[Federal Register Volume 59, Number 213 (Friday, November 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27405]


[[Page Unknown]]

[Federal Register: November 4, 1994]


      
                                                   VOL. 59, NO. 213

                                           Friday, November 4, 1994

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 94-052-2]

 

Availability of Determination of Nonregulated Status for 
Genetically Engineered Canola

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that certain 
Laurate canola lines are no longer considered regulated articles under 
our regulations governing the introduction of certain genetically 
engineered organisms. Our determination is based on our evaluation of 
data submitted by Calgene, Inc., in its petition for a determination of 
nonregulated status, an analysis of other scientific data, and our 
review of comments received from the public in response to a June 1994 
notice announcing our receipt of the Calgene petition. This notice also 
announces the availability of our written determination document and 
its associated environmental assessment and finding of no significant 
impact.

EFFECTIVE DATE: October 31, 1994.

ADDRESSES: The determination, an environmental assessment and finding 
of no significant impact, the petition, and all written comments 
received regarding the petition 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 to inspect those documents are asked to call 
in advance of visiting at (202) 690-2817.

FOR FURTHER INFORMATION CONTACT: Dr. Sivramiah Shantharam, Chief, 
Microorganisms Branch, Biotechnology Permits, BBEP, APHIS, USDA, room 
850, Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782, (301) 
436-7612. To obtain a copy of the determination or the environmental 
assessment and finding of no significant impact, contact Ms. Kay 
Peterson at (301) 436-7601.

SUPPLEMENTARY INFORMATION:

Background

    On March 31, 1994, the Animal and Plant Health Inspection Service 
(APHIS) received a petition from Calgene, Inc., of Davis, CA, seeking a 
determination that certain Laurate canola lines and their progeny do 
not present a plant pest risk and, therefore, are not regulated 
articles under APHIS' regulations in 7 CFR part 340.
    On June 14, 1994, APHIS published a notice in the Federal Register 
(59 FR 30569, Docket No. 94-052-1) announcing the receipt of the 
Calgene petition and stating that the petition was available for public 
review. The notice also discussed the role of APHIS and the Food and 
Drug Administration in regulating the Laurate canola lines and food 
products derived from them. In the notice, APHIS solicited written 
comments from the public as to whether the Laurate canola lines posed a 
plant pest risk. The comments were to have been received by APHIS on or 
before August 15, 1994.
    APHIS received a total of 17 comments on the Calgene petition. The 
comments were submitted by farmers, associations, universities, a farm 
cooperative, State officials, a seed company, and an environmental 
organization. Most of the comments were in favor of the petition; none 
were critical of this particular petition. APHIS has provided a 
discussion of the comments in the determination document, which is 
available upon request from the individual listed under FOR FURTHER 
INFORMATION CONTACT.

Analysis

    Laurate canola has been described by Calgene as any Brassica napus 
cultivar or its progeny containing the 12:0 ACP thioesterase (TE) gene 
from California bay (Umbellularia californica) (referred to below as 
the bay TE gene) with its associated napin promoter and napin 
terminator regions. The bay TE gene encodes the 12:0 ACP thioesterase 
enzyme. Activity of the bay TE enzyme results in the accumulation of 
the 12-carbon saturated fatty acid, laurate, in the canola seed. 
Laurate canola may also contain a kanamycin resistance (nptII) gene, 
35S promoter from cauliflower mosaic virus, tml 3' terminator, ori 
(origin of replication) pRi from Agrobacterium rhizogenes, a segment of 
the transposable element Tn5, right and left T-DNA border sequences 
from Agrobacterium tumefaciens, and a Lac Z' polylinker sequence. The 
bay TE gene is expressed only in the seed by a seed-specific napin 
promoter from Brassica rapa.
    The Laurate canola lines have been considered ``regulated 
articles'' under APHIS' regulations in 7 CFR part 340 because their 
noncoding regulatory sequences were derived from the plant pathogens A. 
tumefaciens and cauliflower mosaic virus. However, 22 field tests of 
the Laurate canola lines have been conducted at approximately 21 sites 
in California, Georgia, and Michigan under permits issued by APHIS, and 
the field reports from those tests indicate that there were no 
deleterious effects on plants, nontarget organisms, or the environment 
as a result of the Laurate canola lines' release into the environment.

Determination

    Based on its analysis of the data submitted by Calgene, a review of 
other scientific data, the comments received from the public, and a 
review of field tests of the original transformant lines pCGN3828-212/
86-18 and pCGN3828-212/86-23 and other lines derived from those two 
transformants, APHIS has determined that the subject Laurate canola 
lines: (1) Exhibit no plant pathogenic properties; (2) are no more 
likely to become weeds than their nonengineered parental varieties; (3) 
are unlikely to increase the weediness potential of any other 
cultivated plant or native wild species with which the organisms can 
interbreed; (4) will not cause damage to processed agricultural 
commodities; and (5) are unlikely to harm other organisms, such as bees 
or earthworms, that are beneficial to agriculture. APHIS has also 
concluded that there is a reasonable certainty that new progeny 
varieties bred from the Laurate canola lines pCGN3828-212/86-18 and 
pCGN3828-212/86-23 will not exhibit new plant pest properties, i.e., 
properties substantially different from any observed in the field-
tested Laurate canola lines, or those observed in standard canola in 
traditional breeding programs.
    The effect of this determination is that the two original 
transformant Laurate canola lines designated pCGN3828-212/86-18 and 
pCGN3828-212/86-23, and all other lines bred from those two 
transformants by sexual or asexual reproduction involving Mendelian 
inheritance, are no longer considered regulated articles under APHIS' 
regulations in 7 CFR part 340. Therefore, the permit and notification 
requirements pertaining to regulated articles under those regulations 
no longer apply to the field testing, importation, or interstate 
movement of the subject Laurate canola lines or their progeny. However, 
the importation of the Laurate canola lines and any Laurate canola 
nursery stock or seeds capable of propagation is still subject to the 
restrictions found in APHIS' foreign quarantine notices in 7 CFR part 
319.

National Environmental Policy Act

    An environmental assessment (EA) has been prepared to examine the 
potential environmental impacts associated with this determination. The 
EA was prepared in accordance with: (1) The National Environmental 
Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et seq.), (2) Regulations of 
the Council on Environmental Quality for Implementing the Procedural 
Provisions of NEPA (40 CFR parts 1500-1508), (3) USDA Regulations 
Implementing NEPA (7 CFR part 1b), and (4) APHIS Guidelines 
Implementing NEPA (44 FR 50381-50384, August 28, 1979, and 44 FR 51272-
51274, August 31, 1979). Based on that EA, APHIS has reached a finding 
of no significant impact (FONSI) with regard to its determination that 
the Laurate canola lines designated as pCGN3828-212/86-18 and pCGN3828-
212/86-23, and other lines bred from those two transformants by sexual 
or asexual reproduction involving Mendelian inheritance, are no longer 
regulated articles under its regulations in 7 CFR part 340. Copies of 
the EA and the FONSI are available upon request from the individual 
listed under FOR FURTHER INFORMATION CONTACT.

    Done in Washington, DC, this 31st day of October, 1994.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 94-27405 Filed 11-3-94; 8:45 am]
BILLING CODE 3410-34-P