14710 Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 

■ h. By adding a parenthetical 

containing an OMB citation at the end 

of the section to read as set forth below. 

§ 71.20 Approval of livestock facilities. 

* * * 

(5) Any reactor, suspect, exposed, 

high-risk, or scrapie positive livestock 

shall be held in quarantined pens apart 

from all other livestock at the facility. 

This requirement shall not apply to 

scrapie-exposed sheep that are not also 

designated high-risk animals or to sheep 

or goats designated under 9 CFR part 79 

as scrapie-exposed or high-risk animals 

that either are not pregnant based on the 

animal being male, an owner 

certification that any female animals 

have not been exposed to a male in the 

preceding 6 months, or a certificate 

issued by an accredited veterinarian 

stating the animals are open; or that the 

animals are under 12 months of age and 

are not visibly pregnant and are 

maintained in the same pen only with 

other animals that will be moved 

directly to slaughter or to a terminal 

feedlot in accordance with 9 CFR parts 

71 and 79. 

(6) No reactor, suspect, exposed, highrisk, or scrapie-positive livestock, nor 

any livestock that show signs of being 

infected with any infectious, contagious, 

or communicable disease, may be sold 

at or moved from the facility, except in 

accordance with 9 CFR parts 71, 75, 78, 

79, and 85. 

Records 

(7) Documents such as weight tickets, 

sales slips, and records of origin, 

identification, and destination that 

relate to livestock that are in, or that 

have been in, the facility shall be 

maintained by the facility for a period 

of 2 years, or for a period of 5 years in 

the case of sheep or goats. APHIS 

representatives and State 

representatives shall be permitted to 

review and copy those documents 

during normal business hours. 

* * * * * 

(11) Quarantined pens shall be clearly 

labeled with paint or placarded with the 

word ‘‘Quarantined’’ or the name of the 

disease of concern, and shall be cleaned 

and disinfected in accordance with 9 

CFR part 71 as well as 9 CFR 54.7(e)(2) 

if the disease of concern is scrapie and 

the quarantined animal gave birth or 

aborted at the facility, before being used 

to pen livestock that are not reactor, 

suspect, exposed, high-risk, or scrapiepositive animals. 

* * * * * 

(17) Sheep and goats: 

—This facility will handle breeding 

sheep or goats: [Initials of operator, 

date] 

—This facility will handle slaughter 

sheep or goats: [Initials of operator, 

date] 

—This facility will handle scrapieexposed goats or high-risk sheep or 

goats: [Initials of operator, date] 

—This facility will not handle goats 

known to be scrapie-exposed or sheep 

or goats known to be high-risk 

animals, nor permit such animals to 

enter the facility: [Initials of operator, 

date] 

(i) All sheep and goats must be 

received, handled, and released by the 

facility only in accordance with 9 CFR 

parts 71 and 79. 

(ii) All sheep and goats at the facility 

must be officially identified and 

relevant records related to those 

identified animals must be maintained 

by the facility operator, as required 

under 9 CFR part 79. 

(iii) The identity of sheep and goats 

from consistent States and inconsistent 

States must be maintained by the 

facility operator. 

(iv) Sexually intact animals that do 

not meet the requirements of part 79 to 

be sold as breeding animals must be 

maintained in separated enclosures at 

all times from animals that may be 

offered for sale as breeding animals 

unless all animals maintained in an 

enclosure arrived at the facility as part 

of the same consignment and are 

separated prior to sale. 

(v) Any sheep or goats that are 

designated, with regard to scrapie, as 

high-risk, suspect or scrapie-positive 

animals, and goats designated with 

regard to scrapie as exposed animals, 

excluding slaughter sheep or goats that 

are designated as exposed or high-risk 

animals and are not pregnant, must be 

held in quarantined pens while at the 

facility. 

Approvals 

(18) Request for approval: 

I hereby request approval for this 

facility to operate as an approved 

livestock facility for the classes of 

livestock indicated in paragraphs (14) 

through (17) of this agreement. I 

acknowledge that I have received a copy 

of 9 CFR parts 71, 75, 78, 79, and 85, 

and acknowledge that I have been 

informed and understand that failure to 

abide by the provisions of this 

agreement and the applicable provisions 

of 9 CFR parts 71, 75, 78, 79, and 85 

constitutes a basis for the withdrawal of 

this approval. [Printed name and 

signature of operator, date of signature] 

* * * * * 

(Approved by the Office of Management 

and Budget under control number 0579– 

0258) 

Done in Washington, DC, this 26th day of 

March 2009. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E9–7233 Filed 3–31–09; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Parts 145, 146, and 147 

[Docket No. APHIS–2007–0042] 

RIN 0579–AC78 

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 (the Plan) 

and its auxiliary provisions by 

providing new or modified sampling 

and testing procedures for Plan 

participants and participating flocks. 

The changes were voted on and 

approved by the voting delegates at the 

Plan’s 2006 National Plan Conference. 

These changes will keep the provisions 

of the Plan current with changes in the 

poultry industry and provide for the use 

of new sampling and testing procedures. 

DATES: Effective Date: May 1, 2009. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Andrew R. Rhorer, Senior Coordinator, 

Poultry Improvement Staff, National 

Poultry Improvement Plan, Veterinary 

Services, APHIS, USDA, 1498 Klondike 

Road, Suite 101, Conyers, GA 30094– 

5104; (770) 922–3496. 

SUPPLEMENTARY INFORMATION: 

Background 

The National Poultry Improvement 

Plan (NPIP, also referred to below as 

‘‘the Plan’’) is a cooperative 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 

Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 14711 

1To view the proposed rule and the comments 

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

fdmspublic/component/ 

main?main=DocketDetail&d=APHIS-2007-0042. 

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 May 28, 2008, we published in the 

Federal Register (73 FR 30528–20543, 

Docket No. APHIS–2007–0042) a 

proposal 1 to amend the Plan and its 

auxiliary provisions by providing new 

or modified sampling and testing 

procedures for Plan participants and 

participating flocks. The proposed 

changes were voted on and approved by 

the voting delegates at the Plan’s 2006 

National Plan Conference. These 

changes were intended to keep the 

provisions of the Plan current with 

changes in the poultry industry and 

provide for the use of new sampling and 

testing procedures. 

We solicited comments concerning 

our proposal for 60 days ending July 28, 

2008. We received 11 comments by that 

date. They were from State agencies, a 

university, a diagnostic laboratory 

association, and private citizens. All 11 

commenters raised specific issues 

regarding the proposed rule. Those 

issues are discussed below. 

We proposed to amend §§ 145.14(d) 

and 146.13(b), which describe approved 

tests for avian influenza (AI) under the 

Plan, to approve the use of two agent 

detection tests for AI: The real time 

reverse transcriptase/polymerase chain 

reaction (RRT–PCR) assay and the 

USDA-licensed type A influenza antigen 

capture immunoassay (ACIA). In the 

proposed regulatory text, we stated that 

agent detection tests that detect 

influenza A matrix gene or protein 

would be allowed to be performed by an 

authorized laboratory, but tests that 

determine hemagglutinin (H) or 

neuraminidase (N) subtypes would not 

be allowed to be performed by an 

authorized laboratory. 

Several commenters stated that 

laboratories that are not part of the 

National Animal Health Laboratory 

Network (NAHLN) should not be 

authorized to perform RRT–PCR assays 

for AI. As the commenters noted, many 

laboratories that are considered 

authorized laboratories under the Plan 

are operated by poultry industry groups 

or other parties and thus are not part of 

NALHN, which is composed of State 

and university laboratories and APHIS’ 

National Veterinary Services 

Laboratories (NVSL). 

NAHLN is a multifaceted network 

composed of sets of laboratories that 

focus on different diseases, using 

common testing methods and software 

platforms to process diagnostic requests 

and share information. The State and 

university laboratories in NAHLN 

perform routine diagnostic tests for 

endemic animal diseases as well as 

targeted surveillance and response 

testing for foreign animal diseases. The 

laboratories have the capability and 

capacity to conduct nationwide 

surveillance testing for the early 

detection of an animal disease outbreak, 

and they are able to test large numbers 

of samples rapidly during an outbreak 

and to demonstrate freedom from 

disease after eradication. 

The commenters cited many concerns 

regarding allowing laboratories other 

than NAHLN laboratories to perform 

RRT–PCR assays for AI, including 

conflicts of interest in reporting positive 

results from industry-operated 

laboratories; loss of data or delays in 

reporting to State animal health officials 

in the event of positive results; lack of 

standardization of procedures between 

other laboratories and NALHN; NVSL’s 

lack of resources for auditing industry 

laboratories; the potential for false 

positives or premature reporting from 

non-NAHLN laboratories; and biosafety 

and public health concerns. One of the 

commenters noted that only NALHN 

laboratories are currently authorized to 

perform RRT–PCR assays; this 

commenter stated that this system has 

worked well. 

We agree with the commenters that 

RRT–PCR assays for AI should only be 

performed by NAHLN laboratories. We 

proposed that RRT–PCR assays would 

have to be conducted using the NVSL 

official protocol for RRT–PCR 

(AVPR01510) and be conducted by 

personnel who have passed an NVSL 

proficiency test. The protocol and the 

proficiency testing we proposed to 

require are only available to NALHN 

laboratories and personnel. 

To resolve any confusion that may 

have arisen from our statement that tests 

that detect influenza A matrix gene or 

protein would be allowed to be 

performed by an authorized laboratory, 

we have modified that provision in this 

final rule. The regulatory text in this 

final rule states that agent detection 

tests may be used to detect influenza A 

matrix gene or protein but not to 

determine H or N subtypes. As 

described earlier, the specific 

requirements for performing RRT–PCR 

assays make it clear that only NAHLN 

laboratories can perform those assays. 

(As commenters noted, the ACIA may 

be performed by authorized laboratories 

as well as NAHLN laboratories.) 

The proposed rule contained several 

other proposed changes related to AI. 

We proposed to add in a new § 145.15 

the requirements in § 146.14 for AI 

diagnostic surveillance programs, which 

must include examination of all 

submitted cases of unexplained 

respiratory disease, egg production 

drops, and mortality for AI; this 

proposed change was intended to 

clearly indicate that these requirements 

apply to breeding poultry as well as 

commercial poultry. We proposed to 

increase the frequency at which 

multiplier egg-type chicken breeding 

flocks, multiplier meat-type chicken 

breeding flocks, and multiplier turkey 

breeding flocks that participate in the 

U.S. Avian Influenza Clean 

classifications in §§ 145.23(h)(2), 

145.33(l)(2), and 145.43(g)(2), 

respectively, are tested, allowing 90 

days rather than 180 days between tests. 

We proposed to establish a U.S. Avian 

Influenza Clean classification for 

ostrich, emu, rhea, and cassowary 

breeding flocks. We proposed to modify 

the sampling requirements for the U.S. 

H5/H7 Avian Influenza Monitored 

classification for meat-type turkey 

slaughter plants to allow testing at the 

flock level rather than at slaughter. 

Finally, we proposed to establish a U.S. 

H5/H7 Avian Influenza Monitored 

classification for commercial upland 

game bird slaughter plants, commercial 

waterfowl slaughter plants, raised-forrelease upland game bird premises, and 

raised-for-release waterfowl premises. 

One commenter stated a presumption 

that there is no AI being found in the 

U.S. chicken industry, based on the lack 

of such reports. Based on this 

information, the commenter stated, 

increasing sampling frequency does not 

appear to make sense. The commenter 

recommended instead that we require 

end-of-life testing of long-lived birds, 

such as breeder flocks, and symptomatic 

flocks, such as flocks with respiratory 

disease. The commenter stated that 

testing every meat bird flock in low-risk 

environments, such as conventional 

commercial poultry houses, appears to 

be an unnecessary step to placate 

international trading partners. 

We agree with the commenter that 

testing of breeding flocks and 

symptomatic flocks is important. Our 

proposals to increase the frequency at 

which breeding flocks participating in 

14712 Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 

2USDA/Economic Research Service (ERS), Farm 

Income/Cash receipts, 2002–2007. 

3USDA/ERS, Livestock, Dairy, and Poultry 

Outlook/LDP–M–158, August 20, 2007. 

the U.S. Avian Influenza Clean 

classification are tested and to add 

diagnostic AI surveillance program 

provisions to 9 CFR part 145 speak to 

our concern on those issues. However, 

contrary to the commenter’s assertion, 

occurrences of AI in U.S. poultry are 

rare but regular. The testing 

requirements for participants in the U.S. 

H5/H7 Avian Influenza Monitored 

classifications for meat-type flocks and 

slaughter plants are necessary to 

provide assurance that such flocks and 

slaughter plants are monitored for AI. 

We proposed to establish new 

requirements for authorized laboratories 

in a new § 147.51. These included a 

requirement for an annual site visit and 

recordkeeping audit by the Official State 

Agency (OSA), which the regulations 

define as the State authority recognized 

by the Department to cooperate in the 

administration of the Plan. (In some 

States, the OSA is also the State animal 

health authority; in some States, the 

OSA includes representation from, but 

is not identical to, the State animal 

health authority.) 

One commenter recommended that 

we require that the OSA and the State 

animal health authority of the State in 

which the laboratory is located be in 

concurrence before a laboratory is 

approved. The commenter also 

recommended that the Plan be modified 

where applicable to say that a 

representative of the State animal health 

authority may accompany the OSA 

whenever a site visit is conducted. 

The OSA is the entity designated in 

the NPIP to carry out the administration 

of the Plan within a State and, in that 

capacity, makes the final determination 

on whether to authorize a laboratory. 

Therefore, requiring in the regulations 

that the State animal health authority 

concur with the OSA to authorize a 

laboratory or that the State animal 

health authority participate in site visits 

with the OSA would be inappropriate. 

However, we note that, in those cases 

when the OSA is not the State animal 

health authority itself, the OSA always 

includes representation from the State 

animal health authority. 

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 change discussed in this 

document. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This final rule has been reviewed 

under Executive Order 12866. The rule 

has been determined to be not 

significant for the purposes of Executive 

Order 12866 and, therefore, has not 

been reviewed by the Office of 

Management and Budget. 

In accordance with the Regulatory 

Flexibility Act, we have analyzed the 

potential economic effects of this action 

on small entities. 

We are amending the Plan and its 

auxiliary provisions by providing new 

or modified sampling and testing 

procedures for Plan participants and 

participating flocks. The changes were 

voted on and approved by the voting 

delegates at the Plan’s 2006 National 

Plan Conference. These changes will 

keep the provisions of the Plan current 

with changes in the poultry industry 

and provide for the use of new sampling 

and testing procedures. 

The United States is the world’s 

largest poultry producer, the secondlargest egg producer, and the largest 

exporter of poultry meat. U.S. poultry 

meat production totals over 42 billion 

pounds annually; over four-fifths is 

broiler meat, most of the remainder is 

turkey meat, and a small fraction is 

other chicken meat. Cash receipts (see 

table 1) from sales of poultry and eggs 

(broilers, farm chickens, eggs, turkey, 

ducks, and other poultry) were about 

$28.9 billion in 2005 (with preliminary 

value for 2006 and forecasted value for 

2007 being a little higher).2 Of this total, 

72 percent was from broilers, 14 percent 

from eggs, 11 percent from turkeys, and 

3 percent from other poultry. 

TABLE 1—CASH RECEIPTS FOR POULTRY AND EGGS, UNITED STATES, 2000–05; 2006, AND 2007 

Commodity 2002 2003 2004 2005 2006 P 2007 F

$1000s 

Poultry/eggs ............................................. 21,138,999 23,959,134 29,540,692 28,903,545 27,700,000 29,600,000 

Broilers ..................................................... 13,437,700 15,214,945 20,446,096 20,901,934 19,000,000 20,100,000 

Farm chickens .......................................... 49,850 47,508 57,260 63,963 + + 

Chicken eggs ........................................... 4,232,433 5,273,099 5,239,082 4,000,142 4,400,000 5,100,000 

Turkeys .................................................... 2,643,273 2,631,862 2,995,802 3,157,637 3,500,000 3,500,000 

Ducks ....................................................... 15,300 19,200 20,900 21,390 + + 

Other poultry ............................................ 760,443 772,521 781,553 758,479 800,000 900,000 

P = preliminary, F = Forecast, + = included in other poultry. 

Source: USDA/ERS, Farm Income/Farm Cash Receipts, 1924–2005; 2006P, and 2007.F (http://www.ers.usda.gov/data/FarmIncome/ 

finfidmuxls.htm). 

In terms of tonnage, poultry 

production and trade exceeds that of 

beef or pork. For instance, in 2006, the 

United States produced 41.4 billion 

pounds of poultry meat, compared with 

26.2 billion pounds of beef and 21 

billion pounds of pork. The United 

States also produced 6.5 billion dozen 

eggs in 2006. Per capita consumption of 

poultry meat (103.8 pounds in 2006) 

exceeds per capita consumption of both 

beef (65.7 pounds) and pork (49.3 

pounds). Furthermore, the United States 

exports more poultry meat (5.8 billion 

pounds in 2006) than beef and veal (1.2 

billion pounds) or pork (3 billion 

pounds).3

Broiler production is concentrated in 

a group of States stretching from 

Delaware south along the Atlantic coast 

to Georgia, then westward through 

Alabama, Mississippi, and Arkansas. 

The top broiler-producing State is 

Georgia, followed by Arkansas, 

Alabama, North Carolina, Mississippi, 

and Texas. Operations in these States 

account for over 65 percent of broiler 

cash receipts. 

Most U.S. broiler production is 

conducted under contract with broiler 

processors. The grower normally 

supplies the grow-out house with all the 

necessary heating, cooling, feeding, and 

watering systems. The grower also 

supplies the labor needed in growing 

the birds. The broiler processor supplies 

the chicks, feed, and veterinary 

medicines. The processor schedules 

transportation of the birds from the farm 

Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 14713 

4USDA/ERS, Livestock, Dairy, and Poultry 

Outlook/LDP–M–158, August 20, 2007. 

5Mary E. Delany, Genetic Diversity and 

Conservation of Poultry, p. 261, in W.M. Muir and 

S.E. Aggrey, Poultry Genetics, Breeding and 

Biotechnology, August 2003; Susanne Gura, 

Livestock Genetics Companies: Concentration and 

Proprietary Strategies of an Emerging Power in the 

Global Economy (http://pastoralpeoples.org/docs/ 

Livestock_genetics.pdf). 

6USDA, ERS, Hatchery Production, March 1975; 

Hatchery Production 2006 Summary, April 2007. 

to the slaughter plant. In many cases, 

the processor also supplies the crews 

who place broilers into cages for 

transportation to the slaughter plant. 

The U.S. turkey industry produces 

over one-quarter of a billion birds 

annually, with the live weight of each 

bird averaging over 25 pounds. 

Production of turkeys is somewhat more 

scattered geographically than broiler 

production. The top five turkeyproducing States are Minnesota, North 

Carolina, Missouri, Arkansas, and 

Virginia. The United States is by far the 

world’s largest turkey producer, 

followed by the European Union. Even 

though exports are a major component 

of the U.S. turkey industry, the United 

States consumes more turkey per capita 

than any other country. 

U.S. egg operations produce over 77 

billion eggs annually. Over three-fourths 

of egg production is for human 

consumption (the table-egg market). The 

remainder of production is for the 

hatching market. These eggs are hatched 

to provide replacement birds for the egglaying flocks and broiler chicks for 

grow-out operations. The top five eggproducing States are Iowa, Ohio, 

Pennsylvania, Indiana, and California.4

The United States is the world’s 

largest exporter of poultry meat. Annual 

poultry meat exports totaled about 5.8 

billion pounds in 2006, which is about 

14.5 percent of U.S. production. (All 

trade statistics in this and the following 

paragraph are for 2006.) Demand for 

U.S. poultry meat products has 

fluctuated over the last several years 

due to changing economic conditions 

and currency exchange rates in major 

importing countries. The largest 

importers of U.S. broiler products are 

Russia, Mexico, China, Canada, Hong 

Kong, Turkey, Taiwan, Angola, South 

Korea, and Ukraine. Together, these 

markets accounted for over 74 percent 

of U.S. poultry meat exports, on a 

quantity basis. The United States 

imports only small amounts of poultry 

meat, accounting for less than twotenths of 1 percent of domestic 

production. Over 98 percent of imports 

come from Canada. 

As in the case of poultry meat, U.S. 

exports of live poultry and exports of 

fresh shell eggs are widely distributed 

and significantly outweigh imports of 

these products. The United States 

exported 1,302 million eggs and 

imported 65.4 million eggs in 2006. The 

major importers of eggs are Canada, 

Mexico, Jamaica, United Kingdom, 

Hong Kong, Brazil, Trinidad and 

Tobago, Dominican Republic, Guyana, 

and Nicaragua. These countries 

altogether accounted for about 80 

percent of U.S. egg exports. U.S. imports 

are mainly from Canada, China, France, 

and Taiwan. These countries together 

accounted for 91 percent of U.S. imports 

of eggs. The United States exported 51 

million live poultry and imported 13.7 

million live poultry in 2006. Major 

destinations include Canada, Mexico, 

China, Thailand, Peru, Colombia, 

Guatemala, Indonesia, Egypt, and El 

Salvador. These countries accounted for 

70 percent of U.S. total live poultry 

exports. All U.S. imports of live poultry 

came from Canada, United Kingdom, 

and Italy. 

The decision to participate in the 

NPIP program is voluntary. Being a 

participating flock in NPIP has many 

benefits. These include: The flock being 

recognized as a participating member of 

NPIP; the flock having an approval 

number which may be used on shipping 

labels, certificates, invoices, and other 

documents for identification purposes; 

the flock being listed in the official NPIP 

Directory of Participants; free listing in 

various State fair brochures; and 

receiving emergency disease 

management updates. Furthermore, 

being a participant in the NPIP allows 

for greater ease in moving hatching eggs 

and live birds within a State, across 

State lines, and into international 

markets. In fact, most countries will not 

accept hatching eggs, live birds, table 

eggs, or broilers unless they can be 

shown to be from an NPIP participant. 

Any increased cost to NPIP 

participants due to the proposed rule 

will be minor compared to the expected 

benefits of the changes in this final rule. 

Additional costs are likely to be minor 

because most of the participants already 

had been implementing these changes 

for several years. Even if additional tests 

are required, the additional number of 

birds tested will be very small compared 

to the size of flocks in the industry. 

Individual producers will continue to 

participate in the NPIP program only if 

the benefits they receive from 

participation outweigh the costs. Over 

99 percent of poultry breeders and 

hatcheries, commercial table-egg layer 

flocks, and commercial meat-type 

chicken and turkey slaughter plants are 

Plan participants. 

Impact on Small Entities 

The Regulatory Flexibility Act 

requires that agencies consider the 

economic effects of their rules on small 

entities. According to the Small 

Business Administration’s (SBA’s) 

Office of Advocacy, regulations create 

economic disparities based on size 

when they have a significant economic 

impact on a substantial number of small 

entities. 

Entities engaged in production of 

breeding stock and hatcheries will be 

affected by this final rule. Currently 

there are four major firms that produce 

primary breeding stock of egg-type 

chickens, three breeders of meat-type 

chickens, two breeders of turkeys, and 

one firm producing breeding stock of 

both egg-type and meat-type chickens.5

All of these are large facilities 

headquartered in the United States that 

operate in domestic and international 

markets, and would not be considered 

small entities. Few, if any, small 

producers will be directly affected by 

this final rule. 

Broiler operations (North American 

Industry Classification System [NAICS] 

code 112320), turkey operations (NAICS 

112330), hatcheries (NAICS 112340), 

and other poultry operations (112390) 

could also be affected by the changes in 

this final rule. All of these operations 

are considered to be small if they have 

annual sales of $750,000 or less (SBA 

Table of Small Business Size Standards, 

http://www.sba.gov/idc/groups/public/ 

documents/sba_homepage/ 

serv_sstd_tablepdf.pdf). Commercial egg 

producers (NAICS 112310) are 

considered small if they have annual 

sales of not more than $11.5 million. 

The broiler industry has evolved from 

small backyard flocks to fewer than 50 

highly specialized, vertically integrated 

agribusiness firms. A measure of the 

changing structure is the number and 

size of chicken hatcheries. In 1973, 

there were 989 facilities that hatched all 

chickens in the United States. Those 

hatcheries had the capacity to incubate 

436 million eggs at one time for an 

average capacity of 440,849 eggs per 

facility. In 2006, there were 313 chicken 

hatcheries, with an incubator capacity 

of 910 million eggs for an average 

capacity of 2.9 million eggs per facility. 

Similarly, there were 203 turkey 

hatching facilities with capacity to 

incubate 45 million eggs at one time, for 

an average capacity of 221,675 eggs per 

facility. In 2006, there were 55 turkey 

hatcheries, with an incubator capacity 

of 39 million eggs for an average 

capacity of 703,927 eggs per facility.6

We do not foresee any significant 

impact of this final rule on small 

14714 Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 

entities. The NPIP is a voluntary 

program, so poultry producers can 

decide if it is beneficial for them to 

participate. 

Under these circumstances, the 

Administrator of the Animal and Plant 

Health Inspection Service has 

determined that this action will not 

have a significant economic impact on 

a substantial number of small entities. 

Executive Order 12372 

This program/activity is listed in the 

Catalog of Federal Domestic Assistance 

under No. 10.025 and is subject to 

Executive Order 12372, which requires 

intergovernmental consultation with 

State and local officials. (See 7 CFR part 

3015, subpart V.) 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This rule: (1) Preempts 

all State and local laws and regulations 

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

no retroactive effect; and (3) does not 

require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

Paperwork Reduction Act 

This final rule contains no new 

information collection or recordkeeping 

requirements under the Paperwork 

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

et seq.). 

List of Subjects in 9 CFR Parts 145, 146, 

and 147 

Animal diseases, Poultry and poultry 

products, Reporting and recordkeeping 

requirements. 

■ Accordingly, we are amending 9 CFR 

parts 145, 146, and 147 as follows: 

PART 145—NATIONAL POULTRY 

IMPROVEMENT PLAN FOR BREEDING 

POULTRY 

■ 1. The authority citation for part 145 

continues to read as follows: 

Authority: 7 U.S.C. 8301–8317; 7 CFR 

2.22, 2.80, and 371.4. 

■ 2. Section 145.1 is amended as 

follows: 

■ a. By revising the definition of 

authorized laboratory to read as set 

forth below. 

■ b. By adding, in alphabetical order, 

new definitions of NPIP Technical 

Committee and Senior Coordinator to 

read as set forth below. 

■ c. In the definition of equivalent or 

equivalent requirements, by adding the 

words ‘‘or exceed’’ after the words 

‘‘equal to’’ and the words ‘‘they are’’ 

after the words ‘‘with which.’’ 

§ 145.1 Definitions. 

* * * * * 

Authorized laboratory. An authorized 

laboratory is a laboratory that meets the 

requirements of § 147.51 and is thus 

qualified to perform the assays 

described in part 147 of this subchapter. 

* * * * * 

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. 

* * * * * 

Senior Coordinator. An employee of 

the Service whose duties may include, 

but will not necessarily be limited to: 

(1) Serving as executive secretary of 

the General Conference Committee; 

(2) Serving as chairperson of the Plan 

Conference described in § 147.47; 

(3) Planning, organizing, and 

conducting the Plan Conference; 

(4) Reviewing NPIP authorized 

laboratories as described in § 147.51; 

(5) Coordinating the State 

administration of the NPIP through 

periodic reviews of the administrative 

procedures of the Official State 

Agencies, according to the applicable 

provisions of the Plan and the 

Memorandum of Understanding; 

(6) Coordinating rulemaking to 

incorporate the proposed changes of the 

provisions approved at the Plan 

conference into the regulations in parts 

145, 146, and 147 of this subchapter; 

(7) Directing the production of official 

NPIP publications; 

(8) Proposing an annual budget for 

plan activities and the General 

Conference Committee; and 

(9) Providing overall administration of 

the NPIP. 

* * * * * 

■ 3. In § 145.2, paragraph (a) is amended 

by adding a new sentence at the end of 

the paragraph to read as follows: 

§ 145.2 Administration. 

(a) * * * In the Memorandum of 

Understanding, the Official State 

Agency must designate a contact 

representative to serve as a liaison 

between the Service and the Official 

State Agency. 

* * * * * 

■ 4. Section 145.14 is amended as 

follows: 

■ a. By adding a new paragraph (b)(5) to 

read as set forth below. 

■ b. By revising paragraph (d) to read as 

set forth below. 

§ 145.14 Blood testing. 

* * * * * 

(b) * * * 

(5) The official molecular examination 

procedures for Mycoplasma 

gallisepticum and M. synoviae are the 

polymerase chain reaction (PCR) test 

described in § 147.30 of this subchapter 

and the real-time PCR test described in 

§ 147.31 of this subchapter. 

* * * * * 

(d) For avian influenza. The official 

tests for avian influenza are described in 

paragraphs (d)(1) and (d)(2) of this 

section. 

(1) Antibody detection tests. (i) 

Enzyme-linked immunosorbent assay 

(ELISA). ELISA must be conducted 

using test kits approved by the 

Department and the Official State 

Agency and must be conducted in 

accordance with the recommendations 

of the producer or manufacturer. 

(ii) The agar gel immunodiffusion 

(AGID) test. 

(A) The AGID test must be conducted 

on all ELISA-positive samples. 

(B) The AGID test must be conducted 

using reagents approved by the 

Department and the Official State 

Agency. 

(C) Standard test procedures for the 

AGID test for avian influenza are set 

forth in § 147.9 of this subchapter. The 

test can be conducted on egg yolk or 

blood samples. 

(D) Positive tests for the AGID 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. 

(2) Agent detection tests. Agent 

detection tests may be used to detect 

influenza A matrix gene or protein but 

not to determine hemagglutinin or 

neuraminidase subtypes. Samples for 

agent detection testing should be 

collected from naturally occurring flock 

mortality or clinically ill birds. 

(i) The real time reverse transcriptase/ 

polymerase chain reaction (RRT–PCR) 

assay. 

(A) The RRT–PCR tests must be 

conducted using reagents approved by 

the Department and the Official State 

Agency. The RRT–PCR must be 

conducted using the National Veterinary 

Services Laboratories (NVSL) official 

protocol for RRT–PCR (AVPR01510) and 

must be conducted by personnel who 

have passed an NVSL proficiency test. 

(B) Positive results from the RRT–PCR 

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. 

Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 14715 

(ii) USDA-licensed type A influenza 

antigen capture immunoassay (ACIA). 

(A) The USDA-licensed type A 

influenza ACIA must be conducted 

using test kits approved by the 

Department and the Official State 

Agency and must be conducted in 

accordance with the recommendations 

of the producer or manufacturer. 

(B) Positive results from the ACIA 

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. 

(3) The official determination of a 

flock as positive for the H5 or H7 

subtypes of avian influenza may be 

made only by NVSL. 

* * * * * 

■ 5. Section 145.15 is revised to read as 

follows: 

§ 145.15 Diagnostic surveillance program 

for low pathogenic avian influenza. 

(a) The Official State Agency must 

develop a diagnostic surveillance 

program for H5/H7 low pathogenic 

avian influenza for all poultry in the 

State. The exact provisions of the 

program are at the discretion of the 

States. The Service will use the 

standards in paragraph (b) of this 

section in assessing individual State 

plans for adequacy, including the 

specific provisions that the State 

developed. The standards should be 

used by States in developing those 

plans. 

(b) Avian influenza must be a disease 

reportable to the responsible State 

authority (State veterinarian, etc.) by all 

licensed veterinarians. To accomplish 

this, all laboratories (private, State, and 

university laboratories) that perform 

diagnostic procedures on poultry must 

examine all submitted cases of 

unexplained respiratory disease, egg 

production drops, and mortality for 

avian influenza by both an approved 

serological test and an approved antigen 

detection test. Memoranda of 

understanding or other means must be 

used to establish testing and reporting 

criteria (including criteria that provide 

for reporting H5 and H7 low pathogenic 

avian influenza directly to the Service) 

and approved testing methods. In 

addition, States should conduct 

outreach to poultry producers, 

especially owners of smaller flocks, 

regarding the importance of prompt 

reporting of clinical symptoms 

consistent with avian influenza. 

§ 145.23 [Amended] 

■ 6. In § 145.23, paragraphs (h)(2)(i) and 

(h)(2)(ii) are amended by removing the 

number ‘‘180’’ and replacing it with the 

number ‘‘90’’ each time it occurs. 

§ 145.33 [Amended] 

■ 7. In § 145.33, paragraphs (l)(2)(i) and 

(l)(2)(ii) are amended by removing the 

number ‘‘30’’ and replacing it with the 

number ‘‘15’’ each time it occurs; and by 

removing the number ‘‘180’’ and 

replacing it with the number ‘‘90’’ each 

time it occurs. 

§ 145.43 [Amended] 

■ 8. In § 145.43, paragraphs (g)(2)(i) and 

(g)(2)(ii) are amended by removing the 

number ‘‘180’’ and replacing it with the 

number ‘‘90’’ each time it occurs. 

■ 9. In § 145.52, paragraph (c) is revised 

to read as follows: 

§ 145.52 Participation. 

* * * * * 

(c) Subject to the approval of the 

Service and the Official State Agencies 

in the importing and exporting States, 

participating flocks may report poultry 

sales to importing States by using either 

VS Form 9–3, ‘‘Report of Sales of 

Hatching Eggs, Chicks, and Poults,’’ or 

by using a hatchery invoice form (9–3I) 

approved by the Official State Agency 

and the Service to identify poultry sales 

to clients. If the selling hatchery uses 

the 9–3I form, the following information 

must be included on the form: 

(1) The form number ‘‘9–3I’’, printed 

or stamped on the invoice; 

(2) The hatchery name and address; 

(3) The date of shipment; 

(4) The hatchery invoice number; 

(5) The purchaser name and address; 

(6) The quantity of products sold; 

(7) Identification of the products by 

bird variety or by NPIP stock code as 

listed in the NPIP APHIS 91–55–078 

appendix; and 

(8) The appropriate NPIP illustrative 

design in § 145.10. One of the designs in 

§ 145.10(b) or (g) must be used. The 

following information must be provided 

in or near the NPIP design: 

(i) The NPIP State number and NPIP 

hatchery approval number; and 

(ii) The NPIP classification for which 

product is qualified (e.g., U.S. PullorumTyphoid Clean). 

* * * * * 

■ 10. In § 145.63, a new paragraph (b) is 

added to read as follows: 

§ 145.63 Terminology and classification; 

flocks and products. 

* * * * * 

(b) U.S. Avian Influenza Clean. This 

program is intended to be the basis from 

which the breeding-hatchery industry 

may conduct a program for the 

prevention and control of avian 

influenza. It is intended to determine 

the presence of avian influenza in all 

ostrich, emu, rhea, and cassowary 

breeding flocks through routine 

serological surveillance of each 

participating breeding flock. Acceptable 

tests include antigen and antibody 

detection tests, as approved by the 

Official State Agency. A flock, and the 

hatching eggs and chicks produced from 

it, will qualify for this classification 

when the Official State Agency 

determines that it has met one of the 

following requirements: 

(1) It is a primary breeding flock in 

which 10 percent of the flock, up to a 

maximum of 30 birds, has been tested 

negative for type A influenza virus with 

all pens represented equally and when 

the tested birds are more than 4 months 

of age. Positive samples shall be further 

tested by an authorized laboratory. To 

retain this classification: 

(i) A sample of at least 30 birds must 

be tested negative at intervals of 180 

days, or 

(ii) A sample of less than 10 percent 

of the birds, up to a maximum of 30 

birds, may be tested and found to be 

negative at any one time if all pens are 

equally represented and a total of 30 

birds are tested within each 180-day 

period. 

(2) It is a multiplier breeding flock in 

which a minimum of 30 birds has been 

tested negative to type A influenza virus 

with all pens represented equally and 

when the tested birds are more than 4 

months of age. Positive samples shall be 

further tested by an authorized 

laboratory. To retain this classification: 

(i) A sample of at least 30 birds must 

be tested negative at intervals of 180 

days, or 

(ii) A sample of at least 10 percent of 

birds from each pen with all pens being 

represented must be tested negative at 

intervals of 180 days; or 

(iii) A sample of less than 10 percent 

of the birds may be tested, and found to 

be negative, at any one time if all pens 

are equally represented and a total of 10 

percent of the birds are tested within 

each 180-day period. 

PART 146—NATIONAL POULTRY 

IMPROVEMENT PLAN FOR 

COMMERCIAL POULTRY 

■ 11. 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. 

■ 12. Section 146.1 is amended as 

follows: 

■ a. By revising the definition of 

authorized laboratory and the first 

sentence of the definition of commercial 

meat-type flock to read as set forth 

below. 

14716 Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 

■ b. In the definition of equivalent, by 

adding the words ‘‘or exceed’’ after the 

words ‘‘equal to’’ and the words ‘‘they 

are’’ after the words ‘‘with which.’’ 

§ 146.1 Definitions. 

* * * * * 

Authorized laboratory. An authorized 

laboratory is a laboratory that meets the 

requirements of § 147.51 and is thus 

qualified to perform the assays 

described in part 147 of this subchapter. 

* * * * * 

Commercial meat-type flock. All of 

the meat-type chickens, meat-type 

turkeys, commercial upland game birds, 

or commercial waterfowl on one farm. 

* * * 

* * * * * 

■ 13. In § 146.2, paragraph (a) is 

amended by adding a new sentence at 

the end of the paragraph to read as 

follows: 

§ 146.2 Administration. 

(a) * * * In the Memorandum of 

Understanding, the Official State 

Agency must designate a contact 

representative to serve as a liaison 

between the Service and the Official 

State Agency. 

* * * * * 

■ 14. Section 146.3 is amended by 

revising paragraph (a) and the first 

sentence of paragraph (c) to read as 

follows: 

§ 146.3 Participation. 

(a) Any table-egg producer, raised-forrelease upland game bird premises, and 

raised-for-release waterfowl premises 

and any commercial upland game bird, 

commercial waterfowl, meat-type 

chicken or meat-type turkey slaughter 

plant, including its affiliated flocks, may 

participate in the Plan when the 

producer or plant has demonstrated, to 

the satisfaction of the Official State 

Agency, that its facilities, personnel, 

and practices are adequate for carrying 

out the relevant special provisions of 

this part and has signed an agreement 

with the Official State Agency to 

comply with the relevant special 

provisions of this part. 

* * * * * 

(c) A participating slaughter plant 

shall participate with all of the 

commercial upland game bird, 

commercial waterfowl, meat-type 

chicken and/or meat-type turkey flocks 

that are processed at the facility, 

including affiliated flocks.* * * 

* * * * * 

■ 15. Section 146.6 is revised to read as 

follows: 

§ 146.6 Specific provisions for 

participating slaughter plants. 

(a) Only commercial upland game 

bird, commercial waterfowl, meat-type 

chicken, and meat-type turkey slaughter 

plants that are under continuous 

inspection by the Food Safety and 

Inspection Service of the Department or 

under State inspection that the Food 

Safety and Inspection Service has 

recognized as equivalent to Federal 

inspection may participate in the Plan. 

(b) To participate in the Plan, meattype chicken, meat-type turkey, and 

commercial upland game bird and 

commercial waterfowl slaughter plants 

must follow the relevant special 

provisions in §§ 146.33(a), 146.43(a), 

and 146.53(a), respectively, for sample 

collection and flock monitoring, unless 

they are exempted from the special 

provisions under §§ 146.32(b), 

146.42(b), or 146.52(b), respectively. 

§ 146.9 [Amended] 

■ 16. In § 146.9, paragraph (a) is 

amended by removing the word ‘‘and’’ 

and adding the words ‘‘, and 146.53(a) 

and (b)’’ at the end of the second 

sentence, before the period. 

■ 17. Section 146.11 is amended as 

follows: 

■ a. By revising paragraph (a) to read as 

set forth below. 

■ b. By redesignating paragraphs (b) and 

(c) as (d) and (e), respectively. 

■ c. By adding new paragraphs (b) and 

(c) to read as set forth below. 

§ 146.11 Inspections. 

(a) Each participating slaughter plant 

shall be audited at least once annually 

or a sufficient number of times each 

year to satisfy the Official State Agency 

that the participating slaughter plant is 

in compliance with the provisions of 

this part. The yearly audit will consist 

of an evaluation of 2 weeks’ worth of 

records, selected at random, of the 

following data: 

(1) The actual flock slaughter date for 

each flock. This information must come 

from a verifiable source. Verifiable 

sources include electronic record 

systems that have oversight from the 

Department’s Grain Inspectors, Packers 

and Stockyards Administration or Food 

Safety and Inspection Service (FSIS) 

documents such as FSIS Form 9061–2. 

(2) Laboratory test results for each 

flock slaughtered with the sample 

collection date and test result. The test 

must be NPIP-approved and performed 

in an authorized laboratory of the NPIP. 

(b) A flock will be considered to be 

not conforming to protocol 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. 

(c) Two or more flocks that are found 

to be not conforming to protocol in the 

yearly audit for a slaughter plant shall 

be cause for a deficiency rating for that 

plant. However, if the root cause for the 

deficiency was identified, corrected, 

and documented, the plant will be 

eligible for an immediate reevaluation of 

2 additional weeks’ worth of records, 

again selected at random. If no more 

than one missed flock is identified in 

this reevaluation, the plant will be 

considered in compliance and no 

further action will be required. Plants 

found to be deficient must provide a 

written corrective action plan to the 

auditor within 2 weeks of receipt of the 

deficiency rating. A followup audit on 

the information in paragraphs (a)(1) and 

(a)(2) of this section will occur within 

90 days from the receipt of the 

corrective action plan. Slaughter plants 

will retain their classification and may 

continue to use the Plan emblem in 

§ 146.9(a) during this process. A failure 

on the followup audit may result in 

disbarment from participation according 

to the procedures in § 146.12. 

* * * * * 

■ 18. In § 146.13, paragraph (b) is 

revised to read as follows: 

§ 146.13 Testing. 

* * * * * 

(b) Avian influenza. The official tests 

for avian influenza are described in 

paragraphs (b)(1) and (b)(2) of this 

section: 

(1) Antibody detection tests. (i) 

Enzyme-linked immunosorbent assay 

(ELISA). ELISA must be conducted 

using test kits approved by the 

Department and the Official State 

Agency and must be conducted in 

accordance with the recommendations 

of the producer or manufacturer. 

(ii) The agar gel immunodiffusion 

(AGID) test. 

(A) The AGID test must be conducted 

on all ELISA-positive samples. 

(B) The AGID test must be conducted 

using reagents approved by the 

Department and the Official State 

Agency. 

(C) Standard test procedures for the 

AGID test for avian influenza are set 

forth in § 147.9 of this subchapter. The 

test can be conducted on egg yolk or 

blood samples. 

(D) Positive tests for the AGID 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. 

(2) Agent detection tests. Agent 

detection tests may be used to detect 

Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 14717 

influenza A matrix gene or protein but 

not to determine hemagglutinin or 

neuraminidase subtypes. Samples for 

this testing should be collected from 

naturally occurring flock mortality or 

clinically ill birds. 

(i) The real time reverse transcriptase/ 

polymerase chain reaction (RRT–PCR) 

assay. 

(A) The RRT–PCR tests must be 

conducted using reagents approved by 

the Department and the Official State 

Agency. The RRT–PCR must be 

conducted using the National Veterinary 

Services Laboratories (NVSL) official 

protocol for RRT–PCR (AVPR01510) and 

must be conducted by personnel who 

have passed an NVSL proficiency test. 

(B) Positive results from the RRT–PCR 

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. 

(ii) USDA-licensed type A influenza 

antigen capture immunoassay (ACIA). 

(A) The USDA-licensed type A 

influenza ACIA must be conducted 

using test kits approved by the 

Department and the Official State 

Agency and must be conducted in 

accordance with the recommendations 

of the producer or manufacturer. 

(B) Positive results from the ACIA 

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. 

(3) The official determination of a 

flock as positive for the H5 or H7 

subtypes avian influenza may be made 

only by NVSL. 

■ 19. In § 146.43, in paragraph (a)(1), the 

first sentence 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 birds per flock has tested negative 

for antibodies to type A avian influenza 

virus with an approved test no more 

than 21 days prior to slaughter. * * * 

* * * * * 

■ 20. A new subpart E, ‘‘Special 

Provisions for Commercial Upland 

Game Birds, Commercial Waterfowl, 

Raised-for-Release Upland Game Birds, 

and Raised-for-Release Waterfowl,’’ 

§§ 146.51 through 146.53, is added to 

read as follows: 

Subpart E—Special Provisions for 

Commercial Upland Game Birds, 

Commercial Waterfowl, Raised-for-Release 

Upland Game Birds, and Raised-for-Release 

Waterfowl 

Sec. 

146.51 Definitions. 

146.52 Participation. 

146.53 Terminology and classification; 

slaughter plants and premises. 

Subpart E—Special Provisions for 

Commercial Upland Game Birds, 

Commercial Waterfowl, Raised-forRelease Upland Game Birds, and 

Raised-for-Release Waterfowl 

§ 146.51 Definitions. 

Commercial upland game bird 

slaughter plant. A commercial upland 

game bird slaughter plant that is 

federally inspected or under State 

inspection that the U.S. Department of 

Agriculture’s Food Safety and 

Inspection Service has recognized as 

equivalent to Federal inspection. 

Commercial upland game birds. 

Upland game bird pheasants, quail, or 

partridges grown under confinement for 

the primary purpose of producing meat 

for human consumption. 

Commercial waterfowl. Domesticated 

ducks or geese grown under 

confinement for the primary purpose of 

producing meat for human 

consumption. 

Commercial waterfowl slaughter 

plant. A commercial waterfowl 

slaughter plant that is federally 

inspected or under State inspection that 

the U.S. Department of Agriculture’s 

Food Safety and Inspection Service has 

recognized as equivalent to Federal 

inspection. 

Raised-for-release upland game birds. 

Pheasants, quail, and partridge that are 

raised under confinement for release in 

game preserves and are not breeding 

stock. 

Raised-for-release waterfowl. 

Waterfowl that are raised under 

confinement for release in game 

preserves and are not breeding stock. 

Shift. The working period of a group 

of employees who are on duty at the 

same time. 

§ 146.52 Participation. 

(a) Participating commercial upland 

game bird slaughter plants, commercial 

waterfowl slaughter plants, raised-forrelease upland game bird premises, and 

raised-for-release waterfowl premises 

shall comply with the applicable 

general provisions of Subpart A of this 

part and the special provisions of this 

subpart E. 

(b) Commercial waterfowl and 

commercial upland game bird slaughter 

plants that slaughter fewer than 50,000 

birds annually are exempt from the 

special provisions of this subpart E. 

(c) Raised-for-release upland game 

bird premises and raised-for-release 

waterfowl premises that raise fewer than 

25,000 birds annually are exempt from 

the special provisions of this subpart E. 

§ 146.53 Terminology and classification; 

slaughter plants and premises. 

Participating flocks which have met 

the respective requirements specified in 

this section may be designated by the 

following terms and the corresponding 

designs illustrated in § 146.9 of this 

part: 

(a) U.S. H5/H7 Avian Influenza 

Monitored. This program is intended to 

be the basis from which the commercial 

waterfowl and commercial upland game 

bird 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 commercial 

waterfowl and commercial upland game 

birds through routine surveillance of 

each participating slaughter plant. A 

slaughter plant will qualify for this 

classification when the Official State 

Agency determines that it has met one 

of the following requirements: 

(1) It is a commercial upland game 

bird slaughter plant or commercial 

waterfowl slaughter plant where a 

minimum of 11 birds per shift are tested 

negative for the H5/H7 subtypes of 

avian influenza at slaughter; 

(2) It is a commercial upland game 

bird slaughter plant or commercial 

waterfowl slaughter plant that only 

accepts commercial upland game birds 

or commercial waterfowl from flocks 

where a minimum of 11 birds per flock 

have been tested negative for antibodies 

to the H5/H7 subtypes of avian 

influenza no more than 21 days prior to 

slaughter; or 

(3) It is a commercial upland game 

bird slaughter plant or commercial 

waterfowl slaughter plant that has an 

ongoing active and passive surveillance 

program for H5/H7 subtypes of avian 

influenza that is approved by the 

Official State Agency and the Service. 

(b) U.S. H5/H7 Avian Influenza 

Monitored. This program is intended to 

be the basis from which the raised-forrelease upland game bird and raised-forrelease waterfowl industries 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 

through routine surveillance of each 

participating premises. A premises will 

qualify for the classification when the 

Official State Agency determines that a 

representative sample of 30 birds from 

14718 Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 

21Trade names are used in these procedures 

solely for the purpose of providing specific 

information. Mention of a trade name does not 

constitute a guarantee or warranty of the product by 

the U.S. Department of Agriculture or an 

endorsement over other products not mentioned. 

the participating premises has been 

tested with negative results for the H5/ 

H7 subtypes of avian influenza every 90 

days. 

PART 147—AUXILIARY PROVISIONS 

ON NATIONAL POULTRY 

IMPROVEMENT PLAN 

■ 21. The authority citation continues to 

read as follows: 

Authority: 7 U.S.C. 8301–8317; 7 CFR 

2.22, 2.80, and 371.4. 

■ 22. Section 147.9 is amended as 

follows: 

■ a. By revising paragraph (a)(4)(i)(F) to 

read as follows. 

■ b. By removing figure 1. 

■ c. By redesignating figures 2 and 3 as 

figures 1 and 2, respectively. 

§ 147.9 Standard test procedures for avian 

influenza. 

(a) * * * 

(4) * * * 

(i) * * * 

(F) To prepare the wells, place 50 μl 

of avian influenza AGID antigen in the 

center well using a micropipette with an 

attached pipette tip. Place 50 μl AI 

AGID positive control antiserum in each 

of three alternate peripheral wells, and 

add 50 μl per well of test sera in the 

three remaining wells. This arrangement 

provides a positive control line on each 

side of the test serum, thus providing for 

the development of lines of identity on 

both sides of each test serum (see figure 

1). 

Note: A pattern can be included with 

positive, weak positive, and negative 

reference serum in the test sera wells to aid 

in the interpretation of results (see figure 2). 

* * * * * 

§ 147.12, 147.14–16, 147.30 [Amended] 

■ 23. Sections 147.12, 147.14, 147.15, 

147.16, and 147.30 are amended by 

redesignating footnotes 12 through 24 as 

footnotes 8 through 20, respectively 

■ 24. A new § 147.31 is added to read 

as follows: 

§ 147.31 Laboratory procedures 

recommended for the real-time polymerase 

chain reaction test for Mycoplasma 

gallisepticum (MGLP ReTi). 

(a) DNA extraction. Use Qiagen 

Qiamp Mini Kit for DNA extraction or 

equivalent validated technique/ 

procedure. This kit utilizes the 

following methods: 100 μl of swab 

suspension incubates with 10 μl of 

proteinase K and 400 μl of lysis buffer 

at 56 °C for 10 minutes. Following 

incubation, 100 μl of 100 percent 

ethanol is added to lysate. Wash and 

centrifuge following extraction kit 

recommendations. 

(b) Primer selection. A forward primer 

mglpU26 (5′-CTA GAG GGT TGG ACA 

GTT ATG–3′) located at nucleotide 

positions 765,566 to 765,586 of the M. 

gallisepticum R strain genome sequence; 

a reverse primer mglp164 (5′-GCT GCA 

CTA AAT GAT ACG TCA AA–3′) 

located at nucleotide positions 765,448 

to 765,470 of the M. gallisepticum R 

strain genome sequence; and a Taqman 

dual-labeled probe mglpprobe (5′-FAM– 

CAG TCA TTA ACA ACT TAC CAC 

CAG AAT CTG–BHQ1–3′) located at 

nucleotide positions 765,491 to 765,520 

of the M. gallisepticum R strain genome 

should be used to amplify a 139-bp 

fragment of the lp gene. 

(c) MGLP ReTi. Primers and probe 

should be utilized in a 25 μl reaction 

containing 12.5 μl of Quantitect Probe 

PCR 2X mix (Qiagen, Valencia, CA),21

primers to a final concentration of 0.5 

μmolar, and probe to a final 

concentration of 0.1 μmolar, 1μl of HK– 

UNG Thermolabile Uracil N-glycosylase 

(Epicentre, Madison, WI), 2 μl of water, 

and 5 μl of template. The reaction can 

be performed in a SmartCycler 

(Cepheid, Sunnyvale, CA) or other 

equivalent validated platform procedure 

for real-time thermocycler at 50 °C for 

2 minutes; 95 °C for 15 minutes with 

optics OFF; and 40 cycles of 94 °C for 

15 seconds followed by 60 °C for 60 

seconds with optics ON. 

(d) Determination of positive. For 

each MGLP ReTi assay reaction, the 

threshold cycle number (CT value) was 

determined to be the PCR cycle number 

at which the fluorescence of the reaction 

exceeded 30 units of fluorescence. For 

all samples tested, any MGLP reaction 

that has a recorded CT value was 

considered positive, while any MGLP 

reaction that had no recorded CT value 

was considered negative. 

(e) Controls. Proper controls should 

be used when conducting the MGLP 

ReTi assay as an official test of the Plan. 

Positive, quantitative, extraction, and 

internal controls are commercially 

available from GTCAllison, LLC, 

Mocksville, NC. 

■ 25. Section 147.43 is amended as 

follows: 

■ a. By revising paragraph (d)(4) to read 

as set forth below. 

■ b. In paragraph (d)(6), by removing the 

words ‘‘a forum’’ and adding the words 

‘‘an official advisory committee’’ in 

their place. 

§ 147.43 General Conference Committee. 

* * * * * 

(d) * * * 

(4) Consider each proposal submitted 

as provided in § 147.44 and make 

recommendations to subpart 

Committees and the Conference. Meet 

jointly with the NPIP Technical 

Committee and consider the technical 

aspects and accuracy of each proposal. 

Recommend whether new proposals 

(i.e., proposals that have not been 

submitted as provided in § 147.44) 

should be considered by the delegates to 

the Plan Conference. 

* * * * * 

■ 26. In § 147.45, the first sentence is 

revised to read as follows: 

§ 147.45 Official delegates. 

Each cooperating State shall be 

entitled to one official delegate for each 

of the programs prescribed in subparts 

B, C, D, E, F, G, and H of part 145 of 

this chapter and for each of the 

programs prescribed in subparts B, C, D, 

and E of part 146 of this chapter in 

which it has one or more participants at 

the time of the Conference. * * * 

■ 27. In § 147.46, a new paragraph (a)(9) 

is added to read as follows: 

§ 147.46 Committee consideration of 

proposed changes. 

(a) * * * 

(9) Commercial upland game birds 

and waterfowl and raised-for-release 

upland game birds and waterfowl. 

* * * * * 

■ 28. A new Subpart F, ‘‘Authorized 

Laboratories and Approved Tests,’’ 

§§ 147.51 and 147.52, is added to read 

as follows: 

Subpart F—Authorized Laboratories and 

Approved Tests 

Sec. 

147.51 Authorized laboratory minimum 

requirements. 

147.52 Approved tests. 

Subpart F—Authorized Laboratories 

and Approved Tests 

§ 147.51 Authorized laboratory minimum 

requirements. 

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 and reported as 

described in this part 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 

laboratory must use a regularly 

Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 14719 

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 3 years. 

(c) Laboratory protocol. Official Plan 

assays must be performed and reported 

as described in this part. 

(d) State site visit. The Official State 

Agency will conduct a site visit and 

recordkeeping audit annually. 

(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. 

§ 147.52 Approved tests. 

(a) The procedures for the 

bacteriological examination of poultry 

and poultry environments described in 

this part are approved tests for use in 

the NPIP. In addition, all tests that use 

veterinary biologics (e.g., antiserum and 

other products of biological origin) that 

are licensed or produced by the Service 

and used as described in this part are 

approved for use in the NPIP. 

(b) Diagnostic test kits that are not 

licensed by the Service (e.g., 

bacteriological culturing kits) may be 

approved through the following 

procedure: 

(1) The sensitivity of the kit will be 

estimated in at least three authorized 

laboratories selected by the Service by 

testing known positive samples, as 

determined by the official NPIP 

procedures found in Subparts A, B, C, 

and D of this part. If certain conditions 

or interfering substances are known to 

affect the performance of the kit, 

appropriate samples will be included so 

that the magnitude and significance of 

the effect(s) can be evaluated. 

(2) The specificity of the kit will be 

estimated in at least three authorized 

laboratories selected by the Service by 

testing known negative samples, as 

determined by the official NPIP 

procedures found in this part. If certain 

conditions or interfering substances are 

known to affect the performance of the 

kit, appropriate samples will be 

included so that the magnitude and 

significance of the effect(s) can be 

evaluated. 

(3) The kit will be provided to the 

cooperating laboratories in its final form 

and include the instructions for use. 

The cooperating laboratories must 

perform the assay exactly as stated in 

the supplied instructions. Each 

laboratory must test a panel of at least 

25 known positive clinical samples 

supplied by the manufacturer of the test 

kit. In addition, each laboratory will be 

asked to test 50 known negative clinical 

samples obtained from several sources, 

to provide a representative sampling of 

the general population. The identity of 

the samples must be coded so that the 

cooperating laboratories are blinded to 

identity and classification. Each sample 

must be provided in duplicate or 

triplicate, so that error and repeatability 

data may be generated. 

(4) Cooperating laboratories will 

submit to the kit manufacturer all raw 

data regarding the assay response. Each 

sample tested will be reported as 

positive or negative, and the official 

NPIP procedure used to classify the 

sample must be submitted in addition to 

the assay response value. 

(5) The findings of the cooperating 

laboratories will be evaluated by the 

NPIP technical committee, and the 

technical committee will make a 

recommendation regarding whether to 

approve the test kit to the General 

Conference Committee. If the technical 

committee recommends approval, the 

final approval will be granted in 

accordance with the procedures 

described in §§ 147.46 and 147.47. 

Done in Washington, DC, this 26th day of 

March 2009. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E9–7240 Filed 3–31–09; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2008–1206; Directorate 

Identifier 2008–NE–19–AD; Amendment 39– 

15869; AD 2009–07–10] 

RIN 2120–AA64 

Airworthiness Directives; General 

Electric Company CF6–80A Series 

Turbofan Engines 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: The FAA is adopting a new 

airworthiness directive (AD) for General 

Electric Company (GE) CF6–80A series 

turbofan engines with a high-pressure 

turbine rotor (HPTR) stage 1 disk, part 

number (P/N) 9367M45G06, installed. 

This AD requires removing any HPTR 

stage 1 disk, P/N 9367M45G06, before 

exceeding 2,075 cycles-since-new 

(CSN). This AD results from an error by 

GE that incorrectly cited a cyclic life of 

12,600 CSN for the HPTR stage 1 disk, 

P/N 9367M45G06. We are issuing this 

AD to prevent the HPTR stage 1 disk 

from exceeding its part life, which could 

cause fatigue cracks to start and grow. 

These cracks could result in a possible 

uncontained disk failure and damage to 

the airplane. 

DATES: This AD becomes effective May 

6, 2009. 

ADDRESSES: The Docket Operations 

office is located at the Docket 

Management Facility, U.S. Department 

of Transportation, 1200 New Jersey 

Avenue, SE., West Building Ground 

Floor, Room W12–140, Washington, DC 

20590–0001. 

FOR FURTHER INFORMATION CONTACT: 

Robert Green, Aerospace Engineer, 

Engine Certification Office, FAA, Engine 

& Propeller Directorate, 12 New England 

Executive Park, Burlington, MA 01803; 

e-mail: robert.green@faa.gov; telephone 

(781) 238–7754; fax (781) 238–7199. 

SUPPLEMENTARY INFORMATION: The FAA 

proposed to amend 14 CFR part 39 with 

a proposed AD. The proposed AD 

applies to GE CF6–80A series turbofan 

engines with a HPTR stage 1 disk, P/N 

9367M45G06, installed. We published 

the proposed AD in the Federal Register 

on November 14, 2008 (73 FR 67433). 

That action proposed to require 

removing any HPTR stage 1 disk, P/N 

9367M45G06, before exceeding 2,075 

CSN.