[Federal Register Volume 60, Number 38 (Monday, February 27, 1995)]
[Notices]
[Pages 10537-10538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4741]



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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 95-011-1]


Receipt of Petition for Determination of Nonregulated Status for 
Genetically Engineered Corn

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 AgrEvo USA Company 
seeking a determination of nonregulated status for corn designated as 
``Glufosinate Resistant Corn Transformation Events T14 and T25'' 
genetically engineered for 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 presents a plant pest risk.

DATES: Written comments must be received on or before April 28, 1995.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 95-011-1, Animal and Plant Health Inspection Service, Policy 
and Program Development, Regulatory Analysis and Development, 4700 
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your 
comments refer to Docket No. 95-011-01. 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.

FOR FURTHER INFORMATION CONTACT:
Dr. David Heron, Biotechnologist, Animal and Plant Health Inspection 
Service, Biotechnology, Biologics, and Environmental Protection, 
Biotechnology Permits, 4700 River Road Unit 147, Riverdale, MD 20737-
1237; (301) 734-7612. To obtain a copy of the petition, contact Ms. Kay 
Peterson at (301) 734-7601.

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 23, 1994, APHIS received a petition (APHIS Petition No. 
94-357-01p) from AgrEvo Company USA (AgrEvo) of Wilmington, DE, 
requesting a determination of nonregulated status under 7 CFR part 340 
for herbicide-tolerant corn designed as ``Gulfosinate Resistant Corn 
(GRC) Transformation Events T14 and T25.'' As described in the 
petition, GRC Events T14 and T25 are yellow dent corn plants 
genetically engineered with a stably integrated gene that encodes the 
enzyme phosphinothricin-N-aceyltransferase (PAT). The PAT enzyme 
catalyzes the conversion of L-phosphinothricin, the active ingredient 
in gulfosinate-ammonium, to an inactive form, thereby conferring 
resistance to herbicides in the phosphinothricin class. The PAT gene in 
GRC Events T14 and T25 is a synthetic version of the gene isolated from 
the bacterium Streptomyces viridochromogenes. Expression of the pat 
gene is regulated by the 35S promoter and the 35S terminator derived 
from the plant pathogen cauliflower mosaic virus.
    The subject of corn is currently considered a regulated article 
under the regulations in 7 CFR part 340 because it contains gene 
sequences (promoters, and terminators) derived from a plant pathogen. 
GRC Events T14 and T25 [[Page 10538]] were evaluated in field trials 
conducted under APHIS permits in 1992 and 1993, and under APHIS 
notifications in 1993 and 1994. In the process of reviewing the 
applications for those field trials, APHIS determined that these plants 
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 insect, 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.

    Several issues associated with GRC Events T14 and T25 are also 
currently subject to regulation by other agencies. 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. 135 et seq.). FIFRA requires that all 
pesticides, including herbicides, be registered prior to distribution 
or sale, unless exempt by regulation. Plants that have been genetically 
modified for tolerance or resistant to herbicides are not regulated 
under FIFRA because the plants themselves are not themselves considered 
pesticides.

    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, EPA must approve the new or different use. In conducting 
such an approval, EPA considers the possibility of adverse effects to 
human health and the environment from the use of this herbicide.

    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 
(FEDCA) (21 U.S.C. 201 et seq.), and the Food and Drug Administration 
(FDA) enforces tolerances set by the EPA under the FFDCA.

    The FDA publishes a statement of policy on foods derived from new 
plant varities 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 varities, including 
those developed through the techniques of genetic engineering.

    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 AgrEvo's GRC Events T14 and T25 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 21st day of February 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 95-4741 Filed 2-24-95; 8:45 am]

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