[Federal Register Volume 73, Number 118 (Wednesday, June 18, 2008)]
[Pages 34698-34700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13736]



Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0017]

Bayer CropScience; Availability of Petition and Draft 
Environmental Assessment for 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 that the Animal and Plant Health 
Inspection Service has received a petition from Bayer CropScience 
seeking a determination of nonregulated status for cotton genetically 
engineered for tolerance to the herbicide glyphosate derived from a 
transformation event designated as GHB614. The petition has been 
submitted in accordance with our regulations concerning the 
introduction of certain genetically engineered organisms and products. 
In accordance with those regulations, we are soliciting comments on 
whether this genetically engineered cotton is or could be a plant pest. 
We are making available for public comment the petition and draft 
environmental assessment for the proposed determination of nonregulated 

DATES: We will consider all comments that we receive on or before 
August 18, 2008.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0017 to submit or view comments and 
to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send two copies of 
your comment to Docket No. APHIS-2007-0017, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. APHIS-2007-0017.
    Reading Room: You may read any comments that we receive 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.
    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 or the draft environmental assessment, 
contact Ms. Cindy Eck at (301) 734-0667, e-mail 
cynthia.a.eck@aphis.usda.gov. The petition and the draft environmental 
assessment 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 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 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 and, 
therefore, should not be a regulated article under APHIS' regulations 
in 7 CFR part 340. BCS responded to APHIS' subsequent request for 
additional information and clarification on May 11, 2007. The petition 
is available for public review and comment.


    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 U.S. 
Department of Agriculture (USDA). APHIS has presented three 
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. These are the three alternatives that APHIS is considering: 
(1) Take no action (GHB614 remains a regulated article), (2) deregulate 
GHB614 in whole, or (3) deregulate GHB614 in part.
    In Sec.  403 of the Plant Protection Act (7 U.S.C. 7701 et seq.), 
``plant pest'' is defined as any living stage of any of the following 
that can directly or indirectly injure, cause damage to, or cause 
disease in any plant or plant product: A protozoan, a nonhuman animal, 
a parasitic plant, a bacterium, a fungus, a virus or viroid, an 
infectious agent or other pathogen, or any article similar to or allied 
with any of the foregoing. APHIS views this definition broadly to cover 
direct or indirect injury, disease, or damage not just to agricultural 
crops, but also to other plants, for example, native species, as well 
as to plant parts and plant products whether natural, manufactured, or 
    GHB614 cotton is subject to regulation by other Federal agencies. 
The U.S. Environmental Protection Agency (EPA) is responsible for the 
regulation of pesticides under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA 
requires that all pesticides, including herbicides, be registered prior 
to distribution or sale, unless exempt from EPA regulation. In order to 
be registered as a pesticide under FIFRA, it must be demonstrated that 
when used with common practices, a pesticide will not cause 
unreasonable adverse effects in the environment. Under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 et 
seq.), pesticides added to (or contained in) raw agricultural 
commodities generally

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are considered to be unsafe unless a tolerance or exemption from 
tolerance has been established. Residue tolerances for pesticides are 
established by EPA under the FFDCA, and the U.S. Food and Drug 
Administration (FDA) enforces the tolerances set by EPA. BCS submitted 
the appropriate regulatory package to EPA for registering the use of 
glyphosate herbicide on GBH614 cotton. Safe use of glyphosate has been 
established by the EPA through the registration of glyphosate for use 
on cotton and the setting of tolerances for the herbicide.
    FDA's policy statement concerning regulation of products derived 
from new plant varieties, including those genetically engineered, was 
published in the Federal Register on May 29, 1992 (57 FR 22984-23005). 
Under this policy, FDA uses what is termed a consultation process to 
ensure that human and animal feed safety issues or other regulatory 
issues (e.g., labeling) are resolved prior to commercial distribution 
of a bioengineered food. In compliance with the FDA policy, BCS has 
submitted a food and feed safety and nutritional assessment summary for 
GHB614 cotton to the FDA. This assessment is pending. As of May 29, 
2008, FDA has not announced the completion of BCS' consultation for 
cotton event GHB614 (see http://www.cfsan.fda.gov/lrd/~biocon.html).

National Environmental Policy Act

    A draft EA has been prepared to provide the APHIS decisionmaker 
with a review and analysis of any potential environmental impacts 
associated with the proposed determination of nonregulated status for 
GHB614. The draft 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).
    In accordance with Sec.  340.6(d) of the regulations, we are 
publishing this notice to inform the public that APHIS will accept 
written comments regarding the petition for a determination of 
nonregulated status from interested or affected persons for a period of 
60 days from the date of this notice. We are also soliciting written 
comments from interested or affected persons on the draft EA prepared 
to examine any potential environmental impacts of the proposed 
determination for the deregulation of the subject cotton event. The 
petition and the draft EA are available for public review, and copies 
of the petition and the draft EA are available as indicated under 
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. All public comments received regarding the petition and 
draft EA will be available for public review. After reviewing and 
evaluating the comments on the petition and the draft EA and other 
data, APHIS will furnish a response to the petitioner, either approving 
(in whole or part) or denying the petition. APHIS will then publish a 
notice in the Federal Register announcing the regulatory status of BCS' 
herbicide-tolerant cotton event GHB614 and the availability of APHIS' 
written regulatory and environmental decision.

    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 12th day of June 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-13736 Filed 6-17-08; 8:45 am]