[Federal Register Volume 62, Number 166 (Wednesday, August 27, 1997)]
[Notices]
[Pages 45387-45388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22760]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 97-067-1]
Bejo Zaden BV; Receipt of Petition for Determination of
Nonregulated Status for Genetically Engineered Radicchio Rosso
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 has received a petition from Bejo Zaden BV seeking a
determination of nonregulated status for Radicchio rosso lines
designated as RM3-3, RM3-4, and RM3-6, which have been genetically
engineered for male sterility and tolerance to the herbicide
glufosinate as a marker. 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
Radicchio rosso lines present a plant pest risk.
DATES: Written comments must be received on or before October 27, 1997.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 97-067-1, 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. 97-067-1. 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 4:30 p.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
to facilitate entry into the reading room.
FOR FURTHER INFORMATION CONTACT: Dr. Subhash Gupta, Biotechnology
Evaluation, BSS, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147,
Riverdale, MD 20737-1236; (301) 734-8761. To obtain a copy of the
petition, contact Ms. Kay Peterson at (301) 734-4885; e-mail:
[email protected].
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 May 28, 1997, APHIS received a petition (APHIS Petition No. 97-
148-01p) from Bejo Zaden BV (Bejo) of Warmenhuizen, The Netherlands,
requesting a determination of nonregulated status under 7 CFR part 340
for male sterile, glufosinate-tolerant Radicchio rosso (red-hearted
chicory) lines designated as RM3-3, RM3-4, and RM3-6. The Bejo petition
states that the subject Radicchio rosso lines should not be regulated
by APHIS because they do not present a plant pest risk.
As described in the petition, Radicchio rosso (Cichorium intybus
L.) lines RM3-3, RM3-4, and RM3-6, have been genetically engineered
with a barnase gene from Bacillus amyloliquefaciens encoding a
ribonuclease which inhibits pollen
[[Page 45388]]
formation and results in male sterility of the transformed plants. The
subject Radicchio rosso lines also contain the nptII selectable marker
gene and the bar gene isolated from the bacterium Streptomyces
hygroscopicus. The bar gene encodes a phosphinothricin
acetyltransferase (PAT) enzyme, which, when introduced into a plant
cell, inactivates glufosinate. Linkage of the barnase gene, which
induces male sterility, with the bar gene, a glufosinate tolerance gene
used as a marker, enables identification of the male sterile line for
use in the production of pure hybrid seed. The subject Radicchio rosso
lines were transformed by the Agrobacterium tumefaciens method, and
expression of the introduced genes is controlled in part by gene
sequences derived from the plant pathogen A. tumefaciens.
Radicchio rosso lines RM3-3, RM3-4, and RM3-6 are currently
considered regulated articles under the regulations in 7 CFR part 340
because they contain gene sequences derived from the plant pathogen A.
tumefaciens. The subject Radicchio rosso lines have been evaluated in
field trials conducted since 1993 in Europe, and since 1995 in the
United States. In the process of reviewing the permit applications for
the U.S. field trials of these Radicchio rosso lines, APHIS determined
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 U.S. Environmental Protection Agency (EPA) is responsible for
the regulation of pesticides under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA
requires that all pesticides, including herbicides, be registered prior
to distribution or sale, unless exempt by EPA regulation. In cases in
which the genetically modified plants allow for a new use of an
herbicide or involve a different use pattern for the herbicide, the EPA
must approve the new or different use. In conducting such an approval,
the EPA considers the possibility of adverse effects to human health
and the environment from the use of this herbicide. When the use of the
herbicide on the genetically modified plant would result in an increase
in the residues of the herbicide in a food or feed crop for which the
herbicide is currently registered, or in new residues in a crop for
which the herbicide is not currently registered, establishment of a new
tolerance or a revision of the existing tolerance would be required.
Residue tolerances for pesticides are established by the EPA under the
Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 301 et seq.),
and the Food and Drug Administration (FDA) enforces tolerances set by
the EPA under the FFDCA.
The 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 FFDCA, 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.
Bejo has begun consultation with FDA on the subject Radicchio rosso
lines.
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 the Bejo Zaden BV Radicchio rosso
lines RM3-3, RM3-4, and RM3-6 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 2.17, 2.51, and 371.2(c).
Done in Washington, DC, this 21st day of August 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-22760 Filed 8-26-97; 8:45 am]
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