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



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.


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  



    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 
    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.


    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 
    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]