[Federal Register Volume 65, Number 173 (Wednesday, September 6, 2000)]
[Notices]
[Pages 53976-53977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22807]
========================================================================
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.
========================================================================
Federal Register / Vol. 65 , No. 173 / Wednesday, September 6, 2000 /
Notices
[[Page 53976]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 00-070-1]
Mycogen c/o Dow and Pioneer; Receipt of Petition for
Determination of Nonregulated Status for Corn Genetically Engineered
for Insect Resistance and Glufosinate Herbicide Tolerance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from Mycogen Seeds c/o Dow
AgroSciences LLC and Pioneer Hi-Bred International, Inc., seeking a
determination of nonregulated status for corn designated as line 1507,
which has been genetically engineered for insect resistance and
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 line presents a plant pest risk.
DATES: Written comments must be received on or before November 6, 2000.
ADDRESSES: Please send your comment and three copies to: Docket No. 00-
070-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03,
4700 River Road Unit 118, Riverdale, MD 20737-1238.
Please state that your comment refers to Docket No. 00-070-1.
You may read any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue, SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Susan Koehler, Biotechnology
Assessments Section, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147,
Riverdale, MD 20737-1236; (301) 734-4886. To obtain a copy of the
petition, contact Ms. Kay Peterson at (301) 734-4885; e-mail:
[email protected].
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 May 15, 2000, APHIS received a petition (APHIS Petition No. (00-
136-01p) from Mycogen Seeds c/o Dow AgroSciences LLC (Mycogen c/o Dow)
of Indianapolis, IN, and Pioneer Hi-Bred International, Inc. (Pioneer)
of Johnston, IA, requesting a determination of nonregulated status
under 7 CFR part 340 for corn designated as Zea mays L. cultivar line
1507 (line 1507), which has been genetically engineered for resistance
to certain lepitopteran insect species and tolerance to the herbicide
glufosinate. The Mycogen c/o Dow and Pioneer 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 1507 has been genetically
engineered to express a Cry1F insecticidal protein derived from the
common soil bacterium, Bacillus thuringiensis subsp. aizawai (Bt
aizawai). The petitioners state that the Cry1F protein is effective in
controlling the larvae of such common pests of corn as European corn
borer, southwestern corn borer, black cutworm, and fall armyworm. The
subject corn line also contains the pat gene derived from the bacterium
Streptomyces viridochromogenes. The pat gene encodes the
phosphinothricin acetyltransferase (PAT) protein, which confers
tolerance to the herbicide glufosinate. Expression of these added genes
is controlled in part by gene sequences from the plant pathogens
cauliflower mosaic virus and Agrobacterium tumefaciens. Microprojectile
bombardment was used to transfer the added genes into the recipient
inbred corn line Hi-II.
Corn line 1507 has been considered a regulated article under the
regulations in 7 CFR part 340 because it contains gene sequences from
plant pathogens. This corn has been field tested since 1997 in the
United States under APHIS notifications. In the process of reviewing
the notifications 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 Sec. 403 of the Plant Protection Act (Title IV, Pub. L. 106-224,
114 Stat. 438, 7 U.S.C. 7701-7772), plant pest is defined as any living
stage of any of the following that can directly or indirectly injure,
cause damage to, or cause disease in any plant or plant product: A
protozoan, a nonhuman animal, a parasitic plant, a bacterium, a fungus,
a virus or viroid, an infectious agent or other pathogen, or any
article similar to or allied with any of the foregoing. APHIS views
this definition very broadly. The definition covers direct or indirect
injury, disease, or damage not just to agricultural crops, but also to
[[Page 53977]]
plants in general, for example, native species, as well as to organisms
that may be beneficial to plants, for example, honeybees, rhizobia,
etc.
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. 136 et seq.). FIFRA
requires that all pesticides, including herbicides, be registered prior
to distribution or sale, unless exempt by EPA regulation. In cases in
which 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. 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 EPA under the Federal
Food, Drug and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 et
seq.), and the Food and Drug Administration (FDA) enforces tolerances
set by EPA under the FFDCA. Pesticide petitions have been filed with
EPA to establish a regulation for an exemption from the requirement of
a tolerance for residues of Bt aizawai Cry1F and the genetic material
necessary for its production in or on all raw agricultural commodities.
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 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. The
petitioner has begun consultation with FDA on the subject corn line.
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 FOR FURTHER INFORMATION CONTACT 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. After analyzing the
available information, including comments received from the public,
APHIS will prepare an environmental assessment to examine any potential
environmental impacts associated with a determination of nonregulated
status for the subject corn line. The environmental assessment will be
made available for public comment for a period of 30 days. After
reviewing and evaluating the comments on the environmental assessment
and other data and 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 the Mycogen c/o Dow and
Pioneer insect-resistant and glufosinate-tolerant corn line 1507 and
the availability of APHIS' written decision.
Authority: Title IV, Pub. L. 106-224, 114 Stat. 438, 7 U.S.C.
7701-7772; 7 U.S.C. 166 and 1622n; 31 U.S.C. 9701; 7 CFR 2.22, 2.80,
and 371.3.
Done in Washington, DC, this 30th day of August 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-22807 Filed 9-5-00; 8:45 am]
BILLING CODE 3410-34-P