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glufosinate-ammonium (Rely, Finale) FR Notice for Genetically Engineered Corn 3/96

[Federal Register: March 7, 1996 (Volume 61, Number 46)]
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DEPARTMENT OF AGRICULTURE
[Docket No. 95-076-2]
Plant Genetic Systems (America), Inc.; Availability of Determination of
  Nonregulated Status for Corn Line 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 of our determination that a corn 
line developed by Plant Genetic Systems (America), Inc., designated as 
event MS3 that has been genetically engineered for male sterility and 
tolerance to the herbicide glufosinate as a marker is no longer 
considered a regulated article under our regulations governing the 
introduction of certain genetically engineered organisms. Our 
determination is based on our evaluation of data submitted by Plant 
Genetic Systems (America), Inc., in its petition for a determination of 
nonregulated status, an analysis of other scientific data, and our 
review of comments received from the public in response to a previous 
notice announcing our receipt of the Plant Genetic Systems (America), 
Inc., petition. This notice also announces the availability of our 
written determination document and its associated environmental 
assessment and finding of no significant impact.
EFFECTIVE DATE: February 22, 1996.
ADDRESSES: The determination, an environmental assessment and finding 
of no significant impact, the petition, and all written comments 
received regarding the petition 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 to inspect those documents are asked to call 
in advance of visiting at (202) 690-2817.
FOR FURTHER INFORMATION CONTACT: Dr. James White, Biotechnology 
Permits, BBEP, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-
1237; (301) 734-7612. To obtain a copy of the determination or the 
environmental assessment and finding of no significant impact, contact 
Ms. Kay Peterson at (301) 734-7612; E-mail: mkpeterson@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
    On August 16, 1995, the Animal and Plant Health Inspection Service 
(APHIS) received a petition (APHIS Petition No. 95-228-01p) from Plant 
Genetics Systems (America), Inc., (PGS) of Des Moines, IA, seeking a 
determination that a corn line designated as transformation MS3 (event 
MS3) that has been genetically engineered for male sterility and 
tolerance to the herbicide glufosinate as a marker does not present a 
plant pest risk and, therefore, is not a regulated article under APHIS' 
regulations in 7 CFR part 340.
    On November 16, 1995, APHIS published a notice in the Federal 
Register (60 FR 57570-57571, Docket No. 95-076-1) announcing that the 
PGS petition had been received and was available for public review. The 
notice also discussed the role of APHIS, the Environmental Protection 
Agency, and the Food and Drug Administration in regulating the subject 
corn line and food products derived from it. In the notice, APHIS 
solicited written comments from the public as to whether the subject 
corn line posed a plant pest risk. The comments were to have been 
received by APHIS on or before January 16, 1996.
    APHIS received a total of six comments on the subject petition from 
seed companies, State departments of agriculture, and a seed farm. All 
of the comments were in support of the subject petition.
Analysis
    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. The subject corn line 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.
    Event MS3 has been considered a regulated article under APHIS' 
regulations in 7 CFR part 340 because it contains regulatory gene 
sequences derived from the plant pathogens mentioned above. However, 
evaluation of field data reports from field tests of the subject corn 
line conducted under APHIS permits or notifications since 1992 
indicates that there were no deleterious effects on plants, nontarget 
organisms, or the environment as a result of the subject corn plants' 
release into the environment.
Determination
    Based on its analysis of the data submitted by PGS and a review of 
other scientific data, comments received, and field tests of the 
subject corn line, APHIS has determined that corn line event MS3: (1) 
Exhibits no plant pathogenic properties; (2) is no more likely to 
become a weed than corn developed by traditional breeding techniques; 
(3) is unlikely to increase the weediness potential for any other 
cultivated or wild species with which it can interbreed; (4) will not 
harm threatened or endangered species or other organisms, such as bees, 
which are beneficial to agriculture; and (5) will not cause damage to 
raw or processed agricultural commodities. Therefore, APHIS has 
concluded that corn line event MS3 and any progeny derived from hybrid 
crosses with other nontransformed corn varieties will not exhibit new 
plant pest properties, i.e., properties substantially different from 
any observed for event MS3 corn plants already field tested, or those 
observed for corn in traditional breeding programs.
    The effect of this determination is that PGS' corn line designated 
as event MS3 is no longer considered a regulated article under APHIS' 
regulations in 7 CFR part 340. Therefore, the notification requirements 
pertaining to regulated articles under those regulations no longer 
apply to the field testing, importation, or interstate movement of PGS' 
corn line event MS3 or its progeny. However, the importation of the 
subject corn line or seeds capable of propagation is still subject to 
the restrictions found in APHIS' foreign quarantine notices in 7 CFR 
part 319.
National Environmental Policy Act
    An environmental assessment (EA) has been prepared to examine the 
potential environmental impacts associated with this determination. The 
EA was prepared in accordance with: (1) The National Environmental 
Policy Act of 1969 (NEPA)(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; 60 FR 6000-6005, February 1, 1995). Based 
on that EA, APHIS has reached a finding of no significant impact 
(FONSI) with regard to its determination that corn event MS3 and lines 
developed from it are no longer regulated articles under its 
regulations in 7 CFR part 340. Copies of the EA and the FONSI are 
available upon request from the individual listed under FOR FURTHER 
INFORMATION CONTACT.
    Done in Washington, DC, this 29th day of February, 1996.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.