[Federal Register Volume 60, Number 221 (Thursday, November 16, 1995)]
[Notices]
[Pages 57570-57571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28326]



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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 95-076-1]


Plant Genetic Systems (America), Inc.; Receipt of Petition for 
Determination of Nonregulated Status for Corn Genetically Engineered 
for Male Sterility and Glufosinate Herbicide Tolerance as a Marker

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 Plant Genetic Systems 
(America), Inc., seeking a determination of nonregulated status for a 
corn line designated as event MS3 that has been genetically engineered 
for male sterility and tolerance to the herbicide glufosinate as a 
marker. 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 this corn 
line presents a plant pest risk.

DATES: Written comments must be received on or before January 16, 1996.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 95-076-1, 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. 95-076-1. 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 White, Team Leader, 
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 

[[Page 57571]]
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 August 16, 1995, APHIS received a petition (APHIS Petition No. 
95-228-01p) from Plant Genetic Systems (America), Inc., (PGS) of Des 
Moines, IA, requesting a determination of nonregulated status under 7 
CFR part 340 for a male sterile, glufosinate tolerant corn line 
designated as transformation event MS3 (event MS3). The PGS petition 
states that corn event MS3 should not be regulated by APHIS because it 
does not present a plant pest risk.
    As described in the petition, corn event MS3 has been genetically 
engineered with a gene from Bacillus amyloliquefaciens encoding a 
ribonuclease called barnase, which inhibits pollen formation and 
results in male sterility of the transformed plants. Corn event MS3 
also contains the bar gene isolated from the bacterium Streptomyces 
hygroscopicus that encodes a phosphinothricin acetyltransferase (PAT) 
enzyme, which, when introduced into a plant cell, inactivates 
glufosinate. Linkage of the barnase gene, which induces male sterility, 
with the bar gene, a glufosinate tolerance gene used as a marker, 
enables identification of the male sterile line before the plant begins 
to flower. Event MS3 was transformed via immature embryo 
electroporation in yellow dent corn material. Expression of the 
introduced genes is controlled in part by the P35S promoter derived 
from the plant pathogen cauliflower mosaic virus and the 3'nos sequence 
from the plant pathogen Agrobacterium tumefaciens.
    PGS' corn event MS3 is currently considered a regulated article 
under the regulations in 7 CFR part 340 because it contains the above-
mentioned gene sequences derived from plant pathogenic sources. The 
subject corn line has been evaluated in field trials conducted since 
1992 under APHIS permits or notifications. In the process of reviewing 
the applications for field trials of the corn event MS3, APHIS 
determined that the trials, which were conducted under conditions of 
reproductive and physical 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 herbicides, be registered prior 
to distribution or sale, unless exempt by EPA regulation. In cases in 
which the genetically modified plants allow for a new use of an 
herbicide or involve a different use pattern for the herbicide, the EPA 
must approve the new or different use. In conducting such an approval, 
the EPA considers the possibility of adverse effects to human health 
and the environment from the use of this herbicide. When the use of the 
herbicide on the genetically modified plant would result in an increase 
in the residues of the herbicide in a food or feed crop for which the 
herbicide is currently registered, or in new residues in a crop for 
which the herbicide is not currently registered, establishment of a new 
tolerance or a revision of the existing tolerance would be required. 
Residue tolerances for pesticides are established by the 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 
the EPA under the FFDCA.
    The 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 the 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.
    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 PGS' corn event MS3 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 2.17, 2.51, and 371.2(c).

    Done in Washington, DC, this 8th day of November 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-28326 Filed 11-15-95; 8:45 am]
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