National Poultry Improvement Plan and Auxiliary Provisions, 66631-66647 [2019-23973]
Download as PDF
66631
Proposed Rules
Federal Register
Vol. 84, No. 234
Thursday, December 5, 2019
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Parts 56, 145, 146, and 147
[Docket No. APHIS-2018-0062]
RIN 0579–AE49
National Poultry Improvement Plan and
Auxiliary Provisions
Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule.
AGENCY:
We are proposing to amend
the regulations governing the National
Poultry Improvement Plan (NPIP).
These amendments would establish a
U.S. Newcastle Disease Clean program
within the NPIP, create an NPIP subpart
specific to game birds, revise testing
requirements, and clarify existing
provisions of the regulations. We are
also proposing to amend the regulations
concerning the payment of indemnity
and compensation for low pathogenic
avian influenza to reflect current policy
and operational practices, and to allow
NPIP voting delegates to represent
multiple States during the Biennial
Conferences. These proposed changes
were voted on and approved by the
voting delegates at the NPIP’s 2018
National Plan Conference.
DATES: We will consider all comments
that we receive on or before February 3,
2020.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/#!
docketDetail;D=APHIS-2018-0062.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS-2018-0062, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737–1238.
Supporting documents and any
comments we receive on this docket
may be viewed at https://
www.regulations.gov/#!docketDetail;
jbell on DSKJLSW7X2PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
D=APHIS-2018-0062 or in our reading
room, which is located in Room 1141 of
the USDA South Building, 14th Street
and Independence Avenue SW,
Washington, DC. Normal reading room
hours are 8 a.m. to 4:30 p.m., Monday
through Friday, except holidays. To be
sure someone is there to help you,
please call (202) 799–7039 before
coming.
FOR FURTHER INFORMATION CONTACT: Dr.
Elena Behnke, DVM, Senior
Coordinator, National Poultry
Improvement Plan, VS, APHIS, USDA,
1506 Klondike Road, Suite 101,
Conyers, GA 30094–5104; (770) 922–
3496.
SUPPLEMENTARY INFORMATION:
Background
The National Poultry Improvement
Plan (NPIP, also referred to below as
‘‘the Plan’’) is a cooperative FederalState-industry mechanism for
controlling certain poultry diseases. The
Plan consists of a variety of programs
intended to prevent and control poultry
diseases. Participation in all Plan
programs is voluntary, but breeding
flocks, hatcheries, and dealers must first
qualify as ‘‘U.S. Pullorum-Typhoid
Clean’’ as a condition for participating
in the other Plan programs.
The Plan identifies States,
independent flocks, hatcheries, dealers,
and slaughter plants that meet certain
disease control standards specified in
the Plan’s various programs. As a result,
customers can buy poultry that has
tested clean of certain diseases or that
has been produced under diseaseprevention conditions.
The regulations in 9 CFR parts 56,
145, 146, and 147 (referred to below as
the regulations) contain the provisions
of the Plan. The Animal and Plant
Health Inspection Service (APHIS)
amends these provisions from time to
time to incorporate new scientific
information and technologies within the
Plan, and to ensure the plan reflects
changes to the poultry industry itself.
The changes we are proposing, which
are discussed below, were approved by
the voting delegates at the Plan’s 2018
Biennial Conference.
Participants and voting delegates at
the Biennial Conference represented the
poultry industry, flock owners,
breeders, hatchery men, slaughter
plants, poultry veterinarians, diagnostic
laboratory personnel, Official State
PO 00000
Frm 00001
Fmt 4702
Sfmt 4702
Agencies from cooperating States, and
other poultry industry affiliates. The
proposed amendments are discussed in
the order they would appear in the
regulations.
Proposed Amendments to Part 56
Definitions
The terms H5/H7 LPAI exposed and
H5/H7 LPAI infection (infected) are
currently defined in § 56.1 of the
regulations in a manner that describes
the risks or effects of poultry being
exposed to or contracting the virus.
The current definition of H5/H7 LPAI
exposed provides that all birds or
poultry associated with H5/H7 infected
birds or poultry, whether it is via
excrement or other materials, are
automatically placed in the exposed
category. This could be construed to
suggest that an exposed flock is
potentially infectious because the birds
in the flock have had contact with the
virus in some manner. However, this is
not the case. Although ‘‘exposed’’ birds
have been exposed to the virus, they are
no longer shedding the virus and no
longer considered to be potentially
infectious. As such, they can go to
slaughter to be controlled marketed,
instead of being depopulated. Therefore,
we are proposing to amend the terms
and definitions of H5/H7 LPAI infection
(infected) and H5/H7 LPAI exposed.
The new terms would be H5/H7 LPAI
virus exposed (non-infectious) and H5/
H7 LPAI virus actively infected
(infectious). We are proposing to define
H5/H7 LPAI virus exposed (noninfectious) in the following way. Poultry
would be considered to be exposed
(non-infectious) to H5/H7 LPAI for
purposes of the regulations if:
• Antibodies to the H5 or H7 subtype
of the AI virus that are not a
consequence of vaccination have been
detected in poultry, and
• Samples collected from the flock
using real-time reverse transcription
polymerase chain reaction (RT–PCR) or
virus isolation are determined to be not
infectious for H5/H7 LPAI.
The definition would also provide
that the official determination that H5/
H7 LPAI virus exposure has occurred is
by the identification of antibodies to the
H5 or H7 subtype of AI virus detected
and may only be made by APHIS’
National Veterinary Services
Laboratories (NVSL).
E:\FR\FM\05DEP1.SGM
05DEP1
jbell on DSKJLSW7X2PROD with PROPOSALS
66632
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
We are proposing to define H5/H7
LPAI virus actively infected (infectious)
in the following way. Poultry would be
considered to be infected with H5/H7
LPAI for purposes of the regulations if:
• H5/H7 LPAI virus has been isolated
and identified as such from poultry; or
• Viral antigen or viral RNA specific
to the H5 or H7 subtype of AI virus has
been detected in poultry.
The definition would also provide
that the official determination that H5/
H7 LPAI virus has been isolated and
identified, or viral antigen or viral RNA
specific to the H5 or H7 subtype of AI
virus has been detected, may only be
made by NVSL.
We would also revise references to
H5/H7 LPAI) infection (infected) and
H5/H7 LPAI exposed throughout part 56
of the regulations to these two new
terms instead.
We believe the revised terms better
clarify the distinction between exposed
and infected poultry.
We are also proposing to add
definitions for cleaning, compensation,
disinfection, indemnity, and virus
elimination (VE) to § 56.1 of the
regulations.
We would define cleaning as the
removal of gross contamination, organic
material, and debris from the premises
or respective structures, via mechanical
means like sweeping (dry cleaning) and/
or the use of water and soap or detergent
(wet cleaning), in order to minimize
organic material to prepare for effective
disinfection.
We would define disinfection as
methods used on surfaces to destroy or
eliminate H5/H7 LPAI virus through
physical (e.g., heat) or chemical (e.g.,
disinfectant) means, and would further
specify that a combination of methods
may be required.
Section 56.3 of the regulations
provides that APHIS may indemnify
persons for cleaning and disinfection of
premises, conveyances, and materials
infected with or exposed to LPAI. While
we believe it is clear from context that
§ 56.3 pertains only to cleaning and
disinfection associated with elimination
of LPAI virus, rather than any cleaning
and disinfection activities whatsoever
that may be conducted on an affected
premises, adding definitions of the
terms to the regulations would further
clarify our intent.
For a similar reason, we are proposing
to add the term virus elimination after
every reference to cleaning and
disinfection in part 56 of the
regulations. Virus elimination is the
term used in many foreign countries for
cleaning and disinfection measures
conducted to destroy or eliminate all
virus on an affected premises; we would
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
define it in that way in § 56.1. This
would also underscore the restrictive
sense in which cleaning and
disinfection is being used within part
56.
The term compensation would also be
new to part 56. We would define
compensation in § 56.1 as
reimbursement for the activities
associated with the depopulation of
infected or exposed poultry, including
the disposal of contaminated carcasses
and materials and the cleaning and
disinfection of premises, conveyances,
and materials that came into contact
with infected or exposed poultry. The
definition would further provide that, in
the case of contaminated materials, if
the cost of cleaning and disinfection
would exceed the value of the materials,
or cleaning and disinfection would be
impracticable for any reason, APHIS
would base compensation on the fair
market value (depreciated value) of
those materials. Finally, the definition
would specify that compensation does
not include payment for depopulated
birds or eggs destroyed, as those
payments would constitute indemnity.
We would define indemnity as
payments representing the fair market
value of destroyed birds and eggs.
Indemnity would not include
reimbursements for depopulation (by
which we mean the act of depopulation,
rather than the depopulated poultry), or
for disposal, destroyed materials, or
cleaning and disinfection (virus
elimination) activities, as these would
be covered under the definition of
compensation.
Currently, the regulations in part 56
refer only to indemnity, regardless of
the activity for which APHIS is
providing reimbursement. However, the
procedures for the payment of
indemnity for destroyed birds or eggs
differ significantly from those for the
payment of indemnity for cleaning and
disinfection. As a result, APHIS’
Veterinary Services (VS) program, in
conjunction with State departments of
agriculture, has developed a guidance
document, VS Guidance document
8601.2 that clarifies how the two
processes differ.1 The guidance
document makes the distinction
between compensation and indemnity
that we are proposing to codify in the
regulations themselves. We would also
amend part 56 throughout to change
references to ‘‘indemnity’’ that pertain
to reimbursement for activities, rather
than the destroyed poultry or eggs
themselves, to ‘‘compensation.’’
1 See https://poultryimprovement.org/documents/
ISRCPGuidanceDocument.pdf.
PO 00000
Frm 00002
Fmt 4702
Sfmt 4702
Payment of Indemnity
The regulations in § 56.3 describe
conditions for the payment of indemnity
for H5/H7 LPAI. Paragraph (a) of the
section lists activities that may be
eligible for indemnity for H5/H7 LPAI:
The destruction and disposal of infected
poultry, the destruction of any eggs
during outbreak testing, and
disinfection of areas and materials that
have come in contact with infected
poultry. Paragraph (b) describes the
percentage of costs that are eligible for
indemnity for the listed activities,
depending on certain criteria.
Currently, paragraph (b) provides that,
if poultry meet the definition of
commercial, but does not participate in
their respective NPIP Avian Influenza
program, the maximum amount of
indemnity that may be paid for eligible
activities is 25 percent. Commercial
poultry that do participate in Plan AI
programs, however, may receive up to
100 percent indemnity.
This paragraph currently does not
reflect the fact that the NPIP regulations
themselves specifically exempt poultry
operations that fall below certain size
thresholds from having to participate in
the NPIP AI programs. The exemption
numbers are currently listed in 9 CFR
part 146. We are proposing to amend
paragraph (b) to clarify that poultry
operations that are exempted by the
Plan regulations from having to
participate in Plan AI programs because
of their size may still receive up to 100
percent indemnity and/or compensation
for eligible activities.
Determination of Indemnity
The current regulations in § 56.4
describe how APHIS determines fair
market value regarding the destruction
of infected or exposed poultry; this
includes determining indemnity for
cleaning and disinfection procedures.
The regulations currently state that
APHIS will use an appraisal by an
APHIS official appraiser and State
official appraiser, or, in instances when
APHIS and State authorities agree,
either the APHIS appraiser or State
appraiser alone, to determine fair
market value for indemnity for
destroyed poultry and eggs. However,
we have discontinued use of appraisers
in favor of an indemnity calculator
drawn from multiple data points in
order to determine fair market value for
destroyed birds and eggs. We are
therefore proposing to amend § 56.4 to
indicate that appraisal calculator values
will be used to determine the amount of
indemnity paid for destroyed birds and
eggs.
E:\FR\FM\05DEP1.SGM
05DEP1
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
Section 56.4 also describes how
reimbursement may be paid for disposal
activities. Currently, as a precondition
for submitting a claim, the claimant,
Cooperating State Agency, and APHIS
must jointly enter into a cooperative
agreement. However, State Agencies
have stated that their participation in
the cooperative agreement is not
necessary. We are proposing to amend
the regulations accordingly.
Finally, § 56.4 describes how
indemnity may be paid for cleaning and
disinfection activities. Currently, we
require the claimant, the Cooperating
State Agency, and APHIS to enter into
a compliance agreement. The claimant
then submits receipts or other
documentation regarding the activities,
and APHIS evaluates them against the
cleaning and disinfection procedures in
§ 56.5 of the regulations and the initial
State response and containment plan,
the requirements for which are found in
§ 56.10 of the regulations.
To streamline reimbursement for
cleaning and disinfection activities, we
have developed a calculator for cleaning
and disinfection as well, the APHIS flatrate virus elimination (VE) calculator.
The calculator provides a per-squarefoot rate for premises with floor-raised
birds and per-cubic-foot rate for
premises with caged birds for cleaning
and disinfection activities that we have
previously determined to fall within the
scope of the regulations as reimbursable
activities.
While the VE calculator covers the
majority of production types and VE
scenarios, it does not cover every
possibility. In such instances, the
existing procedures for claiming
compensation for cleaning and
disinfection would apply. The floorraised rates would be used by APHIS as
the baseline for compensation in such
instances, and the claimant would be
afforded the opportunity to demonstrate
through receipts or other documentation
the uniqueness of his or her situation.
jbell on DSKJLSW7X2PROD with PROPOSALS
NPIP Certifications for Poultry Moved
for Controlled Marketing
Section 56.5 provides that, at the
discretion of APHIS and the
Cooperating State Agency, poultry that
has been infected with or exposed to
H5/H7 LPAI may be moved for
controlled marketing rather than
depopulated. We are proposing to
amend the section to indicate that
poultry moved for controlled marketing
maintain their current NPIP
certifications. This amendment would
help provide assurances to slaughtering
facilities that receive such flocks.
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
Revisions to Part 145
Definitions
Section 145.1 of the regulations
provides general definitions of terms
used within the NPIP regulations. We
are proposing to add a definition for the
term Newcastle disease, and to revise
the existing definition for avian
influenza. Both the new definition and
the revised definition would be
modeled on the definitions of these
terms found in the World Organization
for Animal Health’s (OIE’s) Terrestrial
Animal Health Code, to which the
United States is a signatory.2
Specific Provisions for Participating
Dealers
Section 145.7 of the regulations
requires participating dealers to follow
all applicable provisions in part 145.
However, the section refers to dealers in
‘‘poultry breeding stock, hatching eggs,
or baby or started poultry’’ while the
definition of dealer in § 145.1 refers to
dealers as individuals or businesses that
deal in commerce with hatching eggs,
newly-hatched poultry, and/or started
poultry. We are proposing to revise
§ 145.7 so that it refers to dealers using
the same term as in the definition in
§ 145.1. The revised section would also
indicate that dealers must comply with
the regulations in the relevant part of
the NPIP regulations. It would also
specify the NPIP Program Standards that
are applicable to such dealers, as well
as the provisions of the NPIP regulations
that provide for approval of alternatives
to those standards.
Testing
The regulations in §§ 145.14 and
146.13 discuss the official avian
influenza (AI) antibody detection tests,
the enzyme-linked immunosorbent
assay (ELISA) test and agar gel
immunodiffusion (AGID) test, in regard
to poultry testing requirements within
the NPIP.
We are proposing to require that,
when ELISA test samples are positive
for AI, an AGID test must be conducted
within 48 hours. This is because the
AGID test is used as a confirmatory test
on presumptive positives using the
ELISA test. Timely corroboratory testing
is therefore necessary in order to
determine the disease status of the
tested flock. Additionally, the AGID test
must comply with the relevant NPIP
requirements and would specify the
relevant NPIP Program Standards, as
well as provide a citation to the
2 To view the Code, go to https://www.oie.int/
standard-setting/terrestrial-code/access-online/.
PO 00000
Frm 00003
Fmt 4702
Sfmt 4702
66633
provisions for approval of alternate
standards.
Additionally, these sections currently
provide that agent detection tests for AI
may be used to detect influenza A
matrix gene or protein. We are
proposing to amend these sections to
provide that agent detection tests may
be used to detect influenza A virus
rather than specifically influenza A
matrix gene or protein. The existing
limitation imposes an unnecessary
technical restriction on test design and
precludes the use of lateral flow antigen
immunoassays that target the influenza
nucleoprotein and still reliably indicate
the presence or absence of AI in a test
sample.
For reasons that we discuss below, we
are also proposing to add provisions
regarding official tests for Newcastle
disease (ND) to these two sections. The
regulations would say that the official
ND tests are serological tests for
antibody detection and molecular-based
tests for antigen detection that are listed
in the Program Standards document as
determined by APHIS to reliably detect
ND infection. The Program Standards
document would indicate that the
approved serological tests for ND are
currently the ELISA and
hemagglutination inhibition (HI) tests,
and the approved molecular-based test
for ND is PCR.
Proposed Newcastle Disease Clean
Program
The regulations in § 145.43 provide
disease-free, or Clean, classifications
that may be applied to turkey breeding
flocks, and eggs and poults from turkey
breeding flocks, provided that they meet
certain requirements demonstrating
freedom from that disease. Similar
classification systems exist in § 145.45
for compartments within the turkey
breeding-hatchery industry; § 145.73 for
egg-type chicken breeding flocks, as
well as their eggs and chicks; § 145.74
for compartments within the egg-type
chicken breeding-hatchery industry;
§ 145.83 for meat-type chicken breeding
flocks, as well as their eggs and chicks;
and § 145.84 for compartments within
the meat-type chicken breedinghatchery industry.
We are proposing to amend each of
these sections to establish an ND Clean
program. The ND Clean program is
intended to allow the turkey breedinghatchery, egg-type chicken breedinghatchery, and meat-type chicken
breeding-hatchery industries, as well as
compartments within those industries,
to demonstrate freedom from ND based
on vaccination and/or monitoring of
each participating breeding flock.
Lastly, in regards to this paragraph’s
E:\FR\FM\05DEP1.SGM
05DEP1
jbell on DSKJLSW7X2PROD with PROPOSALS
66634
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
language, we note that the original
voting resolution in § 145.43 stated
‘‘vaccination and monitoring of each
participating breeding flock;’’ however,
given that vaccination is optional, we
have replaced ‘‘and’’ with ‘‘and/or’’ to
accurately reflect the intended
requirements.
For a flock to gain ND Clean status,
the Official State Agency (OSA) would
have to determine that the flock is a
primary breeding flock that either (1)
has been vaccinated for ND using
USDA-licensed vaccines and response
to vaccination is serologically
monitored using an approved
serological ND test when the birds are
more than 4 months of age; or (2) is
unvaccinated for ND, in which a
minimum of 30 birds have tested
negative to ND using an approved test
when more than 4 months of age. We
would require serological testing for
vaccinated flocks because it indicates
the increased presence of antibodies in
vaccinated birds.
To retain ND Clean classification for
a vaccinated flock, the vaccine would
have to be a USDA-licensed vaccine
administered during the early stages of
development through rearing, and an
inactivated vaccine as final vaccination
prior to the onset of egg production; the
flock would have to be have been
monitored for antibody response using
an approved serological test (again,
currently the ELISA or HI test) and the
results would have to be compatible
with immunological response against
ND vaccination; and testing would have
to include a minimum of 30 birds with
a serologic monitoring program when
the birds are more than 4 months of age
and prior to the onset of production and
not longer than every 90 days thereafter.
To retain ND Clean classification for
unvaccinated flocks, during each 90-day
period, all primary spent fowl, up to a
maximum of 30, would have to test
negative to ND within 21 days prior to
movement to slaughter; and either a
minimum of 30 birds for flock would
have to test negative using an approved
ND test (either serological or molecularbased) at intervals of 90 days, or a
sample of fewer than 30 birds could be
tested, provided that all pens are
equally represented and a total of 30
birds is tested within each 90 day
period.
Finally, for an ND Clean program for
flocks to exist within a State, ND would
have to be a disease reportable to the
responsible State authority by all
licensed veterinarians within the State.
To accomplish this, all laboratories
(including private, State, and university
laboratories) that perform diagnostic
procedures on poultry would have to
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
examine all submitted cases of
unexplained respiratory disease, egg
production drops, and mortality for ND.
In § 145.15 of the regulations, as a
general NPIP requirement, we require
diagnostic surveillance for LPAI within
participating States. Part of this
diagnostic surveillance must include
LPAI being a reportable disease. This
requirement for the ND Clean program
is modeled on that existing requirement
for LPAI surveillance.
The requirements for ND Clean
compartments would be similar to the
existing requirements for AI Clean
compartments, and we would
accordingly revise sections of the
regulations regarding the establishment
and maintenance of AI Clean
compartments so that they would also
apply to the establishment and
maintenance of ND Clean
Compartments.
Removal of the Pullorum Typhoid
Agglutination Test for S. Enteritidis
Clean Classifications
The regulations in §§ 145.23(d),
145.73(d), and 145.83(d) contain
requirements for S. Enteritidis Clean
classifications in the multiplier egg-type
chicken breeding industry, primary eggtype chicken breeding industry, and
primary meat-type chicken breeding
industry, respectively. We are proposing
to remove testing using the pullorumtyphoid (PT) agglutination test from the
U.S. S. Enteritidis Clean classification
requirements.
The PT agglutination test was adopted
as a test for S. enteritidis in the 1980s
based on similarities between the two
diseases, and on the presumption that it
could be used for both diseases.
However, the test has since proven to be
unreliable in detecting the presence of
S. enteritidis. It would, however,
continue to be used for testing for PT,
for which it is reliable.
Revisions to Testing Protocols for AI in
the Multiplier Meat-Type Chicken
Breeding Industry
Section 145.33 contains, among other
things, requirements for determining a
participating multiplier meat-type
chicken breeding flock is free of AI for
purposes of a Clean classification.
Paragraph (l)(1) of that section provides
three different possible testing protocols
for a flock to retain Clean status.
While the first option states at least 15
birds must test negative at intervals of
90 days, and the third option requires a
total of 15 samples collected and tested
within a 90 day period, the second
option requires 30 birds to be tested
within each 90 day testing period. Our
intent has always been that a total of 15
PO 00000
Frm 00004
Fmt 4702
Sfmt 4702
birds must be tested in each of the three
options to retain the AI Clean
classification; the discrepancy in the
second option is the result of a drafting
error. We are proposing to revise the
second option to correct this error.
The section also currently requires
serological tests for testing of multiplier
spent fowl. This limitation is not
warranted because molecular-based
tests such as PCR are also reliable for
such testing. We are proposing to revise
the section so that any AI test approved
in accordance with § 145.14 may be
used.
Proposed Revisions to NPIP Provisions
for Hobbyist and Exhibition Waterfowl,
Exhibition Poultry and Raised-forRelease Waterfowl Breeding Flocks and
Products
Subpart E of part 145, ‘‘Special
Provisions for Hobbyist and Exhibition
Waterfowl, Exhibition Poultry, and
Game Bird Breeding Flocks and
Products’’ (§§ 145.51–145.54), contains
Plan requirements specific to the
hobbyist, exhibition, and game bird
industries. We are proposing several
changes to this subpart.
First, we are proposing to remove all
references to game birds from subpart E
due to the addition of proposed subpart
J to part 145. The game bird industry
has grown rapidly and has become more
complex since its inception, and the
terminology, production methods, and
end uses in the industry are now
significantly different than those in
other poultry industries. Currently,
subpart E does not have specific
requirements for any one group of birds
covered by its provisions, and subpart J
would add testing regimes, terminology,
and programs specifically designed for
the game bird industry.
In addition to the removal of game
bird references, we would revise all
references to ‘‘waterfowl’’ within the
subpart to instead refer to ‘‘raised-forrelease waterfowl,’’ and would remove
the definition for waterfowl from
§ 145.51 of the regulations, and add a
definition for raised-for-release
waterfowl in its place. We are proposing
to define raised-for-release waterfowl as
domesticated fowl that normally swim,
such as ducks and geese, grown under
confinement for the primary purpose of
producing eggs, chicks, started, or
mature birds for release on game
preserves or in the wild.
Waterfowl is currently defined in
§ 145.51 as domesticated fowl that
normally swim, such as ducks and
geese, and it is only apparent from
subsequent sections of subpart E that
the subpart does not apply to meat-type
waterfowl, which are instead covered by
E:\FR\FM\05DEP1.SGM
05DEP1
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
jbell on DSKJLSW7X2PROD with PROPOSALS
the provisions of a separate subpart I.
These revisions would help to further
clarify the scope of subpart E.
We are also proposing to add a
definition for hobbyist poultry. We
would define hobbyist poultry as
domesticated fowl which are bred for
the purposes of meat and/or egg
production on a small scale as
determined by the Official State Agency.
This would also help clarify the scope
of subpart E.
Section 145.52 contains requirements
that flocks of hobbyist and exhibition
waterfowl, exhibition poultry, and game
bird breeding flocks, and the eggs and
baby poultry produced from them, must
meet in order to participate in the Plan.
We are proposing to amend the
introductory text of the section to
remove the term ‘‘baby poultry’’ and
instead indicate that it applies to chicks,
started, and mature poultry. This will
provide more clarity regarding the
applicability of the section and align it
with the terminology used elsewhere in
part 145 of the regulations. We are also
proposing revisions to the introductory
text that reflect the usage the term
‘‘raised-for-release waterfowl’’
throughout the subpart and the creation
of a new subpart J for gamebirds.
Paragraph (c) of § 145.52 currently
recommends that waterfowl and
gallinaceous flocks in open-air facilities
be kept separate. However, it is a best
practice not to commingle waterfowl,
which can act as asymptomatic vectors
of disease, and gallinaceous flocks,
regardless of whether they are kept in
contained or open-air facilities. We are
proposing to amend paragraph (c)
accordingly.
Finally, we are proposing to add a
paragraph (f) to the section to indicate
that all participating raised-for-release
waterfowl flocks, whether breeders or
non-breeders, will be considered to be
enrolled under subpart E of part 145 of
the regulations. While provisions for
non-breeding raised-for-release flocks
are contained in part 146 of the
regulations, rather than part 145, the
testing requirements are identical. This
will afford Plan participants some
discretion in revising the intended use
of a particular flock without
jeopardizing the flock’s status.
Terminology and Classification; Flocks
and Products
Section 145.53 of the regulations
provide Clean classifications that may
be applied to participating hobbyist and
exhibition waterfowl, exhibition
poultry, and game bird breeding flocks,
and the eggs and baby poultry produced
from them, provided that they meet
certain requirements demonstrating
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
freedom from that disease. We are
proposing several changes to this
section. This section would also discuss
that hatcheries should be kept in
sanitary conditions according to their
relevant subpart and would specify the
applicable part of the NPIP Program
Standards that pertains to such
hatcheries.
In paragraph (b)(5), we are proposing
to remove the term ‘‘exhibition
waterfowl’’ and use the term ‘‘exhibition
poultry.’’
Additionally, paragraph (f) of § 145.53
contains requirements for a Salmonella
Monitored classification. The
Salmonella program currently only
contains Salmonella testing and
interventions at the hatchery level, and
calls for five environmental samples
from a hatchery every 30 days
performed at an authorized laboratory in
order for breeders to claims their
products are monitored for Salmonella.
We are proposing to add requirements
for representative sampling of pullets
and breeder farms. Hatched chicks
transferred to farms are still at risk of
contracting Salmonella.
Special Provisions for Egg/Meat-Type
Game Bird and Raised-for-Release
Game Bird Breeding Flocks and
Products
As we mentioned above, we are
proposing to establish a new subpart J
for the game bird industry. We are
amending §§ 145.24, 145.34, 145.44,
145.54, and 145.94 to align them with
the rest of the section regarding testing.
The separation of the game bird
industry from hobby and exhibition
poultry in subpart E is necessary
because the current definitions and
provisions do not match the production
methods and end uses for the game bird
industry.
Subpart J would consist of four
sections: §§ 145.101 for definitions,
145.102 for participation, 145.103 for
terminology and classification of flocks
and products, and 145.104 for
terminology and classification of States.
The requirements in proposed subpart
J are drawn from the existing
requirements in subpart E; however,
some of the definitions, terms, and
provisions would be unique to subpart
J, and reflect the unique nature of the
game bird industry. Key differences
between subpart E and subpart J include
the following:
• In subpart J, we are proposing to
allow breeders to also hatch and/or
grow out birds and still meet the
definition of breeder. This will have the
effect of allowing premises with
breeding and ‘‘grow out’’ birds to be
covered under one NPIP number, and
PO 00000
Frm 00005
Fmt 4702
Sfmt 4702
66635
will account for a common production
model in the game bird industry.
• We are proposing definitions for the
terms dealer, grower, and hatchery.
Subpart E relies on the general
definition for dealer in § 145.1 of the
regulations, and does not contain
definitions for growers or hatcheries.
However, in order for NPIP to accurately
register game bird operations,
definitions of these three terms are
warranted within subpart J.
• The terms chick, egg, mature bird,
and started bird, and raised-for-release
bird would be defined within subpart J.
Definitions are warranted in order to
characterize these products within the
game bird industry.
• While subpart E requires hatching
eggs produced by breeding flocks to be
fumigated or otherwise sanitized,
subpart J would provide a third option
in addition to fumigation or
sanitization, ‘‘nest cleaning.’’ ‘‘Nest
clean’’ eggs are produced within the
game bird industry on wire or otherwise
away from the litter.
• We are proposing to allow a
breeder, hatchery, or grower to also be
a dealer without being categorized as a
dealer, provided that, when reselling
products, the breeder, hatchery, or
grower has purchased those products
from an NPIP participant with equal or
greater classifications or from a flock
with equivalent or greater testing
requirements under official supervision.
This allowance would simplify the
registration and recordkeeping process
for Plan participants within the game
bird industry.
• The Pullorum-Typhoid Clean
classification requirements reflect the
terminology and production methods in
the game bird industry.
Proposed Amendments to Part 146
Part 146, subpart E, contains
definitions and requirements for Plan
participants within the game bird,
commercial waterfowl, and raised-forrelease waterfowl industries who
produce meat- or egg-type flocks.
We are proposing to update the
terminology in subpart E to match the
other subparts within part 146 by
replacing the term ‘‘commercial’’ with
‘‘egg/meat-type.’’
Additionally, we are proposing to
eliminate all provisions related to
‘‘grow-out’’ production from part 146;
such poultry would be included in
subpart E and our proposed subpart J
within part 145.
Proposed Amendments to Part 147
Official Delegates
Section 147.45 provides requirements
regarding delegation and voter
E:\FR\FM\05DEP1.SGM
05DEP1
66636
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
representation for the NPIP’s Biennial
Conferences. The text currently states
that each cooperating State is entitled to
one official delegate for each of the
programs in parts 145 and 146.
We are proposing to allow a single,
participating delegate to represent
multiple States. Companies often have
operations in various States, and this
change would help those companies
save money by appointing a single
individual to represent all of the States
where the company has operations.
Approval of Conference
Recommendations by the Department
Section 147.48 discusses the
incorporation of recommendations from
the NPIP Biennial Conferences into the
NPIP provisions. The regulations do not
currently have an established timeframe
for the publication of NPIP Biennial
Conference proposed changes; therefore,
we are proposing to establish that we
would publish a proposed rule to
amend the regulations in the Federal
Register within 14 months of the
Biennial Conference. This will help
ensure that, when a Biennial Conference
is reviewing recommendations for
amendments to the regulations, the
regulations are up-to-date at the time of
the Conference.
Authorized Laboratories
jbell on DSKJLSW7X2PROD with PROPOSALS
In § 147.52, the regulations state the
minimum requirements for an APHIS
authorized laboratory evaluation to
ensure that they are in compliance with
NPIP regulations. Within § 147.52,
paragraph (b) contains requirements to
be a trained laboratory technician.
Currently, testing procedures may only
be overseen by technicians who
successfully complete Service-approved
laboratory workshops for Plan-specific
diseases within the past 4 years.
We are proposing to amend
§ 147.52(b) by removing the word
‘‘within’’ and replacing it with the word
‘‘every.’’ Technicians should attend a
workshop for an individual Plan at 4year intervals versus any time during a
4-year span. We are also proposing a
minor editorial change to the paragraph
which will indicate that ‘‘all authorized
laboratories’’ must be overseen by a
technician who meets the
aforementioned criteria.
Executive Orders 12866 and 13771 and
Regulatory Flexibility Act
This proposed rule has been
determined to be not significant for the
purposes of Executive Order 12866 and,
therefore, has not been reviewed by the
Office of Management and Budget.
Further, because this rule is not
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
significant, it is not a regulatory action
under Executive Order 13771.
In accordance with the Regulatory
Flexibility Act, we have analyzed the
potential economic effects of this action
on small entities. The analysis is
summarized below. Copies of the full
analysis are available by contacting the
person listed under FOR FURTHER
INFORMATION CONTACT or on the
Regulations.gov website (see ADDRESSES
above for instructions for accessing
Regulations.gov).
This rulemaking would result in
various changes to regulations in 9 CFR
parts 56 and 145 through 147,
modifying provisions of the NPIP. The
modifications are recommended by the
NPIP General Conference Committee
(GCC), which represents cooperating
State agencies and poultry industry
members and advises the Secretary on
issues pertaining to poultry health. The
proposed rule would, among other
changes, remove the Pullorum-Typhoid
agglutination test as a test under which
a flock can achieve Salmonella
enteritidis clean classification, due to its
unreliability; propose a Newcastle
Disease Clean Program; specify that
ELISA-positive samples for Avian
Influenza (AI) must be sent for
corroboratory testing within 48 hours;
and broaden the criteria under which AI
detection tests can be approved, while
still requiring that the tests reliably
detect AI virus. In addition, the
proposed rule would clarify the testing
period for AI tests to maintain AI Clean
classification by correcting an editorial
error; clarify that flocks that have been
designated exposed to HPAI are not
considered infectious; clarify when
indemnity may be paid to breeders
within the NPIP program; clarify the
types of poultry in commerce; and
clarify that NPIP dealers must follow the
Program Standards in addition to the
regulations. The proposal would create
NPIP provisions specific to the game
bird breeders industry and would set
forth Salmonella testing for breeders, in
addition to hatchers, relative to
Salmonella Monitored status.
These changes would align the
regulations with international standards
and make them more transparent to
APHIS stakeholders and the general
public. The changes included in this
rule were voted on and approved by the
voting delegates at the Plan’s 2018
Biennial Conference.
The establishments that would 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
PO 00000
Frm 00006
Fmt 4702
Sfmt 4702
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 GCC
on behalf of Plan members, that is,
changes recognized by the poultry
industry as in their interest. We note
that NPIP membership is voluntary.
Under these circumstances, the
Administrator of the Animal and Plant
Health Inspection Service has
determined that this action, if
promulgated, will not have a significant
economic impact on a substantial
number of small entities.
Executive Order 12372
This program/activity is listed in the
Catalog of Federal Domestic Assistance
under No. 10.025 and is subject to
Executive Order 12372, which requires
intergovernmental consultation with
State and local officials. (See 2 CFR
chapter IV.)
Executive Order 12988
This proposed rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. If this proposed rule is
adopted: (1) All State and local laws and
regulations that are in conflict with this
rule will be preempted; (2) no
retroactive effect will be given to this
rule; and (3) administrative proceedings
will not be required before parties may
file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with Section 3507(d) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), the reporting,
recordkeeping, and third-party
disclosure requirements included in this
proposed rule have been submitted for
approval to the Office of Management
and Budget (OMB). Please send
comments on the Information Collection
Request (ICR) to OMB’s Office of
Information and Regulatory Affairs via
email to oira_submissions@
omb.eop.gov, Attention: Desk Officer for
APHIS, Washington, DC 20503. Please
state that your comments refer to Docket
No. APHIS–2018–0062. Please send a
copy of your comments to the USDA
using one of the methods described
under ADDRESSES at the beginning of
this document.
APHIS is proposing to amend the
National Poultry Improvement Program
regulations to establish a U.S. Newcastle
Disease Clean program within NPIP.
The Newcastle Disease Clean program is
intended to allow the turkey breedinghatchery, egg-type chicken breedinghatchery, and meat-type chicken
breeding-hatchery industries, as well as
compartments within those industries,
to demonstrate freedom from ND based
E:\FR\FM\05DEP1.SGM
05DEP1
jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
on vaccination and/or monitoring of
each participating breeding flock.
APHIS intends to determine the
presence of Newcastle disease virus
through vaccination and monitoring of
each participating breeding flock.
Implementing this rule will require
information collection activities such as
a revised flock selecting and testing
reports; applications for U.S. Avian Flu
and Newcastle Disease clean
compartment, clean compartment
component registrations, and
compartment component removal;
component audits; compliance
statements; compliance agreements;
description of business processes;
biosecurity plans; appraisal and
indemnity claims; response and
containment plans; and recordkeeping.
We are soliciting comments from the
public (as well as affected agencies)
concerning our proposed information
collection requirements. These
comments will help us:
(1) Evaluate whether the proposed
information collection is necessary for
the proper performance of our agency’s
functions, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the proposed
information collection, including the
validity of the methodology and
assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
information collection on those who are
to respond (such as through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology; e.g., permitting
electronic submission of responses).
Estimate of burden: Public burden for
this collection of information is
estimated to average 1.84 hours per
response.
Respondents: Commercial poultry
producers and State agricultural
officials.
Estimated annual number of
respondents: 1,361.
Estimated annual number of
responses per respondent: 18.
Estimated annual number of
responses: 23,857.
Estimated total annual burden on
respondents: 43,810 hours. (Due to
averaging, the total annual burden hours
may not equal the product of the annual
number of responses multiplied by the
reporting burden per response.)
A copy of the information collection
may be viewed on the Regulations.gov
website or in our reading room. (A link
to Regulations.gov and information on
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
the location and hours of the reading
room are provided under the heading
ADDRESSES at the beginning of this
proposed rule.) Copies can also be
obtained from Mr. Joseph Moxey,
APHIS’ Information Collection
Coordinator, at (301) 851–2483. APHIS
will respond to any ICR-related
comments in the final rule. All
comments will also become a matter of
public record.
E-Government Act Compliance
The Animal and Plant Health
Inspection Service is committed to
compliance with the E-Government Act
to promote the use of the internet and
other information technologies, to
provide increased opportunities for
citizen access to Government
information and services, and for other
purposes. For information pertinent to
E-Government Act compliance related
to this proposed rule, please contact Mr.
Joseph Moxey, APHIS’ Information
Collection Coordinator, at (301) 851–
2483.
List of Subjects
9 CFR Part 56
Animal diseases, Indemnity
payments, Low pathogenic avian
influenza, Poultry.
9 CFR Parts 145, 146, and 147
Animal diseases, Poultry and poultry
products, Reporting and recordkeeping
requirements.
Accordingly, we propose to amend 9
CFR parts 56, 145, 146, and 147 as
follows:
PART 56—CONTROL OF H5/H7 LOW
PATHOGENIC AVIAN INFLUENZA
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 adding, in alphabetical order,
definitions for Cleaning, Compensation,
and Disinfection;
■ b. By removing the definitions for H5/
H7 LPAI exposed and H5/H7 LPAI
infection (infected); and
■ c. By adding, in alphabetical order,
definitions for H5/H7 LPAI virus
actively infected (infectious), H5/H7
LPAI virus exposed (non-infectious),
Indemnity, and Virus elimination (VE).
The additions read as follows:
■
■
§ 56.1
Definitions.
*
*
*
*
*
Cleaning. The removal of gross
contamination, organic material, and
debris from the premises or respective
PO 00000
Frm 00007
Fmt 4702
Sfmt 4702
66637
structures, via mechanical means like
sweeping (dry cleaning) and/or the use
of water and soap or detergent (wet
cleaning), in order to minimize organic
material to prepare for effective
disinfection.
*
*
*
*
*
Compensation. In the case of H5/H7
LPAI detection, compensation
specifically refers to reimbursement for
the activities associated with the
depopulation of infected or exposed
poultry, including the disposal of
contaminated carcasses and materials
and the cleaning and disinfection of
premises, conveyances, and materials
that came into contact with infected or
exposed poultry. In the case of
contaminated materials, if the cost of
cleaning and disinfection would exceed
the value of the materials, or cleaning
and disinfection would be impracticable
for any reason, APHIS will base
compensation on the fair market value
(depreciated value) of those materials.
Compensation does not include
payment for depopulated birds or eggs
destroyed (see definition of Indemnity
in this section).
*
*
*
*
*
Disinfection. Methods used on
surfaces to destroy or eliminate H5/H7
LPAI virus through physical (e.g., heat)
or chemical (e.g., disinfectant) means. A
combination of methods may be
required.
*
*
*
*
*
H5/H7 LPAI virus actively infected
(infectious). (1) Poultry will be
considered to be infected with H5/H7
LPAI for the purposes of this part if:
(i) H5/H7 LPAI virus has been
isolated and identified as such from
poultry; or
(ii) Viral antigen or viral RNA specific
to the H5 or H7 subtype of AI virus has
been detected in poultry.
(2) The official determination that H5/
H7 LPAI virus has been isolated and
identified, or viral antigen or viral RNA
specific to the H5 or H7 subtype of AI
virus has been detected, may only be
made by the National Veterinary
Services Laboratories.
H5/H7 LPAI virus exposed (noninfectious). (1) Poultry will be
considered to be exposed (noninfectious) to H5/H7 LPAI for the
purposes of this part if:
(i) Antibodies to the H5 or H7 subtype
of the AI virus that are not a
consequence of vaccination have been
detected in poultry; and
(ii) Samples collected from the flock
using real-time reverse transcription
polymerase chain reaction (RT–PCR) or
virus isolation are determined to be not
infectious for H5/H7 LPAI.
E:\FR\FM\05DEP1.SGM
05DEP1
66638
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
(2) The official determination that H5/
H7 LPAI virus exposure has occurred is
by the identification of antibodies to the
H5 or H7 subtype of AI virus detected
and may only be made by the National
Veterinary Services Laboratories.
Indemnity. Payments representing the
fair market value of destroyed birds and
eggs. Indemnity does not include
reimbursements for depopulation,
disposal, destroyed materials, or
cleaning and disinfection (virus
elimination) activities (see definition of
Compensation in this section).
*
*
*
*
*
Virus elimination (VE). Cleaning and
disinfection measures conducted to
destroy or eliminate all AI virus on an
affected premises.
■ 3. Section 56.3 is amended by revising
the section heading and paragraphs (a)
introductory text and (b) and (c) to read
as follows:
jbell on DSKJLSW7X2PROD with PROPOSALS
§ 56.3 Payment of indemnity and/or
compensation.
(a) Activities eligible for indemnity
and/or compensation. The
Administrator may pay indemnity and/
or compensation for the activities listed
in this paragraph (a), as provided in
paragraph (b) of this section:
*
*
*
*
*
(b) Percentage of costs eligible for
indemnity. Except for poultry that are
described by the categories in this
paragraph (b), the Administrator is
authorized to pay 100 percent of the
costs and/or compensation, as
determined in accordance with § 56.4,
of the activities described in paragraphs
(a)(1) through (3) of this section,
regardless of whether the infected or
exposed poultry participate in the Plan.
For infected or exposed poultry that are
described by the categories in this
paragraph (b), the Administrator is
authorized to pay 25 percent of the costs
of the activities described in paragraphs
(a)(1) through (3) of this section:
(1)(i) The poultry are from a breeding
flock, commercial flock, or slaughter
plant that participates in any Plan
program in part 145 or 146 of this
chapter but that does not participate in
the U.S. Avian Influenza Clean, U.S.
H5/H7 Avian Influenza Clean, or U.S.
H5/H7 Avian Influenza Monitored
program of the Plan available to the
flock in part 145 or 146 of this chapter;
and
(ii) The poultry are from:
(A) A commercial table-egg laying
premises with at least 75,000 birds; or
(B) A meat-type chicken slaughter
plant that slaughters at least 200,000
meat-type chickens in an operating
week; or
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
(C) A meat-type turkey slaughter plant
that slaughters at least 2 million meattype turkeys in a 12 month period; or
(D) A commercial waterfowl and
commercial upland game bird slaughter
plant that slaughters at least 50,000
birds annually; or
(E) A raised-for-release upland game
bird premises, raised-for-release
waterfowl premises, and commercial
upland game bird or commercial
waterfowl producing eggs for human
consumption premises that raise at least
25,000 birds annually; or
(F) A breeder flock premises with at
least 5,000 birds.
(2) The poultry are located in a State
that does not participate in the
diagnostic surveillance program for H5/
H7 LPAI, as described in § 146.14 of this
chapter, or that does not have an initial
State response and containment plan for
H5/H7 LPAI that is approved by APHIS
under § 56.10, unless such poultry
participate in the Plan with another
State that does participate in the
diagnostic surveillance program for H5/
H7 LPAI, as described in § 146.14 of this
chapter, and has an initial State
response and containment plan for H5/
H7 LPAI that is approved by APHIS
under § 56.10.
(c) Other sources of payment. If the
recipient of indemnity and/or
compensation for any of the activities
listed in paragraphs (a)(1) through (3) of
this section also receives payment for
any of those activities from a State or
from other sources, the indemnity and/
or compensation provided under this
part may be reduced by the total amount
of payment received from the State or
other sources to the extent that total
payments do not exceed 100 percent of
total reimbursable indemnity and/or
compensation amounts.
■ 4. Section 56.4 is revised to read as
follows:
§ 56.4 Determination of indemnity and/or
compensation amounts.
(a) Destruction and disposal of
poultry. (1) Indemnity for the
destruction of poultry and/or eggs
infected with or exposed to H5/H7 LPAI
will be based on the fair market value
of the poultry and/or eggs, as
determined by an appraisal. The
appraisal will use the current APHIS
appraisal calculator values; if no such
calculator value exists, an APHIS
official appraiser will provide an
appraisal of fair market value. An
indemnity request form must be signed
by the owners and grower (if applicable)
of the poultry and received by APHIS
prior to the destruction of the poultry
and eggs, unless the owners, grower,
APHIS, and the Cooperating State
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
Agency agree in writing that the poultry
may be destroyed immediately. Reports
of appraisals must show the number of
birds and the value per head. Complete
inventory records of all birds and/or
eggs on the premises must be provided
to APHIS prior to the start of
depopulation.
(2) Compensation for disposal of
poultry and/or eggs infected with or
exposed to H5/H7 LPAI will be based on
receipts or other documentation
maintained by the claimant verifying
expenditures for disposal activities
authorized by this part. Any disposal of
poultry infected with or exposed to H5/
H7 LPAI for which compensation is
requested must be performed under a
compliance agreement between the
claimant and APHIS. APHIS will review
claims for compensation for disposal to
ensure that all expenditures relate
directly to activities described in § 56.5
and in the initial State response and
containment plan described in § 56.10.
If disposal is performed by the
Cooperating State Agency, APHIS will
compensate the Cooperating State
Agency for disposal under a cooperative
agreement.
(3) The destruction and disposal of
the poultry and/or eggs must be
conducted in accordance with the initial
State response and containment plan for
H5/H7 LPAI, as described in § 56.10.
(b) Cleaning and disinfection (virus
elimination). (1) Compensation for
cleaning and disinfection (virus
elimination) of premises, conveyances,
and materials that came into contact
with poultry that are infected with or
exposed to H5/H7 LPAI will be
determined using the current APHIS
flat-rate virus elimination (VE)
calculator in effect at the time of the
infection.
(2) For premises types for which a
flat-rate VE calculator is not available,
reimbursement will be based on receipts
or other documentation maintained by
the claimant verifying expenditures for
cleaning and disinfection (virus
elimination) activities authorized by
this part. Any cleaning and disinfection
(virus elimination) of premises,
conveyances, and materials for which
compensation is requested must be
performed under a compliance
agreement between the claimant, the
Cooperating State Agency, and APHIS.
APHIS will review claims for
compensation for cleaning and
disinfection (virus elimination) to
ensure that all expenditures relate
directly to activities described in § 56.5
and in the initial State response and
containment plan described in § 56.10.
(i) In the case of materials, if the cost
of cleaning and disinfection (virus
E:\FR\FM\05DEP1.SGM
05DEP1
jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
elimination) would exceed the value of
the materials or cleaning and
disinfection (virus elimination) would
be impracticable for any reason,
compensation for the destruction of the
materials will be based on the fair
market value (depreciated value) of
those materials, as determined by an
appraisal. Materials will be appraised by
an APHIS official appraiser.
Compensation for disposal of the
materials will be based on receipts or
other documentation maintained by the
claimant verifying expenditures for
disposal activities authorized by this
part. Appraisals of materials must be
reported on forms furnished by APHIS
and must be signed by the appraisers
and by the owners of the materials to
indicate agreement with the appraisal
amount. Appraisals of materials must be
signed and received by APHIS prior to
the disassembly or destruction of the
materials, unless the owners, APHIS,
and the Cooperating State Agency agree
in writing that the materials may be
disassembled and/or destroyed
immediately. Any disposal of materials
for which compensation is requested
must be performed under a compliance
agreement between the claimant, the
Cooperating State Agency, and APHIS.
APHIS will review claims for
compensation for disposal to ensure that
all expenditures relate directly to
activities described in § 56.5 and in the
initial State response and containment
plan described in § 56.10.
(ii) [Reserved]
(c) Requirements for compliance
agreements. The compliance agreement
is a comprehensive document that
describes the depopulation, disposal,
and cleaning and disinfection (virus
elimination) plans for poultry that were
infected with or exposed to H5/H7
LPAI, or a premises that contained such
poultry. The compliance agreement
must set out cost estimates that include
labor, materials, supplies, equipment,
personal protective equipment, and any
additional information deemed
necessary by APHIS. A compliance
agreement must indicate what tasks will
be completed, who will be responsible
for each task, and how much the work
is expected to cost. 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.
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
(Approved by the Office of Management and
Budget under control number 0579–0007)
5. Section 56.5 is amended as follows:
a. By revising the section heading;
b. In paragraph (c)(1) introductory
text, by adding the words ‘‘and maintain
their current National Poultry
Improvement Plan (NPIP) certifications’’
after the words ‘‘controlled marketing’’;
and
■ c. By revising paragraphs (c)(2) and
(d).
The revisions read as follows:
■
■
■
§ 56.5 Destruction and disposal of poultry
and cleaning and disinfection (virus
elimination) of premises, conveyances, and
materials.
*
*
*
*
*
(c) * * *
(2) Poultry moved for controlled
marketing will not be eligible for
indemnity under § 56.3. However, any
costs related to cleaning and
disinfection (virus elimination) of
premises, conveyances, and materials
that came into contact with poultry that
are moved for controlled marketing will
be eligible for compensation under
§ 56.3.
(d) Cleaning and disinfection (virus
elimination) of premises, conveyances,
and materials. Premises, conveyances,
and materials that came into contact
with poultry infected with or exposed to
H5/H7 LPAI must be cleaned and
disinfected; Provided, that materials for
which the cost of cleaning and
disinfection would exceed the value of
the materials or for which cleaning and
disinfection would be impracticable for
any reason may be destroyed and
disposed. Cleaning and disinfection
must be performed in accordance with
the initial State response and
containment plan described in § 56.10,
which must be approved by APHIS.
Cleaning and disinfection must also be
performed in accordance with any
applicable State and local
environmental regulations.
■ 6. Section 56.6 is amended as follows:
■ a. By revising the section heading;
■ b. In paragraph (a), by removing the
word ‘‘Compensation’’ and adding the
word ‘‘Indemnity’’ in its place;
■ c. By revising paragraph (b); and
■ d. In paragraph (c), by adding the
words ‘‘(virus elimination)’’ after the
word ‘‘disinfection’’ each time it
appears.
The revisions read as follows:
§ 56.6 Presentation of claims for indemnity
and/or compensation.
*
*
*
*
*
(b) Indemnity for the value of eggs to
be destroyed due to infection or
exposure to H5/H7 LPAI; and
*
*
*
*
*
PO 00000
Frm 00009
Fmt 4702
Sfmt 4702
66639
7. Section 56.8 is amended as follows:
a. In paragraph (a) introductory text,
by removing the word ‘‘may’’ and
adding the word ‘‘shall’’ in its place;
and
■ b. By revising paragraph (b).
The revision reads as follows:
■
■
§ 56.8
Conditions for payment.
*
*
*
*
*
(b)(1) If indemnity for the destroyed
poultry or eggs is being provided for 100
percent of eligible costs under § 56.3(b),
the Administrator may pay contractors
eligible for indemnity under this section
100 percent of the amount determined
in paragraph (a) of this section.
(2) If indemnity for the destroyed
poultry or eggs is being provided for 25
percent of eligible costs under § 56.3(b),
the Administrator may pay contractors
eligible for indemnity 25 percent of the
amount determined in paragraph (a) of
this section.
*
*
*
*
*
§ 56.9
[Amended]
8. Section 56.9 is amended as follows:
a. In paragraph (a), by removing the
citation ‘‘§ 56.4(a)(1)’’ and adding the
citation ‘‘§ 56.4(a)’’ in its place; and
■ b. In paragraph (b), by adding the
words ‘‘and/or compensation’’ after the
word ‘‘indemnity’’ both times it
appears.
■
■
§ 56.10
[Amended]
9. In § 56.10, paragraph (a)
introductory text is amended by adding
the words ‘‘and/or compensation’’ after
the word ‘‘indemnity’’.
■
PART 145—NATIONAL POULTRY
IMPROVEMENT PLAN FOR BREEDING
POULTRY
10. 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.
11. Section 145.1 is amended as
follows:
■ a. By revising the definition for Avian
influenza;
■ b. By adding a definition for
Newcastle disease in alphabetical order;
and
■ c. By revising the definition for NPIP
Program Standards.
The revisions and addition read as
follows:
■
§ 145.1
Definitions.
*
*
*
*
*
Avian influenza. Avian influenza is
defined as an infection of poultry
caused by any influenza A virus of the
H5 or H7 subtypes or by any influenza
A virus with an intravenous
E:\FR\FM\05DEP1.SGM
05DEP1
66640
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
pathogenicity index (IVPI) greater than
1.2 (or as an alternative at least 75
percent mortality).
*
*
*
*
*
Newcastle disease. Newcastle disease
(ND) is defined as an infection of
poultry caused by Newcastle disease
virus (NDV), which is an avian
paramyxovirus serotype 1 (APMV–1)
that meets one of the following criteria
for virulence:
(1) The virus has an intracerebral
pathogenicity index (ICPI) in day-old
chicks (Gallusgallus) of 0.7 or greater; or
(2) Multiple basic amino acids have
been demonstrated in the virus (either
directly or by deduction) at the Cterminus of the F2 protein and
phenylalanine at residue 117, which is
the N-terminus of the F1 protein. The
term ‘multiple basic amino acids’ refers
to at least three arginine or lysine
residues between residues 113 and 116.
Failure to demonstrate the characteristic
pattern of amino acid residues as
described above would require
characterization of the isolated virus by
an ICPI test.
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 National Poultry
Improvement Plan (NPIP) website 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.
*
*
*
*
*
■ 12. Section 145.7 is revised to read as
follows:
jbell on DSKJLSW7X2PROD with PROPOSALS
§ 145.7 Specific provisions for
participating dealers.
Dealers in hatching eggs, newly
hatched poultry, or started poultry shall
comply with the provisions in this part
(within the NPIP Program Standards
document, Program Standard C applies
to hatcheries; alternatives to the
program standards may also be
approved by the Administrator under
§ 147.53).
■ 13. Section 145.14 is amended as
follows:
■ a. By revising paragraphs (d)(1) and
(2) introductory text; and
■ b. By adding paragraph (e).
The revisions and addition read as
follows:
§ 145.14
Testing.
*
*
*
*
*
(d) * * *
(1) Antibody detection tests—(i)
ELISA test. (A) The ELISA test must be
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
conducted using test kits approved by
the Department and the Official State
Agency and must be conducted in
accordance with the recommendations
of the producer or manufacturer.
(B) When positive ELISA samples are
identified, an AGID test must be
conducted within 48 hours.
(ii) Agar gel immunodiffusion (AGID)
test. (A) The AGID test must be
conducted using reagents approved by
the Department and the Official State
Agency.
(B) The AGID test for avian influenza
must be conducted in accordance with
this section (within the NPIP Program
Standards document, Program Standard
A applies to blood and yolk testing
procedures; alternatives to the program
standards may also be approved by the
Administrator under § 147.53) for the
avian influenza agar gel
immunodiffusion (AGID) test. The test
can be conducted on egg yolk or blood
samples. The AGID test is not
recommended for use in waterfowl.
(C) Positive tests for the AGID 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.
(2) Agent detection tests. Agent
detection tests may be used to detect
influenza A virus but not to determine
hemagglutinin or neuraminidase
subtypes. Samples for agent detection
testing should be collected from
naturally occurring flock mortality or
clinically ill birds.
*
*
*
*
*
(e) For Newcastle Disease (ND). The
official tests for ND are serological tests
for antibody detection or molecularbased tests for antigen detection.
*
*
*
*
*
§ 145.23
[Amended]
14. Section 145.23 is amended as
follows:
■ a. By removing paragraphs (d)(1)(vi)
and (vii) and redesignating paragraphs
(d)(1)(viii) and (ix) as paragraphs
(d)(1)(vi) and (vii), respectively; and
■ b. By removing paragraph (d)(3) and
redesignating paragraphs (d)(4) and (5)
as paragraphs (d)(3) and (4),
respectively.
■
§ 145.24
[Amended]
15. In § 145.24, paragraph (a)(1)(i) is
amended by removing ‘‘§ 145.23(b)(3)(i)
through (vii), § 145.33(b)(3)(i) through
(vii), § 145.43(b)(3)(i) through (vi),
§ 145.53(b)(3)(i) through (vii),
§ 145.73(b)(2)(i), § 145.83(b)(2)(i), and
§ 145.93(b)(3)(i) through (vii)’’ and
adding ‘‘§§ 145.23(b)(3)(i) through (vii),
145.33(b)(3)(i) through (vii),
■
PO 00000
Frm 00010
Fmt 4702
Sfmt 4702
145.43(b)(3)(i) through (vi),
145.53(b)(3)(i) through (vii),
145.73(b)(2)(i), 145.83(b)(2)(i),
145.93(b)(3)(i) through (vii), and
145.103(b)(3)(i) through (ix)’’ in its
place.
■ 16. Section 145.33 is amended as
follows:
■ a. In paragraph (l)(1)(ii), by removing
the number ‘‘30’’ and adding the
number ‘‘15’’ in its place; and
■ b. By revising paragraph (l)(2).
The revision reads as follows:
§ 145.33 Terminology and classification;
flocks and products.
*
*
*
*
*
(l) * * *
(2) During each 90-day period, all
multiplier spent fowl, up to a maximum
of 30, must be tested and found negative
for avian influenza within 21 days prior
to movement to slaughter.
*
*
*
*
*
§ 145.34
[Amended]
17. In § 145.34, paragraph (a)(1)(i) is
amended by removing ‘‘§ 145.23(b)(3)(i)
through (vii), § 145.33(b)(3)(i) through
(vii), § 145.43(b)(3)(i) through (vi),
§ 145.53(b)(3)(i) through (vii),
§ 145.73(b)(2)(i), § 145.83(b)(2)(i), and
§ 145.93(b)(3)(i) through (vii)’’ and
adding ‘‘§§ 145.23(b)(3)(i) through (vii),
145.33(b)(3)(i) through (vii),
145.43(b)(3)(i) through (vi),
145.53(b)(3)(i) through (vii),
145.73(b)(2)(i), 145.83(b)(2)(i),
145.93(b)(3)(i) through (vii), and
145.103 (b)(3)(i) through (ix)’’ in its
place.
■ 18. Section 145.43 is amended by
adding paragraph (h) to read as follows:
■
§ 145.43 Terminology and classification;
flocks and products.
*
*
*
*
*
(h) U.S. Newcastle Disease Clean. The
program in this paragraph (h) is
intended to be the basis from which the
breeding-hatchery industry may
conduct a program for the prevention
and control of Newcastle disease. It is
intended to determine the presence of
Newcastle disease in primary breeding
turkeys through vaccination and/or
monitoring of each participating
breeding flock. A flock and the hatching
eggs and poults produced from it will
qualify for the classification in this
paragraph (h) when the Official State
Agency determines that they have met
the following requirements:
(1) It is a primary breeding flock that
is either:
(i) Vaccinated for Newcastle disease
using USDA-licensed vaccines and
response to vaccination is serologically
monitored using an approved test as
E:\FR\FM\05DEP1.SGM
05DEP1
jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
66641
described in § 145.14 when more than 4
months of age, and meets the criteria in
paragraph (h)(2) of this section to retain
classification; or
(ii) Unvaccinated for Newcastle
disease, in which a minimum of 30
birds have tested negative to ND using
an approved test as described in
§ 145.14 when more than 4 months of
age and meets the criteria in paragraph
(h)(3) of this section to retain
classification.
(2) To retain the classification in this
paragraph (h), for vaccinated flocks:
(i) Vaccines for ND must be USDAlicensed vaccines administered during
early stages of development through
rearing, and inactivated vaccines as
final vaccination prior to the onset of
egg production; and
(ii) The flock has been monitored for
antibody response using approved
serological tests as listed in § 145.14 and
the results are compatible with
immunological response against ND
vaccination; and
(iii) Testing must include a minimum
of 30 birds with a serologic monitoring
program when more than 4 months of
age and prior to the onset of production
and not longer than every 90 days
thereafter.
(3) To retain the classification in this
paragraph (h) for unvaccinated flocks:
(i) A minimum of 30 birds per flock
must test negative using an approved
test in § 145.14 at intervals of 90 days;
or
(ii) A sample of fewer than 30 birds
may be tested, and found negative, at
any one time if all pens are equally
represented and a total of 30 birds is
tested within each 90-day period; and
(iii) During each 90-day period, all
primary spent fowl, up to a maximum
of 30, must test negative to ND within
21 days prior to movement to slaughter.
(4) Newcastle disease must be a
disease reportable to the responsible
State authority (State veterinarian, etc.)
by all licensed veterinarians. To
accomplish this, all laboratories
(private, State, and university
laboratories) that perform diagnostic
procedures on poultry must examine all
submitted cases of unexplained
respiratory disease, egg production
drops, and mortality for ND.
*
*
*
*
*
145.33(b)(3)(i) through (vii),
145.43(b)(3)(i) through (vi),
145.53(b)(3)(i) through (vii),
145.73(b)(2)(i), § 145.83(b)(2)(i),
145.93(b)(3)(i) through (vii), and
145.103(b)(3)(i) through (ix)’’ in this
place.
■ 20. Section 145.45 is amended as
follows:
■ a. By revising paragraph (a)
introductory text;
■ b. In paragraph (a)(1) introductory
text, by adding the words ‘‘and ND’’
after the word ‘‘AI’’ each time it
appears;
■ c. In paragraph (a)(1)(i):
■ i. By adding the words ‘‘and ND Clean
in accordance with § 145.43(h)’’ after
the citation ‘‘§ 145.43(g)’’;
■ ii. By adding the words ‘‘and ND’’
after the words ‘‘official tests for AI’’
and adding the words ‘‘and (e)’’ after the
citation ‘‘§ 145.14(d)’’; and
■ iii. By removing the word ‘‘AIrelated’’ and adding the words ‘‘AI and
ND-related’’ in its place;
■ d. In paragraphs (a)(1)(iii)
introductory text, (a)(1)(iii)(B) and (E),
and (a)(1)(v), by adding the words ‘‘and
ND’’ after the word ‘‘AI’’ each time it
appears;
■ e. In paragraph (a)(1)(vi), by adding
the words ‘‘and ND’’ after the word
‘‘Influenza’’;
■ f. In paragraph (a)(2)(iii):
■ i. By removing the words ‘‘Clean
classification’’ and adding the words
‘‘and ND Clean classifications’’ in their
place;
■ ii. By adding the words ‘‘and ND’’
after the word ‘‘AI’’ both times it
appears; and
■ iii. By removing the words ‘‘avian
influenza surveillance’’ and adding the
words ‘‘avian influenza and ND
surveillance’’ in their place;
■ g. In paragraph (a)(3)(iii), by adding
the words ‘‘and ND’’ after the word
‘‘Influenza’’;
■ h. In paragraph (a)(3)(iv), by adding
the words ‘‘and ND Clean program as
described in § 145.43(h)’’ after the
citation ‘‘§ 145.43(g)’’; and
■ i. In paragraph (a)(3)(vii), by adding
the words ‘‘and (h)’’ after the citation
‘‘145.43(g)’’.
The revision reads as follows:
primary breeding-hatchery company
that is free of H5/H7 avian influenza
(AI) and ND. This compartment has the
purpose of protecting the defined
subpopulation and avoiding the
introduction and spread of H5/H7 AI
and ND 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:
*
*
*
*
*
■ 21. The heading for subpart E,
consisting of §§ 145.51 through 146.54,
is revised to read as follows:
§ 145.45 Terminology and classification;
compartments.
§ 145.44
(a) US H5/H7 AI and ND Clean
Compartment. The program in this
section is intended to be the basis from
which the primary turkey breedinghatchery industry may demonstrate the
existence and implementation of a
program that has been approved by the
Official State Agency and APHIS to
establish a compartment consisting of a
Participating flocks of hobbyist and
exhibition poultry, raised-for-release
waterfowl, and the eggs, chicks, started,
and mature poultry produced from them
shall comply with the applicable
general provisions of subpart A of this
part and the special provisions of this
subpart. The special provisions that
apply to meat-type waterfowl flocks are
found in subpart I of this part. The
special provisions that apply to game
[Amended]
19. In § 145.44, paragraph (a)(1)(i) is
amended by removing ‘‘§ 145.23(b)(3)(i)
through (vii), § 145.33(b)(3)(i) through
(vii), § 145.43(b)(3)(i) through (vi),
§ 145.53(b)(3)(i) through (vii),
§ 145.73(b)(2)(i), § 145.83(b)(2)(i), and
§ 145.93(b)(3)(i) through (vii)’’ and
adding ‘‘§§ 145.23(b)(3)(i) through (vii),
■
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
PO 00000
Frm 00011
Fmt 4702
Sfmt 4702
Subpart E—Special Provisions for
Hobbyist and Exhibition Poultry, and
Raised-for-Release Waterfowl
Breeding Flocks and Products
22. Section 145.51 is amended as
follows:
■ a. By removing the definition for
Game birds;
■ b. By adding, in alphabetical order,
definitions for Hobbyist poultry and
Raised-for-release waterfowl; and
■ c. By removing the definition for
Waterfowl.
The additions read as follows:
■
§ 145.51
Definitions.
*
*
*
*
*
Hobbyist poultry. Domesticated fowl
which are bred for the purposes of meat
and/or egg production on a small scale
as determined by the Official State
Agency.
Raised-for-release waterfowl.
Domesticated fowl that normally swim,
such as ducks and geese, grown under
confinement for the primary purpose of
producing eggs, chicks, started, or
mature birds for release on game
preserves or in the wild.
■ 23. Section 145.52 is amended as
follows:
■ a. By revising the introductory text;
■ b. In paragraph (c), by removing the
words ‘‘in open air facilities’’; and
■ c. By adding paragraph (f).
The revision and addition read as
follows:
§ 145.52
E:\FR\FM\05DEP1.SGM
Participation.
05DEP1
66642
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
bird flocks are found in subpart J of this
part.
*
*
*
*
*
(f) All participating raised-for-release
waterfowl flocks, regardless of whether
they are breeders or non-breeders, shall
be enrolled under this subpart.
■ 24. Section 145.53 is amended as
follows:
■ a. In paragraph (b)(5), by removing the
words ‘‘exhibition waterfowl or’’; and
■ b. By revising paragraph (f).
The revision reads as follows:
§ 145.53 Terminology and classification;
flocks and products.
jbell on DSKJLSW7X2PROD with PROPOSALS
*
*
*
*
*
(f) U.S. Salmonella Monitored. The
program in this paragraph (f) is intended
to be the basis from which the breedinghatching 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 poultry
through an effective and practical
sanitation and testing program at the
breeder farm and in the hatchery. This
will afford other segments of the poultry
industry an opportunity to reduce the
incidence of Salmonella in their
products. The following requirements
must be met for a flock or hatchery to
be eligible for the classification in this
paragraph (f) as determined by the
Official State Agency:
(1) Hatcheries must be kept in a
sanitary condition as applicable and as
outlined in § 145.6 (within the NPIP
Program Standards document, Program
Standard C applies to hatcheries;
alternatives to the program standards
may also be approved by the
Administrator under § 147.53).
(2) An Authorized Agent shall collect
and submit to an authorized laboratory:
(i) A minimum of five samples from
the hatchery at least every 30 days while
in operation. These samples may
include: Hatchery debris, swabs from
hatchers, setters, hatchery environment,
hatchery equipment, sexing tables and
belts, meconium, chick box papers,
hatching trays, or chick transfer devices.
Samples will be examined
bacteriologically at an authorized
laboratory for Salmonella; and
(ii) Annual environmental samples
from each pullet and breeder farm in
accordance with this section (within the
NPIP Program Standards document,
Program Standard B applies to
bacteriological examination procedures;
alternatives to the program standards
may also be approved by the
Administrator under § 147.53). Samples
will be examined bacteriologically at an
authorized laboratory for Salmonella.
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
(3) If Salmonella is identified through
this testing:
(i) A qualified poultry health
professional knowledgeable with the
operation will be consulted and will:
(A) Review test results to evaluate the
Salmonella monitoring program.
(B) Use the Salmonella monitoring
program test results to develop
appropriate and practical Salmonella
intervention measures.
(ii) [Reserved]
(4) To claim products are of the
classification in this paragraph (f), all
products shall be derived from a farm or
hatchery that meets the requirements of
the classification.
*
*
*
*
*
§ 145.54
[Amended]
25. In § 145.54, paragraph (a)(1)(i) is
amended by removing ‘‘§ 145.23(b)(3)(i)
through (vii), § 145.33(b)(3)(i) through
(vii), § 145.43(b)(3)(i) through (vi),
§ 145.53(b)(3)(i) through (vii),
§ 145.73(b)(2)(i), § 145.83(b)(2)(i), and
§ 145.93(b)(3)(i) through (vii)’’ and
adding ‘‘§§ 145.23(b)(3)(i) through (vii),
145.33(b)(3)(i) through (vii),
145.43(b)(3)(i) through (vi),
145.53(b)(3)(i) through (vii),
145.73(b)(2)(i), 145.83(b)(2)(i),
145.93(b)(3)(i) through (vii), and
145.103(b)(3)(i) through (ix)’’ in its
place.
■ 26. Section 145.73 is amended as
follows:
■ a. By removing paragraphs (d)(1)(vi)
and (vii) and redesignating paragraphs
(d)(1)(viii) and (ix) as paragraphs
(d)(1)(vi) and (vii), respectively;
■ b. By removing paragraph (d)(3) and
redesignating paragraphs (d)(4) and (5)
as paragraphs (d)(3) and (4),
respectively; and
■ c. By adding paragraph (h).
The addition reads as follows:
■
§ 145.73 Terminology and classification;
flocks and products.
*
*
*
*
*
(h) U.S. Newcastle Disease Clean. The
program in this paragraph (h) is
intended to be the basis from which the
breeding-hatchery industry may
conduct a program for the prevention
and control of Newcastle disease. It is
intended to determine the presence of
Newcastle disease in primary breeding
chickens through vaccination and/or
monitoring of each participating
breeding flock. A flock and the hatching
eggs and chicks produced from it will
qualify for the classification in this
paragraph (h) when the Official State
Agency determines that they have met
the following requirements:
(1) It is a primary breeding flock that
is either:
PO 00000
Frm 00012
Fmt 4702
Sfmt 4702
(i) Vaccinated for Newcastle disease
using USDA-licensed vaccines and
response to vaccination is serologically
monitored using an approved test as
described in § 145.14 when more than 4
months of age and meets the criteria in
paragraph (h)(2) of this section to retain
classification; or
(ii) Unvaccinated for Newcastle
disease, in which a minimum of 30
birds have tested negative to ND using
an approved test as described in
§ 145.14 when more than 4 months of
age and meets criteria in paragraph
(h)(3) of this section to retain
classification.
(2) To retain the classification in this
paragraph (h), for vaccinated flocks:
(i) Vaccines for ND must be USDAlicensed vaccines administered during
early stages of development through
rearing, and inactivated vaccines as
final vaccination prior to the onset of
egg production; and
(ii) The flock has been monitored for
antibody response using approved
serological tests as listed in § 145.14 and
the results are compatible with
immunological response against ND
vaccination; and
(iii) Testing must include a minimum
of 30 birds with a serologic monitoring
program when more than 4 months of
age and prior to the onset of production
and not longer than every 90 days
thereafter.
(3) To retain the classification in this
paragraph (h) for unvaccinated flocks:
(i) A minimum of 30 birds per flock
must test negative using an approved
test as described in § 145.14 at intervals
of 90 days; or
(ii) A sample of fewer than 30 birds
may be tested, and found negative, at
any one time if all pens are equally
represented and a total of 30 birds is
tested within each 90-day period; and
(iii) During each 90-day period, all
primary spent fowl, up to a maximum
of 30, must test negative to ND within
21 days prior to movement to slaughter.
(4) Newcastle disease must be a
disease reportable to the responsible
State authority (State veterinarian, etc.)
by all licensed veterinarians. To
accomplish this, all laboratories
(private, State, and university
laboratories) that perform diagnostic
procedures on poultry must examine all
submitted cases of unexplained
respiratory disease, egg production
drops, and mortality for ND.
■ 27. Section 145.74 is amended as
follows:
■ a. In paragraph (a) introductory text,
by revising the paragraph heading,
adding the words ‘‘and Newcastle
disease (ND)’’ after the word ‘‘(AI)’’, and
E:\FR\FM\05DEP1.SGM
05DEP1
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
adding the words ‘‘and ND’’ after the
word ‘‘AI’’;
■ b. In paragraph (a)(1) introductory
text, by adding the words ‘‘and ND’’
after the word ‘‘AI’’ each time it
appears;
■ c. In paragraph (a)(1)(i):
■ i. By adding the words ‘‘and ND Clean
in accordance with § 145.73(h)’’ after
the words ‘‘in accordance with
§ 145.73(f)’’;
■ ii. By adding the words ‘‘and ND’’
after the words ‘‘official tests for AI’’
and adding the words ‘‘and (e)’’ after the
citation ‘‘§ 145.14(d)’’; and
■ iii. By removing the word ‘‘AIrelated’’ and adding the words ‘‘AI and
ND-related’’ in its place;
■ d. In paragraphs (a)(1)(iii), (a)(1)(iii)(B)
and (E), and (a)(1)(v), by adding the
words ‘‘and ND’’ after the word ‘‘AI’’
each time it appears;
■ e. In paragraph (a)(1)(vi), by adding
the words ‘‘and ND’’ after the word
‘‘Influenza’’;
■ f. In paragraph (a)(2)(iii):
■ i. By removing the words ‘‘Clean
classification’’ and adding the words
‘‘and ND Clean classifications’’ in their
place;
■ ii. By adding the words ‘‘and ND’’
after the word ‘‘AI’’ both times it
appears; and
■ iii. By removing the words ‘‘avian
influenza surveillance’’ and adding the
words ‘‘avian influenza and ND
surveillance’’ in their place;
■ g. In paragraph (a)(3)(iii), by adding
the words ‘‘and ND’’ after the word
‘‘Influenza’’;
■ h. In paragraph (a)(3)(iv), by adding
the words ‘‘and ND Clean program as
described in § 145.73(h)’’ after the
citation ‘‘§ 145.73(f)’’;
■ i. In paragraph (a)(3)(vii), by adding
the words ‘‘and (h)’’ after the citation
‘‘145.73(f); and
■ j. In paragraph (a)(4), by adding the
words ‘‘and/or ND’’ after the word ‘‘AI’’
both times it appears.
The revision reads as follows:
jbell on DSKJLSW7X2PROD with PROPOSALS
§ 145.74 Terminology and classification;
compartments.
(a) U.S. Avian Influenza and
Newcastle Disease Clean Compartment.
* * *
*
*
*
*
*
■ 28. Section 145.83 is amended as
follows:
■ a. By removing paragraph (e)(1)(iv)
and redesignating paragraphs (e)(1)(v)
and (vi) as paragraphs (e)(1)(iv) and (v),
respectively; and
■ b. By adding paragraph (h).
The addition reads as follows:
§ 145.83 Terminology and classification;
flocks and products.
*
*
*
VerDate Sep<11>2014
*
*
17:13 Dec 04, 2019
Jkt 250001
(h) U.S. Newcastle Disease (ND)
Clean. The program in this paragraph
(h) is intended to be the basis from
which the breeding-hatchery industry
may conduct a program for the
prevention and control of Newcastle
disease. It is intended to determine the
presence of Newcastle disease in
primary breeding chickens through
vaccination and/or monitoring of each
participating breeding flock. A flock and
the hatching eggs and chicks produced
from it will qualify for the classification
in this paragraph (h) when the Official
State Agency determines that they have
met the following requirements:
(1) It is a primary breeding flock that
is either:
(i) Vaccinated for Newcastle disease
using USDA-licensed vaccines and
response to vaccination is serologically
monitored using an approved test as
described in § 145.14 when more than 4
months of age and meets the criteria in
paragraph (h)(2) of this section to retain
classification; or
(ii) Unvaccinated for Newcastle
disease, in which a minimum of 30
birds have tested negative to ND using
an approved test as described in
§ 145.14 when more than 4 months of
age and meets criteria in paragraph
(h)(3) of this section to retain
classification.
(2) To retain the classification in this
paragraph (h), for vaccinated flocks:
(i) Vaccines for ND must be USDAlicensed vaccines administered during
early stages of development through
rearing, and inactivated vaccines as
final vaccination prior to the onset of
egg production; and
(ii) The flock has been monitored for
antibody response using approved
serological tests as described in § 145.14
and the results are compatible with
immunological response against ND
vaccination; and
(iii) Testing must include a minimum
of 30 birds with a serologic monitoring
program when more than 4 months of
age and prior to the onset of production,
and not longer than every 90 days
thereafter.
(3) To retain the classification in this
paragraph (h) for unvaccinated flocks:
(i) A minimum of 30 birds per flock
must test negative using an approved
test as described in § 145.14 at intervals
of 90 days; or
(ii) A sample of fewer than 30 birds
may be tested, and found negative, at
any one time if all pens are equally
represented and a total of 30 birds is
tested within each 90-day period; and
(iii) During each 90-day period, all
primary spent fowl, up to a maximum
of 30, must test negative to ND within
21 days prior to movement to slaughter.
PO 00000
Frm 00013
Fmt 4702
Sfmt 4702
66643
(4) Newcastle disease must be a
disease reportable to the responsible
State authority (State veterinarian, etc.)
by all licensed veterinarians. To
accomplish this, all laboratories
(private, State, and university
laboratories) that perform diagnostic
procedures on poultry must examine all
submitted cases of unexplained
respiratory disease, egg production
drops, and mortality for ND.
■ 29. Section 145.84 is amended as
follows:
■ a. In paragraph (a) introductory text,
by revising the heading, adding the
words ‘‘and Newcastle disease (ND)’’
after the words ‘‘influenza (AI)’’, and
adding the words ‘‘and ND’’ after the
words ‘‘H5/H7 AI’’;
■ b. In paragraph (a)(1) introductory
text, by adding the words ‘‘and ND’’
after the word ‘‘AI’’ each time it
appears;
■ c. By revising paragraph (a)(1)(i);
■ d. In paragraphs (a)(1)(iii)
introductory text, (a)(1)(iii)(B) and (E),
and (a)(1)(v), by adding the words ‘‘and
ND’’ after the word ‘‘AI’’ each time it
appears;
■ e. In paragraph (a)(1)(vi), by adding
the words ‘‘and ND’’ after the word
‘‘Influenza’’;
■ f. In paragraph (a)(2)(iii):
■ i. Removing the words ‘‘Clean
classification’’ and adding the words
‘‘and ND Clean classifications’’ in their
place;
■ ii. Adding the words ‘‘and ND’’ after
the word ‘‘AI’’ both times it appears;
and
■ iii. Removing the words ‘‘avian
influenza surveillance’’ and adding the
words ‘‘avian influenza and ND
surveillance’’ in their place;
■ g. In paragraph (a)(3)(iv), by adding
the words ‘‘and ND Clean program as
described in § 145.83(h)’’ after the
citation ‘‘§ 145.83(g)’’; and
■ h. In paragraph (a)(3)(vii), by adding
the words ’’ and (h)’’ after the citation
‘‘145.83(g)’’.
The revisions read as follows:
§ 145.84 Terminology and classification;
compartments.
(a) U.S. Avian Influenza and
Newcastle Disease Clean Compartment.
* * *
(1) * * *
(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) and ND Clean in accordance
with § 145.83(h). 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
E:\FR\FM\05DEP1.SGM
05DEP1
66644
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
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 and ND, as described
in § 145.14(d) and (e), 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 H5/H7 AI and ND-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.
*
*
*
*
*
§ 145.94
[Amended]
30. In § 145.94, paragraph (a)(1)(i) is
amended by removing the word ‘‘and’’
and adding the words ‘‘, and
145.103(b)(3)(i) through (ix)’’ after the
words ‘‘145.93(b)(3)(i) through (vii)’’.
■ 31. Subpart J, consisting of §§ 145.101
through 145.104, is added to read as
follows:
■
Subpart J—Special Provisions for Egg/
Meat-Type Game Bird and Raised-forRelease Game Bird Breeding Flocks and
Products
Sec.
145.101 Definitions.
145.102 Participation.
145.103 Terminology and classification;
flocks and products.
145.104 Terminology and classification;
States.
Subpart J—Special Provisions for Egg/
Meat-Type Game Bird and Raised-forRelease Game Bird Breeding Flocks
and Products
jbell on DSKJLSW7X2PROD with PROPOSALS
§ 145.101
Definitions.
Except where the context otherwise
requires, for the purposes of this subpart
the following terms shall be construed,
respectively, to mean:
Egg/meat-type bird. Birds grown
under confinement for the primary
purpose of producing eggs and/or meat
for human consumption.
Game birds. Domesticated fowl such
as pheasants, partridge, quail, grouse,
and guineas, but not doves and pigeons.
Raised-for-release bird. Birds grown
under confinement for the primary
purpose of producing eggs, chicks,
started, or mature birds for release on
game preserves or in the wild.
§ 145.102
Participation.
Participating flocks of egg/meat-type
game birds, raised-for-release game
birds, and the products produced from
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
them shall comply with the applicable
general provisions of subpart A of this
part and the special provisions of this
subpart. Participation is broken into the
following categories of operation and
products:
(a) The categories for operation are:
(1) Breeder. An individual or business
that maintains a breeding flock for the
purpose of producing eggs, chicks,
started, or mature birds. A breeder that
is also a hatchery and/or grower shall be
categorized as a breeder.
(2) Hatchery. A category of operations
in which an individual or business does
not have a breeding flock, but hatches
eggs for the purpose of producing
chicks, started, or mature birds. A
hatchery that is also a grower shall be
categorized as a hatchery.
(3) Grower. A category of operations
in which an individual or business does
not have a breeding flock or hatchery,
but raises birds for the purpose of
selling started or mature birds.
(4) Dealer. An individual or business
that resells eggs, chicks, started, or
mature birds. Products a dealer handles
are typically resold within 30 days or
less.
(b) The categories for products are:
(1) Egg. An egg laid by a female bird
for the purpose of hatching a chick.
(2) Chick. A bird that is newly
hatched from an egg.
(3) Started Bird. A bird that is
between the age of a newly hatched
chick and a mature bird.
(4) Mature Bird. A bird that is fully
colored and has reached the average
maximum size specific to each species.
(c) Products shall lose their identity
under Plan terminology when not
maintained by Plan participants under
the conditions prescribed in § 145.5(a).
(d) Hatching eggs produced by
breeding flocks shall be nest clean,
fumigated, or otherwise sanitized in
accordance with part 147 of this
subchapter.
(e) It is recommended that
gallinaceous flocks and waterfowl flocks
be kept separate.
(f) Any nutritive material provided to
baby poultry must be free of the avian
pathogens that are officially represented
in the Plan disease classifications listed
in § 145.10.
(g) A flock of game birds that are not
breeders, but are located on the same
premise as game bird breeders, shall be
covered under the same NPIP hatchery
approval number as long as the
appropriate testing requirements have
been met.
(h) All participating raised-for-release
game bird flocks, regardless of whether
they are breeders or non-breeders, shall
be enrolled under this subpart.
PO 00000
Frm 00014
Fmt 4702
Sfmt 4702
(i) A breeder, hatchery, or grower may
also be a dealer without being
categorized as a dealer. To resell
products under the assigned NPIP
number and avoid losing NPIP flock
classifications, products must be
purchased from an NPIP participant
with equal or greater classifications or
from a flock with equivalent or greater
testing requirements under official
supervision.
(j) Subject to the approval of the
Service and the Official State Agencies
in the importing and exporting States,
participating flocks may report poultry
sales to importing States by using either
VS Form 9–3, ‘‘Report of Sales of
Hatching Eggs, Chicks, and Poults,’’ or
by using an invoice form (9–3I)
approved by the Official State Agency
and the Service to identify poultry sales
to clients. If the 9–3I form is used, the
following information must be included
on the form:
(1) The form number ‘‘9–3I’’, printed
or stamped on the invoice;
(2) The seller name and address;
(3) The date of shipment;
(4) The invoice number;
(5) The purchaser name and address;
(6) The quantity of products sold;
(7) Identification of the products by
bird variety or by NPIP stock code as
listed in the NPIP APHIS 91–55–078
appendix; and
(8) The appropriate NPIP illustrative
design in § 145.10. One of the designs in
§ 145.10(b) or (g) must be used. The
following information must be provided
in or near the NPIP design:
(i) The NPIP State number and NPIP
approval number; and
(ii) The NPIP classification for which
product is qualified (e.g., U.S. PullorumTyphoid Clean).
§ 145.103 Terminology and classification;
flocks and products.
Participating flocks, and the eggs,
chicks, started, and mature birds
produced from them, which have met
the respective requirements specified in
this section may be designated by the
following terms and the corresponding
designs illustrated in § 145.10.
(a) [Reserved]
(b) U.S. Pullorum-Typhoid Clean. A
flock in which freedom from pullorum
and typhoid has been demonstrated to
the Official State Agency under the
criteria in this paragraph (b). (See
§ 145.14 relating to the official blood
test where applicable.):
(1) It has been officially blood tested
with either no reactors or reactors that,
upon further bacteriological
examination conducted in accordance
with part 147 of this subchapter, fail to
isolate S. pullorum or S. gallinarum.
E:\FR\FM\05DEP1.SGM
05DEP1
jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
(2) It is a started or mature bird flock
that meets the following specifications
as determined by the Official State
Agency and the Service:
(i) The flock is located in a State
where all persons performing poultry
disease diagnostic services within the
State are required to report to the
Official State Agency within 48 hours
the source of all poultry specimens from
which S. pullorum or S. gallinarum is
isolated;
(ii) The flock is composed entirely of
birds that originated from U.S.
Pullorum-Typhoid Clean breeding
flocks or from flocks that met equivalent
requirements under official supervision;
and
(iii) The flock is located on a premises
where a flock not classified as U.S.
Pullorum-Typhoid Clean was located
the previous year; Provided, That an
Authorized Testing Agent must blood
test up to 300 birds per flock, as
described in § 145.14, if the Official
State Agency determines that the flock
has been exposed to pullorum-typhoid.
In making determinations of exposure
and setting the number of birds to be
blood tested, the Official State Agency
shall evaluate the results of any blood
tests, described in § 145.14(a)(1), that
were performed on an unclassified flock
located on the premises during the
previous year; the origins of the
unclassified flock; and the probability of
contacts between the flock for which
qualification is being sought and
infected wild birds, contaminated feed
or waste, or birds, equipment, supplies,
or personnel from flocks infected with
pullorum-typhoid.
(3) It is a breeding flock that
originated from U.S. Pullorum-Typhoid
Clean breeding flocks or from flocks that
met equivalent requirements under
official supervision, and in which a
sample of 300 birds from flocks of more
than 300, and each bird in flocks of 300
or less, has been officially tested for
pullorum-typhoid: Provided, That a
bacteriological examination monitoring
program or serological examination
monitoring program for game birds
acceptable to the Official State Agency
and approved by the Service may be
used in lieu of annual blood testing:
And provided further, That it is located
in a State in which it has been
determined by the Service that:
(i) All hatcheries within the State are
qualified as ‘‘National Plan Hatcheries’’
or have met equivalent requirements for
pullorum-typhoid control under official
supervision;
(ii) All hatchery supply flocks within
the State, are qualified as U.S.
Pullorum-Typhoid Clean or have met
equivalent requirements for pullorum-
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
typhoid control under official
supervision: Provided, That if other
domesticated fowl, except waterfowl,
are maintained on the same premises as
the participating flock, freedom from
pullorum-typhoid infection shall be
demonstrated by an official blood test of
each of these fowl;
(iii) All shipments of products other
than U.S. Pullorum-Typhoid Clean, or
equivalent, into the State are prohibited;
(iv) All persons performing poultry
disease diagnostic services within the
State are required to report to the
Official State Agency within 48 hours
the source of all poultry specimens from
which S. pullorum or S. gallinarum is
isolated;
(v) All reports of any disease outbreak
involving a disease covered under the
Plan are promptly followed by an
investigation by the Official State
Agency to determine the origin of the
infection; Provided, That if the origin of
the infection involves another State, or
if there is exposure to poultry in another
State from the infected flock, then the
National Poultry Improvement Plan will
conduct an investigation;
(vi) All flocks found to be infected
with pullorum or typhoid are
quarantined until marketed or destroyed
under the supervision of the Official
State Agency, or until subsequently
blood tested, following the procedure
for reacting flocks as contained in
§ 145.14(a)(5), and all birds fail to
demonstrate pullorum or typhoid
infection;
(vii) All poultry, including exhibition,
exotic, and game birds, but excluding
waterfowl, going to public exhibition
shall come from U.S. Pullorum-Typhoid
Clean or equivalent flocks, or have had
a negative pullorum-typhoid test within
90 days of going to public exhibition;
and
(viii) The flock is located in a State in
which pullorum disease or fowl typhoid
is not known to exist nor to have existed
in hatchery supply flocks within the
State during the preceding 24 months.
(ix) Discontinuation of any of the
conditions or procedures described in
paragraphs (b)(3)(i) through (viii) of this
section, or the occurrence of repeated
outbreaks of pullorum or typhoid in
poultry breeding flocks within or
originating within the State shall be
grounds for the Service to revoke its
determination that such conditions and
procedures have been met or complied
with. Such action shall not be taken
until a thorough investigation has been
made by the Service and the Official
State Agency has been given an
opportunity to present its views.
(c) U.S. H5/H7 Avian Influenza Clean.
The program in this paragraph (c) is
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
66645
intended to be the basis from which the
game bird industry may conduct a
program for the prevention and control
of the H5 and H7 subtypes of avian
influenza. It is intended to determine
the presence of the H5 and H7 subtypes
of avian influenza in game bird flocks
through routine surveillance of each
participating flock. A flock or premise,
and the hatching eggs, chicks, started,
and mature birds produced from it, will
qualify for the classification in this
paragraph (c) when the Official State
Agency determines that it has met the
following requirements:
(1) It is a 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. To
retain the classification in this
paragraph (c):
(i) A sample of at least 30 birds must
be tested negative at intervals of 90
days; or
(ii) A sample of fewer than 30 birds
may be tested, and found to be negative,
at any one time if all pens are equally
represented and a total of 30 birds are
tested within each 90-day period.
(2) For participants with non-breeding
flocks retained for raised-for-release or
other purposes on the same premises as
a breeding flock, a representative
sample of at least 30 birds from the
participating premise must be tested
negative to the H5 and H7 subtypes of
avian influenza as provided in
§ 145.14(d) when more than 4 months of
age, every 90 days.
(d) U.S. Salmonella Monitored. The
program in this paragraph (d) is
intended to be the basis from which the
game bird 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 the classification in this
paragraph (d):
(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 the
classification in this paragraph (d), all
products shall be derived from a
hatchery that meets the requirements of
the classification.
E:\FR\FM\05DEP1.SGM
05DEP1
66646
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
(3) The classification in this
paragraph (d) may be revoked by the
Official State Agency if the participant
fails to follow recommended corrective
measures.
§ 145.104
States.
Terminology and classification;
(a) U.S. Pullorum-Typhoid Clean
State. (1) A State will be declared a U.S.
Pullorum-Typhoid Clean State when it
has been determined by the Service that:
(i) The State is in compliance with the
provisions contained in
§§ 145.23(b)(3)(i) through (vii),
145.33(b)(3)(i) through (vii),
145.43(b)(3)(i) through (vi),
145.53(b)(3)(i) through (vii),
145.73(b)(2)(i), 145.83(b)(2)(i),
145.93(b)(3)(i) through (vii), and
145.103(b)(3)(i) through (ix).
(ii) No pullorum disease or fowl
typhoid is known to exist nor to have
existed in hatchery supply flocks within
the State during the preceding 12
months: Provided, That pullorum
disease or fowl typhoid found within
the preceding 24 months in waterfowl,
exhibition poultry, and game bird
breeding flocks will not prevent a State,
which is otherwise eligible, from
qualifying.
(2) Discontinuation of any of the
conditions described in paragraph
(a)(1)(i) of this section, or repeated
outbreaks of pullorum or typhoid occur
in hatchery supply flocks described in
paragraph (a)(1)(ii) of this section, or if
an infection spreads from the
originating premises, the Service shall
have grounds to revoke its
determination that the State is entitled
to the classification in this paragraph
(a). Such action shall not be taken until
a thorough investigation has been made
by the Service and the Official State
Agency has been given an opportunity
for a hearing in accordance with rules
of practice adopted by the
Administrator.
(b) [Reserved]
PART 146—NATIONAL POULTRY
IMPROVEMENT PLAN FOR
COMMERCIAL POULTRY
32. The authority citation for part 146
continues to read as follows:
■
jbell on DSKJLSW7X2PROD with PROPOSALS
Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22,
2.80, and 371.4.
33. Section 146.13 is amended as
follows:
■ a. By revising paragraph (b)(1); and
■ b. In paragraph (b)(2) introductory
text, by removing the words ‘‘matrix
gene or protein’’ and adding the word
‘‘virus’’ in their place.
The revision reads as follows:
■
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
§ 146.13
Testing.
*
*
*
*
*
(b) * * *
(1) Antibody detection tests—(i)
Enzyme-linked immunosorbent assay
(ELISA) test. (A) The ELISA test must be
conducted using test kits approved by
the Department and the Official State
Agency and must be conducted in
accordance with the recommendations
of the producer or manufacturer.
(B) When positive ELISA samples are
identified, an AGID test must be
conducted within 48 hours.
(ii) Agar gel immunodiffusion (AGID)
test. (A) The AGID test must be
conducted using reagents approved by
the Department and the Official State
Agency.
(B) The AGID test for avian influenza
must be conducted in accordance with
this section (within the NPIP Program
Standards, Program Standard A applies
to blood and yolk testing procedures;
alternatives to the program standards
may also be approved by the
Administrator under § 147.53) for the
avian influenza agar gel
immunodiffusion (AGID) test. The test
can be conducted on egg yolk or blood
samples. The AGID test is not
recommended for use in waterfowl.
(C) Positive tests for the AGID 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.
*
*
*
*
*
■ 34. Section 146.51 is revised to read
as follows:
§ 146.51
Definitions.
Except where the context otherwise
requires, for the purposes of this subpart
the following terms shall be construed,
respectively, to mean:
Egg/meat-type game birds.
Domesticated fowl such as pheasants,
partridge, quail, grouse, and guineas,
but not doves and pigeons grown under
confinement for the primary purposes of
producing eggs and/or meat for human
consumption.
Egg/meat-type waterfowl.
Domesticated ducks or geese grown
under confinement for the primary
purposes of producing eggs and/or meat
for human consumption.
Meat-type game bird slaughter plant.
A meat-type game bird slaughter plant
that is federally inspected or under State
inspection that the U.S. Department of
Agriculture’s Food Safety and
Inspection Service has recognized as
equivalent to Federal inspection.
Meat-type waterfowl slaughter plant.
A meat-type waterfowl slaughter plant
that is federally inspected or under State
PO 00000
Frm 00016
Fmt 4702
Sfmt 4702
inspection that the U.S. Department of
Agriculture’s Food Safety and
Inspection Service has recognized as
equivalent to Federal inspection.
Shift. The working period of a group
of employees who are on duty at the
same time.
■ 35. Section 146.52 is revised to read
as follows:
§ 146.52
Participation.
(a) Participating meat-type game bird
slaughter plants, meat-type waterfowl
slaughter plants, and egg-type game bird
and egg-type waterfowl premises
producing eggs for human consumption
shall comply with the applicable
general provisions of subpart A of this
part and the special provisions of this
subpart.
(b) Meat-type game bird slaughter
plants and Meat-type waterfowl
slaughter plants that slaughter fewer
than 50,000 birds annually are exempt
from the special provisions of this
subpart.
(c) Egg-type game bird and egg-type
waterfowl premises with fewer than
25,000 birds are exempt from the special
provisions of this subpart.
■ 36. Section 146.53 is amended as
follows:
■ a. In the introductory text, by adding
the words ‘‘slaughter plants and’’ after
the word ‘‘participating’’;
■ b. By revising paragraph (a)
introductory text;
■ c. In paragraph (a)(1), by removing the
words ‘‘commercial upland’’ and adding
the word ‘‘meat-type’’ in their place and
by removing the word ‘‘commercial’’
and adding the word ‘‘meat-type’’ in its
place;
■ d. By revising paragraph (a)(2);
■ e. In paragraph (a)(3), by removing the
words ‘‘commercial upland’’ and adding
the word ‘‘meat-type’’ in their place and
by removing the word ‘‘commercial’’
and adding the word ‘‘meat-type’’ in its
place;
■ f. In paragraph (a)(4), by removing the
words ‘‘a commercial upland’’ and
adding the words ‘‘an egg-type’’ in their
place and by adding the word ‘‘eggtype’’ after the words ‘‘game bird or’’.
■ g. In paragraph (a)(5), by removing the
words ‘‘a commercial upland’’ and
adding the words ‘‘an egg-type’’ in their
place and by adding the word ‘‘eggtype’’ after the words ‘‘game bird or’’.
■ h. By removing and reserving
paragraph (b).
The revisions read as follows:
§ 146.53 Terminology and classification;
slaughter plants and premises.
*
*
*
*
*
(a) U.S. H5/H7 Avian Influenza
Monitored. The program in this
E:\FR\FM\05DEP1.SGM
05DEP1
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules
paragraph (a) is intended to be the basis
from which the egg/meat-type game bird
and egg/meat-type waterfowl 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 egg/meat-type game birds
and egg/meat-type waterfowl through
routine surveillance of each
participating slaughter plant or, in the
case of egg-producing flocks, the regular
surveillance of these flocks. A slaughter
plant or flock will qualify for the
classification in this paragraph (a) when
the Official State Agency determines
that it has met one of the following
requirements:
*
*
*
*
*
(2) It is a meat-type game bird
slaughter plant or meat-type waterfowl
slaughter plant that only accepts egg/
meat-type game birds or egg/meat-type
waterfowl from flocks where a
minimum of 11 birds per flock have
been tested negative for the H5/H7
subtypes of avian influenza, as provided
in § 146.13(b), no more than 21 days
prior to slaughter;
*
*
*
*
*
§ 147.48 Approval of conference
recommendations by the Department.
Proposals adopted by the official
delegates will be recommended to the
Department for incorporation into the
provisions of the National Poultry
Improvement Plan (NPIP) in parts 56,
145, and 146 of this chapter and this
subpart. The Department reserves the
right to approve or disapprove the
recommendations of the conference as
an integral part of its sponsorship of the
National Poultry Improvement Plan.
The Department will publish the
recommendations in the Federal
Register within 14 months following the
NPIP Biennial Conference.
■ 40. In § 147.52, paragraph (b) is
revised to read as follows:
§ 147.52
Authorized laboratories.
*
*
*
*
*
(b) Trained technicians. Testing
procedures at all authorized laboratories
must be run or overseen by a laboratory
technician who every 4 years has
attended, and satisfactorily completed,
Service-approved laboratory workshops
for Plan-specific diseases.
*
*
*
*
*
PART 147—AUXILIARY PROVISIONS
ON NATIONAL POULTRY
IMPROVEMENT PLAN
Done in Washington, DC, this 28th day of
October 2019.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
37. The authority citation for part 147
continues to read as follows:
[FR Doc. 2019–23973 Filed 12–4–19; 8:45 am]
■
BILLING CODE 3410–34–P
Authority: 7 U.S.C. 8301–8317; 7 CFR
2.22, 2.80, and 371.4.
38. Section 147.45 is revised to read
as follows:
SMALL BUSINESS ADMINISTRATION
■
jbell on DSKJLSW7X2PROD with PROPOSALS
§ 147.45
13 CFR Part 124
Official delegates.
Each cooperating State shall be
entitled to one official delegate for each
of the programs prescribed in parts 145
and 146 of this subchapter in which it
has one or more participants at the time
of the Conference. The official delegates
shall be elected by a representative
group of participating industry members
and be certified by the Official State
Agency. It is recommended but not
required that the official delegates be
Plan participants. Individuals may be
allowed to be an official delegate or
alternate delegate for up to three States
in which that delegate has flocks or is
a plan participant with
acknowledgement and approval of the
Official State Agencies. Each official
delegate shall endeavor to obtain, prior
to the Conference, the recommendations
of industry members of their State with
respect to each proposed change.
■ 39. Section 147.48 is revised to read
as follows:
VerDate Sep<11>2014
17:13 Dec 04, 2019
Jkt 250001
Tribal Consultations for Consolidation
of Mentor Prote´ge´ Programs and Other
Government Contracting Amendments
(RIN 3245–AG94)
U.S. Small Business
Administration.
ACTION: Notice of tribal consultation
meetings.
AGENCY:
The U.S. Small Business
Administration (SBA) announces that it
is holding tribal consultation meetings
in Minneapolis, Minnesota, Anchorage,
Alaska, Albuquerque, New Mexico, and
Oklahoma City, Oklahoma concerning
the proposed revisions to the 8(a)
Business Development (BD) program
regulations. Testimony presented at
these tribal consultations will become
part of the administrative record for
SBA’s consideration when the Agency
deliberates on approaches to changes in
the regulations pertaining to the 8(a) BD
program.
SUMMARY:
PO 00000
Frm 00017
Fmt 4702
Sfmt 4702
66647
The Tribal Consultation meeting
dates are as follows:
1. Tuesday, December 10, 2019, 10:00
a.m. to 2:00 p.m. (CST), Minneapolis,
Minnesota. The pre-registration
deadline for this Tribal Consultation
meeting is December 6, 2019.
2. Wednesday, January 8, 2020, 10:00
a.m. to 4:00 p.m. (AKST), Anchorage,
Alaska. The pre-registration deadline for
this Tribal Consultation meeting is
January 2, 2020.
3. Tuesday, January 14, 2020, 10:00
a.m. to 2:00 p.m. (MST), Albuquerque,
New Mexico. The pre-registration
deadline for this Tribal Consultation
meeting is January 7, 2020.
4. Thursday, January 16, 2020, 10:00
a.m. to 2:00 p.m. (CST), Oklahoma City,
Oklahoma. The pre-registration deadline
for this Tribal Consultation meeting is
January 9, 2020.
ADDRESSES:
1. The Tribal Consultation meeting in
Minneapolis, Minnesota will be held at
the SBA Minnesota District Office,
Training Center, 330 Second Avenue
South, Minneapolis, MN 55401.
2. The Tribal Consultation meeting in
Anchorage, Alaska will be held at the
Z.J. Loussac Public Library, 3600 Denali
Street, Anchorage, AK 99503.
3. The Tribal Consultation meeting in
Albuquerque, New Mexico will be held
at the Indian Pueblo Cultural Center,
2401 12th Street NW, Albuquerque,
New Mexico 87104.
4. The Tribal Consultation meeting in
Oklahoma City, Oklahoma will be held
at the Francis Tuttle Technology Center,
Corporate Training Center Building,
12777 North Rockwell Avenue,
Oklahoma City, OK 73142.
5. Send pre-registration requests to
attend and/or testify to Chequita Carter
of SBA’s Office of Native American
Affairs, U.S. Small Business
Administration, 409 3rd Street SW,
Washington, DC 20416;
Chequita.Carter@sba.gov; or Facsimile
to (202) 481–2177.
6. You may submit comments,
identified by RIN 3245–AG94, by any of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov and follow the
instructions for submitting comments.
• Mail (for paper, disk, or CD–ROM
submissions): To Brenda Fernandez,
Office of Procurement Policy and
Liaison, U.S. Small Business
Administration, 409 3rd Street SW,
Washington, DC 20416; or
Brenda.Fernandez@sba.gov.
Instructions: All submissions received
must include the agency name and
docket number or Regulatory
Information Number (RIN) for this
DATES:
E:\FR\FM\05DEP1.SGM
05DEP1
Agencies
[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Proposed Rules]
[Pages 66631-66647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23973]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 /
Proposed Rules
[[Page 66631]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 56, 145, 146, and 147
[Docket No. APHIS-2018-0062]
RIN 0579-AE49
National Poultry Improvement Plan and Auxiliary Provisions
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: We are proposing to amend the regulations governing the
National Poultry Improvement Plan (NPIP). These amendments would
establish a U.S. Newcastle Disease Clean program within the NPIP,
create an NPIP subpart specific to game birds, revise testing
requirements, and clarify existing provisions of the regulations. We
are also proposing to amend the regulations concerning the payment of
indemnity and compensation for low pathogenic avian influenza to
reflect current policy and operational practices, and to allow NPIP
voting delegates to represent multiple States during the Biennial
Conferences. These proposed changes were voted on and approved by the
voting delegates at the NPIP's 2018 National Plan Conference.
DATES: We will consider all comments that we receive on or before
February 3, 2020.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2018-0062.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2018-0062, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2018-
0062 or in our reading room, which is located in Room 1141 of the USDA
South Building, 14th Street and Independence Avenue SW, Washington, DC.
Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 799-7039 before coming.
FOR FURTHER INFORMATION CONTACT: Dr. Elena Behnke, DVM, Senior
Coordinator, National Poultry Improvement Plan, VS, APHIS, USDA, 1506
Klondike Road, Suite 101, Conyers, GA 30094-5104; (770) 922-3496.
SUPPLEMENTARY INFORMATION:
Background
The National Poultry Improvement Plan (NPIP, also referred to below
as ``the Plan'') is a cooperative Federal-State-industry mechanism for
controlling certain poultry diseases. The Plan consists of a variety of
programs intended to prevent and control poultry diseases.
Participation in all Plan programs is voluntary, but breeding flocks,
hatcheries, and dealers must first qualify as ``U.S. Pullorum-Typhoid
Clean'' as a condition for participating in the other Plan programs.
The Plan identifies States, independent flocks, hatcheries,
dealers, and slaughter plants that meet certain disease control
standards specified in the Plan's various programs. As a result,
customers can buy poultry that has tested clean of certain diseases or
that has been produced under disease-prevention conditions.
The regulations in 9 CFR parts 56, 145, 146, and 147 (referred to
below as the regulations) contain the provisions of the Plan. The
Animal and Plant Health Inspection Service (APHIS) amends these
provisions from time to time to incorporate new scientific information
and technologies within the Plan, and to ensure the plan reflects
changes to the poultry industry itself. The changes we are proposing,
which are discussed below, were approved by the voting delegates at the
Plan's 2018 Biennial Conference.
Participants and voting delegates at the Biennial Conference
represented the poultry industry, flock owners, breeders, hatchery men,
slaughter plants, poultry veterinarians, diagnostic laboratory
personnel, Official State Agencies from cooperating States, and other
poultry industry affiliates. The proposed amendments are discussed in
the order they would appear in the regulations.
Proposed Amendments to Part 56
Definitions
The terms H5/H7 LPAI exposed and H5/H7 LPAI infection (infected)
are currently defined in Sec. 56.1 of the regulations in a manner that
describes the risks or effects of poultry being exposed to or
contracting the virus.
The current definition of H5/H7 LPAI exposed provides that all
birds or poultry associated with H5/H7 infected birds or poultry,
whether it is via excrement or other materials, are automatically
placed in the exposed category. This could be construed to suggest that
an exposed flock is potentially infectious because the birds in the
flock have had contact with the virus in some manner. However, this is
not the case. Although ``exposed'' birds have been exposed to the
virus, they are no longer shedding the virus and no longer considered
to be potentially infectious. As such, they can go to slaughter to be
controlled marketed, instead of being depopulated. Therefore, we are
proposing to amend the terms and definitions of H5/H7 LPAI infection
(infected) and H5/H7 LPAI exposed.
The new terms would be H5/H7 LPAI virus exposed (non-infectious)
and H5/H7 LPAI virus actively infected (infectious). We are proposing
to define H5/H7 LPAI virus exposed (non-infectious) in the following
way. Poultry would be considered to be exposed (non-infectious) to H5/
H7 LPAI for purposes of the regulations if:
Antibodies to the H5 or H7 subtype of the AI virus that
are not a consequence of vaccination have been detected in poultry, and
Samples collected from the flock using real-time reverse
transcription polymerase chain reaction (RT-PCR) or virus isolation are
determined to be not infectious for H5/H7 LPAI.
The definition would also provide that the official determination
that H5/H7 LPAI virus exposure has occurred is by the identification of
antibodies to the H5 or H7 subtype of AI virus detected and may only be
made by APHIS' National Veterinary Services Laboratories (NVSL).
[[Page 66632]]
We are proposing to define H5/H7 LPAI virus actively infected
(infectious) in the following way. Poultry would be considered to be
infected with H5/H7 LPAI for purposes of the regulations if:
H5/H7 LPAI virus has been isolated and identified as such
from poultry; or
Viral antigen or viral RNA specific to the H5 or H7
subtype of AI virus has been detected in poultry.
The definition would also provide that the official determination
that H5/H7 LPAI virus has been isolated and identified, or viral
antigen or viral RNA specific to the H5 or H7 subtype of AI virus has
been detected, may only be made by NVSL.
We would also revise references to H5/H7 LPAI) infection (infected)
and H5/H7 LPAI exposed throughout part 56 of the regulations to these
two new terms instead.
We believe the revised terms better clarify the distinction between
exposed and infected poultry.
We are also proposing to add definitions for cleaning,
compensation, disinfection, indemnity, and virus elimination (VE) to
Sec. 56.1 of the regulations.
We would define cleaning as the removal of gross contamination,
organic material, and debris from the premises or respective
structures, via mechanical means like sweeping (dry cleaning) and/or
the use of water and soap or detergent (wet cleaning), in order to
minimize organic material to prepare for effective disinfection.
We would define disinfection as methods used on surfaces to destroy
or eliminate H5/H7 LPAI virus through physical (e.g., heat) or chemical
(e.g., disinfectant) means, and would further specify that a
combination of methods may be required.
Section 56.3 of the regulations provides that APHIS may indemnify
persons for cleaning and disinfection of premises, conveyances, and
materials infected with or exposed to LPAI. While we believe it is
clear from context that Sec. 56.3 pertains only to cleaning and
disinfection associated with elimination of LPAI virus, rather than any
cleaning and disinfection activities whatsoever that may be conducted
on an affected premises, adding definitions of the terms to the
regulations would further clarify our intent.
For a similar reason, we are proposing to add the term virus
elimination after every reference to cleaning and disinfection in part
56 of the regulations. Virus elimination is the term used in many
foreign countries for cleaning and disinfection measures conducted to
destroy or eliminate all virus on an affected premises; we would define
it in that way in Sec. 56.1. This would also underscore the
restrictive sense in which cleaning and disinfection is being used
within part 56.
The term compensation would also be new to part 56. We would define
compensation in Sec. 56.1 as reimbursement for the activities
associated with the depopulation of infected or exposed poultry,
including the disposal of contaminated carcasses and materials and the
cleaning and disinfection of premises, conveyances, and materials that
came into contact with infected or exposed poultry. The definition
would further provide that, in the case of contaminated materials, if
the cost of cleaning and disinfection would exceed the value of the
materials, or cleaning and disinfection would be impracticable for any
reason, APHIS would base compensation on the fair market value
(depreciated value) of those materials. Finally, the definition would
specify that compensation does not include payment for depopulated
birds or eggs destroyed, as those payments would constitute indemnity.
We would define indemnity as payments representing the fair market
value of destroyed birds and eggs. Indemnity would not include
reimbursements for depopulation (by which we mean the act of
depopulation, rather than the depopulated poultry), or for disposal,
destroyed materials, or cleaning and disinfection (virus elimination)
activities, as these would be covered under the definition of
compensation.
Currently, the regulations in part 56 refer only to indemnity,
regardless of the activity for which APHIS is providing reimbursement.
However, the procedures for the payment of indemnity for destroyed
birds or eggs differ significantly from those for the payment of
indemnity for cleaning and disinfection. As a result, APHIS' Veterinary
Services (VS) program, in conjunction with State departments of
agriculture, has developed a guidance document, VS Guidance document
8601.2 that clarifies how the two processes differ.\1\ The guidance
document makes the distinction between compensation and indemnity that
we are proposing to codify in the regulations themselves. We would also
amend part 56 throughout to change references to ``indemnity'' that
pertain to reimbursement for activities, rather than the destroyed
poultry or eggs themselves, to ``compensation.''
---------------------------------------------------------------------------
\1\ See https://poultryimprovement.org/documents/ISRCPGuidanceDocument.pdf.
---------------------------------------------------------------------------
Payment of Indemnity
The regulations in Sec. 56.3 describe conditions for the payment
of indemnity for H5/H7 LPAI. Paragraph (a) of the section lists
activities that may be eligible for indemnity for H5/H7 LPAI: The
destruction and disposal of infected poultry, the destruction of any
eggs during outbreak testing, and disinfection of areas and materials
that have come in contact with infected poultry. Paragraph (b)
describes the percentage of costs that are eligible for indemnity for
the listed activities, depending on certain criteria.
Currently, paragraph (b) provides that, if poultry meet the
definition of commercial, but does not participate in their respective
NPIP Avian Influenza program, the maximum amount of indemnity that may
be paid for eligible activities is 25 percent. Commercial poultry that
do participate in Plan AI programs, however, may receive up to 100
percent indemnity.
This paragraph currently does not reflect the fact that the NPIP
regulations themselves specifically exempt poultry operations that fall
below certain size thresholds from having to participate in the NPIP AI
programs. The exemption numbers are currently listed in 9 CFR part 146.
We are proposing to amend paragraph (b) to clarify that poultry
operations that are exempted by the Plan regulations from having to
participate in Plan AI programs because of their size may still receive
up to 100 percent indemnity and/or compensation for eligible
activities.
Determination of Indemnity
The current regulations in Sec. 56.4 describe how APHIS determines
fair market value regarding the destruction of infected or exposed
poultry; this includes determining indemnity for cleaning and
disinfection procedures. The regulations currently state that APHIS
will use an appraisal by an APHIS official appraiser and State official
appraiser, or, in instances when APHIS and State authorities agree,
either the APHIS appraiser or State appraiser alone, to determine fair
market value for indemnity for destroyed poultry and eggs. However, we
have discontinued use of appraisers in favor of an indemnity calculator
drawn from multiple data points in order to determine fair market value
for destroyed birds and eggs. We are therefore proposing to amend Sec.
56.4 to indicate that appraisal calculator values will be used to
determine the amount of indemnity paid for destroyed birds and eggs.
[[Page 66633]]
Section 56.4 also describes how reimbursement may be paid for
disposal activities. Currently, as a precondition for submitting a
claim, the claimant, Cooperating State Agency, and APHIS must jointly
enter into a cooperative agreement. However, State Agencies have stated
that their participation in the cooperative agreement is not necessary.
We are proposing to amend the regulations accordingly.
Finally, Sec. 56.4 describes how indemnity may be paid for
cleaning and disinfection activities. Currently, we require the
claimant, the Cooperating State Agency, and APHIS to enter into a
compliance agreement. The claimant then submits receipts or other
documentation regarding the activities, and APHIS evaluates them
against the cleaning and disinfection procedures in Sec. 56.5 of the
regulations and the initial State response and containment plan, the
requirements for which are found in Sec. 56.10 of the regulations.
To streamline reimbursement for cleaning and disinfection
activities, we have developed a calculator for cleaning and
disinfection as well, the APHIS flat-rate virus elimination (VE)
calculator. The calculator provides a per-square-foot rate for premises
with floor-raised birds and per-cubic-foot rate for premises with caged
birds for cleaning and disinfection activities that we have previously
determined to fall within the scope of the regulations as reimbursable
activities.
While the VE calculator covers the majority of production types and
VE scenarios, it does not cover every possibility. In such instances,
the existing procedures for claiming compensation for cleaning and
disinfection would apply. The floor-raised rates would be used by APHIS
as the baseline for compensation in such instances, and the claimant
would be afforded the opportunity to demonstrate through receipts or
other documentation the uniqueness of his or her situation.
NPIP Certifications for Poultry Moved for Controlled Marketing
Section 56.5 provides that, at the discretion of APHIS and the
Cooperating State Agency, poultry that has been infected with or
exposed to H5/H7 LPAI may be moved for controlled marketing rather than
depopulated. We are proposing to amend the section to indicate that
poultry moved for controlled marketing maintain their current NPIP
certifications. This amendment would help provide assurances to
slaughtering facilities that receive such flocks.
Revisions to Part 145
Definitions
Section 145.1 of the regulations provides general definitions of
terms used within the NPIP regulations. We are proposing to add a
definition for the term Newcastle disease, and to revise the existing
definition for avian influenza. Both the new definition and the revised
definition would be modeled on the definitions of these terms found in
the World Organization for Animal Health's (OIE's) Terrestrial Animal
Health Code, to which the United States is a signatory.\2\
---------------------------------------------------------------------------
\2\ To view the Code, go to https://www.oie.int/standard-setting/terrestrial-code/access-online/.
---------------------------------------------------------------------------
Specific Provisions for Participating Dealers
Section 145.7 of the regulations requires participating dealers to
follow all applicable provisions in part 145. However, the section
refers to dealers in ``poultry breeding stock, hatching eggs, or baby
or started poultry'' while the definition of dealer in Sec. 145.1
refers to dealers as individuals or businesses that deal in commerce
with hatching eggs, newly-hatched poultry, and/or started poultry. We
are proposing to revise Sec. 145.7 so that it refers to dealers using
the same term as in the definition in Sec. 145.1. The revised section
would also indicate that dealers must comply with the regulations in
the relevant part of the NPIP regulations. It would also specify the
NPIP Program Standards that are applicable to such dealers, as well as
the provisions of the NPIP regulations that provide for approval of
alternatives to those standards.
Testing
The regulations in Sec. Sec. 145.14 and 146.13 discuss the
official avian influenza (AI) antibody detection tests, the enzyme-
linked immunosorbent assay (ELISA) test and agar gel immunodiffusion
(AGID) test, in regard to poultry testing requirements within the NPIP.
We are proposing to require that, when ELISA test samples are
positive for AI, an AGID test must be conducted within 48 hours. This
is because the AGID test is used as a confirmatory test on presumptive
positives using the ELISA test. Timely corroboratory testing is
therefore necessary in order to determine the disease status of the
tested flock. Additionally, the AGID test must comply with the relevant
NPIP requirements and would specify the relevant NPIP Program
Standards, as well as provide a citation to the provisions for approval
of alternate standards.
Additionally, these sections currently provide that agent detection
tests for AI may be used to detect influenza A matrix gene or protein.
We are proposing to amend these sections to provide that agent
detection tests may be used to detect influenza A virus rather than
specifically influenza A matrix gene or protein. The existing
limitation imposes an unnecessary technical restriction on test design
and precludes the use of lateral flow antigen immunoassays that target
the influenza nucleoprotein and still reliably indicate the presence or
absence of AI in a test sample.
For reasons that we discuss below, we are also proposing to add
provisions regarding official tests for Newcastle disease (ND) to these
two sections. The regulations would say that the official ND tests are
serological tests for antibody detection and molecular-based tests for
antigen detection that are listed in the Program Standards document as
determined by APHIS to reliably detect ND infection. The Program
Standards document would indicate that the approved serological tests
for ND are currently the ELISA and hemagglutination inhibition (HI)
tests, and the approved molecular-based test for ND is PCR.
Proposed Newcastle Disease Clean Program
The regulations in Sec. 145.43 provide disease-free, or Clean,
classifications that may be applied to turkey breeding flocks, and eggs
and poults from turkey breeding flocks, provided that they meet certain
requirements demonstrating freedom from that disease. Similar
classification systems exist in Sec. 145.45 for compartments within
the turkey breeding-hatchery industry; Sec. 145.73 for egg-type
chicken breeding flocks, as well as their eggs and chicks; Sec. 145.74
for compartments within the egg-type chicken breeding-hatchery
industry; Sec. 145.83 for meat-type chicken breeding flocks, as well
as their eggs and chicks; and Sec. 145.84 for compartments within the
meat-type chicken breeding-hatchery industry.
We are proposing to amend each of these sections to establish an ND
Clean program. The ND Clean program is intended to allow the turkey
breeding-hatchery, egg-type chicken breeding-hatchery, and meat-type
chicken breeding-hatchery industries, as well as compartments within
those industries, to demonstrate freedom from ND based on vaccination
and/or monitoring of each participating breeding flock. Lastly, in
regards to this paragraph's
[[Page 66634]]
language, we note that the original voting resolution in Sec. 145.43
stated ``vaccination and monitoring of each participating breeding
flock;'' however, given that vaccination is optional, we have replaced
``and'' with ``and/or'' to accurately reflect the intended
requirements.
For a flock to gain ND Clean status, the Official State Agency
(OSA) would have to determine that the flock is a primary breeding
flock that either (1) has been vaccinated for ND using USDA-licensed
vaccines and response to vaccination is serologically monitored using
an approved serological ND test when the birds are more than 4 months
of age; or (2) is unvaccinated for ND, in which a minimum of 30 birds
have tested negative to ND using an approved test when more than 4
months of age. We would require serological testing for vaccinated
flocks because it indicates the increased presence of antibodies in
vaccinated birds.
To retain ND Clean classification for a vaccinated flock, the
vaccine would have to be a USDA-licensed vaccine administered during
the early stages of development through rearing, and an inactivated
vaccine as final vaccination prior to the onset of egg production; the
flock would have to be have been monitored for antibody response using
an approved serological test (again, currently the ELISA or HI test)
and the results would have to be compatible with immunological response
against ND vaccination; and testing would have to include a minimum of
30 birds with a serologic monitoring program when the birds are more
than 4 months of age and prior to the onset of production and not
longer than every 90 days thereafter.
To retain ND Clean classification for unvaccinated flocks, during
each 90-day period, all primary spent fowl, up to a maximum of 30,
would have to test negative to ND within 21 days prior to movement to
slaughter; and either a minimum of 30 birds for flock would have to
test negative using an approved ND test (either serological or
molecular-based) at intervals of 90 days, or a sample of fewer than 30
birds could be tested, provided that all pens are equally represented
and a total of 30 birds is tested within each 90 day period.
Finally, for an ND Clean program for flocks to exist within a
State, ND would have to be a disease reportable to the responsible
State authority by all licensed veterinarians within the State. To
accomplish this, all laboratories (including private, State, and
university laboratories) that perform diagnostic procedures on poultry
would have to examine all submitted cases of unexplained respiratory
disease, egg production drops, and mortality for ND. In Sec. 145.15 of
the regulations, as a general NPIP requirement, we require diagnostic
surveillance for LPAI within participating States. Part of this
diagnostic surveillance must include LPAI being a reportable disease.
This requirement for the ND Clean program is modeled on that existing
requirement for LPAI surveillance.
The requirements for ND Clean compartments would be similar to the
existing requirements for AI Clean compartments, and we would
accordingly revise sections of the regulations regarding the
establishment and maintenance of AI Clean compartments so that they
would also apply to the establishment and maintenance of ND Clean
Compartments.
Removal of the Pullorum Typhoid Agglutination Test for S. Enteritidis
Clean Classifications
The regulations in Sec. Sec. 145.23(d), 145.73(d), and 145.83(d)
contain requirements for S. Enteritidis Clean classifications in the
multiplier egg-type chicken breeding industry, primary egg-type chicken
breeding industry, and primary meat-type chicken breeding industry,
respectively. We are proposing to remove testing using the pullorum-
typhoid (PT) agglutination test from the U.S. S. Enteritidis Clean
classification requirements.
The PT agglutination test was adopted as a test for S. enteritidis
in the 1980s based on similarities between the two diseases, and on the
presumption that it could be used for both diseases. However, the test
has since proven to be unreliable in detecting the presence of S.
enteritidis. It would, however, continue to be used for testing for PT,
for which it is reliable.
Revisions to Testing Protocols for AI in the Multiplier Meat-Type
Chicken Breeding Industry
Section 145.33 contains, among other things, requirements for
determining a participating multiplier meat-type chicken breeding flock
is free of AI for purposes of a Clean classification. Paragraph (l)(1)
of that section provides three different possible testing protocols for
a flock to retain Clean status.
While the first option states at least 15 birds must test negative
at intervals of 90 days, and the third option requires a total of 15
samples collected and tested within a 90 day period, the second option
requires 30 birds to be tested within each 90 day testing period. Our
intent has always been that a total of 15 birds must be tested in each
of the three options to retain the AI Clean classification; the
discrepancy in the second option is the result of a drafting error. We
are proposing to revise the second option to correct this error.
The section also currently requires serological tests for testing
of multiplier spent fowl. This limitation is not warranted because
molecular-based tests such as PCR are also reliable for such testing.
We are proposing to revise the section so that any AI test approved in
accordance with Sec. 145.14 may be used.
Proposed Revisions to NPIP Provisions for Hobbyist and Exhibition
Waterfowl, Exhibition Poultry and Raised-for-Release Waterfowl Breeding
Flocks and Products
Subpart E of part 145, ``Special Provisions for Hobbyist and
Exhibition Waterfowl, Exhibition Poultry, and Game Bird Breeding Flocks
and Products'' (Sec. Sec. 145.51-145.54), contains Plan requirements
specific to the hobbyist, exhibition, and game bird industries. We are
proposing several changes to this subpart.
First, we are proposing to remove all references to game birds from
subpart E due to the addition of proposed subpart J to part 145. The
game bird industry has grown rapidly and has become more complex since
its inception, and the terminology, production methods, and end uses in
the industry are now significantly different than those in other
poultry industries. Currently, subpart E does not have specific
requirements for any one group of birds covered by its provisions, and
subpart J would add testing regimes, terminology, and programs
specifically designed for the game bird industry.
In addition to the removal of game bird references, we would revise
all references to ``waterfowl'' within the subpart to instead refer to
``raised-for-release waterfowl,'' and would remove the definition for
waterfowl from Sec. 145.51 of the regulations, and add a definition
for raised-for-release waterfowl in its place. We are proposing to
define raised-for-release waterfowl as domesticated fowl that normally
swim, such as ducks and geese, grown under confinement for the primary
purpose of producing eggs, chicks, started, or mature birds for release
on game preserves or in the wild.
Waterfowl is currently defined in Sec. 145.51 as domesticated fowl
that normally swim, such as ducks and geese, and it is only apparent
from subsequent sections of subpart E that the subpart does not apply
to meat-type waterfowl, which are instead covered by
[[Page 66635]]
the provisions of a separate subpart I. These revisions would help to
further clarify the scope of subpart E.
We are also proposing to add a definition for hobbyist poultry. We
would define hobbyist poultry as domesticated fowl which are bred for
the purposes of meat and/or egg production on a small scale as
determined by the Official State Agency. This would also help clarify
the scope of subpart E.
Section 145.52 contains requirements that flocks of hobbyist and
exhibition waterfowl, exhibition poultry, and game bird breeding
flocks, and the eggs and baby poultry produced from them, must meet in
order to participate in the Plan.
We are proposing to amend the introductory text of the section to
remove the term ``baby poultry'' and instead indicate that it applies
to chicks, started, and mature poultry. This will provide more clarity
regarding the applicability of the section and align it with the
terminology used elsewhere in part 145 of the regulations. We are also
proposing revisions to the introductory text that reflect the usage the
term ``raised-for-release waterfowl'' throughout the subpart and the
creation of a new subpart J for gamebirds.
Paragraph (c) of Sec. 145.52 currently recommends that waterfowl
and gallinaceous flocks in open-air facilities be kept separate.
However, it is a best practice not to commingle waterfowl, which can
act as asymptomatic vectors of disease, and gallinaceous flocks,
regardless of whether they are kept in contained or open-air
facilities. We are proposing to amend paragraph (c) accordingly.
Finally, we are proposing to add a paragraph (f) to the section to
indicate that all participating raised-for-release waterfowl flocks,
whether breeders or non-breeders, will be considered to be enrolled
under subpart E of part 145 of the regulations. While provisions for
non-breeding raised-for-release flocks are contained in part 146 of the
regulations, rather than part 145, the testing requirements are
identical. This will afford Plan participants some discretion in
revising the intended use of a particular flock without jeopardizing
the flock's status.
Terminology and Classification; Flocks and Products
Section 145.53 of the regulations provide Clean classifications
that may be applied to participating hobbyist and exhibition waterfowl,
exhibition poultry, and game bird breeding flocks, and the eggs and
baby poultry produced from them, provided that they meet certain
requirements demonstrating freedom from that disease. We are proposing
several changes to this section. This section would also discuss that
hatcheries should be kept in sanitary conditions according to their
relevant subpart and would specify the applicable part of the NPIP
Program Standards that pertains to such hatcheries.
In paragraph (b)(5), we are proposing to remove the term
``exhibition waterfowl'' and use the term ``exhibition poultry.''
Additionally, paragraph (f) of Sec. 145.53 contains requirements
for a Salmonella Monitored classification. The Salmonella program
currently only contains Salmonella testing and interventions at the
hatchery level, and calls for five environmental samples from a
hatchery every 30 days performed at an authorized laboratory in order
for breeders to claims their products are monitored for Salmonella. We
are proposing to add requirements for representative sampling of
pullets and breeder farms. Hatched chicks transferred to farms are
still at risk of contracting Salmonella.
Special Provisions for Egg/Meat-Type Game Bird and Raised-for-Release
Game Bird Breeding Flocks and Products
As we mentioned above, we are proposing to establish a new subpart
J for the game bird industry. We are amending Sec. Sec. 145.24,
145.34, 145.44, 145.54, and 145.94 to align them with the rest of the
section regarding testing. The separation of the game bird industry
from hobby and exhibition poultry in subpart E is necessary because the
current definitions and provisions do not match the production methods
and end uses for the game bird industry.
Subpart J would consist of four sections: Sec. Sec. 145.101 for
definitions, 145.102 for participation, 145.103 for terminology and
classification of flocks and products, and 145.104 for terminology and
classification of States.
The requirements in proposed subpart J are drawn from the existing
requirements in subpart E; however, some of the definitions, terms, and
provisions would be unique to subpart J, and reflect the unique nature
of the game bird industry. Key differences between subpart E and
subpart J include the following:
In subpart J, we are proposing to allow breeders to also
hatch and/or grow out birds and still meet the definition of breeder.
This will have the effect of allowing premises with breeding and ``grow
out'' birds to be covered under one NPIP number, and will account for a
common production model in the game bird industry.
We are proposing definitions for the terms dealer, grower,
and hatchery. Subpart E relies on the general definition for dealer in
Sec. 145.1 of the regulations, and does not contain definitions for
growers or hatcheries. However, in order for NPIP to accurately
register game bird operations, definitions of these three terms are
warranted within subpart J.
The terms chick, egg, mature bird, and started bird, and
raised-for-release bird would be defined within subpart J. Definitions
are warranted in order to characterize these products within the game
bird industry.
While subpart E requires hatching eggs produced by
breeding flocks to be fumigated or otherwise sanitized, subpart J would
provide a third option in addition to fumigation or sanitization,
``nest cleaning.'' ``Nest clean'' eggs are produced within the game
bird industry on wire or otherwise away from the litter.
We are proposing to allow a breeder, hatchery, or grower
to also be a dealer without being categorized as a dealer, provided
that, when reselling products, the breeder, hatchery, or grower has
purchased those products from an NPIP participant with equal or greater
classifications or from a flock with equivalent or greater testing
requirements under official supervision. This allowance would simplify
the registration and recordkeeping process for Plan participants within
the game bird industry.
The Pullorum-Typhoid Clean classification requirements
reflect the terminology and production methods in the game bird
industry.
Proposed Amendments to Part 146
Part 146, subpart E, contains definitions and requirements for Plan
participants within the game bird, commercial waterfowl, and raised-
for-release waterfowl industries who produce meat- or egg-type flocks.
We are proposing to update the terminology in subpart E to match
the other subparts within part 146 by replacing the term ``commercial''
with ``egg/meat-type.''
Additionally, we are proposing to eliminate all provisions related
to ``grow-out'' production from part 146; such poultry would be
included in subpart E and our proposed subpart J within part 145.
Proposed Amendments to Part 147
Official Delegates
Section 147.45 provides requirements regarding delegation and voter
[[Page 66636]]
representation for the NPIP's Biennial Conferences. The text currently
states that each cooperating State is entitled to one official delegate
for each of the programs in parts 145 and 146.
We are proposing to allow a single, participating delegate to
represent multiple States. Companies often have operations in various
States, and this change would help those companies save money by
appointing a single individual to represent all of the States where the
company has operations.
Approval of Conference Recommendations by the Department
Section 147.48 discusses the incorporation of recommendations from
the NPIP Biennial Conferences into the NPIP provisions. The regulations
do not currently have an established timeframe for the publication of
NPIP Biennial Conference proposed changes; therefore, we are proposing
to establish that we would publish a proposed rule to amend the
regulations in the Federal Register within 14 months of the Biennial
Conference. This will help ensure that, when a Biennial Conference is
reviewing recommendations for amendments to the regulations, the
regulations are up-to-date at the time of the Conference.
Authorized Laboratories
In Sec. 147.52, the regulations state the minimum requirements for
an APHIS authorized laboratory evaluation to ensure that they are in
compliance with NPIP regulations. Within Sec. 147.52, paragraph (b)
contains requirements to be a trained laboratory technician. Currently,
testing procedures may only be overseen by technicians who successfully
complete Service-approved laboratory workshops for Plan-specific
diseases within the past 4 years.
We are proposing to amend Sec. 147.52(b) by removing the word
``within'' and replacing it with the word ``every.'' Technicians should
attend a workshop for an individual Plan at 4-year intervals versus any
time during a 4-year span. We are also proposing a minor editorial
change to the paragraph which will indicate that ``all authorized
laboratories'' must be overseen by a technician who meets the
aforementioned criteria.
Executive Orders 12866 and 13771 and Regulatory Flexibility Act
This proposed rule has been determined to be not significant for
the purposes of Executive Order 12866 and, therefore, has not been
reviewed by the Office of Management and Budget. Further, because this
rule is not significant, it is not a regulatory action under Executive
Order 13771.
In accordance with the Regulatory Flexibility Act, we have analyzed
the potential economic effects of this action on small entities. The
analysis is summarized below. Copies of the full analysis are available
by contacting the person listed under FOR FURTHER INFORMATION CONTACT
or on the Regulations.gov website (see ADDRESSES above for instructions
for accessing Regulations.gov).
This rulemaking would result in various changes to regulations in 9
CFR parts 56 and 145 through 147, modifying provisions of the NPIP. The
modifications are recommended by the NPIP General Conference Committee
(GCC), which represents cooperating State agencies and poultry industry
members and advises the Secretary on issues pertaining to poultry
health. The proposed rule would, among other changes, remove the
Pullorum-Typhoid agglutination test as a test under which a flock can
achieve Salmonella enteritidis clean classification, due to its
unreliability; propose a Newcastle Disease Clean Program; specify that
ELISA-positive samples for Avian Influenza (AI) must be sent for
corroboratory testing within 48 hours; and broaden the criteria under
which AI detection tests can be approved, while still requiring that
the tests reliably detect AI virus. In addition, the proposed rule
would clarify the testing period for AI tests to maintain AI Clean
classification by correcting an editorial error; clarify that flocks
that have been designated exposed to HPAI are not considered
infectious; clarify when indemnity may be paid to breeders within the
NPIP program; clarify the types of poultry in commerce; and clarify
that NPIP dealers must follow the Program Standards in addition to the
regulations. The proposal would create NPIP provisions specific to the
game bird breeders industry and would set forth Salmonella testing for
breeders, in addition to hatchers, relative to Salmonella Monitored
status.
These changes would align the regulations with international
standards and make them more transparent to APHIS stakeholders and the
general public. The changes included in this rule were voted on and
approved by the voting delegates at the Plan's 2018 Biennial
Conference.
The establishments that would 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 GCC on
behalf of Plan members, that is, changes recognized by the poultry
industry as in their interest. We note that NPIP membership is
voluntary. Under these circumstances, the Administrator of the Animal
and Plant Health Inspection Service has determined that this action, if
promulgated, will not have a significant economic impact on a
substantial number of small entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 2 CFR chapter IV.)
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are in conflict with this rule will
be preempted; (2) no retroactive effect will be given to this rule; and
(3) administrative proceedings will not be required before parties may
file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with Section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the reporting, recordkeeping, and
third-party disclosure requirements included in this proposed rule have
been submitted for approval to the Office of Management and Budget
(OMB). Please send comments on the Information Collection Request (ICR)
to OMB's Office of Information and Regulatory Affairs via email to
[email protected], Attention: Desk Officer for APHIS,
Washington, DC 20503. Please state that your comments refer to Docket
No. APHIS-2018-0062. Please send a copy of your comments to the USDA
using one of the methods described under ADDRESSES at the beginning of
this document.
APHIS is proposing to amend the National Poultry Improvement
Program regulations to establish a U.S. Newcastle Disease Clean program
within NPIP. The Newcastle Disease Clean program is intended to allow
the turkey breeding-hatchery, egg-type chicken breeding-hatchery, and
meat-type chicken breeding-hatchery industries, as well as compartments
within those industries, to demonstrate freedom from ND based
[[Page 66637]]
on vaccination and/or monitoring of each participating breeding flock.
APHIS intends to determine the presence of Newcastle disease virus
through vaccination and monitoring of each participating breeding
flock. Implementing this rule will require information collection
activities such as a revised flock selecting and testing reports;
applications for U.S. Avian Flu and Newcastle Disease clean
compartment, clean compartment component registrations, and compartment
component removal; component audits; compliance statements; compliance
agreements; description of business processes; biosecurity plans;
appraisal and indemnity claims; response and containment plans; and
recordkeeping.
We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection requirements.
These comments will help us:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology; e.g., permitting electronic
submission of responses).
Estimate of burden: Public burden for this collection of
information is estimated to average 1.84 hours per response.
Respondents: Commercial poultry producers and State agricultural
officials.
Estimated annual number of respondents: 1,361.
Estimated annual number of responses per respondent: 18.
Estimated annual number of responses: 23,857.
Estimated total annual burden on respondents: 43,810 hours. (Due to
averaging, the total annual burden hours may not equal the product of
the annual number of responses multiplied by the reporting burden per
response.)
A copy of the information collection may be viewed on the
Regulations.gov website or in our reading room. (A link to
Regulations.gov and information on the location and hours of the
reading room are provided under the heading ADDRESSES at the beginning
of this proposed rule.) Copies can also be obtained from Mr. Joseph
Moxey, APHIS' Information Collection Coordinator, at (301) 851-2483.
APHIS will respond to any ICR-related comments in the final rule. All
comments will also become a matter of public record.
E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the E-Government Act to promote the use of the internet
and other information technologies, to provide increased opportunities
for citizen access to Government information and services, and for
other purposes. For information pertinent to E-Government Act
compliance related to this proposed rule, please contact Mr. Joseph
Moxey, APHIS' Information Collection Coordinator, at (301) 851-2483.
List of Subjects
9 CFR Part 56
Animal diseases, Indemnity payments, Low pathogenic avian
influenza, Poultry.
9 CFR Parts 145, 146, and 147
Animal diseases, Poultry and poultry products, Reporting and
recordkeeping requirements.
Accordingly, we propose to amend 9 CFR parts 56, 145, 146, and 147
as follows:
PART 56--CONTROL OF H5/H7 LOW PATHOGENIC AVIAN INFLUENZA
0
1. The authority citation for part 56 continues to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
0
2. Section 56.1 is amended as follows:
0
a. By adding, in alphabetical order, definitions for Cleaning,
Compensation, and Disinfection;
0
b. By removing the definitions for H5/H7 LPAI exposed and H5/H7 LPAI
infection (infected); and
0
c. By adding, in alphabetical order, definitions for H5/H7 LPAI virus
actively infected (infectious), H5/H7 LPAI virus exposed (non-
infectious), Indemnity, and Virus elimination (VE).
The additions read as follows:
Sec. 56.1 Definitions.
* * * * *
Cleaning. The removal of gross contamination, organic material, and
debris from the premises or respective structures, via mechanical means
like sweeping (dry cleaning) and/or the use of water and soap or
detergent (wet cleaning), in order to minimize organic material to
prepare for effective disinfection.
* * * * *
Compensation. In the case of H5/H7 LPAI detection, compensation
specifically refers to reimbursement for the activities associated with
the depopulation of infected or exposed poultry, including the disposal
of contaminated carcasses and materials and the cleaning and
disinfection of premises, conveyances, and materials that came into
contact with infected or exposed poultry. In the case of contaminated
materials, if the cost of cleaning and disinfection would exceed the
value of the materials, or cleaning and disinfection would be
impracticable for any reason, APHIS will base compensation on the fair
market value (depreciated value) of those materials. Compensation does
not include payment for depopulated birds or eggs destroyed (see
definition of Indemnity in this section).
* * * * *
Disinfection. Methods used on surfaces to destroy or eliminate H5/
H7 LPAI virus through physical (e.g., heat) or chemical (e.g.,
disinfectant) means. A combination of methods may be required.
* * * * *
H5/H7 LPAI virus actively infected (infectious). (1) Poultry will
be considered to be infected with H5/H7 LPAI for the purposes of this
part if:
(i) H5/H7 LPAI virus has been isolated and identified as such from
poultry; or
(ii) Viral antigen or viral RNA specific to the H5 or H7 subtype of
AI virus has been detected in poultry.
(2) The official determination that H5/H7 LPAI virus has been
isolated and identified, or viral antigen or viral RNA specific to the
H5 or H7 subtype of AI virus has been detected, may only be made by the
National Veterinary Services Laboratories.
H5/H7 LPAI virus exposed (non-infectious). (1) Poultry will be
considered to be exposed (non-infectious) to H5/H7 LPAI for the
purposes of this part if:
(i) Antibodies to the H5 or H7 subtype of the AI virus that are not
a consequence of vaccination have been detected in poultry; and
(ii) Samples collected from the flock using real-time reverse
transcription polymerase chain reaction (RT-PCR) or virus isolation are
determined to be not infectious for H5/H7 LPAI.
[[Page 66638]]
(2) The official determination that H5/H7 LPAI virus exposure has
occurred is by the identification of antibodies to the H5 or H7 subtype
of AI virus detected and may only be made by the National Veterinary
Services Laboratories.
Indemnity. Payments representing the fair market value of destroyed
birds and eggs. Indemnity does not include reimbursements for
depopulation, disposal, destroyed materials, or cleaning and
disinfection (virus elimination) activities (see definition of
Compensation in this section).
* * * * *
Virus elimination (VE). Cleaning and disinfection measures
conducted to destroy or eliminate all AI virus on an affected premises.
0
3. Section 56.3 is amended by revising the section heading and
paragraphs (a) introductory text and (b) and (c) to read as follows:
Sec. 56.3 Payment of indemnity and/or compensation.
(a) Activities eligible for indemnity and/or compensation. The
Administrator may pay indemnity and/or compensation for the activities
listed in this paragraph (a), as provided in paragraph (b) of this
section:
* * * * *
(b) Percentage of costs eligible for indemnity. Except for poultry
that are described by the categories in this paragraph (b), the
Administrator is authorized to pay 100 percent of the costs and/or
compensation, as determined in accordance with Sec. 56.4, of the
activities described in paragraphs (a)(1) through (3) of this section,
regardless of whether the infected or exposed poultry participate in
the Plan. For infected or exposed poultry that are described by the
categories in this paragraph (b), the Administrator is authorized to
pay 25 percent of the costs of the activities described in paragraphs
(a)(1) through (3) of this section:
(1)(i) The poultry are from a breeding flock, commercial flock, or
slaughter plant that participates in any Plan program in part 145 or
146 of this chapter but that does not participate in the U.S. Avian
Influenza Clean, U.S. H5/H7 Avian Influenza Clean, or U.S. H5/H7 Avian
Influenza Monitored program of the Plan available to the flock in part
145 or 146 of this chapter; and
(ii) The poultry are from:
(A) A commercial table-egg laying premises with at least 75,000
birds; or
(B) A meat-type chicken slaughter plant that slaughters at least
200,000 meat-type chickens in an operating week; or
(C) A meat-type turkey slaughter plant that slaughters at least 2
million meat-type turkeys in a 12 month period; or
(D) A commercial waterfowl and commercial upland game bird
slaughter plant that slaughters at least 50,000 birds annually; or
(E) A raised-for-release upland game bird premises, raised-for-
release waterfowl premises, and commercial upland game bird or
commercial waterfowl producing eggs for human consumption premises that
raise at least 25,000 birds annually; or
(F) A breeder flock premises with at least 5,000 birds.
(2) The poultry are located in a State that does not participate in
the diagnostic surveillance program for H5/H7 LPAI, as described in
Sec. 146.14 of this chapter, or that does not have an initial State
response and containment plan for H5/H7 LPAI that is approved by APHIS
under Sec. 56.10, unless such poultry participate in the Plan with
another State that does participate in the diagnostic surveillance
program for H5/H7 LPAI, as described in Sec. 146.14 of this chapter,
and has an initial State response and containment plan for H5/H7 LPAI
that is approved by APHIS under Sec. 56.10.
(c) Other sources of payment. If the recipient of indemnity and/or
compensation for any of the activities listed in paragraphs (a)(1)
through (3) of this section also receives payment for any of those
activities from a State or from other sources, the indemnity and/or
compensation provided under this part may be reduced by the total
amount of payment received from the State or other sources to the
extent that total payments do not exceed 100 percent of total
reimbursable indemnity and/or compensation amounts.
0
4. Section 56.4 is revised to read as follows:
Sec. 56.4 Determination of indemnity and/or compensation amounts.
(a) Destruction and disposal of poultry. (1) Indemnity for the
destruction of poultry and/or eggs infected with or exposed to H5/H7
LPAI will be based on the fair market value of the poultry and/or eggs,
as determined by an appraisal. The appraisal will use the current APHIS
appraisal calculator values; if no such calculator value exists, an
APHIS official appraiser will provide an appraisal of fair market
value. An indemnity request form must be signed by the owners and
grower (if applicable) of the poultry and received by APHIS prior to
the destruction of the poultry and eggs, unless the owners, grower,
APHIS, and the Cooperating State Agency agree in writing that the
poultry may be destroyed immediately. Reports of appraisals must show
the number of birds and the value per head. Complete inventory records
of all birds and/or eggs on the premises must be provided to APHIS
prior to the start of depopulation.
(2) Compensation for disposal of poultry and/or eggs infected with
or exposed to H5/H7 LPAI will be based on receipts or other
documentation maintained by the claimant verifying expenditures for
disposal activities authorized by this part. Any disposal of poultry
infected with or exposed to H5/H7 LPAI for which compensation is
requested must be performed under a compliance agreement between the
claimant and APHIS. APHIS will review claims for compensation for
disposal to ensure that all expenditures relate directly to activities
described in Sec. 56.5 and in the initial State response and
containment plan described in Sec. 56.10. If disposal is performed by
the Cooperating State Agency, APHIS will compensate the Cooperating
State Agency for disposal under a cooperative agreement.
(3) The destruction and disposal of the poultry and/or eggs must be
conducted in accordance with the initial State response and containment
plan for H5/H7 LPAI, as described in Sec. 56.10.
(b) Cleaning and disinfection (virus elimination). (1) Compensation
for cleaning and disinfection (virus elimination) of premises,
conveyances, and materials that came into contact with poultry that are
infected with or exposed to H5/H7 LPAI will be determined using the
current APHIS flat-rate virus elimination (VE) calculator in effect at
the time of the infection.
(2) For premises types for which a flat-rate VE calculator is not
available, reimbursement will be based on receipts or other
documentation maintained by the claimant verifying expenditures for
cleaning and disinfection (virus elimination) activities authorized by
this part. Any cleaning and disinfection (virus elimination) of
premises, conveyances, and materials for which compensation is
requested must be performed under a compliance agreement between the
claimant, the Cooperating State Agency, and APHIS. APHIS will review
claims for compensation for cleaning and disinfection (virus
elimination) to ensure that all expenditures relate directly to
activities described in Sec. 56.5 and in the initial State response
and containment plan described in Sec. 56.10.
(i) In the case of materials, if the cost of cleaning and
disinfection (virus
[[Page 66639]]
elimination) would exceed the value of the materials or cleaning and
disinfection (virus elimination) would be impracticable for any reason,
compensation for the destruction of the materials will be based on the
fair market value (depreciated value) of those materials, as determined
by an appraisal. Materials will be appraised by an APHIS official
appraiser. Compensation for disposal of the materials will be based on
receipts or other documentation maintained by the claimant verifying
expenditures for disposal activities authorized by this part.
Appraisals of materials must be reported on forms furnished by APHIS
and must be signed by the appraisers and by the owners of the materials
to indicate agreement with the appraisal amount. Appraisals of
materials must be signed and received by APHIS prior to the disassembly
or destruction of the materials, unless the owners, APHIS, and the
Cooperating State Agency agree in writing that the materials may be
disassembled and/or destroyed immediately. Any disposal of materials
for which compensation is requested must be performed under a
compliance agreement between the claimant, the Cooperating State
Agency, and APHIS. APHIS will review claims for compensation for
disposal to ensure that all expenditures relate directly to activities
described in Sec. 56.5 and in the initial State response and
containment plan described in Sec. 56.10.
(ii) [Reserved]
(c) Requirements for compliance agreements. The compliance
agreement is a comprehensive document that describes the depopulation,
disposal, and cleaning and disinfection (virus elimination) plans for
poultry that were infected with or exposed to H5/H7 LPAI, or a premises
that contained such poultry. The compliance agreement must set out cost
estimates that include labor, materials, supplies, equipment, personal
protective equipment, and any additional information deemed necessary
by APHIS. A compliance agreement must indicate what tasks will be
completed, who will be responsible for each task, and how much the work
is expected to cost. 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.
(Approved by the Office of Management and Budget under control
number 0579-0007)
0
5. Section 56.5 is amended as follows:
0
a. By revising the section heading;
0
b. In paragraph (c)(1) introductory text, by adding the words ``and
maintain their current National Poultry Improvement Plan (NPIP)
certifications'' after the words ``controlled marketing''; and
0
c. By revising paragraphs (c)(2) and (d).
The revisions read as follows:
Sec. 56.5 Destruction and disposal of poultry and cleaning and
disinfection (virus elimination) of premises, conveyances, and
materials.
* * * * *
(c) * * *
(2) Poultry moved for controlled marketing will not be eligible for
indemnity under Sec. 56.3. However, any costs related to cleaning and
disinfection (virus elimination) of premises, conveyances, and
materials that came into contact with poultry that are moved for
controlled marketing will be eligible for compensation under Sec.
56.3.
(d) Cleaning and disinfection (virus elimination) of premises,
conveyances, and materials. Premises, conveyances, and materials that
came into contact with poultry infected with or exposed to H5/H7 LPAI
must be cleaned and disinfected; Provided, that materials for which the
cost of cleaning and disinfection would exceed the value of the
materials or for which cleaning and disinfection would be impracticable
for any reason may be destroyed and disposed. Cleaning and disinfection
must be performed in accordance with the initial State response and
containment plan described in Sec. 56.10, which must be approved by
APHIS. Cleaning and disinfection must also be performed in accordance
with any applicable State and local environmental regulations.
0
6. Section 56.6 is amended as follows:
0
a. By revising the section heading;
0
b. In paragraph (a), by removing the word ``Compensation'' and adding
the word ``Indemnity'' in its place;
0
c. By revising paragraph (b); and
0
d. In paragraph (c), by adding the words ``(virus elimination)'' after
the word ``disinfection'' each time it appears.
The revisions read as follows:
Sec. 56.6 Presentation of claims for indemnity and/or compensation.
* * * * *
(b) Indemnity for the value of eggs to be destroyed due to
infection or exposure to H5/H7 LPAI; and
* * * * *
0
7. Section 56.8 is amended as follows:
0
a. In paragraph (a) introductory text, by removing the word ``may'' and
adding the word ``shall'' in its place; and
0
b. By revising paragraph (b).
The revision reads as follows:
Sec. 56.8 Conditions for payment.
* * * * *
(b)(1) If indemnity for the destroyed poultry or eggs is being
provided for 100 percent of eligible costs under Sec. 56.3(b), the
Administrator may pay contractors eligible for indemnity under this
section 100 percent of the amount determined in paragraph (a) of this
section.
(2) If indemnity for the destroyed poultry or eggs is being
provided for 25 percent of eligible costs under Sec. 56.3(b), the
Administrator may pay contractors eligible for indemnity 25 percent of
the amount determined in paragraph (a) of this section.
* * * * *
Sec. 56.9 [Amended]
0
8. Section 56.9 is amended as follows:
0
a. In paragraph (a), by removing the citation ``Sec. 56.4(a)(1)'' and
adding the citation ``Sec. 56.4(a)'' in its place; and
0
b. In paragraph (b), by adding the words ``and/or compensation'' after
the word ``indemnity'' both times it appears.
Sec. 56.10 [Amended]
0
9. In Sec. 56.10, paragraph (a) introductory text is amended by adding
the words ``and/or compensation'' after the word ``indemnity''.
PART 145--NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY
0
10. 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
11. Section 145.1 is amended as follows:
0
a. By revising the definition for Avian influenza;
0
b. By adding a definition for Newcastle disease in alphabetical order;
and
0
c. By revising the definition for NPIP Program Standards.
The revisions and addition read as follows:
Sec. 145.1 Definitions.
* * * * *
Avian influenza. Avian influenza is defined as an infection of
poultry caused by any influenza A virus of the H5 or H7 subtypes or by
any influenza A virus with an intravenous
[[Page 66640]]
pathogenicity index (IVPI) greater than 1.2 (or as an alternative at
least 75 percent mortality).
* * * * *
Newcastle disease. Newcastle disease (ND) is defined as an
infection of poultry caused by Newcastle disease virus (NDV), which is
an avian paramyxovirus serotype 1 (APMV-1) that meets one of the
following criteria for virulence:
(1) The virus has an intracerebral pathogenicity index (ICPI) in
day-old chicks (Gallusgallus) of 0.7 or greater; or
(2) Multiple basic amino acids have been demonstrated in the virus
(either directly or by deduction) at the C-terminus of the F2 protein
and phenylalanine at residue 117, which is the N-terminus of the F1
protein. The term `multiple basic amino acids' refers to at least three
arginine or lysine residues between residues 113 and 116. Failure to
demonstrate the characteristic pattern of amino acid residues as
described above would require characterization of the isolated virus by
an ICPI test.
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 National Poultry Improvement Plan
(NPIP) website 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.
* * * * *
0
12. Section 145.7 is revised to read as follows:
Sec. 145.7 Specific provisions for participating dealers.
Dealers in hatching eggs, newly hatched poultry, or started poultry
shall comply with the provisions in this part (within the NPIP Program
Standards document, Program Standard C applies to hatcheries;
alternatives to the program standards may also be approved by the
Administrator under Sec. 147.53).
0
13. Section 145.14 is amended as follows:
0
a. By revising paragraphs (d)(1) and (2) introductory text; and
0
b. By adding paragraph (e).
The revisions and addition read as follows:
Sec. 145.14 Testing.
* * * * *
(d) * * *
(1) Antibody detection tests--(i) ELISA test. (A) The ELISA test
must be conducted using test kits approved by the Department and the
Official State Agency and must be conducted in accordance with the
recommendations of the producer or manufacturer.
(B) When positive ELISA samples are identified, an AGID test must
be conducted within 48 hours.
(ii) Agar gel immunodiffusion (AGID) test. (A) The AGID test must
be conducted using reagents approved by the Department and the Official
State Agency.
(B) The AGID test for avian influenza must be conducted in
accordance with this section (within the NPIP Program Standards
document, Program Standard A applies to blood and yolk testing
procedures; alternatives to the program standards may also be approved
by the Administrator under Sec. 147.53) for the avian influenza agar
gel immunodiffusion (AGID) test. The test can be conducted on egg yolk
or blood samples. The AGID test is not recommended for use in
waterfowl.
(C) Positive tests for the AGID 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.
(2) Agent detection tests. Agent detection tests may be used to
detect influenza A virus but not to determine hemagglutinin or
neuraminidase subtypes. Samples for agent detection testing should be
collected from naturally occurring flock mortality or clinically ill
birds.
* * * * *
(e) For Newcastle Disease (ND). The official tests for ND are
serological tests for antibody detection or molecular-based tests for
antigen detection.
* * * * *
Sec. 145.23 [Amended]
0
14. Section 145.23 is amended as follows:
0
a. By removing paragraphs (d)(1)(vi) and (vii) and redesignating
paragraphs (d)(1)(viii) and (ix) as paragraphs (d)(1)(vi) and (vii),
respectively; and
0
b. By removing paragraph (d)(3) and redesignating paragraphs (d)(4) and
(5) as paragraphs (d)(3) and (4), respectively.
Sec. 145.24 [Amended]
0
15. In Sec. 145.24, paragraph (a)(1)(i) is amended by removing ``Sec.
145.23(b)(3)(i) through (vii), Sec. 145.33(b)(3)(i) through (vii),
Sec. 145.43(b)(3)(i) through (vi), Sec. 145.53(b)(3)(i) through
(vii), Sec. 145.73(b)(2)(i), Sec. 145.83(b)(2)(i), and Sec.
145.93(b)(3)(i) through (vii)'' and adding ``Sec. Sec. 145.23(b)(3)(i)
through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through
(vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i),
145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix)'' in
its place.
0
16. Section 145.33 is amended as follows:
0
a. In paragraph (l)(1)(ii), by removing the number ``30'' and adding
the number ``15'' in its place; and
0
b. By revising paragraph (l)(2).
The revision reads as follows:
Sec. 145.33 Terminology and classification; flocks and products.
* * * * *
(l) * * *
(2) During each 90-day period, all multiplier spent fowl, up to a
maximum of 30, must be tested and found negative for avian influenza
within 21 days prior to movement to slaughter.
* * * * *
Sec. 145.34 [Amended]
0
17. In Sec. 145.34, paragraph (a)(1)(i) is amended by removing ``Sec.
145.23(b)(3)(i) through (vii), Sec. 145.33(b)(3)(i) through (vii),
Sec. 145.43(b)(3)(i) through (vi), Sec. 145.53(b)(3)(i) through
(vii), Sec. 145.73(b)(2)(i), Sec. 145.83(b)(2)(i), and Sec.
145.93(b)(3)(i) through (vii)'' and adding ``Sec. Sec. 145.23(b)(3)(i)
through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through
(vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i),
145.93(b)(3)(i) through (vii), and 145.103 (b)(3)(i) through (ix)'' in
its place.
0
18. Section 145.43 is amended by adding paragraph (h) to read as
follows:
Sec. 145.43 Terminology and classification; flocks and products.
* * * * *
(h) U.S. Newcastle Disease Clean. The program in this paragraph (h)
is intended to be the basis from which the breeding-hatchery industry
may conduct a program for the prevention and control of Newcastle
disease. It is intended to determine the presence of Newcastle disease
in primary breeding turkeys through vaccination and/or monitoring of
each participating breeding flock. A flock and the hatching eggs and
poults produced from it will qualify for the classification in this
paragraph (h) when the Official State Agency determines that they have
met the following requirements:
(1) It is a primary breeding flock that is either:
(i) Vaccinated for Newcastle disease using USDA-licensed vaccines
and response to vaccination is serologically monitored using an
approved test as
[[Page 66641]]
described in Sec. 145.14 when more than 4 months of age, and meets the
criteria in paragraph (h)(2) of this section to retain classification;
or
(ii) Unvaccinated for Newcastle disease, in which a minimum of 30
birds have tested negative to ND using an approved test as described in
Sec. 145.14 when more than 4 months of age and meets the criteria in
paragraph (h)(3) of this section to retain classification.
(2) To retain the classification in this paragraph (h), for
vaccinated flocks:
(i) Vaccines for ND must be USDA-licensed vaccines administered
during early stages of development through rearing, and inactivated
vaccines as final vaccination prior to the onset of egg production; and
(ii) The flock has been monitored for antibody response using
approved serological tests as listed in Sec. 145.14 and the results
are compatible with immunological response against ND vaccination; and
(iii) Testing must include a minimum of 30 birds with a serologic
monitoring program when more than 4 months of age and prior to the
onset of production and not longer than every 90 days thereafter.
(3) To retain the classification in this paragraph (h) for
unvaccinated flocks:
(i) A minimum of 30 birds per flock must test negative using an
approved test in Sec. 145.14 at intervals of 90 days; or
(ii) A sample of fewer than 30 birds may be tested, and found
negative, at any one time if all pens are equally represented and a
total of 30 birds is tested within each 90-day period; and
(iii) During each 90-day period, all primary spent fowl, up to a
maximum of 30, must test negative to ND within 21 days prior to
movement to slaughter.
(4) Newcastle disease must be a disease reportable to the
responsible State authority (State veterinarian, etc.) by all licensed
veterinarians. To accomplish this, all laboratories (private, State,
and university laboratories) that perform diagnostic procedures on
poultry must examine all submitted cases of unexplained respiratory
disease, egg production drops, and mortality for ND.
* * * * *
Sec. 145.44 [Amended]
0
19. In Sec. 145.44, paragraph (a)(1)(i) is amended by removing ``Sec.
145.23(b)(3)(i) through (vii), Sec. 145.33(b)(3)(i) through (vii),
Sec. 145.43(b)(3)(i) through (vi), Sec. 145.53(b)(3)(i) through
(vii), Sec. 145.73(b)(2)(i), Sec. 145.83(b)(2)(i), and Sec.
145.93(b)(3)(i) through (vii)'' and adding ``Sec. Sec. 145.23(b)(3)(i)
through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through
(vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), Sec.
145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i)
through (ix)'' in this place.
0
20. Section 145.45 is amended as follows:
0
a. By revising paragraph (a) introductory text;
0
b. In paragraph (a)(1) introductory text, by adding the words ``and
ND'' after the word ``AI'' each time it appears;
0
c. In paragraph (a)(1)(i):
0
i. By adding the words ``and ND Clean in accordance with Sec.
145.43(h)'' after the citation ``Sec. 145.43(g)'';
0
ii. By adding the words ``and ND'' after the words ``official tests for
AI'' and adding the words ``and (e)'' after the citation ``Sec.
145.14(d)''; and
0
iii. By removing the word ``AI-related'' and adding the words ``AI and
ND-related'' in its place;
0
d. In paragraphs (a)(1)(iii) introductory text, (a)(1)(iii)(B) and (E),
and (a)(1)(v), by adding the words ``and ND'' after the word ``AI''
each time it appears;
0
e. In paragraph (a)(1)(vi), by adding the words ``and ND'' after the
word ``Influenza'';
0
f. In paragraph (a)(2)(iii):
0
i. By removing the words ``Clean classification'' and adding the words
``and ND Clean classifications'' in their place;
0
ii. By adding the words ``and ND'' after the word ``AI'' both times it
appears; and
0
iii. By removing the words ``avian influenza surveillance'' and adding
the words ``avian influenza and ND surveillance'' in their place;
0
g. In paragraph (a)(3)(iii), by adding the words ``and ND'' after the
word ``Influenza'';
0
h. In paragraph (a)(3)(iv), by adding the words ``and ND Clean program
as described in Sec. 145.43(h)'' after the citation ``Sec.
145.43(g)''; and
0
i. In paragraph (a)(3)(vii), by adding the words ``and (h)'' after the
citation ``145.43(g)''.
The revision reads as follows:
Sec. 145.45 Terminology and classification; compartments.
(a) US H5/H7 AI and ND Clean Compartment. The program in this
section is intended to be the basis from which the primary turkey
breeding-hatchery industry may demonstrate the existence and
implementation of a program that has been approved by the Official
State Agency and APHIS to establish a compartment consisting of a
primary breeding-hatchery company that is free of H5/H7 avian influenza
(AI) and ND. This compartment has the purpose of protecting the defined
subpopulation and avoiding the introduction and spread of H5/H7 AI and
ND within that subpopulation by prohibiting contact with other
commercial poultry operations, other domestic and wild birds, and other
intensive animal operations. The program shall consist of the
following:
* * * * *
0
21. The heading for subpart E, consisting of Sec. Sec. 145.51 through
146.54, is revised to read as follows:
Subpart E--Special Provisions for Hobbyist and Exhibition Poultry,
and Raised-for-Release Waterfowl Breeding Flocks and Products
0
22. Section 145.51 is amended as follows:
0
a. By removing the definition for Game birds;
0
b. By adding, in alphabetical order, definitions for Hobbyist poultry
and Raised-for-release waterfowl; and
0
c. By removing the definition for Waterfowl.
The additions read as follows:
Sec. 145.51 Definitions.
* * * * *
Hobbyist poultry. Domesticated fowl which are bred for the purposes
of meat and/or egg production on a small scale as determined by the
Official State Agency.
Raised-for-release waterfowl. Domesticated fowl that normally swim,
such as ducks and geese, grown under confinement for the primary
purpose of producing eggs, chicks, started, or mature birds for release
on game preserves or in the wild.
0
23. Section 145.52 is amended as follows:
0
a. By revising the introductory text;
0
b. In paragraph (c), by removing the words ``in open air facilities'';
and
0
c. By adding paragraph (f).
The revision and addition read as follows:
Sec. 145.52 Participation.
Participating flocks of hobbyist and exhibition poultry, raised-
for-release waterfowl, and the eggs, chicks, started, and mature
poultry produced from them shall comply with the applicable general
provisions of subpart A of this part and the special provisions of this
subpart. The special provisions that apply to meat-type waterfowl
flocks are found in subpart I of this part. The special provisions that
apply to game
[[Page 66642]]
bird flocks are found in subpart J of this part.
* * * * *
(f) All participating raised-for-release waterfowl flocks,
regardless of whether they are breeders or non-breeders, shall be
enrolled under this subpart.
0
24. Section 145.53 is amended as follows:
0
a. In paragraph (b)(5), by removing the words ``exhibition waterfowl
or''; and
0
b. By revising paragraph (f).
The revision reads as follows:
Sec. 145.53 Terminology and classification; flocks and products.
* * * * *
(f) U.S. Salmonella Monitored. The program in this paragraph (f) 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 poultry through an effective and practical sanitation
and testing program at the breeder farm and in the hatchery. This will
afford other segments of the poultry industry an opportunity to reduce
the incidence of Salmonella in their products. The following
requirements must be met for a flock or hatchery to be eligible for the
classification in this paragraph (f) as determined by the Official
State Agency:
(1) Hatcheries must be kept in a sanitary condition as applicable
and as outlined in Sec. 145.6 (within the NPIP Program Standards
document, Program Standard C applies to hatcheries; alternatives to the
program standards may also be approved by the Administrator under Sec.
147.53).
(2) An Authorized Agent shall collect and submit to an authorized
laboratory:
(i) A minimum of five samples from the hatchery at least every 30
days while in operation. These samples may include: Hatchery debris,
swabs from hatchers, setters, hatchery environment, hatchery equipment,
sexing tables and belts, meconium, chick box papers, hatching trays, or
chick transfer devices. Samples will be examined bacteriologically at
an authorized laboratory for Salmonella; and
(ii) Annual environmental samples from each pullet and breeder farm
in accordance with this section (within the NPIP Program Standards
document, Program Standard B applies to bacteriological examination
procedures; alternatives to the program standards may also be approved
by the Administrator under Sec. 147.53). Samples will be examined
bacteriologically at an authorized laboratory for Salmonella.
(3) If Salmonella is identified through this testing:
(i) A qualified poultry health professional knowledgeable with the
operation will be consulted and will:
(A) Review test results to evaluate the Salmonella monitoring
program.
(B) Use the Salmonella monitoring program test results to develop
appropriate and practical Salmonella intervention measures.
(ii) [Reserved]
(4) To claim products are of the classification in this paragraph
(f), all products shall be derived from a farm or hatchery that meets
the requirements of the classification.
* * * * *
Sec. 145.54 [Amended]
0
25. In Sec. 145.54, paragraph (a)(1)(i) is amended by removing ``Sec.
145.23(b)(3)(i) through (vii), Sec. 145.33(b)(3)(i) through (vii),
Sec. 145.43(b)(3)(i) through (vi), Sec. 145.53(b)(3)(i) through
(vii), Sec. 145.73(b)(2)(i), Sec. 145.83(b)(2)(i), and Sec.
145.93(b)(3)(i) through (vii)'' and adding ``Sec. Sec. 145.23(b)(3)(i)
through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through
(vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i),
145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix)'' in
its place.
0
26. Section 145.73 is amended as follows:
0
a. By removing paragraphs (d)(1)(vi) and (vii) and redesignating
paragraphs (d)(1)(viii) and (ix) as paragraphs (d)(1)(vi) and (vii),
respectively;
0
b. By removing paragraph (d)(3) and redesignating paragraphs (d)(4) and
(5) as paragraphs (d)(3) and (4), respectively; and
0
c. By adding paragraph (h).
The addition reads as follows:
Sec. 145.73 Terminology and classification; flocks and products.
* * * * *
(h) U.S. Newcastle Disease Clean. The program in this paragraph (h)
is intended to be the basis from which the breeding-hatchery industry
may conduct a program for the prevention and control of Newcastle
disease. It is intended to determine the presence of Newcastle disease
in primary breeding chickens through vaccination and/or monitoring of
each participating breeding flock. A flock and the hatching eggs and
chicks produced from it will qualify for the classification in this
paragraph (h) when the Official State Agency determines that they have
met the following requirements:
(1) It is a primary breeding flock that is either:
(i) Vaccinated for Newcastle disease using USDA-licensed vaccines
and response to vaccination is serologically monitored using an
approved test as described in Sec. 145.14 when more than 4 months of
age and meets the criteria in paragraph (h)(2) of this section to
retain classification; or
(ii) Unvaccinated for Newcastle disease, in which a minimum of 30
birds have tested negative to ND using an approved test as described in
Sec. 145.14 when more than 4 months of age and meets criteria in
paragraph (h)(3) of this section to retain classification.
(2) To retain the classification in this paragraph (h), for
vaccinated flocks:
(i) Vaccines for ND must be USDA-licensed vaccines administered
during early stages of development through rearing, and inactivated
vaccines as final vaccination prior to the onset of egg production; and
(ii) The flock has been monitored for antibody response using
approved serological tests as listed in Sec. 145.14 and the results
are compatible with immunological response against ND vaccination; and
(iii) Testing must include a minimum of 30 birds with a serologic
monitoring program when more than 4 months of age and prior to the
onset of production and not longer than every 90 days thereafter.
(3) To retain the classification in this paragraph (h) for
unvaccinated flocks:
(i) A minimum of 30 birds per flock must test negative using an
approved test as described in Sec. 145.14 at intervals of 90 days; or
(ii) A sample of fewer than 30 birds may be tested, and found
negative, at any one time if all pens are equally represented and a
total of 30 birds is tested within each 90-day period; and
(iii) During each 90-day period, all primary spent fowl, up to a
maximum of 30, must test negative to ND within 21 days prior to
movement to slaughter.
(4) Newcastle disease must be a disease reportable to the
responsible State authority (State veterinarian, etc.) by all licensed
veterinarians. To accomplish this, all laboratories (private, State,
and university laboratories) that perform diagnostic procedures on
poultry must examine all submitted cases of unexplained respiratory
disease, egg production drops, and mortality for ND.
0
27. Section 145.74 is amended as follows:
0
a. In paragraph (a) introductory text, by revising the paragraph
heading, adding the words ``and Newcastle disease (ND)'' after the word
``(AI)'', and
[[Page 66643]]
adding the words ``and ND'' after the word ``AI'';
0
b. In paragraph (a)(1) introductory text, by adding the words ``and
ND'' after the word ``AI'' each time it appears;
0
c. In paragraph (a)(1)(i):
0
i. By adding the words ``and ND Clean in accordance with Sec.
145.73(h)'' after the words ``in accordance with Sec. 145.73(f)'';
0
ii. By adding the words ``and ND'' after the words ``official tests for
AI'' and adding the words ``and (e)'' after the citation ``Sec.
145.14(d)''; and
0
iii. By removing the word ``AI-related'' and adding the words ``AI and
ND-related'' in its place;
0
d. In paragraphs (a)(1)(iii), (a)(1)(iii)(B) and (E), and (a)(1)(v), by
adding the words ``and ND'' after the word ``AI'' each time it appears;
0
e. In paragraph (a)(1)(vi), by adding the words ``and ND'' after the
word ``Influenza'';
0
f. In paragraph (a)(2)(iii):
0
i. By removing the words ``Clean classification'' and adding the words
``and ND Clean classifications'' in their place;
0
ii. By adding the words ``and ND'' after the word ``AI'' both times it
appears; and
0
iii. By removing the words ``avian influenza surveillance'' and adding
the words ``avian influenza and ND surveillance'' in their place;
0
g. In paragraph (a)(3)(iii), by adding the words ``and ND'' after the
word ``Influenza'';
0
h. In paragraph (a)(3)(iv), by adding the words ``and ND Clean program
as described in Sec. 145.73(h)'' after the citation ``Sec.
145.73(f)'';
0
i. In paragraph (a)(3)(vii), by adding the words ``and (h)'' after the
citation ``145.73(f); and
0
j. In paragraph (a)(4), by adding the words ``and/or ND'' after the
word ``AI'' both times it appears.
The revision reads as follows:
Sec. 145.74 Terminology and classification; compartments.
(a) U.S. Avian Influenza and Newcastle Disease Clean Compartment. *
* *
* * * * *
0
28. Section 145.83 is amended as follows:
0
a. By removing paragraph (e)(1)(iv) and redesignating paragraphs
(e)(1)(v) and (vi) as paragraphs (e)(1)(iv) and (v), respectively; and
0
b. By adding paragraph (h).
The addition reads as follows:
Sec. 145.83 Terminology and classification; flocks and products.
* * * * *
(h) U.S. Newcastle Disease (ND) Clean. The program in this
paragraph (h) is intended to be the basis from which the breeding-
hatchery industry may conduct a program for the prevention and control
of Newcastle disease. It is intended to determine the presence of
Newcastle disease in primary breeding chickens through vaccination and/
or monitoring of each participating breeding flock. A flock and the
hatching eggs and chicks produced from it will qualify for the
classification in this paragraph (h) when the Official State Agency
determines that they have met the following requirements:
(1) It is a primary breeding flock that is either:
(i) Vaccinated for Newcastle disease using USDA-licensed vaccines
and response to vaccination is serologically monitored using an
approved test as described in Sec. 145.14 when more than 4 months of
age and meets the criteria in paragraph (h)(2) of this section to
retain classification; or
(ii) Unvaccinated for Newcastle disease, in which a minimum of 30
birds have tested negative to ND using an approved test as described in
Sec. 145.14 when more than 4 months of age and meets criteria in
paragraph (h)(3) of this section to retain classification.
(2) To retain the classification in this paragraph (h), for
vaccinated flocks:
(i) Vaccines for ND must be USDA-licensed vaccines administered
during early stages of development through rearing, and inactivated
vaccines as final vaccination prior to the onset of egg production; and
(ii) The flock has been monitored for antibody response using
approved serological tests as described in Sec. 145.14 and the results
are compatible with immunological response against ND vaccination; and
(iii) Testing must include a minimum of 30 birds with a serologic
monitoring program when more than 4 months of age and prior to the
onset of production, and not longer than every 90 days thereafter.
(3) To retain the classification in this paragraph (h) for
unvaccinated flocks:
(i) A minimum of 30 birds per flock must test negative using an
approved test as described in Sec. 145.14 at intervals of 90 days; or
(ii) A sample of fewer than 30 birds may be tested, and found
negative, at any one time if all pens are equally represented and a
total of 30 birds is tested within each 90-day period; and
(iii) During each 90-day period, all primary spent fowl, up to a
maximum of 30, must test negative to ND within 21 days prior to
movement to slaughter.
(4) Newcastle disease must be a disease reportable to the
responsible State authority (State veterinarian, etc.) by all licensed
veterinarians. To accomplish this, all laboratories (private, State,
and university laboratories) that perform diagnostic procedures on
poultry must examine all submitted cases of unexplained respiratory
disease, egg production drops, and mortality for ND.
0
29. Section 145.84 is amended as follows:
0
a. In paragraph (a) introductory text, by revising the heading, adding
the words ``and Newcastle disease (ND)'' after the words ``influenza
(AI)'', and adding the words ``and ND'' after the words ``H5/H7 AI'';
0
b. In paragraph (a)(1) introductory text, by adding the words ``and
ND'' after the word ``AI'' each time it appears;
0
c. By revising paragraph (a)(1)(i);
0
d. In paragraphs (a)(1)(iii) introductory text, (a)(1)(iii)(B) and (E),
and (a)(1)(v), by adding the words ``and ND'' after the word ``AI''
each time it appears;
0
e. In paragraph (a)(1)(vi), by adding the words ``and ND'' after the
word ``Influenza'';
0
f. In paragraph (a)(2)(iii):
0
i. Removing the words ``Clean classification'' and adding the words
``and ND Clean classifications'' in their place;
0
ii. Adding the words ``and ND'' after the word ``AI'' both times it
appears; and
0
iii. Removing the words ``avian influenza surveillance'' and adding the
words ``avian influenza and ND surveillance'' in their place;
0
g. In paragraph (a)(3)(iv), by adding the words ``and ND Clean program
as described in Sec. 145.83(h)'' after the citation ``Sec.
145.83(g)''; and
0
h. In paragraph (a)(3)(vii), by adding the words '' and (h)'' after the
citation ``145.83(g)''.
The revisions read as follows:
Sec. 145.84 Terminology and classification; compartments.
(a) U.S. Avian Influenza and Newcastle Disease Clean Compartment. *
* *
(1) * * *
(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) and ND Clean
in accordance with Sec. 145.83(h). 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
[[Page 66644]]
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 and ND, as described
in Sec. 145.14(d) and (e), 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 H5/H7 AI and ND-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.
* * * * *
Sec. 145.94 [Amended]
0
30. In Sec. 145.94, paragraph (a)(1)(i) is amended by removing the
word ``and'' and adding the words ``, and 145.103(b)(3)(i) through
(ix)'' after the words ``145.93(b)(3)(i) through (vii)''.
0
31. Subpart J, consisting of Sec. Sec. 145.101 through 145.104, is
added to read as follows:
Subpart J--Special Provisions for Egg/Meat-Type Game Bird and Raised-
for-Release Game Bird Breeding Flocks and Products
Sec.
145.101 Definitions.
145.102 Participation.
145.103 Terminology and classification; flocks and products.
145.104 Terminology and classification; States.
Subpart J--Special Provisions for Egg/Meat-Type Game Bird and
Raised-for-Release Game Bird Breeding Flocks and Products
Sec. 145.101 Definitions.
Except where the context otherwise requires, for the purposes of
this subpart the following terms shall be construed, respectively, to
mean:
Egg/meat-type bird. Birds grown under confinement for the primary
purpose of producing eggs and/or meat for human consumption.
Game birds. Domesticated fowl such as pheasants, partridge, quail,
grouse, and guineas, but not doves and pigeons.
Raised-for-release bird. Birds grown under confinement for the
primary purpose of producing eggs, chicks, started, or mature birds for
release on game preserves or in the wild.
Sec. 145.102 Participation.
Participating flocks of egg/meat-type game birds, raised-for-
release game birds, and the products produced from them shall comply
with the applicable general provisions of subpart A of this part and
the special provisions of this subpart. Participation is broken into
the following categories of operation and products:
(a) The categories for operation are:
(1) Breeder. An individual or business that maintains a breeding
flock for the purpose of producing eggs, chicks, started, or mature
birds. A breeder that is also a hatchery and/or grower shall be
categorized as a breeder.
(2) Hatchery. A category of operations in which an individual or
business does not have a breeding flock, but hatches eggs for the
purpose of producing chicks, started, or mature birds. A hatchery that
is also a grower shall be categorized as a hatchery.
(3) Grower. A category of operations in which an individual or
business does not have a breeding flock or hatchery, but raises birds
for the purpose of selling started or mature birds.
(4) Dealer. An individual or business that resells eggs, chicks,
started, or mature birds. Products a dealer handles are typically
resold within 30 days or less.
(b) The categories for products are:
(1) Egg. An egg laid by a female bird for the purpose of hatching a
chick.
(2) Chick. A bird that is newly hatched from an egg.
(3) Started Bird. A bird that is between the age of a newly hatched
chick and a mature bird.
(4) Mature Bird. A bird that is fully colored and has reached the
average maximum size specific to each species.
(c) Products shall lose their identity under Plan terminology when
not maintained by Plan participants under the conditions prescribed in
Sec. 145.5(a).
(d) Hatching eggs produced by breeding flocks shall be nest clean,
fumigated, or otherwise sanitized in accordance with part 147 of this
subchapter.
(e) It is recommended that gallinaceous flocks and waterfowl flocks
be kept separate.
(f) Any nutritive material provided to baby poultry must be free of
the avian pathogens that are officially represented in the Plan disease
classifications listed in Sec. 145.10.
(g) A flock of game birds that are not breeders, but are located on
the same premise as game bird breeders, shall be covered under the same
NPIP hatchery approval number as long as the appropriate testing
requirements have been met.
(h) All participating raised-for-release game bird flocks,
regardless of whether they are breeders or non-breeders, shall be
enrolled under this subpart.
(i) A breeder, hatchery, or grower may also be a dealer without
being categorized as a dealer. To resell products under the assigned
NPIP number and avoid losing NPIP flock classifications, products must
be purchased from an NPIP participant with equal or greater
classifications or from a flock with equivalent or greater testing
requirements under official supervision.
(j) Subject to the approval of the Service and the Official State
Agencies in the importing and exporting States, participating flocks
may report poultry sales to importing States by using either VS Form 9-
3, ``Report of Sales of Hatching Eggs, Chicks, and Poults,'' or by
using an invoice form (9-3I) approved by the Official State Agency and
the Service to identify poultry sales to clients. If the 9-3I form is
used, the following information must be included on the form:
(1) The form number ``9-3I'', printed or stamped on the invoice;
(2) The seller name and address;
(3) The date of shipment;
(4) The invoice number;
(5) The purchaser name and address;
(6) The quantity of products sold;
(7) Identification of the products by bird variety or by NPIP stock
code as listed in the NPIP APHIS 91-55-078 appendix; and
(8) The appropriate NPIP illustrative design in Sec. 145.10. One
of the designs in Sec. 145.10(b) or (g) must be used. The following
information must be provided in or near the NPIP design:
(i) The NPIP State number and NPIP approval number; and
(ii) The NPIP classification for which product is qualified (e.g.,
U.S. Pullorum-Typhoid Clean).
Sec. 145.103 Terminology and classification; flocks and products.
Participating flocks, and the eggs, chicks, started, and mature
birds produced from them, which have met the respective requirements
specified in this section may be designated by the following terms and
the corresponding designs illustrated in Sec. 145.10.
(a) [Reserved]
(b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from
pullorum and typhoid has been demonstrated to the Official State Agency
under the criteria in this paragraph (b). (See Sec. 145.14 relating to
the official blood test where applicable.):
(1) It has been officially blood tested with either no reactors or
reactors that, upon further bacteriological examination conducted in
accordance with part 147 of this subchapter, fail to isolate S.
pullorum or S. gallinarum.
[[Page 66645]]
(2) It is a started or mature bird flock that meets the following
specifications as determined by the Official State Agency and the
Service:
(i) The flock is located in a State where all persons performing
poultry disease diagnostic services within the State are required to
report to the Official State Agency within 48 hours the source of all
poultry specimens from which S. pullorum or S. gallinarum is isolated;
(ii) The flock is composed entirely of birds that originated from
U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met
equivalent requirements under official supervision; and
(iii) The flock is located on a premises where a flock not
classified as U.S. Pullorum-Typhoid Clean was located the previous
year; Provided, That an Authorized Testing Agent must blood test up to
300 birds per flock, as described in Sec. 145.14, if the Official
State Agency determines that the flock has been exposed to pullorum-
typhoid. In making determinations of exposure and setting the number of
birds to be blood tested, the Official State Agency shall evaluate the
results of any blood tests, described in Sec. 145.14(a)(1), that were
performed on an unclassified flock located on the premises during the
previous year; the origins of the unclassified flock; and the
probability of contacts between the flock for which qualification is
being sought and infected wild birds, contaminated feed or waste, or
birds, equipment, supplies, or personnel from flocks infected with
pullorum-typhoid.
(3) It is a breeding flock that originated from U.S. Pullorum-
Typhoid Clean breeding flocks or from flocks that met equivalent
requirements under official supervision, and in which a sample of 300
birds from flocks of more than 300, and each bird in flocks of 300 or
less, has been officially tested for pullorum-typhoid: Provided, That a
bacteriological examination monitoring program or serological
examination monitoring program for game birds acceptable to the
Official State Agency and approved by the Service may be used in lieu
of annual blood testing: And provided further, That it is located in a
State in which it has been determined by the Service that:
(i) All hatcheries within the State are qualified as ``National
Plan Hatcheries'' or have met equivalent requirements for pullorum-
typhoid control under official supervision;
(ii) All hatchery supply flocks within the State, are qualified as
U.S. Pullorum-Typhoid Clean or have met equivalent requirements for
pullorum-typhoid control under official supervision: Provided, That if
other domesticated fowl, except waterfowl, are maintained on the same
premises as the participating flock, freedom from pullorum-typhoid
infection shall be demonstrated by an official blood test of each of
these fowl;
(iii) All shipments of products other than U.S. Pullorum-Typhoid
Clean, or equivalent, into the State are prohibited;
(iv) All persons performing poultry disease diagnostic services
within the State are required to report to the Official State Agency
within 48 hours the source of all poultry specimens from which S.
pullorum or S. gallinarum is isolated;
(v) All reports of any disease outbreak involving a disease covered
under the Plan are promptly followed by an investigation by the
Official State Agency to determine the origin of the infection;
Provided, That if the origin of the infection involves another State,
or if there is exposure to poultry in another State from the infected
flock, then the National Poultry Improvement Plan will conduct an
investigation;
(vi) All flocks found to be infected with pullorum or typhoid are
quarantined until marketed or destroyed under the supervision of the
Official State Agency, or until subsequently blood tested, following
the procedure for reacting flocks as contained in Sec. 145.14(a)(5),
and all birds fail to demonstrate pullorum or typhoid infection;
(vii) All poultry, including exhibition, exotic, and game birds,
but excluding waterfowl, going to public exhibition shall come from
U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a
negative pullorum-typhoid test within 90 days of going to public
exhibition; and
(viii) The flock is located in a State in which pullorum disease or
fowl typhoid is not known to exist nor to have existed in hatchery
supply flocks within the State during the preceding 24 months.
(ix) Discontinuation of any of the conditions or procedures
described in paragraphs (b)(3)(i) through (viii) of this section, or
the occurrence of repeated outbreaks of pullorum or typhoid in poultry
breeding flocks within or originating within the State shall be grounds
for the Service to revoke its determination that such conditions and
procedures have been met or complied with. Such action shall not be
taken until a thorough investigation has been made by the Service and
the Official State Agency has been given an opportunity to present its
views.
(c) U.S. H5/H7 Avian Influenza Clean. The program in this paragraph
(c) is intended to be the basis from which the game bird industry may
conduct a program for the prevention and control of the H5 and H7
subtypes of avian influenza. It is intended to determine the presence
of the H5 and H7 subtypes of avian influenza in game bird flocks
through routine surveillance of each participating flock. A flock or
premise, and the hatching eggs, chicks, started, and mature birds
produced from it, will qualify for the classification in this paragraph
(c) when the Official State Agency determines that it has met the
following requirements:
(1) It is a 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. To retain the
classification in this paragraph (c):
(i) A sample of at least 30 birds must be tested negative at
intervals of 90 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be
negative, at any one time if all pens are equally represented and a
total of 30 birds are tested within each 90-day period.
(2) For participants with non-breeding flocks retained for raised-
for-release or other purposes on the same premises as a breeding flock,
a representative sample of at least 30 birds from the participating
premise must be 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, every 90 days.
(d) U.S. Salmonella Monitored. The program in this paragraph (d) is
intended to be the basis from which the game bird 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 the
classification in this paragraph (d):
(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 the classification in this paragraph
(d), all products shall be derived from a hatchery that meets the
requirements of the classification.
[[Page 66646]]
(3) The classification in this paragraph (d) may be revoked by the
Official State Agency if the participant fails to follow recommended
corrective measures.
Sec. 145.104 Terminology and classification; States.
(a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared
a U.S. Pullorum-Typhoid Clean State when it has been determined by the
Service that:
(i) The State is in compliance with the provisions contained in
Sec. Sec. 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through
(vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii),
145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and
145.103(b)(3)(i) through (ix).
(ii) No pullorum disease or fowl typhoid is known to exist nor to
have existed in hatchery supply flocks within the State during the
preceding 12 months: Provided, That pullorum disease or fowl typhoid
found within the preceding 24 months in waterfowl, exhibition poultry,
and game bird breeding flocks will not prevent a State, which is
otherwise eligible, from qualifying.
(2) Discontinuation of any of the conditions described in paragraph
(a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid
occur in hatchery supply flocks described in paragraph (a)(1)(ii) of
this section, or if an infection spreads from the originating premises,
the Service shall have grounds to revoke its determination that the
State is entitled to the classification in this paragraph (a). Such
action shall not be taken until a thorough investigation has been made
by the Service and the Official State Agency has been given an
opportunity for a hearing in accordance with rules of practice adopted
by the Administrator.
(b) [Reserved]
PART 146--NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY
0
32. 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
33. Section 146.13 is amended as follows:
0
a. By revising paragraph (b)(1); and
0
b. In paragraph (b)(2) introductory text, by removing the words
``matrix gene or protein'' and adding the word ``virus'' in their
place.
The revision reads as follows:
Sec. 146.13 Testing.
* * * * *
(b) * * *
(1) Antibody detection tests--(i) Enzyme-linked immunosorbent assay
(ELISA) test. (A) The ELISA test must be conducted using test kits
approved by the Department and the Official State Agency and must be
conducted in accordance with the recommendations of the producer or
manufacturer.
(B) When positive ELISA samples are identified, an AGID test must
be conducted within 48 hours.
(ii) Agar gel immunodiffusion (AGID) test. (A) The AGID test must
be conducted using reagents approved by the Department and the Official
State Agency.
(B) The AGID test for avian influenza must be conducted in
accordance with this section (within the NPIP Program Standards,
Program Standard A applies to blood and yolk testing procedures;
alternatives to the program standards may also be approved by the
Administrator under Sec. 147.53) for the avian influenza agar gel
immunodiffusion (AGID) test. The test can be conducted on egg yolk or
blood samples. The AGID test is not recommended for use in waterfowl.
(C) Positive tests for the AGID 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
34. Section 146.51 is revised to read as follows:
Sec. 146.51 Definitions.
Except where the context otherwise requires, for the purposes of
this subpart the following terms shall be construed, respectively, to
mean:
Egg/meat-type game birds. Domesticated fowl such as pheasants,
partridge, quail, grouse, and guineas, but not doves and pigeons grown
under confinement for the primary purposes of producing eggs and/or
meat for human consumption.
Egg/meat-type waterfowl. Domesticated ducks or geese grown under
confinement for the primary purposes of producing eggs and/or meat for
human consumption.
Meat-type game bird slaughter plant. A meat-type game bird
slaughter plant that is federally inspected or under State inspection
that the U.S. Department of Agriculture's Food Safety and Inspection
Service has recognized as equivalent to Federal inspection.
Meat-type waterfowl slaughter plant. A meat-type waterfowl
slaughter plant that is federally inspected or under State inspection
that the U.S. Department of Agriculture's Food Safety and Inspection
Service has recognized as equivalent to Federal inspection.
Shift. The working period of a group of employees who are on duty
at the same time.
0
35. Section 146.52 is revised to read as follows:
Sec. 146.52 Participation.
(a) Participating meat-type game bird slaughter plants, meat-type
waterfowl slaughter plants, and egg-type game bird and egg-type
waterfowl premises producing eggs for human consumption shall comply
with the applicable general provisions of subpart A of this part and
the special provisions of this subpart.
(b) Meat-type game bird slaughter plants and Meat-type waterfowl
slaughter plants that slaughter fewer than 50,000 birds annually are
exempt from the special provisions of this subpart.
(c) Egg-type game bird and egg-type waterfowl premises with fewer
than 25,000 birds are exempt from the special provisions of this
subpart.
0
36. Section 146.53 is amended as follows:
0
a. In the introductory text, by adding the words ``slaughter plants
and'' after the word ``participating'';
0
b. By revising paragraph (a) introductory text;
0
c. In paragraph (a)(1), by removing the words ``commercial upland'' and
adding the word ``meat-type'' in their place and by removing the word
``commercial'' and adding the word ``meat-type'' in its place;
0
d. By revising paragraph (a)(2);
0
e. In paragraph (a)(3), by removing the words ``commercial upland'' and
adding the word ``meat-type'' in their place and by removing the word
``commercial'' and adding the word ``meat-type'' in its place;
0
f. In paragraph (a)(4), by removing the words ``a commercial upland''
and adding the words ``an egg-type'' in their place and by adding the
word ``egg-type'' after the words ``game bird or''.
0
g. In paragraph (a)(5), by removing the words ``a commercial upland''
and adding the words ``an egg-type'' in their place and by adding the
word ``egg-type'' after the words ``game bird or''.
0
h. By removing and reserving paragraph (b).
The revisions read as follows:
Sec. 146.53 Terminology and classification; slaughter plants and
premises.
* * * * *
(a) U.S. H5/H7 Avian Influenza Monitored. The program in this
[[Page 66647]]
paragraph (a) is intended to be the basis from which the egg/meat-type
game bird and egg/meat-type waterfowl 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 egg/
meat-type game birds and egg/meat-type waterfowl through routine
surveillance of each participating slaughter plant or, in the case of
egg-producing flocks, the regular surveillance of these flocks. A
slaughter plant or flock will qualify for the classification in this
paragraph (a) when the Official State Agency determines that it has met
one of the following requirements:
* * * * *
(2) It is a meat-type game bird slaughter plant or meat-type
waterfowl slaughter plant that only accepts egg/meat-type game birds or
egg/meat-type waterfowl from flocks where a minimum of 11 birds per
flock have been tested negative for the H5/H7 subtypes of avian
influenza, as provided in Sec. 146.13(b), no more than 21 days prior
to slaughter;
* * * * *
PART 147--AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN
0
37. 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
38. Section 147.45 is revised to read as follows:
Sec. 147.45 Official delegates.
Each cooperating State shall be entitled to one official delegate
for each of the programs prescribed in parts 145 and 146 of this
subchapter in which it has one or more participants at the time of the
Conference. The official delegates shall be elected by a representative
group of participating industry members and be certified by the
Official State Agency. It is recommended but not required that the
official delegates be Plan participants. Individuals may be allowed to
be an official delegate or alternate delegate for up to three States in
which that delegate has flocks or is a plan participant with
acknowledgement and approval of the Official State Agencies. Each
official delegate shall endeavor to obtain, prior to the Conference,
the recommendations of industry members of their State with respect to
each proposed change.
0
39. Section 147.48 is revised to read as follows:
Sec. 147.48 Approval of conference recommendations by the Department.
Proposals adopted by the official delegates will be recommended to
the Department for incorporation into the provisions of the National
Poultry Improvement Plan (NPIP) in parts 56, 145, and 146 of this
chapter and this subpart. The Department reserves the right to approve
or disapprove the recommendations of the conference as an integral part
of its sponsorship of the National Poultry Improvement Plan. The
Department will publish the recommendations in the Federal Register
within 14 months following the NPIP Biennial Conference.
0
40. In Sec. 147.52, paragraph (b) is revised to read as follows:
Sec. 147.52 Authorized laboratories.
* * * * *
(b) Trained technicians. Testing procedures at all authorized
laboratories must be run or overseen by a laboratory technician who
every 4 years has attended, and satisfactorily completed, Service-
approved laboratory workshops for Plan-specific diseases.
* * * * *
Done in Washington, DC, this 28th day of October 2019.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-23973 Filed 12-4-19; 8:45 am]
BILLING CODE 3410-34-P