E9-21092. 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 [phone] 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; [phone], e-mail: [e-mail]. To obtain copies of the petition, final environmental assessment, or the finding of no significant impact, contact Ms. Cindy Eck at [phone]; e-mail: [e-mail]. 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 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.

Footnotes

1.  To 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.