National Poultry Improvement Plan and Auxiliary Provisions, 57200-57215 [2010-23248]
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sections of the NOSB Policy and
Procedures Manual: Section IV
(Establishing Ad-hoc Committees),
Section V (NOP/NOSB Collaboration),
and Section VIII (Recommendations on
sunset Review Policy). Additionally,
they will present a recommendation to
update the NOSB New Member Guide.
The Meeting Is Open to the Public.
The NOSB has scheduled time for
public input for Monday, October 25,
2010, from 10 a.m. to 5:30 p.m. and
Wednesday, October 27, 2010 from 8
a.m. to 5 p.m. Individuals and
organizations wishing to make oral
presentations at the meeting must
forward their requests by e-mail, phone,
or mail to Ms. Lisa Ahramjian (see FOR
FURTHER INFORMATION CONTACT section
above). Individuals or organizations will
be given one five-minute slot to present
their views. All persons making oral
presentations are requested to provide
their comments in writing and indicate
the topic of their comment, referencing
specific NOSB recommendations/topics
or noting if they plan to cover multiple
topics. Written submissions may
contain information other than that
presented at the oral presentation.
Anyone may submit written comments
at the meeting. Persons submitting
written comments are asked to provide
30 copies.
Interested persons may visit the
NOSB portion of the NOP Web site at
https://www.ams.usda.gov/nop to view
available meeting documents prior to
the meeting, or visit
www.regulations.gov to submit and view
comments (see ADDRESSES section
above). Documents presented at the
meeting will be posted for review on the
NOP Web site approximately six weeks
following the meeting.
Proposed rule.
[Docket No. APHIS-2009-0031]
We are proposing to amend
the National Poultry Improvement Plan
(the Plan) and its auxiliary provisions
by providing new or modified sampling
and testing procedures for Plan
participants and participating flocks.
The proposed changes were voted on
and approved by the voting delegates at
the Plan’s 2008 National Plan
Conference. These changes would keep
the provisions of the Plan current with
changes in the poultry industry and
provide for the use of new sampling and
testing procedures.
DATES: We will consider all comments
that we receive on or before November
19, 2010.
ADDRESSES: You may submit comments
by either of the following methods:
∑ Federal eRulemaking Portal: Go to
(https://www.regulations.gov/
fdmspublic/component/
main?main=DocketDetail&d=APHIS2009-0031) to submit or view comments
and to view supporting and related
materials available electronically.
∑ Postal Mail/Commercial Delivery:
Please send one copy of your comment
to Docket No. APHIS-2009-0031,
Regulatory Analysis and Development,
PPD, APHIS, Station 3A-03.8, 4700
River Road Unit 118, Riverdale, MD
20737-1238. Please state that your
comment refers to Docket No. APHIS2009-0031.
Reading Room: You may read any
comments that we receive on this
docket in our reading room. The reading
room 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) 690-2817 before
coming.
Other Information: Additional
information about APHIS and its
programs is available on the Internet at
(https://www.aphis.usda.gov).
FOR FURTHER INFORMATION CONTACT: Mr.
Andrew R. Rhorer, Senior Coordinator,
Poultry Improvement Staff, National
Poultry Improvement Plan, Veterinary
Services, APHIS, USDA, 1498 Klondike
Road, Suite 101, Conyers, GA 300945104; (770) 922-3496.
SUPPLEMENTARY INFORMATION:
RIN 0579-AD21
Background
National Poultry Improvement Plan and
Auxiliary Provisions
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
Dated: September 13, 2010.
David R. Shipman,
Acting Administrator, Agricultural Marketing
Service.
[FR Doc. 2010–23337 Filed 9–17–10; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Parts 56, 145, 146, and 147
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ACTION:
Animal and Plant Health
Inspection Service, USDA.
AGENCY:
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SUMMARY:
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Plan consists of a variety of programs
intended to prevent and control poultry
diseases. Participation in all Plan
programs is voluntary, but breeding
flocks, hatcheries, and dealers must first
qualify as ‘‘U.S. Pullorum-Typhoid
Clean’’ as a condition for participating in
the other Plan programs.
The Plan identifies States, flocks,
hatcheries, dealers, and slaughter plants
that meet certain disease control
standards specified in the Plan’s various
programs. As a result, customers can
buy poultry that has tested clean of
certain diseases or that has been
produced under disease-prevention
conditions.
The regulations in 9 CFR parts 145,
146, and 147 (referred to below as the
regulations) contain the provisions of
the Plan. The Animal and Plant Health
Inspection Service (APHIS, also referred
to as ‘‘the Service’’) of the U.S.
Department of Agriculture (USDA, also
referred to as ‘‘the Department’’) amends
these provisions from time to time to
incorporate new scientific information
and technologies within the Plan.
The proposed amendments discussed
in this document are consistent with the
recommendations approved by the
voting delegates to the National Plan
Conference that was held from June 5
through June 7, 2008. Participants in the
2008 National Plan Conference
represented flockowners, breeders,
hatcherymen, slaughter plants, and
Official State Agencies from all
cooperating States. The proposed
amendments are discussed in detail
below.
Simplifying Indemnity Provisions in
Part 56
The regulations in 9 CFR part 56 set
out conditions for the payment of
indemnity for costs associated with
poultry that are infected with or
exposed to the H5 or H7 subtypes of low
pathogenic avian influenza (H5/H7
LPAI). Section 56.3 states that
indemnity may be paid for destruction
and disposal of poultry that were
infected with or exposed to H5/H7
LPAI, destruction of eggs for testing for
H5/H7 LPAI, and cleaning and
disinfection of premises, conveyances,
and materials that came into contact
with poultry that were infected with or
exposed to H5/H7 LPAI (or destruction
and disposal, if the cost of cleaning and
disinfection would exceed the value of
the materials or cleaning and
disinfection would be impractical).
Section 56.3 also sets the percentages
of the costs of those activities that are
eligible for indemnity. Specifically,
paragraph (b) of § 56.3 indicates that the
Administrator is authorized to pay 100
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percent indemnity for costs related to all
poultry that are infected with or
exposed to H5/H7 LPAI, unless those
poultry do not participate in the avian
influenza (AI) surveillance program
provided for poultry in the regulations
in 9 CFR part 145 or 146. For those
poultry, the Administrator is authorized
to pay indemnity for only 25 percent of
costs. The payment of only 25 percent
indemnity thus provides an incentive
for producers to participate in AI
surveillance programs. The specific
poultry that are eligible for only 25
percent indemnity, as listed in
paragraphs (b)(1) through (b)(6), are:
∑ Egg-type breeding chickens from a
flock that participates in any Plan
program in 9 CFR part 145 but that does
not participate in the U.S. Avian
Influenza Clean program of the Plan in
§ 145.23(h);
∑ Meat-type breeding chickens from a
flock that participates in any Plan
program in 9 CFR part 145 but that does
not participate in the U.S. Avian
Influenza Clean program of the Plan in
§ 145.33(l);
∑ Breeding turkeys from a flock that
participates in any Plan program in 9
CFR part 145 but that does not
participate in the U.S. H5/H7 Avian
Influenza Clean program of the Plan in
§ 145.43(g);
∑ Commercial table-egg layers from a
premises that has 75,000 or more birds
and that does not participate in the U.S.
H5/H7 Avian Influenza Monitored
program of the Plan in § 146.23(a);
∑ Commercial meat-type chickens that
are associated with a slaughter plant
that slaughters 200,000 or more meattype chickens per operating week and
that does not participate in the U.S. H5/
H7 Avian Influenza Monitored program
of the Plan in § 146.33(a); and
∑ Commercial meat-type turkeys that
are associated with a slaughter plant
that slaughters 2 million or more meattype turkeys in a 12-month period and
that does not participate in the U.S. H5/
H7 Avian Influenza Monitored program
of the Plan in § 146.43(a).
The regulations in paragraph (b)(7)
also provide for the payment of 25
percent indemnity for any poultry
located in a State that does not
participate in the diagnostic
surveillance program for H5/H7 LPAI,
as described in § 146.14, 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
and has an initial State response and
containment plan for H5/H7 LPAI that
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is approved by APHIS. This provision is
intended to provide States with an
incentive to participate in the NPIP’s AI
surveillance and control programs.
Since the regulations in part 56 were
established, an H5/H7 LPAI surveillance
program has been added that covers
new types of commercial poultry,
namely the program for commercial
upland game birds, commercial
waterfowl, raised-for-release upland
game birds, and raised-for-release
waterfowl in § 146.53(a). The program
in § 146.53(a) contains size thresholds
for each of the various types of poultry
included in the program. Slaughter
plants and premises above these size
thresholds are required to participate in
the program in § 146.53(a) in order to
participate in the Plan, similar to the
size thresholds for slaughter plants and
premises in the other subparts in 9 CFR
part 146. In addition, in this document,
we are proposing to add to 9 CFR part
145 provisions for an AI surveillance
program for meat-type waterfowl
breeding flocks, in proposed § 145.93(c).
(See the description under the heading
‘‘New Provisions for Meat-Type
Waterfowl Breeding Flocks and
Products’’ later in this document.)
Our general intention in establishing
§ 56.3 was to provide an incentive to
participate in NPIP AI surveillance
programs for all poultry for which such
programs are available. To ensure that
§ 56.3 continues to provide such an
incentive as new AI surveillance
programs are added for new types of
poultry, we are proposing to change the
structure of § 56.3 to refer more
generally to AI surveillance programs
available to breeding poultry in 9 CFR
part 145 and to commercial poultry in
part 146. In order to do this, we would
remove paragraphs (b)(1) through (b)(6)
from § 56.3, redesignate paragraph (b)(7)
as paragraph (b)(3), and add two new
paragraphs (b)(1) and (b)(2) to cover
breeding poultry and commercial
poultry, respectively.
Paragraph (b)(1) would provide that
poultry that are from a breeding flock
that participates in any Plan program in
9 CFR part 145 but that does not
participate in the U.S. Avian Influenza
Clean or the U.S. H5/H7 Avian
Influenza Clean program of the Plan
available to the flock in 9 CFR part 145
would only be eligible for 25 percent
indemnity.
Paragraph (b)(2) would provide that
poultry that are from a commercial flock
or slaughter plant that does not
participate in the U.S. Avian Influenza
Monitored program available to the
commercial flock or slaughter plant in 9
CFR part 146 would only be eligible for
25 percent indemnity. As part of this
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change, we are proposing to add a
definition of commercial flock or
slaughter plant to § 56.1, which sets out
definitions of terms used in part 56. We
would define commercial flock or
slaughter plant as a commercial poultry
flock or slaughter plant that is required
because of its size to participate in the
special provisions in 9 CFR part 146 in
order to participate in the Plan. (Subpart
A of part 146 contains the general
provisions; subparts B through E
contain special provisions for specific
types of commercial poultry.) We would
also remove the definitions of
commercial meat-type flock,
commercial table-egg layer flock,
commercial table-egg layer premises,
meat-type chicken, and meat-type
turkey from § 56.1, as they would no
longer be necessary.
These changes would simplify the
regulations and more clearly express the
principle that, for certain poultry
operations, participation in NPIP AI
surveillance programs is required in
order for the poultry to be eligible for
100 percent indemnity in the event of
an H5/H7 LPAI outbreak.
Amendments to Flock Testing
Requirements and Procedures for
Mycoplasma Bacteria
The regulations in § 145.14 set out
testing requirements for breeding flocks
participating in NPIP programs in part
145. Paragraph (b) in § 145.14 sets out
testing requirements for Mycoplasma
gallisepticum and M. synoviae. We are
proposing to make several changes to
these testing requirements to update
them and make them consistent with
current best practices.
We are proposing to amend paragraph
(b) at several locations to indicate that
these testing requirements apply to M.
meleagridis as well as M. gallisepticum
and M. synoviae. Currently, paragraph
(c) of § 145.14 covers M. meleagridis;
this paragraph refers the reader to
§ 145.43(d)(2) for a list of official blood
tests for M. meleagridis. (Paragraph
(d)(3) of § 145.43 provides additional
instructions on testing for M.
meleagridis.) However, many of the
testing procedures work for all three
bacteria, and it makes sense to address
testing for these bacteria together in
§ 145.14(b) because they are also
addressed together in § 147.6, which
sets out a procedure for determining the
status of flocks reacting to tests for these
three bacteria. Accordingly, we are
proposing to remove and reserve
§§ 145.14(c) and 145.43(d)(2) and (d)(3).
The testing provisions in paragraph
(b) have referred to blood testing
specifically. However, the regulations in
§ 147.30 provide a molecular
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examination procedure for M.
gallisepticum and M. synoviae, and the
regulations in § 147.31 provide another
molecular examination procedure for M.
gallisepticum. These molecular
examination procedures do not involve
blood testing. Therefore, we are
proposing to make several changes in
paragraph (b) to indicate that the
regulations provide for testing
procedures generally.
Paragraph (b)(1) of § 145.14 currently
provides for the use of the
hemagglutination inhibition (HI) test,
the microhemagglutination inhibition
test, and the enzyme-linked
immunosorbent assay (ELISA) test to
confirm the positive results of other
serological tests. We are proposing to
remove the ELISA test from this list.
The ELISA test is a screening assay and
should not be used to confirm positive
serological results.
Paragraph (b)(5) of § 145.14 currently
provides that the official molecular
examination procedures for M.
gallisepticum and M. synoviae are the
polymerase chain reaction (PCR) test
described in § 147.30 and the real-time
PCR test described in § 147.31.
However, the real-time PCR test in
§ 147.31 is approved only for M.
gallisepticum. We are therefore
proposing to remove the reference to the
real-time PCR as an official molecular
examination procedure for M. synoviae.
If, at some point in the future, we
expand the use of the molecular
examination procedures in §§ 147.30
and 147.31 to M. meleagridis and the
use of the real-time PCR test in § 147.31
to M. synoviae, we will amend
§ 145.14(b)(5) accordingly.
As noted earlier, § 147.6 sets out a
procedure for determining the status of
flocks reacting to tests for M.
gallisepticum, M. meleagridis, and M.
synoviae. We are proposing to make
several updates to this section.
The introductory text of § 147.6
currently states that the official tests for
Mycoplasma are the macroagglutination
tests for Mycoplasma antibodies, as
described in ‘‘Standard Methods for
Testing Avian Sera for the Presence of
Mycoplasma Gallisepticum Antibodies’’
published by the Agricultural Research
Service, USDA, March 1966, and the
microagglutination tests, as reported in
the Proceedings, Sixteenth Annual
Meeting of the American Association of
Veterinary Laboratory Diagnosticians,
1973. The introductory text goes on to
state that procedures for isolation and
identification of Mycoplasma may be
found in Isolation and Identification of
Avian Pathogens, published by the
American Association of Avian
Pathologists, and §§ 147.15 and 147.16.
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However, as noted earlier, there are
several official tests for Mycoplasma,
not just the macroagglutination test in
the 1966 Agricultural Research Service
publication. In addition, § 145.14(b)(1)
lists all the official tests; it is not
necessary to do so again in § 147.6.
Accordingly, we would remove the first
sentence of the introductory text of
§ 147.6. In addition, we would add to
the list of procedures for isolation and
identification of Mycoplasma a
reference to the Manual of Diagnostic
Tests and Vaccines for Terrestrial
Animals, which is published by the
World Organization for Animal Health
(OIE). These procedures are
internationally recognized as
efficacious.
Paragraph (a)(1) of § 147.6 states that,
if a flock is tested by the tube
agglutination or the serum plate test and
the test is negative, the flock’s status is
negative for Mycoplasma. We would
amend this paragraph to include the
ELISA and the official molecular
examination procedures. These tests are
also effective at determining a flock’s
status.
Paragraph (a)(2) of § 147.6 states that,
if the tube agglutination or the serum
plate test is positive, the HI test and/or
the serum plate dilution (SPD) test shall
be conducted. However, for egg-type
and meat-type chicken and waterfowl,
exhibition poultry, and game bird
flocks, if more than 50 percent of the
samples are positive for either M.
gallisepticum, M. synoviae, or both,
paragraph (a)(2) requires the HI and/or
the SPD test to be conducted on 10
percent of the positive samples or 25
positive samples, whichever is greater.
We are amending the list of screening
assays that require confirmation to
include the ELISA, as listed in proposed
paragraph (a)(1). We are removing the
SPD test from the list of confirmatory
tests for serological screening assays
because there are currently no
laboratories that use this test; the HI test
is widely used and accepted as the
preferred test.
For that reason, we would also
remove the SPD test from the list of
confirmatory tests for the HI test when
more than 50 percent of the samples
from egg-type and meat-type chicken
flocks and waterfowl, exhibition
poultry, and game bird flocks are
positive on the HI test. This change
would provide for the use of only the HI
test as a confirmatory test in this case.
We would also remove the text
indicating that this confirmatory
procedure is required only for egg-type
and meat-type chicken flocks and
waterfowl, exhibition poultry, and game
bird flocks, as the procedure is
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necessary any time more than 50
percent of the samples are positive on
the HI test, to confirm the validity of the
test.
Paragraph (a)(4) of § 147.6 states that,
if HI titers of 1:40 or SPD titers of 1:5
are found, the flock shall be considered
suspicious and shall be retested in
accordance with § 147.6(a)(6). Paragraph
(a)(6) states that, 14 days after the
previous bleeding date, all birds or a
random sample comprised of 75 birds
shall be tested by the serum plate or
tube agglutination test, and that tested
birds shall be identified by numbered
bands.
We are proposing to move this
information into paragraph (a)(2), as it
follows naturally from the other
information about administering the HI
test. We would also make some changes
to it. First, we would remove all
references to the SPD test, for reasons
discussed earlier; under this proposal,
paragraph (a)(2) would state only that HI
titers of 1:40 or more may be interpreted
as suspicious. We would replace the
current procedure of testing with SPD or
tube agglutination with a culture
procedure. In this procedure,
appropriate antigen detection samples
would be taken promptly (within 7 days
of the original sampling) from 30
clinically affected birds and examined
by an approved cultural technique
individually, or pooled (up to 5 swabs
per test) and used in a molecular
examination procedure or in vivo
bioassay. The molecular examination
procedure and in vivo bioassay are
widely accepted as confirmatory tests
for this procedure.
We are proposing to remove the
requirement to identify tested birds by
numbered bands because other means
are available to identify birds that have
been tested; Official State Agencies can
work with producers to determine the
most cost-effective method in individual
cases.
In § 145.14, paragraph (b)(1) states
that HI titers of 1:40 or less may be
interpreted as equivocal, and final
judgment may be based on further
samplings and/or culture of reactors. As
noted earlier, § 147.6 refers to HI titers
of 1:40 or less as ‘‘suspicious.’’ We are
proposing to amend § 145.14(b)(1) to be
consistent with § 147.6.
Paragraphs (a)(3) through (a)(15) of
§ 147.6 provide extensive procedures for
testing and retesting flocks that have
been tested with HI in order to
determine whether they are eligible for
the classification for which they are
tested. We are proposing to replace
these paragraphs with new paragraphs
(a)(3) and (a)(4), which would provide a
much simpler procedure. Under
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proposed paragraph (a)(3), if the in vivo
bioassay, molecular examination
procedure, or culture procedure referred
to in proposed paragraph (a)(2) is
negative, the Official State Agency
would be able to qualify the flock for the
classification for which it was tested. In
the event of contaminated cultures, we
would require the molecular
examination technique to be used to
make a final determination. Under
proposed paragraph (a)(4), if the in vivo
bioassay, molecular examination
procedures, or culture procedures are
positive, the flock would be considered
infected. These proposed provisions
would greatly simplify the regulations
and recognize the utility of the in vivo
bioassay, molecular examination
procedures, and culture procedures.
Changes to AI Clean Programs for EggType and Meat-Type Chicken Breeding
Flocks
The regulations set out requirements
for the U.S. Avian Influenza Clean
classification for multiplier egg-type
chicken breeding flocks, multiplier
meat-type chicken breeding flocks,
primary egg-type chicken breeding
flocks, and primary meat-type chicken
breeding flocks at §§ 145.23(h),
145.33(l), 145.73(f), and 145.83(g)
respectively.
The current requirements for these
U.S. Avian Influenza Clean
classifications are nearly identical. The
introductory text of §§ 145.23(h),
145.33(l), 145.73(f), and 145.83(g) states
that the U.S. Avian Influenza Clean
program is intended to be the basis from
which the breeding-hatchery industry
may conduct a program for the
prevention and control of avian
influenza. It is intended to determine
the presence of avian influenza in
breeding chickens through routine
serological surveillance of each
participating breeding flock. A flock and
the hatching eggs and chicks produced
from it will qualify for this classification
when the Official State Agency
determines that they have met the
requirements of the relevant paragraph
listed earlier.
Each of those paragraphs contains a
subparagraph indicating that a flock is
eligible for the classification if a
minimum of 30 birds have been tested
negative for antibodies to avian
influenza when more than 4 months of
age and prior to the onset of egg
production. To retain this classification,
a sample of at least 30 birds must be
tested negative at intervals of 90 days,
and primary spent fowl must be tested
within 30 days prior to movement to
slaughter. Alternatively, a sample of
fewer than 30 birds may be tested, and
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found to be negative, at any one time if
all pens are equally represented and a
total of 30 birds is tested within each
90-day period. (The only exception is
for meat-type chicken multiplier
breeding flocks, which are only required
to have 15 birds tested, at the same 90day interval, in order to be eligible for
and to retain the classification.)
We are proposing to make several
changes to these classifications. First,
we are proposing to remove the
references to serological surveillance
from the introductory text of the
classifications, instead referring simply
to ‘‘surveillance.’’ As we are proposing
to refer in the regulatory text
specifically to the AI testing procedures
in § 145.14(d), referring to serological
surveillance in the introductory text is
not necessary. In addition, some of the
tests in § 145.14(d) are not serological
tests — for example, the real-time
reverse transcriptase PCR assay in
paragraph (d)(2)(i).
We would continue to require a
minimum of 30 birds to be tested
negative for antibodies to avian
influenza when more than 4 months of
age and prior to the onset of egg
production, and we would continue to
provide the 2 options for retaining the
U.S. Avian Influenza Clean
classification that are found in the
current regulations. We are proposing to
add a third option by which flocks
could retain the classification. Under
this option, the flock could retain the
classification if the flock is tested as
provided in § 145.14(d) and found
negative at intervals of 30 days or less,
and a total of 30 (15 for meat-type
multiplier breeding flocks) samples are
collected and tested within each 90-day
period. This option would provide
additional flexibility to use the flock
screening tests in § 145.14(d)(2).
We are also proposing to put in place
requirements for testing spent fowl for
each of the options for retaining the U.S.
Avian Influenza Clean classification. As
noted earlier, under the current
regulations, spent fowl are required to
be tested only if the sample of 30 birds
is being tested and found negative at
intervals of 90 days. However, testing of
spent fowl is a useful addition to
surveillance for any of the options for
retaining classification, both the existing
options and the one we are proposing.
Accordingly, we are proposing to
require spent fowl testing as part of all
of the options for retaining
classification. Specifically, we would
require in paragraphs §§ 145.23(h)(2),
145.33(l)(2), 145.73(f)(2), and
145.83(g)(2) that all spent fowl, up to a
maximum of 30, be tested serologically
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and found negative within 21 days prior
to movement to slaughter.
We are proposing to reduce the
number of days before slaughter within
which spent fowl must be tested from
30 to 21 to be consistent with testing
requirement for the NPIP AI
surveillance programs in part 146 in
which poultry (meat-type chickens and
meat-type turkeys) are moved to
slaughter. A 21-day testing requirement
would also be consistent with the
guidelines for AI surveillance in the OIE
Terrestrial Animal Health Code.1 We are
proposing to require only a sample of a
maximum of 30 spent fowl to be tested,
rather than the current requirement to
test all spent fowl, because it is not
necessary to test more than 30 spent
fowl in order to provide adequate
assurance that the flock is free of AI;
this is consistent with the general
requirement to test 30 birds per flock.
Changes to H5/H7 AI Clean Programs
for Turkey Breeding Flocks and for
Waterfowl, Exhibition Poultry, and
Game Bird Breeding Flocks
The regulations set out requirements
for the U.S. H5/H7 Avian Influenza
Clean classification for turkey breeding
flocks and for waterfowl, exhibition
poultry, and game bird breeding flocks
in §§ 145.43(g) and 145.53(e),
respectively. We are proposing to make
some minor changes to the text of these
classifications to standardize and clarify
their language. We are also proposing to
add spent fowl testing requirements for
all surveillance options in these
classifications.
The introductory text of both
§§ 145.43(g) and 145.53(e) is similar to
that of the U.S. Avian Influenza Clean
classifications discussed earlier, except
that both refer to the H5 and H7
subtypes of AI. We are proposing to
change those references to refer to ‘‘the
H5/H7 subtypes of avian influenza,’’ as
that usage is consistent with our
references to these two subtypes in 9
CFR part 146. We are also proposing to
remove the word ‘‘serological’’ from the
same place as in the introductory text to
the U.S. Avian Influenza Clean
classifications for breeding chickens, for
the same reasons discussed earlier with
regard to those AI classifications.
Within §§ 145.43(g) and 145.53(e),
paragraphs (g)(1) and (e)(1) address
primary breeding flocks for turkeys and
for waterfowl, game birds, and
exhibition poultry, respectively, while
paragraphs (g)(2) and (e)(2) address
multiplier breeding flocks. Each of these
1 The guidelines may be viewed on the Internet
at (https://www.oie.int/eng/normes/mcode/
en_chapitre_1.10.4.htm).
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paragraphs refers in its introductory text
to testing using the agar gel
immunodiffusion test in § 147.9. As all
of the tests in § 145.14(d) are effective at
testing for AI in turkeys and in
waterfowl, exhibition poultry, and game
birds, we are proposing to remove the
specific references to agar gel
immunodiffusion testing. Instead, we
would add the words ‘‘as provided in
§ 145.14(d)’’ to references to AI testing to
direct the reader to the approved AI
tests.
We are proposing to put in place
requirements for testing spent fowl for
each of the options for retaining the U.S.
H5/H7 Avian Influenza Clean
classification for turkey breeding flocks
and waterfowl, exhibition poultry, and
game bird breeding flocks. Similar to the
spent fowl testing requirements for
chickens discussed earlier, spent fowl
from turkey breeding flocks are
currently required to be tested only if a
sample of 30 birds is being tested and
found negative at intervals of 90 days.
However, testing of spent fowl is a
useful addition to surveillance for any
of the options for retaining the U.S. H5/
H7 Avian Influenza Clean classification.
Accordingly, we are proposing to add a
new paragraph § 145.43(g)(3) to require
all spent fowl from turkey breeding
flocks, up to a maximum of 30, to be
tested serologically and found negative
within 21 days prior to movement to
slaughter for all of the surveillance
options. (We would redesignate current
paragraph (g)(3), which contains
reporting requirements that apply if
killed AI vaccine is used, as paragraph
(g)(4).)
The U.S. H5/H7 Avian Influenza
Clean classification for waterfowl,
exhibition poultry, and game bird
breeding flocks does not currently
include spent fowl testing requirements.
However, testing any spent fowl that are
produced by these flocks for AI would
be a useful addition to surveillance for
this classification as well. Therefore, we
are proposing to add a new paragraph
§ 145.53(e)(3) to require spent fowl to be
tested for these flocks as well.
The classification provisions for
primary and multiplier turkey breeding
flocks in § 145.43(g)(1) and (g)(2),
respectively, require that flocks test
negative for antibodies to type A AI
virus. Positive results must be further
tested by an authorized laboratory using
the hemagglutination inhibition test to
detect antibodies to the hemagglutinin
subtypes H5 and H7 when more than 4
months of age and prior to the onset of
egg production. We are proposing to
remove this 2-step process and instead
require that a minimum of 30 birds test
negative to the H5/H7 subtypes of AI.
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The testing procedures in § 145.14(d) set
out the official tests for AI and indicate
that the official determination of a flock
as positive for the H5 or H7 subtypes of
avian influenza may be made only by
the National Veterinary Services
Laboratories. It is appropriate to refer to
these testing procedures, which apply to
all poultry covered in 9 CFR part 145,
rather than setting out a separate testing
procedure in the turkey breeding flock
U.S. H5/H7 Avian Influenza Clean
classification. This change would also
make the provisions in § 145.43
consistent with the other AI
classifications in the regulations.
The regulations in § 145.53(e)(1) and
(e)(2) also refer to testing for antibodies
to the H5 and H7 subtypes of AI. As
other AI classifications refer to testing
for the disease itself and not antibodies
to the disease, we would remove
references to testing for antibodies to
make the regulations consistent.
We are proposing to make one other
change related to AI in part 145. In
§ 145.1, we are proposing to add a
definition of avian influenza. We would
define AI as ‘‘an infection or disease of
poultry caused by viruses in the family
Orthomyxoviridae, genus Influenzavirus
A.’’ Including this definition would
provide additional clarity regarding AI.
Salmonella Negative Status for Primary
Meat-Type Chicken Breeding Flocks in
the U.S. Salmonella Monitored
Classification
The regulations in § 145.83(f) set out
provisions for the U.S. Salmonella
Monitored classification for primary
meat-type chicken breeding flocks and
the hatching eggs and chicks produced
from it. This classification requires
participating flocks to be maintained in
compliance with §§ 147.21, 147.24(a),
and 147.26, requires feed to be
processed, stored, and transported to
prevent contamination with Salmonella,
and requires chicks to be hatched in a
hatchery meeting the requirements of
§§ 147.23 and 147.24(b) and sanitized or
fumigated. It also contains testing
procedures designed to verify the flock’s
Salmonella status.
In recent years, trading partners have
begun to require that baby chicks and
hatching eggs originate from breeding
flocks free of certain serotypes of
Salmonella. The current provisions of
the U.S. Salmonella Monitored
classification do not provide for
serotyping. Therefore, we are proposing
to add a serotyping provision to
paragraph (f)(1)(vi). This paragraph
currently requires an Authorized Agent
to take environmental samples as
described in § 147.12 from each flock at
4 months of age and every 30 days
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thereafter. An authorized laboratory for
Salmonella must then examine the
environmental samples
bacteriologically. We are proposing to
require all Salmonella isolates from a
flock to be serogrouped and reported to
the Official State Agency on a monthly
basis.
We are also proposing to amend
paragraph (f)(1)(vii), which provides
that owners of flocks may vaccinate
with a paratyphoid vaccine if they leave
a sample unvaccinated until the flock
reaches 4 months of age, to indicate that
this sample will allow for the
serological testing that would be
required under proposed paragraph
(f)(1)(vi).
Some trading partners’ import
requirements separate the Salmonella
status of the flock from the status of the
hatchery containing the hatching eggs
and chicks produced from it. A primary
meat-type chicken breeding flock can
thus be considered to be free of
Salmonella, based on regular testing,
even if there is environmental
Salmonella contamination in the
hatchery. However, the current U.S.
Salmonella Monitored classification
does not provide for this; it applies to
both the flock and the hatching eggs and
chicks produced from it. To provide
flock owners with a means to
demonstrate their flock’s Salmonellanegative status, we are proposing to add
a new paragraph (f)(1)(viii) with
provisions under which a flock could be
considered ‘‘Salmonella negative.’’
Under proposed paragraph (f)(1)(viii),
any flock entering the production period
that is in compliance with all the
requirements of § 145.83(f) with no
history of Salmonella isolations would
be considered ‘‘Salmonella negative’’
and could retain this definition as long
as no environmental or bird salmonella
isolations are identified and confirmed
from the flock or flock environment by
sampling on 4 separate collection dates
over a minimum of a 2-week period.
Sampling and testing would have to be
performed as described in proposed
paragraph (f)(1)(vi). An unconfirmed
environmental Salmonella isolation
would not change this Salmonella
negative status, as the ‘‘Salmonella
negative’’ status is intended to reflect
only the status of the flock itself.
These proposed provisions would
provide participants in the U.S.
Salmonella Monitored classification for
primary meat-type breeding turkeys
with new means to verify the flock’s
Salmonella status for trading partners.
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New Provisions for Meat-Type
Waterfowl Breeding Flocks and Products
We are proposing to add a new
subpart I to 9 CFR part 145, which
would consist of §§ 145.91 through
145.94. This subpart would set out
special provisions for the participation
of meat-type waterfowl breeding flocks
and products in the Plan. Although
subpart E in 9 CFR part 145 provides
special provisions for waterfowl,
exhibition poultry, and game bird
breeding flocks and products, these
provisions are directed towards
hobbyist and exhibition waterfowl and
are not necessarily suited for meat-type
waterfowl breeding flocks. Adding a
new subpart I would allow the NPIP to
address issues related to meat-type
waterfowl breeding flocks specifically.
We are proposing to amend subpart E
to make it clear that meat-type
waterfowl breeding flocks would no
longer be covered under that subpart.
We would amend the section heading of
subpart E and the introductory text of
§ 145.52, ‘‘Participation,’’ to indicate that
the subpart’s applicability is limited to
hobbyist and exhibition waterfowl. We
would add a sentence to the
introductory text of § 145.52 indicating
that the special provisions that apply to
meat-type waterfowl flocks are found in
subpart I of part 145. We would also
amend §§ 145.53 and 145.54 in a few
places to reflect these changes. The
amendments can be found in the
proposed regulatory text at the end of
this document.
The structure of subpart I would be
similar to the structure of subparts B
through H in part 145. Section 145.91,
‘‘Definitions,’’ would contain a
definition of meat-type waterfowl
breeding flocks. This term would be
defined as: Flocks of domesticated duck
or goose that are composed of stock that
has been developed and is maintained
for the primary purpose of producing
baby poultry that will be raised under
confinement for the primary purpose of
producing meat for human
consumption.
Section 145.92, ‘‘Participation,’’ would
state that participating flocks of meattype waterfowl and the eggs and baby
poultry produced from them shall
comply with the applicable general
provisions of subpart A of part 145 and
the special provisions of proposed
subpart I. In addition:
∑ Started poultry would lose their
identity under Plan terminology when
not maintained by Plan participants
under the conditions prescribed in
§ 145.5(a).
∑ Hatching eggs produced by primary
breeding flocks would have to be
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fumigated (see § 147.25) or otherwise
sanitized.
∑ Any nutritive material provided to
baby poultry would have to be free of
the avian pathogens that are officially
represented in the Plan disease
classifications listed in § 145.10.
These conditions, which are similar to
the conditions for participation in other
subparts in part 145, would help to
ensure that flocks that participate in the
Plan are free of poultry diseases.
Section 145.93, ‘‘Terminology and
classification; flocks and products,’’
would set out conditions for two Plan
classifications for meat-type breeding
waterfowl, the U.S. Pullorum-Typhoid
Clean classification and the U.S. Avian
Influenza Clean classification. The
provisions of these classifications are
similar to those for other types of
poultry in part 145.
Paragraph (a) would be reserved, as it
is in other subparts in part 145.
Paragraph (b) would contain the
requirements for the U.S. PullorumTyphoid Clean classification. A
qualifying flock would be one in which
freedom from pullorum and typhoid has
been demonstrated to the Official State
Agency under the criteria in one of
proposed paragraphs (b)(1) through
(b)(5).
Proposed paragraph (b)(1) would
provide that a flock would qualify if it
has been officially blood tested within
the past 12 months with no reactors.
Proposed paragraph (b)(2) would
provide that a flock would qualify if it
is a multiplier breeding flock, or a
breeding flock composed of progeny of
a primary breeding flock which is
intended solely for the production of
multiplier breeding flocks, and meets
the following specifications as
determined by the Official State Agency
and the Service:
∑ 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;
∑ 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
∑ The flock is located on a premises
where a flock not classified as U.S.
Pullorum-Typhoid Clean was located
the previous year. In this circumstance,
an Authorized Testing Agent would
have to 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-
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typhoid. In making determinations of
exposure and setting the number of
birds to be blood tested, the Official
State Agency would 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.
(NOTE: In addition to requiring blood
testing when a flock not classified as
U.S. Pullorum-Typhoid Clean was
located on a premises the previous year,
similar provisions in §§ 145.23(b)(2)(iii),
145.33(b)(2)(iii), 145.43(b)(2)(iii), and
145.53(b)(2)(iii) also require blood
testing when no poultry has been
located on the premises the previous
year. Testing is not necessary in the
latter circumstance, and we are
proposing to remove the requirement to
conduct blood testing on a flock when
no poultry was located on the premises
the previous year in each of these
paragraphs.)
Paragraph (b)(3) would provide that a
flock would qualify if it is a multiplier
breeding flock that originated from U.S.
Pullorum-Typhoid Clean breeding
flocks or from flocks that met equivalent
requirements under official supervision,
and is located in a State in which it has
been determined by the Service that:
∑ All hatcheries within the State are
qualified as ‘‘National Plan Hatcheries’’
or have met equivalent requirements for
pullorum-typhoid control under official
supervision;
∑ All hatchery supply flocks within
the State are qualified as U.S. PullorumTyphoid Clean or have met equivalent
requirements for pullorum-typhoid
control under official supervision.
However, if other domesticated fowl are
maintained on the same premises as the
participating flock, freedom from
pullorum-typhoid infection would be
demonstrated by an official blood test of
each of these fowl;
∑ All shipments of products other
than U.S. Pullorum-Typhoid Clean, or
equivalent, into the State are prohibited;
∑ 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;
∑ All reports of any disease outbreak
involving a disease covered under the
Plan are promptly followed by an
investigation by the Official State
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Agency to determine the origin of the
infection. 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 NPIP
would conduct an investigation;
∑ 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; and
∑ 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.
Discontinuation of any of these
conditions or procedures, or the
occurrence of repeated outbreaks of
pullorum or typhoid in poultry breeding
flocks within or originating within the
State would be grounds for the Service
to revoke its determination that such
conditions and procedures have been
met or complied with. Such action
would 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.
Paragraph (b)(4) would provide that a
flock would qualify if it is a multiplier
breeding flock located in a State which
has been determined by the Service to
be in compliance with the provisions of
proposed paragraph (a)(3), and 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.
Paragraph (b)(5) would provide that a
flock would qualify if it is a primary
breeding flock located in a State
determined to be in compliance with
the provisions of paragraph (a)(4) of this
section, and in which a sample of 300
birds from flocks of more than 300, and
each bird in flocks of 300 or less, has
been officially tested for pullorumtyphoid within the past 12 months with
no reactors. However, when a flock is a
primary breeding flock located in a State
which has been deemed to be a U.S.
Pullorum-Typhoid Clean State for the
past 3 years, and during which time no
isolation of pullorum or typhoid has
been made that can be traced to a source
in that State, a bacteriological
examination monitoring program or a
serological examination monitoring
program acceptable to the Official State
Agency and approved by the Service
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could be used in lieu of annual blood
testing.
Compliance with any one of these
provisions is sufficient to ensure that
pullorum-typhoid is not present in a
meat-type waterfowl breeding flock in
the U.S. Pullorum-Typhoid Clean
classification, as evidenced by the
success of these provisions when used
for the classification in other types of
poultry.
Proposed paragraph (c) would set out
the provisions of the U.S. Avian
Influenza Clean classification. The
intent of this program would be to serve
as the basis from which the meat-type
waterfowl breeding-hatchery industry
may conduct a program for the
prevention and control of H5/H7 AI. It
would be intended to determine the
presence of the H5/H7 AI in meat-type
waterfowl breeding flocks through
routine surveillance of each
participating breeding flock. There
would be separate surveillance
provisions for primary breeding flocks
and multiplier breeding flocks of meattype waterfowl.
Paragraph (c)(1) would provide that a
primary meat-type waterfowl breeding
flock would qualify for the U.S. Avian
Influenza Clean classification if a
minimum of 30 birds from the flock
have been tested negative to H5/H7 AI
as provided in § 145.14(d) when more
than 4 months of age. To retain this
classification:
∑ A sample of at least 30 birds would
have to be tested negative at intervals of
90 days; or
∑ A sample of fewer than 30 birds
could be tested, and found to be
negative, at any one time if all pens
were equally represented and a total of
30 birds were tested within each 90-day
period.
Paragraph (c)(2) would provide that a
multiplier meat-type waterfowl breeding
flock would also qualify for the
classification if a minimum of 30 birds
from the flock have been tested negative
to H5/H7 AI as provided in § 145.14(d)
when more than 4 months of age. The
options for retaining the classification
would be identical to those for primary
breeding flocks.
Consistent with the changes proposed
in this document to require testing of
spent fowl in the AI programs for other
types of poultry, paragraph (c)(3) would
require that, during each 90-day period,
all primary and multiplier spent fowl,
up to a maximum of 30, be tested
serologically and found negative within
21 days prior to movement to slaughter.
These provisions would be sufficient
to determine whether H5/H7 AI is
present in participating meat-type
waterfowl breeding flocks. Similar
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provisions have been used successfully
in other AI classifications in part 145.
Section 145.94, ‘‘Terminology and
classification; States,’’ would set out
conditions for the U.S. PullorumTyphoid Clean State classification.
Several of the subparts for specific types
of poultry in part 145 contain provisions
for this classification. To be declared a
U.S. Pullorum-Typhoid Clean State,
APHIS would have to determine that the
following two requirements have been
met:
∑ 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), and
proposed 145.93(b)(3)(i) through (vii).
Compliance with these provisions
ensures that the State has the
infrastructure to detect and respond to
outbreaks of pullorum-typhoid; and
∑ 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. However, pullorum disease or
fowl typhoid found within the
preceding 24 months in waterfowl,
exhibition poultry, and game bird
breeding flocks would not prevent a
State that is otherwise eligible from
qualifying. This exception is standard in
the U.S. Pullorum-Typhoid Clean State
classifications; while pullorum disease
is found extremely rarely in the United
States, it is most often found in these
types of poultry, often outside a
commercial poultry production setting,
and it is not necessary to remove a U.S.
Pullorum-Typhoid Clean State
classification for such a finding.
If these conditions are discontinued,
or repeated outbreaks of pullorum or
typhoid occur in hatchery supply flocks
of this section, or if an infection spreads
from the originating premises, APHIS
would have grounds to revoke its
determination that the State is entitled
to this classification. Such action would
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.
As noted, several of the subparts for
specific types of poultry in part 145
contain provisions for the U.S.
Pullorum-Typhoid Clean State
classification. All of those subparts
contain lists of the provisions with
which the State must be in compliance.
Some of these do not reflect the addition
of relevant provisions in subparts G and
H (for primary egg-type chicken and
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primary meat-type chicken breeding
flocks, respectively); none of these
include the provisions in
§ 145.93(b)(3)(i) through (vii) that we are
proposing to add. We are therefore also
proposing to update the lists of
provisions with which a State must be
in compliance in order to be declared a
U.S. Pullorum-Typhoid Clean State in
§§ 145.24(a)(1)(i), 145.34(a)(1)(i),
145.44(a)(1)(i), and 145.54(a)(1)(i) to
keep them up to date and to reflect the
proposed changes.
jdjones on DSK8KYBLC1PROD with PROPOSALS-1
Definition of H5/H7 LPAI in Part 146
In § 146.1, the term H5/H7 low
pathogenic avian influenza (LPAI) is
defined as follows: ‘‘An infection of
poultry caused by an influenza A virus
of H5 or H7 subtype that has an
intravenous pathogenicity index test in
6-week-old chickens less than 1.2 or any
infection with influenza A viruses of H5
or H7 subtype for which nucleotide
sequencing has not demonstrated the
presence of multiple basic amino acids
at the cleavage site of the
hemagglutinin.’’
We added this definition to the
regulations in an interim rule effective
and published in the Federal Register
on September 26, 2006 (71 FR 5360156333, Docket No. APHIS-2005-0109). It
was based on the OIE guidelines for AI
that were current at the time of
publication.
Since then, the OIE has updated its AI
guidelines, including the definition of
H5/H7 LPAI. To ensure that our
regulations continue to be consistent
with the OIE guidelines, we are
proposing to update the definition of
H5/H7 LPAI. The new definition would
read: ‘‘An infection of poultry caused by
an influenza A virus of H5 or H7
subtype that has an intravenous
pathogenicity index in 6-week-old
chickens less than 1.2 or less than 75
percent mortality in 4- to 8-week-old
chickens infected intravenously, or an
infection with influenza A viruses of H5
or H7 subtype with a cleavage site that
is not consistent with a previously
identified highly pathogenic avian
influenza virus.’’ This change would
keep the regulations up to date with
international standards.
Addition of Provisions for Commercial
Table-Egg Layer Pullets
Subpart B of part 146 (§§ 146.21
through 146.24) contains special
provisions for commercial table-egg
layer flocks. We are proposing to add
provisions for commercial table-egg
layer pullets to subpart B.
We would define a table-egg layer
pullet in § 146.21 as a sexually
immature domesticated chicken grown
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for the primary purpose of producing
eggs for human consumption. By
definition, because the table-egg layer
pullet is not sexually mature, it cannot
yet lay eggs. Pullets are typically less
than 20 weeks of age. Table-egg layer
pullets are moved to a layer house when
they become sexually mature, after
which they are called table-egg layers.
The regulations in subpart B have
focused on table-egg layer flocks
themselves, but the introduction of
table-egg layer pullets into a flock is a
potential pathway for the introduction
of diseases, particularly as table-egg
layer flocks are often assembled from
multiple pullet sources. Thus, we are
proposing to include provisions in the
special provisions for commercial tableegg layers in subpart B of part 146 to
address the table-egg layer pullets that
will ultimately be moved onto the tableegg layer premises.
In addition, the definition of
commercial table-egg layer flock in
§ 146.1 reads: ‘‘All table-egg layers of
one classification in one barn or house.’’
We are proposing to replace this with a
new definition: ‘‘All table-egg layers of
common age or pullet source on one
premises.’’ Table-egg layer flocks are
normally composed of birds of common
age or pullet source, but the birds may
be in one house or multiple houses;
older table-egg layer premises are more
likely to have one flock spread across
multiple houses. By removing the
requirement that a flock be contained in
a single barn or house and instead
designating a flock as a group of tableegg layers of common age or pullet
source, we would more accurately
reflect the organization of table-egg layer
flocks. We would retain the definition of
commercial table-egg layer premises in
§ 146.1, which indicates that a premises
includes all contiguous flocks of
commercial table-egg layers under
common ownership, to reflect the fact
that a commercial table-egg layer
premises may comprise many
individual flocks.
We would also add a definition of
commercial table-egg layer pullet flock
to § 146.1. This definition would read as
follows: ‘‘A table-egg layer flock prior to
the onset of egg production.’’
In § 146.23, paragraph (a) sets out the
requirements of the U.S. H5/H7 Avian
Influenza Monitored program for
commercial table-egg layers. The
introductory text of this paragraph states
that this program is intended to be the
basis from which the table-egg layer
industry may conduct a program to
monitor for the H5/H7 subtypes of AI.
It is intended to determine the presence
of the H5/H7 subtypes of AI in table-egg
layers through routine serological
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57207
surveillance of each participating
commercial table-egg layer flock.
We are proposing to amend this
discussion to refer to commercial tableegg layer pullet flocks as well as
commercial table-egg layer flocks. We
are also proposing to remove the
reference to serological testing
specifically, for reasons similar to those
given earlier for removing the specific
references to serological testing from the
U.S. H5/H7 Avian Influenza Clean
classification for turkey breeding flocks
and for waterfowl, exhibition poultry,
and game bird breeding flocks.
Within paragraph (a), paragraphs
(a)(1), (a)(2), and (a)(3) set out the
requirements for surveillance of
commercial table-egg layers. We are
proposing to add a new paragraph (a)(1)
with requirements for table-egg layer
pullet flocks and redesignate current
(a)(1), (a)(2), and (a)(3) as paragraphs
(a)(2)(i), (a)(2)(ii), and (a)(2)(iii). In those
paragraphs, we would remove
references to testing negative for
antibodies to H5/H7 AI and instead refer
simply to testing negative for H5/H7 AI,
for the reasons mentioned earlier with
regard to similar changes to the U.S. H5/
H7 Avian Influenza Clean classification
for turkey breeding flocks. We would
also remove the current references to
testing egg samples and add references
to the official AI tests in § 146.13(b), for
the reasons mentioned earlier with
regard to similar changes to the U.S. H5/
H7 Avian Influenza Clean classification
for waterfowl, game bird, and exhibition
poultry breeding flocks.
Proposed paragraph (a)(1) would
provide two options by which table-egg
layer pullet flocks could qualify for the
U.S. H5/H7 Avian Influenza Monitored
classification. Such a flock would
qualify if:
∑ It is a commercial table-egg layer
pullet flock in which a minimum of 11
birds have been tested negative to the
H5/H7 subtypes of AI as provided in
§ 146.13(b) within 30 days prior to
movement; or
∑ It is a commercial table-egg layer
pullet flock that has an ongoing active
and diagnostic surveillance program for
the H5/H7 subtypes of AI which the
number of birds tested is equivalent to
the number required in the other option
and that is approved by the Official
State Agency and the Service.
Any ongoing active and diagnostic
surveillance program that is approved
by the Official State Agency and APHIS
would have to test a number of birds
equivalent to the first requirement, but
this by itself would not be sufficient to
secure approval for the program; the
Official State Agency and APHIS would
have to agree that the detailed testing
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plan for the alternate program is
sufficient to establish a level of
confidence for the detection of AI that
is equivalent to that of the first
requirement. Allowing participating
flocks to develop an alternative ongoing
active and diagnostic surveillance
program of equivalent efficacy would
give the flock owners some flexibility.
In § 146.24, paragraph (a) sets out the
provisions for the U.S. H5/H7 Avian
Influenza Monitored State, Layers
classification. We would amend these
provisions to indicate that this
classification also includes table-egg
layer pullet flocks. Under paragraph
(a)(1)(i), in order for a State to qualify
for the U.S. H5/H7 Avian Influenza
Monitored State, Layers classification,
all the commercial table-egg layer flocks
that are not exempt from the special
provisions of subpart B under § 146.22
and all the commercial table-egg layer
pullet flocks that supply those flocks
within the State would have to be
classified as U.S. H5/H7 Avian
Influenza Monitored under § 146.23(a).
Requirements for specimen reporting
and subtyping in paragraphs (a)(1)(iii)
and (a)(1)(iv) would also apply to
commercial table-egg layer pullet flocks
as well as commercial table-egg layer
flocks. Finally, under paragraph
(a)(1)(v), all table-egg layer pullet flocks
within the State that are found to be
infected with H5/H7 AI would have to
be quarantined, in accordance with an
initial State response and containment
plan as described in 9 CFR part 56 and
under the supervision of the Official
State Agency, the same as is currently
required for table-egg layer flocks.
These changes would expand the
reach of the U.S. H5/H7 Avian Influenza
Monitored classification for commercial
table-egg layers and make it more
effective.
Testing Procedures for Other U.S. H5/
H7 Avian Influenza Monitored
Classifications in Part 146
Within part 146, § 146.33 contains the
requirements for the U.S. H5/H7 Avian
Influenza Monitored classification for
meat-type chicken slaughter plants,
§ 146.43 contains the requirements for
that classification for meat-type turkey
slaughter plants, § 146.53(a) contains
the requirements for commercial
waterfowl and commercial upland game
bird slaughter plants, and § 146.53(b)
contains the requirements for raised-forrelease upland game birds and raisedfor-release waterfowl. Similar to other
classifications discussed earlier in this
proposal, all of these classifications
contain testing requirements for H5/H7
LPAI but do not specify that testing
must be conducted as provided in
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§ 146.13(b), which contains the official
AI tests for part 146. We are proposing
to amend these requirements to indicate
that birds must be tested for these
classifications as provided in
§ 146.13(b). In addition, we are
proposing to remove a reference to
testing for antibodies to H5/H7 LPAI in
§ 146.53(a)(2), for reasons identical to
those given for similar changes
described earlier in this document.
Shoe Cover Sampling Technique for
Collection of Salmonella Samples
Section 147.12 sets out procedures for
collection, isolation, and identification
of Salmonella from environmental
samples, cloacal swabs, chick box
papers, and meconium samples.
Paragraph (a) of § 147.12 sets out
procedures specific to egg- and meattype chickens, waterfowl, exhibition
poultry, and game birds. This paragraph
includes various methods for collecting
samples and a procedure for testing
chick meconium.
We are proposing to add a new
sampling technique in a proposed new
paragraph (a)(6). This technique uses
absorbable shoe covers to collect
samples. Absorbable fabric shoe covers
involve the exposure of the bottom
surface of shoe covers to the surface of
floor litter and slat areas. The shoe cover
sampling technique would involve
wearing clean latex gloves and placing
the shoe covers over footwear that is
only worn inside the poultry house.
This could be footwear dedicated to the
facility or disposable overshoes. Each
pair of shoe covers would be worn
while walking at a normal pace over a
distance of 305 meters (1000 feet). For
flocks with fewer than 500 breeders, at
least 1 pair of shoe covers would be
worn to sample the floor of the bird
area. For flocks with 500 or more
breeders, at least 2 pairs of shoe covers
would be worn to sample the floor of
the bird area. After sampling, each shoe
cover would be placed in a sterile
container with 30 ml of double strength
skim milk, to protect Salmonella
viability during storage and shipment.
The sterile containers would have to be
sealed and promptly refrigerated at 2 to
4 °C or place in a cooler with ice or ice
packs, but not frozen. Samples would
have to be stored at refrigerator
temperatures of 2 to 4 °C no more than
5 days prior to culturing.
This procedure would provide an
effective alternative means to collect
Salmonella samples in poultry houses.
Approved Tests
Within § 147.52, paragraph (b) sets
out a procedure by which diagnostic test
kits that are not licensed by APHIS (e.g.,
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Sfmt 4702
bacteriological culturing kits) may be
approved for use in the NPIP. We are
proposing to list in a new paragraph (c)
in § 147.52 the test kits that have been
approved through this process. These
are the test kits we are proposing to list:
∑ Rapid Chek©Select TMSalmonella
Test Kit, Strategic Diagnostics, Inc.
Newark, DE 19713.
∑ ADIAFOOD Rapid Pathogen
Detection System for Salmonella spp.,
AES Chemunex Canada. Laval, QC
(Canada) H7L4S3.
∑ DuPont Qualicon BAX Polymerase
Chain Reaction (PCR)-based assay for
Salmonella, DuPont Qualicon,
Wilmington, DE 19810.
Updates
The regulations in § 145.10 provide
for the use of certain terms and
illustrative designs to designate
participants in NPIP programs for
breeding poultry; the regulations in
§ 146.9 do the same for commercial
poultry. Both of these sections refer to
certain subparts of parts 145 and 146,
respectively, that include provisions for
the programs; § 145.10 refers to subparts
B, C, D, E, and F, while § 146.9 refers
to subparts B, C, and D. However, these
lists do not include subparts that have
been added recently: Subparts G and H
in part 145 and subpart E in part 146.
To correct the errors and ensure that the
regulations accommodate the addition
of future subparts, we are removing the
lists of subparts from §§ 145.10 and
146.9 and instead referring generally to
parts 145 and 146, respectively.
Within §§ 145.10 and 146.9, we are
also updating the lists of classifications
eligible to use the various illustrative
designs. These lists have become out of
date as well.
Section 147.45, ‘‘Official delegates,’’
provides that each cooperating State
shall be entitled to one official delegate
to the Plan Conference for each of the
programs prescribed in subparts B, C, D,
E, F, G, and H of part 145 and for each
of the programs prescribed in subparts
B, C, D, and E of part 146 in which it
has one or more participants at the time
of the conference. Rather than proposing
to update this list to reflect the proposed
addition of a new subpart I in part 145,
we are proposing to simply refer to each
of the programs prescribed in parts 145
and 146, generally. In both parts 145
and 146, subpart A sets out general
provisions for participation in the NPIP,
but not specific programs; thus,
referring generally to the programs
prescribed in parts 145 and 146
includes all the necessary programs.
Making this change would simplify the
regulations.
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Executive Order 12866 and Regulatory
Flexibility Act
jdjones on DSK8KYBLC1PROD with PROPOSALS-1
This proposed rule has been reviewed
under Executive Order 12866. The
proposed rule has been determined to
be not significant for the purposes of
Executive Order 12866 and, therefore,
has not been reviewed by the Office of
Management and Budget.
In accordance with the Regulatory
Flexibility Act, we have analyzed the
potential economic effects of this action
on small entities. The analysis is
summarized below. Copies of the full
analysis are available by contacting the
person listed under FOR FURTHER
INFORMATION CONTACT or on the
Regulations.gov Web site (see
ADDRESSES above for instructions for
accessing Regulations.gov).
This rule would introduce a set of
minor changes to the NPIP and would
not involve significant changes in
program operations. These changes are
in line with the industry’s best practices
and would likely involve no additional
costs in order to meet these
requirements. Additionally, the NPIP is
a voluntary program established
between the industry and State and
Federal governments. Any person
producing or dealing in products may
participate in the NPIP when he or she
has demonstrated that his or her
facilities, personnel, and practices are
adequate for carrying out the applicable
provisions of the NPIP. NPIP
participation allows for greater ease in
moving hatching eggs, live birds, and
commercial poultry products within a
State, across State lines, and into other
countries. Most countries will not
accept hatching eggs, live birds, or
commercial poultry products from a
U.S. operation unless it can be shown to
be an NPIP participant. The poultry
industry plays an important role in the
U.S. economy, and the proposed
amendments would help to ensure the
safety of the industry and benefit the
economy.
Under these circumstances, the
Administrator of the Animal and Plant
Health Inspection Service has
determined that this action would not
have a significant economic impact on
a substantial number of small entities.
Executive Order 12372
This program/activity is listed in the
Catalog of Federal Domestic Assistance
under No. 10.025 and is subject to
Executive Order 12372, which requires
intergovernmental consultation with
State and local officials. (See 7 CFR part
3015, subpart V.)
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Executive Order 12988
This proposed rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. If this proposed rule is
adopted: (1) No retroactive effect will be
given to this rule; and (2) administrative
proceedings will not be required before
parties may file suit in court challenging
this rule.
Paperwork Reduction Act
This proposed rule contains no new
information collection or recordkeeping
requirements under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et
seq.).
List of Subjects
9 CFR Part 56
Animal diseases, Indemnity
payments, Low pathogenic avian
influenza, Poultry.
57209
d. By redesignating paragraph (b)(7) as
paragraph (b)(3).
■
§ 56.3
Payment of indemnity.
*
*
*
*
*
(b) * * *
(1) The poultry are from a breeding
flock that participates in any Plan
program in part 145 of this chapter but
that does not participate in the U.S.
Avian Influenza Clean or the U.S. H5/
H7 Avian Influenza Clean program of
the Plan available to the flock in part
145 of this chapter; or
(2) The poultry are from a commercial
flock or slaughter plant, but the flock or
slaughter plant does not participate in
the U.S. Avian Influenza Monitored
program available to the commercial
flock or slaughter plant in part 146 of
this chapter; or
*
*
*
*
*
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 145–NATIONAL POULTRY
IMPROVEMENT PLAN FOR BREEDING
POULTRY
PART 56—CONTROL OF H5/H7 LOW
PATHOGENIC AVIAN INFLUENZA
■
1. The authority citation for 9 CFR
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 removing the definitions of
commercial meat-type flock,
commercial table-egg layer flock,
commercial table-egg layer premises,
meat-type chicken, and meat-type
turkey.
■ b. By adding a definition of
commercial flock or slaughter plant, in
alphabetical order, to read as set forth
below.
■
■
§ 56.1
Definitions.
*
*
*
*
*
Commercial flock or slaughter plant.
A commercial poultry flock or slaughter
plant that is required because of its size
to participate in the special provisions
in part 146 of this chapter in order to
participate in the Plan.
*
*
*
*
*
■ 3. Section 56.3 is amended as follows:
■ a. In paragraph (b) introductory text,
by removing the word ‘‘(b)(7)’’ each time
it occurs and adding the word ‘‘(b)(3)’’ in
its place.
■ b. By revising paragraphs (b)(1) and
(b)(2) to read as set forth below.
■ c. By removing paragraphs (b)(4)
through (b)(6).
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4. 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.
5. Section 145.1 is amended by
adding, in alphabetical order, a new
definition of avian influenza to read as
set forth below.
§ 145.1
Definitions.
*
*
*
*
*
Avian influenza. An infection or
disease of poultry caused by viruses in
the family Orthomyxoviridae, genus
Influenzavirus A.
*
*
*
*
*
■ 6. Section 145.10 is amended as
follows:
■ a. By revising the introductory text to
read as set forth below.
■ b. In paragraph (r), by removing the
words ‘‘and 145.53(e)’’ and adding the
words ‘‘145.63(b), 145.73(f), and
145.83(g)’’ in their place.
■ c. In paragraph (t), by removing the
citation ‘‘§ 145.43(g)’’ and adding the
words ‘‘§§ 145.43(g), 145.53(e), and
145.93(b)’’ in its place.
§ 145.10 Terminology and classification;
flocks, products, and States.
Participating flocks, products
produced from them, and States that
have met the requirements of a
classification in this part may be
designated by the corresponding
illustrative design in this section.
*
*
*
*
*
■ 7. Section 145.14 is amended as
follows:
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■ a. In the introductory text, in the first
sentence, by removing the word ‘‘blood’’
each time it occurs.
■ b. In the introductory text, in the
second sentence, by removing the words
‘‘Blood samples’’ and adding the word
‘‘Samples’’ in its place; and by removing
the word ‘‘drawn’’ and adding the word
‘‘collected’’ in its place.
■ c. By revising the introductory text of
paragraph (b) and paragraph (b)(1) to
read as set forth below.
■ d. In paragraph (b)(2), by adding the
word ‘‘serological’’ before the word
‘‘tests’’; and by adding the words ‘‘, M.
meleagridis,’’ after the word
‘‘gallisepticum’’.
■ e. By revising paragraph (b)(5) to read
as set forth below.
■ f. By removing and reserving
paragraph (c).
§ 145.14
Testing.
*
*
*
*
(b) For Mycoplasma gallisepticum, M.
meleagridis, and M. synoviae. (1) The
official blood tests for M. gallisepticum,
M. meleagridis, and M. synoviae shall be
the serum plate agglutination test, the
tube agglutination test, the
hemagglutination inhibition (HI) test,
the microhemagglutination inhibition
test, the enzyme-linked immunosorbent
assay (ELISA) test,3 a PCR-based test, or
a combination of two or more of these
tests. The HI test or the
microhemagglutination inhibition test
shall be used to confirm the positive
results of other serological tests. HI
titers of 1:40 or more may be interpreted
as suspicious, and final judgment must
be based on further samplings and/or
culture of reactors.
*
*
*
*
*
(5) The official molecular examination
procedures for M. gallisepticum are the
polymerase chain reaction (PCR) test
described in § 147.30 of this subchapter
and the real-time PCR test described in
§ 147.31 of this subchapter. The official
molecular examination procedure for M.
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*
3 Procedures for the enzyme-linked
immunosorbent assay (ELISA) test are set forth in
the following publications:
A.A. Ansari, R.F. Taylor, T.S. Chang,
‘‘Application of Enzyme-Linked Immunosorbent
Assay for Detecting Antibody to Mycoplasma
gallisepticum Infections in Poultry,’’ Avian
Diseases, Vol. 27, No. 1, pp. 21–35, January-March
1983; and
H.M. Opitz, J.B. Duplessis, and M.J. Cyr, ‘‘Indirect
Micro-Enzyme-Linked Immunosorbent Assay for
the Detection of Antibodies to Mycoplasma
synoviae and M. gallisepticum,’’ Avian Diseases,
Vol. 27, No. 3, pp. 773–786, July-September 1983;
and
H.B. Ortmayer and R. Yamamoto, ‘‘Mycoplasma
Meleagridis Antibody Detection by Enzyme-Linked
Immunosorbent Assay (ELISA),’’ Proceedings, 30th
Western Poultry Disease Conference, pp. 63–66,
March 1981.
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synoviae is the PCR test described in
§ 147.30 of this subchapter.
*
*
*
*
*
■ 8. Section 145.23 is amended as
follows:
■ a. In paragraph (b)(2)(iii), in the first
sentence, by removing the words ‘‘either
no poultry or’’, and by removing the
word ‘‘were’’ and adding the word ‘‘was’’
in its place.
■ b. In paragraph (h) introductory text,
by removing the words ‘‘serological’’ and
‘‘one of’’.
■ c. By adding a new paragraph (h)(1)
and revising paragraph (h)(2) to read as
set forth below.
§ 145.23 Terminology and classification;
flocks and products.
*
*
*
*
*
(h) * * *
(1) It is a multiplier breeding flock in
which a minimum of 30 birds have been
tested negative for antibodies to avian
influenza when more than 4 months of
age. To retain this classification:
(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 is
tested within each 90-day period; or
(iii) The flock is tested as provided in
§ 145.14(d) at intervals of 30 days or less
and found to be negative, and a total of
30 samples are collected and tested
within each 90-day period; and
(2) During each 90-day period, all
multiplier spent fowl, up to a maximum
of 30, must be tested and found negative
within 21 days prior to movement to
slaughter.
*
*
*
*
*
§ 145.24
[Amended]
9. In § 145.24, paragraph (a)(1)(i) is
amended by removing the word ‘‘and’’
and by adding the words ‘‘, and
§ 145.93(b)(3)(i) through (vii)’’ before the
period at the end of the paragraph.
■ 10. Section 145.33 is amended as
follows:
■ a. In paragraph (b)(2)(iii), in the first
sentence, by removing the words ‘‘either
no poultry or’’, and by removing the
word ‘‘were’’ and adding the word ‘‘was’’
in its place.
■ b. In paragraph (l) introductory text,
by removing the words ‘‘serological’’ and
‘‘one of’’.
■ c. By adding a new paragraph (l)(1)
and revising paragraph (l)(2) to read as
set forth below.
■
§ 145.33 Terminology and classification;
flocks and products.
*
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*
*
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*
Fmt 4702
*
Sfmt 4702
(l) * * *
(1) It is a multiplier breeding flock in
which a minimum of 30 birds have been
tested negative for antibodies to avian
influenza when more than 4 months of
age. To retain this classification:
(i) A sample of at least 15 birds must
be tested negative at intervals of 90
days; or
(ii) A sample of fewer than 15 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 is
tested within each 90-day period; or
(iii) The flock is tested as provided in
§ 145.14(d) at intervals of 30 days or less
and found to be negative, and a total of
15 samples are collected and tested
within each 90-day period; and
(2) During each 90-day period, all
multiplier spent fowl, up to a maximum
of 30, must be tested and found negative
within 21 days prior to movement to
slaughter.
*
*
*
*
*
§ 145.34
[Amended]
11. In § 145.34, paragraph (a)(1)(i) is
amended by removing the word ‘‘and’’
and by adding the words ‘‘, and
§ 145.93(b)(3)(i) through (vii)’’ before the
period at the end of the paragraph.
■ 12. Section 145.43 is amended as
follows:
■ a. In paragraph (b)(2)(iii), in the first
sentence, by removing the words ‘‘either
no poultry or’’, and by removing the
word ‘‘were’’ and adding the word ‘‘was’’
in its place.
■ b. By removing and reserving
paragraphs (d)(2) and (d)(3).
■ c. In paragraph (f)(5), by redesignating
footnote 6 as footnote 5.
■ d. In paragraph (g) introductory text,
by removing the words ‘‘H5 and H7’’ and
adding the word ‘‘H5/H7’’ in their place
each time they appear; and by removing
the word ‘‘serological’’.
■ e. By revising paragraph (g)(1)
introductory text and paragraph (g)(2)
introductory text to read as set forth
below.
■ f. In paragraphs (g)(1)(i) and (g)(2)(i),
by removing the words ‘‘Provided, that
primary spent fowl be tested within 30
days prior to movement to disposal;’’.
■ g. By redesignating paragraph (g)(3) as
paragraph (g)(4).
■ h. By adding a new paragraph (g)(3) to
read as set forth below.
■
§ 145.43 Terminology and classification;
flocks and products.
*
*
*
*
*
(g) * * *
(1) It is a primary breeding flock in
which a minimum of 30 birds have been
tested negative to the H5/H7 subtypes of
avian influenza as provided in
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§ 145.14(d) when more than 4 months of
age and prior to the onset of egg
production. To retain this classification:
*
*
*
*
*
(2) It is a multiplier breeding flock in
which a minimum of 30 birds have been
tested negative to the H5/H7 subtypes of
avian influenza as provided in
§ 145.14(d) when more than 4 months of
age and prior to the onset of egg
production. To retain this classification:
*
*
*
*
*
(3) During each 90-day period, all
spent fowl, up to a maximum of 30,
must be tested and found negative
within 21 days prior to movement to
slaughter.
§ 145.44
[Amended]
13. In § 145.44, paragraph (a)(1)(i) is
amended by removing the word ‘‘and’’;
and by adding the words ‘‘,
§ 145.73(b)(2)(i), § 145.83(b)(2)(i), and
§ 145.93(b)(3)(i) through (vii)’’ before the
period at the end of the paragraph.
■
Subpart E—Special Provisions for
Hobbyist and Exhibition Waterfowl,
Exhibition Poultry, and Game Bird
Breeding Flocks and Products
14. The heading for subpart E is
revised to read as set forth above.
■ 15. In § 145.52, the introductory text
is revised to read as follows:
■
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§ 145.52
Participation.
Participating flocks of hobbyist and
exhibition waterfowl, exhibition
poultry, and game birds, and the eggs
and baby poultry produced from them
shall comply with the applicable
general provisions of subpart A of this
part and the special provisions of this
subpart E. The special provisions that
apply to meat-type waterfowl flocks are
found in subpart I of this part.
*
*
*
*
*
■ 16. Section 145.53 is amended as
follows:
■ a. In paragraph (b)(2)(iii), in the first
sentence, by removing the words ‘‘either
no poultry or’’, and by removing the
word ‘‘were’’ and adding the word ‘‘was’’
in its place.
■ b. In paragraph (b)(5), by adding the
words ‘‘hobbyist or exhibition’’ before
the word ‘‘waterfowl’’.
■ c. In paragraph (e) in the introductory
text, second sentence, by adding the
words ‘‘hobbyist or exhibition’’ before
the word ‘‘waterfowl’’; and by removing
the word ‘‘serological’’.
■ d. In the introductory text of
paragraph (e)(1), by removing the words
‘‘for antibodies’’; and by removing the
words ‘‘by the agar gel immunodiffusion
test specified in § 147.9 of this chapter’’
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and adding the words ‘‘as provided in
§ 145.14(d)’’ in their place.
■ e. In the introductory text of
paragraph (e)(2), by removing the words
‘‘for antibodies’’; and by removing the
words ‘‘by the agar gel immunodiffusion
test specified in § 147.9 of this chapter’’
and adding the words ‘‘as provided in
§ 145.14(d)’’ in their place.
■ f. By adding a new paragraph (e)(3) to
read as set forth below.
§ 145.53 Terminology and classification;
flocks and products.
*
*
*
*
*
(e) * * *
(3) During each 90-day period, all
spent fowl, up to a maximum of 30,
must be tested and found negative
within 21 days prior to movement to
slaughter.
§ 145.54
[Amended]
17. In § 145.54, paragraph (a)(1)(i) is
amended by removing the word ‘‘and’’;
and by adding the words ‘‘,
§ 145.73(b)(2)(i), § 145.83(b)(2)(i), and
§ 145.93(b)(3)(i) through (vii)’’ before the
period at the end of the paragraph.
■ 18. In § 145.73, paragraph (f) is
amended as follows:
■ a. In the introductory text, second
sentence, by removing the word
‘‘serological.’’
■ b. By revising paragraph (f)(1) and
adding a new paragraph (f)(2) to read as
set forth below.
■
§ 145.73 Terminology and classification;
flocks and products.
*
*
*
*
*
(f) * * *
(1) It is a primary breeding flock in
which a minimum of 30 birds have been
tested negative for antibodies to avian
influenza when more than 4 months of
age. To retain this classification:
(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 is
tested within each 90-day period; or
(iii) The flock is tested as provided in
§ 145.14(d) at intervals of 30 days or less
and found to be negative, and a total of
30 samples are collected and tested
within each 90-day period; and
(2) During each 90-day period, all
primary spent fowl, up to a maximum
of 30, must be tested serologically and
found negative within 21 days prior to
movement to slaughter.
■ 19. Section 145.83 is amended as
follows:
■ a. In paragraph (f)(1)(vi), by removing
the semicolon at the end of the
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57211
paragraph and adding a period in its
place; and by adding a new sentence at
the end of the paragraph to read as set
forth below.
■ b. In paragraph (f)(1)(vii), by adding
the words ‘‘to allow for the serological
testing required under paragraph
(f)(1)(vi) of this section’’ after the word
‘‘age’’.
■ c. By adding a new paragraph
(f)(1)(viii) to read as set forth below.
■ d. In paragraph (f)(3), by removing the
words ‘‘this classification’’ and adding
the words ‘‘paragraphs (f)(1)(i) through
(f)(1)(vii) of this section’’ in their place.
■ e. In the introductory text of
paragraph (g), second sentence, by
removing the word ‘‘serological.’’
■ f. By revising paragraph (g)(1) and
adding a new paragraph (g)(2) to read as
set forth below.
§ 145.83 Terminology and classification;
flocks and products.
*
*
*
*
*
(f) * * *
(1) * * *
(vi) * * *All salmonella isolates from
a flock shall be serogrouped and shall be
reported to the Official State Agency on
a monthly basis;
*
*
*
*
*
(viii) Any flock entering the
production period that is in compliance
with all the requirements of § 145.83(f)
with no history of Salmonella isolations
shall be considered ‘‘Salmonella
negative’’ and may retain this definition
as long as no environmental or bird
salmonella isolations are identified and
confirmed from the flock or flock
environment by sampling on 4 separate
collection dates over a minimum of a 2week period. Sampling and testing must
be performed as described in paragraph
(f)(1)(vi) of this section. An unconfirmed
environmental Salmonella isolation
shall not change this Salmonella
negative status.
*
*
*
*
*
(g) * * *
(1) It is a primary breeding flock in
which a minimum of 30 birds have been
tested negative for antibodies to avian
influenza when more than 4 months of
age. To retain this classification:
(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 is
tested within each 90-day period; or
(iii) The flock is tested as provided in
§ 145.14(d) at intervals of 30 days or less
and found to be negative, and a total of
30 samples are collected and tested
within each 90-day period; and
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(2) During each 90-day period, all
primary spent fowl, up to a maximum
of 30, must be tested serologically and
found negative within 21 days prior to
movement to slaughter.
■ 20. A new subpart I, consisting of
§§ 145.91 through 145.94, is added to
read as follows:
Subpart I— Special Provisions for MeatType Waterfowl Breeding Flocks and
Products
Sec.
145.91 Definitions.
145.92 Participation.
145.93 Terminology and classification;
flocks and products.
145.94 Terminology and classification;
States.
Subpart I— Special Provisions for
Meat-Type Waterfowl Breeding Flocks
and Products
§ 145.91
Definitions.
Except where the context otherwise
requires, for the purposes of this subpart
the following term shall be construed to
mean:
Meat-type waterfowl breeding flocks.
Flocks of domesticated duck or goose
that are composed of stock that has been
developed and is maintained for the
primary purpose of producing baby
poultry that will be raised under
confinement for the primary purpose of
producing meat for human
consumption.
§ 145.92
Participation.
jdjones on DSK8KYBLC1PROD with PROPOSALS-1
Participating flocks of meat-type
waterfowl and the eggs and baby poultry
produced from them shall comply with
the applicable general provisions of
subpart A of this part and the special
provisions of this subpart I.
(a) Started poultry shall lose their
identity under Plan terminology when
not maintained by Plan participants
under the conditions prescribed in
§ 145.5(a).
(b) Hatching eggs produced by
primary breeding flocks shall be
fumigated (see § 147.25 of this chapter)
or otherwise sanitized.
(c) 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.
§ 145.93 Terminology and classification;
flocks and products.
Participating flocks, and the eggs and
baby poultry produced from them, that
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]
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(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 one of the following
paragraphs (b)(1) through (b)(5) of this
section (See § 145.14 relating to the
official blood test where applicable.):
(1) It has been officially blood tested
within the past 12 months with no
reactors.
(2) It is a multiplier breeding flock, or
a breeding flock composed of progeny of
a primary breeding flock which is
intended solely for the production of
multiplier breeding flocks, and 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 multiplier breeding flock
that originated from U.S. PullorumTyphoid Clean breeding flocks or from
flocks that met equivalent requirements
under official supervision, and 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;
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(ii) All hatchery supply flocks within
the State are qualified as U.S. PullorumTyphoid Clean or have met equivalent
requirements for pullorum-typhoid
control under official supervision:
Provided, That if other domesticated
fowl 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;
(viii) Discontinuation of any of the
conditions or procedures described in
paragraphs (a)(3)(i), (ii), (iii), (iv), (v),
(vi), and (vii) 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.
(4) It is a multiplier breeding flock
located in a State which has been
determined by the Service to be in
compliance with the provisions of
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paragraph (a)(3) of this section, and 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.
(5) It is a primary breeding flock
located in a State determined to be in
compliance with the provisions of
paragraph (a)(4) of this section, and in
which a sample of 300 birds from flocks
of more than 300, and each bird in
flocks of 300 or less, has been officially
tested for pullorum-typhoid within the
past 12 months with no reactors:
Provided, That when a flock is a
primary breeding flock located in a State
which has been deemed to be a U.S.
Pullorum-Typhoid Clean State for the
past 3 years, and during which time no
isolation of pullorum or typhoid has
been made that can be traced to a source
in that State, a bacteriological
examination monitoring program or a
serological examination monitoring
program acceptable to the Official State
Agency and approved by the Service
may be used in lieu of annual blood
testing.
(c) U.S. H5/H7 Avian Influenza Clean.
This program is intended to be the basis
from which the breeding-hatchery
industry may conduct a program for the
prevention and control of the H5/H7
subtypes of avian influenza. It is
intended to determine the presence of
the H5/H7 subtypes of avian influenza
in meat-type waterfowl breeding flocks
through routine surveillance of each
participating breeding flock. A flock,
and the hatching eggs and baby poultry
produced from it, will qualify for this
classification when the Official State
Agency determines that it has met one
of the following requirements:
(1) It is a primary breeding flock in
which a minimum of 30 birds have been
tested negative to the H5/H7 subtypes of
avian influenza as provided in
§ 145.14(d) when more than 4 months of
age. To retain this classification:
(i) A sample of at least 30 birds must
be tested and found to be 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) It is a multiplier breeding flock in
which a minimum of 30 birds have been
tested negative to the H5/H7 subtypes of
avian influenza as provided in
§ 145.14(d) when more than 4 months of
age. To retain this classification:
(i) A sample of at least 30 birds must
be tested negative at intervals of 180
days; or
(ii) A sample of fewer than 30 birds
may be tested, and found to be negative,
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at any one time if all pens are equally
represented and a total of 30 birds are
tested within each 180-day period.
(3) During each 90-day period, all
spent fowl, up to a maximum of 30,
must be tested serologically and found
negative within 21 days prior to
movement to slaughter.
§ 145.94
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), and
145.93(b)(3)(i) through (vii).
(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
that 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 this classification. 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
57213
b. By adding a new definition of
commercial table-egg layer pullet flock
to read as set forth below.
■
§ 146.1
Definitions.
*
*
*
*
*
Commercial table-egg layer flock. All
table-egg layers of common age or pullet
source on one premises.
*
*
*
*
*
Commercial table-egg layer pullet
flock. A table-egg layer flock prior to the
onset of egg production.
*
*
*
*
*
H5/H7 low pathogenic avian
influenza (LPAI) . An infection of
poultry caused by an influenza A virus
of H5 or H7 subtype that has an
intravenous pathogenicity index in 6week-old chickens less than 1.2 or less
than 75 percent mortality in 4- to 8week-old chickens infected
intravenously, or an infection with
influenza A viruses of H5 or H7 subtype
with a cleavage site that is not
consistent with a previously identified
highly pathogenic avian influenza virus.
*
*
*
*
*
■ 23. Section 146.9 is amended as
follows.
■ a. By revising the introductory text to
read as set forth below.
■ b. In paragraph (a), by removing the
word ‘‘and’’ and by adding the words ‘‘,
and 146.53(a)’’ before the period.
§ 146.9 Terminology and classification;
flocks, products, and States.
Participating flocks, products
produced from them, and States that
have met the requirements of a
classification in this part may be
designated by the corresponding
illustrative design in this section.
*
*
*
*
*
■ 24. Section 146.21 is amended by
adding a new definition of table-egg
layer pullet to read as set forth below.
§ 146.21
Definitions.
*
*
*
*
*
Table-egg layer pullet. A sexually
immature domesticated chicken grown
for the primary purpose of producing
eggs for human consumption.
■ 25. In § 146.23, paragraph (a) is
revised to read as follows:
21. The authority citation for part 146
continues to read as follows:
§ 146.23 Terminology and classification;
flocks and products.
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22,
2.80, and 371.4.
*
■
22. Section 146.1 is amended as
follows:
■ a. By revising the definitions of
commercial table-egg layer flock and
H5/H7 low pathogenic avian influenza
(LPAI) to read as set forth below.
■
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*
*
*
*
(a) U.S. H5/H7 Avian Influenza
Monitored. This program is intended to
be the basis from which the table-egg
layer industry may conduct a program
to monitor for the H5/H7 subtypes of
avian influenza. It is intended to
determine the presence of the H5/H7
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subtypes of avian influenza in table-egg
layers and table-egg layer pullets
through routine surveillance of each
participating commercial table-egg layer
and table-egg layer pullet flock. A flock
will qualify for this classification when
the Official State Agency determines
that it has met one of the following
requirements:
(1) Table-egg layer pullet flocks. (i) It
is a commercial table-egg layer pullet
flock in which a minimum of 11 birds
have been tested negative to the H5/H7
subtypes of avian influenza as provided
in § 146.13(b) within 30 days prior to
movement; or
(ii) It is a commercial table-egg layer
pullet flock that has an ongoing active
and diagnostic surveillance program for
the H5/H7 subtypes of avian influenza
in which the number of birds tested is
equivalent to the number required in
paragraph (a)(1)(i) and that is approved
by the Official State Agency and the
Service.
(2) Table-egg layer flocks. (i) It is a
commercial table-egg layer flock in
which a minimum of 11 birds have been
tested negative to the H5/H7 subtypes of
avian influenza as provided in
§ 146.13(b) within 30 days prior to
disposal;
(ii) It is a commercial table-egg layer
flock in which a minimum of 11 birds
have been tested negative for the H5/H7
subtypes of avian influenza as provided
in § 146.13(b) within a 12-month period;
or
(iii) It is a commercial table-egg layer
flock that has an ongoing active and
diagnostic surveillance program for the
H5/H7 subtypes of avian influenza in
which the number of birds tested is
equivalent to the number required in
paragraph (a)(2)(i) or paragraph (a)(2)(ii)
of this section and that is approved by
the Official State Agency and the
Service.
*
*
§ 146.24
*
*
*
[Amended]
26. Section 146.24 is amended as
follows:
■ a. In paragraph (a)(1)(i), by adding the
words ‘‘and all commercial table-egg
layer pullet flocks that supply those
flocks’’ after the word ‘‘flocks’’.
■ b. In paragraphs (a)(1)(iii) through
(a)(1)(v), by adding the words ‘‘and
table-egg layer pullet’’ after the word
‘‘layer’’ each time it occurs.
jdjones on DSK8KYBLC1PROD with PROPOSALS-1
■
§ 146.33
[Amended]
27. In § 146.33, paragraphs (a)(1) and
(a)(2) are amended by adding the words
‘‘, as provided in § 146.13(b),’’ after the
word ‘‘influenza,’’ each time it occurs.
■
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§ 146.43
[Amended]
28. In § 146.43, paragraph (a)(1) is
amended by adding the words ‘‘, as
provided in § 146.13(b),’’ after the word
‘‘influenza’’ and by removing the word
‘‘virus’’.
■
§ 146.53
[Amended]
29. Section 146.53 is amended as
follows:
■ a. In paragraph (a)(1), by adding the
words ‘‘, as provided in § 146.13(b),’’
after the word ‘‘influenza.’’
■ b. In paragraph (a)(2), by removing the
words ‘‘antibodies to’’ and by adding the
words ‘‘, as provided in § 146.13(b),’’
after the word ‘‘influenza.’’
■ c. In paragraph (b), in the last
sentence, by adding the words ‘‘, as
provided in § 146.13(b),’’ after the word
‘‘influenza.’’
■
PART 147–AUXILIARY PROVISIONS
ON NATIONAL POULTRY
IMPROVEMENT PLAN
30. 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.
31. Section 147.6 is amended as
follows:
■ a. By revising the introductory text
and paragraphs (a)(1) through (a)(4) to
read as set forth below.
■ b. By removing paragraphs (a)(5)
through (a)(15).
■
§ 147.6 Procedures for determining the
status of flocks reacting to test for
Mycoplasma gallisepticum, Mycoplasma
synoviae, and Mycoplasma melagridis.
Procedures for isolation and
identification of Mycoplasma may be
found in Isolation and Identification of
Avian Pathogens, published by the
American Association of Avian
Pathologists; Kleven, S.H., F.T.W.
Jordan, and J.M. Bradbury, Avian
Mycoplasmosis (Mycoplasma
gallisepticum), Manual of Diagnostic
Tests and Vaccines for Terrestrial
Animals, Fifth Ed., Office International
des Epizooties, pp 842-855, 2004; and
§§ 147.15 and 147.16.
(a) * * *
(1) If the tube agglutination test,
enzyme-labeled immunosorbent assay
(ELISA), official molecular examination
procedure, or serum plate test is
negative, the flock qualifies for the
classification for which it was tested.
(2) If the tube agglutination, ELISA, or
serum plate test is positive, the
hemaglutination inhibition (HI) test or a
molecular examination procedure shall
be conducted: Provided, for the HI test,
that if more than 50 percent of the
samples are positive for M.
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Sfmt 4702
gallisepticum, M. meleagridis, or M.
synoviae, the HI test shall be conducted
on 10 percent of the positive samples or
25 positive samples, whichever is
greater. HI titers of 1:40 or more may be
interpreted as suspicious and
appropriate antigen detection samples
should be taken promptly (within 7
days of the original sampling) from 30
clinically affected birds and examined
by an approved cultural technique
individually, or pooled (up to 5 swabs
per test) and used in a molecular
examination procedure or in vivo
bioassay.
(3) If the in vivo bioassay, molecular
examination procedure, or culture
procedure is negative, the Official State
Agency may qualify the flock for the
classification for which it was tested. In
the event of contaminated cultures, the
molecular examination technique must
be used to make a final determination.
(4) If the in vivo bioassay, molecular
examination procedure, or culture
procedure is positive, the flock will be
considered infected.
*
*
*
*
*
§§ 147.12, 147.14, 147.15, 147.16, 147.30,
and 147.31 [Amended]
32. In §§ 147.12, 147.14, 147.15,
147.16, 147.30, and 147.31, footnotes 9
through 21 are redesignated as footnotes
10 through 22, respectively.
■
33. Section 147.12 is amended by
adding a new paragraph (a)(6) to read as
follows:
■
§ 147.12 Procedures for collection,
isolation, and identification of Salmonella
from environmental samples, cloacal
swabs, chick box papers, and meconium
samples.
*
*
*
*
*
(a) * * *
(6) Shoe cover sampling technique.
Absorbable fabric shoe covers involve
the exposure of the bottom surface of
shoe covers to the surface of floor litter
and slat areas. Wearing clean latex
gloves, place the shoe covers over
footwear that is only worn inside the
poultry house. This can be footwear
dedicated to the facility or disposable
overshoes. Each pair of shoe covers
should be worn while walking at a
normal pace over a distance of 305
meters (1000 feet). For flocks with fewer
than 500 breeders, at least 1 pair of shoe
covers should be worn to sample the
floor of the bird area. For flocks with
500 or more breeders, at least 2 pairs of
shoe covers should be worn to sample
the floor of the bird area. After
sampling, place each shoe cover in a
sterile container with 30 ml of double
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20SEP1
Federal Register / Vol. 75, No. 181 / Monday, September 20, 2010 / Proposed Rules
strength skim milk.9 Seal the sterile
containers and promptly refrigerate
them at 2 to 4 °C or place in a cooler
with ice or ice packs. Do not freeze.
Samples should be stored at refrigerator
temperatures of 2 to 4 °C no more than
5 days prior to culturing.
*
*
*
*
*
■ 34. In § 147.45, the first sentence is
revised to read as follows:
§ 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 chapter in which it has
one or more participants at the time of
the Conference. * * *
■ 35. In § 147.52, a new paragraph (c) is
added to read as follows:
§ 147.52
Approved tests.
*
*
*
*
*
(c) The following diagnostic test kits
that are not licensed by the Service (e.g.,
bacteriological culturing kits) are
approved for use in the NPIP:
(1) Rapid Chek©Select TMSalmonella
Test Kit, Strategic Diagnostics, Inc.
Newark, DE 19713.
(2) ADIAFOOD Rapid Pathogen
Detection System for Salmonella spp.,
AES Chemunex Canada. Laval, QC
(Canada) H7L4S3.
(3) DuPont Qualicon BAX Polymerase
Chain Reaction (PCR)-based assay for
Salmonella, DuPont Qualicon,
Wilmington, DE 19810.
Done in Washington, DC, this 13th day
of September 2010.
Kevin Shea
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2010–23248 Filed 9–17–10: 8:45 am]
BILLING CODE: 3410–34–S
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA–2010–0692; Airspace
Docket No. 10–AEA–16]
jdjones on DSK8KYBLC1PROD with PROPOSALS-1
Proposed Establishment of Class E
Airspace; Crewe, VA
Federal Aviation
Administration (FAA), DOT.
AGENCY:
9 Obtain procedure for preparing double strength
skim milk from USDA-APHIS ‘‘Recommended
Sample Collection Methods for Environmental
Samples,’’ available from the National Poultry
Improvement Plan, Veterinary Services, APHIS,
USDA, 1498 Klondike Road, Suite 200, Conyers, GA
30094.
VerDate Mar<15>2010
14:31 Sep 17, 2010
Jkt 220001
Notice of proposed rulemaking
(NPRM).
ACTION:
This action proposes to
establish Class E Airspace at Crewe, VA,
to accommodate the additional airspace
needed for the Standard Instrument
Approach Procedures (SIAPs)
developed for Crewe Municipal Airport.
This action would enhance the safety
and airspace management of Instrument
Flight Rules (IFR) operations at the
airport.
SUMMARY:
0901 UTC. Comments must be
received on or before November 4, 2010.
ADDRESSES: Send comments on this rule
to: U.S. Department of Transportation,
Docket Operations, West Building
Ground Floor, Room W12–140, 1200
New Jersey, SE., Washington, DC
20590–0001; Telephone: 1–800–647–
5527; Fax: 202–493–2251. You must
identify the Docket Number FAA–2010–
0692; Airspace Docket No. 10–AEA–16,
at the beginning of your comments. You
may also submit and review received
comments through the Internet at
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Melinda Giddens, Operations Support
Group, Eastern Service Center, Federal
Aviation Administration, P.O. Box
20636, Atlanta, Georgia 30320;
telephone (404) 305–5610.
SUPPLEMENTARY INFORMATION:
DATES:
Comments Invited
Interested persons are invited to
comment on this rule by submitting
such written data, views, or arguments,
as they may desire. Comments that
provide the factual basis supporting the
views and suggestions presented are
particularly helpful in developing
reasoned regulatory decisions on the
proposal. Comments are specifically
invited on the overall regulatory,
aeronautical, economic, environmental,
and energy-related aspects of the
proposal.
Communications should identify both
docket numbers (FAA Docket No. FAA–
2010–0692; Airspace Docket No. 10–
AEA–16) and be submitted in triplicate
to the Docket Management System (see
ADDRESSES section for address and
phone number). You may also submit
comments through the Internet at
https://www.regulations.gov.
Comments wishing the FAA to
acknowledge receipt of their comments
on this action must submit with those
comments a self-addressed stamped
postcard on which the following
statement is made: ‘‘Comments to
Docket No. FAA–2010–0692; Airspace
Docket No. 10–AEA–16.’’ The postcard
PO 00000
Frm 00022
Fmt 4702
Sfmt 4702
57215
will be date/time stamped and returned
to the commenter.
All communications received before
the specified closing date for comments
will be considered before taking action
on the proposed rule. The proposal
contained in this notice may be changed
in light of the comments received. A
report summarizing each substantive
public contact with FAA personnel
concerned with this rulemaking will be
filed in the docket.
Availability of NPRMs
An electronic copy of this document
may be downloaded from and
comments submitted through https://
www.regulations.gov. Recently
published rulemaking documents can
also be accessed through the FAA’s Web
page at https://www.faa.gov/
airports_airtraffic/air_traffic/
publications/airspace_amendments/.
You may review the public docket
containing the proposal, any comments
received, and any final disposition in
person in the Dockets Office (see the
ADDRESSES section for address and
phone number) between 9 a.m. and 5
p.m., Monday through Friday, except
Federal Holidays. An informal docket
may also be examined during normal
business hours at the office of the
Eastern Service Center, Federal Aviation
Administration, room 210, 1701
Columbia Avenue, College Park, Georgia
30337.
Persons interested in being placed on
a mailing list for future NPRM’s should
contact the FAA’s Office of Rulemaking,
(202) 267–9677, to request a copy of
Advisory circular No. 11–2A, Notice of
Proposed Rulemaking distribution
System, which describes the application
procedure.
The Proposal
The FAA is considering an
amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to establish
Class E airspace at Crewe, VA to provide
controlled airspace required to support
the SIAPs developed for Crewe
Municipal Airport. Class E airspace
extending upward from 700 feet above
the surface would be established for the
safety and management of IFR
operations.
Class E airspace designations are
published in Paragraph 6005 of FAA
order 7400.9U, signed August 18, 2010,
and effective September 15, 2010, which
is incorporated by reference in 14 CFR
71.1. The Class E airspace designation
listed in this document will be
published subsequently in the Order.
The FAA has determined that this
proposed regulation only involves an
established body of technical
E:\FR\FM\20SEP1.SGM
20SEP1
Agencies
[Federal Register Volume 75, Number 181 (Monday, September 20, 2010)]
[Proposed Rules]
[Pages 57200-57215]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23248]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 56, 145, 146, and 147
[Docket No. APHIS-2009-0031]
RIN 0579-AD21
National Poultry Improvement Plan and Auxiliary Provisions
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: We are proposing to amend the National Poultry Improvement
Plan (the Plan) and its auxiliary provisions by providing new or
modified sampling and testing procedures for Plan participants and
participating flocks. The proposed changes were voted on and approved
by the voting delegates at the Plan's 2008 National Plan Conference.
These changes would keep the provisions of the Plan current with
changes in the poultry industry and provide for the use of new sampling
and testing procedures.
DATES: We will consider all comments that we receive on or before
November 19, 2010.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to (https://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2009-0031) to submit or view comments
and to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send one copy of
your comment to Docket No. APHIS-2009-0031, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2009-0031.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room 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) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at (https://www.aphis.usda.gov).
FOR FURTHER INFORMATION CONTACT: Mr. Andrew R. Rhorer, Senior
Coordinator, Poultry Improvement Staff, National Poultry Improvement
Plan, Veterinary Services, APHIS, USDA, 1498 Klondike Road, Suite 101,
Conyers, GA 30094-5104; (770) 922-3496.
SUPPLEMENTARY INFORMATION:
Background
The National Poultry Improvement Plan (NPIP, also referred to below
as ``the Plan'') is a cooperative Federal-State-industry mechanism for
controlling certain poultry diseases. The Plan consists of a variety of
programs intended to prevent and control poultry diseases.
Participation in all Plan programs is voluntary, but breeding flocks,
hatcheries, and dealers must first qualify as ``U.S. Pullorum-Typhoid
Clean'' as a condition for participating in the other Plan programs.
The Plan identifies States, flocks, hatcheries, dealers, and
slaughter plants that meet certain disease control standards specified
in the Plan's various programs. As a result, customers can buy poultry
that has tested clean of certain diseases or that has been produced
under disease-prevention conditions.
The regulations in 9 CFR parts 145, 146, and 147 (referred to below
as the regulations) contain the provisions of the Plan. The Animal and
Plant Health Inspection Service (APHIS, also referred to as ``the
Service'') of the U.S. Department of Agriculture (USDA, also referred
to as ``the Department'') amends these provisions from time to time to
incorporate new scientific information and technologies within the
Plan.
The proposed amendments discussed in this document are consistent
with the recommendations approved by the voting delegates to the
National Plan Conference that was held from June 5 through June 7,
2008. Participants in the 2008 National Plan Conference represented
flockowners, breeders, hatcherymen, slaughter plants, and Official
State Agencies from all cooperating States. The proposed amendments are
discussed in detail below.
Simplifying Indemnity Provisions in Part 56
The regulations in 9 CFR part 56 set out conditions for the payment
of indemnity for costs associated with poultry that are infected with
or exposed to the H5 or H7 subtypes of low pathogenic avian influenza
(H5/H7 LPAI). Section 56.3 states that indemnity may be paid for
destruction and disposal of poultry that were infected with or exposed
to H5/H7 LPAI, destruction of eggs for testing for H5/H7 LPAI, and
cleaning and disinfection of premises, conveyances, and materials that
came into contact with poultry that were infected with or exposed to
H5/H7 LPAI (or destruction and disposal, if the cost of cleaning and
disinfection would exceed the value of the materials or cleaning and
disinfection would be impractical).
Section 56.3 also sets the percentages of the costs of those
activities that are eligible for indemnity. Specifically, paragraph (b)
of Sec. 56.3 indicates that the Administrator is authorized to pay 100
[[Page 57201]]
percent indemnity for costs related to all poultry that are infected
with or exposed to H5/H7 LPAI, unless those poultry do not participate
in the avian influenza (AI) surveillance program provided for poultry
in the regulations in 9 CFR part 145 or 146. For those poultry, the
Administrator is authorized to pay indemnity for only 25 percent of
costs. The payment of only 25 percent indemnity thus provides an
incentive for producers to participate in AI surveillance programs. The
specific poultry that are eligible for only 25 percent indemnity, as
listed in paragraphs (b)(1) through (b)(6), are:
Egg-type breeding chickens from a flock that participates
in any Plan program in 9 CFR part 145 but that does not participate in
the U.S. Avian Influenza Clean program of the Plan in Sec. 145.23(h);
Meat-type breeding chickens from a flock that participates
in any Plan program in 9 CFR part 145 but that does not participate in
the U.S. Avian Influenza Clean program of the Plan in Sec. 145.33(l);
Breeding turkeys from a flock that participates in any
Plan program in 9 CFR part 145 but that does not participate in the
U.S. H5/H7 Avian Influenza Clean program of the Plan in Sec.
145.43(g);
Commercial table-egg layers from a premises that has
75,000 or more birds and that does not participate in the U.S. H5/H7
Avian Influenza Monitored program of the Plan in Sec. 146.23(a);
Commercial meat-type chickens that are associated with a
slaughter plant that slaughters 200,000 or more meat-type chickens per
operating week and that does not participate in the U.S. H5/H7 Avian
Influenza Monitored program of the Plan in Sec. 146.33(a); and
Commercial meat-type turkeys that are associated with a
slaughter plant that slaughters 2 million or more meat-type turkeys in
a 12-month period and that does not participate in the U.S. H5/H7 Avian
Influenza Monitored program of the Plan in Sec. 146.43(a).
The regulations in paragraph (b)(7) also provide for the payment of
25 percent indemnity for any poultry located in a State that does not
participate in the diagnostic surveillance program for H5/H7 LPAI, as
described in Sec. 146.14, 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 and has an initial State response and
containment plan for H5/H7 LPAI that is approved by APHIS. This
provision is intended to provide States with an incentive to
participate in the NPIP's AI surveillance and control programs.
Since the regulations in part 56 were established, an H5/H7 LPAI
surveillance program has been added that covers new types of commercial
poultry, namely the program for commercial upland game birds,
commercial waterfowl, raised-for-release upland game birds, and raised-
for-release waterfowl in Sec. 146.53(a). The program in Sec.
146.53(a) contains size thresholds for each of the various types of
poultry included in the program. Slaughter plants and premises above
these size thresholds are required to participate in the program in
Sec. 146.53(a) in order to participate in the Plan, similar to the
size thresholds for slaughter plants and premises in the other subparts
in 9 CFR part 146. In addition, in this document, we are proposing to
add to 9 CFR part 145 provisions for an AI surveillance program for
meat-type waterfowl breeding flocks, in proposed Sec. 145.93(c). (See
the description under the heading ``New Provisions for Meat-Type
Waterfowl Breeding Flocks and Products'' later in this document.)
Our general intention in establishing Sec. 56.3 was to provide an
incentive to participate in NPIP AI surveillance programs for all
poultry for which such programs are available. To ensure that Sec.
56.3 continues to provide such an incentive as new AI surveillance
programs are added for new types of poultry, we are proposing to change
the structure of Sec. 56.3 to refer more generally to AI surveillance
programs available to breeding poultry in 9 CFR part 145 and to
commercial poultry in part 146. In order to do this, we would remove
paragraphs (b)(1) through (b)(6) from Sec. 56.3, redesignate paragraph
(b)(7) as paragraph (b)(3), and add two new paragraphs (b)(1) and
(b)(2) to cover breeding poultry and commercial poultry, respectively.
Paragraph (b)(1) would provide that poultry that are from a
breeding flock that participates in any Plan program in 9 CFR part 145
but that does not participate in the U.S. Avian Influenza Clean or the
U.S. H5/H7 Avian Influenza Clean program of the Plan available to the
flock in 9 CFR part 145 would only be eligible for 25 percent
indemnity.
Paragraph (b)(2) would provide that poultry that are from a
commercial flock or slaughter plant that does not participate in the
U.S. Avian Influenza Monitored program available to the commercial
flock or slaughter plant in 9 CFR part 146 would only be eligible for
25 percent indemnity. As part of this change, we are proposing to add a
definition of commercial flock or slaughter plant to Sec. 56.1, which
sets out definitions of terms used in part 56. We would define
commercial flock or slaughter plant as a commercial poultry flock or
slaughter plant that is required because of its size to participate in
the special provisions in 9 CFR part 146 in order to participate in the
Plan. (Subpart A of part 146 contains the general provisions; subparts
B through E contain special provisions for specific types of commercial
poultry.) We would also remove the definitions of commercial meat-type
flock, commercial table-egg layer flock, commercial table-egg layer
premises, meat-type chicken, and meat-type turkey from Sec. 56.1, as
they would no longer be necessary.
These changes would simplify the regulations and more clearly
express the principle that, for certain poultry operations,
participation in NPIP AI surveillance programs is required in order for
the poultry to be eligible for 100 percent indemnity in the event of an
H5/H7 LPAI outbreak.
Amendments to Flock Testing Requirements and Procedures for Mycoplasma
Bacteria
The regulations in Sec. 145.14 set out testing requirements for
breeding flocks participating in NPIP programs in part 145. Paragraph
(b) in Sec. 145.14 sets out testing requirements for Mycoplasma
gallisepticum and M. synoviae. We are proposing to make several changes
to these testing requirements to update them and make them consistent
with current best practices.
We are proposing to amend paragraph (b) at several locations to
indicate that these testing requirements apply to M. meleagridis as
well as M. gallisepticum and M. synoviae. Currently, paragraph (c) of
Sec. 145.14 covers M. meleagridis; this paragraph refers the reader to
Sec. 145.43(d)(2) for a list of official blood tests for M.
meleagridis. (Paragraph (d)(3) of Sec. 145.43 provides additional
instructions on testing for M. meleagridis.) However, many of the
testing procedures work for all three bacteria, and it makes sense to
address testing for these bacteria together in Sec. 145.14(b) because
they are also addressed together in Sec. 147.6, which sets out a
procedure for determining the status of flocks reacting to tests for
these three bacteria. Accordingly, we are proposing to remove and
reserve Sec. Sec. 145.14(c) and 145.43(d)(2) and (d)(3).
The testing provisions in paragraph (b) have referred to blood
testing specifically. However, the regulations in Sec. 147.30 provide
a molecular
[[Page 57202]]
examination procedure for M. gallisepticum and M. synoviae, and the
regulations in Sec. 147.31 provide another molecular examination
procedure for M. gallisepticum. These molecular examination procedures
do not involve blood testing. Therefore, we are proposing to make
several changes in paragraph (b) to indicate that the regulations
provide for testing procedures generally.
Paragraph (b)(1) of Sec. 145.14 currently provides for the use of
the hemagglutination inhibition (HI) test, the microhemagglutination
inhibition test, and the enzyme-linked immunosorbent assay (ELISA) test
to confirm the positive results of other serological tests. We are
proposing to remove the ELISA test from this list. The ELISA test is a
screening assay and should not be used to confirm positive serological
results.
Paragraph (b)(5) of Sec. 145.14 currently provides that the
official molecular examination procedures for M. gallisepticum and M.
synoviae are the polymerase chain reaction (PCR) test described in
Sec. 147.30 and the real-time PCR test described in Sec. 147.31.
However, the real-time PCR test in Sec. 147.31 is approved only for M.
gallisepticum. We are therefore proposing to remove the reference to
the real-time PCR as an official molecular examination procedure for M.
synoviae. If, at some point in the future, we expand the use of the
molecular examination procedures in Sec. Sec. 147.30 and 147.31 to M.
meleagridis and the use of the real-time PCR test in Sec. 147.31 to M.
synoviae, we will amend Sec. 145.14(b)(5) accordingly.
As noted earlier, Sec. 147.6 sets out a procedure for determining
the status of flocks reacting to tests for M. gallisepticum, M.
meleagridis, and M. synoviae. We are proposing to make several updates
to this section.
The introductory text of Sec. 147.6 currently states that the
official tests for Mycoplasma are the macroagglutination tests for
Mycoplasma antibodies, as described in ``Standard Methods for Testing
Avian Sera for the Presence of Mycoplasma Gallisepticum Antibodies''
published by the Agricultural Research Service, USDA, March 1966, and
the microagglutination tests, as reported in the Proceedings, Sixteenth
Annual Meeting of the American Association of Veterinary Laboratory
Diagnosticians, 1973. The introductory text goes on to state that
procedures for isolation and identification of Mycoplasma may be found
in Isolation and Identification of Avian Pathogens, published by the
American Association of Avian Pathologists, and Sec. Sec. 147.15 and
147.16.
However, as noted earlier, there are several official tests for
Mycoplasma, not just the macroagglutination test in the 1966
Agricultural Research Service publication. In addition, Sec.
145.14(b)(1) lists all the official tests; it is not necessary to do so
again in Sec. 147.6. Accordingly, we would remove the first sentence
of the introductory text of Sec. 147.6. In addition, we would add to
the list of procedures for isolation and identification of Mycoplasma a
reference to the Manual of Diagnostic Tests and Vaccines for
Terrestrial Animals, which is published by the World Organization for
Animal Health (OIE). These procedures are internationally recognized as
efficacious.
Paragraph (a)(1) of Sec. 147.6 states that, if a flock is tested
by the tube agglutination or the serum plate test and the test is
negative, the flock's status is negative for Mycoplasma. We would amend
this paragraph to include the ELISA and the official molecular
examination procedures. These tests are also effective at determining a
flock's status.
Paragraph (a)(2) of Sec. 147.6 states that, if the tube
agglutination or the serum plate test is positive, the HI test and/or
the serum plate dilution (SPD) test shall be conducted. However, for
egg-type and meat-type chicken and waterfowl, exhibition poultry, and
game bird flocks, if more than 50 percent of the samples are positive
for either M. gallisepticum, M. synoviae, or both, paragraph (a)(2)
requires the HI and/or the SPD test to be conducted on 10 percent of
the positive samples or 25 positive samples, whichever is greater.
We are amending the list of screening assays that require
confirmation to include the ELISA, as listed in proposed paragraph
(a)(1). We are removing the SPD test from the list of confirmatory
tests for serological screening assays because there are currently no
laboratories that use this test; the HI test is widely used and
accepted as the preferred test.
For that reason, we would also remove the SPD test from the list of
confirmatory tests for the HI test when more than 50 percent of the
samples from egg-type and meat-type chicken flocks and waterfowl,
exhibition poultry, and game bird flocks are positive on the HI test.
This change would provide for the use of only the HI test as a
confirmatory test in this case. We would also remove the text
indicating that this confirmatory procedure is required only for egg-
type and meat-type chicken flocks and waterfowl, exhibition poultry,
and game bird flocks, as the procedure is necessary any time more than
50 percent of the samples are positive on the HI test, to confirm the
validity of the test.
Paragraph (a)(4) of Sec. 147.6 states that, if HI titers of 1:40
or SPD titers of 1:5 are found, the flock shall be considered
suspicious and shall be retested in accordance with Sec. 147.6(a)(6).
Paragraph (a)(6) states that, 14 days after the previous bleeding date,
all birds or a random sample comprised of 75 birds shall be tested by
the serum plate or tube agglutination test, and that tested birds shall
be identified by numbered bands.
We are proposing to move this information into paragraph (a)(2), as
it follows naturally from the other information about administering the
HI test. We would also make some changes to it. First, we would remove
all references to the SPD test, for reasons discussed earlier; under
this proposal, paragraph (a)(2) would state only that HI titers of 1:40
or more may be interpreted as suspicious. We would replace the current
procedure of testing with SPD or tube agglutination with a culture
procedure. In this procedure, appropriate antigen detection samples
would be taken promptly (within 7 days of the original sampling) from
30 clinically affected birds and examined by an approved cultural
technique individually, or pooled (up to 5 swabs per test) and used in
a molecular examination procedure or in vivo bioassay. The molecular
examination procedure and in vivo bioassay are widely accepted as
confirmatory tests for this procedure.
We are proposing to remove the requirement to identify tested birds
by numbered bands because other means are available to identify birds
that have been tested; Official State Agencies can work with producers
to determine the most cost-effective method in individual cases.
In Sec. 145.14, paragraph (b)(1) states that HI titers of 1:40 or
less may be interpreted as equivocal, and final judgment may be based
on further samplings and/or culture of reactors. As noted earlier,
Sec. 147.6 refers to HI titers of 1:40 or less as ``suspicious.'' We
are proposing to amend Sec. 145.14(b)(1) to be consistent with Sec.
147.6.
Paragraphs (a)(3) through (a)(15) of Sec. 147.6 provide extensive
procedures for testing and retesting flocks that have been tested with
HI in order to determine whether they are eligible for the
classification for which they are tested. We are proposing to replace
these paragraphs with new paragraphs (a)(3) and (a)(4), which would
provide a much simpler procedure. Under
[[Page 57203]]
proposed paragraph (a)(3), if the in vivo bioassay, molecular
examination procedure, or culture procedure referred to in proposed
paragraph (a)(2) is negative, the Official State Agency would be able
to qualify the flock for the classification for which it was tested. In
the event of contaminated cultures, we would require the molecular
examination technique to be used to make a final determination. Under
proposed paragraph (a)(4), if the in vivo bioassay, molecular
examination procedures, or culture procedures are positive, the flock
would be considered infected. These proposed provisions would greatly
simplify the regulations and recognize the utility of the in vivo
bioassay, molecular examination procedures, and culture procedures.
Changes to AI Clean Programs for Egg-Type and Meat-Type Chicken
Breeding Flocks
The regulations set out requirements for the U.S. Avian Influenza
Clean classification for multiplier egg-type chicken breeding flocks,
multiplier meat-type chicken breeding flocks, primary egg-type chicken
breeding flocks, and primary meat-type chicken breeding flocks at
Sec. Sec. 145.23(h), 145.33(l), 145.73(f), and 145.83(g) respectively.
The current requirements for these U.S. Avian Influenza Clean
classifications are nearly identical. The introductory text of
Sec. Sec. 145.23(h), 145.33(l), 145.73(f), and 145.83(g) states that
the U.S. Avian Influenza Clean program is intended to be the basis from
which the breeding-hatchery industry may conduct a program for the
prevention and control of avian influenza. It is intended to determine
the presence of avian influenza in breeding chickens through routine
serological surveillance of each participating breeding flock. A flock
and the hatching eggs and chicks produced from it will qualify for this
classification when the Official State Agency determines that they have
met the requirements of the relevant paragraph listed earlier.
Each of those paragraphs contains a subparagraph indicating that a
flock is eligible for the classification if a minimum of 30 birds have
been tested negative for antibodies to avian influenza when more than 4
months of age and prior to the onset of egg production. To retain this
classification, a sample of at least 30 birds must be tested negative
at intervals of 90 days, and primary spent fowl must be tested within
30 days prior to movement to slaughter. Alternatively, 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 is
tested within each 90-day period. (The only exception is for meat-type
chicken multiplier breeding flocks, which are only required to have 15
birds tested, at the same 90-day interval, in order to be eligible for
and to retain the classification.)
We are proposing to make several changes to these classifications.
First, we are proposing to remove the references to serological
surveillance from the introductory text of the classifications, instead
referring simply to ``surveillance.'' As we are proposing to refer in
the regulatory text specifically to the AI testing procedures in Sec.
145.14(d), referring to serological surveillance in the introductory
text is not necessary. In addition, some of the tests in Sec.
145.14(d) are not serological tests -- for example, the real-time
reverse transcriptase PCR assay in paragraph (d)(2)(i).
We would continue to require a minimum of 30 birds to be tested
negative for antibodies to avian influenza when more than 4 months of
age and prior to the onset of egg production, and we would continue to
provide the 2 options for retaining the U.S. Avian Influenza Clean
classification that are found in the current regulations. We are
proposing to add a third option by which flocks could retain the
classification. Under this option, the flock could retain the
classification if the flock is tested as provided in Sec. 145.14(d)
and found negative at intervals of 30 days or less, and a total of 30
(15 for meat-type multiplier breeding flocks) samples are collected and
tested within each 90-day period. This option would provide additional
flexibility to use the flock screening tests in Sec. 145.14(d)(2).
We are also proposing to put in place requirements for testing
spent fowl for each of the options for retaining the U.S. Avian
Influenza Clean classification. As noted earlier, under the current
regulations, spent fowl are required to be tested only if the sample of
30 birds is being tested and found negative at intervals of 90 days.
However, testing of spent fowl is a useful addition to surveillance for
any of the options for retaining classification, both the existing
options and the one we are proposing. Accordingly, we are proposing to
require spent fowl testing as part of all of the options for retaining
classification. Specifically, we would require in paragraphs Sec. Sec.
145.23(h)(2), 145.33(l)(2), 145.73(f)(2), and 145.83(g)(2) that all
spent fowl, up to a maximum of 30, be tested serologically and found
negative within 21 days prior to movement to slaughter.
We are proposing to reduce the number of days before slaughter
within which spent fowl must be tested from 30 to 21 to be consistent
with testing requirement for the NPIP AI surveillance programs in part
146 in which poultry (meat-type chickens and meat-type turkeys) are
moved to slaughter. A 21-day testing requirement would also be
consistent with the guidelines for AI surveillance in the OIE
Terrestrial Animal Health Code.\1\ We are proposing to require only a
sample of a maximum of 30 spent fowl to be tested, rather than the
current requirement to test all spent fowl, because it is not necessary
to test more than 30 spent fowl in order to provide adequate assurance
that the flock is free of AI; this is consistent with the general
requirement to test 30 birds per flock.
---------------------------------------------------------------------------
\1\ The guidelines may be viewed on the Internet at (https://www.oie.int/eng/normes/mcode/en_chapitre_1.10.4.htm).
---------------------------------------------------------------------------
Changes to H5/H7 AI Clean Programs for Turkey Breeding Flocks and for
Waterfowl, Exhibition Poultry, and Game Bird Breeding Flocks
The regulations set out requirements for the U.S. H5/H7 Avian
Influenza Clean classification for turkey breeding flocks and for
waterfowl, exhibition poultry, and game bird breeding flocks in
Sec. Sec. 145.43(g) and 145.53(e), respectively. We are proposing to
make some minor changes to the text of these classifications to
standardize and clarify their language. We are also proposing to add
spent fowl testing requirements for all surveillance options in these
classifications.
The introductory text of both Sec. Sec. 145.43(g) and 145.53(e) is
similar to that of the U.S. Avian Influenza Clean classifications
discussed earlier, except that both refer to the H5 and H7 subtypes of
AI. We are proposing to change those references to refer to ``the H5/H7
subtypes of avian influenza,'' as that usage is consistent with our
references to these two subtypes in 9 CFR part 146. We are also
proposing to remove the word ``serological'' from the same place as in
the introductory text to the U.S. Avian Influenza Clean classifications
for breeding chickens, for the same reasons discussed earlier with
regard to those AI classifications.
Within Sec. Sec. 145.43(g) and 145.53(e), paragraphs (g)(1) and
(e)(1) address primary breeding flocks for turkeys and for waterfowl,
game birds, and exhibition poultry, respectively, while paragraphs
(g)(2) and (e)(2) address multiplier breeding flocks. Each of these
[[Page 57204]]
paragraphs refers in its introductory text to testing using the agar
gel immunodiffusion test in Sec. 147.9. As all of the tests in Sec.
145.14(d) are effective at testing for AI in turkeys and in waterfowl,
exhibition poultry, and game birds, we are proposing to remove the
specific references to agar gel immunodiffusion testing. Instead, we
would add the words ``as provided in Sec. 145.14(d)'' to references to
AI testing to direct the reader to the approved AI tests.
We are proposing to put in place requirements for testing spent
fowl for each of the options for retaining the U.S. H5/H7 Avian
Influenza Clean classification for turkey breeding flocks and
waterfowl, exhibition poultry, and game bird breeding flocks. Similar
to the spent fowl testing requirements for chickens discussed earlier,
spent fowl from turkey breeding flocks are currently required to be
tested only if a sample of 30 birds is being tested and found negative
at intervals of 90 days. However, testing of spent fowl is a useful
addition to surveillance for any of the options for retaining the U.S.
H5/H7 Avian Influenza Clean classification. Accordingly, we are
proposing to add a new paragraph Sec. 145.43(g)(3) to require all
spent fowl from turkey breeding flocks, up to a maximum of 30, to be
tested serologically and found negative within 21 days prior to
movement to slaughter for all of the surveillance options. (We would
redesignate current paragraph (g)(3), which contains reporting
requirements that apply if killed AI vaccine is used, as paragraph
(g)(4).)
The U.S. H5/H7 Avian Influenza Clean classification for waterfowl,
exhibition poultry, and game bird breeding flocks does not currently
include spent fowl testing requirements. However, testing any spent
fowl that are produced by these flocks for AI would be a useful
addition to surveillance for this classification as well. Therefore, we
are proposing to add a new paragraph Sec. 145.53(e)(3) to require
spent fowl to be tested for these flocks as well.
The classification provisions for primary and multiplier turkey
breeding flocks in Sec. 145.43(g)(1) and (g)(2), respectively, require
that flocks test negative for antibodies to type A AI virus. Positive
results must be further tested by an authorized laboratory using the
hemagglutination inhibition test to detect antibodies to the
hemagglutinin subtypes H5 and H7 when more than 4 months of age and
prior to the onset of egg production. We are proposing to remove this
2-step process and instead require that a minimum of 30 birds test
negative to the H5/H7 subtypes of AI. The testing procedures in Sec.
145.14(d) set out the official tests for AI and indicate that the
official determination of a flock as positive for the H5 or H7 subtypes
of avian influenza may be made only by the National Veterinary Services
Laboratories. It is appropriate to refer to these testing procedures,
which apply to all poultry covered in 9 CFR part 145, rather than
setting out a separate testing procedure in the turkey breeding flock
U.S. H5/H7 Avian Influenza Clean classification. This change would also
make the provisions in Sec. 145.43 consistent with the other AI
classifications in the regulations.
The regulations in Sec. 145.53(e)(1) and (e)(2) also refer to
testing for antibodies to the H5 and H7 subtypes of AI. As other AI
classifications refer to testing for the disease itself and not
antibodies to the disease, we would remove references to testing for
antibodies to make the regulations consistent.
We are proposing to make one other change related to AI in part
145. In Sec. 145.1, we are proposing to add a definition of avian
influenza. We would define AI as ``an infection or disease of poultry
caused by viruses in the family Orthomyxoviridae, genus Influenzavirus
A.'' Including this definition would provide additional clarity
regarding AI.
Salmonella Negative Status for Primary Meat-Type Chicken Breeding
Flocks in the U.S. Salmonella Monitored Classification
The regulations in Sec. 145.83(f) set out provisions for the U.S.
Salmonella Monitored classification for primary meat-type chicken
breeding flocks and the hatching eggs and chicks produced from it. This
classification requires participating flocks to be maintained in
compliance with Sec. Sec. 147.21, 147.24(a), and 147.26, requires feed
to be processed, stored, and transported to prevent contamination with
Salmonella, and requires chicks to be hatched in a hatchery meeting the
requirements of Sec. Sec. 147.23 and 147.24(b) and sanitized or
fumigated. It also contains testing procedures designed to verify the
flock's Salmonella status.
In recent years, trading partners have begun to require that baby
chicks and hatching eggs originate from breeding flocks free of certain
serotypes of Salmonella. The current provisions of the U.S. Salmonella
Monitored classification do not provide for serotyping. Therefore, we
are proposing to add a serotyping provision to paragraph (f)(1)(vi).
This paragraph currently requires an Authorized Agent to take
environmental samples as described in Sec. 147.12 from each flock at 4
months of age and every 30 days thereafter. An authorized laboratory
for Salmonella must then examine the environmental samples
bacteriologically. We are proposing to require all Salmonella isolates
from a flock to be serogrouped and reported to the Official State
Agency on a monthly basis.
We are also proposing to amend paragraph (f)(1)(vii), which
provides that owners of flocks may vaccinate with a paratyphoid vaccine
if they leave a sample unvaccinated until the flock reaches 4 months of
age, to indicate that this sample will allow for the serological
testing that would be required under proposed paragraph (f)(1)(vi).
Some trading partners' import requirements separate the Salmonella
status of the flock from the status of the hatchery containing the
hatching eggs and chicks produced from it. A primary meat-type chicken
breeding flock can thus be considered to be free of Salmonella, based
on regular testing, even if there is environmental Salmonella
contamination in the hatchery. However, the current U.S. Salmonella
Monitored classification does not provide for this; it applies to both
the flock and the hatching eggs and chicks produced from it. To provide
flock owners with a means to demonstrate their flock's Salmonella-
negative status, we are proposing to add a new paragraph (f)(1)(viii)
with provisions under which a flock could be considered ``Salmonella
negative.''
Under proposed paragraph (f)(1)(viii), any flock entering the
production period that is in compliance with all the requirements of
Sec. 145.83(f) with no history of Salmonella isolations would be
considered ``Salmonella negative'' and could retain this definition as
long as no environmental or bird salmonella isolations are identified
and confirmed from the flock or flock environment by sampling on 4
separate collection dates over a minimum of a 2-week period. Sampling
and testing would have to be performed as described in proposed
paragraph (f)(1)(vi). An unconfirmed environmental Salmonella isolation
would not change this Salmonella negative status, as the ``Salmonella
negative'' status is intended to reflect only the status of the flock
itself.
These proposed provisions would provide participants in the U.S.
Salmonella Monitored classification for primary meat-type breeding
turkeys with new means to verify the flock's Salmonella status for
trading partners.
[[Page 57205]]
New Provisions for Meat-Type Waterfowl Breeding Flocks and Products
We are proposing to add a new subpart I to 9 CFR part 145, which
would consist of Sec. Sec. 145.91 through 145.94. This subpart would
set out special provisions for the participation of meat-type waterfowl
breeding flocks and products in the Plan. Although subpart E in 9 CFR
part 145 provides special provisions for waterfowl, exhibition poultry,
and game bird breeding flocks and products, these provisions are
directed towards hobbyist and exhibition waterfowl and are not
necessarily suited for meat-type waterfowl breeding flocks. Adding a
new subpart I would allow the NPIP to address issues related to meat-
type waterfowl breeding flocks specifically.
We are proposing to amend subpart E to make it clear that meat-type
waterfowl breeding flocks would no longer be covered under that
subpart. We would amend the section heading of subpart E and the
introductory text of Sec. 145.52, ``Participation,'' to indicate that
the subpart's applicability is limited to hobbyist and exhibition
waterfowl. We would add a sentence to the introductory text of Sec.
145.52 indicating that the special provisions that apply to meat-type
waterfowl flocks are found in subpart I of part 145. We would also
amend Sec. Sec. 145.53 and 145.54 in a few places to reflect these
changes. The amendments can be found in the proposed regulatory text at
the end of this document.
The structure of subpart I would be similar to the structure of
subparts B through H in part 145. Section 145.91, ``Definitions,''
would contain a definition of meat-type waterfowl breeding flocks. This
term would be defined as: Flocks of domesticated duck or goose that are
composed of stock that has been developed and is maintained for the
primary purpose of producing baby poultry that will be raised under
confinement for the primary purpose of producing meat for human
consumption.
Section 145.92, ``Participation,'' would state that participating
flocks of meat-type waterfowl and the eggs and baby poultry produced
from them shall comply with the applicable general provisions of
subpart A of part 145 and the special provisions of proposed subpart I.
In addition:
Started poultry would lose their identity under Plan
terminology when not maintained by Plan participants under the
conditions prescribed in Sec. 145.5(a).
Hatching eggs produced by primary breeding flocks would
have to be fumigated (see Sec. 147.25) or otherwise sanitized.
Any nutritive material provided to baby poultry would have
to be free of the avian pathogens that are officially represented in
the Plan disease classifications listed in Sec. 145.10.
These conditions, which are similar to the conditions for
participation in other subparts in part 145, would help to ensure that
flocks that participate in the Plan are free of poultry diseases.
Section 145.93, ``Terminology and classification; flocks and
products,'' would set out conditions for two Plan classifications for
meat-type breeding waterfowl, the U.S. Pullorum-Typhoid Clean
classification and the U.S. Avian Influenza Clean classification. The
provisions of these classifications are similar to those for other
types of poultry in part 145.
Paragraph (a) would be reserved, as it is in other subparts in part
145. Paragraph (b) would contain the requirements for the U.S.
Pullorum-Typhoid Clean classification. A qualifying flock would be one
in which freedom from pullorum and typhoid has been demonstrated to the
Official State Agency under the criteria in one of proposed paragraphs
(b)(1) through (b)(5).
Proposed paragraph (b)(1) would provide that a flock would qualify
if it has been officially blood tested within the past 12 months with
no reactors.
Proposed paragraph (b)(2) would provide that a flock would qualify
if it is a multiplier breeding flock, or a breeding flock composed of
progeny of a primary breeding flock which is intended solely for the
production of multiplier breeding flocks, and meets the following
specifications as determined by the Official State Agency and the
Service:
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;
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
The flock is located on a premises where a flock not
classified as U.S. Pullorum-Typhoid Clean was located the previous
year. In this circumstance, an Authorized Testing Agent would have to
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 would
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.
(NOTE: In addition to requiring blood testing when a flock not
classified as U.S. Pullorum-Typhoid Clean was located on a premises the
previous year, similar provisions in Sec. Sec. 145.23(b)(2)(iii),
145.33(b)(2)(iii), 145.43(b)(2)(iii), and 145.53(b)(2)(iii) also
require blood testing when no poultry has been located on the premises
the previous year. Testing is not necessary in the latter circumstance,
and we are proposing to remove the requirement to conduct blood testing
on a flock when no poultry was located on the premises the previous
year in each of these paragraphs.)
Paragraph (b)(3) would provide that a flock would qualify if it is
a multiplier breeding flock that originated from U.S. Pullorum-Typhoid
Clean breeding flocks or from flocks that met equivalent requirements
under official supervision, and is located in a State in which it has
been determined by the Service that:
All hatcheries within the State are qualified as
``National Plan Hatcheries'' or have met equivalent requirements for
pullorum-typhoid control under official supervision;
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. However, if other
domesticated fowl are maintained on the same premises as the
participating flock, freedom from pullorum-typhoid infection would be
demonstrated by an official blood test of each of these fowl;
All shipments of products other than U.S. Pullorum-Typhoid
Clean, or equivalent, into the State are prohibited;
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;
All reports of any disease outbreak involving a disease
covered under the Plan are promptly followed by an investigation by the
Official State
[[Page 57206]]
Agency to determine the origin of the infection. 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 NPIP would conduct an
investigation;
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; and
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.
Discontinuation of any of these conditions or procedures, or the
occurrence of repeated outbreaks of pullorum or typhoid in poultry
breeding flocks within or originating within the State would be grounds
for the Service to revoke its determination that such conditions and
procedures have been met or complied with. Such action would 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.
Paragraph (b)(4) would provide that a flock would qualify if it is
a multiplier breeding flock located in a State which has been
determined by the Service to be in compliance with the provisions of
proposed paragraph (a)(3), and 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.
Paragraph (b)(5) would provide that a flock would qualify if it is
a primary breeding flock located in a State determined to be in
compliance with the provisions of paragraph (a)(4) of this section, and
in which a sample of 300 birds from flocks of more than 300, and each
bird in flocks of 300 or less, has been officially tested for pullorum-
typhoid within the past 12 months with no reactors. However, when a
flock is a primary breeding flock located in a State which has been
deemed to be a U.S. Pullorum-Typhoid Clean State for the past 3 years,
and during which time no isolation of pullorum or typhoid has been made
that can be traced to a source in that State, a bacteriological
examination monitoring program or a serological examination monitoring
program acceptable to the Official State Agency and approved by the
Service could be used in lieu of annual blood testing.
Compliance with any one of these provisions is sufficient to ensure
that pullorum-typhoid is not present in a meat-type waterfowl breeding
flock in the U.S. Pullorum-Typhoid Clean classification, as evidenced
by the success of these provisions when used for the classification in
other types of poultry.
Proposed paragraph (c) would set out the provisions of the U.S.
Avian Influenza Clean classification. The intent of this program would
be to serve as the basis from which the meat-type waterfowl breeding-
hatchery industry may conduct a program for the prevention and control
of H5/H7 AI. It would be intended to determine the presence of the H5/
H7 AI in meat-type waterfowl breeding flocks through routine
surveillance of each participating breeding flock. There would be
separate surveillance provisions for primary breeding flocks and
multiplier breeding flocks of meat-type waterfowl.
Paragraph (c)(1) would provide that a primary meat-type waterfowl
breeding flock would qualify for the U.S. Avian Influenza Clean
classification if a minimum of 30 birds from the flock have been tested
negative to H5/H7 AI as provided in Sec. 145.14(d) when more than 4
months of age. To retain this classification:
A sample of at least 30 birds would have to be tested
negative at intervals of 90 days; or
A sample of fewer than 30 birds could be tested, and found
to be negative, at any one time if all pens were equally represented
and a total of 30 birds were tested within each 90-day period.
Paragraph (c)(2) would provide that a multiplier meat-type
waterfowl breeding flock would also qualify for the classification if a
minimum of 30 birds from the flock have been tested negative to H5/H7
AI as provided in Sec. 145.14(d) when more than 4 months of age. The
options for retaining the classification would be identical to those
for primary breeding flocks.
Consistent with the changes proposed in this document to require
testing of spent fowl in the AI programs for other types of poultry,
paragraph (c)(3) would require that, during each 90-day period, all
primary and multiplier spent fowl, up to a maximum of 30, be tested
serologically and found negative within 21 days prior to movement to
slaughter.
These provisions would be sufficient to determine whether H5/H7 AI
is present in participating meat-type waterfowl breeding flocks.
Similar provisions have been used successfully in other AI
classifications in part 145.
Section 145.94, ``Terminology and classification; States,'' would
set out conditions for the U.S. Pullorum-Typhoid Clean State
classification. Several of the subparts for specific types of poultry
in part 145 contain provisions for this classification. To be declared
a U.S. Pullorum-Typhoid Clean State, APHIS would have to determine that
the following two requirements have been met:
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), and proposed 145.93(b)(3)(i) through
(vii). Compliance with these provisions ensures that the State has the
infrastructure to detect and respond to outbreaks of pullorum-typhoid;
and
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. However, pullorum disease or fowl typhoid found
within the preceding 24 months in waterfowl, exhibition poultry, and
game bird breeding flocks would not prevent a State that is otherwise
eligible from qualifying. This exception is standard in the U.S.
Pullorum-Typhoid Clean State classifications; while pullorum disease is
found extremely rarely in the United States, it is most often found in
these types of poultry, often outside a commercial poultry production
setting, and it is not necessary to remove a U.S. Pullorum-Typhoid
Clean State classification for such a finding.
If these conditions are discontinued, or repeated outbreaks of
pullorum or typhoid occur in hatchery supply flocks of this section, or
if an infection spreads from the originating premises, APHIS would have
grounds to revoke its determination that the State is entitled to this
classification. Such action would 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.
As noted, several of the subparts for specific types of poultry in
part 145 contain provisions for the U.S. Pullorum-Typhoid Clean State
classification. All of those subparts contain lists of the provisions
with which the State must be in compliance. Some of these do not
reflect the addition of relevant provisions in subparts G and H (for
primary egg-type chicken and
[[Page 57207]]
primary meat-type chicken breeding flocks, respectively); none of these
include the provisions in Sec. 145.93(b)(3)(i) through (vii) that we
are proposing to add. We are therefore also proposing to update the
lists of provisions with which a State must be in compliance in order
to be declared a U.S. Pullorum-Typhoid Clean State in Sec. Sec.
145.24(a)(1)(i), 145.34(a)(1)(i), 145.44(a)(1)(i), and 145.54(a)(1)(i)
to keep them up to date and to reflect the proposed changes.
Definition of H5/H7 LPAI in Part 146
In Sec. 146.1, the term H5/H7 low pathogenic avian influenza
(LPAI) is defined as follows: ``An infection of poultry caused by an
influenza A virus of H5 or H7 subtype that has an intravenous
pathogenicity index test in 6-week-old chickens less than 1.2 or any
infection with influenza A viruses of H5 or H7 subtype for which
nucleotide sequencing has not demonstrated the presence of multiple
basic amino acids at the cleavage site of the hemagglutinin.''
We added this definition to the regulations in an interim rule
effective and published in the Federal Register on September 26, 2006
(71 FR 53601-56333, Docket No. APHIS-2005-0109). It was based on the
OIE guidelines for AI that were current at the time of publication.
Since then, the OIE has updated its AI guidelines, including the
definition of H5/H7 LPAI. To ensure that our regulations continue to be
consistent with the OIE guidelines, we are proposing to update the
definition of H5/H7 LPAI. The new definition would read: ``An infection
of poultry caused by an influenza A virus of H5 or H7 subtype that has
an intravenous pathogenicity index in 6-week-old chickens less than 1.2
or less than 75 percent mortality in 4- to 8-week-old chickens infected
intravenously, or an infection with influenza A viruses of H5 or H7
subtype with a cleavage site that is not consistent with a previously
identified highly pathogenic avian influenza virus.'' This change would
keep the regulations up to date with international standards.
Addition of Provisions for Commercial Table-Egg Layer Pullets
Subpart B of part 146 (Sec. Sec. 146.21 through 146.24) contains
special provisions for commercial table-egg layer flocks. We are
proposing to add provisions for commercial table-egg layer pullets to
subpart B.
We would define a table-egg layer pullet in Sec. 146.21 as a
sexually immature domesticated chicken grown for the primary purpose of
producing eggs for human consumption. By definition, because the table-
egg layer pullet is not sexually mature, it cannot yet lay eggs.
Pullets are typically less than 20 weeks of age. Table-egg layer
pullets are moved to a layer house when they become sexually mature,
after which they are called table-egg layers. The regulations in
subpart B have focused on table-egg layer flocks themselves, but the
introduction of table-egg layer pullets into a flock is a potential
pathway for the introduction of diseases, particularly as table-egg
layer flocks are often assembled from multiple pullet sources. Thus, we
are proposing to include provisions in the special provisions for
commercial table-egg layers in subpart B of part 146 to address the
table-egg layer pullets that will ultimately be moved onto the table-
egg layer premises.
In addition, the definition of commercial table-egg layer flock in
Sec. 146.1 reads: ``All table-egg layers of one classification in one
barn or house.'' We are proposing to replace this with a new
definition: ``All table-egg layers of common age or pullet source on
one premises.'' Table-egg layer flocks are normally composed of birds
of common age or pullet source, but the birds may be in one house or
multiple houses; older table-egg layer premises are more likely to have
one flock spread across multiple houses. By removing the requirement
that a flock be contained in a single barn or house and instead
designating a flock as a group of table-egg layers of common age or
pullet source, we would more accurately reflect the organization of
table-egg layer flocks. We would retain the definition of commercial
table-egg layer premises in Sec. 146.1, which indicates that a
premises includes all contiguous flocks of commercial table-egg layers
under common ownership, to reflect the fact that a commercial table-egg
layer premises may comprise many individual flocks.
We would also add a definition of commercial table-egg layer pullet
flock to Sec. 146.1. This definition would read as follows: ``A table-
egg layer flock prior to the onset of egg production.''
In Sec. 146.23, paragraph (a) sets out the requirements of the
U.S. H5/H7 Avian Influenza Monitored program for commercial table-egg
layers. The introductory text of this paragraph states that this
program is intended to be the basis from which the table-egg layer
industry may conduct a program to monitor for the H5/H7 subtypes of AI.
It is intended to determine the presence of the H5/H7 subtypes of AI in
table-egg layers through routine serological surveillance of each
participating commercial table-egg layer flock.
We are proposing to amend this discussion to refer to commercial
table-egg layer pullet flocks as well as commercial table-egg layer
flocks. We are also proposing to remove the reference to serological
testing specifically, for reasons similar to those given earlier for
removing the specific references to serological testing from the U.S.
H5/H7 Avian Influenza Clean classification for turkey breeding flocks
and for waterfowl, exhibition poultry, and game bird breeding flocks.
Within paragraph (a), paragraphs (a)(1), (a)(2), and (a)(3) set out
the requirements for surveillance of commercial table-egg layers. We
are proposing to add a new paragraph (a)(1) with requirements for
table-egg layer pullet flocks and redesignate current (a)(1), (a)(2),
and (a)(3) as paragraphs (a)(2)(i), (a)(2)(ii), and (a)(2)(iii). In
those paragraphs, we would remove references to testing negative for
antibodies to H5/H7 AI and instead refer simply to testing negative for
H5/H7 AI, for the reasons mentioned earlier with regard to similar
changes to the U.S. H5/H7 Avian Influenza Clean classification for
turkey breeding flocks. We would also remove the current references to
testing egg samples and add references to the official AI tests in
Sec. 146.13(b), for the reasons mentioned earlier with regard to
similar changes to the U.S. H5/H7 Avian Influenza Clean classification
for waterfowl, game bird, and exhibition poultry breeding flocks.
Proposed paragraph (a)(1) would provide two options by which table-
egg layer pullet flocks could qualify for the U.S. H5/H7 Avian
Influenza Monitored classification. Such a flock would qualify if:
It is a commercial table-egg layer pullet flock in which a
minimum of 11 birds have been tested negative to the H5/H7 subtypes of
AI as provided in Sec. 146.13(b) within 30 days prior to movement; or
It is a commercial table-egg layer pullet flock that has
an ongoing active and diagnostic surveillance program for the H5/H7
subtypes of AI which the number of birds tested is equivalent to the
number required in the other option and that is approved by the
Official State Agency and the Service.
Any ongoing active and diagnostic surveillance program that is
approved by the Official State Agency and APHIS would have to test a
number of birds equivalent to the first requirement, but this by itself
would not be sufficient to secure approval for the program; the
Official State Agency and APHIS would have to agree that the detailed
testing
[[Page 57208]]
plan for the alternate program is sufficient to establish a level of
confidence for the detection of AI that is equivalent to that of the
first requirement. Allowing participating flocks to develop an
alternative ongoing active and diagnostic surveillance program of
equivalent efficacy would give the flock owners some flexibility.
In Sec. 146.24, paragraph (a) sets out the provisions for the U.S.
H5/H7 Avian Influenza Monitored State, Layers classification. We would
amend these provisions to indicate that this classification also
includes table-egg layer pullet flocks. Under paragraph (a)(1)(i), in
order for a State to qualify for the U.S. H5/H7 Avian Influenza
Monitored State, Layers classification, all the commercial table-egg
layer flocks that are not exempt from the special provisions of subpart
B under Sec. 146.22 and all the commercial table-egg layer pullet
flocks that supply those flocks within the State would have to be
classified as U.S. H5/H7 Avian Influenza Monitored under Sec.
146.23(a). Requirements for specimen reporting and subtyping in
paragraphs (a)(1)(iii) and (a)(1)(iv) would also apply to commercial
table-egg layer pullet flocks as well as commercial table-egg layer
flocks. Finally, under paragraph (a)(1)(v), all table-egg layer pullet
flocks within the State that are found to be infected with H5/H7 AI
would have to be quarantined, in accordance with an initial State
response and containment plan as described in 9 CFR part 56 and under
the supervision of the Official State Agency, the same as is currently
required for table-egg layer flocks.
These changes would expand the reach of the U.S. H5/H7 Avian
Influenza Monitored classification for commercial table-egg layers and
make it more effective.
Testing Procedures for Other U.S. H5/H7 Avian Influenza Monitored
Classifications in Part 146
Within part 146, Sec. 146.33 contains the requirements for the
U.S. H5/H7 Avian Influenza Monitored classification for meat-type
chicken slaughter plants, Sec. 146.43 contains the requirements for
that classification for meat-type turkey slaughter plants, Sec.
146.53(a) contains the requirements for commercial waterfowl and
commercial upland game bird slaughter plants, and Sec. 146.53(b)
contains the requirements for raised-for-release upland game birds and
raised-for-release waterfowl. Similar to other classifications
discussed earlier in this proposal, all of these classifications
contain testing requirements for H5/H7 LPAI but do not specify that
testing must be conducted as provided in Sec. 146.13(b), which
contains the official AI tests for part 146. We are proposing to amend
these requirements to indicate that birds must be tested for these
classifications as provided in Sec. 146.13(b). In addition, we are
proposing to remove a reference to testing for antibodies to H5/H7 LPAI
in Sec. 146.53(a)(2), for reasons identical to those given for similar
changes described earlier in this document.
Shoe Cover Sampling Technique for Collection of Salmonella Samples
Section 147.12 sets out procedures for collection, isolation, and
identification of Salmonella from environmental samples, cloacal swabs,
chick box papers, and meconium samples. Paragraph (a) of Sec. 147.12
sets out procedures specific to egg- and meat-type chickens, waterfowl,
exhibition poultry, and game birds. This paragraph includes various
methods for collecting samples and a procedure for testing chick
meconium.
We are proposing to add a new sampling technique in a proposed new
paragraph (a)(6). This technique uses absorbable shoe covers to collect
samples. Absorbable fabric shoe covers involve the exposure of the
bottom surface of shoe covers to the surface of floor litter and slat
areas. The shoe cover sampling technique would involve wearing clean
latex gloves and placing the shoe covers over footwear that is only
worn inside the poultry house. This could be footwear dedicated to the
facility or disposable overshoes. Each pair of shoe covers would be
worn while walking at a normal pace over a distance of 305 meters (1000
feet). For flocks with fewer than 500 breeders, at least 1 pair of shoe
covers would be worn to sample the floor of the bird area. For flocks
with 500 or more breeders, at least 2 pairs of shoe covers would be
worn to sample the floor of the bird area. After sampling, each shoe
cover would be placed in a sterile container with 30 ml of double
strength skim milk, to protect Salmonella viability during storage and
shipment. The sterile containers would have to be sealed and promptly
refrigerated at 2 to 4 [deg]C or place in a cooler with ice or ice
packs, but not frozen. Samples would have to be stored at refrigerator
temperatures of 2 to 4 [deg]C no more than 5 days prior to culturing.
This procedure would provide an effective alternative means to
collect Salmonella samples in poultry houses.
Approved Tests
Within Sec. 147.52, paragraph (b) sets out a procedure by which
diagnostic test kits that are not licensed by APHIS (e.g.,
bacteriological culturing kits) may be approved for use in the NPIP. We
are proposing to list in a new paragraph (c) in Sec. 147.52 the test
kits that have been approved through this process. These are the test
kits we are proposing to list:
Rapid Chek(copyright)Select TMSalmonella Test Kit,
Strategic Diagnostics, Inc. Newark, DE 19713.
ADIAFOOD Rapid Pathogen Detection System for Salmonella
spp., AES Chemu