[Federal Register Volume 61, Number 23 (Friday, February 2, 1996)]
[Notices]
[Pages 3899-3900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2259]
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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. 23 / Friday, February 2, 1996 /
Notices
[[Page 3899]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 96-002-1]
Asgrow Seed Co.; Receipt of Petition for Determination of
Nonregulated Status for Squash Line Genetically Engineered for 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 the Asgrow Seed Company
seeking a determination of nonregulated status for a squash line
designated as CZW-3 that has been genetically engineered for virus
resistance. 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 squash
line presents a plant pest risk.
DATES: Written comments must be received on or before April 2, 1996.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 96-002-1, 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. 96-002-1. 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 White, 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 18, 1995, APHIS received a petition (APHIS Petition No.
95-352-01p) from the Asgrow Seed Company (Asgrow) of Kalamazoo, MI,
requesting a determination of nonregulated status under 7 CFR part 340
for a yellow crookneck squash line designated as CZW-3 (line CZW-3)
that has been genetically engineered to contain genes that confer virus
resistance. The Asgrow petition states that squash line CZW-3 should
not be regulated by APHIS because it does not present a plant pest
risk.
As described in the petition, line CZW-3 has been genetically
engineered to contain the coat protein genes from cucumber mosaic
virus, watermelon mosaic virus 2, and zucchini yellow mosaic virus for
resistance to these three viruses. The subject squash 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 35S promoters and terminators from the plant pathogen
cauliflower mosaic virus. The Agrobacterium tumefaciens vector system
was used to transfer the plasmid containing the DNA elements described
above into the yellow crookneck squash parental line.
Line CZW-3 has been considered a regulated article under the
regulations in 7 CFR part 340 because it contains gene sequences from
plant pathogens. The subject squash line has been evaluated in field
trials conducted in 1993 and 1994 under APHIS permits. In the process
of reviewing the applications for field trials of line CZW-3, 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 Food, Drug, and Cosmetic Act, 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.
[[Page 3900]]
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 Asgrow's yellow crookneck squash
line CZW-3 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 30th day of January 1996.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-2259 Filed 2-1-96; 8:45 am]
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