[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 
[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 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