[Federal Register: May 22, 2009 (Volume 74, Number 98)]
[Notices]
[Page 23987-23988]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22my09-32]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0017]
Bayer CropScience; Determination of Nonregulated Status for
Cotton Genetically Engineered for Glyphosate Herbicide Tolerance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination that a cotton
line developed by Bayer CropScience, designated as transformation event
GHB614, 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 the Bayer CropScience 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 announcing the availability of the petition for nonregulated
status, our environmental assessment, and the pest risk assessment.
This notice also announces the availability of our determination and
finding of no significant impact.
DATES: Effective Date: May 22, 2009.
ADDRESSES: You may read the petition, the final environmental
assessment, the pest risk assessment, the determination, the finding of
no significant impact, comments we received on our previous notice, and
our responses to those comments 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.
To view these documents on the Internet, go to http://
www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2007-0017.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr. Patricia Beetham, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-0664, e-mail: patricia.k.beetham@aphis.usda.gov.
To obtain copies of the petition, final environmental assessment, or
the finding of no significant impact, contact Ms. Cindy Eck by
telephone at (301) 734-0667 or via e-mail:
cynthia.a.eck@aphis.usda.gov. The petition, final environmental
assessment and finding of no significant impact are also available on
the Internet at http://www.aphis.usda.gov/brs/aphisdocs/06_33201p.pdf
and http://www.aphis.usda.gov/brs/aphisdocs/06_33201p_ea.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 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 340.6 describe the form that a
petition for a determination of nonregulated status
[[Page 23988]]
must take and the information that must be included in the petition.
On November 28, 2006, APHIS received a petition seeking a
determination of nonregulated status (APHIS No. 06-332-01p) from Bayer
CropScience (BCS) of Research Triangle Park, NC, for cotton (Gossypium
hirsutum) designated as transformation event GHB614, which has been
genetically engineered for tolerance to the herbicide glyphosate,
stating that cotton line GHB614 does not present a plant pest risk. BCS
responded to APHIS' subsequent request for additional information and
clarification on May 11, 2007.
Analysis
As described in the petition, cotton transformation event GHB614
utilizes the enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS)
gene isolated from a previously deregulated cotton event (Event GA21;
APHIS petition number 97-099-01) and introduces two amino acid
substitutions within the EPSPS gene (designated 2mEPSPS). These
modifications decrease the binding affinity to glyphosate, thus
producing tolerance to the herbicide. The 2mEPSPS protein allows the
plant to tolerate applications of the broad spectrum herbicide
glyphosate. Regulatory elements for the transgenes were obtained from
Agrobacterium tumefaciens and were introduced into cotton cells using
Agrobacterium-mediated transformation methodology. These regulatory
sequences are not transcribed and do not encode proteins.
Transformation event GHB614 has been considered a regulated article
under the regulations in 7 CFR part 340 because it contains gene
sequences from a plant pathogen. GHB614 cotton has been field tested in
the United States since 2002 under notifications authorized by the
APHIS. In the process of reviewing the permits for field trials of the
subject cotton plants, APHIS determined that the vectors and other
elements were disarmed and that trials, which were conducted under
conditions of reproductive and physical confinement or isolation, would
not present a risk of plant pest introduction or dissemination. APHIS
has presented two alternatives in the draft environmental assessment
(EA) based on its analyses of data submitted by BCS, a review of other
scientific data, as well as data gathered from field tests conducted
under APHIS oversight.
In a notice \1\ published in the Federal Register on June 18, 2008
(73 FR 34968-34700, Docket No. APHIS-2007-0017), APHIS announced the
availability of BCS' petition and a draft EA for public comment. APHIS
solicited comments on whether the subject cotton event would present a
plant pest risk and on the EA. APHIS received nine comments by the
close of the 60-day comment period, which ended on August 18, 2008.
There were six comments that supported deregulation, two from cotton
industry groups and four from individuals. There were three comments
that opposed deregulation, one comment from a non-government
organization and two comments from individuals. APHIS has addressed the
issues raised during the comment period and has provided responses to
these comments as an attachment to the finding of no significant
impact.
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\1\ To view the notice, petition, EA, and the comments we
received, go to http://www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2007-0017.
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Determination
Based on APHIS' analysis of field, greenhouse and laboratory data
submitted by BCS, references provided in the petition, information
described in the final EA and in the finding of no significant impact,
and a careful evaluation of the comments provided by the public, APHIS
has determined that GHB614 cotton will not pose a plant pest risk for
the following reasons: (1) Gene introgression from GlyTolTM
cotton (event GHB614) into wild relatives in the United States and its
territories is extremely unlikely and is not likely to increase the
weediness potential of any resulting progeny or adversely affect
genetic diversity of related plants any more than would introgression
from traditional cotton varieties; (2) it exhibits no characteristics
that would cause it to be weedier than the non-genetically engineered
parent cotton line or any other cultivated cotton; (3) it does not pose
a risk to non-target organisms, including organisms beneficial to
agriculture and Federally listed threatened or endangered species, and
species proposed for listing; (4) it does not pose a threat to
biodiversity as it does not exhibit traits that increase its weediness,
and its unconfined cultivation should not lead to increased weediness
of other cultivated cotton, it exhibits no changes in disease
susceptibility, and it is unlikely to harm non-target organisms common
to the agricultural ecosystem or Federally listed or proposed
threatened or endangered species; (5) compared to current cotton pest
and weed management practices, cultivation of GlyTolTM
cotton should not impact standard agricultural practices in cotton
cultivation including those for organic farmers; and (6) disease
susceptibility and compositional profiles of GlyTolTM cotton
are similar to those of its parent line and other cotton cultivars
grown in the United States; therefore no direct or indirect plant pest
effects on raw or processed plant commodities are expected.
National Environmental Policy Act
To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with the
determination of nonregulated status for GHB614 cotton, an EA was
prepared. 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 the
final EA, the pest risk assessment, other pertinent scientific data,
and our evaluation of the comments provided by the public, APHIS has
reached a finding of no significant impact (FONSI) with regard to the
determination that BCS' GHB614 cotton line and lines developed from it
are no longer regulated articles under its regulations in 7 CFR part
340. Copies of the final EA and FONSI are available as indicated in the
ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 18th day of May 2009.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E9-11972 Filed 5-21-09; 8:45 am]
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