[Federal Register Volume 61, Number 14 (Monday, January 22, 1996)]
[Notices]
[Pages 1557-1558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-661]



 ========================================================================
 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. 61, No. 14 / Monday, January 22, 1996 / 
Notices  

[[Page 1557]]


DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 95-090-1]


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

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 the Monsanto Company 
seeking a determination of nonregulated status for certain potato lines 
genetically engineered for resistance to the Colorado potato beetle. 
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 March 22, 1996.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 95-090-1, 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. 95-090-1. 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.

FOR FURTHER INFORMATION CONTACT: Dr. James Lackey, Biotechnology 
Permits, BBEP, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, 
MD 20737-1237; (301) 734-7612. To obtain a copy of the petition, 
contact Ms. Kay Peterson at (301) 734-7612.

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 December 4, 1995, APHIS received a petition (APHIS Petition No. 
95-338-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, 
requesting a determination of nonregulated status under 7 CFR part 340 
for two Superior potato lines (SPBT02-5 and SPBT02-7) which have been 
transformed with plasmid vector PV-STBT02. On December 15, 1995, APHIS 
received Monsanto's amendment to its petition to include five Atlantic 
potato lines (ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31 and ATBT04-36) 
transformed with plasmid vector PV-STBT04. Plasmid vectors PV-STBT02 
and PV-STBT04 confer resistance to the Colorado potato beetle (CPB). 
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, the two Superior potato lines 
transformed with plasmid vector PV-STBT02 and the five Atlantic potato 
lines transformed with plasmid vector PV-STBT04 have been genetically 
engineered to contain the cryIIIA gene from the common soil bacterium 
Bacillus thuringiensis subsp. tenebrionis (Btt), which encodes a delta-
endotoxin insect control protein that is effective against CPB. The 
components of the two plasmid vectors, PV-STBT02 and PV-STBT04, are 
identical with the exception of the promoter for the cryIIIA gene. In 
the two Superior potato lines transformed with plasmid vector PV-
STBT02, expression of the cryIIIA gene is controlled by the enhanced 
cauliflower mosaic virus (CaMV) 35S promoter and the nontranslated 
region of the pea small subunit of ribulose-1,5-bisphosphate 
carboxylase. In the five Atlantic potato lines transformed with plasmid 
vector PV-STBT04, the second chimeric gene consists of the Arabidopsis 
thaliana ribulose-1,5-bisphosphate carboxylase small subunit ats1A 
promoter.
    The subject potato lines also contain the nptII gene from the 
prokaryotic transposon Tn5 which encodes the enzyme neomycin 
phosphotransferase II and is used as a selectable marker for 
transformation. Expression of the nptII gene in the two Superior and 
five Atlantic potato lines is controlled by the CaMV 35S promoter and 
the 3' region of the nopaline synthase gene. The genes used to develop 
the subject potato lines were stably transferred into the genome of 
potato plants through the use of an Agrobacterium tumefaciens 
transformation system.
    Plasmid vector PV-STBT02 is the same vector used to transform the 
seven Russet Burbank potato lines for which APHIS issued a 
determination of nonregulated status on March 2, 1995 (60 FR 13108-
13109, March 10, 1995). However, unlike the Russet Burbank potato 
variety, which is male sterile, Superior and Atlantic potato varieties 
are male fertile.
    The subject Superior and Atlantic potato lines have been considered 
regulated articles under the regulations in 7 CFR part 340 because they 
contain gene sequences derived from plant pathogens. The subject potato 
lines have been evaluated in field trials conducted since 1992 under 
APHIS permits or notifications. In the process of reviewing the 
applications for field trials of these 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 

[[Page 1558]]
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 insecticides, be registered 
prior to distribution or sale, unless exempt by EPA regulation. Residue 
tolerances for pesticides are established by EPA under the Federal 
Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 201 et seq.), and the 
Food and Drug Administration (FDA) enforces tolerances set by EPA under 
the FFDCA. EPA announced issuance of a conditional registration to 
Monsanto on May 5, 1995, for full commercialization of the plant 
pesticide Btt CryIII(A) delta endotoxin and the genetic material 
necessary for its production in potato. In addition to the 
registration, EPA also issued an exemption from the requirement of a 
tolerance for residues of the subject plant pesticide in potatoes on 
May 3, 1995 (60 FR 21725-21728), as requested by Monsanto.
    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 completed its consultations with FDA for Russet Burbank potato 
lines containing the Btt cryIII(A) gene and has initiated consultations 
with FDA for the Superior and Atlantic potato lines that are the 
subject of this notice.
    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 Superior potato lines SPBT02-5 and SPBT02-7 and Atlantic 
potato lines ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31, and ATBT04-36, 
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 11th day of January 1996.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-661 Filed 1-19-96; 8:45 am]
BILLING CODE 3410-34-P