[Federal Register Volume 69, Number 191 (Monday, October 4, 2004)]
[Notices]
[Pages 59181-59182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E4-2471]
[[Page 59181]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-076-1]
Monsanto Co.; Availability of Petition and Environmental
Assessment for Determination of Nonregulated Status for Cotton
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
seeking a determination of nonregulated status for cotton designated as
MON 88913, 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 cotton
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
3, 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. 04-076-1,
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. 04-076-1.
E-mail: Address your comment to
[email protected]. Your comment must be contained in the body
of your message; do not send attached files.
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. Michael Blanchette, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-5141. To obtain copies of the petition or the
environmental assessment, contact Ms. Terry Hampton at (301) 734-5715;
e-mail: [email protected]. The petition and environmental
assessment are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/04_08601p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/04_08601p_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 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 March 26, 2004, APHIS received a petition from Monsanto Company
of St. Louis, MO, (Monsanto), requesting a determination of
nonregulated status under 7 CFR part 340 for cotton (Gossypium hirsutum
L.) designated as MON 88913, which has been genetically engineered for
tolerance to the herbicide glyphosate. The Monsanto petition states
that the subject cotton should not be regulated by APHIS because it
does not present a plant pest risk.
As described in the petition, MON 88913 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 gene sequences derived from the plant pathogens
figwort mosaic virus and cauliflower mosaic virus. The Agrobacterium
tumefaciens transformation method was used to transfer the added genes
into the recipient upland cotton variety Coker 312.
MON 88913 cotton 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 cotton, 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, Monsanto has submitted glyphosate
residue data and proposed labeling to EPA for the
[[Page 59182]]
expanded use of Roundup UltraMAX([reg]) herbicide on MON 88913.
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 previously
established an exemption from the requirement for a tolerance for the
CP4 EPSPS protein in or on all raw agricultural commodities.
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 has begun consultation with FDA on the food and feed safety
and nutritional assessment of the subject cotton.
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 Monsanto's
88913 cotton, 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 cotton. 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 Monsanto's glyphosate-tolerant MON 88913 cotton
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 28th day of September 2004.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E4-2471 Filed 10-1-04; 8:45 am]
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