[Federal Register Volume 62, Number 156 (Wednesday, August 13, 1997)]
[Notices]
[Pages 43311-43312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21371]


 ========================================================================
 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.
 
 ========================================================================
 

  Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / 
Notices  

[[Page 43311]]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 97-052-1]


Monsanto Co. and Dekalb Genetics Corp.; Receipt of Petition for 
Determination of Nonregulated Status for Genetically Engineered Corn

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 
and Dekalb Genetics Corporation seeking a determination of nonregulated 
status for a corn line designated as GA21, which has been genetically 
engineered for tolerance to the herbicide glyphosate. 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 October 14, 1997.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 97-052-1, 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. 97-052-1. 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 
to facilitate entry into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Ray Dobert, Biotechnology 
Evaluation, BSS, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 146, 
Riverdale, MD 20737-1236; (301) 734-8365. To obtain a copy of the 
petition, contact Ms. Kay Peterson at (301) 734-4885; e-mail: 
[email protected].

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 April 9, 1997, APHIS received a petition (APHIS Petition No. 97-
099-01p) from the Monsanto Company of St. Louis, MO, and Dekalb 
Genetics Corporation of Mystic, CT (Monsanto/Dekalb), requesting a 
determination of nonregulated status under 7 CFR part 340 for a 
glyphosate-tolerant corn line designated as GA21. The Monsanto/Dekalb 
petition states that the subject corn line should not be regulated by 
APHIS because it does not present a plant pest risk.
    As described in the petition, corn line GA21 has been genetically 
engineered to contain a modified corn 5-enolpyruvylshikimate-3-
phosphate synthase (EPSPS) protein, which, when expressed in the plant, 
confers tolerance to glyphosate, the active ingredient in the herbicide 
Roundup. The modified corn EPSPS gene was introduced into 
the parental inbred (AT) corn line by the particle acceleration method 
and its expression is controlled in part by the rice actin promoter and 
intron and the NOS 3' termination sequence derived from the plant 
pathogen Agrobacterium tumefaciens.
    The Monsanto/Dekalb corn line GA21 is currently considered a 
regulated article under the regulations in 7 CFR part 340 because it 
contains a gene sequence derived from a plant pathogen. The subject 
corn line has been evaluated in field trials conducted since 1994 under 
APHIS notifications. In the process of reviewing the notifications for 
field trials of this corn line, APHIS determined that the vectors and 
other elements were disarmed and 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 genetically modified plants allow for a new or different use 
pattern for the herbicide, EPA must approve the new or different use. 
Accordingly, Monsanto submitted to the EPA an application to register 
Roundup herbicide for use over-the-top on glyphosate-
tolerant corn, and EPA has approved a label for such use.

[[Page 43312]]

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), as amended (21 U.S.C. 301 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. 
Monsanto has begun consultation with the FDA on the subject corn line.
    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 petitioners, 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 
petitioners, 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 the Monsanto/Dekalb corn 
line GA21 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 6th day of August 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-21371 Filed 8-12-97; 8:45 am]
BILLING CODE 3410-34-P