[Federal Register Volume 71, Number 23 (Friday, February 3, 2006)]
[Notices]
[Pages 5801-5802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1481]


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 Notices
                                                 Federal Register
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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 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
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  Federal Register / Vol. 71, No. 23 / Friday, February 3, 2006 / 
Notices  

[[Page 5801]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 04-112-2]


Monsanto Company; Availability of Determination of Nonregulated 
Status for Corn Genetically Engineered To Express High Lysine Levels

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that the 
Monsanto Company corn designated as transformation event LY038, which 
has been genetically engineered to express a lysine-insensitive 
dihydrodipicolinate synthase (cDHDPS) enzyme to allow for the 
accumulation of higher levels of lysine in the germ of the seed, is no 
longer considered a regulated article under our regulations governing 
the introduction of certain genetically engineered organisms. Our 
determination is based on our evaluation of data submitted by the 
Monsanto Company in their petition for a determination of nonregulated 
status, our analysis of other scientific data, and comments received 
from the public in response to a previous notice announcing the 
availability of the petition for nonregulated status and an 
environmental assessment. This notice also announces the availability 
of our written determination and our finding of no significant impact.

DATES: Effective Date: January 23, 2006.

ADDRESSES: You may read the petition, the environmental assessment, the 
determination, the finding of no significant impact, and the comments 
that we received on Docket No. 04-112-1 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.
    You may also view the comments we received on Docket No. 04-112-1 
on the Internet. Go to http://www.regulations.gov, click on the 
``Advanced Search'' tab and select ``Docket Search.'' In the Docket ID 
field, enter APHIS-2005-0075 then click on ``Submit.''

FOR FURTHER INFORMATION CONTACT: Dr. Levis Handley, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-5721. To obtain copies of the determination, the 
petition, the environmental assessment (EA), or the finding of no 
significant impact (FONSI), contact Ms. Ingrid Berlanger at (301) 734-
4885; e-mail: [email protected]. The petition and the 
EA, including the FONSI and determination, are also available on the 
Internet at: http://www.aphis.usda.gov/brs/aphisdocs/04_22901p.pdf, 
http://www.aphis.usda.gov/brs/aphisdocs/04_22901p_p.ea.pdf, and 
http://www.aphis.usda.gov/brs/aphisdocs2/04_22901p_com.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(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 a determination of nonregulated status 
must take and the information that must be included in the petition.
    On August 16, 2004, APHIS received a petition (APHIS Petition 
Number 04-229-01p) from Monsanto Company (Monsanto) of St. Louis, MO, 
on behalf of Renessen LLC of Deerfield, IL, requesting a determination 
of nonregulated status under 7 CFR part 340 for corn (Zea mays L.) 
designated as transformation event LY038 which has been genetically 
engineered to produce higher levels of lysine in the seed than is 
typically found in corn. The Monsanto petition states that the subject 
corn should not be regulated by APHIS because it does not present a 
plant pest risk.
    As described in the petition, the LY038 corn has been genetically 
modified to express the cordapA gene from Cornybacterium glutamicum. 
This gene encodes for lysine-insensitive dihydrodipicolinate synthase 
(cDHDPS) enzyme. The expression of cordapA is under the control of the 
maize Glb1 promoter, which directs cDHDPS expression predominately in 
the germ of the seed, resulting in accumulation of lysine in the grain. 
Corn-soybean meal based diets formulated for poultry and swine are 
characteristically deficient in lysine and require the addition of 
supplemental lysine for optimal animal growth and production. 
Development of LY038 corn may provide an alternative to direct addition 
of supplemental lysine to poultry and swine diets.
    In a notice published in the Federal Register on September 27, 2005 
(70 FR 56411-56443, Docket No. 04-112-1), APHIS announced the 
availability of the Monsanto petition and an environmental assessment 
(EA). APHIS solicited comments on whether the subject corn would 
present a plant pest risk and on the EA. APHIS received 14 comments by 
the close of the 60-day comment period, which ended on November 28, 
2005. Seven of the comments supported a determination of nonregulated 
status for LY038 corn and seven were opposed. None of the comments 
addressed specific plant pest issues. APHIS' response to these comments 
can be found in an attachment to the finding of no significant impact 
(FONSI).

Determination

    Based on APHIS' analysis of field, greenhouse, and laboratory data 
submitted by Monsanto, references

[[Page 5802]]

provided in the petition, other relevant information as described in 
the EA, and comments provided by the public, APHIS has determined that 
LY038 will not pose a plant pest risk for the following reasons: (1) It 
exhibits no plant pathogenic properties (although it was originally 
engineered with regulatory sequences derived from plant pathogens, 
these plants are neither infected nor can incite disease); (2) it 
exhibits no characteristics that would cause it to be more weedy than 
the non-transgenic parent corn line or other cultivated corn; (3) gene 
introgression from LY038 into wild relatives in the United States and 
its territories is extremely unlikely and is not likely to increase the 
weediness potential of any resulting progeny nor adversely affect 
genetic diversity of related plants any more than would introgression 
from traditional corn hybrids; (4) disease and insect susceptibility is 
similar to non-transgenic corn; (5) it exhibits no potential to have a 
significant adverse impact on organisms beneficial to agriculture; (6) 
compared to current agricultural practices, cultivation of line LY038 
and its progeny should not reduce the ability to control insects or 
weeds in corn or other crops. In addition to our finding of no plant 
pest risk, there will be no effect on threatened or endangered species 
resulting from a determination on nonregulated status for LY038 and its 
progeny.
    Therefore, APHIS has concluded that the subject corn and any 
progeny derived from hybrid crosses with other non-transformed corn 
varieties will be no more of a plant pest than corn varieties in 
traditional breeding programs that are not subject to regulation under 
7 CFR part 340. The effect of this determination is that Monsanto LY038 
corn is no longer considered a regulated article under APHIS' 
regulations in 7 CFR part 340. The requirements pertaining to regulated 
articles under those regulations no longer apply to the subject corn or 
its progeny. However, importation of LY038 corn and seeds capable of 
propagation are still subject to the restrictions found in APHIS' 
foreign quarantine notices in 7 CFR part 319 and imported seed 
regulations in 7 CFR part 361.

National Environmental Policy Act

    An EA was prepared to examine any potential environmental impacts 
and plant pest risk associated with the determination of nonregulated 
status for the Monsanto LY038 corn. 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).
    Based on that EA, APHIS has reached a FONSI with regard to the 
determination that Monsanto LY038 corn and lines developed from it are 
no longer regulated articles under its regulations in 7 CFR part 340. 
Copies of the EA and FONSI are available from the individual listed 
under FOR FURTHER INFORMATION CONTACT.

    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 30th day of January 2006.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E6-1481 Filed 2-2-06; 8:45 am]
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