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 


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4538 Federal Register / Vol. 79, No. 18 / Tuesday, January 28, 2014 / Proposed Rules 

1http://www.aphis.usda.gov/animal_health/

animal_dis_spec/poultry/ 

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/#!document

Detail;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 FederalState-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 meattype 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, §§ 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. 

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 


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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 § 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 §§ 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 § 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 

§ 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 § 147.51) and for 

approving diagnostic test kits that are 

not licensed by the Service (in § 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 

§ 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 § 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 

§ 145.1 as well, as amendments to that 

part make it necessary to refer to the 

NPIP Program Standards in part 145. 

Proposed § 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 § 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 § 147.53 would describe 

where approved tests and sanitation 

procedures could be found and the 

process for changing them. Paragraph (a) 

of proposed § 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 § 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 

§ 147.52(a). 

Under paragraph (c) of proposed 

§ 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 


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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 § 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 § 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 

§ 147.52 to § 147.54. As noted earlier, 

proposed § 147.53 would include the 

provisions currently found in 

§ 147.52(a), meaning it would not be 

necessary to include § 147.52(a) in 

proposed § 147.54. Instead, paragraph 

(b) of § 147.52 would become the entire 

text of § 147.54. 

Paragraph (c) of current § 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 eggtype 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 standardsetting 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 


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2The 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.’’ 

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. 

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 §§ 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: 


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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 § 145.43(g) (for 

turkeys), or U.S. Avian Influenza Clean 

in accordance with the classifications in 

§§ 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 § 56.10 and that 

participates in the diagnostic 

surveillance program for H5/H7 LPAI as 

described in § 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 § 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 NAIrelated 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 NAIrelated 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 


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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 

§ 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 § 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 

§§ 145.43(g), 145.73(f), or 145.83(g), and 

diagnostic surveillance for H5/H7 LPAI 

as described in § 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 § 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 §§ 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 §§ 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 § 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 

§ 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 § 56.1, with the proposed 

wording discussed above, and to make 

the same clarification about the 

pathogenicity index test as we are 

proposing in § 146.1. We are also 

proposing to add the proposed 

definition of H5/H7 LPAI to § 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 


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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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 


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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 § 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 

§ 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 °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 °F for 

the 72 hours prior to cleaning and 

disinfection. However, the initial 

heating to 100 °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 § 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 § 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 § 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 § 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 § 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 § 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 § 145.14, which discusses approved 

tests for breeding poultry and 

commercial poultry, paragraph (d) sets 


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out official tests for AI. In § 146.13, 

which discusses approved tests for 

commercial poultry, paragraph (b) 

addresses the same topic as § 145.14(d). 

Approved antibody detection tests for 

AI are set out in paragraph (d)(1) of 

§ 145.14 and (b)(1) of § 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 § 145.14 and 

paragraph (b)(2)(ii) of § 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 

§§ 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 realtime 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 

§ 145.14 and paragraph (b)(2)(i) of 

§ 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 §§ 145.14(d)(2)(i) and 

146.13(b)(2)(i). 

Nest Clean Hatching Eggs for Breeding 

Chickens 

The regulations in §§ 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 § 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 meattype industries to avoid sanitizing eggs 

and instead insist on nest clean eggs. 

To recognize this practice, we are 

proposing to amend §§ 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 EggType 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 

§§ 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 § 145.23 and 

paragraph (f)(2) of § 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 

§ 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 § 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 § 145.14 to qualify for these 

programs. 

Changes to AI Clean Programs for MeatType 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 

§§ 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 § 145.33 and 

paragraph (g)(1) of § 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 § 145.14. 

Currently, paragraph (h)(2) of § 145.23 

and paragraph (f)(2) of § 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 § 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. 


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New U.S. Salmonella Enteritidis 

Monitored Classification for Multiplier 

Meat-Type Breeding Chickens 

We are proposing to establish in 

§ 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 meattype 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 § 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 

§ 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 § 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 

§ 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 § 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. 


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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 § 145.53 set out 

classifications for hobbyist and 

exhibition waterfowl, exhibition 

poultry, and game bird breeding flocks 

and products. Paragraph (e) in § 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 

§ 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 

§ 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 § 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 

§ 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 


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Federal Register / Vol. 79, No. 18 / Tuesday, January 28, 2014 / Proposed Rules 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 § 145.83, 

except to reflect moving tests from part 

147 to the NPIP Program Standards, as 

discussed earlier. 

Paragraph (e)(3) of § 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 § 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 § 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 

§ 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 °F or above, or to a 

minimum temperature of 165 °F for at 

least 20 minutes, or to a minimum 

temperature of 184 °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 


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4550 Federal Register / Vol. 79, No. 18 / Tuesday, January 28, 2014 / Proposed Rules 

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 § 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 § 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 tableegg 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 

(§§ 146.31 through 146.33) define meattype 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 § 146.31 with the definition given 

above. We would add a new paragraph 

(c) to § 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 § 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 meattype 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 § 146.1 to 

include spent fowl, so that provisions 

allowing commercial meat-type flocks to 

participate with another Official State 

Agency in § 146.2(c) would apply to 

spent fowl as well. In § 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 § 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 § 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 


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are available prior to slaughter, 

consistent with our proposed changes to 

§ 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 

§ 146.13(b). 

Paragraph (a) of § 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 § 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 § 145.1 but not in part 147. We would 

add to § 147.41 a definition of NPIP 

Technical Committee that would be 

identical to the definition in § 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 § 147.51 to 

§ 147.52, we are proposing some 

additional amendments. Paragraph (a) of 

current § 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 § 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 § 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 § 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 § 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 

§ 147.52. 

Miscellaneous Corrections 

The regulations in paragraph (c) of 

§ 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 

§ 145.10 now includes classifications in 

§§ 145.73(b), 145.83(b), and 145.93(b). 

We are proposing to update that 

paragraph and other paragraphs in 

§ 145.10 to include all of the 

classifications in the regulations that 

correspond to the specified illustrative 

designs. 

In §§ 145.23 and 145.33, paragraph (b) 

sets out the U.S. Pullorum-Typhoid 

Clean classification for multiplier 

breeding egg-type chickens and meattype 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 § 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 § 145.33 to 

§ 145.83. We would correct the 

citations. 

In § 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 


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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 § 147.43. However, paragraph (d)(2) 

of § 147.43 does not discuss submission 

of proposals for changes to the Plan; 

paragraph (d)(4) does. We would correct 

the reference in § 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 

■ 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. 

■ 2. Section 56.1 is amended as follows: 

■ a. By revising the definition of H5/H7 

low pathogenic avian influenza (LPAI). 

■ 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: 

§ 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. 

* * * * * 

■ 3. Section 56.4 is amended by adding 

a new paragraph (d) to read as follows: 

§ 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. 

* * * * * 

■ 4. Section 56.5 is amended as follows: 

■ a. By revising paragraph (c)(1)(i). 

■ b. By adding new paragraphs (c)(1)(iii) 

and (c)(1)(iv). 

■ c. By revising paragraphs (d)(1)(i) and 

(d)(1)(iii). 

■ d. By removing paragraph (d)(1)(iv). 

■ 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: 

§ 56.5 Destruction and disposal of poultry 

and cleaning and disinfection of premises, 

conveyances, and materials. 

* * * * * 

(c) * * * 


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(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 § 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 § 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 § 56.10. * * * 

* * * * * 

PART 145—NATIONAL POULTRY 

IMPROVEMENT PLAN FOR BREEDING 

POULTRY 

■ 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. 

■ 6. Section 145.1 is amended as 

follows: 

■ a. In the definition of authorized 

agent, by removing the words ‘‘as 

described in §§ 147.1(a) and 147.12’’ 

and adding the words ‘‘in accordance 

with part 147’’ in their place. 

■ b. In the definition of authorized 

laboratory, by removing the citation 

‘‘§ 147.51’’ and adding the citation 

‘‘§ 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. 

■ c. In the definition of authorized 

testing agent, by removing the words 

‘‘as described in §§ 147.1(a) and 147.12’’ 

and adding the words ‘‘in accordance 

with part 147’’ in their place. 

■ d. By adding, in alphabetical order, 

definitions of H5/H7 low pathogenic 

avian influenza (LPAI) and NPIP 

Program Standards. 

■ 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. 

■ f. In the definition of Senior 

Coordinator, in paragraph (4), by 

removing the citation ‘‘§ 147.51’’ and 

adding the citation ‘‘§ 147.52’’ in its 

place. 

The additions read as follows: 

§ 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 

§ 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. 

* * * * * 

§ 145.2 [Amended] 

■ 7. In § 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. 

■ 8. Section 145.3 is amended as 

follows: 

■ 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,’’. 

■ b. By redesignating paragraphs (d) and 

(e) as paragraphs (e) and (f), 

respectively. 

■ c. By adding a new paragraph (d). 

The addition reads as follows: 

§ 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. 

* * * * * 

§ 145.5 [Amended] 

■ 9. Section 145.5 is amended as 

follows: 

■ a. In paragraph (a), by removing the 

words ‘‘as recommended in §§ 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. 

■ b. In paragraph (c), by removing the 

words ‘‘or F’’ and adding the words ‘‘F, 

G, H, or I’’ in their place. 

■ 10. Section 145.6 is amended as 

follows: 

■ a. By revising the second sentence in 

paragraph (a) introductory text. 

■ b. In paragraphs (a)(1), (a)(2), (a)(3), 

and (a)(4), by removing the words ‘‘as 

outlined in § 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: 

§ 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 § 147.53(d), will be 

considered as a guide in determining 

compliance with this provision. * * * 

* * * * * 

■ 11. Section 145.10 is amended as 

follows: 


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■ 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. 

■ 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: 

§ 145.10 Terminology and classification; 

flocks, products, and States. 

* * * * * 

(c) U.S. M. Gallisepticum Clean. (See 

§§ 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 §§ 145.24(a), 145.34(a), 

145.44(a), 145.54(a), and 145.94(a).) 

* * * * * 

(m) U.S. S. Enteritidis Clean. (See 

§§ 145.23(d), 145.73(d), and 145.83(e).) 

* * * * * 

(o) U.S. Salmonella Monitored. (See 

§§ 145.53(f), 145.83(f), and 145.93(d).) 

* * * * * 

(t) U.S. H5/H7 Avian Influenza Clean. 

(See §§ 145.43(g), 145.53(e), and 

145.93(c).) 

* * * * * 

■ 12. Section 145.14 is amended as 

follows: 

■ a. In paragraph (a)(1), by revising the 

second sentence. 

■ b. In paragraph (a)(6)(ii), by revising 

the second sentence. 

■ c. In paragraph (b)(1), by adding a 

sentence after the second sentence. 

■ d. By revising paragraph (b)(3). 

■ e. By revising paragraph (d)(1)(ii)(C). 

■ f. In paragraph (d)(2)(i), by removing 

the word ‘‘(AVPR01510)’’. 

■ g. By revising paragraph (d)(2)(ii)(B). 

The revisions read as follows: 

§ 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. 

* * * * * 

■ 13. In § 145.22, paragraph (b) is 

revised to read as follows: 

§ 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. 

* * * * * 

■ 14. Section 145.23 is amended as 

follows: 

■ a. In paragraph (b) introductory text, 

by removing the citation ‘‘(5)’’ and 

adding the citation ‘‘(b)(4)’’ in its place. 

■ b. In paragraph (c)(1) introductory 

text, by removing the words ‘‘in 

compliance with the provisions of 

§ 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. 

■ c. In paragraph (c)(1)(ii)(C), by 

removing the words ‘‘§ 147.8 of this 

chapter’’ and adding the words ‘‘part 

147 of this subchapter’’ in their place. 

■ d. In paragraph (c)(3), by removing the 

words ‘‘as described in § 147.24(a) of 

this chapter’’ and adding the words ‘‘in 

accordance with part 147 of this 

subchapter’’ in their place. 

■ e. In paragraph (d)(1)(iv), by removing 

the words ‘‘in compliance with 

§§ 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. 

■ f. In paragraph (d)(1)(v), by removing 

the words ‘‘as described in § 147.12 of 

this chapter’’ and adding the words ‘‘in 

accordance with part 147 of this 

subchapter’’ in their place. 

■ g. In paragraphs (d)(1)(vii), by 

removing the words ‘‘as described in 

§ 147.11 of this chapter’’ and adding the 

words ‘‘in accordance with part 147 of 

this subchapter’’ in their place. 

■ h. By revising paragraphs (d)(1)(viii) 

and (d)(1)(ix). 

■ i. In paragraph (d)(2), by removing the 

words ‘‘as described in § 147.11(a) of 

this chapter’’ and adding the words ‘‘in 

accordance with part 147 of this 

subchapter’’ in their place. 

■ j. In paragraph (e)(1) introductory text, 

by removing the words ‘‘in compliance 

with the provisions of § 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. 

■ k. In paragraph (e)(1)(ii)(B), by 

removing the words ‘‘§ 147.8 of this 

chapter’’ and adding the words ‘‘part 

147 of this subchapter’’ in their place. 

■ l. In paragraph (e)(3), by removing the 

words ‘‘as described in § 147.24(a) of 

this chapter’’ and adding the words ‘‘in 

accordance with part 147 of this 

subchapter’’ in their place. 

■ m. In paragraph (f)(3), by removing the 

words ‘‘in compliance with the 

provisions of § 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. 

■ n. In paragraph (f)(5), by removing the 

words ‘‘as described in § 147.24(a) of 

this chapter’’ and adding the words ‘‘in 

accordance with part 147 of this 

subchapter’’ in their place. 

■ o. In paragraph (g)(3), by removing the 

words ‘‘in compliance with the 

provisions of § 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. 

■ p. In paragraph (g)(5), by removing the 

words ‘‘as described in § 147.24(a) of 

this chapter’’ and adding the words ‘‘in 

accordance with part 147 of this 

subchapter’’ in their place. 

■ q. In paragraph (h)(1) introductory 

text, by adding the words ‘‘and found’’ 

before the word ‘‘negative’’ and by 

removing the words ‘‘for antibodies’’. 

■ r. By revising paragraph (h)(2). 


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The revisions read as follows: 

§ 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. 

* * * * * 

■ 15. In § 145.32, paragraph (b) is 

revised to read as follows: 

§ 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. 

* * * * * 

■ 16. Section 145.33 is amended as 

follows: 

■ a. In paragraph (b) introductory text, 

by removing the citation ‘‘(5)’’ and 

adding the citation ‘‘(b)(4)’’ in its place. 

■ b. In paragraph (c)(1) introductory 

text, by removing the words ‘‘in 

compliance with the provisions of 

§ 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. 

■ c. In paragraph (c)(1)(ii)(C), by 

removing the words ‘‘§ 147.8 of this 

chapter’’ and adding the words ‘‘part 

147 of this subchapter’’ in their place. 

■ d. In paragraph (c)(2), by removing the 

words ‘‘(see §§ 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. 

■ e. In paragraph (c)(3), by removing the 

words ‘‘as described in § 147.24(a) of 

this chapter’’ and adding the words ‘‘in 

accordance with part 147 of this 

subchapter’’ in their place. 

■ 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. 

■ g. In paragraph (d)(1)(ii), by removing 

the words ‘‘in compliance with 

§§ 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. 

■ h. By revising paragraph (d)(1)(vi). 

■ i. In paragraph (d)(1)(vii), by removing 

the words ‘‘as described in § 147.12 of 

this chapter’’ and adding the words ‘‘in 

accordance with part 147 of this 

subchapter’’ in their place. 

■ j. By revising paragraph (d)(2). 

■ k. In paragraph (e)(1) introductory 

text, by removing the words ‘‘in 

compliance with the provisions of 

§ 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. 

■ l. In paragraph (e)(1)(ii)(B), by 

removing the words ‘‘§ 147.8 of this 

chapter’’ and adding the words ‘‘part 

147 of this subchapter’’ in their place. 

■ m. In paragraph (e)(3), by removing 

the words ‘‘as described in § 147.24(a) of 

this chapter’’ and adding the words ‘‘in 

accordance with part 147 of this 

subchapter’’ in their place. 

■ 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. 

■ o. In paragraph (f)(3), by removing the 

words ‘‘in compliance with the 

provisions of § 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. 

■ p. In paragraph (f)(5), by removing the 

words ‘‘as described in § 147.24(a) of 

this chapter’’ and adding the words ‘‘in 

accordance with part 147 of this 

subchapter’’ in their place. 

■ q. In paragraph (g)(3), by removing the 

words ‘‘in compliance with the 

provisions of § 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. 

■ r. In paragraph (g)(5), by removing the 

words ‘‘as described in § 147.24(a) of 

this chapter’’ and adding the words ‘‘in 

accordance with part 147 of this 

subchapter’’ in their place. 

■ s. In paragraph (j)(2), by removing the 

words ‘‘paragraph (c)(1)(i) of this 

section’’ and adding the words 

‘‘§ 145.83(c)(1)(i)’’ in their place. 

■ t. In paragraphs (j)(3) and (k)(3), by 

removing the words ‘‘as described in 

§ 147.24(a) of this chapter’’ and adding 

the words ‘‘in accordance with part 147 

of this subchapter’’ in their place. 

■ u. In paragraph (k)(2), by removing the 

words ‘‘paragraph (e)(1)(i) of this 

section’’ and adding the words 

‘‘§ 145.83(d)(1)(i)’’ in their place. 

■ v. In paragraph (l)(1) introductory 

text, by adding the words ‘‘using an 

approved test as described in § 145.14’’ 

after the word ‘‘influenza’’. 

■ w. By revising paragraph (l)(2). 

■ x. By adding a new paragraph (m). 

The revisions read as follows: 

§ 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. 


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(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. 

* * * * * 

§ 145.42 [Amended] 

■ 17. In § 145.42, paragraph (b) is 

amended by removing the words ‘‘(see 

§ 147.25 of this chapter)’’ and adding 

the words ‘‘in accordance with part 147 

of this subchapter’’ in their place. 

■ 18. Section 145.43 is amended as 

follows: 

■ a. In paragraph (c)(1), by removing the 

words ‘‘in accordance with the 

conditions and procedures described in 

§ 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. 

■ b. In paragraph (c)(2), by removing the 

words ‘‘applicable conditions outlined 

in § 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. 

■ c. By adding a sentence at the end of 

paragraph (e)(1). 

■ d. In paragraph (e)(2), by removing the 

words ‘‘the procedures outlined in 

§ 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. 

■ e. By removing paragraph (e)(3). 

■ 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. 

■ g. In paragraphs (f)(2), (f)(4), and (f)(6), 

by removing the words ‘‘as described in 

§ 147.12 of this chapter’’ and adding the 

words ‘‘in accordance with part 147 of 

this subchapter’’ in their place. 

■ h. By revising paragraph (g)(3). 

The revisions read as follows: 

§ 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. 

* * * * * 

■ 19. Add § 145.45 to read as follows: 

§ 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 

§ 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 § 56.10 of 

this chapter and that participates in the 

diagnostic surveillance program for H5/ 

H7 low pathogenicity AI as described in 

§ 145.15. Within the compartment, all 

official tests for AI, as described in 

§ 145.14(d), must be conducted in State 

or Federal laboratories or in NPIP 

authorized laboratories that meet the 

minimum standards described in 

§ 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 


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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 § 145.43(g) and diagnostic 

surveillance for H5/H7 low 

pathogenicity AI as described in 

§ 145.15; 

(v) Conducting audits of 

compartments at least once every 2 

years to: 

(A) Confirm that the primary breeding 

company’s establishments are 


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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 

§ 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 §§ 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] 

■ 20. Section 145.52 is amended as 

follows: 

■ a. In paragraph (b), by removing the 

words ‘‘(see § 147.25 of this chapter)’’ 

and adding the words ‘‘in accordance 

with part 147 of this subchapter’’ in 

their place. 

■ b. By redesignating paragraphs (c) and 

(d) as paragraphs (d) and (e), 

respectively. 

■ c. By adding a new paragraph (c). 

The addition reads as follows: 

§ 145.52 Participation. 

* * * * * 

(c) It is recommended that waterfowl 

flocks and gallinaceous flocks in openair facilities be kept separate. 

* * * * * 

■ 21. Section 145.53 is amended as 

follows: 

■ a. In paragraph (c)(1) introductory 

text, by removing the words ‘‘in 

compliance with the provisions of 

§ 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. 

■ b. In paragraph (c)(3), by removing the 

words ‘‘as described in § 147.24(a) of 

this chapter’’ and adding the words ‘‘in 

accordance with part 147 of this 

subchapter’’ in their place. 

■ c. In paragraph (d)(1) introductory 

text, by removing the words ‘‘in 

compliance with the provisions of 

§ 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. 

■ d. In paragraph (d)(1)(ii)(B), by 

removing the words ‘‘§ 147.8 of this 

chapter’’ and adding the words ‘‘part 

147 of this subchapter’’ in their place. 

■ e. In paragraph (d)(3), by removing the 

words ‘‘as described in § 147.24(a) of 

this chapter’’ and adding the words ‘‘in 

accordance with part 147 of this 

subchapter’’ in their place. 

■ f. By revising paragraphs (e)(1) 

introductory text and (e)(2) introductory 

text to read as set forth below. 

■ g. In paragraphs (e)(1)(i) and (e)(1)(ii), 

by removing the number ‘‘90’’ and 

adding the number ‘‘180’’ in its place. 

■ h. By revising paragraph (e)(3). 

■ i. By adding paragraph (f). 

The revision and addition read as 

follows: 

§ 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 § 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 § 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. 

* * * * * 

§ 145.62 [Amended] 

■ 22. In § 145.62, paragraph (b) is 

amended by removing the words ‘‘(see 

§ 147.22 of this chapter)’’ and adding 

the words ‘‘in accordance with part 147 

of this subchapter’’ in their place. 

■ 23. In § 145.72, paragraph (b) is 

revised to read as follows: 

§ 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. 

* * * * * 

■ 24. Section 145.73 is amended as 

follows: 

■ a. In paragraph (c)(1) introductory 

text, by removing the words ‘‘in 

compliance with the provisions of 

§ 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. 

■ b. In paragraph (c)(3), by removing the 

words ‘‘as described in § 147.24(a)’’ and 


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adding the words ‘‘in accordance with 

part 147’’ in their place. 

■ c. In paragraph (d)(1)(iv), by removing 

the words ‘‘in compliance with 

§§ 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. 

■ d. In paragraph (d)(1)(v), by removing 

the words ‘‘as described in § 147.12’’ 

and adding the words ‘‘in accordance 

with part 147’’ in their place. 

■ e. In paragraph (d)(1)(vii), by 

removing the words ‘‘as described in 

§ 147.11’’ and adding the words ‘‘in 

accordance with part 147’’ in their 

place. 

■ f. By revising paragraph (d)(1)(ix). 

■ g. In paragraph (d)(2), by removing the 

words ‘‘as described in § 147.11(a)’’ and 

adding the words ‘‘in accordance with 

part 147’’ in their place. 

■ h. In paragraph (e)(1) introductory 

text, by removing the words ‘‘in 

compliance with the provisions of 

§ 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. 

■ i. In paragraph (e)(3), by removing the 

words ‘‘as described in § 147.24(a)’’ and 

adding the words ‘‘in accordance with 

part 147’’ in their place. 

■ j. In paragraph (f)(1) introductory text, 

by adding the words ‘‘and found’’ before 

the word ‘‘negative’’ and by removing 

the words ‘‘for antibodies’’. 

■ k. By revising paragraph (f)(2). 

The revisions read as follows: 

§ 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. 

■ 25. A new § 145.74 is added to read 

as follows: 

§ 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 

§ 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 § 56.10 of 

this chapter and that participates in the 

diagnostic surveillance program for H5/ 

H7 low pathogenicity AI as described in 

§ 145.15. Within the compartment, all 

official tests for AI, as described in 

§ 145.14(d), must be conducted in State 

or Federal laboratories or in NPIP 

authorized laboratories that meet the 

minimum standards described in 

§ 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 


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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 

§ 145.73(f) and diagnostic surveillance 

for H5/H7 low pathogenicity AI as 

described in § 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 

§ 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 §§ 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 


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and the Service has reevaluated the 

management and biosecurity measures 

of the compartment and approved said 

compartment for trade. 

(b) [Reserved] 

■ 26. In § 145.82, paragraph (b) is 

revised to read as follows: 

§ 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. 

* * * * * 

■ 27. Section 145.83 is amended as 

follows: 

■ a. In paragraph (c)(1) introductory 

text, by removing the words ‘‘in 

compliance with the provisions of 

§ 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. 

■ b. In paragraph (c)(3), by removing the 

words ‘‘as described in § 147.24(a)’’ and 

adding the words ‘‘in accordance with 

part 147’’ in their place. 

■ c. In paragraph (d)(1) introductory 

text, by removing the words ‘‘in 

compliance with the provisions of 

§ 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. 

■ d. In paragraph (d)(3), by removing the 

words ‘‘as described in § 147.24(a)’’ and 

adding the words ‘‘in accordance with 

part 147’’ in their place. 

■ e. By revising paragraphs (e)(1) and 

(e)(3). 

■ f. In paragraph (e)(6) introductory text, 

by removing the words ‘‘or greatgrandparent’’ and adding the words 

‘‘great-grandparent, or grandparent’’ in 

their place. 

■ g. In paragraph (e)(6)(i)(B), by 

removing the words ‘‘as described in 

§ 147.12(a)’’ and adding the words ‘‘in 

accordance with part 147’’ in their 

place. 

■ h. In paragraph (e)(6)(i)(C), by 

removing the words ‘‘as described in 

§ 147.11’’ and adding the words ‘‘in 

accordance with part 147’’ in their 

place. 

■ i. In paragraph (e)(6)(i)(D), by 

removing the words ‘‘as specified in 

§ 147.12(a)’’ and adding the words ‘‘in 

accordance with part 147’’ in their 

place. 

■ j. In paragraph (f)(1)(i), by removing 

the words ‘‘in compliance with 

§§ 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. 

■ k. By revising paragraph (f)(1)(iv). 

■ l. In paragraph (f)(1)(vi), by removing 

the words ‘‘as described in § 147.12’’ 

and adding the words ‘‘in accordance 

with part 147’’ in their place. 

■ m. By revising paragraph (f)(2). 

■ n. In paragraph (g)(1) introductory 

text, by adding the words ‘‘using an 

approved test as described in § 145.14’’ 

after the word ‘‘influenza’’. 

■ o. By revising paragraph (g)(2). 

The revisions read as follows: 

§ 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. 

* * * * * 


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(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. 

■ 28. Add § 145.84 to read as follows: 

§ 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 

§ 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 § 56.10 of 

this chapter and that participates in the 

diagnostic surveillance program for H5/ 

H7 low pathogenicity AI as described in 

§ 145.15. Within the compartment, all 

official tests for AI, as described in 

§ 145.14(d), must be conducted in State 

or Federal laboratories or in NPIP 

authorized laboratories that meet the 

minimum standards described in 

§ 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. 


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(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 

§ 145.83(g) and diagnostic surveillance 

for H5/H7 low pathogenicity AI as 

described in § 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 

§ 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 §§ 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] 

§ 145.92 [Amended] 

■ 29. In § 145.92, paragraph (b) is 

amended by removing the words ‘‘(see 

§ 147.25 of this chapter)’’ and adding 

the words ‘‘in accordance with part 147 

of this subchapter’’ in their place. 

■ 30. Section 145.93 is amended as 

follows: 

■ a. By revising paragraph (c)(3). 

■ b. By adding a new paragraph (d). 

The revision and addition read as 

follows: 

§ 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. 


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(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 °F or above, or to a 

minimum temperature of 165 °F for at 

least 20 minutes, or to a minimum 

temperature of 184 °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 

■ 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. 

■ 32. Section 146.1 is amended as 

follows: 

■ a. By revising the definition of 

authorized laboratory. 

■ b. In the definition of commercial 

meat-type flock, by adding the words 

‘‘spent fowl,’’ after the word 

‘‘chickens,’’. 

■ 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’’. 

■ 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: 

§ 146.1 Definitions. 

* * * * * 

Authorized laboratory. An authorized 

laboratory is a laboratory that meets the 

requirements of § 147.52 and is thus 

qualified to perform the assays in 

accordance with part 147 of this 

subchapter. 

* * * * * 

§ 146.2 [Amended] 

■ 33. In § 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. 

§ 146.3 [Amended] 

■ 34. Section 146.3 is amended as 

follows: 

■ a. In paragraph (c), by adding the 

words ‘‘, spent fowl,’’ after the word 

‘‘chicken’’. 

■ b. By removing paragraph (e). 

§ 146.5 [Amended] 

■ 35. In § 146.5, paragraph (b) is 

amended by removing the words ‘‘as 

recommended in § 147.21(c)’’ and 

adding the words ‘‘in accordance with 

part 147’’ in their place. 

■ 36. In § 146.11, paragraph (b) is 

revised to read as follows: 

§ 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. 

* * * * * 

■ 37. Section 146.13 is amended as 

follows: 

■ a. In paragraph (a)(1), by removing the 

words ‘‘the requirements in § 147.8’’ 

and adding the words ‘‘part 147’’ in 

their place. 

■ b. By revising paragraph (b)(1)(ii)(C). 

■ c. In paragraph (b)(2)(i), by removing 

the word ‘‘(AVPR01510)’’. 

■ d. By revising paragraph (b)(2)(ii)(B). 

The revisions read as follows: 

§ 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. 

* * * * * 

■ 38. Section 146.23 is amended by 

revising the introductory text of 

paragraphs (a), (a)(1), and (a)(2) to read 

as follows: 

§ 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 


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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: 

* * * * * 

■ 39. Section 146.31 is amended by 

adding, in alphabetical order, a 

definition of spent fowl to read as 

follows: 

§ 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. 

■ 40. Section 146.32 is amended by 

adding a new paragraph (c) to read as 

follows: 

§ 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. 

■ 41. Section 146.33 is amended as 

follows: 

■ a. In paragraph (a)(1), by removing the 

words ‘‘for antibodies’’. 

■ b. By revising paragraph (a)(2). 

The revision reads as follows: 

§ 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 § 146.13(b); or 

* * * * * 

■ 42. In § 146.43, paragraph (a)(1) is 

revised to read as follows: 

§ 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 

§ 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 

■ 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. 

■ 44. Section 147.1 is revised to read as 

follows: 

§ 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 § 147.51. Blood testing 

procedures may also be approved by the 

Administrator in accordance with 

§ 147.53(d)(1). 

§§ 147.2 through 147.9 [Removed and 

Reserved] 

■ 45. Sections 147.2 through 147.9 are 

removed and reserved. 

■ 46. Section 147.10 is revised to read 

as follows: 

§ 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 

§ 147.51. Bacteriological examination 

procedures may also be approved by the 

Administrator in accordance with 

§ 147.53(d)(1). 

§§ 147.11 through 147.17 [Removed and 

Reserved] 

■ 47. Sections 147.11 through 147.17 

are removed and reserved. 

■ 48. Section 147.21 is revised to read 

as follows: 

§ 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 

§ 147.51. Sanitation procedures may 

also be approved by the Administrator 

in accordance with § 147.53(d)(2). 

§§ 147.22 through 147.27 [Removed and 

Reserved] 

■ 49. Sections 147.22 through 147.27 

are removed and reserved. 

■ 50. Section 147.30 is revised to read 

as follows: 

§ 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 

§ 147.51. Molecular examination 

procedures may also be approved by the 

Administrator in accordance with 

§ 147.53(d)(1). 

§ 147.31 [Removed and Reserved] 

■ 51. Section 147.31 is removed and 

reserved. 

■ 52. In § 147.41, a new definition of 

NPIP Technical Committee is added, in 

alphabetical order, to read as follows: 

§ 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. 

* * * * * 

§ 147.44 [Amended] 

■ 53. In § 147.44, paragraph (b) is 

amended by removing the citation 

‘‘§ 147.43(d)(2)’’ and adding the citation 

‘‘§ 147.43(d)(4)’’ in its place. 

■ 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 

§ 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 


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sanitation procedures approved by the 

Administrator under § 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. 

§ 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 

§ 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 

§ 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. 

§ 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 


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

§ 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 

§ 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 §§ 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 


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