[Federal Register: September 8, 2006 (Volume 71, Number 174)]
[Notices]
[Page 53076-53077]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08se06-33]
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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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[[Page 53076]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2006-0140]
Bayer CropScience; Availability of an Environmental Assessment
and a Preliminary Decision for an Extension of a Determination of
Nonregulated Status for Rice Genetically Engineered for Glufosinate
Herbicide Tolerance
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 prepared an environmental assessment for a
preliminary decision to extend a determination of nonregulated status.
The original determination and the requested extension involve rice
lines genetically engineered to be tolerant to the herbicide
glufosinate. We have received a petition from Bayer CropScience
requesting the extension for a rice line, designated as LLRICE601,
based on its similarity to previously deregulated rice lines, LLRICE62
and LLRICE06.
DATES: We will consider all comments we receive on or before October
10, 2006.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov and,
in the lower ``Search Regulations and Federal Actions'' box, select
``Animal and Plant Health Inspection Service'' from the agency drop-
down menu, then click on ``Submit.'' In the Docket ID column, select
APHIS-2006-0140 to submit or view public comments and to view
supporting and related materials available electronically. Information
on using Regulations.gov, including instructions for accessing
documents, submitting comments, and viewing the docket after the close
of the comment period, is available through the site's ``User Tips''
link.
Postal Mail/Commercial Delivery: Please send four copies of your
comment (an original and three copies) to Docket No. APHIS-2006-0140,
Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. APHIS-2006-0140.
Reading Room: You may read 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.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr. Neil Hoffman, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-6331. To obtain copies of the extension request
or the environmental assessment, contact Mr. Steve Bennett at (301)
734-5672; e-mail: steven.m.bennett@aphis.usda.gov. The extension
request and the environmental assessment are also available on the
Internet at http://www.aphis.usda.gov/brs/aphisdocs/06_23401p.pdf and
http://www.aphis.usda.gov/brs/aphisdocs/06_23401p_ea.pdf.
SUPPLEMENTARY INFORMATION:
Background
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 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. The section describes the form that a petition for a
determination of nonregulated status must take, the information that
must be included in the petition, and the actions that will be taken by
APHIS once a petition has been submitted. Under the regulations in
Sec. 340.6(e), 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
(i.e., the organism with nonregulated status) and the regulated article
in question.
On August 18, 2006, APHIS received a request for an extension of a
determination of nonregulated status (APHIS No. 06-234-01p) from Bayer
CropScience (Bayer) of Research Triangle Park, NC, for rice (Oryza
sativa L.) designated as Liberty Link[supreg] Transformation Event
LLRICE601, which has been genetically engineered for tolerance to the
herbicide glufosinate. The request Bayer CropScience submitted seeks an
extension of the determination of nonregulated status issued \1\ in
response to APHIS petition number 98-329-01p for glufosinate-tolerant
rice transformation events LLRICE06 and LLRICE62, the antecedent
organisms. Because rice line LLRICE601 is similar to antecedent rice
lines LLRICE06 and LLRICE62, Bayer CropScience requests a determination
that rice line LLRICE601 does not present a plant pest risk and,
therefore, is not a regulated article under APHIS' regulations in 7 CFR
part 340.
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\1\ See 64 FR 22595, published April 27, 1999, Docket No. 98-
126-2.
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On July 31, 2006, Bayer CropScience notified APHIS that trace
levels of LLRICE601 were detected in long grain commercial rice.
Subsequently, Bayer CropScience supplied APHIS and the Food and Drug
Administration (FDA) with information about the molecular
characterization and agronomic performance of LLRICE601. APHIS
completed a preliminary risk
[[Page 53077]]
assessment and determined that LLRICE601 did not pose any environmental
concerns.
Analysis
Like the antecedent organisms LLRICE62 and LLRICE06, rice line
LLRICE601 has been genetically engineered to contain the bar gene
isolated from the bacterium Streptomyces hygroscopicus, under the
control of a 35S promoter sequence derived from cauliflower mosaic
virus (35S CaMV). The bar gene encodes a phosphinothricin
acetyltransferase (PAT) enzyme that confers tolerance to the herbicide
glufosinate. LLRICE601 and LLRICE62 produce a single PAT protein of the
same apparent molecular weight, as demonstrated by Western blotting.
LLRICE06 does not produce sufficient protein for the size to be
determined by this method. The level of expression of the PAT protein
produced in LLRICE601 plants falls between that of the two antecedent
organisms LLRICE62 and LLRICE06.
The DNA construct was introduced into the LLRICE06 and LLRICE62 by
direct gene transfer, but was introduced into LLRICE601 by
Agrobacterium-mediated transformation. Both direct gene transfer and
Agrobacterium-mediated transformation are standard practices for
introduction of genetic material into plant genomes; APHIS does not,
therefore, consider this difference significant.
The 35S CaMV promoter is slightly longer for LLRICE601 than it is
for LLRICE06 or LLRICE62. APHIS does not consider this difference
significant. The promoter in LLRICE601 has been used in other events
that have APHIS and FDA approval, and no unusual effects have been
observed in those events. The 35S CaMV promoter is among the most
common gene sequences used in genetically engineered plants and has a
long history of safe use.
LLRICE601 uses the nos (nopaline synthase) terminator, while
LLRICE06 and LLRICE62 use the 35S CaMV terminator. The function of the
31 terminator is to provide a polyadenylation site, a
necessary part of the mRNA transcript of the gene. In LLRICE601, the
nos terminator is truncated. However, the PAT protein is still made, so
the truncation does not affect the function of the transgene. The nos
terminator is widely used in genetic engineering, and has been approved
in a number of deregulated products, e.g., LLCotton25 and MON810 corn.
APHIS does not consider LLRICE601's use of a different terminator than
the antecedent organisms to be a significant difference because both
sequences provide the same function.
LLRICE06 was originally genetically engineered into the medium
grain variety M202, and LLRICE62 was originally genetically engineered
into the medium grain variety Bengal and has since been bred into other
rice varieties, including long grain varieties. LLRICE601 was
originally genetically engineered in the long grain variety Cocodrie.
APHIS does not consider this difference significant.
Rice line LLRICE601 has been considered a regulated article under
APHIS regulations in 7 CFR part 340, and it was field tested under
APHIS authorization between 1998 and 2001. Numerous field trials of
LLRICE601 were conducted under notification during this time period.
The sequence of the PAT protein produced in LLRICE601 is identical
to the sequence produced in the approved cotton line LLCotton25. These
sequences vary from the PAT proteins in LLRICE06 and LLRICE62 by a
single amino acid at position 2, where the former have an aspartic acid
residue and the latter have a serine. APHIS does not consider this
difference to be significant because lines corresponding to both
versions of the protein have undergone applicable reviews by APHIS and
FDA.
Conclusion
Accordingly, we have concluded that rice line LLRICE601 is similar
to the antecedent organisms in APHIS petition number 98-329-01p, and we
have reached a preliminary decision that rice line LLRICE601 should no
longer be regulated under the regulations in 7 CFR part 340.
We will consider all comments we receive regarding this preliminary
decision during the comment period for this notice (see DATES above),
after which APHIS will issue its final decision. Until the final
decision is made, LLRICE601 will remain a regulated article.
Should the preliminary decision be made final, LLRICE601 would no
longer be considered a regulated article under the regulations in 7 CFR
part 340, and the requirements pertaining to regulated articles under
those regulations would no longer apply to the field testing,
importation, or interstate movement of LLRICE601 or its progeny.
National Environmental Policy Act
To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with the
proposed extension of a determination of nonregulated status for
LLRICE601, an environmental assessment (EA) has been prepared. 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).
The EA may be viewed on the Regulations.gov Web site or in our
reading room (see ADDRESSES above for instructions for accessing
Regulations.gov and information on the location and hours of the
reading room). The EA is also available as described under FOR FURTHER
INFORMATION CONTACT. We will consider all comments we receive regarding
the EA during the comment period for this notice (see DATES above).
In accordance with Sec. 372.9(e) of APHIS' NEPA Implementing
Procedures, the APHIS decisionmaker will consider the alternatives
discussed in environmental documents in reaching a determination on the
merits of the proposed action (i.e., the decision regarding the
regulatory status of rice line LLRICE601).
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 1st day of September 2006.
W. Ron DeHaven,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E6-14921 Filed 9-7-06; 8:45 am]
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