[Federal Register Volume 67, Number 205 (Wednesday, October 23, 2002)]
[Notices]
[Pages 65087-65088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26923]


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 Notices
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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 
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  Federal Register / Vol. 67, No. 205 / Wednesday, October 23, 2002 / 
Notices  

[[Page 65087]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 00-078-2]


Monsanto Co.; Availability of 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 of our determination that the 
Monsanto Company corn designated as Event MON 863, which has been 
genetically engineered for insect resistance, is no longer considered a 
regulated article under our regulations governing the introduction of 
certain genetically engineered organisms and products. Our 
determination is based on our evaluation of data submitted by Monsanto 
Company in its petition for a determination of nonregulated status, our 
analysis of other scientific data, and comments received from the 
public in response to a previous notice. This notice also announces the 
availability of our written determination document and our finding of 
no significant impact.

EFFECTIVE DATE: October 8, 2002.

ADDRESSES: You may read a copy of the determination, an environmental 
assessment and finding of no significant impact, the petition for a 
determination of nonregulated status submitted by Monsanto Company, and 
all comments received on the petition and the environmental assessment 
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, Biotechnology 
Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-8365. To obtain a copy of the 
determination or the environmental assessment and finding of no 
significant impact, contact Ms. Kay Peterson at (301) 734-4885; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    On May 17, 2001, the Animal and Plant Health Inspection Service 
(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 
stated that the subject corn should not be regulated by APHIS because 
it does not present a plant pest risk.
    On March 14, 2002, APHIS published a notice in the Federal Register 
(67 FR 11458-11459, Docket No. 00-078-1) announcing that the Monsanto 
petition and an environmental assessment (EA) were available for public 
review. This notice also discussed the role of APHIS, the Environmental 
Protection Agency, and the Food and Drug Administration in regulating 
the subject corn and food products derived from it. APHIS received 
1,383 comments on the petition and the EA during the 60-day comment 
period, which ended May 13, 2002. The comments were received from 
private individuals, farmers (including corn growers and organic 
farmers), universities, seed companies, State governors, State 
department of agriculture directors, State corn growers' associations, 
State and regional agricultural business and trade associations, a 
national corn growers' association, an organic trade association, a 
State seed association, a consumer group, an environmental 
organization, a university cooperative extension specialist, an 
agronomic consultant, and a corn product manager. There were 542 
comments in support of the subject petition, and 841 were opposed. The 
comment letters in support of deregulation for MON 863 stressed the 
environmental benefits of using MON 863 to control CRW, including the 
reductions in pesticide use and user exposure to toxic chemicals, 
reductions in farm labor time and costs, the effectiveness and 
consistency of MON 863 in controlling CRW, and the advantages to 
growers in increased yields and crop quality. Other comments in favor 
of deregulation for the subject corn concerned the absence of evidence 
of plant pest and environmental risk presented by MON 863.
    The comments in opposition to deregulation for MON 863 corn 
included allegations concerning the potential for polluting the purity 
of organically grown corn, the inevitability of the development of 
insect resistance to Bacillus thuringiensis (Bt) and the consequent 
loss to organic farmers of the spray form of Bt, the toxic effects of 
Bt-containing pollen on nontargets, the potential for upsetting the 
microbial balances in the soil, the possible development of human 
allergic reactions to Bt corn, and the need for a moratorium on 
genetically engineered crops due to the alleged inadequacy of U.S. 
regulation of genetically engineered crops. One commenter contended 
that a full environmental impact assessment was required prior to 
commercial growing of MON 863 corn because allowing large-scale 
commercialization of this corn constituted a major Federal action 
significantly affecting the environment. The commenter further found 
the EA inadequate in its treatment of the potential for the development 
of insect resistance to the Cry 3Bb1 protein, the unavailability to the 
public of certain information on nontarget effects, the failure to 
address the cumulative issue of gene stacking through cross-
pollination, the failure to address the susceptibility of MON 863 to 
corn stunt disease, the failure to adequately address the impacts on 
organic farmers of contamination by transgenic varieties, the failure 
to

[[Page 65088]]

address the economic impacts on U.S. corn farmers of the loss of 
European markets, and the failure to address the environmental impacts 
of the illegal grant of certain genetic resources from the public trust 
into the possession of commercial entities. One additional comment 
concerned the need for study of the impacts of Bt corn in the ruminant 
and human diets and the potential for lateral gene flow in the enteric 
milieu. We have provided responses to these comments as an attachment 
to our finding of no significant impact, which is available from the 
person listed under FOR FURTHER INFORMATION CONTACT.
    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 
stated 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.
    The subject 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.

Determination

    Based on its analysis of the data submitted by Monsanto, a review 
of other scientific data, field tests of the subject corn, and comments 
submitted by the public, APHIS has determined that MON 863 corn: (1) 
Exhibits no plant pathogenic properties; (2) is no more likely to 
become a weed than corn developed by traditional breeding techniques; 
(3) is unlikely to increase the weediness potential for any other 
cultivated or wild species with which it can interbreed; (4) will not 
harm threatened or endangered species or organisms, such as bees, that 
are beneficial to agriculture; and (5) will not cause damage to raw or 
processed agricultural commodities. Therefore, APHIS has concluded that 
the subject corn and any progeny derived from hybrid crosses with other 
nontransformed corn varieties will be as safe to grow as corn in 
traditional breeding programs that is not subject to regulation under 7 
CFR part 340.
    The effect of this determination is that Monsanto's MON 863 corn is 
no longer considered a regulated article under APHIS' regulations in 7 
CFR part 340. Therefore, the requirements pertaining to regulated 
articles under those regulations no longer apply to the subject corn or 
its progeny. However, importation of MON 863 corn or seeds capable of 
propagation are still subject to the restrictions found in APHIS' 
foreign quarantine notices in 7 CFR part 319.

National Environmental Policy Act

    An EA was prepared to examine the potential environmental impacts 
associated with this determination. 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). Based on that EA, APHIS has reached a finding of no 
significant impact (FONSI) with regard to its determination that MON 
863 corn and lines developed from it are no longer regulated articles 
under its regulations in 7 CFR part 340. Copies of the EA and FONSI are 
available upon request from the individual listed under the FOR FURTHER 
INFORMATION CONTACT section of this notice.

    Done in Washington, DC, this 17th day of October 2002.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-26923 Filed 10-22-02; 8:45 am]
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