[Federal Register Volume 68, Number 100 (Friday, May 23, 2003)]
[Proposed Rules]
[Pages 28169-28175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12995]



[[Page 28169]]

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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 [email protected]. 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