[Federal Register Volume 63, Number 35 (Monday, February 23, 1998)]
[Notices]
[Pages 8897-8898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4492]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 97-119-1]
AgrEvo USA Co.; 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.
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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from AgrEvo USA Company
seeking a determination of nonregulated status for corn designated as
Transformation Event CBH-351, 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 presents a plant pest risk.
DATES: Written comments must be received on or before April 24, 1998.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 97-119-1, 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. 97-119-1. 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
to facilitate entry into the reading room.
FOR FURTHER INFORMATION CONTACT: Dr. Susan Koehler, Biotechnology and
Biological Analysis, 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:
mkpeterson@aphis.usda.gov.
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 September 22, 1997, APHIS received a petition (APHIS Petition
No. 97-265-01p) from AgrEvo USA Company (AgrEvo) of Wilmington, DE,
requesting a determination of nonregulated status under 7 CFR part 340
for corn designated as
[[Page 8898]]
Transformation Event CBH-351 (event CBH-351), which has been
genetically engineered for insect resistance and tolerance to the
herbicide glufosinate. The AgrEvo 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, event CBH-351 corn has been
genetically engineered to express a Cry9C insecticidal protein derived
from the common soil bacterium, Bacillus thuringiensis subsp. tolworthi
(Bt tolworthi). The petitioner states that the Cry9C protein is
effective in controlling the larvae of the European corn borer during
the complete growing season. The subject corn also contains the bar
gene derived from the bacterium Streptomyces hygroscopicus. The bar
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 (PA91 x H99) x H99. While the
subject corn contains the bla selectable marker gene, which is normally
expressed in bacteria, tests indicate that this gene is not expressed
in the plant.
Event CBH-351 corn 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 1995 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 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.
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. A pesticide petition has been filed with
EPA to establish a regulation for an exemption from the requirement of
a tolerance for residues of Bt tolworthi Cry9C 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.
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 AgrEvo's insect resistant and
glufosinate-tolerant corn event CBH-351 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 2.22, 2.80, and 371.2(c).
Done in Washington, DC, this 18th day of February 1998.
Craig A. Reed,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-4492 Filed 2-20-98; 8:45 am]
BILLING CODE 3410-34-P
