National Poultry Improvement Plan and Auxiliary Provisions, 38752-38768 [2014-16037]
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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations
Clean’’ as a condition for participating
in the other Plan programs.
Animal and Plant Health Inspection
The Plan identifies States, flocks,
Service
hatcheries, dealers, and slaughter plants
that meet certain disease control
9 CFR Parts 56, 145, 146, and 147
standards specified in the Plan’s various
programs. As a result, customers can
[Docket No. APHIS–2011–0101]
buy poultry that has tested clean of
certain diseases or that has been
RIN 0579–AD83
produced under disease-prevention
National Poultry Improvement Plan and conditions.
The regulations in 9 CFR parts 145,
Auxiliary Provisions
146, and 147 (referred to below as the
AGENCY: Animal and Plant Health
regulations) contain the provisions of
Inspection Service, USDA.
the Plan. The Animal and Plant Health
Inspection Service (APHIS, also referred
ACTION: Final rule.
to as ‘‘the Service’’) of the U.S.
SUMMARY: We are amending the National Department of Agriculture (USDA, also
Poultry Improvement Plan (NPIP, the
referred to as ‘‘the Department’’) amends
Plan) and its auxiliary provisions by
these provisions from time to time to
removing the descriptions of specific
incorporate new scientific information
tests and sanitation procedures from the and technologies within the Plan.
regulations. Instead, we will require
On January 28, 2014, we published in
tests to be performed and sanitation to
the Federal Register (79 FR 4538–4567,
be maintained in a manner approved by Docket No. APHIS–2011–0101) a
the Administrator. Approved
proposal 1 to amend the regulations by
procedures will be listed in an NPIP
removing tests and detailed testing
Program Standards document, which we procedures, as well as sanitation
are making available on the NPIP Web
procedures, from part 147, and making
site. In addition, we are establishing
these available in an NPIP Program
new compartment classifications for
Standards document. In addition, we
defined subpopulations of primary
proposed to establish U.S. H5/H7 Avian
breeding turkeys, primary egg-type
Influenza Clean Compartment and U.S.
chickens, and primary meat-type
Avian Influenza Clean Compartment
chickens. We are also providing new or
classifications for defined
modified sampling and testing
subpopulations of primary breeding
procedures for Plan participants and
turkeys, primary egg-type breeding
participating flocks. The changes in this chickens, and primary meat-type
final rule were voted on and approved
breeding chickens. We also proposed
by the voting delegates at the Plan’s
several other changes.
2010 and 2012 National Plan
We solicited comments concerning
Conferences. These changes will
our proposal for 60 days ending March
streamline the provisions of the Plan,
31, 2014. We received 11 comments by
keep those provisions current with
that date. They were from producers,
changes in the poultry industry, and
poultry associations, and the general
provide for the use of new sampling and public. Of the 11 comments we
testing procedures.
received, 7 directly addressed the
proposed rule. These comments are
DATES: Effective Date: August 8, 2014.
discussed below.
FOR FURTHER INFORMATION CONTACT: Dr.
Part 146 of the regulations contains
Denise Brinson, DVM, Director,
National Poultry Improvement Plan, VS, the NPIP provisions for commercial
poultry. Currently, the only disease
APHIS, USDA, 1506 Klondike Road,
addressed in this part is H5/H7 low
Suite 101, Conyers, GA 30094–5104;
pathogenic avian influenza; under part
(770) 922–3496.
146, table-egg layer flocks, meat-type
SUPPLEMENTARY INFORMATION:
chicken slaughter plants, meat-type
turkey slaughter plants, and certain
Background
types of game birds and waterfowl may
The National Poultry Improvement
participate in U.S. H5/H7 Avian
Plan (NPIP, also referred to below as
Influenza Monitored classifications.
‘‘the Plan’’) is a cooperative FederalSection 146.11 sets out the audit
State-industry mechanism for
process for participating slaughter
controlling certain poultry diseases. The plants. Paragraph (b) states that flocks
Plan consists of a variety of programs
slaughtered at a slaughter plant will be
intended to prevent and control poultry considered to be not conforming to the
diseases. Participation in all Plan
programs is voluntary, but breeding
1 To view the proposed rule and the comments
flocks, hatcheries, and dealers must first we received, go to https://www.regulations.gov/
#!docketDetail;D=APHIS-2011-0101.
qualify as ‘‘U.S. Pullorum-Typhoid
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DEPARTMENT OF AGRICULTURE
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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 proposed to amend
paragraph (b) to refer to samples being
collected and tested and to results being
returned prior to movement to
slaughter.
The seven commenters who
addressed the rule opposed this change.
They stated that requiring testing prior
to slaughter, rather than prior to
movement to slaughter, allows
companies that have been sampling
flocks at processing to continue doing
so. It also allows producers whose
flocks were inadvertently not sampled
in the field to be tested at the slaughter
plant and remain compliant.
They also stated that the proposed
requirement to test prior to movement to
slaughter would inadvertently combine
the different testing requirements for
participating slaughter plants in each
subpart in part 146 into one set of
testing requirements. This would
prevent the different types of
participating slaughter plants from
setting different testing requirements.
One commenter stated that the change
would limit the flexibility of Official
State Agencies and industry to develop
alternative testing protocols in which
the same number of birds are tested, as
allowed under the regulations.
We believe it is important to have the
test results for a flock returned prior to
movement to slaughter to prevent
potentially diseased birds from being
exposed to other, healthy birds and
possibly requiring cleaning and
disinfection at the slaughter plant. The
NPIP General Conference voted to
approve this change at the 2012
Biennial Conference, reflecting the
general consensus of NPIP participants.
However, we are postponing the
finalization of this change until an
alternative proposal put forward by the
commenters can be voted on during the
2014 NPIP Biennial Conference, which
is scheduled to take place in Charlotte,
NC, from July 10 through 12, 2014.
Based on that vote, we will either retain
this change in a stand-alone final rule or
make alterations to the testing
requirements in a separate proposed
rule.
We are making a minor change and
two corrections to the proposal in this
final rule. Paragraph (a)(1)(i) of the
proposed compartmentalization sections
in §§ 145.45, 145.74, and 145.84
indicated that the company applying for
compartmentalization would have to,
upon request, work with the Official
State Agency to provide data on the
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incidence of notifiable avian influenza
(NAI) for bird populations outside of the
proposed compartment in the State.
However, Official State Agencies are
focused on commercial poultry
populations and may not have data on
the NAI status of backyard birds or
migratory birds. In addition, while
compartments may trade with other
commercial bird populations, they
should be secured against any disease
risk posed by backyard birds or
migratory birds. Therefore, we are
changing each of these proposed
paragraphs to indicate that the Official
State Agency may provide data on the
NAI status of other commercial poultry
populations located in the State, upon
request.
Paragraph (a)(1)(v) of the proposed
compartmentalization sections
contained a grammatical redundancy,
which we have removed in this final
rule.
We also requested comment on the
new Program Standards document. We
did not receive any comments.
However, one of the approved tests
listed in the Program Standards
document, the Rapid Chek© SelectTM
Salmonella Test Kit, is now produced
by Romer Labs. We have updated the
Program Standards document
accordingly.
Therefore, for the reasons given in the
proposed rule and in this document, we
are adopting the proposed rule as a final
rule, with the changes discussed in this
document.
Executive Order 12866 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.
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 on the
Regulations.gov Web site (see footnote 1
in this document for a link to
Regulations.gov) or by contacting the
person listed under FOR FURTHER
INFORMATION CONTACT.
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 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’s
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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 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 7 CFR part
3015, subpart V.)
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.
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
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 are amending 9 CFR
parts 56, 145, 146, and 147 as follows:
PART 56—CONTROL OF H5/H7 LOW
PATHOGENIC AVIAN INFLUENZA
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.
2. Section 56.1 is amended as follows:
a. By revising the definition of H5/H7
low pathogenic avian influenza (LPAI).
■ b. In paragraph (1)(iii) of the
definition of H5/H7 LPAI virus infection
(infected), by adding the words ‘‘the
Cooperating State Agency, the Official
State Agency, and’’ before the word
‘‘APHIS’’.
■
■
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38753
The revision reads as follows:
§ 56.1
Definitions.
*
*
*
*
*
H5/H7 low pathogenic avian
influenza (LPAI). An infection of
poultry caused by an influenza A virus
of H5 or H7 subtype that has an
intravenous pathogenicity index in 6week-old chickens less than or equal to
1.2 or causes less than 75 percent
mortality in 4- to 8-week-old chickens
infected intravenously, or an infection
with influenza A viruses of H5 or H7
subtype with a cleavage site that is not
consistent with a previously identified
highly pathogenic avian influenza virus.
*
*
*
*
*
■ 3. Section 56.4 is amended by adding
a new paragraph (d) to read as follows:
§ 56.4 Determination of indemnity
amounts.
*
*
*
*
*
(d) Requirements for compliance
agreements. The compliance agreement
is a comprehensive document that
describes the depopulation, disposal,
and cleaning and disinfection plans for
poultry that were infected with or
exposed to H5/H7 LPAI, or a premises
that contained such poultry. The
compliance agreement sets out APHIS
responsibilities, owner responsibilities,
and Cooperating State Agency
responsibilities. The compliance
agreement must include the owner’s
name and the name and address of the
affected premises. The compliance
agreement must have signatories that
include, but are not necessarily limited
to, the owner, the grower (if applicable),
the Cooperating State Agency
representative, the State veterinarian,
and the APHIS area supervisor. In
addition, the compliance agreement
must contain a flock plan with
estimated cost breakdowns that include
labor, materials, personal protective
equipment, travel expenses for
personnel involved, and any additional
information deemed necessary by the
Service. A signed compliance agreement
is required before beginning any work
for which indemnity funds will be
requested. Once work associated with
the compliance agreement is completed,
receipts and documentation detailing
the activities specified in the agreement
should be forwarded to APHIS for
review, approval, and final payment.
This documentation should be
submitted to APHIS no later than 30
days after the quarantine release of the
affected or exposed premises.
*
*
*
*
*
■ 4. Section 56.5 is amended as follows:
■ a. By revising paragraph (c)(1)(i).
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b. By adding paragraphs (c)(1)(iii) and
(c)(1)(iv).
■ c. By revising paragraphs (d)(1)(i) and
(d)(1)(iii).
■ d. By removing paragraph (d)(1)(iv).
■ e. By removing the second, third, and
fourth sentences after the heading of
paragraph (d)(2)(i) and adding five
sentences in their place.
■ f. By revising the first sentence after
the heading of paragraph (d)(3).
The revisions and additions read as
follows:
■
§ 56.5 Destruction and disposal of poultry
and cleaning and disinfection of premises,
conveyances, and materials.
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(c) * * *
(1) * * *
(i) Poultry infected with or exposed to
H5/H7 LPAI must not be transported to
a market for controlled marketing until
approved by the Cooperating State
Agency in accordance with the initial
State response and containment plan
described in § 56.10.
*
*
*
*
*
(iii) Routes to slaughter must avoid
other commercial poultry operations
whenever possible. All load-out
equipment, trailers, and trucks used on
premises that have housed poultry that
were infected with or exposed to H5/H7
LPAI must be cleaned and disinfected
and not enter other poultry premises or
facilities for 48 hours after removing
such poultry from their premises.
(iv) Flocks moved for controlled
marketing must be the last poultry
marketed during the week they are
marketed.
*
*
*
*
*
(d) * * *
(1) * * *
(i) Secure all feathers and debris that
might blow around outside the house in
which the infected or exposed poultry
were held by gathering and pushing the
material into the house;
*
*
*
*
*
(iii) Close the house in which the
poultry were held, maintaining just
enough ventilation to remove moisture.
Leave the house undisturbed for a
minimum of 72 hours.
(2) * * *
(i) * * * Compost manure, debris,
and feed by windrowing in the house if
possible. If this is not possible, set up
a system for hauling manure, debris,
and feed to an approved site for burial,
piling, or composting. Manure, debris,
and feed may be removed from the
house or premises and disposed of by
composting it on site, leaving it in a
undisturbed pile on site, or removing it
from the site in covered vehicles. Land
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application of manure, debris, and feed
should only be performed in accordance
with the initial State response and
containment plan described in § 56.10.
Clean out the house or move or spread
litter as determined by the Cooperating
State Agency and in accordance with
the initial State response and
containment plan. * * *
*
*
*
*
*
(3) * * * Premises should remain
empty until testing provides negative
virus detection results and checked by
the Cooperating State Agency in
accordance with the initial State
response and containment plan
described in § 56.10. * * *
*
*
*
*
*
PART 145—NATIONAL POULTRY
IMPROVEMENT PLAN FOR BREEDING
POULTRY
5. 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.
6. Section 145.1 is amended as
follows:
■ a. In the definition of authorized
agent, by removing the words ‘‘as
described in §§ 147.1(a) and 147.12’’
and adding the words ‘‘in accordance
with part 147’’ in their place.
■ b. In the definition of authorized
laboratory, by removing the citation
‘‘§ 147.51’’ and adding the citation
‘‘§ 147.52’’ in its place; and by removing
the words ‘‘the assays described in’’ and
adding the words ‘‘assays in accordance
with’’ in their place.
■ c. In the definition of authorized
testing agent, by removing the words
‘‘as described in §§ 147.1(a) and 147.12’’
and adding the words ‘‘in accordance
with part 147’’ in their place.
■ d. By adding, in alphabetical order,
definitions of H5/H7 low pathogenic
avian influenza (LPAI) and NPIP
Program Standards.
■ e. In the definition of reactor, by
removing the words ‘‘parts 145 or 147
of this chapter’’ and adding the words
‘‘this part or in accordance with part
147 of this subchapter’’ in their place.
■ f. In the definition of Senior
Coordinator, in paragraph (4), by
removing the citation ‘‘§ 147.51’’ and
adding the citation ‘‘§ 147.52’’ in its
place.
The additions read as follows:
■
§ 145.1
Definitions.
*
*
*
*
*
H5/H7 low pathogenic avian
influenza (LPAI). An infection of
poultry caused by an influenza A virus
of H5 or H7 subtype that has an
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intravenous pathogenicity index in 6week-old chickens less than or equal to
1.2 or causes less than 75 percent
mortality in 4- to 8-week-old chickens
infected intravenously, or an infection
with influenza A viruses of H5 or H7
subtype with a cleavage site that is not
consistent with a previously identified
highly pathogenic avian influenza virus.
*
*
*
*
*
NPIP Program Standards. A
document that contains tests and
sanitation procedures approved by the
Administrator in accordance with
§ 147.53 of this subchapter for use under
this subchapter. This document may be
obtained from the NPIP Web site at
https://www.aphis.usda.gov/animal_
health/animal_dis_spec/poultry/ or by
writing to the Service at National
Poultry Improvement Plan, APHIS,
USDA, 1506 Klondike Road, Suite 101,
Conyers, GA 30094.
*
*
*
*
*
§ 145.2
[Amended]
7. In § 145.2, paragraph (e) is amended
by removing the words ‘‘follow the
laboratory protocols outlined in part 147
of this chapter’’ and adding the words
‘‘conduct tests in accordance with part
147 of this subchapter’’ in their place.
■
8. Section 145.3 is amended as
follows:
■ a. In paragraph (c), second sentence,
by removing the word ‘‘He’’ and adding
the words ‘‘The participant’’ in its place;
and by adding the word ‘‘and’’ before
the word ‘‘cassowaries,’’.
■ b. By redesignating paragraphs (d) and
(e) as paragraphs (e) and (f),
respectively.
■ c. By adding a new paragraph (d).
The addition reads as follows:
■
§ 145.3
Participation.
*
*
*
*
*
(d) To ensure that Plan diseases are
not spread, flocks must be qualified for
their intended Plan classifications
before being moved into breeder
production facilities.
*
*
*
*
*
§ 145.5
[Amended]
9. Section 145.5 is amended as
follows:
■ a. In paragraph (a), by removing the
words ‘‘as recommended in §§ 147.21
and 147.22 (a) and (e) of this chapter’’
and adding the words ‘‘in accordance
with part 147 of this subchapter’’ in
their place.
■ b. In paragraph (c), by removing the
words ‘‘or F’’ and adding the words ‘‘F,
G, H, or I’’ in their place.
■ 10. Section 145.6 is amended as
follows:
■
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a. By revising the second sentence in
paragraph (a) introductory text.
■ b. In paragraphs (a)(1), (a)(2), (a)(3),
and (a)(4), by removing the words ‘‘as
outlined in § 147.24 of this chapter’’ and
adding the words ‘‘in accordance with
part 147 of this subchapter’’ in their
place.
The revision reads as follows:
■
§ 145.6 Specific provisions for
participating hatcheries.
(a) * * * The sanitary procedures
outlined in the NPIP Program
Standards, or other procedures
approved by the Administrator in
accordance with § 147.53(d), will be
considered as a guide in determining
compliance with this provision. * * *
*
*
*
*
*
■ 11. Section 145.10 is amended as
follows:
■ a. In paragraph (b) introductory text,
by removing the words ‘‘and 145.63(a)’’
and adding the words ‘‘145.63(a),
145.73(b), 145.83(b), and 145.93(b)’’ in
their place.
■ b. By revising paragraph (c)
introductory text, paragraph (g)
introductory text, paragraph (m)
introductory text, paragraph (o)
introductory text, and paragraph (t)
introductory text.
The revisions read as follows:
§ 145.10 Terminology and classification;
flocks, products, and States.
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(c) U.S. M. Gallisepticum Clean. (See
§§ 145.23(c), 145.23(f), 145.33(c),
145.33(f), 145.43(c), 145.53(c), 145.73(c),
and 145.83(c).)
*
*
*
*
*
(g) U.S. Pullorum-Typhoid Clean
State. (See §§ 145.24(a), 145.34(a),
145.44(a), 145.54(a), and 145.94(a).)
*
*
*
*
*
(m) U.S. S. Enteritidis Clean. (See
§§ 145.23(d), 145.73(d), and 145.83(e).)
*
*
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*
(o) U.S. Salmonella Monitored. (See
§§ 145.53(f), 145.83(f), and 145.93(d).)
*
*
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*
*
(t) U.S. H5/H7 Avian Influenza Clean.
(See §§ 145.43(g), 145.53(e), and
145.93(c).)
*
*
*
*
*
■ 12. Section 145.14 is amended as
follows:
■ a. In paragraph (a)(1), by revising the
second sentence.
■ b. In paragraph (a)(6)(ii), by revising
the third sentence.
■ c. In paragraph (b)(1), by adding a
sentence after the second sentence.
■ d. By revising paragraph (b)(3).
■ e. By revising paragraph (d)(1)(ii)(C).
■ f. In paragraph (d)(2)(i)(A), by
removing the word ‘‘(AVPR01510)’’.
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g. By revising paragraph (d)(2)(ii)(B).
The revisions and addition read as
follows:
■
§ 145.14
Testing.
(a) * * *
(1) * * * Official blood tests must be
conducted in accordance with part 147
of this subchapter or according to
literature provided by the
producer. * * *
*
*
*
*
*
(6) * * *
(ii) * * * Bacteriological examination
must be conducted in accordance with
part 147 of this subchapter. * * *
*
*
*
*
*
(b) * * *
(1) * * * Tests must be conducted in
accordance with this paragraph (b) and
in accordance with part 147 of this
subchapter. * * *
*
*
*
*
*
(3) When reactors to the test for which
the flock was tested are submitted to a
laboratory as prescribed by the Official
State Agency, the final status of the
flock will be determined in accordance
with part 147 of this subchapter.
*
*
*
*
*
(d) * * *
(1) * * *
(ii) * * *
(C) The AGID test for avian influenza
must be conducted in accordance with
part 147 of this subchapter. The test can
be conducted on egg yolk or blood
samples. The AGID test is not
recommended for use in waterfowl.
*
*
*
*
*
(2) * * *
(ii) * * *
(B) Chicken and turkey flocks that test
positive on the ACIA must be further
tested using the RRT–PCR or virus
isolation. Positive results from the RRT–
PCR or virus isolation must be further
tested by Federal Reference Laboratories
using appropriate tests for confirmation.
Final judgment may be based upon
further sampling and appropriate tests
for confirmation.
*
*
*
*
*
■ 13. In § 145.22, paragraph (b) is
revised to read as follows:
§ 145.22
Participation.
*
*
*
*
*
(b) Hatching eggs produced by
multiplier breeding flocks should be
nest clean. They may be fumigated in
accordance with part 147 of this
subchapter or otherwise sanitized.
*
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*
*
*
■ 14. Section 145.23 is amended as
follows:
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38755
a. In paragraph (b) introductory text,
by removing the citation ‘‘(5)’’ and
adding the citation ‘‘(4)’’ in its place.
■ b. In paragraph (c)(1) introductory
text, by removing the words ‘‘in
compliance with the provisions of
§ 147.26 of this chapter’’ and adding the
words ‘‘in accordance with part 147 of
this subchapter with respect to
Mycoplasma isolation, sanitation, and
management’’ in their place.
■ c. In paragraph (c)(1)(ii)(C), by
removing the words ‘‘§ 147.8 of this
chapter’’ and adding the words ‘‘part
147 of this subchapter’’ in their place.
■ d. In paragraph (c)(3), by removing the
words ‘‘as described in § 147.24(a) of
this chapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter’’ in their place.
■ e. In paragraph (d)(1)(iv), by removing
the words ‘‘in compliance with
§§ 147.21, 147.24(a), and 147.26 of this
chapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter with respect to flock
sanitation, cleaning and disinfection,
and Salmonella isolation, sanitation,
and management’’ in their place.
■ f. In paragraph (d)(1)(v), by removing
the words ‘‘as described in § 147.12 of
this chapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter’’ in their place.
■ g. In paragraph (d)(1)(vii), by
removing the words ‘‘as described in
§ 147.11 of this chapter’’ and adding the
words ‘‘in accordance with part 147 of
this subchapter’’ in their place.
■ h. By revising paragraphs (d)(1)(viii)
and (d)(1)(ix).
■ i. In paragraph (d)(2), by removing the
words ‘‘as described in § 147.11(a) of
this chapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter’’ in their place.
■ j. In paragraph (e)(1) introductory text,
by removing the words ‘‘in compliance
with the provisions of § 147.26 of this
chapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter with respect to Mycoplasma
isolation, sanitation, and management’’
in their place.
■ k. In paragraph (e)(1)(ii)(B), by
removing the words ‘‘§ 147.8 of this
chapter’’ and adding the words ‘‘part
147 of this subchapter’’ in their place.
■ l. In paragraph (e)(3), by removing the
words ‘‘as described in § 147.24(a) of
this chapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter’’ in their place.
■ m. In paragraph (f)(3), by removing the
words ‘‘in compliance with the
provisions of § 147.26 of this chapter’’
and adding the words ‘‘in accordance
with part 147 of this subchapter with
respect to Mycoplasma isolation,
■
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sanitation, and management’’ in their
place.
■ n. In paragraph (f)(5), by removing the
words ‘‘as described in § 147.24(a) of
this chapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter’’ in their place.
■ o. In paragraph (g)(3), by removing the
words ‘‘in compliance with the
provisions of § 147.26 of this chapter’’
and adding the words ‘‘in accordance
with part 147 of this subchapter with
respect to Mycoplasma isolation,
sanitation, and management’’ in their
place.
■ p. In paragraph (g)(5), by removing the
words ‘‘as described in § 147.24(a) of
this chapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter’’ in their place.
■ q. In paragraph (h)(1) introductory
text, by adding the words ‘‘and found’’
before the word ‘‘negative’’ and by
removing the words ‘‘for antibodies’’.
The revisions read as follows:
§ 145.23 Terminology and classification;
flocks and products.
*
*
*
*
*
(d) * * *
(1) * * *
(viii) Hatching eggs are collected as
quickly as possible, and their sanitation
is maintained in accordance with part
147 of this subchapter.
(ix) Hatching eggs produced by the
flock are incubated in a hatchery whose
sanitation is maintained in accordance
with part 147 of this subchapter and
sanitized either by a procedure
approved by the Official State Agency or
in accordance with part 147 of this
subchapter.
*
*
*
*
*
■ 15. In § 145.32, paragraph (b) is
revised to read as follows:
§ 145.32
Participation.
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*
*
*
*
*
■ (b) Hatching eggs produced by
multiplier breeding flocks should be
nest clean. They may be fumigated in
accordance with part 147 of this
subchapter or otherwise sanitized.
*
*
*
*
*
■ 16. Section 145.33 is amended as
follows:
■ a. In paragraph (b) introductory text,
by removing the citation ‘‘(5)’’ and
adding the citation ‘‘(4)’’ in its place.
■ b. In paragraph (c)(1) introductory
text, by removing the words ‘‘in
compliance with the provisions of
§ 147.26 of this chapter’’ and adding the
words ‘‘in accordance with part 147 of
this subchapter with respect to
Mycoplasma isolation, sanitation, and
management’’ in their place.
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c. In paragraph (c)(1)(ii)(C), by
removing the words ‘‘§ 147.8 of this
chapter’’ and adding the words ‘‘part
147 of this subchapter’’ in their place.
■ d. In paragraph (c)(2), by removing the
words ‘‘(see §§ 147.22, 147.23, and
147.24)’’ and by adding the words ‘‘and
in accordance with part 147 of this
subchapter’’ before the period at the end
of the paragraph.
■ e. In paragraph (c)(3), by removing the
words ‘‘as described in § 147.24(a) of
this chapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter’’ in their place.
■ f. In paragraph (c)(4), by removing the
words ‘‘approved by the Department’’
and adding the words ‘‘in accordance
with part 147 of this subchapter’’ in
their place.
■ g. In paragraph (d)(1)(ii), by removing
the words ‘‘in compliance with
§§ 147.21, 147.24(a), and 147.26 of this
chapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter with respect to flock
sanitation, cleaning and disinfection,
and Salmonella isolation, sanitation,
and management’’ in their place.
■ h. By revising paragraph (d)(1)(vi).
■ i. In paragraph (d)(1)(vii), by removing
the words ‘‘as described in § 147.12 of
this chapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter’’ in their place.
■ j. By revising paragraph (d)(2).
■ k. In paragraph (e)(1) introductory
text, by removing the words ‘‘in
compliance with the provisions of
§ 147.26 of this chapter’’ and adding the
words ‘‘in accordance with part 147 of
this subchapter with respect to
Mycoplasma isolation, sanitation, and
management’’ in their place.
■ l. In paragraph (e)(1)(ii)(B), by
removing the words ‘‘§ 147.8 of this
chapter’’ and adding the words ‘‘part
147 of this subchapter’’ in their place.
■ m. In paragraph (e)(3), by removing
the words ‘‘as described in § 147.24(a) of
this chapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter’’ in their place.
■ n. In paragraph (e)(4), by removing the
words ‘‘approved by the Department’’
and adding the words ‘‘in accordance
with part 147 of this subchapter’’ in
their place.
■ o. In paragraph (f)(3), by removing the
words ‘‘in compliance with the
provisions of § 147.26 of this chapter’’
and adding the words ‘‘in accordance
with part 147 of this subchapter with
respect to Mycoplasma isolation,
sanitation, and management’’ in their
place.
■ p. In paragraph (f)(5), by removing the
words ‘‘as described in § 147.24(a) of
this chapter’’ and adding the words ‘‘in
■
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accordance with part 147 of this
subchapter’’ in their place.
■ q. In paragraph (g)(3), by removing the
words ‘‘in compliance with the
provisions of § 147.26 of this chapter’’
and adding the words ‘‘in accordance
with part 147 of this subchapter with
respect to Mycoplasma isolation,
sanitation, and management’’ in their
place.
■ r. In paragraph (g)(5), by removing the
words ‘‘as described in § 147.24(a) of
this chapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter’’ in their place.
■ s. In paragraph (j)(2), by removing the
words ‘‘paragraph (c)(1)(i) of this
section’’ and adding the words
‘‘§ 145.83(c)(1)(i)’’ in their place.
■ t. In paragraphs (j)(3) and (k)(3), by
removing the words ‘‘as described in
§ 147.24(a) of this chapter’’ and adding
the words ‘‘in accordance with part 147
of this subchapter’’ in their place.
■ u. In paragraph (k)(2), by removing the
words ‘‘paragraph (e)(1)(i) of this
section’’ and adding the words
‘‘§ 145.83(d)(1)(i)’’ in their place.
■ v. In paragraph (l)(1) introductory
text, by adding the words ‘‘using an
approved test as described in § 145.14’’
after the word ‘‘influenza’’.
■ w. By adding paragraph (m).
The revisions and addition read as
follows:
§ 145.33 Terminology and classification;
flocks and products.
*
*
*
*
*
(d) * * *
(1) * * *
(vi) 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;
*
*
*
*
*
(2) The Official State Agency may
monitor the effectiveness of the
sanitation practices in accordance with
part 147 of this subchapter.
*
*
*
*
*
(m) U.S. Salmonella Enteritidis
Monitored. This classification is
intended for multiplier meat-type
breeders wishing to monitor their
breeding flocks for Salmonella
enteritidis.
(1) A flock and the hatching eggs and
chicks produced from it shall be eligible
for this classification if they meet the
following requirements, as determined
by the Official State Agency:
(i) The flock originated from a U.S. S.
Enteritidis Clean primary meat-type
breeding flock.
(ii) The flock is maintained in
accordance with part 147 of this
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subchapter with respect to Salmonella
isolation, sanitation, and management.
(iii) Environmental samples are
collected from the flock in accordance
with part 147 of this subchapter at 16–
18 and 40–45 weeks of age. The samples
shall be examined bacteriologically for
group D Salmonella at an authorized
laboratory, and cultures from group D
positive samples shall be serotyped.
(2) The following actions must be
taken with respect to the test results that
are generated from this S. enteritidis
monitoring program:
(i) If S. enteritidis is isolated from an
environmental sample collected from
the flock in accordance with paragraph
(m)(1)(iii) of this section, a thorough
evaluation of the practices and programs
associated with the sampled flock shall
be conducted with the goal of
ascertaining the reason(s) for the
positive finding.
(ii) The test results and the results of
any evaluations performed in
accordance with paragraph (m)(2)(i) of
this section will be reported on a
quarterly basis to the Official State
Agency and the NPIP Senior
Coordinator.
(iii) Participating broiler integrators
shall combine their respective test
results (and the results of any associated
evaluations) to help guide their
decisionmaking regarding programs and
practices to implement or maintain to
address S. enteritidis.
(iv) Aggregate data regarding the
prevalence of S. enteritidis in
participating U.S. meat-type parent
breeding flocks shall be made available
to the U.S. Poultry and Egg Association
and the National Chicken Council.
(3) This classification may be revoked
by the Official State Agency if the
participant fails to comply with the
requirements of this classification. The
Official State Agency shall not revoke
the participant’s classification until the
participant has been given an
opportunity for a hearing in accordance
with rules of practice adopted by the
Official State Agency.
*
*
*
*
*
words ‘‘in accordance with part 147 of
this subchapter with respect to
Mycoplasma isolation, sanitation, and
management’’ in their place.
■ b. In paragraph (c)(2), by removing the
words ‘‘applicable conditions outlined
in § 147.26 of this chapter are being
met’’ and adding the words ‘‘flock is
being maintained in accordance with
part 147 of this subchapter with respect
to Mycoplasma isolation, sanitation, and
management’’ in their place.
■ c. By adding a sentence at the end of
paragraph (e)(1).
■ d. In paragraph (e)(2), by removing the
words ’’ § 147.6 of this chapter’’ and by
adding the words ’’ part 147 of this
subchapter’’ in their place.
■ e. By removing paragraph (e)(3).
■ f. In paragraph (f) introductory text, by
removing the words ‘‘as described in
subpart C of part 147 of this chapter’’
and adding the words ‘‘in accordance
with part 147 of this subchapter’’ in
their place.
■ g. In paragraphs (f)(2), (f)(4), and (f)(6),
by removing the words ‘‘, as described
in § 147.12 of this chapter’’ and adding
the words ‘‘in accordance with part 147
of this subchapter’’ in their place.
■ h. By revising paragraph (g)(3).
The addition and revision read as
follows:
§ 145.42
(a) U.S. H5/H7 Avian Influenza Clean
Compartment. This program is intended
to be the basis from which the primary
turkey breeding-hatchery industry may
demonstrate the existence and
implementation of a program that has
been approved by the Official State
Agency and the Service to establish a
compartment consisting of a primary
breeding-hatchery company that is free
of H5/H7 avian influenza (AI), also
referred to as notifiable avian influenza
(NAI). This compartment has the
[Amended]
17. In § 145.42, paragraph (b) is
amended by removing the words ‘‘(see
§ 147.25 of this chapter)’’ and adding
the words ‘‘in accordance with part 147
of this subchapter’’ after the word
‘‘sanitized’’.
■ 18. Section 145.43 is amended as
follows:
■ a. In paragraph (c)(1), by removing the
words ‘‘in accordance with the
conditions and procedures described in
§ 147.26 of this chapter’’ and adding the
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■
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§ 145.43 Terminology and classification;
flocks and products.
*
*
*
*
*
(e) * * *
(1) * * * It is recommended that any
birds that are showing clinical signs of
M. synoviae infection be included in
samples taken.
*
*
*
*
*
(g) * * *
(3) All spent fowl being marketed for
meat from flocks that have been tested
as required by this paragraph shall be
tested at a rate of 6 birds per flock
within 21 days prior to movement to
slaughter.
*
*
*
*
*
■ 19. Section 145.45 is added to subpart
D to read as follows:
§ 145.45 Terminology and classification;
compartments.
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purpose of protecting the defined
subpopulation and avoiding the
introduction and spread of NAI 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:
(1) Definition of the compartment.
Based on the guidelines established by
the World Organization for Animal
Health (OIE) in the Terrestrial Animal
Health Code and the guidelines in this
paragraph (a), the primary breeder
company will define the compartment
with respect to NAI. Specifically, the
company will use a comprehensive
biosecurity program to define the
compartment as a subpopulation of
poultry with a health status for NAI that
is separate from birds and poultry
outside the compartment. The Official
State Agency and the Service must
approve all documentation submitted to
substantiate the defined compartment as
adequate to qualify for epidemiological
separation from other potential sources
of infection of NAI. Guidelines for the
definition of the compartment include:
(i) Definition and description of the
subpopulation of birds and their health
status. All birds included in the
compartment must be U.S. H5/H7 Avian
Influenza Clean in accordance with
§ 145.43(g). The poultry must also be
located in a State that has an initial
State response and containment plan
approved by APHIS under § 56.10 of
this chapter and that participates in the
diagnostic surveillance program for H5/
H7 low pathogenicity AI as described in
§ 145.15. Within the compartment, all
official tests for AI, as described in
§ 145.14(d), must be conducted in State
or Federal laboratories or in NPIP
authorized laboratories that meet the
minimum standards described in
§ 147.52 of this subchapter. In addition,
the company must provide to the
Service upon request any relevant
historical and current NAI-related data
for reference regarding surveillance for
the disease within the compartment.
Upon request, the Official State Agency
may provide such data for other
commercial poultry populations located
in the State.
(ii) Description of animal
identification and traceability processes.
The primary breeder company must also
include a description of its animal
identification and traceability records,
including examples of Veterinary
Services (VS) Form 9–5, ‘‘Report of
Hatcheries, Dealers and Independent
Flocks’’; VS Form 9–2, ‘‘Flock Selection
and Testing Report’’; VS Form 9–3,
‘‘Report of Sales of Hatching Eggs,
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Chicks and Poults’’; VS Form 9–9, ’’
Hatchery Inspection Report’’; set and
hatch records; egg receipts; and egg/
chick invoices for the subpopulation.
Documentation must also include breed
identification (NPIP stock code). The
Service should ensure that an effective
flock identification system and
traceability system are in place.
(iii) Definition and description of the
physical components or establishments
of the defined compartment. The
primary breeder company must provide
documentation establishing that the
defined compartment is
epidemiologically separated from other
poultry and bird populations. The
documentation must be approved by the
Official State Agency and the Service as
indicating adequate epidemiological
separation to maintain the
compartment’s separate health status
with respect to NAI. The documentation
should include descriptions of:
(A) The physical and spatial factors
that separate the compartment from
surrounding bird populations and affect
the biosecurity status of the
compartment.
(B) Relevant environmental factors
that may affect exposure of the birds to
AI.
(C) The functional boundary and
fencing that are used to control access
to the compartment.
(D) Facilities and procedures to
prevent access by wild birds and to
provide separation from other relevant
hosts.
(E) The relevant infrastructural factors
that may affect exposure to AI,
including the construction and design of
buildings or physical components,
cleaning and disinfection of buildings
and physical components between
production groups with quality
assurance verification, cleaning and
disinfection of equipment, and
introduction of equipment or material
into the compartment.
(iv) Definition and description of the
functional relationships between
components of the defined
compartment. Functional relationships
between components of the
compartment include traffic movement
and flow at and among premises,
personnel movement at and among
premises, exposure to live bird
populations, and any other factors that
could affect biosecurity of the
compartment. All physical components
of the compartment must be maintained
in compliance with hygiene and
biosecurity procedures for poultry
primary breeding flocks and hatcheries
in accordance with part 147 of this
subchapter. In addition, the company
must provide a biosecurity plan for the
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compartment and all included
components. The biosecurity plan
should include:
(A) Requirements that company
employees and contract growers limit
their contact with live birds outside the
compartment.
(B) An education and training
program for company employees and
contractors.
(C) Standard operating procedures for
company employees, contractors, and
outside maintenance personnel.
(D) Requirements for company
employees and non-company personnel
who visit any premises within the
compartment.
(E) Company veterinary infrastructure
to ensure flock monitoring and disease
diagnosis and control measures.
(F) Policies for management of
vehicles and equipment used within the
compartment to connect the various
premises.
(G) Farm site requirements (location,
layout, and construction).
(H) Pest management program.
(I) Cleaning and disinfection process.
(J) Requirements for litter and dead
bird removal and/or disposal.
(v) Description of other factors
important for maintaining the
compartment. The company veterinary
infrastructure will assess sanitary
measures, environmental risk factors,
and management and husbandry
practices that relate to the separation of
the compartment and the health status
of the birds contained within the
compartment that may affect risk of
exposure to NAI. This assessment must
include a description of internal
monitoring and auditing systems (e.g.,
quality assurance and quality control
programs) to demonstrate the
effectiveness of the compartment. Upon
request, the Service will provide the
company with information on the
epidemiology of NAI and the associated
risk pathways in which the components
of the compartment are located.
(vi) Approval or denial. Based on this
documentation provided under this
paragraph (a)(1), as well as any other
information the Service and the Official
State Agency determine to be necessary,
the Service and the Official State
Agency will approve or deny the
classification of the compartment as
U.S. H5/H7 Avian Influenza Clean.
(2) Company activities for
maintenance of the compartment. (i)
The primary breeder company’s
management of biosecurity,
surveillance, and disease control efforts
must be uniform and equivalent among
all components that are a part of the
compartment. Oversight and inspection
of these management practices must be
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conducted by the company’s licensed,
accredited veterinarians.
(ii) Veterinary staff from the Official
State Agency and NPIP staff will work
in partnership with licensed, accredited
veterinarians to train and certify
auditors through Service-approved
workshops. The trained auditors will
conduct biosecurity and operational
audits at least once every 2 years to
ensure the integrity of the compartment.
These audits will include evaluation of
the critical control points and standard
operating practices within the
compartment, verification of the health
status of the flock(s) contained within
the compartment, and examination of
the biosecurity and management system
of the integrated components of the
compartment.
(iii) In addition, the company must
demonstrate compliance with paragraph
(a)(1) of this section for remaining in the
U.S. H5/H7 Avian Influenza Clean
classification, surveillance for NAI
within the compartment, and
conducting tests in State or Federal
laboratories or in NPIP authorized
laboratories. Accredited veterinarians
are responsible for the enforcement of
active and passive surveillance of NAI
in primary breeder flocks. Baseline
health status must be maintained for all
flocks or subpopulations within the
compartment, indicating the dates and
negative results of all avian influenza
surveillance and monitoring testing, the
dates and history of last disease
occurrence (if any), the number of
outbreaks, and the methods of disease
control that were applied.
(iv) Documentation will be
maintained in the company’s database
and will be verified as required by the
Service and/or the Official State
Agency.
(3) Service and Official State Agency
activities for maintenance of the
compartment. The Service will work in
cooperation with the Official State
Agencies to ensure the continued
integrity of any recognized
compartments. Activities will include:
(i) Oversight of the establishment and
management of compartments;
(ii) Establishment of effective
partnerships between the Service, the
Plan, and the primary breeder industry;
(iii) Approval or denial of
classification of compartments as U.S.
H5/H7 Avian Influenza Clean
Compartments under paragraph (a)(1) of
this section;
(iv) Official certification of the health
status of the compartment, and
commodities that may be traded from it
through participation in the Plan for
avian diseases, including the U.S. H5/
H7 Avian Influenza Clean program as
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described in § 145.43(g) and diagnostic
surveillance for H5/H7 low
pathogenicity AI as described in
§ 145.15;
(v) Conducting audits of
compartments at least once every 2
years to:
(A) Confirm that the primary breeding
company’s establishments are
epidemiologically distinct and
pathways for the introduction of disease
into the compartment are closed
through routine operational procedures;
and
(B) Evaluate and assess the
management and husbandry practices
relating to biosecurity to determine
whether they are in compliance with
hygiene and biosecurity procedures for
poultry primary breeding flocks and
hatcheries in accordance with part 147
of this subchapter;
(vi) Providing, upon request, model
plans for management and husbandry
practices relating to biosecurity in
accordance with part 147 of this
subchapter, risk evaluations in
conjunction with the primary breeder
industry (including disease surveillance
such as VS Form 9–4, ‘‘Summary of
Breeding Flock Participation’’), and
diagnostic capability summaries and
systems for initial State response and
containment plans in accordance with
§ 56.10 of this chapter; and
(vii) Publicizing and sharing
compartment information with
international trading partners, upon
request, to establish approval and
recognition of the compartment,
including timeliness and accuracy of
disease reporting and surveillance
measures as described in §§ 145.15 and
145.43(g).
(4) Emergency response and
notification. In the case of a confirmed
positive of NAI in the subpopulation of
the compartment, the management of
the compartment must notify the
Service. The Service will immediately
suspend the status of the compartment.
A compartment will be eligible to
resume trade with importing countries
only after the compartment has adopted
the necessary measures to reestablish
the biosecurity level and confirm that
NAI is not present in the compartment
and the Service has reevaluated the
management and biosecurity measures
of the compartment and approved said
compartment for trade.
(b) [Reserved]
■ 20. Section 145.52 is amended as
follows:
■ a. In paragraph (b), by removing the
words ‘‘(see § 147.25 of this chapter)’’
and adding the words ‘‘in accordance
with part 147 of this subchapter’’ after
the word ‘‘sanitized’’.
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b. By redesignating paragraphs (c) and
(d) as paragraphs (d) and (e),
respectively.
■ c. By adding a new paragraph (c).
The addition reads as follows:
■
§ 145.52
Participation.
*
*
*
*
*
(c) It is recommended that waterfowl
flocks and gallinaceous flocks in openair facilities be kept separate.
*
*
*
*
*
■ 21. Section 145.53 is amended as
follows:
■ a. In paragraph (c)(1) introductory
text, by removing the words ‘‘in
compliance with the provisions of
§ 147.26 of this chapter’’ and adding the
words ‘‘in accordance with part 147 of
this subchapter with respect to
Mycoplasma isolation, sanitation, and
management’’ in their place.
■ b. In paragraph (c)(3), by removing the
words ‘‘as described in § 147.24(a) of
this chapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter’’ in their place.
■ c. In paragraph (d)(1) introductory
text, by removing the words ‘‘in
compliance with the provisions of
§ 147.26 of this chapter’’ and adding the
words ‘‘in accordance with part 147 of
this subchapter with respect to
Mycoplasma isolation, sanitation, and
management’’ in their place.
■ d. In paragraph (d)(1)(ii)(B), by
removing the words ‘‘§ 147.8 of this
chapter’’ and adding the words ‘‘part
147 of this subchapter’’ in their place.
■ e. In paragraph (d)(3), by removing the
words ‘‘as described in § 147.24(a) of
this chapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter’’ in their place.
■ f. By revising paragraphs (e)(1)
introductory text and (e)(2) introductory
text.
■ g. In paragraphs (e)(1)(i) and (e)(1)(ii),
by removing the number ‘‘90’’ and
adding the number ‘‘180’’ in its place.
■ h. By revising paragraph (e)(3).
■ i. By adding paragraph (f).
The revisions and addition read as
follows:
(2) It is a multiplier breeding flock in
which a minimum of 30 birds has been
tested negative to the H5 and H7
subtypes of avian influenza as provided
in § 145.14(d) when more than 4 months
of age; Provided, that waterfowl flocks
may test a minimum of 30 cloacal swabs
for virus isolation. To retain this
classification:
*
*
*
*
*
(3) A sample of at least 30 birds must
be tested and found negative to H5/H7
avian influenza within 21 days prior to
movement to slaughter.
(f) U.S. Salmonella Monitored. This
program is intended to be the basis from
which the hatching industry may
conduct a program for the prevention
and control of salmonellosis. It is
intended to reduce the incidence of
Salmonella organisms in day-old
poultry through an effective and
practical sanitation program in the
hatchery. This will afford other
segments of the poultry industry an
opportunity to reduce the incidence of
Salmonella in their products. The
following requirements must be met for
a flock to be of this classification:
(1) An Authorized Agent shall collect
a minimum of five environmental
samples, e.g., chick papers, hatching
trays, and chick transfer devices, from
the hatchery at least every 30 days.
Testing must be performed at an
authorized laboratory.
(2) To claim products are of this
classification, all products shall be
derived from a hatchery that meets the
requirements of the classification.
(3) This classification may be revoked
by the Official State Agency if the
participant fails to follow recommended
corrective measures.
*
*
*
*
*
§ 145.62
[Amended]
22. In § 145.62, paragraph (b) is
amended by removing the words ‘‘(see
§ 147.22 of this chapter)’’ and adding
the words ‘‘in accordance with part 147
of this subchapter’’ in their place.
■ 23. In § 145.72, paragraph (b) is
revised to read as follows:
■
§ 145.53 Terminology and classification;
flocks and products.
§ 145.72
*
*
*
*
*
*
(e) * * *
(1) It is a primary breeding flock in
which a minimum of 30 birds has been
tested negative to the H5 and H7
subtypes of avian influenza as provided
in § 145.14(d) when more than 4 months
of age; Provided, that waterfowl flocks
may test a minimum of 30 cloacal swabs
for virus isolation. To retain this
classification:
*
*
*
*
*
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Participation.
*
*
*
*
(b) Hatching eggs produced by
primary breeding flocks should be nest
clean. They may be fumigated in
accordance with part 147 of this
subchapter or otherwise sanitized.
*
*
*
*
*
■ 24. Section 145.73 is amended as
follows:
■ a. In paragraph (c)(1) introductory
text, by removing the words ‘‘in
compliance with the provisions of
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§ 147.26 of this subchapter’’ and adding
the words ‘‘in accordance with part 147
of this subchapter with respect to
Mycoplasma isolation, sanitation, and
management’’ in their place.
■ b. In paragraph (c)(3), by removing the
words ‘‘as described in § 147.24(a)’’ and
adding the words ‘‘in accordance with
part 147’’ in their place.
■ c. In paragraph (d)(1)(iv), by removing
the words ‘‘in compliance with
§§ 147.21, 147.24(a), and 147.26 of this
subchapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter with respect to flock
sanitation, cleaning and disinfection,
and Salmonella isolation, sanitation,
and management’’ in their place.
■ d. In paragraph (d)(1)(v), by removing
the words ‘‘as described in § 147.12’’
and adding the words ‘‘in accordance
with part 147’’ in their place.
■ e. In paragraph (d)(1)(vii), by
removing the words ‘‘as described in
§ 147.11’’ and adding the words ‘‘in
accordance with part 147’’ in their
place.
■ f. By revising paragraph (d)(1)(ix).
■ g. In paragraph (d)(2), by removing the
words ‘‘as described in § 147.11(a)’’ and
adding the words ‘‘in accordance with
part 147’’ in their place.
■ h. In paragraph (e)(1) introductory
text, by removing the words ‘‘in
compliance with the provisions of
§ 147.26 of this subchapter’’ and adding
the words ‘‘in accordance with part 147
of this subchapter with respect to
Mycoplasma isolation, sanitation, and
management’’ in their place.
■ i. In paragraph (e)(3), by removing the
words ‘‘as described in § 147.24(a)’’ and
adding the words ‘‘in accordance with
part 147’’ in their place.
■ j. In paragraph (f)(1) introductory text,
by adding the words ‘‘and found’’ before
the word ‘‘negative’’ and by removing
the words ‘‘antibodies to’’.
■ k. By revising paragraph (f)(2).
The revisions read as follows:
§ 145.73 Terminology and classification;
flocks and products.
emcdonald on DSK67QTVN1PROD with RULES
*
*
*
*
*
(d) * * *
(1) * * *
(ix) Hatching eggs produced by the
flock are incubated in a hatchery whose
sanitation is maintained in accordance
with part 147 of this subchapter and
sanitized either by a procedure
approved by the Official State Agency or
in accordance with part 147 of this
subchapter.
*
*
*
*
*
(f) * * *
(2) A sample of at least 11 birds must
be tested and found negative for avian
influenza within 21 days prior to
movement to slaughter.
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25. Section 145.74 is added to subpart
G to read as follows:
■
§ 145.74 Terminology and classification;
compartments.
(a) U.S. Avian Influenza Clean
Compartment. This program is intended
to be the basis from which the primary
egg-type chicken breeding-hatchery
industry may demonstrate the existence
and implementation of a program that
has been approved by the Official State
Agency and the Service to establish a
compartment consisting of a primary
breeding-hatchery company that is free
of H5/H7 avian influenza (AI), also
referred to as notifiable avian influenza
(NAI). This compartment has the
purpose of protecting the defined
subpopulation and avoiding the
introduction and spread of NAI 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:
(1) Definition of the compartment.
Based on the guidelines established by
the World Organization for Animal
Health (OIE) in the Terrestrial Animal
Health Code and the guidelines in this
paragraph (a), the primary breeder
company will define the compartment
with respect to NAI. Specifically, the
company will use a comprehensive
biosecurity program to define the
compartment as a subpopulation of
poultry with a health status for NAI that
is separate from birds and poultry
outside the compartment. The Official
State Agency and the Service must first
approve all documentation submitted by
the company to substantiate the defined
compartment as adequate to qualify for
epidemiological separation from other
potential sources of infection of NAI.
Guidelines for the definition of the
compartment include:
(i) Definition and description of the
subpopulation of birds and their health
status. All birds included in the
compartment must be U.S. Avian
Influenza Clean in accordance with
§ 145.73(f). The poultry must also be
located in a State that has an initial
State response and containment plan
approved by APHIS under § 56.10 of
this chapter and that participates in the
diagnostic surveillance program for H5/
H7 low pathogenicity AI as described in
§ 145.15. Within the compartment, all
official tests for AI, as described in
§ 145.14(d), must be conducted in State
or Federal laboratories or in NPIP
authorized laboratories that meet the
minimum standards described in
§ 147.52 of this subchapter. In addition,
the company must provide to the
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Service upon request any relevant
historical and current NAI-related data
for reference regarding surveillance for
the disease within the compartment.
Upon request, the Official State Agency
may provide such data for other
commercial poultry populations located
in the State.
(ii) Description of animal
identification and traceability processes.
The primary breeder company must also
include a description of its animal
identification and traceability records,
including examples of Veterinary
Services (VS) Form 9–5, ‘‘Report of
Hatcheries, Dealers and Independent
Flocks’’; VS Form 9–2, ‘‘Flock Selection
and Testing Report’’; VS Form 9–3,
‘‘Report of Sales of Hatching Eggs,
Chicks and Poults’’; VS Form 9–9, ’’
Hatchery Inspection Report’’; set and
hatch records; egg receipts; and egg/
chick invoices for the subpopulation.
Documentation must also include breed
identification (NPIP stock code). The
Service should ensure that an effective
flock identification system and
traceability system are in place.
(iii) Definition and description of the
physical components or establishments
of the defined compartment. The
primary breeder company must provide
documentation establishing that the
defined compartment is
epidemiologically separated from other
poultry and bird populations. The
documentation must be approved by the
Official State Agency and the Service as
indicating adequate epidemiological
separation to maintain the
compartment’s separate health status
with respect to NAI. The documentation
should include descriptions of:
(A) The physical and spatial factors
that separate the compartment from
surrounding bird populations and affect
the biosecurity status of the
compartment.
(B) Relevant environmental factors
that may affect exposure of the birds to
AI.
(C) The functional boundary and
fencing that are used to control access
to the compartment.
(D) Facilities and procedures to
prevent access by wild birds and to
provide separation from other relevant
hosts.
(E) The relevant infrastructural factors
that may affect exposure to AI,
including the construction and design of
buildings or physical components,
cleaning and disinfection of buildings
and physical components between
production groups with quality
assurance verification, cleaning and
disinfection of equipment, and
introduction of equipment or material
into the compartment.
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(iv) Definition and description of the
functional relationships between
components of the defined
compartment. Functional relationships
between components of the
compartment include traffic movement
and flow at and among premises,
personnel movement at and among
premises, exposure to live bird
populations, and any other factors that
could affect biosecurity of the
compartment. All physical components
of the compartment must be maintained
in compliance with hygiene and
biosecurity procedures for poultry
primary breeding flocks and hatcheries
in accordance with part 147 of this
subchapter. In addition, the company
must provide a biosecurity plan for the
compartment and all included
components. The biosecurity plan
should include but not be limited to:
(A) Requirements that company
employees and contract growers limit
their contact with live birds outside the
compartment.
(B) An education and training
program for company employees and
contractors.
(C) Standard operating procedures for
company employees, contractors, and
outside maintenance personnel.
(D) Requirements for company
employees and non-company personnel
who visit any premises within the
compartment.
(E) Company veterinary infrastructure
to ensure flock monitoring and disease
diagnosis and control measures.
(F) Policies for management of
vehicles and equipment used within the
compartment to connect the various
premises.
(G) Farm site requirements (location,
layout, and construction).
(H) Pest management program.
(I) Cleaning and disinfection process.
(J) Requirements for litter and dead
bird removal and/or disposal.
(v) Description of other factors
important for maintaining the
compartment. The company veterinary
infrastructure will assess sanitary
measures, environmental risk factors,
and management and husbandry
practices that relate to the separation of
the compartment and the health status
of the birds contained within the
compartment that may affect risk of
exposure to NAI. This assessment must
include a description of internal
monitoring and auditing systems (e.g.,
quality assurance and quality control
programs) to demonstrate the
effectiveness of the compartment. Upon
request, the Service will provide the
company with information on the
epidemiology of NAI and the associated
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risk pathways in which the components
of the compartment are located.
(vi) Approval or denial. Based on the
documentation provided under this
paragraph (a)(1), as well as any other
information the Service and the Official
State Agency determine to be necessary,
the Service and the Official State
Agency will approve or deny the
classification of the compartment as
U.S. Avian Influenza Clean.
(2) Company activities for
maintenance of the compartment. (i)
The primary breeder company’s
management of biosecurity,
surveillance, and disease control efforts
must be uniform and equivalent among
all components that are a part of the
compartment. Oversight and inspection
of these management practices must be
conducted by the company’s licensed,
accredited veterinarians.
(ii) Veterinary staff from the Official
State Agency and NPIP staff will work
in partnership with licensed, accredited
veterinarians to train and certify
auditors through Service-approved
workshops. The trained auditors will
conduct biosecurity and operational
audits at least once every 2 years to
ensure the integrity of the compartment.
These audits will include evaluation of
the critical control points and standard
operating practices within the
compartment, verification of the health
status of the flock(s) contained within
the compartment, and examination of
the biosecurity and management system
of the integrated components of the
compartment.
(iii) In addition, the company must
demonstrate compliance with paragraph
(a)(1) of this section for remaining in the
U.S. Avian Influenza Clean
classification, surveillance for NAI
within the compartment, and
conducting tests in State or Federal
laboratories or in NPIP authorized
laboratories. Accredited veterinarians
are responsible for the enforcement of
active and passive surveillance of NAI
in primary breeder flocks. Baseline
health status must be maintained for all
flocks or subpopulations within the
compartment, indicating the dates and
negative results of all avian influenza
surveillance and monitoring testing, the
dates and history of last disease
occurrence (if any), the number of
outbreaks, and the methods of disease
control that were applied.
(iv) Documentation will be
maintained in the company’s database
and will be verified as required by the
Service and/or the Official State
Agency.
(3) Service and Official State Agency
activities for maintenance of the
compartment. The Service will work in
PO 00000
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Sfmt 4700
38761
cooperation with the Official State
Agencies to ensure the continued
integrity of any recognized
compartments. Activities include:
(i) Oversight of the establishment and
management of compartments;
(ii) Establishment of effective
partnerships between the Service, the
Plan, and the primary breeder industry;
(iii) Approval or denial of
classification of compartments as U.S.
Avian Influenza Clean Compartments
under paragraph (a)(1) of this section;
(iv) Official certification of the health
status of the compartment, and
commodities that may be traded from it
through participation in the Plan for
avian diseases, including the U.S. Avian
Influenza Clean program as described in
§ 145.73(f) and diagnostic surveillance
for H5/H7 low pathogenicity AI as
described in § 145.15;
(v) Conducting audits of
compartments at least once every 2
years to:
(A) Confirm that the primary breeding
company’s establishments are
epidemiologically distinct and
pathways for the introduction of disease
into the compartment are closed
through routine operational procedures;
and
(B) Evaluate and assess the
management and husbandry practices
relating to biosecurity to determine
whether they are in compliance with
hygiene and biosecurity procedures for
poultry primary breeding flocks and
hatcheries in accordance with part 147
of this subchapter;
(vi) Providing, upon request, model
plans for management and husbandry
practices relating to biosecurity in
accordance with part 147 of this
subchapter, risk evaluations in
conjunction with the primary breeder
industry (including disease surveillance
such as VS Form 9–4, ‘‘Summary of
Breeding Flock Participation’’), and
diagnostic capability summaries and
systems for initial State response and
containment plans in accordance with
§ 56.10 of this chapter; and
(vii) Publicizing and sharing
compartment information with
international trading partners, upon
request, to establish approval and
recognition of the compartment,
including timeliness and accuracy of
disease reporting and surveillance
measures as described in §§ 145.15 and
145.73(f).
(4) Emergency response and
notification. In the case of a confirmed
positive of NAI in the subpopulation of
the compartment, the management of
the compartment must notify the
Service. The Service will immediately
suspend the status of the compartment.
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A compartment will be eligible to
resume trade with importing countries
only after the compartment has adopted
the necessary measures to reestablish
the biosecurity level and confirm that
NAI is not present in the compartment
and the Service has reevaluated the
management and biosecurity measures
of the compartment and approved said
compartment for trade.
(b) [Reserved]
■ 26. In § 145.82, paragraph (b) is
revised to read as follows:
§ 145.82
Participation.
emcdonald on DSK67QTVN1PROD with RULES
*
*
*
*
*
(b) Hatching eggs produced by
primary breeding flocks should be nest
clean. They may be fumigated in
accordance with part 147 of this
subchapter or otherwise sanitized.
*
*
*
*
*
■ 27. Section 145.83 is amended as
follows:
■ a. In paragraph (c)(1) introductory
text, by removing the words ‘‘in
compliance with the provisions of
§ 147.26 of this subchapter’’ and adding
the words ‘‘in accordance with part 147
of this subchapter with respect to
Mycoplasma isolation, sanitation, and
management’’ in their place.
■ b. In paragraph (c)(3), by removing the
words ‘‘as described in § 147.24(a)’’ and
adding the words ‘‘in accordance with
part 147’’ in their place.
■ c. In paragraph (d)(1) introductory
text, by removing the words ‘‘in
compliance with the provisions of
§ 147.26 of this subchapter’’ and adding
the words ‘‘in accordance with part 147
of this subchapter with respect to
Mycoplasma isolation, sanitation, and
management’’ in their place.
■ d. In paragraph (d)(3), by removing the
words ‘‘as described in § 147.24(a)’’ and
adding the words ‘‘in accordance with
part 147’’ in their place.
■ e. By revising paragraphs (e)(1) and
(e)(3).
■ f. In paragraph (e)(6) introductory text,
by removing the words ‘‘or greatgrandparent’’ and adding the words
‘‘great-grandparent, or grandparent’’ in
their place.
■ g. In paragraph (e)(6)(i)(B), by
removing the words ‘‘as described in
§ 147.12(a)’’ and adding the words ‘‘in
accordance with part 147’’ in their
place.
■ h. In paragraph (e)(6)(i)(C), by
removing the words ‘‘as described in
§ 147.11’’ and adding the words ‘‘in
accordance with part 147’’ in their
place.
■ i. In paragraph (e)(6)(i)(D), by
removing the words ‘‘as specified in
§ 147.12(a)’’ and adding the words ‘‘in
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Jkt 232001
accordance with part 147’’ in their
place.
■ j. In paragraph (f)(1)(i), by removing
the words ‘‘in compliance with
§§ 147.21, 147.24(a), and 147.26 of this
subchapter’’ and adding the words ‘‘in
accordance with part 147 of this
subchapter with respect to flock
sanitation, cleaning and disinfection,
and Salmonella isolation, sanitation,
and management’’ in their place.
■ k. By revising paragraph (f)(1)(iv).
■ l. In paragraph (f)(1)(vi), by removing
the words ‘‘as described in § 147.12’’
and adding the words ‘‘in accordance
with part 147’’ in their place.
■ m. By revising paragraph (f)(2).
■ n. In paragraph (g)(1) introductory
text, by adding the words ‘‘using an
approved test as described in § 145.14’’
after the word ‘‘influenza’’.
The revisions read as follows:
§ 145.83 Terminology and classification;
flocks and products.
*
*
*
*
*
(e) * * *
(1) A flock and the hatching eggs and
chicks produced from it shall be eligible
for this classification if they meet the
following requirements, as determined
by the Official State Agency:
(i) The flock originated from a U.S. S.
Enteritidis Clean flock, or one of the
following samples has been examined
bacteriologically for S. enteritidis at an
authorized laboratory in accordance
with part 147 of this subchapter and any
group D Salmonella samples have been
serotyped:
(A) A sample of chick papers, hatcher
tray swabs, or fluff collected and
cultured in accordance with part 147 of
this subchapter; and
(B) Samples of intestinal and liver or
spleen tissues from a minimum of 30
chicks that died within 7 days after
hatching and have been preserved daily
by freezing prior to shipment to an
authorized laboratory.
(ii) The flock is maintained in
compliance with isolation, sanitation,
and management procedures for
Salmonella in accordance with part 147
of this subchapter.
(iii) Environmental samples are
collected from the flock by or under the
supervision of an Authorized Agent, in
accordance with part 147 of this
subchapter, when the flock reaches 4
months of age and every 30 days
thereafter. Once the flock is in egg
production and chicks are hatching
from it, the samples must include at
least 4 individual test assay results
every 30 days in flocks of more than 500
birds or 2 individual assays per month
in flocks of 500 birds or fewer. One of
these results must come from samples
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Sfmt 4700
collected from hatched chicks at a
participating hatchery derived from said
flock. These individual test assays may
be derived from pooled samples from
the farm or hatchery in accordance with
part 147 of this subchapter, but must be
run as separate test assays in the
laboratory. The environmental samples
shall be examined bacteriologically for
group D Salmonella at an authorized
laboratory, and cultures from group D
positive samples shall be serotyped.
(iv) Blood samples from 300 birds
from the flock are officially tested with
pullorum antigen when the flock is at
least 4 months of age. All birds with
positive or inconclusive reactions, up to
a maximum of 25 birds, shall be
submitted to an authorized laboratory
and examined for the presence of group
D Salmonella in accordance with part
147 of this subchapter. Cultures from
group D positive samples shall be
serotyped.
(v) Hatching eggs produced by the
flock are collected as quickly as possible
and their sanitation is maintained in
accordance with part 147 of this
subchapter.
(vi) Hatching eggs produced by the
flock are incubated in a hatchery whose
sanitation is maintained in accordance
with part 147 of this subchapter, and the
hatchery must have been sanitized
either by a procedure approved by the
Official State Agency or by fumigation
in accordance with part 147 of this
subchapter.
*
*
*
*
*
(3) If SE is isolated from an
environmental sample collected from
the flock in accordance with paragraph
(e)(1)(iii) of this section, an additional
environmental sampling and 25 live cull
birds or fresh dead birds (if present), or
other randomly selected live birds if
fewer than 25 culls can be found in the
flock, must be bacteriologically
examined for SE in accordance with
part 147 of this subchapter. If only 1
bird from the 25-bird sample is found
positive for SE., the participant may
request bacteriological examination of a
second 25-bird sample from the flock. In
addition, if the flock with the SE
isolation is in egg production and eggs
are under incubation, the next four
consecutive hatches shall be examined
bacteriologically in accordance with
part 147 of this subchapter. Samples
shall be collected from all of the
hatching unit’s chick trays and basket
trays of hatching eggs, or from all chick
box papers from the flock, and tested,
pooling the samples into a minimum of
10 separate assays. Any followup
hatchery-positive SE isolations shall
result in discontinuation of subsequent
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hatches until the flock status is
determined by bird culture. The flock
will be disqualified for the U.S. S.
Enteritidis Clean classification if a bird
or subsequent flock environmental assay
results in isolation of SE.
*
*
*
*
*
(f) * * *
(1) * * *
(iv) 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.
*
*
*
*
*
(2) The Official State Agency may
monitor the effectiveness of the
sanitation practices in accordance with
part 147 of this subchapter.
*
*
*
*
*
■ 28. Section 145.84 is added to subpart
H to read as follows:
emcdonald on DSK67QTVN1PROD with RULES
§ 145.84 Terminology and classification;
compartments.
(a) U.S. Avian Influenza Clean
Compartment. This program is intended
to be the basis from which the primary
meat-type chicken breeding-hatchery
industry may demonstrate the existence
and implementation of a program that
has been approved by the Official State
Agency and the Service to establish a
compartment consisting of a primary
breeding-hatchery company that is free
of H5/H7 avian influenza (AI), also
referred to as notifiable avian influenza
(NAI). This compartment has the
purpose of protecting the defined
subpopulation and avoiding the
introduction and spread of NAI 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:
(1) Definition of the compartment.
Based on the guidelines established by
the World Organization for Animal
Health (OIE) in the Terrestrial Animal
Health Code and the guidelines in this
paragraph (a), the primary breeder
company will define the compartment
with respect to NAI. Specifically, the
company will use a comprehensive
biosecurity program to define the
compartment as a subpopulation of
poultry with a health status for NAI that
is separate from birds and poultry
outside the compartment. The Official
State Agency and the Service must first
approve all documentation submitted by
the company to substantiate the defined
compartment as adequate to qualify for
epidemiological separation from other
potential sources of infection of NAI.
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Jkt 232001
Guidelines for the definition of the
compartment include:
(i) Definition and description of the
subpopulation of birds and their health
status. All birds included in the
compartment must be U.S. Avian
Influenza Clean in accordance with
§ 145.83(g). The poultry must also be
located in a State that has an initial
State response and containment plan
approved by APHIS under § 56.10 of
this chapter and that participates in the
diagnostic surveillance program for H5/
H7 low pathogenicity AI as described in
§ 145.15. Within the compartment, all
official tests for AI, as described in
§ 145.14(d), must be conducted in State
or Federal laboratories or in NPIP
authorized laboratories that meet the
minimum standards described in
§ 147.52 of this subchapter. In addition,
the company must provide to the
Service upon request any relevant
historical and current NAI-related data
for reference regarding surveillance for
the disease and the health status of the
compartment. Upon request, the Official
State Agency may provide such data for
other commercial poultry populations
located in the State.
(ii) Description of animal
identification and traceability processes.
The primary breeder company must also
include a description of its animal
identification and traceability records,
including examples of Veterinary
Services (VS) Form 9–5, ‘‘Report of
Hatcheries, Dealers and Independent
Flocks’’; VS Form 9–2, ‘‘Flock Selection
and Testing Report’’; VS Form 9–3,
‘‘Report of Sales of Hatching Eggs,
Chicks and Poults’’; VS Form 9–9, ’’
Hatchery Inspection Report’’; set and
hatch records; egg receipts; and egg/
chick invoices for the subpopulation.
Documentation must also include breed
identification (NPIP stock code). The
Service should ensure that an effective
flock identification system and
traceability system are in place.
(iii) Definition and description of the
physical components or establishments
of the defined compartment. The
primary breeder company must provide
documentation establishing that the
defined compartment is
epidemiologically separated from other
poultry and bird populations. The
documentation must be approved by the
Official State Agency and the Service as
indicating adequate epidemiological
separation to maintain the
compartment’s separate health status
with respect to NAI. The documentation
should include descriptions of:
(A) The physical and spatial factors
that separate the compartment from
surrounding bird populations and affect
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38763
the biosecurity status of the
compartment.
(B) Relevant environmental factors
that may affect exposure of the birds to
AI.
(C) The functional boundary and
fencing that are used to control access
to the compartment.
(D) Facilities and procedures to
prevent access by wild birds and to
provide separation from other relevant
hosts.
(E) The relevant infrastructural factors
that may affect exposure to AI,
including the construction and design of
buildings or physical components,
cleaning and disinfection of buildings
and physical components between
production groups with quality
assurance verification, cleaning and
disinfection of equipment, and
introduction of equipment or material
into the compartment.
(iv) Definition and description of the
functional relationships between
components of the defined
compartment. Functional relationships
between components of the
compartment include traffic movement
and flow at and among premises,
personnel movement at and among
premises, exposure to live bird
populations, and any other factors that
could affect biosecurity of the
compartment. All physical components
of the compartment must be maintained
in compliance with hygiene and
biosecurity procedures for poultry
primary breeding flocks and hatcheries
in accordance with part 147 of this
subchapter. In addition, the company
must provide a biosecurity plan for the
compartment and all included
components. The biosecurity plan
should include but not be limited to:
(A) Requirements that company
employees and contract growers limit
their contact with live birds outside the
compartment.
(B) An education and training
program for company employees and
contractors.
(C) Standard operating procedures for
company employees, contractors, and
outside maintenance personnel.
(D) Requirements for company
employees and non-company personnel
who visit any premises within the
compartment.
(E) Company veterinary infrastructure
to ensure flock monitoring and disease
diagnosis and control measures.
(F) Policies for management of
vehicles and equipment used within the
compartment to connect the various
premises.
(G) Farm site requirements (location,
layout, and construction).
(H) Pest management program.
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(I) Cleaning and disinfection process.
(J) Requirements for litter and dead
bird removal and/or disposal.
(v) Description of other factors
important for maintaining the
compartment. The company veterinary
infrastructure will assess sanitary
measures, environmental risk factors,
and management and husbandry
practices that relate to the separation of
the compartment and the health status
of the birds contained within the
compartment that may affect risk of
exposure to NAI. This assessment must
include a description of internal
monitoring and auditing systems (e.g.,
quality assurance and quality control
programs) to demonstrate the
effectiveness of the compartment. Upon
request, the Service will provide the
company with information on the
epidemiology of NAI and the associated
risk pathways in which the components
of the compartment are located.
(vi) Approval or denial. Based on the
documentation provided under this
paragraph (a)(1), as well as any other
information the Service and the Official
State Agency determine to be necessary,
the Service and the Official State
Agency will approve or deny the
classification of the compartment as
U.S. Avian Influenza Clean.
(2) Company activities for
maintenance of the compartment. (i)
The primary breeder company’s
management of biosecurity,
surveillance, and disease control efforts
must be uniform and equivalent among
all components that are a part of the
compartment. Oversight and inspection
of these management practices must be
conducted by the company’s licensed,
accredited veterinarians.
(ii) Veterinary staff from the Official
State Agency and NPIP staff will work
in partnership with licensed, accredited
veterinarians to train and certify
auditors through Service-approved
workshops. The trained auditors will
conduct biosecurity and operational
audits at least once every 2 years to
ensure the integrity of the compartment.
These audits will include evaluation of
the critical control points and standard
operating practices within the
compartment, verification of the health
status of the flock(s) contained within
the compartment, and examination of
the biosecurity and management system
of the integrated components of the
compartment.
(iii) In addition, the company must
demonstrate compliance with paragraph
(a)(1) of this section for remaining in the
U.S. Avian Influenza Clean
classification, surveillance for NAI
within the compartment, and
conducting tests in State or Federal
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laboratories or in NPIP authorized
laboratories. Accredited veterinarians
are responsible for the enforcement of
active and passive surveillance of NAI
in primary breeder flocks. Baseline
health status must be maintained for all
flocks or subpopulations within the
compartment, indicating the dates and
negative results of all avian influenza
surveillance and monitoring testing, the
dates and history of last disease
occurrence (if any), the number of
outbreaks, and the methods of disease
control that were applied.
(iv) Documentation will be
maintained in the company’s database
and will be verified as required by the
Service and/or the Official State
Agency.
(3) Service and Official State Agency
activities for maintenance of the
compartment. The Service will work in
cooperation with the Official State
Agencies to ensure the continued
integrity of any recognized
compartments. Activities include:
(i) Oversight of the establishment and
management of compartments;
(ii) Establishment of effective
partnerships between the Service, the
Plan, and the primary breeder industry;
(iii) Approval or denial of
classification of compartments as U.S.
Avian Influenza Clean Compartments
under paragraph (a)(1) of this section;
(iv) Official certification of the health
status of the compartment, and
commodities that may be traded from it
through participation in the Plan for
avian diseases, including the U.S. Avian
Influenza Clean program as described in
§ 145.83(g) and diagnostic surveillance
for H5/H7 low pathogenicity AI as
described in § 145.15;
(v) Conducting audits of
compartments at least once every 2
years to:
(A) Confirm that the primary breeding
company’s establishments are
epidemiologically distinct and
pathways for the introduction of disease
into the compartment are closed
through routine operational procedures;
and
(B) Evaluate and assess the
management and husbandry practices
relating to biosecurity to determine
whether they are in compliance with
hygiene and biosecurity procedures for
poultry primary breeding flocks and
hatcheries in accordance with part 147
of this subchapter;
(vi) Providing, upon request, model
plans for management and husbandry
practices relating to biosecurity in
accordance with part 147 of this
subchapter, risk evaluations in
conjunction with the primary breeder
industry (including disease surveillance
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such as VS Form 9–4, ‘‘Summary of
Breeding Flock Participation’’), and
diagnostic capability summaries and
systems for initial State response and
containment plans in accordance with
§ 56.10 of this chapter; and
(vii) Publicizing and sharing
compartment information with
international trading partners, upon
request, to establish approval and
recognition of the compartment,
including timeliness and accuracy of
disease reporting and surveillance
measures as described in §§ 145.15 and
145.83(g).
(4) Emergency response and
notification. In the case of a confirmed
positive of NAI in the subpopulation of
the compartment, the management of
the compartment must notify the
Service. The Service will immediately
suspend the status of the compartment.
A compartment would be eligible to
resume trade with importing countries
only after the compartment has adopted
the necessary measures to reestablish
the biosecurity level and confirm that
NAI is not present in the compartment
and the Service has reevaluated the
management and biosecurity measures
of the compartment and approved said
compartment for trade.
(b) [Reserved]
§ 145.92
[Amended]
29. In § 145.92, paragraph (b) is
amended by removing the words ‘‘(see
§ 147.25 of this chapter)’’ and adding
the words ‘‘in accordance with part 147
of this subchapter’’ after the word
‘‘sanitized’’.
■ 30. Section 145.93 is amended as
follows:
■ a. By revising paragraph (c)(3).
■ b. By adding paragraph (d).
The revision and addition read as
follows:
■
§ 145.93 Terminology and classification;
flocks and products.
*
*
*
*
*
(c) * * *
(3) A sample of at least 30 birds must
be tested and found negative to H5/H7
avian influenza within 21 days prior to
movement to slaughter.
(d) U.S. Salmonella Monitored. This
program is intended to be the basis from
which the breeding-hatching 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 day-old waterfowl 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
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opportunity to reduce the incidence of
Salmonella in their products.
(1) A flock and the hatching eggs and
day-old waterfowl produced from it
must meet the following requirements,
as determined by the Official State
Agency, to be eligible for this
classification:
(i) The flock is maintained in
compliance with isolation, sanitation,
and management procedures for
Salmonella in accordance with part 147
of this subchapter.
(ii) If feed contains animal protein,
the protein products must have been
heated throughout to a minimum
temperature of 190 °F or above, or to a
minimum temperature of 165 °F for at
least 20 minutes, or to a minimum
temperature of 184 °F under 70 lbs.
pressure during the manufacturing
process.
(iii) Feed shall be stored and
transported in a manner that prevents
contamination.
(iv) Waterfowl 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.
(v) An Authorized Agent shall take
environmental samples from the
hatchery every 30 days, i.e., meconium
or box liner paper. An authorized
laboratory for Salmonella shall examine
the samples bacteriologically.
(vi) 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.
(vii) Flocks may be vaccinated with a
paratyphoid vaccine: Provided, that a
sample of at least 100 birds will be
segregated and shall remain
unvaccinated until the flock reaches at
least 4 months of age.
(2) The Official State Agency may
monitor the effectiveness of the egg
sanitation practices in accordance with
part 147 of this subchapter.
(3) To claim products are of this
classification, all products shall be
derived from a hatchery and flock that
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.
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PART 146—NATIONAL POULTRY
IMPROVEMENT PLAN FOR
COMMERCIAL POULTRY
31. 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.
32. Section 146.1 is amended as
follows:
■ a. By revising the definition of
authorized laboratory.
■ b. In the definition of commercial
meat-type flock, by adding the words
‘‘spent fowl,’’ after the word
‘‘chickens,’’.
■ c. In the definition of H5/H7 low
pathogenic avian influenza (LPAI), by
adding the words ‘‘or equal to’’ before
the number ‘‘1.2’’ and by adding the
word ‘‘causes’’ before the words ‘‘less
than 75’’.
■ d. In paragraph (1)(iii) of the
definition of H5/H7 LPAI virus infection
(infected), by adding the words ‘‘the
Cooperating State Agency, the Official
State Agency, and’’ before the word
‘‘APHIS’’.
The revision reads as follows:
■
§ 146.1
Definitions.
*
*
*
*
*
Authorized laboratory. An authorized
laboratory is a laboratory that meets the
requirements of § 147.52 and is thus
qualified to perform the assays in
accordance with part 147 of this
subchapter.
*
*
*
*
*
§ 146.2
[Amended]
33. In § 146.2, paragraph (e) is
amended by removing the words
‘‘follow the laboratory protocols
outlined in part 147 of this chapter’’ and
adding the words ‘‘conduct tests in
accordance with part 147 of this
subchapter’’ in their place.
■
§ 146.3
[Amended]
34. Section 146.3 is amended as
follows:
■ a. In paragraph (c), by adding the
words ‘‘, spent fowl,’’ after the word
‘‘chicken’’.
■ b. By removing paragraph (e).
■
§ 146.5
[Amended]
35. In § 146.5, paragraph (b) is
amended by removing the words ‘‘as
recommended in § 147.21(c)’’ and
adding the words ‘‘in accordance with
part 147’’ in their place.
■ 36. Section 146.13 is amended as
follows:
■ a. In paragraph (a)(1), by removing the
words ‘‘the requirements in § 147.8’’
and adding the words ‘‘part 147’’ in
their place.
■
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b. By revising paragraph (b)(1)(ii)(C).
c. In paragraph (b)(2)(i), by removing
the word ‘‘(AVPR01510)’’.
■ d. By revising paragraph (b)(2)(ii)(B).
The revisions read as follows:
■
■
§ 146.13
Testing.
*
*
*
*
*
(b) * * *
(1) * * *
(ii) * * *
(C) The AGID test for avian influenza
must be conducted in accordance with
part 147 of this subchapter. The test can
be conducted on egg yolk or blood
samples. The AGID test is not
recommended for use in waterfowl.
*
*
*
*
*
(2) * * *
(ii) * * *
(B) Chicken and turkey flocks that test
positive on the ACIA must be retested
using the RRT–PCR or virus isolation.
Positive results from the RRT–PCR or
virus isolation must be further tested by
Federal Reference Laboratories using
appropriate tests for confirmation. Final
judgment may be based upon further
sampling and appropriate tests for
confirmation.
*
*
*
*
*
■ 37. Section 146.23 is amended by
revising the heading of paragraph (a),
removing the introductory text of
paragraph (a), and revising the
introductory text of paragraphs (a)(1),
and (a)(2) to read as follows:
§ 146.23 Terminology and classification;
flocks and products.
*
*
*
*
*
(a) U.S. H5/H7 Avian Influenza
Monitored—(1) Table-egg layer pullet
flocks. This program is intended to be
the basis from which the table-egg layer
industry may conduct a program to
monitor for the H5/H7 subtypes of avian
influenza. It is intended to determine
the presence of the H5/H7 subtypes of
avian influenza in table-egg layer pullets
through routine surveillance of each
participating commercial table-egg layer
pullet flock. A flock will qualify for this
classification when the Official State
Agency determines that it has met one
of the following requirements:
*
*
*
*
*
(2) Table-egg layer flocks. This
program is intended to be the basis from
which the table-egg layer industry may
conduct a program to monitor for the
H5/H7 subtypes of avian influenza. It is
intended to determine the presence of
the H5/H7 subtypes of avian influenza
in table-egg layer through routine
surveillance of each participating
commercial table-egg layer flock. A
flock will qualify for this classification
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listed in the NPIP Program Standards, as
defined in § 147.51. Blood testing
procedures may also be approved by the
Administrator in accordance with
§ 147.53(d)(1).
when the Official State Agency
determines that it has met one of the
following requirements:
*
*
*
*
*
■ 38. Section 146.31 is amended by
adding, in alphabetical order, a
definition of spent fowl to read as
follows:
§ 146.31
(Approved by the Office of Management
and Budget under control number 0579–
0007)
Definitions.
*
*
*
*
*
Spent fowl. Domesticated poultry that
were in production of hatching eggs or
commercial table eggs and have been
removed from such production.
■ 39. Section 146.32 is amended by
adding a new paragraph (c) to read as
follows:
§ 146.32
Participation.
*
*
*
*
*
(c) If spent fowl are slaughtered at
meat-type chicken slaughter plants that
participate in the Plan, they may
participate in the Plan through the
provisions of this subpart C.
§ 146.33
[Amended]
40. In § 146.33, paragraph (a)(1) is
amended by removing the words
‘‘antibodies to’’.
■ 41. In § 146.43, paragraph (a)(1) is
revised to read as follows:
■
§§ 147.2 through 147.9
Reserved]
[Removed and
44. Sections 147.2 through 147.9 are
removed and reserved.
■ 45. Section 147.10 is revised to read
as follows:
■
§ 147.10 Bacteriological examination
procedures.
Bacteriological examination must be
conducted in a manner approved by the
Administrator. Approved bacteriological
examination procedures are listed in the
NPIP Program Standards, as defined in
§ 147.51. Bacteriological examination
procedures may also be approved by the
Administrator in accordance with
§ 147.53(d)(1).
§§ 147.11 through 147.17
Reserved]
[Removed and
46. Sections 147.11 through 147.17
are removed and reserved.
■
47. Section 147.21 is revised to read
as follows:
§ 146.43 Terminology and classification;
meat-type turkey slaughter plants.
■
*
§ 147.21
*
*
*
*
(a) * * *
(1) It is a meat-type turkey slaughter
plant that accepts only meat-type
turkeys from flocks where a minimum
of 6 samples per flock have been
collected no more than 21 days prior to
movement to slaughter and tested
negative with an approved test for type
A avian influenza, as provided in
§ 146.13(b). It is recommended that
samples be collected from flocks over 10
weeks of age with respiratory signs such
as coughing, sneezing, snicking,
sinusitis, or rales; depression; or
decreases in food or water intake.
*
*
*
*
*
Sanitation procedures.
Sanitation must be maintained in a
manner approved by the Administrator.
Approved procedures for maintaining
sanitation are listed in the NPIP
Program Standards, as defined in
§ 147.51 Sanitation procedures may also
be approved by the Administrator in
accordance with § 147.53(d)(2)
(Approved by the Office of Management
and Budget under control number 0579–
0007)
§§ 147.22 through 147.27
Reserved]
[Removed and
48. Sections 147.22 through 147.27
are removed and reserved.
■
■
■
42. The authority citation for part 147
continues to read as follows:
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PART 147—AUXILIARY PROVISIONS
ON NATIONAL POULTRY
IMPROVEMENT PLAN
§ 147.30 Molecular examination
procedures.
Authority: 7 U.S.C. 8301–8317; 7 CFR
2.22, 2.80, and 371.4.
Molecular examination must be
conducted in a manner approved by the
Administrator. Approved molecular
examination procedures are listed in the
NPIP Program Standards, as defined in
§ 147.51. Molecular examination
procedures may also be approved by the
Administrator in accordance with
§ 147.53(d)(1).
43. Section 147.1 is revised to read as
follows:
■
§ 147.1
Blood testing procedures.
Blood testing must be conducted in a
manner approved by the Administrator.
Approved blood testing procedures are
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49. Section 147.30 is revised to read
as follows:
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§ 147.31
[Removed and Reserved]
50. Section 147.31 is removed and
reserved.
■ 51. In § 147.41, a new definition of
NPIP Technical Committee is added, in
alphabetical order, to read as follows:
■
§ 147.41
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.
*
*
*
*
*
§ 147.44
[Amended]
52. In § 147.44, paragraph (b) is
amended by removing the citation
‘‘§ 147.43(d)(2)’’ and adding the citation
‘‘§ 147.43(d)(4)’’ in its place.
■ 53. In part 147, subpart F is revised to
read as follows:
■
Subpart F—Authorized Laboratories and
Approved Tests and Sanitation Procedures
Sec.
147.51 Definitions.
147.52 Authorized laboratories.
147.53 Approved tests and sanitation
procedures.
147.54 Approval of diagnostic test kits not
licensed by the Service.
Subpart F—Authorized Laboratories
and Approved Tests and Sanitation
Procedures
§ 147.51
Definitions.
The following definitions apply in
this subpart:
Administrator. The Administrator,
Animal and Plant Health Inspection
Service, or any other employee of the
Animal and Plant Health Inspection
Service delegated to act in the
Administrator’s stead.
Animal and Plant Health Inspection
Service (APHIS, the Service). The
Animal and Plant Health Inspection
Service of the U.S. Department of
Agriculture.
NPIP or Plan. The National Poultry
Improvement Plan.
NPIP Program Standards. A
document that contains tests and
sanitation procedures approved by the
Administrator under § 147.53 for use
under this subchapter. This document
may be obtained from the NPIP Web site
at https://www.poultryimprovement.org/
or by writing to the Service at National
Poultry Improvement Plan, APHIS,
USDA, 1506 Klondike Road, Suite 101,
Conyers, GA 30094.
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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.
emcdonald on DSK67QTVN1PROD with RULES
§ 147.52
Authorized laboratories.
These minimum requirements are
intended to be the basis on which an
authorized laboratory of the Plan can be
evaluated to ensure that official Plan
assays are performed in accordance with
the NPIP Program Standards or other
procedures approved by the
Administrator in accordance with
§ 147.53(d)(1) and reported as described
in paragraph (f) of this section. A
satisfactory evaluation will result in the
laboratory being recognized by the NPIP
office of the Service as an authorized
laboratory qualified to perform the
assays provided for in this part.
(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. The authorized laboratory
must use a regularly scheduled check
test for each assay that it performs.
(b) Trained technicians. The testing
procedures at the laboratory must be run
or overseen by a laboratory technician
who has attended and satisfactorily
completed Service-approved laboratory
workshops for Plan-specific diseases
within the past 4 years.
(c) Laboratory protocol. Official Plan
assays must be performed and reported
as described in the NPIP Program
Standards or in accordance with other
procedures approved by the
Administrator in accordance with
§ 147.53(d)(1). Assays must be
performed using control reagents
approved by the Plan or the reagent
manufacturer.
(d) State site visit. The Official State
Agency will conduct a site visit and
recordkeeping audit annually. 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.
(e) Service review. Authorized
laboratories will be reviewed by the
Service (NPIP staff) every 3 years. The
Service’s review may include, but will
not necessarily be limited to, checking
records, laboratory protocol, check-test
proficiency, technician training, and
peer review.
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(f) Reporting. (1) A memorandum of
understanding or other means shall be
used to establish testing and reporting
criteria to the Official State Agency,
including criteria that provide for
reporting H5 and H7 low pathogenic
avian influenza directly to the Service.
(2) Salmonella pullorum and
Mycoplasma Plan disease reactors must
be reported to the Official State Agency
within 48 hours.
(g) Verification. Random samples may
also be required to be submitted for
verification as specified by the Official
State Agency.
§ 147.53 Approved tests and sanitation
procedures.
(a)(1) All tests that are used to qualify
flocks for NPIP classifications must be
approved by the Administrator as
effective and accurate at determining
whether a disease is present in a poultry
flock or in the environment.
(2) All sanitation procedures
performed as part of qualifying for an
NPIP classification must be approved by
the Administrator as effective at
reducing the risk of incidence of disease
in a poultry flock or hatchery.
(b) Tests and sanitation procedures
that have been approved by the
Administrator may be found in the NPIP
Program Standards. In addition, all tests
that use veterinary biologics (e.g.,
antiserum and other products of
biological origin) that are licensed or
produced by the Service and used as
described in the NPIP Program
Standards are approved for use in the
NPIP.
(c) New tests and sanitation
procedures, or changes to existing tests
and sanitation procedures, that have
been approved by the NPIP in
accordance with the process described
in subpart E of this part are subject to
approval by the Administrator. NPIP
participants may submit new tests and
sanitation procedures, or changes to
current tests and sanitation procedures,
through that process.
(d)(1) Persons who wish to have a test
approved by the Administrator as
effective and accurate at determining
whether a disease is present in a flock
or in the environment may apply for
approval by submitting the test, along
with any supporting information and
data, to the National Poultry
Improvement Plan, APHIS, USDA, 1506
Klondike Road, Suite 101, Conyers, GA
30094. Upon receipt of such an
application, the NPIP Technical
Committee will review the test and any
supporting information and data
supplied with the application. If the
NPIP Technical Committee determines
the test to be of potential general use,
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Fmt 4700
Sfmt 4700
38767
the test will be submitted for
consideration by the General Conference
Committee of the NPIP in accordance
with subpart E of this part, and the
Administrator will respond with
approval or denial of the test.
(2) Persons who wish to have a
sanitation procedure approved by the
Administrator as effective at reducing
the risk of incidence of disease in a
poultry flock or hatchery may apply for
approval by submitting the sanitation
procedure, along with any supporting
information and data, to the National
Poultry Improvement Plan, APHIS,
USDA, 1506 Klondike Road, Suite 101,
Conyers, GA 30094. Upon receipt of
such an application, the NPIP Technical
Committee will review the sanitation
procedure and any supporting
information and data supplied with the
application. If the NPIP Technical
Committee determines the sanitation
procedure to be of potential general use,
the sanitation procedure will be
submitted for consideration by the
General Conference Committee of the
NPIP in accordance with subpart E of
this part, and the Administrator will
respond with approval or denial of the
test.
(e)(1) When the Administrator
approves a new test or sanitation
procedure or a change to an existing test
or sanitation procedure, APHIS will
publish a notice in the Federal Register
making available the test or sanitation
procedure. The notice will also provide
for a public comment period.
(2)(i) After the close of the public
comment period, APHIS will publish a
notice in the Federal Register indicating
that the test or sanitation procedure will
be added to the NPIP Program
Standards, or that the NPIP Program
Standards will be updated to reflect
changes to an existing test or sanitation
procedure, if:
(A) No comments were received on
the notice;
(B) The comments on the notice
supported the action described in the
notice; or
(C) The comments on the notice were
evaluated but did not change the
Administrator’s determination that
approval of the test or sanitation
procedure is appropriate based on the
standards in paragraph (a) of this
section.
(ii) If comments indicate that changes
should be made to the test or sanitation
procedure as it was made available in
the initial notice, APHIS will publish a
notice in the Federal Register indicating
that changes were made to the initial
test or sanitation procedure.
(iii) Whenever APHIS adds or makes
changes to tests or sanitation
E:\FR\FM\09JYR1.SGM
09JYR1
38768
Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations
procedures, APHIS will make available
a new version of the NPIP Program
Standards that reflects the additions or
changes.
(iv) If comments present information
that causes the Administrator to
determine that approval of the test or
sanitation procedure would not be
appropriate, APHIS will publish a
notice informing the public of this
determination after the close of the
comment period.
emcdonald on DSK67QTVN1PROD with RULES
§ 147.54 Approval of diagnostic test kits
not licensed by the Service.
Diagnostic test kits that are not
licensed by the Service (e.g.,
bacteriological culturing kits) may be
approved through the following
procedure:
(a) The sensitivity of the kit will be
estimated in at least three authorized
laboratories selected by the Service 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. 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.
(b) The specificity of the kit will be
estimated in at least three authorized
laboratories selected by the Service 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
§ 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.
(c) 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 clinical samples
supplied by the manufacturer of the test
kit. In addition, each laboratory will be
asked to test 50 known negative clinical
samples obtained from several sources,
to provide a representative sampling of
the general population. The identity of
the samples must be coded so that the
cooperating laboratories are blinded to
identity and classification. Each sample
must be provided in duplicate or
triplicate, so that error and repeatability
data may be generated.
VerDate Mar<15>2010
16:31 Jul 08, 2014
Jkt 232001
(d) Cooperating laboratories will
submit to the kit manufacturer all raw
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.
(e) The findings of the cooperating
laboratories will be evaluated by the
NPIP Technical Committee, and the
Technical Committee will make a
recommendation regarding whether to
approve the test kit to the General
Conference Committee. If the Technical
Committee recommends approval, the
final approval will be granted in
accordance with the procedures
described in §§ 147.46 and 147.47.
(f) 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.
Done in Washington, DC, this 3rd day of
July 2014.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2014–16037 Filed 7–7–14; 4:15 pm]
BILLING CODE 3410–34–P
NUCLEAR REGULATORY
COMMISSION
10 CFR Part 140
[NRC–2013–0072]
RIN 3150–AJ25
Inflation Adjustments to the PriceAnderson Act Financial Protection
Regulations; Corrections
Nuclear Regulatory
Commission.
ACTION: Correcting amendments.
AGENCY:
The U.S. Regulatory
Commission (NRC) published a final
rule in the Federal Register on July 12,
2013, to amend its regulations to satisfy
a statutory requirement to adjust the
maximum total and annual standard
deferred premiums specified in the
Price-Anderson Act for inflation at least
once during each 5-year period
following August 20, 2003. This
correcting amendment makes a
necessary conforming change to a
concomitant NRC regulation.
DATES: This rule is effective on July 9,
2014.
ADDRESSES: Please refer to Docket ID
NRC–2013–0072 when contacting the
NRC about the availability of
SUMMARY:
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
information for this final rule. You may
obtain publicly-available information
related to this final rule by any of the
following methods:
• Federal Rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2013–0072. Address
questions about NRC dockets to Carol
Gallagher; telephone: 301–287–3422;
email: Carol.Gallagher@nrc.gov. For
technical questions, contact the
individual listed in the FOR FURTHER
INFORMATION CONTACT section of this
final rule.
• NRC’s Agencywide Documents
Access and Management System
(ADAMS): You may obtain publiclyavailable documents online in the
ADAMS Public Documents collection at
https://www.nrc.gov/reading-rm/
adams.html. To begin the search, select
‘‘ADAMS Public Documents’’ and then
select ‘‘Begin Web-based ADAMS
Search.’’ For problems with ADAMS,
please contact the NRC’s Public
Document Room (PDR) reference staff at
1–800–397–4209, 301–415–4737, or by
email to pdr.resource@nrc.gov. The
ADAMS accession number for each
document referenced in this document
(if that document is available in
ADAMS) is provided the first time that
a document is referenced.
• NRC’s PDR: You may examine and
purchase copies of public documents at
the NRC’s PDR, Room O1–F21, One
White Flint North, 11555 Rockville
Pike, Rockville, Maryland 20852.
FOR FURTHER INFORMATION CONTACT:
Michael Purdie, Office of the Nuclear
Reactor Regulation, U.S. Nuclear
Regulatory Commission, Washington DC
20555–0001, telephone 301–415–0244,
email: Michael.Purdie@nrc.gov.
SUPPLEMENTARY INFORMATION: The NRC
published a final rule in the Federal
Register on July 12, 2013 (78 FR 41835),
that amended its regulations at part 140
of Title 10 of the Code of Federal
Regulations (10 CFR) to satisfy the
requirement in section 170t., ‘‘Inflation
Adjustment,’’ of the Atomic Energy Act
of 1954, as amended, to adjust the
maximum total and annual standard
deferred premiums specified in the
Price-Anderson Act for inflation at least
once during each 5-year period
following August 20, 2003. The final
rule amended the numerical dollar
amounts of the deferred premiums
listed in 10 CFR 140.11(a)(4). A
concomitant NRC regulation at 10 CFR
140.21 also states the numerical dollar
amount of the deferred premium, but
was not amended in the final rule. The
regulations at 10 CFR 140.21 should
cross-reference the deferred premium as
stated at 10 CFR 140.11(a)(4). This
E:\FR\FM\09JYR1.SGM
09JYR1
]]>Agencies
[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Rules and Regulations]
[Pages 38752-38768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16037]
[[Page 38752]]
=======================================================================
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 56, 145, 146, and 147
[Docket No. APHIS-2011-0101]
RIN 0579-AD83
National Poultry Improvement Plan and Auxiliary Provisions
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are amending the National Poultry Improvement Plan (NPIP,
the Plan) and its auxiliary provisions by removing the descriptions of
specific tests and sanitation procedures from the regulations. Instead,
we will require tests to be performed and sanitation to be maintained
in a manner approved by the Administrator. Approved procedures will be
listed in an NPIP Program Standards document, which we are making
available on the NPIP Web site. In addition, we are establishing new
compartment classifications for defined subpopulations of primary
breeding turkeys, primary egg-type chickens, and primary meat-type
chickens. We are also providing new or modified sampling and testing
procedures for Plan participants and participating flocks. The changes
in this final rule were voted on and approved by the voting delegates
at the Plan's 2010 and 2012 National Plan Conferences. These changes
will streamline the provisions of the Plan, keep those provisions
current with changes in the poultry industry, and provide for the use
of new sampling and testing procedures.
DATES: Effective Date: August 8, 2014.
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.
On January 28, 2014, we published in the Federal Register (79 FR
4538-4567, Docket No. APHIS-2011-0101) a proposal \1\ to amend the
regulations by removing tests and detailed testing procedures, as well
as sanitation procedures, from part 147, and making these available in
an NPIP Program Standards document. In addition, we proposed to
establish U.S. H5/H7 Avian Influenza Clean Compartment and U.S. Avian
Influenza Clean Compartment classifications for defined subpopulations
of primary breeding turkeys, primary egg-type breeding chickens, and
primary meat-type breeding chickens. We also proposed several other
changes.
---------------------------------------------------------------------------
\1\ To view the proposed rule and the comments we received, go
to https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0101.
---------------------------------------------------------------------------
We solicited comments concerning our proposal for 60 days ending
March 31, 2014. We received 11 comments by that date. They were from
producers, poultry associations, and the general public. Of the 11
comments we received, 7 directly addressed the proposed rule. These
comments are discussed below.
Part 146 of the regulations contains the NPIP provisions for
commercial poultry. Currently, the only disease addressed in this part
is H5/H7 low pathogenic avian influenza; under part 146, table-egg
layer flocks, meat-type chicken slaughter plants, meat-type turkey
slaughter plants, and certain types of game birds and waterfowl may
participate in U.S. H5/H7 Avian Influenza Monitored classifications.
Section 146.11 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
proposed to amend paragraph (b) to refer to samples being collected and
tested and to results being returned prior to movement to slaughter.
The seven commenters who addressed the rule opposed this change.
They stated that requiring testing prior to slaughter, rather than
prior to movement to slaughter, allows companies that have been
sampling flocks at processing to continue doing so. It also allows
producers whose flocks were inadvertently not sampled in the field to
be tested at the slaughter plant and remain compliant.
They also stated that the proposed requirement to test prior to
movement to slaughter would inadvertently combine the different testing
requirements for participating slaughter plants in each subpart in part
146 into one set of testing requirements. This would prevent the
different types of participating slaughter plants from setting
different testing requirements. One commenter stated that the change
would limit the flexibility of Official State Agencies and industry to
develop alternative testing protocols in which the same number of birds
are tested, as allowed under the regulations.
We believe it is important to have the test results for a flock
returned prior to movement to slaughter to prevent potentially diseased
birds from being exposed to other, healthy birds and possibly requiring
cleaning and disinfection at the slaughter plant. The NPIP General
Conference voted to approve this change at the 2012 Biennial
Conference, reflecting the general consensus of NPIP participants.
However, we are postponing the finalization of this change until an
alternative proposal put forward by the commenters can be voted on
during the 2014 NPIP Biennial Conference, which is scheduled to take
place in Charlotte, NC, from July 10 through 12, 2014. Based on that
vote, we will either retain this change in a stand-alone final rule or
make alterations to the testing requirements in a separate proposed
rule.
We are making a minor change and two corrections to the proposal in
this final rule. Paragraph (a)(1)(i) of the proposed
compartmentalization sections in Sec. Sec. 145.45, 145.74, and 145.84
indicated that the company applying for compartmentalization would have
to, upon request, work with the Official State Agency to provide data
on the
[[Page 38753]]
incidence of notifiable avian influenza (NAI) for bird populations
outside of the proposed compartment in the State. However, Official
State Agencies are focused on commercial poultry populations and may
not have data on the NAI status of backyard birds or migratory birds.
In addition, while compartments may trade with other commercial bird
populations, they should be secured against any disease risk posed by
backyard birds or migratory birds. Therefore, we are changing each of
these proposed paragraphs to indicate that the Official State Agency
may provide data on the NAI status of other commercial poultry
populations located in the State, upon request.
Paragraph (a)(1)(v) of the proposed compartmentalization sections
contained a grammatical redundancy, which we have removed in this final
rule.
We also requested comment on the new Program Standards document. We
did not receive any comments. However, one of the approved tests listed
in the Program Standards document, the Rapid Chek(copyright) Select\TM\
Salmonella Test Kit, is now produced by Romer Labs. We have updated the
Program Standards document accordingly.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Executive Order 12866 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.
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
on the Regulations.gov Web site (see footnote 1 in this document for a
link to Regulations.gov) or by contacting the person listed under FOR
FURTHER INFORMATION CONTACT.
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 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's
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 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 7 CFR part 3015, subpart V.)
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.
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
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 are amending 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 as follows:
0
a. By revising the definition of H5/H7 low pathogenic avian influenza
(LPAI).
0
b. In paragraph (1)(iii) of the definition of H5/H7 LPAI virus
infection (infected), by adding the words ``the Cooperating State
Agency, the Official State Agency, and'' before the word ``APHIS''.
The revision reads as follows:
Sec. 56.1 Definitions.
* * * * *
H5/H7 low pathogenic avian influenza (LPAI). An infection of
poultry caused by an influenza A virus of H5 or H7 subtype that has an
intravenous pathogenicity index in 6-week-old chickens less than or
equal to 1.2 or causes less than 75 percent mortality in 4- to 8-week-
old chickens infected intravenously, or an infection with influenza A
viruses of H5 or H7 subtype with a cleavage site that is not consistent
with a previously identified highly pathogenic avian influenza virus.
* * * * *
0
3. Section 56.4 is amended by adding a new paragraph (d) to read as
follows:
Sec. 56.4 Determination of indemnity amounts.
* * * * *
(d) Requirements for compliance agreements. The compliance
agreement is a comprehensive document that describes the depopulation,
disposal, and cleaning and disinfection plans for poultry that were
infected with or exposed to H5/H7 LPAI, or a premises that contained
such poultry. The compliance agreement sets out APHIS responsibilities,
owner responsibilities, and Cooperating State Agency responsibilities.
The compliance agreement must include the owner's name and the name and
address of the affected premises. The compliance agreement must have
signatories that include, but are not necessarily limited to, the
owner, the grower (if applicable), the Cooperating State Agency
representative, the State veterinarian, and the APHIS area supervisor.
In addition, the compliance agreement must contain a flock plan with
estimated cost breakdowns that include labor, materials, personal
protective equipment, travel expenses for personnel involved, and any
additional information deemed necessary by the Service. A signed
compliance agreement is required before beginning any work for which
indemnity funds will be requested. Once work associated with the
compliance agreement is completed, receipts and documentation detailing
the activities specified in the agreement should be forwarded to APHIS
for review, approval, and final payment. This documentation should be
submitted to APHIS no later than 30 days after the quarantine release
of the affected or exposed premises.
* * * * *
0
4. Section 56.5 is amended as follows:
0
a. By revising paragraph (c)(1)(i).
[[Page 38754]]
0
b. By adding paragraphs (c)(1)(iii) and (c)(1)(iv).
0
c. By revising paragraphs (d)(1)(i) and (d)(1)(iii).
0
d. By removing paragraph (d)(1)(iv).
0
e. By removing the second, third, and fourth sentences after the
heading of paragraph (d)(2)(i) and adding five sentences in their
place.
0
f. By revising the first sentence after the heading of paragraph
(d)(3).
The revisions and additions read as follows:
Sec. 56.5 Destruction and disposal of poultry and cleaning and
disinfection of premises, conveyances, and materials.
* * * * *
(c) * * *
(1) * * *
(i) Poultry infected with or exposed to H5/H7 LPAI must not be
transported to a market for controlled marketing until approved by the
Cooperating State Agency in accordance with the initial State response
and containment plan described in Sec. 56.10.
* * * * *
(iii) Routes to slaughter must avoid other commercial poultry
operations whenever possible. All load-out equipment, trailers, and
trucks used on premises that have housed poultry that were infected
with or exposed to H5/H7 LPAI must be cleaned and disinfected and not
enter other poultry premises or facilities for 48 hours after removing
such poultry from their premises.
(iv) Flocks moved for controlled marketing must be the last poultry
marketed during the week they are marketed.
* * * * *
(d) * * *
(1) * * *
(i) Secure all feathers and debris that might blow around outside
the house in which the infected or exposed poultry were held by
gathering and pushing the material into the house;
* * * * *
(iii) Close the house in which the poultry were held, maintaining
just enough ventilation to remove moisture. Leave the house undisturbed
for a minimum of 72 hours.
(2) * * *
(i) * * * Compost manure, debris, and feed by windrowing in the
house if possible. If this is not possible, set up a system for hauling
manure, debris, and feed to an approved site for burial, piling, or
composting. Manure, debris, and feed may be removed from the house or
premises and disposed of by composting it on site, leaving it in a
undisturbed pile on site, or removing it from the site in covered
vehicles. Land application of manure, debris, and feed should only be
performed in accordance with the initial State response and containment
plan described in Sec. 56.10. Clean out the house or move or spread
litter as determined by the Cooperating State Agency and in accordance
with the initial State response and containment plan. * * *
* * * * *
(3) * * * Premises should remain empty until testing provides
negative virus detection results and checked by the Cooperating State
Agency in accordance with the initial State response and containment
plan described in Sec. 56.10. * * *
* * * * *
PART 145--NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY
0
5. 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
6. Section 145.1 is amended as follows:
0
a. In the definition of authorized agent, by removing the words ``as
described in Sec. Sec. 147.1(a) and 147.12'' and adding the words ``in
accordance with part 147'' in their place.
0
b. In the definition of authorized laboratory, by removing the citation
``Sec. 147.51'' and adding the citation ``Sec. 147.52'' in its place;
and by removing the words ``the assays described in'' and adding the
words ``assays in accordance with'' in their place.
0
c. In the definition of authorized testing agent, by removing the words
``as described in Sec. Sec. 147.1(a) and 147.12'' and adding the words
``in accordance with part 147'' in their place.
0
d. By adding, in alphabetical order, definitions of H5/H7 low
pathogenic avian influenza (LPAI) and NPIP Program Standards.
0
e. In the definition of reactor, by removing the words ``parts 145 or
147 of this chapter'' and adding the words ``this part or in accordance
with part 147 of this subchapter'' in their place.
0
f. In the definition of Senior Coordinator, in paragraph (4), by
removing the citation ``Sec. 147.51'' and adding the citation ``Sec.
147.52'' in its place.
The additions read as follows:
Sec. 145.1 Definitions.
* * * * *
H5/H7 low pathogenic avian influenza (LPAI). An infection of
poultry caused by an influenza A virus of H5 or H7 subtype that has an
intravenous pathogenicity index in 6-week-old chickens less than or
equal to 1.2 or causes less than 75 percent mortality in 4- to 8-week-
old chickens infected intravenously, or an infection with influenza A
viruses of H5 or H7 subtype with a cleavage site that is not consistent
with a previously identified highly pathogenic avian influenza virus.
* * * * *
NPIP Program Standards. A document that contains tests and
sanitation procedures approved by the Administrator in accordance with
Sec. 147.53 of this subchapter for use under this subchapter. This
document may be obtained from the NPIP Web site at https://www.aphis.usda.gov/animal_health/animal_dis_spec/poultry/ or by
writing to the Service at National Poultry Improvement Plan, APHIS,
USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094.
* * * * *
Sec. 145.2 [Amended]
0
7. In Sec. 145.2, paragraph (e) is amended by removing the words
``follow the laboratory protocols outlined in part 147 of this
chapter'' and adding the words ``conduct tests in accordance with part
147 of this subchapter'' in their place.
0
8. Section 145.3 is amended as follows:
0
a. In paragraph (c), second sentence, by removing the word ``He'' and
adding the words ``The participant'' in its place; and by adding the
word ``and'' before the word ``cassowaries,''.
0
b. By redesignating paragraphs (d) and (e) as paragraphs (e) and (f),
respectively.
0
c. By adding a new paragraph (d).
The addition reads as follows:
Sec. 145.3 Participation.
* * * * *
(d) To ensure that Plan diseases are not spread, flocks must be
qualified for their intended Plan classifications before being moved
into breeder production facilities.
* * * * *
Sec. 145.5 [Amended]
0
9. Section 145.5 is amended as follows:
0
a. In paragraph (a), by removing the words ``as recommended in
Sec. Sec. 147.21 and 147.22 (a) and (e) of this chapter'' and adding
the words ``in accordance with part 147 of this subchapter'' in their
place.
0
b. In paragraph (c), by removing the words ``or F'' and adding the
words ``F, G, H, or I'' in their place.
0
10. Section 145.6 is amended as follows:
[[Page 38755]]
0
a. By revising the second sentence in paragraph (a) introductory text.
0
b. In paragraphs (a)(1), (a)(2), (a)(3), and (a)(4), by removing the
words ``as outlined in Sec. 147.24 of this chapter'' and adding the
words ``in accordance with part 147 of this subchapter'' in their
place.
The revision reads as follows:
Sec. 145.6 Specific provisions for participating hatcheries.
(a) * * * The sanitary procedures outlined in the NPIP Program
Standards, or other procedures approved by the Administrator in
accordance with Sec. 147.53(d), will be considered as a guide in
determining compliance with this provision. * * *
* * * * *
0
11. Section 145.10 is amended as follows:
0
a. In paragraph (b) introductory text, by removing the words ``and
145.63(a)'' and adding the words ``145.63(a), 145.73(b), 145.83(b), and
145.93(b)'' in their place.
0
b. By revising paragraph (c) introductory text, paragraph (g)
introductory text, paragraph (m) introductory text, paragraph (o)
introductory text, and paragraph (t) introductory text.
The revisions read as follows:
Sec. 145.10 Terminology and classification; flocks, products, and
States.
* * * * *
(c) U.S. M. Gallisepticum Clean. (See Sec. Sec. 145.23(c),
145.23(f), 145.33(c), 145.33(f), 145.43(c), 145.53(c), 145.73(c), and
145.83(c).)
* * * * *
(g) U.S. Pullorum-Typhoid Clean State. (See Sec. Sec. 145.24(a),
145.34(a), 145.44(a), 145.54(a), and 145.94(a).)
* * * * *
(m) U.S. S. Enteritidis Clean. (See Sec. Sec. 145.23(d),
145.73(d), and 145.83(e).)
* * * * *
(o) U.S. Salmonella Monitored. (See Sec. Sec. 145.53(f),
145.83(f), and 145.93(d).)
* * * * *
(t) U.S. H5/H7 Avian Influenza Clean. (See Sec. Sec. 145.43(g),
145.53(e), and 145.93(c).)
* * * * *
0
12. Section 145.14 is amended as follows:
0
a. In paragraph (a)(1), by revising the second sentence.
0
b. In paragraph (a)(6)(ii), by revising the third sentence.
0
c. In paragraph (b)(1), by adding a sentence after the second sentence.
0
d. By revising paragraph (b)(3).
0
e. By revising paragraph (d)(1)(ii)(C).
0
f. In paragraph (d)(2)(i)(A), by removing the word ``(AVPR01510)''.
0
g. By revising paragraph (d)(2)(ii)(B).
The revisions and addition read as follows:
Sec. 145.14 Testing.
(a) * * *
(1) * * * Official blood tests must be conducted in accordance with
part 147 of this subchapter or according to literature provided by the
producer. * * *
* * * * *
(6) * * *
(ii) * * * Bacteriological examination must be conducted in
accordance with part 147 of this subchapter. * * *
* * * * *
(b) * * *
(1) * * * Tests must be conducted in accordance with this paragraph
(b) and in accordance with part 147 of this subchapter. * * *
* * * * *
(3) When reactors to the test for which the flock was tested are
submitted to a laboratory as prescribed by the Official State Agency,
the final status of the flock will be determined in accordance with
part 147 of this subchapter.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(C) The AGID test for avian influenza must be conducted in
accordance with part 147 of this subchapter. The test can be conducted
on egg yolk or blood samples. The AGID test is not recommended for use
in waterfowl.
* * * * *
(2) * * *
(ii) * * *
(B) Chicken and turkey flocks that test positive on the ACIA must
be further tested using the RRT-PCR or virus isolation. Positive
results from the RRT-PCR or virus isolation must be further tested by
Federal Reference Laboratories using appropriate tests for
confirmation. Final judgment may be based upon further sampling and
appropriate tests for confirmation.
* * * * *
0
13. In Sec. 145.22, paragraph (b) is revised to read as follows:
Sec. 145.22 Participation.
* * * * *
(b) Hatching eggs produced by multiplier breeding flocks should be
nest clean. They may be fumigated in accordance with part 147 of this
subchapter or otherwise sanitized.
* * * * *
0
14. Section 145.23 is amended as follows:
0
a. In paragraph (b) introductory text, by removing the citation ``(5)''
and adding the citation ``(4)'' in its place.
0
b. In paragraph (c)(1) introductory text, by removing the words ``in
compliance with the provisions of Sec. 147.26 of this chapter'' and
adding the words ``in accordance with part 147 of this subchapter with
respect to Mycoplasma isolation, sanitation, and management'' in their
place.
0
c. In paragraph (c)(1)(ii)(C), by removing the words ``Sec. 147.8 of
this chapter'' and adding the words ``part 147 of this subchapter'' in
their place.
0
d. In paragraph (c)(3), by removing the words ``as described in Sec.
147.24(a) of this chapter'' and adding the words ``in accordance with
part 147 of this subchapter'' in their place.
0
e. In paragraph (d)(1)(iv), by removing the words ``in compliance with
Sec. Sec. 147.21, 147.24(a), and 147.26 of this chapter'' and adding
the words ``in accordance with part 147 of this subchapter with respect
to flock sanitation, cleaning and disinfection, and Salmonella
isolation, sanitation, and management'' in their place.
0
f. In paragraph (d)(1)(v), by removing the words ``as described in
Sec. 147.12 of this chapter'' and adding the words ``in accordance
with part 147 of this subchapter'' in their place.
0
g. In paragraph (d)(1)(vii), by removing the words ``as described in
Sec. 147.11 of this chapter'' and adding the words ``in accordance
with part 147 of this subchapter'' in their place.
0
h. By revising paragraphs (d)(1)(viii) and (d)(1)(ix).
0
i. In paragraph (d)(2), by removing the words ``as described in Sec.
147.11(a) of this chapter'' and adding the words ``in accordance with
part 147 of this subchapter'' in their place.
0
j. In paragraph (e)(1) introductory text, by removing the words ``in
compliance with the provisions of Sec. 147.26 of this chapter'' and
adding the words ``in accordance with part 147 of this subchapter with
respect to Mycoplasma isolation, sanitation, and management'' in their
place.
0
k. In paragraph (e)(1)(ii)(B), by removing the words ``Sec. 147.8 of
this chapter'' and adding the words ``part 147 of this subchapter'' in
their place.
0
l. In paragraph (e)(3), by removing the words ``as described in Sec.
147.24(a) of this chapter'' and adding the words ``in accordance with
part 147 of this subchapter'' in their place.
0
m. In paragraph (f)(3), by removing the words ``in compliance with the
provisions of Sec. 147.26 of this chapter'' and adding the words ``in
accordance with part 147 of this subchapter with respect to Mycoplasma
isolation,
[[Page 38756]]
sanitation, and management'' in their place.
0
n. In paragraph (f)(5), by removing the words ``as described in Sec.
147.24(a) of this chapter'' and adding the words ``in accordance with
part 147 of this subchapter'' in their place.
0
o. In paragraph (g)(3), by removing the words ``in compliance with the
provisions of Sec. 147.26 of this chapter'' and adding the words ``in
accordance with part 147 of this subchapter with respect to Mycoplasma
isolation, sanitation, and management'' in their place.
0
p. In paragraph (g)(5), by removing the words ``as described in Sec.
147.24(a) of this chapter'' and adding the words ``in accordance with
part 147 of this subchapter'' in their place.
0
q. In paragraph (h)(1) introductory text, by adding the words ``and
found'' before the word ``negative'' and by removing the words ``for
antibodies''.
The revisions read as follows:
Sec. 145.23 Terminology and classification; flocks and products.
* * * * *
(d) * * *
(1) * * *
(viii) Hatching eggs are collected as quickly as possible, and
their sanitation is maintained in accordance with part 147 of this
subchapter.
(ix) Hatching eggs produced by the flock are incubated in a
hatchery whose sanitation is maintained in accordance with part 147 of
this subchapter and sanitized either by a procedure approved by the
Official State Agency or in accordance with part 147 of this
subchapter.
* * * * *
0
15. In Sec. 145.32, paragraph (b) is revised to read as follows:
Sec. 145.32 Participation.
* * * * *
0
(b) Hatching eggs produced by multiplier breeding flocks should be nest
clean. They may be fumigated in accordance with part 147 of this
subchapter or otherwise sanitized.
* * * * *
0
16. Section 145.33 is amended as follows:
0
a. In paragraph (b) introductory text, by removing the citation ``(5)''
and adding the citation ``(4)'' in its place.
0
b. In paragraph (c)(1) introductory text, by removing the words ``in
compliance with the provisions of Sec. 147.26 of this chapter'' and
adding the words ``in accordance with part 147 of this subchapter with
respect to Mycoplasma isolation, sanitation, and management'' in their
place.
0
c. In paragraph (c)(1)(ii)(C), by removing the words ``Sec. 147.8 of
this chapter'' and adding the words ``part 147 of this subchapter'' in
their place.
0
d. In paragraph (c)(2), by removing the words ``(see Sec. Sec. 147.22,
147.23, and 147.24)'' and by adding the words ``and in accordance with
part 147 of this subchapter'' before the period at the end of the
paragraph.
0
e. In paragraph (c)(3), by removing the words ``as described in Sec.
147.24(a) of this chapter'' and adding the words ``in accordance with
part 147 of this subchapter'' in their place.
0
f. In paragraph (c)(4), by removing the words ``approved by the
Department'' and adding the words ``in accordance with part 147 of this
subchapter'' in their place.
0
g. In paragraph (d)(1)(ii), by removing the words ``in compliance with
Sec. Sec. 147.21, 147.24(a), and 147.26 of this chapter'' and adding
the words ``in accordance with part 147 of this subchapter with respect
to flock sanitation, cleaning and disinfection, and Salmonella
isolation, sanitation, and management'' in their place.
0
h. By revising paragraph (d)(1)(vi).
0
i. In paragraph (d)(1)(vii), by removing the words ``as described in
Sec. 147.12 of this chapter'' and adding the words ``in accordance
with part 147 of this subchapter'' in their place.
0
j. By revising paragraph (d)(2).
0
k. In paragraph (e)(1) introductory text, by removing the words ``in
compliance with the provisions of Sec. 147.26 of this chapter'' and
adding the words ``in accordance with part 147 of this subchapter with
respect to Mycoplasma isolation, sanitation, and management'' in their
place.
0
l. In paragraph (e)(1)(ii)(B), by removing the words ``Sec. 147.8 of
this chapter'' and adding the words ``part 147 of this subchapter'' in
their place.
0
m. In paragraph (e)(3), by removing the words ``as described in Sec.
147.24(a) of this chapter'' and adding the words ``in accordance with
part 147 of this subchapter'' in their place.
0
n. In paragraph (e)(4), by removing the words ``approved by the
Department'' and adding the words ``in accordance with part 147 of this
subchapter'' in their place.
0
o. In paragraph (f)(3), by removing the words ``in compliance with the
provisions of Sec. 147.26 of this chapter'' and adding the words ``in
accordance with part 147 of this subchapter with respect to Mycoplasma
isolation, sanitation, and management'' in their place.
0
p. In paragraph (f)(5), by removing the words ``as described in Sec.
147.24(a) of this chapter'' and adding the words ``in accordance with
part 147 of this subchapter'' in their place.
0
q. In paragraph (g)(3), by removing the words ``in compliance with the
provisions of Sec. 147.26 of this chapter'' and adding the words ``in
accordance with part 147 of this subchapter with respect to Mycoplasma
isolation, sanitation, and management'' in their place.
0
r. In paragraph (g)(5), by removing the words ``as described in Sec.
147.24(a) of this chapter'' and adding the words ``in accordance with
part 147 of this subchapter'' in their place.
0
s. In paragraph (j)(2), by removing the words ``paragraph (c)(1)(i) of
this section'' and adding the words ``Sec. 145.83(c)(1)(i)'' in their
place.
0
t. In paragraphs (j)(3) and (k)(3), by removing the words ``as
described in Sec. 147.24(a) of this chapter'' and adding the words
``in accordance with part 147 of this subchapter'' in their place.
0
u. In paragraph (k)(2), by removing the words ``paragraph (e)(1)(i) of
this section'' and adding the words ``Sec. 145.83(d)(1)(i)'' in their
place.
0
v. In paragraph (l)(1) introductory text, by adding the words ``using
an approved test as described in Sec. 145.14'' after the word
``influenza''.
0
w. By adding paragraph (m).
The revisions and addition read as follows:
Sec. 145.33 Terminology and classification; flocks and products.
* * * * *
(d) * * *
(1) * * *
(vi) 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;
* * * * *
(2) The Official State Agency may monitor the effectiveness of the
sanitation practices in accordance with part 147 of this subchapter.
* * * * *
(m) U.S. Salmonella Enteritidis Monitored. This classification is
intended for multiplier meat-type breeders wishing to monitor their
breeding flocks for Salmonella enteritidis.
(1) A flock and the hatching eggs and chicks produced from it shall
be eligible for this classification if they meet the following
requirements, as determined by the Official State Agency:
(i) The flock originated from a U.S. S. Enteritidis Clean primary
meat-type breeding flock.
(ii) The flock is maintained in accordance with part 147 of this
[[Page 38757]]
subchapter with respect to Salmonella isolation, sanitation, and
management.
(iii) Environmental samples are collected from the flock in
accordance with part 147 of this subchapter at 16-18 and 40-45 weeks of
age. The samples shall be examined bacteriologically for group D
Salmonella at an authorized laboratory, and cultures from group D
positive samples shall be serotyped.
(2) The following actions must be taken with respect to the test
results that are generated from this S. enteritidis monitoring program:
(i) If S. enteritidis is isolated from an environmental sample
collected from the flock in accordance with paragraph (m)(1)(iii) of
this section, a thorough evaluation of the practices and programs
associated with the sampled flock shall be conducted with the goal of
ascertaining the reason(s) for the positive finding.
(ii) The test results and the results of any evaluations performed
in accordance with paragraph (m)(2)(i) of this section will be reported
on a quarterly basis to the Official State Agency and the NPIP Senior
Coordinator.
(iii) Participating broiler integrators shall combine their
respective test results (and the results of any associated evaluations)
to help guide their decisionmaking regarding programs and practices to
implement or maintain to address S. enteritidis.
(iv) Aggregate data regarding the prevalence of S. enteritidis in
participating U.S. meat-type parent breeding flocks shall be made
available to the U.S. Poultry and Egg Association and the National
Chicken Council.
(3) This classification may be revoked by the Official State Agency
if the participant fails to comply with the requirements of this
classification. The Official State Agency shall not revoke the
participant's classification until the participant has been given an
opportunity for a hearing in accordance with rules of practice adopted
by the Official State Agency.
* * * * *
Sec. 145.42 [Amended]
0
17. In Sec. 145.42, paragraph (b) is amended by removing the words
``(see Sec. 147.25 of this chapter)'' and adding the words ``in
accordance with part 147 of this subchapter'' after the word
``sanitized''.
0
18. Section 145.43 is amended as follows:
0
a. In paragraph (c)(1), by removing the words ``in accordance with the
conditions and procedures described in Sec. 147.26 of this chapter''
and adding the words ``in accordance with part 147 of this subchapter
with respect to Mycoplasma isolation, sanitation, and management'' in
their place.
0
b. In paragraph (c)(2), by removing the words ``applicable conditions
outlined in Sec. 147.26 of this chapter are being met'' and adding the
words ``flock is being maintained in accordance with part 147 of this
subchapter with respect to Mycoplasma isolation, sanitation, and
management'' in their place.
0
c. By adding a sentence at the end of paragraph (e)(1).
0
d. In paragraph (e)(2), by removing the words '' Sec. 147.6 of this
chapter'' and by adding the words '' part 147 of this subchapter'' in
their place.
0
e. By removing paragraph (e)(3).
0
f. In paragraph (f) introductory text, by removing the words ``as
described in subpart C of part 147 of this chapter'' and adding the
words ``in accordance with part 147 of this subchapter'' in their
place.
0
g. In paragraphs (f)(2), (f)(4), and (f)(6), by removing the words ``,
as described in Sec. 147.12 of this chapter'' and adding the words
``in accordance with part 147 of this subchapter'' in their place.
0
h. By revising paragraph (g)(3).
The addition and revision read as follows:
Sec. 145.43 Terminology and classification; flocks and products.
* * * * *
(e) * * *
(1) * * * It is recommended that any birds that are showing
clinical signs of M. synoviae infection be included in samples taken.
* * * * *
(g) * * *
(3) All spent fowl being marketed for meat from flocks that have
been tested as required by this paragraph shall be tested at a rate of
6 birds per flock within 21 days prior to movement to slaughter.
* * * * *
0
19. Section 145.45 is added to subpart D to read as follows:
Sec. 145.45 Terminology and classification; compartments.
(a) U.S. H5/H7 Avian Influenza Clean Compartment. This program is
intended to be the basis from which the primary turkey breeding-
hatchery industry may demonstrate the existence and implementation of a
program that has been approved by the Official State Agency and the
Service to establish a compartment consisting of a primary breeding-
hatchery company that is free of H5/H7 avian influenza (AI), also
referred to as notifiable avian influenza (NAI). This compartment has
the purpose of protecting the defined subpopulation and avoiding the
introduction and spread of NAI 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:
(1) Definition of the compartment. Based on the guidelines
established by the World Organization for Animal Health (OIE) in the
Terrestrial Animal Health Code and the guidelines in this paragraph
(a), the primary breeder company will define the compartment with
respect to NAI. Specifically, the company will use a comprehensive
biosecurity program to define the compartment as a subpopulation of
poultry with a health status for NAI that is separate from birds and
poultry outside the compartment. The Official State Agency and the
Service must approve all documentation submitted to substantiate the
defined compartment as adequate to qualify for epidemiological
separation from other potential sources of infection of NAI. Guidelines
for the definition of the compartment include:
(i) Definition and description of the subpopulation of birds and
their health status. All birds included in the compartment must be U.S.
H5/H7 Avian Influenza Clean in accordance with Sec. 145.43(g). The
poultry must also be located in a State that has an initial State
response and containment plan approved by APHIS under Sec. 56.10 of
this chapter and that participates in the diagnostic surveillance
program for H5/H7 low pathogenicity AI as described in Sec. 145.15.
Within the compartment, all official tests for AI, as described in
Sec. 145.14(d), must be conducted in State or Federal laboratories or
in NPIP authorized laboratories that meet the minimum standards
described in Sec. 147.52 of this subchapter. In addition, the company
must provide to the Service upon request any relevant historical and
current NAI-related data for reference regarding surveillance for the
disease within the compartment. Upon request, the Official State Agency
may provide such data for other commercial poultry populations located
in the State.
(ii) Description of animal identification and traceability
processes. The primary breeder company must also include a description
of its animal identification and traceability records, including
examples of Veterinary Services (VS) Form 9-5, ``Report of Hatcheries,
Dealers and Independent Flocks''; VS Form 9-2, ``Flock Selection and
Testing Report''; VS Form 9-3, ``Report of Sales of Hatching Eggs,
[[Page 38758]]
Chicks and Poults''; VS Form 9-9, '' Hatchery Inspection Report''; set
and hatch records; egg receipts; and egg/chick invoices for the
subpopulation. Documentation must also include breed identification
(NPIP stock code). The Service should ensure that an effective flock
identification system and traceability system are in place.
(iii) Definition and description of the physical components or
establishments of the defined compartment. The primary breeder company
must provide documentation establishing that the defined compartment is
epidemiologically separated from other poultry and bird populations.
The documentation must be approved by the Official State Agency and the
Service as indicating adequate epidemiological separation to maintain
the compartment's separate health status with respect to NAI. The
documentation should include descriptions of:
(A) The physical and spatial factors that separate the compartment
from surrounding bird populations and affect the biosecurity status of
the compartment.
(B) Relevant environmental factors that may affect exposure of the
birds to AI.
(C) The functional boundary and fencing that are used to control
access to the compartment.
(D) Facilities and procedures to prevent access by wild birds and
to provide separation from other relevant hosts.
(E) The relevant infrastructural factors that may affect exposure
to AI, including the construction and design of buildings or physical
components, cleaning and disinfection of buildings and physical
components between production groups with quality assurance
verification, cleaning and disinfection of equipment, and introduction
of equipment or material into the compartment.
(iv) Definition and description of the functional relationships
between components of the defined compartment. Functional relationships
between components of the compartment include traffic movement and flow
at and among premises, personnel movement at and among premises,
exposure to live bird populations, and any other factors that could
affect biosecurity of the compartment. All physical components of the
compartment must be maintained in compliance with hygiene and
biosecurity procedures for poultry primary breeding flocks and
hatcheries in accordance with part 147 of this subchapter. In addition,
the company must provide a biosecurity plan for the compartment and all
included components. The biosecurity plan should include:
(A) Requirements that company employees and contract growers limit
their contact with live birds outside the compartment.
(B) An education and training program for company employees and
contractors.
(C) Standard operating procedures for company employees,
contractors, and outside maintenance personnel.
(D) Requirements for company employees and non-company personnel
who visit any premises within the compartment.
(E) Company veterinary infrastructure to ensure flock monitoring
and disease diagnosis and control measures.
(F) Policies for management of vehicles and equipment used within
the compartment to connect the various premises.
(G) Farm site requirements (location, layout, and construction).
(H) Pest management program.
(I) Cleaning and disinfection process.
(J) Requirements for litter and dead bird removal and/or disposal.
(v) Description of other factors important for maintaining the
compartment. The company veterinary infrastructure will assess sanitary
measures, environmental risk factors, and management and husbandry
practices that relate to the separation of the compartment and the
health status of the birds contained within the compartment that may
affect risk of exposure to NAI. This assessment must include a
description of internal monitoring and auditing systems (e.g., quality
assurance and quality control programs) to demonstrate the
effectiveness of the compartment. Upon request, the Service will
provide the company with information on the epidemiology of NAI and the
associated risk pathways in which the components of the compartment are
located.
(vi) Approval or denial. Based on this documentation provided under
this paragraph (a)(1), as well as any other information the Service and
the Official State Agency determine to be necessary, the Service and
the Official State Agency will approve or deny the classification of
the compartment as U.S. H5/H7 Avian Influenza Clean.
(2) Company activities for maintenance of the compartment. (i) The
primary breeder company's management of biosecurity, surveillance, and
disease control efforts must be uniform and equivalent among all
components that are a part of the compartment. Oversight and inspection
of these management practices must be conducted by the company's
licensed, accredited veterinarians.
(ii) Veterinary staff from the Official State Agency and NPIP staff
will work in partnership with licensed, accredited veterinarians to
train and certify auditors through Service-approved workshops. The
trained auditors will conduct biosecurity and operational audits at
least once every 2 years to ensure the integrity of the compartment.
These audits will include evaluation of the critical control points and
standard operating practices within the compartment, verification of
the health status of the flock(s) contained within the compartment, and
examination of the biosecurity and management system of the integrated
components of the compartment.
(iii) In addition, the company must demonstrate compliance with
paragraph (a)(1) of this section for remaining in the U.S. H5/H7 Avian
Influenza Clean classification, surveillance for NAI within the
compartment, and conducting tests in State or Federal laboratories or
in NPIP authorized laboratories. Accredited veterinarians are
responsible for the enforcement of active and passive surveillance of
NAI in primary breeder flocks. Baseline health status must be
maintained for all flocks or subpopulations within the compartment,
indicating the dates and negative results of all avian influenza
surveillance and monitoring testing, the dates and history of last
disease occurrence (if any), the number of outbreaks, and the methods
of disease control that were applied.
(iv) Documentation will be maintained in the company's database and
will be verified as required by the Service and/or the Official State
Agency.
(3) Service and Official State Agency activities for maintenance of
the compartment. The Service will work in cooperation with the Official
State Agencies to ensure the continued integrity of any recognized
compartments. Activities will include:
(i) Oversight of the establishment and management of compartments;
(ii) Establishment of effective partnerships between the Service,
the Plan, and the primary breeder industry;
(iii) Approval or denial of classification of compartments as U.S.
H5/H7 Avian Influenza Clean Compartments under paragraph (a)(1) of this
section;
(iv) Official certification of the health status of the
compartment, and commodities that may be traded from it through
participation in the Plan for avian diseases, including the U.S. H5/H7
Avian Influenza Clean program as
[[Page 38759]]
described in Sec. 145.43(g) and diagnostic surveillance for H5/H7 low
pathogenicity AI as described in Sec. 145.15;
(v) Conducting audits of compartments at least once every 2 years
to:
(A) Confirm that the primary breeding company's establishments are
epidemiologically distinct and pathways for the introduction of disease
into the compartment are closed through routine operational procedures;
and
(B) Evaluate and assess the management and husbandry practices
relating to biosecurity to determine whether they are in compliance
with hygiene and biosecurity procedures for poultry primary breeding
flocks and hatcheries in accordance with part 147 of this subchapter;
(vi) Providing, upon request, model plans for management and
husbandry practices relating to biosecurity in accordance with part 147
of this subchapter, risk evaluations in conjunction with the primary
breeder industry (including disease surveillance such as VS Form 9-4,
``Summary of Breeding Flock Participation''), and diagnostic capability
summaries and systems for initial State response and containment plans
in accordance with Sec. 56.10 of this chapter; and
(vii) Publicizing and sharing compartment information with
international trading partners, upon request, to establish approval and
recognition of the compartment, including timeliness and accuracy of
disease reporting and surveillance measures as described in Sec. Sec.
145.15 and 145.43(g).
(4) Emergency response and notification. In the case of a confirmed
positive of NAI in the subpopulation of the compartment, the management
of the compartment must notify the Service. The Service will
immediately suspend the status of the compartment. A compartment will
be eligible to resume trade with importing countries only after the
compartment has adopted the necessary measures to reestablish the
biosecurity level and confirm that NAI is not present in the
compartment and the Service has reevaluated the management and
biosecurity measures of the compartment and approved said compartment
for trade.
(b) [Reserved]
0
20. Section 145.52 is amended as follows:
0
a. In paragraph (b), by removing the words ``(see Sec. 147.25 of this
chapter)'' and adding the words ``in accordance with part 147 of this
subchapter'' after the word ``sanitized''.
0
b. By redesignating paragraphs (c) and (d) as paragraphs (d) and (e),
respectively.
0
c. By adding a new paragraph (c).
The addition reads as follows:
Sec. 145.52 Participation.
* * * * *
(c) It is recommended that waterfowl flocks and gallinaceous flocks
in open-air facilities be kept separate.
* * * * *
0
21. Section 145.53 is amended as follows:
0
a. In paragraph (c)(1) introductory text, by removing the words ``in
compliance with the provisions of Sec. 147.26 of this chapter'' and
adding the words ``in accordance with part 147 of this subchapter with
respect to Mycoplasma isolation, sanitation, and management'' in their
place.
0
b. In paragraph (c)(3), by removing the words ``as described in Sec.
147.24(a) of this chapter'' and adding the words ``in accordance with
part 147 of this subchapter'' in their place.
0
c. In paragraph (d)(1) introductory text, by removing the words ``in
compliance with the provisions of Sec. 147.26 of this chapter'' and
adding the words ``in accordance with part 147 of this subchapter with
respect to Mycoplasma isolation, sanitation, and management'' in their
place.
0
d. In paragraph (d)(1)(ii)(B), by removing the words ``Sec. 147.8 of
this chapter'' and adding the words ``part 147 of this subchapter'' in
their place.
0
e. In paragraph (d)(3), by removing the words ``as described in Sec.
147.24(a) of this chapter'' and adding the words ``in accordance with
part 147 of this subchapter'' in their place.
0
f. By revising paragraphs (e)(1) introductory text and (e)(2)
introductory text.
0
g. In paragraphs (e)(1)(i) and (e)(1)(ii), by removing the number
``90'' and adding the number ``180'' in its place.
0
h. By revising paragraph (e)(3).
0
i. By adding paragraph (f).
The revisions and addition read as follows:
Sec. 145.53 Terminology and classification; flocks and products.
* * * * *
(e) * * *
(1) It is a primary breeding flock in which a minimum of 30 birds
has been tested negative to the H5 and H7 subtypes of avian influenza
as provided in Sec. 145.14(d) when more than 4 months of age;
Provided, that waterfowl flocks may test a minimum of 30 cloacal swabs
for virus isolation. To retain this classification:
* * * * *
(2) It is a multiplier breeding flock in which a minimum of 30
birds has been tested negative to the H5 and H7 subtypes of avian
influenza as provided in Sec. 145.14(d) when more than 4 months of
age; Provided, that waterfowl flocks may test a minimum of 30 cloacal
swabs for virus isolation. To retain this classification:
* * * * *
(3) A sample of at least 30 birds must be tested and found negative
to H5/H7 avian influenza within 21 days prior to movement to slaughter.
(f) U.S. Salmonella Monitored. This program is intended to be the
basis from which the hatching industry may conduct a program for the
prevention and control of salmonellosis. It is intended to reduce the
incidence of Salmonella organisms in day-old poultry through an
effective and practical sanitation program in the hatchery. This will
afford other segments of the poultry industry an opportunity to reduce
the incidence of Salmonella in their products. The following
requirements must be met for a flock to be of this classification:
(1) An Authorized Agent shall collect a minimum of five
environmental samples, e.g., chick papers, hatching trays, and chick
transfer devices, from the hatchery at least every 30 days. Testing
must be performed at an authorized laboratory.
(2) To claim products are of this classification, all products
shall be derived from a hatchery that meets the requirements of the
classification.
(3) This classification may be revoked by the Official State Agency
if the participant fails to follow recommended corrective measures.
* * * * *
Sec. 145.62 [Amended]
0
22. In Sec. 145.62, paragraph (b) is amended by removing the words
``(see Sec. 147.22 of this chapter)'' and adding the words ``in
accordance with part 147 of this subchapter'' in their place.
0
23. In Sec. 145.72, paragraph (b) is revised to read as follows:
Sec. 145.72 Participation.
* * * * *
(b) Hatching eggs produced by primary breeding flocks should be
nest clean. They may be fumigated in accordance with part 147 of this
subchapter or otherwise sanitized.
* * * * *
0
24. Section 145.73 is amended as follows:
0
a. In paragraph (c)(1) introductory text, by removing the words ``in
compliance with the provisions of
[[Page 38760]]
Sec. 147.26 of this subchapter'' and adding the words ``in accordance
with part 147 of this subchapter with respect to Mycoplasma isolation,
sanitation, and management'' in their place.
0
b. In paragraph (c)(3), by removing the words ``as described in Sec.
147.24(a)'' and adding the words ``in accordance with part 147'' in
their place.
0
c. In paragraph (d)(1)(iv), by removing the words ``in compliance with
Sec. Sec. 147.21, 147.24(a), and 147.26 of this subchapter'' and
adding the words ``in accordance with part 147 of this subchapter with
respect to flock sanitation, cleaning and disinfection, and Salmonella
isolation, sanitation, and management'' in their place.
0
d. In paragraph (d)(1)(v), by removing the words ``as described in
Sec. 147.12'' and adding the words ``in accordance with part 147'' in
their place.
0
e. In paragraph (d)(1)(vii), by removing the words ``as described in
Sec. 147.11'' and adding the words ``in accordance with part 147'' in
their place.
0
f. By revising paragraph (d)(1)(ix).
0
g. In paragraph (d)(2), by removing the words ``as described in Sec.
147.11(a)'' and adding the words ``in accordance with part 147'' in
their place.
0
h. In paragraph (e)(1) introductory text, by removing the words ``in
compliance with the provisions of Sec. 147.26 of this subchapter'' and
adding the words ``in accordance with part 147 of this subchapter with
respect to Mycoplasma isolation, sanitation, and management'' in their
place.
0
i. In paragraph (e)(3), by removing the words ``as described in Sec.
147.24(a)'' and adding the words ``in accordance with part 147'' in
their place.
0
j. In paragraph (f)(1) introductory text, by adding the words ``and
found'' before the word ``negative'' and by removing the words
``antibodies to''.
0
k. By revising paragraph (f)(2).
The revisions read as follows:
Sec. 145.73 Terminology and classification; flocks and products.
* * * * *
(d) * * *
(1) * * *
(ix) Hatching eggs produced by the flock are incubated in a
hatchery whose sanitation is maintained in accordance with part 147 of
this subchapter and sanitized either by a procedure approved by the
Official State Agency or in accordance with part 147 of this
subchapter.
* * * * *
(f) * * *
(2) A sample of at least 11 birds must be tested and found negative
for avian influenza within 21 days prior to movement to slaughter.
0
25. Section 145.74 is added to subpart G to read as follows:
Sec. 145.74 Terminology and classification; compartments.
(a) U.S. Avian Influenza Clean Compartment. This program is
intended to be the basis from which the primary egg-type chicken
breeding-hatchery industry may demonstrate the existence and
implementation of a program that has been approved by the Official
State Agency and the Service to establish a compartment consisting of a
primary breeding-hatchery company that is free of H5/H7 avian influenza
(AI), also referred to as notifiable avian influenza (NAI). This
compartment has the purpose of protecting the defined subpopulation and
avoiding the introduction and spread of NAI 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:
(1) Definition of the compartment. Based on the guidelines
established by the World Organization for Animal Health (OIE) in the
Terrestrial Animal Health Code and the guidelines in this paragraph
(a), the primary breeder company will define the compartment with
respect to NAI. Specifically, the company will use a comprehensive
biosecurity program to define the compartment as a subpopulation of
poultry with a health status for NAI that is separate from birds and
poultry outside the compartment. The Official State Agency and the
Service must first approve all documentation submitted by the company
to substantiate the defined compartment as adequate to qualify for
epidemiological separation from other potential sources of infection of
NAI. Guidelines for the definition of the compartment include:
(i) Definition and description of the subpopulation of birds and
their health status. All birds included in the compartment must be U.S.
Avian Influenza Clean in accordance with Sec. 145.73(f). The poultry
must also be located in a State that has an initial State response and
containment plan approved by APHIS under Sec. 56.10 of this chapter
and that participates in the diagnostic surveillance program for H5/H7
low pathogenicity AI as described in Sec. 145.15. Within the
compartment, all official tests for AI, as described in Sec.
145.14(d), must be conducted in State or Federal laboratories or in
NPIP authorized laboratories that meet the minimum standards described
in Sec. 147.52 of this subchapter. In addition, the company must
provide to the Service upon request any relevant historical and current
NAI-related data for reference regarding surveillance for the disease
within the compartment. Upon request, the Official State Agency may
provide such data for other commercial poultry populations located in
the State.
(ii) Description of animal identification and traceability
processes. The primary breeder company must also include a description
of its animal identification and traceability records, including
examples of Veterinary Services (VS) Form 9-5, ``Report of Hatcheries,
Dealers and Independent Flocks''; VS Form 9-2, ``Flock Selection and
Testing Report''; VS Form 9-3, ``Report of Sales of Hatching Eggs,
Chicks and Poults''; VS Form 9-9, '' Hatchery Inspection Report''; set
and hatch records; egg receipts; and egg/chick invoices for the
subpopulation. Documentation must also include breed identification
(NPIP stock code). The Service should ensure that an effective flock
identification system and traceability system are in place.
(iii) Definition and description of the physical components or
establishments of the defined compartment. The primary breeder company
must provide documentation establishing that the defined compartment is
epidemiologically separated from other poultry and bird populations.
The documentation must be approved by the Official State Agency and the
Service as indicating adequate epidemiological separation to maintain
the compartment's separate health status with respect to NAI. The
documentation should include descriptions of:
(A) The physical and spatial factors that separate the compartment
from surrounding bird populations and affect the biosecurity status of
the compartment.
(B) Relevant environmental factors that may affect exposure of the
birds to AI.
(C) The functional boundary and fencing that are used to control
access to the compartment.
(D) Facilities and procedures to prevent access by wild birds and
to provide separation from other relevant hosts.
(E) The relevant infrastructural factors that may affect exposure
to AI, including the construction and design of buildings or physical
components, cleaning and disinfection of buildings and physical
components between production groups with quality assurance
verification, cleaning and disinfection of equipment, and introduction
of equipment or material into the compartment.
[[Page 38761]]
(iv) Definition and description of the functional relationships
between components of the defined compartment. Functional relationships
between components of the compartment include traffic movement and flow
at and among premises, personnel movement at and among premises,
exposure to live bird populations, and any other factors that could
affect biosecurity of the compartment. All physical components of the
compartment must be maintained in compliance with hygiene and
biosecurity procedures for poultry primary breeding flocks and
hatcheries in accordance with part 147 of this subchapter. In addition,
the company must provide a biosecurity plan for the compartment and all
included components. The biosecurity plan should include but not be
limited to:
(A) Requirements that company employees and contract growers limit
their contact with live birds outside the compartment.
(B) An education and training program for company employees and
contractors.
(C) Standard operating procedures for company employees,
contractors, and outside maintenance personnel.
(D) Requirements for company employees and non-company personnel
who visit any premises within the compartment.
(E) Company veterinary infrastructure to ensure flock monitoring
and disease diagnosis and control measures.
(F) Policies for management of vehicles and equipment used within
the compartment to connect the various premises.
(G) Farm site requirements (location, layout, and construction).
(H) Pest management program.
(I) Cleaning and disinfection process.
(J) Requirements for litter and dead bird removal and/or disposal.
(v) Description of other factors important for maintaining the
compartment. The company veterinary infrastructure will assess sanitary
measures, environmental risk factors, and management and husbandry
practices that relate to the separation of the compartment and the
health status of the birds contained within the compartment that may
affect risk of exposure to NAI. This assessment must include a
description of internal monitoring and auditing systems (e.g., quality
assurance and quality control programs) to demonstrate the
effectiveness of the compartment. Upon request, the Service will
provide the company with information on the epidemiology of NAI and the
associated risk pathways in which the components of the compartment are
located.
(vi) Approval or denial. Based on the documentation provided under
this paragraph (a)(1), as well as any other information the Service and
the Official State Agency determine to be necessary, the Service and
the Official State Agency will approve or deny the classification of
the compartment as U.S. Avian Influenza Clean.
(2) Company activities for maintenance of the compartment. (i) The
primary breeder company's management of biosecurity, surveillance, and
disease control efforts must be uniform and equivalent among all
components that are a part of the compartment. Oversight and inspection
of these management practices must be conducted by the company's
licensed, accredited veterinarians.
(ii) Veterinary staff from the Official State Agency and NPIP staff
will work in partnership with licensed, accredited veterinarians to
train and certify auditors through Service-approved workshops. The
trained auditors will conduct biosecurity and operational audits at
least once every 2 years to ensure the integrity of the compartment.
These audits will include evaluation of the critical control points and
standard operating practices within the compartment, verification of
the health status of the flock(s) contained within the compartment, and
examination of the biosecurity and management system of the integrated
components of the compartment.
(iii) In addition, the company must demonstrate compliance with
paragraph (a)(1) of this section for remaining in the U.S. Avian
Influenza Clean classification, surveillance for NAI within the
compartment, and conducting tests in State or Federal laboratories or
in NPIP authorized laboratories. Accredited veterinarians are
responsible for the enforcement of active and passive surveillance of
NAI in primary breeder flocks. Baseline health status must be
maintained for all flocks or subpopulations within the compartment,
indicating the dates and negative results of all avian influenza
surveillance and monitoring testing, the dates and history of last
disease occurrence (if any), the number of outbreaks, and the methods
of disease control that were applied.
(iv) Documentation will be maintained in the company's database and
will be verified as required by the Service and/or the Official State
Agency.
(3) Service and Official State Agency activities for maintenance of
the compartment. The Service will work in cooperation with the Official
State Agencies to ensure the continued integrity of any recognized
compartments. Activities include:
(i) Oversight of the establishment and management of compartments;
(ii) Establishment of effective partnerships between the Service,
the Plan, and the primary breeder industry;
(iii) Approval or denial of classification of compartments as U.S.
Avian Influenza Clean Compartments under paragraph (a)(1) of this
section;
(iv) Official certification of the health status of the
compartment, and commodities that may be traded from it through
participation in the Plan for avian diseases, including the U.S. Avian
Influenza Clean program as described in Sec. 145.73(f) and diagnostic
surveillance for H5/H7 low pathogenicity AI as described in Sec.
145.15;
(v) Conducting audits of compartments at least once every 2 years
to:
(A) Confirm that the primary breeding company's establishments are
epidemiologically distinct and pathways for the introduction of disease
into the compartment are closed through routine operational procedures;
and
(B) Evaluate and assess the management and husbandry practices
relating to biosecurity to determine whether they are in compliance
with hygiene and biosecurity procedures for poultry primary breeding
flocks and hatcheries in accordance with part 147 of this subchapter;
(vi) Providing, upon request, model plans for management and
husbandry practices relating to biosecurity in accordance with part 147
of this subchapter, risk evaluations in conjunction with the primary
breeder industry (including disease surveillance such as VS Form 9-4,
``Summary of Breeding Flock Participation''), and diagnostic capability
summaries and systems for initial State response and containment plans
in accordance with Sec. 56.10 of this chapter; and
(vii) Publicizing and sharing compartment information with
international trading partners, upon request, to establish approval and
recognition of the compartment, including timeliness and accuracy of
disease reporting and surveillance measures as described in Sec. Sec.
145.15 and 145.73(f).
(4) Emergency response and notification. In the case of a confirmed
positive of NAI in the subpopulation of the compartment, the management
of the compartment must notify the Service. The Service will
immediately suspend the status of the compartment.
[[Page 38762]]
A compartment will be eligible to resume trade with importing countries
only after the compartment has adopted the necessary measures to
reestablish the biosecurity level and confirm that NAI is not present
in the compartment and the Service has reevaluated the management and
biosecurity measures of the compartment and approved said compartment
for trade.
(b) [Reserved]
0
26. In Sec. 145.82, paragraph (b) is revised to read as follows:
Sec. 145.82 Participation.
* * * * *
(b) Hatching eggs produced by primary breeding flocks should be
nest clean. They may be fumigated in accordance with part 147 of this
subchapter or otherwise sanitized.
* * * * *
0
27. Section 145.83 is amended as follows:
0
a. In paragraph (c)(1) introductory text, by removing the words ``in
compliance with the provisions of Sec. 147.26 of this subchapter'' and
adding the words ``in accordance with part 147 of this subchapter with
respect to Mycoplasma isolation, sanitation, and management'' in their
place.
0
b. In paragraph (c)(3), by removing the words ``as described in Sec.
147.24(a)'' and adding the words ``in accordance with part 147'' in
their place.
0
c. In paragraph (d)(1) introductory text, by removing the words ``in
compliance with the provisions of Sec. 147.26 of this subchapter'' and
adding the words ``in accordance with part 147 of this subchapter with
respect to Mycoplasma isolation, sanitation, and management'' in their
place.
0
d. In paragraph (d)(3), by removing the words ``as described in Sec.
147.24(a)'' and adding the words ``in accordance with part 147'' in
their place.
0
e. By revising paragraphs (e)(1) and (e)(3).
0
f. In paragraph (e)(6) introductory text, by removing the words ``or
great-grandparent'' and adding the words ``great-grandparent, or
grandparent'' in their place.
0
g. In paragraph (e)(6)(i)(B), by removing the words ``as described in
Sec. 147.12(a)'' and adding the words ``in accordance with part 147''
in their place.
0
h. In paragraph (e)(6)(i)(C), by removing the words ``as described in
Sec. 147.11'' and adding the words ``in accordance with part 147'' in
their place.
0
i. In paragraph (e)(6)(i)(D), by removing the words ``as specified in
Sec. 147.12(a)'' and adding the words ``in accordance with part 147''
in their place.
0
j. In paragraph (f)(1)(i), by removing the words ``in compliance with
Sec. Sec. 147.21, 147.24(a), and 147.26 of this subchapter'' and
adding the words ``in accordance with part 147 of this subchapter with
respect to flock sanitation, cleaning and disinfection, and Salmonella
isolation, sanitation, and management'' in their place.
0
k. By revising paragraph (f)(1)(iv).
0
l. In paragraph (f)(1)(vi), by removing the words ``as described in
Sec. 147.12'' and adding the words ``in accordance with part 147'' in
their place.
0
m. By revising paragraph (f)(2).
0
n. In paragraph (g)(1) introductory text, by adding the words ``using
an approved test as described in Sec. 145.14'' after the word
``influenza''.
The revisions read as follows:
Sec. 145.83 Terminology and classification; flocks and products.
* * * * *
(e) * * *
(1) A flock and the hatching eggs and chicks produced from it shall
be eligible for this classification if they meet the following
requirements, as determined by the Official State Agency:
(i) The flock originated from a U.S. S. Enteritidis Clean flock, or
one of the following samples has been examined bacteriologically for S.
enteritidis at an authorized laboratory in accordance with part 147 of
this subchapter and any group D Salmonella samples have been serotyped:
(A) A sample of chick papers, hatcher tray swabs, or fluff
collected and cultured in accordance with part 147 of this subchapter;
and
(B) Samples of intestinal and liver or spleen tissues from a
minimum of 30 chicks that died within 7 days after hatching and have
been preserved daily by freezing prior to shipment to an authorized
laboratory.
(ii) The flock is maintained in compliance with isolation,
sanitation, and management procedures for Salmonella in accordance with
part 147 of this subchapter.
(iii) Environmental samples are collected from the flock by or
under the supervision of an Authorized Agent, in accordance with part
147 of this subchapter, when the flock reaches 4 months of age and
every 30 days thereafter. Once the flock is in egg production and
chicks are hatching from it, the samples must include at least 4
individual test assay results every 30 days in flocks of more than 500
birds or 2 individual assays per month in flocks of 500 birds or fewer.
One of these results must come from samples collected from hatched
chicks at a participating hatchery derived from said flock. These
individual test assays may be derived from pooled samples from the farm
or hatchery in accordance with part 147 of this subchapter, but must be
run as separate test assays in the laboratory. The environmental
samples shall be examined bacteriologically for group D Salmonella at
an authorized laboratory, and cultures from group D positive samples
shall be serotyped.
(iv) Blood samples from 300 birds from the flock are officially
tested with pullorum antigen when the flock is at least 4 months of
age. All birds with positive or inconclusive reactions, up to a maximum
of 25 birds, shall be submitted to an authorized laboratory and
examined for the presence of group D Salmonella in accordance with part
147 of this subchapter. Cultures from group D positive samples shall be
serotyped.
(v) Hatching eggs produced by the flock are collected as quickly as
possible and their sanitation is maintained in accordance with part 147
of this subchapter.
(vi) Hatching eggs produced by the flock are incubated in a
hatchery whose sanitation is maintained in accordance with part 147 of
this subchapter, and the hatchery must have been sanitized either by a
procedure approved by the Official State Agency or by fumigation in
accordance with part 147 of this subchapter.
* * * * *
(3) If SE is isolated from an environmental sample collected from
the flock in accordance with paragraph (e)(1)(iii) of this section, an
additional environmental sampling and 25 live cull birds or fresh dead
birds (if present), or other randomly selected live birds if fewer than
25 culls can be found in the flock, must be bacteriologically examined
for SE in accordance with part 147 of this subchapter. If only 1 bird
from the 25-bird sample is found positive for SE., the participant may
request bacteriological examination of a second 25-bird sample from the
flock. In addition, if the flock with the SE isolation is in egg
production and eggs are under incubation, the next four consecutive
hatches shall be examined bacteriologically in accordance with part 147
of this subchapter. Samples shall be collected from all of the hatching
unit's chick trays and basket trays of hatching eggs, or from all chick
box papers from the flock, and tested, pooling the samples into a
minimum of 10 separate assays. Any followup hatchery-positive SE
isolations shall result in discontinuation of subsequent
[[Page 38763]]
hatches until the flock status is determined by bird culture. The flock
will be disqualified for the U.S. S. Enteritidis Clean classification
if a bird or subsequent flock environmental assay results in isolation
of SE.
* * * * *
(f) * * *
(1) * * *
(iv) 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.
* * * * *
(2) The Official State Agency may monitor the effectiveness of the
sanitation practices in accordance with part 147 of this subchapter.
* * * * *
0
28. Section 145.84 is added to subpart H to read as follows:
Sec. 145.84 Terminology and classification; compartments.
(a) U.S. Avian Influenza Clean Compartment. This program is
intended to be the basis from which the primary meat-type chicken
breeding-hatchery industry may demonstrate the existence and
implementation of a program that has been approved by the Official
State Agency and the Service to establish a compartment consisting of a
primary breeding-hatchery company that is free of H5/H7 avian influenza
(AI), also referred to as notifiable avian influenza (NAI). This
compartment has the purpose of protecting the defined subpopulation and
avoiding the introduction and spread of NAI 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:
(1) Definition of the compartment. Based on the guidelines
established by the World Organization for Animal Health (OIE) in the
Terrestrial Animal Health Code and the guidelines in this paragraph
(a), the primary breeder company will define the compartment with
respect to NAI. Specifically, the company will use a comprehensive
biosecurity program to define the compartment as a subpopulation of
poultry with a health status for NAI that is separate from birds and
poultry outside the compartment. The Official State Agency and the
Service must first approve all documentation submitted by the company
to substantiate the defined compartment as adequate to qualify for
epidemiological separation from other potential sources of infection of
NAI. Guidelines for the definition of the compartment include:
(i) Definition and description of the subpopulation of birds and
their health status. All birds included in the compartment must be U.S.
Avian Influenza Clean in accordance with Sec. 145.83(g). The poultry
must also be located in a State that has an initial State response and
containment plan approved by APHIS under Sec. 56.10 of this chapter
and that participates in the diagnostic surveillance program for H5/H7
low pathogenicity AI as described in Sec. 145.15. Within the
compartment, all official tests for AI, as described in Sec.
145.14(d), must be conducted in State or Federal laboratories or in
NPIP authorized laboratories that meet the minimum standards described
in Sec. 147.52 of this subchapter. In addition, the company must
provide to the Service upon request any relevant historical and current
NAI-related data for reference regarding surveillance for the disease
and the health status of the compartment. Upon request, the Official
State Agency may provide such data for other commercial poultry
populations located in the State.
(ii) Description of animal identification and traceability
processes. The primary breeder company must also include a description
of its animal identification and traceability records, including
examples of Veterinary Services (VS) Form 9-5, ``Report of Hatcheries,
Dealers and Independent Flocks''; VS Form 9-2, ``Flock Selection and
Testing Report''; VS Form 9-3, ``Report of Sales of Hatching Eggs,
Chicks and Poults''; VS Form 9-9, '' Hatchery Inspection Report''; set
and hatch records; egg receipts; and egg/chick invoices for the
subpopulation. Documentation must also include breed identification
(NPIP stock code). The Service should ensure that an effective flock
identification system and traceability system are in place.
(iii) Definition and description of the physical components or
establishments of the defined compartment. The primary breeder company
must provide documentation establishing that the defined compartment is
epidemiologically separated from other poultry and bird populations.
The documentation must be approved by the Official State Agency and the
Service as indicating adequate epidemiological separation to maintain
the compartment's separate health status with respect to NAI. The
documentation should include descriptions of:
(A) The physical and spatial factors that separate the compartment
from surrounding bird populations and affect the biosecurity status of
the compartment.
(B) Relevant environmental factors that may affect exposure of the
birds to AI.
(C) The functional boundary and fencing that are used to control
access to the compartment.
(D) Facilities and procedures to prevent access by wild birds and
to provide separation from other relevant hosts.
(E) The relevant infrastructural factors that may affect exposure
to AI, including the construction and design of buildings or physical
components, cleaning and disinfection of buildings and physical
components between production groups with quality assurance
verification, cleaning and disinfection of equipment, and introduction
of equipment or material into the compartment.
(iv) Definition and description of the functional relationships
between components of the defined compartment. Functional relationships
between components of the compartment include traffic movement and flow
at and among premises, personnel movement at and among premises,
exposure to live bird populations, and any other factors that could
affect biosecurity of the compartment. All physical components of the
compartment must be maintained in compliance with hygiene and
biosecurity procedures for poultry primary breeding flocks and
hatcheries in accordance with part 147 of this subchapter. In addition,
the company must provide a biosecurity plan for the compartment and all
included components. The biosecurity plan should include but not be
limited to:
(A) Requirements that company employees and contract growers limit
their contact with live birds outside the compartment.
(B) An education and training program for company employees and
contractors.
(C) Standard operating procedures for company employees,
contractors, and outside maintenance personnel.
(D) Requirements for company employees and non-company personnel
who visit any premises within the compartment.
(E) Company veterinary infrastructure to ensure flock monitoring
and disease diagnosis and control measures.
(F) Policies for management of vehicles and equipment used within
the compartment to connect the various premises.
(G) Farm site requirements (location, layout, and construction).
(H) Pest management program.
[[Page 38764]]
(I) Cleaning and disinfection process.
(J) Requirements for litter and dead bird removal and/or disposal.
(v) Description of other factors important for maintaining the
compartment. The company veterinary infrastructure will assess sanitary
measures, environmental risk factors, and management and husbandry
practices that relate to the separation of the compartment and the
health status of the birds contained within the compartment that may
affect risk of exposure to NAI. This assessment must include a
description of internal monitoring and auditing systems (e.g., quality
assurance and quality control programs) to demonstrate the
effectiveness of the compartment. Upon request, the Service will
provide the company with information on the epidemiology of NAI and the
associated risk pathways in which the components of the compartment are
located.
(vi) Approval or denial. Based on the documentation provided under
this paragraph (a)(1), as well as any other information the Service and
the Official State Agency determine to be necessary, the Service and
the Official State Agency will approve or deny the classification of
the compartment as U.S. Avian Influenza Clean.
(2) Company activities for maintenance of the compartment. (i) The
primary breeder company's management of biosecurity, surveillance, and
disease control efforts must be uniform and equivalent among all
components that are a part of the compartment. Oversight and inspection
of these management practices must be conducted by the company's
licensed, accredited veterinarians.
(ii) Veterinary staff from the Official State Agency and NPIP staff
will work in partnership with licensed, accredited veterinarians to
train and certify auditors through Service-approved workshops. The
trained auditors will conduct biosecurity and operational audits at
least once every 2 years to ensure the integrity of the compartment.
These audits will include evaluation of the critical control points and
standard operating practices within the compartment, verification of
the health status of the flock(s) contained within the compartment, and
examination of the biosecurity and management system of the integrated
components of the compartment.
(iii) In addition, the company must demonstrate compliance with
paragraph (a)(1) of this section for remaining in the U.S. Avian
Influenza Clean classification, surveillance for NAI within the
compartment, and conducting tests in State or Federal laboratories or
in NPIP authorized laboratories. Accredited veterinarians are
responsible for the enforcement of active and passive surveillance of
NAI in primary breeder flocks. Baseline health status must be
maintained for all flocks or subpopulations within the compartment,
indicating the dates and negative results of all avian influenza
surveillance and monitoring testing, the dates and history of last
disease occurrence (if any), the number of outbreaks, and the methods
of disease control that were applied.
(iv) Documentation will be maintained in the company's database and
will be verified as required by the Service and/or the Official State
Agency.
(3) Service and Official State Agency activities for maintenance of
the compartment. The Service will work in cooperation with the Official
State Agencies to ensure the continued integrity of any recognized
compartments. Activities include:
(i) Oversight of the establishment and management of compartments;
(ii) Establishment of effective partnerships between the Service,
the Plan, and the primary breeder industry;
(iii) Approval or denial of classification of compartments as U.S.
Avian Influenza Clean Compartments under paragraph (a)(1) of this
section;
(iv) Official certification of the health status of the
compartment, and commodities that may be traded from it through
participation in the Plan for avian diseases, including the U.S. Avian
Influenza Clean program as described in Sec. 145.83(g) and diagnostic
surveillance for H5/H7 low pathogenicity AI as described in Sec.
145.15;
(v) Conducting audits of compartments at least once every 2 years
to:
(A) Confirm that the primary breeding company's establishments are
epidemiologically distinct and pathways for the introduction of disease
into the compartment are closed through routine operational procedures;
and
(B) Evaluate and assess the management and husbandry practices
relating to biosecurity to determine whether they are in compliance
with hygiene and biosecurity procedures for poultry primary breeding
flocks and hatcheries in accordance with part 147 of this subchapter;
(vi) Providing, upon request, model plans for management and
husbandry practices relating to biosecurity in accordance with part 147
of this subchapter, risk evaluations in conjunction with the primary
breeder industry (including disease surveillance such as VS Form 9-4,
``Summary of Breeding Flock Participation''), and diagnostic capability
summaries and systems for initial State response and containment plans
in accordance with Sec. 56.10 of this chapter; and
(vii) Publicizing and sharing compartment information with
international trading partners, upon request, to establish approval and
recognition of the compartment, including timeliness and accuracy of
disease reporting and surveillance measures as described in Sec. Sec.
145.15 and 145.83(g).
(4) Emergency response and notification. In the case of a confirmed
positive of NAI in the subpopulation of the compartment, the management
of the compartment must notify the Service. The Service will
immediately suspend the status of the compartment. A compartment would
be eligible to resume trade with importing countries only after the
compartment has adopted the necessary measures to reestablish the
biosecurity level and confirm that NAI is not present in the
compartment and the Service has reevaluated the management and
biosecurity measures of the compartment and approved said compartment
for trade.
(b) [Reserved]
Sec. 145.92 [Amended]
0
29. In Sec. 145.92, paragraph (b) is amended by removing the words
``(see Sec. 147.25 of this chapter)'' and adding the words ``in
accordance with part 147 of this subchapter'' after the word
``sanitized''.
0
30. Section 145.93 is amended as follows:
0
a. By revising paragraph (c)(3).
0
b. By adding paragraph (d).
The revision and addition read as follows:
Sec. 145.93 Terminology and classification; flocks and products.
* * * * *
(c) * * *
(3) A sample of at least 30 birds must be tested and found negative
to H5/H7 avian influenza within 21 days prior to movement to slaughter.
(d) U.S. Salmonella Monitored. This program is intended to be the
basis from which the breeding-hatching 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 day-
old waterfowl 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
[[Page 38765]]
opportunity to reduce the incidence of Salmonella in their products.
(1) A flock and the hatching eggs and day-old waterfowl produced
from it must meet the following requirements, as determined by the
Official State Agency, to be eligible for this classification:
(i) The flock is maintained in compliance with isolation,
sanitation, and management procedures for Salmonella in accordance with
part 147 of this subchapter.
(ii) If feed contains animal protein, the protein products must
have been heated throughout to a minimum temperature of
190[emsp14][deg]F or above, or to a minimum temperature of
165[emsp14][deg]F for at least 20 minutes, or to a minimum temperature
of 184[emsp14][deg]F under 70 lbs. pressure during the manufacturing
process.
(iii) Feed shall be stored and transported in a manner that
prevents contamination.
(iv) Waterfowl 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.
(v) An Authorized Agent shall take environmental samples from the
hatchery every 30 days, i.e., meconium or box liner paper. An
authorized laboratory for Salmonella shall examine the samples
bacteriologically.
(vi) 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.
(vii) Flocks may be vaccinated with a paratyphoid vaccine:
Provided, that a sample of at least 100 birds will be segregated and
shall remain unvaccinated until the flock reaches at least 4 months of
age.
(2) The Official State Agency may monitor the effectiveness of the
egg sanitation practices in accordance with part 147 of this
subchapter.
(3) To claim products are of this classification, all products
shall be derived from a hatchery and flock that 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.
PART 146--NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY
0
31. 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
32. Section 146.1 is amended as follows:
0
a. By revising the definition of authorized laboratory.
0
b. In the definition of commercial meat-type flock, by adding the words
``spent fowl,'' after the word ``chickens,''.
0
c. In the definition of H5/H7 low pathogenic avian influenza (LPAI), by
adding the words ``or equal to'' before the number ``1.2'' and by
adding the word ``causes'' before the words ``less than 75''.
0
d. In paragraph (1)(iii) of the definition of H5/H7 LPAI virus
infection (infected), by adding the words ``the Cooperating State
Agency, the Official State Agency, and'' before the word ``APHIS''.
The revision reads as follows:
Sec. 146.1 Definitions.
* * * * *
Authorized laboratory. An authorized laboratory is a laboratory
that meets the requirements of Sec. 147.52 and is thus qualified to
perform the assays in accordance with part 147 of this subchapter.
* * * * *
Sec. 146.2 [Amended]
0
33. In Sec. 146.2, paragraph (e) is amended by removing the words
``follow the laboratory protocols outlined in part 147 of this
chapter'' and adding the words ``conduct tests in accordance with part
147 of this subchapter'' in their place.
Sec. 146.3 [Amended]
0
34. Section 146.3 is amended as follows:
0
a. In paragraph (c), by adding the words ``, spent fowl,'' after the
word ``chicken''.
0
b. By removing paragraph (e).
Sec. 146.5 [Amended]
0
35. In Sec. 146.5, paragraph (b) is amended by removing the words ``as
recommended in Sec. 147.21(c)'' and adding the words ``in accordance
with part 147'' in their place.
0
36. Section 146.13 is amended as follows:
0
a. In paragraph (a)(1), by removing the words ``the requirements in
Sec. 147.8'' and adding the words ``part 147'' in their place.
0
b. By revising paragraph (b)(1)(ii)(C).
0
c. In paragraph (b)(2)(i), by removing the word ``(AVPR01510)''.
0
d. By revising paragraph (b)(2)(ii)(B).
The revisions read as follows:
Sec. 146.13 Testing.
* * * * *
(b) * * *
(1) * * *
(ii) * * *
(C) The AGID test for avian influenza must be conducted in
accordance with part 147 of this subchapter. The test can be conducted
on egg yolk or blood samples. The AGID test is not recommended for use
in waterfowl.
* * * * *
(2) * * *
(ii) * * *
(B) Chicken and turkey flocks that test positive on the ACIA must
be retested using the RRT-PCR or virus isolation. Positive results from
the RRT-PCR or virus isolation must be further tested by Federal
Reference Laboratories using appropriate tests for confirmation. Final
judgment may be based upon further sampling and appropriate tests for
confirmation.
* * * * *
0
37. Section 146.23 is amended by revising the heading of paragraph (a),
removing the introductory text of paragraph (a), and revising the
introductory text of paragraphs (a)(1), and (a)(2) to read as follows:
Sec. 146.23 Terminology and classification; flocks and products.
* * * * *
(a) U.S. H5/H7 Avian Influenza Monitored--(1) Table-egg layer
pullet flocks. This program is intended to be the basis from which the
table-egg layer industry may conduct a program to monitor for the H5/H7
subtypes of avian influenza. It is intended to determine the presence
of the H5/H7 subtypes of avian influenza in table-egg layer pullets
through routine surveillance of each participating commercial table-egg
layer pullet flock. A flock will qualify for this classification when
the Official State Agency determines that it has met one of the
following requirements:
* * * * *
(2) Table-egg layer flocks. This program is intended to be the
basis from which the table-egg layer industry may conduct a program to
monitor for the H5/H7 subtypes of avian influenza. It is intended to
determine the presence of the H5/H7 subtypes of avian influenza in
table-egg layer through routine surveillance of each participating
commercial table-egg layer flock. A flock will qualify for this
classification
[[Page 38766]]
when the Official State Agency determines that it has met one of the
following requirements:
* * * * *
0
38. Section 146.31 is amended by adding, in alphabetical order, a
definition of spent fowl to read as follows:
Sec. 146.31 Definitions.
* * * * *
Spent fowl. Domesticated poultry that were in production of
hatching eggs or commercial table eggs and have been removed from such
production.
0
39. Section 146.32 is amended by adding a new paragraph (c) to read as
follows:
Sec. 146.32 Participation.
* * * * *
(c) If spent fowl are slaughtered at meat-type chicken slaughter
plants that participate in the Plan, they may participate in the Plan
through the provisions of this subpart C.
Sec. 146.33 [Amended]
0
40. In Sec. 146.33, paragraph (a)(1) is amended by removing the words
``antibodies to''.
0
41. In Sec. 146.43, paragraph (a)(1) is revised to read as follows:
Sec. 146.43 Terminology and classification; meat-type turkey
slaughter plants.
* * * * *
(a) * * *
(1) It is a meat-type turkey slaughter plant that accepts only
meat-type turkeys from flocks where a minimum of 6 samples per flock
have been collected no more than 21 days prior to movement to slaughter
and tested negative with an approved test for type A avian influenza,
as provided in Sec. 146.13(b). It is recommended that samples be
collected from flocks over 10 weeks of age with respiratory signs such
as coughing, sneezing, snicking, sinusitis, or rales; depression; or
decreases in food or water intake.
* * * * *
PART 147--AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN
0
42. 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
43. Section 147.1 is revised to read as follows:
Sec. 147.1 Blood testing procedures.
Blood testing must be conducted in a manner approved by the
Administrator. Approved blood testing procedures are listed in the NPIP
Program Standards, as defined in Sec. 147.51. Blood testing procedures
may also be approved by the Administrator in accordance with Sec.
147.53(d)(1).
(Approved by the Office of Management and Budget under control
number 0579-0007)
Sec. Sec. 147.2 through 147.9 [Removed and Reserved]
0
44. Sections 147.2 through 147.9 are removed and reserved.
0
45. Section 147.10 is revised to read as follows:
Sec. 147.10 Bacteriological examination procedures.
Bacteriological examination must be conducted in a manner approved
by the Administrator. Approved bacteriological examination procedures
are listed in the NPIP Program Standards, as defined in Sec. 147.51.
Bacteriological examination procedures may also be approved by the
Administrator in accordance with Sec. 147.53(d)(1).
Sec. Sec. 147.11 through 147.17 [Removed and Reserved]
0
46. Sections 147.11 through 147.17 are removed and reserved.
0
47. Section 147.21 is revised to read as follows:
Sec. 147.21 Sanitation procedures.
Sanitation must be maintained in a manner approved by the
Administrator. Approved procedures for maintaining sanitation are
listed in the NPIP Program Standards, as defined in
Sec. 147.51 Sanitation procedures may also be approved by the
Administrator in accordance with Sec. 147.53(d)(2)
(Approved by the Office of Management and Budget under control
number 0579-0007)
Sec. Sec. 147.22 through 147.27 [Removed and Reserved]
0
48. Sections 147.22 through 147.27 are removed and reserved.
0
49. Section 147.30 is revised to read as follows:
Sec. 147.30 Molecular examination procedures.
Molecular examination must be conducted in a manner approved by the
Administrator. Approved molecular examination procedures are listed in
the NPIP Program Standards, as defined in Sec. 147.51. Molecular
examination procedures may also be approved by the Administrator in
accordance with Sec. 147.53(d)(1).
Sec. 147.31 [Removed and Reserved]
0
50. Section 147.31 is removed and reserved.
0
51. In Sec. 147.41, a new definition of NPIP Technical Committee is
added, in alphabetical order, to read as follows:
Sec. 147.41 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.
* * * * *
Sec. 147.44 [Amended]
0
52. In Sec. 147.44, paragraph (b) is amended by removing the citation
``Sec. 147.43(d)(2)'' and adding the citation ``Sec. 147.43(d)(4)''
in its place.
0
53. In part 147, subpart F is revised to read as follows:
Subpart F--Authorized Laboratories and Approved Tests and Sanitation
Procedures
Sec.
147.51 Definitions.
147.52 Authorized laboratories.
147.53 Approved tests and sanitation procedures.
147.54 Approval of diagnostic test kits not licensed by the Service.
Subpart F--Authorized Laboratories and Approved Tests and
Sanitation Procedures
Sec. 147.51 Definitions.
The following definitions apply in this subpart:
Administrator. The Administrator, Animal and Plant Health
Inspection Service, or any other employee of the Animal and Plant
Health Inspection Service delegated to act in the Administrator's
stead.
Animal and Plant Health Inspection Service (APHIS, the Service).
The Animal and Plant Health Inspection Service of the U.S. Department
of Agriculture.
NPIP or Plan. The National Poultry Improvement Plan.
NPIP Program Standards. A document that contains tests and
sanitation procedures approved by the Administrator under Sec. 147.53
for use under this subchapter. This document may be obtained from the
NPIP Web site at https://www.poultryimprovement.org/ or by writing to
the Service at National Poultry Improvement Plan, APHIS, USDA, 1506
Klondike Road, Suite 101, Conyers, GA 30094.
[[Page 38767]]
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.
Sec. 147.52 Authorized laboratories.
These minimum requirements are intended to be the basis on which an
authorized laboratory of the Plan can be evaluated to ensure that
official Plan assays are performed in accordance with the NPIP Program
Standards or other procedures approved by the Administrator in
accordance with Sec. 147.53(d)(1) and reported as described in
paragraph (f) of this section. A satisfactory evaluation will result in
the laboratory being recognized by the NPIP office of the Service as an
authorized laboratory qualified to perform the assays provided for in
this part.
(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. The authorized laboratory must use a
regularly scheduled check test for each assay that it performs.
(b) Trained technicians. The testing procedures at the laboratory
must be run or overseen by a laboratory technician who has attended and
satisfactorily completed Service-approved laboratory workshops for
Plan-specific diseases within the past 4 years.
(c) Laboratory protocol. Official Plan assays must be performed and
reported as described in the NPIP Program Standards or in accordance
with other procedures approved by the Administrator in accordance with
Sec. 147.53(d)(1). Assays must be performed using control reagents
approved by the Plan or the reagent manufacturer.
(d) State site visit. The Official State Agency will conduct a site
visit and recordkeeping audit annually. 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.
(e) Service review. Authorized laboratories will be reviewed by the
Service (NPIP staff) every 3 years. The Service's review may include,
but will not necessarily be limited to, checking records, laboratory
protocol, check-test proficiency, technician training, and peer review.
(f) Reporting. (1) A memorandum of understanding or other means
shall be used to establish testing and reporting criteria to the
Official State Agency, including criteria that provide for reporting H5
and H7 low pathogenic avian influenza directly to the Service.
(2) Salmonella pullorum and Mycoplasma Plan disease reactors must
be reported to the Official State Agency within 48 hours.
(g) Verification. Random samples may also be required to be
submitted for verification as specified by the Official State Agency.
Sec. 147.53 Approved tests and sanitation procedures.
(a)(1) All tests that are used to qualify flocks for NPIP
classifications must be approved by the Administrator as effective and
accurate at determining whether a disease is present in a poultry flock
or in the environment.
(2) All sanitation procedures performed as part of qualifying for
an NPIP classification must be approved by the Administrator as
effective at reducing the risk of incidence of disease in a poultry
flock or hatchery.
(b) Tests and sanitation procedures that have been approved by the
Administrator may be found in the NPIP Program Standards. In addition,
all tests that use veterinary biologics (e.g., antiserum and other
products of biological origin) that are licensed or produced by the
Service and used as described in the NPIP Program Standards are
approved for use in the NPIP.
(c) New tests and sanitation procedures, or changes to existing
tests and sanitation procedures, that have been approved by the NPIP in
accordance with the process described in subpart E of this part are
subject to approval by the Administrator. NPIP participants may submit
new tests and sanitation procedures, or changes to current tests and
sanitation procedures, through that process.
(d)(1) Persons who wish to have a test approved by the
Administrator as effective and accurate at determining whether a
disease is present in a flock or in the environment may apply for
approval by submitting the test, along with any supporting information
and data, to the National Poultry Improvement Plan, APHIS, USDA, 1506
Klondike Road, Suite 101, Conyers, GA 30094. Upon receipt of such an
application, the NPIP Technical Committee will review the test and any
supporting information and data supplied with the application. If the
NPIP Technical Committee determines the test to be of potential general
use, the test will be submitted for consideration by the General
Conference Committee of the NPIP in accordance with subpart E of this
part, and the Administrator will respond with approval or denial of the
test.
(2) Persons who wish to have a sanitation procedure approved by the
Administrator as effective at reducing the risk of incidence of disease
in a poultry flock or hatchery may apply for approval by submitting the
sanitation procedure, along with any supporting information and data,
to the National Poultry Improvement Plan, APHIS, USDA, 1506 Klondike
Road, Suite 101, Conyers, GA 30094. Upon receipt of such an
application, the NPIP Technical Committee will review the sanitation
procedure and any supporting information and data supplied with the
application. If the NPIP Technical Committee determines the sanitation
procedure to be of potential general use, the sanitation procedure will
be submitted for consideration by the General Conference Committee of
the NPIP in accordance with subpart E of this part, and the
Administrator will respond with approval or denial of the test.
(e)(1) When the Administrator approves a new test or sanitation
procedure or a change to an existing test or sanitation procedure,
APHIS will publish a notice in the Federal Register making available
the test or sanitation procedure. The notice will also provide for a
public comment period.
(2)(i) After the close of the public comment period, APHIS will
publish a notice in the Federal Register indicating that the test or
sanitation procedure will be added to the NPIP Program Standards, or
that the NPIP Program Standards will be updated to reflect changes to
an existing test or sanitation procedure, if:
(A) No comments were received on the notice;
(B) The comments on the notice supported the action described in
the notice; or
(C) The comments on the notice were evaluated but did not change
the Administrator's determination that approval of the test or
sanitation procedure is appropriate based on the standards in paragraph
(a) of this section.
(ii) If comments indicate that changes should be made to the test
or sanitation procedure as it was made available in the initial notice,
APHIS will publish a notice in the Federal Register indicating that
changes were made to the initial test or sanitation procedure.
(iii) Whenever APHIS adds or makes changes to tests or sanitation
[[Page 38768]]
procedures, APHIS will make available a new version of the NPIP Program
Standards that reflects the additions or changes.
(iv) If comments present information that causes the Administrator
to determine that approval of the test or sanitation procedure would
not be appropriate, APHIS will publish a notice informing the public of
this determination after the close of the comment period.
Sec. 147.54 Approval of diagnostic test kits not licensed by the
Service.
Diagnostic test kits that are not licensed by the Service (e.g.,
bacteriological culturing kits) may be approved through the following
procedure:
(a) The sensitivity of the kit will be estimated in at least three
authorized laboratories selected by the Service 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. 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.
(b) The specificity of the kit will be estimated in at least three
authorized laboratories selected by the Service 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.
(c) 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 clinical samples supplied by the manufacturer of the test kit.
In addition, each laboratory will be asked to test 50 known negative
clinical samples obtained from several sources, to provide a
representative sampling of the general population. The identity of the
samples must be coded so that the cooperating laboratories are blinded
to identity and classification. Each sample must be provided in
duplicate or triplicate, so that error and repeatability data may be
generated.
(d) Cooperating laboratories will submit to the kit manufacturer
all raw 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.
(e) The findings of the cooperating laboratories will be evaluated
by the NPIP Technical Committee, and the Technical Committee will make
a recommendation regarding whether to approve the test kit to the
General Conference Committee. If the Technical Committee recommends
approval, the final approval will be granted in accordance with the
procedures described in Sec. Sec. 147.46 and 147.47.
(f) 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.
Done in Washington, DC, this 3rd day of July 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-16037 Filed 7-7-14; 4:15 pm]
BILLING CODE 3410-34-P
