[Federal Register Volume 62, Number 224 (Thursday, November 20, 1997)]
[Notices]
[Pages 61961-61962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30508]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 97-094-1]


Monsanto Co.; Receipt of Petition for Determination of 
Nonregulated Status for Potato Lines Genetically Engineered for Insect 
and Virus Resistance

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 Monsanto Company 
seeking a determination of nonregulated status for certain potato lines 
genetically engineered for resistance to the Colorado potato beetle and 
potato leaf roll virus. 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 potato 
lines present a plant pest risk.

DATES: Written comments must be received on or before January 20, 1998.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 97-094-1, 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. 97-094-1. 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. James White, Biotechnology 
Evaluation, BSS, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-5940. 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 July 23, 1997, APHIS received a petition (APHIS Petition No. 97-
204-01p) from Monsanto Company (Monsanto) of St. Louis, MO, requesting 
a determination of nonregulated status under 7 CFR part 340 for seven 
NewLeaf Plus Russet Burbank potato lines (RBMT21-129, 
RBMT21-152, RBMT21-350, RBMT22-82, RBMT22-186, RBMT22-238, RBMT22-262), 
which have genetically engineered for resistance to the Colorado potato 
beetle (CPB) and potato leaf roll virus (PLRV). The Monsanto petition 
states that the subject potato lines should not be regulated by APHIS 
because they do not present a plant pest risk.
    As described in the petition, all seven of the subject Russet 
Burbank potato lines have been genetically engineered to contain the 
cryIIIA gene from Bacillus thuringiensis subsp. tenebrionis (Btt), 
which encodes an insecticidal protein that is effective against CPB, 
and the PLRV replicase gene (PLRVrep), which imparts resistance to 
PLRV. In addition to the cryIIIA gene and the PLRVrep gene, these 
potato lines contain either the nptII selectable marker gene (RBMT21-
129, RBMT21-152, and RBMT21-350) or the CP4 EPSPS selectable marker 
gene (RBMT22-82, RBMT22-186, RBMT22-238, and RBMT22-262). The subject 
potato lines were developed through the use of the Agrobacterium 
tumefaciens transformation system, and expression of the introduced 
genes is controlled in part by gene sequences derived from the plant 
pests A. tumefaciens and Figwort mosaic virus.
    The subject potato lines have been considered regulated articles 
under the regulations in 7 CFR part 340 because they contain gene 
sequences derived from plant pests. These potato lines have been 
evaluated in field trials conducted since 1994 under APHIS permits. In 
the process of reviewing the applications for field trials of the 
subject potato lines, 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

[[Page 61962]]

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 insecticides, be registered 
prior to distribution or sale, unless exempt by EPA regulation. In this 
regard, EPA has issued a registration to Monsanto for full 
commercialization of the plant pesticide Btt Cry III(A) delta endotoxin 
and the genetic material necessary for its production in potato. 
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. In addition to the registration, 
EPA has issued exemptions from the requirement of a tolerance for 
residues of the subject plant pesticide CryIII(A) in potatoes, for the 
NPTII and CP4 EPSPS proteins as plant pesticide inert ingredients in 
all plants, and for the PLRV replicase protein 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. 
Monsanto has entered into consultation with FDA on the subject potato 
lines.
    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 NewLeaf Plus 
Russet Burbank potato lines RBMT21-129, RBMT21-152, RBMT21-350, RBMT22-
82, RBMT22-186, RBMT22-238, RBMT22-262 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 14th day of November 1997.
Craig A. Reed,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-30508 Filed 11-19-97; 8:45 am]
BILLING CODE 3410-34-P