[Federal Register Volume 61, Number 230 (Wednesday, November 27, 1996)]
[Notices]
[Pages 60257-60258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30319]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 96-079-1]


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.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has received a petition from the Dekalb Genetics 
Corporation seeking a determination of nonregulated status for a corn 
line designated as DBT418 that has been genetically engineered for 
insect resistance. 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 January 27, 1997.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 96-079-1, 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. 96-079-1. 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. Subhash Gupta, Biotechnologist, 
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.

[[Page 60258]]

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 October 17, 1996, APHIS received a petition (APHIS Petition No. 
96-291-01p) from the Dekalb Genetics Corporation (Dekalb) of Mystic, 
CT, requesting a determination of nonregulated status under 7 CFR part 
340 for an insect-resistant corn line designated as DBT418. The 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 DBT418 has been genetically 
engineered to express a CryIA(c) insect control protein derived from 
the common soil bacterium Bacillus thuringiensis subsp. kurstaki (Bt). 
The petitioner states that the Bt delta-endotoxin protein is expressed 
at an effective level in plant tissue in the subject corn line and is 
effective in controlling the European corn borer throughout the growing 
season. Corn line DBT418 also expresses the bar gene isolated from 
Streptomyces hygroscopicus that encodes a phosphinothricin 
acetyltransferase (PAT) enzyme, which, when introduced into a plant 
cell, inactivates glufosinate, also known as phosphinothricin, the 
active ingredient in the herbicides Basta, Rely, 
Finale, and Liberty. The cryIA(c) and bar genes 
were introduced into the subject corn line by microprojectile 
bombardment and their expression is controlled in part by gene 
sequences derived from the plant pathogens cauliflower mosaic virus and 
Agrobacterium tumefaciens.
    Dekalb's corn line DBT418 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 applications for 
field trials of the subject corn, 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 insecticides, be registered 
prior to distribution or sale, unless exempt by EPA regulation. 
Accordingly, Dekalb has submitted to the EPA an application to register 
insect-resistant corn containing the plant pesticide active ingredient 
Bt CryIA(c) delta-endotoxin and the genetic material necessary for its 
production in 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. Dekalb has also 
submitted pesticide petitions to the EPA for exemptions from tolerance 
requirements for residues of the Bt CryIA(c) delta-endotoxin active 
ingredient and the PAT enzyme inert ingredient in corn.
    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.
    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 Dekalb's corn line DBT418 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 21st day of November 1996.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-30319 Filed 11-26-96; 8:45 am]
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