[Federal Register Volume 74, Number 61 (Wednesday, April 1, 2009)]
[Rules and Regulations]
[Pages 14710-14719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-7240]
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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: Final rule.
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SUMMARY: We are amending 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 changes were voted on and approved by the voting delegates
at the Plan's 2006 National Plan Conference. These changes will 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: Effective Date: May 1, 2009.
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
[[Page 14711]]
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.
On May 28, 2008, we published in the Federal Register (73 FR 30528-
20543, Docket No. APHIS-2007-0042) a proposal \1\ 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 were intended
to keep the provisions of the Plan current with changes in the poultry
industry and provide for the use of new sampling and testing
procedures.
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\1\ To view the proposed rule and the comments we received, go
to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0042.
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We solicited comments concerning our proposal for 60 days ending
July 28, 2008. We received 11 comments by that date. They were from
State agencies, a university, a diagnostic laboratory association, and
private citizens. All 11 commenters raised specific issues regarding
the proposed rule. Those issues are discussed below.
We proposed to amend Sec. Sec. 145.14(d) and 146.13(b), which
describe approved tests for avian influenza (AI) under the Plan, to
approve the use of two agent detection tests for AI: The real time
reverse transcriptase/polymerase chain reaction (RRT-PCR) assay and the
USDA-licensed type A influenza antigen capture immunoassay (ACIA). In
the proposed regulatory text, we stated that agent detection tests that
detect influenza A matrix gene or protein would be allowed to be
performed by an authorized laboratory, but tests that determine
hemagglutinin (H) or neuraminidase (N) subtypes would not be allowed to
be performed by an authorized laboratory.
Several commenters stated that laboratories that are not part of
the National Animal Health Laboratory Network (NAHLN) should not be
authorized to perform RRT-PCR assays for AI. As the commenters noted,
many laboratories that are considered authorized laboratories under the
Plan are operated by poultry industry groups or other parties and thus
are not part of NALHN, which is composed of State and university
laboratories and APHIS' National Veterinary Services Laboratories
(NVSL).
NAHLN is a multifaceted network composed of sets of laboratories
that focus on different diseases, using common testing methods and
software platforms to process diagnostic requests and share
information. The State and university laboratories in NAHLN perform
routine diagnostic tests for endemic animal diseases as well as
targeted surveillance and response testing for foreign animal diseases.
The laboratories have the capability and capacity to conduct nationwide
surveillance testing for the early detection of an animal disease
outbreak, and they are able to test large numbers of samples rapidly
during an outbreak and to demonstrate freedom from disease after
eradication.
The commenters cited many concerns regarding allowing laboratories
other than NAHLN laboratories to perform RRT-PCR assays for AI,
including conflicts of interest in reporting positive results from
industry-operated laboratories; loss of data or delays in reporting to
State animal health officials in the event of positive results; lack of
standardization of procedures between other laboratories and NALHN;
NVSL's lack of resources for auditing industry laboratories; the
potential for false positives or premature reporting from non-NAHLN
laboratories; and biosafety and public health concerns. One of the
commenters noted that only NALHN laboratories are currently authorized
to perform RRT-PCR assays; this commenter stated that this system has
worked well.
We agree with the commenters that RRT-PCR assays for AI should only
be performed by NAHLN laboratories. We proposed that RRT-PCR assays
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. The protocol and the proficiency testing we proposed
to require are only available to NALHN laboratories and personnel.
To resolve any confusion that may have arisen from our statement
that tests that detect influenza A matrix gene or protein would be
allowed to be performed by an authorized laboratory, we have modified
that provision in this final rule. The regulatory text in this final
rule states that agent detection tests may be used to detect influenza
A matrix gene or protein but not to determine H or N subtypes. As
described earlier, the specific requirements for performing RRT-PCR
assays make it clear that only NAHLN laboratories can perform those
assays. (As commenters noted, the ACIA may be performed by authorized
laboratories as well as NAHLN laboratories.)
The proposed rule contained several other proposed changes related
to AI. We proposed to add in a new Sec. 145.15 the requirements in
Sec. 146.14 for AI diagnostic surveillance programs, which must
include examination of all submitted cases of unexplained respiratory
disease, egg production drops, and mortality for AI; this proposed
change was intended to clearly indicate that these requirements apply
to breeding poultry as well as commercial poultry. We proposed to
increase the frequency at which multiplier egg-type chicken breeding
flocks, multiplier meat-type chicken breeding flocks, and multiplier
turkey breeding flocks that participate in the U.S. Avian Influenza
Clean classifications in Sec. Sec. 145.23(h)(2), 145.33(l)(2), and
145.43(g)(2), respectively, are tested, allowing 90 days rather than
180 days between tests. We proposed to establish a U.S. Avian Influenza
Clean classification for ostrich, emu, rhea, and cassowary breeding
flocks. We proposed to modify the sampling requirements for the U.S.
H5/H7 Avian Influenza Monitored classification for meat-type turkey
slaughter plants to allow testing at the flock level rather than at
slaughter. Finally, we proposed to establish a U.S. H5/H7 Avian
Influenza Monitored classification for commercial upland game bird
slaughter plants, commercial waterfowl slaughter plants, raised-for-
release upland game bird premises, and raised-for-release waterfowl
premises.
One commenter stated a presumption that there is no AI being found
in the U.S. chicken industry, based on the lack of such reports. Based
on this information, the commenter stated, increasing sampling
frequency does not appear to make sense. The commenter recommended
instead that we require end-of-life testing of long-lived birds, such
as breeder flocks, and symptomatic flocks, such as flocks with
respiratory disease. The commenter stated that testing every meat bird
flock in low-risk environments, such as conventional commercial poultry
houses, appears to be an unnecessary step to placate international
trading partners.
We agree with the commenter that testing of breeding flocks and
symptomatic flocks is important. Our proposals to increase the
frequency at which breeding flocks participating in
[[Page 14712]]
the U.S. Avian Influenza Clean classification are tested and to add
diagnostic AI surveillance program provisions to 9 CFR part 145 speak
to our concern on those issues. However, contrary to the commenter's
assertion, occurrences of AI in U.S. poultry are rare but regular. The
testing requirements for participants in the U.S. H5/H7 Avian Influenza
Monitored classifications for meat-type flocks and slaughter plants are
necessary to provide assurance that such flocks and slaughter plants
are monitored for AI.
We proposed to establish new requirements for authorized
laboratories in a new Sec. 147.51. These included a requirement for an
annual site visit and recordkeeping audit by the Official State Agency
(OSA), which the regulations define as the State authority recognized
by the Department to cooperate in the administration of the Plan. (In
some States, the OSA is also the State animal health authority; in some
States, the OSA includes representation from, but is not identical to,
the State animal health authority.)
One commenter recommended that we require that the OSA and the
State animal health authority of the State in which the laboratory is
located be in concurrence before a laboratory is approved. The
commenter also recommended that the Plan be modified where applicable
to say that a representative of the State animal health authority may
accompany the OSA whenever a site visit is conducted.
The OSA is the entity designated in the NPIP to carry out the
administration of the Plan within a State and, in that capacity, makes
the final determination on whether to authorize a laboratory.
Therefore, requiring in the regulations that the State animal health
authority concur with the OSA to authorize a laboratory or that the
State animal health authority participate in site visits with the OSA
would be inappropriate. However, we note that, in those cases when the
OSA is not the State animal health authority itself, the OSA always
includes representation from the State animal health authority.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
change discussed in this document.
Executive Order 12866 and Regulatory Flexibility Act
This final 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.
In accordance with the Regulatory Flexibility Act, we have analyzed
the potential economic effects of this action on small entities.
We are amending the Plan and its auxiliary provisions by providing
new or modified sampling and testing procedures for Plan participants
and participating flocks. The changes were voted on and approved by the
voting delegates at the Plan's 2006 National Plan Conference. These
changes will 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).\2\ Of this total, 72 percent was from broilers, 14 percent
from eggs, 11 percent from turkeys, and 3 percent from other poultry.
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\2\ 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
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Commodity 2002 2003 2004 2005 2006 \P\ 2007 \F\
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$1000s
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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
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P = preliminary, F = Forecast, + = included in other poultry.
Source: USDA/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 United States produced 41.4
billion pounds of poultry meat, compared with 26.2 billion pounds of
beef and 21 billion pounds of pork. The United States 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 United States
exports more poultry meat (5.8 billion pounds in 2006) than beef and
veal (1.2 billion pounds) or pork (3 billion pounds).\3\
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\3\ USDA/ERS, Livestock, Dairy, and Poultry Outlook/LDP-M-158,
August 20, 2007.
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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
[[Page 14713]]
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.\4\
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\4\ USDA/ERS, Livestock, Dairy, and Poultry Outlook/LDP-M-158,
August 20, 2007.
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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 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 an NPIP participant.
Any increased cost to NPIP participants due to the proposed rule
will be minor compared to the expected benefits of the changes in this
final rule. 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 are required, the additional number of
birds tested will 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
will be affected by this final 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.\5\
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 will be
directly affected by this final rule.
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\5\ 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).
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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 changes in this final rule. All of these operations are
considered to be small if they have annual sales of $750,000 or less
(SBA 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 per facility. In 2006, there were 313 chicken hatcheries,
with an incubator capacity of 910 million eggs for an average capacity
of 2.9 million eggs per facility. 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 per facility. In 2006,
there were 55 turkey hatcheries, with an incubator capacity of 39
million eggs for an average capacity of 703,927 eggs per facility.\6\
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\6\ USDA, ERS, Hatchery Production, March 1975; Hatchery
Production 2006 Summary, April 2007.
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We do not foresee any significant impact of this final rule on
small
[[Page 14714]]
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 will
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 final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are in conflict with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
This final rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
List of Subjects in 9 CFR Parts 145, 146, and 147
Animal diseases, Poultry and poultry products, Reporting and
recordkeeping requirements.
0
Accordingly, we are amending 9 CFR parts 145, 146, and 147 as follows:
PART 145--NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY
0
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.
0
2. Section 145.1 is amended as follows:
0
a. By revising the definition of authorized laboratory to read as set
forth below.
0
b. By adding, in alphabetical order, new definitions of NPIP Technical
Committee and Senior Coordinator to read as set forth below.
0
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.
* * * * *
0
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.
* * * * *
0
4. Section 145.14 is amended as follows:
0
a. By adding a new paragraph (b)(5) to read as set forth below.
0
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. Agent detection tests may be used to
detect influenza A matrix gene or protein but not to determine
hemagglutinin or neuraminidase subtypes. 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.
[[Page 14715]]
(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.
* * * * *
0
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 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]
0
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]
0
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]
0
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.
0
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).
* * * * *
0
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
0
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.
0
12. Section 146.1 is amended as follows:
0
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.
[[Page 14716]]
0
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. * * *
* * * * *
0
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.
* * * * *
0
14. Section 146.3 is amended by revising paragraph (a) and the first
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.* * *
* * * * *
0
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]
0
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.
0
17. Section 146.11 is amended as follows:
0
a. By revising paragraph (a) to read as set forth below.
0
b. By redesignating paragraphs (b) and (c) as (d) and (e),
respectively.
0
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. 146.9(a) during this process. A failure on
the followup audit may result in disbarment from participation
according to the procedures in Sec. 146.12.
* * * * *
0
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. Agent detection tests may be used to
detect
[[Page 14717]]
influenza A matrix gene or protein but not to determine hemagglutinin
or neuraminidase subtypes. 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.
(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.
0
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. * * *
* * * * *
0
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
[[Page 14718]]
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
0
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.
0
22. Section 147.9 is amended as follows:
0
a. By revising paragraph (a)(4)(i)(F) to read as follows.
0
b. By removing figure 1.
0
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 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. 147.12, 147.14-16, 147.30 [Amended]
0
23. Sections 147.12, 147.14, 147.15, 147.16, and 147.30 are amended by
redesignating footnotes 12 through 24 as footnotes 8 through 20,
respectively
0
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 [micro]l of swab suspension incubates with 10
[micro]l of proteinase K and 400 [micro]l of lysis buffer at 56 [deg]C
for 10 minutes. Following incubation, 100 [micro]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 139-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
[micro]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 [micro]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.
0
25. Section 147.43 is amended as follows:
0
a. By revising paragraph (d)(4) to read as set forth below.
0
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.
* * * * *
0
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. * * *
0
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.
* * * * *
0
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
[[Page 14719]]
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 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 26th day of March 2009.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E9-7240 Filed 3-31-09; 8:45 am]
BILLING CODE 3410-34-P