[Federal Register Volume 60, Number 109 (Wednesday, June 7, 1995)]
[Notices]
[Pages 30061-30062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13919]



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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. 60, No. 109 / Wednesday, June 7, 1995 / 
Notices  

[[Page 30061]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 95-041-1]


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 Monsanto Company 
seeking a determination of nonregulated status for a corn line 
designated as MON 80100 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 August 7, 1995.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 95-041-1, Regulatory Analysis and Development, PPD, APHIS, 
Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1237. Please 
state that your comments refer to Docket No. 95-041-1. 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. Ved Malik, 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) 734-7601.

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 April 3, 1995, APHIS received a petition (APHIS Petition No. 95-
093-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, 
requesting a determination of nonregulated status under 7 CFR part 340 
for an insect-resistant corn line designated as MON 80100. The Monsanto 
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 MON 80100 has been 
genetically engineered with the cryIA(b) gene that encodes for a 
CryIA(b) insect control protein derived from the common soil bacterium 
Bacillus thuringiensis subsp. kurstaki (Btk). 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 
effective against certain lepidopteran insects, including European corn 
borer (ECB). ECB is a major corn pest that reduces yield by disrupting 
normal plant physiology and causing damage to the leaves, stalks, and 
ears. Results of field tests conducted by Monsanto under permits and 
notifications granted by APHIS and under an experimental use permit 
obtained from the Environmental Protection Agency (EPA) indicate that 
corn plants producing the CryIA(b) protein were protected throughout 
the growing season from leaf and stalk feeding damage caused by ECB. In 
addition to expressing the CryIA(b) protein, the plants also express 
the selectable marker enzyme 5-enolpyruvylshikimate-3-phosphate 
synthase (CP4 EPSPS). The cryIA(b) gene and the CP4 EPSPS marker gene 
were introduced into the subject corn line by a particle acceleration 
method and their expression is under the control of the enhanced 35S 
promoter derived from the plant pathogen cauliflower mosaic virus.
    Monsanto's MON 80100 corn line 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 was evaluated in field trials conducted under APHIS permits or 
notifications from 1992 through 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 
[[Page 30062]] 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 exempted by EPA regulation. Accordingly, Monsanto has 
submitted to the EPA an application to register the transgenic plant 
pesticide Btk CryIA(b) insect control protein as produced in corn.
    Under the Federal Food, Drug, and Cosmetic Act (FFDCA) (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 the EPA under the FFDCA; the Food and Drug 
Administration (FDA) enforces the tolerances set by the EPA. Monsanto 
has also submitted to the EPA a pesticide petition (PP 5F4473) 
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.
    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 line 
to avoid duplication and ensure 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 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 Monsanto's MON 80100 corn line 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 1st day of June 1995.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-13919 Filed 6-6-95; 8:45 am]
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