[Federal Register Volume 69, Number 158 (Tuesday, August 17, 2004)]
[Notices]
[Pages 51058-51059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18788]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 04-030-1]


Mycogen c/o Dow; Availability of Environmental Assessment for 
Extension of Determination of Nonregulated Status for Corn Genetically 
Engineered for Insect Resistance and Glufosinate 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 prepared an environmental assessment for a 
preliminary decision to extend to one additional corn line our 
determination that a corn line developed by Mycogen Seeds c/o Dow 
AgroSciences LLC is no longer considered a regulated article under our 
regulations governing the introduction of certain genetically 
engineered organisms. We are making this environmental assessment 
available for public comment.

DATES: We will consider all comments we receive on or before September 
16, 2004.

ADDRESSES: You may submit comments by any of the following methods:
     Postal mail/commercial delivery: Please send four copies 
of your comments (an original and three copies) to Docket No. 04-030-1, 
Regulatory Analysis and Development, PPD, APHIS, Suite 3C71, 4700 River 
Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment 
refers to Docket No. 04-030-1.
     E-mail: Address your comment to 
[email protected]. Your comment must be contained in the body 
of your message; do not send attached files. Please include your name 
and address in your message and ``Docket No. 04-030-1'' on the subject 
line.
     Agency Web site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html for a form you can use to submit an e-mail comment through 
the APHIS Web site.
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for locating this 
docket and submitting comments.
    Reading Room: You may read the extension request, the environmental 
assessment, and any comments we receive on this notice in our reading 
room. The reading room is located in room 1141, 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 that someone is available to help you, please call 
(202) 690-2817 before coming.
    Other Information: 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: Ms. Robyn Rose, Biotechnology 
Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-0489. To obtain copies of the 
extension request or the environmental assessment, contact Ms. Terry 
Hampton at (301) 734-5715; e-mail: [email protected]. The 
extension request and the environmental assessment are also available 
on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/

[[Page 51059]]

03--18101p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/03_18101p_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. Further, the regulations in 340.6(e)(2) provide that a 
person may request that APHIS extend a determination of nonregulated 
status to other organisms. Such a request must include information to 
establish the similarity of the antecedent organism and the regulated 
article in question.
    On June 30, 2003, APHIS received a request for an extension of a 
determination of nonregulated status (APHIS No. 03-181-01p) from 
Mycogen Seeds c/o Dow AgroSciences LLC (Mycogen/Dow) of Indianapolis, 
IN, for corn (Zea mays L.) designated as maize line 6275 (corn line 
6275), which has been genetically engineered for resistance to certain 
lepidopteran insect pests and tolerance to the herbicide glufosinate. 
The Mycogen/Dow request seeks an extension of a determination of 
nonregulated status issued in response to APHIS petition number 00-136-
01p for insect resistant and glufosinate-tolerant corn line 1507, the 
antecedent organism (see 66 FR 42624-42625, published August 14, 2001, 
Docket No. 00-070-3). Based on the similarity of the antecedent 
organism corn line 1507 and corn line 6275, Mycogen/Dow requests a 
determination that corn line 6275 does not present a plant pest risk 
and, therefore, is not a regulated article under APHIS' regulations in 
7 CFR part 340.

Analysis

    Like the antecedent organism, corn line 6275 has been genetically 
engineered to express a Cry1F insecticidal protein derived from the 
common soil bacterium Bacillus thuringiensis subsp. Aizawi (Bt aizawi). 
The Cry1F protein is said to be effective in controlling certain 
lepidopteran pests of corn, including European corn borer, black 
cutworm, fall army worm, and southwestern corn borer. Corn line 6275 
also contains the bar gene isolated from the bacterium Streptomyces 
hygroscopicus. The bar gene encodes a phosphinothricin 
acetyltransferase enzyme which confers tolerance to the herbicide 
glufosinate. The antecedent organism contains the pat gene derived from 
the bacterium Streptomyces viridochromogenes. The pat gene encodes a 
phosphinothricin acetyltransferase (PAT) protein, which also confers 
tolerance to glufosinate herbicides. Corn line 6275 was developed 
through use of Agrobacterium-mediated transformation, while 
microprojectile bombardment was used to transfer the added genes into 
the antecedent organism, corn line 1507. The recipient line used in 
both the antecedent organism and corn line 6275 was the public line 
designated Hi-II.
    Corn line 6275 expresses an insecticidal crystal protein identical 
in amino acid sequence to the Cry1F protein expressed in line 1507, 
both lines express an identical protein which confers tolerance to the 
herbicide glufosinate, and the recipient line used in both lines was 
the same public line Hi-II. Accordingly, we have determined that corn 
line 6275 is similar to the antecedent organism in APHIS petition 
number 00-136-01p and we are proposing that corn line 6275 should no 
longer be regulated under the regulations in 7 CFR part 340.
    Corn line 6275 has been considered a regulated article under APHIS 
regulations in 7 CFR part 340 because it contains gene sequences 
derived from plant pathogens. However, corn line 6275 has been field 
tested since 1999 under APHIS authorizations. In the process of 
reviewing the notifications for field trials of the subject corn, 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.
    Should APHIS approve the Mycogen/Dow request for an extension of a 
determination of nonregulated status, corn line 6275 would no longer be 
considered a regulated article under APHIS' regulations in 7 CFR part 
340. Therefore, the requirements pertaining to regulated articles under 
those regulations would no longer apply to the field testing, 
importation, or interstate movement of the subject corn line or its 
progeny.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with a 
proposed extension of a determination of nonregulated status for 
Mycogen/Dow's corn line 6275, an environmental assessment (EA) has been 
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). Copies of the 
Mycogen/Dow extension request and the EA are available as indicated in 
the FOR FURTHER INFORMATION CONTACT section of this notice.

    Done in Washington, DC, this 12th day of August 2004.
W. Ron DeHaven,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-18788 Filed 8-16-04; 8:45 am]
BILLING CODE 3410-34-P