[Federal Register: May 16, 2006 (Volume 71, Number 94)]
[Notices]
[Page 28296-28298]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16my06-35]
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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
[[Page 28297]]
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: ingrid.e.berlanger@aphis.usda.gov. The petition and
the EA are also available on the Internet at: http://www.aphis.usda.gov/brs/aphisdocs/04_26401p.pdf and http://
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
[[Page 28298]]
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]
BILLING CODE 3410-34-P