[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 3410-34-P