[Federal Register Volume 71, Number 117 (Monday, June 19, 2006)]
[Proposed Rules]
[Pages 35203-35220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-5468]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 145 and 147

[Docket No. APHIS-2006-0008]


National Poultry Improvement Plan and Auxiliary Provisions

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: We are proposing to amend the National Poultry Improvement 
Plan (the Plan) and its auxiliary provisions by providing new or 
modified sampling and testing procedures for Plan participants and 
participating flocks. The proposed changes were voted on and approved 
by the voting delegates at the Plan's 2004 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 
August 18, 2006.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and, in the

[[Page 35204]]

lower ``Search Regulations and Federal Actions'' box, select ``Animal 
and Plant Health Inspection Service'' from the agency drop-down menu, 
then click on ``Submit.'' In the Docket ID column, select APHIS-2006-
0008 to submit or view public comments and to view supporting and 
related materials available electronically. Information on using 
Regulations.gov, including instructions for accessing documents, 
submitting comments, and viewing the docket after the close of the 
comment period, is available through the site's ``User Tips'' link.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. APHIS-
2006-0008, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. APHIS-2006-0008.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room is located in room 1141 of 
the USDA South Building, 14th Street and Independence Avenue, SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

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

SUPPLEMENTARY INFORMATION:

Background

    The National Poultry Improvement Plan (NPIP, also referred to below 
as ``the Plan'') is a cooperative Federal-State-industry mechanism for 
controlling certain poultry diseases. The Plan consists of a variety of 
programs intended to prevent and control 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.
    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 July 8 to July 10, 2004. 
Participants in the 2004 National Plan Conference represented 
flockowners, breeders, hatcherymen, and Official State Agencies from 
all cooperating States. The proposed amendments are discussed in detail 
below.

New Definition of Authorized Testing Agent

    The regulations in Sec.  145.11(a) state that the Official State 
Agency may designate qualified persons as Authorized Agents to do the 
sample collecting and blood testing provided for in Sec.  145.14 and 
the selecting required for the U.S. Approved classification in Sec.  
145.53(a). The term Authorized Agent in the definitions in Sec.  145.1 
simply refers to any person authorized under Sec.  145.11(a) to perform 
functions under 9 CFR part 145. Thus, the term Authorized Agent as it 
is currently used in the regulations refers to persons with different 
tasks and capabilities, which could cause confusion. For example, 
Authorized Agents who may be authorized to collect blood samples should 
not be allowed to perform blood testing unless they have been 
specifically authorized to perform both duties.
    To address this problem, we are proposing to establish a new term, 
``Authorized Testing Agent,'' that would refer to persons authorized to 
perform blood testing and collect samples, and use the existing term 
``Authorized Agent'' to refer to persons only authorized to collect 
samples. We would amend Sec.  145.11(a) to state that the Official 
State Agency may designate 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. We would also add a new 
definition to Sec.  145.1 of the term Authorized Testing Agent that 
would read ``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.'' The definition of Authorized Agent would be revised to read 
``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.''
    To accomplish this change, we would change references to 
``Authorized Agent'' when the term specifically designates a person who 
performs blood testing for pullorum typhoid to instead refer to 
``Authorized Testing Agent.'' These references occur in Sec. Sec.  
145.14, 145.23(b)(2)(iii), 145.33(b)(2)(iii), 145.43(b)(2)(iii), and 
145.53(b)(2)(iii).
    We are also proposing to remove the reference in Sec.  145.11(a) to 
the U.S. Approved classification in Sec.  145.53(a), as this 
classification no longer exists.
    A related change we are proposing concerns the U.S. Sanitation 
Monitored, Turkeys program. Paragraph (f)(2) of Sec.  145.43 requires 
that the poults for a breeding flock that is a candidate for this 
classification must be ``placed in a building that has been cleaned, 
disinfected, and examined bacteriologically for the presence of 
Salmonella by an Authorized Agent, as described in Sec.  147.12 of this 
chapter.'' As indicated in the discussion above, the Authorized Agent's 
role is to collect samples for bacteriological examination for 
Salmonella, not to perform the bacteriological examination. 
Accordingly, we would amend this requirement to read: ``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 chapter.''

Clarification of Supervisory Role in Selecting and Testing of 
Participating Flocks

    In Sec.  145.11, paragraph (b) states: ``The Official State Agency 
shall employ or authorize qualified persons as State Inspectors to 
perform or supervise the performance of the selecting and testing of 
participating flocks, and to perform the official inspections necessary 
to verify compliance with the requirements of the Plan.'' We would

[[Page 35205]]

amend this paragraph to remove the reference to supervising the 
performance of selecting and testing. In addition, to improve clarity, 
we would indicate that the testing that State Inspectors should perform 
is qualification testing, referring to testing undertaken to determine 
whether a flock meets the criteria for participation in a Plan program. 
These changes would have the effect of requiring that a State Inspector 
perform the selecting and qualification testing of flocks that apply 
for participation in the Plan.
    Most Official State Agencies already require that State Inspectors 
perform selecting and qualification testing in order to ensure that a 
State representative is involved in NPIP testing at least once in the 
life of a participating flock. Subsequent testing is typically 
performed by Authorized Agents, who are typically employees of the 
company that owns the poultry. Foreign governments have also encouraged 
us to make this change in order to increase governmental involvement in 
NPIP testing. This proposed requirement would increase governmental 
oversight of participating flocks in States where such oversight is not 
already required.

Requiring That Participating Hatcheries Be Audited at Least Once 
Annually

    The regulations in Sec.  145.12(a) require that each participating 
hatchery be inspected a sufficient number of times each year to satisfy 
the Official State Agency that the operations of the hatchery are in 
compliance with the provisions of the Plan. We are proposing to change 
this requirement to indicate that participating hatcheries must be 
audited, rather than inspected. As the regulations in Sec.  145.12(b) 
state, on-site inspections of flocks and premises are conducted only if 
the State inspector determines that a breach of sanitation, blood 
testing, or other provisions has occurred for Plan programs for which 
the flocks have been or are being qualified. In order for the State 
inspector to determine that a breach of Plan provisions has occurred, 
the inspector first examines records submitted to the Official State 
Agency. We believe ``audit'' is a better term to describe this process 
than ``inspect,'' as inspections are typically presumed to take place 
on-site.
    In addition, the phrase ``a sufficient number of times each year'' 
does not establish a minimum number of times a participating hatchery 
must be inspected. We are proposing to add a requirement that 
participating hatcheries be audited a minimum of one time annually. 
This change would ensure that participating hatcheries are audited at 
regular intervals while allowing the Official State Agency to audit 
more often if the Official State Agency determines that more audits are 
necessary to establish that the operations of the hatchery are in 
compliance with the provisions of the Plan.

Approved Tests

    In order to establish and maintain eligibility for classifications 
under the Plan, poultry flocks must be tested regularly for various 
diseases. Descriptions of how to conduct some bacteriological tests are 
provided in 9 CFR part 147. Other acceptable tests using veterinary 
biologics are licensed by APHIS'' Center for Veterinary Biologics (CVB) 
according to the testing and licensing procedure described in 9 CFR 
part 113. Tests produced by CVB also may be used.
    Diagnostic test kits, such as polymerase chain reaction (PCR) and 
other bacteriological culturing test kits, are also a useful tool for 
performing tests. The NPIP has approved a procedure for testing 
diagnostic test kits and approving them for use by Plan participants, 
and this procedure has already been used to approve one test kit. 
However, we have not previously included this procedure in the Plan 
regulations. This proposal would establish a new section, Sec.  145.15, 
``Approved tests,'' setting out this procedure.
    Paragraph (a) of proposed Sec.  145.15 would read as follows: ``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.'' The 
regulations currently do not explicitly state that veterinary biologics 
licensed or produced by the Service and used as described in part 147 
are approved for use in Plan testing; this proposed new language would 
correct that oversight.
    Proposed paragraph (b) would set out a procedure by which 
diagnostic test kits that are not licensed by the Service could be 
approved for use in the NPIP. The required steps in this procedure 
would be as follows:
     The sensitivity of the kit would 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 9 CFR part 147. If certain conditions or interfering substances are 
known to affect the performance of the kit, appropriate samples would 
be included so that the magnitude and significance of the effect(s) can 
be evaluated.
     The specificity of the kit would 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 9 CFR part 147. If certain conditions or interfering substances are 
known to affect the performance of the kit, appropriate samples would 
be included so that the magnitude and significance of the effect(s) can 
be evaluated.
     The kit would be provided to the cooperating laboratories 
in its final form and include the instructions for use. The cooperating 
laboratories would perform the assay exactly as stated in the supplied 
instructions. Each laboratory would test a panel of at least 25 known 
positive clinical samples supplied by the manufacturer of the test kit. 
In addition, each laboratory would 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 would be coded so that the cooperating laboratories are blinded 
to identity and classification. Each sample would have to be provided 
in duplicate or triplicate, so that error and repeatability data could 
be generated.
     Cooperating laboratories would submit to the kit 
manufacturer all raw data regarding the assay response. Each sample 
tested would be reported as positive or negative and the official NPIP 
procedure used to classify the sample would be submitted in addition to 
the assay response value.
     The findings of the cooperating laboratories would be 
evaluated by the NPIP technical committee and the technical committee 
would make a recommendation regarding whether to approve the test kit 
to the General Conference Committee. If the technical committee 
recommends approval, the final approval would be granted in accordance 
with the procedures described in Sec. Sec.  147.46 and 147.47.
    We believe this procedure would be sufficient for determining 
whether a test kit is accurate and, if it is accurate, for approving it 
for use in the NPIP.

Separation of Provisions for Primary and Multiplier Breeding Flocks of 
Egg-Type and Meat-Type Chickens

    Within 9 CFR part 145, the regulations in subpart B (Sec. Sec.  
145.21

[[Page 35206]]

through 145.24) and subpart C (Sec. Sec.  145.31 through 145.34) set 
out the programs of the NPIP that apply to egg-type chicken breeding 
flocks and products and meat-type chicken breeding flocks and products, 
respectively. The programs described in these subparts include 
provisions for both primary breeding flocks (a term that includes 
pedigree, grandparent, and great-grandparent breeding flocks) and 
multiplier breeding flocks.
    Because multiplier breeding flocks are produced from primary 
breeding flocks, it is especially important to ensure that primary 
breeding flocks participating in NPIP programs are free of disease; 
therefore, the program requirements for primary breeding flocks in 
these subparts are generally more stringent than the program 
requirements for multiplier breeding flocks. In addition, some programs 
in these subparts are only intended for use by either primary breeding 
flocks or multiplier breeding flocks. Listing both sets of program 
requirements in the same section, with what are, in some cases, 
ambiguous indications regarding whether they are intended for use by 
primary or multiplier breeding flocks within the text describing the 
programs, could lead to confusion.
    Therefore, we are proposing to establish new subparts G and H in 9 
CFR part 145 for primary egg-type chicken breeding flocks and primary 
meat-type chicken breeding flocks, respectively. We are also proposing 
to remove provisions in subparts B and C of 9 CFR part 145 that are 
specific to primary breeding flocks. The changes we would make to 
accomplish this are summarized in the four tables that follow.

   Table 1.--Proposed Changes to and Deletions From the Provisions in
                       Subpart B of 9 CFR Part 145
------------------------------------------------------------------------
  Program  (if applicable)          Location           Proposed change
------------------------------------------------------------------------
                              Sec.   145.22         Indicate that
                               introductory text.    multiplier flocks
                                                     participate in this
                                                     subpart.
                              Sec.   145.22(b)....  Make existing
                                                     requirement for
                                                     primary flocks
                                                     apply to multiplier
                                                     flocks (see
                                                     discussion later
                                                     under this
                                                     heading).
U.S. Pullorum--Typhoid Clean  Sec.   145.23(b)(2).  Remove 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'' (see
                                                     discussion later
                                                     under this
                                                     heading).
                              Sec.   145.23(b)(5).  Remove.
U.S. M. Gallisepticum Clean.  Sec.                  Remove.
                               145.23(c)(1)(i).
                              Sec.   145.23(c)(2).  Remove 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''.
U.S. M. Synoviae Clean......  Sec.                  Remove.
                               145.23(e)(1)(i).
                              Sec.   145.23(e)(2).  Remove 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''.
U.S. Avian Influenza Clean..  Sec.   145.23(h)(1).  Remove.
------------------------------------------------------------------------


   Table 2.--Proposed Changes to and Deletions From the Provisions in
                       Subpart C of 9 CFR Part 145
------------------------------------------------------------------------
  Program  (if applicable)          Location               Change
------------------------------------------------------------------------
                              Sec.   145.32         Indicate that
                               introductory text.    multiplier flocks
                                                     participate in this
                                                     subpart.
                              Sec.   145.32(b)....  Make existing
                                                     requirement for
                                                     primary flocks
                                                     apply to multiplier
                                                     flocks (see
                                                     discussion later
                                                     under this
                                                     heading).
U.S. Pullorum-Typhoid Clean.  Sec.   145.33(b)(2).  Remove 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'' (see
                                                     discussion later
                                                     under this
                                                     heading).
                              Sec.   145.33(b)(5).  Remove.
U.S.M. Gallisepticum Clean..  Sec.                  Remove.
                               145.33(c)(1)(i).
                              Sec.   145.33(c)(2).  Remove 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''.
U.S. M. Synoviae Clean......  Sec.                  Remove.
                               145.33(e)(1)(i).

[[Page 35207]]

 
                              Sec.   145.33(e)(2).  Remove 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''.
U.S. S. Enteritidis Clean...  Sec.   145.33(h)....  Remove.
U.S. Salmonella Monitored...  Sec.   145.33(i)....  Remove.
U.S. Avian Influenza Clean..  Sec.   145.33(l)(1).  Remove.
------------------------------------------------------------------------


                          Table 3.--Derivation of Proposed Subpart G of 9 CFR Part 145
----------------------------------------------------------------------------------------------------------------
                                        Proposed new section or
     Program  (if applicable)                  paragraph                   Based on           Copied or moved?
----------------------------------------------------------------------------------------------------------------
                                    Sec.   145.71.................  Sec.   145.21 and new  Copied.
                                                                     definition of
                                                                     primary breeding
                                                                     flock.
                                    Sec.   145.72.................  Sec.   145.22 and new  Copied.
                                                                     language indicating
                                                                     that the subpart
                                                                     applies to primary
                                                                     breeding flocks.
U.S. Pullorum-Typhoid Clean.......  Sec.   145.73(b)(1)...........  Sec.   145.23(b)(1)..  Copied.
                                    Sec.   145.73(b)(2)...........  Sec.   145.23(b)(3)    (b)(3) and (b)(4)
                                                                     through (b)(5).        copied; (b)(5)
                                                                                            moved.
U.S. M. Gallisepticum Clean.......  Sec.   145.73(c)(1)(i)........  Sec.                   Moved.
                                                                     145.23(c)(1)(i).
                                    Sec.   145.73(c)(2)...........  Language in Sec.       Moved and changed
                                                                     145.23(c)(2) and new   (see discussion
                                                                     language.              later under this
                                                                                            heading).
                                    Sec.   145.73(c)(3)...........  Sec.   145.23(c)(3)..  Copied.
U.S. S. Enteritidis Clean.........  Sec.   145.73(d)..............  Sec.   145.23(d).....  Copied.
U.S. M. Synoviae Clean............  Sec.   145.73(e)(1)(i)........  Sec.                   Moved.
                                                                     145.23(e)(1)(i).
                                    Sec.   145.73(e)(2)...........  Language in Sec.       Moved and changed
                                                                     145.23(e)(2) and new   (see discussion
                                                                     language.              later under this
                                                                                            heading).
                                    Sec.   145.73(e)(3)...........  Sec.   145.23(e)(3)..  Copied.
U.S. Avian Influenza Clean........  Sec.   145.73(f)..............  Sec.   145.23(f).....  Copied.
                                    Sec.   145.73(f)(1)...........  Sec.   145.73(f)(1)..  Moved.
----------------------------------------------------------------------------------------------------------------


                          Table 4.--Derivation of Proposed Subpart G of 9 CFR Part 145
----------------------------------------------------------------------------------------------------------------
                                        Proposed new section or
      Program (if applicable)                  paragraph                   Based on           Copied or moved?
----------------------------------------------------------------------------------------------------------------
                                    Sec.   145.81.................  Sec.   145.31 with     Copied.
                                                                     primary definition.
                                    Sec.   145.82.................  Sec.   145.32 and      Copied.
                                                                     very little new
                                                                     language.
U.S. Pullorum-Typhoid Clean.......  Sec.   145.83(b)(1)...........  Sec.   145.33(b)(1)..  Copied.
                                    Sec.   145.83(b)(2)...........  Sec.   145.33(b)(3)    (b)(3) and (b)(4)
                                                                     through (b)(5).        copied; (b)(5)
                                                                                            moved.
U.S. M. Gallisepticum Clean.......  Sec.   145.83(c)(1)(i)........  Sec.                   Moved.
                                                                     145.33(c)(1)(i).
                                    Sec.   145.83(c)(2)...........  Language in Sec.       Moved and changed
                                                                     145.33(c)(2) and new   (see discussion
                                                                     language.              later under this
                                                                                            heading).
                                    Sec.   145.83(c)(3)...........  Sec.   145.33(c)(3)..  Copied.
U.S. M. Synoviae Clean............  Sec.   145.83(d)(1)(i)........  Sec.                   Moved.
                                                                     145.33(e)(1)(i).
                                    Sec.   145.83(d)(2)...........  Language in Sec.       Moved and changed
                                                                     145.33(e)(2) and new   (see discussion
                                                                     language.              later under this
                                                                                            heading).
                                    Sec.   145.83(d)(3)...........  Sec.   145.33(e)(3)..  Copied.
U.S. S. Enteritidis Clean.........  Sec.   145.83(e)..............  Sec.   145.33(h).....  Moved.
U.S. Salmonella Monitored.........  Sec.   145.83(f)..............  Sec.   145.33(i).....  Moved and changed
                                                                                            (see discussion
                                                                                            later under this
                                                                                            heading).
U.S. Avian Influenza Clean........  Sec.   145.83(g)..............  Sec.   145.33(l).....  Copied.
                                    Sec.   145.83(g)(1)...........  Sec.   145.33(l)(1)..  Moved.
----------------------------------------------------------------------------------------------------------------

    The new definition of primary egg-type chicken breeding flocks in 
Sec.  145.71 would read: ``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.'' The new definition of primary meat-type chicken breeding 
flocks in Sec.  145.81 would read: ``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.''
    As mentioned previously, for meat-type chickens, the U.S. 
Sanitation Monitored program in Sec.  145.33(d) and the U.S. M. 
Synoviae Monitored program in Sec.  145.33(k) would not be

[[Page 35208]]

included in the new primary breeding flock subpart, as they apply to 
multiplier breeding flocks only. The U.S. Salmonella Monitored program 
for meat-type chickens, which is currently described in paragraph Sec.  
145.33(i) and which would be moved to Sec.  145.83(f), requires that 
flocks participating in that program also participate in the U.S. 
Sanitation Monitored program; we would remove that requirement as part 
of the move of the U.S. Salmonella Monitored program to Sec.  
145.83(f).
    The requirements for the U.S. Pullorum-Typhoid Clean State 
classification (reproduced in both Sec.  145.24(a) and Sec.  145.34(a)) 
specify that, to earn this classification, the State must be in 
compliance with provisions contained in the requirements of the U.S. 
Pullorum-Typhoid Clean programs for egg-type chicken, meat-type 
chicken, meat-type turkey, and waterfowl, exhibition poultry, and game 
bird breeding flocks. We would amend Sec. Sec.  145.24(a) and 145.34(a) 
to also include references to the pullorum-typhoid programs for primary 
breeding flocks that would be set out in Sec. Sec.  145.73(b) and 
145.83(b). Similarly, the requirements for the U.S. M. Gallisepticum 
Clean State, Meat-Type Chickens classification in Sec.  145.34(b) 
specify that, to earn this classification, all meat-type chicken 
breeding flocks in production are classified as U.S. M. Gallisepticum 
Clean or have met equivalent requirements. We would amend the paragraph 
to refer to the U.S. M. Gallisepticum Clean programs in Sec.  145.33(c) 
and proposed Sec.  145.83(c).
    We are also proposing to amend the requirements for primary 
breeding flocks regarding handling of products that are not of the U.S. 
M. Gallisepticum Clean or U.S. M. Synoviae Clean classifications. The 
regulations in Sec. Sec.  145.23(c)(2) and 145.23(e)(2) presently 
require that participants handling U.S. M. Gallisepticum Clean products 
keep those products separate from other products in a manner 
satisfactory to the Official State Agency; the regulations in 
Sec. Sec.  145.33(c)(2) and 145.33(e)(2) have a similar requirement for 
a participant handling U.S. M. Synoviae Clean products. These 
provisions would remain the same for multiplier breeding flocks, but in 
moving primary breeding flock provisions for these classifications to 
the new subparts, we would amend this requirement to state that a 
participant handling products of these classifications shall handle 
only products of equivalent status. This stricter biosecurity standard 
would be more appropriate for primary breeding flocks.
    Finally, we are proposing to make two changes to the regulations 
for egg-type and meat-type chickens:
     The regulations in Sec. Sec.  145.22(b) and 145.32(b) 
currently require hatching eggs produced by primary breeding flocks of 
egg-type and meat-type chickens, respectively, to be fumigated in 
accordance with Sec.  147.25 or otherwise sanitized. This requirement 
should apply to both primary and multiplier breeding flocks. 
Accordingly, we are proposing to extend it to multiplier breeding 
flocks in Sec.  145.22(b) and Sec.  145.32(b).
     The regulations in Sec. Sec.  145.23(b)(2) and 
145.33(b)(2) refer to a testing program for either multiplier breeding 
flocks or ``a breeding flock composed of progeny of a primary breeding 
flock which is intended solely for the purpose of production of 
multiplier breeding flocks.'' Such a flock would normally be classified 
as a multiplier flock, and it is treated identically to a multiplier 
flock in these regulations. Accordingly, we are proposing to delete the 
quoted language to eliminate the possibility of confusion.
    We would also make minor editorial changes to the new primary 
breeding flock subparts to improve clarity and consistency.

Testing in U.S. Avian Influenza Clean Programs for Egg-Type and Meat-
Type Chickens

    In the current regulations, the U.S. Avian Influenza Clean programs 
for egg-type and meat-type chicken breeding flocks and products are set 
out at Sec.  145.23(h) and Sec.  145.33(l), respectively. As discussed 
earlier in this document, we would move the requirements for primary 
breeding flocks to new subparts for primary egg-type and meat-type 
chicken breeding flocks; the provisions of the U.S. Avian Influenza 
Clean programs that relate to primary breeding flocks of egg-type and 
meat-type chickens would be found at Sec.  145.73(f) and Sec.  
145.83(g), respectively, under this proposal. The provisions of the 
U.S. Avian Influenza Clean programs for multiplier breeding flocks of 
egg-type and meat-type chickens would remain at Sec.  145.23(h) and 
Sec.  145.33(l). We are proposing to make several changes to the 
provisions of the U.S. Avian Influenza Clean programs for both primary 
and multiplier breeding flocks of egg-type and meat-type chickens.
    The U.S. Avian Influenza Clean programs for primary breeding flocks 
of egg-type and meat-type chickens presently require that a sample of 
at least 30 birds be tested negative at intervals of 90 days; a sample 
of fewer than 30 birds may be tested and found to be negative at any 
one time if all pens are equally represented and a total of 30 birds is 
tested within each 90-day period. The programs for multiplier breeding 
flocks are the same except that the relevant interval is 180 days.
    We are proposing to require for egg-type chickens that, in addition 
to the current testing requirements, primary and multiplier spent fowl 
be tested within 30 days prior to movement to disposal. Similarly, we 
would require for meat-type chickens that, in addition to the current 
testing requirements, primary and multiplier spent fowl be tested 
within 30 days prior to movement to slaughter. (We would use different 
terms--i.e., disposal and slaughter--because the economic value of a 
spent table-egg laying hen has eliminated slaughter as a viable option 
in many parts of the country.) This requirement would ensure that the 
samples taken from spent fowl are tested in a timely fashion for the 
presence of avian influenza, which would help prevent further spread of 
the virus within and outside the flock if it is present.
    For meat-type chickens, we are also proposing to require that the 
30 birds tested for avian influenza be tested prior to the onset of egg 
production. If infected birds produce eggs, the eggs can serve as 
fomites for the transmission of the disease. This requirement would 
ensure that, if any avian influenza virus is present in a meat-type 
chicken flock, it is not spread from the flock to a hatchery by the 
movement of eggs.

Sample Sizes and Procedures for M. Galliseptium and M. Synoviae in 
Primary Breeding Flocks of Meat-Type Chickens

    In the current regulations, the U.S. M. Gallisepticum Clean and 
U.S. M. Synoviae Clean programs for meat-type chicken breeding flocks 
and products set out testing requirements for primary meat-type chicken 
breeding flocks in Sec.  145.33(c)(1)(i) and Sec.  145.33(e)(1)(i), 
respectively. As discussed earlier in this document, we would move 
these requirements to a new subpart for primary meat-type chicken 
breeding flocks; these requirements would be found at Sec.  
145.83(c)(1)(i) and Sec.  145.83(d)(1)(i), respectively, under this 
proposal.
    We are additionally proposing to change these testing requirements 
as they apply to primary breeding flocks. Currently, paragraph 
(c)(1)(i) of Sec.  145.33 requires that primary breeding flocks 
demonstrate freedom from M. gallisepticum by testing all birds or a 
sample of at least 300 birds for M. gallisepticum when more than 4 
months of age. To retain this classification, a

[[Page 35209]]

minimum of 150 birds must be tested at intervals of not more than 90 
days; a sample 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. Paragraph (e)(1)(i) of Sec.  145.33 sets out 
a similar requirement relating to testing for M. synoviae.
    The requirement that 150 birds be tested at intervals of not more 
than 90 days provides an adequate indication that a primary meat-type 
chicken breeding flock is free of M. gallisepticum and M. synoviae. 
However, in order for primary breeders to have a high level of 
confidence that the birds they are producing and marketing are free of 
M. gallisepticum and M. synoviae, testing must be performed more 
frequently than every 90 days; testing at intervals more frequent than 
every 90 days is permitted under the current sampling and testing plans 
for M. gallisepticum and M. synoviae, but it is not mandatory.
    Therefore, we are proposing to require that, for a meat-type 
chicken primary breeding flock to retain the classifications U.S. M. 
Gallisepticum Clean or U.S. M. Synoviae Clean, a minimum of 40 birds 
must be tested at intervals of not more than 28 days, with a total of 
at least 150 birds tested within each 90-day period. We believe this 
change would provide greater assurance for primary breeders that their 
flocks are free of M. gallisepticum and M. synoviae while still 
allowing for some flexibility in the testing plan.

Sample Types in U.S. Sanitation Monitored Program for Turkeys

    The U.S. Sanitation Monitored Program for turkey breeding flocks, 
as provided in Sec.  145.43(f), requires in paragraph (f)(1) that 
hatchery debris (dead germ hatching eggs, fluff, and meconium collected 
by sexors), a sample of the poults that died within 10 days after 
hatching, or both, from each candidate breeding flock produced by a 
primary breeder must be examined bacteriologically at an authorized 
laboratory for Salmonella. If the candidate flock is approved for the 
U.S. Sanitation Monitored classification, paragraph (f)(7) requires 
that hatchery debris (dead germ hatching eggs, fluff, and meconium 
collected by sexors), a sample of the poults that died within 10 days 
after hatching, or both, be cultured from poults produced from hatching 
eggs from each flock as a means of evaluating the effectiveness of the 
control procedures.
    We are proposing to add swabs collected from hatch debris in the 
hatch trays as material that can be sampled for testing for Salmonella 
in paragraphs (f)(1) and (f)(7) of Sec.  145.43. Testing swabs 
collected from hatch debris can be a very effective way to determine 
whether Salmonella is present in the hatchery. Because the current 
regulations provide that a combination of hatchery debris and poult 
samples may be used in Salmonella testing, we would amend the 
regulations to indicate that hatchery debris, swabs collected from 
hatch debris in the hatch trays, and poult samples, either alone or in 
combination, may be used for Salmonella testing.
    We are also proposing to require that the sample of poults that 
died within 10 days of hatching consist of all of those poults, up to a 
maximum of 10. If more than 10 poults died within 10 days of hatching, 
a sample of 10 poults would be adequate for testing purposes; this 
change would ensure that adequate samples are available for testing 
without placing an unnecessary burden on owners of turkey breeding 
flocks.

Testing in U.S. Avian Influenza Clean Program for Turkeys

    The U.S. H5/H7 Avian Influenza Clean Program for breeding turkeys, 
whose provisions are set out in Sec.  145.43(g), contains testing 
requirements for both primary and multiplier breeding flocks in order 
to determine their freedom from the H5 and H7 subtypes of avian 
influenza. We are proposing to make three changes to these testing 
requirements for both primary and multiplier breeding flocks.
    In order for either a primary or a multiplier turkey breeding flock 
to be eligible for the U.S. H5/H7 Avian Influenza Clean classification, 
the regulations currently require that a minimum of 30 birds from the 
flock has been tested negative for antibodies to the H5 and H7 subtypes 
of avian influenza by the agar gel immunodiffusion (AGID) test 
specified in Sec.  147.9. We are proposing to instead require that a 
minimum of 30 birds from the flock be tested for antibodies to type A 
avian influenza virus (a larger category that includes the H5 and H7 
subtypes) by AGID. Positive samples would be required to be tested by 
an authorized laboratory (as defined in Sec.  145.1) using the 
hemagglutination inhibition test to detect antibodies to the 
hemagglutinin subtypes H5 and H7. Requiring the use of the 
hemagglutination inhibition test would provide more certainty as to 
whether any avian influenza virus detected in turkey breeding flocks is 
H5 or H7 subtype avian influenza.
    Similar to a proposed change discussed under the heading ``Testing 
in U.S. Avian Influenza Clean Programs for Egg-Type and Meat-Type 
Chickens,'' we are also proposing to amend Sec.  145.43(g)(1) regarding 
turkey breeding flocks to require that the 30 birds tested for H5 and 
H7 avian influenza be tested prior to the onset of egg production. If 
infected birds produce eggs, the eggs can serve as fomites for the 
transmission of the disease. This requirement would ensure that, if any 
H5 or H7 avian influenza virus is present in a turkey flock, it is not 
spread from the flock to a hatchery by the movement of eggs.
    To retain the U.S. H5/H7 Avian Influenza Clean classification, a 
sample of 30 birds must be tested negative at intervals of 90 days for 
primary turkey breeding flocks and at intervals of 180 days for 
multiplier turkey breeding flocks. For both primary and multiplier 
turkey breeding flocks, we are proposing to add a requirement that 
spent fowl be tested within 30 days prior to movement to disposal. This 
requirement would ensure that the samples taken from spent fowl are 
tested in a timely fashion for the presence of H5 and H7 avian 
influenza, which would help prevent further spread of the virus within 
the flock if it is present.

Limiting the Avian Influenza Program for Waterfowl, Game Bird, and 
Exhibition Poultry Breeding Flocks to the H5/H7 Subtypes of Avian 
Influenza

    In Sec.  145.53, paragraph (e) sets out the provisions of the U.S. 
Avian Influenza Clean program for waterfowl, game bird, and exhibition 
poultry breeding flocks. That program currently does not distinguish 
among the subtypes of avian influenza. Most avian influenza virus 
strains are low pathogenic and cause few or no clinical signs in 
infected birds. However, the H5 and H7 subtypes of low pathogenic avian 
influenza are considered the most dangerous, as they have the ability 
to mutate into highly pathogenic avian influenza. Wild waterfowl, 
shorebirds, and gulls serve as natural hosts and reservoirs for avian 
influenza viruses, and all subtypes of avian influenza can typically be 
found in the waterfowl population. Because the domestic waterfowl 
population is essentially an extension of the wild waterfowl 
population, it is unrealistic to expect owners of waterfowl breeding 
flocks to be able to demonstrate complete freedom from avian influenza 
in their flocks. Concentrating their efforts on preventing the 
occurrence of the two strains of low pathogenic avian influenza that 
can mutate into viruses that are dangerous would be a more effective 
use of their resources.
    Therefore, we are proposing to amend the U.S. Avian Influenza Clean 
program

[[Page 35210]]

for waterfowl, game bird, and exhibition poultry breeding flocks in 
Sec.  145.53(e) to indicate that it applies to the H5 and H7 subtypes 
of avian influenza only. The testing requirements would remain 
unchanged. This proposed change would more effectively use the 
resources of waterfowl, exhibition poultry, and game bird breeding 
flock owners while allowing them to demonstrate freedom from the two 
most dangerous subtypes of avian influenza.

Sample Size in U.S. Pullorum-Typhoid Clean Program for Ostrich, Emu, 
Rhea, and Cassowary Breeding Flocks

    The U.S. Pullorum-Typhoid Clean program for ostrich, emu, rhea, and 
cassowary breeding flocks, whose provisions are set out in Sec.  
145.63(a), requires that either participating flocks either be 
officially blood tested within the past 12 months with no reactors or 
that samples from the flock be tested for pullorum-typhoid according to 
the size of the flocks:
     In flocks of 30 or fewer birds, each bird must be tested;
     In flocks of 30 to 300 birds, a minimum of 30 birds must 
be tested; and
     In flocks of more than 300 birds, 10 percent of all birds 
must be tested.
    Most of the flocks that participate in the U.S. Pullorum-Typhoid 
Clean program for ostrich, emu, rhea, and cassowary breeding flocks, 
however, consist of fewer than 30 birds. This means that all the birds 
must be tested in order to maintain U.S. Pullorum-Typhoid Clean status. 
The costs associated with testing every bird in their flocks have 
discouraged many owners of ostrich, emu, rhea, and cassowary breeding 
flocks from participating in the NPIP.
    Therefore, we are proposing to require that, for breeding flocks of 
ostrich, emu, rhea, or cassowary with fewer than 300 birds, either 10 
percent of the birds or 1 bird from each pen, whichever is greater, 
must be tested for pullorum-typhoid. We believe samples of this 
proportion would provide adequate information regarding the pullorum-
typhoid status of such flocks. The requirement that at least one bird 
from each pen be tested would ensure that the disease is not present in 
any part of the production facility.
    In addition, we are proposing to require that a minimum of 30 birds 
be sampled from flocks of 300 or more birds. This would represent a 
reduction in the number of birds required to be sampled and tested; for 
example, an owner of a 400-bird flock is presently required to sample 
and test a minimum of 10 percent of its birds, or 40 birds, while under 
this requirement the owner would be required to sample and test a 
minimum of 30 birds. However, we believe that 30 birds is a sufficient 
sample size to determine whether an ostrich, emu, rhea, or cassowary 
breeding flock is free of pullorum-typhoid.
    The introductory text of Sec.  145.14 currently requires that a 
minimum of 30 birds (regardless of type of poultry) be tested for 
pullorum-typhoid, and that if a house contains fewer than 30 birds, all 
the birds in the house must be tested. To accommodate the proposed 
change to the ostrich, emu, rhea, or cassowary testing requirements, we 
are also proposing to modify the requirements in Sec.  145.14 to 
exclude ostriches, emus, rheas, and cassowaries.

Laboratory Procedure Recommended for the Bacteriological Examination of 
Salmonella in Turkeys

    The regulations in Sec.  147.11(a) set out a recommended laboratory 
procedure for the bacteriological examination of Salmonella in egg- and 
meat-type chickens, waterfowl, exhibition poultry, and game birds. The 
regulations in Sec.  147.11(b) set out a procedure to accomplish the 
same examination in turkeys. However, the procedures in Sec.  147.11(a) 
and Sec.  147.11(b) are nearly identical, and there is no reason the 
procedure in Sec.  147.11(a) could not be effectively used for the 
bacteriological examination of Salmonella in turkeys. Therefore, we are 
proposing to remove and reserve paragraph Sec.  147.11(b) and add 
turkeys to the list of poultry for which the procedure in Sec.  
147.11(a) may be used.
    Besides adding turkeys to the list of poultry in the paragraph 
heading in Sec.  47.11(a), this change would require one additional 
amendment to the regulations. The introductory text of paragraph (a) 
currently recommends that all reactors to the pullorum-typhoid tests, 
up to 25 birds, and birds from Salmonella enteritidis-positive 
environments be cultured in accordance with both the direct and 
selective enrichment procedures described in Sec.  147.11(a). However, 
Sec.  145.14(a)(6)(ii) requires that if a flock has more than four 
reactors to the standard tube agglutination test or the 
microagglutination test, a minimum of four reactors must be submitted 
to an authorized laboratory for bacteriological examination. Testing 
turkeys for pullorum-typhoid tends to result in a higher rate of false 
positives than testing other types of poultry; thus, we would add 
language to the introductory text of Sec.  147.11(a) indicating that 
turkeys would be tested in the numbers specified in Sec.  
145.14(a)(6)(ii). This proposed language would provide that the number 
of turkeys tested complies with the regulations without placing an 
undue burden on participating turkey flocks.

Selective Enrichment in Approved Rapid Detection Method for Salmonella

    The regulations in Sec.  147.12 set out procedures for collection, 
isolation, and identification of Salmonella from environmental samples, 
cloacal swabs, chick box papers, and meconium samples. Paragraph (b) of 
Sec.  147.12 describes methods for the isolation and identification of 
Salmonella from such samples. Paragraph (b)(3) sets out an approved 
rapid detection method for such isolation and identification.
    We are proposing to amend Sec.  147.12(b)(3) by adding a 
requirement that selective enrichment be performed using a PCR-based 
assay approved by the NPIP. Currently, the regulations state that the 
rapid detection method should be used following selective enrichment, 
but they do not provide any instructions as to how selective enrichment 
should be accomplished. By specifically referring to an NPIP-approved 
PCR-based assay, we would ensure that selective enrichment was 
performed in a manner that ensures that the rest of the approved rapid 
detection method can be used.
    As described earlier in this document, we are proposing to 
establish new standards by which the NPIP would approve certain PCR 
tests in proposed Sec.  145.15. We would add that citation to the 
proposed requirement that a PCR-based assay be used in Sec.  
147.12(b)(3) in order to ensure clarity.

Laboratory Procedure Recommended for the Bacteriological Examination of 
Poults for Salmonella

    The regulations in Sec.  147.17 set out a recommended procedure for 
the bacteriological examination of cull chicks for Salmonella. The U.S. 
Sanitation Monitored program for meat-type turkeys in Sec.  145.43(f) 
requires that poults that die within 10 days of hatching be examined 
bacteriologically at an authorized laboratory for Salmonella. However, 
there currently exists in the regulations no recommended procedure for 
the bacteriological examination of poults for Salmonella. Since the 
procedure for the bacteriological examination of cull chicks for 
Salmonella in Sec.  147.17 can be used effectively for poults as well, 
we are proposing to amend the regulations to indicate that the 
procedure may be used for poults.

[[Page 35211]]

    As discussed earlier in this document, we are proposing to amend 
the U.S. Sanitation Monitored program for turkeys to require that 10 
poults be sampled and bacteriologically examined if poults are used as 
a sample type. The testing procedure in Sec.  147.17 for cull chicks 
requires that 15 pools (5 organ pools, 5 yolk pools, and 5 intestinal 
pools) be generated from 25 randomly selected 1-to 5-day-old cull 
chicks. One cull chick can provide material for each of the pool types, 
but each pool is required to be created from 5 cull chicks. This would 
be impossible to accomplish with a 10-poult sample size. Accordingly, 
we would indicate that, if poults are tested, two poults should be used 
to generate each of the five organ pools, yolk pools, and intestinal 
pools. We would make other similar amendments to accommodate the 
addition of poults as well. However, we would not make any changes to 
the steps required by the procedure for either cull chicks or poults.

PCR Test for M. gallisepticum and M. synoviae

    The regulations in 9 CFR part 147 currently do not contain any 
molecular examination procedures. However, since PCR testing is now 
routinely used for diagnosing M. gallisepticum and M. synoviae, we 
believe it would be useful to include a recommended laboratory 
procedure for performing such PCR testing in the Plan. Therefore, we 
are proposing to establish a new subpart D in 9 CFR part 147, called 
``Molecular Examination Procedures,'' in order to differentiate the PCR 
test from the blood testing procedures, bacteriological examination 
procedures, and sanitation procedures contained elsewhere in 9 CFR part 
147. Section 147.30 in the new subpart D would set out the recommended 
laboratory procedure for the PCR test for M. gallisepticum and M. 
synoviae. A detailed description of the procedure can be found in the 
rule portion of this document.

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.
    We are proposing to amend 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 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.
    The poultry industry plays an important role in the U.S. economy. 
The industry directly employs about 240,000 workers.\1\ The poultry 
industry is comprised of highly integrated companies that combine 
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 broiler and turkey industries all 
over the globe. Improved genetic products 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 chickens are carefully controlled 
by primary breeding companies.
---------------------------------------------------------------------------

    \1\ USDA/FAS, Export Promotion Increase Employment in U.S. 
Poultry Industry, FASONLINE (http://www.fas.usda.gov/dlp/poultry/success.html), May 6, 2002.
---------------------------------------------------------------------------

    Almost all birds are produced on a contractual basis between the 
company and 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 farmers 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 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 in 2003. Ten States 
(listed in table 5) accounted for over 79 percent of broilers in the 
United States. 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 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 5.--Broilers, Egg-Laying Chickens, and Turkeys: Value by Major States, 2003
----------------------------------------------------------------------------------------------------------------
                   Broilers                           Egg-laying chickens                    Turkeys
----------------------------------------------------------------------------------------------------------------
                                  Value in                          Value in                         Value in
            State                millions of         State         millions of        State         millions of
                                   dollars                           dollars                          dollars
----------------------------------------------------------------------------------------------------------------
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

[[Page 35212]]

 
Other States.................           3,292  Other States....           1,932  Other States...             599
----------------------------------------------------------------------------------------------------------------
    U.S. total...............          15,215  ................           5,315  ...............           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.\2\ 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. Additionally, the United States 
also produced 87.2 billion eggs. 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.\3\
---------------------------------------------------------------------------

    \2\ USDA/ERS, Cash receipts by commodity groups and selected 
commodities, United States, 1997-2003, August 2004.
    \3\ USDA/ERS, Livestock, Dairy and Poultry Outlook/LDP-M-122, 
August 2004.
---------------------------------------------------------------------------

    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.\4\ The major importers 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). These countries altogether accounted for a total of $1,720 
million worth of exports of U.S. poultry. U.S. imports of poultry and 
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.
---------------------------------------------------------------------------

    \4\ USDA/ERS, Foreign Agricultural Trade of the United States, 
September 2004.
---------------------------------------------------------------------------

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 would be affected by this proposal are 
those engaged in production of 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) would be 
positively, at least qualitatively, affected as they would benefit from 
the supply of improved and healthy breeding stock. There were a total 
of 79,600 commercial growers with sales in 2002.\5\ 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 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.
---------------------------------------------------------------------------

    \5\ USDA/NASS, 2002 Census of Agriculture-State Data (Table 13), 
page 356.
---------------------------------------------------------------------------

    This proposed rule would introduce a series of minor changes to the 
NPIP and would 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 would likely involve no additional 
costs in order to meet these requirements. Additionally, the NPIP is a 
voluntary program established between the industry and State and 
Federal governments. Any person producing or dealing in products may 
participate in the NPIP when he or she has demonstrated that his or her 
facilities, personnel, and practices are adequate for carrying out the 
applicable provisions of the NPIP. 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 moving hatching eggs or live birds within States, across State 
lines, and into other countries. The poultry industry plays a very 
important role in the U.S. economy, and the proposed amendments would 
help to ensure the safety of the industry and benefit the economy.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action would 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

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

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 in 9 CFR Parts 145 and 147

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


[[Page 35213]]


    Accordingly, we propose to amend 9 CFR parts 145 and 147 as 
follows:

PART 145--NATIONAL POULTRY IMPROVEMENT PLAN

    1. 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.

    2. Section 145.1 would be amended as follows:
    a. By revising the definition of Authorized Agent to read as set 
forth below.
    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.
* * * * *
    3. In Sec.  145.11, paragraphs (a) and (b) would be 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]

    4. In Sec.  145.12, paragraph (a), the word ``inspected'' would be 
removed and the words ``audited at least one time annually or'' would 
be added in its place.
    5. In Sec.  145.14, in the introductory text of the section, the 
second, third, and fifth sentences would be 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.
* * * * *
    5a. A new Sec.  145.15 would be 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 3 
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 3 
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.
    (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.
    6. In subpart B, the subpart heading would be revised to read as 
follows:

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


Sec.  145.22  [Amended]

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


Sec.  145.23  [Amended]

    8. Section 145.23 would be amended as follows:
    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''.
    b. In paragraph (b)(2)(iii), by adding the word ``Testing'' after 
the word ``Authorized''.
    c. By removing paragraph (b)(5).
    d. By removing and reserving paragraph (c)(1)(i).

[[Page 35214]]

    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''.
    f. By removing and reserving paragraph (e)(1)(i).
    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''.
    h. By removing and reserving paragraph (h)(1).
    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]

    9. Section 145.24 would be amended as follows:
    a. In paragraph (a)(1)(i), by removing the word ``and'' and adding 
the words ``, Sec.  145.73(b)(2)(i) and Sec.  145.83(b)(2)(i)'' before 
the period.
    b. By adding and reserving paragraph (b).
    10. In subpart C, the subpart heading would be revised to read as 
follows:

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


Sec.  145.32  [Amended]

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


Sec.  145.33  [Amended]

    12. Section 145.33 would be amended as follows:
    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,''.
    b. In paragraph (b)(2)(iii), by adding the word ``Testing'' after 
the word ``Authorized''.
    c. By removing paragraph (b)(5).
    d. By removing and reserving paragraph (c)(1)(i).
    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''.
    f. By removing and reserving paragraph (e)(1)(i).
    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''.
    h. By removing and reserving paragraphs (h) and (i).
    i. By removing and reserving paragraph (l)(1).
    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.''
    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]

    Section 145.34 would be amended as follows:
    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)'' 
before the period.
    b. In paragraph (b)(1)(ii), by adding the words ``in accordance 
with Sec. Sec. 1A145.33(c) and 145.83(c)'' after the word ``Clean''.
    14. Section 145.43 would be amended as follows:
    a. In paragraph (b)(2)(iii), by adding the word ``Testing'' after 
the word ``Authorized''.
    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 chapter.
* * * * *
    (7) 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, 
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 
chapter. 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 chapter. 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]

    15. Section 145.53 would be amended as follows:
    a. In paragraph (b)(2)(iii), by adding the word ``Testing'' after 
the word ``Authorized''.
    b. In paragraph (e), in the paragraph heading, by adding the words 
``H5/H7'' before the words ``Avian Influenza''.

[[Page 35215]]

    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.
    16. In Sec.  145.63, paragraph (a)(2) would be 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.
* * * * *
    17. A new Subpart G would be 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 chapter) 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;
    (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 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

[[Page 35216]]

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 chapter 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 chapter.
    (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 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 chapter. 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 chapter, 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 chapter. Cultures from 
positive samples shall be serotyped.
    (viii) Hatching eggs are collected as quickly as possible and are 
handled as described in Sec.  147.22 of this chapter and are sanitized 
or fumigated (see Sec.  147.25 of this chapter).
    (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 chapter, and sanitized either by a 
procedure approved by the Official State Agency or fumigated (see Sec.  
147.25 of this chapter).
    (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 chapter, 
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

[[Page 35217]]

provisions of Sec.  147.26 of this chapter 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 chapter.
    (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]
    18. A new subpart H would be 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 chapter) 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 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 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 chapter, 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

[[Page 35218]]

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 chapter 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 chapter 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 chapter.
    (d) U.S. M. Synoviae Clean. (1) A flock maintained in compliance 
with the provisions of Sec.  147.26 of this chapter 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 chapter 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 chapter.
    (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 
chapter; or
    (B) A sample of chick papers collected and cultured as described in 
Sec.  147.12(c) of this chapter; 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 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 chapter.
    (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 chapter, 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 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 chapter. 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 
chapter.
    (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 chapter, 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 chapter must be 
bacteriologically examined for SE as described in Sec.  147.11 of this 
chapter. 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.

[[Page 35219]]

    (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 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 
(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 chapter;
    (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 chapter and sanitized or 
fumigated (see Sec.  147.25 of this chapter).
    (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 chapter 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 chapter 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:
    (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

    19. 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.


Sec.  147.7  [Amended]

    20. In Sec.  147.7, paragraph (b)(1)(vii), the citation ``Sec.  
147.6'' would be removed and the citation ``Sec.  147.6(a)'' would be 
added in its place.
    21. Section 147.11 would be amended as follows:
    a. In paragraph (a), the introductory text would be revised to read 
as set forth below.
    b. Paragraph (b) would be removed and reserved.


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 4 reactors to the pullorum-typhoid 
tests in the flock, a minimum of 4 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]

    22. In Sec.  147.12, paragraph (b)(3) would be amended by adding 
the words

[[Page 35220]]

``using a PCR-based assay approved by the NPIP under Sec.  145.15'' 
after the word ``enrichment''.
    23. Section 147.17 would be amended as follows:
    a. The section heading, the introductory text of the section, and 
paragraphs (a) and (c) would be revised to read as set forth below.
    b. In paragraph (d), the number ``15'' would be removed.


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.
* * * * *
    24. A new subpart D would be 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:


MG-F    5'      GAG     CTA     ATC    TGT    AAA    GTT    GGT    C
MG-R    5'      GCT     TCC     TTG    CGG    TTA    GCA    AC
 

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


MS-F    5'      GAG     AAG     CAA    AAT    AGT    GAT    ATC    A
MS-R    5'      CAG     TCG     TCT    CCG    AAG    TTA    ACA    A
 

    (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 12th day of June 2006.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 06-5468 Filed 6-16-06; 8:45 am]
BILLING CODE 3410-34-P