Monsanto Co.; Availability of Petition and Environmental
Assessment for Determination of Nonregulated Status for Cotton
Genetically Engineered for Insect Resistance
[Federal Register: March 18, 2002 (Volume 67, Number 52)]
[Notices]
[Page 11973-11974]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18mr02-35]
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Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 01-025-1]
Monsanto Co.; Availability of Petition and Environmental
Assessment for Determination of Nonregulated Status for Cotton
Genetically Engineered for Insect Resistance
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
Event 15985, which has been genetically engineered for insect
resistance. 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
event 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 that are postmarked,
delivered, or e-mailed by May 17, 2002.
ADDRESSES: You may submit comments by postal mail/commercial delivery
or by e-mail. If you use postal mail/commercial delivery, please send
four copies of your comments (an original and three copies) to Docket
No. 01-025-1, Regulatory Analysis and Development, PPD, APHIS, Suite
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comments refer to Docket No. 01-025-1. If you use 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.
01-025-1'' on the subject line.
You may read the petition, the environmental assessment, and any
comments we receive on this notice of availability in our reading room.
The reading room is located in room 1141, 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 that someone is available to help you, please call
(202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. David Heron, Plant Protection and
Quarantine, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-5141. To obtain a copy of the petition or the
environmental assessment, contact Ms. Kay Peterson at (301) 734-4885;
e-mail: Kay.Peterson@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 a determination of nonregulated status must take
and the information that must be included in the petition.
On December 7, 2000, APHIS received a petition (APHIS Petition No.
00-342-01p) from Monsanto Company (Monsanto) of St. Louis, MO,
requesting a determination of nonregulated status under 7 CFR part 340
for cotton (Gossypium hirsutum L.) designated as Bollgard II
CottonEvent 15985 (event 15985), which has been genetically engineered
for resistance to certain lepidopteran insect pests. The Monsanto
petition states that the subject cotton event should not be regulated
by APHIS because it does not present a plant pest risk.
As described in the petition, cotton event 15985 has been
genetically engineered to express a Cry2Ab insecticidal protein derived
from the common soil bacterium Bacillus thuringiensis subsp. kurstaki
(Btk). The petitioner states that the Cry2Ab protein is effective in
providing protection from the feeding of lepidopteran insect pests such
as tobacco budworm, pink bollworm, and cotton bollworm. The subject
cotton event also expresses the -D-glucuronidase (GUS) protein
used as a selectable marker. Expression of the added genes is
controlled in part by gene sequences from the plant pathogens
cauliflower mosaic virus and Agrobacterium tumefaciens. Particle
acceleration technology was used to transfer the added genes into the
recipient Delta and Pine Land Company variety 50B (DP50B). Cotton
cultivar DP50B expresses a Btk Cry1Ac insecticidal protein and a NTPII
selectable marker protein, and was developed from cotton event 531,
which was deregulated by APHIS in 1995 (APHIS No. 94-308-01p).
Cotton event 15985 has been considered a regulated article under
the regulations in 7 CFR part 340 because it contains gene sequences
from plant pathogens. This cotton event has been field tested since
1998 in the United States under APHIS notifications. 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 containment or isolation, would not present a risk of
plant pest introduction or dissemination.
[[Page 11974]]
In section 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 a request to
EPA for registration of Cry2Ab as a plant-incorporated protectant.
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. In response to the
filing of Monsanto's pesticide petition, EPA has established a
regulation for an exemption from the requirement of a tolerance for
residues of Btk Cry2Ab and the genetic material necessary for its
production 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. The
petitioner has begun consultation with FDA on the subject cotton 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 Monsanto's
cotton event 15985, an environmental assessment 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 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 environmental assessment prepared to examine any environmental
impacts of the proposed determination for the subject cotton event
15985. The petition and the environmental assessment and any comments
received are available for public review, and copies of the petition
and the environmental assessment may be ordered (see 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 environmental
assessment 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
insect-resistant cotton event 15985 and the availability of APHIS'
written decision.
Authority: 7 U.S.C. 166, 1622n, 7756, and 7761-7772; 31 U.S.C.
9701; 7 CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 12th day of March 2002.
W. Ron DeHaven,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-6458 Filed 3-15-02; 8:45 am]
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