[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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                        Commodity                              2002            2003            2004            2005          2006 \P\        2007 \F\
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                                                                                                      $1000s
                                                         -----------------------------------------------------------------------------------------------
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