[Federal Register Volume 70, Number 1 (Monday, January 3, 2005)]
[Notices]
[Pages 70-71]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E4-3908]


 ========================================================================
 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.
 
 ========================================================================
 

  Federal Register / Vol. 70, No. 1 / Monday, January 3, 2005 / 
Notices  

[[Page 70]]



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.

-----------------------------------------------------------------------

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: 
[email protected]. 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]
BILLING CODE 3410-34-P