[Federal Register Volume 66, Number 157 (Tuesday, August 14, 2001)]
[Notices]
[Pages 42624-42625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20307]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 00-070-3]


Mycogen c/o Dow and Pioneer; Availability 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 determination that the 
Mycogen Seeds c/o Dow AgroSciences LLC and Pioneer Hi-Bred 
International, Inc., corn line designated as line 1507, 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 determination is based on our evaluation of 
data submitted by Mycogen Seeds c/o Dow AgroSciences LLC and Pioneer 
Hi-Bred International, Inc., in their petition for a determination of 
nonregulated status and our analysis of other scientific data. This 
notice also announces the availability of our written determination 
document and a finding of no significant impact.

EFFECTIVE DATE: June 14, 2001.

ADDRESSES: You may read the determination, an environmental assessment 
and finding of no significant impact, and the petition 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. 
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.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Susan Koehler, Biotechnology 
Assessments Section, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-4886. To obtain a copy of the determination or 
the environmental assessment and finding of no significant impact, 
contact Ms. Kay Peterson at (301) 734-4885; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    On May 15, 2000, the Animal and Plant Health Inspection Service 
(APHIS) received a petition (APHIS Petition No. 00-136-01p) from 
Mycogen Seeds c/o Dow AgroSciences LLC (Mycogen c/o Dow), of 
Indianapolis, IN, and Pioneer Hi-Bred International, Inc. (Pioneer), of 
Johnston, IA, seeking a determination that a corn line designated as 
Zea mays L. cultivar line 1507 (line 1507), which has been genetically 
engineered for resistance to certain lepidopteran insect species and 
tolerance to the herbicide glufosinate, does not present a plant pest 
risk and, therefore, is not a regulated article under APHIS' 
regulations in 7 CFR part 340.
    On September 6, 2000, APHIS published a notice in the Federal 
Register (65 FR 53976-53977, Docket No. 00-070-1) announcing that the 
Mycogen c/o Dow and Pioneer petition had been received and was 
available for public review. The notice also discussed the role of 
APHIS, the Environmental Protection Agency, and the Food and Drug 
Administration in regulating the subject corn line and food products 
derived from it. In the notice, APHIS solicited written comments from 
the public as to whether corn line 1507 posed a plant pest risk. The 
comments were to have been received by APHIS on or before November 6, 
2000. APHIS received no comments on the subject petition during the 
designated 60-day comment period.
    APHIS then published a notice in the Federal Register on April 18, 
2001 (66 FR 19915-19916, Docket No. 00-070-2), announcing the 
availability for public

[[Page 42625]]

comment of an environmental assessment (EA) for a proposed 
determination that corn line 1507 would no longer be considered a 
regulated article under our regulations governing the introduction of 
certain genetically engineered organisms. Comments were to have been 
received by APHIS on or before May 18, 2001. We received no comments on 
the EA during the designated 30-day comment period.

Analysis

    Corn line 1507 has been genetically engineered to express a Cry1F 
insecticidal protein derived from the common soil bacterium Bacillus 
thuringiensis subsp. aizawai (Bt aizawai). The Cry1F protein is said to 
be effective in controlling the larvae of common pests of corn such as 
European corn borer, southwestern corn borer, black cutworm, fall 
armyworm, and corn ear worm. The subject corn line also contains the 
pat gene derived from the bacterium Streptomyces viridochromogenes. The 
pat gene encodes a phosphinothricin acetyltransferase (PAT) protein, 
which confers tolerance to the herbicide glufosinate. Expression of the 
added genes is controlled in part by gene sequences from the plant 
pathogens cauliflower mosaic virus and Agrobacterium tumefaciens. The 
microprojectile bombardment method was used to transfer the added genes 
into the recipient inbred corn line Hi-II.
    Corn line 1507 has been considered a regulated article under APHIS' 
regulations in 7 CFR part 340 because it contains gene sequences 
derived from plant pathogens. However, evaluation of data from field 
tests conducted under APHIS notifications since 1997 indicates that 
there were no deleterious effects on plants, nontarget organisms, or 
the environment as a result of the environmental release of the subject 
corn line.

Determination

    Based on its analysis of the data submitted by Mycogen c/o Dow and 
Pioneer and a review of other scientific data and field tests of the 
subject corn line, APHIS has determined that corn line 1507: (1) 
Exhibits no plant pathogenic properties; (2) is no more likely to 
become a weed than insect-resistant and herbicide-tolerant corn 
varieties developed by traditional plant breeding; (3) is unlikely to 
increase the weediness potential for any sexually compatible cultivated 
or wild species; (4) will not cause damage to raw or processed 
agricultural commodities; (5) will not harm nontarget organisms, 
including threatened or endangered species or organisms that are 
recognized as beneficial to the agricultural ecosystem; and (6) should 
not reduce the ability to control insects or weeds in corn or other 
crops. Therefore, APHIS has concluded that the subject corn line and 
any progeny derived from hybrid crosses with other corn varieties will 
be as safe to grow as corn in traditional breeding programs that is not 
subject to regulation under 7 CFR part 340.
    The effect of this determination is that the Mycogen c/o Dow and 
Pioneer corn line 1507 is no longer 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 subject corn line or its progeny. However, importation of 
corn line 1507 or seeds capable of propagation are still subject to the 
restrictions found in APHIS' foreign quarantine notices in 7 CFR part 
319.

National Environmental Policy Act

    An EA has been prepared to examine the potential environmental 
impacts associated with this determination. 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 
finding of no significant impact (FONSI) with regard to its 
determination that the Mycogen c/o Dow and Pioneer corn line 1507 and 
lines developed from it are no longer regulated articles under its 
regulations in 7 CFR part 340. Copies of the EA and the FONSI are 
available upon request from the individual listed under FOR FURTHER 
INFORMATION CONTACT.

    Done in Washington, DC, this 2nd day of August 2001.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 01-20307 Filed 8-13-01; 8:45 am]
BILLING CODE 3410-34-P