sec. Sec. 145.14(d)(2) and 146.13(b)(2), respectively.
Authorized laboratories would be allowed to perform tests that detect
influenza A matrix gene or protein, but not tests that determine
hemagglutinin or neuraminidase subtypes; all tests that determine those
subtypes should be performed by National Animal Health Laboratory
Network members, to ensure the reliability of their results. Samples
for agent detection testing would be collected from naturally occurring
flock mortality or clinically ill birds, to increase the sensitivity of
the testing.
We would provide for the use of two agent detection tests: The real
time reverse transcriptase/polymerase chain reaction (RRT-PCR) assay
and the USDA-licensed type A influenza antigen capture immunoassay
(ACIA). The RRT-PCR and the ACIA are rapid flock screening tools that
can provide highly specific, scalable results on the same day (the RRT-
PCR within 3 to 5 hours and the ACIA within 15 minutes). These tests
would have significant value both as screening tests and as part of
initial State response and containment plans to control avian influenza
(as described in 9 CFR 56.10).
The RRT-PCR tests would have to be conducted using reagents
approved by the Department and the Official State Agency. The RRT-PCR
would have to be conducted using the NVSL official protocol for RRT-PCR
(AVPR01510) and be conducted by personnel who have passed an NVSL
proficiency test. Positive results from the RRT-PCR would have to be
further tested by Federal Reference Laboratories using appropriate
tests for confirmation. Final judgment could be based upon further
sampling and appropriate tests for confirmation.
The USDA-licensed type A influenza ACIA would have to be conducted
using test kits approved by the Department and the Official State
Agency and would have to be conducted in accordance with the
recommendations of the producer or manufacturer. Positives on the ACIA
would have to be further tested by Federal Reference Laboratories using
appropriate tests for confirmation. Final judgment could be based upon
further sampling and appropriate tests for confirmation.
Finally, we would amend Sec. 145.14(d) to indicate there as well
that the official determination of a flock as positive for the H5 or H7
subtypes avian influenza may be made only by NVSL.
In a related change, we are proposing to move the requirements in
Sec. 145.15, ``Approved tests,'' to a new Sec. 147.52. We would also
add a new Sec. 147.51 to describe the requirements for authorized
laboratories; these proposed changes are discussed later in this
document under the heading ``Authorized Laboratories.'' The new
Sec. Sec. 147.51 and 147.52 would be placed in a new subpart in 9 CFR
part 147 to collect the provisions governing approval of laboratories
and tests.
Diagnostic Surveillance Plan for H5/H7 Low Pathogenic Avian Influenza
In an interim rule published and effective September 26, 2006 (71
FR 53601-56333, Docket No. APHIS-2005-0109), we amended the regulations
to establish a voluntary control program for the H5/H7 subtypes of low
pathogenic avian influenza (H5/H7 LPAI) in commercial poultry--
specifically, in table-egg layers, meat-type chickens, and meat-type
turkeys. This voluntary control program includes a requirement for
participating States to develop a diagnostic surveillance program that
includes all poultry in the State, not just commercial poultry. The
regulations governing the development of such a program are found in
Sec. 146.14. Participation in the voluntary control program is a
condition for States and large producers to be eligible to receive 100
percent indemnity for costs related to an outbreak of H5/H7 LPAI under
9 CFR part 56.
We are proposing to add a new Sec. 145.15 that duplicates the
regulations in Sec. 146.14 to ensure that participants in the NPIP for
breeding poultry are aware that States participating in the voluntary
control program must develop a diagnostic surveillance program that
includes both breeding and commercial poultry.
Testing Requirements for U.S. Avian Influenza Clean Programs for
Multiplier Egg-Type Chicken, Meat-Type Chicken, and Turkey Breeding
Flocks
The regulations set out requirements for the U.S. Avian Influenza
Clean classifications for multiplier egg-type chicken breeding flocks,
multiplier meat-type chicken breeding flocks, and multiplier turkey
breeding flocks at Sec. Sec. 145.23(h)(2), 145.33(l)(2), and
145.43(g)(2), respectively. These paragraphs all require that, for a
multiplier breeding flock to retain the U.S. Avian Influenza Clean
classification, a sample of at least 30 birds must be tested negative
at intervals of 180 days, or a sample of fewer than 30 birds may be
tested, and found to be negative, at any one time if all pens are
equally represented and a total of 30 birds is tested within each 180-
day period.
However, due to the virulence of the avian influenza virus and the
minute amount of infective fecal material and respiratory secretions
required to transmit the virus and infect a flock, industry
participants have determined that the 180-day interval between tests is
too long to provide satisfactory assurance that the flocks being tested
are U.S. Avian Influenza Clean for these types of poultry.
The U.S. Avian Influenza Clean programs for primary breeding flocks
of egg-type chickens, meat-type chickens, and turkeys (in Sec. Sec.
145.73(f)(1), 145.83(g)(1), and 145.43(g)(1), respectively) require
testing every 90 days. We believe this interval is appropriate for all
flocks of these types of poultry. Therefore, we are proposing to
replace references to the 180-day testing interval in Sec. Sec.
145.23(h)(2), 145.33(l)(2), and 145.43(g)(2) with references to a 90-
day testing interval. We believe this change would help to ensure that
flocks with the U.S. Avian Influenza Clean classification are free of
avian influenza.
The regulations currently require that 30 birds be tested negative
at intervals of 180 days. For multiplier breeding flocks of egg-type
chickens and turkeys, we would retain the requirement that 30 birds be
tested while reducing the
[[Page 30531]]
interval at which they are tested to 90 days. For multiplier breeding
flocks of meat-type chickens, we would require that 15 birds be tested
negative every 90 days. Egg-type chicken and turkey breeding flocks
receive much more regular supervision than meat-type chicken breeding
flocks, and those industries determined that testing the same number of
birds over a shorter interval would be practical. The changes to the
testing requirement for meat-type chicken breeding flocks would result
in the same number of these birds being tested as are tested under the
current regulations, but would still increase the assurance that the
flocks tested are U.S. Avian Influenza Clean by providing more frequent
results.
The waterfowl, exhibition poultry, and game bird breeding industry
considered this change and determined that it is not appropriate at
this time; multiplier waterfowl, exhibition poultry, and game bird
breeding flocks participating in the U.S. Avian Influenza Clean program
would continue to be tested at intervals of 180 days.
Option for Reporting Poultry Sales for Waterfowl, Exhibition Poultry,
and Game Bird Breeding Flocks and Products
The regulations for the participation of waterfowl, exhibition
poultry, and game bird breeding flocks in Sec. 145.52 state that,
subject to the approval of the Service and the Official State Agencies
in the relevant States, participating flocks may report poultry sales
by using printouts of computerized monthly shipping and receiving
reports in lieu of Veterinary Services (VS) Form 9-3, ``Report of Sales
of Hatching Eggs, Chicks, and Poults.'' The regulations do not state
what information would need to be included in such monthly shipping and
receiving reports if they are used in lieu of VS Form 9-3. We are
proposing to add requirements for these monthly shipping and receiving
reports to the regulations.
The regulations would state specifically that a hatchery invoice
form (9-3I) approved by the Official State Agency and the Service may
be used in lieu of VS Form 9-3 to identify poultry sales to clients. If
the selling hatchery uses the 9-3I form, we would require that the
following information be included on the form:
The form number ``9-3I,'' printed or stamped on the
invoice;
The hatchery name and address;
The date of shipment;
The hatchery invoice number;
The purchaser name and address;
The quantity of products sold;
Identification of the products by bird variety or by NPIP
stock code as listed in the NPIP APHIS 91-55-078 appendix; and
The appropriate NPIP illustrative design in Sec. 145.10.
One of the designs in Sec. 145.10(b) or (g) would have to be used. The
following information would have to be provided in or near the NPIP
design:
[cir] The NPIP State number and NPIP hatchery approval number; and
[cir] The NPIP classification for which product is qualified (e.g.,
U.S. Pullorum-Typhoid Clean).
This change would ensure that reports provided in lieu of VS Form
9-3 would have standard information and make it easy to use such
reports in place of that form.
New U.S. Avian Influenza Clean Classification for Ostrich, Emu, Rhea,
and Cassowary Breeding Flocks and Products
Subpart F of 9 CFR part 145 contains the special Plan provisions
for ostrich, emu, rhea, and cassowary breeding flocks and products.
Section 145.63 contains the requirements for ostrich, emu, rhea, and
cassowary breeding flocks to earn the U.S. Pullorum-Typhoid Clean
classification. We are proposing to add a U.S. Avian Influenza Clean
classification to Sec. 145.63, in a new paragraph (b). This
classification would be the basis from which the breeding-hatchery
industry may conduct a program for the prevention and control of avian
influenza. It would be intended to determine the presence of avian
influenza in all ostrich, emu, rhea, and cassowary breeding flocks
through routine serological surveillance of each participating breeding
flock.
Acceptable tests would include antigen and antibody detection
tests, as approved by the Official State Agency.
An ostrich, emu, rhea, or cassowary breeding flock, and the
hatching eggs and chicks produced from it, would qualify for this
classification when the Official State Agency determines that it has
met one of the following requirements:
It is a primary breeding flock in which 10 percent of the
flock, up to a maximum of 30 birds, has been tested negative for type A
influenza virus with all pens represented equally and when the tested
birds are more than 4 months of age. Positive samples would be further
tested by an authorized laboratory. To retain this classification, a
sample of at least 30 birds would have to be tested negative at
intervals of 180 days, or a sample of less than 10 percent of the birds
up to a maximum of 30 birds could be tested, and found to be negative,
at any one time if all pens are equally represented and a total of 30
birds are tested within each 180-day period.
It is a multiplier breeding flock in which a minimum of 30
birds has been tested negative to type A influenza virus with all pens
represented equally and when the tested birds are more than 4 months of
age. Positive samples would be further tested by an authorized
laboratory. To retain this classification, a sample of at least 30
birds would have to be tested negative at intervals of 180 days, or a
sample of at least 10 percent of birds from each pen with all pens
being represented would have to be tested negative at intervals of 180
days; or a sample of less than 10 percent of the birds could be tested,
and found to be negative, at any one time if all pens are equally
represented and a total of 10 percent of the birds are tested within
each 180-day period.
These requirements are similar to the requirements in the U.S.
Avian Influenza Clean classification for waterfowl, exhibition poultry,
and game bird breeding flocks and products.
Audit Process for Commercial Poultry Slaughter Plants
In part 146, which contains the NPIP provisions for commercial
poultry, Sec. 146.11 sets out the process for inspecting participating
slaughter plants. Paragraph (a) of Sec. 146.11 requires each
participating slaughter plant to be audited at least once annually or a
sufficient number of times each year to satisfy the Official State
Agency that the participating slaughter plant is in compliance with the
provisions of 9 CFR part 146. Paragraph (b) provides that on-site
inspections of any participating flocks and premises will be conducted
if a State Inspector determines that a breach of testing has occurred
for the Plan programs for which the flocks are certified. Paragraph (c)
provides that the official H5/H7 LPAI testing records of all
participating flocks and slaughter plants shall be examined annually by
a State Inspector and that official H5/H7 LPAI testing records shall be
maintained for 3 years.
The regulations currently do not provide any detail regarding the
audit process described in paragraph (a). We are proposing to describe
this process in detail in the regulations, to inform regulated parties,
trading partners, and the general public regarding the information we
examine and the consequences if an audit finds that a slaughter plant
is not complying with the regulations.
The yearly audit would consist of an evaluation of 2 weeks' worth
of records,
[[Page 30532]]
selected at random, of the following data:
The actual flock slaughter date for each flock. This
information would be required to come from a verifiable source.
Verifiable sources would include electronic record systems that have
oversight from the Department's Grain Inspection, Packers and
Stockyards Administration or Food Safety and Inspection Service (FSIS)
documents such as FSIS Form 9061-2.
Laboratory test results for each flock slaughtered with
the sample collection date and test result. The test would have to be
NPIP-approved and performed in an authorized laboratory of the NPIP.
We would redesignate current paragraphs (b) and (c) as paragraphs
(d) and (e), respectively, and add new paragraphs (b) and (c) to
further describe the audit process. Under proposed paragraph (b), a
flock would be considered to be not conforming to protocol if there are
no test results available, if the flock was not tested within 21 days
before slaughter, or if the test results for the flock were not
returned before slaughter.
Under proposed paragraph (c), two or more flocks that are found to
be not conforming to protocol in the yearly audit for a slaughter plant
would be cause for a deficiency rating for that plant. However, if the
root cause for the deficiency was identified, corrected, and
documented, the plant would be eligible for an immediate reevaluation
of 2 additional weeks' worth of records, again selected at random. If
no more than one missed flock was identified in this reevaluation, the
plant would be considered in compliance and no further action would be
required. Plants found to be deficient would have to provide a written
corrective action plan to the auditor within 2 weeks of receipt of the
deficiency rating. A followup audit on the information in proposed
paragraphs (a)(1) and (a)(2) would occur within 90 days from the
receipt of the corrective action plan. Slaughter plants would retain
their Plan classification and could continue to use the Plan emblem
during this process. However, a failure on the followup audit could
result in disbarment from participation in the NPIP according to the
procedures in Sec. 146.12.
Sampling at Commercial Meat-Type Turkey Slaughter Plants
The regulations in Sec. 146.43(a) set out the requirements meat-
type turkey slaughter plants must fulfill in order to qualify for the
U.S. H5/H7 Avian Influenza Monitored classification. Paragraphs (a)(1)
and (a)(2) offer two options for qualifying for the classification: The
plant must either test a sample of a minimum of 60 birds each month for
antibodies to type A avian influenza virus or have an ongoing active
and diagnostic surveillance program for the H5/H7 subtypes of avian
influenza in which the number of birds tested is equivalent to 60 each
month and that is approved by the Official State Agency and the
Service.
We are proposing to amend paragraph (a)(1) to indicate that a
participating meat-type turkey slaughter plant may accept only meat-
type turkeys from flocks where a minimum of 6 birds per flock has
tested negative for antibodies to type A avian influenza virus with an
approved test no more than 21 days prior to slaughter. This level of
testing is sufficient to establish the meat-type turkey slaughter plant
as U.S. H5/H7 Avian Influenza Monitored under the Plan.
The proposed provisions would also explicitly allow for testing at
the flock level (prior to slaughter), an option that has been requested
by the meat-type turkey industry. Testing at slaughter would still be
authorized under paragraph Sec. 146.43(a)(2), which allows slaughter
plants to use any ongoing active and diagnostic surveillance program
for the H5/H7 subtypes of avian influenza in which the number of birds
tested is equivalent to the number required in paragraph (a)(1) and
that is approved by the Official State Agency and the Service. Testing
at slaughter could fulfill this requirement, subject to approval by the
Official State Agency and the Service.
New U.S. H5/H7 Avian Influenza Classification for Raised-for-Release
Upland Game Birds, Raised-for-Release Waterfowl, Commercial Upland Game
Birds and Commercial Waterfowl
The regulations in 9 CFR part 146 provide for the participation of
commercial table-egg layers, commercial meat-type chickens, and
commercial meat-type turkeys in the NPIP and in the U.S. H5/H7 Avian
Influenza Monitored classification. The commercial upland game bird and
waterfowl industries and the raised-for-release upland game bird and
waterfowl industries have expressed interest in controlling H5/H7 avian
influenza in their flocks by participating in part 146 and in a U.S.
H5/H7 Avian Influenza Monitored classification. In this document, we
are proposing to provide for such a classification.
We would add provisions for the participation of these birds in the
NPIP in a new Subpart E of part 146, titled ``Special Provisions for
Commercial Upland Game Birds, Commercial Waterfowl, Raised-for-Release
Upland Game Birds, and Raised-for-Release Waterfowl.'' Specifically,
the subpart would provide for the participation of commercial upland
game bird slaughter plants, commercial waterfowl slaughter plants,
raised-for-release upland game bird premises, and raised-for-release
waterfowl premises in the Plan. It would also describe the testing that
would be required for commercial upland game bird and commercial
waterfowl slaughter plants and raised-for-release upland game bird and
waterfowl premises to achieve the U.S. H5/H7 Avian Influenza Monitored
classification.
Section 146.51 of this new subpart would define the types of birds
to which these special provisions would apply as follows:
Commercial upland game birds. Upland game bird pheasants, quail, or
partridges grown under confinement for the primary purpose of producing
meat for human consumption.
Commercial waterfowl. Domesticated ducks or geese grown under
confinement for the primary purpose of producing meat for human
consumption
Raised-for-release upland game birds. Pheasants, quail, and
partridge that are raised under confinement for release in game
preserves and are not breeding stock.
Raised-for-release waterfowl. Waterfowl that are raised under
confinement for release in game preserves and are not breeding stock.
This section defines commercial upland game bird and commercial
waterfowl slaughter plants as plants that are federally inspected or
under State inspection that FSIS has recognized as equivalent to
Federal inspection. It also defines shift as: ``The working period of a
group of employees who are on duty at the same time.''
Section 146.52, ``Participation,'' would state that participating
commercial upland game bird slaughter plants, commercial waterfowl
slaughter plants, raised-for-release upland game bird premises, and
raised-for-release waterfowl premises shall comply with applicable
general provisions of subpart A of part 146 and the special provisions
of proposed subpart E, which include the proposed testing requirements.
However, the section would provide exemptions from the special
provisions of subpart E for:
Commercial waterfowl and commercial upland game bird
slaughter plants that slaughter fewer than 50,000 birds annually.
Raised-for-release upland game bird premises and raised-
for-release
[[Page 30533]]
waterfowl premises that raise fewer than 25,000 birds annually.
The proposed size standard for commercial waterfowl and commercial
upland game bird slaughter plants is consistent with the National Duck
Council's definitions for such plants. The proposed size standard for
raised-for-release upland game bird premises and raised-for-release
waterfowl premises is consistent with the North American Gamebird
Association's definition of a commercial premises of these types.
Section 146.53, ``Terminology and classification; slaughter plants
and premises,'' would set out active surveillance requirements for
participating commercial upland game bird slaughter plants, commercial
waterfowl slaughter plants, raised-for-release upland game bird
premises, and raised-for-release waterfowl premises.
Paragraph (a) would set out active surveillance requirements for
commercial upland game bird slaughter plants and commercial waterfowl
slaughter plants. The active surveillance requirements we are proposing
to add in Sec. 146.53(a) are intended for commercial upland game bird
slaughter plants and commercial waterfowl slaughter plants that
slaughter 50,000 or more of these types of poultry annually. However,
smaller commercial upland game bird slaughter plants and commercial
waterfowl slaughter plants are eligible to participate in the NPIP, as
long as the State in which they are located participates in the NPIP.
We believe that diagnostic surveillance in accordance with Sec. 146.14
and inspections in accordance with Sec. 146.11, which are required in
the general provisions in subpart A, are adequate to determine whether
H5/H7 LPAI is present on such premises.
Under paragraph (a) of proposed Sec. 145.53, a commercial upland
game bird slaughter plant or commercial waterfowl slaughter plant would
be eligible for the U.S. H5/H7 Avian Influenza Monitored classification
if it meets one of the following requirements:
It is a commercial upland game bird slaughter plant or
commercial waterfowl slaughter plant where a minimum of 11 birds per
shift are tested negative for the H5/H7 subtypes of avian influenza at
slaughter;
It is a commercial upland game bird slaughter plant or
commercial waterfowl slaughter plant that only accepts commercial
upland game birds or commercial waterfowl from flocks where a minimum
of 11 birds per flock have been tested negative for antibodies to the
H5/H7 subtypes of avian influenza no more than 21 days prior to
slaughter; or
It is a commercial upland game bird slaughter plant or
commercial waterfowl slaughter plant that has an ongoing active and
passive surveillance program for H5/H7 subtypes of avian influenza that
is approved by the Official State Agency and the Service.
Both of the first two of these proposed testing requirements would
be sufficient to establish the commercial waterfowl or commercial
upland game bird slaughter plants as U.S. H5/H7 Avian Influenza
Monitored under the Plan, consistent with the other U.S. H5/H7 Avian
Influenza Monitored classifications in 9 CFR part 146. Allowing
participating slaughter plants to choose between them would give the
slaughter plants some flexibility.
Any ongoing active and diagnostic surveillance program that is
approved by the Official State Agency and APHIS would have to test a
number of birds equivalent to the other two options, but this by itself
would not be sufficient to secure approval for the program; the
Official State Agency and APHIS would have to agree that the detailed
testing plan for the alternate program is sufficient to establish a
level of confidence for the detection of AI that is equivalent to that
of the other two options. Allowing participating slaughter plants to
develop an alternative ongoing active and diagnostic surveillance
program of equivalent efficacy would give the plants some additional
flexibility.
Paragraph (b) would set out active surveillance requirements for
raised-for-release upland game bird premises and raised-for-release
waterfowl premises. The active surveillance requirements we are
proposing to add in Sec. 146.53(b) are intended for raised-for-release
upland game bird premises and raised-for-release waterfowl premises
that raise 25,000 or more of these types of poultry annually. However,
smaller raised-for-release upland game bird premises and raised-for-
release waterfowl premises are eligible to participate in the NPIP, as
long as the State in which they are located participates in the NPIP.
We believe that diagnostic surveillance in accordance with Sec.
146.14, which is required in the general provisions in subpart A, is
adequate to monitor whether H5/H7 LPAI is present on such premises.
Under paragraph (b), a raised-for-release upland game bird premises
or raised-for-release waterfowl premises would qualify for the U.S. H5/
H7 Avian Influenza Monitored classification when the Official State
Agency determines that a representative sample of 30 birds from the
participating premises has been tested with negative results for the
H5/H7 subtypes of avian influenza every 90 days. This testing would be
for premises monitoring purposes and would not be intended to establish
the premises as free of the H5/H7 subtypes of avian influenza.
Because this change would expand the ranks of commercial poultry
producers who are eligible to participate in the Plan, we would amend
the definition of commercial meat-type flock in Sec. 146.1 to include
commercial upland game birds and commercial waterfowl; amend Sec.
146.3 to reflect the participation of the commercial upland game bird
slaughter plants, commercial waterfowl slaughter plants, raised-for-
release upland game bird premises, and raised-for-release waterfowl
premises; make appropriate changes to Sec. 146.6 to reflect the
addition of the two new types of slaughter plants; and amend Sec.
146.9 to indicate that the new participants may use the U.S. H5/H7
Avian Influenza Monitored illustrative design.
We would amend Sec. 147.45 to indicate that each cooperating State
is entitled to one delegate for the program we are proposing to
describe in a new subpart E in 9 CFR part 146. (In addition, in a final
rule that was published in the Federal Register on January 12, 2007 (72
FR 1416-1426, Docket No. APHIS-2006-0008), and effective on February
12, 2007, we added new subparts G and H for primary egg-type and meat-
type chicken breeding flocks, but neglected to update Sec. 147.45 to
indicate that each cooperating State would be entitled to one delegate
for each of these subparts. We are proposing to correct that error in
this document.) We would also amend Sec. 147.46(a) to establish a
committee to give preliminary considerations to proposed changes
falling in the field of commercial upland game birds and waterfowl and
raised-for-release upland game birds and waterfowl.
Amendment to Standard AGID Test Procedure for Avian Influenza
The regulations in Sec. 147.9(a) describe the standard AGID test
procedure for avian influenza. Within Sec. 147.9(a), paragraph
(a)(4)(i)(F) describes two options for placing AGID antigen, AI AGID
positive control antiserum, and test sera into wells formed in agar on
a petri plate. Paragraph (a)(4)(i)(F)(1) describes a method (shown in
figure 1) in which AGID antigen is placed in the center well, AI AGID
positive control antiserum is placed in each of two opposite wells, and
test sera are placed in each of the four remaining wells. Paragraph
(a)(4)(i)(F)(2) describes a method (shown in figure 2) in which
[[Page 30534]]
AGID antigen is placed in the center well, AI AGID positive control
antiserum is placed in each of three alternate peripheral wells, and
test sera are placed in each of the three remaining wells.
BILLING CODE 3410-34-P
[GRAPHIC] [TIFF OMITTED] TP28MY08.003
[GRAPHIC] [TIFF OMITTED] TP28MY08.004
BILLING CODE 3410-34-C
[[Page 30535]]
The arrangement in figure 1 provides a positive control line on one
side of the test serum, thus providing for the development of lines of
identity; the arrangement in figure 2 provides a positive control line
on each side of the test serum, thus providing for the development of
lines of identity on both sides of each test serum. While most positive
test sera will result in clear-cut evidence of a positive agar gel
reaction, there are times early in AI infection when the test sera may
only contain small amounts of antibody. This will cause the tips of the
lines of identity to bend slightly inward, which is indicative of a
weak positive on the AGID. Having two lines converging towards a test
well provides a better opportunity to have an accurate and precise
interpretation of the positive reaction or to distinguish a nonspecific
reaction.
Therefore, we are proposing to remove the option described in
paragraph (a)(4)(i)(F)(1) from the regulations. A revised (a)(4)(i)(F)
would only set out the second option; figure 1 would be removed, and
figures 2 and 3 would be redesignated as figures 1 and 2, respectively.
Laboratory Procedures for New Real-Time Polymerase Chain Reaction Test
for Mycoplasma Gallisepticum
Subpart D of 9 CFR part 147 sets out procedures to follow when
performing molecular examinations for Plan diseases. We are proposing
to add a new description of the laboratory procedures recommended for
the real-time polymerase chain reaction (PCR) test for Mycoplasma
gallisepticum (MGLP ReTi) in Sec. 147.31. The method described in
proposed Sec. 147.31 has been published in peer-reviewed journals and
validated with over 1,200 samples. It has also been shown to be more
sensitive than traditional isolation methods. Adding this testing
procedure to the regulations would keep Plan molecular examination
procedures current with recent science. A detailed description of the
procedure can be found in the text of proposed Sec. 147.31 that
appears at the end of this document.
In a related change, we are proposing to add a new paragraph (b)(5)
to Sec. 145.14(b), which describes the official tests for M.
gallisepticum and M. synoviae. This new paragraph would state that the
official molecular examination procedures for M. gallisepticum and M.
synoviae are the PCR test described in Sec. 147.30 and the real-time
PCR test described in proposed Sec. 147.31. Adding this language in
Sec. 145.14(b)(5) would clearly indicate that the tests described in
Sec. 147.30 and proposed Sec. 147.31 are considered official tests of
the Plan.
Amendments to General Conference Committee Description
The regulations in Sec. 147.43(d) describe the duties and
functions of the General Conference Committee (GCC) of the National
Poultry Improvement Plan in advising and administering the Plan. We are
proposing to make two changes in this paragraph:
Paragraph (d)(4) of Sec. 147.43 provides that the GCC
will recommend whether new proposals (i.e., proposals that have not
been submitted as provided in Sec. 147.44) should be considered by the
delegates to the Plan Conference. We would add that the GCC will
consider each proposal submitted as provided in Sec. 147.44 and make
recommendations to subpart Committees and the Conference, and that it
will meet jointly with the NPIP Technical Committee and consider the
technical aspects and accuracy of each proposal. These amendments would
reflect current Plan operations.
Paragraph (d)(6) provides that the GCC will serve as a
forum for the study of problems relating to poultry health and as the
need arises, to make specific recommendations to the Secretary of
Agriculture concerning ways in which the Department may assist the
industry in solving these problems. Because the GCC acts as an official
advisory committee, we would remove the words ``a forum'' and replace
them with the words ``an official advisory committee.''
Authorized Laboratories
In the definitions in Sec. Sec. 145.1 and 146.1, authorized
laboratory is defined as a laboratory designated by an Official State
Agency, subject to review by the Service, to perform the blood testing
and bacteriological examinations provided for in 9 CFR part 145. Under
this definition, the Service's review will include, but will not
necessarily be limited to, checking records, laboratory protocol,
check-test proficiency, periodic duplicate samples, and peer review. A
satisfactory review will result in the authorized laboratory being
recognized by the Service as a nationally approved laboratory qualified
to perform the blood testing and bacteriological examinations provided
for in 9 CFR part 145 or the diagnostic assays provided for in 9 CFR
part 146.
In this document, we are proposing to add more detailed
requirements for authorized laboratories to the regulations. We would
establish a new Sec. 147.51 with the heading ``Authorized laboratory
minimum requirements.'' This section would be added in a new subpart F
with the heading ``Authorized laboratories and approval of tests.''
The introductory text of Sec. 147.51 would state that the section
contains minimum requirements that are intended to be the basis on
which an authorized laboratory of the Plan can be evaluated to ensure
that official Plan assays are performed and reported as described in 9
CFR part 147. A satisfactory evaluation would result in the laboratory
being recognized by the NPIP office of the Service as an authorized
laboratory qualified to perform the assays provided for in 9 CFR part
147. The minimum requirements would be the following:
Check-test proficiency. The laboratory would have to use a
regularly scheduled check test for each assay that it performs. The
check test serves to ensure the integrity of the testing procedure as
it is being performed in the laboratory.
Trained technicians. The testing procedures at the
laboratory would have to be run or overseen by a laboratory technician
who has attended and satisfactorily completed Service-approved
laboratory workshops for Plan-specific diseases within the past 3
years. This training requirement would ensure that the tests are being
run consistently across authorized laboratories.
Laboratory protocol. Official Plan assays would have to be
performed and reported as described in 9 CFR part 147.
State site visit. The Official State Agency would conduct
a site visit and recordkeeping audit annually.
Service review. Authorized laboratories would be reviewed
by the NPIP staff every 3 years. The Service's review might include,
but would not necessarily be limited to, checking records, laboratory
protocol, check-test proficiency, technician training, and peer review.
This requirement (with the exception of the Service checking technician
training) is taken from the current definition of authorized laboratory
in Sec. 145.1.
Reporting. A memorandum of understanding or other means
would be used to establish testing and reporting criteria to the
Official State Agency, including criteria that provide for reporting H5
and H7 low pathogenic avian influenza directly to the Service.
Salmonella pullorum and Mycoplasma Plan disease reactors would have to
be reported to the Official State Agency within 48 hours.
Verification. Random samples could also be required to be
submitted for verification as specified by the Official State Agency.
[[Page 30536]]
These requirements would ensure that authorized laboratories
perform accurate and rigorous testing in the service of Plan programs.
To reflect this change, we would revise the definitions of
authorized laboratory in Sec. Sec. 145.1 and 146.1. The new
definitions would read: ``An authorized laboratory is a laboratory that
meets the requirements of Sec. 147.51 and is thus qualified to perform
the assays described in part 147 of this subchapter.''
Miscellaneous Change
In the January 2008 final rule mentioned earlier in this document,
we removed and reserved paragraph (b) of Sec. 147.11, which contained
footnotes 8 through 11 in 9 CFR part 147. However, we neglected to
redesignate the other footnotes in that part to reflect the removal of
those four footnotes. In this proposal, we would correct that error by
redesignating footnotes 12 through 24 as footnotes 8 through 20.
Executive Order 12866 and Regulatory Flexibility Act
This proposed 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.
We are proposing to amend the Plan and its auxiliary provisions by
providing new or modified sampling and testing procedures for Plan
participants and participating flocks. The proposed changes were voted
on and approved by the voting delegates at the Plan's 2006 National
Plan Conference. These changes would keep the provisions of the Plan
current with changes in the poultry industry and provide for the use of
new sampling and testing procedures.
The United States is the world's largest poultry producer, the
second-largest egg producer, and the largest exporter of poultry meat.
U.S. poultry meat production totals over 42 billion pounds annually;
over four-fifths is broiler meat, most of the remainder is turkey meat,
and a small fraction is other chicken meat. Cash receipts (see table 1)
from sales of poultry and eggs (broilers, farm chickens, eggs, turkey,
ducks, and other poultry) were about $28.9 billion in 2005 (with
preliminary value for 2006 and forecasted value for 2007 being a little
higher).\1\ Of this total, 72 percent was from broilers, 14 percent
from eggs, 11 percent from turkeys, and 3 percent from other poultry.
---------------------------------------------------------------------------
\1\ USDA/Economic Research Service (ERS), Farm Income/Cash
receipts, 2002-2007.
Table 1.--Cash Receipts for Poultry and Eggs, United States, 2000-05, 2006, and 2007
--------------------------------------------------------------------------------------------------------------------------------------------------------
Commodity 2002 2003 2004 2005 2006 \P\ 2007 \F\
--------------------------------------------------------------------------------------------------------------------------------------------------------
$1,000
-----------------------------------------------------------------------------------------------------------------
Poultry/eggs.......................... 21,138,999 23,959,134 29,540,692 28,903,545 27,700,000 29,600,000
Broilers.............................. 13,437,700 15,214,945 20,446,096 20,901,934 19,000,000 20,100,000
Farm chickens......................... 49,850 47,508 57,260 63,963 + +
Chicken eggs.......................... 4,232,433 5,273,099 5,239,082 4,000,142 4,400,000 5,100,000
Turkeys............................... 2,643,273 2,631,862 2,995,802 3,157,637 3,500,000 3,500,000
Ducks................................. 15,300 19,200 20,900 21,390 + +
Other poultry......................... 760,443 772,521 781,553 758,479 800,000 900,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
P = preliminary, F = forecast, + = included in other poultry.
Source: USDA/Economic Research Service (ERS), Farm Income/Farm cash Receipts, 1924-2005, 2006\P\, and 2007\F\) (http://www.ers.usda.gov/data/FarmIncome/
finfidmuxls.htm).
In terms of tonnage, poultry production and trade exceeds that of
beef or pork. For instance, in 2006, the U.S. produced 41.4 billion
pounds of poultry meat, compared with 26.2 billion pounds of beef and
21 billion pounds of pork. The U.S. also produced 6.5 billion dozen
eggs in 2006. Per capita consumption of poultry meat (103.8 pounds in
2006) exceeds per capita consumption of both beef (65.7 pounds) and
pork (49.3 pounds). Furthermore, the U.S. exports more poultry meat
(5.8 billion pounds in 2006) than beef and veal (1.2 billion pounds) or
pork (3 billion pounds).\2\
---------------------------------------------------------------------------
\2\ USDA/ERS, Livestock, Dairy, and Poultry Outlook/LDP-M-158,
August 20, 2007.
---------------------------------------------------------------------------
Broiler production is concentrated in a group of States stretching
from Delaware south along the Atlantic coast to Georgia, then westward
through Alabama, Mississippi, and Arkansas. The top broiler-producing
State is Georgia, followed by Arkansas, Alabama, North Carolina,
Mississippi, and Texas. Operations in these States account for over 65
percent of broiler cash receipts.
Most U.S. broiler production is conducted under contract with
broiler processors. The grower normally supplies the grow-out house
with all the necessary heating, cooling, feeding, and watering systems.
The grower also supplies the labor needed in growing the birds. The
broiler processor supplies the chicks, feed, and veterinary medicines.
The processor schedules transportation of the birds from the farm to
the slaughter plant. In many cases, the processor also supplies the
crews who place broilers into cages for transportation to the slaughter
plant.
The U.S. turkey industry produces over one-quarter of a billion
birds annually, with the live weight of each bird averaging over 25
pounds. Production of turkeys is somewhat more scattered geographically
than broiler production. The top five turkey-producing States are
Minnesota, North Carolina, Missouri, Arkansas, and Virginia. The United
States is by far the world's largest turkey producer, followed by the
European Union. Even though exports are a major component of the U.S.
turkey industry, the United States consumes more turkey per capita than
any other country.
U.S. egg operations produce over 77 billion eggs annually. Over
three-fourths of egg production is for human consumption (the table-egg
market). The remainder of production is for the hatching market. These
eggs are hatched to provide replacement birds for the egg-laying flocks
and broiler chicks for grow-out operations. The top five egg-producing
States are Iowa, Ohio, Pennsylvania, Indiana, and California.\3\
---------------------------------------------------------------------------
\3\ USDA/ERS, Livestock, Dairy, and Poultry Outlook/LDP-M-158,
August 20, 2007.
---------------------------------------------------------------------------
The United States is the world's largest exporter of poultry meat.
Annual poultry meat exports totaled about 5.8 billion pounds in 2006,
which is about 14.5 percent of U.S. production. (All trade statistics
in this and the following
[[Page 30537]]
paragraph are for 2006.) Demand for U.S. poultry meat products has
fluctuated over the last several years due to changing economic
conditions and currency exchange rates in major importing countries.
The largest importers of U.S. broiler products are Russia, Mexico,
China, Canada, Hong Kong, Turkey, Taiwan, Angola, South Korea, and
Ukraine. Together, these markets accounted for over 74 percent of U.S.
poultry meat exports, on a quantity basis. The United States imports
only small amounts of poultry meat, accounting for less than two-tenths
of 1 percent of domestic production. Over 98 percent of imports come
from Canada.
As in the case of poultry meat, U.S. exports of live poultry and
exports of fresh shell eggs are widely distributed and significantly
outweigh imports of these products. The United States exported 1.302
million eggs and imported 65.4 million eggs in 2006. The major
importers of eggs are Canada, Mexico, Jamaica, United Kingdom, Hong
Kong, Brazil, Trinidad and Tobago, Dominican Republic, Guyana, and
Nicaragua. These countries altogether accounted for about 80 percent of
U.S. egg exports. U.S. imports are mainly from Canada, China, France,
and Taiwan. These countries together accounted for 91 percent of U.S.
imports of eggs. The United States exported 51 million live poultry and
imported 13.7 million live poultry in 2006. Major destinations include
Canada, Mexico, China, Thailand, Peru, Colombia, Guatemala, Indonesia,
Egypt, and El Salvador. These countries accounted for 70 percent of
U.S. total live poultry exports. All U.S. imports of live poultry came
from Canada, United Kingdom, and Italy.
The decision to participate in the NPIP program is voluntary. Being
a participating flock in NPIP has many benefits. These include: The
flock being recognized as a participating member of NPIP; the flock
having an approval number which may be used on shipping labels,
certificates, invoices, and other documents for identification
purposes; the flock being listed in the official NPIP Directory of
Participants; free listing in various State fair brochures; and
receiving emergency disease management updates. Furthermore, being a
participant in the NPIP allows for greater ease in moving hatching eggs
and live birds within a State, across State lines, and into
international markets. In fact, most countries will not accept hatching
eggs, live birds, table eggs, or broilers unless they can be shown to
be from a NPIP participant.
Any increased cost to NPIP participants due to the proposed rule
would be minor compared to the expected benefits of the proposed
program changes. Additional costs are likely to be minor because most
of the participants already had been implementing these changes for
several years. Even if additional tests were required, the additional
number of birds tested would be very small compared to the size of
flocks in the industry. Individual producers will continue to
participate in the NPIP program only if the benefits they receive from
participation outweigh the costs. Over 99 percent of poultry breeders
and hatcheries, commercial table-egg layer flocks, and commercial meat-
type chicken and turkey slaughter plants are Plan participants.
Impact on Small Entities
The Regulatory Flexibility Act requires that agencies consider the
economic effects of their rules on small entities. According to the
Small Business Administration's (SBA's) Office of Advocacy, regulations
create economic disparities based on size when they have a significant
economic impact on a substantial number of small entities.
Entities engaged in production of breeding stock and hatcheries
would be affected by the rule. Currently there are four major firms
that produce primary breeding stock of egg-type chickens, three
breeders of meat-type chickens, two breeders of turkeys, and one firm
producing breeding stock of both egg-type and meat-type chickens.\4\
All of these are large facilities headquartered in the United States
that operate in domestic and international markets, and would not be
considered small entities. Few, if any, small producers would be
directly affected by this proposed rule.
---------------------------------------------------------------------------
\4\ Mary E. Delany, Genetic Diversity and Conservation of
Poultry, p.261, in W.M. Muir and S.E. Aggrey, Poultry Genetics,
Breeding and Biotechnology, August 2003; Susanne Gura, Livestock
Genetics Companies: Concentration and Proprietary Strategies of an
Emerging Power in the Global Economy (http://pastoralpeoples.org/
docs/Livestock--genetics.pdf).
---------------------------------------------------------------------------
Broiler operations (North American Industry Classification System
[NAICS] code 112320), turkey operations (NAICS 112330), hatcheries
(NAICS 112340), and other poultry operations (112390) could also be
affected by the proposed changes. All of these operations are
considered to be small if they have annual sales of $750,000 or less
(U.S. Small Business Administration Table of Small Business Size
Standards, http://www.sba.gov/idc/groups/public/documents/sba_
homepage/serv_sstd_tablepdf.pdf). Commercial egg producers (NAICS
112310) are considered small if they have annual sales of not more than
$11.5 million.
The broiler industry has evolved from small backyard flocks to
fewer than 50 highly specialized, vertically integrated agribusiness
firms. A measure of the changing structure is the number and size of
chicken hatcheries. In 1973, there were 989 facilities that hatched all
chickens in the United States. Those hatcheries had the capacity to
incubate 436 million eggs at one time for an average capacity of
440,849 eggs. In 2006, there were 313 chicken hatcheries, with an
incubator capacity of 910 million eggs for an average capacity of 2.9
million eggs. Similarly, there were 203 turkey hatching facilities with
capacity to incubate 45 million eggs at one time, for an average
capacity of 221,675 eggs. In 2006, there were 55 turkey hatcheries,
with an incubator capacity of 39 million eggs for an average capacity
of 703,927 eggs.\5\
---------------------------------------------------------------------------
\5\ USDA, ERS, Hatchery Production, March 1975; Hatchery
Production 2006 Summary, April 2007.
---------------------------------------------------------------------------
We do not foresee any significant impact of the proposed rule on
small entities. The NPIP is a voluntary program, so poultry producers
can decide if it is beneficial for them to participate.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are in conflict with this rule will
be preempted; (2) no retroactive effect will be given to this rule; and
(3) administrative proceedings will not be required before parties may
file suit in court challenging this rule.
Paperwork Reduction Act
This proposed rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
[[Page 30538]]
List of Subjects in 9 CFR Parts 145, 146, and 147
Animal diseases, Poultry and poultry products, Reporting and
recordkeeping requirements.
Accordingly, we propose to amend 9 CFR parts 145, 146, and 147 as
follows:
PART 145--NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY
1. The authority citation for part 145 continues to read as
follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
2. Section 145.1 is amended as follows:
a. By revising the definition of authorized laboratory to read as
set forth below.
b. By adding, in alphabetical order, new definitions of NPIP
Technical Committee and Senior Coordinator to read as set forth below.
c. In the definition of equivalent or equivalent requirements, by
adding the words ``or exceed'' after the words ``equal to'' and the
words ``they are'' after the words ``with which.''
Sec. 145.1 Definitions.
* * * * *
Authorized laboratory. An authorized laboratory is a laboratory
that meets the requirements of Sec. 147.51 and is thus qualified to
perform the assays described in part 147 of this subchapter.
* * * * *
NPIP Technical Committee. A committee made up of technical experts
on poultry health, biosecurity, surveillance, and diagnostics. The
committee consists of representatives from the poultry and egg
industries, universities, and State and Federal governments and is
appointed by the Senior Coordinator and approved by the General
Conference Committee.
* * * * *
Senior Coordinator. An employee of the Service whose duties may
include, but will not necessarily be limited to:
(1) Serving as executive secretary of the General Conference
Committee;
(2) Serving as chairperson of the Plan Conference described in
Sec. 147.47;
(3) Planning, organizing, and conducting the Plan Conference;
(4) Reviewing NPIP authorized laboratories as described in Sec.
147.51;
(5) Coordinating the State administration of the NPIP through
periodic reviews of the administrative procedures of the Official State
Agencies, according to the applicable provisions of the Plan and the
Memorandum of Understanding;
(6) Coordinating rulemaking to incorporate the proposed changes of
the provisions approved at the Plan conference into the regulations in
parts 145, 146, and 147 of this subchapter;
(7) Directing the production of official NPIP publications;
(8) Proposing an annual budget for plan activities and the General
Conference Committee; and
(9) Providing overall administration of the NPIP.
* * * * *
3. In Sec. 145.2, paragraph (a) is amended by adding a new
sentence at the end of the paragraph to read as follows:
Sec. 145.2 Administration.
(a) * * * In the Memorandum of Understanding, the Official State
Agency must designate a contact representative to serve as a liaison
between the Service and the Official State Agency.
* * * * *
4. Section 145.14 is amended as follows:
a. By adding a new paragraph (b)(5) to read as set forth below.
b. By revising paragraph (d) to read as set forth below.
Sec. 145.14 Blood testing.
* * * * *
(b) * * *
(5) The official molecular examination procedures for Mycoplasma
gallisepticum and M. synoviae are the polymerase chain reaction (PCR)
test described in Sec. 147.30 of this subchapter and the real-time PCR
test described in Sec. 147.31 of this subchapter.
* * * * *
(d) For avian influenza. The official tests for avian influenza are
described in paragraphs (d)(1) and (d)(2) of this section.
(1) Antibody detection tests--(i) Enzyme-linked immunosorbent assay
(ELISA). ELISA must be conducted using test kits approved by the
Department and the Official State Agency and must be conducted in
accordance with the recommendations of the producer or manufacturer.
(ii) The agar gel immunodiffusion (AGID) test. (A) The AGID test
must be conducted on all ELISA-positive samples.
(B) The AGID test must be conducted using reagents approved by the
Department and the Official State Agency.
(C) Standard test procedures for the AGID test for avian influenza
are set forth in Sec. 147.9 of this subchapter. The test can be
conducted on egg yolk or blood samples.
(D) Positive tests for the AGID must be further tested by Federal
Reference Laboratories using appropriate tests for confirmation. Final
judgment may be based upon further sampling and appropriate tests for
confirmation.
(2) Agent detection tests. Tests that detect influenza A matrix
gene or protein may be performed by an authorized laboratory. Tests
that determine hemagglutinin or neuraminidase subtypes may not be
performed by an authorized laboratory. Samples for agent detection
testing should be collected from naturally occurring flock mortality or
clinically ill birds.
(i) The real time reverse transcriptase/polymerase chain reaction
(RRT-PCR) assay. (A) The RRT-PCR tests must be conducted using reagents
approved by the Department and the Official State Agency. The RRT-PCR
must be conducted using the National Veterinary Services Laboratories
(NVSL) official protocol for RRT-PCR (AVPR01510) and must be conducted
by personnel who have passed an NVSL proficiency test.
(B) Positive results from the RRT-PCR must be further tested by
Federal Reference Laboratories using appropriate tests for
confirmation. Final judgment may be based upon further sampling and
appropriate tests for confirmation.
(ii) USDA-licensed type A influenza antigen capture immunoassay
(ACIA). (A) The USDA-licensed type A influenza ACIA must be conducted
using test kits approved by the Department and the Official State
Agency and must be conducted in accordance with the recommendations of
the producer or manufacturer.
(B) Positive results from the ACIA must be further tested by
Federal Reference Laboratories using appropriate tests for
confirmation. Final judgment may be based upon further sampling and
appropriate tests for confirmation.
(3) The official determination of a flock as positive for the H5 or
H7 subtypes of avian influenza may be made only by NVSL.
* * * * *
5. Section 145.15 is revised to read as follows:
Sec. 145.15 Diagnostic surveillance program for low pathogenic avian
influenza.
(a) The Official State Agency must develop a diagnostic
surveillance program for H5/H7 low pathogenic avian influenza for all
poultry in the State. The exact provisions of the program are at the
discretion of the States. The Service will use the standards in
paragraph (b) of this
[[Page 30539]]
section in assessing individual State plans for adequacy, including the
specific provisions that the State developed. The standards should be
used by States in developing those plans.
(b) Avian influenza must be a disease reportable to the responsible
State authority (State veterinarian, etc.) by all licensed
veterinarians. To accomplish this, all laboratories (private, State,
and university laboratories) that perform diagnostic procedures on
poultry must examine all submitted cases of unexplained respiratory
disease, egg production drops, and mortality for avian influenza by
both an approved serological test and an approved antigen detection
test. Memoranda of understanding or other means must be used to
establish testing and reporting criteria (including criteria that
provide for reporting H5 and H7 low pathogenic avian influenza directly
to the Service) and approved testing methods. In addition, States
should conduct outreach to poultry producers, especially owners of
smaller flocks, regarding the importance of prompt reporting of
clinical symptoms consistent with avian influenza.
Sec. 145.23 [Amended]
6. In Sec. 145.23, paragraphs (h)(2)(i) and (h)(2)(ii) are amended
by removing the number ``180'' and replacing it with the number ``90''
each time it occurs.
Sec. 145.33 [Amended]
7. In Sec. 145.33, paragraphs (l)(2)(i) and (l)(2)(ii) are amended
by removing the number ``30'' and replacing it with the number ``15''
each time it occurs; and by removing the number ``180'' and replacing
it with the number ``90'' each time it occurs
Sec. 145.43 [Amended]
8. In Sec. 145.43, paragraphs (g)(2)(i) and (g)(2)(ii) are amended
by removing the number ``180'' and replacing it with the number ``90''
each time it occurs.
9. In Sec. 145.52, paragraph (c) is revised to read as follows:
Sec. 145.52 Participation.
* * * * *
(c) Subject to the approval of the Service and the Official State
Agencies in the importing and exporting States, participating flocks
may report poultry sales to importing States by using either VS Form 9-
3, ``Report of Sales of Hatching Eggs, Chicks, and Poults'' or by using
a hatchery invoice form (9-3I) approved by the Official State Agency
and the Service to identify poultry sales to clients. If the selling
hatchery uses the 9-3I form, the following information must be included
on the form:
(1) The form number ``9-3I'', printed or stamped on the invoice;
(2) The hatchery name and address;
(3) The date of shipment;
(4) The hatchery invoice number;
(5) The purchaser name and address;
(6) The quantity of products sold;
(7) Identification of the products by bird variety or by NPIP stock
code as listed in the NPIP APHIS 91-55-078 appendix; and
(8) The appropriate NPIP illustrative design in Sec. 145.10. One
of the designs in Sec. 145.10(b) or (g) must be used. The following
information must be provided in or near the NPIP design:
(i) The NPIP State number and NPIP hatchery approval number; and
(ii) The NPIP classification for which product is qualified (e.g.,
U.S. Pullorum-Typhoid Clean).
* * * * *
10. In Sec. 145.63, a new paragraph (b) is added to read as
follows:
Sec. 145.63 Terminology and classification; flocks and products.
* * * * *
(b) U.S. Avian Influenza Clean. This program is intended to be the
basis from which the breeding-hatchery industry may conduct a program
for the prevention and control of avian influenza. It is intended to
determine the presence of avian influenza in all ostrich, emu, rhea,
and cassowary breeding flocks through routine serological surveillance
of each participating breeding flock. Acceptable tests include antigen
and antibody detection tests, as approved by the Official State Agency.
A flock, and the hatching eggs and chicks produced from it, will
qualify for this classification when the Official State Agency
determines that it has met one of the following requirements:
(1) It is a primary breeding flock in which 10 percent of the
flock, up to a maximum of 30 birds, has been tested negative for type A
influenza virus with all pens represented equally and when the tested
birds are more than 4 months of age. Positive samples shall be further
tested by an authorized laboratory. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at
intervals of 180 days, or
(ii) A sample of less than 10 percent of the birds up to a maximum
of 30 birds may be tested, and found to be negative, at any one time if
all pens are equally represented and a total of 30 birds are tested
within each 180-day period.
(2) It is a multiplier breeding flock in which a minimum of 30
birds has been tested negative to type A influenza virus with all pens
represented equally and when the tested birds are more than 4 months of
age. Positive samples shall be further tested by an authorized
laboratory. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at
intervals of 180 days, or
(ii) A sample of at least 10 percent of birds from each pen with
all pens being represented must be tested negative at intervals of 180
days; or
(iii) A sample of less than 10 percent of the birds may be tested,
and found to be negative, at any one time if all pens are equally
represented and a total of 10 percent of the birds are tested within
each 180-day period.
PART 146--NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY
11. The authority citation for part 146 continues to read as
follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
12. Section 146.1 is amended as follows:
a. By revising the definition of authorized laboratory and the
first sentence of the definition of commercial meat-type flock to read
as set forth below.
b. In the definition of equivalent, by adding the words ``or
exceed'' after the words ``equal to'' and the words ``they are'' after
the words ``with which.''
Sec. 146.1 Definitions.
* * * * *
Authorized laboratory. An authorized laboratory is a laboratory
that meets the requirements of Sec. 147.51 and is thus qualified to
perform the assays described in part 147 of this subchapter.
* * * * *
Commercial meat-type flock. All of the meat-type chickens, meat-
type turkeys, commercial upland game birds, or commercial waterfowl on
one farm. * * *
* * * * *
13. In Sec. 146.2, paragraph (a) is amended by adding a new
sentence at the end of the paragraph to read as follows:
Sec. 146.2 Administration.
(a) * * * In the Memorandum of Understanding, the Official State
Agency must designate a contact representative to serve as a liaison
between the Service and the Official State Agency.
* * * * *
14. Section 146.3 is amended by revising paragraph (a) and the
first
[[Page 30540]]
sentence of paragraph (c) to read as follows:
Sec. 146.3 Participation.
(a) Any table-egg producer, raised-for-release upland game bird
premises, and raised-for-release waterfowl premises and any commercial
upland game bird, commercial waterfowl, meat-type chicken or meat-type
turkey slaughter plant, including its affiliated flocks, may
participate in the Plan when the producer or plant has demonstrated, to
the satisfaction of the Official State Agency, that its facilities,
personnel, and practices are adequate for carrying out the relevant
special provisions of this part and has signed an agreement with the
Official State Agency to comply with the relevant special provisions of
this part.
* * * * *
(c) A participating slaughter plant shall participate with all of
the commercial upland game bird, commercial waterfowl, meat-type
chicken and/or meat-type turkey flocks that are processed at the
facility, including affiliated flocks. * * *
* * * * *
15. Section 146.6 is revised to read as follows:
Sec. 146.6 Specific provisions for participating slaughter plants.
(a) Only commercial upland game bird, commercial waterfowl, meat-
type chicken, and meat-type turkey slaughter plants that are under
continuous inspection by the Food Safety and Inspection Service of the
Department or under State inspection that the Food Safety and
Inspection Service has recognized as equivalent to Federal inspection
may participate in the Plan.
(b) To participate in the Plan, meat-type chicken, meat-type
turkey, and commercial upland game bird and commercial waterfowl
slaughter plants must follow the relevant special provisions in
Sec. Sec. 146.33(a), 146.43(a), and 146.53(a), respectively, for
sample collection and flock monitoring, unless they are exempted from
the special provisions under Sec. Sec. 146.32(b), 146.42(b), or
146.52(b), respectively.
Sec. 146.9 [Amended]
16. In Sec. 146.9, paragraph (a) is amended by removing the word
``and'' and adding the words ``, and 146.53(a) and (b)'' at the end of
the second sentence, before the period.
17. Section 146.11 is amended as follows:
a. By revising paragraph (a) to read as set forth below.
b. By redesignating paragraphs (b) and (c) as (d) and (e),
respectively.
c. By adding new paragraphs (b) and (c) to read as set forth below.
Sec. 146.11 Inspections.
(a) Each participating slaughter plant shall be audited at least
once annually or a sufficient number of times each year to satisfy the
Official State Agency that the participating slaughter plant is in
compliance with the provisions of this part. The yearly audit will
consist of an evaluation of 2 weeks' worth of records, selected at
random, of the following data:
(1) The actual flock slaughter date for each flock. This
information must come from a verifiable source. Verifiable sources
include electronic record systems that have oversight from the
Department's Grain Inspectors, Packers and Stockyards Administration or
Food Safety and Inspection Service (FSIS) documents such as FSIS Form
9061-2.
(2) Laboratory test results for each flock slaughtered with the
sample collection date and test result. The test must be NPIP approved
and performed in an authorized laboratory of the NPIP.
(b) A flock will be considered to be not conforming to protocol if
there are no test results available, if the flock was not tested within
21 days before slaughter, or if the test results for the flocks were
not returned before slaughter.
(c) Two or more flocks that are found to be not conforming to
protocol in the yearly audit for a slaughter plant shall be cause for a
deficiency rating for that plant. However, if the root cause for the
deficiency was identified, corrected, and documented, the plant will be
eligible for an immediate reevaluation of 2 additional weeks' worth of
records, again selected at random. If no more than one missed flock is
identified in this reevaluation, the plant will be considered in
compliance and no further action will be required. Plants found to be
deficient must provide a written corrective action plan to the auditor
within 2 weeks of receipt of the deficiency rating. A followup audit on
the information in paragraphs (a)(1) and (a)(2) of this section will
occur within 90 days from the receipt of the corrective action plan.
Slaughter plants will retain their classification and may continue to
use the Plan emblem in Sec. 149.9(a) during this process. A failure on
the followup audit may result in disbarment from participation
according to the procedures in Sec. 146.12.
* * * * *
18. In Sec. 146.13, paragraph (b) is revised to read as follows:
Sec. 146.13 Testing.
* * * * *
(b) Avian influenza. The official tests for avian influenza are
described in paragraphs (b)(1) and (b)(2) of this section:
(1) Antibody detection tests--(i) Enzyme-linked immunosorbent assay
(ELISA). ELISA must be conducted using test kits approved by the
Department and the Official State Agency and must be conducted in
accordance with the recommendations of the producer or manufacturer.
(ii) The agar gel immunodiffusion (AGID) test. (A) The AGID test
must be conducted on all ELISA-positive samples.
(B) The AGID test must be conducted using reagents approved by the
Department and the Official State Agency.
(C) Standard test procedures for the AGID test for avian influenza
are set forth in Sec. 147.9 of this subchapter. The test can be
conducted on egg yolk or blood samples.
(D) Positive tests for the AGID must be further tested by Federal
Reference Laboratories using appropriate tests for confirmation. Final
judgment may be based upon further sampling and appropriate tests for
confirmation.
(2) Agent detection tests. Tests that detect influenza A matrix
gene or protein may be performed by an authorized laboratory. Tests
that determine hemagglutinin or neuraminidase subtypes may not be
performed by an authorized laboratory. Samples for this testing should
be collected from naturally occurring flock mortality or clinically ill
birds.
(i) The real time reverse transcriptase/polymerase chain reaction
(RRT-PCR) assay. (A) The RRT-PCR tests must be conducted using reagents
approved by the Department and the Official State Agency. The RRT-PCR
must be conducted using the National Veterinary Services Laboratories
(NVSL) official protocol for RRT-PCR (AVPR01510) and must be conducted
by personnel who have passed an NVSL proficiency test.
(B) Positive results from the RRT-PCR must be further tested by
Federal Reference Laboratories using appropriate tests for
confirmation. Final judgment may be based upon further sampling and
appropriate tests for confirmation.
(ii) USDA-licensed type A influenza antigen capture immunoassay
(ACIA). (A) The USDA-licensed type A influenza ACIA must be conducted
using test kits approved by the Department and the Official State
Agency and must be conducted in accordance with the recommendations of
the producer or manufacturer.
[[Page 30541]]
(B) Positive results from the ACIA must be further tested by
Federal Reference Laboratories using appropriate tests for
confirmation. Final judgment may be based upon further sampling and
appropriate tests for confirmation.
(3) The official determination of a flock as positive for the H5 or
H7 subtypes avian influenza may be made only by NVSL.
19. In Sec. 146.43, in paragraph (a)(1), the first sentence is
revised to read as follows:
Sec. 146.43 Terminology and classification; meat-type turkey
slaughter plants.
* * * * *
(a) * * *
(1) It is a meat-type turkey slaughter plant that accepts only
meat-type turkeys from flocks where a minimum of 6 birds per flock has
tested negative for antibodies to type A avian influenza virus with an
approved test no more than 21 days prior to slaughter. * * *
* * * * *
20. A new subpart E, ``Special Provisions for Commercial Upland
Game Birds, Commercial Waterfowl, Raised-for-Release Upland Game Birds,
and Raised-for-Release Waterfowl,'' Sec. Sec. 146.51 through 146.53,
is added to read as follows:
Subpart E--Special Provisions for Commercial Upland Game Birds,
Commercial Waterfowl, Raised-for-Release Upland Game Birds, and Raised-
for-Release Waterfowl
Sec.
146.51 Definitions.
146.52 Participation.
146.53 Terminology and classification; slaughter plants and
premises.
Subpart E--Special Provisions for Commercial Upland Game Birds,
Commercial Waterfowl, Raised-for-Release Upland Game Birds, and
Raised-for-Release Waterfowl
Sec. 146.51 Definitions.
Commercial upland game bird slaughter plant. A commercial upland
game bird slaughter plant that is federally inspected or under State
inspection that the U.S. Department of Agriculture's Food Safety and
Inspection Service has recognized as equivalent to Federal inspection.
Commercial upland game birds. Upland game bird pheasants, quail, or
partridges grown under confinement for the primary purpose of producing
meat for human consumption.
Commercial waterfowl. Domesticated ducks or geese grown under
confinement for the primary purpose of producing meat for human
consumption.
Commercial waterfowl slaughter plant. A commercial waterfowl
slaughter plant that is federally inspected or under State inspection
that the U.S. Department of Agriculture's Food Safety and Inspection
Service has recognized as equivalent to Federal inspection.
Raised-for-release upland game birds. Pheasants, quail, and
partridge that are raised under confinement for release in game
preserves and are not breeding stock.
Raised-for-release waterfowl. Waterfowl that are raised under
confinement for release in game preserves and are not breeding stock.
Shift. The working period of a group of employees who are on duty
at the same time.
Sec. 146.52 Participation.
(a) Participating commercial upland game bird slaughter plants,
commercial waterfowl slaughter plants, raised-for-release upland game
bird premises, and raised-for-release waterfowl premises shall comply
with the applicable general provisions of Subpart A of this part and
the special provisions of this subpart E.
(b) Commercial waterfowl and commercial upland game bird slaughter
plants that slaughter fewer than 50,000 birds annually are exempt from
the special provisions of this subpart E.
(c) Raised-for-release upland game bird premises and raised-for-
release waterfowl premises that raise fewer than 25,000 birds annually
are exempt from the special provisions of this subpart E.
Sec. 146.53 Terminology and classification; slaughter plants and
premises.
Participating flocks which have met the respective requirements
specified in this section may be designated by the following terms and
the corresponding designs illustrated in Sec. 146.9 of this part:
(a) U.S. H5/H7 Avian Influenza Monitored. This program is intended
to be the basis from which the commercial waterfowl and commercial
upland game bird industry may conduct a program to monitor for the H5/
H7 subtypes of avian influenza. It is intended to determine the
presence of the H5/H7 subtypes of avian influenza in commercial
waterfowl and commercial upland game birds through routine surveillance
of each participating slaughter plant. A slaughter plant will qualify
for this classification when the Official State Agency determines that
it has met one of the following requirements:
(1) It is a commercial upland game bird slaughter plant or
commercial waterfowl slaughter plant where a minimum of 11 birds per
shift are tested negative for the H5/H7 subtypes of avian influenza at
slaughter;
(2) It is a commercial upland game bird slaughter plant or
commercial waterfowl slaughter plant that only accepts commercial
upland game birds or commercial waterfowl from flocks where a minimum
of 11 birds per flock have been tested negative for antibodies to the
H5/H7 subtypes of avian influenza no more than 21 days prior to
slaughter; or
(3) It is a commercial upland game bird slaughter plant or
commercial waterfowl slaughter plant that has an ongoing active and
passive surveillance program for H5/H7 subtypes of avian influenza that
is approved by the Official State Agency and the Service.
(b) U.S. H5/H7 Avian Influenza Monitored. This program is intended
to be the basis from which the raised-for-release upland game bird and
raised-for-release waterfowl industries may conduct a program to
monitor for the H5/H7 subtypes of avian influenza. It is intended to
determine the presence of the H5/H7 subtypes of avian influenza through
routine surveillance of each participating premises. A premises will
qualify for the classification when the Official State Agency
determines that a representative sample of 30 birds from the
participating premises has been tested with negative results for the
H5/H7 subtypes of avian influenza every 90 days.
PART 147--AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN
21. The authority citation continues to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
22. Section 147.9 is amended as follows:
a. By revising paragraph (a)(4)(i)(F) to read as follows.
b. By removing figure 1.
c. By redesignating figures 2 and 3 as figures 1 and 2,
respectively.
Sec. 147.9 Standard test procedures for avian influenza.
(a) * * *
(4) * * *
(i) * * *
(F) To prepare the wells, place 50 [mu]l of avian influenza AGID
antigen in the center well using a micropipette with an attached
pipette tip. Place 50 [mu]l AI AGID positive control antiserum in each
of three alternate peripheral wells, and add 50 [mu]l per well of test
sera in the three remaining wells. This arrangement provides a positive
control line on each
[[Page 30542]]
side of the test serum, thus providing for the development of lines of
identity on both sides of each test serum (see figure 1).
Note: A pattern can be included with positive, weak positive,
and negative reference serum in the test sera wells to aid in the
interpretation of results (see figure 2).
* * * * *
Sec. Sec. 147.12, 147.14, 147.15, 147.16, 147.30 [Amended]
23. Sections 147.12, 147.14, 147.15, 147.16, and 147.30 are amended
by redesignating footnotes 12 through and 24 as footnotes 8 through 20,
respectively.
24. A new Sec. 147.31 is added to read as follows:
Sec. 147.31 Laboratory procedures recommended for the real-time
polymerase chain reaction test for Mycoplasma gallisepticum (MGLP
ReTi).
(a) DNA extraction. Use Qiagen Qiamp Mini Kit for DNA extraction or
equivalent validated technique/procedure. This kit utilizes the
following methods: 100 [mu]l of swab suspension incubates with 10 [mu]l
of proteinase K and 400 [mu]l of lysis buffer at 56 [deg]C for 10
minutes. Following incubation, 100 [mu]l of 100 percent ethanol is
added to lysate. Wash and centrifuge following extraction kit
recommendations.
(b) Primer selection. A forward primer mglpU26 (5'-CTA GAG GGT TGG
ACA GTT ATG-3') located at nucleotide positions 765,566 to 765,586 of
the M. gallisepticum R strain genome sequence; a reverse primer mglp164
(5'-GCT GCA CTA AAT GAT ACG TCA AA-3') located at nucleotide positions
765,448 to 765,470 of the M. gallisepticum R strain genome sequence;
and a Taqman dual-labeled probe mglpprobe (5'-FAM-CAG TCA TTA ACA ACT
TAC CAC CAG AAT CTG-BHQ1-3') located at nucleotide positions 765,491 to
765,520 of the M. gallisepticum R strain genome should be used to
amplify a 13-bp fragment of the lp gene.
(c) MGLP ReTi. Primers and probe should be utilized in a 25 [mu]l
reaction containing 12.5 [mu]l of Quantitect Probe PCR 2X mix (Qiagen,
Valencia, CA),\21\ primers to a final concentration of 0.5 [mu]molar,
and probe to a final concentration of 0.1 [mu]molar, 1 [mu]l of HK-UNG
Thermolabile Uracil N-glycosylase (Epicentre, Madison, WI), 2 [mu]l of
water, and 5 [mu]l of template. The reaction can be performed in a
SmartCycler (Cepheid, Sunnyvale, CA) or other equivalent validated
platform procedure for real-time thermocycler at 50 [deg]C for 2
minutes; 95 [deg]C for 15 minutes with optics OFF; and 40 cycles of 94
[deg]C for 15 seconds followed by 60 [deg]C for 60 seconds with optics
ON.
---------------------------------------------------------------------------
\21\ Trade names are used in these procedures solely for the
purpose of providing specific information. Mention of a trade name
does not constitute a guarantee or warranty of the product by the
U.S. Department of Agriculture or an endorsement over other products
not mentioned.
---------------------------------------------------------------------------
(d) Determination of positive. For each MGLP ReTi assay reaction,
the threshold cycle number (CT value) was determined to be the PCR
cycle number at which the fluorescence of the reaction exceeded 30
units of fluorescence. For all samples tested, any MGLP reaction that
has a recorded CT value was considered positive, while any MGLP
reaction that had no recorded CT value was considered negative.
(e) Controls. Proper controls should be used when conducting the
MGLP ReTi assay as an official test of the Plan. Positive,
quantitative, extraction, and internal controls are commercially
available from GTCAllison, LLC, Mocksville, NC.
25. Section 147.43 is amended as follows:
a. By revising paragraph (d)(4) to read as set forth below.
b. In paragraph (d)(6), by removing the words ``a forum'' and
adding the words ``an official advisory committee'' in their place.
Sec. 147.43 General Conference Committee.
* * * * *
(d) * * *
(4) Consider each proposal submitted as provided in Sec. 147.44
and make recommendations to subpart Committees and the Conference. Meet
jointly with the NPIP Technical Committee and consider the technical
aspects and accuracy of each proposal. Recommend whether new proposals
(i.e., proposals that have not been submitted as provided in Sec.
147.44) should be considered by the delegates to the Plan Conference.
* * * * *
26. In Sec. 147.45, the first sentence is revised to read as
follows:
Sec. 147.45 Official delegates.
Each cooperating State shall be entitled to one official delegate
for each of the programs prescribed in subparts B, C, D, E, F, G, and H
of part 145 of this chapter and for each of the programs prescribed in
subparts B, C, D, and E of part 146 of this chapter in which it has one
or more participants at the time of the Conference. * * *
27. In Sec. 147.46, a new paragraph (a)(9) is added to read as
follows:
Sec. 147.46 Committee consideration of proposed changes.
(a) * * *
(9) Commercial upland game birds and waterfowl and raised-for-
release upland game birds and waterfowl.
* * * * *
28. A new Subpart F, ``Authorized Laboratories and Approved
Tests,'' Sec. Sec. 147.51 and 147.52, is added to read as follows:
Subpart F--Authorized Laboratories and Approved Tests
Sec.
147.51 Authorized laboratory minimum requirements.
147.52 Approved tests.
Subpart F--Authorized Laboratories and Approved Tests
Sec. 147.51 Authorized laboratory minimum requirements.
These minimum requirements are intended to be the basis on which an
authorized laboratory of the Plan can be evaluated to ensure that
official Plan assays are performed and reported as described in this
part. A satisfactory evaluation will result in the laboratory being
recognized by the NPIP office of the Service as an authorized
laboratory qualified to perform the assays provided for in this part.
(a) Check-test proficiency. The laboratory must use a regularly
scheduled check test for each assay that it performs.
(b) Trained technicians. The testing procedures at the laboratory
must be run or overseen by a laboratory technician who has attended and
satisfactorily completed Service-approved laboratory workshops for
Plan-specific diseases within the past 3 years.
(c) Laboratory protocol. Official Plan assays must be performed and
reported as described in this part.
(d) State site visit. The Official State Agency will conduct a site
visit and recordkeeping audit annually.
(e) Service review. Authorized laboratories will be reviewed by the
Service (NPIP staff) every 3 years. The Service's review may include,
but will not necessarily be limited to, checking records, laboratory
protocol, check-test proficiency, technician training, and peer review.
(f) Reporting. (1) A memorandum of understanding or other means
shall be used to establish testing and reporting criteria to the
Official State Agency, including criteria that provide for reporting H5
and H7 low pathogenic avian influenza directly to the Service.
(2) Salmonella pullorum and Mycoplasma Plan disease reactors must
be reported to the Official State Agency within 48 hours.
(g) Verification. Random samples may also be required to be
submitted for
[[Page 30543]]
verification as specified by the Official State Agency.
Sec. 147.52 Approved tests.
(a) The procedures for the bacteriological examination of poultry
and poultry environments described in this part are approved tests for
use in the NPIP. In addition, all tests that use veterinary biologics
(e.g., antiserum and other products of biological origin) that are
licensed or produced by the Service and used as described in this part
are approved for use in the NPIP.
(b) Diagnostic test kits that are not licensed by the Service
(e.g., bacteriological culturing kits) may be approved through the
following procedure:
(1) The sensitivity of the kit will be estimated in at least three
authorized laboratories selected by the Service by testing known
positive samples, as determined by the official NPIP procedures found
in Subparts A, B, C, and D of this part. If certain conditions or
interfering substances are known to affect the performance of the kit,
appropriate samples will be included so that the magnitude and
significance of the effect(s) can be evaluated.
(2) The specificity of the kit will be estimated in at least three
authorized laboratories selected by the Service by testing known
negative samples, as determined by the official NPIP procedures found
in this part. If certain conditions or interfering substances are known
to affect the performance of the kit, appropriate samples will be
included so that the magnitude and significance of the effect(s) can be
evaluated.
(3) The kit will be provided to the cooperating laboratories in its
final form and include the instructions for use. The cooperating
laboratories must perform the assay exactly as stated in the supplied
instructions. Each laboratory must test a panel of at least 25 known
positive clinical samples supplied by the manufacturer of the test kit.
In addition, each laboratory will be asked to test 50 known negative
clinical samples obtained from several sources, to provide a
representative sampling of the general population. The identity of the
samples must be coded so that the cooperating laboratories are blinded
to identity and classification. Each sample must be provided in
duplicate or triplicate, so that error and repeatability data may be
generated.
(4) Cooperating laboratories will submit to the kit manufacturer
all raw data regarding the assay response. Each sample tested will be
reported as positive or negative, and the official NPIP procedure used
to classify the sample must be submitted in addition to the assay
response value.
(5) The findings of the cooperating laboratories will be evaluated
by the NPIP technical committee, and the technical committee will make
a recommendation regarding whether to approve the test kit to the
General Conference Committee. If the technical committee recommends
approval, the final approval will be granted in accordance with the
procedures described in Sec. Sec. 147.46 and 147.47.
Done in Washington, DC, this 20th day of May 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-11739 Filed 5-27-08; 8:45 am]
BILLING CODE 3410-34-P