[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)]
[Rules and Regulations]
[Pages 53247-53252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19245]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 56, 145, 146, and 147

[Docket No. APHIS-2014-0101]
RIN 0579-AE16


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), 
its auxiliary provisions, and the indemnity regulations for the control 
of H5 and H7 low pathogenic avian influenza. Specifically, we are 
clarifying who may participate in the NPIP, amending participation 
requirements, amending definitions for poultry and breeding stock, 
amending the approval process for new diagnostic tests, and amending 
slaughter plant inspection and laboratory inspection and testing 
requirements. These changes will align the regulations with 
international standards and make them more transparent to Animal and 
Plant Health Inspection Service stakeholders and the general public. 
The changes in this final rule were voted on and approved by the voting 
delegates at the Plan's 2014 National Plan Conference.

DATES: Effective September 12, 2016.

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 (also referred to as 
``the Department'') amends these provisions from time to time to 
incorporate new scientific information and technologies within the 
Plan. In addition, the regulations in 9 CFR part 56 set out conditions 
for the payment of indemnity for costs associated with poultry that are 
infected with or exposed to H5/H7 low pathogenic avian influenza and 
provisions for a cooperative control program for the disease.
    On March 24, 2016, we published in the Federal Register (81 FR 
15652-15660, Docket No. APHIS-2014-0101) a proposal \1\ to amend the 
regulations by clarifying who may participate in the NPIP and amending 
participation requirements. In addition, we proposed to amend 
definitions of poultry and breeding stock, amend the approval process 
for new diagnostic tests, and amend slaughter plant inspection and 
laboratory inspection and testing requirements.
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    \1\ To view the proposed rule and the comment we received, go to 
http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0101.
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    We solicited comments concerning our proposal for 60 days ending 
May 23, 2016. We received one comment by that date. It was from an 
individual. The issues raised by the commenter are discussed below.
    In the March 2016 proposed rule, we proposed to amend the 
definition of breeding flock in Sec.  56.1 to remove the word 
``chicks'' and replace it with the word ``progeny.'' The commenter 
objected to this change, suggesting that many people would not know the 
meaning of the latter term and would find it confusing.
    We are not making any changes to the final rule in response to this 
comment. As stated in the March 2016 proposed rule, the term 
``progeny'' is more accurate than ``chicks'' in this context because it 
is more inclusive of both chicken and turkey flocks. Young turkeys are 
known as poults rather than chicks. In addition, as we noted in the 
proposed rule, the change in terminology also makes our definition of 
breeding flock in Sec.  56.1 consistent with our definition of 
multiplier breeding flock in Sec.  145.1.
    The March 2016 proposed rule included a minor change to Sec.  
145.12, which contains requirements for the retention and examination 
of records for all flocks maintained primarily for hatching eggs. We 
proposed to specify, in paragraph (b) of that section, that records for 
all breeder flock hatcheries must be made available for annual 
examination by a State inspector. Historically, testing records were 
retained at the hatchery, which allowed for examination of the records 
during annual inspections, but that is no longer the case. Many 
commercial hatcheries now keep testing records at the corporate office 
or another site. Our proposed amendment to Sec.  145.12 was intended to 
reflect this change in recordkeeping practices in the industry and also 
to allow flexibility in the regulations regarding who may make the 
records available to the State inspector.
    The commenter objected to this proposed change, stating that the

[[Page 53248]]

records should be kept at the hatchery with the flocks so that 
taxpayers do not have to incur additional costs due to the need for 
inspectors to travel to different locations.
    We do not agree with this comment. As noted above, we are amending 
the regulations to reflect current practices in the industry. By 
allowing hatcheries the discretion to maintain records where they would 
most readily be accessible when needed, we are relieving a regulatory 
burden. The commenter provides no evidence to support the claim that 
having the records kept at sites other than the hatcheries will result 
in additional costs to taxpayers.
    The commenter also stated that the proposed rule would have the 
effect of loosening testing standards, thereby increasing the risk of 
the spread of disease.
    We did not propose to loosen existing testing standards, as the 
commenter claims. We proposed instead to make some editorial changes to 
Sec.  145.14(b) to remove references to tests that are no longer being 
used, update terminology that is no longer current, and otherwise 
clarify the testing requirements in that section.
    Finally, the commenter objected to our proposed changes to the 
slaughter plant inspection requirements in Sec.  146.11.
    We will not be making any changes to the final rule in response to 
this comment. The commenter did not offer a rationale for opposing the 
proposed amendments to Sec.  146.11, which were intended to clarify our 
slaughter plant inspection requirements and remove language that 
conflicted with requirements set out elsewhere in part 146.

Miscellaneous

    In this final rule, we are making one minor editorial change to 
correct an error in the regulatory text of the proposed rule.
    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 
intended to amend paragraph (b) to state that ``a flock will be 
considered to be conforming to protocol if it meets the requirements as 
described in Sec. Sec.  146.33(a), 146.43(a), 146.53(a).'' However, we 
inadvertently referred to Sec.  145.33(a) instead of Sec.  146.33(a). 
In this final rule, we are correcting that error.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
change discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been 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.
    We are amending the NPIP, its auxiliary provisions, and the 
indemnity regulations for the control of H5 and H7 low pathogenic avian 
influenza to align the regulations with international standards and 
make them more transparent to stakeholders and the general public. The 
changes in this final rule were voted on and approved by the voting 
delegates at the 2014 NPIP National Plan Conference.
    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 to or modification of requirements 
could potentially result in a cost to certain entities, we do not 
expect the costs to be significant. NPIP membership is voluntary. The 
changes contained in this final rule were decided upon by the NPIP 
General Conference Committee on behalf of Plan members; that is, the 
changes were recognized by the poultry industry as being in their 
interest.
    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 2 CFR chapter IV.)

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

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this final rule, which were 
filed under 0579-0445, have been submitted for approval to the Office 
of Management and Budget (OMB). When OMB notifies us of its decision, 
if approval is denied, we will publish a document in the Federal 
Register providing notice of what action we plan to take.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this rule, please contact Ms. Kimberly Hardy, 
APHIS' Information Collection Coordinator, at (301) 851-2727.

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:

[[Page 53249]]

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 by revising the definition of breeding flock 
to read as follows:


Sec.  56.1  Definitions.

* * * * *
    Breeding flock. A flock that is composed of stock that has been 
developed for commercial egg or meat production and is maintained for 
the principal purpose of producing progeny for the ultimate production 
of eggs or meat for human consumption.
* * * * *

PART 145--NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY

0
3. 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.


Sec.  145.2  [Amended]

0
4. In Sec.  145.2, paragraph (d) is amended by removing the reference 
``Sec.  145.3(d)'' and adding the reference ``Sec.  145.3(e)'' in its 
place.

0
5. Section 145.3 is amended as follows:
0
a. By redesignating paragraphs (a) through (f) as paragraphs (b) 
through (g), respectively.
0
b. By adding a new paragraph (a).
    The addition reads as follows:


Sec.  145.3  Participation.

    (a) The National Poultry Improvement Plan is a cooperative Federal-
State-Industry program through which new or existing diagnostic 
technology can be effectively applied to improve poultry and poultry 
products by controlling or eliminating specific poultry diseases. The 
Plan consists of programs that identify States, flocks, hatcheries, 
dealers, and slaughter plants that meet specific disease control 
standards specified in the Plan. Participants shall maintain records to 
demonstrate that they adhere to the disease control programs in which 
they participate.
* * * * *


Sec.  145.12  [Amended]

0
6. Section 145.12 is amended by adding, in paragraph (b), the words 
``made available to and'' before the word ``examined''.

0
7. Section 145.14 is amended as follows:
0
a. By revising paragraph (a)(5).
0
b. By revising paragraph (b)(1).
    The revisions read as follows:


Sec.  145.14  Testing.

* * * * *
    (a) * * *
    (5) The official blood test shall include the testing of a sample 
of blood from each bird in the flock: Provided, That under specified 
conditions (see applicable provisions of Sec. Sec.  145.23, 145.33, 
145.43, 145.53, 145.63, 145.73, 145.83, and 145.93) the testing of a 
portion or sample of the birds may be used in lieu of testing each 
bird.
* * * * *
    (b) * * *
    (1) The official tests for M. gallisepticum, M. meleagridis, and M. 
synoviae shall be the serum plate agglutination test, the 
hemagglutination inhibition (HI) test, the enzyme-linked immunosorbent 
assay (ELISA) test,\3\ or a molecular based test. The HI test or 
molecular based test shall be used to confirm the positive results of 
other serological screening tests. HI titers of 1:40 or more may be 
interpreted as suspicious, and final judgment must be based on further 
samplings and/or culture of reactors. Tests must be conducted in 
accordance with this paragraph (b) and in accordance with part 147 of 
this subchapter.
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    \3\ Procedures for the enzyme-linked immunosorbent assay (ELISA) 
test are set forth in the following publications:
    A.A. Ansari, R.F. Taylor, T.S. Chang, ``Application of Enzyme-
Linked Immunosorbent Assay for Detecting Antibody to Mycoplasma 
gallisepticum Infections in Poultry,'' Avian Diseases, Vol. 27, No. 
1, pp. 21-35, January-March 1983; and
    H.M. Opitz, J.B. Duplessis, and M.J. Cyr, ``Indirect Micro-
Enzyme-Linked Immunosorbent Assay for the Detection of Antibodies to 
Mycoplasma synoviae and M. gallisepticum,'' Avian Diseases, Vol. 27, 
No. 3, pp. 773-786, July-September 1983; and
    H.B. Ortmayer and R. Yamamoto, ``Mycoplasma Meleagridis Antibody 
Detection by Enzyme-Linked Immunosorbent Assay (ELISA),'' 
Proceedings, 30th Western Poultry Disease Conference, pp. 63-66, 
March 1981.
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* * * * *

0
8. In Sec.  145.42, paragraph (b) is revised to read as follows:


Sec.  145.42  Participation.

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

0
9. Section 145.53 is amended as follows:
0
a. By revising paragraphs (c)(1)(i), (c)(1)(ii) introductory text, and 
(c)(1)(ii)(A).
0
b. By revising paragraphs (d)(1)(i), (d)(1)(ii) introductory text, and 
(d)(1)(ii)(A).
    The revisions read as follows:


Sec.  145.53  Terminology and classification; flocks and products.

* * * * *
    (c) * * *
    (1) * * *
    (i) It is a flock in which all birds or a sample of at least 300 
birds has been tested for M. gallisepticum as provided in Sec.  
145.14(b) when more than 4 months of age or upon reaching sexual 
maturity: Provided, That to retain this classification, a random sample 
of serum or egg yolk or a targeted bird sample of the choanal palatine 
cleft/fissure area using appropriate swabs from all the birds in the 
flock if the flock size is less than 30, but at least 30 birds, shall 
be tested at intervals of not more than 90 days: And provided further, 
That a sample comprised of less than 30 birds may be tested at any one 
time, with the approval of the Official State Agency and the 
concurrence of the Service, provided that a total of at least 30 birds, 
or all birds in the flock if flock size is less than 30, is tested 
within each 90-day period; or
    (ii) It is a multiplier breeding flock which originated as U.S. M. 
Gallisepticum Clean baby poultry from primary breeding flocks and a 
random sample comprised of 50 percent of the birds in the flock, with a 
maximum of 200 birds and a minimum of 30 birds per flock or all birds 
in the flock if the flock size is less than 30 birds, has been tested 
for M. gallisepticum as provided in Sec.  145.14(b) when more than 4 
months of age or upon reaching sexual maturity: Provided, That to 
retain this classification, the flock shall be subjected to one of the 
following procedures:
    (A) At intervals of not more than 90 days, a random sample of serum 
or egg yolk or a targeted bird sample of the choanal palatine cleft/
fissure area using appropriate swabs from all the birds in the flock if 
flock size is less than 30, but at least 30 birds, shall be tested; or
* * * * *
    (d) * * *
    (1) * * *
    (i) It is a flock in which all birds or a sample of at least 300 
birds has been tested for M. synoviae as provided in Sec.  145.14(b) 
when more than 4 months of age or upon reaching sexual maturity: 
Provided, That to retain this classification, a random sample of serum 
or egg yolk or a targeted bird sample of the choanal palatine cleft/
fissure area using appropriate swabs (C.P. swabs) from all the birds in 
the

[[Page 53250]]

flock if flock size is less than 30, but at least 30 birds, shall be 
tested at intervals of not more than 90 days: And provided further, 
That a sample comprised of less than 30 birds may be tested at any one 
time with the approval of the Official State Agency and the concurrence 
of the Service, provided that a total of at least 30 birds is tested 
within each 90-day period; or
    (ii) It is a multiplier breeding flock that originated as U.S. M. 
Synoviae Clean chicks from primary breeding flocks and from which a 
random sample comprised of 50 percent of the birds in the flock, with a 
maximum of 200 birds and a minimum of 30 birds per flock or all birds 
in the flock if the flock is less than 30 birds, has been tested for M. 
synoviae as provided in Sec.  145.14(b) when more than 4 months of age 
or upon reaching sexual maturity: Provided, That to retain this 
classification, the flock shall be subjected to one of the following 
procedures:
    (A) At intervals of not more than 90 days, a random sample of serum 
or egg yolk or a targeted bird sample of the choanal palantine cleft/
fissure area using appropriate swabs from all the birds in the flock if 
the flock size is less than 30, but at least 30 birds shall be tested: 
Provided, That a sample of fewer than 30 birds may be tested at any one 
time with the approval of the Official State Agency and the concurrence 
of the Service, provided that a total of at least 30 birds, or the 
entire flock if flock size is less than 30, is tested each time and a 
total of at least 30 birds is tested within each 90-day period; or
* * * * *

0
10. Section 145.83 is amended as follows:
0
a. By revising paragraph (f)(1)(i).
0
b. By removing paragraphs (f)(1)(ii) and (f)(1)(iii).
0
c. By redesignating paragraphs (f)(1)(iv) through (f)(1)(viii) as 
paragraphs (f)(1)(ii) through (f)(1)(vi).
0
d. In newly redesignated paragraphs (f)(1)(v) and (f)(1)(vi) by 
removing the words ``(f)(1)(vi)'' and adding the words ``(f)(1)(iv)'' 
in their place.
0
e. By revising paragraph (f)(3).
    The revisions read as follows:


Sec.  145.83  Terminology and classification; flocks and products.

* * * * *
    (f) * * *
    (1) * * *
    (i) Measures shall be implemented to control Salmonella challenge 
through feed, feed storage, and feed transport.
* * * * *
    (3) In order for a hatchery to sell products of paragraphs 
(f)(1)(i) through (f)(1)(vi) of this section, all products handled 
shall meet the requirements of the classification.
* * * * *

0
11. In Sec.  145.92, paragraph (b) is revised to read as follows:


Sec.  145.92  Participation.

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


Sec.  145.93  [Amended]

0
12. In Sec.  145.93, paragraph (c)(3) is amended by removing the number 
``30'' and adding the number ``11'' in its place.

PART 146--NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY

0
13. 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
14. Section 146.1 is amended by revising the definition of poultry to 
read as follows:


Sec.  146.1  Definitions.

* * * * *
    Poultry. Domesticated fowl, including chickens, turkeys, waterfowl, 
and game birds, except doves and pigeons, that are bred for the primary 
purpose of producing eggs or meat.
* * * * *

0
15. Section 146.2 is amended by revising paragraph (c) to read as 
follows:


Sec.  146.2  Administration.

* * * * *
    (c)(1) An Official State Agency may accept for participation a 
commercial table-egg layer pullet flock, commercial table-egg layer 
flock, or a commercial meat-type flock (including an affiliated flock) 
located in another participating State under a mutual understanding and 
agreement, in writing, between the two Official State Agencies 
regarding conditions of participation and supervision.
    (2) An Official State Agency may accept for participation a 
commercial table-egg layer pullet flock, commercial table-egg layer 
flock, or a commercial meat-type flock (including an affiliated flock) 
located in a State that does not participate in the Plan under a mutual 
understanding and agreement, in writing, between the owner of the flock 
and the Official State Agency regarding conditions of participation and 
supervision.
* * * * *


Sec.  146.3  [Amended]

0
16. In Sec.  146.3, paragraph (a) is amended by adding the words 
``commercial table-egg layer pullet flock,'' before the words ``table-
egg producer''.

0
17. In Sec.  146.11, paragraph (b) is revised to read as follows:


Sec.  146.11  Inspections.

* * * * *
    (b) A flock will be considered to be conforming to protocol if it 
meets the requirements as described in Sec.  146.33(a), Sec.  
146.43(a), or Sec.  146.53(a).
* * * * *


Sec.  146.51  [Amended]

0
18. Section 146.51 is amended as follows:
0
a. In the definition of commercial upland game birds by removing the 
word ``purpose'' and adding in its place ``purposes'' and adding the 
words ``eggs and/or'' before the word ``meat''.
0
b. In the definition of commercial waterfowl, by removing the word 
``purpose'' and adding in its place ``purposes'' and adding the words 
``eggs and/or'' before the word ``meat''.

0
19. Section 146.52 is amended by revising paragraphs (a) and (c) to 
read as follows:


Sec.  146.52  Participation.

    (a) Participating commercial upland game bird slaughter plants, 
commercial waterfowl slaughter plants, raised-for-release upland game 
bird premises, raised-for-release waterfowl premises, and commercial 
upland game bird and commercial waterfowl producing eggs for human 
consumption premises shall comply with the applicable general 
provisions of subpart A of this part and the special provisions of this 
subpart E.
* * * * *
    (c) Raised-for-release upland game bird premises, raised-for-
release waterfowl premises, and commercial upland game bird and 
commercial waterfowl producing eggs for human consumption premises that 
raise fewer than 25,000 birds annually are exempt from the special 
provisions of this subpart E.

0
20. Section 146.53 is amended as follows:
0
a. In paragraph (a) introductory text, by adding the words ``or, in the 
case of egg-producing flocks, the regular surveillance of these 
flocks'' after the words ``participating slaughter plant''.

[[Page 53251]]

0
b. By adding paragraphs (a)(4) and (a)(5).
    The additions read as follows:


Sec.  146.53  Terminology and classification; slaughter plants and 
premises.

* * * * *
    (a) * * *
    (4) It is a commercial upland game bird or waterfowl flock that 
produces eggs for human consumption where a minimum of 11 birds per 
flock have been tested negative to the H5/H7 subtypes of avian 
influenza as provided in Sec.  146.13(b) within 30 days of disposal or 
within a 12 month period.
    (5) It is a commercial upland game bird or waterfowl flock that has 
an on-going active and passive surveillance program for H5/H7 subtypes 
of avian influenza that is approved by the Official State Agency and 
the Service.
* * * * *

PART 147--AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN

0
21. 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
22. In Sec.  147.52, paragraph (d) is revised to read as follows:


Sec.  147.52  Authorized laboratories.

* * * * *
    (d) State site visit. The Official State Agency will conduct a site 
visit and recordkeeping audit at least once every 2 years. 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.
* * * * *

0
23. Section 147.54 is revised to read as follows:


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

    (a) Diagnostic test kits that are not licensed by the Service 
(e.g., bacteriological culturing kits) may be approved through the 
following procedure:
    (1) The sensitivity of the kit will be evaluated in at least three 
NPIP authorized laboratories 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. 
Field samples for which the presence or absence of the target organism 
or analyte has been determined by the current NPIP test should be used, 
not spiked samples or pure cultures. Samples from a variety of field 
cases representing a range of low, medium, and high analyte 
concentrations should be used. In some cases it may be necessary to 
utilize samples from experimentally infected animals. Spiked samples 
(clinical sample matrix with a known amount of pure culture added) 
should only be used in the event that no other sample types are 
available. Pure cultures should never be used. Additionally, 
laboratories should be selected for their experience with testing for 
the target organism or analyte with the current NPIP approved test. If 
certain conditions or interfering substances are known to affect the 
performance of the kit, appropriate samples will be included so that 
the magnitude and significance of the effect(s) can be evaluated.
    (2) The specificity of the kit will be evaluated in at least three 
NPIP authorized laboratories 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.
    (3) The kit will be provided to the cooperating laboratories in its 
final form and include the instructions for use. The cooperating 
laboratories must perform the assay exactly as stated in the supplied 
instructions. Each laboratory must test a panel of at least 25 known 
positive samples. In addition, each laboratory will be asked to test at 
least 50 known negative samples obtained from several sources, to 
provide a representative sampling of the general population. The 
cooperating laboratories must perform a current NPIP procedure or NPIP 
approved test on the samples alongside the test kit for comparison.
    (4) Cooperating laboratories will submit to the kit manufacturer 
all raw data regarding the assay response. Each sample tested will be 
reported as positive or negative, and the official NPIP procedure used 
to classify the sample must be submitted in addition to the assay 
response value. A completed worksheet for diagnostic test evaluation is 
required to be submitted with the raw data and may be obtained by 
contacting the NPIP Senior Coordinator. Raw data and the completed 
worksheet for diagnostic test evaluation must be submitted to the NPIP 
Senior Coordinator 4 months prior to the next scheduled General 
Conference Committee meeting, which is when approval will be sought.
    (5) The findings of the cooperating laboratories will be evaluated 
by the NPIP Technical Committee, and the Technical Committee will make 
a majority recommendation whether to approve the test kit to the 
General Conference Committee at the next scheduled General Conference 
Committee meeting. If the Technical Committee recommends approval, the 
final approval will be granted in accordance with the procedures 
described in Sec. Sec.  147.46, 147.47, and 147.48.
    (6) 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.
    (b) Approved tests modification and removal. (1) The specific data 
required for modifications of previously approved tests will be taken 
on a case-by-case basis by the technical committee.
    (2) If the Technical Committee determines that only additional 
field data is needed at the time of submission for a modification of a 
previously approved test, allow for a conditional approval for 60 days 
for data collection side-by-side with a current test. The submitting 
party must provide complete protocol and study design, including 
criteria for pass/fail to the Technical Committee. The Technical 
Committee must review the data prior to final approval. This would only 
apply to the specific situation where a modified test needs additional 
field data with poultry to be approved.
    (3) Approved diagnostic tests may be removed from the Plan by 
submission of a proposed change from a participant, Official State 
Agency, the Department, or other interested person or industry 
organization. The data in support of removing an approved test will be 
compiled and evaluated by the NPIP Technical Committee, and the 
Technical Committee will make a majority recommendation whether to 
remove the test kit to the General Conference Committee at the next 
scheduled General Conference Committee meeting. If the Technical 
Committee recommends removal, the final decision to remove the test 
will be granted in accordance with the procedures described in 
Sec. Sec.  147.46, 147.47, and 147.48.


[[Page 53252]]


    Done in Washington, DC, this 9th day of August 2016.
Jere L. Dick,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-19245 Filed 8-11-16; 8:45 am]
BILLING CODE 3410-34-P