[Federal Register Volume 67, Number 52 (Monday, March 18, 2002)]
[Notices]
[Pages 11973-11974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6458]


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 Notices
                                                 Federal Register
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 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 
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  Federal Register / Vol. 67, No. 52 / Monday, March 18, 2002 / 
Notices  

[[Page 11973]]



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 [email protected]. 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: [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 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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