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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51268 Federal Register / Vol. 73, No. 170 / Tuesday, September 2, 2008 / Notices 

Transformation event X17–2 has been 

considered a regulated article under the 

regulations in 7 CFR part 340 because it 

contains gene sequences from plant 

pathogens. X17–2 papaya has been field 

tested in the United States since 1999 

under notifications authorized by the 

U.S. Department of Agriculture (USDA). 

APHIS has presented two alternatives in 

the draft environmental assessment (EA) 

based on its analyses of data submitted 

by UFL–IFAS, a review of other 

scientific data, and field tests conducted 

under APHIS oversight. APHIS may: (1) 

Take no action (X17–2 papaya remains 

a regulated article); or (2) deregulate 

X17–2 papaya in whole (the preferred 

alternative). 

In section 403 of the Plant Protection 

Act (7 U.S.C. 7701 et seq.), ‘‘plant pest’’

is defined as any living stage of any of 

the following that can directly or 

indirectly injure, cause damage to, or 

cause disease in any plant or plant 

product: A protozoan, a nonhuman 

animal, a parasitic plant, a bacterium, a 

fungus, a virus or viroid, an infectious 

agent or other pathogen, or any article 

similar to or allied with any of the 

foregoing. APHIS views this definition 

broadly to cover direct or indirect 

injury, disease, or damage not just to 

agricultural crops, but also to other 

plant parts and plant products whether 

natural, manufactured, or processed. 

X17–2 papaya is subject to regulation 

by other Federal agencies. Under the 

Coordinated Framework for the 

Regulation of Biotechnology, the U.S. 

Environmental Protection Agency (EPA) 

is responsible for the regulation of 

pesticides under the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA), as amended (7 U.S.C. 136 et 

seq.). FIFRA requires that all pesticides, 

including herbicides, be registered prior 

to distribution or sale, unless exempt by 

EPA regulation. In order to be registered 

as a pesticide under FIFRA, it must be 

demonstrated that when used with 

common practices, a pesticide will not 

cause unreasonable adverse effects in 

the environment. Because the use of 

Plant Incorporated Protectants (PIP), 

such as viral coat proteins, is considered 

pesticidal, the University of Florida has 

submitted a registration package to EPA 

for X17–2 papaya. 

Under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended (21 

U.S.C. 301 et seq.), pesticides added to 

(or contained in) raw agricultural 

commodities generally are considered to 

be unsafe unless a tolerance or 

exemption from tolerance has been 

established. Residue tolerances for 

pesticides are established by EPA under 

the FFDCA, and the U.S. Food and Drug 

Administration (FDA) enforces the 

tolerances set by EPA. EPA has 

previously granted a tolerance 

exemption for PRSV coat protein in 

papaya. 

The FDA policy statement concerning 

regulation of products derived from new 

plant varieties, including those 

genetically engineered, was published 

in the Federal Register on May 29, 

1992, and appears at 57 FR 22984–

23005. Under this policy, FDA ensures 

that human food and animal feed, 

including those derived from 

bioengineered sources, are safe and 

wholesome. The University of Florida 

has submitted a food and feed safety 

and nutritional assessment summary to 

FDA for X17–2 papaya in 2007 that is 

currently under agency review. 

A draft EA has been prepared to 

provide the APHIS decisionmaker with 

a review and analysis of any potential 

environmental impacts associated with 

the proposed determination of 

nonregulated status for X17–2 papaya. 

The draft EA was prepared in 

accordance with: (1) The National 

Environmental Policy Act of 1969 

(NEPA), as amended (42 U.S.C. 4321 et 

seq.), (2) regulations of the Council on 

Environmental Quality for 

implementing the procedural provisions 

of NEPA (40 CFR parts 1500–1508), (3) 

USDA regulations implementing NEPA 

(7 CFR part 1b), and (4) APHIS’ NEPA 

Implementing Procedures (7 CFR part 

372). 

In accordance with § 340.6(d) of the 

regulations, we are publishing this 

notice to inform the public that APHIS 

will accept written comments regarding 

the petition for a determination of 

nonregulated status from interested or 

affected persons for a period of 60 days 

from the date of this notice. We are also 

soliciting written comments from 

interested or affected persons on the 

draft EA prepared to examine any 

environmental impacts of the proposed 

determination for the deregulation of 

the subject papaya event. The petition, 

the draft EA, and any comments 

received are available for public review, 

and copies of the petitions and the draft 

EA are available as indicated under 

ADDRESSES and FOR FURTHER

INFORMATION CONTACT above. 

After the comment period closes, 

APHIS will review all written comments 

received during the comment period 

and any other relevant information. 

After reviewing and evaluating the 

comments on the petition and the EA 

and other data and information, APHIS 

will furnish a response to the petitioner, 

either approving or denying the 

petition. APHIS will then publish a 

notice in the Federal Register 

announcing the regulatory status of 

UFL–IFAS PRSV-resistant papaya event 

X17–2 and the availability of APHIS’

written regulatory and environmental 

decision. 

Authority: 7 U.S.C. 7701–7772 and 7781–

7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 

371.3. 

Done in Washington, DC, this 26th day of 

August 2008. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E8–20289 Filed 8–29–08; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Grain Inspection, Packers and 

Stockyards Administration 

Designation for the Aberdeen, (SD), 

Decatur (IL), Hastings (NE), Fulton (IL), 

Missouri, and South Carolina Areas 

AGENCY: Grain Inspection, Packers and 

Stockyards Administration, USDA. 

ACTION: Notice. 

SUMMARY: We are announcing 

designation of the following 

organizations to provide official services 

under the United States Grain Standards 

Act, as amended (USGSA): Aberdeen 

Grain Inspection, Inc. (Aberdeen); 

Decatur Grain Inspection, Inc. (Decatur); 

Hastings Grain Inspection, Inc. 

(Hastings); John R. McCrea Agency, Inc. 

(McCrea); Missouri Department of 

Agriculture (Missouri); and South 

Carolina Department of Agriculture 

(South Carolina). 

DATES: Effective October 1, 2008. 

ADDRESSES: USDA, GIPSA, Karen 

Guagliardo, Chief, Review Branch, 

Compliance Division, STOP 3604, Room 

1647–S, 1400 Independence Avenue, 

SW., Washington, DC 20250–3604. 

FOR FURTHER INFORMATION CONTACT: 

Karen Guagliardo at 202–720–7312, email Karen.W.Guagliardo@usda.gov. 

Read Applications: All applications 

and comments will be available for 

public inspection at the office above 

during regular business hours (7 CFR 

1.27(b)). 

SUPPLEMENTARY INFORMATION: In the 

March 3, 2008, Federal Register (73 FR 

11387), we requested applications for 

designation to provide official services 

in the geographic areas assigned to the 

official agencies named above. 

Applications were due by April 2, 2008. 

Aberdeen, Decatur, Hastings, McCrea, 

Missouri, and South Carolina were the 

sole applicants for designation to 

provide official services in the entire 

area currently assigned to them, so 


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