51266 Federal Register / Vol. 73, No. 170 / Tuesday, September 2, 2008 / Notices 

authorized by the PPA concerning the 

importation of fruits and vegetables into 

the United States from certain parts of 

the world are contained in ‘‘Subpart—

Fruits and Vegetables’’ (7 CFR 319.56–

1 through 319.56–47). 

Under these regulations, peppers from 

Costa Rica, El Salvador, Guatemala, 

Honduras, and Nicaragua are subject to 

certain conditions before entering the 

United States to prevent the 

introduction of plant pests into the 

United States. The regulations require 

the use of information collection 

activities including inspections by 

Central American national plant 

protection organization officials, fruit 

fly trapping, monitoring, and 

recordkeeping, box labeling, and a 

phytosanitary certificate. 

We are asking the Office of 

Management and Budget (OMB) to 

approve our use of these information 

collection activities for an additional 3 

years. 

The purpose of this notice is to solicit 

comments from the public (as well as 

affected agencies) concerning our 

information collection. These comments 

will help us: 

(1) Evaluate whether the collection of 

information is necessary for the proper 

performance of the functions of the 

Agency, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of our 

estimate of the burden of the collection 

of information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, through use, as 

appropriate, of automated, electronic, 

mechanical, and other collection 

technologies; e.g., permitting electronic 

submission of responses. 

Estimate of burden: The public 

reporting burden for this collection of 

information is estimated to average 

0.0037936 hours per response. 

Respondents: National plant 

protection organization officials and 

growers and shippers of peppers in 

Costa Rica, El Salvador, Guatemala, 

Honduras, and Nicaragua. 

Estimated annual number of 

respondents: 245. 

Estimated annual number of 

responses per respondent: 3,226.653. 

Estimated annual number of 

responses: 790,530. 

Estimated total annual burden on 

respondents: 2,999 hours. (Due to 

averaging, the total annual burden hours 

may not equal the product of the annual 

number of responses multiplied by the 

reporting burden per response.) 

All responses to this notice will be 

summarized and included in the request 

for OMB approval. All comments will 

also become a matter of public record. 

Done in Washington, DC, this 26th day of 

August 2008. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E8–20288 Filed 8–29–08; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2008–0098] 

Solicitation of Letters of Interest To 

Participate in Biotechnology Quality 

Management System Pilot Project 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public 

that the Animal and Plant Health 

Inspection Service is soliciting letters of 

interest to participate in a voluntary 

pilot project for its Biotechnology 

Quality Management System (BQMS). 

The BQMS is a voluntary compliance 

assistance program designed to help 

stakeholders develop sound 

management practices, thus enhancing 

compliance with the regulatory 

requirements for field trials and 

movement of genetically engineered 

organisms in 7 CFR part 340. The Pilot 

Development Project will test the 

applicability of a biotechnology quality 

management audit standard and 

accompanying guidelines and assist 

APHIS in further development of 

BQMS. APHIS’ goal for the pilot project 

is to obtain feedback from participants 

on the strengths and areas for 

improvement to the audit standard and 

guidelines prior to full implementation 

of the system. 

DATES: Letters of interest will be 

accepted from September 2, 2008, to 

October 1, 2008. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Edward Jhee, Biotechnology Quality 

Management System Program Manager, 

Biotechnology Regulatory Services, 

APHIS, 4700 River Road Unit 91, 

Riverdale, MD 20737–1236; (301) 734–

6356, edward.m.jhee@aphis.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The U.S. Department of Agriculture’s 

(USDA) Animal and Plant Health 

Inspection Service (APHIS), regulates 

the introduction—meaning the 

importation, interstate movement, and 

environmental release—of genetically 

engineered (GE) organisms that are, or 

may be, plant pests. It is essential that 

applicants approved to introduce 

regulated GE organisms comply with all 

APHIS regulations and permit 

conditions. To improve compliance, 

APHIS is developing a voluntary, auditbased compliance assistance program 

known as the Biotechnology Quality 

Management System (BQMS). BQMS 

will help universities, small businesses, 

and large companies develop sound 

management practices to enhance 

compliance with the regulatory 

requirements for field trials and 

movements of GE organisms in 7 CFR 

part 340. 

APHIS is seeking voluntary 

participants for a BQMS pilot project 

who will serve as a broad representation 

of the regulated community. APHIS will 

select participants who are: 

(1) Currently conducting regulated 

environmental field release and 

movements under notification or 

permit, and who 

(2) Intend to apply for a renewal or 

new notification or permit, annually, for 

the next 3 years. 

APHIS will select one applicant from 

each of the following three categories to 

participate in the pilot project: One 

applicant from a large corporate 

business (greater than 50 employees), 1 

applicant from a small business (less 

than 15 employees), and 1 applicant 

from an academic institution. 

Participants in the BQMS Pilot 

Development Project will review the 

BQMS process and provide feedback. 

Specifically, participants will test the 

feasibility of the BQMS standards and 

guidelines by developing and 

implementing a quality management 

system for their organization that 

proactively manages regulated 

movement and field releases. 

Participating in the quality management 

system will demonstrate an 

organization’s commitment to regulatory 

accountability, increased transparency, 

and identification and implementation 

of measures to minimize the occurrence 

of compliance infractions. 

A draft audit standard for the BQMS 

program and a series of guidelines to 

assist participants in using this 

compliance assistance program to 

proactively comply with APHIS 

regulations are presently undergoing a 

technical review with audit industry 

experts. This review will be completed 

before the pilot project begins. 

Organizations that wish to participate 

in the BQMS Pilot Development Project 


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Federal Register / Vol. 73, No. 170 / Tuesday, September 2, 2008 / Notices 51267 

should submit a letter of interest (1–2 

pages) that includes the following: 

(1) A short description of current 

active notifications and permits; and 

(2) A statement of the organization’s 

commitment to: 

• Develop and implement a BQMS 

program within their organization; 

• Attend all required training 

sessions on the development and 

implementation of a BQMS to be held 

by APHIS-BRS-Regulatory Operations 

Programs (ROP); 

• Establish methods and procedures 

for monitoring critical processes and 

procedures for the movement and field 

testing of regulated GE agriculture; 

• Provide required data and provide 

feedback to APHIS-BRS-ROP on how to 

improve the BQMS program standard 

and guidelines; 

• Participate in surveys after 

completing training modules; and 

• Submit to a third-party external 

verification audit. 

APHIS will accept letters of interest 

through October 1, 2008. APHIS will 

evaluate letters and notify all applicants 

of its final selections. You may submit 

participation letters of interest by mail 

or e-mail to the person listed under FOR

FURTHER INFORMATION CONTACT at the 

beginning of this notice. 

Done in Washington, DC, this 26th day of 

August 2008. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E8–20285 Filed 8–29–08; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2008–0054] 

University of Florida; Availability of 

Petition and Environmental 

Assessment for Determination of 

Nonregulated Status for Papaya 

Genetically Engineered for Resistance 

to the Papaya Ringspot Virus 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public 

that the Animal and Plant Health 

Inspection Service has received a 

petition from the University of Florida 

seeking a determination of nonregulated 

status for papaya genetically engineered 

for resistance to the papaya ringspot 

virus derived from a transformation 

event designated as X17–2. The petition 

has been submitted in accordance with 

our regulations concerning the 

introduction of certain genetically 

engineered organisms and products. In 

accordance with those regulations, we 

are soliciting comments on whether this 

genetically engineered papaya is or 

could be a plant pest. We are also 

making available for public comment a 

draft environmental assessment for the 

proposed determination of nonregulated 

status. 

DATES: We will consider all comments 

we receive on or before November 3, 

2008. 

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=APHIS=2008 =0054 to submit or view 

comments and to view supporting and 

related materials available 

electronically. 

• Postal Mail/Commercial Delivery: 

Please send two copies of your comment 

to Docket No. APHIS–2008–0054, 

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. APHIS–

2008–0054. 

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: Mr. 

John Cordts, Biotechnology Regulatory 

Services, APHIS, 4700 River Road Unit 

147, Riverdale, MD 20737–1236; (301) 

734–5531, e-mail: 

john.m.cordts@aphis.usda.gov. To 

obtain copies of the petition or the 

environmental assessment, contact Ms. 

Cindy Eck at (301) 734–0667, e-mail: 

cynthia.a.eck@aphis.usda.gov. The 

petition and the environmental 

assessment are also available on the 

Internet at http://www.aphis.usda.gov/ 

brs/aphisdocs/04_33701p.pdf and 

http://www.aphis.usda.gov/brs/ 

aphisdocs/04_33701p_ea.pdf. 

SUPPLEMENTARY INFORMATION: 

Background 

The regulations in 7 CFR part 340, 

‘‘Introduction of Organisms and 

Products Altered or Produced Through 

Genetic Engineering Which Are Plant 

Pests or Which There Is Reason To 

Believe Are Plant Pests,’’ regulate, 

among other things, the introduction 

(importation, interstate movement, or 

release into the environment) of 

organisms and products altered or 

produced through genetic engineering 

that are plant pests or that there is 

reason to believe are plant pests. Such 

genetically engineered organisms and 

products are considered ‘‘regulated 

articles.’’

The regulations in § 340.6(a) provide 

that any person may submit a petition 

to the Animal and Plant Health 

Inspection Service (APHIS) seeking a 

determination that an article should not 

be regulated under 7 CFR part 340. 

Paragraphs (b) and (c) of § 340.6 

describe the form that a petition for a 

determination of nonregulated status 

must take and the information that must 

be included in the petition. 

On December 2, 2004, APHIS received 

a petition seeking a determination of 

nonregulated status (APHIS No. 04–

337–01p) from the University of Florida, 

Institute of Food and Agricultural 

Sciences (UFL–IFAS) of Homestead, FL, 

for papaya (Carica papaya L.) 

designated as transformation event X17–

2, which has been genetically 

engineered for resistance to the papaya 

ringspot virus (PRSV), stating that 

papaya line X17–2 does not present a 

plant pest risk and, therefore, should 

not be a regulated article under APHIS’

regulations in 7 CFR part 340. UFL–

IFAS responded to APHIS’ subsequent 

requests for additional information and 

clarification and submitted revisions to 

their petition on January 12, 2007, and 

June 14, 2007. The petition is available 

for public review and comment. 

Analysis 

As described in the petition, papaya 

transformation event X17–2 has been 

genetically engineered with a sequence 

from the PRSV. This sequence was 

derived from the PRSV coat protein (cp) 

gene and introduced into X17–2 papaya 

along with one plant-expressed 

selectable marker gene, nptII, via 

Agrobacterium-mediated 

transformation. The marker gene is 

commonly used and enables researchers 

to select those plant tissues that have 

been successfully transformed with the 

gene of interest. The resistance to PRSV 

appears to be conferred through post 

transcriptional gene silencing. 


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