[Federal Register: January 3, 2005 (Volume 70, Number 1)]
[Notices]
[Page 70-71]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ja05-24]
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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. 04-076-3]
Monsanto Co.; Availability of Determination of Nonregulated
Status for Cotton Genetically Engineered for Tolerance to the Herbicide
Glyphosate
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 cotton designated as MON 88913, which has been
genetically engineered for tolerance to the herbicide glyphosate, is no
longer considered a regulated article under our regulations governing
the introduction of certain genetically engineered organisms. Our
determination is based on our evaluation of data submitted by Monsanto
Company in its petition for a determination of non-regulated 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 and our finding of no
significant impact.
DATES: Effective Date: December 20, 2004.
ADDRESSES: You may read the determination, the 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 of the 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 someone is there to help you,
please call (202) 690-2817 before coming.
You may view APHIS documents published in the Federal Register and
related information, including the names of groups and individuals who
have commented on APHIS dockets, on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html
.
FOR FURTHER INFORMATION CONTACT: Mr. Michael Blanchette, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-5141. To obtain a copy of the determination or
environmental assessment and finding of no significant impact, contact
Ms. Terry Hampton at (301) 734-5715; e-mail:
Terry.A.Hampton@aphis.usda.gov. The petition and environmental
assessment are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/04_08601p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/04_08601p_ea.pdf.
The determination
and the final environmental assessment and finding of no significant
impact are available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/04_08601p_com.pdf
.
SUPPLEMENTARY INFORMATION:
Background
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 March 26, 2004, APHIS received a petition from Monsanto Company
of St. Louis, MO (Monsanto), requesting a determination of nonregulated
status under 7 CFR part 340 for cotton (Gossypium hirsutum L.)
designated as MON 88913, which has been genetically engineered for
tolerance to the herbicide glyphosate. The Monsanto petition states
that the subject cotton should not be regulated by APHIS because it
does not present a plant pest risk.
On October 4, 2004, APHIS published a notice in the Federal
Register (69 FR 59181-59182, Docket No. 04-076-1) announcing that the
Monsanto petition and an environmental assessment (EA) were available
for public review. The notice also discussed the role of APHIS, the
Environmental Protection Agency, and the Food and Drug Administration
in regulating the subject cotton and food products developed from it.
In a subsequent notice published in the Federal Register on November
24, 2004 (69 FR 68301-68302, Docket No. 04-076-2), APHIS announced the
availability of an addendum to the Monsanto petition.
APHIS received three comments on the petition and the EA during the
60-day comment period, which ended December 4, 2004. The comments were
from a university professor, a trade organization, and a private
individual. Two of the commenters supported nonregulated status for MON
8891, while the third commenter opposed it. APHIS has provided a
response to these comments as an attachment to the finding of no
significant impact (FONSI). The EA and FONSI are available as indicated
under FOR FURTHER INFORMATION CONTACT.
MON 88913 has been genetically engineered to express a 5-
enolpyruvyshikimate-3-phosphate synthase protein from Agrobacterium sp.
strain CP4 (CP4 EPSPS), which confers tolerance to the herbicide
glyphosate. Expression of the added genes is controlled in part by gene
sequences derived from the plant pathogens figwort mosaic virus and
cauliflower mosaic virus. The Agrobacterium tumefaciens transformation
method was used to transfer the added genes into the recipient upland
cotton variety Coker 312.
MON 88913 cotton has been considered a regulated article under the
[[Page 71]]
regulations in 7 CFR part 340 because it contains gene sequences from
plant pathogens. 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 confinement or
isolation, would not present a risk of plant pest introduction or
dissemination.
Determination
Based on its analysis of the data submitted by Monsanto Company, a
review of other scientific data, field tests of the subject cotton, and
comments submitted by the public, APHIS has determined that MON 88913
cotton: (1) Exhibits no plant pathogenic properties; (2) is no more
likely to become weedy than the non-transgenic parental line or other
cultivated cotton; (3) is unlikely to increase the weediness potential
for any other cultivated or wild species with which it can interbreed;
(4) will not cause damage to raw or processed agricultural commodities;
(5) will not harm threatened or endangered species or organisms that
are beneficial to agriculture; and (6) should not reduce the ability to
control pests and weeds in cotton or other crops. Therefore, APHIS has
concluded that the subject cotton and any progeny derived from hybrid
crosses with other non-transformed cotton varieties will be as safe to
grow as cotton in traditional breeding programs that is not subject to
regulation under 7 CFR part 340.
The effect of this determination is that Monsanto Company's MON
88913 cotton 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 cotton or its progeny. However, importation of MON 88913 cotton
and seeds capable of propagation are still subject to the restrictions
found in APHIS' foreign quarantine notices in 7 CFR part 319 and
imported seed regulations in 7 CFR part 361.
National Environmental Policy Act
An EA was prepared to examine any potential environmental impacts
associated with the proposed determination of non-regulated status for
the subject cotton event. 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 FONSI with regard to the
determination that Monsanto MON 88913 cotton 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 as indicated in the FOR
FURTHER INFORMATION CONTACT section of this notice.
Done in Washington, DC, this 27th day of December 2004.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E4-3908 Filed 12-30-04; 8:45 am]
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