National Poultry Improvement Plan and Auxiliary Provisions, 28351-28356 [2018-13128]
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28351
Rules and Regulations
Federal Register
Vol. 83, No. 118
Tuesday, June 19, 2018
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents.
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
Animal and Plant Health
Inspection Service, USDA.
ACTION: Final rule.
AGENCY:
We are amending the
regulations governing the National
Poultry Improvement Plan (NPIP) by
updating and clarifying several
provisions, including those concerning
NPIP participation, voting requirements,
testing procedures, and standards. The
changes in this final rule were voted on
and approved by the voting delegates at
the Plan’s 2016 National Plan
Conference.
SUMMARY:
DATES:
Effective July 19, 2018.
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.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
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Background
The National Poultry Improvement
Plan (NPIP, also referred to below as
‘‘the Plan’’) is a cooperative FederalState-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.
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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 diseaseprevention conditions.
The regulations in 9 CFR parts 145,
146, and 147 (referred to below as the
regulations) contain the provisions of
the Plan. The Animal and Plant Health
Inspection Service (APHIS or the
Service) amends these provisions from
time to time to incorporate new
scientific information and technologies
within the Plan.
On April 9, 2018, we published in the
Federal Register (83 FR 15082–15089,
Docket No. APHIS–2017–0055) a
proposal 1 to amend the regulations by
updating and clarifying several
provisions, including those concerning
NPIP participation, voting requirements,
testing procedures, and standards.
We solicited comments concerning
our proposal for 30 days ending May 9,
2018. We received two comments by
that date. One individual was generally
opposed to the rule and the poultry
industry, but did not address any
specific provisions of the proposed rule.
The other commenter also did not
address the provisions of the proposed
rule, but instead addressed his
comments to the statements made by the
first commenter.
Therefore, for the reasons given in the
proposed rule, we are adopting the
proposed rule as a final rule, without
change.
Regulations.gov website (see footnote 1
in this document for a link to
Regulations.gov) or by contacting the
person listed under FOR FURTHER
INFORMATION CONTACT.
We are amending the NPIP, its
auxiliary provisions, and the indemnity
regulations for the control of H5 and H7
low pathogenic avian influenza to align
the regulations with international
standards and make them more
transparent to stakeholders and the
general public. The changes in this final
rule were voted on and approved by the
voting delegates at the 2016 NPIP
National Plan Conference.
The establishments that will be
affected by the rule—principally entities
engaged in poultry production and
processing—are predominantly small by
Small Business Administration
standards. In those instances in which
an addition to or modification of
requirements could potentially result in
a cost to certain entities, we do not
expect the costs to be significant. NPIP
membership is voluntary. The changes
contained in this final rule were
decided upon by the NPIP General
Conference Committee and voting
delegates during the 2016 NPIP Biennial
Conference; the changes were
recognized by the poultry industry as
being in their interest.
Under these circumstances, the
Administrator of the Animal and Plant
Health Inspection Service has
determined that this action will not
have a significant economic impact on
a substantial number of small entities.
Executive Orders 12866 and 13771 and
Regulatory Flexibility Act
Executive Order 12372
This final rule has been determined to
be not significant for the purposes of
Executive Order 12866 and, therefore,
has not been reviewed by the Office of
Management and Budget. Further,
because this rule is not significant, it is
not a regulatory action under Executive
Order 13771.
We have prepared an analysis
regarding the economic effects of this
final rule on small entities. The analysis
is summarized below. Copies of the full
analysis are available on the
1 To view the proposed rule, supporting
document, and the comments we received, go to
https://www.regulations.gov/
#!docketDetail;D=APHIS-2017-0055.
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This program/activity is listed in the
Catalog of Federal Domestic Assistance
under No. 10.025 and is subject to
Executive Order 12372, which requires
intergovernmental consultation with
State and local officials. (See 2 CFR
chapter IV.)
Executive Order 12988
This final rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. This rule: (1) Preempts
all State and local laws and regulations
that are in conflict with this rule; (2) has
no retroactive effect; and (3) does not
require administrative proceedings
before parties may file suit in court
challenging this rule.
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Paperwork Reduction Act
This final rule contains no new
information collection or recordkeeping
requirements under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
adding the words ‘‘, unless otherwise
specified within the Plan program’’ after
the words ‘‘must be tested’’; and
■ b. By revising paragraph (d)(2)(i)(A).
The revision reads as follows:
List of Subjects in 9 CFR Parts 145, 146,
and 147
Animal diseases, Poultry and poultry
products, Reporting and recordkeeping
requirements.
Accordingly, we are amending 9 CFR
parts 145, 146, and 147 as follows:
*
PART 145—NATIONAL POULTRY
IMPROVEMENT PLAN FOR BREEDING
POULTRY
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.
2. In § 145.1, the definition of NPIP
Technical Committee is amended by
adding three sentences after the last
sentence to read as follows:
■
§ 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.
*
*
*
*
*
§ 145.4
[Amended]
3. In § 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’’.
■
§ 145.10
[Amended]
4. In § 145.10, paragraph (o) is
amended by adding the citation
‘‘§ 145.73(g),’’ after the citation
‘‘§ 145.53(f),’’.
■ 5. Section 145.14 is amended as
follows:
■ 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
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■
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§ 145.14
Testing.
*
*
*
*
(d) * * *
(2) * * *
(i) * * *
(A) The RRT–PCR tests must be
conducted using reagents approved by
the Department and the Official State
Agency. The RRT–PCR must be
conducted using the National Veterinary
Services Laboratories (NVSL) official
protocol for RRT–PCR or a test kit
licensed by the Department and
approved by the Official State Agency
and the State Animal Health Official,
and must be conducted by personnel
who have passed an NVSL proficiency
test. For non-National Animal Health
Laboratory Network (NAHLN)
authorized laboratories:
(1) RRT–PCR testing may be used by
primary breeder company authorized
laboratories.
(2) RRT–PCR testing can only be
performed on their own breeding flocks
and only used for routine surveillance.
(3) The authorized laboratory must
have a quality system that is accredited
as ISO/IEC 17025 or equivalent to
perform the avian influenza RRT–PCR
assay.
(4) The use of the RRT–PCR test by
the authorized laboratory must be
approved in the memorandum of
understanding (MOU) between the
authorized laboratory, the Official State
Agency, and the State Animal Health
Official(s) of both the location of the
authorized laboratory and the location
where the breeding flocks reside.
(5) Split samples for testing must
occur between the authorized laboratory
and a NAHLN laboratory at a frequency
designated in the MOU.
*
*
*
*
*
■ 6. In § 145.23, paragraph (b)(1) is
revised to read as follows:
§ 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.
*
*
*
*
*
■ 7. In § 145.33, paragraph (b)(1) is
revised to read as follows:
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§ 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.
*
*
*
*
*
■ 8. In § 145.43, paragraphs (b)(1) and
(5) are revised to read as follows:
§ 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.
*
*
*
*
*
■ 9. Section 145.45 is amended as
follows:
■ a. By revising paragraph (a)
introductory text; and
■ b. By removing the word ‘‘NAI’’ and
adding the words ‘‘H5/H7 AI’’ in its
place each time it appears in the
following paragraphs:
■ i. Paragraph (a)(1) introductory text;
■ ii. Paragraph (a)(1)(i);
■ iii. Paragraph (a)(1)(iii) introductory
text;
■ iv. Paragraph (a)(1)(v);
■ v. Paragraph (a)(2)(iii); and
■ vi. Paragraph (a)(4).
The revision reads as follows:
§ 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
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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:
*
*
*
*
*
■ 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:
§ 145.52
Participation.
*
*
*
*
(d) * * *
(7) The NPIP hatchery approval
number of the shipping hatchery;
*
*
*
*
*
■ 11. Section 145.53 is amended as
follows:
■ a. By revising paragraphs (b)(1) and
(b)(5);
■ 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.
■ c. By revising paragraph (c)(1)(ii)
introductory text;
■ 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;
■ 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.
■ f. By revising paragraph (d)(1)(ii)
introductory text; and
■ 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:
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*
§ 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
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bacteriological examination conducted
in accordance with part 147 of this
subchapter, fail to isolate S. pullorum or
S. gallinarum.
*
*
*
*
*
(5) It is a primary breeding flock
located in a State determined to be in
compliance with the provisions of
paragraph (b)(4) of this section, and in
which a sample of 300 birds from flocks
of more than 300, and each bird in
flocks of 300 or less, has been officially
tested for pullorum-typhoid within the
past 12 months with either no reactors
or reactors that, upon further
bacteriological examination conducted
in accordance with part 147 of this
subchapter, fail to isolate S. pullorum or
S. gallinarum: Provided, That a
bacteriological examination monitoring
program or serological examination
monitoring program for game birds
acceptable to the Official State Agency
and approved by the Service may be
used in lieu of annual blood testing:
And Provided further, That when a flock
is a hobbyist or exhibition waterfowl or
exhibition poultry primary breeding
flock located in a State which has been
deemed to be a U.S. Pullorum-Typhoid
Clean State for the past 3 years, and
during which time no isolation of
pullorum or typhoid has been made that
can be traced to a source in that State,
a bacteriological examination
monitoring program or a serological
examination monitoring program
acceptable to the Official State Agency
and approved by the Service may be
used in lieu of annual blood testing.
(c) * * *
(1) * * *
(ii) It is a multiplier breeding flock
which originated as U.S. M.
Gallisepticum Clean baby poultry from
primary breeding flocks and from which
a random sample of birds has been
tested for M. gallisepticum as provided
in § 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 § 145.14(b) when more
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28353
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:
*
*
*
*
*
■ 12. Section 145.63 is amended by
revising paragraphs (a)(1) and (a)(2)(i) to
read as follows:
§ 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.
*
*
*
*
*
■ 13. Section 145.73 is amended as
follows:
■ a. By revising paragraphs (b)(1) and
(b)(2)(ii); and
■ b. By adding paragraph (g).
The revisions and addition read as
follows:
§ 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
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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.
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(vi) Owners of flocks may vaccinate
with a paratyphoid vaccine: Provided,
That a sample of 350 birds, which will
be banded for identification, shall
remain unvaccinated until the flock
reaches at least 4 months of age to allow
for the serological testing required
under paragraph (g)(1)(iv) of this
section.
(vii) Any flock entering the
production period that is in compliance
with all the requirements of this
paragraph (g) with no history of
Salmonella isolations shall be
considered ‘‘Salmonella negative’’ and
may retain this definition as long as no
environmental or bird Salmonella
isolations are identified and confirmed
from the flock or flock environment by
sampling on four separate collection
dates over a minimum of a 2-week
period. Sampling and testing must be
performed as described in paragraph
(g)(1)(vi) of this section. An
unconfirmed environmental Salmonella
isolation shall not change this
Salmonella negative status.
(2) The Official State Agency may
monitor the effectiveness of the
sanitation practices in accordance with
part 147 of this subchapter.
(3) In order for a hatchery to sell
products of paragraphs (g)(1)(i) through
(vii) of this section, all products
handled shall meet the requirements of
the classification.
(4) This classification may be revoked
by the Official State Agency if the
participant fails to follow recommended
corrective measures.
§ 145.74
[Amended]
14. Section 145.74 is amended as
follows:
■ 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.
■ b. By removing the word ‘‘NAI’’ and
adding the words ‘‘H5/H7 AI’’ in its
place each time it appears in the
following paragraphs:
i. Paragraph (a)(1) introductory text;
ii. Paragraph (a)(1)(iii) introductory
text;
iii. Paragraph (a)(1)(v);
iv. Paragraph (a)(2)(iii); and
v. Paragraph (a)(4).
■ c. By removing the word ‘‘NAIrelated’’ and adding the words ‘‘H5/H7
AI-related’’ in its place in paragraph
(a)(1)(i).
■ 15. Section 145.82 is amended by
adding paragraph (d) to read as follows:
■
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§ 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.
■ 16. Section 145.83 is amended by
revising paragraphs (b)(1) and (b)(2)(ii)
to read as follows:
§ 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.
*
*
*
*
*
§ 145.84
[Amended]
17. Section 145.84 is amended as
follows:
■ 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
■ b. By removing the word ‘‘NAI’’ and
adding the words ‘‘H5/H7 AI’’ in its
place each time it appears in the
following paragraphs:
i. Paragraph (a)(1) introductory text;
ii. Paragraph (a)(1)(iii) introductory
text;
iii. Paragraph (a)(1)(v);
iv. Paragraph (a)(2)(iii); and
v. Paragraph (a)(4).
■ c. By removing the word ‘‘NAIrelated’’ and adding the words ‘‘H5/H7
■
E:\FR\FM\19JNR1.SGM
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Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations
AI-related’’ in its place in paragraph
(a)(1)(i).
■ 18. Section 145.93 is amended as
follows:
■ a. By revising paragraph (b)(1);
■ 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;
■ c. In paragraph (b)(4), by removing the
words ‘‘paragraph (a)(3)’’ and adding the
words ‘‘paragraph (b)(3)’’ in their place;
and
■ d. By revising paragraph (b)(5).
The revisions read as follows:
§ 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.
*
*
*
*
*
daltland on DSKBBV9HB2PROD with RULES
PART 146—NATIONAL POULTRY
IMPROVEMENT PLAN FOR
COMMERCIAL POULTRY
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.
20. In § 146.1, a definition of NPIP
Technical Committee is added in
alphabetical order to read as follows:
■
VerDate Sep<11>2014
20:20 Jun 18, 2018
Jkt 244001
§ 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.
*
*
*
*
*
[Amended]
21. In § 146.23, paragraphs (a)(1)(i)
and (a)(2)(i) are amended by removing
the number ‘‘30’’ and adding the
number ‘‘21’’ in its place.
■
PART 147—AUXILIARY PROVISIONS
ON NATIONAL POULTRY
IMPROVEMENT PLAN
22. The authority citation for part 147
continues to read as follows:
■
Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22,
2.80, and 371.4.
23. In § 147.41, the definition of NPIP
Technical Committee is amended by
adding three sentences after the last
sentence to read as follows:
■
§ 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.
*
*
*
*
*
PO 00000
Frm 00005
Fmt 4700
24. In § 147.43, paragraph (b) is
amended by adding a sentence after the
second sentence to read as follows:
■
*
§ 146.23
28355
Sfmt 4700
§ 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. * * *
*
*
*
*
*
■ 25. In § 147.46, paragraph (d) is
amended by adding a sentence after the
last sentence to read as follows:
§ 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.
*
*
*
*
*
■ 26. In § 147.51, the definition of NPIP
Technical Committee is amended by
adding three sentences after the last
sentence to read as follows:
§ 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.
■ 27. In § 147.52, paragraph (a) is
revised to read as follows:
§ 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.
*
*
*
*
*
E:\FR\FM\19JNR1.SGM
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Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations
28. In § 147.54, paragraphs (a)(1), (3),
and (4) are revised to read as follows:
■
daltland on DSKBBV9HB2PROD with RULES
§ 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.
VerDate Sep<11>2014
20:20 Jun 18, 2018
Jkt 244001
(4) Cooperating laboratories will
submit to the kit manufacturer all
compiled output data regarding the
assay response. Each sample tested will
be reported as positive or negative, and
the official NPIP procedure used to
classify the sample must be submitted
in addition to the assay response value.
A completed worksheet for diagnostic
test evaluation is required to be
submitted with the compiled output
data and may be obtained by contacting
the NPIP Senior Coordinator. Data and
the completed worksheet for diagnostic
test evaluation must be submitted to the
NPIP Senior Coordinator 4 months prior
to the next scheduled General
Conference Committee meeting, which
is when approval will be sought.
*
*
*
*
*
Done in Washington, DC, this 13th day of
June 2018.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2018–13128 Filed 6–18–18; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA–2017–1061; Airspace
Docket No. 17–AEA–20]
RIN 2120–AA66
Amendment of Class D Airspace and
Class E Airspace, and Removal of
Class E Airspace; Binghamton, NY
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule.
AGENCY:
This action amends Class D
airspace, Class E surface airspace, and
Class E airspace extending upward from
700 feet above the surface; and removes
Class E airspace designated as an
extension to a Class D surface area; at
Greater Binghamton Airport/Edwin A.
Link Field (formerly Binghamton
Regional Airport/Edwin A. Link Field),
Binghamton, NY. This action
accommodates airspace reconfiguration
due to the decommissioning of the
Binghamton VHF omni-directional radio
range tactical air navigation aid
(VORTAC), and cancellation of the VOR
approaches. Controlled airspace is
necessary for the safety and
management of instrument flight rules
(IFR) operations at the airport. This
action also updates the geographic
coordinates of the airport, and corrects
the airport’s name. Additionally, this
SUMMARY:
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
action replaces the outdated term
‘‘Airport/Facility Directory’’ with the
term ‘‘Chart Supplement’’ in Class D
and E surface airspace descriptions.
DATES: Effective 0901 UTC, September
13, 2018. The Director of the Federal
Register approves this incorporation by
reference action under Title 1 Code of
Federal Regulations, part 51, subject to
the annual revision of FAA Order
7400.11 and publication of conforming
amendments.
ADDRESSES: FAA Order 7400.11B,
Airspace Designations and Reporting
Points, and subsequent amendments can
be viewed online at https://www.faa.gov/
air_traffic/publications/. For further
information, you can contact the
Airspace Policy Group, Federal Aviation
Administration, 800 Independence
Avenue SW, Washington, DC 20591;
telephone: (202) 267–8783. The Order is
also available for inspection at the
National Archives and Records
Administration (NARA). For
information on the availability of FAA
Order 7400.11B at NARA, call (202)
741–6030, or go to https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
FAA Order 7400.11, Airspace
Designations and Reporting Points, is
published yearly and effective on
September 15.
FOR FURTHER INFORMATION CONTACT: John
Fornito, Operations Support Group,
Eastern Service Center, Federal Aviation
Administration, 1701 Columbia Ave.,
College Park, GA 30337; telephone (404)
305–6364.
SUPPLEMENTARY INFORMATION:
Authority for This Rulemaking
The FAA’s authority to issue rules
regarding aviation safety is found in
Title 49 of the United States Code.
Subtitle I, Section 106 describes the
authority of the FAA Administrator.
Subtitle VII, Aviation Programs,
describes in more detail the scope of the
agency’s authority. This rulemaking is
promulgated under the authority
described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that
section, the FAA is charged with
prescribing regulations to assign the use
of airspace necessary to ensure the
safety of aircraft and the efficient use of
airspace. This regulation is within the
scope of that authority as it amends
Class D and Class E airspace at Greater
Binghamton Airport/Edwin A. Link
Field, Binghamton, NY, to support IFR
operations at the airport.
History
The FAA published a notice of
proposed rulemaking in the Federal
E:\FR\FM\19JNR1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 118 (Tuesday, June 19, 2018)]
[Rules and Regulations]
[Pages 28351-28356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13128]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
========================================================================
Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules
and Regulations
[[Page 28351]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 145, 146, and 147
[Docket No. APHIS-2017-0055]
RIN 0579-AE37
National Poultry Improvement Plan and Auxiliary Provisions
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are amending the regulations governing the National Poultry
Improvement Plan (NPIP) by updating and clarifying several provisions,
including those concerning NPIP participation, voting requirements,
testing procedures, and standards. The changes in this final rule were
voted on and approved by the voting delegates at the Plan's 2016
National Plan Conference.
DATES: Effective July 19, 2018.
FOR FURTHER INFORMATION CONTACT: Dr. Denise Heard, DVM, Senior
Coordinator, National Poultry Improvement Plan, VS, APHIS, USDA, 1506
Klondike Road, Suite 101, Conyers, GA 30094-5104; (770) 922-3496.
SUPPLEMENTARY INFORMATION:
Background
The National Poultry Improvement Plan (NPIP, also referred to below
as ``the Plan'') is a cooperative Federal-State-industry mechanism for
controlling certain poultry diseases. The Plan consists of a variety of
programs intended to prevent and control poultry diseases.
Participation in all Plan programs is voluntary, but breeding flocks,
hatcheries, and dealers must first qualify as ``U.S. Pullorum-Typhoid
Clean'' as a condition for participating in the other Plan programs.
The Plan identifies States, independent flocks, hatcheries,
dealers, and slaughter plants that meet certain disease control
standards specified in the Plan's various programs. As a result,
customers can buy poultry that has tested clean of certain diseases or
that has been produced under disease-prevention conditions.
The regulations in 9 CFR parts 145, 146, and 147 (referred to below
as the regulations) contain the provisions of the Plan. The Animal and
Plant Health Inspection Service (APHIS or the Service) amends these
provisions from time to time to incorporate new scientific information
and technologies within the Plan.
On April 9, 2018, we published in the Federal Register (83 FR
15082-15089, Docket No. APHIS-2017-0055) a proposal \1\ to amend the
regulations by updating and clarifying several provisions, including
those concerning NPIP participation, voting requirements, testing
procedures, and standards.
---------------------------------------------------------------------------
\1\ To view the proposed rule, supporting document, and the
comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2017-0055.
---------------------------------------------------------------------------
We solicited comments concerning our proposal for 30 days ending
May 9, 2018. We received two comments by that date. One individual was
generally opposed to the rule and the poultry industry, but did not
address any specific provisions of the proposed rule. The other
commenter also did not address the provisions of the proposed rule, but
instead addressed his comments to the statements made by the first
commenter.
Therefore, for the reasons given in the proposed rule, we are
adopting the proposed rule as a final rule, without change.
Executive Orders 12866 and 13771 and Regulatory Flexibility Act
This final rule has been determined to be not significant for the
purposes of Executive Order 12866 and, therefore, has not been reviewed
by the Office of Management and Budget. Further, because this rule is
not significant, it is not a regulatory action under Executive Order
13771.
We have prepared an analysis regarding the economic effects of this
final rule on small entities. The analysis is summarized below. Copies
of the full analysis are available on the Regulations.gov website (see
footnote 1 in this document for a link to Regulations.gov) or by
contacting the person listed under FOR FURTHER INFORMATION CONTACT.
We are amending the NPIP, its auxiliary provisions, and the
indemnity regulations for the control of H5 and H7 low pathogenic avian
influenza to align the regulations with international standards and
make them more transparent to stakeholders and the general public. The
changes in this final rule were voted on and approved by the voting
delegates at the 2016 NPIP National Plan Conference.
The establishments that will be affected by the rule--principally
entities engaged in poultry production and processing--are
predominantly small by Small Business Administration standards. In
those instances in which an addition to or modification of requirements
could potentially result in a cost to certain entities, we do not
expect the costs to be significant. NPIP membership is voluntary. The
changes contained in this final rule were decided upon by the NPIP
General Conference Committee and voting delegates during the 2016 NPIP
Biennial Conference; the changes were recognized by the poultry
industry as being in their interest.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 2 CFR chapter IV.)
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are in conflict with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
[[Page 28352]]
Paperwork Reduction Act
This final rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
List of Subjects in 9 CFR Parts 145, 146, and 147
Animal diseases, Poultry and poultry products, Reporting and
recordkeeping requirements.
Accordingly, we are amending 9 CFR parts 145, 146, and 147 as
follows:
PART 145--NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY
0
1. The authority citation for part 145 continues to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
0
2. In Sec. 145.1, the definition of NPIP Technical Committee is
amended by adding three sentences after the last sentence to read as
follows:
Sec. 145.1 Definitions.
* * * * *
NPIP Technical Committee. * * * The NPIP Technical Committee is
divided into three subcommittees (Mycoplasma, Salmonella, and Avian
Influenza). NPIP Technical Committee Members may serve on one, two, or
all three subcommittees. The committee will evaluate proposed changes
to the Provisions and Program Standards of the Plan which include, but
are not limited to, tests and sanitation procedures, and provide
recommendations to the Delegates of the National Plan Conference as to
whether they are scientifically or technically sound.
* * * * *
Sec. 145.4 [Amended]
0
3. In Sec. 145.4, paragraph (d)(2) is amended by adding the words
``and any other disease for which the flock into which the birds are
being introduced holds a disease classification'' after the words
``pullorum-typhoid''.
Sec. 145.10 [Amended]
0
4. In Sec. 145.10, paragraph (o) is amended by adding the citation
``Sec. 145.73(g),'' after the citation ``Sec. 145.53(f),''.
0
5. Section 145.14 is amended as follows:
0
a. In the introductory text, in the third sentence, by adding the words
``unless otherwise specified within the Plan program,'' after the words
``30 birds per house,'' and in the last sentence, by adding the words
``, unless otherwise specified within the Plan program'' after the
words ``must be tested''; and
0
b. By revising paragraph (d)(2)(i)(A).
The revision reads as follows:
Sec. 145.14 Testing.
* * * * *
(d) * * *
(2) * * *
(i) * * *
(A) The RRT-PCR tests must be conducted using reagents approved by
the Department and the Official State Agency. The RRT-PCR must be
conducted using the National Veterinary Services Laboratories (NVSL)
official protocol for RRT-PCR or a test kit licensed by the Department
and approved by the Official State Agency and the State Animal Health
Official, and must be conducted by personnel who have passed an NVSL
proficiency test. For non-National Animal Health Laboratory Network
(NAHLN) authorized laboratories:
(1) RRT-PCR testing may be used by primary breeder company
authorized laboratories.
(2) RRT-PCR testing can only be performed on their own breeding
flocks and only used for routine surveillance.
(3) The authorized laboratory must have a quality system that is
accredited as ISO/IEC 17025 or equivalent to perform the avian
influenza RRT-PCR assay.
(4) The use of the RRT-PCR test by the authorized laboratory must
be approved in the memorandum of understanding (MOU) between the
authorized laboratory, the Official State Agency, and the State Animal
Health Official(s) of both the location of the authorized laboratory
and the location where the breeding flocks reside.
(5) Split samples for testing must occur between the authorized
laboratory and a NAHLN laboratory at a frequency designated in the MOU.
* * * * *
0
6. In Sec. 145.23, paragraph (b)(1) is revised to read as follows:
Sec. 145.23 Terminology and classification; flocks and products.
* * * * *
(b) * * *
(1) It has been officially blood tested with either no reactors or
reactors that, upon further bacteriological examination conducted in
accordance with part 147 of this subchapter, fail to isolate S.
pullorum or S. gallinarum.
* * * * *
0
7. In Sec. 145.33, paragraph (b)(1) is revised to read as follows:
Sec. 145.33 Terminology and classification; flocks and products.
* * * * *
(b) * * *
(1) It has been officially blood tested with either no reactors or
reactors that, upon further bacteriological examination conducted in
accordance with part 147 of this subchapter, fail to isolate S.
pullorum or S. gallinarum.
* * * * *
0
8. In Sec. 145.43, paragraphs (b)(1) and (5) are revised to read as
follows:
Sec. 145.43 Terminology and classification; flocks and products.
* * * * *
(b) * * *
(1) It has been officially blood tested with either no reactors or
reactors that, upon further bacteriological examination conducted in
accordance with part 147 of this subchapter, fail to isolate S.
pullorum or S. gallinarum.
* * * * *
(5) It is a primary breeding flock located in a State determined to
be in compliance with the provisions of paragraph (b)(4) of this
section and in which a sample of 300 birds from flocks of more than
300, and each bird in flocks of 300 or less, has been officially tested
for pullorum-typhoid with either no reactors or reactors that, upon
further bacteriological examination conducted in accordance with part
147 of this subchapter, fail to isolate S. pullorum or S. gallinarum:
Provided, That a bacteriological examination monitoring program
acceptable to the Official State Agency and approved by APHIS may be
used in lieu of blood testing.
* * * * *
0
9. Section 145.45 is amended as follows:
0
a. By revising paragraph (a) introductory text; and
0
b. By removing the word ``NAI'' and adding the words ``H5/H7 AI'' in
its place each time it appears in the following paragraphs:
0
i. Paragraph (a)(1) introductory text;
0
ii. Paragraph (a)(1)(i);
0
iii. Paragraph (a)(1)(iii) introductory text;
0
iv. Paragraph (a)(1)(v);
0
v. Paragraph (a)(2)(iii); and
0
vi. Paragraph (a)(4).
The revision reads as follows:
Sec. 145.45 Terminology and classification; compartments.
(a) US H5/H7 AI Clean Compartment. This program is intended to be
the basis from which the primary turkey breeding-hatchery industry may
demonstrate the existence and implementation of a program that has
[[Page 28353]]
been approved by the Official State Agency and APHIS to establish a
compartment consisting of a primary breeding-hatchery company that is
free of H5/H7 avian influenza (AI). For the purpose of the compartment,
avian influenza is defined according to the OIE Terrestrial Animal
Health Code Chapter 10.4. This compartment has the purpose of
protecting the defined subpopulation and avoiding the introduction and
spread of H5/H7 AI within that subpopulation by prohibiting contact
with other commercial poultry operations, other domestic and wild
birds, and other intensive animal operations. The program shall consist
of the following:
* * * * *
0
10. Section 145.52 is amended by redesignating paragraphs (d)(7) and
(d)(8) as paragraphs (d)(8) and (d)(9), respectively, and by adding a
new paragraph (d)(7) to read as follows:
Sec. 145.52 Participation.
* * * * *
(d) * * *
(7) The NPIP hatchery approval number of the shipping hatchery;
* * * * *
0
11. Section 145.53 is amended as follows:
0
a. By revising paragraphs (b)(1) and (b)(5);
0
b. In paragraph (c)(1)(i), by adding the words ``trachea or'' before
the word ``choanal'' and by removing the words ``palatine cleft/fissure
area'' and adding the word ``cleft'' in their place.
0
c. By revising paragraph (c)(1)(ii) introductory text;
0
d. In paragraph (c)(1)(ii)(A), by adding the words ``trachea or''
before the word ``choanal'' and by removing the words ``palatine cleft/
fissure area'' and adding the word ``cleft'' in their place;
0
e. In paragraph (d)(1)(i), by adding the words ``trachea or'' before
the word ``choanal'' and by removing the words ``palatine cleft/fissure
area'' and adding the word ``cleft'' in their place.
0
f. By revising paragraph (d)(1)(ii) introductory text; and
0
g. In paragraph (d)(1)(ii)(A), by adding the words ``trachea or''
before the word ``choanal'' and by removing the words ``palatine cleft/
fissure area'' and adding the word ``cleft'' in their place.
The revisions read as follows:
Sec. 145.53 Terminology and classification; flocks and products.
* * * * *
(b) * * *
(1) It has been officially blood tested within the past 12 months
with either no reactors or reactors that, upon further bacteriological
examination conducted in accordance with part 147 of this subchapter,
fail to isolate S. pullorum or S. gallinarum.
* * * * *
(5) It is a primary breeding flock located in a State determined to
be in compliance with the provisions of paragraph (b)(4) of this
section, and in which a sample of 300 birds from flocks of more than
300, and each bird in flocks of 300 or less, has been officially tested
for pullorum-typhoid within the past 12 months with either no reactors
or reactors that, upon further bacteriological examination conducted in
accordance with part 147 of this subchapter, fail to isolate S.
pullorum or S. gallinarum: Provided, That a bacteriological examination
monitoring program or serological examination monitoring program for
game birds acceptable to the Official State Agency and approved by the
Service may be used in lieu of annual blood testing: And Provided
further, That when a flock is a hobbyist or exhibition waterfowl or
exhibition poultry primary breeding flock located in a State which has
been deemed to be a U.S. Pullorum-Typhoid Clean State for the past 3
years, and during which time no isolation of pullorum or typhoid has
been made that can be traced to a source in that State, a
bacteriological examination monitoring program or a serological
examination monitoring program acceptable to the Official State Agency
and approved by the Service may be used in lieu of annual blood
testing.
(c) * * *
(1) * * *
(ii) It is a multiplier breeding flock which originated as U.S. M.
Gallisepticum Clean baby poultry from primary breeding flocks and from
which a random sample of birds has been tested for M. gallisepticum as
provided in Sec. 145.14(b) when more than 4 months of age or upon
reaching sexual maturity. For flocks of more than 400 birds, 200 birds
shall be tested. For flocks of 60 to 400 birds, 50 percent of the birds
shall be tested. For flocks of fewer than 60 birds, all birds shall be
tested up to a maximum of 30 birds: Provided, that to retain this
classification, the flock shall be subjected to one of the following
procedures:
* * * * *
(d) * * *
(1) * * *
(ii) It is a multiplier breeding flock that originated as U.S. M.
Synoviae Clean chicks from primary breeding flocks and from which a
random sample of birds has been tested for M. synoviae as provided in
Sec. 145.14(b) when more than 4 months of age or upon reaching sexual
maturity. For flocks of more than 400 birds, 200 birds shall be tested.
For flocks of 60 to 400 birds, 50 percent of the birds shall be tested.
For flocks of fewer than 60 birds, all birds shall be tested up to a
maximum of 30 birds: Provided, that to retain this classification, the
flock shall be subjected to one of the following procedures:
* * * * *
0
12. Section 145.63 is amended by revising paragraphs (a)(1) and
(a)(2)(i) to read as follows:
Sec. 145.63 Terminology and classification; flocks and products.
* * * * *
(a) * * *
(1) It has been officially blood tested within the past 12 months
with either no reactors or reactors that, upon further bacteriological
examination conducted in accordance with part 147 of this subchapter,
fail to isolate S. pullorum or S. gallinarum.
(2) * * *
(i)(A) It is a multiplier or primary breeding flock of fewer than
300 birds in which a sample of 10 percent of the birds in a flock or at
least 1 bird from each pen, whichever is more, has been officially
tested for pullorum-typhoid within the past 12 months with either no
reactors or reactors that, upon further bacteriological examination
conducted in accordance with part 147 of this subchapter, fail to
isolate S. pullorum or S. gallinarum; or
(B) It is a multiplier or primary breeding flock of 300 birds or
more in which a sample of a minimum of 30 birds has been officially
tested for pullorum-typhoid within the past 12 months with either no
reactors or reactors that, upon further bacteriological examination
conducted in accordance with part 147 of this subchapter, fail to
isolate S. pullorum or S. gallinarum.
* * * * *
0
13. Section 145.73 is amended as follows:
0
a. By revising paragraphs (b)(1) and (b)(2)(ii); and
0
b. By adding paragraph (g).
The revisions and addition read as follows:
Sec. 145.73 Terminology and classification; flocks and products.
* * * * *
(b) * * *
(1) It has been officially blood tested with either no reactors or
reactors that, upon further bacteriological examination conducted in
accordance
[[Page 28354]]
with part 147 of this subchapter, fail to isolate S. pullorum or S.
gallinarum.
(2) * * *
(ii) In the primary breeding flock, a sample of 300 birds from
flocks of more than 300, and each bird in flocks of 300 or less, has
been officially tested for pullorum-typhoid with either no reactors or
reactors that, upon further bacteriological examination conducted in
accordance with part 147 of this subchapter, fail to isolate S.
pullorum or S. gallinarum: Provided, That a bacteriological examination
monitoring program acceptable to the Official State Agency and approved
by APHIS may be used in lieu of blood testing.
* * * * *
(g) U.S. Salmonella Monitored. This program is intended to be the
basis from which the primary egg-type breeder industry may conduct a
program for the prevention and control of salmonellosis. It is intended
to reduce the incidence of Salmonella organisms in hatching eggs and
chicks through an effective and practical sanitation program at the
breeder farm and in the hatchery. This will afford other segments of
the poultry industry an opportunity to reduce the incidence of
Salmonella in their products.
(1) A flock and the hatching eggs and chicks produced from it that
have met the following requirements, as determined by the Official
State Agency:
(i) The flock is maintained in accordance with part 147 of this
subchapter with respect to flock sanitation, cleaning and disinfection,
and Salmonella isolation, sanitation, and management.
(ii) Measures shall be implemented to control Salmonella challenge
through feed, feed storage, and feed transport.
(iii) Chicks shall be hatched in a hatchery whose sanitation is
maintained in accordance with part 147 of this subchapter and sanitized
or fumigated in accordance with part 147 of this subchapter.
(iv) An Authorized Agent shall take environmental samples from the
hatchery every 30 days; i.e., meconium or chick papers. An authorized
laboratory for Salmonella shall examine the samples bacteriologically.
(v) An Authorized Agent shall take environmental samples in
accordance with part 147 of this subchapter from each flock at 4 months
of age and every 30 days thereafter. An authorized laboratory for
Salmonella shall examine the environmental samples bacteriologically.
All Salmonella isolates from a flock shall be serogrouped and shall be
reported to the Official State Agency on a monthly basis.
(vi) Owners of flocks may vaccinate with a paratyphoid vaccine:
Provided, That a sample of 350 birds, which will be banded for
identification, shall remain unvaccinated until the flock reaches at
least 4 months of age to allow for the serological testing required
under paragraph (g)(1)(iv) of this section.
(vii) Any flock entering the production period that is in
compliance with all the requirements of this paragraph (g) with no
history of Salmonella isolations shall be considered ``Salmonella
negative'' and may retain this definition as long as no environmental
or bird Salmonella isolations are identified and confirmed from the
flock or flock environment by sampling on four separate collection
dates over a minimum of a 2-week period. Sampling and testing must be
performed as described in paragraph (g)(1)(vi) of this section. An
unconfirmed environmental Salmonella isolation shall not change this
Salmonella negative status.
(2) The Official State Agency may monitor the effectiveness of the
sanitation practices in accordance with part 147 of this subchapter.
(3) In order for a hatchery to sell products of paragraphs
(g)(1)(i) through (vii) of this section, all products handled shall
meet the requirements of the classification.
(4) This classification may be revoked by the Official State Agency
if the participant fails to follow recommended corrective measures.
Sec. 145.74 [Amended]
0
14. Section 145.74 is amended as follows:
0
a. In paragraph (a) introductory text, in the first sentence, by
removing the words ``, also referred to as notifiable avian influenza
(NAI)'' and, in the second sentence, by removing the word ``NAI'' and
adding the words ``H5/H7 AI'' in its place.
0
b. By removing the word ``NAI'' and adding the words ``H5/H7 AI'' in
its place each time it appears in the following paragraphs:
i. Paragraph (a)(1) introductory text;
ii. Paragraph (a)(1)(iii) introductory text;
iii. Paragraph (a)(1)(v);
iv. Paragraph (a)(2)(iii); and
v. Paragraph (a)(4).
0
c. By removing the word ``NAI-related'' and adding the words ``H5/H7
AI-related'' in its place in paragraph (a)(1)(i).
0
15. Section 145.82 is amended by adding paragraph (d) to read as
follows:
Sec. 145.82 Participation.
* * * * *
(d) Poultry must be protected from vectors known to be in the wild
and thus must be housed in enclosed structures during brooding,
rearing, grow-out, or laying periods with no intentional access to the
outdoors, creatures found in the wild, or raised on open range or
pasture, or be provided with untreated open source water such as that
directly from a pond, stream, or spring that wild birds or vermin have
access to for usage for drinking water, as a cooling agent, or during a
wash down/clean out process.
0
16. Section 145.83 is amended by revising paragraphs (b)(1) and
(b)(2)(ii) to read as follows:
Sec. 145.83 Terminology and classification; flocks and products.
* * * * *
(b) * * *
(1) It has been officially blood tested with either no reactors or
reactors that, upon further bacteriological examination conducted in
accordance with part 147 of this subchapter, fail to isolate S.
pullorum or S. gallinarum.
(2) * * *
(ii) In the primary breeding flock, a sample of 300 birds from
flocks of more than 300, and each bird in flocks of 300 or less, has
been officially tested for pullorum-typhoid with either no reactors or
reactors that, upon further bacteriological examination conducted in
accordance with part 147 of this subchapter, fail to isolate S.
pullorum or S. gallinarum: Provided, That a bacteriological examination
monitoring program acceptable to the Official State Agency and approved
by APHIS may be used in lieu of blood testing.
* * * * *
Sec. 145.84 [Amended]
0
17. Section 145.84 is amended as follows:
0
a. In the introductory text of paragraph (a), in the first sentence, by
removing the words ``, also referred to as notifiable avian influenza
(NAI)'' and, in the second sentence, by removing the word ``NAI'' and
adding the words ``H5/H7 AI'' in its place; and
0
b. By removing the word ``NAI'' and adding the words ``H5/H7 AI'' in
its place each time it appears in the following paragraphs:
i. Paragraph (a)(1) introductory text;
ii. Paragraph (a)(1)(iii) introductory text;
iii. Paragraph (a)(1)(v);
iv. Paragraph (a)(2)(iii); and
v. Paragraph (a)(4).
0
c. By removing the word ``NAI-related'' and adding the words ``H5/H7
[[Page 28355]]
AI-related'' in its place in paragraph (a)(1)(i).
0
18. Section 145.93 is amended as follows:
0
a. By revising paragraph (b)(1);
0
b. In paragraph (b)(3)(viii), by removing the words ``paragraphs
(a)(3)(i),'' and adding the words ``paragraphs (b)(3)(i),'' in their
place;
0
c. In paragraph (b)(4), by removing the words ``paragraph (a)(3)'' and
adding the words ``paragraph (b)(3)'' in their place; and
0
d. By revising paragraph (b)(5).
The revisions read as follows:
Sec. 145.93 Terminology and classification; flocks and products.
* * * * *
(b) * * *
(1) It has been officially blood tested within the past 12 months
with either no reactors or reactors that, upon further bacteriological
examination conducted in accordance with part 147 of this subchapter,
fail to isolate S. pullorum or S. gallinarum.
* * * * *
(5) It is a primary breeding flock located in a State determined to
be in compliance with provisions of paragraph (b)(3) of this section,
and in which a sample of 300 birds from flocks of more than 300, and
each bird in flocks of 300 or less, has been officially tested for
pullorum-typhoid within the past 12 months with either no reactors or
reactors that, upon further bacteriological examination conducted in
accordance with part 147 of this subchapter, fail to isolate S.
pullorum or S. gallinarum: Provided, That when a flock is a primary
breeding flock located in a State which has been deemed to be a U.S.
Pullorum-Typhoid Clean State for the past 3 years, and during which
time no isolation of pullorum or typhoid has been made that can be
traced to a source in that State, a bacteriological examination
monitoring program or a serological examination monitoring program
acceptable to the Official State Agency and approved by the Service may
be used in lieu of annual blood testing.
* * * * *
PART 146--NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY
0
19. The authority citation for part 146 continues to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
0
20. In Sec. 146.1, a definition of NPIP Technical Committee is added
in alphabetical order to read as follows:
Sec. 146.1 Definitions.
* * * * *
NPIP Technical Committee. A committee made up of technical experts
on poultry health, biosecurity, surveillance, and diagnostics. The
committee consists of representatives from the poultry and egg
industries, universities, and State and Federal governments and is
appointed by the Senior Coordinator and approved by the General
Conference Committee. The NPIP Technical Committee is divided into
three subcommittees (Mycoplasma, Salmonella, and Avian Influenza). NPIP
Technical Committee Members may serve on one, two, or all three
subcommittees. The committee will evaluate proposed changes to the
Provisions and Program Standards of the Plan which include, but are not
limited to, tests and sanitation procedures, and provide
recommendations to the Delegates of the National Plan Conference as to
whether they are scientifically or technically sound.
* * * * *
Sec. 146.23 [Amended]
0
21. In Sec. 146.23, paragraphs (a)(1)(i) and (a)(2)(i) are amended by
removing the number ``30'' and adding the number ``21'' in its place.
PART 147--AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN
0
22. The authority citation for part 147 continues to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
0
23. In Sec. 147.41, the definition of NPIP Technical Committee is
amended by adding three sentences after the last sentence to read as
follows:
Sec. 147.41 Definitions.
* * * * *
NPIP Technical Committee. * * * The NPIP Technical Committee is
divided into three subcommittees (Mycoplasma, Salmonella, and Avian
Influenza). NPIP Technical Committee Members may serve on one, two, or
all three subcommittees. The committee will evaluate proposed changes
to the Provisions and Program Standards of the Plan which include, but
are not limited to, tests and sanitation procedures, and provide
recommendations to the Delegates of the National Plan Conference as to
whether they are scientifically or technically sound.
* * * * *
0
24. In Sec. 147.43, paragraph (b) is amended by adding a sentence
after the second sentence to read as follows:
Sec. 147.43 General Conference Committee.
* * * * *
(b) * * * The ballots for electing regional committee members and
their alternates will be printed in such a way as to allow the specific
selection of one nominee for member, and one nominee for alternate from
the remaining nominees. * * *
* * * * *
0
25. In Sec. 147.46, paragraph (d) is amended by adding a sentence
after the last sentence to read as follows:
Sec. 147.46 Committee consideration of proposed changes.
* * * * *
(d) * * * Once completed, the combined committee report will be
distributed electronically to the Official State Agencies prior to the
delegates voting on the final day of the biennial conference.
* * * * *
0
26. In Sec. 147.51, the definition of NPIP Technical Committee is
amended by adding three sentences after the last sentence to read as
follows:
Sec. 147.51 Definitions.
* * * * *
NPIP Technical Committee. * * * The NPIP Technical Committee is
divided into three subcommittees (Mycoplasma, Salmonella, and Avian
Influenza). NPIP Technical Committee Members may serve on one, two, or
all three subcommittees. The committee will evaluate proposed changes
to the Provisions and Program Standards of the Plan which include, but
are not limited to, tests and sanitation procedures, and provide
recommendations to the Delegates of the National Plan Conference as to
whether they are scientifically or technically sound.
0
27. In Sec. 147.52, paragraph (a) is revised to read as follows:
Sec. 147.52 Authorized laboratories.
* * * * *
(a) Check-test proficiency. The NPIP will serve as the lead agency
for the coordination of available check tests from the National
Veterinary Services Laboratories. Further, the NPIP may approve and
authorize additional laboratories to produce and distribute a check
test as needed. The authorized laboratory must use the next available
check test for each assay that it performs.
* * * * *
[[Page 28356]]
0
28. In Sec. 147.54, paragraphs (a)(1), (3), and (4) are revised to
read as follows:
Sec. 147.54 Approval of diagnostic test kits not licensed by the
Service.
(a) * * *
(1) The sensitivity of the kit will be evaluated in at least three
NPIP authorized laboratories by testing known positive samples, as
determined by the official NPIP procedures found in the NPIP Program
Standards or through other procedures approved by the Administrator.
Field samples, for which the presence or absence of the target organism
or analyte has been determined by the current NPIP test, are the
preferred samples and should be used when possible. Samples from a
variety of field cases representing a range of low, medium, and high
analyte concentrations should be used. In some cases it may be
necessary to utilize samples from experimentally infected animals.
Spiked samples (clinical sample matrix with a known amount of pure
culture added) should only be used in the event that no other sample
types are available. When the use of spiked samples may be necessary,
prior approval from the NPIP Technical Committee is required. Pure
cultures should never be used. Additionally, laboratories should be
selected for their experience with testing for the target organism or
analyte with the current NPIP approved test. (e.g., a Salmonella test
should be evaluated by NPIP authorized laboratories that test for
Salmonella routinely). If certain conditions or interfering substances
are known to affect the performance of the kit, appropriate samples
will be included so that the magnitude and significance of the
effect(s) can be evaluated.
* * * * *
(3) The kit will be provided to the cooperating laboratories in its
final form and include the instructions for use. The cooperating
laboratories must perform the assay exactly as stated in the supplied
instructions. Each laboratory must test a panel of at least 25 known
positive samples. In addition, each laboratory must test at least 50
known negative samples obtained from several sources, to provide a
representative sampling of the general population. The cooperating
laboratories must perform a current NPIP procedure or NPIP approved
test on the samples alongside the test kit for comparison and must
provide an outline of the method on the worksheet for diagnostic test
evaluation. Reproducibility and robustness data should also be
included.
(4) Cooperating laboratories will submit to the kit manufacturer
all compiled output data regarding the assay response. Each sample
tested will be reported as positive or negative, and the official NPIP
procedure used to classify the sample must be submitted in addition to
the assay response value. A completed worksheet for diagnostic test
evaluation is required to be submitted with the compiled output data
and may be obtained by contacting the NPIP Senior Coordinator. Data and
the completed worksheet for diagnostic test evaluation must be
submitted to the NPIP Senior Coordinator 4 months prior to the next
scheduled General Conference Committee meeting, which is when approval
will be sought.
* * * * *
Done in Washington, DC, this 13th day of June 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-13128 Filed 6-18-18; 8:45 am]
BILLING CODE 3410-34-P
