[Federal Register Volume 69, Number 156 (Friday, August 13, 2004)]
[Notices]
[Pages 50154-50155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18523]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 04-010-2]


Mycogen c/o Dow; Availability of Determination of Nonregulated 
Status for Cotton Lines 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 that the Mycogen Seeds c/o Dow 
AgroSciences LLC cotton lines designated as Cry1F cotton event 281-24-
236 and Cry1Ac cotton event 3006-210-23, which have been genetically 
engineered for insect resistance, are no longer considered regulated 
articles under our regulations governing the introduction of certain 
genetically engineered organisms. Our determination is based on our 
evaluation of data submitted by Mycogen Seeds c/o Dow AgroSciences LLC 
in its petitions for determinations 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 and our finding of no 
significant impact.

EFFECTIVE DATE: July 15, 2004.

ADDRESSES: You may read the petitions, the determination, the 
environmental assessment and finding of no significant impact, and all 
comments that we received on this docket 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: Dr. Susan Koehler, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-4886. To obtain copies of the petitions or the 
environmental assessment and finding of no significant impact, contact 
Ms. Terry Hampton at (301) 734-5715; e-mail: 
[email protected]. The petitions and the environmental 
assessment and finding of no significant impact are also available on 
the Internet at:
     http://www.aphis.usda.gov/brs/aphisdocs/03_03601p.pdf
     http://www.aphis.usda.gov/brs/aphisdocs/03_03601p_ea.pdf
     http://www.aphis.usda.gov/brs/aphisdocs/03_03602p.pdf
     http://www.aphis.usda.gov/brs/aphisdocs/03_03602p_ea.pdf

SUPPLEMENTARY INFORMATION:

Background

    On February 5, 2003, the Animal and Plant Health Inspection Service 
(APHIS) received two petitions from Mycogen Seeds c/o Dow AgroSciences 
LLC (Mycogen/Dow) of Indianapolis, IN, requesting determinations of 
nonregulated status under 7 CFR part 340 for cotton (Gossypium hirsutum 
L.) designated as Cry1F cotton event 281-24-236 (cotton event Cry1F) 
(APHIS Petition No. 03-036-01p) and Cry1Ac cotton event 3006-210-23 
(cotton event Cry1Ac) (APHIS Petition No. 03-036-02p), which have been 
genetically engineered for resistance to certain lepidopteran insect 
pests. The Mycogen/Dow petitions state that the subject cotton events 
should not be regulated by APHIS because they do not present a plant 
pest risk.
    On March 9, 2004, APHIS published a notice in the Federal Register 
(69 FR 10972-10973, Docket No. 04-010-1) announcing that the Mycogen/
Dow petitions and an environmental assessment (EA) were available for 
public review and comment. 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. APHIS received six comments on the petitions and the 
EA during the 60-day comment period which ended May 10, 2004. The 
comments were from three individuals, an industry organization, a 
cotton farmer, and an academic research center. Four of the comments 
were in favor of deregulation for the subject cotton lines, based on 
predicted economic and environmental benefits resulting from higher 
yields and reduced pesticide use. The combination of the two subject 
cotton lines through breeding after deregulation was also seen as a 
means of reducing the potential for the development of resistance in 
lepidopteran populations. The one commenter opposed to deregulation for 
the subject cotton lines suggested the need for many more years

[[Page 50155]]

of testing and more stringent regulation of all genetically engineered 
crop plants. The remaining commenter expressed the opinion that a 
partial deregulation of the subject cotton lines should be approved, 
with restrictions imposed so that additional field tests and monitoring 
could be conducted to provide data in certain areas of concern. APHIS 
has carefully considered these comments and suggestions, and a response 
to the comments is included as an attachment to the finding of no 
significant impact (FONSI).
    Cotton events Cry1F and Cry1Ac have been genetically engineered to 
express synthetic insecticidal proteins derived from the common soil 
bacterium Bacillus thuringiensis (Bt). The petitioner states that the 
Cry1F and Cry1Ac proteins are effective in providing protection from 
the feeding of lepidopteran insect pests such as tobacco budworm, beet 
armyworm, soybean looper, and cotton bollworm. The subject cotton 
events also express the pat gene derived from Streptomyces 
viridochromogenes, a non-pathogenic bacterium. The pat gene encodes the 
enzyme phosphinothricin acetyltransferase (PAT), which confers 
tolerance to glufosinate herbicides and is present in cotton events 
Cry1F and Cry1Ac as a selectable marker. The subject cotton events were 
developed through use of the Agrobacterium-mediated transformation 
method. Cotton events Cry1F and Cry1Ac were developed primarily so that 
they could be crossed to produce a cotton line which contains both the 
insecticidal proteins and thereby to maintain a range of effective 
control options for lepidopteran insect pests and to reduce the 
potential for the development of resistance to Bt insecticides.
    Cotton events Cry1F and Cry1Ac have been considered regulated 
articles under the regulations in 7 CFR part 340 because they contain 
gene sequences from the plant pathogen Agrobacterium tumefaciens. These 
cotton events have been field tested since 1999 in the United States 
under APHIS notifications. 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 Mycogen/Dow, a 
review of other scientific data, field tests of the subject cotton, and 
comments submitted by the public, APHIS has determined that cotton 
event Cry1F and cotton event Cry1Ac: (1) Exhibit no plant pathogenic 
properties; (2) are no more likely to become weedy than the non-
transgenic parental line or other cultivated cotton; (3) are unlikely 
to increase the weediness potential for any other cultivated or wild 
species with which they 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 events and any progeny derived from hybrid crosses with other 
nontransformed cotton varieties will be as safe to grow as cotton in 
traditional breeding programs that are not subject to regulation under 
7 CFR part 340.
    The effect of this determination is that Mycogen/Dow's Cry1F cotton 
event 281-24-236 and Cry1Ac cotton event 3006-210-23 are no longer 
considered regulated articles 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 cotton events Cry1F and Cry1Ac 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.
    An EA was prepared to examine the potential environmental impacts 
associated with the proposed determinations of nonregulated status for 
Mycogen/Dow's Cry1F cotton event 281-24-236 and Cry1Ac cotton event 
3006-210-23. 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 its determination that Cry1F 
cotton event 281-24-236 and Cry1Ac cotton event 3006-210-23 and lines 
developed from them 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.

    Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR 
2.22, 2.80, and 371.3.

    Done in Washington, DC, this 9th day of August 2004.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-18523 Filed 8-12-04; 8:45 am]
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