[Federal Register Volume 74, Number 168 (Tuesday, September 1, 2009)]
[Pages 45163-45164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21092]



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 

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: [email protected]. To 
obtain copies of the petition, final environmental assessment, or the 
finding of no significant impact, contact Ms. Cindy Eck at (301) 734-
0667; e-mail: [email protected]. 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.



    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 
    The regulations in Sec.  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 Sec.  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.


    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

[[Page 45164]]

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 
    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).

    \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.


    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 

    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]