[Federal Register Volume 60, Number 173 (Thursday, September 7, 1995)]
[Notices]
[Pages 46573-46574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22129]
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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. 173 / Thursday, September 7, 1995 /
Notices
[[Page 46573]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 95-067-1]
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 Northrup King
Company seeking a determination of nonregulated status for a corn line
designated as Bt11 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 November 6, 1995.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 95-067-1, 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. 95-067-1. 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,
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) 734-7612.
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 a determination of nonregulated status must take
and the information that must be included in the petition.
On July 14, 1995, APHIS received a petition (APHIS Petition No. 95-
195-01p) from the Northrup King Company (Northrup King) of Golden
Valley, MN, requesting a determination of nonregulated status under 7
CFR part 340 for an insect resistant corn line designated as Bt11. The
Northrup King 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 Bt11 has been genetically
engineered to contain the cryIA(b) gene from Bacillus thuringiensis
subsp. kurstaki (Btk), which expresses a delta-endotoxin insecticidal
protein known to be effective against certain lepidopteran insects,
including European corn borer. Corn line Bt11 also contains the pat
gene isolated from Streptomyces viridochromogenes that encodes a
phosphinothricin-N-acetyl transferase (PAT) enzyme. When introduced
into a plant cell, the PAT enzyme inactivates the herbicide glufosinate
and is used in corn line Bt11 as a selective marker. Expression of the
introduced genes is controlled by the 35S promoter derived from the
plant pathogen cauliflower mosaic virus and a NOS terminator derived
from the nopaline synthase gene of Agrobacterium tumefaciens.
Corn line Bt11 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 1992 under permits or
notifications issued by APHIS, and since 1993, field trials have also
been conducted under an experimental use permit issued by the
Environmental Protection Agency (EPA). 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
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 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.
Under the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C.
301 et seq.), pesticides added to raw agricultural commodities
generally are
[[Page 46574]]
considered to be unsafe unless a tolerance or exemption from tolerance
has been established. Foods containing unsafe pesticides are deemed to
be adulterated. Residue tolerances for pesticides are established by
EPA under the FFDCA; the Food and Drug Administration (FDA) enforces
the tolerances set by EPA.
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 Northrup King's corn line Bt11 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 30th day of August 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-22129 Filed 9-6-95; 8:45 am]
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