[Federal Register Volume 60, Number 61 (Thursday, March 30, 1995)]
[Notices]
[Pages 16428-16430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7835]



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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 95-023-1]


Receipt of Petition for Determination of Nonregulated Status for 
Genetically Engineered Cotton

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 Monsanto Company 
seeking a determination of nonregulated status for cotton lines 
designated as 1445 and 1698 that have been genetically engineered for 
tolerance to [[Page 16429]] 
the herbicide glyphosate. 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 these cotton 
lines present a plant pest risk.

DATES: Written comments must be received on or before May 30, 1995.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 95-023-1, Regulatory Analysis and Development, PPD, APHIS, 
Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1228. Please 
state that your comments refer to Docket No. 95-023-1. 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, Branch 
Chief, Biotechnology Permits, BBEP, APHIS, Suite 5B05, 4700 River Road 
Unit 147, Riverdale, MD 20737-1228; (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 February 14, 1995, APHIS received a petition (APHIS Petition No. 
95-045-01p) from the Monsanto Company of St. Louis, MO, requesting a 
determination of nonregulated status under 7 CFR part 340 for cotton 
lines designated as 1445 and 1698 that have been genetically engineered 
for tolerance to the herbicide glyphosate. As described in the 
petition, cotton (Gossypium hirsutum L.) lines 1445 and 1698 contain 
the gene for CP4 EPSPS (5-enolpyruvylshikimate-3-phosphate synthase) 
isolated from Agrobacterium sp. strain CP4, which encodes an enzyme 
conferring tolerance to glyphosate, the active ingredient in 
Roundup<Register> herbicide. Cotton lines 1445 and 1698 also contain 
the nptII gene, which encodes the selectable marker neomycin 
phosphotransferase II, and the aad gene, which encodes the bacterial 
selectable marker 3''(9)-O-aminoglycoside adenylyltransferase. 
Expression of the nptII gene is driven by the 35S promoter derived from 
the plant pathogen cauliflower mosaic virus. The subject cotton lines 
were produced through the use of Agrobacterium tumefaciens 
transformation, a full description of which is provided in the 
petition.
    The subject cotton lines are currently considered regulated 
articles under the regulations in 7 CFR part 340 because they contain 
gene sequences (vectors, vector agents, promoters, and terminators) 
derived from plant pathogens. Cotton lines 1445 and 1698 were evaluated 
in field trials conducted under APHIS permits or notifications in 1992, 
1993, and 1994. In the process of reviewing the applications for those 
field trials, APHIS determined that the vectors were disarmed, and that 
the trials did 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.
    Cotton lines 1445 and 1698 are 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. 135 et seq.). FIFRA requires that all pesticides, including 
herbicides, be registered prior to distribution or sale, unless exempt 
by regulation. Plants that have been genetically modified for tolerance 
or resistance to herbicides are not regulated under 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, EPA must approve the new or different use. In conducting 
such an approval, 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, [[Page 16430]] 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 the Monsanto Company's 
cotton lines 1445 and 1698 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 March 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-7835 Filed 3-29-95; 8:45 am]
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