Calgene, Inc.; Receipt of Petition for Determination of Nonregulated Status of Genetically Engineered Canola

SUMMARY: We are advising the public that the Animal and Plant Health

Inspection Service (APHIS) has received a petition from Calgene, Inc.,

seeking a determination of nonregulated status for its Laurate canola

(Brassica napus). In accordance with our regulations, we are soliciting

public comments on whether such canola presents a plant pest risk. This

action is necessary to enable interested persons to advise APHIS on any

plant pest issues raised by this petition.

DATES: Written comments must be received on or before August 15, 1994.

ADDRESSES: Please send an original and three copies of your comments to

Chief, Regulatory Analysis and Development, PPD, APHIS, USDA, room 804,

Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782. Please

state that your comments refer to Docket No. 94-052-1. A copy of the

Calgene 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 this room are asked to call

in advance of visiting at (202) 690-2817. To obtain a copy of the

Calgene petition, contact Ms. Kay Peterson at (301) 436-7601.

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.

SUPPLEMENTARY INFORMATION: On March 31, 1994, the Animal and Plant

Health Inspection Service (APHIS) received a ``Petition for

Determination of Nonregulated Status under 7 CFR part 340'' from

Calgene, Inc. (Calgene), of Davis, CA. The Calgene petition seeks a

determination that its Laurate canola (Brassica napus) is not a

``regulated article'' under regulations at 7 CFR part 340 (the

regulations).

The Calgene petition states that Laurate canola should not be

regulated by APHIS because it does not present a plant pest risk.

Laurate canola has been defined by Calgene as any Brassica napus

cultivar or progeny of a B. napus line containing the 12:0 ACP

thioesterase gene from California bay (Umbellularia californica) (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. The bay TE

gene is controlled by a seed specific, napin promoter from Brassica

rapa. Laurate canola may also contain the kanr gene with its

associated 35S promoter and tml 3' terminator, the ori pRi, the left T-

DNA border and right T-DNA border, a Tn5 transposon segment, and a Lac

Z' polylinker sequence. Laurate canola has been field tested since 1992

in 16 field trials under 5 permits granted by APHIS.

Calgene states that laurate (lauric acid) is a major component of

consumer products such as laundry detergent and shampoo, and that

edible uses of high laurate oils include nondairy coffee whitener and

whipped toppings. Current sources of laurate are coconut and palm

kernel oils.

Laurate canola is currently considered a regulated article under

the regulations because it contains gene sequences (vectors, promoters,

and terminators) derived from plant pathogenic sources. In the process

of reviewing applications for field trials with Laurate canola, APHIS

determined that the vectors and other elements were disarmed and that

the trials did not present a risk of plant pest introduction or

dissemination.

In the Federal Plant Pest Act (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.

Food or animal feed uses of Laurate canola may be subject to

regulation by the Food and Drug Administration (FDA) under the

authority of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 201 et

seq.). FDA's policy statement concerning regulation of plants derived

from new plant varieties was published in the Federal Register on May

29, 1992 (57 FR 22984-23005).

Under Sec. 340.6 of the regulations, any person may submit a

petition to seek a determination that a particular regulated article

should not be regulated by APHIS. In accordance with the regulations,

this notice establishes that comments on the petition will be accepted

for a period of 60 days from the date of this notice. After reviewing

the data submitted by the petitioner, written comments received during

the comment period, and other relevant information, APHIS will prepare

a decision document on the regulatory status of Laurate canola.

Authority: 7 U.S.C. 150aa-150jj, 151-167, 1622n; 31 U.S.C. 9701;

7 CFR 2.17, 2.51, and 371.2(c).

Done in Washington, DC, this 8th day of June 1994.

Bobby R. Acord,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 94-14413 Filed 6-13-94; 8:45 am]

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