Aventis CropScience; Availability of Environmental
To unsubscribe please go to:
http://www.epa.gov/fedreg/subscribe.htm
http://www.epa.gov/fedreg/
======================================================
[Federal Register: March 1, 2002 (Volume 67, Number 41)]
[Notices]
[Page 9431-9432]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01mr02-27]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 01-101-1]
Aventis CropScience; Availability of Environmental Assessment for
Extension of Determination of Nonregulated Status for Canola
Genetically Engineered for Glufosinate Herbicide Tolerance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that an environmental assessment
has been prepared for a proposed decision to extend to one additional
canola event our determination that a canola event developed by Aventis
CropScience, which has been genetically engineered for tolerance to the
herbicide glufosinate, is no longer considered a regulated article
under our regulations governing the introduction of certain genetically
engineered organisms. We are making this environmental assessment
available to the public for review and comment.
DATES: We will consider all comments we receive that are postmarked,
delivered, or e-mailed by April 1, 2002.
ADDRESSES: You may submit comments by postal mail/commercial delivery
or by e-mail. If you use postal mail/commercial delivery, please send
four copies of your comment (an original and three copies) to: Docket
No. 01-101-1, Regulatory Analysis and Development, PPD, APHIS, Station
3C71, 4700 River
[[Page 9432]]
Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment
refers to Docket No. 01-101-1. If you use e-mail, address your comment
to <A
HREF="mailto:regulations@aphis.usda.gov">regulations@aphis.usda.gov</A>. Your
comment must be contained in the
body of your message; do not send attached files. Please include your
name and address in your message and ``Docket No. 01-101-1'' on the
subject line.
You may read the extension request, the environmental assessment,
and any comments that we receive on this docket in our reading room.
The reading room is located in room 1141 of the USDA South Building,
14th Street and Independence Avenue SW., Washington, DC. Normal reading
room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except
holidays. To be sure someone is there to help you, please call (202)
690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
<A
HREF="http://www.aphis.usda.gov/ppd/rad/webrepor.html">http://www.aphis.usda.gov/ppd/rad/webrepor.html</A>.
FOR FURTHER INFORMATION CONTACT: Dr. Hanu Pappu, Plant Protection and
Quarantine, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-5299. To obtain a copy of the extension request
or the environmental assessment, contact Ms. Kay Peterson at (301) 734-
4885; e-mail: <A
HREF="mailto:Kay.Peterson@aphis.usda.gov">Kay.Peterson@aphis.usda.gov</A>.
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. Further, the regulations in Sec. 340.6(e)(2) provide that
a person may request that APHIS extend a determination of nonregulated
status to other organisms.
Such a request must include information to establish the similarity of
the antecedent organism and the regulated article in question.
Background
On July 25, 2001, APHIS received a request for an extension of a
determination of nonregulated status (APHIS No. 01-206-02p) from
Aventis CropScience (Aventis) of Research Triangle Park, NC, for a
canola (Brassica napus L.) transformation event designated as Topas 19/
2 (event Topas 19/2), which has been genetically engineered for
tolerance to the herbicide glufosinate. The Aventis request seeks an
extension of a determination of nonregulated status issued for
glufosinate-tolerant canola transformation event T45, the antecedent
organism, in response to APHIS petition number 97-205-01p (see 63 FR
6703-6704, Docket No. 97-091-2, published February 10, 1998). Based on
the similarity of canola event Topas 19/2 to the antecedent organism,
Aventis requests a determination that glufosinate-tolerant canola event
Topas 19/2 does not present a plant pest risk and, therefore, is not a
regulated article under APHIS' regulations in 7 CFR part 340.
Analysis
Like the antecedent organism, canola event Topas 19/2 has been
genetically engineered to contain a pat gene derived from Streptomyces
viridochromogenes. The pat gene encodes the enzyme phosphinothricin-N-
acetyltransferase (PAT), which confers tolerance to the herbicide
glufosinate. The subject canola event and the antecedent organism were
developed through use of the Agrobacterium tumefaciens method, and
expression of the added genes in Topas 19/2 and the antecedent organism
is controlled in part by gene sequences derived from the plant pathogen
cauliflower mosaic virus. In summary, the Aventis extension request
states that canola event Topas 19/2 and the antecedent organism contain
the same genetic elements with the exception of the antibiotic
resistance marker gene nptII in Topas 19/2, which was used as a
transformant selection tool during the developmental process. The
parental variety used to develop the antecedent organism was the B.
napus var. AC EXCEL, while the B. Napus cultivar Topas was used for
transforming canola event Topas 19/2.
Canola event Topas 19/2 and the antecedent organism were
genetically engineered using the same transformation method and contain
the same enzyme that makes the plants tolerant to the herbicide
glufosinate. Accordingly, we have determined that canola event Topas
19/2 is similar to the antecedent organism in APHIS petition number 97-
205-01p, and we are proposing that canola event Topas 19/2 should no
longer be regulated under the regulations in 7 CFR part 340.
The subject canola event has been considered a regulated article
under APHIS' regulations in 7 CFR part 340 because it contains gene
sequences derived from plant pathogens. However, canola event Topas 19/
2 has been extensively field tested in Canada, and after having
received the appropriate Canadian approvals, has been marketed
commercially in Canada since 1995 with no reports of adverse effects on
human health or the environment.
Should APHIS approve Aventis' request for an extension of a
determination of nonregulated status, canola event Topas 19/2 would no
longer be considered a regulated article under APHIS' regulations in 7
CFR part 340. Therefore, the requirements pertaining to regulated
articles under those regulations would no longer apply to the field
testing, importation, or interstate movement of the subject canola
event or its progeny.
National Environmental Policy Act
An environmental assessment (EA) has been prepared to examine any
potential environmental impacts associated with the proposed extension
of a determination of nonregulated status for the subject canola event.
The EA was prepared in accordance with: (1) The National Environmental
Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2)
regulations of the Council on Environmental Quality for implementing
the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA
Implementing Procedures (7 CFR part 372). Copies of the Aventis
extension request and the EA are available from the individual listed
under FOR FURTHER INFORMATION CONTACT.
Done in Washington, DC, this 25th day of February 2002.
W. Ron DeHaven,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-4909 Filed 2-28-02; 8:45 am]
BILLING CODE 3410-34-P
Partial thread listing: