[Federal Register: October 23, 2002 (Volume 67, Number 205)]
[Notices]
[Page 65087-65088]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc02-33]
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[[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:
Kay.Peterson@aphis.usda.gov.
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]
BILLING CODE 3410-34-P
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