[Federal Register Volume 65, Number 173 (Wednesday, September 6, 2000)]
[Notices]
[Pages 53976-53977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22807]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
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  Federal Register / Vol. 65 , No. 173 / Wednesday, September 6, 2000 / 
Notices  

[[Page 53976]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 00-070-1]


Mycogen c/o Dow and Pioneer; Receipt of Petition for 
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 received a petition from Mycogen Seeds c/o Dow 
AgroSciences LLC and Pioneer Hi-Bred International, Inc., seeking a 
determination of nonregulated status for corn designated as line 1507, 
which has been genetically engineered for insect resistance and 
tolerance to the herbicide glufosinate. 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 public comments on whether 
this corn line presents a plant pest risk.

DATES: Written comments must be received on or before November 6, 2000.

ADDRESSES: Please send your comment and three copies to: Docket No. 00-
070-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03, 
4700 River Road Unit 118, Riverdale, MD 20737-1238.
    Please state that your comment refers to Docket No. 00-070-1.
    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.
    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: Dr. Susan Koehler, Biotechnology 
Assessments Section, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-4886. To obtain a copy of the 
petition, contact Ms. Kay Peterson at (301) 734-4885; e-mail: 
[email protected].

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. 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 May 15, 2000, 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, requesting a determination of nonregulated status 
under 7 CFR part 340 for corn designated as Zea mays L. cultivar line 
1507 (line 1507), which has been genetically engineered for resistance 
to certain lepitopteran insect species and tolerance to the herbicide 
glufosinate. The Mycogen c/o Dow and Pioneer petition states that the 
subject corn line should not be regulated by APHIS because it does not 
present a plant pest risk.
    As described in the petition, 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 petitioners state that the Cry1F protein is effective in 
controlling the larvae of such common pests of corn as European corn 
borer, southwestern corn borer, black cutworm, and fall armyworm. The 
subject corn line also contains the pat gene derived from the bacterium 
Streptomyces viridochromogenes. The pat gene encodes the 
phosphinothricin acetyltransferase (PAT) protein, which confers 
tolerance to the herbicide glufosinate. Expression of these added genes 
is controlled in part by gene sequences from the plant pathogens 
cauliflower mosaic virus and Agrobacterium tumefaciens. Microprojectile 
bombardment 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 the 
regulations in 7 CFR part 340 because it contains gene sequences from 
plant pathogens. This corn has been field tested since 1997 in the 
United States under APHIS notifications. 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 containment or isolation, would not present a risk of plant 
pest introduction or dissemination.
    In Sec. 403 of the Plant Protection Act (Title IV, Pub. L. 106-224, 
114 Stat. 438, 7 U.S.C. 7701-7772), 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 very broadly. The definition covers direct or indirect 
injury, disease, or damage not just to agricultural crops, but also to

[[Page 53977]]

plants in general, for example, native species, as well as to organisms 
that may be beneficial to plants, for example, honeybees, rhizobia, 
etc.
    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 by EPA regulation. In cases in 
which genetically modified plants allow for a new use of an herbicide 
or involve a different use pattern for the herbicide, EPA must approve 
the new or different use. When the use of the herbicide on the 
genetically modified plant would result in an increase in the residues 
of the herbicide in a food or feed crop for which the herbicide is 
currently registered, or in new residues in a crop for which the 
herbicide is not currently registered, establishment of a new tolerance 
or a revision of the existing tolerance would be required. Residue 
tolerances for pesticides are established by EPA under the Federal 
Food, Drug and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 et 
seq.), and the Food and Drug Administration (FDA) enforces tolerances 
set by EPA under the FFDCA. Pesticide petitions have been filed with 
EPA to establish a regulation for an exemption from the requirement of 
a tolerance for residues of Bt aizawai Cry1F and the genetic material 
necessary for its production in or on all raw agricultural commodities.
    FDA published a statement of policy on foods derived from new plant 
varieties in the Federal Register on May 29, 1992 (57 FR 22984-23005). 
The FDA statement of policy includes a discussion of FDA's authority 
for ensuring food safety under the FFDCA, and provides guidance to 
industry on the scientific considerations associated with the 
development of foods derived from new plant varieties, including those 
plants developed through the techniques of genetic engineering. The 
petitioner has begun consultation with FDA on the subject corn line.
    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 Determination of 
Nonregulated Status from any interested person for a period of 60 days 
from the date of this notice. The petition and any comments received 
are available for public review, and copies of the petition may be 
ordered (see the FOR FURTHER INFORMATION CONTACT section of this 
notice).
    After the comment period closes, APHIS will review the data 
submitted by the petitioner, all written comments received during the 
comment period, and any other relevant information. After analyzing the 
available information, including comments received from the public, 
APHIS will prepare an environmental assessment to examine any potential 
environmental impacts associated with a determination of nonregulated 
status for the subject corn line. The environmental assessment will be 
made available for public comment for a period of 30 days. After 
reviewing and evaluating the comments on the environmental assessment 
and other data and information, APHIS will furnish a response to the 
petitioner, either approving the petition in whole or in part, or 
denying the petition. APHIS will then publish a notice in the Federal 
Register announcing the regulatory status of the Mycogen c/o Dow and 
Pioneer insect-resistant and glufosinate-tolerant corn line 1507 and 
the availability of APHIS' written decision.

    Authority: Title IV, Pub. L. 106-224, 114 Stat. 438, 7 U.S.C. 
7701-7772; 7 U.S.C. 166 and 1622n; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, 
and 371.3.


    Done in Washington, DC, this 30th day of August 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-22807 Filed 9-5-00; 8:45 am]
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