Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 45163 

activities, including a phytosanitary 

certificate with an additional 

declaration statement and box labeling. 

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 

0.121875 hours per response. 

Respondents: Importers and the 

national plant protection organization of 

Thailand. 

Estimated annual number of 

respondents: 10. 

Estimated annual number of 

responses per respondent: 64. 

Estimated annual number of 

responses: 640. 

Estimated total annual burden on 

respondents: 78 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 2009. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E9–21098 Filed 8–31–09; 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; 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 of 

our determination that a papaya line 

developed by the University of Florida, 

designated as transformation event X17– 

2, which has been genetically 

engineered for resistance to the papaya 

ringspot virus, is no longer considered 

a regulated article under our regulations 

governing the introduction of certain 

genetically engineered organisms. Our 

determination is based on our 

evaluation of data submitted by the 

University of Florida in its petition for 

a determination of nonregulated status, 

our analysis of other scientific data, our 

response to comments received from the 

public on the petition for nonregulated 

status for papaya line X17–2, and our 

associated environmental assessment. 

This notice also announces the 

availability of our written determination 

of nonregulated status and finding of no 

significant impact. 

DATES: Effective Date: September 1, 

2009. 

ADDRESSES: You may read the petition, 

final environmental assessment, 

determination, finding of no significant 

impact, comments we received on the 

petition, and our responses to those 

comments 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. See the Supplementary 

Information section of this notice for a 

link to view these documents on the 

Internet. 

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, final 

environmental assessment, or the 

finding of no significant impact, contact 

Ms. Cindy Eck at (301) 734–0667; email: cynthia.a.eck@aphis.usda.gov. 

The petition, final environmental 

assessment and finding of no significant 

impact 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 may be 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, 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. 

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 

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45164 Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 

1To view the notice, petition, EA, and the 

comments we received, go to http:// 

www.regulations.gov/fdmspublic/component/ 

main?main=DocketDetail&d=APHIS-2008-0054. 

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. 

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 acknowledged by 

the U.S. Department of Agriculture 

(USDA). In the process of reviewing the 

notifications for field trials of the 

subject papaya plants, APHIS 

determined that the vectors and other 

elements were disarmed and that trials, 

which were conducted under conditions 

of reproductive and physical 

confinement or isolation, would not 

present a risk of plant pest introduction 

or dissemination. APHIS presented two 

alternatives in the draft environmental 

assessment (EA) based on its analyses of 

data submitted by the University of 

Florida, a review of other scientific data, 

as well as data gathered from field tests 

conducted under APHIS oversight: (1) 

Take no action (X17–2 papaya remains 

a regulated article); or (2) deregulate 

X17–2 papaya in whole (the preferred 

alternative). 

In a notice 1 published in the Federal 

Register on September 2, 2008 (73 FR 

51267–51268, Docket No. APHIS–2008– 

0054), APHIS announced the 

availability of the University of Florida’s 

petition and on APHIS’ associated draft 

EA for public comment. APHIS solicited 

comments on whether the subject 

papaya would present a plant pest risk 

and on its EA for the deregulation 

petition. APHIS received over 12,000 

comments by the close of the 60-day 

comment period, which ended on 

November 3, 2008. There were 18 

comments from scientific organizations 

or individuals that supported 

deregulation. One individual supported 

deregulation as long as the taste of 

organic papayas was not damaged. 

Approximately 175 unique comments 

opposed to the deregulation were 

submitted. The remaining 

approximately 12,000 comments were 

form letters opposing deregulation in 

principle; all of those letters raised 

essentially identical points and had 

been compiled by organizations 

generally opposed to genetic 

engineering of plants. APHIS has 

addressed the issues raised during the 

comment period and has provided 

responses to these comments as an 

attachment to the finding of no 

significant impact (FONSI). 

Determination 

Based on APHIS’ analysis of field, 

greenhouse, and laboratory data 

submitted by the University of Florida, 

references provided in the petition, 

additional scientific data, information 

described in the EA, comments 

provided by the public, and APHIS’ 

evaluation of those comments, APHIS 

has determined that X17–2 papaya will 

not pose a plant pest risk for the 

following reasons: (1) Disease 

susceptibility and compositional 

profiles of X17–2 are similar to other 

papaya varieties, therefore no direct or 

indirect effects on raw or processed 

plant commodities are expected; (2) 

X17–2 will not hybridize with any 

native papaya species, although it may 

hybridize with feral or other Carica 

papaya plants; known mitigation 

methods to exclude GE pollen are 

described and lead APHIS to conclude 

that significant effects on both organic 

and conventional growers are unlikely; 

(3) it exhibits no characteristics that 

would cause it to be more weedy than 

the non-genetically engineered papaya 

from which it was developed or other 

papayas; (4) X17–2 does not exhibit 

changes in pest or disease susceptibility 

(other than resistance to PRSV), 

therefore significant impacts on 

biodiversity of papaya or other 

organisms in the environment are 

unlikely; (5) in assessing viral 

interaction issues, APHIS considered 

the potential for recombination, 

heteroencapsidation and synergy and 

concluded that the likelihood of 

development of new viruses or viruses 

with novel/altered properties is very 

low; (6) the anti-viral activity of the 

inserted genes does not pose risks to 

non-target organisms, including 

beneficial organisms and threatened and 

endangered species; (7) compared to 

current papaya PRSV management 

practices, cultivation of X17–2 should 

not significantly impact standard 

agricultural practices or commercial 

uses of papaya; (8) multiple years of 

growing X17–2 papaya has not resulted 

in observable changes to the 

environment, therefore APHIS 

concludes that significant cumulative 

impacts resulting from granting X17–2 

nonregulated status are unlikely to 

occur. 

National Environmental Policy Act 

To provide the public with 

documentation of APHIS’ 

environmental review and analysis of 

any potential environmental impacts 

associated with the determination of 

nonregulated status for X17–2 papaya, 

an EA was prepared. The 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). Based on that EA, other pertinent 

scientific data, and its analyses of public 

comments received on the EA, APHIS 

has reached a FONSI with regard to the 

determination that the University of 

Florida’s X17–2 papaya line and lines 

developed from it should not result in 

any significant impacts once they are no 

longer regulated articles under its 

regulations in 7 CFR part 340. Copies of 

the EA and FONSI are available as 

indicated in the ADDRESSES and FOR

FURTHER INFORMATION CONTACT sections 

of this notice. 

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 2009. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E9–21092 Filed 8–31–09; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Research Service 

Notice of Intent To Grant Exclusive 

License 

AGENCY: Agricultural Research Service, 

USDA. 

ACTION: Notice of intent. 

SUMMARY: Notice is hereby given that 

the U.S. Department of Agriculture, 

Agricultural Research Service, intends 

to grant to T. A. Seeds LLC of Jersey 

Shore, Pennsylvania, an exclusive 

license to the soybean variety described 

in Plant Variety Protection Certificate 

Number 200300169, ‘‘Moon Cake,’’ 

issued on December 15, 2003. 

DATES: Comments must be received on 

or before October 1, 2009. 

ADDRESSES: Send comments to: USDA, 

ARS, Office of Technology Transfer, 

5601 Sunnyside Avenue, Rm. 4–1174, 

Beltsville, Maryland 20705–5131. 

FOR FURTHER INFORMATION CONTACT: June 

Blalock of the Office of Technology 

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