[Federal Register: July 24, 2008 (Volume 73, Number 143)]
[Notices]               
[Page 43202-43203]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jy08-38]                         

-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0030]

 
Monsanto Company; Availability of Determination of Nonregulated 
Status for Corn Genetically Engineered for Insect Resistance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: We are advising the public of our determination that a corn 
line developed by the Monsanto Company, designated as transformation 
event MON 89034, which has been genetically engineered for insect 
resistance, 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 its associated environmental assessment. This notice also 
announces the availability of our written determination and our finding 
of no significant impact.

DATES: Effective Date: July 24, 2008.

ADDRESSES: You may read the petition, environmental assessment, 
determination, finding of no significant impact, the comments we 
received on our previous notice, and our responses to those comments 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. Those documents may also be 
viewed on the Internet at http://www.regulations.gov/fdmspublic/
component/main?main=DocketDetail&d=APHIS-2007-0030.

FOR FURTHER INFORMATION CONTACT: Dr. Robyn Rose, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-0489, e-mail: robyn.i.rose@aphis.usda.gov. To 
obtain copies of the petition, environmental assessment, or the finding 
of no significant impact, contact Ms. Cindy Eck at (301) 734-0667, e-
mail: cynthia.a.eck@aphis.usda.gov. To view those documents on the 
Internet, go to http://www.aphis.usda.gov/brs/aphisdocs/06_29801p.pdf 
and http://www.aphis.usda.gov/brs/aphisdocs/06_29801p_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(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 October 26, 2006, APHIS received a petition seeking a 
determination of nonregulated status (APHIS No. 06-298-01p) from the 
Monsanto Company (Monsanto) of St. Louis, MO, for corn (Zea mays L.) 
designated as transformation event MON 89034, which has been 
genetically engineered for resistance to European corn borer and other 
lepidopteran pests, stating that corn line MON 89034 does not present a 
plant pest risk and, therefore, should not be a regulated article under 
APHIS' regulations in 7 CFR part 340. Monsanto responded to APHIS' 
subsequent request for additional information and clarification and 
submitted an addendum to their petition on January 23, 2007.

Analysis

    As described in the petition, corn transformation event MON 89034 
has been genetically engineered to express the transgenes cry1A.105 and 
cry2Ab2, both of which were derived from a well-characterized gene 
sequence from Bacillus thuringiensis, and encode insect control 
proteins. The neomycin phosphotransferase II (nptII) gene was used as a 
selectable marker, but was eliminated by traditional breeding methods 
in the later stages of development of MON 89034. Thus, MON 89034 
contains only the cry1A.105 and cry2Ab2 expression cassettes. 
Expression of the transgenes by corn plants renders the corn line 
resistant to European corn borer, as well as other lepidopteran pests. 
Regulatory elements for the transgenes were obtained from Agrobacterium 
tumefaciens. These regulatory sequences are not transcribed and do not 
encode proteins. The DNA was introduced into corn cells using 
Agrobacterium-mediated transformation methodology with the T-DNA binary 
transformation vector designated PV ZMIR245.
    In a notice \1\ published in the Federal Register on December 13, 
2007 (72 FR 70817-70819, Docket No. APHIS-2007-0030), we announced our 
receipt of the Monsanto petition and solicited comments on whether MON 
89034 corn is or could be a plant pest. In that notice, we also made 
available for public comment a draft environmental assessment we 
prepared to analyze any potential environmental effects associated with 
the proposed

[[Page 43203]]

determination of nonregulated status for the MON 89034 corn event.
---------------------------------------------------------------------------

    \1\ To view the notice, petition, environmental assessment, and 
the comments we received, go to http://www.regulations.gov/
fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0030.
---------------------------------------------------------------------------

    We received 29 comments by the close of the 60-day comment period, 
which ended on February 11, 2008. There were 5 comments submitted in 
support of the petition to grant nonregulated status to MON 89034 corn 
and 24 that were opposed. APHIS' responses to these comments can be 
found as an attachment to the finding of no significant impact.

Determination

    Based on APHIS' analysis of field, greenhouse and laboratory data 
submitted by Monsanto, references provided in the petition, other 
relevant information described in the environmental assessment, and 
comments provided by the public, APHIS has determined that MON 89034 
will not pose a plant pest risk for the following reasons: (1) Gene 
introgression from MON 89034 corn 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 or adversely 
affect genetic diversity of related plants any more than would 
introgression from traditional corn hybrids; (2) it exhibits no 
characteristics that would cause it to be more weedy than the non-
genetically engineered parent corn line or other cultivated corn; (3) 
it does not pose a risk to non-target organisms, including beneficial 
organisms and threatened or endangered species, because the 
insecticidal activity of the Cry1A.105 and Cry2Ab2 proteins are limited 
to lepidopteran target pest species; (4) it does not pose a threat to 
biodiversity as it does not exhibit traits that increase its weediness 
and its unconfined cultivation should not lead to increased weediness 
of other cultivated corn, it exhibits no changes in disease 
susceptibility, and it is unlikely to harm non-target organisms common 
to the agricultural ecosystem or threatened or endangered species 
recognized by the U.S. Fish and Wildlife Service; (5) compared to 
current corn pest and weed management practices, cultivation of MON 
89034 corn should not impact standard agricultural practices in corn 
cultivation and controlling volunteer corn any differently than any 
other deregulated corn line expressing Cry proteins. Moreover, MON 
89034 should not present any new or different impacts on organic 
farmers from those Bt corn lines that are currently cultivated; and (6) 
disease susceptibility and compositional profiles of MON 89034 corn are 
similar to those of its parent variety and other corn cultivars grown 
in the United States, therefore no direct or indirect plant pest 
effects on raw or processed plant commodities are expected.
    In conclusion, APHIS has determined that there will be no effect on 
the federally listed threatened or endangered species, species proposed 
for listing, or their designated or proposed critical habitat resulting 
from a determination of nonregulated status for MON 89034 and its 
progeny. APHIS also concludes that new varieties bred from MON 89034 
corn are unlikely to exhibit new plant pest properties, i.e., 
properties substantially different from any observed for corn event MON 
89034, or those observed for other corn varieties not considered 
regulated articles under 7 CFR part 340.

National Environmental Policy Act

    An EA was prepared to provide the APHIS decisionmaker with a review 
and analysis of any potential environmental impacts associated with the 
determination of nonregulated status for MON 89034. 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, and other pertinent 
scientific data, APHIS has reached a FONSI with regard to the 
determination that Monsanto corn line MON 89034 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 as indicated in the 
ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.

    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 18th day of July 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-16947 Filed 7-23-08; 8:45 am]

BILLING CODE 3410-34-P