[Federal Register Volume 61, Number 244 (Wednesday, December 18, 1996)]
[Notices]
[Pages 66650-66651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32079]


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 Notices
                                                 Federal Register
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 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.
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  Federal Register / Vol. 61, No. 244 / Wednesday, December 18, 1996 / 
Notices  

[[Page 66650]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 96-095-1]


Monsanto Co.; Receipt of Petition for Determination of 
Nonregulated Status for Genetically Engineered Corn

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 the Monsanto Company 
seeking a determination of nonregulated status for a corn line 
designated as MON 802 that has been genetically engineered for insect 
resistance and 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 February 18, 
1997.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 96-095-1, 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. 96-095-1. 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 Lackey, BSS, PPQ, APHIS, 
Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 
734-7612. To obtain a copy of the petition, contact Ms. Kay Peterson at 
(301) 734-7612; 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 November 12, 1996, APHIS received a petition (APHIS Petition No. 
96-317-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, 
requesting a determination of nonregulated status under 7 CFR part 340 
for an insect-resistant and herbicide-tolerant corn line designated as 
MON 802. The Monsanto 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 MON 802 has been 
genetically engineered to express a CryIA(b) insect control protein 
derived from the common soil bacterium Bacillus thuringiensis subsp. 
kurstaki (Bt). The petitioner states that expression of the Bt delta-
endotoxin protein protects the subject corn line from leaf and stalk 
feeding damage caused by the European corn borer throughout the growing 
season. Corn line MON 802 also expresses the CP4 EPSPS protein isolated 
from Agrobacterium sp. strain CP4 and the GOX protein cloned from 
Achromobacter sp. strain LBAA, which, when introduced into a plant 
cell, confer tolerance to glyphosate, the active ingredient in the 
herbicide Roundup. The cryIA(b), CP4 EPSPS, and gox genes 
were introduced into the subject corn line by the particle acceleration 
method and their expression is controlled in part by the intron from 
the corn hsp70 gene and by gene sequences derived from the plant 
pathogens cauliflower mosaic virus and Agrobacterium tumefaciens. The 
selectable marker gene nptII is present in the subject corn line under 
the control of its own bacterial promoter.
    Monsanto's corn line MON 802 is currently considered a regulated 
article under the regulations in 7 CFR part 340 because it contains 
gene sequences derived from plant pathogenic sources. The subject corn 
line has been evaluated in field trials conducted since 1993 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

[[Page 66651]]

all pesticides, including insecticides, be registered prior to 
distribution or sale, unless exempt by EPA regulation. Accordingly, 
Monsanto has submitted to the EPA an application to register the plant 
pesticide active ingredient Bt CryIA(b) delta-endotoxin and the genetic 
material necessary for its production in corn. In cases in which the 
genetically modified plant allows for a new or different use pattern 
for an herbicide, the EPA must approve the new or different use. 
Monsanto has submitted to the EPA an application to register 
Roundup herbicide for use on corn. 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 EPA has granted exemptions from the requirement of a 
tolerance for residues of the CryIA(b) and CP4 EPSPS proteins and the 
genetic material necessary for their production in all plants, and 
Monsanto has submitted to the EPA a request for an exemption from the 
requirement of a tolerance for the GOX enzyme.
    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 completed 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 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 Monsanto's corn line MON 802 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 12th day of December 1996.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-32079 Filed 12-17-96; 8:45 am]
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