[Federal Register Volume 62, Number 35 (Friday, February 21, 1997)]
[Notices]
[Pages 7996-7997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4308]


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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 97-006-1]


Calgene, Inc.; 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 Calgene, Inc., seeking 
a determination of nonregulated status for cotton lines designated as 
BXN with Bt cotton lines derived from transformation events 
31807 and 31808 that have been genetically engineered for tolerance to 
the herbicide bromoxynil and for resistance to lepidopteran insect 
pests. 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 April 22, 1997.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 97-006-1, 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. 97-006-1. 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. James White, 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. 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 January 13, 1997, APHIS received a petition (APHIS Petition No. 
97-013-01p) from Calgene, Inc., (Calgene) of Davis, CA, requesting a 
determination of nonregulated status under 7 CFR part 340 for 
bromoxynil-tolerant and lepidopteran insect-resistant cotton lines 
designated as BXN with BT derived from transformation events 
31807 and 31808 (events 31807 and 31808). The Calgene petition states 
that the subject cotton lines should not be regulated by APHIS because 
they do not present a plant pest risk.
    As described in the petition, events 31807 and 31808 have been 
genetically engineered to express a nitrilase enzyme isolated from 
Klebsiella pneumoniae subsp. ozaenae which degrades the herbicide 
bromoxynil, and a CryIA(c) insect control protein originally derived 
from Bacillus thuringiensis subsp. kurstaki HD-73 (Bt). The subject 
cotton lines also contain the nptII gene which

[[Page 7997]]

codes for the enzyme neomycin phosphotransferase and has been used as a 
selectable marker in the development of the transgenic cotton plants. 
Expression of the introduced genes is controlled in part by noncoding 
DNA sequences derived from the plant pathogens Agrobacterium 
tumefaciens and cauliflower mosaic virus. The Agrobacterium 
transformation system was used to transfer the added genes into the 
Gossypium hirsutum (var. Coker 130) parental plants.
    The subject cotton lines are currently considered regulated 
articles under the regulations in 7 CFR part 340 because they contain 
gene sequences derived from plant pathogenic sources. Events 31807 and 
31808 have been evaluated in field trials conducted since 1994 under 
APHIS notifications. In the process of reviewing the notifications for 
field trials of these cotton lines, 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 and herbicides, be 
registered prior to distribution or sale, unless exempt by EPA 
regulation. Accordingly, the plant pesticide active ingredient Bt 
CryIA(c) delta-endotoxin will be regulated by EPA under an existing 
registration. In cases in which the genetically modified plant allows 
for a new or different use pattern for an herbicide, the EPA must 
approve the new or different use. 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 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. 
Calgene has entered into the consultative process with the FDA on the 
subject cotton lines.
    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 Calgene's BXN with Bt 
cotton lines derived from transformation events 31807 and 31808 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 14th day of February 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-4308 Filed 2-20-97; 8:45 am]
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