[Federal Register Volume 60, Number 147 (Tuesday, August 1, 1995)]
[Notices]
[Pages 39146-39147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18777]
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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.
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Federal Register / Vol. 60, No. 147 / Tuesday, August 1, 1995 /
Notices
[[Page 39146]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 95-059-1]
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 B16 that has been genetically engineered for
tolerance to the herbicide glufosinate. 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 2, 1995.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 95-059-1, 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. 95-059-1. 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. Keith Reding, Biotechnologist,
Biotechnology Permits, BBEP, APHIS, Suite 5B05, 4700 River Road, Unit
147, Riverdale, MD 20737-1237; (301) 734-7612. To obtain a copy of the
petition, contact Ms. Kay Peterson at (301) 734-7601.
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 May 25, 1995, APHIS received a petition (APHIS Petition No. 95-
145-01p) from the Dekalb Genetics Corporation (Dekalb) of Mystic, CT,
requesting a determination of nonregulated status under 7 CFR part 340
for a glufosinate tolerant corn line designated as B16. 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 B16 has been genetically
engineered with 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 herbicide
Liberty. The bar gene was introduced into the subject
corn line by microprojectile bombardment and its expression is under
the control of the 35S promoter derived from the plant pathogen
cauliflower mosaic virus and the Agrobacterium tumefaciens transcript 7
(Tr 7) 3' regulatory region. Dekalb's corn line B16 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 1991 under APHIS permits or 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.
This genetically engineered corn line is also currently subject to
regulation by other agencies. 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. Plants that have been genetically modified for
tolerance or resistance to herbicides are not regulated under the FIFRA
because the plants themselves are not considered pesticides.
In cases in which the genetically modified plants allow for a new
use of an herbicide or involve a different use pattern for the
herbicide, the EPA must approve the new or different use. In
[[Page 39147]]
conducting such an approval, the EPA considers the possibility of
adverse effects to human health and the environment from the use of
this herbicide. 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) (21 U.S.C. 201 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.
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 B16 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 2.17, 2.51, and 371.2(c).
Done in Washington, DC, this 24th day of July 1995.
Lonnie J. King,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-18777 Filed 7-31-95; 8:45 am]
BILLING CODE 3410-34-P
