83 FR 28351 - National Poultry Improvement Plan and Auxiliary Provisions

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 83, Issue 118 (June 19, 2018)

Page Range		28351-28356
FR Document		2018-13128
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.
Federal Register, Volume 83 Issue 118 (Tuesday, June 19, 2018)
[Federal Register Volume 83, Number 118 (Tuesday, June 19, 2018)]
[Rules and Regulations]
[Pages 28351-28356]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13128]



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Rules and Regulations
                                                Federal Register
________________________________________________________________________

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 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 

========================================================================


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.

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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
28351

Rules and Regulations Federal Register
Vol. 83, No. 118

Tuesday, June 19, 2018

This section of the FEDERAL REGISTER The Plan identifies States, Regulations.gov website (see footnote 1
contains regulatory documents having general independent flocks, hatcheries, dealers, in this document for a link to
applicability and legal effect, most of which and slaughter plants that meet certain Regulations.gov) or by contacting the
are keyed to and codified in the Code of disease control standards specified in person listed under FOR FURTHER
Federal Regulations, which is published under the Plan’s various programs. As a result, INFORMATION CONTACT.
50 titles pursuant to 44 U.S.C. 1510.
customers can buy poultry that has We are amending the NPIP, its
The Code of Federal Regulations is sold by tested clean of certain diseases or that auxiliary provisions, and the indemnity
the Superintendent of Documents. has been produced under disease- regulations for the control of H5 and H7
prevention conditions. low pathogenic avian influenza to align
The regulations in 9 CFR parts 145,
DEPARTMENT OF AGRICULTURE the regulations with international
146, and 147 (referred to below as the
standards and make them more
regulations) contain the provisions of
Animal and Plant Health Inspection transparent to stakeholders and the
the Plan. The Animal and Plant Health
Service general public. The changes in this final
Inspection Service (APHIS or the
rule were voted on and approved by the
Service) amends these provisions from
9 CFR Parts 145, 146, and 147 voting delegates at the 2016 NPIP
time to time to incorporate new
National Plan Conference.
[Docket No. APHIS–2017–0055] scientific information and technologies
within the Plan. The establishments that will be
RIN 0579–AE37 On April 9, 2018, we published in the affected by the rule—principally entities
Federal Register (83 FR 15082–15089, engaged in poultry production and
National Poultry Improvement Plan and Docket No. APHIS–2017–0055) a processing—are predominantly small by
Auxiliary Provisions proposal 1 to amend the regulations by Small Business Administration
AGENCY: Animal and Plant Health updating and clarifying several standards. In those instances in which
Inspection Service, USDA. provisions, including those concerning an addition to or modification of
NPIP participation, voting requirements, requirements could potentially result in
ACTION: Final rule.
testing procedures, and standards. a cost to certain entities, we do not
SUMMARY: We are amending the We solicited comments concerning expect the costs to be significant. NPIP
regulations governing the National our proposal for 30 days ending May 9, membership is voluntary. The changes
Poultry Improvement Plan (NPIP) by 2018. We received two comments by contained in this final rule were
updating and clarifying several that date. One individual was generally decided upon by the NPIP General
provisions, including those concerning opposed to the rule and the poultry Conference Committee and voting
NPIP participation, voting requirements, industry, but did not address any delegates during the 2016 NPIP Biennial
testing procedures, and standards. The specific provisions of the proposed rule. Conference; the changes were
changes in this final rule were voted on The other commenter also did not recognized by the poultry industry as
and approved by the voting delegates at address the provisions of the proposed being in their interest.
the Plan’s 2016 National Plan rule, but instead addressed his Under these circumstances, the
Conference. comments to the statements made by the Administrator of the Animal and Plant
first commenter. Health Inspection Service has
DATES: Effective July 19, 2018. Therefore, for the reasons given in the
FOR FURTHER INFORMATION CONTACT: Dr. determined that this action will not
proposed rule, we are adopting the
Denise Heard, DVM, Senior have a significant economic impact on
proposed rule as a final rule, without
Coordinator, National Poultry a substantial number of small entities.
change.
Improvement Plan, VS, APHIS, USDA, Executive Order 12372
1506 Klondike Road, Suite 101, Executive Orders 12866 and 13771 and
Conyers, GA 30094–5104; (770) 922– Regulatory Flexibility Act This program/activity is listed in the
3496. This final rule has been determined to Catalog of Federal Domestic Assistance
be not significant for the purposes of under No. 10.025 and is subject to
SUPPLEMENTARY INFORMATION:
Executive Order 12866 and, therefore, Executive Order 12372, which requires
Background has not been reviewed by the Office of intergovernmental consultation with
The National Poultry Improvement Management and Budget. Further, State and local officials. (See 2 CFR
Plan (NPIP, also referred to below as because this rule is not significant, it is chapter IV.)
‘‘the Plan’’) is a cooperative Federal- not a regulatory action under Executive
Order 13771. Executive Order 12988
State-industry mechanism for
controlling certain poultry diseases. The We have prepared an analysis This final rule has been reviewed
Plan consists of a variety of programs regarding the economic effects of this under Executive Order 12988, Civil
intended to prevent and control poultry final rule on small entities. The analysis Justice Reform. This rule: (1) Preempts
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diseases. Participation in all Plan is summarized below. Copies of the full all State and local laws and regulations
programs is voluntary, but breeding analysis are available on the that are in conflict with this rule; (2) has
flocks, hatcheries, and dealers must first 1 To view the proposed rule, supporting
no retroactive effect; and (3) does not
qualify as ‘‘U.S. Pullorum-Typhoid document, and the comments we received, go to
require administrative proceedings
Clean’’ as a condition for participating http://www.regulations.gov/ before parties may file suit in court
in the other Plan programs. #!docketDetail;D=APHIS-2017-0055. challenging this rule.

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28352 Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations

Paperwork Reduction Act adding the words ‘‘, unless otherwise § 145.33 Terminology and classification;
specified within the Plan program’’ after flocks and products.
This final rule contains no new
information collection or recordkeeping the words ‘‘must be tested’’; and * * * * *
requirements under the Paperwork ■ b. By revising paragraph (d)(2)(i)(A). (b) * * *
Reduction Act of 1995 (44 U.S.C. 3501 The revision reads as follows: (1) It has been officially blood tested
et seq.). with either no reactors or reactors that,
§ 145.14 Testing. upon further bacteriological
List of Subjects in 9 CFR Parts 145, 146, * * * * * examination conducted in accordance
and 147 (d) * * * with part 147 of this subchapter, fail to
Animal diseases, Poultry and poultry (2) * * * isolate S. pullorum or S. gallinarum.
products, Reporting and recordkeeping (i) * * * * * * * *
requirements. (A) The RRT–PCR tests must be ■ 8. In § 145.43, paragraphs (b)(1) and
Accordingly, we are amending 9 CFR conducted using reagents approved by (5) are revised to read as follows:
parts 145, 146, and 147 as follows: the Department and the Official State
Agency. The RRT–PCR must be § 145.43 Terminology and classification;
PART 145—NATIONAL POULTRY conducted using the National Veterinary flocks and products.
IMPROVEMENT PLAN FOR BREEDING Services Laboratories (NVSL) official * * * * *
POULTRY protocol for RRT–PCR or a test kit (b) * * *
licensed by the Department and (1) It has been officially blood tested
■ 1. The authority citation for part 145 approved by the Official State Agency with either no reactors or reactors that,
continues to read as follows: and the State Animal Health Official, upon further bacteriological
Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, and must be conducted by personnel examination conducted in accordance
2.80, and 371.4. who have passed an NVSL proficiency with part 147 of this subchapter, fail to
■ 2. In § 145.1, the definition of NPIP test. For non-National Animal Health isolate S. pullorum or S. gallinarum.
Technical Committee is amended by Laboratory Network (NAHLN) * * * * *
adding three sentences after the last authorized laboratories: (5) It is a primary breeding flock
sentence to read as follows: (1) RRT–PCR testing may be used by located in a State determined to be in
primary breeder company authorized compliance with the provisions of
§ 145.1 Definitions. laboratories. paragraph (b)(4) of this section and in
* * * * * (2) RRT–PCR testing can only be which a sample of 300 birds from flocks
NPIP Technical Committee. * * * performed on their own breeding flocks of more than 300, and each bird in
The NPIP Technical Committee is and only used for routine surveillance. flocks of 300 or less, has been officially
divided into three subcommittees (3) The authorized laboratory must tested for pullorum-typhoid with either
(Mycoplasma, Salmonella, and Avian have a quality system that is accredited no reactors or reactors that, upon further
Influenza). NPIP Technical Committee as ISO/IEC 17025 or equivalent to bacteriological examination conducted
Members may serve on one, two, or all perform the avian influenza RRT–PCR in accordance with part 147 of this
three subcommittees. The committee assay. subchapter, fail to isolate S. pullorum or
will evaluate proposed changes to the (4) The use of the RRT–PCR test by S. gallinarum: Provided, That a
Provisions and Program Standards of the authorized laboratory must be bacteriological examination monitoring
the Plan which include, but are not approved in the memorandum of program acceptable to the Official State
limited to, tests and sanitation understanding (MOU) between the Agency and approved by APHIS may be
procedures, and provide authorized laboratory, the Official State used in lieu of blood testing.
recommendations to the Delegates of the Agency, and the State Animal Health * * * * *
National Plan Conference as to whether Official(s) of both the location of the ■ 9. Section 145.45 is amended as
they are scientifically or technically authorized laboratory and the location
sound. follows:
where the breeding flocks reside. ■ a. By revising paragraph (a)
* * * * * (5) Split samples for testing must introductory text; and
§ 145.4 [Amended] occur between the authorized laboratory ■ b. By removing the word ‘‘NAI’’ and
and a NAHLN laboratory at a frequency adding the words ‘‘H5/H7 AI’’ in its
■ 3. In § 145.4, paragraph (d)(2) is designated in the MOU. place each time it appears in the
amended by adding the words ‘‘and any following paragraphs:
* * * * *
other disease for which the flock into ■ i. Paragraph (a)(1) introductory text;
which the birds are being introduced ■ 6. In § 145.23, paragraph (b)(1) is
■ ii. Paragraph (a)(1)(i);
holds a disease classification’’ after the revised to read as follows:
■ iii. Paragraph (a)(1)(iii) introductory
words ‘‘pullorum-typhoid’’. § 145.23 Terminology and classification; text;
§ 145.10 [Amended] flocks and products. ■ iv. Paragraph (a)(1)(v);
* * * * * ■ v. Paragraph (a)(2)(iii); and
■ 4. In § 145.10, paragraph (o) is ■ vi. Paragraph (a)(4).
amended by adding the citation (b) * * *
(1) It has been officially blood tested The revision reads as follows:
‘‘§ 145.73(g),’’ after the citation
‘‘§ 145.53(f),’’. with either no reactors or reactors that, § 145.45 Terminology and classification;
upon further bacteriological compartments.
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■ 5. Section 145.14 is amended as
examination conducted in accordance
follows: (a) US H5/H7 AI Clean Compartment.
with part 147 of this subchapter, fail to
■ a. In the introductory text, in the third This program is intended to be the basis
isolate S. pullorum or S. gallinarum.
sentence, by adding the words ‘‘unless from which the primary turkey
otherwise specified within the Plan * * * * * breeding-hatchery industry may
program,’’ after the words ‘‘30 birds per ■ 7. In § 145.33, paragraph (b)(1) is demonstrate the existence and
house,’’ and in the last sentence, by revised to read as follows: implementation of a program that has

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been approved by the Official State bacteriological examination conducted than 4 months of age or upon reaching
Agency and APHIS to establish a in accordance with part 147 of this sexual maturity. For flocks of more than
compartment consisting of a primary subchapter, fail to isolate S. pullorum or 400 birds, 200 birds shall be tested. For
breeding-hatchery company that is free S. gallinarum. flocks of 60 to 400 birds, 50 percent of
of H5/H7 avian influenza (AI). For the * * * * * the birds shall be tested. For flocks of
purpose of the compartment, avian (5) It is a primary breeding flock fewer than 60 birds, all birds shall be
influenza is defined according to the located in a State determined to be in tested up to a maximum of 30 birds:
OIE Terrestrial Animal Health Code compliance with the provisions of Provided, that to retain this
Chapter 10.4. This compartment has the paragraph (b)(4) of this section, and in classification, the flock shall be
purpose of protecting the defined which a sample of 300 birds from flocks subjected to one of the following
subpopulation and avoiding the of more than 300, and each bird in procedures:
introduction and spread of H5/H7 AI flocks of 300 or less, has been officially * * * * *
within that subpopulation by tested for pullorum-typhoid within the ■ 12. Section 145.63 is amended by
prohibiting contact with other past 12 months with either no reactors revising paragraphs (a)(1) and (a)(2)(i) to
commercial poultry operations, other or reactors that, upon further read as follows:
domestic and wild birds, and other bacteriological examination conducted
intensive animal operations. The in accordance with part 147 of this § 145.63 Terminology and classification;
program shall consist of the following: subchapter, fail to isolate S. pullorum or flocks and products.
* * * * * S. gallinarum: Provided, That a * * * * *
■ 10. Section 145.52 is amended by bacteriological examination monitoring (a) * * *
redesignating paragraphs (d)(7) and program or serological examination (1) It has been officially blood tested
(d)(8) as paragraphs (d)(8) and (d)(9), monitoring program for game birds within the past 12 months with either
respectively, and by adding a new acceptable to the Official State Agency no reactors or reactors that, upon further
paragraph (d)(7) to read as follows: and approved by the Service may be bacteriological examination conducted
used in lieu of annual blood testing: in accordance with part 147 of this
§ 145.52 Participation. And Provided further, That when a flock subchapter, fail to isolate S. pullorum or
* * * * * is a hobbyist or exhibition waterfowl or S. gallinarum.
(d) * * * exhibition poultry primary breeding (2) * * *
(7) The NPIP hatchery approval flock located in a State which has been (i)(A) It is a multiplier or primary
number of the shipping hatchery; deemed to be a U.S. Pullorum-Typhoid breeding flock of fewer than 300 birds
* * * * * Clean State for the past 3 years, and in which a sample of 10 percent of the
during which time no isolation of birds in a flock or at least 1 bird from
■ 11. Section 145.53 is amended as
pullorum or typhoid has been made that each pen, whichever is more, has been
follows:
can be traced to a source in that State, officially tested for pullorum-typhoid
■ a. By revising paragraphs (b)(1) and
a bacteriological examination within the past 12 months with either
(b)(5);
■ b. In paragraph (c)(1)(i), by adding the
monitoring program or a serological no reactors or reactors that, upon further
words ‘‘trachea or’’ before the word examination monitoring program bacteriological examination conducted
‘‘choanal’’ and by removing the words acceptable to the Official State Agency in accordance with part 147 of this
‘‘palatine cleft/fissure area’’ and adding and approved by the Service may be subchapter, fail to isolate S. pullorum or
the word ‘‘cleft’’ in their place. used in lieu of annual blood testing. S. gallinarum; or
■ c. By revising paragraph (c)(1)(ii)
(c) * * * (B) It is a multiplier or primary
introductory text; (1) * * * breeding flock of 300 birds or more in
■ d. In paragraph (c)(1)(ii)(A), by adding
(ii) It is a multiplier breeding flock which a sample of a minimum of 30
the words ‘‘trachea or’’ before the word which originated as U.S. M. birds has been officially tested for
‘‘choanal’’ and by removing the words Gallisepticum Clean baby poultry from pullorum-typhoid within the past 12
‘‘palatine cleft/fissure area’’ and adding primary breeding flocks and from which months with either no reactors or
the word ‘‘cleft’’ in their place; a random sample of birds has been reactors that, upon further
■ e. In paragraph (d)(1)(i), by adding the
tested for M. gallisepticum as provided bacteriological examination conducted
words ‘‘trachea or’’ before the word in § 145.14(b) when more than 4 months in accordance with part 147 of this
‘‘choanal’’ and by removing the words of age or upon reaching sexual maturity. subchapter, fail to isolate S. pullorum or
‘‘palatine cleft/fissure area’’ and adding For flocks of more than 400 birds, 200 S. gallinarum.
the word ‘‘cleft’’ in their place. birds shall be tested. For flocks of 60 to * * * * *
■ f. By revising paragraph (d)(1)(ii)
400 birds, 50 percent of the birds shall ■ 13. Section 145.73 is amended as
introductory text; and be tested. For flocks of fewer than 60 follows:
■ g. In paragraph (d)(1)(ii)(A), by adding
birds, all birds shall be tested up to a ■ a. By revising paragraphs (b)(1) and
the words ‘‘trachea or’’ before the word maximum of 30 birds: Provided, that to (b)(2)(ii); and
‘‘choanal’’ and by removing the words retain this classification, the flock shall ■ b. By adding paragraph (g).
‘‘palatine cleft/fissure area’’ and adding be subjected to one of the following The revisions and addition read as
the word ‘‘cleft’’ in their place. procedures: follows:
The revisions read as follows: * * * * *
(d) * * * § 145.73 Terminology and classification;
§ 145.53 Terminology and classification; (1) * * * flocks and products.
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flocks and products. (ii) It is a multiplier breeding flock * * * * *
* * * * * that originated as U.S. M. Synoviae (b) * * *
(b) * * * Clean chicks from primary breeding (1) It has been officially blood tested
(1) It has been officially blood tested flocks and from which a random sample with either no reactors or reactors that,
within the past 12 months with either of birds has been tested for M. synoviae upon further bacteriological
no reactors or reactors that, upon further as provided in § 145.14(b) when more examination conducted in accordance

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AI-related’’ in its place in paragraph § 146.1 Definitions. ■ 24. In § 147.43, paragraph (b) is
(a)(1)(i). * * * * * amended by adding a sentence after the
■ 18. Section 145.93 is amended as NPIP Technical Committee. A second sentence to read as follows:
follows: committee made up of technical experts § 147.43 General Conference Committee.
■ a. By revising paragraph (b)(1); on poultry health, biosecurity,
■ b. In paragraph (b)(3)(viii), by
* * * * *
surveillance, and diagnostics. The
removing the words ‘‘paragraphs (b) * * * The ballots for electing
committee consists of representatives
(a)(3)(i),’’ and adding the words regional committee members and their
from the poultry and egg industries,
‘‘paragraphs (b)(3)(i),’’ in their place; alternates will be printed in such a way
universities, and State and Federal
■ c. In paragraph (b)(4), by removing the
as to allow the specific selection of one
governments and is appointed by the
words ‘‘paragraph (a)(3)’’ and adding the nominee for member, and one nominee
Senior Coordinator and approved by the
words ‘‘paragraph (b)(3)’’ in their place; for alternate from the remaining
General Conference Committee. The
and nominees. * * *
NPIP Technical Committee is divided
■ d. By revising paragraph (b)(5). into three subcommittees (Mycoplasma, * * * * *
The revisions read as follows: Salmonella, and Avian Influenza). NPIP ■ 25. In § 147.46, paragraph (d) is
Technical Committee Members may amended by adding a sentence after the
§ 145.93 Terminology and classification;
serve on one, two, or all three last sentence to read as follows:
flocks and products.
subcommittees. The committee will
* * * * * evaluate proposed changes to the
§ 147.46 Committee consideration of
(b) * * * proposed changes.
Provisions and Program Standards of
(1) It has been officially blood tested * * * * *
the Plan which include, but are not
within the past 12 months with either (d) * * * Once completed, the
limited to, tests and sanitation
no reactors or reactors that, upon further combined committee report will be
procedures, and provide
bacteriological examination conducted distributed electronically to the Official
recommendations to the Delegates of the
in accordance with part 147 of this State Agencies prior to the delegates
National Plan Conference as to whether
subchapter, fail to isolate S. pullorum or voting on the final day of the biennial
they are scientifically or technically
S. gallinarum. conference.
sound.
* * * * * * * * * *
* * * * *
(5) It is a primary breeding flock ■ 26. In § 147.51, the definition of NPIP
located in a State determined to be in § 146.23 [Amended] Technical Committee is amended by
compliance with provisions of adding three sentences after the last
paragraph (b)(3) of this section, and in ■ 21. In § 146.23, paragraphs (a)(1)(i)
and (a)(2)(i) are amended by removing sentence to read as follows:
which a sample of 300 birds from flocks
of more than 300, and each bird in the number ‘‘30’’ and adding the § 147.51 Definitions.
flocks of 300 or less, has been officially number ‘‘21’’ in its place. * * * * *
tested for pullorum-typhoid within the NPIP Technical Committee. * * *
PART 147—AUXILIARY PROVISIONS
past 12 months with either no reactors The NPIP Technical Committee is
ON NATIONAL POULTRY
or reactors that, upon further divided into three subcommittees
IMPROVEMENT PLAN
bacteriological examination conducted (Mycoplasma, Salmonella, and Avian
in accordance with part 147 of this ■ 22. The authority citation for part 147 Influenza). NPIP Technical Committee
subchapter, fail to isolate S. pullorum or continues to read as follows: Members may serve on one, two, or all
S. gallinarum: Provided, That when a three subcommittees. The committee
flock is a primary breeding flock located Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, will evaluate proposed changes to the
in a State which has been deemed to be 2.80, and 371.4. Provisions and Program Standards of
a U.S. Pullorum-Typhoid Clean State for ■ 23. In § 147.41, the definition of NPIP the Plan which include, but are not
the past 3 years, and during which time Technical Committee is amended by limited to, tests and sanitation
no isolation of pullorum or typhoid has adding three sentences after the last procedures, and provide
been made that can be traced to a source sentence to read as follows: recommendations to the Delegates of the
in that State, a bacteriological National Plan Conference as to whether
examination monitoring program or a § 147.41 Definitions. they are scientifically or technically
serological examination monitoring * * * * * sound.
program acceptable to the Official State NPIP Technical Committee. * * * ■ 27. In § 147.52, paragraph (a) is
Agency and approved by the Service The NPIP Technical Committee is revised to read as follows:
may be used in lieu of annual blood divided into three subcommittees
testing. (Mycoplasma, Salmonella, and Avian § 147.52 Authorized laboratories.
* * * * * Influenza). NPIP Technical Committee * * * * *
Members may serve on one, two, or all (a) Check-test proficiency. The NPIP
PART 146—NATIONAL POULTRY three subcommittees. The committee will serve as the lead agency for the
IMPROVEMENT PLAN FOR will evaluate proposed changes to the coordination of available check tests
COMMERCIAL POULTRY Provisions and Program Standards of from the National Veterinary Services
the Plan which include, but are not Laboratories. Further, the NPIP may
■ 19. The authority citation for part 146 limited to, tests and sanitation approve and authorize additional
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continues to read as follows: procedures, and provide laboratories to produce and distribute a
Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, recommendations to the Delegates of the check test as needed. The authorized
2.80, and 371.4. National Plan Conference as to whether laboratory must use the next available
■ 20. In § 146.1, a definition of NPIP they are scientifically or technically check test for each assay that it
Technical Committee is added in sound. performs.
alphabetical order to read as follows: * * * * * * * * * *

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28356 Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations

■ 28. In § 147.54, paragraphs (a)(1), (3), (4) Cooperating laboratories will action replaces the outdated term
and (4) are revised to read as follows: submit to the kit manufacturer all ‘‘Airport/Facility Directory’’ with the
compiled output data regarding the term ‘‘Chart Supplement’’ in Class D
§ 147.54 Approval of diagnostic test kits assay response. Each sample tested will and E surface airspace descriptions.
not licensed by the Service.
be reported as positive or negative, and DATES: Effective 0901 UTC, September
(a) * * * the official NPIP procedure used to 13, 2018. The Director of the Federal
(1) The sensitivity of the kit will be classify the sample must be submitted Register approves this incorporation by
evaluated in at least three NPIP in addition to the assay response value. reference action under Title 1 Code of
authorized laboratories by testing A completed worksheet for diagnostic Federal Regulations, part 51, subject to
known positive samples, as determined test evaluation is required to be the annual revision of FAA Order
by the official NPIP procedures found in submitted with the compiled output 7400.11 and publication of conforming
the NPIP Program Standards or through data and may be obtained by contacting amendments.
other procedures approved by the the NPIP Senior Coordinator. Data and ADDRESSES: FAA Order 7400.11B,
Administrator. Field samples, for which the completed worksheet for diagnostic Airspace Designations and Reporting
the presence or absence of the target test evaluation must be submitted to the Points, and subsequent amendments can
organism or analyte has been NPIP Senior Coordinator 4 months prior be viewed online at http://www.faa.gov/
determined by the current NPIP test, are to the next scheduled General air_traffic/publications/. For further
the preferred samples and should be Conference Committee meeting, which information, you can contact the
used when possible. Samples from a is when approval will be sought. Airspace Policy Group, Federal Aviation
variety of field cases representing a * * * * * Administration, 800 Independence
range of low, medium, and high analyte Avenue SW, Washington, DC 20591;
Done in Washington, DC, this 13th day of
concentrations should be used. In some June 2018. telephone: (202) 267–8783. The Order is
cases it may be necessary to utilize also available for inspection at the
Kevin Shea,
samples from experimentally infected National Archives and Records
Administrator, Animal and Plant Health
animals. Spiked samples (clinical Administration (NARA). For
Inspection Service.
sample matrix with a known amount of information on the availability of FAA
[FR Doc. 2018–13128 Filed 6–18–18; 8:45 am]
pure culture added) should only be used Order 7400.11B at NARA, call (202)
BILLING CODE 3410–34–P
in the event that no other sample types 741–6030, or go to https://
are available. When the use of spiked www.archives.gov/federal-register/cfr/
samples may be necessary, prior ibr-locations.html.
approval from the NPIP Technical DEPARTMENT OF TRANSPORTATION
FAA Order 7400.11, Airspace
Committee is required. Pure cultures Designations and Reporting Points, is
Federal Aviation Administration
should never be used. Additionally, published yearly and effective on
laboratories should be selected for their September 15.
14 CFR Part 71
experience with testing for the target
FOR FURTHER INFORMATION CONTACT: John
organism or analyte with the current [Docket No. FAA–2017–1061; Airspace
Docket No. 17–AEA–20] Fornito, Operations Support Group,
NPIP approved test. (e.g., a Salmonella
Eastern Service Center, Federal Aviation
test should be evaluated by NPIP RIN 2120–AA66 Administration, 1701 Columbia Ave.,
authorized laboratories that test for
College Park, GA 30337; telephone (404)
Salmonella routinely). If certain Amendment of Class D Airspace and 305–6364.
conditions or interfering substances are Class E Airspace, and Removal of
SUPPLEMENTARY INFORMATION:
known to affect the performance of the Class E Airspace; Binghamton, NY
kit, appropriate samples will be Authority for This Rulemaking
included so that the magnitude and AGENCY: Federal Aviation
Administration (FAA), DOT. The FAA’s authority to issue rules
significance of the effect(s) can be
ACTION: Final rule. regarding aviation safety is found in
evaluated.
Title 49 of the United States Code.
* * * * * SUMMARY: This action amends Class D Subtitle I, Section 106 describes the
(3) The kit will be provided to the airspace, Class E surface airspace, and authority of the FAA Administrator.
cooperating laboratories in its final form Class E airspace extending upward from Subtitle VII, Aviation Programs,
and include the instructions for use. 700 feet above the surface; and removes describes in more detail the scope of the
The cooperating laboratories must Class E airspace designated as an agency’s authority. This rulemaking is
perform the assay exactly as stated in extension to a Class D surface area; at promulgated under the authority
the supplied instructions. Each Greater Binghamton Airport/Edwin A. described in Subtitle VII, Part A,
laboratory must test a panel of at least Link Field (formerly Binghamton Subpart I, Section 40103. Under that
25 known positive samples. In addition, Regional Airport/Edwin A. Link Field), section, the FAA is charged with
each laboratory must test at least 50 Binghamton, NY. This action prescribing regulations to assign the use
known negative samples obtained from accommodates airspace reconfiguration of airspace necessary to ensure the
several sources, to provide a due to the decommissioning of the safety of aircraft and the efficient use of
representative sampling of the general Binghamton VHF omni-directional radio airspace. This regulation is within the
population. The cooperating range tactical air navigation aid scope of that authority as it amends
laboratories must perform a current (VORTAC), and cancellation of the VOR Class D and Class E airspace at Greater
NPIP procedure or NPIP approved test approaches. Controlled airspace is
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Binghamton Airport/Edwin A. Link
on the samples alongside the test kit for necessary for the safety and Field, Binghamton, NY, to support IFR
comparison and must provide an management of instrument flight rules operations at the airport.
outline of the method on the worksheet (IFR) operations at the airport. This
for diagnostic test evaluation. action also updates the geographic History
Reproducibility and robustness data coordinates of the airport, and corrects The FAA published a notice of
should also be included. the airport’s name. Additionally, this proposed rulemaking in the Federal

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Document Created: 2018-07-02 11:21:01
Document Modified: 2018-07-02 11:21:01
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		Effective July 19, 2018.
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.
FR Citation		83 FR 28351
RIN Number		0579-AE37
CFR Citation		9 CFR 145 9 CFR 146 9 CFR 147
CFR Associated		Animal Diseases; Poultry and Poultry Products and Reporting and Recordkeeping Requirements
83 FR 28351 - National Poultry Improvement Plan and Auxiliary Provisions

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 83, Issue 118 (June 19, 2018)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
