glufosinate-ammonium (Rely, Finale) FR Notice for Genetically Engineered Corn 3/96
[Federal Register: March 7, 1996 (Volume 61, Number 46)]
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.
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: email@example.com.
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.
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.
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
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
Done in Washington, DC, this 29th day of February, 1996.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.