[Federal Register Volume 60, Number 34 (Tuesday, February 21, 1995)]
[Notices]
[Pages 9656-9657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4182]



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Notices
                                                Federal Register
________________________________________________________________________

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. 34 / Tuesday, February 21, 1995 / 
Notices

[[Page 9656]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 95-007-1]


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 Ciba Seeds seeking a 
determination of nonregulated status for corn designated as ``Event 176 
Corn'' 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 presents a plant pest risk.

DATES: Written comments must be received on or before April 24, 1995.

ADDRESSES: Please send an original and there copies of your comments to 
Docket No. 95-007-1, 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. 95-007-01. 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. Ved Malik, Biotechnologist, 
Animal and Plant Health Inspection Service, Biotechnology, 
Biologics, and Environmental Protection, Biotechnology Permits, 
4700 River Road Unit 147, Riverdale, MD 20737-1237. The telephone 
number of the agency will change when agency offices in 
Hyattsville, MD, move to Riverdale, MD, during February. Telephone: 
(301) 436-7612 (Hyattsville): (301) 734-7612 (Riverdale). To obtain 
a copy of the petition, contact Ms. Kay Peterson at (301) 436-7601 
(Hyattsville) or (301) 734-7601 (Riverdale).

SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340, 
``Information 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 November 15, 1994, APHIS received a petition (APHIS Petition No. 
94-319-01p) from Ciba Seeds (a division of Ciba-Geigy Corporation) of 
Research Triangle Park, NC, requesting a determination of nonregulated 
status under 7 CFR part 340 for insect-resistant corn designated as 
``Event 176 Corn.'' Event 176 Corn is genetically engineered with the 
synthetic gene that codes for an insecticidal protein naturally 
produced by Bacillus thuringiensis subsp. kurstaki (Btk). The Ciba 
Seeds petition states that the subject corn should not be regulated by 
APHIS because it does not present a plant pest risk.
    As described in the petition, the subject corn was genetically 
engineered to produce an insect control protein representing a 
truncated form of the CryIA(b) protein that occurs naturally in Btk, a 
common gram-positive soil bacterium. This protein is a member of a 
class of insecticidal proteins, also known as delta-endotoxins, that 
are produced as parasporal crystals by B. thuringiensis in nature, and 
are known to be quite selective in their toxicity to specific 
organisms, while nontoxic to all other organisms.
    Btk proteins are very effective against certain lepidopteran 
(caterpillar) insects, including European corn borer (ECB) (Ostrinia 
nubilalis (Hubner)). ECB is a major corn pest that reduces yield by 
disrupting normal plant physiology and causing physical damage to the 
plant and ear that results in stalk lodging, dropped ears, and damaged 
grain. Results of field tests conducted by Ciba Seeds under permits 
granted by AHPIS and the Environmental Protection Agency (EPA) indicate 
that corn plants producing the CryIA(b) protein are quite effective in 
controlling ECB. The corn plants under evaluation preferentially 
express the insect control protein in leaf tissue and pollen (both 
feeding sources for ECB), while minimizing its production in other 
plant tissues, including kernels, where it is not needed for control of 
the target pest.
    As described in the petition, the cryIA(b) gene expressed in the 
transgenic corn plants encodes a protein that is identical to the first 
648 amino acids of the full-length, 1,155-amino-acid CryIA(b) protein 
that occurs in nature. This truncated protein contains the portion of 
the native protein that is responsible for its insecticidal activity. 
Two different tissue-specific promoters, both derived from corn, confer 
protein expression in green tissue and pollen, respectively. In 
addition to expressing the CryIA(b) protein, the plants also express 
the enzyme phosphinothricin acetyltransferase, currently used in the 
plant as a selectable marker. Expression of the selectable market gene 
is regulated by the 35S promoter, while expression of the CryIA(b) 
protein is controlled in part by the 35S terminator. The 35S promoter 
and the 35S terminator are derived from the plant pathogen cauliflower 
mosaic virus.
    Ciba Seeds' Event 176 Corn is currently considered a regulated 
article under the regulations in 7 CFR part 340 because it contains 
gene sequences [[Page 9657]] (vectors, promoters, and terminators) 
derived from plant pathogenic sources. Event 176 Corn was 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 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 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 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. Accordingly, Ciba Seeds has 
submitted to the EPA an application to register this transgenic plant 
pesticide, the Btk CryIA(b) insect control protein as produced in corn. 
On January 13, 1995, EPA announced receipt of this application (EPA 
File Symbol 66736-R) in the Federal Register (60 FR 3209; OPP-30377; 
FRL-4928-9).
    Under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.), pesticides added to raw agricultural commodities generally are 
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 Federal Food, Drug, and Cosmetic Act; the Food and Drug 
Administration (FDA) enforces the tolerances set by the EPA. Ciba Seeds 
has also submitted to the EPA a pesticide petition (pp 4F4395) 
proposing to amend 40 CFR part 180 to establish a tolerance exemption 
for residues of the plant pesticide active ingredient B. thuringiensis 
delta-endotoxin as produced in corn by a cryIA(b) gene and its 
controlling sequences. On February 1, 1995, EPA announced receipt of 
this petition in the Federal Register (60 FR 6092-6093; PF-618; FRL-
4930-3).
    Consistent with the ``Coordinated Framework for Regulation of 
Biotechnology'' (51 FR 23302-23350, June 26, 1986), APHIS and the EPA 
are coordinating their review of this genetically engineered corn to 
avoid duplication and assure that all relevant issues are addressed.
    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 
authority for ensuring food safety under the Federal Food, Drug, and 
Cosmetic Act, 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 
avaible 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 Ciba Seeds' Event 176 Corn 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 13th day of February 1995.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-4182 Filed 2-17-95; 8:45 am]
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