[Federal Register: August 13, 2004 (Volume 69, Number 156)]
[Notices]
[Page 50154-50155]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au04-36]
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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:
Terry.A.Hampton@aphis.usda.gov. 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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