[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
________________________________________________________________________
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]
BILLING CODE 3410-34-M
