[Federal Register: September 1, 2009 (Volume 74, Number 168)]
[Notices]
[Page 45163-45164]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01se09-22]
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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.
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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; e-mail: 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 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.
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
[[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
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).
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\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.
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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]
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