[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Proposed Rules]
[Pages 15082-15089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07076]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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 

  Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Proposed 
Rules  

[[Page 15082]]



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: Proposed rule.

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

SUMMARY: We are proposing to amend 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. These proposed 
changes were voted on and approved by the voting delegates at the 
NPIP's 2016 National Plan Conference.

DATES: We will consider all comments that we receive on or before May 
9, 2018.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0055.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2017-0055, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2017-
0055 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW, Washington, DC. 
Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

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. The changes we are proposing, which 
are discussed below, were approved by the voting delegates at the 
Plan's 2016 Biennial Conference.
    Participants and voting delegates at the Biennial Conference 
represented the poultry industry, flockowners, breeders, hatcherymen, 
slaughter plants, poultry veterinarians, diagnostic laboratory 
personnel, Official State Agencies from cooperating States, and other 
poultry industry affiliates. The proposed amendments are discussed in 
the order they would appear in the regulations.

Definitions

    The term NPIP Technical Committee is currently defined in Sec.  
Sec.  145.1, 147.41, and 147.51 as ``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.'' We are proposing to amend the definition to 
specify that the committee is divided into three subcommittees 
(Mycoplasma, Salmonella, and Avian Influenza), and that committee 
members may serve on one, two, or all three of those subcommittees. For 
many technical committee members, belonging to all three subcommittees 
can be time consuming and daunting. Therefore, having the flexibility 
to serve on just one or two of the subcommittees if they so choose 
would allow members to focus their expertise on their specific disease 
areas. The amended definition would also explain more of the purpose of 
the committee, i.e., that it evaluates proposed changes to the 
regulations and program standards and provides recommendations to the 
Delegates of the National Plan Conference as to whether proposals are 
scientifically or technically sound. In addition to amending the 
definition in the sections where it currently appears in parts 145 and 
147, we would also add the definition to part 146 for the sake of 
consistency across the regulations.

Addition of Birds to Existing Flocks

    In Sec.  145.4, paragraph (d) states that participants in the Plan 
may not buy or receive products for any purpose from nonparticipants 
unless they are part of an equivalent program, as determined by the 
Official State Agency. The regulations do, however, make an exception 
to that requirement by allowing participants to buy or receive products 
from flocks that are neither participants nor part of an equivalent 
program, for use in breeding flocks or for experimental purposes, with 
the permission of the Official State Agency (OSA) and the concurrence 
of APHIS and after first segregating the birds before introducing them 
into the breeding flock, and introducing them only after they have 
reached sexual maturity and have been tested and found negative for 
pullorum-typhoid.
    We are proposing to amend that testing requirement so that it 
includes testing not only for pullorum-typhoid, but also for any other 
disease for which

[[Page 15083]]

the flock they are being introduced into holds a disease classification 
(e.g., M. gallisepticum or M. synoviae). As noted previously, breeding 
flocks must first qualify as ``U.S. Pullorum-Typhoid Clean'' as a 
condition for participating in the other Plan programs, hence the 
current requirement that birds test negative for pullorum-typhoid 
before being introduced into a flock. Requiring that they also test 
negative for any other disease for which the flock holds status would 
ensure that the flock maintains its eligibility for those other Plan 
programs.

Testing

    The regulations in Sec.  145.14 regarding testing state that for 
Plan programs in which a representative sample may be tested in lieu of 
an entire flock, except the ostrich, emu, rhea, and cassowary program 
in Sec.  145.63(a), the minimum number tested shall be 30 birds per 
house, and when a house contains fewer than 30 birds, all the birds in 
the house must be tested. However, over the years a number of Plan 
programs have been amended to allow for alternative sampling and 
testing approaches. In order for the text of Sec.  145.14 to not be at 
odds with the provisions governing those Plan programs, we would amend 
the introductory text of the section to include the caveat ``unless 
otherwise specified within the Plan program.''
    We are also proposing to amend Sec.  145.14(d) to add provisions 
for the use of real-time reverse transcriptase polymerase chain 
reaction (RRT-PCR) testing for avian influenza (AI) by primary breeder 
authorized laboratories. The current regulations provide that RRT-PCR 
testing must be conducted using reagents approved by the Department and 
the Official State Agency and using the National Veterinary Services 
Laboratories (NVSL) official protocol for RRT-PCR and performed by 
personnel who have passed an NVSL proficiency test.
    We are proposing to allow NPIP primary breeder authorized 
laboratories to use federally licensed kits or NVSL tests on their own 
breeding flocks for more flexibility. An NPIP primary breeder 
authorized laboratory with an accredited quality assurance program that 
can satisfactorily pass a proficiency test provided by the Service 
using the NVSL approved protocol or federally licensed kit would be 
allowed to run this assay as a routine surveillance measure. An 
authorized laboratory's use of the test would be addressed in the 
memorandum of understanding between the laboratory, the Official State 
Agency, and the State Animal Health Official of the State or States 
where the laboratory and the breeding flocks are located. A follow-up 
of any positive results would continue to be handled by the Department 
and the Official State Agency and confirmed by NVSL.

Reactors

    We are proposing to amend Sec. Sec.  145.23, 145.33, 145.43, 
145.53, 145.63, 145.73, 145.83, and 145.93 regarding the U.S. Pullorum-
Typhoid Clean classification. The regulations in each of these sections 
describe the means by which flocks may demonstrate freedom from 
pullorum and typhoid to the Official State Agency. One of those means 
is that the flock was officially blood tested with no reactors.
    In order to take into account the possibility of test results that 
indicate the presence of a reactor in the flock, but that upon further 
testing are found negative for S. pullorum or S. gallinarum, we are 
proposing to amend those sections. Specifically, the regulations would 
provide that a flock could demonstrate freedom from pullorum and 
typhoid when it has been officially blood tested with either no 
reactors or reactors that, upon further bacteriological examination 
conducted in accordance with part 147 of the regulations, fail to 
isolate S. pullorum or S. gallinarum.

Terminology

    We are proposing to amend the regulations in Sec. Sec.  145.45, 
145.74, and 145.84 regarding avian influenza clean compartments. These 
sections currently use the term notifiable avian influenza, or NAI, but 
that term has been removed from the World Health Organization (OIE) 
Terrestrial Code and Terrestrial Manual. We would instead refer to H5/
H7 avian influenza to harmonize the regulations with current OIE 
terminology.

Shipping Forms

    The regulations in Sec.  145.52(d) set out the information that 
participating flocks are to provide in reporting poultry sales to 
importing States. One of the pieces of information required is the NPIP 
hatchery approval number of the selling hatchery. Because the hatchery 
that ships the poultry may differ from the hatchery filling the order, 
we would amend the paragraph to also require the NPIP hatchery approval 
number of the shipping hatchery. This would aid in traceback efforts 
should the need arise.

Sampling Sites

    We are proposing to amend the regulations in Sec.  145.53 regarding 
the U.S. M. Gallisepticum Clean and U.S. M. Synoviae Clean 
classifications to add the trachea as a sampling site. The trachea is 
the best anatomical location to sample for those diseases, and both the 
choanal cleft and the trachea are recommended sampling sites for M. 
gallisepticum and M. synoviae detection by PCR and culture. As part of 
this change, we would remove references to the ``choanal palatine 
cleft/fissure area'' and simply refer to the choanal cleft for 
clarity's sake.
    Those same Plan classifications also provide instructions for the 
number of birds to be sampled. The current regulations in Sec.  
145.53(c) and (d) call for a random sample of 50 percent of the birds 
in the flock, with a maximum of 200 birds and a minimum of 30 birds per 
flock or all birds in the flock if the flock size is less than 30 
birds. The phrasing of the sample sizes has been a source of confusion 
for some growers and field technicians who gather the samples, so we 
are proposing to modify the wording to provide more clarity. The actual 
sample sizes would remain the same.

U.S. Salmonella Monitored

    We are proposing to amend Sec.  145.73 by adding a new paragraph 
(g), entitled U.S. Salmonella Monitored. The primary egg-type breeder 
companies routinely monitor their flocks and chicks for all Salmonella 
serotypes with the goal of producing Salmonella-free product. The 
addition of a Salmonella Monitored program for primary egg-type breeder 
companies would formalize those efforts and provide recognition and 
potential additional marketing opportunities for flocks that choose to 
participate.
    The provisions of the new paragraph would mirror those of existing 
Sec.  145.83(f), which is the U.S. Salmonella Monitored program for 
primary meat-type chicken breeding flocks. We would reflect this 
proposed program for primary egg-type chicken breeding flocks by adding 
a reference to Sec.  145.73(g) to Sec.  145.10(o), which is where the 
illustrative design for the U.S. Salmonella Monitored program is 
located.

Biosecurity Measures

    The regulations in Sec.  145.82 set out participation requirements 
for primary meat-type chicken breeding flocks. We are proposing to 
amend this section by adding a new paragraph (d) that would provide 
that 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

[[Page 15084]]

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. These additional biosecurity 
measures are intended to protect these flocks from the introduction of 
disease from natural sources.

Sample Size

    We are proposing to amend Sec.  146.23 to change the testing 
requirements for commercial table-egg laying flocks. The current 
regulations state that a sample of at least 11 birds from table-egg 
layer pullet flocks and table-egg layer flocks participating in the 
U.S. H5/H7 Avian Influenza Monitored classification must test negative 
to H5/H7 subtypes of avian influenza within 30 days prior to movement. 
We would change that time period to 21 days.
    We are proposing this change to reflect the OIE's established 
maximum incubation period for avian influenza of 21 days. This change 
would also make the H5/H7 Avian Influenza Monitored program for 
commercial table-egg layers consistent with the corresponding programs 
for commercial broilers and turkeys.

General Conference Committee

    We are proposing to amend Sec.  147.43 to clarify election 
procedures for the regional committee members of the General Conference 
Committee. The current regulations simply state that regional committee 
members and their alternates will be elected by the official delegates 
of their respective regions; in practice, the nominee receiving the 
most votes would become the committee member and the nominee in second 
place would become the alternate. We are proposing to amend the 
regulations to specify that ballots will be printed to allow the 
regional delegates to cast a vote for the member and another vote for 
the alternate. This change would allow the region's delegates to 
specifically vote for their committee member and alternate rather than 
having the nominee with the second-most votes becoming the alternate by 
default.

Committee Consideration of Proposed Changes

    The regulations in Sec.  147.46 provide that various committees 
make recommendations to the conference as a whole concerning each 
proposal considered at the biennial conference. The individual 
committee reports are submitted to the chairman of the conference, who 
combines them into one report showing, in numerical sequence, the 
committee recommendations on each proposal. We are proposing to amend 
paragraph (d) of that section to provide that, after completing the 
combined report, the chairman will distribute copies of the report 
electronically to the Official State Agency in advance of the voting, 
which takes place on the last day of the conference. This would allow 
the OSA to in turn provide the full report to the delegates from their 
States, which would provide them more time to review and discuss the 
proposals and thus make more informed decisions when voting on the 
proposals.

Authorized Laboratories

    We are proposing to amend Sec.  147.52(a) regarding the 
administration of check tests at authorized laboratories. The 
regulations currently state that NPIP will coordinate the distribution 
of check tests from NVSL to authorized laboratories. An authorized 
laboratory must use a regularly scheduled check test for each assay 
that it performs.
    We are proposing to provide that the NPIP may approve and authorize 
additional laboratories to produce and distribute check tests as 
needed. This change would allow us to supplement the supply of check 
tests produced by NVSL with kits prepared by other approved 
laboratories, and NPIP and NVSL would work together to ensure that 
laboratory tests and submissions are accurate. We would also replace 
the current reference to ``regularly scheduled'' check tests with a 
reference to ``the next available'' check test. This more accurately 
describes the manner in which NPIP administers check tests to its 
authorized laboratories.

Approval of Diagnostic Test Kits

    We are proposing to amend the regulations in Sec.  147.54 regarding 
the approval of diagnostic test kits not licensed by the Service. 
First, we would amend paragraph (a)(1), which currently provides that 
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. (Field samples are preferred due to the often 
unrealistic outcomes of spiked samples.) In order to ensure that spiked 
samples are used only as a last resort, we would add a requirement that 
prior approval must be obtained from the NPIP Technical Committee. The 
NPIP Technical Committee is made up of technical experts on poultry 
health, biosecurity, surveillance, and diagnostics drawn from the 
poultry and egg industries, universities, and State and Federal 
governments, and therefore would be in a position to decide whether the 
use of spiked samples would be useful or appropriate under a given set 
of circumstances.
    Paragraph (a)(1) also states that when evaluating an unlicensed 
test, laboratories should be selected for their experience with testing 
for the target organism or analyte with the current NPIP approved test. 
For the sake of clarity, we would add an example of what is intended by 
that requirement. Specifically, we would add ``(e.g., a Salmonella test 
should be evaluated by NPIP authorized laboratories that test for 
Salmonella routinely).''
    Paragraph (a)(3) provides that, when evaluating an unlicensed test 
kit, the cooperating laboratories must perform a current NPIP procedure 
or NPIP approved test on the samples alongside the test kit for 
comparison. We are proposing to amend that requirement to state that 
the cooperating laboratory must also provide an outline of the method 
on the worksheet for diagnostic test evaluation and include 
reproducibility and robustness data. This additional requirement would 
allow the NPIP Technical Committee to fully evaluate the new test 
utilizing a concise template for information. Currently, companies 
submit upwards 50 pages of raw data to the Technical Committee to 
evaluate in order to make a recommendation. The new worksheet is only 
two pages, and the company submitting the test would only insert the 
most pertinent information needed for the Technical Committee to 
evaluate that test. The supporting data would also be submitted along 
with the 2-page worksheet, but would only need to be referenced when 
something was not clear on the worksheet.
    Finally, the regulations in paragraph (a)(4) refer to ``raw data'' 
compiled during the evaluation of the unlicensed test kit. We are 
proposing instead to refer to ``compiled output data.'' This change 
would reduce the amount of information (raw data) that companies would 
need to submit to the Technical Committee with the worksheet described 
in the previous paragraph. By eliminating the need for companies to 
submit only their complied output data rather than all the data in its 
raw form, we would reduce by up to half the amount of information to be 
submitted, which would also benefit the Technical Committee reviewers.

Editorial Correction

    The regulations in Sec.  145.93 contains several references to 
paragraph (a) of that section, which is reserved. We

[[Page 15085]]

would correct those references to cite paragraph (b).
Executive Orders 12866 and 13771 and Regulatory Flexibility Act
    This proposed 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.
    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on small entities. The 
analysis is summarized below. Copies of the full analysis are available 
by contacting the person listed under FOR FURTHER INFORMATION CONTACT 
or on the Regulations.gov website (see ADDRESSES above for instructions 
for accessing Regulations.gov).
    This rulemaking would result in various changes to 9 CFR parts 145 
through 147, modifying provisions of the National Poultry Improvement 
Plan (NPIP). The modifications are recommended by the NPIP General 
Conference Committee (GCC), which represents cooperating State agencies 
and poultry industry members and advises the Secretary on issues 
pertaining to poultry health. The rule would amend definitions, clarify 
the final determination status of pullorum-typhoid reactors, clarify 
requirements prior to comingling, allow for the use of reverse 
transcription polymerase chain reaction (RRT-PCR) for avian influenza 
surveillance under certain conditions, clarify testing requirements, 
update World Organization for Animal Health terminology, update testing 
requirements for M. gallisepticum and M. synoviae PCR testing, amend 
Form 9-31 requirements, add a U.S. Salmonella Monitored classification 
program, amend participation requirements, amend testing requirements 
for U.S. H5/H7 AI Monitored Classification Program, amend participation 
and voting requirements, amend Committee consideration of proposed 
changes, clarify check test proficiency requirements, and clarify 
requirements for new test submissions.
    These changes would align the regulations with international 
standards and make them more transparent to APHIS stakeholders and the 
general public. The changes in this proposed rule were voted on and 
approved by the voting delegates at the Plan's 2016 Biennial 
Conference.
    The establishments that would be affected by the proposed changes--
principally entities engaged in poultry production and processing--are 
predominantly small by Small Business Administration standards. In 
those instances in which an addition or modification could potentially 
result in a cost to certain entities, we do not expect the costs to be 
significant. This proposed rule embodies changes decided upon by the 
NPIP GCC on behalf of Plan members, that is, changes recognized by the 
poultry industry as in their interest. We note that NPIP membership is 
voluntary.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.
Executive Order 12372
    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 2 CFR chapter IV.)
Executive Order 12988
    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are in conflict with this rule will 
be preempted; (2) no retroactive effect will be given to this rule; and 
(3) administrative proceedings will not be required before parties may 
file suit in court challenging this rule.
Paperwork Reduction Act
    This proposed 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 propose to amend 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.

[[Page 15086]]

    (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 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

[[Page 15087]]

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) 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 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

[[Page 15088]]

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; 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).
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:
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).
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 (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:


[[Page 15089]]


    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.
* * * * *
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 3rd day of April 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-07076 Filed 4-6-18; 8:45 am]
 BILLING CODE 3410-34-P