National Poultry Improvement Plan and Auxiliary Provisions, 15652-15660 [2016-06664]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 81, Number 57 (Thursday, March 24, 2016)]
[Proposed Rules]
[Pages 15652-15660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06664]


========================================================================
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.

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


Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / 
Proposed Rules

[[Page 15652]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 56, 145, 146, and 147

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


National Poultry Improvement Plan and Auxiliary Provisions

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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

SUMMARY: We are proposing to amend the National Poultry Improvement 
Plan (NPIP, the Plan), its auxiliary provisions, and the indemnity 
regulations for the control of H5 and H7 low pathogenic avian influenza 
to clarify participation in the NPIP and amend participation 
requirements, amend definitions for poultry and breeding stock, amend 
the approval process for new diagnostic tests, and amend laboratory 
inspection and testing requirements. These changes would align the 
regulations with international standards and make them more transparent 
to Animal and Plant Health Inspection Service stakeholders and the 
general public. The proposed changes were voted on and approved by the 
voting delegates at the Plan's 2014 National Plan Conference.

DATES: We will consider all comments that we receive on or before May 
23, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2014-0101.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2014-0101, 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 https://www.regulations.gov/#!docketDetail;D=APHIS-2014-
0101 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 Brinson, DVM, Director, 
National Poultry Improvement Plan, VS, APHIS, USDA, 1506 Klondike Road, 
Suite 101, Conyers, GA 30094-5104; (770) 922-3496.

SUPPLEMENTARY INFORMATION:

Background

    The National Poultry Improvement Plan (NPIP, also referred to below 
as ``the Plan'') is a cooperative Federal-State-industry mechanism for 
controlling certain poultry diseases. The Plan consists of a variety of 
programs intended to prevent and control poultry diseases. 
Participation in all Plan programs is voluntary, but breeding flocks, 
hatcheries, and dealers must first qualify as ``U.S. Pullorum-Typhoid 
Clean'' as a condition for participating in the other Plan programs.
    The Plan identifies States, flocks, hatcheries, dealers, and 
slaughter plants that meet certain disease control standards specified 
in the Plan's various programs. As a result, customers can buy poultry 
that has tested clean of certain diseases or that has been produced 
under disease-prevention conditions.
    The regulations in 9 CFR parts 145, 146, and 147 (referred to below 
as the regulations) contain the provisions of the Plan. The Animal and 
Plant Health Inspection Service (APHIS, also referred to as ``the 
Service'') of the U.S. Department of Agriculture (USDA, also referred 
to as ``the Department'') amends these provisions from time to time to 
incorporate new scientific information and technologies within the 
Plan. In addition, the regulations in 9 CFR part 56 set out conditions 
for the payment of indemnity for costs associated with poultry that are 
infected with or exposed to H5/H7 low pathogenic avian influenza (LPAI) 
and provisions for a cooperative control program for the disease.
    The proposed amendments discussed in this document are consistent 
with the recommendations approved by the voting delegates to the last 
National Plan Conference, which was held on July 10 through 12, 2014. 
Participants in the National Plan Conference represented flockowners, 
breeders, hatcherymen, slaughter plants, poultry veterinarians, 
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.

Description of Plan Intention

    The NPIP regulations in 9 CFR parts 145 and 146 contain 
requirements that must be observed by flocks that participate in the 
Plan. Currently, Sec.  145.3 details the process by which a person 
becomes eligible to participate in the Plan. Any person producing or 
dealing in products may participate when he/she has demonstrated, to 
the satisfaction of the Official State Agency, that his/her facilities, 
personnel, and practices are adequate for carrying out the applicable 
provisions of the Plan, and has signed an agreement with the Official 
State Agency to comply with the general and the applicable specific 
provisions of the Plan and any regulations of the Official State Agency 
under Sec.  145.2. Affiliated flockowners may participate in the plan 
without signing an agreement with the Official State Agency. We are 
proposing to add additional language to this section to clarify that 
the NPIP is a cooperative Federal-State-Industry program through which 
new or existing diagnostic technology can be effectively applied to 
improve poultry and poultry products by controlling or eliminating 
specific poultry diseases. Because the Plan consists of programs that 
identify States, flocks, hatcheries, dealers, and slaughter plants that 
meet specific disease control standards specified in the Plan, we also 
propose to clarify that recordkeeping is important to demonstrate that 
participants adhere to the disease control programs in which they 
participate. We are proposing to add this language to paragraph (a) of 
Sec.  145.3.

Revision of Records Retention Requirement for Hatchery Inspections

    The regulations in Sec.  145.12 contain requirements for the 
retention and

[[Page 15653]]

examination of records for all flocks maintained primarily for hatching 
eggs. Historically, testing records were retained at the hatchery, 
which allowed for examination of the records during annual inspections. 
However, not many commercial hatcheries currently keep testing records 
for their breeder flocks at the hatchery and may instead keep the 
records at the corporate office. Therefore, we are proposing a minor 
change to the regulations to specify that records for all breeder flock 
hatcheries must be made available for annual examination by a State 
inspector. This change also maintains flexibility in who must make the 
records available. Such people may include the hatchery manager, the 
quality assurance manager, the laboratory manager, the breeder manager, 
or the hatchery information specialist.

Clarification of Official Testing Requirements for Pullorum-Typhoid, 
Mycoplasma gallisepticum, M. meleagridis, and M. synoviae

    The regulations in Sec.  145.14 contain requirements for conducting 
official tests for pullorum-typhoid, Mycoplasma gallisepticum, M. 
meleagridis, M. synoviae, and avian influenza. Paragraph (a) outlines 
specific testing requirements for pullorum-typhoid. Currently, 
paragraph (a)(5) states that the official blood test for pullorum-
typhoid shall include the testing of a sample of blood from each bird 
in the flock, provided that, under specified conditions in Sec. Sec.  
145.23, 145.33, 145.43, 145.53, and 145.63, the testing of a portion or 
sample of birds may be used in lieu of testing each bird. We are 
proposing to add Sec. Sec.  145.73, 145.83, and 145.93 to the list of 
sections referenced in Sec.  145.14(a)(5) as those sections are also 
applicable to pullorum-typhoid blood testing.
    Paragraph (b) outlines specific testing requirements for M. 
gallisepticum, M. meleagridis, and M. synoviae. Currently, official 
tests for M. gallisepticum, M. meleagridis, and M. synoviae include the 
serum plate agglutination test, the tube agglutination test, the 
hemagglutination inhibition (HI) test, the microhemagglutination 
inhibition test, the enzyme-linked immunosorbent assay, and the 
polymerase chain reaction (PCR)-based test. We are proposing to remove 
references to the tube agglutination test because that test is outdated 
and no longer in use. We are also proposing to remove references to the 
microhemagglutination test as the term microhemagglutination is an 
outdated term. In addition, we are proposing to remove the reference to 
the PCR test and replace it with the words ``molecular based test.'' 
This change is necessary because there are other molecular based tests 
in addition to the PCR test. Also, changing the language in the 
regulations to ``molecular based test'' allows for greater testing 
flexibility in the event that a better and more cost-effective or 
efficient molecular based test is developed in the future. Finally, 
while the widely accepted industry standard has been to use either the 
HI test or a molecular based test to confirm the positive results of 
serological screening tests, this requirement has not previously been 
included in our regulations. Therefore, we are proposing to amend the 
regulations to make that clarification.

Requirements for Nest Clean Hatching Eggs for Breeding Turkeys

    In a final rule \1\ published in the Federal Register on July 9, 
2014 (79 FR 38752-38768, Docket No. APHIS-2011-0101), with an effective 
date of August 8, 2014, we amended the regulations by, among other 
things, amending the requirements for participation in the Plan by 
multiplier egg-type breeding chickens, multiplier meat-type breeding 
chickens, primary egg-type breeding chickens, and primary meat-type 
breeding chickens to state that hatching eggs produced by the relevant 
flocks should be nest clean, and that they may be fumigated in 
accordance with part 147 or otherwise sanitized. ``Nest clean'' eggs 
are eggs that are collected from nests frequently to keep them clean 
without further processing. These changes were necessary because it has 
become standard practice within the industry to avoid sanitizing eggs 
and instead insist on nest clean eggs, which have been found to hatch 
better and provide a better chick than other eggs, even when they are 
sanitized. In addition, removing the requirement for fumigation and 
instead stating that hatching eggs ``may be'' fumigated or otherwise 
sanitized addresses changes made due to health restrictions and 
concerns related to staff safety, as well as aligning with changes made 
to the provisions for multiplier egg-type and meat-type chicken 
breeding flocks and primary egg-type and meat-type breeding flocks, 
following the 2010 NPIP Plan Conference.
---------------------------------------------------------------------------

    \1\ To view the final rule and related documents, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0101.
---------------------------------------------------------------------------

    The regulations in Sec.  145.42 outline the requirements with which 
turkey flocks, and the eggs and poults produced from them, must comply 
in order to participate in the Plan. Due to the same restrictions and 
concerns for staff safety for workers in the turkey industry and the 
same standard practice and benefits of requiring nest clean eggs, we 
are proposing to make the same changes to paragraph (b) of this section 
that were made in the July 2014 final rule for Sec. Sec.  145.22(b), 
145.32(b), 145.72(b), and 145.82(b).
    We are also proposing to amend the definition of breeding flock in 
Sec.  56.1 in order to be more inclusive of both chicken and turkey 
flocks. Currently, the definition for breeding flock refers to a 
``flock that is composed of stock that has been developed for 
commercial egg or meat production and is maintained for the principal 
purpose of producing chicks for the ultimate production of eggs or meat 
for human consumption.'' We propose to amend this definition to remove 
the word ``chicks'' and replace it with the word ``progeny.'' This 
change is also consistent with the definition of multiplier breeding 
flock in Sec.  145.1.

Changes to U.S. M. gallisepticum Clean and U.S. M. synoviae Clean 
Classification for Breeding Flocks of Hobbyist and Exhibition 
Waterfowl, Exhibition Poultry, and Game Birds

    The regulations in Sec.  145.53 set out classifications for 
hobbyist and exhibition waterfowl, exhibition poultry, and game bird 
breeding flocks and products. Paragraph (c) in Sec.  145.53 sets out 
the U.S. M. gallisepticum Clean classification for such poultry while 
paragraph (d) of that section sets out the U.S. M. synoviae Clean 
classification for such poultry.
    We are proposing to require targeted bird sampling of the choanal 
palatine cleft/fissure area using appropriate swabs as an alternative 
to the random serum or egg yolk sampling currently required for 
retention of the U.S. M. gallisepticum Clean classification. The 
choanal palatine cleft/fissure area is easier to swab and is also a 
very reliable site for detection of M. gallisepticum and M. synoviae. 
The targeted sampling of this area would provide a greater likelihood 
of detecting the organism of concern than either the random serum or 
egg yolk sampling methods.
    We are also proposing to change the size of the sample for U.S. M. 
gallisepticum testing from the current 5 percent of birds in the flock 
to at least 30 birds, or all birds in the flock if the flock size is 
less than 30. We would make the same change for a multiplier breeding 
flock which originated as U.S. M. gallisepticum Clean baby poultry from 
primary breeding flocks. Currently, sampling of such flocks must 
consist of at least 2 percent of birds in the flock. These changes 
would provide for a more appropriate level of sampling for M.

[[Page 15654]]

gallisepticum, particularly for those flocks that contain fewer than 30 
birds.
    Because M. gallisepticum and M. synoviae spread and infect birds 
similarly, we are proposing to amend the U.S. M. synoviae Clean 
classification to require that retention of that classification may 
also be obtained either by random sampling of serum or egg yolk or a 
targeted bird sample of the choanal palatine cleft/fissure area using 
appropriate swabs. Currently, the regulations do not specify how 
sampling is to be conducted. In addition, we are proposing to change 
the size of the sample for U.S. M. synoviae testing from at least 150 
birds in the flock to at least 30 birds, or all birds in the flock if 
the flock size is less than 30. Finally, for a multiplier breeding 
flock which originated as U.S. M. synoviae Clean baby poultry from 
primary breeding flocks, we would remove the requirement for sampling a 
minimum of 75 birds and instead require that a random sample contain 50 
percent of the birds in the flock with a maximum of 200 birds and a 
minimum of 30 birds, or all birds in the flock if the flock is less 
than 30 birds. This sampling would have to be conducted on birds that 
are at least 4 months of age or upon reaching sexual maturity.
    Assuming a normal distribution and an infection rate of 1 percent, 
changing the sample sizes as proposed does not greatly affect the 
chance of detecting a positive sample (confidence interval 
approximately 95 percent). These proposed sample size changes would 
allow us to increase the efficiency of the NPIP program by allowing 
resources to be used elsewhere.

Changes to U.S. Salmonella Monitored Certification Requirements

    The regulations in Sec.  145.83 set out the requirements for the 
classification of participating flocks, and the eggs and chicks 
produced from them, with respect to certain diseases. Paragraph (f) of 
Sec.  145.83 sets out requirements for preventing and controlling 
Salmonella in the breeding-hatching industry. Currently, a flock may be 
designated as U.S. Salmonella Monitored when, among other things, feed 
used for the flock, if containing animal proteins, adheres to certain 
processing requirements. We are proposing to remove these requirements 
because we believe that the rendering industry has appropriate 
standards to deal with the transmission of Salmonella through poultry 
feed and, therefore, these requirements are not necessary in the NPIP 
regulations. In addition, most of the primary meat type chicken 
industry today does not use animal protein products in their feed due 
to concerns of disease transmission. Therefore, we propose to amend the 
regulations in paragraph (f)(1)(i) to instead state that ``measures 
shall be implemented to control Salmonella challenge through the feed, 
feed storage, and feed transport.'' We also propose to remove 
paragraphs (f)(1)(ii) and (f)(1)(iii) and renumber paragraphs 
(f)(1)(iv) through (f)(1)(viii) as paragraphs (f)(1)(ii) through 
(f)(1)(vi).

Revision to Sanitation Requirements for Meat-Type Waterfowl

    The regulations in Sec. Sec.  145.91 and 145.92 set out special 
provisions for meat-type waterfowl and the eggs and baby poultry 
produced from them. Currently, paragraph (b) of Sec.  145.92 requires 
that hatching eggs produced by primary breeding flocks be fumigated in 
accordance with part 147 or otherwise sanitized. We are proposing to 
remove the requirement for fumigation and instead state that hatching 
eggs should be ``nest clean'' and that they ``may be'' fumigated or 
otherwise sanitized. We would also extend these requirements to 
multiplier breeding flocks, as these proposed requirements are meant to 
mirror the changes made to the provisions for multiplier egg-type and 
meat-type chicken breeding flocks and primary egg-type and meat-type 
breeding flocks, following the 2010 NPIP conference as well as the 
changes we are proposing to the regulations for breeding turkeys in 
Sec.  145.42.

Revision to Sample Size for U.S. H5/H7 Avian Influenza Clean 
Classification

    The regulations in Sec.  145.93 set out requirements for the 
classification of participating flocks of meat-type waterfowl and the 
eggs and baby poultry produced from them, with respect to certain 
diseases. Paragraph (c) of Sec.  145.93 sets out requirements for the 
classification of such flocks as U.S. H5/H7 Avian Influenza Clean. 
Currently, the regulations state that, in order for multiplier breeding 
flocks to retain this classification, a sample of at least 30 birds 
must either be tested negative for avian influenza at intervals of 180 
days, a sample of fewer than 30 birds may be tested and found negative 
for avian influenza at any one time if all pens are equally represented 
and a total of 30 birds are tested within each 180-day period, or a 
sample of at least 30 birds are tested and found negative to H5/H7 
avian influenza within 21 days prior to movement to slaughter.
    In the July 2014 final rule, we amended the regulations by changing 
the number of breeding birds required to be tested for avian influenza 
prior to movement to slaughter in Sec. Sec.  145.23, 145.33, and 
145.73. Rather than requiring 30 spent fowl to be tested, we now 
require the testing of a sample of 11 birds prior to movement to 
slaughter. This change was necessary because, generally, the entire 
flock of egg-type breeding chickens will be moved to slaughter at one 
time. Testing 11 birds per flock is also consistent with the testing 
requirements for meat-type commercial chickens moved to slaughter under 
the U.S. H5/H7 Avian Influenza Monitored program in Sec.  146.33, and 
provides adequate assurance that the flock is free of avian influenza. 
We are proposing to make the same change for meat-type waterfowl 
breeding flocks. Aligning sample numbers across similar flocks 
simplifies plan participation.

Changes to the List of Commercial Poultry Plan Participants

    Part 146 of the regulations contains the NPIP provisions for 
commercial poultry. Section 146.3 provides requirements for 
participation in the Plan by commercial table-egg producers, raised-
for-release upland game bird or waterfowl premises, commercial upland 
game bird or waterfowl slaughter plants, and meat-type chicken or 
turkey slaughter plants. We propose to amend the regulations to add 
commercial table-egg layer pullet flocks to the list of Plan 
participants in paragraph (c)(1) of Sec.  146.2 and paragraph (a) in 
Sec.  146.3. A commercial table-egg layer pullet flock is currently 
defined in Sec.  146.1 as a table-egg layer flock prior to the onset of 
egg production. The inclusion of these flock owners as Plan 
participants provides a means for NPIP staff to identify participation 
in the Plan and to help facilitate the movement of birds within States 
and across State lines.
    Finally, we are proposing to amend the definition of poultry in 
Sec.  146.1 to make it more inclusive of all domesticated fowl bred for 
the purpose of providing eggs or meat, including waterfowl and game 
birds. This change would be consistent with the poultry definition in 
Sec.  56.1 and Sec.  145.1.

Amendment to Slaughter Plant Inspection Requirements

    Section 146.11 of the regulations sets out the audit process for 
participating slaughter plants. Paragraph (b) states that flocks 
slaughtered at a slaughter plant will be considered to be not 
conforming to the required protocol of the classifications if there are 
no test results available, if the flock was not tested within 21 days 
before slaughter, or if the test results for the flocks were not 
returned before slaughter. We are

[[Page 15655]]

proposing to amend paragraph (b) to state that a flock will be 
considered to be conforming to protocol if it meets the requirements 
described in Sec. Sec.  146.33(a), 146.43(a), or 146.53(a). This change 
would correct problems inadvertently caused by combining all allowed 
testing requirements in 9 CFR part 146, subparts C, D, and E for 
participating slaughter plants into one set of testing requirements. 
One such problem was that the language in paragraph (b) directly 
contradicted the requirement allowing for testing at the slaughter 
plant on a shift basis. This change would also allow for future 
amendments to testing requirements for each subpart independent of one 
another and without having to amend the regulations in Sec.  146.11.

Addition of Testing Commercial Table-Egg Producing Upland Game Birds 
and Waterfowl for Avian Influenza

    The regulations in Sec. Sec.  146.51 through 146.53 contain special 
provisions related to the participation in the NPIP program by 
commercial upland game birds, commercial waterfowl, raised-for-release 
upland game birds, and raised-for-release waterfowl and the 
classification of such flocks as U.S. H5/H7 Avian Influenza Monitored. 
Commercial upland game birds and waterfowl are sometimes grown for the 
primary purpose of producing eggs for human consumption, notably in 
specialty markets, restaurants, and health food outlets. Because a 
significant number of these flocks are large in size, we believe that 
the creation of a mechanism for NPIP participation and avian influenza 
surveillance for such flocks would be beneficial to the poultry 
industry as a whole. Therefore, we are proposing to amend the 
definition for commercial upland game birds and commercial waterfowl in 
Sec.  146.51 to include birds grown for egg production. Currently, the 
definitions for these categories of birds include only those birds 
grown for the primary purpose of producing meat for human consumption.
    We are also proposing to add commercial upland game birds and 
commercial waterfowl producing eggs for human consumption to the list 
of Plan participants in paragraphs (a) and (c) of Sec.  146.52. We 
would also change the word ``purpose'' under both the definition for 
commercial upland game birds and commercial waterfowl to ``purposes.''
    Paragraph (a) of Sec.  146.53 contains the U.S. H5/H7 Avian 
Influenza Monitored classification for commercial waterfowl and 
commercial upland game birds. Currently, the commercial waterfowl and 
commercial upland game bird industry may earn U.S. H5/H7 Influenza 
Monitored classification by participating in routine surveillance for 
H5/H7 avian influenza through participating slaughter plants. We are 
proposing to add provisions for the regular surveillance of commercial 
waterfowl and game bird egg-producing flocks for avian influenza in new 
paragraphs (a)(4) and (a)(5). These provisions would require that a 
minimum of 11 birds per flock be tested negative to H5/H7 avian 
influenza as provided in Sec.  146.13 within 30 days of disposal or 
within a 12 month period or that the participating flock has an on-
going active and passive surveillance program for H5/H7 avian influenza 
approved by the Official State Agency and the Service.

Amendments to Authorized Laboratory Requirements

    Subpart F of part 147 contains provisions for authorized 
laboratories and approved test and sanitation procedures under the 
NPIP. Section 147.52 contains the current provisions for approving 
authorized laboratories. While these provisions currently require 
laboratories to undergo an annual site visit and recordkeeping audit by 
their Official State Agency in order to maintain authorization, 
laboratory procedures and personnel generally do not change on a yearly 
basis. In addition, the need for Official State Agencies to inspect 
laboratories in other States serving industry members within their own 
States has proven to unnecessarily consume time and travel funds best 
utilized in other areas of the Plan. Therefore, we are proposing to 
amend the regulations to require that site visits take place at least 
once every 2 years.

Amendments to the Approval Process for New Diagnostic Tests

    Section 147.54 outlines the required procedures for the approval of 
diagnostic test kits that are not licensed by APHIS. Current paragraph 
(a) states that the sensitivity of the kit will be estimated by testing 
known positive samples, as determined by official NPIP procedures found 
in the NPIP program standards or via other procedures approved by the 
Administrator. Because it is difficult to define a minor test 
modification versus a major test modification and to determine what 
data might be needed beforehand for a new test, we are proposing to 
allow the conditional use of a modified test side by side with the 
approved versions using field samples. This would make it easier for 
laboratories to participate in the test validation process. Field 
samples would have to be composed of those samples for which the 
presence or absence of the target organism or analyte has been 
determined by the current NPIP test rather than spiked samples or pure 
cultures. In addition, samples would have to come from a variety of 
field cases representing a range of low, medium, and high analyte 
concentrations. Spiked samples should only be used in the event that no 
other sample types are available. These changes would ensure that 
samples used for validation represent real samples and contain the same 
analytes and extraneous material that would be found in clinical 
samples. Realistic samples are critical to ensuring that a test will 
perform adequately with normal use. We are also proposing to clarify 
that laboratories should only be selected for their experience with 
testing for the target organism or analyte with the current NPIP 
approved test. Finally, we are proposing to remove the requirement that 
authorized laboratories be selected by the Service and clarify that the 
specificity of the kit will be ``evaluated'' rather than ``estimated'' 
in both current paragraphs (a) and (b) to provide more specific 
information on test performance. We are proposing this change because 
authorized NPIP laboratories use the same standards and guidelines. 
Therefore, any NPIP-authorized laboratory should be able to be utilized 
by any company seeking approval of a new test.
    We are also proposing to revise the regulations in current 
paragraph (c) to remove the requirement for clinical samples to be 
supplied by the manufacturer of the test kit. Further, we propose to 
require that at least 50 known negative samples be tested by each 
laboratory rather than the currently required 50 known negative 
clinical samples. Because it can be difficult to find clinical samples 
and to share clinical samples for logistical reasons, removing the 
requirements for clinical samples and for samples to be supplied by the 
test kit manufacturer would allow any entity to provide clinical 
samples. However, the negative samples would have to contain relevant 
sample matrices/extraneous material which would be found in clinical 
samples. In addition, requiring at least 50 known negative samples 
rather than 50 known negative samples is necessary because, in the 
past, we have received fewer than 50 samples from a company when more 
samples were unavailable. This change would make it clearer that we 
view any sample sets consisting of fewer than 50 samples as incomplete 
and that we

[[Page 15656]]

would not review such sample sets. We are also proposing to add 
language allowing cooperating laboratories to perform a current NPIP 
procedure or test on samples alongside the test kit for comparison, and 
specific testing procedures for Salmonella, Mycoplasma, and avian 
influenza, as well as molecular-based testing procedures to better 
account for the differences among the three agents.
    Paragraph (d) states that laboratories must submit assay response 
data to the kit manufacturer along with the official NPIP procedure. We 
are proposing to require that a worksheet for diagnostic test 
evaluation be submitted along with the raw data from the assay response 
and that the data and completed worksheet be submitted to the NPIP 
Senior Coordinator 4 months before the next General Conference 
Committee meeting, which is when test approval would be sought. 
Worksheets would be obtained by contacting the NPIP Senior Coordinator. 
The diagnostic test evaluation worksheet is intended to provide a 
standardized template to ensure that all needed data for test 
evaluation has been prepared and that the data is available in a 
uniform manner. This would make review of the data easier for the NPIP 
Technical Committee, which would facilitate the test approval process.
    Paragraph (e) puts forth the process by which the NPIP Technical 
Committee will make their decision about whether to approve a new 
diagnostic test. We propose to clarify that a majority of the members 
of the Technical Committee would have to recommend whether to approve 
the test kit and that this recommendation would have to occur at the 
next scheduled General Conference Committee meeting.
    Currently, the regulations do not provide procedures for modifying 
or removing diagnostic tests. Therefore, we are proposing to 
redesignate the introductory paragraph for Sec.  147.54 as paragraph 
(a) and the following paragraphs (a) through (f) as paragraphs (a)(1) 
through (6) and add a new paragraph (b) to describe how diagnostic 
tests may be modified or removed. The proposed requirements would 
require the submission of data in support of modifying or removing the 
test in question to the NPIP Technical Committee in a manner similar to 
that in place for the approval of new test kits in current paragraph 
(e).

Executive Order 12866 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.
    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 Web site (see ADDRESSES above for 
instructions for accessing Regulations.gov).
    The changes in this proposed rule are recommended by the NPIP 
General Conference Committee, which represents cooperating State 
agencies and poultry industry members and advises the Secretary of 
Agriculture on issues pertaining to poultry health. The proposed 
amendments to these regulations would improve the regulatory 
environment for poultry and poultry products.
    This rulemaking would result in various changes to 9 CFR parts 56 
and 145-147, modifying provisions of the NPIP. The proposed rule would 
clarify participation in the NPIP and amend participation requirements, 
amend definitions for poultry and breeding stock, amend the approval 
process for new diagnostic tests, and amend inspection and laboratory 
testing requirements. The proposed amendments to these regulations 
would improve the regulatory environment for poultry and poultry 
products.
    The establishments that would be affected by the proposed rule--
principally entities engaged in poultry production and processing--are 
predominantly small by Small Business Administration standards. In 
those instances in which an addition or modification could potentially 
result in a cost to certain entities, we do not expect the costs to be 
significant. This rule embodies changes decided upon by the NPIP 
General Conference Committee on behalf of Plan members, that is, 
changes recognized by the poultry industry as in their interest. We 
note that NPIP membership is voluntary.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action would 
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.)

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. APHIS-
2014-0101. Please send a copy of your comments to: (1) APHIS, using one 
of the methods described under ADDRESSES at the beginning of this 
document, and (2) Clearance Officer, OCIO, USDA, Room 404-W, 14th 
Street and Independence Avenue SW., Washington, DC 20250. A comment to 
OMB is best assured of having its full effect if OMB receives it within 
30 days of publication of this proposed rule.
    We are proposing to amend the NPIP, its auxiliary provisions, and 
the indemnity regulations for the control of H5 and H7 low pathogenic 
avian influenza to clarify participation in the NPIP and amend 
participation requirements, amend definitions for poultry and breeding 
stock, amend the approval process for new diagnostic tests, and amend 
laboratory inspection and testing requirements. These changes would 
align the regulations with international standards and make them more 
transparent to APHIS stakeholders and the general public.
    Implementing this rule will require certain new information 
collection activities such as Waterfowl and Game Bird Surveillance and 
Diagnostic Test Evaluation Worksheets. APHIS is asking OMB to approve, 
for 3 years, its use of these information collection activities in 
connection with APHIS' efforts to continually improve the health of the 
U.S. poultry population and the quality of U.S. poultry products. The 
NPIP has an existing information collection under OMB control number 
0579-0007. At the next renewal of 0579-0007, we will merge the 
activities added by this proposed rule, subject to OMB approval.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;

[[Page 15657]]

    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 1.8 hours per response.
    Respondents: Flock owners, breeders, hatchery owners, table egg 
producers, laboratory personnel, and State animal health officials.
    Estimated annual number of respondents: 10.
    Estimated annual number of responses per respondent: 1.
    Estimated annual number of responses: 10.
    Estimated total annual burden on respondents: 18 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    Copies of this information collection can be obtained from Ms. 
Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 
851-2727.

E-Government Act Compliance

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

List of Subjects

9 CFR Part 56

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

9 CFR Parts 145, 146, and 147

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

    Accordingly, we propose to amend 9 CFR parts 56, 145, 146, and 147 
as follows:

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

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

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

0
2. Section 56.1 is amended by revising the definition of breeding flock 
to read as follows:


Sec.  56.1  Definitions.

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

PART 145--NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY

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

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


Sec.  145.2  [Amended]

0
4. In Sec.  145.2, paragraph (d) is amended by removing the words 
``Sec.  145.3(d)'' and adding the words ``Sec.  145.3(e)'' in their 
place.
0
5. Section 145.3 is amended as follows:
0
a. By redesignating paragraphs (a) through (f) as paragraphs (b) 
through (g), respectively.
0
b. By adding a new paragraph (a).
    The addition reads as follows:


Sec.  145.3  Participation.

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


Sec.  145.12  [Amended]

0
6. Section 145.12 is amended by adding, in paragraph (b), the words 
``made available to and'' before the word ``examined''.
0
7. Section 145.14 is amended as follows:
0
a. By revising paragraph (a)(5).
0
b. By revising paragraph (b)(1).
    The revisions read as follows:


Sec.  145.14  Testing.

* * * * *
    (a) * * *
    (5) The official blood test shall include the testing of a sample 
of blood from each bird in the flock: Provided, That under specified 
conditions (see applicable provisions of Sec. Sec.  145.23, 145.33, 
145.43, 145.53, 145.63, 145.73, 145.83, and 145.93) the testing of a 
portion or sample of the birds may be used in lieu of testing each 
bird.
* * * * *
    (b) * * *
    (1) The official tests for M. gallisepticum, M. meleagridis, and M. 
synoviae shall be the serum plate agglutination test, the 
hemagglutination inhibition (HI) test, the enzyme-linked immunosorbent 
assay (ELISA) test \3\, or a molecular based test. The HI test or 
molecular based test shall be used to confirm the positive results of 
other serological screening tests. HI titers of 1:40 or more may be 
interpreted as suspicious, and final judgment must be based on further 
samplings and/or culture of reactors. Tests must be conducted in 
accordance with this paragraph (b) and in accordance with part 147 of 
this subchapter.
* * * * *
    \3\ Procedures for the enzyme-linked immunosorbent assay (ELISA) 
test are set forth in the following publications:

A.A. Ansari, R.F. Taylor, T.S. Chang, ``Application of Enzyme-Linked 
Immunosorbent Assay for Detecting Antibody to Mycoplasma gallisepticum 
Infections in Poultry,'' Avian Diseases, Vol. 27, No. 1, pp. 21-35, 
January-March 1983; and
H.M. Opitz, J.B. Duplessis, and M.J. Cyr, ``Indirect Micro-Enzyme-
Linked Immunosorbent Assay for the Detection of Antibodies to 
Mycoplasma synoviae and M. gallisepticum,'' Avian Diseases, Vol. 27, 
No. 3, pp. 773-786, July-September 1983; and
H.B. Ortmayer and R. Yamamoto, ``Mycoplasma Meleagridis Antibody 
Detection by Enzyme-Linked Immunosorbent Assay (ELISA),'' Proceedings, 
30th Western Poultry Disease Conference, pp. 63-66, March 1981.
0
8. In Sec.  145.42, paragraph (b) is revised to read as follows:

[[Page 15658]]

Sec.  145.42  Participation.

* * * * *
    (b) Hatching eggs should be nest clean. They may be fumigated in 
accordance with part 147 of this subchapter or otherwise sanitized.
* * * * *
0
9. Section 145.53 is amended as follows:
0
a. By revising paragraphs (c)(1)(i), (c)(1)(ii) introductory text, and 
(c)(1)(ii)(A).
0
b. By revising paragraphs (d)(1)(i), (d)(1)(ii) introductory text, and 
(d)(1)(ii)(A).
    The revisions read as follows:


Sec.  145.53  Terminology and classification; flocks and products.

* * * * *
    (c) * * *
    (1) * * *
    (i) It is a flock in which all birds or a sample of at least 300 
birds has been tested for M. gallisepticum as provided in Sec.  
145.14(b) when more than 4 months of age or upon reaching sexual 
maturity: Provided, That to retain this classification, a random sample 
of serum or egg yolk or a targeted bird sample of the choanal palatine 
cleft/fissure area using appropriate swabs from all the birds in the 
flock if the flock size is less than 30, but at least 30 birds, shall 
be tested at intervals of not more than 90 days: And provided further, 
That a sample comprised of less than 30 birds may be tested at any one 
time, with the approval of the Official State Agency and the 
concurrence of the Service, provided that a total of at least 30 birds, 
or all birds in the flock if flock size is less than 30, is tested 
within each 90-day period; or
    (ii) It is a multiplier breeding flock which originated as U.S. M. 
Gallisepticum Clean baby poultry from primary breeding flocks and a 
random sample comprised of 50 percent of the birds in the flock, with a 
maximum of 200 birds and a minimum of 30 birds per flock or all birds 
in the flock if the flock size is less than 30 birds, has been tested 
for M. gallisepticum as provided in Sec.  145.14(b) when more than 4 
months of age or upon reaching sexual maturity: Provided, That to 
retain this classification, the flock shall be subjected to one of the 
following procedures:
    (A) At intervals of not more than 90 days, a random sample of serum 
or egg yolk or a targeted bird sample of the choanal palatine cleft/
fissure area using appropriate swabs from all the birds in the flock if 
flock size is less than 30, but at least 30 birds, shall be tested; or
* * * * *
    (d) * * *
    (1) * * *
    (i) It is a flock in which all birds or a sample of at least 300 
birds has been tested for M. synoviae as provided in Sec.  145.14(b) 
when more than 4 months of age or upon reaching sexual maturity: 
Provided, That to retain this classification, a random sample of serum 
or egg yolk or a targeted bird sample of the choanal palatine cleft/
fissure area using appropriate swabs (C.P. swabs) from all the birds in 
the flock if flock size is less than 30, but at least 30 birds, shall 
be tested at intervals of not more than 90 days: And provided further, 
That a sample comprised of less than 30 birds may be tested at any one 
time with the approval of the Official State Agency and the concurrence 
of the Service, provided that a total of at least 30 birds is tested 
within each 90-day period; or
    (ii) It is a multiplier breeding flock that originated as U.S. M. 
Synoviae Clean chicks from primary breeding flocks and from which a 
random sample comprised of 50 percent of the birds in the flock, with a 
maximum of 200 birds and a minimum of 30 birds per flock or all birds 
in the flock if the flock is less than 30 birds, has been tested for M. 
synoviae as provided in Sec.  145.14(b) when more than 4 months of age 
or upon reaching sexual maturity: Provided, That to retain this 
classification, the flock shall be subjected to one of the following 
procedures:
    (A) At intervals of not more than 90 days, a random sample of serum 
or egg yolk or a targeted bird sample of the choanal palantine cleft/
fissure area using appropriate swabs from all the birds in the flock if 
the flock size is less than 30, but at least 30 birds shall be tested: 
Provided, That a sample of fewer than 30 birds may be tested at any one 
time with the approval of the Official State Agency and the concurrence 
of the Service, provided that a total of at least 30 birds, or the 
entire flock if flock size is less than 30, is tested each time and a 
total of at least 30 birds is tested within each 90-day period; or
* * * * *
0
10. Section 145.83 is amended as follows:
0
a. By revising paragraph (f)(1)(i).
0
b. By removing paragraphs (f)(1)(ii) and (f)(1)(iii).
0
c. By redesignating paragraphs (f)(1)(iv) through (f)(1)(viii) as 
paragraphs (f)(1)(ii) through (f)(1)(vi).
0
d. In newly redesignated paragraphs (f)(1)(v) and (f)(1)(vi) by 
removing the words ``(f)(1)(vi)'' and adding the words ``(f)(1)(iv)'' 
in their place.
0
e. By revising paragraph (f)(3).
    The revisions read as follows:


Sec.  145.83  Terminology and classification; flocks and products.

* * * * *
    (f) * * *
    (1) * * *
    (i) Measures shall be implemented to control Salmonella challenge 
through feed, feed storage, and feed transport.
* * * * *
    (3) In order for a hatchery to sell products of paragraphs 
(f)(1)(i) through (f)(1)(vi) of this section, all products handled 
shall meet the requirements of the classification.
* * * * *
0
11. In Sec.  145.92, paragraph (b) is revised to read as follows:


Sec.  145.92  Participation.

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


Sec.  145.93  [Amended]

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

PART 146--NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY

0
13. The authority citation for part 146 continues to read as follows:

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

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


Sec.  146.1  Definitions.

* * * * *
    Poultry. Domesticated fowl, including chickens, turkeys, waterfowl, 
and game birds, except doves and pigeons, that are bred for the primary 
purpose of producing eggs or meat.
* * * * *
0
15. Section 146.2 is amended by revising paragraph (c) to read as 
follows:


Sec.  146.2  Administration.

* * * * *
    (c)(1) An Official State Agency may accept for participation a 
commercial table-egg layer pullet flock, commercial table-egg layer 
flock, or a commercial meat-type flock (including an affiliated flock) 
located in another participating State under a mutual understanding and

[[Page 15659]]

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


Sec.  146.3  [Amended]

0
16. In Sec.  146.3, paragraph (a) is amended by adding the words 
``commercial table-egg layer pullet flock,'' before the words ``table-
egg producer''.
0
17. In Sec.  146.11, paragraph (b) is revised to read as follows:


Sec.  146.11  Inspections.

* * * * *
    (b) A flock will be considered to be conforming to protocol if it 
meets the requirements as described in Sec.  145.33(a), Sec.  
146.43(a), or Sec.  146.53(a) of this chapter.
* * * * *


Sec.  146.51  [Amended]

0
18. Section 146.51 is amended as follows:
0
a. In the definition of commercial upland game birds by changing the 
word ``purpose'' to ``purposes'' and adding the words ``eggs and/or'' 
before the word ``meat''.
0
b. In the definition of commercial waterfowl, by changing the word 
``purpose'' to ``purposes'' and adding the words ``eggs and/or'' before 
the word ``meat''.
0
19. Section 146.52 is amended by revising paragraphs (a) and (c) to 
read as follows:


Sec.  146.52  Participation.

    (a) Participating commercial upland game bird slaughter plants, 
commercial waterfowl slaughter plants, raised-for-release upland game 
bird premises, raised-for-release waterfowl premises, and commercial 
upland game bird and commercial waterfowl producing eggs for human 
consumption premises shall comply with the applicable general 
provisions of subpart A of this part and the special provisions of this 
subpart E.
* * * * *
    (c) Raised-for-release upland game bird premises, raised-for-
release waterfowl premises, and commercial upland game bird and 
commercial waterfowl producing eggs for human consumption premises that 
raise fewer than 25,000 birds annually are exempt from the special 
provisions of this subpart E.
0
20. Section 146.53 is amended as follows:
0
a. In paragraph (a) introductory text, by adding the words ``or, in the 
case of egg-producing flocks, the regular surveillance of these 
flocks'' after the words ``participating slaughter plant''.
0
b. By adding paragraphs (a)(4) and (a)(5).
    The additions read as follows:


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

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

PART 147--AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN

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

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

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


Sec.  147.52  Authorized laboratories.

* * * * *
    (d) State site visit. The Official State Agency will conduct a site 
visit and recordkeeping audit at least once every 2 years. This will 
include, but may not be limited to, review of technician training 
records, check test proficiency, and test results. The information from 
the site visit and recordkeeping audit will be made available to the 
NPIP upon request.
* * * * *
0
23. Section 147.54 is revised to read as follows:


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

    (a) Diagnostic test kits that are not licensed by the Service 
(e.g., bacteriological culturing kits) may be approved through the 
following procedure:
    (1) The sensitivity of the kit will be evaluated in at least three 
NPIP authorized laboratories by testing known positive samples, as 
determined by the official NPIP procedures found in the NPIP Program 
Standards or through other procedures approved by the Administrator. 
Field samples for which the presence or absence of the target organism 
or analyte has been determined by the current NPIP test should be used, 
not spiked samples or pure cultures. Samples from a variety of field 
cases representing a range of low, medium, and high analyte 
concentrations should be used. In some cases it may be necessary to 
utilize samples from experimentally infected animals. Spiked samples 
(clinical sample matrix with a known amount of pure culture added) 
should only be used in the event that no other sample types are 
available. Pure cultures should never be used. Additionally, 
laboratories should be selected for their experience with testing for 
the target organism or analyte with the current NPIP approved test. If 
certain conditions or interfering substances are known to affect the 
performance of the kit, appropriate samples will be included so that 
the magnitude and significance of the effect(s) can be evaluated.
    (2) The specificity of the kit will be evaluated in at least three 
NPIP authorized laboratories by testing known negative samples, as 
determined by tests conducted in accordance with the NPIP Program 
Standards or other procedures approved by the Administrator in 
accordance with Sec.  147.53(d)(1). If certain conditions or 
interfering substances are known to affect the performance of the kit, 
appropriate samples will be included so that the magnitude and 
significance of the effect(s) can be evaluated.
    (3) The kit will be provided to the cooperating laboratories in its 
final form and include the instructions for use. The cooperating 
laboratories must perform the assay exactly as stated in the supplied 
instructions. Each laboratory must test a panel of at least 25 known 
positive samples. In addition, each laboratory will be asked to test at 
least 50 known negative samples obtained from several sources, to 
provide a representative sampling of the general population. The 
cooperating laboratories must perform a current NPIP procedure or NPIP 
approved test on the samples alongside the test kit for comparison.
    (4) Cooperating laboratories will submit to the kit manufacturer 
all raw data regarding the assay response. Each

[[Page 15660]]

sample tested will be reported as positive or negative, and the 
official NPIP procedure used to classify the sample must be submitted 
in addition to the assay response value. A completed worksheet for 
diagnostic test evaluation is required to be submitted with the raw 
data and may be obtained by contacting the NPIP Senior Coordinator. Raw 
data and the completed worksheet for diagnostic test evaluation must be 
submitted to the NPIP Senior Coordinator 4 months prior to the next 
scheduled General Conference Committee meeting, which is when approval 
will be sought.
    (5) The findings of the cooperating laboratories will be evaluated 
by the NPIP Technical Committee, and the Technical Committee will make 
a majority recommendation whether to approve the test kit to the 
General Conference Committee at the next scheduled General Conference 
Committee meeting. If the Technical Committee recommends approval, the 
final approval will be granted in accordance with the procedures 
described in Sec. Sec.  147.46, 147.47, and 147.48.
    (6) Diagnostic test kits that are not licensed by the Service 
(e.g., bacteriological culturing kits) and that have been approved for 
use in the NPIP in accordance with this section are listed in the NPIP 
Program Standards.
    (b) Approved tests modification and removal. (1) The specific data 
required for modifications of previously approved tests will be taken 
on a case-by-case basis by the technical committee.
    (2) If the Technical Committee determines that only additional 
field data is needed at the time of submission for a modification of a 
previously approved test, allow for a conditional approval for 60 days 
for data collection side-by-side with a current test. The submitting 
party must provide complete protocol and study design, including 
criteria for pass/fail to the Technical Committee. The Technical 
Committee must review the data prior to final approval. This would only 
apply to the specific situation where a modified test needs additional 
field data with poultry to be approved.
    (3) Approved diagnostic tests may be removed from the Plan by 
submission of a proposed change from a participant, Official State 
Agency, the Department, or other interested person or industry 
organization. The data in support of removing an approved test will be 
compiled and evaluated by the NPIP Technical Committee, and the 
Technical Committee will make a majority recommendation whether to 
remove the test kit to the General Conference Committee at the next 
scheduled General Conference Committee meeting. If the Technical 
Committee recommends removal, the final decision to remove the test 
will be granted in accordance with the procedures described in 
Sec. Sec.  147.46, 147.47, and 147.48.

    Done in Washington, DC, this 18th day of March 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-06664 Filed 3-23-16; 8:45 am]
BILLING CODE 3410-34-P