[Federal Register Volume 60, Number 113 (Tuesday, June 13, 1995)]
[Notices]
[Pages 31139-31140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-14382]



 ========================================================================
 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. 60, No. 113 / Tuesday, June 13, 1995 / 
Notices  

[[Page 31139]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 95-042-1]


Receipt of Petition for Determination of Nonregulated Status for 
Genetically Engineered Tomato Line

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 a tomato line 
designated as 8338 that has been genetically engineered for delayed 
ripening. 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 tomato 
line presents a plant pest risk.

DATES: Written comments must be received on or before August 14, 1995.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 95-042-1, Regulatory Analysis and Development, PPD, APHIS, 
Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1237. Please 
state that your comments refer to Docket No. 95-042-1. 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. Susan Koehler, 
Biotechnologist, Biotechnology Permits, BBEP, APHIS, 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) 734-7601.

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 February 22, 1995, APHIS received a petition (APHIS Petition No. 
95-053-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, 
requesting a determination of nonregulated status under 7 CFR part 340 
for a tomato line designated as 8338 that has been genetically 
engineered for delayed ripening. The Monsanto petition states that the 
subject tomato line shall not be regulated by APHIS because it does not 
present a plant pest risk.
    As described in the petition, tomato line 8338 has been genetically 
engineered to express the enzyme 1-aminocyclopropane-1-carboxylic acid 
deaminase (ACCd), which catalizes deamination of ACC, an essential 
precursor for ethylene biosynthesis. Levels of ethylene control the 
rate of fruit ripening, and removal of ACC in the subject tomato line 
reduces ethylene production and delays ripening. The accd gene, which 
confers the delayed-ripening trait, was isolated from the soil 
bacterium Pseudomonas chloroaphis, strain 6G5. Tomato line 8338 also 
contains the neomycin phosphotransferase (nptII) selectable marker gene 
which encodes the enzyme NPTII. The presence of the NPTII protein in 
the plant genome confers tolerance to the antibiotic kanamycin and 
allows selection of the transformed cells in the presence of kanamycin. 
Expression of the accd gene and the nptII gene is driven by 
constitutive 35S promoters derived from the plant pathogenic 
caulimoviruses figwort mosaic virus and cauliflower mosaic virus, 
respectively. The subject tomato line was transformed through the use 
of disarmed vectors from a common soil-borne bacterium, the plant 
pathogen Agrobacterium tumefaciens.
    Tomato line 8338 is currently considered a regulated article under 
the regulations in 7 CFR part 340 because it contains the 35S promoters 
and 3' regulatory gene sequences derived from the plant pathogens 
mentioned above, and because A. tumefaciens was used as the plant 
transformation vector. Tomato line 8338 was evaluated in field trials 
conducted under APHIS permits or notifications since 1992. In the 
process of reviewing the applications for those field trials, APHIS 
determined that the vectors and other elements were disarmed and that 
the trials, which were conducted under conditions of reproductive 
confinement, 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.
    Food or animal feed uses of the subject tomato line may be subject 
to [[Page 31140]] regulation by the Food and Drug Administration (FDA) 
under the authority of the Federal Food, Drug, and Cosmetic Act (FFDCA) 
(21 U.S.C. 301 et seq.). The 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 the 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 completed its 
consultation with the FDA on the food safety of the subject tomato 
line.
    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 tomato line 8338 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 2.17, 2.51, and 371.2(c).

    Done in Washington, DC, this 5th day of June 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-14382 Filed 6-12-95; 8:45 am]
BILLING CODE 3410-34-M