[Federal Register Volume 79, Number 18 (Tuesday, January 28, 2014)]
[Proposed Rules]
[Pages 4538-4567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01036]



[[Page 4537]]

Vol. 79

Tuesday,

No. 18

January 28, 2014

Part II





Department of Agriculture





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





Animal and Plant Health Inspection Service





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





9 CFR Parts 56, 145, 146, et al.





National Poultry Improvement Plan and Auxiliary Provisions; Proposed 
Rule

  Federal Register / Vol. 79 , No. 18 / Tuesday, January 28, 2014 / 
Proposed Rules  

[[Page 4538]]


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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 56, 145, 146, and 147

[Docket No. APHIS-2011-0101]
RIN 0579-AD83


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 (NPIP, the Plan) and its auxiliary provisions by removing the 
descriptions of specific tests and sanitation procedures from the 
regulations. Instead, we would require tests to be performed and 
sanitation to be maintained in a manner approved by the Administrator. 
Approved procedures would be listed in an NPIP Program Standards 
document, which we would make available on the NPIP Web site. In 
addition, we are proposing to establish new compartment classifications 
for defined subpopulations of primary breeding turkeys, primary egg-
type chickens, and primary meat-type chickens. We would also provide 
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 2010 and 2012 National 
Plan Conferences. These changes would streamline the provisions of the 
Plan, keep those provisions 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 March 
31, 2014.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2011-0101-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2011-0101, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2011-
0101 or in our reading room, which 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) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Denise Brinson, DVM, Acting 
Director, National Poultry Improvement Plan, VS, APHIS, USDA, 1506 
Klondike Road, Suite 101, Conyers, GA 30094-5104; (770) 922-3496.

SUPPLEMENTARY INFORMATION:

Background

    The National Poultry Improvement Plan (NPIP, also referred to below 
as ``the Plan'') is a cooperative Federal-State-industry mechanism for 
controlling certain poultry diseases. The Plan consists of a variety of 
programs intended to prevent and control poultry diseases. 
Participation in all Plan programs is voluntary, but breeding flocks, 
hatcheries, and dealers must first qualify as ``U.S. Pullorum-Typhoid 
Clean'' as a condition for participating in the other Plan programs.
    The Plan identifies States, flocks, hatcheries, dealers, and 
slaughter plants that meet certain disease control standards specified 
in the Plan's various programs. As a result, customers can buy poultry 
that has tested clean of certain diseases or that has been produced 
under disease-prevention conditions.
    The regulations in 9 CFR parts 145, 146, and 147 (referred to below 
as the regulations) contain the provisions of the Plan. The Animal and 
Plant Health Inspection Service (APHIS, also referred to as ``the 
Service'') of the U.S. Department of Agriculture (USDA, also referred 
to as ``the Department'') amends these provisions from time to time to 
incorporate new scientific information and technologies within the 
Plan.
    The proposed amendments discussed in this document are consistent 
with the recommendations approved by the voting delegates to the last 
two National Plan Conferences, which were held on September 1 and 2, 
2010, and September 25 through 27, 2012. Participants in both National 
Plan Conferences represented flockowners, breeders, hatcherymen, 
slaughter plants, and Official State Agencies from all cooperating 
States.
    We are proposing two major changes to the regulations. One is to 
remove tests and detailed testing procedures, as well as sanitation 
procedures, from the regulations in part 147. The regulations in part 
147 would instead indicate that tests and sanitation procedures must be 
approved by the Administrator and can be found in an NPIP Program 
Standards document. The other is to establish U.S. H5/H7 Avian 
Influenza Clean Compartment and U.S. Avian Influenza Clean Compartment 
classifications for defined subpopulations of primary breeding turkeys, 
primary egg-type breeding chickens, and primary meat-type breeding 
chickens. These changes are the first discussed below. The remaining 
proposed amendments are discussed in the order they would appear in the 
regulations.

Moving Tests and Sanitation Procedures From 9 CFR Part 147 to a Program 
Standards Document

    The NPIP regulations in 9 CFR parts 145 and 146 contain 
requirements that must be observed by flocks that participate in the 
Plan. These requirements include requirements to test poultry for the 
specific disease addressed by each classification in which the flock 
participates. The procedures by which that testing is conducted are 
largely contained in 9 CFR part 147, subparts A, B, and D. Subpart A 
sets out blood testing procedures, subpart B sets out bacteriological 
examination procedures, and subpart D sets out molecular examination 
procedures, which currently include polymerase chain reaction (PCR) 
tests.
    Some of these tests are referred to specifically in 9 CFR parts 145 
and 146. In addition, Sec. Sec.  145.14 and 146.13 contain some 
requirements for the use of various tests in part 147 to determine 
whether flocks are eligible for certain NPIP classifications.
    Subpart C of part 147 contains various sanitation procedures. These 
are set out as guidelines for the production of healthy poultry, 
although some of them are referred to in parts 145 and 146.
    We are proposing to move the tests and sanitation procedures in 
subparts A, B, C, and D of part 147 to an NPIP Program Standards 
document, which would be made available to the public on the NPIP's Web 
site.\1\ We would take public comments on changes to the NPIP Program 
Standards through notices published in the Federal Register, rather 
than through the rulemaking process that we currently use.
---------------------------------------------------------------------------

    \1\ http://www.aphis.usda.gov/animal_health/animal_dis_spec/poultry/
---------------------------------------------------------------------------

    We are proposing to take this action for several reasons. First, 
there are constant changes in the science and technology that go into 
developing effective, efficient tests. In order to have a successful 
voluntary program to

[[Page 4539]]

reduce the incidence of disease in poultry, we need to be able to 
update the NPIP testing procedures when new scientific evidence 
indicates that different procedures can increase the reliability of a 
test, or when new technology is developed to make a test more efficient 
or accurate.
    In addition, new tests are also continually developed that can 
provide valuable alternatives to existing approved tests. For example, 
there has been a great deal of progress in developing PCR tests in 
recent years. Adding such tests allows NPIP participants to take 
advantage of the latest testing technology.
    Similarly, the sanitation procedures used as best practices to 
prevent the introduction or spread of disease in a poultry flock are 
constantly changing, as more information becomes available about 
possible sources of infection and about the effectiveness of various 
means of preventing infection.
    In the past, we have updated the regulations once every 2 years, 
following the biennial Plan Conference. However, with the continual 
changes in diagnostic science and testing technology, and in best 
practices for maintaining sanitation, the biennial update schedule has 
resulted in the regulations becoming out-of-date between updates. When 
this happens, sometimes the Plan's General Conference Committee (GCC) 
approves interim changes to the tests or sanitation procedures in 
accordance with the process outlined in Sec.  147.43(d)(5)(iii).
    However, it would make the program more effective if all 
participants could be made aware of the new tests and sanitation 
procedures as soon as possible, by updating a document recognized in 
the regulations as a resource for tests and sanitation procedures. 
Moving the testing and sanitation procedures to an NPIP Program 
Standards document, and replacing those procedures in the regulations 
with performance standards as described below, would allow for quicker 
updates to the allowed testing and sanitation procedures while 
continuing to allow for public comment on the testing and sanitation 
procedures. This would potentially make those updates available to 
producers and others 2 years or more earlier than they could be made 
available through the rulemaking process we currently use.
    Finally, tests can be difficult to render in the regulations. The 
current regulations in Sec. Sec.  147.11 and 147.12, for example, 
contain diagrams and flowcharts that are part of larger processes, all 
of which require several pages to describe in narrative format. We 
believe that it that would be easier to understand some of our tests if 
they were laid out in another fashion, which would be possible in an 
NPIP Program Standards document.
    The regulations in parts 145 and 146 currently refer to specific 
sections within part 147. We are proposing to revise these references 
to state more generally that tests must be conducted and sanitation 
must be maintained in accordance with part 147. For example, we are 
proposing to replace references to conducting egg yolk testing for 
Mycoplasma in accordance with Sec.  147.8 with references to conducting 
such testing in accordance with 9 CFR part 147 generally. We are 
proposing to replace references to maintaining flocks in Mycoplasma 
classifications in compliance with the Mycoplasma and Salmonella 
sanitation procedures in Sec.  147.26 with references to maintaining 
the flock in accordance with part 147 with respect to Mycoplasma 
isolation, sanitation, and management. Similar changes would be made 
with respect to other tests and sanitation procedures. The specific 
changes we are proposing to make are set out in the regulatory text at 
the end of this document.
    In subparts A, B, and D of part 147, we are proposing to indicate 
that blood testing, bacteriological examination, and molecular 
examination must be conducted in a manner approved by the 
Administrator. We would further state that approved testing procedures 
are listed in the NPIP Program Standards and that testing procedures 
may also be approved by the Administrator, as described in provisions 
we are proposing to add to subpart F of part 147. Subpart C would 
contain a similar placeholder for sanitation procedures.
    Subpart F of part 147 currently sets out procedures for approving 
authorized laboratories (in Sec.  147.51) and for approving diagnostic 
test kits that are not licensed by the Service (in Sec.  147.52). We 
are proposing to reorganize this subpart and add a new section 
indicating where to find tests and sanitary procedures and how they are 
approved.
    In our proposed reorganization, a new Sec.  147.51 would set out 
definitions of key terms. Administrator, Animal and Plant Health 
Inspection Service (APHIS), Plan or NPIP, and NPIP Technical Committee 
would be defined as they are elsewhere in the regulations. We are also 
proposing to define NPIP Program Standards as a document that contains 
tests and sanitation procedures approved by the Administrator in 
accordance with proposed Sec.  147.53 for use under the regulations in 
parts 145 and 146. The definition would indicate that this document may 
be obtained from the NPIP Web site at http://www.aphis.usda.gov/animal_health/animal_dis_spec/poultry/ or by writing to the Service 
at National Poultry Improvement Plan, APHIS, USDA, 1506 Klondike Road, 
Suite 101, Conyers, GA 30094. We would add this definition to Sec.  
145.1 as well, as amendments to that part make it necessary to refer to 
the NPIP Program Standards in part 145.
    Proposed Sec.  147.52 would contain the current provisions for 
approving authorized laboratories, although rather than referring to 
the laboratories' ability to perform tests in accordance with part 147, 
the regulations would refer to performing tests in accordance with the 
NPIP Program Standards or other tests approved by the Administrator in 
accordance with proposed Sec.  147.53. (We are also proposing to make 
some changes to this section that are unrelated to the removal of tests 
from the regulations; these other changes are discussed later in this 
document.)
    Proposed Sec.  147.53 would describe where approved tests and 
sanitation procedures could be found and the process for changing them. 
Paragraph (a) of proposed Sec.  147.53 would set out performance 
standards for the approval tests and sanitation procedures. Paragraph 
(a)(1) would indicate that all tests that are used to qualify flocks 
for NPIP classifications must be approved by the Administrator as 
effective and accurate at determining whether a disease is present in a 
poultry flock or in the environment. Paragraph (a)(2) would indicate 
that all sanitation procedures performed as part of qualifying for an 
NPIP classification must be approved by the Administrator as effective 
at reducing the risk of incidence of disease in a poultry flock or 
hatchery.
    Paragraph (b) of proposed Sec.  147.53 would indicate that tests 
and sanitation procedures that have been approved by the Administrator 
may be found in the NPIP Program Standards. In addition, paragraph (b) 
would indicate that 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 the NPIP Program 
Standards are approved for use in the NPIP. This provision is found in 
current Sec.  147.52(a).
    Under paragraph (c) of proposed Sec.  147.53, any new tests and 
sanitation procedures, or changes to existing tests and sanitation 
procedures, that have been approved by the NPIP in accordance with the 
process described in 9 CFR part 147 subpart E would be

[[Page 4540]]

approved by the Administrator. Subpart E describes the process 
currently used to consider changes to the NPIP regulations and to other 
aspects of the NPIP. As noted earlier, it includes provisions for 
making immediate changes to tests or sanitation procedures when 
necessary. Proposed paragraph (c) would indicate that NPIP participants 
may submit new tests and sanitation procedures, or changes to current 
tests and sanitation procedures, through that process.
    Proposed paragraph (d) of Sec.  147.53 would describe the processes 
for submitting other tests or sanitation procedures for approval by the 
Administrator and the NPIP Technical Committee. The NPIP Technical 
Committee is made up of technical experts on poultry health, 
biosecurity, surveillance, and diagnostics. The committee consists of 
representatives from the poultry and egg industries, universities, and 
State and Federal governments and is appointed by the Senior 
Coordinator and approved by the GCC. The Technical Committee conducts 
primary review of tests and sanitation procedures submitted at NPIP 
conferences. The process described in proposed paragraph (d) would be 
an alternative process for interested persons who do not want to or 
cannot submit their ideas for changes at an NPIP conference.
    Under proposed paragraph (d), persons who wish to have a test or 
sanitation procedure approved by the Administrator would be able to 
apply for approval by submitting the test or sanitation procedure, 
along with any supporting information and data, to the NPIP. Upon 
receipt of such an application, the Technical Committee would review 
the test or sanitation procedure and any supporting information and 
data supplied with the application. If the Administrator and the 
Technical Committee determine the test or sanitation procedure to be of 
potential general use, the Administrator would submit the test or 
sanitation procedure for consideration by the GCC of the NPIP in 
accordance with subpart E of part 147, and the Administrator would 
respond with approval or denial of the test or sanitation procedure.
    Proposed paragraph (e) would describe the procedure for taking 
public comment on changes to the Program Standards. When the 
Administrator approves a new test or sanitation procedure or a change 
to an existing test or sanitation procedure, APHIS would publish a 
notice in the Federal Register making available the test or sanitation 
procedure. The notice would also provide for a public comment period, 
typically of 60 days.
    After the close of the public comment period, APHIS would publish a 
notice in the Federal Register indicating that the test or sanitation 
procedure will be added to the NPIP Program Standards, or that the NPIP 
Program Standards will be updated to reflect changes to an existing 
test or sanitation procedure, if:
     No comments were received on the notice;
     The comments on the notice supported the action described 
in the notice; or
     The comments on the notice were evaluated but did not 
change the Administrator's determination that approval of the test or 
sanitation procedure is appropriate based on the standards in proposed 
Sec.  147.53(a).
    If comments indicate that changes should be made to the test or 
sanitation procedure as it was made available in the initial notice, 
APHIS will publish a notice in the Federal Register indicating that 
changes were made to the initial test or sanitation procedure.
    Whenever APHIS adds or makes changes to tests or sanitation 
procedures, APHIS will make available a new version of the NPIP Program 
Standards that reflects the additions or changes. The new version of 
the NPIP Program Standards would also be available on the NPIP Web 
site.
    If comments present information that causes the Administrator to 
determine that approval of the test or sanitation procedure would not 
be appropriate, APHIS will publish a notice informing the public of 
this determination after the close of the comment period.
    We are proposing to move the provisions for approval of test kits 
from Sec.  147.52 to Sec.  147.54. As noted earlier, proposed Sec.  
147.53 would include the provisions currently found in Sec.  147.52(a), 
meaning it would not be necessary to include Sec.  147.52(a) in 
proposed Sec.  147.54. Instead, paragraph (b) of Sec.  147.52 would 
become the entire text of Sec.  147.54.
    Paragraph (c) of current Sec.  147.52 lists specific test kits that 
have been approved for use. We would move this list to the NPIP Program 
Standards, and a new paragraph (f) would indicate that the list of 
approved test kits could be found in that document.
    We believe these changes would make it easier for APHIS, Official 
State Agencies, and the poultry industry to implement timely changes to 
tests and sanitation procedures, while continuing to make those 
procedures publicly available in an easily accessible document. We 
welcome public comment on this approach.
    At the 2010 NPIP Plan Conference, attendees approved some changes 
to existing tests and sanitation procedures in part 147, as well as two 
new molecular examination procedures and a new set of sanitation 
procedures. (The last of these is discussed briefly under the next 
heading in this document.)
    At the 2012 NPIP Plan Conference, attendees approved a laboratory 
procedure to establish inter-laboratory equivalence for molecular 
identification of Plan diseases sampled in the poultry upper 
respiratory tract; amendments to current approved molecular examination 
procedures to allow for the use of equally effective diagnostic 
procedures; new diagnostic test kits; and a statement on the use of 
cloacal swabs from waterfowl as specimens for the reverse real-time PCR 
assay in certain circumstances.
    If this proposed rule is finalized and the regulations are revised 
to remove tests and sanitation procedures, we will include the changes 
to existing tests and sanitation procedures and the new tests and 
sanitation procedures that were approved at the 2010 and 2012 Plan 
Conferences in the NPIP Program Standards. We are providing a draft 
version of the Program Standards that contains these new or revised 
tests and sanitation procedures, as well as the existing tests and 
sanitation procedures, to the public for review and comment. It is 
available on Regulations.gov (see ADDRESSES above for instructions on 
accessing Regulations.gov).

U.S. Avian Influenza Clean Compartment Classifications for Defined 
Subpopulations of Poultry

    We are proposing to establish a new U.S. H5/H7 Avian Influenza 
Clean Compartment classification for defined subpopulations of primary 
breeding turkeys and new U.S. Avian Influenza Clean Compartment 
classifications for defined subpopulations of primary egg-type breeding 
chickens and primary meat-type breeding chickens. These classifications 
are based on the compartmentalization guidelines issued by the World 
Organization of Animal Health (OIE), an international standard-setting 
body for veterinary health issues in which the United States 
participates. If these Avian Influenza Clean Compartment 
classifications are internationally recognized, they would add an 
option for producers wishing to ensure uninterrupted trade in breeding 
establishment flocks and products in the event of an avian influenza 
(AI) outbreak.
    The OIE defines a compartment as ``an animal subpopulation 
contained in one or more establishments under a

[[Page 4541]]

common biosecurity management system with a distinct health status with 
respect to a specific disease or specific diseases for which required 
surveillance, control and biosecurity measures have been applied for 
the purpose of international trade.'' \2\ An animal subpopulation is 
defined as ``a distinct part of a population identifiable according to 
specific common animal health characteristics,'' in this case a common 
biosecurity level. A subpopulation can be one flock (which the OIE 
defines as ``a number of animals of one kind kept together under human 
control or a congregation of gregarious wild animals'') or can be 
composed of multiple flocks.
---------------------------------------------------------------------------

    \2\ The OIE's Terrestrial Animal Health Code is available for 
review at http://www.oie.int/en/international-standard-setting/terrestrial-code/access-online/. The definition of a compartment is 
contained in the glossary. Other chapters of the Code that are 
relevant to compartmentalization are 4.3, ``Zoning and 
compartmentalisation,'' and 4.4, ``Application of 
compartmentalisation.''
---------------------------------------------------------------------------

    Currently, when outbreaks of H5/H7 AI occur, States impose movement 
restrictions on States or areas within a State that are considered to 
be affected with H5/H7 AI. In addition, other countries may impose 
restrictions on the trade of poultry and poultry products from the 
State or area. In these situations, the remainder of the United States 
is still considered free of the disease. (The OIE refers to any area 
treated separately from another area in a country with respect to a 
disease as a ``zone.'') Individual breeding poultry producers, 
meanwhile, have been able to use the appropriate AI classification to 
demonstrate that their flocks, and the hatching eggs, chicks, and 
poults produced from them, undergo routine serological surveillance for 
AI and are free from disease. However, when there is an outbreak of H5/
H7 AI in a zone (a defined geographical region), all producers within 
the zone are typically considered to be affected with H5/H7 AI, 
regardless of whether the disease is present in their flocks, and are 
thus subject to movement restrictions, including restrictions on export 
of their products.
    As implied above, besides resulting in domestic movement 
restrictions, the presence of H5/H7 AI in a zone can interrupt exports 
from that zone. Although low pathogenicity AI (LPAI) is normally not a 
disease of concern, the H5 and H7 subtypes of LPAI can mutate into 
highly pathogenic AI (HPAI), a serious disease of birds and other 
species, including humans. The OIE refers to H5/H7 LPAI and HPAI 
collectively as notifiable AI (NAI), while the NPIP regulations in part 
145 have historically referred to H5/H7 AI as the subtypes of concern. 
The proposed compartment classifications refer to NAI to be consistent 
with the OIE standards, although the terms are equivalent.
    Although the proposed compartment classifications are concerned 
only with NAI, the classifications' titles would reflect the flock-
level NPIP AI classifications that play crucial roles in the proposed 
compartment classifications: The primary breeding turkey AI 
classification refers to H5/H7 AI, and the primary egg-type breeding 
chicken and meat-type breeding chicken AI classifications refer to AI 
generally.
    As the OIE states, the essential difference between zoning and 
compartmentalization is that the recognition of zones is based on 
geographical boundaries, whereas the recognition of compartments is 
based on epidemiologic boundaries, which are established by management 
practices and biosecurity. The new U.S. Avian Influenza Clean 
Compartment classifications would allow primary breeder companies to 
establish epidemiological boundaries for subpopulations of primary 
breeding turkeys, primary egg-type chickens, and primary meat-type 
chickens by establishing management practices and biosecurity for those 
subpopulations. If recognized as compartments, these subpopulations 
would not be considered to be affected by an NAI outbreak, even if part 
or all of the subpopulation was located within a State or an area 
within a State that was affected with H5/H7 AI, unless required active 
and passive surveillance showed the disease to be present within the 
compartment. For example, if a population of primary breeding turkeys 
located in two States was considered a compartment by our trading 
partners, and an outbreak of NAI occurred in one of those States, 
international trade in the products of that compartment from both 
States could continue uninterrupted. Thus, establishing the U.S. H5/H7 
Avian Influenza Clean Compartment classification for primary breeding 
turkeys and the U.S. Avian Influenza Clean Compartment classifications 
for primary breeding egg-type chickens and meat-type chickens could 
give producers additional options with respect to international trade 
if the compartments are internationally recognized.
    We are proposing to add the compartment classifications to the 
regulations in new Sec. Sec.  145.45, 145.74, and 145.84, for primary 
breeding turkeys, primary egg-type breeding chickens, and primary meat-
type breeding chickens, respectively. In part 145, the existing 
subparts for each of those types of poultry contain sections setting 
out classifications for individual flocks and, in the case of turkeys, 
for States; we believe that new sections with compartment-level 
classifications would help to indicate that the classifications apply 
to entire subpopulations of poultry, and not just individual flocks. 
The compartment provisions described below would be identical for 
turkeys, egg-type chickens, and meat-type chickens, except that 
references to existing flock classifications would be different for 
each type of poultry.
    Proposed paragraph (a) of the new sections would contain the 
provisions of the U.S. H5/H7 Avian Influenza Clean Compartment 
classification for turkeys and the U.S. Avian Influenza Clean 
Compartment classification for egg-type chickens and meat-type 
chickens. The introductory text of paragraph (a) would state that the 
compartment program is intended to be the basis from which the primary 
turkey, egg-type chicken, or meat-type chicken breeding-hatchery 
industry may demonstrate the existence and implementation of a program 
that has been approved by the Official State Agency and the Service to 
establish a compartment consisting of a primary breeding-hatchery 
company that is free of NAI. This compartment would have the purpose of 
protecting the defined subpopulation and avoiding the introduction and 
spread of NAI within that subpopulation by prohibiting contact with 
other commercial poultry operations, other domestic and wild birds, and 
other intensive animal operations. (The last includes such operations 
as swine operations, in which the AI virus can also circulate.)
    Proposed paragraph (a)(1) would set out the conditions for 
definition of the compartment. The primary breeder company seeking to 
establish a compartment would have to define the compartment with 
respect to NAI based on the guidelines established by the OIE in the 
Terrestrial Animal Health Code and the guidelines in proposed paragraph 
(a). Specifically, the company would have to use a comprehensive 
biosecurity program to define the compartment as a subpopulation of 
poultry with a health status for NAI that is separate from birds and 
poultry outside the compartment. The Official State Agency and the 
Service would have to approve all documentation submitted to 
substantiate the defined compartment as adequate to qualify for 
epidemiological separation from other potential sources of infection of 
NAI. Guidelines for the definition of the compartment would include:

[[Page 4542]]

    Definition and description of the subpopulation of birds and their 
health status. All poultry included in the compartment would have to be 
U.S. H5/H7 Avian Influenza Clean in accordance with the classification 
in Sec.  145.43(g) (for turkeys), or U.S. Avian Influenza Clean in 
accordance with the classifications in Sec. Sec.  145.73(f) (for egg-
type chickens) or 145.83(g) (for meat-type chickens). The poultry would 
also have to be located in a State that has an initial State response 
and containment plan approved by APHIS under Sec.  56.10 and that 
participates in the diagnostic surveillance program for H5/H7 LPAI as 
described in Sec.  145.15. States that have this plan and program in 
place are cooperators in the voluntary control program for NAI. Within 
the compartment, all official tests for AI, as described in Sec.  
145.14(d), would have to be conducted in NPIP authorized laboratories 
or in State or Federal laboratories.
    In addition, the company would have to provide to the Service upon 
request any relevant historical and current NAI-related data for 
reference regarding surveillance for the disease within the 
compartment. Upon request, the company would also work with the 
Official State Agency to obtain NAI-related data for other bird 
populations located in the State. This would allow APHIS to evaluate 
the previous disease status of the compartment and other bird 
populations located in the State, if necessary.
    Description of animal identification and traceability processes. 
Animal identification and traceability are essential components of a 
rigorous biosecurity and flock management plan. Accordingly, the 
primary breeder company would have to include a description of its 
animal identification and traceability records, including various APHIS 
forms, set and hatch records, egg receipts, and egg/chick invoices for 
the subpopulation. Documentation would also have to include breed 
identification (NPIP stock code). The Service would ensure that an 
effective flock identification system and traceability system are in 
place.
    Definition and description of the physical components or 
establishments of the defined compartment. This documentation would 
establish that the defined compartment is epidemiologically separated 
from other poultry and bird populations. The documentation would have 
to be approved by the Official State Agency and the Service as 
indicating adequate epidemiological separation to maintain the 
compartment's separate health status with respect to NAI. The 
documentation would include descriptions of:
     The physical and spatial factors that separate the 
compartment from surrounding bird populations and affect the 
biosecurity status of the compartment.
     The relevant environmental factors that may affect 
exposure of the birds to AI.
     The functional boundary and fencing that are used to 
control access to the compartment.
     Facilities and procedures to prevent access by wild birds 
and to provide separation from other relevant hosts.
     The relevant infrastructural factors that may affect 
exposure to AI, including the construction and design of buildings or 
physical components, cleaning and disinfection of buildings and 
physical components between production groups with quality assurance 
verification, cleaning and disinfection of equipment, and introduction 
of equipment or material into the compartment.
    Definition and description of the functional relationships between 
components of the defined compartment. Functional relationships between 
components of the compartment would include traffic movement and flow 
at and among premises, personnel movement at and among premises, 
exposure to live bird populations, and any other factors that could 
affect biosecurity of the compartment.
    To address risks associated with functional relationships, all 
physical components of the compartment would have to be maintained in 
compliance with hygiene and biosecurity procedures for poultry primary 
breeding flocks and hatcheries in accordance with 9 CFR part 147. These 
procedures are best practices designed to address possible sources of 
infection within a compartment and to prevent the introduction of 
disease into a compartment. As part of this action, we would establish 
these approved procedures in the sanitation procedures section of the 
NPIP Program Standards. The documentation submitted by the company 
would have to demonstrate the company's consideration of and plan for 
complying with these procedures. In particular, the company would have 
to provide a biosecurity plan for the compartment and all included 
components. The plan would have to include:
     Requirements that company employees and contract growers 
limit their contact with live birds outside the compartment;
     An education and training program for company employees 
and contractors;
     Standard operating procedures for company employees, 
contractors, and outside maintenance personnel;
     Requirements for company employees and non-company 
personnel who visit any premises within the compartment;
     Company veterinary infrastructure to ensure flock 
monitoring and disease diagnosis and control measures;
     Policies for management of vehicles and equipment used 
within the compartment to connect the various premises;
     Farm site requirements (location, layout, and 
construction);
     Pest (insect and rodent) management program;
     Cleaning and disinfection process; and
     Requirements for litter and dead bird removal and/or 
disposal.
    Description of other factors important for maintaining the 
compartment. The company veterinary infrastructure would assess 
sanitary measures, environmental risk factors, and management and 
husbandry practices that relate to the separation of the compartment 
and the health status of the birds contained within the compartment 
that may affect risk of exposure to NAI. This would include internal 
monitoring and auditing systems (e.g. quality assurance and quality 
control programs) to demonstrate the effectiveness of the compartment. 
We would provide the company, upon request, with information on the 
epidemiology of NAI and the associated risk pathways in which the 
components of the compartment are located.
    Based on the documentation provided, as well as any other 
information the Service and the Official State Agency determine to be 
necessary, the Service and the Official State Agency would approve or 
deny the classification of the compartment as U.S. H5/H7 Avian 
Influenza Clean or U.S. Avian Influenza Clean.
    Proposed paragraph (a)(2) would set out requirements for the 
company to maintain the U.S. Avian Influenza Clean Compartment 
classification once it has been established.
    The primary breeder company's management of biosecurity, 
surveillance, and disease control efforts would have to be uniform and 
equivalent among all components that are a part of the compartment. 
Oversight and inspection of these management practices would be 
conducted by the company's licensed, accredited veterinarians. 
Specifically, veterinary

[[Page 4543]]

staff from the Official State Agency and the NPIP would work in 
partnership with licensed, accredited company veterinarians to train 
and certify auditors through Service-approved workshops. The trained 
auditors would conduct biosecurity and operational audits and 
inspections of facilities and components at least once every 2 years to 
ensure the integrity of the compartment. These audits would include 
evaluation of the critical control points and standard operating 
practices within the compartment, verification of the health status of 
the flock(s) contained within the compartment, and examination of the 
biosecurity and management system of the integrated components of the 
compartment.
    The company would also need to maintain its AI Plan classifications 
for all flocks and products that comprise the compartment, continue to 
conduct surveillance for NAI within the compartment in accordance with 
Sec.  145.15, and conduct tests in State and Federal laboratories or in 
NPIP authorized laboratories. Accredited veterinarians would be 
responsible for the enforcement of active and passive surveillance of 
NAI in primary breeder flocks. Baseline health status would have to be 
maintained and documented for all flocks or subpopulations within the 
compartment, indicating the dates and negative results of all avian 
influenza surveillance and monitoring testing, the dates and history of 
last disease occurrence (if any), the number of outbreaks, and the 
methods of disease control that were applied.
    Documentation of surveillance and testing would be maintained in 
the company's database and would be verified as required by the Service 
and/or the Official State Agency, in addition to the reporting required 
for the AI Clean Plan classifications for all flocks and products and 
the reporting required under Sec.  145.15.
    Proposed paragraph (a)(3) would discuss the activities the Service, 
in cooperation with the Official State Agencies, will conduct to 
maintain the compartment once it has been established. This paragraph 
would clearly spell out how APHIS and the Official State Agencies would 
work to ensure the continued integrity of any recognized compartments, 
potentially helping to increase international acceptance of the 
proposed compartment classifications. Generally, the Service's 
responsibilities would include:
     Oversight of the establishment and management of 
compartments;
     Establishment of effective partnerships among the Service, 
the Plan, and the primary breeder industry;
     Approval or denial of classification of compartments as 
U.S. H5/H7 Avian Influenza Clean or U.S. Avian Influenza Clean under 
proposed paragraph (a)(1);
     Official certification of the health status of the 
compartment, and commodities that may be traded from it, through 
participation in the Plan for avian diseases, including the active 
surveillance programs described in Sec. Sec.  145.43(g), 145.73(f), or 
145.83(g), and diagnostic surveillance for H5/H7 LPAI as described in 
Sec.  145.15;
     Conducting audits of compartments at least once every 2 
years to confirm that the primary breeding company's establishments are 
epidemiologically distinct and pathways for the introduction of disease 
into the compartment are closed through routine operational procedures 
and to evaluate and assess the management and husbandry practices 
relating to biosecurity to determine whether they are in compliance 
with hygiene and biosecurity procedures for poultry primary breeding 
flocks and hatcheries in accordance with part 147;
     Providing, upon request, model plans for management and 
husbandry practices relating to biosecurity in accordance with part 
147, risk evaluations in conjunction with the primary breeder industry 
(including disease surveillance such as VS Form 9-4, ``Summary of 
Breeding Flock Participation''), and diagnostic capability summaries 
and systems for initial State response and containment plans in 
accordance with Sec.  56.10;
     Publicizing and sharing compartment information with 
international trading partners, upon request, to establish approval and 
recognition of the compartment, including timeliness and accuracy of 
disease reporting and surveillance measures as described in Sec. Sec.  
145.15 and 145.43(g), 145.73(f), or 145.83(g).
    Proposed paragraph (a)(4) would address emergency response and 
notification. In the case of a confirmed positive of NAI in the 
subpopulation of the compartment, the management of the compartment 
would notify the Service. The Service would immediately suspend the 
status of the compartment. Compartments would be eligible to resume 
trade with importing countries only after the compartment has adopted 
the necessary measures to reestablish the biosecurity level and confirm 
that NAI is not present in the compartment and the Service has 
reevaluated the management and biosecurity measures of the compartment 
and approved said compartment for trade.

Definition of H5/H7 LPAI

    The regulations in 9 CFR part 56 set out conditions for the payment 
of indemnity for costs associated with poultry that are infected with 
or exposed to H5/H7 LPAI and provisions for a cooperative control 
program for the disease. This control program involves APHIS, the 
Official State Agencies that cooperate with APHIS in the administration 
of the Plan, and Cooperating State Agencies. If the Official State 
Agency can enforce the movement restrictions and other provisions of 
part 56, it is the Cooperating State Agency; otherwise, the Cooperating 
State Agency is the State animal health authority. Part 146 of the 
regulations contains various active surveillance programs for H5/H7 
LPAI in commercial poultry. The terms H5/H7 low pathogenic avian 
influenza (LPAI) and H5/H7 LPAI virus infection (infected) are defined 
in Sec. Sec.  56.1 and 146.1.
    We are proposing to make two editorial changes to the current 
definition of H5/H7 LPAI. The definition of this term in Sec.  146.1 
currently indicates that an H5/H7 AI virus can be considered LPAI when 
it has an intravenous pathogenicity index test in 6-week-old chickens 
less than 1.2 or less than 75 percent mortality in 4- to 8-week-old 
chickens infected intravenously. We would amend the definition to 
indicate that the pathogenicity index test can be less than or equal to 
1.2, and to clarify that the virus causes the mortality in the 
intravenously infected chickens.
    The definition of H5/H7 LPAI in Sec.  56.1 omits the criterion of 
less than 75 percent mortality in 4- to 8-week-old chickens infected 
intravenously; we are proposing to add this criterion to the definition 
in Sec.  56.1, with the proposed wording discussed above, and to make 
the same clarification about the pathogenicity index test as we are 
proposing in Sec.  146.1. We are also proposing to add the proposed 
definition of H5/H7 LPAI to Sec.  145.1, which sets out definitions for 
the NPIP programs for commercial breeding poultry, as the term H5/H7 
LPAI is used extensively in 9 CFR part 145.
    Along with providing various diagnostic criteria, the H5/H7 LPAI 
virus infection (infected) definition provides that, in the case of 
isolated serological positive results, H5/H7 LPAI infection may be 
ruled out on the basis of a thorough epidemiological investigation that 
does not demonstrate

[[Page 4544]]

further evidence of H5/H7 LPAI infection, as determined by APHIS.
    We are proposing to amend this definition to indicate that, in the 
case of isolated serological positive results, the Cooperating State 
Agency and the Official State Agency would participate in the 
determination that a thorough epidemiological investigation does not 
demonstrate further evidence of H5/H7 LPAI infection. As these agencies 
cooperate in the administration of the Plan and the H5/H7 LPAI control 
provisions in part 56, it would be appropriate to involve them in 
making such a determination.
    It is not necessary to add this definition to Sec.  145.1, because 
the term ``H5/H7 LPAI infection'' is not used in that part.

Additional Information on Compliance Agreements

    Section 56.4 sets out provisions for determination of indemnity 
amounts, including indemnity provided for cleaning and disinfection of 
premises, conveyances, and materials that came into contact with 
poultry that are infected with or exposed to H5/H7 LPAI. When indemnity 
is requested for disposal of poultry, the regulations in paragraph 
(a)(2) of Sec.  56.4 require that disposal be performed under a 
compliance agreement between the claimant, the Cooperating State 
Agency, and APHIS. Similarly, when indemnity is requested for cleaning 
and disinfection of premises, conveyances, and materials or for 
disposal of those articles, the regulations in Sec.  56.4(c) require 
that such activities be performed under a compliance agreement. 
Requiring such activities to be performed under compliance agreements 
ensures that the claimant, the Cooperating State Agency, and APHIS have 
a common understanding of what work is to be performed before that work 
is undertaken and indemnity is requested for it.
    The current regulations do not specify anything about the 
compliance agreement beyond the fact that it must exist for certain 
costs to be eligible for indemnification. In the course of responding 
to H5/H7 LPAI outbreaks, we have developed some more specific 
requirements for compliance agreements to ensure that they effectively 
document the activities eligible for indemnity and include other 
information necessary for the prompt payment of indemnity. We are 
proposing to add a new paragraph (d) to Sec.  56.4 to set out 
requirements for a compliance agreement, to ensure a common 
understanding of what information a compliance agreement must contain 
and how it will be used.
    Paragraph (d) would state that the compliance agreement is a 
comprehensive document that describes the depopulation, disposal, and 
cleaning and disinfection plans for poultry that were infected with or 
exposed to H5/H7 LPAI, or a premises that contained such poultry. It 
would also indicate that the compliance agreement sets out APHIS 
responsibilities, owner responsibilities, and Cooperating State Agency 
responsibilities. The compliance agreement would have to include the 
owner's name and the name and address of the affected premises. The 
compliance agreement would have to have signatories that include, but 
are not necessarily limited to, the owner, the grower (if applicable), 
the Cooperating State Agency representative, the State veterinarian, 
and the APHIS area supervisor. Concurrence from these parties would 
help to prevent misunderstandings.
    In addition, the compliance agreement would be required to contain 
a flock plan with estimated cost breakdowns that include labor, 
materials, personal protective equipment, travel expenses for personnel 
involved, and any additional information deemed necessary by the 
Service. This would ensure a common understanding of the activities to 
be performed under the compliance agreement.
    A compliance agreement is typically submitted in multiple stages as 
work is undertaken, as changing circumstances can necessitate changes 
in the compliance agreement. However, it is important that the final 
compliance agreement be submitted promptly to APHIS so that indemnity 
can be paid promptly. Accordingly, we would require the final 
compliance agreement to be submitted to the Service no later than 30 
days after the premises is released from quarantine for H5 or H7 LPAI.

Controlled Marketing

    Section 56.5 sets out provisions for destruction and disposal of 
poultry and cleaning and disinfection of premises, conveyances, and 
materials in the event of an H5/H7 LPAI outbreak. Paragraph (c)(1) of 
Sec.  56.5 provides that, at the discretion of the Cooperating State 
Agency and APHIS, poultry that has been infected with or exposed to H5/
H7 LPAI can be moved for controlled marketing in accordance with the 
initial State response and containment plan described in Sec.  56.10, 
if they are not moved until 21 days after the acute phase of the 
infection and if they are tested within 7 days of movement and found to 
be free of the virus.
    We are proposing to remove the requirement that poultry may only be 
moved for controlled marketing after 21 days have passed since the 
acute phase of the infection. As LPAI is by definition a low 
pathogenicity disease, it can be difficult to determine the exact acute 
phase of the infection. Determining the acute phase has caused serious 
delays in the marketing of LPAI-infected and -exposed flocks.
    If States want to permit controlled marketing in the event of an 
LPAI outbreak, States are required to include provisions for it in 
their initial State response and containment plans for LPAI. (Section 
56.10 sets out the requirements for initial State response and 
containment plans.) Such provisions must include adequate safeguards to 
prevent the transmission of the virus from the flock to be moved for 
controlled marketing, and we are proposing to add two new requirements 
to paragraph (c) of Sec.  56.5 to ensure that flocks moved for 
controlled marketing do not spread the virus. Most importantly, the 
flocks would still need to be tested within 7 days of movement and 
found to be free of the virus. We believe these constitute adequate 
safeguards against the spread of LPAI virus. We would replace the 21-
day requirement with a requirement that the poultry may not be 
transported for controlled marketing until approved by the Cooperating 
State Agency in accordance with the initial State response and 
containment plan.
    We are proposing to add two requirements to the existing controlled 
marketing requirements, in new paragraphs (c)(1)(iii) and (c)(1)(iv). 
Proposed paragraph (c)(1)(iii) would require that poultry moved for 
controlled marketing be moved to slaughter along routes that avoid 
other commercial poultry operations whenever possible. It would also 
require all load-out equipment, trailers, and trucks used on premises 
that have housed poultry that were infected with or exposed to H5/H7 
LPAI to be cleaned and disinfected and not enter other poultry premises 
or facilities for 48 hours after removing such poultry from their 
premises. These requirements would reduce the risk that poultry and 
equipment moved for controlled marketing would spread H5/H7 LPAI to 
other poultry premises or facilities.
    Proposed paragraph (c)(1)(iv) would require poultry moved for 
controlled marketing to be the last poultry marketed during the week 
they are marketed. Marketing poultry moved for controlled marketing at 
the end of the

[[Page 4545]]

week gives the marketer the weekend to conduct thorough cleaning and 
disinfection of the market premises, to further mitigate the risk of 
H5/H7 LPAI transmission. It also minimizes cross traffic with other 
poultry arriving at the plant.

Updates to Cleaning and Disinfection Guidelines for H5/H7 LPAI

    Paragraph (d) of Sec.  56.5 sets out guidelines for the development 
of a cleaning and disinfection plan for a premises and the materials 
and conveyances on that premises. We are proposing several updates to 
those guidelines based on our experience conducting cleaning and 
disinfection for H5/H7 LPAI and on the latest scientific information 
regarding the disease.
    We note that not all of the guidelines may be applicable to all 
premises. The initial State response and containment plans for H5/H7 
LPAI described in Sec.  56.10 are expected to provide cleaning and 
disinfection plans tailored to poultry production conditions in each 
State. Nevertheless, the guidelines in paragraph (d) provide a general 
model for the development of cleaning and disinfection plans in the 
initial State response and containment plans, which is why it is 
important to update them.
    Paragraph (d)(1) provides guidelines for preparing for cleaning and 
disinfection. Paragraph (d)(1)(i) recommends that persons conducting 
cleaning and disinfection secure and remove all feathers that might 
blow around outside the house in which the infected or exposed poultry 
were held by raking them together and burning the pile. We are 
proposing to indicate that any debris should be secured as well, and 
that these materials should not be raked together and burned but rather 
gathered and pushed into the affected poultry house. This would allow 
the feathers and other materials to be addressed in the confined space 
of the house at the same time as the materials found inside the house, 
reducing the risk of spreading H5/H7 LPAI.
    Paragraph (d)(1)(iii) recommends that the house in which the 
poultry were held be closed, maintaining just enough ventilation to 
remove moisture, and heated to 100[emsp14][deg]F to begin composting. 
After this, the house should be left undisturbed for a minimum of 21 
days and as long as possible thereafter to allow as much H5/H7 LPAI 
virus as possible to die a natural death. Paragraph (d)(1)(iv) then 
recommends that the house be reheated to 100[emsp14][deg]F for the 72 
hours prior to cleaning and disinfection. However, the initial heating 
to 100[emsp14][deg]F, the 21-day period, and the subsequent reheating 
are not necessary, given current knowledge about the time the virus can 
survive outside of its host and the environmental requirements for its 
survival. Leaving the house undisturbed for 72 hours, rather than for 
21 days and without any heating requirements, would kill H5/H7 LPAI 
virus that may be present in the house and in any feathers and debris 
collected in the house. Therefore, we are proposing to indicate that 
the house should be left undisturbed for a minimum of 72 hours, and we 
would not indicate that the house should be heated before this period 
or reheated prior to cleaning and disinfection.
    Paragraph (d)(2) of Sec.  56.5 provides guidelines for the cleaning 
and disinfection process. Paragraph (d)(2)(i) addresses disposal of 
manure, debris, and feed. The paragraph indicates that manure, debris, 
and feed should be composted in the house if possible. We are proposing 
to amend this guideline to indicate that windrowing should be the 
composting method used when composting is possible. Windrowing (piling 
the material to be composted into long rows) is suitable to composting 
large volumes of material, if necessary, and also allows for turning 
the composted material if necessary to increase the effectiveness of 
the composting.
    The paragraph goes on to discuss various means of disposal of 
manure, debris, and feed. We are proposing to add a sentence to the 
guidelines indicating that manure, debris, and feed may be composted on 
site, left in an undisturbed pile on site, or removed from the site in 
covered vehicles for disposal. We are also proposing to indicate that 
land application of manure, debris, and feed should only be performed 
in accordance with the initial State response and containment plan for 
H5/H7 LPAI described in Sec.  56.10. Land application can present 
disease and environmental hazards if not performed in accordance with 
approved guidelines.
    Finally, the current guidelines indicate that the house should not 
be cleaned out and litter should not be moved or spread until any H5/H7 
LPAI virus that may have contaminated the manure and litter is dead, as 
determined by the Cooperating State Agency. This conflicts with 
guidance earlier in the paragraph in which a system may be set up for 
moving manure, debris, and feed to an approved site for burial, piling, 
or composting. Instead, we would indicate that houses should be cleaned 
out and litter should be moved or spread only as determined by the 
Cooperating State Agency and in accordance with the initial State 
response and containment plan.
    Paragraph (d)(3) of Sec.  56.5 provides guidelines for activities 
after cleaning and disinfection. It currently indicates that premises 
should be checked for virus before repopulation in accordance with the 
initial State response and containment plan. We are proposing to amend 
this to indicate that premises should remain empty until testing 
provides negative virus detection results and the premises has been 
checked by the Cooperating State Agency in accordance with the initial 
State response and containment plan. The proposed text would indicate 
better what type of check should be made for virus on the premises.

Testing Flocks Before Movement Into Breeder Production Facilities

    In Sec.  145.3, paragraph (c) requires that participants submit 
reports on each breeding flock before the birds in the flock reach 24 
weeks of age, or, in the case of ostriches, emus, rheas, and 
cassowaries, before the birds reach 20 months of age. This report 
includes identifying information, the source of the birds, and the 
intended classification of the birds. However, the Plan currently does 
not contain a requirement that participating flocks be tested for their 
classifications before moving into breeder production facilities.
    It is a common practice in breeding poultry production to move 
pullets (sexually immature domesticated chickens grown for the primary 
purpose of producing hatching eggs) or spiking males (males used to 
increase the fertility of aging breeder hens) from a single poultry 
house to multiple hen houses. The movement of untested pullets and 
spiking males puts the industry at risk for unknowingly spreading Plan 
diseases. Therefore, we are proposing to add a new paragraph (d) to 
Sec.  145.3 that would require flocks to be qualified for their 
intended Plan classifications before being moved into breeder 
production facilities. This proposed change would ensure that poultry 
being moved into breeder production facilities are free of diseases in 
their intended Plan classifications.
    In paragraph (c) of Sec.  145.3, we are also proposing to make a 
gender-specific reference gender-neutral and to add the word ``and'' to 
a series currently written as ``ostriches, emus, rheas, cassowaries.''

Avian Influenza Testing

    In Sec.  145.14, which discusses approved tests for breeding 
poultry and commercial poultry, paragraph (d) sets

[[Page 4546]]

out official tests for AI. In Sec.  146.13, which discusses approved 
tests for commercial poultry, paragraph (b) addresses the same topic as 
Sec.  145.14(d).
    Approved antibody detection tests for AI are set out in paragraph 
(d)(1) of Sec.  145.14 and (b)(1) of Sec.  146.13. One of these tests 
is the agar gel immunodiffusion (AGID) test. While this test is 
reliable for most poultry, it is not reliable for waterfowl. Because 
the regulations do not currently reflect this, we are proposing to add 
a statement that the AGID test is not recommended for use in waterfowl.
    Paragraph (d)(2)(ii) of Sec.  145.14 and paragraph (b)(2)(ii) of 
Sec.  146.13 discuss testing for AI with a USDA-licensed type A 
influenza antigen capture immunoassay (ACIA). These paragraphs indicate 
that positive results from the ACIA must be further tested by Federal 
Reference Laboratories using appropriate tests for confirmation. The 
ACIA test, a screening test typically used on chicken and turkey 
flocks, is rapid and sensitive but can result in false positives. 
Conducting another confirmatory test before submitting to a Federal 
Reference Laboratory would ensure that fewer false positive results are 
submitted to Federal Reference Laboratories.
    Therefore, we are proposing to amend Sec. Sec.  145.14(d)(2)(ii)(B) 
and 146.13(b)(2)(ii)(B) to require all chicken and turkey flocks that 
test positive on the ACIA to be retested using the real-time reverse 
transcriptase/polymerase chain reaction assay (RRT-PCR) or using virus 
isolation. If those tests are positive for AI, those results would be 
further tested by Federal Reference Laboratories for confirmation.
    We are proposing to make one other minor change to the AI testing 
requirements. Paragraphs (d)(2)(i) of Sec.  145.14 and paragraph 
(b)(2)(i) of Sec.  146.13 both require the RRT-PCR to be conducted 
using the National Veterinary Services Laboratories (NVSL) official 
protocol for the RRT-PCR, which has been numbered AVPR01510. However, 
NVSL now uses a new numbering system, meaning the number of the 
official protocol has changed, and it may change again in the future. 
To ensure that the regulations do not point to an incorrect protocol 
number, we are removing the protocol number from the regulations in 
Sec. Sec.  145.14(d)(2)(i) and 146.13(b)(2)(i).

Nest Clean Hatching Eggs for Breeding Chickens

    The regulations in Sec. Sec.  145.22, 145.32, 145.72, and 145.82 
provide requirements for participation in the NPIP for multiplier egg-
type breeding chickens, multiplier meat-type breeding chickens, primary 
egg-type breeding chickens, and primary meat-type breeding chickens, 
respectively. Paragraph (b) of each of these sections requires hatching 
eggs produced by these flocks to be fumigated according to the 
procedure in Sec.  147.25 or otherwise sanitized.
    Eggs that are collected from nests frequently, to keep them clean 
without further processing, are known in the poultry industry as ``nest 
clean'' eggs. In recent years, the chicken industry has found that nest 
clean eggs hatch better and provide a better chick than other eggs, 
even when they are sanitized. Consequently, it has become standard 
practice in both the egg-type and meat-type industries to avoid 
sanitizing eggs and instead insist on nest clean eggs.
    To recognize this practice, we are proposing to amend Sec. Sec.  
145.22(b), 145.32(b), 145.72(b), and 145.82(b) to state that hatching 
eggs produced by the relevant flocks should be nest clean, and that 
they may be fumigated in accordance with part 147 or otherwise 
sanitized.

Changes to AI Clean Programs for Egg-Type Chicken Breeding Flocks

    The regulations set out requirements for the U.S. Avian Influenza 
Clean classification for multiplier egg-type chicken breeding flocks 
and primary egg-type chicken breeding flocks in Sec. Sec.  145.23(h) 
and 145.73(f), respectively. We are proposing to amend certain 
provisions in these programs and revise their requirements for spent 
fowl testing.
    After breeding chickens are no longer productive, they are moved to 
slaughter to capture their meat value. This movement provides an 
opportunity for additional testing to verify a breeding flock's AI 
Clean status. Currently, paragraph (h)(2) of Sec.  145.23 and paragraph 
(f)(2) of Sec.  145.73 require that, during each 90-day testing period, 
all spent fowl up to a maximum of 30 must be tested and found negative 
within 21 days prior to movement to slaughter. Rather than requiring up 
to 30 spent fowl to be tested, we are proposing to require instead the 
testing of a sample of at least 11 birds prior to movement to 
slaughter. Generally, the entire flock of egg-type breeding chickens 
will be moved to slaughter at one time. Testing 11 birds per flock is 
consistent with the testing requirements for meat-type commercial 
chickens moved to slaughter under the U.S. H5/H7 Avian Influenza 
Monitored program in Sec.  146.33, and would provide adequate assurance 
that the flock is free of AI.
    In addition, both the multiplier and primary egg-type chicken AI 
Clean programs indicate that to qualify for the classification, a 
minimum of 30 birds must be tested negative for antibodies to AI when 
more than 4 months of age. We are proposing to clarify that the birds 
must be tested and found negative. We are also proposing to remove the 
words ``for antibodies,'' as some tests approved in Sec.  145.14 for AI 
do not test for antibodies but rather for the AI virus itself; this 
change would allow participants in these AI Clean programs the 
opportunity to use all of the tests approved in Sec.  145.14 to qualify 
for these programs.

Changes to AI Clean Programs for Meat-Type Chicken Breeding Flocks

    The regulations set out requirements for the U.S. Avian Influenza 
Clean classification for multiplier meat-type chicken breeding flocks 
and primary meat-type chicken breeding flocks at Sec. Sec.  145.33(l) 
and 145.83(g), respectively. We are proposing to amend certain 
provisions in these programs and revise their requirements for spent 
fowl testing, although not in the same way as for egg-type chickens.
    Paragraph (l)(1) of Sec.  145.33 and paragraph (g)(1) of Sec.  
145.83 require that, to qualify for the classification, a minimum of 30 
birds from the flock test negative for antibodies to AI when more than 
4 months of age. We are proposing to clarify the requirement for 
testing by indicating that the testing must be conducted using an 
approved test described in Sec.  145.14.
    Currently, paragraph (h)(2) of Sec.  145.23 and paragraph (f)(2) of 
Sec.  145.73 require that, during each 90-day testing period, all spent 
fowl up to a maximum of 30 must be tested and found negative within 21 
days prior to movement to slaughter. We are proposing to make two 
changes to this requirement. First, we would require that the spent 
fowl be tested serologically for AI, rather than using the agent 
detection tests listed in paragraph (d)(2) of Sec.  145.14, and we 
would clarify that the spent fowl would have to be found negative for 
antibodies to AI. This would make the requirement for testing of spent 
fowl consistent with the other requirements in the AI Clean programs 
for primary and multiplier meat-type chickens, which refer to 
serological testing for antibodies to the virus. Second, we would 
require the spent fowl to be tested 21 days prior to slaughter, rather 
than prior to movement to slaughter. This would reduce delays 
associated with marketing spent fowl while continuing to provide 
testing to assure the flock's AI Clean status.

[[Page 4547]]

New U.S. Salmonella Enteritidis Monitored Classification for Multiplier 
Meat-Type Breeding Chickens

    We are proposing to establish in Sec.  145.33 a new U.S. Salmonella 
Enteritidis Monitored classification for multiplier meat-type breeding 
chickens. The classification would be added in a new paragraph (m). 
This classification would be intended for multiplier meat-type breeders 
wishing to monitor their breeding flocks for Salmonella enteritidis 
(SE). As SE is both a poultry health and a public health concern, 
participants would also combine data to help guide decisionmaking on 
addressing SE and to provide overall data for outside organizations on 
the prevalence of SE in multiplier meat-type breeding chickens.
    A flock and the hatching eggs and chicks produced from it would be 
eligible for this classification if they meet the following 
requirements, as determined by the Official State Agency:
     The flock originated from a U.S. S. Enteritidis Clean 
primary meat-type breeding flock.
     The flock is maintained in accordance with 9 CFR part 147 
with respect to Salmonella isolation, sanitation, and management.
     Environmental samples are collected from the flock in 
accordance with 9 CFR part 147 at 16-18 and 40-45 weeks of age. The 
samples would have to be examined bacteriologically for group D 
Salmonella at an authorized laboratory, and cultures from group D 
positive samples would be serotyped.
    The following actions would have to be taken with respect to the 
test results that are generated from the proposed SE monitoring 
program:
     If SE is isolated from an environmental sample, a thorough 
evaluation of the practices and programs associated with the sampled 
flock would have to be conducted with the goal of ascertaining the 
reason(s) for the positive finding.
     The test results and the results of any evaluations after 
SE is isolated from an environmental sample would be reported on a 
quarterly basis to the Official State Agency and the NPIP Senior 
Coordinator.
     Participating broiler integrators would have to combine 
their respective test results (and the results of any associated 
evaluations) to help guide their decisionmaking regarding programs and 
practices to implement or maintain to address SE.
     Aggregate data regarding the prevalence of SE in 
participating U.S. meat-type parent breeding flocks would be made 
available to the U.S. Poultry and Egg Association and the National 
Chicken Council. Those bodies could use these data to better inform and 
guide their discussions on this topic with regulators and consumers.
    This classification could be revoked by the Official State Agency 
if the participant fails to comply with the requirements of this 
classification. The Official State Agency would 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.

Changes to U.S. M. Synoviae Clean Classification for Breeding Turkey 
Flocks

    Paragraph (e) of Sec.  145.43 sets out requirements for the U.S. M. 
Synoviae Clean classification for turkey breeding flocks. Paragraphs 
(e)(1) and (e)(2) set out testing requirements for participating flocks 
to demonstrate that they are free of Mycoplasma synoviae. Paragraph 
(e)(3) sets out an alternative path to qualifying for the 
classification. Under this paragraph, flocks located on premises which, 
during 3 consecutive years, have contained breeding flocks qualified as 
U.S. M. Synoviae Clean, as described in paragraph (e)(1) of Sec.  
145.43, may qualify for this classification by a negative blood test of 
at least 100 birds from flocks of more than 100 and each bird in flocks 
of 100 or less, when more than 12 weeks of age, and by testing a 
minimum of 30 samples from male flocks and 60 samples from female 
flocks at 28-30 weeks of age and at 45 weeks of age.
    We are proposing to remove this paragraph. M. synoviae is difficult 
to diagnose in breeding turkeys, with few if any clinical signs. For 
this reason, we believe that samples should be collected from breeding 
turkeys and testing performed for this bacterium no less than every 4 
to 6 weeks, as required in paragraph (e)(1) of this classification. 
Removing the option to qualify with less frequent testing in paragraph 
(e)(3) will help to validate the M. Synoviae Clean status of 
participating turkey breeding flocks.
    In addition, we are proposing to add to the end of paragraph 
(e)(1), which describes the testing requirements for this 
classification, a sentence indicating that it is recommended that 
samples be collected from birds with clinical signs of M. synoviae 
infection. Although, as noted earlier, clinical signs of M. synoviae 
infection in turkeys are rare, concentrating testing on any birds that 
do show clinical signs of infection will help to find any M. synoviae 
present in the flock.

Changes to Spent Fowl Testing in U.S. H5/H7 Avian Influenza Clean 
Classification for Breeding Turkey Flocks

    Paragraph (g) of Sec.  145.43 sets out requirements for the U.S. 
H5/H7 Avian Influenza Clean classification for turkey breeding flocks. 
We are proposing to revise its requirement for spent fowl testing. 
Currently, paragraph (g)(3) of Sec.  145.43 requires all spent fowl 
from participating flocks, up to a maximum of 30, to be tested and 
found negative within 21 days prior to movement to slaughter.
    Although paragraph (g) requires testing turkey breeding flocks for 
AI every 90 days, most commercial turkey breeding flocks participating 
in the classification test much more frequently. Given the high level 
of overall surveillance, we believe it is not necessary to test 30 
birds when spent fowl are moved to slaughter. Testing 6 birds per flock 
would be consistent with the testing requirements for meat-type 
commercial turkey flocks moved to slaughter plants participating in the 
U.S. H5/H7 Avian Influenza Monitored program in Sec.  146.43, and would 
provide adequate assurance that the flock is free of AI. Accordingly, 
we are proposing to revise paragraph (g)(3) to require that all spent 
fowl from participating flocks that are being marketed for meat be 
tested at a rate of 6 birds per flock within 21 days prior to movement 
to slaughter. This change would reduce burdens on participating 
flockowners while continuing to assure that H5/H7 AI is not present in 
the flock.

Recommendation for Participating Hobbyist and Exhibition Waterfowl, 
Exhibition Poultry, and Game Bird Breeding Flocks

    Section 145.52 discusses requirements for participation in the Plan 
for hobbyist and exhibition waterfowl, exhibition poultry, and game 
bird breeding flocks. We are proposing to add to these requirements a 
recommendation to keep separate waterfowl flocks and gallinaceous 
flocks (i.e., game birds and other ``land fowl'') that are housed in 
open-air facilities. Waterfowl are the primary reservoir for AI virus, 
and they could easily spread the virus to gallinaceous flocks if they 
are housed in open-air facilities and not kept separate. This would not 
be a requirement to participate, but a recommendation to address a 
potential risk associated with keeping the two types of birds in an 
open-air facility and improve the overall biosecurity of participating 
facilities that have both waterfowl and gallinaceous flocks.

[[Page 4548]]

Changes to U.S. H5/H7 Avian Influenza Clean Classification for Hobbyist 
and Exhibition Waterfowl, Exhibition Poultry, and Game Bird Breeding 
Flocks and Products and for Commercial Waterfowl Breeding Flocks and 
Products

    The regulations in Sec.  145.53 set out classifications for 
hobbyist and exhibition waterfowl, exhibition poultry, and game bird 
breeding flocks and products. Paragraph (e) in Sec.  145.53 sets out 
the U.S. H5/H7 Avian Influenza Clean classification for such poultry.
    We are proposing to amend this classification to provide for the 
testing of cloacal swabs for virus isolation in place of birds for 
primary and multiplier breeding flocks composed of waterfowl. Waterfowl 
are more prone than other avian species to AI enteric carrier status, 
and ducks are somewhat immunologically unresponsive to AI exposure. The 
lack of an immune response in ducks means that antigenic tests that 
determine whether the AI virus itself is present, rather than an immune 
response to it, would provide a more accurate determination of a 
waterfowl breeding flock's AI status. More accurate AI testing would 
also reduce the necessity of frequent antibody serotyping to determine 
whether the AI virus detected in the waterfowl is of the H5 or H7 
subtypes that are the focus of this classification.
    As noted, this subpart includes hobbyist and exhibition poultry. In 
such poultry, the difference between a primary breeding flock and a 
multiplier breeding flock can be less clear than in more commercially 
oriented poultry sectors. While the U.S. H5/H7 Avian Influenza Clean 
program currently requires primary breeding flocks of hobbyist and 
exhibition waterfowl, exhibition poultry, and game birds to be tested 
at 90-day intervals, as opposed to 180 days for multiplier breeding 
flocks of such poultry, we do not believe it is necessary to make a 
distinction between the two types of flocks in this poultry sector. 
Therefore, we are proposing to change the 90-day testing interval for 
primary breeding flocks to be the same as the 180-day interval for 
multiplier breeding flocks. This would make the requirements for 
primary and multiplier breeding flocks identical; we would retain the 
separate sets of requirements to parallel other NPIP classifications.
    In addition, the U.S. H5/H7 Avian Influenza Clean classification 
for hobbyist and exhibition waterfowl, exhibition poultry, and game 
bird breeding flocks and products contains a provision for testing 
spent fowl similar to those discussed earlier in this document. 
Specifically, paragraph (e)(3) requires that, during each 90-day 
period, all spent fowl, up to a maximum of 30, must be tested and found 
negative within 21 days prior to movement to slaughter. The U.S. H5/H7 
Avian Influenza Clean classification for commercial breeding waterfowl, 
in Sec.  145.93(c), contains an identical provision. We are proposing 
to amend both of these classifications to require a sample of at least 
30 birds to be tested prior to movement to slaughter. Testing at this 
level is appropriate for these types of poultry, which are at higher 
risk for AI. We are also proposing to amend the spent fowl testing 
requirements in these classifications to clarify that the spent fowl 
must test negative to H5/H7 AI.
    Finally, in the U.S. H5/H7 Avian Influenza Clean classification for 
commercial breeding waterfowl, the spent fowl requirement refers to the 
fowl being tested serologically. We are proposing to remove the word 
``serologically'' to give commercial waterfowl producers the option to 
use the nonserological tests approved in Sec.  145.13(d).

U.S. Salmonella Monitored Classification for Hobbyist and Exhibition 
Waterfowl, Exhibition Poultry, and Game Bird Breeding Flocks and 
Products

    We are proposing to add a new U.S. Salmonella Monitored 
classification for hobbyist and exhibition waterfowl, exhibition 
poultry, and game bird breeding flocks and products. The classification 
would be added in a new paragraph (f) in Sec.  145.53. This program is 
intended to be the basis from which the hatching industry may conduct a 
program for the prevention and control of salmonellosis. It is intended 
to reduce the incidence of Salmonella organisms in day-old poultry 
through an effective and practical sanitation program in the hatchery. 
This program would afford other segments of the poultry industry an 
opportunity to reduce the incidence of Salmonella in their products.
    Under this classification, an Authorized Agent would collect a 
minimum of five environmental samples, e.g., chick papers, hatching 
trays, and chick transfer devices, from the hatchery at least every 30 
days. Testing would have to be performed at an authorized laboratory. 
To claim products are of this classification, all products would have 
to be derived from a hatchery that meets the requirements of the 
proposed classification. This classification would be revoked by the 
Official State Agency if the participant fails to follow recommended 
corrective measures.
    This change would give hobbyist and exhibition waterfowl, 
exhibition poultry, and game bird breeders an opportunity to 
participate in a formal Salmonella control program.

Changes to U.S. S. Enteritidis Clean Classification for Primary Meat-
Type Breeding Chickens

    We are proposing several changes to the U.S. S. Enteritidis Clean 
classification for primary meat-type breeding chickens, which is found 
in Sec.  145.83(e). These changes are intended to improve the 
sensitivity of testing and the overall ability to detect SE in primary 
breeding flocks with additional hatchery samples.
    Paragraph (e)(1) of the classification states that a flock and the 
hatching eggs and chicks produced from it shall be eligible for this 
classification if the flock originated from a U.S. S. Enteritidis Clean 
flock or if one of two samples has been examined bacteriologically for 
S. enteritidis at an authorized laboratory and any group D Salmonella 
samples have been serotyped. Paragraph (e)(1)(i)(A) provides the option 
of testing a sample of a 25-gram sample of meconium from the chicks in 
the flock, paragraph (e)(1)(i)(B) provides the option of testing a 
sample of chick papers, and paragraph (e)(1)(i)(C) provides the option 
of testing a sample of 10 chicks that died within 7 days after 
hatching.
    We are proposing to remove the option of testing meconium, as it 
does not provide optimal sensitivity to SE. To provide additional 
sensitivity for the environmental testing, we would expand the option 
for testing a sample of chick papers to include hatcher tray swabs or 
fluff. Finally, we are proposing to replace the option of testing a 
sample of 10 chicks that died within 7 days after hatching with an 
option to test samples of intestinal and liver or spleen tissues from a 
minimum of 30 chicks that died within 7 days after hatching and have 
been preserved daily by freezing prior to shipment to an authorized 
laboratory. The additional instructions on the type of tissue to be 
tested and its method of preservation, and the increase in tested 
samples from 10 to 30, will make the test more sensitive. The proposed 
options are thus better options for qualifying a primary breeding flock 
for the U.S. S. Enteritidis Clean classification than those currently 
in the regulations.
    Paragraph (e)(1)(ii) currently contains requirements for feed used 
in U.S. S. Enteritidis Clean flocks. We are proposing to remove these 
requirements, as they have become standard industry practice and it is 
no

[[Page 4549]]

longer necessary to include them in the regulations. We would 
redesignate paragraphs (e)(1)(iii) through (e)(1)(vii) as (e)(1)(ii) 
through (e)(1)(vi).
    Paragraph (e)(1)(iv) currently contains a general requirement to 
collect and test environmental samples after the flock reaches 4 months 
of age to maintain the flock's U.S. S. Enteritidis Clean status. We are 
proposing to add new, more specific requirements for environmental 
testing after the flock is in egg production and chicks are hatching 
from it. Environmental samples collected during egg production would 
have to include at least 4 individual test assay results every 30 days 
in flocks of more than 500 birds or 2 individual test assay results per 
month in flocks of 500 birds or fewer. This requirement would ensure 
that an adequate level of surveillance is conducted. One of these 
results would have to come from samples collected from hatched chicks 
at a participating hatchery derived from the flock. This requirement 
would ensure that the products of the flock are tested for SE on a 
routine basis and would give a better chance of finding any SE 
infection. We would indicate that the individual test assays could be 
derived from pooled samples from the farm or hatchery, but would have 
to be run as separate test assays in the laboratory, to allow the 
results to be traced back to the hatchery samples if necessary.
    We are not proposing to make any changes to the remaining 
requirements currently in paragraph (e)(1) of Sec.  145.83, except to 
reflect moving tests from part 147 to the NPIP Program Standards, as 
discussed earlier.
    Paragraph (e)(3) of Sec.  145.83 sets out followup actions if SE is 
isolated from an environmental sample. Currently, in such 
circumstances, 25 randomly selected live birds from the flock and/or 
500 cloacal swabs must be bacteriologically examined for SE. 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 subjected 
to blood testing each 30 days and no positive samples are found.
    We are proposing to change these requirements to make the required 
testing more sensitive to SE. Instead of testing 25 randomly selected 
live birds or 500 cloacal swabs, we would require both the 
bacteriological examination of an additional environmental sampling and 
25 live cull birds or fresh dead birds (if present), or 25 other 
randomly selected live birds if fewer than 25 cull birds can be found 
in the flock. Requiring the environmental sampling in all cases would 
increase the chances that this followup testing will find SE if it is 
present, and the testing of cull birds or fresh dead birds rather than 
randomly selected birds would concentrate testing on birds most likely 
to be infected. In addition, if the flock with the SE isolation is in 
egg production and eggs are under incubation, the regulations would 
require the next four consecutive hatches to be examined 
bacteriologically. Samples would be collected from all of the hatching 
unit's chick trays and basket trays of hatching eggs, or from all chick 
box papers from the flock, and tested, pooling the samples into a 
minimum of 10 separate assays. Any followup hatchery-positive SE 
isolations would result in discontinuation of subsequent hatches until 
the flock status is determined by bird culture. The flock would be 
disqualified for the U.S. S. Enteritidis Clean classification if a bird 
or subsequent flock environmental assay results in isolation of SE. 
These provisions would provide more certainty regarding the presence of 
SE in the flock than the current provisions do.
    Paragraph (e)(6) of Sec.  145.83 sets out provisions by which a 
pedigree, experimental, or great-grandparent flock that is removed from 
the U.S. S. Enteritidis Clean program may be reinstated to the program. 
We are proposing to make these provisions applicable to grandparent 
flocks as well, as the corrective measures and testing required in that 
paragraph would be equally effective at ensuring that a grandparent 
flock is free of SE as they are for other types of flocks.
    These changes would improve the effectiveness of the U.S. S. 
Enteritidis Clean classification.

New U.S. Salmonella Monitored Classification for Meat-Type Waterfowl 
Breeding Flocks

    Section 145.93 contains various classifications for meat-type 
waterfowl breeding flocks. (This section applies to commercial meat-
type waterfowl breeding flocks, as opposed to the hobbyist and 
exhibition waterfowl breeding flocks covered by Sec.  145.53.) We are 
proposing to add a new U.S. Salmonella Monitored classification for 
meat-type waterfowl breeding flocks and products. The classification 
would be added in a new paragraph (d) in Sec.  145.93.
    The proposed program is intended to be the basis from which the 
meat-type waterfowl 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 day-
old waterfowl through an effective and practical sanitation program at 
the breeder farm and in the hatchery. This would afford other segments 
of the poultry industry an opportunity to reduce the incidence of 
Salmonella in their products.
    A flock and the hatching eggs and day-old waterfowl produced from 
it would have to meet the following requirements, as determined by the 
Official State Agency, to be eligible for this classification:
     The flock would have to be maintained in compliance with 
isolation, sanitation, and management procedures for Salmonella in 
accordance with part 147.
     If feed contains animal protein, the protein products 
would have to have been heated throughout to a minimum temperature of 
190[emsp14][deg]F or above, or to a minimum temperature of 
165[emsp14][deg]F for at least 20 minutes, or to a minimum temperature 
of 184[emsp14][deg]F under 70 lbs. pressure during the manufacturing 
process. These heating requirements would prevent Salmonella from being 
introduced into the flock via feed.
     Feed would have to be stored and transported in a manner 
that prevents contamination.
     Waterfowl would have to be hatched in a hatchery whose 
sanitation is maintained in accordance with part 147 and sanitized or 
fumigated in accordance with part 147.
     An Authorized Agent would take environmental samples from 
the hatchery every 30 days, i.e., meconium or box liner paper. An 
authorized laboratory for Salmonella would examine the samples 
bacteriologically.
     In addition, an Authorized Agent would take environmental 
samples in accordance with part 147 from each flock at 4 months of age 
and every 30 days thereafter, and an authorized laboratory for 
Salmonella would examine the environmental samples bacteriologically.
     Flocks would be allowed to be vaccinated with a 
paratyphoid vaccine (which helps to protect birds against Salmonella), 
provided that a sample of at least 100 birds is segregated and remains 
unvaccinated until the flock reaches at least 4 months of age. 
Requiring some birds to be segregated and unvaccinated would ensure 
that they can be tested for Salmonella without the antibodies from the 
vaccine causing false-positive results.
    The Official State Agency would monitor the effectiveness of the 
egg

[[Page 4550]]

sanitation practices in accordance with part 147. To claim products are 
of this classification, all products would have to be derived from a 
hatchery and flock that meet the requirements of the proposed 
classification. Finally, this classification would be revoked by the 
Official State Agency if the participant fails to follow recommended 
corrective measures.

Clarification of Testing Requirements for Participating Slaughter 
Plants

    Part 146 of the regulations contains the NPIP provisions for 
commercial poultry. Currently, the only disease addressed in this part 
is H5/H7 LPAI; under part 146, table-egg layer flocks, meat-type 
chicken slaughter plants, meat-type turkey slaughter plants, and 
certain types of game birds and waterfowl may participate in U.S. H5/H7 
Avian Influenza Monitored classifications.
    Under subparts C, D, and E of part 146, slaughter plants for 
various types of poultry can participate, provided that they meet 
certain testing requirements. One option available for all types of 
slaughter plants is to slaughter only birds from flocks where a 
specified number of birds have been tested and found negative for H5/H7 
AI no more than 21 days prior to slaughter.
    Section 146.11 sets out the audit process for participating 
slaughter plants. Paragraph (b) states that flocks slaughtered at a 
slaughter plant will be considered to be not conforming to the required 
protocol of the classifications if there are no test results available, 
if the flock was not tested within 21 days before slaughter, or if the 
test results for the flocks were not returned before slaughter.
    We are proposing to amend paragraph (b) to refer to samples being 
collected and tested and to results being returned prior to movement to 
slaughter. These changes would clarify the requirements and make the 
regulations in Sec.  146.11(b) consistent with the relevant U.S. H5/H7 
Avian Influenza Monitored classifications. In addition, it is important 
to have the test results for a flock returned prior to movement to 
slaughter to prevent the flock from being exposed to other, healthy 
birds and possibly requiring cleaning and disinfection at the slaughter 
plant.

Clarifying Testing Requirements for Commercial Table-Egg Layer Pullet 
Flocks and Table-Egg Layer Flocks

    The regulations in Sec.  146.23(a) provide the U.S. H5/H7 Avian 
Influenza Monitored classification for table-egg layer pullet flocks 
and table-egg layer flocks. Separate testing requirements are set out 
for each type of flock in paragraphs (a)(1) and (a)(2), respectively. 
The introductory text for paragraph (a) addresses the table-egg layer 
industry generally, including both table-egg layer pullet flocks and 
table-egg layer flocks. This has caused some confusion. To make it 
clear that each type of flock needs to participate and maintain its 
classification separately, we are proposing to reformat paragraph (a) 
so that it includes introductory text in paragraphs (a)(1) and (a)(2) 
that is specific to each type of flock. The testing requirements would 
remain the same.

Providing for Spent Fowl To Participate in H5/H7 LPAI Control Program 
for Commercial Meat-Type Chickens

    The regulations in part 146 do not provide explicitly for the 
participation of spent fowl. Spent fowl are domesticated poultry, 
typically chickens, that were in production of hatching eggs or 
commercial table eggs and have been removed from such production. 
Although they were not raised for the primary purpose of meat 
production, such fowl no longer have value as layers and thus are 
slaughtered for meat at meat-type chicken slaughter plants.
    However, the special provisions for the participation of meat-type 
chicken slaughter plants in subpart C of part 146 (Sec. Sec.  146.31 
through 146.33) define meat-type chicken as a domesticated chicken 
grown for the primary purpose of producing meat, including but not 
limited to broilers, roasters, fryers, and cornish, meaning spent fowl 
are not specifically authorized to participate under those provisions. 
Accordingly, we are proposing to amend subpart C to provide for the 
participation of spent fowl in the meat-type chicken slaughter plant 
provisions.
    We are proposing to define spent fowl in Sec.  146.31 with the 
definition given above. We would add a new paragraph (c) to Sec.  
146.32, which discusses participation in the special provisions for 
meat-type chicken slaughter plants, indicating that spent fowl 
slaughtered at meat-type chicken slaughter plants that participate in 
the NPIP may participate in the NPIP under the provisions of subpart C.
    We are also proposing to amend the U.S. H5/H7 Avian Influenza 
Monitored classification in Sec.  146.33. This classification provides 
three options for participation in the program. Two of those options 
refer generically to birds tested at the slaughter plants or otherwise 
under surveillance testing and thus could apply both to meat-type 
chickens and spent fowl without modification. The third requires meat-
type chicken slaughter plants to accept only meat-type chickens from 
flocks where surveillance is performed for H5/H7 AI. We would amend 
this option to indicate that meat-type chicken slaughter plants could 
also accept spent fowl from flocks where surveillance was being 
performed for H5/H7 AI. The surveillance requirements for meat-type 
chickens and spent fowl would be the same, as they are based on 
statistical principles for disease detection.
    These changes would necessitate two minor changes elsewhere in part 
146. To accommodate spent fowl flocks that may wish to participate in a 
State other than the State in which they are located, we would amend 
the definition of commercial meat-type flock in Sec.  146.1 to include 
spent fowl, so that provisions allowing commercial meat-type flocks to 
participate with another Official State Agency in Sec.  146.2(c) would 
apply to spent fowl as well. In Sec.  146.3, we would amend the 
requirement in paragraph (c) that a participating slaughter plant 
participate with all the poultry processed at that facility to include 
spent fowl.
    These changes would allow spent fowl flocks to participate in the 
U.S. H5/H7 Avian Influenza Monitored program, thus providing for 
additional surveillance for H5/H7 LPAI in the poultry industry overall.

Changes to the U.S. H5/H7 Avian Influenza Monitored Classifications for 
Commercial Meat-Type Chickens and Turkey Slaughter Plants

    Besides the changes related to including spent fowl in the 
classification, we are proposing to clarify some wording in the U.S. 
H5/H7 Avian Influenza Monitored classification for commercial meat-type 
chicken slaughter plants. Paragraph (a)(2) of Sec.  146.33 provides 
participating slaughter plants the option to qualify for the 
classification if they accept only meat-type chickens from flocks where 
a minimum of 11 birds have been tested negative for antibodies to the 
H5/H7 subtypes of avian influenza, as provided in Sec.  146.13(b), no 
more than 21 days prior to slaughter. This wording has confused some 
participants in the program regarding when samples should be collected. 
We are proposing to change it to read ``where samples from a minimum of 
11 birds have been collected no more than 21 days prior to slaughter 
and tested negative to the H5/H7 subtypes of avian influenza.'' We 
believe this wording will better convey that it is the testing that has 
to occur no more than 21 days prior to slaughter; the results can come 
later, as long as they

[[Page 4551]]

are available prior to slaughter, consistent with our proposed changes 
to Sec.  146.11.
    Both paragraphs (a)(1) and (a)(2) of this classification refer to 
testing for antibodies to H5/H7 AI; we are proposing to remove the 
words ``for antibodies'' to allow for the use of the agent detection 
tests approved in Sec.  146.13(b).
    Paragraph (a) of Sec.  146.43 contains the U.S. H5/H7 Avian 
Influenza Monitored classification for commercial turkey slaughter 
plants. Paragraph (a)(1) allows meat-type turkey slaughter plants to 
participate in the classification if they accept only meat-type turkeys 
from flocks where a minimum of 6 birds per flock has tested negative 
for antibodies to type A avian influenza, as provided in Sec.  
146.13(b), with an approved test no more than 21 days prior to 
slaughter. The regulations indicate that 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. They also recommend that samples be collected from flocks over 
10 weeks of age with respiratory signs such as coughing, sneezing, 
snicking, sinusitis, or rales; depression; or decreases in food or 
water intake, to maximize the chances of finding AI should it be 
present.
    We are proposing to revise the testing requirement to read ``where 
a minimum of 6 samples per flock have been collected no more than 21 
days prior to movement to slaughter and tested negative.'' This revised 
language would help to clarify what is involved in testing. We would 
require the testing to take place prior to movement to slaughter, 
rather than prior to slaughter, as an additional precaution. We would 
also remove the current reference to testing for antibodies.
    Finally, we would remove the sentence describing how positive 
samples would be handled. It is not necessary to specify this in the 
regulations, as this process is handled by APHIS internally, and we may 
wish to change the process in the future.

Other Changes to 9 CFR Part 147

    As discussed earlier, we are retaining subpart E and revising F of 
part 147. We are proposing minor changes to those subparts. Subpart E 
refers to the NPIP Technical Committee, which is defined in Sec.  145.1 
but not in part 147. We would add to Sec.  147.41 a definition of NPIP 
Technical Committee that would be identical to the definition in Sec.  
145.1. That definition reads: ``A committee made up of technical 
experts on poultry health, biosecurity, surveillance, and diagnostics. 
The committee consists of representatives from the poultry and egg 
industries, universities, and State and Federal governments and is 
appointed by the Senior Coordinator and approved by the General 
Conference Committee.''
    Besides the proposed changes to the requirements for authorized 
laboratories discussed earlier, including moving those requirements 
from Sec.  147.51 to Sec.  147.52, we are proposing some additional 
amendments. Paragraph (a) of current Sec.  147.51 requires an 
authorized laboratory to use a regularly scheduled check test for all 
the tests it performs. We would add text indicating that the NPIP will 
serve as the lead agency for the coordination of available check tests 
from the NVSL, which among its other duties provides check tests for 
authorized laboratories.
    Paragraph (b) of current Sec.  147.51 indicates that testing 
procedures at an authorized laboratory must be run or overseen by a 
laboratory technician who has attended and satisfactorily completed 
Service-approved laboratory workshops for Plan-specific diseases within 
the past 3 years. Cuts to both State and Federal budgets have made it 
more difficult to provide and attend workshops in recent years. Given 
these constraints, we are proposing to increase the interval at which 
the workshops must be given to 4 years. We do not believe this would 
adversely affect laboratory technician performance given the other 
requirements for authorized laboratories, which include site visits 
from the Official State Agency and the Service and reporting 
requirements; increasing the interval would ease a burden on State and 
Federal participants.
    Paragraph (c) of current Sec.  147.51 indicates that official Plan 
assays must be performed and reported as described in part 147. Besides 
amending this paragraph to refer to the NPIP Program Standards or other 
procedures approved by the Administrator, we would also add that assays 
must be performed using control reagents approved by the Plan or the 
reagent manufacturer. This would ensure that control assays are 
accurate and effective.
    Paragraph (d) of current Sec.  147.51 states that the Official 
State Agency will conduct a site visit and recordkeeping audit 
annually, but does not describe what the site visit and audit will 
entail. We would add text indicating that these would include, but may 
not be limited to, review of technician training records, check test 
proficiency, and test results. The information from the site visit and 
recordkeeping audit would also be made available to the NPIP upon 
request.
    We are also proposing to update references to Sec.  147.51 in the 
definition of authorized laboratory in parts 145 and 146, and in the 
definition of Senior Coordinator in part 145, to refer to Sec.  147.52.

Miscellaneous Corrections

    The regulations in paragraph (c) of Sec.  145.5 require a flock to 
participate in the U.S. Pullorum-Typhoid Clean classification in order 
to participate in the Plan. The list of subparts in 9 CFR part 145 that 
contain such a classification is out of date. We are proposing to 
update it to include subparts G, H, and I.
    Section 145.10 shows illustrative designs corresponding to various 
classifications. For some of the classifications, the references to 
classifications are out of date; for example, the U.S. Pullorum-Typhoid 
Clean classification whose illustrative design is included in paragraph 
(a) of Sec.  145.10 now includes classifications in Sec. Sec.  
145.73(b), 145.83(b), and 145.93(b). We are proposing to update that 
paragraph and other paragraphs in Sec.  145.10 to include all of the 
classifications in the regulations that correspond to the specified 
illustrative designs.
    In Sec. Sec.  145.23 and 145.33, paragraph (b) sets out the U.S. 
Pullorum-Typhoid Clean classification for multiplier breeding egg-type 
chickens and meat-type chickens, respectively. The introductory text 
refers to meeting one of the criteria in paragraphs (b)(1) through 
(b)(5) to qualify for the classification, but these paragraphs only 
contain subparagraphs (b)(1) through (b)(4). We are proposing to 
correct the reference accordingly.
    In Sec.  145.33, paragraphs (j) and (k) set out requirements for 
the U.S. M. Gallisepticum Monitored and U.S. M. Synoviae Monitored 
classifications, respectively, for multiplier breeding meat-type 
chickens. These classifications prohibit setting eggs from these 
classifications in hatchers or incubators in which U.S. M. 
Gallisepticum Clean or U.S. M. Synoviae Clean primary breeding flocks 
are set. However, the paragraph references for these primary breeding 
flock classifications are out of date, as the provisions for primary 
breeding flocks were moved from Sec.  145.33 to Sec.  145.83. We would 
correct the citations.
    In Sec.  146.3, which discusses participation in the Plan for 
commercial poultry, paragraph (e) states that commercial table-egg 
layers will cease to participate in the Plan after September 26, 2008, 
unless the majority

[[Page 4552]]

of the commercial table-egg layer delegates vote to continue 
participation. As the table-egg layer delegates have voted to continue 
participation, it is not necessary to retain this provision in the 
regulations, and we are proposing to remove paragraph (e).
    Section 147.44 sets out the process for submitting, compiling, and 
distributing proposed changes to the NPIP. Paragraph (b) of that 
section indicates that proposed changes shall be submitted in writing 
so as to reach the Service not later than 150 days prior to the opening 
date of the Plan Conference, except as provided in paragraph (d)(2) of 
Sec.  147.43. However, paragraph (d)(2) of Sec.  147.43 does not 
discuss submission of proposals for changes to the Plan; paragraph 
(d)(4) does. We would correct the reference in Sec.  147.44(b) 
accordingly.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been determined to be not significant for 
the purposes of Executive Order 12866 and, therefore, has not been 
reviewed by the Office of Management and Budget.
    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on small entities. The 
analysis is summarized below. Copies of the full analysis are available 
by contacting the person listed under FOR FURTHER INFORMATION CONTACT 
or on the Regulations.gov Web site (see ADDRESSES above for 
instructions for accessing Regulations.gov).
    The changes in this proposed rule are recommended by the NPIP GCC, 
which represents cooperating State agencies and poultry industry 
members and advises the Secretary of Agriculture on issues pertaining 
to poultry health. The proposed amendments to these regulations would 
improve the regulatory environment for poultry and poultry products.
    This proposed rule would move approved tests and testing procedures 
from the Code of Federal Regulations to a program standards document; 
add compartmentalization standards to the NPIP regulations; and make a 
number of specific changes, including adding or amending definitions of 
technical terms to specific sections, amending poultry disease 
classifications and laboratory procedures, and adding specific tests 
for certain poultry diseases.
    The establishments that would be affected by the proposed rule--
principally entities engaged in poultry production and processing--are 
predominantly small by Small Business Administration standards. In 
those instances in which an addition or modification could potentially 
result in a cost to certain entities, we do not expect the costs to be 
significant. This rule embodies changes decided upon by the NPIP GCC on 
behalf of Plan members, that is, changes recognized by the poultry 
industry as in their interest. We note that NPIP membership is 
voluntary.
    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.)

Paperwork Reduction Act

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

List of Subjects

9 CFR Part 56

    Animal diseases, Indemnity payments, Low pathogenic avian 
influenza, Poultry.

9 CFR Parts 145, 146, and 147

    Animal diseases, Poultry and poultry products, Reporting and 
recordkeeping requirements.
    Accordingly, we propose to amend 9 CFR parts 56, 145, 146, and 147 
as follows:

PART 56--CONTROL OF H5/H7 LOW PATHOGENIC AVIAN INFLUENZA

0
1. The authority citation for part 56 continues to read as follows:

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

0
2. Section 56.1 is amended as follows:
0
a. By revising the definition of H5/H7 low pathogenic avian influenza 
(LPAI).
0
b. In the definition of H5/H7 LPAI virus infection (infected), by 
adding the words ``the Cooperating State Agency, the Official State 
Agency, and'' before the word ``APHIS''.
    The revision reads as follows:


Sec.  56.1  Definitions.

* * * * *
    H5/H7 low pathogenic avian influenza (LPAI). An infection of 
poultry caused by an influenza A virus of H5 or H7 subtype that has an 
intravenous pathogenicity index in 6-week-old chickens less than or 
equal to 1.2 or causes less than 75 percent mortality in 4- to 8-week-
old chickens infected intravenously, or an infection with influenza A 
viruses of H5 or H7 subtype with a cleavage site that is not consistent 
with a previously identified highly pathogenic avian influenza virus.
* * * * *
0
3. Section 56.4 is amended by adding a new paragraph (d) to read as 
follows:


Sec.  56.4  Determination of indemnity amounts.

* * * * *
    (d) Requirements for compliance agreements. The compliance 
agreement is a comprehensive document that describes the depopulation, 
disposal, and cleaning and disinfection plans for poultry that were 
infected with or exposed to H5/H7 LPAI, or a premises that contained 
such poultry. The compliance agreement sets out APHIS responsibilities, 
owner responsibilities, and Cooperating State Agency responsibilities. 
The compliance agreement must include the owner's name and the name and 
address of the affected premises. The compliance agreement must have 
signatories that include, but are not necessarily limited to, the 
owner, the grower (if applicable), the Cooperating State Agency 
representative, the State veterinarian, and the APHIS area supervisor. 
In addition, the compliance agreement must contain a flock plan with 
estimated cost breakdowns that include labor, materials, personal 
protective equipment, travel expenses for personnel involved, and any 
additional information deemed necessary by the Service. The final 
compliance agreement must be submitted to the Service no later than 30 
days after the affected premises is released from quarantine for H5 or 
H7 LPAI.
* * * * *
0
4. Section 56.5 is amended as follows:
0
a. By revising paragraph (c)(1)(i).
0
b. By adding new paragraphs (c)(1)(iii) and (c)(1)(iv).
0
c. By revising paragraphs (d)(1)(i) and (d)(1)(iii).
0
d. By removing paragraph (d)(1)(iv).
0
e. By revising the second, third, and fourth sentences after the 
heading of paragraph (d)(2)(i) and the first sentence after the heading 
of paragraph (d)(3).
    The revisions and additions read as follows:


Sec.  56.5  Destruction and disposal of poultry and cleaning and 
disinfection of premises, conveyances, and materials.

* * * * *
    (c) * * *

[[Page 4553]]

    (1) * * *
    (i) Poultry infected with or exposed to H5/H7 LPAI must not be 
transported to a market for controlled marketing until approved by the 
Cooperating State Agency in accordance with the initial State response 
and containment plan described in Sec.  56.10.
* * * * *
    (iii) Routes to slaughter must avoid other commercial poultry 
operations whenever possible. All load-out equipment, trailers, and 
trucks used on premises that have housed poultry that were infected 
with or exposed to H5/H7 LPAI must be cleaned and disinfected and not 
enter other poultry premises or facilities for 48 hours after removing 
such poultry from their premises.
    (iv) Flocks moved for controlled marketing must be the last poultry 
marketed during the week they are marketed.
* * * * *
    (d) * * *
    (1) * * *
    (i) Secure all feathers and debris that might blow around outside 
the house in which the infected or exposed poultry were held by 
gathering and pushing the material into the house;
* * * * *
    (iii) Close the house in which the poultry were held, maintaining 
just enough ventilation to remove moisture. Leave the house undisturbed 
for a minimum of 72 hours.
    (2) * * *
    (i) * * * Compost manure, debris, and feed by windrowing in the 
house if possible. If this is not possible, set up a system for hauling 
manure, debris, and feed to an approved site for burial, piling, or 
composting. Manure, debris and feed may be removed from the house or 
premises and disposed of by composting it on site, leaving it in a 
undisturbed pile on site, or removing it from the site in covered 
vehicles. Land application of manure, debris, and feed should only be 
performed in accordance with the initial State response and containment 
plan described in Sec.  56.10. Clean out the house or move or spread 
litter as determined by the Cooperating State Agency and in accordance 
with the initial State response and containment plan. * * *
* * * * *
    (3) * * * Premises should remain empty until testing provides 
negative virus detection results and checked by the Cooperating State 
Agency in accordance with the initial State response and containment 
plan described in Sec.  56.10. * * *
* * * * *

PART 145--NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY

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

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

0
6. Section 145.1 is amended as follows:
0
a. In the definition of authorized agent, by removing the words ``as 
described in Sec. Sec.  147.1(a) and 147.12'' and adding the words ``in 
accordance with part 147'' in their place.
0
b. In the definition of authorized laboratory, by removing the citation 
``Sec.  147.51'' and adding the citation ``Sec.  147.52'' in its place; 
and by removing the words ``the assays described in'' and adding the 
words ``assays in accordance with'' in their place.
0
c. In the definition of authorized testing agent, by removing the words 
``as described in Sec. Sec.  147.1(a) and 147.12'' and adding the words 
``in accordance with part 147'' in their place.
0
d. By adding, in alphabetical order, definitions of H5/H7 low 
pathogenic avian influenza (LPAI) and NPIP Program Standards.
0
e. In the definition of reactor, by removing the words ``parts 145 or 
147 of this chapter'' and adding the words ``this part or in accordance 
with part 147 of this subchapter'' in their place.
0
f. In the definition of Senior Coordinator, in paragraph (4), by 
removing the citation ``Sec.  147.51'' and adding the citation ``Sec.  
147.52'' in its place.
    The additions read as follows:


Sec.  145.1  Definitions.

* * * * *
    H5/H7 low pathogenic avian influenza (LPAI). An infection of 
poultry caused by an influenza A virus of H5 or H7 subtype that has an 
intravenous pathogenicity index in 6-week-old chickens less than or 
equal to 1.2 or causes less than 75 percent mortality in 4- to 8-week-
old chickens infected intravenously, or an infection with influenza A 
viruses of H5 or H7 subtype with a cleavage site that is not consistent 
with a previously identified highly pathogenic avian influenza virus.
* * * * *
    NPIP Program Standards. A document that contains tests and 
sanitation procedures approved by the Administrator in accordance with 
Sec.  147.53 of this subchapter for use under this subchapter. This 
document may be obtained from the NPIP Web site at http://www.aphis.usda.gov/animal_health/animal_dis_spec/poultry/ or by 
writing to the Service at National Poultry Improvement Plan, APHIS, 
USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094.
* * * * *


Sec.  145.2  [Amended]

0
7. In Sec.  145.2, paragraph (e) is amended by removing the words 
``follow the laboratory protocols outlined in part 147 of this 
chapter'' and adding the words ``conduct tests in accordance with part 
147 of this subchapter'' in their place.
0
8. Section 145.3 is amended as follows:
0
a. In paragraph (c), by removing the word ``He'' and adding the words 
``The participant'' in its place; and by adding the word ``and'' before 
the word ``cassowaries,''.
0
b. By redesignating paragraphs (d) and (e) as paragraphs (e) and (f), 
respectively.
0
c. By adding a new paragraph (d).
    The addition reads as follows:


Sec.  145.3  Participation.

* * * * *
    (d) To ensure that Plan diseases are not spread, flocks should be 
qualified for their intended Plan classifications before being moved 
into breeder production facilities.
* * * * *


Sec.  145.5  [Amended]

0
9. Section 145.5 is amended as follows:
0
a. In paragraph (a), by removing the words ``as recommended in 
Sec. Sec.  147.21 and 147.22 (a) and (e) of this chapter'' and adding 
the words ``in accordance with part 147 of this subchapter'' in their 
place.
0
b. In paragraph (c), by removing the words ``or F'' and adding the 
words ``F, G, H, or I'' in their place.
0
10. Section 145.6 is amended as follows:
0
a. By revising the second sentence in paragraph (a) introductory text.
0
b. In paragraphs (a)(1), (a)(2), (a)(3), and (a)(4), by removing the 
words ``as outlined in Sec.  147.24 of this chapter'' and adding the 
words ``in accordance with part 147 of this subchapter'' in their 
place.
    The revision reads as follows:


Sec.  145.6  Specific provisions for participating hatcheries.

    (a) * * * The sanitary procedures outlined in the NPIP Program 
Standards, or other procedures approved by the Administrator in 
accordance with Sec.  147.53(d), will be considered as a guide in 
determining compliance with this provision. * * *
* * * * *
0
11. Section 145.10 is amended as follows:

[[Page 4554]]

0
a. In paragraph (b) introductory text, by removing the words ``and 
145.63(a)'' and adding the words ``145.63(a), 145.73(b), 145.83(b), and 
145.93(b)'' in their place.
0
b. By revising paragraph (c) introductory text, paragraph (g) 
introductory text, paragraph (m) introductory text, paragraph (o) 
introductory text, and paragraph (t) introductory text.
    The revisions read as follows:


Sec.  145.10  Terminology and classification; flocks, products, and 
States.

* * * * *
    (c) U.S. M. Gallisepticum Clean. (See Sec. Sec.  145.23(c), 
145.23(f), 145.33(c), 145.33(f), 145.43(c), 145.53(c), 145.73(c), and 
145.83(c).)
* * * * *
    (g) U.S. Pullorum-Typhoid Clean State. (See Sec. Sec.  145.24(a), 
145.34(a), 145.44(a), 145.54(a), and 145.94(a).)
* * * * *
    (m) U.S. S. Enteritidis Clean. (See Sec. Sec.  145.23(d), 
145.73(d), and 145.83(e).)
* * * * *
    (o) U.S. Salmonella Monitored. (See Sec. Sec.  145.53(f), 
145.83(f), and 145.93(d).)
* * * * *
    (t) U.S. H5/H7 Avian Influenza Clean. (See Sec. Sec.  145.43(g), 
145.53(e), and 145.93(c).)
* * * * *
0
12. Section 145.14 is amended as follows:
0
a. In paragraph (a)(1), by revising the second sentence.
0
b. In paragraph (a)(6)(ii), by revising the second sentence.
0
c. In paragraph (b)(1), by adding a sentence after the second sentence.
0
d. By revising paragraph (b)(3).
0
e. By revising paragraph (d)(1)(ii)(C).
0
f. In paragraph (d)(2)(i), by removing the word ``(AVPR01510)''.
0
g. By revising paragraph (d)(2)(ii)(B).
    The revisions read as follows:


Sec.  145.14  Testing.

    (a) * * *
    (1) * * * Official blood tests must be conducted in accordance with 
part 147 of this subchapter or according to literature provided by the 
producer. * * *
* * * * *
    (6) * * *
    (ii) * * * Bacteriological examination must be conducted in 
accordance with part 147 of this subchapter. * * *
* * * * *
    (b) * * *
    (1) * * * Tests must be conducted in accordance with this paragraph 
(b) and in accordance with part 147 of this subchapter. * * *
* * * * *
    (3) When reactors to the test for which the flock was tested are 
submitted to a laboratory as prescribed by the Official State Agency, 
the final status of the flock will be determined in accordance with 
part 147 of this subchapter.
* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (C) The AGID test for avian influenza must be conducted in 
accordance with part 147 of this subchapter. The test can be conducted 
on egg yolk or blood samples. The AGID test is not recommended for use 
in waterfowl.
* * * * *
    (2) * * *
    (ii) * * *
    (B) Chicken and turkey flocks that test positive on the ACIA must 
be retested using the RRT-PCR or virus isolation. Positive results from 
the RRT-PCR or virus isolation must be further tested by Federal 
Reference Laboratories using appropriate tests for confirmation. Final 
judgment may be based upon further sampling and appropriate tests for 
confirmation.
* * * * *
0
13. In Sec.  145.22, paragraph (b) is revised to read as follows:


Sec.  145.22  Participation.

* * * * *
    (b) Hatching eggs produced by multiplier breeding flocks should be 
nest clean. They may be fumigated in accordance with part 147 of this 
subchapter or otherwise sanitized.
* * * * *
0
14. Section 145.23 is amended as follows:
0
a. In paragraph (b) introductory text, by removing the citation ``(5)'' 
and adding the citation ``(b)(4)'' in its place.
0
b. In paragraph (c)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this chapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
c. In paragraph (c)(1)(ii)(C), by removing the words ``Sec.  147.8 of 
this chapter'' and adding the words ``part 147 of this subchapter'' in 
their place.
0
d. In paragraph (c)(3), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
e. In paragraph (d)(1)(iv), by removing the words ``in compliance with 
Sec. Sec.  147.21, 147.24(a), and 147.26 of this chapter'' and adding 
the words ``in accordance with part 147 of this subchapter with respect 
to flock sanitation, cleaning and disinfection, and Salmonella 
isolation, sanitation, and management'' in their place.
0
f. In paragraph (d)(1)(v), by removing the words ``as described in 
Sec.  147.12 of this chapter'' and adding the words ``in accordance 
with part 147 of this subchapter'' in their place.
0
g. In paragraphs (d)(1)(vii), by removing the words ``as described in 
Sec.  147.11 of this chapter'' and adding the words ``in accordance 
with part 147 of this subchapter'' in their place.
0
h. By revising paragraphs (d)(1)(viii) and (d)(1)(ix).
0
i. In paragraph (d)(2), by removing the words ``as described in Sec.  
147.11(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
j. In paragraph (e)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this chapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
k. In paragraph (e)(1)(ii)(B), by removing the words ``Sec.  147.8 of 
this chapter'' and adding the words ``part 147 of this subchapter'' in 
their place.
0
l. In paragraph (e)(3), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
m. In paragraph (f)(3), by removing the words ``in compliance with the 
provisions of Sec.  147.26 of this chapter'' and adding the words ``in 
accordance with part 147 of this subchapter with respect to Mycoplasma 
isolation, sanitation, and management'' in their place.
0
n. In paragraph (f)(5), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
o. In paragraph (g)(3), by removing the words ``in compliance with the 
provisions of Sec.  147.26 of this chapter'' and adding the words ``in 
accordance with part 147 of this subchapter with respect to Mycoplasma 
isolation, sanitation, and management'' in their place.
0
p. In paragraph (g)(5), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
q. In paragraph (h)(1) introductory text, by adding the words ``and 
found'' before the word ``negative'' and by removing the words ``for 
antibodies''.
0
r. By revising paragraph (h)(2).

[[Page 4555]]

    The revisions read as follows:


Sec.  145.23  Terminology and classification; flocks and products.

* * * * *
    (d) * * *
    (1) * * *
    (viii) Hatching eggs are collected as quickly as possible, and 
their sanitation is maintained in accordance with part 147 of this 
subchapter.
    (ix) Hatching eggs produced by the flock are incubated in a 
hatchery whose sanitation is maintained in accordance with part 147 of 
this subchapter and sanitized either by a procedure approved by the 
Official State Agency or in accordance with part 147 of this 
subchapter.
* * * * *
    (h) * * *
    (2) A sample of at least 11 birds must be tested and found negative 
to avian influenza within 21 days prior to slaughter.
* * * * *
0
15. In Sec.  145.32, paragraph (b) is revised to read as follows:


Sec.  145.32  Participation.

* * * * *
    (b) Hatching eggs produced by multiplier breeding flocks should be 
nest clean. They may be fumigated in accordance with part 147 of this 
subchapter or otherwise sanitized.
* * * * *
0
16. Section 145.33 is amended as follows:
0
a. In paragraph (b) introductory text, by removing the citation ``(5)'' 
and adding the citation ``(b)(4)'' in its place.
0
b. In paragraph (c)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this chapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
c. In paragraph (c)(1)(ii)(C), by removing the words ``Sec.  147.8 of 
this chapter'' and adding the words ``part 147 of this subchapter'' in 
their place.
0
d. In paragraph (c)(2), by removing the words ``(see Sec. Sec.  147.22, 
147.23, and 147.24)'' and by adding the words ``and in accordance with 
part 147 of this subchapter'' before the period at the end of the 
paragraph.
0
e. In paragraph (c)(3), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
f. In paragraph (c)(4), by removing the words ``approved by the 
Department'' and adding the words ``in accordance with part 147 of this 
subchapter'' in their place.
0
g. In paragraph (d)(1)(ii), by removing the words ``in compliance with 
Sec. Sec.  147.21, 147.24(a), and 147.26 of this chapter'' and adding 
the words ``in accordance with part 147 of this subchapter with respect 
to flock sanitation, cleaning and disinfection, and Salmonella 
isolation, sanitation, and management'' in their place.
0
h. By revising paragraph (d)(1)(vi).
0
i. In paragraph (d)(1)(vii), by removing the words ``as described in 
Sec.  147.12 of this chapter'' and adding the words ``in accordance 
with part 147 of this subchapter'' in their place.
0
j. By revising paragraph (d)(2).
0
k. In paragraph (e)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this chapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
l. In paragraph (e)(1)(ii)(B), by removing the words ``Sec.  147.8 of 
this chapter'' and adding the words ``part 147 of this subchapter'' in 
their place.
0
m. In paragraph (e)(3), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
n. In paragraph (e)(4), by removing the words ``approved by the 
Department'' and adding the words ``in accordance with part 147 of this 
subchapter'' in their place.
0
o. In paragraph (f)(3), by removing the words ``in compliance with the 
provisions of Sec.  147.26 of this chapter'' and adding the words ``in 
accordance with part 147 of this subchapter with respect to Mycoplasma 
isolation, sanitation, and management'' in their place.
0
p. In paragraph (f)(5), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
q. In paragraph (g)(3), by removing the words ``in compliance with the 
provisions of Sec.  147.26 of this chapter'' and adding the words ``in 
accordance with part 147 of this subchapter with respect to Mycoplasma 
isolation, sanitation, and management'' in their place.
0
r. In paragraph (g)(5), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
s. In paragraph (j)(2), by removing the words ``paragraph (c)(1)(i) of 
this section'' and adding the words ``Sec.  145.83(c)(1)(i)'' in their 
place.
0
t. In paragraphs (j)(3) and (k)(3), by removing the words ``as 
described in Sec.  147.24(a) of this chapter'' and adding the words 
``in accordance with part 147 of this subchapter'' in their place.
0
u. In paragraph (k)(2), by removing the words ``paragraph (e)(1)(i) of 
this section'' and adding the words ``Sec.  145.83(d)(1)(i)'' in their 
place.
0
v. In paragraph (l)(1) introductory text, by adding the words ``using 
an approved test as described in Sec.  145.14'' after the word 
``influenza''.
0
w. By revising paragraph (l)(2).
0
x. By adding a new paragraph (m).
    The revisions read as follows:


Sec.  145.33  Terminology and classification; flocks and products.

* * * * *
    (d) * * *
    (1) * * *
    (vi) Chicks shall be hatched in a hatchery whose sanitation is 
maintained in accordance with part 147 of this subchapter and sanitized 
or fumigated in accordance with part 147 of this subchapter;
* * * * *
    (2) The Official State Agency may monitor the effectiveness of the 
sanitation practices in accordance with part 147 of this subchapter.
* * * * *
    (l) * * *
    (2) During each 90-day period, all primary spent fowl, up to a 
maximum of 30, must be tested serologically and found negative for 
antibodies to avian influenza within 21 days prior to slaughter.
    (m) U.S. Salmonella Enteritidis Monitored. This classification is 
intended for multiplier meat-type breeders wishing to monitor their 
breeding flocks for 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 primary 
meat-type breeding flock.
    (ii) The flock is maintained in accordance with part 147 of this 
subchapter with respect to Salmonella isolation, sanitation, and 
management.
    (iii) Environmental samples are collected from the flock in 
accordance with part 147 of this subchapter at 16-18 and 40-45 weeks of 
age. The samples shall be examined bacteriologically for group D 
Salmonella at an authorized laboratory, and cultures from group D 
positive samples shall be serotyped.

[[Page 4556]]

    (2) The following actions must be taken with respect to the test 
results that are generated from this S. enteritidis monitoring program:
    (i) If S. enteritidis is isolated from an environmental sample 
collected from the flock in accordance with paragraph (m)(1)(iii) of 
this section, a thorough evaluation of the practices and programs 
associated with the sampled flock shall be conducted with the goal of 
ascertaining the reason(s) for the positive finding.
    (ii) The test results and the results of any evaluations performed 
in accordance with paragraph (m)(2)(i) of this section will be reported 
on a quarterly basis to the Official State Agency and the NPIP Senior 
Coordinator.
    (iii) Participating broiler integrators shall combine their 
respective test results (and the results of any associated evaluations) 
to help guide their decisionmaking regarding programs and practices to 
implement or maintain to address S. enteritidis.
    (iv) Aggregate data regarding the prevalence of S. enteritidis in 
participating U.S. meat-type parent breeding flocks shall be made 
available to the U.S. Poultry and Egg Association and the National 
Chicken Council.
    (3) This classification may be revoked by the Official State Agency 
if the participant fails to comply with the requirements of this 
classification. 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.
* * * * *


Sec.  145.42  [Amended]

0
17. In Sec.  145.42, paragraph (b) is amended by removing the words 
``(see Sec.  147.25 of this chapter)'' and adding the words ``in 
accordance with part 147 of this subchapter'' in their place.
0
18. Section 145.43 is amended as follows:
0
a. In paragraph (c)(1), by removing the words ``in accordance with the 
conditions and procedures described in Sec.  147.26 of this chapter'' 
and adding the words ``in accordance with part 147 of this subchapter 
with respect to Mycoplasma isolation, sanitation, and management'' in 
their place.
0
b. In paragraph (c)(2), by removing the words ``applicable conditions 
outlined in Sec.  147.26 of this chapter are being met'' and adding the 
words ``flock is being maintained in accordance with part 147 of this 
subchapter with respect to Mycoplasma isolation, sanitation, and 
management'' in their place.
0
c. By adding a sentence at the end of paragraph (e)(1).
0
d. In paragraph (e)(2), by removing the words ``the procedures outlined 
in Sec.  147.6 of this chapter will be used to determine'' and by 
adding the words ``will be determined in accordance with part 147 of 
this subchapter'' before the period at the end of the paragraph.
0
e. By removing paragraph (e)(3).
0
f. In paragraph (f) introductory text, by removing the words ``as 
described in subpart C of part 147 of this chapter'' and adding the 
words ``in accordance with part 147 of this subchapter'' in their 
place.
0
g. In paragraphs (f)(2), (f)(4), and (f)(6), by removing the words ``as 
described in Sec.  147.12 of this chapter'' and adding the words ``in 
accordance with part 147 of this subchapter'' in their place.
0
h. By revising paragraph (g)(3).
    The revisions read as follows:


Sec.  145.43  Terminology and classification; flocks and products.

* * * * *
    (e) * * *
    (1) * * * It is recommended that samples be collected from birds 
with clinical signs of M. synoviae infection.
* * * * *
    (g) * * *
    (3) All spent fowl being marketed for meat from flocks that have 
been tested as required by this paragraph shall be tested at a rate of 
6 birds per flock within 21 days prior to movement to slaughter.
* * * * *
0
19. Add Sec.  145.45 to read as follows:


Sec.  145.45  Terminology and classification; compartments.

    (a) U.S. H5/H7 Avian Influenza Clean Compartment. This program is 
intended to be the basis from which the primary turkey breeding-
hatchery industry may demonstrate the existence and implementation of a 
program that has been approved by the Official State Agency and the 
Service to establish a compartment consisting of a primary breeding-
hatchery company that is free of H5/H7 avian influenza (AI), also 
referred to as notifiable avian influenza (NAI). This compartment has 
the purpose of protecting the defined subpopulation and avoiding the 
introduction and spread of NAI within that subpopulation by prohibiting 
contact with other commercial poultry operations, other domestic and 
wild birds, and other intensive animal operations. The program shall 
consist of the following:
    (1) Definition of the compartment. Based on the guidelines 
established by the World Organization for Animal Health (OIE) in the 
Terrestrial Animal Health Code and the guidelines in this paragraph 
(a), the primary breeder company will define the compartment with 
respect to NAI. Specifically, the company will use a comprehensive 
biosecurity program to define the compartment as a subpopulation of 
poultry with a health status for NAI that is separate from birds and 
poultry outside the compartment. The Official State Agency and the 
Service must approve all documentation submitted to substantiate the 
defined compartment as adequate to qualify for epidemiological 
separation from other potential sources of infection of NAI. Guidelines 
for the definition of the compartment include:
    (i) Definition and description of the subpopulation of birds and 
their health status. All birds included in the compartment must be U.S. 
H5/H7 Avian Influenza Clean in accordance with Sec.  145.43(g). The 
poultry must also be located in a State that has an initial State 
response and containment plan approved by APHIS under Sec.  56.10 of 
this chapter and that participates in the diagnostic surveillance 
program for H5/H7 low pathogenicity AI as described in Sec.  145.15. 
Within the compartment, all official tests for AI, as described in 
Sec.  145.14(d), must be conducted in State or Federal laboratories or 
in NPIP authorized laboratories that meet the minimum standards 
described in Sec.  147.52 of this subchapter. In addition, the company 
must provide to the Service upon request any relevant historical and 
current NAI-related data for reference regarding surveillance for the 
disease within the compartment. Upon request, the company must also 
work with the Official State Agency to provide such data for other bird 
populations located in the State.
    (ii) Description of animal identification and traceability 
processes. The primary breeder company must also include a description 
of its animal identification and traceability records, including 
examples of Veterinary Services (VS) Form 9-5, ``Report of Hatcheries, 
Dealers and Independent Flocks''; VS Form 9-2, ``Flock Selection and 
Testing Report''; VS Form 9-3, ``Report of Sales of Hatching Eggs, 
Chicks and Poults''; VS Form 9-9, '' Hatchery Inspection Report''; set 
and hatch records; egg receipts; and egg/chick invoices for the 
subpopulation. Documentation must also include breed identification 
(NPIP stock code). The Service should ensure that an effective flock 
identification system and traceability system are in place.
    (iii) Definition and description of the physical components or 
establishments of the defined compartment. The

[[Page 4557]]

primary breeder company must provide documentation establishing that 
the defined compartment is epidemiologically separated from other 
poultry and bird populations. The documentation must be approved by the 
Official State Agency and the Service as indicating adequate 
epidemiological separation to maintain the compartment's separate 
health status with respect to NAI. The documentation should include 
descriptions of:
    (A) The physical and spatial factors that separate the compartment 
from surrounding bird populations and affect the biosecurity status of 
the compartment.
    (B) Relevant environmental factors that may affect exposure of the 
birds to AI.
    (C) The functional boundary and fencing that are used to control 
access to the compartment.
    (D) Facilities and procedures to prevent access by wild birds and 
to provide separation from other relevant hosts.
    (E) The relevant infrastructural factors that may affect exposure 
to AI, including the construction and design of buildings or physical 
components, cleaning and disinfection of buildings and physical 
components between production groups with quality assurance 
verification, cleaning and disinfection of equipment, and introduction 
of equipment or material into the compartment.
    (iv) Definition and description of the functional relationships 
between components of the defined compartment. Functional relationships 
between components of the compartment include traffic movement and flow 
at and among premises, personnel movement at and among premises, 
exposure to live bird populations, and any other factors that could 
affect biosecurity of the compartment. All physical components of the 
compartment must be maintained in compliance with hygiene and 
biosecurity procedures for poultry primary breeding flocks and 
hatcheries in accordance with part 147 of this subchapter. In addition, 
the company must provide a biosecurity plan for the compartment and all 
included components. The biosecurity plan should include:
    (A) Requirements that company employees and contract growers limit 
their contact with live birds outside the compartment.
    (B) An education and training program for company employees and 
contractors.
    (C) Standard operating procedures for company employees, 
contractors, and outside maintenance personnel.
    (D) Requirements for company employees and non-company personnel 
who visit any premises within the compartment.
    (E) Company veterinary infrastructure to ensure flock monitoring 
and disease diagnosis and control measures.
    (F) Policies for management of vehicles and equipment used within 
the compartment to connect the various premises.
    (G) Farm site requirements (location, layout, and construction).
    (H) Pest management program.
    (I) Cleaning and disinfection process.
    (J) Requirements for litter and dead bird removal and/or disposal.
    (v) Description of other factors important for maintaining the 
compartment. The company veterinary infrastructure will assess sanitary 
measures, environmental risk factors, and management and husbandry 
practices that relate to the separation of the compartment and the 
health status of the birds contained within the compartment that may 
affect risk of exposure to NAI. This assessment must include a 
description of internal monitoring and auditing systems (e.g., quality 
assurance and quality control programs) to demonstrate the 
effectiveness of the compartment. Upon request, the Service will 
provide the company with information on the epidemiology of NAI and the 
associated risk pathways in which the components of the compartment are 
located is available from the Service.
    (vi) Approval or denial. Based on this documentation provided under 
this paragraph (a)(1), as well as any other information the Service and 
the Official State Agency determine to be necessary, the Service and 
the Official State Agency will approve or deny the classification of 
the compartment as U.S. H5/H7 Avian Influenza Clean.
    (2) Company activities for maintenance of the compartment. (i) The 
primary breeder company's management of biosecurity, surveillance, and 
disease control efforts must be uniform and equivalent among all 
components that are a part of the compartment. Oversight and inspection 
of these management practices must be conducted by the company's 
licensed, accredited veterinarians.
    (ii) Veterinary staff from the Official State Agency and NPIP staff 
will work in partnership with licensed, accredited veterinarians to 
train and certify auditors through Service-approved workshops. The 
trained auditors will conduct biosecurity and operational audits at 
least once every 2 years to ensure the integrity of the compartment. 
These audits will include evaluation of the critical control points and 
standard operating practices within the compartment, verification of 
the health status of the flock(s) contained within the compartment, and 
examination of the biosecurity and management system of the integrated 
components of the compartment.
    (iii) In addition, the company must demonstrate compliance with 
paragraph (a)(1) of this section for remaining in the U.S. H5/H7 Avian 
Influenza Clean classification, surveillance for NAI within the 
compartment, and conducting tests in State or Federal laboratories or 
in NPIP authorized laboratories. Accredited veterinarians are 
responsible for the enforcement of active and passive surveillance of 
NAI in primary breeder flocks. Baseline health status must be 
maintained for all flocks or subpopulations within the compartment, 
indicating the dates and negative results of all avian influenza 
surveillance and monitoring testing, the dates and history of last 
disease occurrence (if any), the number of outbreaks, and the methods 
of disease control that were applied.
    (iv) Documentation will be maintained in the company's database and 
will be verified as required by the Service and/or the Official State 
Agency.
    (3) Service and Official State Agency activities for maintenance of 
the compartment. The Service will work in cooperation with the Official 
State Agencies to ensure the continued integrity of any recognized 
compartments. Activities will include:
    (i) Oversight of the establishment and management of compartments;
    (ii) Establishment of effective partnerships between the Service, 
the Plan, and the primary breeder industry;
    (iii) Approval or denial of classification of compartments as U.S. 
H5/H7 Avian Influenza Clean Compartments under paragraph (a)(1) of this 
section;
    (iv) Official certification of the health status of the 
compartment, and commodities that may be traded from it through 
participation in the Plan for avian diseases, including the U.S. H5/H7 
Avian Influenza Clean program as described in Sec.  145.43(g) and 
diagnostic surveillance for H5/H7 low pathogenicity AI as described in 
Sec.  145.15;
    (v) Conducting audits of compartments at least once every 2 years 
to:
    (A) Confirm that the primary breeding company's establishments are

[[Page 4558]]

epidemiologically distinct and pathways for the introduction of disease 
into the compartment are closed through routine operational procedures; 
and
    (B) Evaluate and assess the management and husbandry practices 
relating to biosecurity to determine whether they are in compliance 
with hygiene and biosecurity procedures for poultry primary breeding 
flocks and hatcheries in accordance with part 147 of this subchapter;
    (vi) Providing, upon request, model plans for management and 
husbandry practices relating to biosecurity in accordance with part 147 
of this subchapter, risk evaluations in conjunction with the primary 
breeder industry (including disease surveillance such as VS Form 9-4, 
``Summary of Breeding Flock Participation''), and diagnostic capability 
summaries and systems for initial State response and containment plans 
in accordance with Sec.  56.10 of this chapter; and
    (vii) Publicizing and sharing compartment information with 
international trading partners, upon request, to establish approval and 
recognition of the compartment, including timeliness and accuracy of 
disease reporting and surveillance measures as described in Sec. Sec.  
145.15 and 145.43(g).
    (4) Emergency response and notification. In the case of a confirmed 
positive of NAI in the subpopulation of the compartment, the management 
of the compartment must notify the Service. The Service will 
immediately suspend the status of the compartment. A compartment will 
be eligible to resume trade with importing countries only after the 
compartment has adopted the necessary measures to reestablish the 
biosecurity level and confirm that NAI is not present in the 
compartment and the Service has reevaluated the management and 
biosecurity measures of the compartment and approved said compartment 
for trade.
    (b) [Reserved]
0
20. Section 145.52 is amended as follows:
0
a. In paragraph (b), by removing the words ``(see Sec.  147.25 of this 
chapter)'' and adding the words ``in accordance with part 147 of this 
subchapter'' in their place.
0
b. By redesignating paragraphs (c) and (d) as paragraphs (d) and (e), 
respectively.
0
c. By adding a new paragraph (c).
    The addition reads as follows:


Sec.  145.52  Participation.

* * * * *
    (c) It is recommended that waterfowl flocks and gallinaceous flocks 
in open-air facilities be kept separate.
* * * * *
0
21. Section 145.53 is amended as follows:
0
a. In paragraph (c)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this chapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
b. In paragraph (c)(3), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
c. In paragraph (d)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this chapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
d. In paragraph (d)(1)(ii)(B), by removing the words ``Sec.  147.8 of 
this chapter'' and adding the words ``part 147 of this subchapter'' in 
their place.
0
e. In paragraph (d)(3), by removing the words ``as described in Sec.  
147.24(a) of this chapter'' and adding the words ``in accordance with 
part 147 of this subchapter'' in their place.
0
f. By revising paragraphs (e)(1) introductory text and (e)(2) 
introductory text to read as set forth below.
0
g. In paragraphs (e)(1)(i) and (e)(1)(ii), by removing the number 
``90'' and adding the number ``180'' in its place.
0
h. By revising paragraph (e)(3).
0
i. By adding paragraph (f).
    The revision and addition read as follows:


Sec.  145.53  Terminology and classification; flocks and products.

* * * * *
    (e) * * *
    (1) It is a primary breeding flock in which a minimum of 30 birds 
has been tested negative to the H5 and H7 subtypes of avian influenza 
as provided in Sec.  145.14(d) when more than 4 months of age; 
Provided, that waterfowl flocks may test a minimum of 30 cloacal swabs 
for virus isolation. To retain this classification:
* * * * *
    (2) It is a multiplier breeding flock in which a minimum of 30 
birds has been tested negative to the H5 and H7 subtypes of avian 
influenza as provided in Sec.  145.14(d) when more than 4 months of 
age; Provided, that waterfowl flocks may test a minimum of 30 cloacal 
swabs for virus isolation. To retain this classification:
* * * * *
    (3) A sample of at least 30 birds must be tested and found negative 
to H5/H7 avian influenza within 21 days prior to movement to slaughter.
    (f) U.S. Salmonella Monitored. This program is intended to be the 
basis from which the hatching industry may conduct a program for the 
prevention and control of salmonellosis. It is intended to reduce the 
incidence of Salmonella organisms in day-old poultry through an 
effective and practical sanitation program in the hatchery. This will 
afford other segments of the poultry industry an opportunity to reduce 
the incidence of Salmonella in their products. The following 
requirements must be met for a flock to be of this classification:
    (1) An Authorized Agent shall collect a minimum of five 
environmental samples, e.g., chick papers, hatching trays, and chick 
transfer devices, from the hatchery at least every 30 days. Testing 
must be performed at an authorized laboratory.
    (2) To claim products are of this classification, all products 
shall be derived from a hatchery that meets the requirements of the 
classification.
    (3) This classification may be revoked by the Official State Agency 
if the participant fails to follow recommended corrective measures.
* * * * *


Sec.  145.62  [Amended]

0
22. In Sec.  145.62, paragraph (b) is amended by removing the words 
``(see Sec.  147.22 of this chapter)'' and adding the words ``in 
accordance with part 147 of this subchapter'' in their place.
0
23. In Sec.  145.72, paragraph (b) is revised to read as follows:


Sec.  145.72  Participation.

* * * * *
    (b) Hatching eggs produced by primary breeding flocks should be 
nest clean. They may be fumigated in accordance with part 147 of this 
subchapter or otherwise sanitized.
* * * * *
0
24. Section 145.73 is amended as follows:
0
a. In paragraph (c)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this subchapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
b. In paragraph (c)(3), by removing the words ``as described in Sec.  
147.24(a)'' and

[[Page 4559]]

adding the words ``in accordance with part 147'' in their place.
0
c. In paragraph (d)(1)(iv), by removing the words ``in compliance with 
Sec. Sec.  147.21, 147.24(a), and 147.26 of this subchapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to flock sanitation, cleaning and disinfection, and Salmonella 
isolation, sanitation, and management'' in their place.
0
d. In paragraph (d)(1)(v), by removing the words ``as described in 
Sec.  147.12'' and adding the words ``in accordance with part 147'' in 
their place.
0
e. In paragraph (d)(1)(vii), by removing the words ``as described in 
Sec.  147.11'' and adding the words ``in accordance with part 147'' in 
their place.
0
f. By revising paragraph (d)(1)(ix).
0
g. In paragraph (d)(2), by removing the words ``as described in Sec.  
147.11(a)'' and adding the words ``in accordance with part 147'' in 
their place.
0
h. In paragraph (e)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this subchapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
i. In paragraph (e)(3), by removing the words ``as described in Sec.  
147.24(a)'' and adding the words ``in accordance with part 147'' in 
their place.
0
j. In paragraph (f)(1) introductory text, by adding the words ``and 
found'' before the word ``negative'' and by removing the words ``for 
antibodies''.
0
k. By revising paragraph (f)(2).
    The revisions read as follows:


Sec.  145.73  Terminology and classification; flocks and products.

* * * * *
    (d) * * *
    (1) * * *
    (ix) Hatching eggs produced by the flock are incubated in a 
hatchery whose sanitation is maintained in accordance with part 147 of 
this subchapter and sanitized either by a procedure approved by the 
Official State Agency or in accordance with part 147 of this 
subchapter.
* * * * *
    (f) * * *
    (2) A sample of at least 11 birds must be tested and found negative 
to avian influenza within 21 days prior to movement to slaughter.
0
25. A new Sec.  145.74 is added to read as follows:


Sec.  145.74  Terminology and classification; compartments.

    (a) U.S. Avian Influenza Clean Compartment. This program is 
intended to be the basis from which the primary egg-type chicken 
breeding-hatchery industry may demonstrate the existence and 
implementation of a program that has been approved by the Official 
State Agency and the Service to establish a compartment consisting of a 
primary breeding-hatchery company that is free of H5/H7 avian influenza 
(AI), also referred to as notifiable avian influenza (NAI). This 
compartment has the purpose of protecting the defined subpopulation and 
avoiding the introduction and spread of NAI within that subpopulation 
by prohibiting contact with other commercial poultry operations, other 
domestic and wild birds, and other intensive animal operations. The 
program shall consist of the following:
    (1) Definition of the compartment. Based on the guidelines 
established by the World Organization for Animal Health (OIE) in the 
Terrestrial Animal Health Code and the guidelines in this paragraph 
(a), the primary breeder company will define the compartment with 
respect to NAI. Specifically, the company will use a comprehensive 
biosecurity program to define the compartment as a subpopulation of 
poultry with a health status for NAI that is separate from birds and 
poultry outside the compartment. The Official State Agency and the 
Service must approve all documentation submitted to substantiate the 
defined compartment as adequate to qualify for epidemiological 
separation from other potential sources of infection of NAI. Guidelines 
for the definition of the compartment include:
    (i) Definition and description of the subpopulation of birds and 
their health status. All birds included in the compartment must be U.S. 
Avian Influenza Clean in accordance with Sec.  145.73(f). The poultry 
must also be located in a State that has an initial State response and 
containment plan approved by APHIS under Sec.  56.10 of this chapter 
and that participates in the diagnostic surveillance program for H5/H7 
low pathogenicity AI as described in Sec.  145.15. Within the 
compartment, all official tests for AI, as described in Sec.  
145.14(d), must be conducted in State or Federal laboratories or in 
NPIP authorized laboratories that meet the minimum standards described 
in Sec.  147.52 of this subchapter. In addition, the company must 
provide to the Service upon request any relevant historical and current 
NAI-related data for reference regarding surveillance for the disease 
within the compartment. Upon request, the company must also work with 
the Official State Agency to provide such data for other bird 
populations located in the State.
    (ii) Description of animal identification and traceability 
processes. The primary breeder company must also include a description 
of its animal identification and traceability records, including 
examples of Veterinary Services (VS) Form 9-5, ``Report of Hatcheries, 
Dealers and Independent Flocks''; VS Form 9-2, ``Flock Selection and 
Testing Report''; VS Form 9-3, ``Report of Sales of Hatching Eggs, 
Chicks and Poults''; VS Form 9-9, ``Hatchery Inspection Report''; set 
and hatch records; egg receipts; and egg/chick invoices for the 
subpopulation. Documentation must also include breed identification 
(NPIP stock code). The Service should ensure that an effective flock 
identification system and traceability system are in place.
    (iii) Definition and description of the physical components or 
establishments of the defined compartment. The primary breeder company 
must provide documentation establishing that the defined compartment is 
epidemiologically separated from other poultry and bird populations. 
The documentation must be approved by the Official State Agency and the 
Service as indicating adequate epidemiological separation to maintain 
the compartment's separate health status with respect to NAI. The 
documentation should include descriptions of:
    (A) The physical and spatial factors that separate the compartment 
from surrounding bird populations and affect the biosecurity status of 
the compartment.
    (B) Relevant environmental factors that may affect exposure of the 
birds to AI.
    (C) The functional boundary and fencing that are used to control 
access to the compartment.
    (D) Facilities and procedures to prevent access by wild birds and 
to provide separation from other relevant hosts.
    (E) The relevant infrastructural factors that may affect exposure 
to AI, including the construction and design of buildings or physical 
components, cleaning and disinfection of buildings and physical 
components between production groups with quality assurance 
verification, cleaning and disinfection of equipment, and introduction 
of equipment or material into the compartment.
    (iv) Definition and description of the functional relationships 
between components of the defined compartment. Functional relationships 
between components of the compartment include traffic movement and flow 
at and among premises, personnel movement at and among

[[Page 4560]]

premises, exposure to live bird populations, and any other factors that 
could affect biosecurity of the compartment. All physical components of 
the compartment must be maintained in compliance with hygiene and 
biosecurity procedures for poultry primary breeding flocks and 
hatcheries in accordance with part 147 of this subchapter. In addition, 
the company must provide a biosecurity plan for the compartment and all 
included components. The biosecurity plan should include:
    (A) Requirements that company employees and contract growers limit 
their contact with live birds outside the compartment.
    (B) An education and training program for company employees and 
contractors.
    (C) Standard operating procedures for company employees, 
contractors, and outside maintenance personnel.
    (D) Requirements for company employees and non-company personnel 
who visit any premises within the compartment.
    (E) Company veterinary infrastructure to ensure flock monitoring 
and disease diagnosis and control measures.
    (F) Policies for management of vehicles and equipment used within 
the compartment to connect the various premises.
    (G) Farm site requirements (location, layout, and construction).
    (H) Pest management program.
    (I) Cleaning and disinfection process.
    (J) Requirements for litter and dead bird removal and/or disposal.
    (v) Description of other factors important for maintaining the 
compartment. The company veterinary infrastructure will assess sanitary 
measures, environmental risk factors, and management and husbandry 
practices that relate to the separation of the compartment and the 
health status of the birds contained within the compartment that may 
affect risk of exposure to NAI. This assessment must include a 
description of internal monitoring and auditing systems (e.g., quality 
assurance and quality control programs) to demonstrate the 
effectiveness of the compartment. Upon request, the Service will 
provide the company with information on the epidemiology of NAI and the 
associated risk pathways in which the components of the compartment are 
located is available from the Service.
    (vi) Approval or denial. Based on the documentation provided under 
this paragraph (a)(1), as well as any other information the Service and 
the Official State Agency determine to be necessary, the Service and 
the Official State Agency will approve or deny the classification of 
the compartment as U.S. Avian Influenza Clean.
    (2) Company activities for maintenance of the compartment. (i) The 
primary breeder company's management of biosecurity, surveillance, and 
disease control efforts must be uniform and equivalent among all 
components that are a part of the compartment. Oversight and inspection 
of these management practices must be conducted by the company's 
licensed, accredited veterinarians.
    (ii) Veterinary staff from the Official State Agency and NPIP staff 
will work in partnership with licensed, accredited veterinarians to 
train and certify auditors through Service-approved workshops. The 
trained auditors will conduct biosecurity and operational audits at 
least once every 2 years to ensure the integrity of the compartment. 
These audits will include evaluation of the critical control points and 
standard operating practices within the compartment, verification of 
the health status of the flock(s) contained within the compartment, and 
examination of the biosecurity and management system of the integrated 
components of the compartment.
    (iii) In addition, the company must demonstrate compliance with 
paragraph (a)(1) of this section for remaining in the U.S. Avian 
Influenza Clean classification, surveillance for NAI within the 
compartment, and conducting tests in State or Federal laboratories or 
in NPIP authorized laboratories. Accredited veterinarians are 
responsible for the enforcement of active and passive surveillance of 
NAI in primary breeder flocks. Baseline health status must be 
maintained for all flocks or subpopulations within the compartment, 
indicating the dates and negative results of all avian influenza 
surveillance and monitoring testing, the dates and history of last 
disease occurrence (if any), the number of outbreaks, and the methods 
of disease control that were applied.
    (iv) Documentation will be maintained in the company's database and 
will be verified as required by the Service and/or the Official State 
Agency.
    (3) Service and Official State Agency activities for maintenance of 
the compartment. The Service will work in cooperation with the Official 
State Agencies to ensure the continued integrity of any recognized 
compartments. Activities will include:
    (i) Oversight of the establishment and management of compartments;
    (ii) Establishment of effective partnerships between the Service, 
the Plan, and the primary breeder industry;
    (iii) Approval or denial of classification of compartments as U.S. 
Avian Influenza Clean Compartments under paragraph (a)(1) of this 
section;
    (iv) Official certification of the health status of the 
compartment, and commodities that may be traded from it through 
participation in the Plan for avian diseases, including the U.S. Avian 
Influenza Clean program as described in Sec.  145.73(f) and diagnostic 
surveillance for H5/H7 low pathogenicity AI as described in Sec.  
145.15;
    (v) Conducting audits of compartments at least once every 2 years 
to:
    (A) Confirm that the primary breeding company's establishments are 
epidemiologically distinct and pathways for the introduction of disease 
into the compartment are closed through routine operational procedures; 
and
    (B) Evaluate and assess the management and husbandry practices 
relating to biosecurity to determine whether they are in compliance 
with hygiene and biosecurity procedures for poultry primary breeding 
flocks and hatcheries in accordance with part 147 of this subchapter;
    (vi) Providing, upon request, model plans for management and 
husbandry practices relating to biosecurity in accordance with part 147 
of this subchapter, risk evaluations in conjunction with the primary 
breeder industry (including disease surveillance such as VS Form 9-4, 
``Summary of Breeding Flock Participation''), and diagnostic capability 
summaries and systems for initial State response and containment plans 
in accordance with Sec.  56.10 of this chapter; and
    (vii) Publicizing and sharing compartment information with 
international trading partners, upon request, to establish approval and 
recognition of the compartment, including timeliness and accuracy of 
disease reporting and surveillance measures as described in Sec. Sec.  
145.15 and 145.73(f).
    (4) Emergency response and notification. In the case of a confirmed 
positive of NAI in the subpopulation of the compartment, the management 
of the compartment must notify the Service. The Service will 
immediately suspend the status of the compartment. A compartment will 
be eligible to resume trade with importing countries only after the 
compartment has adopted the necessary measures to reestablish the 
biosecurity level and confirm that NAI is not present in the 
compartment

[[Page 4561]]

and the Service has reevaluated the management and biosecurity measures 
of the compartment and approved said compartment for trade.
    (b) [Reserved]
0
26. In Sec.  145.82, paragraph (b) is revised to read as follows:


Sec.  145.82  Participation.

* * * * *
    (b) Hatching eggs produced by primary breeding flocks should be 
nest clean. They may be fumigated in accordance with part 147 of this 
subchapter or otherwise sanitized.
* * * * *
0
27. Section 145.83 is amended as follows:
0
a. In paragraph (c)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this subchapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
b. In paragraph (c)(3), by removing the words ``as described in Sec.  
147.24(a)'' and adding the words ``in accordance with part 147'' in 
their place.
0
c. In paragraph (d)(1) introductory text, by removing the words ``in 
compliance with the provisions of Sec.  147.26 of this subchapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to Mycoplasma isolation, sanitation, and management'' in their 
place.
0
d. In paragraph (d)(3), by removing the words ``as described in Sec.  
147.24(a)'' and adding the words ``in accordance with part 147'' in 
their place.
0
e. By revising paragraphs (e)(1) and (e)(3).
0
f. In paragraph (e)(6) introductory text, by removing the words ``or 
great-grandparent'' and adding the words ``great-grandparent, or 
grandparent'' in their place.
0
g. In paragraph (e)(6)(i)(B), by removing the words ``as described in 
Sec.  147.12(a)'' and adding the words ``in accordance with part 147'' 
in their place.
0
h. In paragraph (e)(6)(i)(C), by removing the words ``as described in 
Sec.  147.11'' and adding the words ``in accordance with part 147'' in 
their place.
0
i. In paragraph (e)(6)(i)(D), by removing the words ``as specified in 
Sec.  147.12(a)'' and adding the words ``in accordance with part 147'' 
in their place.
0
j. In paragraph (f)(1)(i), by removing the words ``in compliance with 
Sec. Sec.  147.21, 147.24(a), and 147.26 of this subchapter'' and 
adding the words ``in accordance with part 147 of this subchapter with 
respect to flock sanitation, cleaning and disinfection, and Salmonella 
isolation, sanitation, and management'' in their place.
0
k. By revising paragraph (f)(1)(iv).
0
l. In paragraph (f)(1)(vi), by removing the words ``as described in 
Sec.  147.12'' and adding the words ``in accordance with part 147'' in 
their place.
0
m. By revising paragraph (f)(2).
0
n. In paragraph (g)(1) introductory text, by adding the words ``using 
an approved test as described in Sec.  145.14'' after the word 
``influenza''.
0
o. By revising paragraph (g)(2).
    The revisions read as follows:


Sec.  145.83  Terminology and classification; flocks and products.

* * * * *
    (e) * * *
    (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 in accordance with part 147 of 
this subchapter and any group D Salmonella samples have been serotyped:
    (A) A sample of chick papers, hatcher tray swabs, or fluff 
collected and cultured in accordance with part 147 of this subchapter; 
and
    (B) Samples of intestinal and liver or spleen tissues from a 
minimum of 30 chicks that died within 7 days after hatching and have 
been preserved daily by freezing prior to shipment to an authorized 
laboratory.
    (ii) The flock is maintained in compliance with isolation, 
sanitation, and management procedures for Salmonella in accordance with 
part 147 of this subchapter.
    (iii) Environmental samples are collected from the flock by or 
under the supervision of an Authorized Agent, in accordance with part 
147 of this subchapter, when the flock reaches 4 months of age and 
every 30 days thereafter. Once the flock is in egg production and 
chicks are hatching from it, the samples must include at least 4 
individual test assay results every 30 days in flocks of more than 500 
birds or 2 individual assays per month in flocks of 500 birds or fewer. 
One of these results must come from samples collected from hatched 
chicks at a participating hatchery derived from said flock. These 
individual test assays may be derived from pooled samples from the farm 
or hatchery in accordance with part 147 of this subchapter, but must be 
run as separate test assays in the laboratory. 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.
    (iv) 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 part 
147 of this subchapter. Cultures from group D positive samples shall be 
serotyped.
    (v) Hatching eggs produced by the flock are collected as quickly as 
possible and their sanitation is maintained in accordance with part 147 
of this subchapter.
    (vi) Hatching eggs produced by the flock are incubated in a 
hatchery whose sanitation is maintained in accordance with part 147 of 
this subchapter, and the hatchery must have been sanitized either by a 
procedure approved by the Official State Agency or by fumigation in 
accordance with part 147 of this subchapter.
    (2) * * *
    (3) If SE is isolated from an environmental sample collected from 
the flock in accordance with paragraph (e)(1)(iii) of this section, an 
additional environmental sampling and 25 live cull birds or fresh dead 
birds (if present), or other randomly selected live birds if fewer than 
25 culls can be found in the flock, must be bacteriologically examined 
for SE in accordance with part 147 of this subchapter. If only 1 bird 
from the 25-bird sample is found positive for SE, the participant may 
request bacteriological examination of a second 25-bird sample from the 
flock. In addition, if the flock with the SE isolation is in egg 
production and eggs are under incubation, the next four consecutive 
hatches shall be examined bacteriologically in accordance with part 147 
of this subchapter. Samples shall be collected from all of the hatching 
unit's chick trays and basket trays of hatching eggs, or from all chick 
box papers from the flock, and tested, pooling the samples into a 
minimum of 10 separate assays. Any followup hatchery-positive SE 
isolations shall result in discontinuation of subsequent hatches until 
the flock status is determined by bird culture. The flock will be 
disqualified for the U.S. S. Enteritidis Clean classification if a bird 
or subsequent flock environmental assay results in isolation of SE.
* * * * *

[[Page 4562]]

    (f) * * *
    (1) * * *
    (iv) Chicks shall be hatched in a hatchery whose sanitation is 
maintained in accordance with part 147 of this subchapter and sanitized 
or fumigated in accordance with part 147 of this subchapter.
* * * * *
    (2) The Official State Agency may monitor the effectiveness of the 
sanitation practices in accordance with part 147 of this subchapter.
* * * * *
    (g) * * *
    (2) During each 90-day period, all primary spent fowl, up to a 
maximum of 30 must be tested serologically and found negative for 
antibodies to avian influenza within 21 days prior to slaughter.
0
28. Add Sec.  145.84 to read as follows:


Sec.  145.84  Terminology and classification; compartments.

    (a) U.S. Avian Influenza Clean Compartment. This program is 
intended to be the basis from which the primary meat-type chicken 
breeding-hatchery industry may demonstrate the existence and 
implementation of a program that has been approved by the Official 
State Agency and the Service to establish a compartment consisting of a 
primary breeding-hatchery company that is free of H5/H7 avian influenza 
(AI), also referred to as notifiable avian influenza (NAI). This 
compartment has the purpose of protecting the defined subpopulation and 
avoiding the introduction and spread of NAI within that subpopulation 
by prohibiting contact with other commercial poultry operations, other 
domestic and wild birds, and other intensive animal operations. The 
program shall consist of the following:
    (1) Definition of the compartment. Based on the guidelines 
established by the World Organization for Animal Health (OIE) in the 
Terrestrial Animal Health Code and the guidelines in this paragraph 
(a), the primary breeder company will define the compartment with 
respect to NAI. Specifically, the company will use a comprehensive 
biosecurity program to define the compartment as a subpopulation of 
poultry with a health status for NAI that is separate from birds and 
poultry outside the compartment. The Official State Agency and the 
Service must approve all documentation submitted to substantiate the 
defined compartment as adequate to qualify for epidemiological 
separation from other potential sources of infection of NAI. Guidelines 
for the definition of the compartment include:
    (i) Definition and description of the subpopulation of birds and 
their health status. All birds included in the compartment must be U.S. 
Avian Influenza Clean in accordance with Sec.  145.83(g). The poultry 
must also be located in a State that has an initial State response and 
containment plan approved by APHIS under Sec.  56.10 of this chapter 
and that participates in the diagnostic surveillance program for H5/H7 
low pathogenicity AI as described in Sec.  145.15. Within the 
compartment, all official tests for AI, as described in Sec.  
145.14(d), must be conducted in State or Federal laboratories or in 
NPIP authorized laboratories that meet the minimum standards described 
in Sec.  147.52 of this subchapter. In addition, the company must 
provide to the Service upon request any relevant historical and current 
NAI-related data for reference regarding surveillance for the disease 
and the health status of the compartment. Upon request, the company 
must also work with the Official State Agency to provide such data 
other bird populations located in the State.
    (ii) Description of animal identification and traceability 
processes. The primary breeder company must also include a description 
of its animal identification and traceability records, including 
examples of Veterinary Services (VS) Form 9-5, ``Report of Hatcheries, 
Dealers and Independent Flocks''; VS Form 9-2, ``Flock Selection and 
Testing Report''; VS Form 9-3, ``Report of Sales of Hatching Eggs, 
Chicks and Poults''; VS Form 9-9, '' Hatchery Inspection Report''; set 
and hatch records; egg receipts; and egg/chick invoices for the 
subpopulation. Documentation must also include breed identification 
(NPIP stock code). The Service should ensure that an effective flock 
identification system and traceability system are in place.
    (iii) Definition and description of the physical components or 
establishments of the defined compartment. The primary breeder company 
must provide documentation establishing that the defined compartment is 
epidemiologically separated from other poultry and bird populations. 
The documentation must be approved by the Official State Agency and the 
Service as indicating adequate epidemiological separation to maintain 
the compartment's separate health status with respect to NAI. The 
documentation should include descriptions of:
    (A) The physical and spatial factors that separate the compartment 
from surrounding bird populations and affect the biosecurity status of 
the compartment.
    (B) Relevant environmental factors that may affect exposure of the 
birds to AI.
    (C) The functional boundary and fencing that are used to control 
access to the compartment.
    (D) Facilities and procedures to prevent access by wild birds and 
to provide separation from other relevant hosts.
    (E) The relevant infrastructural factors that may affect exposure 
to AI, including the construction and design of buildings or physical 
components, cleaning and disinfection of buildings and physical 
components between production groups with quality assurance 
verification, cleaning and disinfection of equipment, and introduction 
of equipment or material into the compartment.
    (iv) Definition and description of the functional relationships 
between components of the defined compartment. Functional relationships 
between components of the compartment include traffic movement and flow 
at and among premises, personnel movement at and among premises, 
exposure to live bird populations, and any other factors that could 
affect biosecurity of the compartment. All physical components of the 
compartment must be maintained in compliance with hygiene and 
biosecurity procedures for poultry primary breeding flocks and 
hatcheries in accordance with part 147 of this subchapter. In addition, 
the company must provide a biosecurity plan for the compartment and all 
included components. The biosecurity plan should include:
    (A) Requirements that company employees and contract growers limit 
their contact with live birds outside the compartment.
    (B) An education and training program for company employees and 
contractors.
    (C) Standard operating procedures for company employees, 
contractors, and outside maintenance personnel.
    (D) Requirements for company employees and non-company personnel 
who visit any premises within the compartment.
    (E) Company veterinary infrastructure to ensure flock monitoring 
and disease diagnosis and control measures.
    (F) Policies for management of vehicles and equipment used within 
the compartment to connect the various premises.
    (G) Farm site requirements (location, layout, and construction).
    (H) Pest management program.
    (I) Cleaning and disinfection process.

[[Page 4563]]

    (J) Requirements for litter and dead bird removal and/or disposal.
    (v) Description of other factors important for maintaining the 
compartment. The company veterinary infrastructure will assess sanitary 
measures, environmental risk factors, and management and husbandry 
practices that relate to the separation of the compartment and the 
health status of the birds contained within the compartment that may 
affect risk of exposure to NAI. This assessment must include a 
description of internal monitoring and auditing systems (e.g., quality 
assurance and quality control programs) to demonstrate the 
effectiveness of the compartment. Upon request, the Service will 
provide the company with information on the epidemiology of NAI and the 
associated risk pathways in which the components of the compartment are 
located is available from the Service.
    (vi) Approval or denial. Based on the documentation provided under 
this paragraph (a)(1), as well as any other information the Service and 
the Official State Agency determine to be necessary, the Service and 
the Official State Agency will approve or deny the classification of 
the compartment as U.S. Avian Influenza Clean.
    (2) Company activities for maintenance of the compartment. (i) The 
primary breeder company's management of biosecurity, surveillance, and 
disease control efforts must be uniform and equivalent among all 
components that are a part of the compartment. Oversight and inspection 
of these management practices must be conducted by the company's 
licensed, accredited veterinarians.
    (ii) Veterinary staff from the Official State Agency and NPIP staff 
will work in partnership with licensed, accredited veterinarians to 
train and certify auditors through Service-approved workshops. The 
trained auditors will conduct biosecurity and operational audits at 
least once every 2 years to ensure the integrity of the compartment. 
These audits will include evaluation of the critical control points and 
standard operating practices within the compartment, verification of 
the health status of the flock(s) contained within the compartment, and 
examination of the biosecurity and management system of the integrated 
components of the compartment.
    (iii) In addition, the company must demonstrate compliance with 
paragraph (a)(1) of this section for remaining in the U.S. Avian 
Influenza Clean classification, surveillance for NAI within the 
compartment, and conducting tests in State or Federal laboratories or 
in NPIP authorized laboratories. Accredited veterinarians are 
responsible for the enforcement of active and passive surveillance of 
NAI in primary breeder flocks. Baseline health status must be 
maintained for all flocks or subpopulations within the compartment, 
indicating the dates and negative results of all avian influenza 
surveillance and monitoring testing, the dates and history of last 
disease occurrence (if any), the number of outbreaks, and the methods 
of disease control that were applied.
    (iv) Documentation will be maintained in the company's database and 
will be verified as required by the Service and/or the Official State 
Agency.
    (3) Service and Official State Agency activities for maintenance of 
the compartment. The Service will work in cooperation with the Official 
State Agencies to ensure the continued integrity of any recognized 
compartments. Activities will include:
    (i) Oversight of the establishment and management of compartments;
    (ii) Establishment of effective partnerships between the Service, 
the Plan, and the primary breeder industry;
    (iii) Approval or denial of classification of compartments as U.S. 
Avian Influenza Clean Compartments under paragraph (a)(1) of this 
section;
    (iv) Official certification of the health status of the 
compartment, and commodities that may be traded from it through 
participation in the Plan for avian diseases, including the U.S. Avian 
Influenza Clean program as described in Sec.  145.83(g) and diagnostic 
surveillance for H5/H7 low pathogenicity AI as described in Sec.  
145.15;
    (v) Conducting audits of compartments at least once every 2 years 
to:
    (A) Confirm that the primary breeding company's establishments are 
epidemiologically distinct and pathways for the introduction of disease 
into the compartment are closed through routine operational procedures; 
and
    (B) Evaluate and assess the management and husbandry practices 
relating to biosecurity to determine whether they are in compliance 
with hygiene and biosecurity procedures for poultry primary breeding 
flocks and hatcheries in accordance with part 147 of this subchapter;
    (vi) Providing, upon request, model plans for management and 
husbandry practices relating to biosecurity in accordance with part 147 
of this subchapter, risk evaluations in conjunction with the primary 
breeder industry (including disease surveillance such as VS Form 9-4, 
``Summary of Breeding Flock Participation''), and diagnostic capability 
summaries and systems for initial State response and containment plans 
in accordance with Sec.  56.10 of this chapter; and
    (vii) Publicizing and sharing compartment information with 
international trading partners, upon request, to establish approval and 
recognition of the compartment, including timeliness and accuracy of 
disease reporting and surveillance measures as described in Sec. Sec.  
145.15 and 145.83(g).
    (4) Emergency response and notification. In the case of a confirmed 
positive of NAI in the subpopulation of the compartment, the management 
of the compartment must notify the Service. The Service will 
immediately suspend the status of the compartment. A compartment would 
be eligible to resume trade with importing countries only after the 
compartment has adopted the necessary measures to reestablish the 
biosecurity level and confirm that NAI is not present in the 
compartment and the Service has reevaluated the management and 
biosecurity measures of the compartment and approved said compartment 
for trade.
    (b) [Reserved]


Sec.  145.92  [Amended]

0
29. In Sec.  145.92, paragraph (b) is amended by removing the words 
``(see Sec.  147.25 of this chapter)'' and adding the words ``in 
accordance with part 147 of this subchapter'' in their place.
0
30. Section 145.93 is amended as follows:
0
a. By revising paragraph (c)(3).
0
b. By adding a new paragraph (d).
    The revision and addition read as follows:


Sec.  145.93  Terminology and classification; flocks and products.

* * * * *
    (c) * * *
    (3) A sample of at least 30 birds must be tested and found negative 
to H5/H7 avian influenza within 21 days prior to movement to slaughter.
    (d) 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 day-
old waterfowl 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.

[[Page 4564]]

    (1) A flock and the hatching eggs and day-old waterfowl produced 
from it must meet the following requirements, as determined by the 
Official State Agency, to be eligible for this classification:
    (i) The flock is maintained in compliance with isolation, 
sanitation, and management procedures for Salmonella in accordance with 
part 147 of this subchapter.
    (ii) If feed contains animal protein, the protein products must 
have been heated throughout to a minimum temperature of 
190[emsp14][deg]F or above, or to a minimum temperature of 
165[emsp14][deg]F for at least 20 minutes, or to a minimum temperature 
of 184[emsp14][deg]F under 70 lbs. pressure during the manufacturing 
process.
    (iii) Feed shall be stored and transported in a manner that 
prevents contamination.
    (iv) Waterfowl shall be hatched in a hatchery whose sanitation is 
maintained in accordance with part 147 of this subchapter and sanitized 
or fumigated in accordance with part 147 of this subchapter.
    (v) An Authorized Agent shall take environmental samples from the 
hatchery every 30 days, i.e., meconium or box liner paper. An 
authorized laboratory for Salmonella shall examine the samples 
bacteriologically.
    (vi) An Authorized Agent shall take environmental samples in 
accordance with part 147 of this subchapter from each flock at 4 months 
of age and every 30 days thereafter. An authorized laboratory for 
Salmonella shall examine the environmental samples bacteriologically.
    (vii) Flocks may be vaccinated with a paratyphoid vaccine: 
Provided, that a sample of at least 100 birds will be segregated and 
shall remain unvaccinated until the flock reaches at least 4 months of 
age.
    (2) The Official State Agency may monitor the effectiveness of the 
egg sanitation practices in accordance with part 147 of this 
subchapter.
    (3) To claim products are of this classification, all products 
shall be derived from a hatchery and flock that 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.

PART 146--NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY

0
31. The authority citation for part 146 continues to read as follows:

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

0
32. Section 146.1 is amended as follows:
0
a. By revising the definition of authorized laboratory.
0
b. In the definition of commercial meat-type flock, by adding the words 
``spent fowl,'' after the word ``chickens,''.
0
c. In the definition of H5/H7 low pathogenic avian influenza (LPAI), by 
adding the words ``or equal to'' before the number ``1.2'' and by 
adding the word ``causes'' before the words ``less than 75''.
0
d. In the definition of H5/H7 LPAI virus infection (infected), by 
adding the words ``the Cooperating State Agency, the Official State 
Agency, and'' before the word ``APHIS''.
    The revision reads as follows:


Sec.  146.1  Definitions.

* * * * *
    Authorized laboratory. An authorized laboratory is a laboratory 
that meets the requirements of Sec.  147.52 and is thus qualified to 
perform the assays in accordance with part 147 of this subchapter.
* * * * *


Sec.  146.2  [Amended]

0
33. In Sec.  146.2, paragraph (e) is amended by removing the words 
``follow the laboratory protocols outlined in part 147 of this 
chapter'' and adding the words ``conduct tests in accordance with part 
147 of this subchapter'' in their place.


Sec.  146.3  [Amended]

0
34. Section 146.3 is amended as follows:
0
a. In paragraph (c), by adding the words ``, spent fowl,'' after the 
word ``chicken''.
0
b. By removing paragraph (e).


Sec.  146.5  [Amended]

0
35. In Sec.  146.5, paragraph (b) is amended by removing the words ``as 
recommended in Sec.  147.21(c)'' and adding the words ``in accordance 
with part 147'' in their place.
0
36. In Sec.  146.11, paragraph (b) is revised to read as follows:


Sec.  146.11  Inspections.

* * * * *
    (b) A flock will be considered to be not conforming to protocol if 
there are no test results available, if samples from the flock were not 
collected and tested within 21 days prior to slaughter, or if the test 
results for the flocks were not returned prior to movement to 
slaughter.
* * * * *
0
37. Section 146.13 is amended as follows:
0
a. In paragraph (a)(1), by removing the words ``the requirements in 
Sec.  147.8'' and adding the words ``part 147'' in their place.
0
b. By revising paragraph (b)(1)(ii)(C).
0
c. In paragraph (b)(2)(i), by removing the word ``(AVPR01510)''.
0
d. By revising paragraph (b)(2)(ii)(B).
    The revisions read as follows:


Sec.  146.13  Testing.

* * * * *
    (b) * * *
    (1) * * *
    (ii) * * *
    (C) The AGID test for avian influenza must be conducted in 
accordance with part 147 of this subchapter. The test can be conducted 
on egg yolk or blood samples. The AGID test is not recommended for use 
in waterfowl.
* * * * *
    (2) * * *
    (ii) * * *
    (B) Chicken and turkey flocks that test positive on the ACIA must 
be retested using the RRT-PCR or virus isolation. Positive results from 
the RRT-PCR or virus isolation must be further tested by Federal 
Reference Laboratories using appropriate tests for confirmation. Final 
judgment may be based upon further sampling and appropriate tests for 
confirmation.
* * * * *
0
38. Section 146.23 is amended by revising the introductory text of 
paragraphs (a), (a)(1), and (a)(2) to read as follows:


Sec.  146.23  Terminology and classification; flocks and products.

* * * * *
    (a) U.S. H5/H7 Avian Influenza Monitored.
    (1) Table-egg layer pullet flocks. This program is intended to be 
the basis from which the table-egg layer industry may conduct a program 
to monitor for the H5/H7 subtypes of avian influenza. It is intended to 
determine the presence of the H5/H7 subtypes of avian influenza in 
table-egg layer pullets through routine surveillance of each 
participating commercial table-egg layer pullet flock. A flock will 
qualify for this classification when the Official State Agency 
determines that it has met one of the following requirements:
* * * * *
    (2) Table-egg layer flocks. This program is intended to be the 
basis from which the table-egg layer industry may conduct a program to 
monitor for the H5/H7 subtypes of avian influenza. It is intended to 
determine the presence of the H5/H7 subtypes of avian influenza

[[Page 4565]]

in table-egg layer through routine surveillance of each participating 
commercial table-egg layer flock. A flock will qualify for this 
classification when the Official State Agency determines that it has 
met one of the following requirements:
* * * * *
0
39. Section 146.31 is amended by adding, in alphabetical order, a 
definition of spent fowl to read as follows:


Sec.  146.31  Definitions.

* * * * *
    Spent fowl. Domesticated poultry that were in production of 
hatching eggs or commercial table eggs and have been removed from such 
production.
0
40. Section 146.32 is amended by adding a new paragraph (c) to read as 
follows:


Sec.  146.32  Participation.

* * * * *
    (c) If spent fowl are slaughtered at meat-type chicken slaughter 
plants that participate in the Plan, they may participate in the Plan 
through the provisions of this subpart C.
0
41. Section 146.33 is amended as follows:
0
a. In paragraph (a)(1), by removing the words ``for antibodies''.
0
b. By revising paragraph (a)(2).
    The revision reads as follows:


Sec.  146.33  Terminology and classification; meat-type chicken 
slaughter plants.

* * * * *
    (a) * * *
    (2) It is a meat-type chicken slaughter plant which accepts only 
meat-type chickens or spent fowl from flocks where samples from a 
minimum of 11 birds have been collected no more than 21 days prior to 
slaughter and tested negative to the H5/H7 subtypes of avian influenza, 
as provided in Sec.  146.13(b); or
* * * * *
0
42. In Sec.  146.43, paragraph (a)(1) is revised to read as follows:


Sec.  146.43  Terminology and classification; meat-type turkey 
slaughter plants.

* * * * *
    (a) * * *
    (1) It is a meat-type turkey slaughter plant that accepts only 
meat-type turkeys from flocks where a minimum of 6 samples per flock 
have been collected no more than 21 days prior to movement to slaughter 
and tested negative with an approved test for type A avian influenza, 
as provided in Sec.  146.13(b). It is recommended that samples be 
collected from flocks over 10 weeks of age with respiratory signs such 
as coughing, sneezing, snicking, sinusitis, or rales; depression; or 
decreases in food or water intake.
* * * * *

PART 147-AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN

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

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

0
44. Section 147.1 is revised to read as follows:


Sec.  147.1  Blood testing procedures.

    Blood testing must be conducted in a manner approved by the 
Administrator. Approved blood testing procedures are listed in the NPIP 
Program Standards, as defined in Sec.  147.51. Blood testing procedures 
may also be approved by the Administrator in accordance with Sec.  
147.53(d)(1).


Sec. Sec.  147.2 through 147.9  [Removed and Reserved]

0
45. Sections 147.2 through 147.9 are removed and reserved.
0
46. Section 147.10 is revised to read as follows:


Sec.  147.10  Bacteriological examination procedures.

    Bacteriological examination must be conducted in a manner approved 
by the Administrator. Approved bacteriological examination procedures 
are listed in the NPIP Program Standards, as defined in Sec.  147.51. 
Bacteriological examination procedures may also be approved by the 
Administrator in accordance with Sec.  147.53(d)(1).


Sec. Sec.  147.11 through 147.17  [Removed and Reserved]

0
47. Sections 147.11 through 147.17 are removed and reserved.
0
48. Section 147.21 is revised to read as follows:


Sec.  147.21  Sanitation procedures.

    Sanitation must be maintained in a manner approved by the 
Administrator. Approved procedures for maintaining sanitation are 
listed in the NPIP Program Standards, as defined in Sec.  147.51. 
Sanitation procedures may also be approved by the Administrator in 
accordance with Sec.  147.53(d)(2).


Sec. Sec.  147.22 through 147.27  [Removed and Reserved]

0
49. Sections 147.22 through 147.27 are removed and reserved.
0
50. Section 147.30 is revised to read as follows:


Sec.  147.30  Molecular examination procedures.

    Molecular examination must be conducted in a manner approved by the 
Administrator. Approved molecular examination procedures are listed in 
the NPIP Program Standards, as defined in Sec.  147.51. Molecular 
examination procedures may also be approved by the Administrator in 
accordance with Sec.  147.53(d)(1).


Sec.  147.31  [Removed and Reserved]

0
51. Section 147.31 is removed and reserved.
0
52. In Sec.  147.41, a new definition of NPIP Technical Committee is 
added, in alphabetical order, to read as follows:


Sec.  147.41  Definitions.

* * * * *
    NPIP Technical Committee. A committee made up of technical experts 
on poultry health, biosecurity, surveillance, and diagnostics. The 
committee consists of representatives from the poultry and egg 
industries, universities, and State and Federal governments and is 
appointed by the Senior Coordinator and approved by the General 
Conference Committee.
* * * * *


Sec.  147.44  [Amended]

0
53. In Sec.  147.44, paragraph (b) is amended by removing the citation 
``Sec.  147.43(d)(2)'' and adding the citation ``Sec.  147.43(d)(4)'' 
in its place.
0
54. In part 147, subpart F is revised to read as follows:
Subpart F--Authorized Laboratories and Approved Tests and Sanitation 
Procedures
Sec.
147.51 Definitions.
147.52 Authorized laboratories.
147.53 Approved tests and sanitation procedures.
147.54 Approval of diagnostic test kits not licensed by the Service.

Subpart F--Authorized Laboratories and Approved Tests and 
Sanitation Procedures


Sec.  147.51  Definitions.

    Administrator. The Administrator, Animal and Plant Health 
Inspection Service, or any other employee of the Animal and Plant 
Health Inspection Service delegated to act in the Administrator's 
stead.
    Animal and Plant Health Inspection Service (APHIS, the Service). 
The Animal and Plant Health Inspection Service of the U.S. Department 
of Agriculture.
    NPIP or Plan. The National Poultry Improvement Plan.
    NPIP Program Standards. A document that contains tests and

[[Page 4566]]

sanitation procedures approved by the Administrator under Sec.  147.53 
for use under this subchapter. This document may be obtained from the 
NPIP Web site at http://www.aphis.usda.gov/animal_health/animal_dis_spec/poultry/ or by writing to the Service at National Poultry 
Improvement Plan, APHIS, USDA, 1506 Klondike Road, Suite 101, Conyers, 
GA 30094.
    NPIP Technical Committee. A committee made up of technical experts 
on poultry health, biosecurity, surveillance, and diagnostics. The 
committee consists of representatives from the poultry and egg 
industries, universities, and State and Federal governments and is 
appointed by the Senior Coordinator and approved by the General 
Conference Committee.


Sec.  147.52  Authorized laboratories.

    These minimum requirements are intended to be the basis on which an 
authorized laboratory of the Plan can be evaluated to ensure that 
official Plan assays are performed in accordance with the NPIP Program 
Standards or other procedures approved by the Administrator in 
accordance with Sec.  147.53(d)(1) and reported as described in 
paragraph (f) of this section. A satisfactory evaluation will result in 
the laboratory being recognized by the NPIP office of the Service as an 
authorized laboratory qualified to perform the assays provided for in 
this part.
    (a) Check-test proficiency. The NPIP will serve as the lead agency 
for the coordination of available check tests from the National 
Veterinary Services Laboratories. The authorized laboratory must use a 
regularly scheduled check test for each assay that it performs.
    (b) Trained technicians. The testing procedures at the laboratory 
must be run or overseen by a laboratory technician who has attended and 
satisfactorily completed Service-approved laboratory workshops for 
Plan-specific diseases within the past 4 years.
    (c) Laboratory protocol. Official Plan assays must be performed and 
reported as described in the NPIP Program Standards or in accordance 
with other procedures approved by the Administrator in accordance with 
Sec.  147.53(d)(1). Assays must be performed using control reagents 
approved by the Plan or the reagent manufacturer.
    (d) State site visit. The Official State Agency will conduct a site 
visit and recordkeeping audit annually. This will include, but may not 
be limited to, review of technician training records, check test 
proficiency, and test results. The information from the site visit and 
recordkeeping audit will be made available to the NPIP upon request.
    (e) Service review. Authorized laboratories will be reviewed by the 
Service (NPIP staff) every 3 years. The Service's review may include, 
but will not necessarily be limited to, checking records, laboratory 
protocol, check-test proficiency, technician training, and peer review.
    (f) Reporting. (1) A memorandum of understanding or other means 
shall be used to establish testing and reporting criteria to the 
Official State Agency, including criteria that provide for reporting H5 
and H7 low pathogenic avian influenza directly to the Service.
    (2) Salmonella pullorum and Mycoplasma Plan disease reactors must 
be reported to the Official State Agency within 48 hours.
    (g) Verification. Random samples may also be required to be 
submitted for verification as specified by the Official State Agency.


Sec.  147.53  Approved tests and sanitation procedures.

    (a)(1) All tests that are used to qualify flocks for NPIP 
classifications must be approved by the Administrator as effective and 
accurate at determining whether a disease is present in a poultry flock 
or in the environment.
    (2) All sanitation procedures performed as part of qualifying for 
an NPIP classification must be approved by the Administrator as 
effective at reducing the risk of incidence of disease in a poultry 
flock or hatchery.
    (b) Tests and sanitation procedures that have been approved by the 
Administrator may be found in the NPIP Program Standards. 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 the NPIP Program Standards are 
approved for use in the NPIP.
    (c) New tests and sanitation procedures, or changes to existing 
tests and sanitation procedures, that have been approved by the NPIP in 
accordance with the process described in subpart E of this part will be 
approved by the Administrator. NPIP participants may submit new tests 
and sanitation procedures, or changes to current tests and sanitation 
procedures, through that process.
    (d)(1) Persons who wish to have a test approved by the 
Administrator as effective and accurate at determining whether a 
disease is present in a flock or in the environment may apply for 
approval by submitting the test, along with any supporting information 
and data, to the National Poultry Improvement Plan, APHIS, USDA, 1506 
Klondike Road, Suite 101, Conyers, GA 30094. Upon receipt of such an 
application, the NPIP Technical Committee will review the test and any 
supporting information and data supplied with the application. If the 
NPIP Technical Committee determines the test to be of potential general 
use, the Administrator will submit the test for consideration by the 
General Conference Committee of the NPIP in accordance with subpart E 
of this part, and the Administrator will respond with approval or 
denial of the test.
    (2) Persons who wish to have a sanitation procedure approved by the 
Administrator as effective at reducing the risk of incidence of disease 
in a poultry flock or hatchery may apply for approval by submitting the 
sanitation procedure, along with any supporting information and data, 
to the National Poultry Improvement Plan, APHIS, USDA, 1506 Klondike 
Road, Suite 101, Conyers, GA 30094. Upon receipt of such an 
application, the NPIP Technical Committee will review the sanitation 
procedure and any supporting information and data supplied with the 
application. If the NPIP Technical Committee determines the sanitation 
procedure to be of potential general use, the Administrator will submit 
the sanitation procedure for consideration by the General Conference 
Committee of the NPIP in accordance with subpart E of this part, and 
the Administrator will respond with approval or denial of the test.
    (e)(1) When the Administrator approves a new test or sanitation 
procedure or a change to an existing test or sanitation procedure, 
APHIS will publish a notice in the Federal Register making available 
the test or sanitation procedure. The notice will also provide for a 
public comment period.
    (2)(i) After the close of the public comment period, APHIS will 
publish a notice in the Federal Register indicating that the test or 
sanitation procedure will be added to the NPIP Program Standards, or 
that the NPIP Program Standards will be updated to reflect changes to 
an existing test or sanitation procedure, if:
    (A) No comments were received on the notice;
    (B) The comments on the notice supported the action described in 
the notice; or
    (C) The comments on the notice were evaluated but did not change 
the Administrator's determination that approval of the test or 
sanitation procedure is appropriate based on the

[[Page 4567]]

standards in paragraph (a) of this section.
    (ii) If comments indicate that changes should be made to the test 
or sanitation procedure as it was made available in the initial notice, 
APHIS will publish a notice in the Federal Register indicating that 
changes were made to the initial test or sanitation procedure.
    (iii) Whenever APHIS adds or makes changes to tests or sanitation 
procedures, APHIS will make available a new version of the NPIP Program 
Standards that reflects the additions or changes.
    (iv) If comments present information that causes the Administrator 
to determine that approval of the test or sanitation procedure would 
not be appropriate, APHIS will publish a notice informing the public of 
this determination after the close of the comment period.


Sec.  147.54  Approval of diagnostic test kits not licensed by the 
Service.

    Diagnostic test kits that are not licensed by the Service (e.g., 
bacteriological culturing kits) may be approved through the following 
procedure:
    (a) The sensitivity of the kit will be estimated in at least three 
authorized laboratories selected by the Service by testing known 
positive samples, as determined by the official NPIP procedures found 
in the NPIP Program Standards or through other procedures approved by 
the Administrator. 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.
    (b) The specificity of the kit will be estimated in at least three 
authorized laboratories selected by the Service by testing known 
negative samples, as determined by tests conducted in accordance with 
the NPIP Program Standards or other procedures approved by the 
Administrator in accordance with Sec.  147.53(d)(1). 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.
    (c) 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.
    (d) 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.
    (e) 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.
    (f) Diagnostic test kits that are not licensed by the Service 
(e.g., bacteriological culturing kits) and that have been approved for 
use in the NPIP in accordance with this section are listed in the NPIP 
Program Standards.

    Done in Washington, DC, this 15th day of January 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-01036 Filed 1-27-14; 8:45 am]
BILLING CODE 3410-34-P