[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
