[Federal Register Volume 59, Number 99 (Tuesday, May 24, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12625]


[[Page Unknown]]

[Federal Register: May 24, 1994]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 93-148-2]

 

Availability of Determination of Nonregulated Status of Monsanto 
Co., Genetically Engineered Soybean Line

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of determination.

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SUMMARY: The Animal and Plant Health Inspection Service (APHIS) is 
announcing the issuance of a determination that glyphosate-tolerant 
soybean line 40-3-2 does not present a plant pest risk and should 
therefore no longer be a regulated article under regulations at 7 CFR 
part 340. APHIS' determination has been made in response to a petition 
received on September 15, 1993, from Monsanto Co. of St. Louis, MO, 
seeking such a determination. This notice also announces the 
availability of the determination, which provides the basis for the 
ruling, as well as the availability of an environmental assessment of 
this action.

EFFECTIVE DATE: This ruling is effective May 18, 1994.

ADDRESSES: The determination, the environmental assessment, the 
Monsanto Co. submission, and written comments received in response to 
our December 6, 1993, notice published in the Federal Register 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 this 
room are requested to call ahead on (202) 690-2817.

FOR FURTHER INFORMATION CONTACT: Ms. Shirley P. Ingebritsen, Regulatory 
Analyst, Biotechnology, Biologics, and Environmental Protection, APHIS, 
USDA, room 850 Federal Building, 6505 Belcrest Road, Hyattsville, MD 
20782, (301) 436-7601. For a copy of the determination or the 
environmental assessment, please write or call Ms. Kay Peterson at this 
same address and telephone number.

SUPPLEMENTARY INFORMATION: On December 6, 1993, the Animal and Plant 
Health Inspection Service (APHIS) published a notice in the Federal 
Register (58 FR 64287-64288, Docket No. 93-148-1), announcing receipt 
of a petition from the Monsanto Co. of St. Louis, MO, that requested a 
determination on the regulatory status of glyphosate-tolerant soybean 
(GTS) line 40-3-2. This notice also indicated APHIS' role, as well as 
those of the United States Environmental Protection Agency and the Food 
and Drug Administration, in the regulation of GTS line 40-3-2, food 
products derived from it, and the herbicide glyphosate that may be used 
in conjunction with it, if a new label for the herbicide is approved. 
This notice further announced that the petition was available for 
public review and invited written comments on whether such soybeans 
present a plant pest risk, to be submitted on or before February 4, 
1994.

Comments

    APHIS received a total of 33 comments on the Monsanto petition from 
farm cooperatives, farmers, a food company, national and State soybean 
associations, a science and technology policy organization, seed 
companies and affiliated research organizations, a State agricultural 
commodity commission for soybeans, State departments of agriculture, 
universities, and a university agricultural experiment station. With a 
single exception, the comments were favorable to the petition. APHIS 
has provided a discussion of the comments in the determination 
document, which is available upon request from the individual listed 
under FOR FURTHER INFORMATION CONTACT.
    GTS line 40-3-2 is described by Monsanto as soybeans containing a 
Roundup ReadyTM gene, and any progeny derived from crosses between 
GTS line 40-3-2 and traditional soybean varieties. The Roundup 
ReadyTM gene contained in GTS line 40-3-2 is a single insert of 
DNA comprised of the enhanced 35S promoter derived from cauliflower 
mosaic virus, the chloroplast transit peptide coding sequence from 
Petunia hybrida fused to the 5-enolpyruvylshikimate-3-phosphate 
synthase (EPSPS) gene derived from Agrobacterium sp. strain CP4, and 
the nopaline synthase 3' terminator from A. tumefaciens. Glyphosate, 
the active ingredient in Roundup herbicide, controls weeds 
due to the inhibition of the enzyme EPSPS. GTS line 40-3-2 soybeans 
express an EPSPS enzyme tolerant to glyphosate, thereby conferring 
tolerance to Roundup herbicide.
    GTS line 40-3-2 contains components from organisms that are known 
plant pathogens, i.e., the bacterium A. tumefaciens and cauliflower 
mosaic virus. GTS line 40-3-2 has, therefore, been a regulated article 
under 7 CFR part 340, and was field tested in 1991, 1992, and 1993 in 
accordance with APHIS regulations. APHIS' determination that GTS line 
40-3-2 does not present a plant pest risk is based on an analysis of 
data and information provided by Monsanto, as well as other relevant 
published scientific data and comments received by APHIS concerning the 
potential plant pest risk of the soybean line. From this review, we 
have determined that the GTS line 40-3-2: (1) Exhibits no plant 
pathogenic properties; (2) is no more likely to become a weed than its 
nonengineered parental variety; (3) is unlikely to increase the 
weediness potential for any other cultivated plant or native wild 
species with which the organism can interbreed; (4) will not cause 
damage to processed agricultural commodities; and (5) is unlikely to 
harm other organisms, such as bees and earthworms, that are beneficial 
to agriculture. In addition, we have determined that there is no reason 
to believe that new progeny bred from GTS line 40-3-2 will exhibit new 
plant pest properties, i.e., properties substantially different from 
any observed for the field tested GTS line 40-3-2, or those observed 
for soybeans in traditional breeding programs.
    The effect of this determination is that GTS line 40-3-2 will no 
longer be considered a regulated article under APHIS regulations at 7 
CFR part 340. Permits and notifications under those regulations will no 
longer be required from APHIS for field testing, importation, or 
interstate movement of those soybean lines or their progeny. Agronomic 
practices involving the GTS line 40-3-2, e.g., cultivation, 
propagation, movement, and cross-breeding with other nonregulated 
soybean lines, can now be conducted without APHIS' approval. 
Importation of GTS line 40-3-2 and seeds capable of propagation is 
still, however, subject to the restrictions found in the Foreign 
Quarantine Notice regulations at 7 CFR part 319. Variety registration 
and/or seed certification for individual soybean lines carrying the 
Roundup ReadyTM gene may involve future actions by the U.S. Plant 
Variety Protection Office and State Seed Certification officials.
    The potential environmental impacts associated with this 
determination have been examined in accordance with: (1) The National 
Environmental Policy Act (NEPA) of 1969 (42 USC 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 Guidelines 
Implementing NEPA (44 FR 50381-50384, August 28, 1979, and 44 FR 51272-
51274, August 31, 1979). An environmental assessment was prepared and a 
finding of no significant impact was reached by APHIS for the 
determination that GTS line 40-3-2 is no longer a regulated article 
under its regulations at 7 CFR part 340.

    Done in Washington, DC, this 18th day of May 1994.
William S. Wallace,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 94-12625 Filed 5-23-94; 8:45 am]
BILLING CODE 3410-34-P