[Federal Register Volume 83, Number 118 (Tuesday, June 19, 2018)]
[Rules and Regulations]
[Pages 28351-28356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13128]



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 Rules and Regulations
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
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  Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules 
and Regulations  

[[Page 28351]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 145, 146, and 147

[Docket No. APHIS-2017-0055]
RIN 0579-AE37


National Poultry Improvement Plan and Auxiliary Provisions

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are amending the regulations governing the National Poultry 
Improvement Plan (NPIP) by updating and clarifying several provisions, 
including those concerning NPIP participation, voting requirements, 
testing procedures, and standards. The changes in this final rule were 
voted on and approved by the voting delegates at the Plan's 2016 
National Plan Conference.

DATES: Effective July 19, 2018.

FOR FURTHER INFORMATION CONTACT: Dr. Denise Heard, DVM, Senior 
Coordinator, 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, independent 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 or the Service) amends these 
provisions from time to time to incorporate new scientific information 
and technologies within the Plan.
    On April 9, 2018, we published in the Federal Register (83 FR 
15082-15089, Docket No. APHIS-2017-0055) a proposal \1\ to amend the 
regulations by updating and clarifying several provisions, including 
those concerning NPIP participation, voting requirements, testing 
procedures, and standards.
---------------------------------------------------------------------------

    \1\ To view the proposed rule, supporting document, and the 
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0055.
---------------------------------------------------------------------------

    We solicited comments concerning our proposal for 30 days ending 
May 9, 2018. We received two comments by that date. One individual was 
generally opposed to the rule and the poultry industry, but did not 
address any specific provisions of the proposed rule. The other 
commenter also did not address the provisions of the proposed rule, but 
instead addressed his comments to the statements made by the first 
commenter.
    Therefore, for the reasons given in the proposed rule, we are 
adopting the proposed rule as a final rule, without change.

Executive Orders 12866 and 13771 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. Further, because this rule is 
not significant, it is not a regulatory action under Executive Order 
13771.
    We have prepared an analysis regarding the economic effects of this 
final rule on small entities. The analysis is summarized below. Copies 
of the full analysis are available on the Regulations.gov website (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 2016 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 and voting delegates during the 2016 NPIP 
Biennial Conference; 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.

[[Page 28352]]

Paperwork Reduction Act

    This final rule contains no new information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

List of Subjects in 9 CFR Parts 145, 146, and 147

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

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

PART 145--NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY

0
1. The authority citation for part 145 continues to read as follows:

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

0
2. In Sec.  145.1, the definition of NPIP Technical Committee is 
amended by adding three sentences after the last sentence to read as 
follows:


Sec.  145.1  Definitions.

* * * * *
    NPIP Technical Committee. * * * The NPIP Technical Committee is 
divided into three subcommittees (Mycoplasma, Salmonella, and Avian 
Influenza). NPIP Technical Committee Members may serve on one, two, or 
all three subcommittees. The committee will evaluate proposed changes 
to the Provisions and Program Standards of the Plan which include, but 
are not limited to, tests and sanitation procedures, and provide 
recommendations to the Delegates of the National Plan Conference as to 
whether they are scientifically or technically sound.
* * * * *


Sec.  145.4  [Amended]

0
3. In Sec.  145.4, paragraph (d)(2) is amended by adding the words 
``and any other disease for which the flock into which the birds are 
being introduced holds a disease classification'' after the words 
``pullorum-typhoid''.


Sec.  145.10  [Amended]

0
4. In Sec.  145.10, paragraph (o) is amended by adding the citation 
``Sec.  145.73(g),'' after the citation ``Sec.  145.53(f),''.

0
5. Section 145.14 is amended as follows:
0
a. In the introductory text, in the third sentence, by adding the words 
``unless otherwise specified within the Plan program,'' after the words 
``30 birds per house,'' and in the last sentence, by adding the words 
``, unless otherwise specified within the Plan program'' after the 
words ``must be tested''; and
0
b. By revising paragraph (d)(2)(i)(A).
    The revision reads as follows:


Sec.  145.14  Testing.

* * * * *
    (d) * * *
    (2) * * *
    (i) * * *
    (A) The RRT-PCR tests must be conducted using reagents approved by 
the Department and the Official State Agency. The RRT-PCR must be 
conducted using the National Veterinary Services Laboratories (NVSL) 
official protocol for RRT-PCR or a test kit licensed by the Department 
and approved by the Official State Agency and the State Animal Health 
Official, and must be conducted by personnel who have passed an NVSL 
proficiency test. For non-National Animal Health Laboratory Network 
(NAHLN) authorized laboratories:
    (1) RRT-PCR testing may be used by primary breeder company 
authorized laboratories.
    (2) RRT-PCR testing can only be performed on their own breeding 
flocks and only used for routine surveillance.
    (3) The authorized laboratory must have a quality system that is 
accredited as ISO/IEC 17025 or equivalent to perform the avian 
influenza RRT-PCR assay.
    (4) The use of the RRT-PCR test by the authorized laboratory must 
be approved in the memorandum of understanding (MOU) between the 
authorized laboratory, the Official State Agency, and the State Animal 
Health Official(s) of both the location of the authorized laboratory 
and the location where the breeding flocks reside.
    (5) Split samples for testing must occur between the authorized 
laboratory and a NAHLN laboratory at a frequency designated in the MOU.
* * * * *

0
6. In Sec.  145.23, paragraph (b)(1) is revised to read as follows:


Sec.  145.23  Terminology and classification; flocks and products.

* * * * *
    (b) * * *
    (1) It has been officially blood tested with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. 
pullorum or S. gallinarum.
* * * * *

0
7. In Sec.  145.33, paragraph (b)(1) is revised to read as follows:


Sec.  145.33  Terminology and classification; flocks and products.

* * * * *
    (b) * * *
    (1) It has been officially blood tested with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. 
pullorum or S. gallinarum.
* * * * *

0
8. In Sec.  145.43, paragraphs (b)(1) and (5) are revised to read as 
follows:


Sec.  145.43  Terminology and classification; flocks and products.

* * * * *
    (b) * * *
    (1) It has been officially blood tested with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. 
pullorum or S. gallinarum.
* * * * *
    (5) It is a primary breeding flock located in a State determined to 
be in compliance with the provisions of paragraph (b)(4) of this 
section and in which a sample of 300 birds from flocks of more than 
300, and each bird in flocks of 300 or less, has been officially tested 
for pullorum-typhoid with either no reactors or reactors that, upon 
further bacteriological examination conducted in accordance with part 
147 of this subchapter, fail to isolate S. pullorum or S. gallinarum: 
Provided, That a bacteriological examination monitoring program 
acceptable to the Official State Agency and approved by APHIS may be 
used in lieu of blood testing.
* * * * *

0
9. Section 145.45 is amended as follows:
0
a. By revising paragraph (a) introductory text; and
0
b. By removing the word ``NAI'' and adding the words ``H5/H7 AI'' in 
its place each time it appears in the following paragraphs:
0
i. Paragraph (a)(1) introductory text;
0
ii. Paragraph (a)(1)(i);
0
iii. Paragraph (a)(1)(iii) introductory text;
0
iv. Paragraph (a)(1)(v);
0
v. Paragraph (a)(2)(iii); and
0
vi. Paragraph (a)(4).
    The revision reads as follows:


Sec.  145.45  Terminology and classification; compartments.

    (a) US H5/H7 AI 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

[[Page 28353]]

been approved by the Official State Agency and APHIS to establish a 
compartment consisting of a primary breeding-hatchery company that is 
free of H5/H7 avian influenza (AI). For the purpose of the compartment, 
avian influenza is defined according to the OIE Terrestrial Animal 
Health Code Chapter 10.4. This compartment has the purpose of 
protecting the defined subpopulation and avoiding the introduction and 
spread of H5/H7 AI 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:
* * * * *

0
10. Section 145.52 is amended by redesignating paragraphs (d)(7) and 
(d)(8) as paragraphs (d)(8) and (d)(9), respectively, and by adding a 
new paragraph (d)(7) to read as follows:


Sec.  145.52  Participation.

* * * * *
    (d) * * *
    (7) The NPIP hatchery approval number of the shipping hatchery;
* * * * *

0
11. Section 145.53 is amended as follows:
0
a. By revising paragraphs (b)(1) and (b)(5);
0
b. In paragraph (c)(1)(i), by adding the words ``trachea or'' before 
the word ``choanal'' and by removing the words ``palatine cleft/fissure 
area'' and adding the word ``cleft'' in their place.
0
c. By revising paragraph (c)(1)(ii) introductory text;
0
d. In paragraph (c)(1)(ii)(A), by adding the words ``trachea or'' 
before the word ``choanal'' and by removing the words ``palatine cleft/
fissure area'' and adding the word ``cleft'' in their place;
0
e. In paragraph (d)(1)(i), by adding the words ``trachea or'' before 
the word ``choanal'' and by removing the words ``palatine cleft/fissure 
area'' and adding the word ``cleft'' in their place.
0
f. By revising paragraph (d)(1)(ii) introductory text; and
0
g. In paragraph (d)(1)(ii)(A), by adding the words ``trachea or'' 
before the word ``choanal'' and by removing the words ``palatine cleft/
fissure area'' and adding the word ``cleft'' in their place.
    The revisions read as follows:


Sec.  145.53  Terminology and classification; flocks and products.

* * * * *
    (b) * * *
    (1) It has been officially blood tested within the past 12 months 
with either no reactors or reactors that, upon further bacteriological 
examination conducted in accordance with part 147 of this subchapter, 
fail to isolate S. pullorum or S. gallinarum.
* * * * *
    (5) It is a primary breeding flock located in a State determined to 
be in compliance with the provisions of paragraph (b)(4) of this 
section, and in which a sample of 300 birds from flocks of more than 
300, and each bird in flocks of 300 or less, has been officially tested 
for pullorum-typhoid within the past 12 months with either no reactors 
or reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. 
pullorum or S. gallinarum: Provided, That a bacteriological examination 
monitoring program or serological examination monitoring program for 
game birds acceptable to the Official State Agency and approved by the 
Service may be used in lieu of annual blood testing: And Provided 
further, That when a flock is a hobbyist or exhibition waterfowl or 
exhibition poultry primary breeding flock located in a State which has 
been deemed to be a U.S. Pullorum-Typhoid Clean State for the past 3 
years, and during which time no isolation of pullorum or typhoid has 
been made that can be traced to a source in that State, a 
bacteriological examination monitoring program or a serological 
examination monitoring program acceptable to the Official State Agency 
and approved by the Service may be used in lieu of annual blood 
testing.
    (c) * * *
    (1) * * *
    (ii) It is a multiplier breeding flock which originated as U.S. M. 
Gallisepticum Clean baby poultry from primary breeding flocks and from 
which a random sample of 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. For flocks of more than 400 birds, 200 birds 
shall be tested. For flocks of 60 to 400 birds, 50 percent of the birds 
shall be tested. For flocks of fewer than 60 birds, all birds shall be 
tested up to a maximum of 30 birds: Provided, that to retain this 
classification, the flock shall be subjected to one of the following 
procedures:
* * * * *
    (d) * * *
    (1) * * *
    (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 of 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. For flocks of more than 400 birds, 200 birds shall be tested. 
For flocks of 60 to 400 birds, 50 percent of the birds shall be tested. 
For flocks of fewer than 60 birds, all birds shall be tested up to a 
maximum of 30 birds: Provided, that to retain this classification, the 
flock shall be subjected to one of the following procedures:
* * * * *

0
12. Section 145.63 is amended by revising paragraphs (a)(1) and 
(a)(2)(i) to read as follows:


Sec.  145.63  Terminology and classification; flocks and products.

* * * * *
    (a) * * *
    (1) It has been officially blood tested within the past 12 months 
with either no reactors or reactors that, upon further bacteriological 
examination conducted in accordance with part 147 of this subchapter, 
fail to isolate S. pullorum or S. gallinarum.
    (2) * * *
    (i)(A) It is a multiplier or primary breeding flock of fewer than 
300 birds in which a sample of 10 percent of the birds in a flock or at 
least 1 bird from each pen, whichever is more, has been officially 
tested for pullorum-typhoid within the past 12 months with either no 
reactors or reactors that, upon further bacteriological examination 
conducted in accordance with part 147 of this subchapter, fail to 
isolate S. pullorum or S. gallinarum; or
    (B) It is a multiplier or primary breeding flock of 300 birds or 
more in which a sample of a minimum of 30 birds has been officially 
tested for pullorum-typhoid within the past 12 months with either no 
reactors or reactors that, upon further bacteriological examination 
conducted in accordance with part 147 of this subchapter, fail to 
isolate S. pullorum or S. gallinarum.
* * * * *

0
13. Section 145.73 is amended as follows:
0
a. By revising paragraphs (b)(1) and (b)(2)(ii); and
0
b. By adding paragraph (g).
    The revisions and addition read as follows:


Sec.  145.73  Terminology and classification; flocks and products.

* * * * *
    (b) * * *
    (1) It has been officially blood tested with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance

[[Page 28354]]

with part 147 of this subchapter, fail to isolate S. pullorum or S. 
gallinarum.
    (2) * * *
    (ii) In the primary breeding flock, a sample of 300 birds from 
flocks of more than 300, and each bird in flocks of 300 or less, has 
been officially tested for pullorum-typhoid with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. 
pullorum or S. gallinarum: Provided, That a bacteriological examination 
monitoring program acceptable to the Official State Agency and approved 
by APHIS may be used in lieu of blood testing.
* * * * *
    (g) U.S. Salmonella Monitored. This program is intended to be the 
basis from which the primary egg-type breeder 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 
chicks 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 opportunity to reduce the incidence of 
Salmonella in their products.
    (1) A flock and the hatching eggs and chicks produced from it that 
have met the following requirements, as determined by the Official 
State Agency:
    (i) The flock is maintained in accordance with part 147 of this 
subchapter with respect to flock sanitation, cleaning and disinfection, 
and Salmonella isolation, sanitation, and management.
    (ii) Measures shall be implemented to control Salmonella challenge 
through feed, feed storage, and feed transport.
    (iii) 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.
    (iv) An Authorized Agent shall take environmental samples from the 
hatchery every 30 days; i.e., meconium or chick papers. An authorized 
laboratory for Salmonella shall examine the samples bacteriologically.
    (v) 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. 
All Salmonella isolates from a flock shall be serogrouped and shall be 
reported to the Official State Agency on a monthly basis.
    (vi) Owners of flocks may vaccinate with a paratyphoid vaccine: 
Provided, That a sample of 350 birds, which will be banded for 
identification, shall remain unvaccinated until the flock reaches at 
least 4 months of age to allow for the serological testing required 
under paragraph (g)(1)(iv) of this section.
    (vii) Any flock entering the production period that is in 
compliance with all the requirements of this paragraph (g) with no 
history of Salmonella isolations shall be considered ``Salmonella 
negative'' and may retain this definition as long as no environmental 
or bird Salmonella isolations are identified and confirmed from the 
flock or flock environment by sampling on four separate collection 
dates over a minimum of a 2-week period. Sampling and testing must be 
performed as described in paragraph (g)(1)(vi) of this section. An 
unconfirmed environmental Salmonella isolation shall not change this 
Salmonella negative status.
    (2) The Official State Agency may monitor the effectiveness of the 
sanitation practices in accordance with part 147 of this subchapter.
    (3) In order for a hatchery to sell products of paragraphs 
(g)(1)(i) through (vii) of this section, all products handled shall 
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.


Sec.  145.74  [Amended]

0
14. Section 145.74 is amended as follows:
0
a. In paragraph (a) introductory text, in the first sentence, by 
removing the words ``, also referred to as notifiable avian influenza 
(NAI)'' and, in the second sentence, by removing the word ``NAI'' and 
adding the words ``H5/H7 AI'' in its place.
0
b. By removing the word ``NAI'' and adding the words ``H5/H7 AI'' in 
its place each time it appears in the following paragraphs:
    i. Paragraph (a)(1) introductory text;
    ii. Paragraph (a)(1)(iii) introductory text;
    iii. Paragraph (a)(1)(v);
    iv. Paragraph (a)(2)(iii); and
    v. Paragraph (a)(4).
0
c. By removing the word ``NAI-related'' and adding the words ``H5/H7 
AI-related'' in its place in paragraph (a)(1)(i).

0
15. Section 145.82 is amended by adding paragraph (d) to read as 
follows:


Sec.  145.82  Participation.

* * * * *
    (d) Poultry must be protected from vectors known to be in the wild 
and thus must be housed in enclosed structures during brooding, 
rearing, grow-out, or laying periods with no intentional access to the 
outdoors, creatures found in the wild, or raised on open range or 
pasture, or be provided with untreated open source water such as that 
directly from a pond, stream, or spring that wild birds or vermin have 
access to for usage for drinking water, as a cooling agent, or during a 
wash down/clean out process.

0
16. Section 145.83 is amended by revising paragraphs (b)(1) and 
(b)(2)(ii) to read as follows:


Sec.  145.83  Terminology and classification; flocks and products.

* * * * *
    (b) * * *
    (1) It has been officially blood tested with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. 
pullorum or S. gallinarum.
    (2) * * *
    (ii) In the primary breeding flock, a sample of 300 birds from 
flocks of more than 300, and each bird in flocks of 300 or less, has 
been officially tested for pullorum-typhoid with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. 
pullorum or S. gallinarum: Provided, That a bacteriological examination 
monitoring program acceptable to the Official State Agency and approved 
by APHIS may be used in lieu of blood testing.
* * * * *


Sec.  145.84   [Amended]

0
17. Section 145.84 is amended as follows:
0
a. In the introductory text of paragraph (a), in the first sentence, by 
removing the words ``, also referred to as notifiable avian influenza 
(NAI)'' and, in the second sentence, by removing the word ``NAI'' and 
adding the words ``H5/H7 AI'' in its place; and
0
b. By removing the word ``NAI'' and adding the words ``H5/H7 AI'' in 
its place each time it appears in the following paragraphs:
    i. Paragraph (a)(1) introductory text;
    ii. Paragraph (a)(1)(iii) introductory text;
    iii. Paragraph (a)(1)(v);
    iv. Paragraph (a)(2)(iii); and
    v. Paragraph (a)(4).
0
c. By removing the word ``NAI-related'' and adding the words ``H5/H7

[[Page 28355]]

AI-related'' in its place in paragraph (a)(1)(i).

0
18. Section 145.93 is amended as follows:
0
a. By revising paragraph (b)(1);
0
b. In paragraph (b)(3)(viii), by removing the words ``paragraphs 
(a)(3)(i),'' and adding the words ``paragraphs (b)(3)(i),'' in their 
place;
0
c. In paragraph (b)(4), by removing the words ``paragraph (a)(3)'' and 
adding the words ``paragraph (b)(3)'' in their place; and
0
d. By revising paragraph (b)(5).
    The revisions read as follows:


Sec.  145.93  Terminology and classification; flocks and products.

* * * * *
    (b) * * *
    (1) It has been officially blood tested within the past 12 months 
with either no reactors or reactors that, upon further bacteriological 
examination conducted in accordance with part 147 of this subchapter, 
fail to isolate S. pullorum or S. gallinarum.
* * * * *
    (5) It is a primary breeding flock located in a State determined to 
be in compliance with provisions of paragraph (b)(3) of this section, 
and in which a sample of 300 birds from flocks of more than 300, and 
each bird in flocks of 300 or less, has been officially tested for 
pullorum-typhoid within the past 12 months with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. 
pullorum or S. gallinarum: Provided, That when a flock is a primary 
breeding flock located in a State which has been deemed to be a U.S. 
Pullorum-Typhoid Clean State for the past 3 years, and during which 
time no isolation of pullorum or typhoid has been made that can be 
traced to a source in that State, a bacteriological examination 
monitoring program or a serological examination monitoring program 
acceptable to the Official State Agency and approved by the Service may 
be used in lieu of annual blood testing.
* * * * *

PART 146--NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY

0
19. 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
20. In Sec.  146.1, a definition of NPIP Technical Committee is added 
in alphabetical order to read as follows:


Sec.  146.1  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. The NPIP Technical Committee is divided into 
three subcommittees (Mycoplasma, Salmonella, and Avian Influenza). NPIP 
Technical Committee Members may serve on one, two, or all three 
subcommittees. The committee will evaluate proposed changes to the 
Provisions and Program Standards of the Plan which include, but are not 
limited to, tests and sanitation procedures, and provide 
recommendations to the Delegates of the National Plan Conference as to 
whether they are scientifically or technically sound.
* * * * *


Sec.  146.23   [Amended]

0
21. In Sec.  146.23, paragraphs (a)(1)(i) and (a)(2)(i) are amended by 
removing the number ``30'' and adding the number ``21'' in its place.

PART 147--AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN

0
22. 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
23. In Sec.  147.41, the definition of NPIP Technical Committee is 
amended by adding three sentences after the last sentence to read as 
follows:


Sec.  147.41  Definitions.

* * * * *
    NPIP Technical Committee. * * * The NPIP Technical Committee is 
divided into three subcommittees (Mycoplasma, Salmonella, and Avian 
Influenza). NPIP Technical Committee Members may serve on one, two, or 
all three subcommittees. The committee will evaluate proposed changes 
to the Provisions and Program Standards of the Plan which include, but 
are not limited to, tests and sanitation procedures, and provide 
recommendations to the Delegates of the National Plan Conference as to 
whether they are scientifically or technically sound.
* * * * *

0
24. In Sec.  147.43, paragraph (b) is amended by adding a sentence 
after the second sentence to read as follows:


Sec.  147.43  General Conference Committee.

* * * * *
    (b) * * * The ballots for electing regional committee members and 
their alternates will be printed in such a way as to allow the specific 
selection of one nominee for member, and one nominee for alternate from 
the remaining nominees. * * *
* * * * *

0
25. In Sec.  147.46, paragraph (d) is amended by adding a sentence 
after the last sentence to read as follows:


Sec.  147.46  Committee consideration of proposed changes.

* * * * *
    (d) * * * Once completed, the combined committee report will be 
distributed electronically to the Official State Agencies prior to the 
delegates voting on the final day of the biennial conference.
* * * * *

0
26. In Sec.  147.51, the definition of NPIP Technical Committee is 
amended by adding three sentences after the last sentence to read as 
follows:


Sec.  147.51  Definitions.

* * * * *
    NPIP Technical Committee. * * * The NPIP Technical Committee is 
divided into three subcommittees (Mycoplasma, Salmonella, and Avian 
Influenza). NPIP Technical Committee Members may serve on one, two, or 
all three subcommittees. The committee will evaluate proposed changes 
to the Provisions and Program Standards of the Plan which include, but 
are not limited to, tests and sanitation procedures, and provide 
recommendations to the Delegates of the National Plan Conference as to 
whether they are scientifically or technically sound.

0
27. In Sec.  147.52, paragraph (a) is revised to read as follows:


Sec.  147.52  Authorized laboratories.

* * * * *
    (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. Further, the NPIP may approve and 
authorize additional laboratories to produce and distribute a check 
test as needed. The authorized laboratory must use the next available 
check test for each assay that it performs.
* * * * *

[[Page 28356]]


0
28. In Sec.  147.54, paragraphs (a)(1), (3), and (4) are revised to 
read as follows:


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

    (a) * * *
    (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, are the 
preferred samples and should be used when possible. 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. When the use of spiked samples may be necessary, 
prior approval from the NPIP Technical Committee is required. 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. (e.g., a Salmonella test 
should be evaluated by NPIP authorized laboratories that test for 
Salmonella routinely). 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 must 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 and must 
provide an outline of the method on the worksheet for diagnostic test 
evaluation. Reproducibility and robustness data should also be 
included.
    (4) Cooperating laboratories will submit to the kit manufacturer 
all compiled output 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 compiled output data 
and may be obtained by contacting the NPIP Senior Coordinator. 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.
* * * * *

    Done in Washington, DC, this 13th day of June 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-13128 Filed 6-18-18; 8:45 am]
 BILLING CODE 3410-34-P