[Federal Register Volume 67, Number 50 (Thursday, March 14, 2002)]
[Notices]
[Pages 11458-11459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6135]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 00-078-1]


Monsanto Co.; Availability of Petition and Environmental 
Assessment for Determination of Nonregulated Status for Corn 
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 corn designated as 
Event MON 863, 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 corn 
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 13, 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. 00-078-l, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comments refer to Docket No. 00-078-1. 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. 00-
078-1 on the subject line.
    You may read a copy of the petition for a determination of 
nonregulated status submitted by Monsanto Company, 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.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, PPQ, APHIS, Suite 
5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-
8365. 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 May 17, 2001, APHIS received a petition (APHIS Petition No. 01-
137-01p) from Monsanto Company (Monsanto) of St. Louis, MO, requesting 
a determination of nonregulated status under 7 CFR part 340 for corn 
(Zea mays L.) designated as Corn Rootworm Protected Corn Event MON 863 
(MON 863), which has been genetically engineered for resistance to the 
larvae of certain corn rootworm (CRW) species. The Monsanto petition 
states that the

[[Page 11459]]

subject corn should not be regulated by APHIS because it does not 
present a plant pest risk.
    As described in the petition, MON 863 corn has been genetically 
engineered to express a Cry3Bb1 insecticidal protein derived from the 
common soil bacterium Bacillus thuringiensis subsp. kumamotoensis (Bt 
kumamotoensis). The petitioner states that the Cry3Bb1 protein is 
effective in controlling the larvae of CRW pests (Coleoptera, 
Diabrotica spp.). The subject corn also contains the nptII marker gene 
derived from the bacterium Escherichia coli. The nptII gene encodes 
neomycin phosphotransferase type II and is used as a selectable marker 
in the initial laboratory stages of plant cell selection. Expression of 
the added genes is controlled in part by gene sequences from the plant 
pathogens cauliflower mosaic virus and Agrobacterium tumefaciens. 
Particle gun acceleration technology was used to transfer the added 
genes into the recipient inbred yellow dent corn line A634.
    MON 863 corn has been considered a regulated article under the 
regulations in 7 CFR part 340 because it contains gene sequences from 
plant pathogens. This corn 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 corn, 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 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 filed an application to 
register the active ingredient B. thuringiensis Cry3Bb protein and the 
genetic material necessary for its production in corn (66 FR 15435-
1536, March 19, 2001). 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 established an exemption from the requirement of a tolerance 
for residues of the B. thuringiensis Cry3Bb1 protein and the genetic 
material necessary for its production in or on all raw agricultural 
commodities (66 FR 24061-24066, May 11, 2001).
    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 completed consultation with FDA on the subject corn.
    In accordance with the regulations in 7 CFR 340.6(d), 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. We are also soliciting written comments 
from interested persons on the environmental assessment (EA) prepared 
to provide the public with documentation of APHIS' review and analysis 
of any potential environmental impacts and plant pest risk associated 
with a proposed determination of nonregulated status for MON 863 corn. 
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). The petition and the EA, and 
any comments received on these documents, are available for public 
review, and copies of the petition and the EA 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 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 insect-resistant MON 863 corn 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 7th day of March 2002.
W. Ron DeHaven,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-6135 Filed 3-13-02; 8:45 am]
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