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
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 inaccordance 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.
We will consider all comments we receive on or before July 17, 2006.
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:firstname.lastname@example.org. 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.
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 § 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 § 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 § 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. 4321et 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 § 340.6(d) of the regulations, we are publishing this notice to inform the public that APHIS will accept written comments regardingthe 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.