[Federal Register Volume 69, Number 210 (Monday, November 1, 2004)]
[Notices]
[Pages 63347-63349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E4-2949]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 04-030-2]


Mycogen c/o Dow; 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 of our decision to extend to one 
additional corn line our determination that a corn line developed by 
Mycogen Seeds c/o Dow AgroSciences LLC, which has been genetically 
engineered for insect resistance and tolerance to the herbicide 
glufosinate, is no longer considered a regulated article under our 
regulations governing the introduction of certain genetically 
engineered organisms. Our decision is based on our evaluation of data 
submitted by Mycogen c/o Dow in its request for an extension of a 
determination of nonregulated status, an analysis of other scientific 
data, and a comment received from the public in response to a previous 
notice. This notice also announces the availability of our written 
determination and our finding of no significant impact.

[[Page 63348]]


EFFECTIVE DATE: October 20, 2004.

ADDRESSES: You may read the extension request, the environmental 
assessment and finding of no significant impact, and the comment we 
received on our previous notice 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.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available 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 a copy of the 
extension request or the environmental assessment and finding of no 
significant impact, contact Ms. Terry Hampton at (301) 734-5715; e-
mail: [email protected]. The extension request and the 
environmental assessment and finding of no significant impact are also 
available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/03_18101p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/03_18101p_ea.pdf.

SUPPLEMENTARY INFORMATION: 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 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. Further, the regulations in Sec.  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.

Background

    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 pests and tolerance to the herbicide glufosinate. Mycogen/
Dow requested 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 corn line 6275 to the antecedent 
corn line 1507, Mycogen/Dow requested 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.
    On August 17, 2004, APHIS published a notice in the Federal 
Register (69 FR 51058-51059, Docket No. 04-030-1) announcing that an 
environmental assessment (EA) for the Mycogen/Dow extension request had 
been prepared and was available for public comment. APHIS received one 
comment on the subject EA during the designated 30-day public comment 
period, which ended September 16, 2004. The comment, which was from a 
private individual, stated, without reference to any supporting data, 
that corn line 6275 should continue to be regulated because it is 
harmful to humans and contains plant pathogens. APHIS evaluated the 
safety of corn line 6275 in the EA and has provided a response to this 
comment as an attachment to the finding of no significant impact 
(FONSI). The EA and FONSI are available as indicated under FOR FURTHER 
INFORMATION CONTACT.

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 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.

Determination

    Based on an analysis of the data submitted by Mycogen/Dow and a 
review of other scientific data, APHIS has determined that corn line 
6275: (1) Exhibits no plant pathogenic properties; (2) is no more 
likely to become a weed than corn varieties developed by traditional 
breeding techniques and is unlikely to increase the weediness potential 
for any other cultivated or wild species with which it can interbreed; 
(3) will not cause damage to raw or processed agricultural commodities; 
(4) will not harm

[[Page 63349]]

threatened or endangered species or other organisms, such as bees, that 
are beneficial to agriculture; and (5) is unlikely to have any 
significant adverse impact on agricultural practices. Therefore, APHIS 
has concluded that corn line 6275 and any progeny derived from crosses 
with other corn varieties will be as safe to grow as corn that is not 
subject to regulation under 7 CFR part 340.
    Because APHIS has determined that the subject corn line does not 
present a plant pest risk based on its similarity to the antecedent 
organism, Mycogen/Dow corn line 6275 will 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 no longer apply to the field testing, importation, or 
interstate movement of the subject corn line or its progeny. However, 
importation of corn line 6275 and seeds capable of propagation are 
still subject to the restrictions found in APHIS' foreign quarantine 
notices in 7 CFR part 319 and imported seed regulations in 7 CFR part 
361.

National Environmental Policy Act

    An EA was prepared to examine any potential environmental impacts 
associated with the proposed extension of a determination of 
nonregulated status for the subject corn line. 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 that EA, APHIS has reached a 
FONSI with regard to the determination that Mycogen/Dow corn line 6275 
and lines developed from it are no longer regulated articles under its 
regulations in 7 CFR part 340. Copies of the EA and FONSI are available 
as indicated under FOR FURTHER INFORMATION CONTACT.

    Done in Washington, DC, this 27th day of October 2004.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E4-2949 Filed 10-29-04; 8:45 am]
BILLING CODE 3410-34-P