38752 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 

1To view the proposed rule and the comments 

we received, go to http://www.regulations.gov/

#!docketDetail;D=APHIS-2011-0101. 

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: Final rule. 

SUMMARY: We are amending 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 will require 

tests to be performed and sanitation to 

be maintained in a manner approved by 

the Administrator. Approved 

procedures will be listed in an NPIP 

Program Standards document, which we 

are making available on the NPIP Web 

site. In addition, we are establishing 

new compartment classifications for 

defined subpopulations of primary 

breeding turkeys, primary egg-type 

chickens, and primary meat-type 

chickens. We are also providing new or 

modified sampling and testing 

procedures for Plan participants and 

participating flocks. The changes in this 

final rule were voted on and approved 

by the voting delegates at the Plan’s 

2010 and 2012 National Plan 

Conferences. These changes will 

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: Effective Date: August 8, 2014. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Denise Brinson, DVM, 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. 

On January 28, 2014, we published in 

the Federal Register (79 FR 4538–4567, 

Docket No. APHIS–2011–0101) a 

proposal 1 to amend the regulations by 

removing tests and detailed testing 

procedures, as well as sanitation 

procedures, from part 147, and making 

these available in an NPIP Program 

Standards document. In addition, we 

proposed to establish U.S. H5/H7 Avian 

Influenza Clean Compartment and U.S. 

Avian Influenza Clean Compartment 

classifications for defined 

subpopulations of primary breeding 

turkeys, primary egg-type breeding 

chickens, and primary meat-type 

breeding chickens. We also proposed 

several other changes. 

We solicited comments concerning 

our proposal for 60 days ending March 

31, 2014. We received 11 comments by 

that date. They were from producers, 

poultry associations, and the general 

public. Of the 11 comments we 

received, 7 directly addressed the 

proposed rule. These comments are 

discussed below. 

Part 146 of the regulations contains 

the NPIP provisions for commercial 

poultry. Currently, the only disease 

addressed in this part is H5/H7 low 

pathogenic avian influenza; 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. 

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 proposed to amend 

paragraph (b) to refer to samples being 

collected and tested and to results being 

returned prior to movement to 

slaughter. 

The seven commenters who 

addressed the rule opposed this change. 

They stated that requiring testing prior 

to slaughter, rather than prior to 

movement to slaughter, allows 

companies that have been sampling 

flocks at processing to continue doing 

so. It also allows producers whose 

flocks were inadvertently not sampled 

in the field to be tested at the slaughter 

plant and remain compliant. 

They also stated that the proposed 

requirement to test prior to movement to 

slaughter would inadvertently combine 

the different testing requirements for 

participating slaughter plants in each 

subpart in part 146 into one set of 

testing requirements. This would 

prevent the different types of 

participating slaughter plants from 

setting different testing requirements. 

One commenter stated that the change 

would limit the flexibility of Official 

State Agencies and industry to develop 

alternative testing protocols in which 

the same number of birds are tested, as 

allowed under the regulations. 

We believe it is important to have the 

test results for a flock returned prior to 

movement to slaughter to prevent 

potentially diseased birds from being 

exposed to other, healthy birds and 

possibly requiring cleaning and 

disinfection at the slaughter plant. The 

NPIP General Conference voted to 

approve this change at the 2012 

Biennial Conference, reflecting the 

general consensus of NPIP participants. 

However, we are postponing the 

finalization of this change until an 

alternative proposal put forward by the 

commenters can be voted on during the 

2014 NPIP Biennial Conference, which 

is scheduled to take place in Charlotte, 

NC, from July 10 through 12, 2014. 

Based on that vote, we will either retain 

this change in a stand-alone final rule or 

make alterations to the testing 

requirements in a separate proposed 

rule. 

We are making a minor change and 

two corrections to the proposal in this 

final rule. Paragraph (a)(1)(i) of the 

proposed compartmentalization sections 

in §§ 145.45, 145.74, and 145.84 

indicated that the company applying for 

compartmentalization would have to, 

upon request, work with the Official 

State Agency to provide data on the 


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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 38753 

incidence of notifiable avian influenza 

(NAI) for bird populations outside of the 

proposed compartment in the State. 

However, Official State Agencies are 

focused on commercial poultry 

populations and may not have data on 

the NAI status of backyard birds or 

migratory birds. In addition, while 

compartments may trade with other 

commercial bird populations, they 

should be secured against any disease 

risk posed by backyard birds or 

migratory birds. Therefore, we are 

changing each of these proposed 

paragraphs to indicate that the Official 

State Agency may provide data on the 

NAI status of other commercial poultry 

populations located in the State, upon 

request. 

Paragraph (a)(1)(v) of the proposed 

compartmentalization sections 

contained a grammatical redundancy, 

which we have removed in this final 

rule. 

We also requested comment on the 

new Program Standards document. We 

did not receive any comments. 

However, one of the approved tests 

listed in the Program Standards 

document, the Rapid Chek© SelectTM

Salmonella Test Kit, is now produced 

by Romer Labs. We have updated the 

Program Standards document 

accordingly. 

Therefore, for the reasons given in the 

proposed rule and in this document, we 

are adopting the proposed rule as a final 

rule, with the changes discussed in this 

document. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This final 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 on the 

Regulations.gov Web site (see footnote 1 

in this document for a link to 

Regulations.gov) or by contacting the 

person listed under FOR FURTHER

INFORMATION CONTACT. 

The establishments that will be 

affected by the 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’s 

General Conference Committee 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 will not 

have a significant economic impact on 

a substantial number of small entities. 

Executive Order 12372 

This program/activity is listed in the 

Catalog of Federal Domestic Assistance 

under No. 10.025 and is subject to 

Executive Order 12372, which requires 

intergovernmental consultation with 

State and local officials. (See 7 CFR part 

3015, subpart V.) 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This rule: (1) Preempts 

all State and local laws and regulations 

that are in conflict with this rule; (2) has 

no retroactive effect; and (3) does not 

require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

Paperwork Reduction Act 

This final rule contains no new 

information collection or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). 

List of Subjects 

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 are amending 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 paragraph (1)(iii) of 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. A signed compliance agreement 

is required before beginning any work 

for which indemnity funds will be 

requested. Once work associated with 

the compliance agreement is completed, 

receipts and documentation detailing 

the activities specified in the agreement 

should be forwarded to APHIS for 

review, approval, and final payment. 

This documentation should be 

submitted to APHIS no later than 30 

days after the quarantine release of the 

affected or exposed premises. 

* * * * * 

■ 4. Section 56.5 is amended as follows: 

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


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■ b. By adding 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 removing the second, third, and 

fourth sentences after the heading of 

paragraph (d)(2)(i) and adding five 

sentences in their place. 

■ f. By revising 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) * * * 

(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), second sentence, 

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 must 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: 


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■ 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: 

■ 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 third 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)(A), by 

removing the word ‘‘(AVPR01510)’’. 

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

The revisions and addition 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 further 

tested 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 ‘‘(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 paragraph (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, 


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38756 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 

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’’. 

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. 

* * * * * 

■ 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 ‘‘(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 adding paragraph (m). 

The revisions and addition 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. 

* * * * * 

(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 


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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 38757 

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. 

(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’’ after the word 

‘‘sanitized’’. 

■ 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 ’’ § 147.6 of this chapter’’ and by 

adding the words ’’ part 147 of this 

subchapter’’ in their place. 

■ 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 addition and revision read as 

follows: 

§ 145.43 Terminology and classification; 

flocks and products. 

* * * * * 

(e) * * * 

(1) * * * It is recommended that any 

birds that are showing clinical signs of 

M. synoviae infection be included in 

samples taken. 

* * * * * 

(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. Section 145.45 is added to subpart 

D 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 Official State Agency 

may provide such data for other 

commercial poultry 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, 


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38758 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 

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. 

(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. 

(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 


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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 38759 

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 

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’’ after 

the word ‘‘sanitized’’. 

■ 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. 

■ 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 revisions 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 


emcdonald on DSK67QTVN1PROD with RULES
38760 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 

§ 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)(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 ‘‘antibodies to’’. 

■ 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 for avian 

influenza within 21 days prior to 

movement to slaughter. 

■ 25. Section 145.74 is added to subpart 

G 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 first 

approve all documentation submitted by 

the company 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 Official State Agency 

may provide such data for other 

commercial poultry 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. 


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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 38761 

(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 but not be limited to: 

(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. 

(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 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. 


emcdonald on DSK67QTVN1PROD with RULES
38762 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 

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] 

■ 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’’. 

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. 

* * * * * 

(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 


emcdonald on DSK67QTVN1PROD with RULES
Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 38763 

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. 

* * * * * 

(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. 

* * * * * 

■ 28. Section 145.84 is added to subpart 

H 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 first 

approve all documentation submitted by 

the company 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 Official 

State Agency may provide such data for 

other commercial poultry 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 but not be limited to: 

(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. 


emcdonald on DSK67QTVN1PROD with RULES
38764 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 

(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. 

(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 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’’ after the word 

‘‘sanitized’’. 

■ 30. Section 145.93 is amended as 

follows: 

■ a. By revising paragraph (c)(3). 

■ b. By adding 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 


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opportunity to reduce the incidence of 

Salmonella in their products. 

(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 paragraph (1)(iii) of 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. 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. 

* * * * * 

■ 37. Section 146.23 is amended by 

revising the heading of paragraph (a), 

removing the introductory text of 

paragraph (a), and revising the 

introductory text of paragraphs (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 

in table-egg layer through routine 

surveillance of each participating 

commercial table-egg layer flock. A 

flock will qualify for this classification 


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38766 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations 

when the Official State Agency 

determines that it has met one of the 

following requirements: 

* * * * * 

■ 38. 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. 

■ 39. 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. 

§ 146.33 [Amended] 

■ 40. In § 146.33, paragraph (a)(1) is 

amended by removing the words 

‘‘antibodies to’’. 

■ 41. 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 

■ 42. 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. 

■ 43. 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). 

(Approved by the Office of Management 

and Budget under control number 0579– 

0007) 

§§ 147.2 through 147.9 [Removed and 

Reserved] 

■ 44. Sections 147.2 through 147.9 are 

removed and reserved. 

■ 45. 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] 

■ 46. Sections 147.11 through 147.17 

are removed and reserved. 

■ 47. 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) 

(Approved by the Office of Management 

and Budget under control number 0579– 

0007) 

§§ 147.22 through 147.27 [Removed and 

Reserved] 

■ 48. Sections 147.22 through 147.27 

are removed and reserved. 

■ 49. 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] 

■ 50. Section 147.31 is removed and 

reserved. 

■ 51. 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] 

■ 52. 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. 

■ 53. 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. 

The following definitions apply in 

this subpart: 

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 

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.poultryimprovement.org/ 

or by writing to the Service at National 

Poultry Improvement Plan, APHIS, 

USDA, 1506 Klondike Road, Suite 101, 

Conyers, GA 30094. 


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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 are subject to 

approval 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 test will be submitted 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 sanitation procedure will be 

submitted 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 

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 


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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 3rd day of 

July 2014. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2014–16037 Filed 7–7–14; 4:15 pm] 

BILLING CODE 3410–34–P 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Part 140 

[NRC–2013–0072] 

RIN 3150–AJ25 

Inflation Adjustments to the PriceAnderson Act Financial Protection 

Regulations; Corrections 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Correcting amendments. 

SUMMARY: The U.S. Regulatory 

Commission (NRC) published a final 

rule in the Federal Register on July 12, 

2013, to amend its regulations to satisfy 

a statutory requirement to adjust the 

maximum total and annual standard 

deferred premiums specified in the 

Price-Anderson Act for inflation at least 

once during each 5-year period 

following August 20, 2003. This 

correcting amendment makes a 

necessary conforming change to a 

concomitant NRC regulation. 

DATES: This rule is effective on July 9, 

2014. 

ADDRESSES: Please refer to Docket ID 

NRC–2013–0072 when contacting the 

NRC about the availability of 

information for this final rule. You may 

obtain publicly-available information 

related to this final rule by any of the 

following methods: 

• Federal Rulemaking Web site: Go to 

http://www.regulations.gov and search 

for Docket ID NRC–2013–0072. Address 

questions about NRC dockets to Carol 

Gallagher; telephone: 301–287–3422; 

email: Carol.Gallagher@nrc.gov. For 

technical questions, contact the 

individual listed in the FOR FURTHER

INFORMATION CONTACT section of this 

final rule. 

• NRC’s Agencywide Documents 

Access and Management System 

(ADAMS): You may obtain publiclyavailable documents online in the 

ADAMS Public Documents collection at 

http://www.nrc.gov/reading-rm/

adams.html. To begin the search, select 

‘‘ADAMS Public Documents’’ and then 

select ‘‘Begin Web-based ADAMS 

Search.’’ For problems with ADAMS, 

please contact the NRC’s Public 

Document Room (PDR) reference staff at 

1–800–397–4209, 301–415–4737, or by 

email to pdr.resource@nrc.gov. The 

ADAMS accession number for each 

document referenced in this document 

(if that document is available in 

ADAMS) is provided the first time that 

a document is referenced. 

• NRC’s PDR: You may examine and 

purchase copies of public documents at 

the NRC’s PDR, Room O1–F21, One 

White Flint North, 11555 Rockville 

Pike, Rockville, Maryland 20852. 

FOR FURTHER INFORMATION CONTACT: 

Michael Purdie, Office of the Nuclear 

Reactor Regulation, U.S. Nuclear 

Regulatory Commission, Washington DC 

20555–0001, telephone 301–415–0244, 

email: Michael.Purdie@nrc.gov. 

SUPPLEMENTARY INFORMATION: The NRC 

published a final rule in the Federal 

Register on July 12, 2013 (78 FR 41835), 

that amended its regulations at part 140 

of Title 10 of the Code of Federal 

Regulations (10 CFR) to satisfy the 

requirement in section 170t., ‘‘Inflation 

Adjustment,’’ of the Atomic Energy Act 

of 1954, as amended, to adjust the 

maximum total and annual standard 

deferred premiums specified in the 

Price-Anderson Act for inflation at least 

once during each 5-year period 

following August 20, 2003. The final 

rule amended the numerical dollar 

amounts of the deferred premiums 

listed in 10 CFR 140.11(a)(4). A 

concomitant NRC regulation at 10 CFR 

140.21 also states the numerical dollar 

amount of the deferred premium, but 

was not amended in the final rule. The 

regulations at 10 CFR 140.21 should 

cross-reference the deferred premium as 

stated at 10 CFR 140.11(a)(4). This 


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