[Federal Register: August 17, 2004 (Volume 69, Number 158)]
[Notices]
[Page 51058-51059]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au04-28]
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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
regulations@aphis.usda.gov. 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: Terry.A.Hampton@aphis.usda.gov. 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