[Federal Register Volume 71, Number 174 (Friday, September 8, 2006)]
[Notices]
[Pages 53076-53077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14921]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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  Federal Register / Vol. 71, No. 174 / Friday, September 8, 2006 / 
Notices  

[[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: [email protected]. 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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