[Federal Register Volume 60, Number 173 (Thursday, September 7, 1995)]
[Notices]
[Pages 46573-46574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22129]



 ========================================================================
 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. 60, No. 173 / Thursday, September 7, 1995 / 
Notices  


[[Page 46573]]


DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 95-067-1]


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 the Northrup King 
Company seeking a determination of nonregulated status for a corn line 
designated as Bt11 that has been genetically engineered for insect 
resistance. 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, 1995.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 95-067-1, 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. 95-067-1. 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.

FOR FURTHER INFORMATION CONTACT: Dr. Subhash Gupta, Biotechnologist, 
Biotechnology Permits, BBEP, APHIS, Suite 5B05, 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) 734-7612.

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 July 14, 1995, APHIS received a petition (APHIS Petition No. 95-
195-01p) from the Northrup King Company (Northrup King) of Golden 
Valley, MN, requesting a determination of nonregulated status under 7 
CFR part 340 for an insect resistant corn line designated as Bt11. The 
Northrup King 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 Bt11 has been genetically 
engineered to contain the cryIA(b) gene from Bacillus thuringiensis 
subsp. kurstaki (Btk), which expresses a delta-endotoxin insecticidal 
protein known to be effective against certain lepidopteran insects, 
including European corn borer. Corn line Bt11 also contains the pat 
gene isolated from Streptomyces viridochromogenes that encodes a 
phosphinothricin-N-acetyl transferase (PAT) enzyme. When introduced 
into a plant cell, the PAT enzyme inactivates the herbicide glufosinate 
and is used in corn line Bt11 as a selective marker. Expression of the 
introduced genes is controlled by the 35S promoter derived from the 
plant pathogen cauliflower mosaic virus and a NOS terminator derived 
from the nopaline synthase gene of Agrobacterium tumefaciens.
    Corn line Bt11 is currently considered a regulated article under 
the regulations in 7 CFR part 340 because it contains gene sequences 
derived from plant pathogenic sources. The subject corn line has been 
evaluated in field trials conducted since 1992 under permits or 
notifications issued by APHIS, and since 1993, field trials have also 
been conducted under an experimental use permit issued by the 
Environmental Protection Agency (EPA). In the process of reviewing the 
applications for field trials of the subject corn, APHIS determined 
that the vectors and other elements were disarmed and that the trials 
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.
    This genetically engineered corn line is also currently subject to 
regulation by other agencies. The 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 insecticides, be registered prior to distribution 
or sale, unless exempt by EPA regulation.
    Under the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 
301 et seq.), pesticides added to raw agricultural commodities 
generally are 

[[Page 46574]]
considered to be unsafe unless a tolerance or exemption from tolerance 
has been established. Foods containing unsafe pesticides are deemed to 
be adulterated. Residue tolerances for pesticides are established by 
EPA under the FFDCA; the Food and Drug Administration (FDA) enforces 
the tolerances set by EPA.
    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.
    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 Northrup King's corn line Bt11 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 30th day of August 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 95-22129 Filed 9-6-95; 8:45 am]

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