[Federal Register Volume 74, Number 98 (Friday, May 22, 2009)]
[Pages 23987-23988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-11972]



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.


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: [email protected]. 
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: 
[email protected]. 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.



    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 
    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.


    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 

    \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.


    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 

    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]