[Federal Register Volume 73, Number 170 (Tuesday, September 2, 2008)]
[Notices]
[Pages 51267-51268]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20289]
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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.
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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 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
(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.
[[Page 51268]]
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 Sec. 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]
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