[Federal Register: May 23, 2003 (Volume 68, Number 100)]
[Proposed Rules]
[Page 28169-28175]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 82, 145, and 147
[Docket No. 03-017-1]
National Poultry Improvement Plan and Auxiliary Provisions
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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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 2002 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 July
22, 2003.
ADDRESSES: You may submit comments by postal mail/commercial delivery
or by e-mail. If you use postal mail/commercial delivery, please send
four copies of your comment (an original and three copies) to: Docket
No. 03-017-1, Regulatory Analysis and Development, PPD, APHIS, Station
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. 03-017-1. If you use e-mail,
address your comment to regulations@aphis.usda.gov. Your comment must
be contained in the body of your message; do not send attached files.
Please include your name and address in your message and ``Docket No.
03-017-1'' on the subject line.
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.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
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 200,
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 egg-transmitted, hatchery-
disseminated poultry diseases. Participation in all Plan programs is
voluntary, but flocks, hatcheries, and dealers must first qualify as
``U.S. Pullorum-Typhoid Clean'' as a condition for participating in the
other Plan programs. Also, the regulations in 9 CFR part 82, subpart C,
which provide for certain testing, restrictions on movement, and other
restrictions on certain chickens, eggs, and other articles due to the
presence of Salmonella enteritidis, prohibit hatching eggs or newly
hatched chicks from egg-type chicken breeding flocks from being moved
interstate unless they are classified ``U.S. S. Enteritidis Monitored''
under the Plan or have met equivalent requirements for S. enteritidis
control, in accordance with 9 CFR 145.23(d), under official Federal or
State supervision. (The name of the ``U.S. S. Enteritidis Monitored''
classification has changed; as discussed below, we are proposing to
amend part 82, subpart C, to reflect this change.)
The Plan identifies States, flocks, hatcheries, and dealers 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 and 147 (referred to below as
the regulations) contain the provisions of the Plan. The Animal and
Plant Health Inspection Service (APHIS) of the U.S. Department of
Agriculture (USDA or 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 May 30 to June 1, 2002.
Participants in the 2002 National Plan Conference represented
flockowners, breeders, hatcherymen, and Official State Agencies from
all cooperating States. The proposed amendments are discussed in
greater detail below.
Update of S. enteritidis Regulations
On February 25, 2002, we published in the Federal Register (67 FR
8466-8475, Docket No. 00-075-2) a final rule that, among other things,
amended Sec. 145.23(d) by changing the name of the ``U.S. S.
Enteritidis Monitored'' classification to ``U.S. S. Enteritidis
Clean.'' We made this change because the monitoring and prevention
elements of this program had been effective enough that the focus of
the program had shifted towards maintaining the freedom of flocks from
Salmonella enteritidis. At the time we made this change, we should have
updated Sec. 82.34 to reflect the classification's new name, but we
failed to do so. Therefore, we are proposing to change the reference to
``U.S. S. Enteritidis Monitored'' in Sec. 82.34 to read ``U.S. S.
Enteritidis Clean'' to make the regulations consistent.
Blood Testing for Pullorum-Typhoid
We propose to reorganize Sec. 145.14(a), which specifies the
procedures for testing flocks for pullorum-typhoid, to improve that
paragraph's clarity. The current paragraph does not clearly state the
order in which the various tests for pullorum-typhoid should be
administered. To save money and time, testing should begin with the
rapid serum test, the enzyme-labeled immunosorbent assay, or the rapid
whole blood plate test. These tests are considered screening tests and
are highly sensitive, which may lead to false positives. To confirm
positive results from these tests, the standard tube agglutination test
or the microagglutination test must be used. If the standard tube
agglutination test or microagglutination test confirms the earlier
positive result, flock owners must submit all the reactors to an
authorized laboratory for bacteriological examination. If there are
four or more reactors in the flock, at least four reactors must be
submitted.
Some owners of small flocks who suspect that the standard tube
agglutination or microagglutination tests have produced false-positive
results may be reluctant to submit reactors for bacteriological
examination, because this process requires that the reactors be
destroyed. In such a situation, the regulations provide that rather
than immediately submitting reactors for bacteriological examination,
the owner may isolate the reactors for 30 days, after which they must
be retested. If the
[[Page 28170]]
reactors continue to test positive, it is mandatory that the reactors
be submitted for bacteriological examination.
While these procedures are enumerated in the current regulations,
their presentation is somewhat unclear, with the result that tests may
be administered in improper order and reactors may be destroyed
unnecessarily for the purposes of bacteriological examination. The
proposed reorganization of Sec. 145.14(a) is intended to eliminate
that possibility by making the regulations easier to understand.
Additionally, in the current regulations, the procedures for
testing for pullorum-typhoid (Sec. 145.14(a)(9)) are presented after
the procedures in Sec. 145.14(a)(7) by which a flock may be determined
to be free of pullorum-typhoid once a flock has tested positive for
this disease. We propose to reorder these paragraphs to reflect the
order in which these procedures would be undertaken by flockowners.
Minimum Weight of Hatching Eggs
At one time, the Plan served as a certification program for
breeders, determining the required characteristics for saleable
hatching eggs of various types. Over the years, the Plan's focus
shifted towards preventing the establishment and spread of poultry
diseases. The poultry industry has developed its own standards for
hatching eggs, and these standards are widely accepted among producers.
Therefore, we believe that the NPIP requirements for the minimum
weights of hatching eggs that are part of the participation criteria
for certain Plan programs are no longer applicable or necessary and
should be removed from the regulations.
In Sec. 145.22, we propose to remove paragraphs (a) and (b), which
require, respectively, that the minimum weight of hatching eggs sold
from egg type chicken breeding flocks shall be \11/22\ ounces, unless
otherwise specified by the purchaser of the eggs, and that
Mediterranean breed eggs shall be reasonably free from tints. In Sec.
145.32, we propose to remove paragraph (a), which requires that the
minimum weight of hatching eggs sold from meat type chicken breeding
flocks shall be 1\10/12\ ounces, except as otherwise specified by the
purchaser of the eggs. In Sec. 145.42, we propose to remove paragraph
(b), which requires that the minimum weight of hatching eggs from
turkey breeding flocks that are shipped interstate shall be 2 ounces
for small varieties and 2\1/2\ ounces for large varieties, unless
otherwise specified by the purchaser of the eggs.
Flock Sampling Levels for M. Gallisepticum and M. Synoviae Programs
For both the U.S. M. Gallisepticum Clean and U.S. M. Synoviae Clean
programs, as provided in Sec. 145.33(c) and (e), respectively, we
propose to modify the current requirements for testing male breeding
birds for the diseases before adding these birds to a participating
multiplier breeding flock. Instead of requiring that 3 percent of the
male breeding birds be tested, we would require that 30 of these birds
be tested, or, if fewer than 30 birds are being introduced, that all of
these birds be tested. We believe that the 3 percent standard, if used
when fewer than 1,000 male breeding birds are being added to a
participating flock, can result in sample sizes that are not large
enough for the test results to be statistically significant. Requiring
that 30 male breeding birds be tested (or that all of the male breeding
birds be tested if fewer than 30 are being introduced) would provide
greater assurance that the male breeding birds being introduced are
free of these diseases.
We also propose to amend Sec. 145.33(c) and (e) by inserting a
reference to the diagnostic procedure in Sec. 145.14(b) for M.
gallisepticum and M. synoviae to clarify that if the male breeding
birds are tested serologically, the test must be carried out as
prescribed in Sec. 145.14(b).
For both the U.S. M. Gallisepticum Monitored and U.S. M. Synoviae
Monitored programs, as provided in Sec. 145.33(j) and (k),
respectively, we propose to increase the sampling level required to
retain this classification from 20 birds, 10 from the front half of the
house and 10 from the back half of the house, to 30 birds, 15 from the
front of the house and 15 from the back of the house. We believe that
20 birds is an insufficient sample size for testing for these diseases,
and that the proposed requirement that 30 birds be tested would provide
more useful results.
Restrictions on Animal Protein in Mash and Pellet Feed
We propose to eliminate the restrictions on the use of animal
protein in mash and pelletized feed that are currently found in the
regulations governing the U.S. S. Enteriditis Clean program, in
paragraphs Sec. 145.33(h)(1)(ii)(A) and (h)(1)(ii)(B); the U.S.
Salmonella Monitored program, in paragraph Sec. 145.33(i)(1)(iii); and
the U.S. Sanitation Monitored program for turkeys, in Sec.
145.43(f)(3). Currently, animal protein used in either pelletized or
mash feed under these programs must be produced under the Salmonella
Education/Reduction program of the Animal Protein Products Industry
(APPI) or, for the U.S. S. Enteriditis Clean and U.S. Sanitation
Monitored programs, the Fishmeal Inspection Program of the National
Marine Fisheries Service (NMFS). We are proposing to remove these
restrictions and allow the use of any animal protein for feed under
these programs.
We originally required animal protein used in pelletized or mash
feed for poultry to be produced under the APPI or NMFS programs because
we believed that such a requirement was an effective way to lower the
risk that animal protein used in feed was contaminated with Salmonella.
However, since that requirement was instituted, technological methods,
such as thermal lethality treatments, and chemical products have been
introduced to control the incidence of Salmonella in protein feed.
These technological and chemical methods are generally more effective
than the program controls in ensuring that Salmonella is not present in
protein used in feed.
In fact, the control programs have often proven ineffective. For
example, in 2000, Salmonella Education/Reduction Program test results
showed that 20 percent of tested protein samples were positive for
Salmonella. This level of positive results is not significantly
different from the level of Salmonella positive results found among
renderers and processors that did not operate under the APPI program.
Removing the requirement that protein used in feed be produced under
the APPI or NMFS programs, therefore, is not likely to reduce the
quality of protein used in feed, and to the extent that it encourages
the use of the more effective technological and chemical Salmonella
control methods, is likely to increase that quality.
In addition, we propose to replace the current thermal lethality
treatment for pelletized feed specified in the U.S. Sanitation
Monitored program for turkeys by providing for the use of any of three
specified thermal lethality treatments or any other equivalent thermal
lethality treatment. Alternatively, we would require that a Food and
Drug Administration-approved Salmonella control product be added to all
finished pellets or conditioned mash feed. Turkey flocks are more
likely than other poultry flocks to be fed animal protein; we have
therefore determined that our regulations for treating animal protein
feed for turkeys should be as specific as possible to ensure that the
animal protein feed prepared for turkey flocks carries the lowest
possible risk of
[[Page 28171]]
infecting turkeys with Salmonella. The proposed additional requirements
would further reduce the chance that turkey feed is infected with
Salmonella under this program.
Reinstatement Procedure for U.S. S. Enteriditis Clean Program
We propose to add a provision for reinstatement to the U.S. S.
Enteriditis Clean program for meat type chicken breeding flocks and
products in a new paragraph Sec. 145.33(h)(6). This reinstatement
provision would require breeders of meat type flocks to undertake
corrective measures to ensure that a flock that has been removed from
the U.S. S. Enteriditis Clean program due to infection is no longer
affected by that bacterium, in addition to any other measures that may
be specified by the Official State Agency. These measures would include
testing and slaughtering infected birds based on the testing of every
bird in the flock, vaccination, medication, cleaning and disinfection
of houses, rodent control, and movement to premises that have been
determined to be environmentally negative for S. Enteriditis as
described in Sec. 147.12(a). Once these measures have been performed,
the flock would be tested and environmental drag swabs would be taken.
If both tests do not indicate the presence of S. Enteriditis, the flock
would be reinstated into the program.
Currently, there is no reinstatement provision for the U.S. S.
Enteriditis Clean program, and as a result primary breeders who wish to
participate in the program must destroy foundation level primary
breeding birds if those birds are part of a flock affected with S.
enteritidis. Such birds often have valuable, specific traits that
cannot be duplicated, and their destruction can result in considerable
losses to the primary breeder. Allowing for reinstatement of flocks
into the U.S. S. Enteriditis Clean program under the proposed
conditions would enable primary breeders to retain their foundation
level primary breeding birds if they are not infected with S.
Enteriditis while continuing to ensure that the flocks that participate
in the U.S. S. Enteritidis Clean program are kept free of this disease.
New U.S. Avian Influenza Clean Programs
We propose to add new U.S. Avian Influenza Clean programs to the
regulations governing turkey breeding flocks and products in Sec.
145.43(g) and to the regulations governing waterfowl, exhibition
poultry, and game breeding flocks and products in Sec. 145.53(e). Both
of these programs are modeled on the existing U.S. Avian Influenza
Clean program for meat type chicken breeding flocks and products, set
out at Sec. 145.33(l). Like the U.S. Avian Influenza Clean program for
meat type chicken breeding flocks and products, the programs for turkey
breeding flocks and products and waterfowl, exhibition poultry, and
game breeding flocks and products would require that a sample of at
least 30 birds must test negative for antibodies to avian influenza, as
indicated by the agar gel immunodiffusion test specified in Sec.
147.9. For primary breeding flocks, the maximum interval between tests
would be 90 days; for multiplier breeding flocks, the maximum interval
between tests would be 180 days. The program for turkeys would
additionally require that if a killed influenza vaccine from a subtype
other than the H5 or H7 subtypes is used for turkeys, the hemagglutinin
and the neruaminidase subtypes of the vaccine must be reported to the
Official State Agency for laboratory and reporting purposes.
Both of these U.S. Avian Influenza Clean programs are intended to
provide flockowners with an optional way to improve their flocks'
marketability in foreign countries. A program requiring regular testing
of turkeys for avian influenza with the agar gel immunodiffusion test
would provide a useful certification to turkey flockowners seeking to
expand their exports to countries that required such testing.
Since most countries require that waterfowl, exhibition poultry,
and game breeding birds be tested for avian influenza before they can
be imported, the avian influenza testing program for those birds would
not only provide exporters with an additional useful certification but
could also save time and expense at export.
Section 145.10 contains illustrative designs or emblems that
correspond to the Plan's various classifications. The design for the
U.S. Avian Influenza Clean program is found in Sec. 145.10(r), which
currently reads ``U.S. Avian Influenza Clean. (See Sec. Sec. 145.23(h)
and 145.33(l).)'' Because we are proposing to establish a U.S. Avian
Influenza Clean program for waterfowl, exhibition poultry, and game
breeding birds, we would amend Sec. 145.10(r) so that it also refers
to Sec. 145.53(e), which is the section that would contain the
requirements of the U.S. Avian Influenza Clean program for waterfowl,
exhibition poultry, and game breeding birds.
We are proposing to refer to the similar program for turkeys as the
U.S. H5/H7 Avian Influenza Clean program, because its intent is to
determine the presence of the H5 and H7 subtypes of avian influenza in
participating flocks. However, Sec. 145.10 does not currently contain
an illustrative design that bears this title. Therefore, we are
proposing to add a new paragraph (t) to Sec. 145.10 which would read
``U.S. H5/H7 Avian Influenza Clean. (See Sec. 145.43(g).)'' This
paragraph would contain an appropriate illustrative design for use with
this program.
Isolation and Identification of Salmonella
We propose to modify the regulations governing the isolation and
identification of Salmonella in Sec. 147.12(b) by adding a rapid
diagnostic method involving a rapid ruthenium-labeled Salmonella
sandwich immunoassay to the list of approved diagnostic methods. The
steps involved in using this method would be detailed in a new
paragraph Sec. 147.12(b)(3). The two other approved methods,
tetrathionate enrichment with delayed secondary enrichment and pre-
enrichment followed by selective enrichment (listed in paragraphs
(b)(1) and (b)(2) of Sec. 147.12, respectively), both require more
time and resources to accomplish than the rapid ruthenium-labeled
Salmonella sandwich immunoassay, while the latter method provides
equally accurate results. Adding this method to the list of approved
methods would provide greater flexibility to diagnostic laboratories
while continuing to ensure accurate results in testing.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The 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.
The objective of the NPIP is to provide a cooperative Industry-
State-Federal program through which new technology can be effectively
applied to the improvement of poultry and poultry products throughout
the country. The provisions of the Plan, developed jointly by industry
members and State and Federal officials, establish standards for the
evaluation of poultry breeding stock and hatchery products with respect
to freedom from hatchery-disseminated diseases. Participation in the
program is voluntary. Currently, the NPIP has active control programs
for pullorum, fowl typhoid, avian mycoplasmas, Salmonella enteritidis,
and avian influenza.
[[Page 28172]]
Periodically, provisions of the Plan are amended to keep current
with the development of the poultry industry and the utilization of new
information as it becomes available, based on the recommendations of
representatives of member States, hatcheries, dealers, flockowners, and
breeders who take part in the Plan's National Plan Conference meetings.
Accordingly, this proposed rule would change some of the Plan's
provisions to keep the provisions of the Plan current with changes in
the poultry industry, establish new certification programs, modify
current disease control practices, and provide for the use of new
sampling and testing procedures. The proposed changes were voted on and
approved by the voting delegates at the Plan's 2002 National Plan
Conference. The proposed changes have been generated by industry
representatives, Official State Agencies, or Federal representatives
with the goal of reducing disease risk and increasing product
marketability.
The United States is the world's largest producer and exporter of
poultry meat and the second-largest egg producer. In 2001, U.S.
producers held a total of 441.1 million chickens, excluding commercial
broilers, whose estimated value was $1.068 billion. Broiler production,
which primarily comes from chickens raised under contract with a
broiler processor, totaled 8.262 billion broilers with a combined live
weight of 41.5 billion pounds. The value of broiler production for that
year was $13.9 billion. The United States is also the world's largest
turkey producer. In 2001, turkey production totaled 269 million birds
with a combined live weight of 6.98 billion pounds and value of $2.8
billion. Finally, in 2000, the United States produced approximately
84.4 million eggs worth an estimated $4.3 billion.\1\
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\1\ USDA, Agricultural Statistics 2002. Washington, DC: National
Agricultural Statistics Service, 2002.
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The U.S. poultry industry plays a significant role in international
trade. In fact, the United States is the world's largest exporter of
both broilers and turkey products. In 2001, broiler exports totaled 5.5
billion pounds, valued at $1.8 billion. Turkey exports for the same
year totaled 487 million pounds and were valued at $257 million. In
addition, 191 million dozen eggs and egg products were exported in
2001.\2\
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\2\ USDA, Poultry and Eggs: Trade. Washington, DC: Economic
Research Service, 2002.
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Participation in the Plan serves as a ``seal of approval'' for eggs
and poultry producers in the sense that tests and procedures
recommended by the Plan are considered optimal for the industry. As
such, while participation in the Plan is voluntary, many foreign
nations, such as Russia, do not accept poultry products unless they
have originated from flocks participating in the Plan.\3\ Consequently,
participation in the Plan increases product marketability both
domestically and internationally, which in turn increases the economic
benefits received by the poultry industry from participation in the
Plan.
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\3\ USDA, Export Requirements for Russia. Washington, DC: Food
Safety and Inspection Service, 2003.
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The Regulatory Flexibility Act requires that agencies consider the
economic impact of their regulations on small entities. Under the North
American Industry Classification System (NAICS) used by the Small
Business Administration, chicken egg operations are considered small
entities if they have $10.5 million or less in annual receipts (NAICS
code 112310). All other poultry products and meat operations are
considered small entities if they have $750,000 or less in annual
receipts (NAICS code 112320).\4\ As this regulation only seeks to make
minor changes in a continuing program in an effort to better safeguard
poultry health, the economic effects on poultry producers are not
expected to be significant.
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\4\ Table of Size Standards based on NAICS 2002. Washington, DC:
U.S. Small Business Administration, 2002.
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The last agricultural census estimated there were 63,246 domestic
poultry and poultry products farms.\5\ Unfortunately, the size
distribution of these farms is not known. However, because most poultry
production is carried out by small farms working under contract with
larger processors or marketing firms, we can assume a fair amount of
poultry production is carried out by small operations.
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\5\ USDA, 1997 Census of Agriculture. Washington, DC: National
Agricultural Statistics Service.
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However, only those producers that voluntarily participate in the
Plan will be affected. As is the case in the majority of voluntary
control programs, individuals are likely to remain in the program as
long as the costs of implementing the program are lower than the added
benefits they receive from the program. In any event, the proposed
changes would not have a significant economic effect on Plan
participants.
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.)
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are in conflict with this rule will
be preempted; (2) no retroactive effect will be given to this rule; and
(3) administrative proceedings will not be required before parties may
file suit in court challenging this rule.
Paperwork Reduction Act
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 82
Animal diseases, Poultry and poultry products, Quarantine,
Reporting and recordkeeping requirements, Transportation.
9 CFR Parts 145 and 147
Animal diseases, Poultry and poultry products, Reporting and
recordkeeping requirements.
Accordingly, we propose to amend 9 CFR parts 82, 145, and 147 as
follows:
PART 82--EXOTIC NEWCASTLE DISEASE (END) AND CHLAMYDIOSIS; POULTRY
DISEASE CAUSED BY SALMONELLA ENTERITIDIS SEROTYPE ENTERITIDIS
1. The authority citation for part 82 would continue to read as
follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
Sec. 82.34 [Amended]
2. Section 82.34 would be amended by removing the word
``Monitored'' and adding the word ``Clean'' in its place.
PART 145--NATIONAL POULTRY IMPROVEMENT PLAN
3. The authority citation for part 145 would continue to read as
follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
4. Section 145.10 would be amended as follows:
a. In paragraph (r), by removing the word ``and'' and adding a
comma in its
[[Page 28173]]
place and by adding the words ``, and 145.53(e)'' after the citation
``145.33(l)''.
b. By adding a new paragraph (t) to read as set forth below.
Sec. 145.10 Terminology and classification; flocks, products, and
States.
* * * * *
(t) U.S. H5/H7 Avian Influenza Clean. (See Sec. 145.43(g).)
[GRAPHIC] [TIFF OMITTED] TP23MY03.043
5. Section 145.14 would be amended as follows:
a. By removing paragraph (a)(9).
b. By redesignating paragraphs (a)(6) through (a)(8) as paragraphs
(a)(7) through (a)(9), respectively.
c. In newly redesignated paragraph (a)(7), in the first sentence,
by removing the words ``reactors are found in serum or blood from any
flock, or''.
d. By adding a new paragraph (a)(6) to read as set forth below.
Sec. 145.14 Blood testing.
* * * * *
(a) * * *
(6) Poultry from flocks undergoing qualification testing for
participation in the Plan that have a positive reaction to an official
blood test named in paragraph (a)(1) of this section shall be evaluated
for pullorum-typhoid as follows:
(i) Serum samples that react on rapid serum test or enzyme-labeled
immunosorbent assay test (ELISA), or blood from birds that react on the
stained antigen, rapid whole-blood test for all birds except turkeys,
shall be tested with either the standard tube agglutination test or the
microagglutination test.
(ii) Reactors to the standard tube agglutination test (in dilutions
of 1:50 or greater) or the microagglutination test (in dilutions of
1:40 or greater) shall be submitted to an authorized laboratory for
bacteriological examination. If there are more than four reactors in a
flock, a minimum of four reactors shall be submitted to the authorized
laboratory; if the flock has four or fewer reactors, all of the
reactors must be submitted. The approved procedure for bacteriological
examination is set forth in Sec. 147.11 of this chapter. When reactors
are submitted to the authorized laboratory within 10 days of the date
of reading an official blood test named in paragraph (a)(6)(i) of this
section, and the bacteriological examination fails to demonstrate
pullorum-typhoid infection, the Official State Agency shall presume
that the flock has no pullorum-typhoid reactors.
(iii) If a flock owner does not wish to submit reactors for
bacteriological examination, then the reactors shall be isolated and
retested within 30 days using an official blood test named in paragraph
(a)(1) of this section. If this retest is positive, additional
examination of the reactors and flock will be performed in accordance
with paragraph (a)(6)(ii) of this section. During this 30-day period,
the flock must be maintained under a security system, specified or
approved by the Official State Agency, that will prevent physical
contact with other birds and assure that personnel, equipment, and
supplies that could be a source of pullorum-typhoid spread are
sanitized.
* * * * *
Sec. 145.22 [Amended]
6. In Sec. 145.22, paragraphs (a) and (b) would be removed and
paragraphs (c) through (e) would be redesignated as paragraphs (a)
through (c), respectively.
Sec. 145.32 [Amended]
7. In Sec. 145.32, paragraph (a) would be removed and paragraphs
(b) through (d) would be redesignated as paragraphs (a) through (c),
respectively.
8. Section 145.33 would be amended as follows:
a. By revising paragraphs (c)(4), (e)(4), (h)(1)(ii)(A),
(h)(1)(ii)(B), (i)(1)(iii), (j)(1), and (k)(1) to read as set forth
below.
b. By adding a new paragraph (h)(6) to read as set forth below.
Sec. 145.33. Terminology and classification; flocks and products.
* * * * *
(c) * * *
(4) Before male breeding birds may be added to a participating
multiplier breeding flock, a sample of at least 30 birds to be added,
with a minimum of 10 birds per pen, shall be tested for M.
gallisepticum as provided in Sec. 145.14(b), or by a polymerase chain
reaction (PCR)-based procedure approved by the Department. If fewer
than 30 male breeding birds are being added, all the birds shall be
tested as described above. The male birds shall be tested no more than
14 days prior to their intended introduction into the flock. If the
serologic testing of the birds yields hemagglutination inhibition
titers of 1:40 or higher as provided in Sec. 145.14(b), or if the PCR
testing is positive for M. gallisepticum, the male birds may not be
added to the flock and must be either retested or destroyed.
* * * * *
(e) * * *
[[Page 28174]]
(4) Before male breeding birds may be added to a participating
multiplier breeding flock, a sample of at least 30 birds to be added,
with a minimum of 10 birds per pen, shall be tested for M. synoviae as
provided in Sec. 145.14(b) or by a polymerase chain reaction (PCR)-
based procedure approved by the Department. If fewer than 30 male
breeding birds are being added, all the birds shall be tested as
described above. The male birds shall be tested no more than 14 days
prior to their intended introduction into the flock. If the serologic
testing of the birds yields hemagglutination inhibition titers of 1:40
or higher as provided in Sec. 145.14(b), or if the PCR testing is
positive for M. synoviae, the male birds may not be added to the flock
and must be either retested or destroyed.
* * * * *
(h) * * *
(1) * * *
(ii) * * *
(A) Pelletized feed must have a minimum moisture content of 14.5
percent and must have been heated throughout to a minimum temperature
of 190 [deg]F, or to a minimum temperature of 165 [deg]F for at least
20 minutes, or to a minimum temperature of 184 [deg]F under 70 lb
pressure during the manufacturing process;
(B) Mash feed may contain animal protein if the finished feed is
treated with a salmonella control product approved by the Food and Drug
Administration.
* * * * *
(6) A pedigree, experimental, or great-grand parent flock that is
removed from the U.S. S. Enteritidis Clean program may be reinstated
whenever the following conditions are met:
(i) The owner attests that corrective measures have been
implemented, which may include one or more of the following:
(A) Test and slaughter infected birds based on blood tests of every
bird in the flock, with either pullorum antigen or by a federally
licensed Salmonella enteritidis enzyme-linked immunosorbent assay
(ELISA) test when the flock is more than 4 months of age.
(B) Perform other corrective actions including, but not limited to,
vaccination, medication, cleaning and disinfection of houses, rodent
control, and movement of uninfected birds to premises that have been
determined to be environmentally negative for S. enteritidis as
described in Sec. 147.12(a) of this chapter.
(C) One hundred percent of blood samples from the birds moved to
the clean premises are tested negative for Salmonella pullorum and
group D Salmonella. All birds with positive or inconclusive reactions,
up to a maximum of 25 birds, shall be submitted to an authorized
laboratory and examined for the presence of group D Salmonella, as
described in Sec. 147.11 of this chapter. Cultures from positive
samples shall be serotyped.
(D) Two consecutive environmental drag swabs taken at the clean
premises collected as specified in Sec. 147.12(a) of this chapter 4
weeks apart are negative for S. enteritidis.
(E) Other corrective measures at the discretion of the Official
State Agency.
(ii) Following reinstatement, a flock will remain eligible for this
classification if the flock is tested in accordance with paragraph
(h)(1)(v) of this section every 30 days and no positive samples are
found and the flock meets the requirements set forth in Sec.
145.33(h).
(i) * * *
(1) * * *
(iii) If feed contains animal protein, the protein products must
have a minimum moisture content of 14.5 percent and must have been
heated throughout to a minimum temperature of 190 [deg]F or above, or
to a minimum temperature of 165 [deg]F for at least 20 minutes, or to a
minimum temperature of 184 [deg]F under 70 lb pressure during the
manufacturing process;
* * * * *
(j) * * * (1) A multiplier breeding flock in which all birds or a
sample of at least 30 birds per house has been tested for M.
gallisepticum as provided in Sec. 145.14(b) when more than 4 months of
age: Provided, That to retain this classification, a minimum of 30
birds per house shall be tested again at 36 to 38 weeks and at 48 to 50
weeks at a minimum: And provided further, That each 30-bird sample
should come from 2 locations within the house (15 from the front half
of the house and 15 from the back half of the house). A representative
sample of males and females should be sampled. The samples shall be
marked ``male'' or ``female.''
* * * * *
(k) * * * (1) A multiplier breeding flock in which all birds or a
sample of at least 30 birds per house has been tested for M. synoviae
as provided in Sec. 145.14(b) when more than 4 months of age:
Provided, That to retain this classification, a minimum of 30 birds per
house shall be tested again at 36 to 38 weeks and at 48 to 50 weeks at
a minimum: And provided further, That each 30-bird sample should come
from 2 locations within the house (15 from the front half of the house
and 15 from the back half of the house). A representative sample of
males and females should be sampled. The samples shall be marked
``male'' or ``female.''
* * * * *
Sec. 145.42 [Amended]
9. In Sec. 145.42, paragraph (b) would be removed and paragraphs
(c) and (d) would be redesignated as paragraphs (b) and (c),
respectively.
10. Section 145.43 would be amended as follows:
a. By revising paragraph (f)(3) to read as set forth below.
b. By adding a new paragraph (g) to read as set forth below.
Sec. 145.43 Terminology and classification; flocks and products.
* * * * *
(f) * * *
(3) Feed for turkeys in the candidate and breeding flock should
meet the following requirements:
(i) All feed manufactured in pellet form must have a maximum
moisture content of 13.5 percent upon delivery to the farm. It should
have been preconditioned to the minimum of one of the following
parameters before pelleting:
(A) Feed is to reach a minimum temperature of 185 [deg]F for a
minimum of 6 minutes of retention in the conditioning chamber. The
conditioned mash feed moisture must be a minimum of 16 percent during
the conditioning process. This method utilizes time retention to allow
permeation to the center core of each feed particle; or
(B) The feed is to be pressurized in order to expedite the transfer
of the heat and moisture to the core of each feed particle. The feed
should be conditioned to the parameters of a minimum of 16 percent
moisture and 200 [deg]F; or
(C) The feed should be submitted to pressurization to the extent
that the initial feed temperature rises to 235 [deg]F for 4 seconds; or
(D) The feed should be submitted to an equivalent thermal lethality
treatment; or
(E) A Food and Drug Administration (FDA)-approved product for
Salmonella control should be added to the finished pellets.
(ii) Mash feed should be treated with an FDA-approved Salmonella
control product.
(iii) All feed is to be stored and transported in such a manner as
to prevent possible contamination with pathogenic bacteria.
[[Page 28175]]
(iv) FDA-approved products for Salmonella control may be added to
either unfinished or finished feed.
* * * * *
(g) U.S. H5/H7 Avian Influenza Clean. This program is intended to
be the basis from which the turkey breeding industry may conduct a
program for the prevention and control of the H5 and H7 subtypes of
avian influenza. It is intended to determine the presence of the H5 and
H7 subtypes of avian influenza in breeding turkeys through routine
serological surveillance of each participating breeding flock. A flock,
and the hatching eggs and poults 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
has been tested negative for antibodies to the H5 and H7 subtypes of
avian influenza by the agar gel immunodiffusion test specified in Sec.
147.9 of this chapter 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 are tested within each 90-day period.
(2) It is a multiplier breeding flock in which a minimum of 30
birds has been tested negative for antibodies to the H5 and H7 subtypes
of avian influenza by the agar gel immunodiffusion test specified in
Sec. 147.9 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, at any one time if all pens are equally represented and a
total of 30 birds are tested within each 180-day period.
(3) For both primary and multiplier breeding flocks, if a killed
influenza vaccine against avian influenza subtypes other than H5 and H7
is used, then the hemagglutinin and the neuraminidase subtypes of the
vaccine must be reported to the Official State Agency for laboratory
and reporting purposes.
* * * * *
11. In Sec. 145.53, a new paragraph (e) would be added to read as
follows:
Sec. 145.53 Terminology and classification; flocks and products.
* * * * *
(e) U.S. 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 avian influenza. It is intended to
determine the presence of avian influenza in waterfowl, exhibition
poultry and game bird breeding flocks 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 it has
met one of the following requirements:
(1) It is a primary breeding flock in which a minimum of 30 birds
has been tested negative for antibodies to avian influenza by the agar
gel immunodiffusion test specified in Sec. 147.9 of this chapter 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 are tested within each 90-day period.
(2) It is a multiplier breeding flock in which a minimum of 30
birds has been tested negative for antibodies to avian influenza by the
agar gel immunodiffusion test specified in Sec. 147.9 of this chapter
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, at any one time if all pens are equally represented and a
total of 30 unvaccinated sentinel birds are tested within each 180-day
period.
PART 147--AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN
12. The authority citation for part 147 would continue to read as
follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
13. Section 147.12 would be amended as follows:
a. In paragraph (b), introductory text, the words ``or the rapid
detection method'' would be added after the word ``procedures.''
b. A new paragraph (b)(3) would be added to read as set forth
below.
Sec. 147.12 Procedures for collection, isolation, and identification
of Salmonella from environmental samples, cloacal swabs, chick box
papers, and meconium samples.
* * * * *
(b) * * *
(3) Approved rapid detection method. After selective enrichment, a
rapid ruthenium-labeled Salmonella sandwich immunoassay may be used to
determine the presence of Salmonella. Positive samples from the
immunoassay are then inoculated to selective plates (such as BGN and
XLT4). Incubate the plates at 37 [deg]C for 20 to 24 hours. Inoculate
three to five Salmonella-suspect colonies from the plates into triple
sugar iron (TSI) and lysine iron agar (LIA) slants. Incubate the slants
at 37 [deg]C for 20 to 24 hours. Screen colonies by serological (i.e.,
serogroup) and biochemical (e.g., API) procedures as shown in
illustration 2. As a supplement to screening three to five Salmonella-
suspect colonies on TSI and LIA slants, a group D colony lift assay may
be utilized to signal the presence of hard-to-detect group D Salmonella
colonies on agar plates.
* * * * *
Done in Washington, DC, this 19th day of May 2003.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-12995 Filed 5-22-03; 8:45 am]
BILLING CODE 3410-34-P
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