[Federal Register Volume 71, Number 94 (Tuesday, May 16, 2006)]
[Notices]
[Pages 28296-28298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7402]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2006-0084]


U.S. Department of Agriculture, Agricultural Research Service; 
Availability of Petition and Environmental Assessment for Determination 
of Nonregulated Status for Plum Genetically Engineered for Resistance 
to Plum Pox

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 U.S. Department of 
Agriculture's Agricultural Research Service seeking a determination of 
nonregulated status for plum designated as transformation event C5, 
which has been genetically engineered to resist infection by plum pox 
virus (PPV). The petition has been submitted in

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accordance with our regulations concerning the introduction of certain 
genetically engineered organisms and products. In accordance with those 
regulations, we are soliciting public comments on whether this plum 
presents a plant pest risk. We are also making available for public 
comment an environmental assessment for the proposed determination of 
nonregulated status.

DATES: We will consider all comments we receive on or before July 17, 
2006.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and, in the lower ``Search Regulations and Federal 
Actions'' box, select ``Animal and Plant Health Inspection Service'' 
from the agency drop-down menu, then click on ``Submit.'' In the Docket 
ID column, select APHIS-2006-0084 to submit or view public comments and 
to view supporting and related materials available electronically. 
Information on using Regulations.gov, including instructions for 
accessing documents, submitting comments, and viewing the docket after 
the close of the comment period, is available through the site's ``User 
Tips'' link.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. APHIS-
2006-0084, 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-2006-0084.
    Reading Room: You may read the petition, the environmental 
assessment, and any comments that we receive 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: Dr. Michael Watson, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-0486. To obtain copies of the petition or the 
environmental assessment (EA), contact Ms. Ingrid Berlanger at (301) 
734-4885; e-mail: [email protected]. The petition and 
the EA are also available on the Internet at: http://www.aphis.usda.gov/brs/aphisdocs/04_26401p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/04_26401p.ea.pdf, respectively.

SUPPLEMENTARY INFORMATION: 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 September 9, 2004, APHIS received a petition (APHIS Petition 
Number 04-264-01p) from the U.S. Department of Agriculture (USDA), 
Agricultural Research Service (ARS), Appalachian Fruit Research Station 
in Kearneysville, WV, requesting a determination of nonregulated status 
under 7 CFR part 340 for plum (Prunus domestica L.) designated as 
transformation event ARS-PLMC5-6 (C5) which has been genetically 
engineered to resist infection by plum pox virus (PPV). The ARS 
petition states that the subject plum should not be regulated by APHIS 
because it does not present a plant pest risk.
    As described in the petition, the C5 plum has been genetically 
engineered with a sequence from the PPV. This sequence was derived from 
the viral coat protein gene. The resistance to plum pox infection 
appears to be conferred through post transcriptional gene silencing. As 
a result of this mechanism, no detectable viral coat protein is found 
in the subject plum.
    Event C5 has been considered a regulated article under the 
regulations in 7 CFR part 340 because it was originally engineered with 
sequences derived from plant pathogens. This plum event has been field 
tested since 1995 in the United States under APHIS permits. It has also 
been field tested in Poland, Romania, and Spain, where plum pox virus 
is present in the environment. In the process of reviewing the permits 
for field trials of the subject plum, APHIS determined that the permit 
conditions provided for appropriate confinement and would not present a 
risk of plant pest introduction or dissemination.
    In Sec.  403 of the Plant Protection Act (7 U.S.C. 7701-7772), 
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 very broadly. The definition 
covers direct or indirect injury, disease, or damage not just to 
agricultural crops, but also to plants in general, for example, native 
species, as well as to organisms that may be beneficial to plants, for 
example, honeybees, rhizobia, etc.
    The Food and Drug Administration (FDA) published a statement of 
policy on foods derived from new plant varieties in the Federal 
Register on May 29, 1992 (57 FR 22984-23005). The FDA statement of 
policy includes a discussion of FDA's authority for ensuring food 
safety under the Federal Food, Drug, and Cosmetic Act and provides 
guidance to industry on the scientific considerations associated with 
the development of foods derived from new plant varieties, including 
those plants developed through the techniques of genetic engineering. 
ARS is consulting with FDA on the subject plum line.
    To provide the public with documentation of APHIS' review and 
analysis of the environmental impacts and plant pest risk associated 
with a proposed determination of nonregulated status for ARS-PLMC5-6 
plum, an environmental assessment (EA) has been 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).
    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

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the petition for a determination of nonregulated status from interested 
persons for a period of 60 days from the date of this notice. We are 
also soliciting written comments from interested persons on the EA 
prepared to examine any environmental impacts of the proposed 
determination for the subject plum event. The petition, the EA, and any 
comments we receive are available for public review on the 
Regulations.gov Web site or in our reading room (instructions for 
accessing Regulations.gov and information on the location and hours of 
the reading room are provided under the heading ADDRESSES at the 
beginning of this notice). Copies of the petitions and the EA are also 
available as indicated in the FOR FURTHER INFORMATION CONTACT section 
of this notice.
    After the comment period closes, APHIS will review the data 
submitted by the petitioner, 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 the petition in whole or in part, or denying the petition. 
APHIS will then publish a notice in the Federal Register announcing the 
regulatory status of ARS-PLMC5-6 plum and the availability of APHIS' 
written 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 10th day of May 2006.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E6-7402 Filed 5-15-06; 8:45 am]
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