[Federal Register Volume 59, Number 35 (Tuesday, February 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-3886]


[[Page Unknown]]

[Federal Register: February 22, 1994]


                                                    VOL. 59, NO. 35

                                         Tuesday, February 22, 1994
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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 93-116-2]

 

Availability of Determination of Nonregulated Status of Calgene, 
Inc., Genetically Engineered Cotton Lines

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of determination.

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SUMMARY: The Animal and Plant Health Inspection Service (APHIS) is 
announcing the issuance of a determination that certain trademarked 
cotton lines, designated BXNTM cotton, do not present a plant pest 
risk and are therefore no longer regulated articles under its 
regulations. APHIS' determination has been made in response to a 
petition received from Calgene, Inc., of Davis, CA, on July 15, 1993, 
seeking a determination from APHIS that BXNTM cotton does not 
present a plant pest risk and is therefore no longer a regulated 
article. The effect of this determination is that cotton lines meeting 
the definition of BXNTM cotton and that have been field tested 
under permit, will no longer be subject to regulation. This notice also 
announces the availability of the determination that provides the basis 
for the ruling, as well as the availability of an environmental 
assessment of this action.

EFFECTIVE DATE: February 15, 1994.

ADDRESSES: The determination, the environmental assessment, the 
Calgene, Inc. submission, and written comments received in response to 
our September 8, 1993, notice published in the Federal Register 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 this 
room are requested to call ahead on (202) 690-2817.

FOR FURTHER INFORMATION CONTACT: Dr. Michael Schechtman, Senior 
Microbiologist, Biotechnology, Biologics, and Environmental Protection, 
APHIS, USDA, room 850 Federal Building, 6505 Belcrest Road, 
Hyattsville, MD 20782, (301) 436-7601. For a copy of the determination 
or the environmental assessment, please write or call Ms. Kay Peterson 
at this same address and telephone number.

SUPPLEMENTARY INFORMATION: On September 8, 1993 (58 FR 47249-47250, 
Docket No. 93-116-1), the Animal and Plant Health Inspection Service 
(APHIS) published a notice announcing receipt of a petition from 
Calgene, Inc. (Calgene) of Davis, CA, that requested a determination on 
the regulatory status of BXNTM cotton. This notice also indicated 
the role of the Food and Drug Administration and the United States 
Environmental Protection Agency in the regulation of food products 
derived from BXNTM cotton and the potential use of the herbicide 
bromoxynil on BXNTM cotton, respectively. This notice further 
announced that the petition was available for public review and invited 
written comments on whether BXNTM cotton poses a plant pest risk, 
to be submitted on or before November 8, 1993.

Comments

    APHIS received a total of 45 comments from State officials, 
universities, farmers associations and cooperative extension services, 
environmental and consumer organizations, and business and professional 
associations. Among these commenters, 34 were in favor of granting the 
petition, 9 were opposed, and 2 others addressed APHIS' decision on the 
petition itself only parenthetically. APHIS has provided a complete 
discussion of the comments and any issues raised by the commenters in 
the determination document, which is available upon request from the 
individual listed under FOR FURTHER INFORMATION CONTACT.
    BXNTM cotton, as defined by its developer (Calgene, Inc., of 
Davis, CA), is any cotton cultivar or progeny of a cotton line 
containing the BXN gene (a gene, derived from the soil microbe 
Klebsiella pneumoniae subsp. ozaenae that encodes the enzyme nitrilase, 
which can degrade the herbicide bromoxynil) with its associated 
regulatory sequences, i.e., sequences that allow for expression of the 
gene's enzyme product. By definition, BXNTM cotton may also 
contain: the kanr marker gene (encoding the enzyme aminoglycoside 
3'-phosphotransferase II, which confers resistance to the antibiotic 
kanamycin) with its associated regulatory sequences; a DNA fragment 
containing the origin of replication of the pRi plasmid from 
Agrobacterium rhizogenes; T-DNA left and right border sequences from an 
Agrobacterium tumefaciens Ti plasmid; a segment of DNA from transposon 
Tn5; a portion of a synthetic polylinker sequence from lacZ'; and a 
segment of DNA containing the origin of replication of plasmid pBR322. 
Expression of the BXNTM gene and the kanr gene is directed by 
copies of the promoter from the 35S gene from cauliflower mosaic virus 
and terminated using sequences derived from the tml gene from the 
octopine-type Ti plasmid pTiA6 from A. tumefaciens.
    BXNTM cotton contains components from organisms that are known 
plant pathogens, i.e., the bacterium Agrobacterium tumefaciens and 
cauliflower mosaic virus. BXNTM cotton has therefore been a 
regulated article under APHIS jurisdiction, and its field tests in 
1989, 1990, 1991, 1992, and 1993 have been in accordance with APHIS 
regulations at 7 CFR part 340. APHIS' determination that BXNTM 
cotton that has been field tested under permit does not present a plant 
pest risk is based on an analysis of data provided to APHIS by Calgene 
and other relevant published scientific data obtained by APHIS 
concerning the components of BXNTM cotton and observable 
properties of the cotton lines themselves. From this review, we have 
determined that these BXNTM cotton lines: (1) Exhibit no plant 
pathogenic properties; (2) are no more likely to become a weed than 
their non-engineered parental varieties; (3) are unlikely to increase 
the weediness potential for any other cultivated plant or native wild 
species with which the organism can interbreed; (4) will not cause 
damage to processed agricultural commodities; and (5) are unlikely to 
harm other organisms, such as bees and earthworms, that are beneficial 
to agriculture. In addition, we have determined that there is a 
reasonable certainty that progeny BXNTM cotton lines bred from 
these lines will not exhibit new plant pest properties, i.e., 
properties substantially different from any observed for the BXNTM 
cotton lines already field tested, or those observed for cotton in 
traditional breeding programs. However, APHIS believes that it is 
prudent to require information to corroborate that new BXNTM 
cotton lines, not derived from BXNTM lines already field tested 
under permit, do not exhibit unexpected qualities.
    Calgene has provided information and data from field testing of 
some of the cotton lines fitting their definition of BXNTM cotton 
and intended to be representative of all those lines. Our 
determination, however, applies only to cotton lines that fit Calgene's 
definition of BXNTM cotton and that have been field tested under 
permit. The effect of this determination is that such cotton lines will 
no longer be considered regulated articles under the APHIS regulations 
at 7 CFR part 340. Permits under those regulations will no longer be 
required from APHIS for field testing, importation, or interstate 
movement of BXNTM cotton lines that have been field tested under 
permit or their progeny. Normal agronomic practices involving these 
BXNTM cotton lines, e.g., cultivation, propagation, movement, and 
cross-breeding with other non-regulated cotton lines, can now be 
conducted without an APHIS permit. (Importation of BXNTM cotton 
(and nursery stock or seeds capable of propagation) is still, however, 
subject to the restrictions found in the Foreign Quarantine Notices 
regulations at 7 CFR part 319.) Variety registration and/or seed 
certification for individual cotton lines carrying the BXNTM gene 
may involve future actions by the U.S. Plant Variety Protection Office 
and State Seed Certification officials.
    The potential environmental impacts associated with this 
determination have been examined in accordance with regulations and 
guidelines implementing the National Environmental Policy Act of 1969 
(42 U.S.C. 4321 et seq.; 40 CFR parts 1500-1508; 7 CFR part 1b; 44 FR 
50381-50384; and 44 FR 51272-51274). An Environmental Assessment (EA) 
was prepared and a Finding of No Significant Impact (FONSI) was reached 
by APHIS for the determination that BXNTM cotton that has been 
field tested under permit is no longer a regulated article under its 
regulations at 7 CFR part 340.

    Done in Washington, DC, this 15th day of February 1994.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 94-3886 Filed 2-18-94; 8:45 am]
BILLING CODE 3410-34-P