This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

44724 

Vol. 75, No. 145 

Thursday, July 29, 2010 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

7 CFR Part 331 

9 CFR Part 121 

[Docket No. APHIS-2009-0070] 

RIN 0579-AD09 

Agricultural Bioterrorism Protection 

Act of 2002; Biennial Review and 

Republication of the Select Agent and 

Toxin List; Reorganization of the 

Select Agent and Toxin List 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Advance notice of proposed 

rulemaking and request for comments. 

SUMMARY: In accordance with the 

Agricultural Bioterrorism Protection Act 

of 2002, we are soliciting public 

comment regarding 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. 

The Act requires the biennial review 

and republication of the list of select 

agents and toxins and the revision of the 

list as necessary. Accordingly, we are 

soliciting public comment on the 

current list of select agents and toxins 

in our regulations and suggestions 

regarding any addition or reduction of 

the animal or plant pathogens currently 

on the list of select agents. In addition, 

we are soliciting public comment on the 

potential reorganization of the list of 

select agents and toxins based on the 

relative potential of each select agent or 

toxin to be misused to adversely affect 

human, plant or animal health. Such 

tiering of the list could allow for the 

application of different security 

measures for those select agents or 

toxins which pose a higher risk to 

animal or plant health if they were to be 

stolen or otherwise misused. 

DATES: We will consider all comments 

that we receive on or before August 30, 

2010. 

ADDRESSES: You may submit comments 

by either of the following methods: 

∑ Federal eRulemaking Portal: Go to 

(http://www.regulations.gov/ 

fdmspublic/component/ 

main?main=DocketDetail&d=APHIS2009-0070) to submit or view 

comments. 

∑ Postal Mail/Commercial Delivery: 

Please send two copies of your comment 

to Docket No. APHIS-2009-0070, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A-03.8, 4700 

River Road Unit 118, Riverdale, MD 

20737-1238. Please state that your 

comment refers to Docket No. APHIS2009-0070. 

Reading Room: You may read any 

comments that we receive on this 

docket in our reading room. The reading 

room is located in room 1141 of the 

USDA South Building, 14th Street and 

Independence Avenue SW., 

Washington, DC. Normal reading room 

hours are 8 a.m. to 4:30 p.m., Monday 

through Friday, except holidays. To be 

sure someone is there to help you, 

please call (202) 690–2817 before 

coming. 

Other Information: Additional 

information about APHIS and its 

programs is available on the Internet at 

(http://www.aphis.usda.gov). 

FOR FURTHER INFORMATION CONTACT: Ms. 

Aimee M. Hyten, Compliance Manager, 

APHIS Agriculture Select Agent 

Program, PPQ, APHIS, 4700 River Road 

Unit 2, Riverdale, MD 20737-1236; (301) 

734-5281. 

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. 

The Animal and Plant Health Inspection 

Service (APHIS) has the primary 

responsibility for implementing the 

provisions of the Act within the 

Department of Agriculture (USDA). 

Veterinary Services (VS) select agents 

and toxins, listed in 9 CFR 121.3, are 

those that have been determined to have 

the potential to pose a severe threat to 

animal health or animal products. Plant 

Protection and Quarantine (PPQ) select 

agents and toxins, listed in 7 CFR 331.3, 

are those that have been determined to 

have the potential to pose a severe 

threat to plant health or plant products. 

Overlap select agents and toxins, listed 

in 9 CFR 121.4, are those that have been 

determined to pose a severe threat to 

public health and safety, to animal 

health, or to animal products. Overlap 

select agents are subject to regulation by 

both APHIS and the Centers for Disease 

Control and Prevention, which has the 

primary responsibility for implementing 

the provisions of the Act for the 

Department of Health and Human 

Services. 

Title II, Subtitle B of the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002 (which is 

cited as the ‘‘Agricultural Bioterrorism 

Protection Act of 2002’’ and referred to 

below as the Act), 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. 

In determining whether to include an 

agent or toxin in the list, the Act 

requires that the following criteria be 

considered: 

∑ The effect of exposure to the agent 

or toxin on animal or plant health, and 

on the production and marketability of 

animal or plant products; 

∑ The pathogenicity of the agent or 

the toxin and the methods by which the 

agent or toxin is transferred to animals 

or plants; 

∑ The availability and effectiveness of 

pharmacotherapies and prophylaxis to 

treat and prevent any illness caused by 

the agent or toxin; and 

∑ Any other criteria that the Secretary 

considers appropriate to protect animal 

or plant health, or animal or plant 

products. 

Paragraph (a)(2) of section 212 of the 

Act requires the Secretary to review and 

republish the list of select agents and 

toxins every 2 years and to revise the 

list as necessary. To fulfill this statutory 

mandate, PPQ and VS each convene 

separate interagency working groups in 

order to review the lists of PPQ and VS 

select agents and toxins, as well as any 

overlap select agents and toxins, and 

develop recommendations regarding 

possible changes to the list using the 

four criteria for listing found in the Act. 

In this document, we are asking for 

WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS

Federal Register / Vol. 75, No. 145 / Thursday, July 29, 2010 / Proposed Rules 44725 

1 You may view the lists of select agents and 

toxins on the Internet at (http:// 

www.regulations.gov/fdmspublic/component/ 

main?main=DocketDetail&d=APHIS-2009-0070). 

comments on the current list1 of select 

agents and toxins and on any other 

significant pathogens so as to inform the 

working groups as they begin the 

biennial review process. 

Reorganization of Current List of 

Select Agents and Toxins 

We are also seeking public comment 

regarding potential reorganization of the 

list of select agents and toxins. Recent 

reports by the National Academies, the 

Executive Order 13486 Working Group, 

and the National Science Advisory 

Board for Biosecurity have 

recommended tiering the list of select 

agents and toxins based on the relative 

potential of each to be misused. If 

implemented, such tiering could allow 

for the application of different security 

measures for those select agents or 

toxins that pose a higher risk to animal 

or plant health if they were to be stolen 

or otherwise misused. 

For those commenters who believe 

tiering the list of select agents and 

toxins is advisable, we also welcome 

recommendations as to what criteria 

should be used to designate high risk 

select agents and toxins. For example, 

potential tiering of the select agent and 

toxin list could reflect one or more of 

the following: 

∑ The relative ease with which a 

particular select agent or toxin might be 

disseminated or transmitted from one 

animal to another or into the 

environment where it could produce a 

deleterious effect upon animal or plant 

health; 

∑ The potential for high animal or 

plant mortality rates; 

∑ The potential for a major animal or 

plant health impact; 

∑ Select agents or toxins whose 

misuse might result in public panic or 

other social or economic disruption; 

∑ Select agents or toxins whose use 

might require Federal, State, and/or 

local officials to take special action in 

planning for major animal or plant 

health disasters. 

Additionally, we are interested in any 

potential corresponding changes to the 

security requirements of the current 

regulations that would be necessary to 

provide appropriate protection of higher 

tier select agents or toxins and whether 

such changes should be prescriptive or 

performance based. 

At the conclusion of the working 

group review process, we will publish 

another document in the Federal 

Register either republishing the lists of 

select agents and toxins in 7 CFR 331.3, 

9 CFR 121.3, and 9 CFR 121.4 or 

proposing changes to one or more of the 

lists. The document may also include 

reorganization of the lists of select 

agents and toxins via tiering of the 

select agents or toxins themselves and/ 

or tiered security requirements. 

This action has been determined to be 

significant for the purposes of Executive 

Order 12866 and, therefore, has been 

reviewed by the Office of Management 

and Budget. 

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

371.3, and 371.4. 

Done in Washington, DC, this 22nd 

day of July 2010. 

John Ferrell 

Deputy Under Secretary for Marketing and 

Regulatory Programs. 

[FR Doc. 2010–18581 Filed 7–28–10; 8:45 am] 

BILLING CODE 3410–34–S 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2010–0725; Directorate 

Identifier 2010–NE–18–AD] 

RIN 2120–AA64 

Airworthiness Directives; Pratt & 

Whitney PW4000 Series Turbofan 

Engines; Correction 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM); correction. 

SUMMARY: The FAA is correcting a 

proposed airworthiness directive (AD) 

which published in the Federal 

Register. That proposed AD would 

apply to Pratt & Whitney PW4000 series 

turbofan engines. The docket number is 

incorrect in all three of its locations. 

This document corrects those 

references. In all other respects, the 

original document remains the same. 

DATES: This correction is effective July 

29, 2010. 

FOR FURTHER INFORMATION CONTACT: 

James Gray, Aerospace Engineer, Engine 

Certification Office, FAA, Engine and 

Propeller Directorate, 12 New England 

Executive Park, Burlington, MA 01803; 

e-mail: james.e.gray@faa.gov; telephone 

(781) 238–7742; fax (781) 238–7199. 

SUPPLEMENTARY INFORMATION: On June 3, 

2010 (75 FR 31330), we published a 

proposed AD, FR Doc. 2010–13314, in 

the Federal Register. That proposed AD 

applies to Pratt & Whitney PW4000 

series turbofan engines. We need to 

make the following correction: 

On page 31330, in the third column, 

under 14 CFR part 39, ‘‘Docket No. 

FAA–2010–0384’’ is corrected to read 

‘‘FAA–2010–0725.’’ 

On page 31331, in the first column, 

under SUPPLEMENTARY INFORMATION, in 

the sixth and seventh lines, ‘‘Docket No. 

FAA 2010–0384’’ is corrected to read 

‘‘FAA–2010–0725.’’ 

On page 31331, in the third column, 

under § 39.13 [Amended], in the fourth 

and fifth lines, ‘‘Docket No. FAA 

2010–0384’’ is corrected to read 

‘‘FAA–2010–0725.’’ 

Issued in Burlington, Massachusetts, on 

July 23, 2010. 

Francis A. Favara, 

Manager, Engine and Propeller Directorate, 

Aircraft Certification Service. 

[FR Doc. 2010–18628 Filed 7–28–10; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2010–0634; Airspace 

Docket No. 10–AWP–8] 

Proposed Establishment of Class E 

Airspace; Clifton/Morenci, AZ 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: This action proposes to 

establish Class E airspace at Greenlee 

County Airport, Clifton/Morenci, AZ. 

To accommodate aircraft using a new 

Area Navigation (RNAV) Global 

Positioning System (GPS) Standard 

Instrument Approach Procedure (SIAP) 

at Greenlee County Airport. The FAA is 

proposing this action to enhance the 

safety and management of aircraft 

operations at the airport. 

DATES: Comments must be received on 

or before September 13, 2010. 

ADDRESSES: Send comments on this 

proposal to the U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590; telephone (202) 

366–9826. You must identify FAA 

Docket No. FAA–2010–0634; Airspace 

Docket No. 10–AWP–8, at the beginning 

of your comments. You may also submit 

comments through the Internet at 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Eldon Taylor, Federal Aviation 

Administration, Operations Support 

Group, Western Service Center, 1601 

WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS