[Federal Register: October 19, 2004 (Volume 69, Number 201)]
[Notices]
[Page 61466-61467]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19oc04-15]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-075-1]
Monsanto Co. and KWS SAAT AG; Availability of Petition and
Environmental Assessment for Determination of Nonregulated Status for
Sugar Beet Genetically Engineered for Tolerance to the Herbicide
Glyphosate
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 Monsanto Company and
KWS SAAT AG seeking a determination of nonregulated status for sugar
beet designated as event H7-1, which has been genetically engineered
for tolerance to the herbicide glyphosate. 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. We are also
making available for public comment an environmental assessment for the
proposed determination of nonregulated status.
DATES: We will consider all comments we receive on or before December
20, 2004.
ADDRESSES: You may submit comments by any of the following methods:
Postal Mail/Commercial Delivery: Please send four copies of your
comment (an original and three copies) to Docket No. 04-075-1,
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. 04-075-1.
E-mail: Address your comment to regulations@aphis.usda.gov. Your
comment must be contained in the body of your message; do not send
attached files. Please include your name and address in your message
and ``Docket No. 04-075-1'' on the subject line.
Agency Web site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html
for a form you can use to submit an e-mail comment through
the APHIS Web site.
Federal eRulemaking Portal: Go to http://www.regulations.gov and
follow the instructions for locating this docket and submitting
comments.
Reading Room: You may read the petition, the environmental
assessment, and any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
Other Information: You may view APHIS documents published in the
Federal Register and related information, including the names of groups
and individuals who have commented on APHIS dockets, on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Mr. John Cordts, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-5531. To obtain copies of the petition or the
environmental assessment (EA), contact Ms. Terry Hampton at (301) 734-
5715; e-mail: Terry.A.Hampton@aphis.usda.gov. The petition and the EA
are also available on the Internet at: http://www.aphis.usda.gov/brs/aphisdocs/03_32301p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/03_32301p_ea.pdf.
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
[[Page 61467]]
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 a determination of nonregulated status must take and the
information that must be included in the petition.
On November 19, 2003, APHIS received a petition (APHIS Petition
Number 03-323-01p) from Monsanto Company of St. Louis, MO, and KWS SAAT
AG of Einbeck, Germany (Monsanto/KWS), requesting a determination of
nonregulated status under 7 CFR part 340 for sugar beet (Beta vulgaris
ssp. vulgaris) designated as event H7-1, which has been genetically
engineered for tolerance to the herbicide glyphosate. The Monsanto/KWS
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, sugar beet event H7-1 has been genetically engineered to
express a 5-enolpyruvyshikimate-3-phosphate synthase protein from
Agrobacterium sp. strain CP4 (CP4 EPSPS), which confers tolerance to
the herbicide glyphosate. Expression of the added genes is controlled
in part by the 35S promoter derived from the plant pathogen figwort
mosaic virus. The Agrobacterium tumefaciens transformation method was
used to transfer the added genes into the KWS proprietary sugar beet
line 3S0057.
Sugar beet event H7-1 has been considered a regulated article under
the regulations in 7 CFR part 340 because it contains gene sequences
from plant pathogens. In the process of reviewing the notifications for
field trials of the subject 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
confinement or isolation, would not present a risk of plant pest
introduction or dissemination.
In Sec. 403 of the Plant Protection Act (7 U.S.C. 7701-7772),
plant pest is defined as any living stage of any of the following that
can directly or indirectly injure, cause damage to, or cause disease in
any plant or plant product: A protozoan, a nonhuman animal, a parasitic
plant, a bacterium, a fungus, a virus or viroid, an infectious agent or
other pathogen, or any article similar to or allied with any of the
foregoing. 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 genetically modified plants allow for a new use of a pesticide or
involve a different use pattern for the pesticide, EPA must approve the
new or different use. Accordingly, EPA has granted a registration for
the use of glyphosate on glyphosate-tolerant sugar beet.
When the use of the pesticide on the genetically modified plant
would result in an increase in the residues in a food or feed crop for
which the pesticide is currently registered, or in new residues in a
crop for which the pesticide 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. EPA has determined that
the existing residue tolerance for glyphosate-tolerant sugar beet is
sufficient to support future use of glyphosate on event H7-1.
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.
Monsanto/KWS has begun consultation with FDA on the subject sugar beet
event.
To provide the public with documentation of APHIS' review and
analysis of the environmental impacts and plant pest risk associated
with a proposed determination of nonregulated status for the Monsanto/
KWS event H7-1 sugar beet, an environmental assessment (EA) has been
prepared. The EA was prepared in accordance with (1) The National
Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et
seq.), (2) regulations of the Council on Environmental Quality for
implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4)
APHIS' NEPA Implementing Procedures (7 CFR part 372).
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 a determination of
nonregulated status from interested persons for a period of 60 days
from the date of this notice. We are also soliciting written comments
from interested persons on the EA prepared to examine any environmental
impacts of the proposed determination for the subject sugar beet event.
The petition and the EA and any comments received are available for
public review, and copies of the petition and the EA are available as
indicated in the FOR FURTHER INFORMATION CONTACT 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. After reviewing and
evaluating the comments on the petition and the EA and other data and
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 Monsanto/KWS glyphosate-tolerant sugar beet
event H7-1 and the availability of APHIS' written decision.
Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.3.
Done in Washington, DC, this 14th day of October 2004.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E4-2710 Filed 10-18-04; 8:45 am]
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