[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Rules and Regulations]
[Pages 38752-38768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16037]



[[Page 38752]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 56, 145, 146, and 147

[Docket No. APHIS-2011-0101]
RIN 0579-AD83


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 (NPIP, 
the Plan) and its auxiliary provisions by removing the descriptions of 
specific tests and sanitation procedures from the regulations. Instead, 
we will require tests to be performed and sanitation to be maintained 
in a manner approved by the Administrator. Approved procedures will be 
listed in an NPIP Program Standards document, which we are making 
available on the NPIP Web site. In addition, we are establishing new 
compartment classifications for defined subpopulations of primary 
breeding turkeys, primary egg-type chickens, and primary meat-type 
chickens. We are also providing new or modified sampling and testing 
procedures for Plan participants and participating flocks. The changes 
in this final rule were voted on and approved by the voting delegates 
at the Plan's 2010 and 2012 National Plan Conferences. These changes 
will streamline the provisions of the Plan, keep those provisions 
current with changes in the poultry industry, and provide for the use 
of new sampling and testing procedures.

DATES: Effective Date: August 8, 2014.

FOR FURTHER INFORMATION CONTACT: Dr. Denise Brinson, DVM, Director, 
National Poultry Improvement Plan, VS, APHIS, USDA, 1506 Klondike Road, 
Suite 101, Conyers, GA 30094-5104; (770) 922-3496.

SUPPLEMENTARY INFORMATION:

Background

    The National Poultry Improvement Plan (NPIP, also referred to below 
as ``the Plan'') is a cooperative Federal-State-industry mechanism for 
controlling certain poultry diseases. The Plan consists of a variety of 
programs intended to prevent and control poultry diseases. 
Participation in all Plan programs is voluntary, but breeding flocks, 
hatcheries, and dealers must first qualify as ``U.S. Pullorum-Typhoid 
Clean'' as a condition for participating in the other Plan programs.
    The Plan identifies States, flocks, hatcheries, dealers, and 
slaughter plants that meet certain disease control standards specified 
in the Plan's various programs. As a result, customers can buy poultry 
that has tested clean of certain diseases or that has been produced 
under disease-prevention conditions.
    The regulations in 9 CFR parts 145, 146, and 147 (referred to below 
as the regulations) contain the provisions of the Plan. The Animal and 
Plant Health Inspection Service (APHIS, also referred to as ``the 
Service'') of the U.S. Department of Agriculture (USDA, also referred 
to as ``the Department'') amends these provisions from time to time to 
incorporate new scientific information and technologies within the 
Plan.
    On January 28, 2014, we published in the Federal Register (79 FR 
4538-4567, Docket No. APHIS-2011-0101) a proposal \1\ to amend the 
regulations by removing tests and detailed testing procedures, as well 
as sanitation procedures, from part 147, and making these available in 
an NPIP Program Standards document. In addition, we proposed to 
establish U.S. H5/H7 Avian Influenza Clean Compartment and U.S. Avian 
Influenza Clean Compartment classifications for defined subpopulations 
of primary breeding turkeys, primary egg-type breeding chickens, and 
primary meat-type breeding chickens. We also proposed several other 
changes.
---------------------------------------------------------------------------

    \1\ To view the proposed rule and the comments we received, go 
to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0101.
---------------------------------------------------------------------------

    We solicited comments concerning our proposal for 60 days ending 
March 31, 2014. We received 11 comments by that date. They were from 
producers, poultry associations, and the general public. Of the 11 
comments we received, 7 directly addressed the proposed rule. These 
comments are discussed below.
    Part 146 of the regulations contains the NPIP provisions for 
commercial poultry. Currently, the only disease addressed in this part 
is H5/H7 low pathogenic avian influenza; under part 146, table-egg 
layer flocks, meat-type chicken slaughter plants, meat-type turkey 
slaughter plants, and certain types of game birds and waterfowl may 
participate in U.S. H5/H7 Avian Influenza Monitored classifications.
    Section 146.11 sets out the audit process for participating 
slaughter plants. Paragraph (b) states that flocks slaughtered at a 
slaughter plant will be considered to be not conforming to the required 
protocol of the classifications 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. We 
proposed to amend paragraph (b) to refer to samples being collected and 
tested and to results being returned prior to movement to slaughter.
    The seven commenters who addressed the rule opposed this change. 
They stated that requiring testing prior to slaughter, rather than 
prior to movement to slaughter, allows companies that have been 
sampling flocks at processing to continue doing so. It also allows 
producers whose flocks were inadvertently not sampled in the field to 
be tested at the slaughter plant and remain compliant.
    They also stated that the proposed requirement to test prior to 
movement to slaughter would inadvertently combine the different testing 
requirements for participating slaughter plants in each subpart in part 
146 into one set of testing requirements. This would prevent the 
different types of participating slaughter plants from setting 
different testing requirements. One commenter stated that the change 
would limit the flexibility of Official State Agencies and industry to 
develop alternative testing protocols in which the same number of birds 
are tested, as allowed under the regulations.
    We believe it is important to have the test results for a flock 
returned prior to movement to slaughter to prevent potentially diseased 
birds from being exposed to other, healthy birds and possibly requiring 
cleaning and disinfection at the slaughter plant. The NPIP General 
Conference voted to approve this change at the 2012 Biennial 
Conference, reflecting the general consensus of NPIP participants. 
However, we are postponing the finalization of this change until an 
alternative proposal put forward by the commenters can be voted on 
during the 2014 NPIP Biennial Conference, which is scheduled to take 
place in Charlotte, NC, from July 10 through 12, 2014. Based on that 
vote, we will either retain this change in a stand-alone final rule or 
make alterations to the testing requirements in a separate proposed 
rule.
    We are making a minor change and two corrections to the proposal in 
this final rule. Paragraph (a)(1)(i) of the proposed 
compartmentalization sections in Sec. Sec.  145.45, 145.74, and 145.84 
indicated that the company applying for compartmentalization would have 
to, upon request, work with the Official State Agency to provide data 
on the

[[Page 38753]]

incidence of notifiable avian influenza (NAI) for bird populations 
outside of the proposed compartment in the State. However, Official 
State Agencies are focused on commercial poultry populations and may 
not have data on the NAI status of backyard birds or migratory birds. 
In addition, while compartments may trade with other commercial bird 
populations, they should be secured against any disease risk posed by 
backyard birds or migratory birds. Therefore, we are changing each of 
these proposed paragraphs to indicate that the Official State Agency 
may provide data on the NAI status of other commercial poultry 
populations located in the State, upon request.
    Paragraph (a)(1)(v) of the proposed compartmentalization sections 
contained a grammatical redundancy, which we have removed in this final 
rule.
    We also requested comment on the new Program Standards document. We 
did not receive any comments. However, one of the approved tests listed 
in the Program Standards document, the Rapid Chek(copyright) Select\TM\ 
Salmonella Test Kit, is now produced by Romer Labs. We have updated the 
Program Standards document accordingly.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This final 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. The 
analysis is summarized below. Copies of the full analysis are available 
on the Regulations.gov Web site (see footnote 1 in this document for a 
link to Regulations.gov) or by contacting the person listed under FOR 
FURTHER INFORMATION CONTACT.
    The establishments that will be affected by the rule--principally 
entities engaged in poultry production and processing--are 
predominantly small by Small Business Administration standards. In 
those instances in which an addition or modification could potentially 
result in a cost to certain entities, we do not expect the costs to be 
significant. This rule embodies changes decided upon by the NPIP's 
General Conference Committee on behalf of Plan members, that is, 
changes recognized by the poultry industry as in their interest. We 
note that NPIP membership is voluntary.
    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

9 CFR Part 56

    Animal diseases, Indemnity payments, Low pathogenic avian 
influenza, Poultry.

9 CFR Parts 145, 146, and 147

    Animal diseases, Poultry and poultry products, Reporting and 
recordkeeping requirements.

    Accordingly, we are amending 9 CFR parts 56, 145, 146, and 147 as 
follows:

PART 56--CONTROL OF H5/H7 LOW PATHOGENIC AVIAN INFLUENZA

0
1. The authority citation for part 56 continues to read as follows:

    Authority:  7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.


0
2. Section 56.1 is amended as follows:
0
a. By revising the definition of H5/H7 low pathogenic avian influenza 
(LPAI).
0
b. In paragraph (1)(iii) of the definition of H5/H7 LPAI virus 
infection (infected), by adding the words ``the Cooperating State 
Agency, the Official State Agency, and'' before the word ``APHIS''.
    The revision reads as follows:


Sec.  56.1  Definitions.

* * * * *
    H5/H7 low pathogenic avian influenza (LPAI). An infection of 
poultry caused by an influenza A virus of H5 or H7 subtype that has an 
intravenous pathogenicity index in 6-week-old chickens less than or 
equal to 1.2 or causes less than 75 percent mortality in 4- to 8-week-
old chickens infected intravenously, or an infection with influenza A 
viruses of H5 or H7 subtype with a cleavage site that is not consistent 
with a previously identified highly pathogenic avian influenza virus.
* * * * *

0
3. Section 56.4 is amended by adding a new paragraph (d) to read as 
follows:


Sec.  56.4  Determination of indemnity amounts.

* * * * *
    (d) Requirements for compliance agreements. The compliance 
agreement is a comprehensive document that describes the depopulation, 
disposal, and cleaning and disinfection plans for poultry that were 
infected with or exposed to H5/H7 LPAI, or a premises that contained 
such poultry. The compliance agreement sets out APHIS responsibilities, 
owner responsibilities, and Cooperating State Agency responsibilities. 
The compliance agreement must include the owner's name and the name and 
address of the affected premises. The compliance agreement must have 
signatories that include, but are not necessarily limited to, the 
owner, the grower (if applicable), the Cooperating State Agency 
representative, the State veterinarian, and the APHIS area supervisor. 
In addition, the compliance agreement must contain a flock plan with 
estimated cost breakdowns that include labor, materials, personal 
protective equipment, travel expenses for personnel involved, and any 
additional information deemed necessary by the Service. A signed 
compliance agreement is required before beginning any work for which 
indemnity funds will be requested. Once work associated with the 
compliance agreement is completed, receipts and documentation detailing 
the activities specified in the agreement should be forwarded to APHIS 
for review, approval, and final payment. This documentation should be 
submitted to APHIS no later than 30 days after the quarantine release 
of the affected or exposed premises.
* * * * *

0
4. Section 56.5 is amended as follows:
0
a. By revising paragraph (c)(1)(i).

[[Page 38754]]

0
b. By adding paragraphs (c)(1)(iii) and (c)(1)(iv).
0
c. By revising paragraphs (d)(1)(i) and (d)(1)(iii).
0
d. By removing paragraph (d)(1)(iv).
0
e. By removing the second, third, and fourth sentences after the 
heading of paragraph (d)(2)(i) and adding five sentences in their 
place.
0
f. By revising the first sentence after the heading of paragraph 
(d)(3).
    The revisions and additions read as follows:


Sec.  56.5  Destruction and disposal of poultry and cleaning and 
disinfection of premises, conveyances, and materials.

* * * * *
    (c) * * *
    (1) * * *
    (i) Poultry infected with or exposed to H5/H7 LPAI must not be 
transported to a market for controlled marketing until approved by the 
Cooperating State Agency in accordance with the initial State response 
and containment plan described in Sec.  56.10.
* * * * *
    (iii) Routes to slaughter must avoid other commercial poultry 
operations whenever possible. All load-out equipment, trailers, and 
trucks used on premises that have housed poultry that were infected 
with or exposed to H5/H7 LPAI must be cleaned and disinfected and not 
enter other poultry premises or facilities for 48 hours after removing 
such poultry from their premises.
    (iv) Flocks moved for controlled marketing must be the last poultry 
marketed during the week they are marketed.
* * * * *
    (d) * * *
    (1) * * *
    (i) Secure all feathers and debris that might blow around outside 
the house in which the infected or exposed poultry were held by 
gathering and pushing the material into the house;
* * * * *
    (iii) Close the house in which the poultry were held, maintaining 
just enough ventilation to remove moisture. Leave the house undisturbed 
for a minimum of 72 hours.
    (2) * * *
    (i) * * * Compost manure, debris, and feed by windrowing in the 
house if possible. If this is not possible, set up a system for hauling 
manure, debris, and feed to an approved site for burial, piling, or 
composting. Manure, debris, and feed may be removed from the house or 
premises and disposed of by composting it on site, leaving it in a 
undisturbed pile on site, or removing it from the site in covered 
vehicles. Land application of manure, debris, and feed should only be 
performed in accordance with the initial State response and containment 
plan described in Sec.  56.10. Clean out the house or move or spread 
litter as determined by the Cooperating State Agency and in accordance 
with the initial State response and containment plan. * * *
* * * * *
    (3) * * * Premises should remain empty until testing provides 
negative virus detection results and checked by the Cooperating State 
Agency in accordance with the initial State response and containment 
plan described in Sec.  56.10. * * *
* * * * *

PART 145--NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY

0
5. 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
6. Section 145.1 is amended as follows:
0
a. In the definition of authorized agent, by removing the words ``as 
described in Sec. Sec.  147.1(a) and 147.12'' and adding the words ``in 
accordance with part 147'' in their place.
0
b. In the definition of authorized laboratory, by removing the citation 
``Sec.  147.51'' and adding the citation ``Sec.  147.52'' in its place; 
and by removing the words ``the assays described in'' and adding the 
words ``assays in accordance with'' in their place.
0
c. In the definition of authorized testing agent, by removing the words 
``as described in Sec. Sec.  147.1(a) and 147.12'' and adding the words 
``in accordance with part 147'' in their place.
0
d. By adding, in alphabetical order, definitions of H5/H7 low 
pathogenic avian influenza (LPAI) and NPIP Program Standards.
0
e. In the definition of reactor, by removing the words ``parts 145 or 
147 of this chapter'' and adding the words ``this part or in accordance 
with part 147 of this subchapter'' in their place.
0
f. In the definition of Senior Coordinator, in paragraph (4), by 
removing the citation ``Sec.  147.51'' and adding the citation ``Sec.  
147.52'' in its place.
    The additions read as follows:


Sec.  145.1  Definitions.

* * * * *
    H5/H7 low pathogenic avian influenza (LPAI). An infection of 
poultry caused by an influenza A virus of H5 or H7 subtype that has an 
intravenous pathogenicity index in 6-week-old chickens less than or 
equal to 1.2 or causes less than 75 percent mortality in 4- to 8-week-
old chickens infected intravenously, or an infection with influenza A 
viruses of H5 or H7 subtype with a cleavage site that is not consistent 
with a previously identified highly pathogenic avian influenza virus.
* * * * *
    NPIP Program Standards. A document that contains tests and 
sanitation procedures approved by the Administrator in accordance with 
Sec.  147.53 of this subchapter for use under this subchapter. This 
document may be obtained from the NPIP Web site at http://www.aphis.usda.gov/animal_health/animal_dis_spec/poultry/ or by 
writing to the Service at National Poultry Improvement Plan, APHIS, 
USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094.
* * * * *


Sec.  145.2  [Amended]

0
7. In Sec.  145.2, paragraph (e) is amended by removing the words 
``follow the laboratory protocols outlined in part 147 of this 
chapter'' and adding the words ``conduct tests in accordance with part 
147 of this subchapter'' in their place.


0
8. Section 145.3 is amended as follows:
0
a. In paragraph (c), second sentence, by removing the word ``He'' and 
adding the words ``The participant'' in its place; and by adding the 
word ``and'' before the word ``cassowaries,''.
0
b. By redesignating paragraphs (d) and (e) as paragraphs (e) and (f), 
respectively.
0
c. By adding a new paragraph (d).
    The addition reads as follows:


Sec.  145.3  Participation.

* * * * *
    (d) To ensure that Plan diseases are not spread, flocks must be 
qualified for their intended Plan classifications before being moved 
into breeder production facilities.
* * * * *


Sec.  145.5  [Amended]

0
9. Section 145.5 is amended as follows:
0
a. In paragraph (a), by removing the words ``as recommended in 
Sec. Sec.  147.21 and 147.22 (a) and (e) of this chapter'' and adding 
the words ``in accordance with part 147 of this subchapter'' in their 
place.
0
b. In paragraph (c), by removing the words ``or F'' and adding the 
words ``F, G, H, or I'' in their place.
0
10. Section 145.6 is amended as follows:

[[Page 38755]]

0
a. By revising the second sentence in paragraph (a) introductory text.
0
b. In paragraphs (a)(1), (a)(2), (a)(3), and (a)(4), by removing the 
words ``as outlined in Sec.  147.24 of this chapter'' and adding the 
words ``in accordance with part 147 of this subchapter'' in their 
place.
    The revision reads as follows:


Sec.  145.6  Specific provisions for participating hatcheries.

    (a) * * * The sanitary procedures outlined in the NPIP Program 
Standards, or other procedures approved by the Administrator in 
accordance with Sec.  147.53(d), will be considered as a guide in 
determining compliance with this provision. * * *
* * * * *

0
11. Section 145.10 is amended as follows:
0
a. In paragraph (b) introductory text, by removing the words ``and 
145.63(a)'' and adding the words ``145.63(a), 145.73(b), 145.83(b), and 
145.93(b)'' in their place.
0
b. By revising paragraph (c) introductory text, paragraph (g) 
introductory text, paragraph (m) introductory text, paragraph (o) 
introductory text, and paragraph (t) introductory text.
    The revisions read as follows:


Sec.  145.10  Terminology and classification; flocks, products, and 
States.

* * * * *
    (c) U.S. M. Gallisepticum Clean. (See Sec. Sec.  145.23(c), 
145.23(f), 145.33(c), 145.33(f), 145.43(c), 145.53(c), 145.73(c), and 
145.83(c).)
* * * * *
    (g) U.S. Pullorum-Typhoid Clean State. (See Sec. Sec.  145.24(a), 
145.34(a), 145.44(a), 145.54(a), and 145.94(a).)
* * * * *
    (m) U.S. S. Enteritidis Clean. (See Sec. Sec.  145.23(d), 
145.73(d), and 145.83(e).)
* * * * *
    (o) U.S. Salmonella Monitored. (See Sec. Sec.  145.53(f), 
145.83(f), and 145.93(d).)
* * * * *
    (t) U.S. H5/H7 Avian Influenza Clean. (See Sec. Sec.  145.43(g), 
145.53(e), and 145.93(c).)
* * * * *
0
12. Section 145.14 is amended as follows:
0
a. In paragraph (a)(1), by revising the second sentence.
0
b. In paragraph (a)(6)(ii), by revising the third sentence.
0
c. In paragraph (b)(1), by adding a sentence after the second sentence.
0
d. By revising paragraph (b)(3).
0
e. By revising paragraph (d)(1)(ii)(C).
0
f. In paragraph (d)(2)(i)(A), by removing the word ``(AVPR01510)''.
0
g. By revising paragraph (d)(2)(ii)(B).
    The revisions and addition read as follows:


Sec.  145.14  Testing.

    (a) * * *
    (1) * * * Official blood tests must be conducted in accordance with 
part 147 of this subchapter or according to literature provided by the 
producer. * * *
* * * * *
    (6) * * *
    (ii) * * * Bacteriological examination must be conducted in 
accordance with part 147 of this subchapter. * * *
* * * * *
    (b) * * *
    (1) * * * Tests must be conducted in accordance with this paragraph 
(b) and in accordance with part 147 of this subchapter. * * *
* * * * *
    (3) When reactors to the test for which the flock was tested are 
submitted to a laboratory as prescribed by the Official State Agency, 
the final status of the flock will be determined in accordance with 
part 147 of this subchapter.
* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (C) The AGID test for avian influenza must be conducted in 
accordance with part 147 of this subchapter. The test can be conducted 
on egg yolk or blood samples. The AGID test is not recommended for use 
in waterfowl.
* * * * *
    (2) * * *
    (ii) * * *
    (B) Chicken and turkey flocks that test positive on the ACIA must 
be further tested using the RRT-PCR or virus isolation. Positive 
results from the RRT-PCR or virus isolation 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.
* * * * *

0
13. In Sec.  145.22, paragraph (b) is revised to read as follows:


Sec.  145.22  Participation.

* * * * *
    (b) Hatching eggs produced by multiplier breeding flocks should be 
nest clean. They may be fumigated in accordance with part 147 of this 
subchapter or otherwise sanitized.
* * * * *

0
14. Section 145.23 is amended as follows:
0
a. In paragraph (b) introductory text, by removing the citation ``(5)'' 
and adding the citation ``(4)'' in its place.
0
b. In paragraph (c)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this chapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
c. In paragraph (c)(1)(ii)(C), by removing the words ``Sec.  147.8 of 
this chapter'' and adding the words ``part 147 of this subchapter'' in 
their place.
0
d. In paragraph (c)(3), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
e. In paragraph (d)(1)(iv), by removing the words ``in compliance with 
Sec. Sec.  147.21, 147.24(a), and 147.26 of this chapter'' and adding 
the words ``in accordance with part 147 of this subchapter with respect 
to flock sanitation, cleaning and disinfection, and Salmonella 
isolation, sanitation, and management'' in their place.
0
f. In paragraph (d)(1)(v), by removing the words ``as described in 
Sec.  147.12 of this chapter'' and adding the words ``in accordance 
with part 147 of this subchapter'' in their place.
0
g. In paragraph (d)(1)(vii), by removing the words ``as described in 
Sec.  147.11 of this chapter'' and adding the words ``in accordance 
with part 147 of this subchapter'' in their place.
0
h. By revising paragraphs (d)(1)(viii) and (d)(1)(ix).
0
i. In paragraph (d)(2), by removing the words ``as described in Sec.  
147.11(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
j. In paragraph (e)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this chapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
k. In paragraph (e)(1)(ii)(B), by removing the words ``Sec.  147.8 of 
this chapter'' and adding the words ``part 147 of this subchapter'' in 
their place.
0
l. In paragraph (e)(3), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
m. In paragraph (f)(3), by removing the words ``in compliance with the 
provisions of Sec.  147.26 of this chapter'' and adding the words ``in 
accordance with part 147 of this subchapter with respect to Mycoplasma 
isolation,

[[Page 38756]]

sanitation, and management'' in their place.
0
n. In paragraph (f)(5), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
o. In paragraph (g)(3), by removing the words ``in compliance with the 
provisions of Sec.  147.26 of this chapter'' and adding the words ``in 
accordance with part 147 of this subchapter with respect to Mycoplasma 
isolation, sanitation, and management'' in their place.
0
p. In paragraph (g)(5), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
q. In paragraph (h)(1) introductory text, by adding the words ``and 
found'' before the word ``negative'' and by removing the words ``for 
antibodies''.
    The revisions read as follows:


Sec.  145.23  Terminology and classification; flocks and products.

* * * * *
    (d) * * *
    (1) * * *
    (viii) Hatching eggs are collected as quickly as possible, and 
their sanitation is maintained in accordance with part 147 of this 
subchapter.
    (ix) Hatching eggs produced by the flock are incubated in a 
hatchery whose sanitation is maintained in accordance with part 147 of 
this subchapter and sanitized either by a procedure approved by the 
Official State Agency or in accordance with part 147 of this 
subchapter.
* * * * *

0
15. In Sec.  145.32, paragraph (b) is revised to read as follows:


Sec.  145.32  Participation.

* * * * *
0
(b) Hatching eggs produced by multiplier breeding flocks should be nest 
clean. They may be fumigated in accordance with part 147 of this 
subchapter or otherwise sanitized.
* * * * *
0
16. Section 145.33 is amended as follows:
0
a. In paragraph (b) introductory text, by removing the citation ``(5)'' 
and adding the citation ``(4)'' in its place.
0
b. In paragraph (c)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this chapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
c. In paragraph (c)(1)(ii)(C), by removing the words ``Sec.  147.8 of 
this chapter'' and adding the words ``part 147 of this subchapter'' in 
their place.
0
d. In paragraph (c)(2), by removing the words ``(see Sec. Sec.  147.22, 
147.23, and 147.24)'' and by adding the words ``and in accordance with 
part 147 of this subchapter'' before the period at the end of the 
paragraph.
0
e. In paragraph (c)(3), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
f. In paragraph (c)(4), by removing the words ``approved by the 
Department'' and adding the words ``in accordance with part 147 of this 
subchapter'' in their place.
0
g. In paragraph (d)(1)(ii), by removing the words ``in compliance with 
Sec. Sec.  147.21, 147.24(a), and 147.26 of this chapter'' and adding 
the words ``in accordance with part 147 of this subchapter with respect 
to flock sanitation, cleaning and disinfection, and Salmonella 
isolation, sanitation, and management'' in their place.
0
h. By revising paragraph (d)(1)(vi).
0
i. In paragraph (d)(1)(vii), by removing the words ``as described in 
Sec.  147.12 of this chapter'' and adding the words ``in accordance 
with part 147 of this subchapter'' in their place.
0
j. By revising paragraph (d)(2).
0
k. In paragraph (e)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this chapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
l. In paragraph (e)(1)(ii)(B), by removing the words ``Sec.  147.8 of 
this chapter'' and adding the words ``part 147 of this subchapter'' in 
their place.
0
m. In paragraph (e)(3), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
n. In paragraph (e)(4), by removing the words ``approved by the 
Department'' and adding the words ``in accordance with part 147 of this 
subchapter'' in their place.
0
o. In paragraph (f)(3), by removing the words ``in compliance with the 
provisions of Sec.  147.26 of this chapter'' and adding the words ``in 
accordance with part 147 of this subchapter with respect to Mycoplasma 
isolation, sanitation, and management'' in their place.
0
p. In paragraph (f)(5), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
q. In paragraph (g)(3), by removing the words ``in compliance with the 
provisions of Sec.  147.26 of this chapter'' and adding the words ``in 
accordance with part 147 of this subchapter with respect to Mycoplasma 
isolation, sanitation, and management'' in their place.
0
r. In paragraph (g)(5), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
s. In paragraph (j)(2), by removing the words ``paragraph (c)(1)(i) of 
this section'' and adding the words ``Sec.  145.83(c)(1)(i)'' in their 
place.
0
t. In paragraphs (j)(3) and (k)(3), by removing the words ``as 
described in Sec.  147.24(a) of this chapter'' and adding the words 
``in accordance with part 147 of this subchapter'' in their place.
0
u. In paragraph (k)(2), by removing the words ``paragraph (e)(1)(i) of 
this section'' and adding the words ``Sec.  145.83(d)(1)(i)'' in their 
place.
0
v. In paragraph (l)(1) introductory text, by adding the words ``using 
an approved test as described in Sec.  145.14'' after the word 
``influenza''.
0
w. By adding paragraph (m).
    The revisions and addition read as follows:


Sec.  145.33  Terminology and classification; flocks and products.

* * * * *
    (d) * * *
    (1) * * *
    (vi) Chicks shall be hatched in a hatchery whose sanitation is 
maintained in accordance with part 147 of this subchapter and sanitized 
or fumigated in accordance with part 147 of this subchapter;
* * * * *
    (2) The Official State Agency may monitor the effectiveness of the 
sanitation practices in accordance with part 147 of this subchapter.
* * * * *
    (m) U.S. Salmonella Enteritidis Monitored. This classification is 
intended for multiplier meat-type breeders wishing to monitor their 
breeding flocks for Salmonella enteritidis.
    (1) A flock and the hatching eggs and chicks produced from it shall 
be eligible for this classification if they meet the following 
requirements, as determined by the Official State Agency:
    (i) The flock originated from a U.S. S. Enteritidis Clean primary 
meat-type breeding flock.
    (ii) The flock is maintained in accordance with part 147 of this

[[Page 38757]]

subchapter with respect to Salmonella isolation, sanitation, and 
management.
    (iii) Environmental samples are collected from the flock in 
accordance with part 147 of this subchapter at 16-18 and 40-45 weeks of 
age. The samples shall be examined bacteriologically for group D 
Salmonella at an authorized laboratory, and cultures from group D 
positive samples shall be serotyped.
    (2) The following actions must be taken with respect to the test 
results that are generated from this S. enteritidis monitoring program:
    (i) If S. enteritidis is isolated from an environmental sample 
collected from the flock in accordance with paragraph (m)(1)(iii) of 
this section, a thorough evaluation of the practices and programs 
associated with the sampled flock shall be conducted with the goal of 
ascertaining the reason(s) for the positive finding.
    (ii) The test results and the results of any evaluations performed 
in accordance with paragraph (m)(2)(i) of this section will be reported 
on a quarterly basis to the Official State Agency and the NPIP Senior 
Coordinator.
    (iii) Participating broiler integrators shall combine their 
respective test results (and the results of any associated evaluations) 
to help guide their decisionmaking regarding programs and practices to 
implement or maintain to address S. enteritidis.
    (iv) Aggregate data regarding the prevalence of S. enteritidis in 
participating U.S. meat-type parent breeding flocks shall be made 
available to the U.S. Poultry and Egg Association and the National 
Chicken Council.
    (3) This classification may be revoked by the Official State Agency 
if the participant fails to comply with the requirements of this 
classification. The Official State Agency shall not revoke the 
participant's classification until the participant has been given an 
opportunity for a hearing in accordance with rules of practice adopted 
by the Official State Agency.
* * * * *


Sec.  145.42  [Amended]

0
17. In Sec.  145.42, paragraph (b) is amended by removing the words 
``(see Sec.  147.25 of this chapter)'' and adding the words ``in 
accordance with part 147 of this subchapter'' after the word 
``sanitized''.

0
18. Section 145.43 is amended as follows:
0
a. In paragraph (c)(1), by removing the words ``in accordance with the 
conditions and procedures described in Sec.  147.26 of this chapter'' 
and adding the words ``in accordance with part 147 of this subchapter 
with respect to Mycoplasma isolation, sanitation, and management'' in 
their place.
0
b. In paragraph (c)(2), by removing the words ``applicable conditions 
outlined in Sec.  147.26 of this chapter are being met'' and adding the 
words ``flock is being maintained in accordance with part 147 of this 
subchapter with respect to Mycoplasma isolation, sanitation, and 
management'' in their place.
0
c. By adding a sentence at the end of paragraph (e)(1).
0
d. In paragraph (e)(2), by removing the words '' Sec.  147.6 of this 
chapter'' and by adding the words '' part 147 of this subchapter'' in 
their place.
0
e. By removing paragraph (e)(3).
0
f. In paragraph (f) introductory text, by removing the words ``as 
described in subpart C of part 147 of this chapter'' and adding the 
words ``in accordance with part 147 of this subchapter'' in their 
place.
0
g. In paragraphs (f)(2), (f)(4), and (f)(6), by removing the words ``, 
as described in Sec.  147.12 of this chapter'' and adding the words 
``in accordance with part 147 of this subchapter'' in their place.
0
h. By revising paragraph (g)(3).
    The addition and revision read as follows:


Sec.  145.43  Terminology and classification; flocks and products.

* * * * *
    (e) * * *
    (1) * * * It is recommended that any birds that are showing 
clinical signs of M. synoviae infection be included in samples taken.
* * * * *
    (g) * * *
    (3) All spent fowl being marketed for meat from flocks that have 
been tested as required by this paragraph shall be tested at a rate of 
6 birds per flock within 21 days prior to movement to slaughter.
* * * * *

0
19. Section 145.45 is added to subpart D to read as follows:


Sec.  145.45  Terminology and classification; compartments.

    (a) U.S. H5/H7 Avian Influenza Clean Compartment. This program is 
intended to be the basis from which the primary turkey breeding-
hatchery industry may demonstrate the existence and implementation of a 
program that has been approved by the Official State Agency and the 
Service to establish a compartment consisting of a primary breeding-
hatchery company that is free of H5/H7 avian influenza (AI), also 
referred to as notifiable avian influenza (NAI). This compartment has 
the purpose of protecting the defined subpopulation and avoiding the 
introduction and spread of NAI within that subpopulation by prohibiting 
contact with other commercial poultry operations, other domestic and 
wild birds, and other intensive animal operations. The program shall 
consist of the following:
    (1) Definition of the compartment. Based on the guidelines 
established by the World Organization for Animal Health (OIE) in the 
Terrestrial Animal Health Code and the guidelines in this paragraph 
(a), the primary breeder company will define the compartment with 
respect to NAI. Specifically, the company will use a comprehensive 
biosecurity program to define the compartment as a subpopulation of 
poultry with a health status for NAI that is separate from birds and 
poultry outside the compartment. The Official State Agency and the 
Service must approve all documentation submitted to substantiate the 
defined compartment as adequate to qualify for epidemiological 
separation from other potential sources of infection of NAI. Guidelines 
for the definition of the compartment include:
    (i) Definition and description of the subpopulation of birds and 
their health status. All birds included in the compartment must be U.S. 
H5/H7 Avian Influenza Clean in accordance with Sec.  145.43(g). The 
poultry must also be located in a State that has an initial State 
response and containment plan approved by APHIS under Sec.  56.10 of 
this chapter and that participates in the diagnostic surveillance 
program for H5/H7 low pathogenicity AI as described in Sec.  145.15. 
Within the compartment, all official tests for AI, as described in 
Sec.  145.14(d), must be conducted in State or Federal laboratories or 
in NPIP authorized laboratories that meet the minimum standards 
described in Sec.  147.52 of this subchapter. In addition, the company 
must provide to the Service upon request any relevant historical and 
current NAI-related data for reference regarding surveillance for the 
disease within the compartment. Upon request, the Official State Agency 
may provide such data for other commercial poultry populations located 
in the State.
    (ii) Description of animal identification and traceability 
processes. The primary breeder company must also include a description 
of its animal identification and traceability records, including 
examples of Veterinary Services (VS) Form 9-5, ``Report of Hatcheries, 
Dealers and Independent Flocks''; VS Form 9-2, ``Flock Selection and 
Testing Report''; VS Form 9-3, ``Report of Sales of Hatching Eggs,

[[Page 38758]]

Chicks and Poults''; VS Form 9-9, '' Hatchery Inspection Report''; set 
and hatch records; egg receipts; and egg/chick invoices for the 
subpopulation. Documentation must also include breed identification 
(NPIP stock code). The Service should ensure that an effective flock 
identification system and traceability system are in place.
    (iii) Definition and description of the physical components or 
establishments of the defined compartment. The primary breeder company 
must provide documentation establishing that the defined compartment is 
epidemiologically separated from other poultry and bird populations. 
The documentation must be approved by the Official State Agency and the 
Service as indicating adequate epidemiological separation to maintain 
the compartment's separate health status with respect to NAI. The 
documentation should include descriptions of:
    (A) The physical and spatial factors that separate the compartment 
from surrounding bird populations and affect the biosecurity status of 
the compartment.
    (B) Relevant environmental factors that may affect exposure of the 
birds to AI.
    (C) The functional boundary and fencing that are used to control 
access to the compartment.
    (D) Facilities and procedures to prevent access by wild birds and 
to provide separation from other relevant hosts.
    (E) The relevant infrastructural factors that may affect exposure 
to AI, including the construction and design of buildings or physical 
components, cleaning and disinfection of buildings and physical 
components between production groups with quality assurance 
verification, cleaning and disinfection of equipment, and introduction 
of equipment or material into the compartment.
    (iv) Definition and description of the functional relationships 
between components of the defined compartment. Functional relationships 
between components of the compartment include traffic movement and flow 
at and among premises, personnel movement at and among premises, 
exposure to live bird populations, and any other factors that could 
affect biosecurity of the compartment. All physical components of the 
compartment must be maintained in compliance with hygiene and 
biosecurity procedures for poultry primary breeding flocks and 
hatcheries in accordance with part 147 of this subchapter. In addition, 
the company must provide a biosecurity plan for the compartment and all 
included components. The biosecurity plan should include:
    (A) Requirements that company employees and contract growers limit 
their contact with live birds outside the compartment.
    (B) An education and training program for company employees and 
contractors.
    (C) Standard operating procedures for company employees, 
contractors, and outside maintenance personnel.
    (D) Requirements for company employees and non-company personnel 
who visit any premises within the compartment.
    (E) Company veterinary infrastructure to ensure flock monitoring 
and disease diagnosis and control measures.
    (F) Policies for management of vehicles and equipment used within 
the compartment to connect the various premises.
    (G) Farm site requirements (location, layout, and construction).
    (H) Pest management program.
    (I) Cleaning and disinfection process.
    (J) Requirements for litter and dead bird removal and/or disposal.
    (v) Description of other factors important for maintaining the 
compartment. The company veterinary infrastructure will assess sanitary 
measures, environmental risk factors, and management and husbandry 
practices that relate to the separation of the compartment and the 
health status of the birds contained within the compartment that may 
affect risk of exposure to NAI. This assessment must include a 
description of internal monitoring and auditing systems (e.g., quality 
assurance and quality control programs) to demonstrate the 
effectiveness of the compartment. Upon request, the Service will 
provide the company with information on the epidemiology of NAI and the 
associated risk pathways in which the components of the compartment are 
located.
    (vi) Approval or denial. Based on this documentation provided under 
this paragraph (a)(1), as well as any other information the Service and 
the Official State Agency determine to be necessary, the Service and 
the Official State Agency will approve or deny the classification of 
the compartment as U.S. H5/H7 Avian Influenza Clean.
    (2) Company activities for maintenance of the compartment. (i) The 
primary breeder company's management of biosecurity, surveillance, and 
disease control efforts must be uniform and equivalent among all 
components that are a part of the compartment. Oversight and inspection 
of these management practices must be conducted by the company's 
licensed, accredited veterinarians.
    (ii) Veterinary staff from the Official State Agency and NPIP staff 
will work in partnership with licensed, accredited veterinarians to 
train and certify auditors through Service-approved workshops. The 
trained auditors will conduct biosecurity and operational audits at 
least once every 2 years to ensure the integrity of the compartment. 
These audits will include evaluation of the critical control points and 
standard operating practices within the compartment, verification of 
the health status of the flock(s) contained within the compartment, and 
examination of the biosecurity and management system of the integrated 
components of the compartment.
    (iii) In addition, the company must demonstrate compliance with 
paragraph (a)(1) of this section for remaining in the U.S. H5/H7 Avian 
Influenza Clean classification, surveillance for NAI within the 
compartment, and conducting tests in State or Federal laboratories or 
in NPIP authorized laboratories. Accredited veterinarians are 
responsible for the enforcement of active and passive surveillance of 
NAI in primary breeder flocks. Baseline health status must be 
maintained for all flocks or subpopulations within the compartment, 
indicating the dates and negative results of all avian influenza 
surveillance and monitoring testing, the dates and history of last 
disease occurrence (if any), the number of outbreaks, and the methods 
of disease control that were applied.
    (iv) Documentation will be maintained in the company's database and 
will be verified as required by the Service and/or the Official State 
Agency.
    (3) Service and Official State Agency activities for maintenance of 
the compartment. The Service will work in cooperation with the Official 
State Agencies to ensure the continued integrity of any recognized 
compartments. Activities will include:
    (i) Oversight of the establishment and management of compartments;
    (ii) Establishment of effective partnerships between the Service, 
the Plan, and the primary breeder industry;
    (iii) Approval or denial of classification of compartments as U.S. 
H5/H7 Avian Influenza Clean Compartments under paragraph (a)(1) of this 
section;
    (iv) Official certification of the health status of the 
compartment, and commodities that may be traded from it through 
participation in the Plan for avian diseases, including the U.S. H5/H7 
Avian Influenza Clean program as

[[Page 38759]]

described in Sec.  145.43(g) and diagnostic surveillance for H5/H7 low 
pathogenicity AI as described in Sec.  145.15;
    (v) Conducting audits of compartments at least once every 2 years 
to:
    (A) Confirm that the primary breeding company's establishments are 
epidemiologically distinct and pathways for the introduction of disease 
into the compartment are closed through routine operational procedures; 
and
    (B) Evaluate and assess the management and husbandry practices 
relating to biosecurity to determine whether they are in compliance 
with hygiene and biosecurity procedures for poultry primary breeding 
flocks and hatcheries in accordance with part 147 of this subchapter;
    (vi) Providing, upon request, model plans for management and 
husbandry practices relating to biosecurity in accordance with part 147 
of this subchapter, risk evaluations in conjunction with the primary 
breeder industry (including disease surveillance such as VS Form 9-4, 
``Summary of Breeding Flock Participation''), and diagnostic capability 
summaries and systems for initial State response and containment plans 
in accordance with Sec.  56.10 of this chapter; and
    (vii) Publicizing and sharing compartment information with 
international trading partners, upon request, to establish approval and 
recognition of the compartment, including timeliness and accuracy of 
disease reporting and surveillance measures as described in Sec. Sec.  
145.15 and 145.43(g).
    (4) Emergency response and notification. In the case of a confirmed 
positive of NAI in the subpopulation of the compartment, the management 
of the compartment must notify the Service. The Service will 
immediately suspend the status of the compartment. A compartment will 
be eligible to resume trade with importing countries only after the 
compartment has adopted the necessary measures to reestablish the 
biosecurity level and confirm that NAI is not present in the 
compartment and the Service has reevaluated the management and 
biosecurity measures of the compartment and approved said compartment 
for trade.
    (b) [Reserved]

0
20. Section 145.52 is amended as follows:
0
a. In paragraph (b), by removing the words ``(see Sec.  147.25 of this 
chapter)'' and adding the words ``in accordance with part 147 of this 
subchapter'' after the word ``sanitized''.
0
b. By redesignating paragraphs (c) and (d) as paragraphs (d) and (e), 
respectively.
0
c. By adding a new paragraph (c).
    The addition reads as follows:


Sec.  145.52  Participation.

* * * * *
    (c) It is recommended that waterfowl flocks and gallinaceous flocks 
in open-air facilities be kept separate.
* * * * *

0
21. Section 145.53 is amended as follows:
0
a. In paragraph (c)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this chapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
b. In paragraph (c)(3), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
c. In paragraph (d)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this chapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
d. In paragraph (d)(1)(ii)(B), by removing the words ``Sec.  147.8 of 
this chapter'' and adding the words ``part 147 of this subchapter'' in 
their place.
0
e. In paragraph (d)(3), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
f. By revising paragraphs (e)(1) introductory text and (e)(2) 
introductory text.
0
g. In paragraphs (e)(1)(i) and (e)(1)(ii), by removing the number 
``90'' and adding the number ``180'' in its place.
0
h. By revising paragraph (e)(3).
0
i. By adding paragraph (f).
    The revisions and addition read as follows:


Sec.  145.53  Terminology and classification; flocks and products.

* * * * *
    (e) * * *
    (1) It is a primary breeding flock in which a minimum of 30 birds 
has been tested negative to the H5 and H7 subtypes of avian influenza 
as provided in Sec.  145.14(d) when more than 4 months of age; 
Provided, that waterfowl flocks may test a minimum of 30 cloacal swabs 
for virus isolation. To retain this classification:
* * * * *
    (2) It is a multiplier breeding flock in which a minimum of 30 
birds has been tested negative to the H5 and H7 subtypes of avian 
influenza as provided in Sec.  145.14(d) when more than 4 months of 
age; Provided, that waterfowl flocks may test a minimum of 30 cloacal 
swabs for virus isolation. To retain this classification:
* * * * *
    (3) A sample of at least 30 birds must be tested and found negative 
to H5/H7 avian influenza within 21 days prior to movement to slaughter.
    (f) U.S. Salmonella Monitored. This program is intended to be the 
basis from which the hatching industry may conduct a program for the 
prevention and control of salmonellosis. It is intended to reduce the 
incidence of Salmonella organisms in day-old poultry through an 
effective and practical sanitation program in the hatchery. This will 
afford other segments of the poultry industry an opportunity to reduce 
the incidence of Salmonella in their products. The following 
requirements must be met for a flock to be of this classification:
    (1) An Authorized Agent shall collect a minimum of five 
environmental samples, e.g., chick papers, hatching trays, and chick 
transfer devices, from the hatchery at least every 30 days. Testing 
must be performed at an authorized laboratory.
    (2) To claim products are of this classification, all products 
shall be derived from a hatchery that meets the requirements of the 
classification.
    (3) This classification may be revoked by the Official State Agency 
if the participant fails to follow recommended corrective measures.
* * * * *


Sec.  145.62  [Amended]

0
22. In Sec.  145.62, paragraph (b) is amended by removing the words 
``(see Sec.  147.22 of this chapter)'' and adding the words ``in 
accordance with part 147 of this subchapter'' in their place.

0
23. In Sec.  145.72, paragraph (b) is revised to read as follows:


Sec.  145.72  Participation.

* * * * *
    (b) Hatching eggs produced by primary breeding flocks should be 
nest clean. They may be fumigated in accordance with part 147 of this 
subchapter or otherwise sanitized.
* * * * *

0
24. Section 145.73 is amended as follows:
0
a. In paragraph (c)(1) introductory text, by removing the words ``in 
compliance with the provisions of

[[Page 38760]]

Sec.  147.26 of this subchapter'' and adding the words ``in accordance 
with part 147 of this subchapter with respect to Mycoplasma isolation, 
sanitation, and management'' in their place.
0
b. In paragraph (c)(3), by removing the words ``as described in Sec.  
147.24(a)'' and adding the words ``in accordance with part 147'' in 
their place.
0
c. In paragraph (d)(1)(iv), by removing the words ``in compliance with 
Sec. Sec.  147.21, 147.24(a), and 147.26 of this subchapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to flock sanitation, cleaning and disinfection, and Salmonella 
isolation, sanitation, and management'' in their place.
0
d. In paragraph (d)(1)(v), by removing the words ``as described in 
Sec.  147.12'' and adding the words ``in accordance with part 147'' in 
their place.
0
e. In paragraph (d)(1)(vii), by removing the words ``as described in 
Sec.  147.11'' and adding the words ``in accordance with part 147'' in 
their place.
0
f. By revising paragraph (d)(1)(ix).
0
g. In paragraph (d)(2), by removing the words ``as described in Sec.  
147.11(a)'' and adding the words ``in accordance with part 147'' in 
their place.
0
h. In paragraph (e)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this subchapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
i. In paragraph (e)(3), by removing the words ``as described in Sec.  
147.24(a)'' and adding the words ``in accordance with part 147'' in 
their place.
0
j. In paragraph (f)(1) introductory text, by adding the words ``and 
found'' before the word ``negative'' and by removing the words 
``antibodies to''.
0
k. By revising paragraph (f)(2).
    The revisions read as follows:


Sec.  145.73  Terminology and classification; flocks and products.

* * * * *
    (d) * * *
    (1) * * *
    (ix) Hatching eggs produced by the flock are incubated in a 
hatchery whose sanitation is maintained in accordance with part 147 of 
this subchapter and sanitized either by a procedure approved by the 
Official State Agency or in accordance with part 147 of this 
subchapter.
* * * * *
    (f) * * *
    (2) A sample of at least 11 birds must be tested and found negative 
for avian influenza within 21 days prior to movement to slaughter.

0
25. Section 145.74 is added to subpart G to read as follows:


Sec.  145.74  Terminology and classification; compartments.

    (a) U.S. Avian Influenza Clean Compartment. This program is 
intended to be the basis from which the primary egg-type chicken 
breeding-hatchery industry may demonstrate the existence and 
implementation of a program that has been approved by the Official 
State Agency and the Service to establish a compartment consisting of a 
primary breeding-hatchery company that is free of H5/H7 avian influenza 
(AI), also referred to as notifiable avian influenza (NAI). This 
compartment has the purpose of protecting the defined subpopulation and 
avoiding the introduction and spread of NAI within that subpopulation 
by prohibiting contact with other commercial poultry operations, other 
domestic and wild birds, and other intensive animal operations. The 
program shall consist of the following:
    (1) Definition of the compartment. Based on the guidelines 
established by the World Organization for Animal Health (OIE) in the 
Terrestrial Animal Health Code and the guidelines in this paragraph 
(a), the primary breeder company will define the compartment with 
respect to NAI. Specifically, the company will use a comprehensive 
biosecurity program to define the compartment as a subpopulation of 
poultry with a health status for NAI that is separate from birds and 
poultry outside the compartment. The Official State Agency and the 
Service must first approve all documentation submitted by the company 
to substantiate the defined compartment as adequate to qualify for 
epidemiological separation from other potential sources of infection of 
NAI. Guidelines for the definition of the compartment include:
    (i) Definition and description of the subpopulation of birds and 
their health status. All birds included in the compartment must be U.S. 
Avian Influenza Clean in accordance with Sec.  145.73(f). The poultry 
must also be located in a State that has an initial State response and 
containment plan approved by APHIS under Sec.  56.10 of this chapter 
and that participates in the diagnostic surveillance program for H5/H7 
low pathogenicity AI as described in Sec.  145.15. Within the 
compartment, all official tests for AI, as described in Sec.  
145.14(d), must be conducted in State or Federal laboratories or in 
NPIP authorized laboratories that meet the minimum standards described 
in Sec.  147.52 of this subchapter. In addition, the company must 
provide to the Service upon request any relevant historical and current 
NAI-related data for reference regarding surveillance for the disease 
within the compartment. Upon request, the Official State Agency may 
provide such data for other commercial poultry populations located in 
the State.
    (ii) Description of animal identification and traceability 
processes. The primary breeder company must also include a description 
of its animal identification and traceability records, including 
examples of Veterinary Services (VS) Form 9-5, ``Report of Hatcheries, 
Dealers and Independent Flocks''; VS Form 9-2, ``Flock Selection and 
Testing Report''; VS Form 9-3, ``Report of Sales of Hatching Eggs, 
Chicks and Poults''; VS Form 9-9, '' Hatchery Inspection Report''; set 
and hatch records; egg receipts; and egg/chick invoices for the 
subpopulation. Documentation must also include breed identification 
(NPIP stock code). The Service should ensure that an effective flock 
identification system and traceability system are in place.
    (iii) Definition and description of the physical components or 
establishments of the defined compartment. The primary breeder company 
must provide documentation establishing that the defined compartment is 
epidemiologically separated from other poultry and bird populations. 
The documentation must be approved by the Official State Agency and the 
Service as indicating adequate epidemiological separation to maintain 
the compartment's separate health status with respect to NAI. The 
documentation should include descriptions of:
    (A) The physical and spatial factors that separate the compartment 
from surrounding bird populations and affect the biosecurity status of 
the compartment.
    (B) Relevant environmental factors that may affect exposure of the 
birds to AI.
    (C) The functional boundary and fencing that are used to control 
access to the compartment.
    (D) Facilities and procedures to prevent access by wild birds and 
to provide separation from other relevant hosts.
    (E) The relevant infrastructural factors that may affect exposure 
to AI, including the construction and design of buildings or physical 
components, cleaning and disinfection of buildings and physical 
components between production groups with quality assurance 
verification, cleaning and disinfection of equipment, and introduction 
of equipment or material into the compartment.

[[Page 38761]]

    (iv) Definition and description of the functional relationships 
between components of the defined compartment. Functional relationships 
between components of the compartment include traffic movement and flow 
at and among premises, personnel movement at and among premises, 
exposure to live bird populations, and any other factors that could 
affect biosecurity of the compartment. All physical components of the 
compartment must be maintained in compliance with hygiene and 
biosecurity procedures for poultry primary breeding flocks and 
hatcheries in accordance with part 147 of this subchapter. In addition, 
the company must provide a biosecurity plan for the compartment and all 
included components. The biosecurity plan should include but not be 
limited to:
    (A) Requirements that company employees and contract growers limit 
their contact with live birds outside the compartment.
    (B) An education and training program for company employees and 
contractors.
    (C) Standard operating procedures for company employees, 
contractors, and outside maintenance personnel.
    (D) Requirements for company employees and non-company personnel 
who visit any premises within the compartment.
    (E) Company veterinary infrastructure to ensure flock monitoring 
and disease diagnosis and control measures.
    (F) Policies for management of vehicles and equipment used within 
the compartment to connect the various premises.
    (G) Farm site requirements (location, layout, and construction).
    (H) Pest management program.
    (I) Cleaning and disinfection process.
    (J) Requirements for litter and dead bird removal and/or disposal.
    (v) Description of other factors important for maintaining the 
compartment. The company veterinary infrastructure will assess sanitary 
measures, environmental risk factors, and management and husbandry 
practices that relate to the separation of the compartment and the 
health status of the birds contained within the compartment that may 
affect risk of exposure to NAI. This assessment must include a 
description of internal monitoring and auditing systems (e.g., quality 
assurance and quality control programs) to demonstrate the 
effectiveness of the compartment. Upon request, the Service will 
provide the company with information on the epidemiology of NAI and the 
associated risk pathways in which the components of the compartment are 
located.
    (vi) Approval or denial. Based on the documentation provided under 
this paragraph (a)(1), as well as any other information the Service and 
the Official State Agency determine to be necessary, the Service and 
the Official State Agency will approve or deny the classification of 
the compartment as U.S. Avian Influenza Clean.
    (2) Company activities for maintenance of the compartment. (i) The 
primary breeder company's management of biosecurity, surveillance, and 
disease control efforts must be uniform and equivalent among all 
components that are a part of the compartment. Oversight and inspection 
of these management practices must be conducted by the company's 
licensed, accredited veterinarians.
    (ii) Veterinary staff from the Official State Agency and NPIP staff 
will work in partnership with licensed, accredited veterinarians to 
train and certify auditors through Service-approved workshops. The 
trained auditors will conduct biosecurity and operational audits at 
least once every 2 years to ensure the integrity of the compartment. 
These audits will include evaluation of the critical control points and 
standard operating practices within the compartment, verification of 
the health status of the flock(s) contained within the compartment, and 
examination of the biosecurity and management system of the integrated 
components of the compartment.
    (iii) In addition, the company must demonstrate compliance with 
paragraph (a)(1) of this section for remaining in the U.S. Avian 
Influenza Clean classification, surveillance for NAI within the 
compartment, and conducting tests in State or Federal laboratories or 
in NPIP authorized laboratories. Accredited veterinarians are 
responsible for the enforcement of active and passive surveillance of 
NAI in primary breeder flocks. Baseline health status must be 
maintained for all flocks or subpopulations within the compartment, 
indicating the dates and negative results of all avian influenza 
surveillance and monitoring testing, the dates and history of last 
disease occurrence (if any), the number of outbreaks, and the methods 
of disease control that were applied.
    (iv) Documentation will be maintained in the company's database and 
will be verified as required by the Service and/or the Official State 
Agency.
    (3) Service and Official State Agency activities for maintenance of 
the compartment. The Service will work in cooperation with the Official 
State Agencies to ensure the continued integrity of any recognized 
compartments. Activities include:
    (i) Oversight of the establishment and management of compartments;
    (ii) Establishment of effective partnerships between the Service, 
the Plan, and the primary breeder industry;
    (iii) Approval or denial of classification of compartments as U.S. 
Avian Influenza Clean Compartments under paragraph (a)(1) of this 
section;
    (iv) Official certification of the health status of the 
compartment, and commodities that may be traded from it through 
participation in the Plan for avian diseases, including the U.S. Avian 
Influenza Clean program as described in Sec.  145.73(f) and diagnostic 
surveillance for H5/H7 low pathogenicity AI as described in Sec.  
145.15;
    (v) Conducting audits of compartments at least once every 2 years 
to:
    (A) Confirm that the primary breeding company's establishments are 
epidemiologically distinct and pathways for the introduction of disease 
into the compartment are closed through routine operational procedures; 
and
    (B) Evaluate and assess the management and husbandry practices 
relating to biosecurity to determine whether they are in compliance 
with hygiene and biosecurity procedures for poultry primary breeding 
flocks and hatcheries in accordance with part 147 of this subchapter;
    (vi) Providing, upon request, model plans for management and 
husbandry practices relating to biosecurity in accordance with part 147 
of this subchapter, risk evaluations in conjunction with the primary 
breeder industry (including disease surveillance such as VS Form 9-4, 
``Summary of Breeding Flock Participation''), and diagnostic capability 
summaries and systems for initial State response and containment plans 
in accordance with Sec.  56.10 of this chapter; and
    (vii) Publicizing and sharing compartment information with 
international trading partners, upon request, to establish approval and 
recognition of the compartment, including timeliness and accuracy of 
disease reporting and surveillance measures as described in Sec. Sec.  
145.15 and 145.73(f).
    (4) Emergency response and notification. In the case of a confirmed 
positive of NAI in the subpopulation of the compartment, the management 
of the compartment must notify the Service. The Service will 
immediately suspend the status of the compartment.

[[Page 38762]]

A compartment will be eligible to resume trade with importing countries 
only after the compartment has adopted the necessary measures to 
reestablish the biosecurity level and confirm that NAI is not present 
in the compartment and the Service has reevaluated the management and 
biosecurity measures of the compartment and approved said compartment 
for trade.
    (b) [Reserved]

0
26. In Sec.  145.82, paragraph (b) is revised to read as follows:


Sec.  145.82  Participation.

* * * * *
    (b) Hatching eggs produced by primary breeding flocks should be 
nest clean. They may be fumigated in accordance with part 147 of this 
subchapter or otherwise sanitized.
* * * * *

0
27. Section 145.83 is amended as follows:
0
a. In paragraph (c)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this subchapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
b. In paragraph (c)(3), by removing the words ``as described in Sec.  
147.24(a)'' and adding the words ``in accordance with part 147'' in 
their place.
0
c. In paragraph (d)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this subchapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
d. In paragraph (d)(3), by removing the words ``as described in Sec.  
147.24(a)'' and adding the words ``in accordance with part 147'' in 
their place.
0
e. By revising paragraphs (e)(1) and (e)(3).
0
f. In paragraph (e)(6) introductory text, by removing the words ``or 
great-grandparent'' and adding the words ``great-grandparent, or 
grandparent'' in their place.
0
g. In paragraph (e)(6)(i)(B), by removing the words ``as described in 
Sec.  147.12(a)'' and adding the words ``in accordance with part 147'' 
in their place.
0
h. In paragraph (e)(6)(i)(C), by removing the words ``as described in 
Sec.  147.11'' and adding the words ``in accordance with part 147'' in 
their place.
0
i. In paragraph (e)(6)(i)(D), by removing the words ``as specified in 
Sec.  147.12(a)'' and adding the words ``in accordance with part 147'' 
in their place.
0
j. In paragraph (f)(1)(i), by removing the words ``in compliance with 
Sec. Sec.  147.21, 147.24(a), and 147.26 of this subchapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to flock sanitation, cleaning and disinfection, and Salmonella 
isolation, sanitation, and management'' in their place.
0
k. By revising paragraph (f)(1)(iv).
0
l. In paragraph (f)(1)(vi), by removing the words ``as described in 
Sec.  147.12'' and adding the words ``in accordance with part 147'' in 
their place.
0
m. By revising paragraph (f)(2).
0
n. In paragraph (g)(1) introductory text, by adding the words ``using 
an approved test as described in Sec.  145.14'' after the word 
``influenza''.
    The revisions read as follows:


Sec.  145.83  Terminology and classification; flocks and products.

* * * * *
    (e) * * *
    (1) A flock and the hatching eggs and chicks produced from it shall 
be eligible for this classification if they meet the following 
requirements, as determined by the Official State Agency:
    (i) The flock originated from a U.S. S. Enteritidis Clean flock, or 
one of the following samples has been examined bacteriologically for S. 
enteritidis at an authorized laboratory in accordance with part 147 of 
this subchapter and any group D Salmonella samples have been serotyped:
    (A) A sample of chick papers, hatcher tray swabs, or fluff 
collected and cultured in accordance with part 147 of this subchapter; 
and
    (B) Samples of intestinal and liver or spleen tissues from a 
minimum of 30 chicks that died within 7 days after hatching and have 
been preserved daily by freezing prior to shipment to an authorized 
laboratory.
    (ii) The flock is maintained in compliance with isolation, 
sanitation, and management procedures for Salmonella in accordance with 
part 147 of this subchapter.
    (iii) Environmental samples are collected from the flock by or 
under the supervision of an Authorized Agent, in accordance with part 
147 of this subchapter, when the flock reaches 4 months of age and 
every 30 days thereafter. Once the flock is in egg production and 
chicks are hatching from it, the samples must include at least 4 
individual test assay results every 30 days in flocks of more than 500 
birds or 2 individual assays per month in flocks of 500 birds or fewer. 
One of these results must come from samples collected from hatched 
chicks at a participating hatchery derived from said flock. These 
individual test assays may be derived from pooled samples from the farm 
or hatchery in accordance with part 147 of this subchapter, but must be 
run as separate test assays in the laboratory. The environmental 
samples shall be examined bacteriologically for group D Salmonella at 
an authorized laboratory, and cultures from group D positive samples 
shall be serotyped.
    (iv) Blood samples from 300 birds from the flock are officially 
tested with pullorum antigen when the flock is at least 4 months of 
age. All birds with positive or inconclusive reactions, up to a maximum 
of 25 birds, shall be submitted to an authorized laboratory and 
examined for the presence of group D Salmonella in accordance with part 
147 of this subchapter. Cultures from group D positive samples shall be 
serotyped.
    (v) Hatching eggs produced by the flock are collected as quickly as 
possible and their sanitation is maintained in accordance with part 147 
of this subchapter.
    (vi) Hatching eggs produced by the flock are incubated in a 
hatchery whose sanitation is maintained in accordance with part 147 of 
this subchapter, and the hatchery must have been sanitized either by a 
procedure approved by the Official State Agency or by fumigation in 
accordance with part 147 of this subchapter.
* * * * *
    (3) If SE is isolated from an environmental sample collected from 
the flock in accordance with paragraph (e)(1)(iii) of this section, an 
additional environmental sampling and 25 live cull birds or fresh dead 
birds (if present), or other randomly selected live birds if fewer than 
25 culls can be found in the flock, must be bacteriologically examined 
for SE in accordance with part 147 of this subchapter. If only 1 bird 
from the 25-bird sample is found positive for SE., the participant may 
request bacteriological examination of a second 25-bird sample from the 
flock. In addition, if the flock with the SE isolation is in egg 
production and eggs are under incubation, the next four consecutive 
hatches shall be examined bacteriologically in accordance with part 147 
of this subchapter. Samples shall be collected from all of the hatching 
unit's chick trays and basket trays of hatching eggs, or from all chick 
box papers from the flock, and tested, pooling the samples into a 
minimum of 10 separate assays. Any followup hatchery-positive SE 
isolations shall result in discontinuation of subsequent

[[Page 38763]]

hatches until the flock status is determined by bird culture. The flock 
will be disqualified for the U.S. S. Enteritidis Clean classification 
if a bird or subsequent flock environmental assay results in isolation 
of SE.
* * * * *
    (f) * * *
    (1) * * *
    (iv) Chicks shall be hatched in a hatchery whose sanitation is 
maintained in accordance with part 147 of this subchapter and sanitized 
or fumigated in accordance with part 147 of this subchapter.
* * * * *
    (2) The Official State Agency may monitor the effectiveness of the 
sanitation practices in accordance with part 147 of this subchapter.
* * * * *
0
28. Section 145.84 is added to subpart H to read as follows:


Sec.  145.84  Terminology and classification; compartments.

    (a) U.S. Avian Influenza Clean Compartment. This program is 
intended to be the basis from which the primary meat-type chicken 
breeding-hatchery industry may demonstrate the existence and 
implementation of a program that has been approved by the Official 
State Agency and the Service to establish a compartment consisting of a 
primary breeding-hatchery company that is free of H5/H7 avian influenza 
(AI), also referred to as notifiable avian influenza (NAI). This 
compartment has the purpose of protecting the defined subpopulation and 
avoiding the introduction and spread of NAI within that subpopulation 
by prohibiting contact with other commercial poultry operations, other 
domestic and wild birds, and other intensive animal operations. The 
program shall consist of the following:
    (1) Definition of the compartment. Based on the guidelines 
established by the World Organization for Animal Health (OIE) in the 
Terrestrial Animal Health Code and the guidelines in this paragraph 
(a), the primary breeder company will define the compartment with 
respect to NAI. Specifically, the company will use a comprehensive 
biosecurity program to define the compartment as a subpopulation of 
poultry with a health status for NAI that is separate from birds and 
poultry outside the compartment. The Official State Agency and the 
Service must first approve all documentation submitted by the company 
to substantiate the defined compartment as adequate to qualify for 
epidemiological separation from other potential sources of infection of 
NAI. Guidelines for the definition of the compartment include:
    (i) Definition and description of the subpopulation of birds and 
their health status. All birds included in the compartment must be U.S. 
Avian Influenza Clean in accordance with Sec.  145.83(g). The poultry 
must also be located in a State that has an initial State response and 
containment plan approved by APHIS under Sec.  56.10 of this chapter 
and that participates in the diagnostic surveillance program for H5/H7 
low pathogenicity AI as described in Sec.  145.15. Within the 
compartment, all official tests for AI, as described in Sec.  
145.14(d), must be conducted in State or Federal laboratories or in 
NPIP authorized laboratories that meet the minimum standards described 
in Sec.  147.52 of this subchapter. In addition, the company must 
provide to the Service upon request any relevant historical and current 
NAI-related data for reference regarding surveillance for the disease 
and the health status of the compartment. Upon request, the Official 
State Agency may provide such data for other commercial poultry 
populations located in the State.
    (ii) Description of animal identification and traceability 
processes. The primary breeder company must also include a description 
of its animal identification and traceability records, including 
examples of Veterinary Services (VS) Form 9-5, ``Report of Hatcheries, 
Dealers and Independent Flocks''; VS Form 9-2, ``Flock Selection and 
Testing Report''; VS Form 9-3, ``Report of Sales of Hatching Eggs, 
Chicks and Poults''; VS Form 9-9, '' Hatchery Inspection Report''; set 
and hatch records; egg receipts; and egg/chick invoices for the 
subpopulation. Documentation must also include breed identification 
(NPIP stock code). The Service should ensure that an effective flock 
identification system and traceability system are in place.
    (iii) Definition and description of the physical components or 
establishments of the defined compartment. The primary breeder company 
must provide documentation establishing that the defined compartment is 
epidemiologically separated from other poultry and bird populations. 
The documentation must be approved by the Official State Agency and the 
Service as indicating adequate epidemiological separation to maintain 
the compartment's separate health status with respect to NAI. The 
documentation should include descriptions of:
    (A) The physical and spatial factors that separate the compartment 
from surrounding bird populations and affect the biosecurity status of 
the compartment.
    (B) Relevant environmental factors that may affect exposure of the 
birds to AI.
    (C) The functional boundary and fencing that are used to control 
access to the compartment.
    (D) Facilities and procedures to prevent access by wild birds and 
to provide separation from other relevant hosts.
    (E) The relevant infrastructural factors that may affect exposure 
to AI, including the construction and design of buildings or physical 
components, cleaning and disinfection of buildings and physical 
components between production groups with quality assurance 
verification, cleaning and disinfection of equipment, and introduction 
of equipment or material into the compartment.
    (iv) Definition and description of the functional relationships 
between components of the defined compartment. Functional relationships 
between components of the compartment include traffic movement and flow 
at and among premises, personnel movement at and among premises, 
exposure to live bird populations, and any other factors that could 
affect biosecurity of the compartment. All physical components of the 
compartment must be maintained in compliance with hygiene and 
biosecurity procedures for poultry primary breeding flocks and 
hatcheries in accordance with part 147 of this subchapter. In addition, 
the company must provide a biosecurity plan for the compartment and all 
included components. The biosecurity plan should include but not be 
limited to:
    (A) Requirements that company employees and contract growers limit 
their contact with live birds outside the compartment.
    (B) An education and training program for company employees and 
contractors.
    (C) Standard operating procedures for company employees, 
contractors, and outside maintenance personnel.
    (D) Requirements for company employees and non-company personnel 
who visit any premises within the compartment.
    (E) Company veterinary infrastructure to ensure flock monitoring 
and disease diagnosis and control measures.
    (F) Policies for management of vehicles and equipment used within 
the compartment to connect the various premises.
    (G) Farm site requirements (location, layout, and construction).
    (H) Pest management program.

[[Page 38764]]

    (I) Cleaning and disinfection process.
    (J) Requirements for litter and dead bird removal and/or disposal.
    (v) Description of other factors important for maintaining the 
compartment. The company veterinary infrastructure will assess sanitary 
measures, environmental risk factors, and management and husbandry 
practices that relate to the separation of the compartment and the 
health status of the birds contained within the compartment that may 
affect risk of exposure to NAI. This assessment must include a 
description of internal monitoring and auditing systems (e.g., quality 
assurance and quality control programs) to demonstrate the 
effectiveness of the compartment. Upon request, the Service will 
provide the company with information on the epidemiology of NAI and the 
associated risk pathways in which the components of the compartment are 
located.
    (vi) Approval or denial. Based on the documentation provided under 
this paragraph (a)(1), as well as any other information the Service and 
the Official State Agency determine to be necessary, the Service and 
the Official State Agency will approve or deny the classification of 
the compartment as U.S. Avian Influenza Clean.
    (2) Company activities for maintenance of the compartment. (i) The 
primary breeder company's management of biosecurity, surveillance, and 
disease control efforts must be uniform and equivalent among all 
components that are a part of the compartment. Oversight and inspection 
of these management practices must be conducted by the company's 
licensed, accredited veterinarians.
    (ii) Veterinary staff from the Official State Agency and NPIP staff 
will work in partnership with licensed, accredited veterinarians to 
train and certify auditors through Service-approved workshops. The 
trained auditors will conduct biosecurity and operational audits at 
least once every 2 years to ensure the integrity of the compartment. 
These audits will include evaluation of the critical control points and 
standard operating practices within the compartment, verification of 
the health status of the flock(s) contained within the compartment, and 
examination of the biosecurity and management system of the integrated 
components of the compartment.
    (iii) In addition, the company must demonstrate compliance with 
paragraph (a)(1) of this section for remaining in the U.S. Avian 
Influenza Clean classification, surveillance for NAI within the 
compartment, and conducting tests in State or Federal laboratories or 
in NPIP authorized laboratories. Accredited veterinarians are 
responsible for the enforcement of active and passive surveillance of 
NAI in primary breeder flocks. Baseline health status must be 
maintained for all flocks or subpopulations within the compartment, 
indicating the dates and negative results of all avian influenza 
surveillance and monitoring testing, the dates and history of last 
disease occurrence (if any), the number of outbreaks, and the methods 
of disease control that were applied.
    (iv) Documentation will be maintained in the company's database and 
will be verified as required by the Service and/or the Official State 
Agency.
    (3) Service and Official State Agency activities for maintenance of 
the compartment. The Service will work in cooperation with the Official 
State Agencies to ensure the continued integrity of any recognized 
compartments. Activities include:
    (i) Oversight of the establishment and management of compartments;
    (ii) Establishment of effective partnerships between the Service, 
the Plan, and the primary breeder industry;
    (iii) Approval or denial of classification of compartments as U.S. 
Avian Influenza Clean Compartments under paragraph (a)(1) of this 
section;
    (iv) Official certification of the health status of the 
compartment, and commodities that may be traded from it through 
participation in the Plan for avian diseases, including the U.S. Avian 
Influenza Clean program as described in Sec.  145.83(g) and diagnostic 
surveillance for H5/H7 low pathogenicity AI as described in Sec.  
145.15;
    (v) Conducting audits of compartments at least once every 2 years 
to:
    (A) Confirm that the primary breeding company's establishments are 
epidemiologically distinct and pathways for the introduction of disease 
into the compartment are closed through routine operational procedures; 
and
    (B) Evaluate and assess the management and husbandry practices 
relating to biosecurity to determine whether they are in compliance 
with hygiene and biosecurity procedures for poultry primary breeding 
flocks and hatcheries in accordance with part 147 of this subchapter;
    (vi) Providing, upon request, model plans for management and 
husbandry practices relating to biosecurity in accordance with part 147 
of this subchapter, risk evaluations in conjunction with the primary 
breeder industry (including disease surveillance such as VS Form 9-4, 
``Summary of Breeding Flock Participation''), and diagnostic capability 
summaries and systems for initial State response and containment plans 
in accordance with Sec.  56.10 of this chapter; and
    (vii) Publicizing and sharing compartment information with 
international trading partners, upon request, to establish approval and 
recognition of the compartment, including timeliness and accuracy of 
disease reporting and surveillance measures as described in Sec. Sec.  
145.15 and 145.83(g).
    (4) Emergency response and notification. In the case of a confirmed 
positive of NAI in the subpopulation of the compartment, the management 
of the compartment must notify the Service. The Service will 
immediately suspend the status of the compartment. A compartment would 
be eligible to resume trade with importing countries only after the 
compartment has adopted the necessary measures to reestablish the 
biosecurity level and confirm that NAI is not present in the 
compartment and the Service has reevaluated the management and 
biosecurity measures of the compartment and approved said compartment 
for trade.
    (b) [Reserved]


Sec.  145.92  [Amended]

0
29. In Sec.  145.92, paragraph (b) is amended by removing the words 
``(see Sec.  147.25 of this chapter)'' and adding the words ``in 
accordance with part 147 of this subchapter'' after the word 
``sanitized''.

0
30. Section 145.93 is amended as follows:
0
a. By revising paragraph (c)(3).
0
b. By adding paragraph (d).
    The revision and addition read as follows:


Sec.  145.93  Terminology and classification; flocks and products.

* * * * *
    (c) * * *
    (3) A sample of at least 30 birds must be tested and found negative 
to H5/H7 avian influenza within 21 days prior to movement to slaughter.
    (d) U.S. Salmonella Monitored. This program is intended to be the 
basis from which the breeding-hatching industry may conduct a program 
for the prevention and control of salmonellosis. It is intended to 
reduce the incidence of Salmonella organisms in hatching eggs and day-
old waterfowl through an effective and practical sanitation program at 
the breeder farm and in the hatchery. This will afford other segments 
of the poultry industry an

[[Page 38765]]

opportunity to reduce the incidence of Salmonella in their products.
    (1) A flock and the hatching eggs and day-old waterfowl produced 
from it must meet the following requirements, as determined by the 
Official State Agency, to be eligible for this classification:
    (i) The flock is maintained in compliance with isolation, 
sanitation, and management procedures for Salmonella in accordance with 
part 147 of this subchapter.
    (ii) If feed contains animal protein, the protein products must 
have been heated throughout to a minimum temperature of 
190[emsp14][deg]F or above, or to a minimum temperature of 
165[emsp14][deg]F for at least 20 minutes, or to a minimum temperature 
of 184[emsp14][deg]F under 70 lbs. pressure during the manufacturing 
process.
    (iii) Feed shall be stored and transported in a manner that 
prevents contamination.
    (iv) Waterfowl shall be hatched in a hatchery whose sanitation is 
maintained in accordance with part 147 of this subchapter and sanitized 
or fumigated in accordance with part 147 of this subchapter.
    (v) An Authorized Agent shall take environmental samples from the 
hatchery every 30 days, i.e., meconium or box liner paper. An 
authorized laboratory for Salmonella shall examine the samples 
bacteriologically.
    (vi) An Authorized Agent shall take environmental samples in 
accordance with part 147 of this subchapter from each flock at 4 months 
of age and every 30 days thereafter. An authorized laboratory for 
Salmonella shall examine the environmental samples bacteriologically.
    (vii) Flocks may be vaccinated with a paratyphoid vaccine: 
Provided, that a sample of at least 100 birds will be segregated and 
shall remain unvaccinated until the flock reaches at least 4 months of 
age.
    (2) The Official State Agency may monitor the effectiveness of the 
egg sanitation practices in accordance with part 147 of this 
subchapter.
    (3) To claim products are of this classification, all products 
shall be derived from a hatchery and flock that meet the requirements 
of the classification.
    (4) This classification may be revoked by the Official State Agency 
if the participant fails to follow recommended corrective measures.

PART 146--NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY

0
31. 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
32. Section 146.1 is amended as follows:
0
a. By revising the definition of authorized laboratory.
0
b. In the definition of commercial meat-type flock, by adding the words 
``spent fowl,'' after the word ``chickens,''.
0
c. In the definition of H5/H7 low pathogenic avian influenza (LPAI), by 
adding the words ``or equal to'' before the number ``1.2'' and by 
adding the word ``causes'' before the words ``less than 75''.
0
d. In paragraph (1)(iii) of the definition of H5/H7 LPAI virus 
infection (infected), by adding the words ``the Cooperating State 
Agency, the Official State Agency, and'' before the word ``APHIS''.
    The revision reads as follows:


Sec.  146.1  Definitions.

* * * * *
    Authorized laboratory. An authorized laboratory is a laboratory 
that meets the requirements of Sec.  147.52 and is thus qualified to 
perform the assays in accordance with part 147 of this subchapter.
* * * * *


Sec.  146.2  [Amended]

0
33. In Sec.  146.2, paragraph (e) is amended by removing the words 
``follow the laboratory protocols outlined in part 147 of this 
chapter'' and adding the words ``conduct tests in accordance with part 
147 of this subchapter'' in their place.


Sec.  146.3  [Amended]

0
34. Section 146.3 is amended as follows:
0
a. In paragraph (c), by adding the words ``, spent fowl,'' after the 
word ``chicken''.
0
b. By removing paragraph (e).


Sec.  146.5  [Amended]

0
35. In Sec.  146.5, paragraph (b) is amended by removing the words ``as 
recommended in Sec.  147.21(c)'' and adding the words ``in accordance 
with part 147'' in their place.
0
36. Section 146.13 is amended as follows:
0
a. In paragraph (a)(1), by removing the words ``the requirements in 
Sec.  147.8'' and adding the words ``part 147'' in their place.
0
b. By revising paragraph (b)(1)(ii)(C).
0
c. In paragraph (b)(2)(i), by removing the word ``(AVPR01510)''.
0
d. By revising paragraph (b)(2)(ii)(B).
    The revisions read as follows:


Sec.  146.13  Testing.

* * * * *
    (b) * * *
    (1) * * *
    (ii) * * *
    (C) The AGID test for avian influenza must be conducted in 
accordance with part 147 of this subchapter. The test can be conducted 
on egg yolk or blood samples. The AGID test is not recommended for use 
in waterfowl.
* * * * *
    (2) * * *
    (ii) * * *
    (B) Chicken and turkey flocks that test positive on the ACIA must 
be retested using the RRT-PCR or virus isolation. Positive results from 
the RRT-PCR or virus isolation 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.
* * * * *

0
37. Section 146.23 is amended by revising the heading of paragraph (a), 
removing the introductory text of paragraph (a), and revising the 
introductory text of paragraphs (a)(1), and (a)(2) to read as follows:


Sec.  146.23  Terminology and classification; flocks and products.

* * * * *
    (a) U.S. H5/H7 Avian Influenza Monitored--(1) Table-egg layer 
pullet flocks. This program is intended to be the basis from which the 
table-egg layer 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 table-egg layer pullets 
through routine surveillance of each participating commercial table-egg 
layer pullet flock. A flock will qualify for this classification when 
the Official State Agency determines that it has met one of the 
following requirements:
* * * * *
    (2) Table-egg layer flocks. This program is intended to be the 
basis from which the table-egg layer 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 
table-egg layer through routine surveillance of each participating 
commercial table-egg layer flock. A flock will qualify for this 
classification

[[Page 38766]]

when the Official State Agency determines that it has met one of the 
following requirements:
* * * * *

0
38. Section 146.31 is amended by adding, in alphabetical order, a 
definition of spent fowl to read as follows:


Sec.  146.31  Definitions.

* * * * *
    Spent fowl. Domesticated poultry that were in production of 
hatching eggs or commercial table eggs and have been removed from such 
production.
0
39. Section 146.32 is amended by adding a new paragraph (c) to read as 
follows:


Sec.  146.32  Participation.

* * * * *
    (c) If spent fowl are slaughtered at meat-type chicken slaughter 
plants that participate in the Plan, they may participate in the Plan 
through the provisions of this subpart C.


Sec.  146.33  [Amended]

0
40. In Sec.  146.33, paragraph (a)(1) is amended by removing the words 
``antibodies to''.
0
41. In Sec.  146.43, paragraph (a)(1) 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 samples per flock 
have been collected no more than 21 days prior to movement to slaughter 
and tested negative with an approved test for type A avian influenza, 
as provided in Sec.  146.13(b). It is recommended that samples be 
collected from flocks over 10 weeks of age with respiratory signs such 
as coughing, sneezing, snicking, sinusitis, or rales; depression; or 
decreases in food or water intake.
* * * * *

PART 147--AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN

0
42. The authority citation for part 147 continues to read as follows:

    Authority:  7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

0
43. Section 147.1 is revised to read as follows:


Sec.  147.1  Blood testing procedures.

    Blood testing must be conducted in a manner approved by the 
Administrator. Approved blood testing procedures are listed in the NPIP 
Program Standards, as defined in Sec.  147.51. Blood testing procedures 
may also be approved by the Administrator in accordance with Sec.  
147.53(d)(1).

    (Approved by the Office of Management and Budget under control 
number 0579-0007)


Sec. Sec.  147.2 through 147.9  [Removed and Reserved]

0
44. Sections 147.2 through 147.9 are removed and reserved.
0
45. Section 147.10 is revised to read as follows:


Sec.  147.10  Bacteriological examination procedures.

    Bacteriological examination must be conducted in a manner approved 
by the Administrator. Approved bacteriological examination procedures 
are listed in the NPIP Program Standards, as defined in Sec.  147.51. 
Bacteriological examination procedures may also be approved by the 
Administrator in accordance with Sec.  147.53(d)(1).


Sec. Sec.  147.11 through 147.17  [Removed and Reserved]

0
46. Sections 147.11 through 147.17 are removed and reserved.

0
47. Section 147.21 is revised to read as follows:


Sec.  147.21  Sanitation procedures.

    Sanitation must be maintained in a manner approved by the 
Administrator. Approved procedures for maintaining sanitation are 
listed in the NPIP Program Standards, as defined in


Sec.  147.51  Sanitation procedures may also be approved by the 
Administrator in accordance with Sec.  147.53(d)(2)

    (Approved by the Office of Management and Budget under control 
number 0579-0007)


Sec. Sec.  147.22 through 147.27  [Removed and Reserved]

0
48. Sections 147.22 through 147.27 are removed and reserved.

0
49. Section 147.30 is revised to read as follows:


Sec.  147.30  Molecular examination procedures.

    Molecular examination must be conducted in a manner approved by the 
Administrator. Approved molecular examination procedures are listed in 
the NPIP Program Standards, as defined in Sec.  147.51. Molecular 
examination procedures may also be approved by the Administrator in 
accordance with Sec.  147.53(d)(1).


Sec.  147.31  [Removed and Reserved]

0
50. Section 147.31 is removed and reserved.

0
51. In Sec.  147.41, a new definition of NPIP Technical Committee is 
added, in alphabetical order, to read as follows:


Sec.  147.41  Definitions.

* * * * *
    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.
* * * * *


Sec.  147.44  [Amended]

0
52. In Sec.  147.44, paragraph (b) is amended by removing the citation 
``Sec.  147.43(d)(2)'' and adding the citation ``Sec.  147.43(d)(4)'' 
in its place.

0
53. In part 147, subpart F is revised to read as follows:
Subpart F--Authorized Laboratories and Approved Tests and Sanitation 
Procedures
Sec.
147.51 Definitions.
147.52 Authorized laboratories.
147.53 Approved tests and sanitation procedures.
147.54 Approval of diagnostic test kits not licensed by the Service.

Subpart F--Authorized Laboratories and Approved Tests and 
Sanitation Procedures


Sec.  147.51  Definitions.

    The following definitions apply in this subpart:
    Administrator. The Administrator, Animal and Plant Health 
Inspection Service, or any other employee of the Animal and Plant 
Health Inspection Service delegated to act in the Administrator's 
stead.
    Animal and Plant Health Inspection Service (APHIS, the Service). 
The Animal and Plant Health Inspection Service of the U.S. Department 
of Agriculture.
    NPIP or Plan. The National Poultry Improvement Plan.
    NPIP Program Standards. A document that contains tests and 
sanitation procedures approved by the Administrator under Sec.  147.53 
for use under this subchapter. This document may be obtained from the 
NPIP Web site at http://www.poultryimprovement.org/ or by writing to 
the Service at National Poultry Improvement Plan, APHIS, USDA, 1506 
Klondike Road, Suite 101, Conyers, GA 30094.

[[Page 38767]]

    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.


Sec.  147.52  Authorized laboratories.

    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 in accordance with the NPIP Program 
Standards or other procedures approved by the Administrator in 
accordance with Sec.  147.53(d)(1) and reported as described in 
paragraph (f) of this section. 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 NPIP will serve as the lead agency 
for the coordination of available check tests from the National 
Veterinary Services Laboratories. The authorized laboratory must use a 
regularly scheduled check test for each assay that it performs.
    (b) Trained technicians. The testing procedures at the laboratory 
must be run or overseen by a laboratory technician who has attended and 
satisfactorily completed Service-approved laboratory workshops for 
Plan-specific diseases within the past 4 years.
    (c) Laboratory protocol. Official Plan assays must be performed and 
reported as described in the NPIP Program Standards or in accordance 
with other procedures approved by the Administrator in accordance with 
Sec.  147.53(d)(1). Assays must be performed using control reagents 
approved by the Plan or the reagent manufacturer.
    (d) State site visit. The Official State Agency will conduct a site 
visit and recordkeeping audit annually. This will include, but may not 
be limited to, review of technician training records, check test 
proficiency, and test results. The information from the site visit and 
recordkeeping audit will be made available to the NPIP upon request.
    (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.  147.53  Approved tests and sanitation procedures.

    (a)(1) All tests that are used to qualify flocks for NPIP 
classifications must be approved by the Administrator as effective and 
accurate at determining whether a disease is present in a poultry flock 
or in the environment.
    (2) All sanitation procedures performed as part of qualifying for 
an NPIP classification must be approved by the Administrator as 
effective at reducing the risk of incidence of disease in a poultry 
flock or hatchery.
    (b) Tests and sanitation procedures that have been approved by the 
Administrator may be found in the NPIP Program Standards. 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 the NPIP Program Standards are 
approved for use in the NPIP.
    (c) New tests and sanitation procedures, or changes to existing 
tests and sanitation procedures, that have been approved by the NPIP in 
accordance with the process described in subpart E of this part are 
subject to approval by the Administrator. NPIP participants may submit 
new tests and sanitation procedures, or changes to current tests and 
sanitation procedures, through that process.
    (d)(1) Persons who wish to have a test approved by the 
Administrator as effective and accurate at determining whether a 
disease is present in a flock or in the environment may apply for 
approval by submitting the test, along with any supporting information 
and data, to the National Poultry Improvement Plan, APHIS, USDA, 1506 
Klondike Road, Suite 101, Conyers, GA 30094. Upon receipt of such an 
application, the NPIP Technical Committee will review the test and any 
supporting information and data supplied with the application. If the 
NPIP Technical Committee determines the test to be of potential general 
use, the test will be submitted for consideration by the General 
Conference Committee of the NPIP in accordance with subpart E of this 
part, and the Administrator will respond with approval or denial of the 
test.
    (2) Persons who wish to have a sanitation procedure approved by the 
Administrator as effective at reducing the risk of incidence of disease 
in a poultry flock or hatchery may apply for approval by submitting the 
sanitation procedure, along with any supporting information and data, 
to the National Poultry Improvement Plan, APHIS, USDA, 1506 Klondike 
Road, Suite 101, Conyers, GA 30094. Upon receipt of such an 
application, the NPIP Technical Committee will review the sanitation 
procedure and any supporting information and data supplied with the 
application. If the NPIP Technical Committee determines the sanitation 
procedure to be of potential general use, the sanitation procedure will 
be submitted for consideration by the General Conference Committee of 
the NPIP in accordance with subpart E of this part, and the 
Administrator will respond with approval or denial of the test.
    (e)(1) When the Administrator approves a new test or sanitation 
procedure or a change to an existing test or sanitation procedure, 
APHIS will publish a notice in the Federal Register making available 
the test or sanitation procedure. The notice will also provide for a 
public comment period.
    (2)(i) After the close of the public comment period, APHIS will 
publish a notice in the Federal Register indicating that the test or 
sanitation procedure will be added to the NPIP Program Standards, or 
that the NPIP Program Standards will be updated to reflect changes to 
an existing test or sanitation procedure, if:
    (A) No comments were received on the notice;
    (B) The comments on the notice supported the action described in 
the notice; or
    (C) The comments on the notice were evaluated but did not change 
the Administrator's determination that approval of the test or 
sanitation procedure is appropriate based on the standards in paragraph 
(a) of this section.
    (ii) If comments indicate that changes should be made to the test 
or sanitation procedure as it was made available in the initial notice, 
APHIS will publish a notice in the Federal Register indicating that 
changes were made to the initial test or sanitation procedure.
    (iii) Whenever APHIS adds or makes changes to tests or sanitation

[[Page 38768]]

procedures, APHIS will make available a new version of the NPIP Program 
Standards that reflects the additions or changes.
    (iv) If comments present information that causes the Administrator 
to determine that approval of the test or sanitation procedure would 
not be appropriate, APHIS will publish a notice informing the public of 
this determination after the close of the comment period.


Sec.  147.54  Approval of diagnostic test kits not licensed by the 
Service.

    Diagnostic test kits that are not licensed by the Service (e.g., 
bacteriological culturing kits) may be approved through the following 
procedure:
    (a) 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 the NPIP Program Standards or through other procedures approved by 
the Administrator. 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.
    (b) 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 tests conducted in accordance with 
the NPIP Program Standards or other procedures approved by the 
Administrator in accordance with Sec.  147.53(d)(1). 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.
    (c) 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.
    (d) 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.
    (e) 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.
    (f) Diagnostic test kits that are not licensed by the Service 
(e.g., bacteriological culturing kits) and that have been approved for 
use in the NPIP in accordance with this section are listed in the NPIP 
Program Standards.

    Done in Washington, DC, this 3rd day of July 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-16037 Filed 7-7-14; 4:15 pm]
BILLING CODE 3410-34-P