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contains regulatory documents having general

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are keyed to and codified in the Code of

Federal Regulations, which is published under

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Rules and Regulations Federal Register

16753 

Vol. 74, No. 69 

Monday, April 13, 2009 

1To view the proposed rule and the comments 

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

fdmspublic/component/ 

main?main=DocketDetail&d=APHIS-2007-0033. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

7 CFR Part 331 

9 CFR Part 121 

[Docket No. APHIS–2007–0033] 

RIN 0579–AC53 

Agricultural Bioterrorism Protection 

Act of 2002; Biennial Review and 

Republication of the Select Agent and 

Toxin List; Delay of Compliance Date 

for Newly Registered Entities 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule; delay of compliance 

date. 

SUMMARY: In a final rule published in 

the Federal Register on October 16, 

2008 (73 FR 61325–61332, Docket No. 

APHIS–2007–0033), and effective 

November 17, 2008, we amended and 

republished the list of select agents and 

toxins that have the potential to pose a 

severe threat to animal or plant health, 

or to animal or plant products, thus 

implementing the findings of the second 

biennial review of that list. Among other 

changes, we changed the entry for 

‘‘Newcastle disease virus (velogenic)’’ to 

read ‘‘virulent Newcastle disease virus,’’ 

thus including some non-velogenic 

strains of Newcastle disease virus as 

select agents. The final rule set the 

compliance date for entities that were 

newly required to register as entities 

possessing select agents or toxins as 

April 14, 2009. Since the publication of 

the final rule, we have been notified of 

entities that use virulent Newcastle 

disease virus and that have not 

previously been registered. This notice 

informs the public that we are extending 

the compliance date for new registrants 

to July 13, 2009, to give us additional 

time to determine how best to regulate 

those entities. 

DATES: The compliance date for entities 

that are newly required to register is 

extended to July 13, 2009. 

FOR FURTHER INFORMATION CONTACT: For 

information concerning the regulations 

in 7 CFR part 331, contact Ms. Cassie 

Armiger, Program Analyst, Select Agent 

Program, PPQ, APHIS, 4700 River Road, 

Unit 2, Riverdale, MD 20737–1231; 

(301) 734–5960. 

For information concerning the 

regulations in 9 CFR part 121, contact 

Dr. Freeda Isaac, Director, NCIE, VS, 

APHIS, 4700 River Road, Unit 39, 

Riverdale, MD 20737–1231; (301) 734– 

8364. 

SUPPLEMENTARY INFORMATION: 

Background 

The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 provides for the 

regulation of certain biological agents 

and toxins that have the potential to 

pose a severe threat to both human and 

animal health, to animal health, to plant 

health, or to animal and plant products. 

Veterinary Services (VS) select agents 

and toxins are those that have been 

determined to have the potential to pose 

a severe threat to animal health or 

animal products. 

Subtitle B (which is cited as the 

‘‘Agricultural Bioterrorism Protection 

Act of 2002’’), section 212(a), provides, 

in part, that the Secretary of Agriculture 

(the Secretary) must establish by 

regulation a list of each biological agent 

and each toxin that the Secretary 

determines has the potential to pose a 

severe threat to animal or plant health, 

or to animal or plant products. 

Paragraph (a)(2) of section 212 requires 

the Secretary to review and republish 

the list every 2 years and to revise the 

list as necessary. 

On August 28, 2007, in accordance 

with the Act, we published in the 

Federal Register (72 FR 49231–49236, 

Docket No. APHIS–2007–0033) a 

proposal 1 to amend and republish the 

list of select agents and toxins that have 

the potential to pose a severe threat to 

animal or plant health, or to animal or 

plant products. Among other things, we 

proposed to add some select agents and 

toxins to the list. 

In the list of VS select agents and 

toxins in 9 CFR 121.3, we also proposed 

to change the entry for ‘‘Newcastle 

disease virus (velogenic)’’ to read 

‘‘virulent Newcastle disease virus,’’ 

consistent with the World Organization 

for Animal Health (OIE) definition of 

the virus. Newcastle disease has 

lentogenic, mesogenic, and velogenic 

strains, the last of which are typically 

virulent; however, consistent with the 

OIE definition, we proposed that any 

Newcastle disease virus could be 

considered virulent if it has an 

intracerebral pathogenicity index in 

day-old chicks of 0.7 or greater or has 

an amino acid sequence at the fusion 

protein cleavage site that is consistent 

with virulent strains of Newcastle 

disease virus. This information was 

provided in a footnote to the proposed 

entry for ‘‘virulent Newcastle disease 

virus.’’ 

We noted in the proposal that ‘‘the 

redefinition of Newcastle disease virus 

(velogenic) to virulent Newcastle 

disease virus may lead to new 

registrants. It is possible that additional 

entities may be in possession of a 

virulent strain of Newcastle disease 

virus that does not fit the current 

definition. However, these strains have 

not circulated in the United States since 

the 1970s. In addition, entities most 

likely to be in possession of virulent 

Newcastle disease virus are already in 

possession of Newcastle disease virus 

(velogenic) and therefore already 

registered.’’ 

We solicited comments concerning 

our proposal for 60 days ending October 

29, 2007. We reopened and extended 

the deadline for comments until 

December 3, 2007, in a document 

published in the Federal Register on 

November 16, 2007 (72 FR 64540, 

Docket No. APHIS–2007–0033). We 

received 62 comments by that date. 

None of the comments addressed the 

proposed change to the entry for 

Newcastle disease virus. 

In a final rule published in the 

Federal Register on October 16, 2008 

(73 FR 61325–61332, Docket No. 

APHIS–2007–0033), and effective 

November 17, 2008, we amended and 

republished the list of select agents and 

toxins, adding the proposed new select 

agents and toxins and finalizing the 

change to the entry for Newcastle 

16754 Federal Register / Vol. 74, No. 69 / Monday, April 13, 2009 / Rules and Regulations 

2The compliance date in the final rule was 

originally published as April 14, 2008; it was 

corrected to April 14, 2009, in a correction 

published on October 27, 2008 (73 FR 63621). 

disease. Entities that possessed the 

select agents and toxins added in the 

final rule and that had not been 

registered were now required to register 

under the select agent regulations. 

To minimize the disruption of 

research or educational projects (e.g., 

teaching demonstrations) involving 

listed select agents or toxins, the final 

rule provided any individual or entity 

possessing newly added select agents or 

toxins as of the effective date of the final 

rule, November 17, 2008, with 

additional time to reach full compliance 

with the select agent regulations. The 

responsible official at all entities that 

possessed a new agent or toxin was 

required to provide notice to APHIS 

regarding their possession of the new 

agent(s) and toxin(s) by November 17, 

2008. The final rule also stated that, by 

April 14, 2009, all previously 

unregistered entities must be registered 

and thus in compliance with the 

regulations.2

Since the publication of the final rule, 

some entities have notified us that they 

use virulent Newcastle disease virus for 

bird vaccines, in research on cancer 

treatment in humans, and as a vector of 

antigenic proteins that enhance immune 

response to cancer and to diseases (e.g., 

influenza and avian influenza). This 

notice informs the public that we are 

extending the compliance date for 

registration of entities that are newly 

required to register to July 13, 2009, to 

give us additional time to determine 

how best to regulate those entities. 

Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, 

371.3, and 371.4. 

Done in Washington, DC, this 8th day of 

April 2009. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E9–8383 Filed 4–10–09; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2008–0827; Directorate 

Identifier 2008–NE–26–AD; Amendment 39– 

15879; AD 2009–08–06] 

RIN 2120–AA64 

Airworthiness Directives; General 

Electric Company (GE) 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 GE 

CF6–80A series turbofan engines with 

certain stage 1 high-pressure turbine 

(HPT) rotor disks, installed. This AD 

requires removal from service of those 

stage 1 HPT rotor disks within 30 days 

after the effective date of the AD. This 

AD results from the FAA learning that 

those disks are susceptible to cracks 

developing at the aft chamfer of the 

blade dovetail slots. We are issuing this 

AD to prevent cracks developing at the 

aft chamfer of the blade dovetail slots 

that could propagate to a failure of the 

disk and cause an uncontained engine 

failure and damage to the airplane. 

DATES: This AD becomes effective May 

18, 2009. 

ADDRESSES: The Docket Operations 

office is located at 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 

and 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 certain stage 1 HPT rotor 

disks, installed. We published the 

proposed AD in the Federal Register on 

September 4, 2008 (73 FR 51604). That 

action proposed to require removal from 

service of those stage 1 HPT rotor disks 

within 30 days after the effective date of 

the AD. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http:// 

www.regulations.gov; or in person at the 

Docket Operations office between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The AD docket 

contains this AD, the regulatory 

evaluation, any comments received, and 

other information. The street address for 

the Docket Operations office (telephone 

(800) 647–5527) is provided in the 

ADDRESSES section. Comments will be 

available in the AD docket shortly after 

receipt. 

Comments 

We provided the public the 

opportunity to participate in the 

development of this AD. We have 

considered the comment received. 

Claim That Cost of Compliance Is 

Underestimated 

One commenter, FedEx Express, 

claims that we greatly underestimated 

the actual cost of compliance with the 

proposed AD. The proposed AD 

estimated 1 work-hour of labor. The 

commenter states that this estimate is 

accurate only when the engine is 

already removed and disassembled to 

piece-part exposure of the disk. The 

commenter states that the true cost to an 

airline, both in disruption to the 

operation and in the subsequent 

unplanned engine shop visit, would 

vastly exceed 1 work-hour. 

We agree that the cost of compliance 

should also cover the work-hours for an 

unplanned engine shop visit. We do not 

agree that it should factor in the cost of 

disruption to the operation. We are 

required to calculate only the direct cost 

to an operator, of labor and parts. We 

changed the cost of compliance 

paragraph to include an estimate for an 

unplanned engine shop visit. 

Clarification of Unsafe Condition 

Statement 

Since we issued the proposed AD, we 

clarified the unsafe condition statement 

as to where potential cracks could occur 

in the disk. We changed ‘‘cracks 

developing in the bottoms of the 

dovetail slots’’ to ‘‘cracks developing at 

the aft chamfer of the blade dovetail 

slots.’’ 

Conclusion 

We have carefully reviewed the 

available data, including the comment 

received, and determined that air safety 

and the public interest require adopting 

the AD with the changes described 

previously. We have determined that 

these changes will neither increase the 

economic burden on any operator nor 

increase the scope of the AD.