[Federal Register Volume 62, Number 40 (Friday, February 28, 1997)]
[Notices]
[Pages 9155-9156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5023]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 96-098-1]
Dupont Agricultural Products; Receipt of Petition for
Determination of Nonregulated Status for Genetically Engineered
Soybeans
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from Dupont Agricultural
Products seeking a determination of nonregulated status for soybeans
designated as sublines G94-1, G94-19, and G168 derived from
transformation event 260-05 that have been genetically engineered to
produce high oleic acid oil. 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 soybean
sublines present a plant pest risk.
DATES: Written comments must be received on or before April 29, 1997.
ADDRESSES: Please send an original and three copies of your comments to
[[Page 9156]]
Docket No. 96-098-1, 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. 96-098-1. 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 4:30p.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. Ved Malik, 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: mkpeterson@aphis.usda.gov.
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 8, 1997, APHIS received a petition (APHIS Petition No.
97-008-01p) from Dupont Agricultural Products (Dupont) of Wilmington,
DE, requesting a determination of nonregulated status under 7 CFR part
340 for high oleic acid soybean sublines G94-1, G94-19, and G168
(sublines G94-1, G94-19, and G168) derived from transformation event
260-05. The Dupont petition states that the subject soybean sublines
should not be regulated by APHIS because they do not present a plant
pest risk.
As described in the petition, sublines G94-1, G94-19, and G168 have
been genetically engineered to contain the GmFad 2-1 gene, which causes
a coordinate silencing of itself and the endogenous GmFad 2-1 gene.
Suppression of the GmFad 2-1 gene in developing soybeans prevents the
addition of a second double bond to oleic acid, resulting in a greatly
increased oleic acid content only in the seed. The resulting oil
contains an abundance of monosaturated oleic acid (82-85%), a reduced
concentration of polysaturated fatty acids, and lower palmitic acid
content. While the subject soybean sublines also contain the GUS and
Amp marker genes, tests indicate that these genes are not expressed in
the transgenic soybean plants. The added genes were introduced into
meristems of the elite soybean line A2396 by the particle bombardment
method, and their expression is controlled in part by gene sequences
derived from the plant pathogens Agrobacterium tumefaciens and
cauliflower mosaic virus.
Dupont's soybean sublines G94-1, G94-19, and G168 are currently
considered regulated articles under the regulations in 7 CFR part 340
because they contain gene sequences derived from plant pathogenic
sources. The subject soybean sublines have been evaluated in field
trials conducted since 1995 under APHIS notifications. In the process
of reviewing these notifications for field trials, 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 Food and Drug Administration (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 FDA statement of
policy includes a discussion of the FDA's authority for ensuring food
safety under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 201 et
seq.), 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. Dupont has begun the consultative
process with FDA on the subject soybean sublines.
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 Dupont's high oleic acid soybean
sublines G94-1, G94-19, and G168 derived from transformation event 260-
05 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 24th day of February 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-5023 Filed 2-27-97; 8:45 am]
BILLING CODE 3410-34-P
