[Federal Register Volume 61, Number 15 (Tuesday, January 23, 1996)]
[Notices]
[Pages 1743-1744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-871]
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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.
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Federal Register / Vol. 61, No. 15 / Tuesday, January 23, 1996 /
Notices
[[Page 1743]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 95-097-1]
Agritope, Inc.; Receipt of Petition for Determination of
Nonregulated Status for Cherry Tomato Line Genetically Engineered for
Modified Fruit Ripening
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 Agritope, Inc., seeking
a determination of nonregulated status for a cherry tomato line
designated as 35-1-N that has been genetically engineered for modified
fruit 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 cherry
tomato line presents a plant pest risk.
DATES: Written comments must be received on or before March 25, 1996.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 95-097-1, 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. 95-097-1. 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. Ved Malik, 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 November 20, 1995, APHIS received a petition (APHIS Petition No.
95-324-01p) from Agritope, Inc., (Agritope) of Beaverton, OR,
requesting a determination of nonregulated status under 7 CFR part 340
for a cherry tomato line designated as 35-1-N (line 35-1-N) that has
been genetically engineered to contain a gene that alters fruit
ripening. The Agritope petition states that cherry tomato line 35-1-N
should not be regulated by APHIS because it does not present a plant
pest risk.
As described in the petition, line 35-1-N has been genetically
engineered to contain the sam-k gene derived from Escherichia coli
bacteriophage T3 that encodes an enzyme, S-adenosylmethionine hydrolase
(SAMase), which alters the ethylene biosynthetic pathway and delays
ripening of the tomato on the vine. The fruit of line 35-1-N ripen
normally when exposed to exogenous ethylene. The subject tomato line
also contains 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 added genes is
controlled by the untranslated 3' region of the nopaline synthase gene
from Agrobacterium tumefaciens. The modified E8 gene promoter from
tomatoes is used to drive the sam-k gene in a developmentally regulated
manner. The A. tumefaciens vector system was used to transfer the
construct pAG-5420 containing the DNA elements described above into the
Large Red Cherry parental line.
Line 35-1-N has been considered a regulated article under the
regulations in 7 CFR part 340 because it contains gene sequences from
the plant pathogen A. tumefaciens. The subject cherry tomato line has
been evaluated in field trials conducted since 1992 under APHIS permits
or notifications. In the process of reviewing the applications for
field trials of line 35-1-N, 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 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 Food and Drug Administration (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 Federal
[[Page 1744]]
Food, Drug, and Cosmetic Act (21 U.S.C. 201 et seq.), 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.
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 Agritope's cherry tomato line 35-1-
N 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 17th day of January 1996.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-871 Filed 1-22-96; 8:45 am]
BILLING CODE 3410-34-P
