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Monsanto Co.; Receipt of Petition for Determination of Nonregulated Status for Potato Lines Genetically Engineered for Insect Resistance
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Monsanto Co.; Receipt of Petition for Determination of
[Federal Register: January 22, 1996 (Volume 61, Number 14)] [Notices]
[Page 1557-1558]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
Notices
Federal Register
This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section.
[[Page 1557]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service [Docket No. 95-090-1]
Monsanto Co.; Receipt of Petition for Determination of Nonregulated Status for Potato Lines Genetically Engineered for Insect Resistance
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 Monsanto Company seeking a determination of nonregulated status for certain potato lines genetically engineered for resistance to the Colorado potato beetle. 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 public comments on whether these potato lines present a plant pest risk.
DATES: Written comments must be received on or before March 22, 1996.
ADDRESSES: Please send an original and three copies of your comments to Docket No. 95-090-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comments refer to Docket No. 95-090-1. A copy of the petition and any comments received may be inspected at USDA, room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing access to that room to inspect the petition or comments are asked to call in advance of visiting at (202) 690-2817.
FOR FURTHER INFORMATION CONTACT: Dr. James Lackey, Biotechnology Permits, BBEP, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1237; (301) 734-7612. To obtain a copy of the petition, contact Ms. Kay Peterson at (301) 734-7612.
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 determination of nonregulated status must take and the information that must be included in the petition. On December 4, 1995, APHIS received a petition (APHIS Petition No. 95-338-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, requesting a determination of nonregulated status under 7 CFR part 340 for two Superior potato lines (SPBT02-5 and SPBT02-7) which have been transformed with plasmid vector PV-STBT02. On December 15, 1995, APHIS received Monsanto's amendment to its petition to include five Atlantic potato lines (ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31 and ATBT04-36) transformed with plasmid vector PV-STBT04. Plasmid vectors PV-STBT02 and PV-STBT04 confer resistance to the Colorado potato beetle (CPB). The Monsanto petition states that the subject potato lines should not be regulated by APHIS because they do not present a plant pest risk. As described in the petition, the two Superior potato lines transformed with plasmid vector PV-STBT02 and the five Atlantic potato lines transformed with plasmid vector PV-STBT04 have been genetically engineered to contain the cryIIIA gene from the common soil bacterium Bacillus thuringiensis subsp. tenebrionis (Btt), which encodes a deltaendotoxin insect control protein that is effective against CPB. The components of the two plasmid vectors, PV-STBT02 and PV-STBT04, are identical with the exception of the promoter for the cryIIIA gene. In the two Superior potato lines transformed with plasmid vector PVSTBT 02, expression of the cryIIIA gene is controlled by the enhanced cauliflower mosaic virus (CaMV) 35S promoter and the nontranslated region of the pea small subunit of ribulose-1,5-bisphosphate carboxylase. In the five Atlantic potato lines transformed with plasmid vector PV-STBT04, the second chimeric gene consists of the Arabidopsis thaliana ribulose-1,5-bisphosphate carboxylase small subunit ats1A promoter.
The subject potato lines also contain the nptII gene from the prokaryotic transposon Tn5 which encodes the enzyme neomycin phosphotransferase II and is used as a selectable marker for transformation. Expression of the nptII gene in the two Superior and five Atlantic potato lines is controlled by the CaMV 35S promoter and the 3' region of the nopaline synthase gene. The genes used to develop the subject potato lines were stably transferred into the genome of potato plants through the use of an Agrobacterium tumefaciens transformation system.
Plasmid vector PV-STBT02 is the same vector used to transform the seven Russet Burbank potato lines for which APHIS issued a determination of nonregulated status on March 2, 1995 (60 FR 13108- 13109, March 10, 1995). However, unlike the Russet Burbank potato variety, which is male sterile, Superior and Atlantic potato varieties are male fertile.
The subject Superior and Atlantic potato lines have been considered regulated articles under the regulations in 7 CFR part 340 because they contain gene sequences derived from plant pathogens. The subject potato lines have been evaluated in field trials conducted since 1992 under APHIS permits or notifications. In the process of reviewing the applications for field trials of these potato lines, APHIS determined that the vectors and other elements were disarmed and that the trials, which were conducted under conditions of reproductive and physical[[Page 1558]]
containment or isolation, would not present a risk of plant pest introduction or dissemination.
In the Federal Plant Pest Act, as amended (7 U.S.C. 150aa et seq.), ``plant pest'' is defined as ``any living stage of: Any insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate animals, bacteria, fungi, other parasitic plants or reproductive parts thereof, viruses, or any organisms similar to or allied with any of the foregoing, or any infectious substances, which can directly or indirectly injure or cause disease or damage in any plants or parts thereof, or any processed, manufactured or other products of plants.'' 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 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 insecticides, be registered prior to distribution or sale, unless exempt by EPA regulation. Residue tolerances for pesticides are established by EPA under the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 201 et seq.), and the Food and Drug Administration (FDA) enforces tolerances set by EPA under the FFDCA. EPA announced issuance of a conditional registration to Monsanto on May 5, 1995, for full commercialization of the plant pesticide Btt CryIII(A) delta endotoxin and the genetic material necessary for its production in potato. In addition to the registration, EPA also issued an exemption from the requirement of a tolerance for residues of the subject plant pesticide in potatoes on May 3, 1995 (60 FR 21725-21728), as requested by Monsanto. 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 FFDCA, 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. Monsanto completed its consultations with FDA for Russet Burbank potato lines containing the Btt cryIII(A) gene and has initiated consultations with FDA for the Superior and Atlantic potato lines that are the subject of this notice.
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 Determination of Nonregulated Status from any interested person for a period of 60 days from the date of this notice. The petition and any comments received are available for public review, and copies of the petition may be ordered (see the ADDRESSES 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. Based on the available 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 Monsanto's Superior potato lines SPBT02-5 and SPBT02-7 and Atlantic potato lines ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31, and ATBT04-36, and the availability of APHIS' written decision.Authority: 7 U.S.C. 150aa-150jj, 151-167, and 1622n; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.2(c).
Done in Washington, DC, this 11th day of January 1996. Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 96-661 Filed 1-19-96; 8:45 am] BILLING CODE 3410-34-P