[Federal Register Volume 59, Number 113 (Tuesday, June 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14413]
[[Page Unknown]]
[Federal Register: June 14, 1994]
VOL. 59, NO. 113
Tuesday, June 14, 1994
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 94-052-1]
Calgene, Inc.; Receipt of Petition for Determination of
Nonregulated Status of Genetically Engineered Canola
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 (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]
BILLING CODE 3410-34-P
