[Federal Register Volume 63, Number 32 (Wednesday, February 18, 1998)]
[Notices]
[Pages 8161-8162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4037]


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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 
 appearing in this section.
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  Federal Register / Vol. 63, No. 32 / Wednesday, February 18, 1998 / 
Notices  

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 98-009-1]


Pioneer Hi-Bred International, Inc.; Receipt of Petition for 
Determination of Nonregulated Status for Corn Genetically Engineered 
for Male Sterility 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 Pioneer Hi-Bred 
International, Inc., seeking a determination of nonregulated status for 
corn lines designated as 676, 678, and 680, which have been genetically 
engineered for male sterility and tolerance to the herbicide 
glufosinate as a marker. 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 
presents a plant pest risk.

DATES: Written comments must be received on or before April 20, 1998.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 98-009-1, Regulatory Analysis and Development, PPD, APHIS, 
Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please 
state that your comments refer to Docket No. 98-009-1. A copy of the 
petition and any comments received may be inspected at USDA, room 1141, 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except 
holidays. Persons wishing access to that room to inspect the petition 
or comments are asked to call in advance of visiting at (202) 690-2817 
to facilitate entry into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Subhash Gupta, Biotechnology and 
Biological Analysis, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-8761. 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 determination of nonregulated status must take and 
the information that must be included in the petition.
    On December 8, 1997, APHIS received a petition (APHIS Petition No. 
97-342-01p) from Pioneer Hi-Bred International, Inc. (Pioneer), of 
Johnston, IA, requesting a determination of nonregulated status under 7 
CFR part 340 for male sterile, glufosinate-tolerant corn lines 
designated as 676, 678, and 680 (lines 676, 678, and 680). The Pioneer 
petition states that the subject corn lines should not be regulated by 
APHIS because they do not present a plant pest risk.
    As described in the petition, corn lines 676, 678, and 680, have 
been genetically engineered to contain an adenine methylase, or dam 
gene derived from Escherichia coli. The dam gene expresses a DNA 
adenine methylase enzyme in specific plant tissue, which results in the 
inability of the transformed plants to produce anthers or pollen. The 
subject corn lines also contain the pat selectable marker gene isolated 
from the bacterium Streptomyces viridochromogenes. The pat gene encodes 
a phosphinothricin acetyltransferase (PAT) enzyme, which, when 
introduced into a plant cell, confers tolerance to the herbicide 
glufosinate. Linkage of the dam gene, which induces male sterility, 
with the pat gene, a glufosinate tolerance gene used as a marker, 
enables identification of the male sterile line for use in the 
production of hybrid seed. The subject corn lines were transformed by 
the particle gun process, and expression of the introduced genes is 
controlled in part by gene sequences derived from the plant pathogen 
cauliflower mosaic virus (CaMV).
    Corn lines 676, 678, and 680 are currently considered regulated 
articles under the regulations in 7 CFR part 340 because they contain 
gene sequences derived from the plant pathogen CaMV. The subject corn 
lines have been evaluated in field trials conducted since 1995 under 
APHIS notifications. In the process of reviewing the permit 
applications for the U.S. field trials of these corn lines, APHIS 
determined 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 the Federal Plant Pest Act, as amended (7 U.S.C. 150aa et seq.), 
``plant pest'' is defined as ``any living stage of: Any insects, mites, 
nematodes, slugs, snails, protozoa, or other invertebrate animals, 
bacteria, fungi, other parasitic plants or reproductive parts thereof, 
viruses, or any organisms similar to or allied with any of the 
foregoing, or any infectious substances, which can directly or 
indirectly injure or cause disease or damage in any plants or parts 
thereof, or any processed, manufactured or other products of plants.'' 
APHIS views this definition very broadly. The definition covers direct 
or indirect injury, disease, or damage not just to agricultural crops, 
but also to 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

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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 the genetically modified plants allow for a new use of an 
herbicide or involve a different use pattern for the herbicide, the EPA 
must approve the new or different use. In conducting such an approval, 
the EPA considers the possibility of adverse effects to human health 
and the environment from the use of this herbicide. The herbicide 
glufosinate is registered for use on corn in the United States. 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 the 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 the EPA under the 
FFDCA. The EPA has granted an exemption from the requirement of a 
tolerance for phosphinothricin acetyltransferase and the genetic 
material necessary for its production in corn and on all raw 
agricultural commodities.
    The 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 the 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. 
Pioneer has begun consultation with FDA on the subject corn lines.
    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 ADDRESSES 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. Based on the 
available 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 Pioneer's male sterile and 
glufosinate-tolerant corn lines 676, 678, and 680, and the availability 
of APHIS' written decision.

    Authority: 7 U.S.C. 150aa-150jj, 151-167, and 1622n; 31 U.S.C. 
9701; 7 CFR 2.17, 2.51, and 371.2(c).

    Done in Washington, DC, this 12th day of February 1998.
Craig A. Reed,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-4037 Filed 2-17-98; 8:45 am]
BILLING CODE 3410-34-P