glufosinate-ammonium (Rely, Finale) Receipt of Petition 2/98
[Federal Register: February 6, 1998 (Volume 63, Number 25)]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 97-130-1]
AgrEvo USA Co.; Receipt of Petition for Determination of
Nonregulated Status for Sugar Beet Genetically Engineered for
Glufosinate Herbicide Tolerance
AGENCY: Animal and Plant Health Inspection Service, USDA.
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from AgrEvo USA Company
seeking a determination of nonregulated status for sugar beet
designated as Transformation Event T120-7, which has been genetically
engineered for tolerance to the herbicide glufosinate. 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 this sugar beet presents a plant pest risk.
DATES: Written comments must be received on or before April 7, 1998.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 97-130-1, 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. 97-130-1. 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. Ved Malik, Biotechnology and
Biological Analysis, 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) 734-4885; e-mail:
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 December 2, 1997, APHIS received a petition (APHIS Petition No.
97-336-01p) from AgrEvo USA Company (AgrEvo) of Wilmington, DE,
requesting a determination of nonregulated status under 7 CFR part 340
for sugar beet (Beta vulgaris L.) designated as Transformation Event
T120-7 (event T120-7), which has been genetically engineered for
tolerance to the herbicide glufosinate. The AgrEvo petition states that
the subject sugar beet should not be regulated by APHIS because it does
not present a plant pest risk.
As described in the petition, event T120-7 sugar beet has been
genetically engineered to contain a synthetic version of the pat gene
derived from Streptomyces viridochromogenes. The pat gene encodes the
enzyme phosphinothricin acetyltransferase (PAT), which confers
tolerance to the herbicide glufosinate. Expression of the pat gene is
controlled by 35S promoter and terminator sequences derived from the
plant pathogen cauliflower mosaic virus. Event T120-7 sugar beet also
contains the aph(3')II or nptII marker gene used in plant
transformation. Expression of the nptII gene is controlled by gene
sequences derived from the plant pathogen Agrobacterium tumefaciens,
and analysis indicates that the NPTII protein is expressed in certain
parts of the subject plants. The A. tumefaciens method was used to
transfer the added genes into the parental sugar beet line.
Event T120-7 sugar beet has been considered a regulated article
under the regulations in 7 CFR part 340 because it contains gene
sequences from plant pathogens. The subject sugar beet has been field
tested in the U.S. since 1994 under APHIS permits. In the process of
reviewing the permit applications for field trials of this sugar beet,
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,
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 genetically modified plants allow
for a new use of an herbicide or involve a different use pattern for
the herbicide, EPA must approve the new or different use. Accordingly,
a submission has been made to EPA for registration of the herbicide
glufosinate for use on sugar beet. 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 EPA under the Federal
Food, Drug and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 et
seq.), and the Food and Drug Administration (FDA) enforces tolerances
set by EPA under the FFDCA.
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 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. AgrEvo
has begun consultation with FDA on the subject sugar beet.
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 AgrEvo's event T120-7 sugar beet
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 2nd day of February 1998.
Craig A. Reed,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-3048 Filed 2-5-98; 8:45 am]
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