[Federal Register Volume 60, Number 207 (Thursday, October 26, 1995)]
[Notices]
[Pages 54839-54840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26616]



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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 95-075-1]


Dupont Agricultural Products; Receipt of Petition for 
Determination of Nonregulated Status for Cotton Genetically Engineered 
for Tolerance to Sulfonylurea Herbicides

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 Dupont Agricultural 
Products seeking a determination of nonregulated status for a cotton 
line designated as 19-51a that has been genetically engineered for 
tolerance to sulfonylurea herbicides. 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 cotton line presents a plant pest risk.

DATES: Written comments must be received on or before December 26, 
1995.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 95-075-1, 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. 95-075-1. 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. Sivramiah Shantharam, Team Leader, 
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 determination of nonregulated status must take and 
the information that must be included in the petition.
    On September 13, 1995, APHIS received a petition (APHIS Petition 
No. 95-256-01p) from Dupont Agricultural Products (Dupont) of 
Wilmington, DE, requesting a determination of nonregulated status under 
7 CFR part 340 for a sulfonylurea-tolerant cotton line designated as 
19-51a. The Dupont petition states that the subject cotton line should 
not be regulated by APHIS because it does not present a plant pest 
risk.
    As described in the petition, cotton line 19-51a has been 
genetically engineered with a gene from tobacco which encodes an 
altered acetolactate synthase enzyme that enhances tolerance to 
sulfonylurea herbicides. The subject cotton line was developed through 
the use of the Agrobacterium tumefaciens transformation system.
    Dupont's cotton line 19-51a is currently considered a regulated 
article under the regulations in 7 CFR part 340 because it contains 
gene sequences derived from the plant pathogen A. 

[[Page 54840]]
tumefaciens. The subject cotton 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 
cotton, 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 cotton 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 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 Dupont's cotton line 19-51a 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 20th day of October 1995.
Lonnie J. King,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-26616 Filed 10-25-95; 8:45 am]
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