October 24, 2002
[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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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. 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 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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