AgrEvo USA Co.; Receipt of Petition for Determination of Nonregulated Status for Rice Genetically Engineered for Glufosinate Herbicide Tolerance

[Federal Register Volume 64, Number 16 (Tuesday, January 26, 1999)]
[Notices]
[Pages 3924-3925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1783]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 98-126-1]


AgrEvo USA Co.; Receipt of Petition for Determination of 
Nonregulated Status for Rice Genetically Engineered for 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 certain rice 
transformation events, which have been genetically engineered for 
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 
these rice transformation events present a plant pest risk.

DATES: Written comments must be received on or before March 29, 1999.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 98-126-1, 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. 98-126-1. 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. David Heron, Biotechnology and 
Biological Analysis, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-5141. To obtain a copy of the 
petition, contact Ms. Kay Peterson at (301) 734-4885; e-mail: 
Kay.Peterson@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 November 25, 1998, APHIS received a petition (APHIS Petition No. 
98-329-01p) from AgrEvo USA Company (AgrEvo) of Wilmington, DE, 
requesting a determination of nonregulated status under 7 CFR part 340 
for rice (Oryza sativa L.) designated as Liberty Link R Rice 
Transformation Events LLRICE06 and LLRICE62 (rice transformation events 
LLRICE06 and LLRICE62), which have been genetically engineered for 
tolerance to the herbicide glufosinate. The AgrEvo petition states that 
the subject rice transformation events should not be regulated by APHIS 
because they do not present a plant pest risk.
    As described in the petition, rice transformation events LLRICE06 
and LLRICE62 have been genetically engineered to contain the bar gene 
derived from Streptomyces hygroscopicus, strain HP632. The bar gene 
encodes the enzyme phosphinothricin-N-acetyltransferase (PAT), which 
confers tolerance to the herbicide glufosinate. Expression of the bar 
gene is controlled by 35S promoter and terminator sequences derived 
from the plant pathogen cauliflower mosaic virus. The direct gene 
transfer method was used to transfer the added genes into the parental 
rice varieties, M202 (LLRICE06) and Bengal (LLRICE62).

[[Page 3925]]

    The subject rice transformation events have been considered 
regulated articles under the regulations in 7 CFR part 340 because they 
contain gene sequences from a plant pathogen. Rice transformation 
events LLRICE06 and LLRICE62 have been field tested in the United 
States since 1997 under APHIS notifications. In the process of 
reviewing the notifications for the field trials of this rice, APHIS 
determined 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.
    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. AgrEvo 
has begun consultation with FDA on the subject rice transformation 
events.
    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 rice transformation events 
LLRICE06 and LLRICE62, 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 20th day of January 1999.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-1783 Filed 1-25-99; 8:45 am]
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