[Federal Register Volume 72, Number 8 (Friday, January 12, 2007)]
[Rules and Regulations]
[Pages 1416-1426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-22635]



[[Page 1416]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 145 and 147

[Docket No. APHIS-2006-0008]
RIN 0579-AC27


National Poultry Improvement Plan and Auxiliary Provisions

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending 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 changes were voted on and approved by the voting delegates 
at the Plan's 2004 National Plan Conference. These changes will keep 
the provisions of the Plan current with changes in the poultry industry 
and provide for the use of new sampling and testing procedures.

EFFECTIVE DATE: February 12, 2007.

FOR FURTHER INFORMATION CONTACT: Mr. Andrew R. Rhorer, Senior 
Coordinator, Poultry Improvement Staff, National Poultry Improvement 
Plan, Veterinary Services, APHIS, USDA, 1498 Klondike Road, Suite 101, 
Conyers, GA 30094-5104; (770) 922-3496.

SUPPLEMENTARY INFORMATION:

Background

    The National Poultry Improvement Plan (NPIP, also referred to below 
as ``the Plan'') is a cooperative Federal-State-industry mechanism for 
controlling certain poultry diseases. The Plan consists of a variety of 
programs intended to prevent and control 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.
    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, also referred to as ``the 
Service'') of the U.S. Department of Agriculture (USDA, also referred 
to as ``the Department'') amends these provisions from time to time to 
incorporate new scientific information and technologies within the 
Plan.
    On June 19, 2006, we published in the Federal Register (71 FR 
35203-35220, Docket No. APHIS-2006-0008) a proposal \1\ to amend the 
Plan by providing new or modified sampling and testing procedures; 
adding a procedure for the approval of diagnostic test kits; 
reorganizing the egg-type and meat-type breeding chicken regulations to 
separate the regulations concerning primary breeding flocks from those 
concerning multiplier breeding flocks; and making other changes to 
update and clarify the regulations.
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    \1\ To view the proposed rule and the comment we received, go to 
http://www.regulations.gov, click on the ``Advanced Search'' tab, 
and select ``Docket Search.'' In the Docket ID field, enter APHIS-
2006-0008, then click on ``Submit.'' Clicking on the Docket ID link 
in the search results page will produce a list of all documents in 
the docket.
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    We solicited comments concerning our proposal for 60 days ending 
August 18, 2006. We received one comment by that date, from a private 
citizen. The commenter raised concerns about the welfare of poultry in 
an agricultural setting.
    APHIS does not have statutory authority to promulgate regulations 
regarding the welfare of poultry in an agricultural setting. The NPIP 
is designed to control the incidence of disease in breeding and 
commercial poultry.
    The commenter also stated that the Plan should have provisions for 
ensuring that Authorized Agents are not corrupt.
    The Official State Agencies that work with APHIS to administer the 
provisions of the Plan designate Authorized Agents to perform sampling 
on flocks that participate in the Plan. Each Official State Agency has 
provisions for determining whether persons are qualified to serve as 
Authorized Agents and for ensuring the integrity of Authorized Agents 
that it designates to perform tasks in the administration of the Plan.
    We are not making any changes in response to this commenter's 
comments.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, without 
change.

Executive Order 12866 and Regulatory Flexibility Act

    This 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.
    We are amending 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 2004 National Plan 
Conference. These changes will keep the provisions of the Plan current 
with changes in the poultry industry and provide for the use of new 
sampling and testing procedures.
    The poultry industry plays an important role in the U.S. economy, 
directly employing approximately 240,000 workers.\2\ The poultry 
industry is primarily composed of two types of companies: Primary 
breeding companies and highly integrated companies that combine 
multiplier breeding, hatching, and growing functions. The primary 
breeder companies are responsible for the development of genetic lines 
of poultry for commercial companies that market the product to final 
consumers. They maintain and expand pure designated blood lines and 
supply breeding stock to commercial poultry companies all over the 
globe. Improved genetic poultry are multiplied through the hatchery 
system. The hatcheries, in turn, supply these more efficient birds to 
producers and growers in nearby States. Hatcheries incubate and hatch 
eggs and sell chicks to the commercial producer when they are 1 day 
old. The commercial producers grow the chicks either for meat 
production or as egg-laying varieties. The genetic lines of both egg-
laying varieties and meat-producing poultry are carefully controlled by 
primary breeding companies.
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    \2\ USDA/FAS, Export Promotion Increase Employment in U.S. 
Poultry Industry, FASONLINE (http://www.fas.usda.gov/dlp/poultry/success.html), May 6, 2002.
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    Almost all birds are produced on a contractual basis between a 
highly integrated company and individual contract growers who raise the 
birds, i.e., growers. In such arrangements, the grower normally 
supplies the poultry house, land, labor, litter, equipment, taxes, 
utilities, and insurance, while the company provides the chicks, feed, 
necessary medications, and supervision. Labor and equipment for 
catching and hauling the birds to market are also provided by the 
company. The company retains title to the birds, and in return growers 
are paid according to the amount produced (pounds of birds or dozens of 
eggs).
    Currently, there are three major firms that produce primary 
breeding stock of

[[Page 1417]]

egg-type chickens, three breeders of meat-type chickens, two breeders 
of turkey, and one firm producing both egg-type and meat-type chickens. 
All of these are large facilities headquartered in the United States, 
and all of them operate in domestic and international markets. Other 
multinational organizations headquartered in Europe, Israel, and Japan 
produce several varieties of breeding stock offered to commercial 
facilities around the globe.
    U.S. broiler production totaled 8.5 billion birds in 2003. Ten 
States accounted for over 79 percent of broilers produced in the United 
States (table 1). U.S. turkey production in 2003 totaled 274 million 
birds. The top 10 turkey-producing States accounted for 82 percent of 
total production. A total of 87.2 billion eggs were produced in 2003. 
Ten States accounted for 62 percent of total egg production. 
Approximately 85 percent of egg production was for human consumption 
(the table-egg market), while the remainder of production was for the 
hatching market.

                Table 1.--Broilers, Egg-Laying Chickens, and Turkeys: Value by Major States, 2003
----------------------------------------------------------------------------------------------------------------
                   Broilers                           Egg-laying chickens                    Turkeys
----------------------------------------------------------------------------------------------------------------
                               Value (million                    Value (million                   Value (million
            State                    $)             State              $)             State             $)
----------------------------------------------------------------------------------------------------------------
Georgia.....................           2,143   Iowa...........             460   Minnesota......             425
Arkansas....................           1,987   Georgia........             396   North Carolina.             398
Alabama.....................           1,838   Ohio...........             374   Missouri.......             286
North Carolina..............           1,512   Pennsylvania...             371   Virginia.......             177
Mississippi.................           1,424   Arkansas.......             344   Arkansas.......             176
Texas.......................           1,032   Texas..........             310   South Carolina.             172
Delaware....................             543   Indiana........             308   California.....             151
Kentucky....................             507   Alabama........             296   Indiana........             139
Maryland....................             495   California.....             282   Pennsylvania...             101
Virginia....................             442   North Carolina.             242   Iowa...........              96
Other States................           3,292   Other States...           1,932   Other States...             599
                             -----------------                 -----------------                 ---------------
U.S. total..................          15,215   U.S. total.....           5,315   U.S. total.....           2,720
----------------------------------------------------------------------------------------------------------------
Source: USDA/NASS, Poultry-Production and Value: 2003 Summary, April 2004.

    Cash receipts from sales of poultry and eggs (broilers, farm 
chickens, eggs, turkey, ducks, and other poultry) were about $23.9 
billion in 2003.\3\ Of this total, 64 percent was from broilers, 22 
percent from eggs, 11 percent from turkeys, and 3 percent from other 
poultry. In terms of tonnage, poultry production and trade exceeds that 
of beef or pork. For instance, in 2003, the United States produced 38.4 
billion pounds of poultry meat, compared with 26.2 billion pounds of 
beef and 19.9 billion pounds of pork. Poultry meat per capita 
consumption (98.9 pounds) exceeded that of both beef (64.9 pounds) and 
pork (51.8). Furthermore, the United States exported more poultry meat 
(5,404 million pounds) than beef and veal (2,518 million pounds) or 
pork (1,717 million pounds) during the same period.\4\
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    \3\ USDA/ERS, Cash receipts by commodity groups and selected 
commodities, United States, 1997-2003, August 2004.
    \4\ USDA/ERS, Livestock, Dairy and Poultry Outlook/LDP-M-122, 
August 2004.
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    The United States is a major exporter of poultry and poultry 
products. It exported poultry and poultry products valued at $2,287 
million in 2003.\5\ The major importers, accounting for $1,720 million 
worth of exports of U.S. poultry, are Russia ($384 million), Canada 
($346 million), Mexico ($293 million), Hong Kong ($236 million), China 
($117 million), Japan ($83 million), South Korea ($56 million), 
European Union ($126 million), Turkey ($42 million), and Taiwan ($37 
million). U.S. imports of poultry and poultry products totaled $307 
million. Of this total, $135 million was from Canada, $113 million from 
China, $19 million from Taiwan, and $16 million from France.
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    \5\ USDA/ERS, Foreign Agricultural Trade of the United States, 
September 2004.
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Impact on Small Entities

    The Regulatory Flexibility Act requires that agencies consider the 
economic impact of their rules on small entities. The Small Business 
Administration has established guidelines for determining which types 
of firms are to be considered small under the Regulatory Flexibility 
Act. The main entities that will be affected by this rule are those 
engaged in production of poultry breeding stock. Currently there are 
three major firms that produce primary breeding stock of egg-type 
chickens, three breeders of meat-type chickens, two breeders of 
turkeys, and one firm producing both egg-type and meat-type chickens. 
All of these are large facilities headquartered in the United States 
and operating in domestic and international markets. Additionally, 
broiler operations (North American Industry Classification System 
[NAICS] 112320), turkey operations (NAICS 112330), hatcheries (NAICS 
112340) and other poultry operations (NAICS 112390) will be positively, 
at least qualitatively, affected, as they will benefit from the supply 
of improved and healthy breeding stock. There were a total of 79,600 
commercial growers with sales in 2002.\6\ Nearly 100 percent of broiler 
operations, 70 percent of turkey operations, and about 43 percent of 
layer operations produce poultry through production contracts. All of 
these commercial grower farms are considered to be small if they have 
annual sales of $750,000 or less. About 93 percent of these farms are 
small, while the rest are large. Commercial egg producers (NAICS 
112310) are considered small if they have annual sales of less than 
$10.5 million.
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    \6\ USDA/NASS, 2002 Census of Agriculture-State Data (Table 13), 
page 356.
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    This rule will introduce a series of minor changes to the NPIP and 
will not involve significant changes in program operations. Most of the 
changes involve clarifications, rearrangements of procedures, and 
definitions of terms. These changes are in line with the industry's 
best practices and will likely involve no additional costs in order to 
meet these requirements. Additionally, the NPIP is a voluntary program 
established between the industry and State and Federal governments. Any 
person producing or dealing in products may participate in the NPIP 
when he or she has demonstrated that his or her facilities, personnel, 
and practices are

[[Page 1418]]

adequate for carrying out the applicable provisions of the NPIP. Since 
most countries will not accept hatching eggs or live birds from a 
producer unless it can be shown to be a NPIP participant, being a 
member of the NPIP allows greater ease in exporting hatching eggs or 
live birds to other countries. The poultry industry plays a very 
important role in the U.S. economy, and the final rule will help to 
ensure the safety of the industry and benefit the economy.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are in conflict with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Paperwork Reduction Act

    This final rule contains no new information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

List of Subjects in 9 CFR Parts 145 and 147

    Animal diseases, Poultry and poultry products, Reporting and 
recordkeeping requirements.


0
Accordingly, we are amending 9 CFR parts 145 and 147 as follows:

PART 145--NATIONAL POULTRY IMPROVEMENT PLAN

0
1. The authority citation for part 145 continues to read as follows:

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.


0
2. Section 145.1 is amended as follows:
0
a. By revising the definition of Authorized Agent to read as set forth 
below.
0
b. By adding, in alphabetical order, a new definition of Authorized 
Testing Agent to read as set forth below.


Sec.  145.1  Definitions.

* * * * *
    Authorized Agent. Any person designated under Sec.  145.11(a) to 
collect official samples for submission to an authorized laboratory as 
described in Sec. Sec.  147.1(a) and 147.12 of this subchapter.
* * * * *
    Authorized Testing Agent. Any person designated under Sec.  
145.11(a) to collect official samples for submission to an authorized 
laboratory as described in Sec. Sec.  147.1(a) and 147.12 of this 
subchapter and to perform the stained antigen, rapid whole blood test 
for pullorum typhoid.
* * * * *

0
3. In Sec.  145.11, paragraphs (a) and (b) are revised to read as 
follows:


Sec.  145.11  Supervision.

    (a) The Official State Agency may designate qualified persons as 
Authorized Agents to do the sample collecting provided for in Sec.  
145.14 and may designate qualified persons as Authorized Testing Agents 
to do the sample collecting and blood testing provided for in Sec.  
145.14.
    (b) The Official State Agency shall employ or authorize qualified 
persons as State Inspectors to perform the qualification testing of 
participating flocks, and to perform the official inspections necessary 
to verify compliance with the requirements of the Plan.
* * * * *


Sec.  145.12  [Amended]

0
4. In Sec.  145.12, paragraph (a), the word ``inspected'' is removed 
and the words ``audited at least one time annually or'' are added in 
its place.

0
5. In Sec.  145.14, in the introductory text of the section, the 
second, third, and fifth sentences are revised to read as follows:


Sec.  145.14  Blood testing.

    * * * Blood samples for official tests shall be drawn by an 
Authorized Agent, Authorized Testing Agent, or State Inspector and 
tested by an authorized laboratory, except that the stained antigen, 
rapid whole-blood test for pullorum-typhoid may be conducted by an 
Authorized Testing Agent or State Inspector. For Plan programs in which 
a representative sample may be tested in lieu of an entire flock, 
except the ostrich, emu, rhea, and cassowary program in Sec.  
145.63(a), the minimum number tested shall be 30 birds per house, with 
at least 1 bird taken from each pen and unit in the house. * * * In 
houses containing fewer than 30 birds other than ostriches, emus, 
rheas, and cassowaries, all birds in the house must be tested.
* * * * *

0
6. A new Sec.  145.15 is added to Subpart A to read as follows:


Sec.  145.15  Approved tests.

    (a) The procedures for the bacteriological examination of poultry 
and poultry environments described in part 147 of this subchapter are 
approved tests for use in the NPIP. In addition, all tests that use 
veterinary biologics (e.g., antiserum and other products of biological 
origin) that are licensed or produced by the Service and used as 
described in part 147 of this subchapter are approved for use in the 
NPIP.
    (b) Diagnostic test kits that are not licensed by the Service 
(e.g., bacteriological culturing kits) may be approved through the 
following procedure:
    (1) The sensitivity of the kit will be estimated in at least three 
authorized laboratories selected by the Service by testing known 
positive samples, as determined by the official NPIP procedures found 
in part 147 of this subchapter. If certain conditions or interfering 
substances are known to affect the performance of the kit, appropriate 
samples will be included so that the magnitude and significance of the 
effect(s) can be evaluated.
    (2) The specificity of the kit will be estimated in at least three 
authorized laboratories selected by the Service by testing known 
negative samples, as determined by the official NPIP procedures found 
in part 147 of this subchapter. If certain conditions or interfering 
substances are known to affect the performance of the kit, appropriate 
samples will be included so that the magnitude and significance of the 
effect(s) can be evaluated.
    (3) The kit will be provided to the cooperating laboratories in its 
final form and include the instructions for use. The cooperating 
laboratories must perform the assay exactly as stated in the supplied 
instructions. Each laboratory must test a panel of at least 25 known 
positive clinical samples supplied by the manufacturer of the test kit. 
In addition, each laboratory will be asked to test 50 known negative 
clinical samples obtained from several sources, to provide a 
representative sampling of the general population. The identity of the 
samples must be coded so that the cooperating laboratories are blinded 
to identity and classification. Each sample must be provided in 
duplicate or triplicate, so that error and repeatability data may be 
generated.

[[Page 1419]]

    (4) Cooperating laboratories will submit to the kit manufacturer 
all raw data regarding the assay response. Each sample tested will be 
reported as positive or negative and the official NPIP procedure used 
to classify the sample must be submitted in addition to the assay 
response value.
    (5) The findings of the cooperating laboratories will be evaluated 
by the NPIP technical committee, and the technical committee will make 
a recommendation regarding whether to approve the test kit to the 
General Conference Committee. If the technical committee recommends 
approval, the final approval will be granted in accordance with the 
procedures described in Sec. Sec.  147.46 and 147.47 of this 
subchapter.

0
7. In subpart B, the subpart heading is revised to read as follows:

Subpart B--Special Provisions for Multiplier Egg-Type Chicken 
Breeding Flocks and Products


Sec.  145.22  [Amended]

0
8. Section 145.22 is amended as follows:
0
a. In the introductory text, by adding the word ``multiplier'' before 
the words ``egg type''.
0
b. In paragraph (b), by removing the word ``primary'' and adding the 
word ``multiplier'' in its place.


Sec.  145.23  [Amended]

0
9. Section 145.23 is amended as follows:
0
a. In paragraph (b)(2), in the introductory text, by removing the words 
``or a breeding flock composed of progeny of a primary breeding flock 
which is intended solely for the production of multiplier breeding 
flocks,''.
0
b. In paragraph (b)(2)(iii), by adding the word ``Testing'' after the 
word ``Authorized''.
0
c. By removing paragraph (b)(5).
0
d. By removing and reserving paragraph (c)(1)(i).
0
e. In paragraph (c)(2), by removing the words ``: Provided, That U.S. 
M. Gallisepticum Clean chicks from primary breeding flocks shall be 
produced in incubators and hatchers in which only eggs from flocks 
qualified under paragraph (c)(1)(i) of this section are set''.
0
f. By removing and reserving paragraph (e)(1)(i).
0
g. In paragraph (e)(2), by removing the words ``: Provided, That U.S. 
M. Synoviae Clean chicks from primary breeding flocks shall be produced 
in incubators and hatchers in which only eggs from flocks qualified 
under paragraph (e)(1)(i) or (ii) of this section are set''.
0
h. By removing and reserving paragraph (h)(1).
0
i. In paragraph (h)(2)(i), by adding the words ``: Provided: That 
multiplier spent fowl must be tested within 30 days prior to movement 
to disposal'' after the words ``180 days''.


Sec.  145.24  [Amended]

0
10. Section 145.24 is amended as follows:
0
a. In paragraph (a)(1)(i), by removing the word ``and'' and by adding 
the words ``, Sec.  145.73(b)(2)(i), and Sec.  145.83(b)(2)(i)'' 
immediately before the period.
0
b. By adding and reserving paragraph (b).

0
11. In subpart C, the subpart heading is revised to read as follows:

Subpart C--Special Provisions for Multiplier Meat-Type Chicken 
Breeding Flocks and Products


Sec.  145.32  [Amended]

0
12. Section 145.32 is amended as follows:
0
a. In the introductory text, by adding the word ``multiplier'' before 
the words ``meat type''.
0
b. In paragraph (b), by removing the word ``primary'' and adding the 
word ``multiplier'' in its place.


Sec.  145.33  [Amended]

0
13. Section 145.33 is amended as follows:
0
a. In paragraph (b)(2), in the introductory text, by removing the words 
``or a breeding flock composed of progeny of a primary breeding flock 
which is intended solely for the production of multiplier breeding 
flocks,''.
0
b. In paragraph (b)(2)(iii), by adding the word ``Testing'' after the 
word ``Authorized''.
0
c. By removing paragraph (b)(5).
0
d. By removing and reserving paragraph (c)(1)(i).
0
e. In paragraph (c)(2), by removing the words ``: Provided, That U.S. 
M. Gallisepticum Clean chicks from primary breeding flocks shall be 
produced in incubators and hatchers in which only eggs from flocks 
qualified under paragraph (c)(1)(i) of this section are set''.
0
f. By removing and reserving paragraph (e)(1)(i).
0
g. In paragraph (e)(2), by removing the words ``: Provided, That U.S. 
M. Synoviae Clean chicks from primary breeding flocks shall be produced 
in incubators and hatchers in which only eggs from flocks qualified 
under paragraph (e)(1)(i) or (ii) of this section are set''.
0
h. By removing and reserving paragraphs (h) and (i).
0
i. By removing and reserving paragraph (l)(1).
0
j. In paragraph (l)(2), in the introductory text, by adding the words 
``and prior to the onset of egg production'' after the word ``age.''
0
k. In paragraph (l)(2)(i), by adding the words ``: Provided: That 
multiplier spent fowl must be tested within 30 days prior to movement 
to slaughter'' after the words ``180 days.''


Sec.  145.34  [Amended]

0
14. Section 145.34 is amended as follows:
0
a. In paragraph (a)(1)(i), by removing the word ``and'' and by adding 
the words ``, Sec.  145.73(b)(2)(i), and Sec.  145.83(b)(2)(i)'' 
immediately before the period.
0
b. In paragraph (b)(1)(ii), by adding the words ``in accordance with 
Sec. Sec.  145.33(c) and 145.83(c)'' after the word ``Clean''.

0
15. Section 145.43 is amended as follows:
0
a. In paragraph (b)(2)(iii), by adding the word ``Testing'' after the 
word ``Authorized''.
0
b. By revising paragraphs (f)(1), (f)(2), (f)(7), (g)(1) introductory 
text, (g)(1)(i), (g)(2) introductory text, and (g)(2)(i) to read as set 
forth below.


Sec.  145.43  Terminology and classification; flocks and products.

* * * * *
    (f) * * *
    (1) Hatchery debris (dead germ hatching eggs, fluff, and meconium 
collected by sexors), swabs collected from hatch debris in hatcher 
trays, a sample of all the poults that died within 10 days after 
hatching up to 10 poults, or a combination of 2 or all 3 of the above, 
from each hatch or a candidate breeding flock produced by a primary 
breeder, are examined bacteriologically at an authorized laboratory for 
Salmonella.
    (2) The poults for the candidate breeding flock are placed in a 
building that has been cleaned and disinfected. An Authorized Agent 
must collect environmental samples from the building and submit them to 
an authorized laboratory for a bacteriological examination for the 
presence of Salmonella, as described in Sec.  147.12 of this 
subchapter.
* * * * *
    (7) Hatchery debris (dead germ hatching eggs, fluff, and meconium 
collected by sexors), swabs collected from hatch debris in hatcher 
trays, a

[[Page 1420]]

sample of all the poults that died within 10 days after hatching up to 
10 poults, or a combination of 2 or all 3 of the above, shall be 
cultured as a means of evaluating the effectiveness of the control 
procedures.
    (g) * * *
    (1) It is a primary breeding flock in which a minimum of 30 birds 
has been tested negative for antibodies to type A avian influenza virus 
by the agar gel immunodiffusion test specified in Sec.  147.9 of this 
subchapter. Positive samples shall be further tested by an authorized 
laboratory using the hemagglutination inhibition test to detect 
antibodies to the hemagglutinin subtypes H5 and H7 when more than 4 
months of age and prior to the onset of egg production. To retain this 
classification:
    (i) A sample of at least 30 birds must be tested negative at 
intervals of 90 days; Provided, that primary spent fowl be tested 
within 30 days prior to movement to disposal; or
* * * * *
    (2) It is a multiplier breeding flock in which a minimum of 30 
birds has been tested negative for antibodies to type A avian influenza 
virus by the agar gel immunodiffusion test specified in Sec.  147.9 of 
this subchapter. Positive samples shall be further tested by an 
authorized laboratory using the hemagglutination inhibition test to 
detect antibodies to the hemagglutinin subtypes H5 and H7 when more 
than 4 months of age and prior to the onset of egg production. To 
retain this classification:
    (i) A sample of at least 30 birds must be tested negative at 
intervals of 180 days; Provided, that multiplier spent fowl be tested 
within 30 days prior to movement to disposal; or
* * * * *


Sec.  145.53  [Amended]

0
16. Section 145.53 is amended as follows:
0
a. In paragraph (b)(2)(iii), by adding the word ``Testing'' after the 
word ``Authorized''.
0
b. In paragraph (e), in the paragraph heading, by adding the words 
``H5/H7'' before the words ``Avian Influenza''.
0
c. In the introductory text of paragraphs (e), (e)(1), and (e)(2), by 
adding the words ``the H5 and H7 subtypes of'' before the words ``avian 
influenza'' each time they occur.

0
17. In Sec.  145.63, paragraph (a)(2) is revised to read as follows:


Sec.  145.63  Terminology and classification; flocks and products.

* * * * *
    (a) * * *
    (2) It is a breeding flock that meets one of the following 
criteria:
    (i)(A) It is a multiplier or primary breeding flock of fewer than 
300 birds in which a sample of 10 percent of the birds in a flock or at 
least 1 bird from each pen, whichever is more, has been officially 
tested for pullorum-typhoid within the past 12 months with no reactors; 
or
    (B) It is a multiplier or primary breeding flock of 300 birds or 
more in which a sample of a minimum of 30 birds has been officially 
tested for pullorum-typhoid within the past 12 months with no reactors.
    (ii) It is a flock that has already been designated U.S. Pullorum-
Typhoid Clean and uses a subsequent bacteriological examination 
monitoring program of hatcher debris or eggs for ostriches, emus, 
rheas, or cassowaries acceptable to the Official State Agency and 
approved by the Service in lieu of annual blood testing.
    (iii) It is a multiplier breeding flock located in a State that has 
been deemed to be a U.S. Pullorum-Typhoid Clean State for the past 3 
years, and during which time no isolation of pullorum or typhoid has 
been made that can be traced to a source in that State, that uses a 
bacteriological examination monitoring program of hatcher debris or 
eggs or a serological examination monitoring program acceptable to the 
Official State Agency and approved by the Service in lieu of annual 
blood testing.
* * * * *

0
18. A new Subpart G is added to read as follows:
Subpart G--Special Provisions for Primary Egg-Type Chicken Breeding 
Flocks and Products
Sec.
145.71 Definitions.
145.72 Participation.
145.73 Terminology and classification; flocks and products.

Subpart G--Special Provisions for Primary Egg-Type Chicken Breeding 
Flocks and Products


Sec.  145.71  Definitions.

    Except where the context otherwise requires, for the purposes of 
this subpart the following terms shall be construed, respectively, to 
mean:
    Chicks. Newly hatched chickens.
    Primary egg-type chicken breeding flocks. Foundation flocks that 
are composed of pedigree, great-grandparent, and grandparent stock that 
has been developed for egg production and are maintained for the 
principal purpose of producing multiplier breeding chicks used to 
produce table egg layers.
    Started chickens. Young chickens (chicks, pullets, cockerels, 
capons) which have been fed and watered and are less than 6 months of 
age.


Sec.  145.72  Participation.

    Participating flocks of primary egg-type chickens, and the eggs and 
chicks produced from them, shall comply with the applicable general 
provisions of subpart A of this part and the special provisions of this 
subpart G.
    (a) Started chickens shall lose their identity under Plan 
terminology when not maintained by Plan participants under the 
conditions prescribed in Sec.  145.5(a).
    (b) Hatching eggs produced by primary breeding flocks shall be 
fumigated (see Sec.  147.25 of this subchapter) or otherwise sanitized.
    (c) Any nutritive material provided to chicks must be free of the 
avian pathogens that are officially represented in the Plan disease 
classifications listed in Sec.  145.10.


Sec.  145.73  Terminology and classification; flocks and products.

    Participating flocks, and the eggs and chicks produced from them, 
which have met the respective requirements specified in this section, 
may be designated by the following terms and the corresponding designs 
illustrated in Sec.  145.10:
    (a) [Reserved]
    (b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from 
pullorum and typhoid has been demonstrated to the Official State Agency 
under the criteria in paragraph (b)(1) or (b)(2) of this section: 
Provided, That a flock qualifying by means of a blood test shall be 
tested within the past 12 months, except that the retesting of a 
participating flock which is retained for more than 12 months shall be 
conducted a minimum of 4 weeks after the induction of molt. (See Sec.  
145.14 relating to the official blood test where applicable.)
    (1) It has been officially blood tested with no reactors.
    (2) It is a primary breeding flock that meets the following 
criteria:
    (i) The primary breeding flock is located in a State in which 
pullorum disease or fowl typhoid is not known to exist nor to have 
existed in hatchery supply flocks during the preceding 12 months and in 
which it has been determined by the Service that:
    (A) All hatcheries within the State are qualified as ``National 
Plan Hatcheries'' or have met equivalent requirements for pullorum-
typhoid control under official supervision;

[[Page 1421]]

    (B) All hatchery supply flocks within the State are qualified as 
U.S. Pullorum-Typhoid Clean or have met equivalent requirements for 
pullorum-typhoid control under official supervision: Provided, That if 
other domesticated fowl, except waterfowl, are maintained on the same 
premises as the participating flock, freedom from pullorum-typhoid 
infection shall be demonstrated by an official blood test of each of 
these fowl;
    (C) All shipments of products other than U.S. Pullorum-Typhoid 
Clean, or equivalent, into the State are prohibited;
    (D) All persons performing poultry disease diagnostic services 
within the State are required to report to the Official State Agency 
within 48 hours the source of all poultry specimens from which S. 
pullorum or S. gallinarum is isolated;
    (E) All reports of any disease outbreak involving a disease covered 
under the Plan are promptly followed by an investigation by the 
Official State Agency to determine the origin of the infection; 
Provided, That if the origin of the infection involves another State, 
or if there is exposure to poultry in another State from the infected 
flock, then officials administering the National Poultry Improvement 
Plan will conduct an investigation;
    (F) All flocks found to be infected with pullorum or typhoid are 
quarantined until marketed or destroyed under the supervision of the 
Official State Agency, or until subsequently blood tested following the 
procedure for reacting flocks as contained in Sec.  145.14(a)(5), and 
all birds fail to demonstrate pullorum or typhoid infection;
    (G) All poultry, including exhibition, exotic, and game birds, but 
excluding waterfowl, going to public exhibition shall come from U.S. 
Pullorum-Typhoid Clean or equivalent flocks, or have had a negative 
pullorum-typhoid test within 90 days of going to public exhibition; and
    (H) Discontinuation of any of the conditions or procedures 
described in paragraphs (b)(2)(i)(A) through (b)(2)(i)(G) of this 
section, or the occurrence of repeated outbreaks of pullorum or typhoid 
in poultry breeding flocks within or originating within the State shall 
be grounds for the Service to revoke its determination that such 
conditions and procedures have been met or complied with. Such action 
shall not be taken until a thorough investigation has been made by the 
Service and the Official State Agency has been given an opportunity to 
present its views; and
    (ii) In the primary breeding flock, a sample of 300 birds from 
flocks of more than 300, and each bird in flocks of 300 or less, has 
been officially tested for pullorum-typhoid with no reactors: Provided, 
That a bacteriological examination monitoring program acceptable to the 
Official State Agency and approved by the Service may be used in lieu 
of blood testing.
    (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in 
compliance with the provisions of Sec.  147.26 of this subchapter and 
in which freedom from M. gallisepticum has been demonstrated under the 
criteria specified in paragraph (c)(1)(i) of this section.
    (i) It is a flock in which all birds or a sample of at least 300 
birds 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 150 birds shall be tested at intervals of 
not more than 90 days: And provided further, That a sample comprised of 
fewer than 150 birds may be tested at any one time, if all pens are 
equally represented and a total of 150 birds is tested within each 90-
day period.
    (ii) [Reserved]
    (2) A participant handling U.S. M. Gallisepticum Clean products 
shall handle only products of equivalent status.
    (3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean 
boxes and delivered in trucks that have been cleaned and disinfected as 
described in Sec.  147.24(a) of this subchapter.
    (d) U.S. S. Enteritidis Clean. This classification is intended for 
primary egg-type breeders wishing to assure their customers that the 
hatching eggs and multiplier chicks produced are certified free of 
Salmonella enteritidis.
    (1) A flock and the hatching eggs and chicks produced from it which 
have met the following requirements as determined by the Official State 
Agency:
    (i) The flock originated from a U.S. S. Enteritidis Clean flock, or 
meconium from the chick boxes and a sample of chicks that died within 7 
days after hatching are examined bacteriologically for salmonella at an 
authorized laboratory. Cultures from positive samples shall be 
serotyped.
    (ii) All feed fed to the flock shall meet the following 
requirements:
    (A) Pelletized feed shall contain either no animal protein or only 
animal protein products produced under the Animal Protein Products 
Industry (APPI) Salmonella Education/Reduction Program. 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 lbs. 
pressure during the manufacturing process.
    (B) Mash feed may contain no animal protein other than an APPI 
animal protein product supplement manufactured in pellet form and 
crumbled: Provided, That mash feed may contain nonpelleted APPI animal 
protein product supplements if the finished feed is treated with a 
salmonella control product approved by the U.S. Food and Drug 
Administration.
    (iii) Feed shall be stored and transported in such a manner as to 
prevent possible contamination;
    (iv) The flock is maintained in compliance with Sec. Sec.  147.21, 
147.24(a), and 147.26 of this subchapter. Rodents and other pests 
should be effectively controlled;
    (v) Environmental samples shall be collected from the flock by an 
Authorized Agent, as described in Sec.  147.12 of this subchapter, when 
the flock is 2 to 4 weeks of age. The samples shall be examined 
bacteriologically for group D salmonella at an authorized laboratory. 
Cultures from positive samples shall be serotyped. The Authorized Agent 
shall also collect samples every 30 days after the first sample has 
been collected.
    (vi) If a Salmonella vaccine is used that causes positive reactions 
with pullorum-typhoid antigen, one of the following options must be 
utilized.
    (A) Administer the vaccine after the pullorum-typhoid testing is 
done as described in paragraph (d)(1)(vii) of this section.
    (B) If an injectable bacterin or live vaccine that does not spread 
is used, keep a sample of 350 birds unvaccinated and banded for 
identification until the flock reaches at least 4 months of age. 
Following negative serological and bacteriological examinations as 
described in paragraph (d)(1)(vii) of this section, vaccinate the 
banded, non-vaccinated birds.
    (vii) Blood samples from 300 non-vaccinated birds as described in 
paragraph (d)(1)(vi) of this section shall be tested 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. 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 subchapter. Cultures 
from positive samples shall be serotyped.

[[Page 1422]]

    (viii) Hatching eggs are collected as quickly as possible and are 
handled as described in Sec.  147.22 of this subchapter and are 
sanitized or fumigated (see Sec.  147.25 of this subchapter).
    (ix) Hatching eggs produced by the flock are incubated in a 
hatchery that is in compliance with the recommendations in Sec. Sec.  
147.23 and 147.24(b) of this subchapter, and sanitized either by a 
procedure approved by the Official State Agency or fumigated (see Sec.  
147.25 of this subchapter).
    (2) A flock shall not be eligible for this classification if 
Salmonella enteritidis serotype enteritidis (SE) is isolated from a 
specimen taken from a bird in the flock. Isolation of SE from an 
environmental or other specimen, as described in paragraph (d)(1)(v) of 
this section, will require bacteriological examination for SE in an 
authorized laboratory, as described in Sec.  147.11(a) of this 
subchapter, of a random sample of 60 live birds from a flock of 5,000 
birds or more, or 30 live birds from a flock with fewer than 5,000 
birds. If only one specimen is found positive for SE, the participant 
may request bacteriological examination of a second sample, equal in 
size to the first sample, from the flock. If no SE is recovered from 
any of the specimens in the second sample, the flock will be eligible 
for the classification.
    (3) A non-vaccinated flock shall be eligible for this 
classification if SE is isolated from an environmental sample collected 
from the flock in accordance with paragraph (d)(1)(v) of this section: 
Provided, That testing is conducted in accordance with paragraph 
(d)(1)(vii) of this section each 30 days and no positive samples are 
found.
    (4) In order for a hatchery to sell products of this 
classification, all products handled shall meet the requirements of the 
classification.
    (5) This classification may be revoked by the Official State Agency 
if the participant fails to follow recommended corrective measures. The 
Official State Agency shall not revoke the participant's classification 
until the participant has been given an opportunity for a hearing in 
accordance with rules of practice adopted by the Official State Agency.
    (e) U.S. M. Synoviae Clean. (1) A flock maintained in compliance 
with the provisions of Sec.  147.26 of this subchapter and in which 
freedom from M. synoviae has been demonstrated under the criteria 
specified in paragraph (e)(1)(i) of this section.
    (i) It is a flock in which a minimum of 300 birds 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 sample of at 
least 150 birds shall be tested at intervals of not more than 90 days: 
And provided further, That a sample comprised of fewer than 150 birds 
may be tested at any one time if all pens are equally represented and a 
total of 150 birds is tested within each 90-day period.
    (ii) [Reserved]
    (2) A participant handling U.S. M. Synoviae Clean products shall 
handle only products of equivalent status.
    (3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and 
delivered in trucks that have been cleaned and disinfected as described 
in Sec.  147.24(a) of this subchapter.
    (f) 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 primary breeding chickens 
through routine serological surveillance of each participating breeding 
flock. A flock and the hatching eggs and chicks produced from it will 
qualify for this classification when the Official State Agency 
determines that they have met the following requirements:
    (1) It is a primary breeding flock in which a minimum of 30 birds 
have been tested negative for antibodies to avian influenza when more 
than 4 months of age. To retain this classification:
    (i) A sample of at least 30 birds must be tested negative at 
intervals of 90 days: Provided, That primary spent fowl must be tested 
within 30 days prior to movement to disposal; or
    (ii) A sample of fewer than 30 birds may be tested, and found to be 
negative, at any one time if all pens are equally represented and a 
total of 30 birds is tested within each 90-day period.
    (2) [Reserved]

0
19. A new subpart H is added to read as follows:
Subpart H--Special Provisions for Primary Meat-Type Chicken Breeding 
Flocks and Products
Sec.
145.81 Definitions.
145.82 Participation.
145.83 Terminology and classification; flocks and products.

Subpart H--Special Provisions for Primary Meat-Type Chicken 
Breeding Flocks and Products


Sec.  145.81  Definitions.

    Except where the context otherwise requires, for the purposes of 
this subpart the following terms shall be construed, respectively, to 
mean:
    Chicks. Newly hatched chickens.
    Primary meat-type chicken breeding flocks. Foundation flocks that 
are composed of pedigree, great-grandparent, and grandparent stock that 
has been developed for meat production and are maintained for the 
principal purpose of producing multiplier breeding chicks used to 
produce commercial broilers.
    Started chickens. Young chickens (chicks, pullets, cockerels, 
capons) which have been fed and watered and are less than 6 months of 
age.


Sec.  145.82  Participation.

    Participating flocks of primary meat-type chickens, and the eggs 
and chicks produced from them, shall comply with the applicable general 
provisions of subpart A of this part and the special provisions of this 
subpart H.
    (a) Started chickens shall lose their identity under Plan 
terminology when not maintained by Plan participants under the 
conditions prescribed in Sec.  145.5(a).
    (b) Hatching eggs produced by primary breeding flocks shall be 
fumigated (see Sec.  147.25 of this subchapter) or otherwise sanitized.
    (c) Any nutritive material provided to chicks must be free of the 
avian pathogens that are officially represented in the Plan disease 
classifications listed in Sec.  145.10.


Sec.  145.83  Terminology and classification; flocks and products.

    Participating flocks, and the eggs and chicks produced from them, 
which have met the respective requirements specified in this section, 
may be designated by the following terms and the corresponding designs 
illustrated in Sec.  145.10:
    (a) [Reserved]
    (b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from 
pullorum and typhoid has been demonstrated to the Official State Agency 
under the criteria in paragraph (b)(1) or (b)(2) of this section: 
Provided, That a flock qualifying by means of a blood test shall be 
tested within the past 12 months, except that the retesting of a 
participating flock which is retained for more than 12 months shall be 
conducted a minimum of 4 weeks after the induction of molt. (See Sec.  
145.14 relating to the official blood test where applicable.)
    (1) It has been officially blood tested with no reactors.
    (2) It is a primary breeding flock that meets the following 
criteria:
    (i) The primary breeding flock is located in a State in which 
pullorum

[[Page 1423]]

disease or fowl typhoid is not known to exist nor to have existed in 
hatchery supply flocks within the State during the preceding 12 months 
and in which it has been determined by the Service that:
    (A) All hatcheries within the State are qualified as ``National 
Plan Hatcheries'' or have met equivalent requirements for pullorum-
typhoid control under official supervision;
    (B) All hatchery supply flocks within the State are qualified as 
U.S. Pullorum-Typhoid Clean or have met equivalent requirements for 
pullorum-typhoid control under official supervision: Provided, That if 
other domesticated fowl, except waterfowl, are maintained on the same 
premises as the participating flock, freedom from pullorum-typhoid 
infection shall be demonstrated by an official blood test of each of 
these fowl;
    (C) All shipments of products other than U.S. Pullorum-Typhoid 
Clean, or equivalent, into the State are prohibited;
    (D) All persons performing poultry disease diagnostic services 
within the State are required to report to the Official State Agency 
within 48 hours the source of all poultry specimens from which S. 
pullorum or S. gallinarum is isolated;
    (E) All reports of any disease outbreak involving a disease covered 
under the Plan are promptly followed by an investigation by the 
Official State Agency to determine the origin of the infection; 
Provided, That if the origin of the infection involves another State, 
or if there is exposure to poultry in another State from the infected 
flock, then officials administering the National Poultry Improvement 
Plan will conduct an investigation;
    (F) All flocks found to be infected with pullorum or typhoid are 
quarantined until marketed or destroyed under the supervision of the 
Official State Agency, or until subsequently blood tested following the 
procedure for reacting flocks as contained in Sec.  145.14(a)(5) of 
this subchapter, and all birds fail to demonstrate pullorum or typhoid 
infection;
    (G) All poultry, including exhibition, exotic, and game birds, but 
excluding waterfowl, going to public exhibition shall come from U.S. 
Pullorum-Typhoid Clean or equivalent flocks, or have had a negative 
pullorum-typhoid test within 90 days of going to public exhibition; and
    (H) Discontinuation of any of the conditions or procedures 
described in paragraphs (b)(2)(i)(A) through (b)(2)(i)(G) of this 
section, or the occurrence of repeated outbreaks of pullorum or typhoid 
in poultry breeding flocks within or originating within the State shall 
be grounds for the Service to revoke its determination that such 
conditions and procedures have been met or complied with. Such action 
shall not be taken until a thorough investigation has been made by the 
Service and the Official State Agency has been given an opportunity to 
present its views; and
    (ii) In the primary breeding flock, a sample of 300 birds from 
flocks of more than 300, and each bird in flocks of 300 or less, has 
been officially tested for pullorum-typhoid with no reactors: Provided, 
That a bacteriological examination monitoring program acceptable to the 
Official State Agency and approved by the Service may be used in lieu 
of blood testing.
    (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in 
compliance with the provisions of Sec.  147.26 of this subchapter and 
in which freedom from M. gallisepticum has been demonstrated under the 
criteria specified in paragraph (c)(1)(i) of this section.
    (i) It is a flock in which all birds or a sample of at least 300 
birds has been tested for M. gallisepticum as provided in Sec.  
145.14(b) of this subchapter when more than 4 months of age: Provided, 
That to retain this classification, a minimum of 40 birds shall be 
tested at intervals of not more than 28 days, and a total of at least 
150 birds shall be tested within each 90-day period.
    (ii) [Reserved]
    (2) A participant handling U.S. M. Gallisepticum Clean products 
must handle only products of equivalent status.
    (3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean 
boxes and delivered in trucks that have been cleaned and disinfected as 
described in Sec.  147.24(a) of this subchapter.
    (d) U.S. M. Synoviae Clean. (1) A flock maintained in compliance 
with the provisions of Sec.  147.26 of this subchapter and in which 
freedom from M. synoviae has been demonstrated under the criteria 
specified in paragraph (d)(1)(i) of this section.
    (i) It is a flock in which all birds or a sample of at least 300 
birds has been tested for M. synoviae as provided in Sec.  145.14(b) of 
this subchapter when more than 4 months of age: Provided, That to 
retain this classification, a sample of at least 40 birds shall be 
tested at intervals of not more than 28 days, and a total of at least 
150 birds shall be tested within each 90-day period.
    (ii) [Reserved]
    (2) A participant handling U.S. M. Synoviae Clean products shall 
handle only products of equivalent status.
    (3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and 
delivered in trucks that have been cleaned and disinfected as described 
in Sec.  147.24(a) of this subchapter.
    (e) U.S. S. Enteritidis Clean. This classification is intended for 
primary meat-type breeders wishing to assure their customers that the 
chicks produced are certified free of Salmonella enteritidis.
    (1) A flock and the hatching eggs and chicks produced from it shall 
be eligible for this classification if they meet the following 
requirements, as determined by the Official State Agency:
    (i) The flock originated from a U.S. S. Enteritidis Clean flock, or 
one of the following samples has been examined bacteriologically for S. 
enteritidis at an authorized laboratory and any group D Salmonella 
samples have been serotyped:
    (A) A 25-gram sample of meconium from the chicks in the flock 
collected and cultured as described in Sec.  147.12(a)(5) of this 
subchapter; or
    (B) A sample of chick papers collected and cultured as described in 
Sec.  147.12(c) of this subchapter; or
    (C) A sample of 10 chicks that died within 7 days after hatching.
    (ii) All feed fed to the flock meets the following requirements:
    (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 lbs. 
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 U.S. Food and 
Drug Administration.
    (C) All feed is stored and transported in such a manner as to 
prevent possible contamination.
    (iii) The flock is maintained in compliance with Sec. Sec.  147.21, 
147.24(a), and 147.26 of this subchapter.
    (iv) Environmental samples are collected from the flock by or under 
the supervision of an Authorized Agent, as described in Sec.  147.12 of 
this subchapter, when the flock reaches 4 months of age and every 30 
days thereafter. The environmental samples shall be examined 
bacteriologically for group D salmonella at an authorized laboratory, 
and cultures from group D positive samples shall be serotyped.
    (v) Blood samples from 300 birds from the flock are officially 
tested with pullorum antigen when the flock is at least 4 months of 
age. All birds with

[[Page 1424]]

positive or inconclusive reactions, up to a maximum of 25 birds, shall 
be submitted to an authorized laboratory and examined for the presence 
of group D salmonella in accordance with Sec. Sec.  147.10 and 147.11 
of this subchapter. Cultures from group D positive samples shall be 
serotyped.
    (vi) Hatching eggs produced by the flock are collected as quickly 
as possible and are handled as described in Sec.  147.22 of this 
subchapter.
    (vii) Hatching eggs produced by the flock are incubated in a 
hatchery that is in compliance with the recommendations in Sec. Sec.  
147.23 and 147.24(b) of this subchapter, and the hatchery must have 
been sanitized either by a procedure approved by the Official State 
Agency or by fumigation.
    (2) If Salmonella enteritidis serotype enteritidis (SE) is isolated 
from a specimen taken from a bird in the flock, except as provided in 
paragraph (e)(3) of this section, the flock shall not be eligible for 
this classification.
    (3) If SE is isolated from an environmental sample collected from 
the flock in accordance with paragraph (e)(1)(iv) of this section, 25 
randomly selected live birds from the flock and/or 500 cloacal swabs 
collected in accordance with Sec.  147.12(a)(2) of this subchapter must 
be bacteriologically examined for SE as described in Sec.  147.11 of 
this subchapter. If only 1 bird from the 25-bird sample is found 
positive for SE, the participant may request bacteriological 
examination of a second 25-bird sample from the flock. If no SE is 
recovered from any of the specimens in the second sample, the flock 
will be eligible for the classification and will remain eligible for 
this classification if the flock is tested in accordance with paragraph 
(e)(1)(v) of this section each 30 days and no positive samples are 
found.
    (4) In order for a hatchery to sell products of this 
classification, all products handled by the hatchery must meet the 
requirements of this paragraph.
    (5) This classification may be revoked by the Official State Agency 
if the participant fails to follow recommended corrective measures. The 
Official State Agency shall not revoke the participant's classification 
until the participant has been given an opportunity for a hearing in 
accordance with rules of practice adopted by the Official State Agency.
    (6) A pedigree, experimental, or great-grandparent 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 subchapter.
    (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 subchapter. 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 subchapter 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 
(e)(1)(v) of this section every 30 days and no positive samples are 
found and the flock meets the requirements set forth in Sec.  
145.83(e).
    (f) U.S. Salmonella Monitored. This program is intended to be the 
basis from which the breeding-hatching industry may conduct a program 
for the prevention and control of salmonellosis. It is intended to 
reduce the incidence of Salmonella organisms in hatching eggs and 
chicks through an effective and practical sanitation program at the 
breeder farm and in the hatchery. This will afford other segments of 
the poultry industry an opportunity to reduce the incidence of 
Salmonella in their products.
    (1) A flock and the hatching eggs and chicks produced from it that 
have met the following requirements, as determined by the Official 
State Agency.
    (i) The flock is maintained in compliance with Sec. Sec.  147.21, 
147.24(a), and 147.26 of this subchapter;
    (ii) 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 lbs. pressure during the 
manufacturing process;
    (iii) Feed shall be stored and transported in a manner to prevent 
possible contamination;
    (iv) Chicks shall be hatched in a hatchery meeting the requirements 
of Sec. Sec.  147.23 and 147.24(b) of this subchapter and sanitized or 
fumigated (see Sec.  147.25 of this subchapter).
    (v) An Authorized Agent shall take environmental samples from the 
hatchery every 30 days; i.e., meconium or chick papers. An authorized 
laboratory for Salmonella shall examine the samples bacteriologically;
    (vi) An Authorized Agent shall take environmental samples as 
described in Sec.  147.12 of this subchapter from each flock at 4 
months of age and every 30 days thereafter. An authorized laboratory 
for Salmonella shall examine the environmental samples 
bacteriologically;
    (vii) Owners of flocks may vaccinate with a paratyphoid vaccine: 
Provided, That a sample of 350 birds, which will be banded for 
identification, shall remain unvaccinated until the flock reaches at 
least 4 months of age.
    (2) The Official State Agency may use the procedures described in 
Sec.  147.14 of this subchapter to monitor the effectiveness of the egg 
sanitation practices.
    (3) In order for a hatchery to sell products of this 
classification, all products handled shall meet the requirements of the 
classification.
    (4) This classification may be revoked by the Official State Agency 
if the participant fails to follow recommended corrective measures.
    (g) 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 primary breeding chickens 
through routine serological surveillance of each participating breeding 
flock. A flock and the hatching eggs and chicks produced from it will 
qualify for this classification when the Official State Agency 
determines that they have met the following requirements:
    (1) It is a primary breeding flock in which a minimum of 30 birds 
have been tested negative for antibodies to avian influenza when more 
than 4 months of age and prior to the onset of egg production. To 
retain this classification:

[[Page 1425]]

    (i) A sample of at least 30 birds must be tested negative at 
intervals of 90 days; Provided, that primary spent fowl be tested 
within 30 days prior to movement to slaughter; or
    (ii) A sample of fewer than 30 birds may be tested, and found to be 
negative, at any one time if all pens are equally represented and a 
total of 30 birds is tested within each 90-day period.
    (2) [Reserved]

PART 147--AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN

0
20. The authority citation for part 147 continues to read as follows:

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.


Sec.  147.7  [Amended]

0
21. In Sec.  147.7, paragraph (b)(1)(vii), the citation ``Sec.  147.6'' 
is removed and the citation ``Sec.  147.6(a)'' is added in its place.

0
22. Section 147.11 is amended as follows:
0
a. In paragraph (a), by revising the introductory text to read as set 
forth below.
0
b. By removing and reserving paragraph (b).


Sec.  147.11  Laboratory procedure recommended for the bacteriological 
examination of salmonella.

    (a) For egg- and meat-type chickens, turkeys, waterfowl, exhibition 
poultry, and game birds. All reactors to the pullorum-typhoid tests, up 
to 25 birds, and birds from Salmonella enteritidis (SE) positive 
environments should be cultured in accordance with both the direct 
enrichment (paragraph (a)(1)) and selective enrichment (paragraph 
(a)(2)) procedures described in this section: Provided, That in 
turkeys, if there are more than four reactors to the pullorum-typhoid 
tests in the flock, a minimum of four reactors as provided for in Sec.  
145.14(a)(6)(ii) of this subchapter shall be submitted to the 
authorized laboratory for bacteriological examination. Careful aseptic 
technique should be used when collecting all tissue samples.
* * * * *


Sec.  147.12  [Amended]

0
23. In Sec.  147.12, paragraph (b)(3) is amended by adding the words 
``using a PCR-based assay approved by the NPIP under Sec.  145.15'' 
after the word ``enrichment''.

0
24. Section 147.17 is amended as follows:
0
a. By revising the section heading, the introductory text of the 
section, and paragraphs (a) and (c) to read as set forth below.
0
b. In paragraph (d), by removing the number ``15''.


Sec.  147.17  Laboratory procedure recommended for the bacteriological 
examination of cull chicks and poults for salmonella.

    The laboratory procedure described in this section is recommended 
for the bacteriological examination of cull chicks from egg-type and 
meat-type chicken flocks and waterfowl, exhibition poultry, and game 
bird flocks and poults from turkey flocks for salmonella.
    (a) For cull chicks, from 25 randomly selected 1- to 5-day-old 
chicks that have not been placed in a brooding house, prepare 5 organ 
pools, 5 yolk pools, and 5 intestinal tissue pools as follows. For 
poults, from a sample of 10 poults that died within 10 days after 
hatching, prepare organ pools, yolk pools, and intestinal pools as 
follows:
    (1) Organ pool: From each of five chicks or two poults, composite 
and mince 1- to 2-gram samples of heart, lung, liver, and spleen 
tissues. Include the proximal wall of the bursa of Fabricius for chicks 
only.
    (2) Yolk pool: From each of five chicks or two poults, composite 
and mince 1- to 2-gram samples of the unabsorbed yolk sac or, if the 
yolk sac is essentially absent, the entire yolk stalk remnant.
    (3) Intestinal pool: From each of five chicks or two poults, 
composite and mince approximately 0.5 cm\2\ sections of the crop wall 
and 5-mm-long sections of the duodenum, cecum, and ileocecal junction.
* * * * *
    (c) For cull chicks, repeat the steps in paragraphs (a) and (b) of 
this section for each 5-chick group until all 25 chicks have been 
examined, producing a total of 15 pools (5 organ, 5 yolk, and 5 
intestinal). For poults, repeat the steps in paragraphs (a) and (b) of 
this section for each two-poult group until all the poults in the 
sample have been examined.
* * * * *

0
25. A new subpart D is added to read as set forth below.

Subpart D--Molecular Examination Procedures


Sec.  147.30  Laboratory procedure recommended for the polymerase chain 
reaction (PCR) test for Mycoplasma gallisepticum and M. synoviae.

    (a) DNA isolation. Isolate DNA from 1 mL of eluate from tracheal 
swabs in PBS or 1 mL of broth culture by a non-phenolic procedure. 
Centrifuge samples at 14,000 x g for 5 to 10 minutes. Decant 
supernatant and wash the pellet with 1 mL of PBS. Centrifuge as above 
and re-suspend the pellet in 25-50 [mu]l of 0.1 percent DEP (Diethyl 
Pyrocarbonate; Sigma) water. Boil at 120 [deg]C for 10 minutes followed 
by 10 minutes incubation at 4 [deg]C. Centrifuge as above and transfer 
the supernatant DNA to a nuclease-free tube. Estimate the DNA 
concentration and purity by spectrophotometric reading at 260 nm and 
280 nm.
    (b) Primer selection. (1) M. gallisepticum. The primer for M. 
gallisepticum should consist of the following sequences:
[GRAPHIC] [TIFF OMITTED] TR12JA07.004

    (2) M. synoviae. The primer for M. synoviae should consist of the 
following sequences:

[[Page 1426]]

[GRAPHIC] [TIFF OMITTED] TR12JA07.005

    (c) Polymerase chain reaction. (1) Treat each sample (100 to 2000 
ng/5 [mu]l) with one of the following 45 [mu]l PCR cocktails:
    (i) 5 [mu]l 10x PCR buffer, 1 [mu]l dNTP (10 mM), 1 [mu]l of 
Reverse primer (50 [mu]M), 1 [mu]l of Forward primer (50 [mu]M), 4 
[mu]l MgCl2 (25 mM), 1 [mu]l taq-polymerase (5 U), 32 [mu]l 
DEP water.
    (ii) 18 [mu]l water, 25 [mu]l PCR mix (Promega), 1 [mu]l Reverse 
primer (50 [mu]M), 1 [mu]l Forward primer (50 [mu]M).
    (2) Perform DNA amplification in a Perkin-Elmer 9600 thermocycler 
or in a Hybaid PCR Express thermocycler.\24\ The optimized PCR program 
is as follows:
---------------------------------------------------------------------------

    \24\ Trade names are used in these procedures solely for the 
purpose of providing specific information. Mention of a trade name 
does not constitute a guarantee or warranty of the product by the 
U.S. Department of Agriculture or an endorsement over other products 
not mentioned.

----------------------------------------------------------------------------------------------------------------
          Temperature ([deg]C)                      Duration                             Cycles
----------------------------------------------------------------------------------------------------------------
94......................................  30 seconds.................  30-40.
55......................................  30 seconds.................  30-40.
72......................................  1 minute...................  30-40.
72......................................  5 minutes..................  1 (final extension).
----------------------------------------------------------------------------------------------------------------

    (d) Electrophoresis. Mix PCR products (5 to 10 [mu]l) with 2 [mu]l 
loading buffer (Sigma) and electrophorese on a 2 percent agarose gel 
containing 0.5 [mu]g/mL ethidium bromide in TAE buffer (40 mM tris; 2 
mM EDTA; pH 8.0 with glacial acetic acid) for 30 minutes at 80 V. M. 
gallisepticum (185 bp) and M. synoviae (214 bp) amplicons can be 
visualized under an ultraviolet transilluminator along with the PCR 
marker (50 to 2000 bp; Sigma).

    Done in Washington, DC, this 28th day of December 2006.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E6-22635 Filed 1-11-07; 8:45 am]
BILLING CODE 3410-34-P