[Federal Register Volume 70, Number 155 (Friday, August 12, 2005)]
[Notices]
[Pages 47168-47169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-4384]


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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 
 statements of organization and functions are examples of documents 
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  Federal Register / Vol. 70, No. 155 / Friday, August 12, 2005 / 
Notices  

[[Page 47168]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 04-114-1]


Monsanto Company; Availability of Petition and Environmental 
Assessment for Determination of Nonregulated Status for Corn 
Genetically Engineered for Insect Resistance

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 received a petition from Monsanto Company 
seeking a determination of nonregulated status for corn designated as 
transformation event MON 88017, which has been genetically engineered 
for resistance to a corn rootworm complex and for tolerance to the 
herbicide glyphosate. The petition has been submitted in accordance 
with our regulations concerning the introduction of certain genetically 
engineered organisms and products. In accordance with those 
regulations, we are soliciting public comments on whether this corn 
presents a plant pest risk. We are also making available for public 
comment an environmental assessment for the proposed determination of 
nonregulated status.

DATES: We will consider all comments we receive on or before October 
11, 2005.

ADDRESSES: You may submit comments by either of the following methods:
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. 04-114-1, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your 
comment refers to Docket No. 04-114-1.
     EDOCKET: Go to http://www.epa.gov/feddocket to submit or 
view public comments. Once you have entered EDOCKET, click on the 
``View Open APHIS Dockets'' link to locate Docket No. 04-114-1.
    Reading Room: You may read the petition, 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.
    Other Information: You may view APHIS documents published in the 
Federal Register and related information on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Robyn Rose, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-0489. To obtain copies of the petition or the 
environmental assessment (EA), contact Ms. Ingrid Berlanger at (301) 
734-4885; e-mail: [email protected]. The petition and 
the EA are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/04_12501p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/04_12501p.ea.pdf.

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. 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 May 4, 2004, APHIS received a petition (APHIS Petition Number 
04-125-01p) from Monsanto Company (Monsanto) of St. Louis, MO, 
requesting a determination of nonregulated status under 7 CFR part 340 
for corn (Zea mays L.) designated as transformation event MON 88017 
which has been genetically engineered for resistance to corn rootworm 
and for tolerance to the herbicide glyphosate. 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, event MON 88017 corn has been 
genetically engineered to express a Cry3Bb1 insecticidal protein 
derived from Bacillus thuringiensis (Bt) subspecies kumamotoensis 
strain EG4691. This gene has been modified to encode six specific amino 
acid substitutions when compared to strain EG4691. Cry3Bb1 expression 
is regulated by the enhanced 35S promoter (e35S) from cauliflower 
mosaic virus, the rice actin intron (ract1 intron) 5' leader sequence 
from wheat chlorophyll a/b-binding protein (wt CAB), and the 3' 
nontranslated region of the 17.3 kDa heat shock protein from wheat. 
Event MON 88017 has also been genetically engineered to express a 5-
enolpyruvylshikimate-3-phosphate synthase protein from Agrobacterium 
sp. strain CP4 (CP4 EPSPS), which confers tolerance to the herbicide 
glyphosate. Expression of cp4 epsps is regulated by the rice actin 1 
(ract1) 5' untranslated region containing the promoter and first intron 
and nopaline synthase 3' polyadenylation signal (NOS 3') from 
Agrobacterium tumefaciens. A construct containing both genes was 
delivered to the recipient corn variety, A xHi-II, through 
Agrobacterium-mediated gene transfer. The petitioner states that the 
Cry3Bb1 protein expressed in MON 88017 is 99.8 percent identical to the 
Cry3Bb1 protein expressed in nonregulated corn line MON 863. The CP4 
EPSPS protein is identical to corn line NK603.

[[Page 47169]]

    Event MON 88017 has been considered a regulated article under the 
regulations in 7 CFR part 340 because it contains gene sequences from 
plant pathogens. This corn event has been field tested since 1999 in 
the United States under APHIS notifications. In the process of 
reviewing the notifications for field trials of the subject corn, APHIS 
determined that the vectors and other elements were disarmed and that 
the trials, which were conducted under conditions of reproductive and 
physical confinement or isolation, would not present a risk of plant 
pest introduction or dissemination.
    In Sec.  403 of the Plant Protection Act (7 U.S.C. 7701-7772), 
plant pest is defined as any living stage of any of the following that 
can directly or indirectly injure, cause damage to, or cause disease in 
any plant or plant product: A protozoan, a nonhuman animal, a parasitic 
plant, a bacterium, a fungus, a virus or viroid, an infectious agent or 
other pathogen, or any article similar to or allied with any of the 
foregoing. APHIS views this definition very broadly. The definition 
covers direct or indirect injury, disease, or damage not just to 
agricultural crops, but also to plants in general, for example, native 
species, as well as to organisms that may be beneficial to plants, for 
example, honeybees, rhizobia, etc.
    The U.S. Environmental Protection Agency (EPA) is responsible for 
the regulation of pesticides under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA 
requires that all pesticides, including herbicides, be registered prior 
to distribution or sale, unless exempt by EPA regulation. In cases in 
which genetically modified plants allow for a new use of a pesticide or 
involve a different use pattern for the pesticide, EPA must approve the 
new or different use. Accordingly, Monsanto submitted a request for 
Section 3 Registration of Cry3Bb1 as a plant-incorporated protectant in 
corn. On December 22, 2004, EPA announced the receipt of the 
application on its Web site (http://www.epa.gov/pesticides/biopesticides/regtools/frnotices2004.htm).
    When the use of the pesticide on the genetically modified plant 
would result in an increase in the residues in a food or feed crop for 
which the pesticide is currently registered, or in new residues in a 
crop for which the pesticide is not currently registered, establishment 
of a new tolerance or a revision of the existing tolerance would be 
required. Residue tolerances for pesticides are established by EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21 
U.S.C. 301 et seq.), and the Food and Drug Administration (FDA) 
enforces tolerances set by EPA under the FFDCA. On March 31, 2004, EPA 
granted a tolerance exemption for Cry3Bb1 (69 FR 16809-16814, March 31, 
2004). The exemption concluded that there was a reasonable certainty of 
no harm from consumption of the protein, as it is digestible in gastric 
fluid and not considered an allergen.
    FDA published a statement of policy on foods derived from new plant 
varieties in the Federal Register on May 29, 1992 (57 FR 22984-23005). 
The FDA statement of policy includes a discussion of FDA's authority 
for ensuring food safety under the FFDCA, and provides guidance to 
industry on the scientific considerations associated with the 
development of foods derived from new plant varieties, including those 
plants developed through the techniques of genetic engineering. 
Monsanto has completed consultation with FDA on the subject corn event 
(BNF No. 97, http://www.cfsan.fda.gov/lrd/biocon.html).
    To provide the public with documentation of APHIS' review and 
analysis of the environmental impacts and plant pest risk associated 
with a proposed determination of nonregulated status for Monsanto's 
event MON 88017 corn, an environmental assessment 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).
    In accordance with Sec.  340.6(d) of the regulations, we are 
publishing this notice to inform the public that APHIS will accept 
written comments regarding the petition for a determination of 
nonregulated status from interested persons for a period of 60 days 
from the date of this notice. We are also soliciting written comments 
from interested persons on the environmental assessment prepared to 
examine any environmental impacts of the proposed determination for the 
subject corn event. The petition and the environmental assessment, and 
any comments received are available for public review, and copies of 
the petitions and the environmental assessment are available as 
indicated in the FOR FURTHER INFORMATION CONTACT section of this 
notice.
    After the comment period closes, APHIS will review the data 
submitted by the petitioner, all written comments received during the 
comment period, and any other relevant information. After reviewing and 
evaluating the comments on the petition and the environmental 
assessment and other data and information, APHIS will furnish a 
response to the petitioner, either approving the petition in whole or 
in part, or denying the petition. APHIS will then publish a notice in 
the Federal Register announcing the regulatory status of Monsanto's 
insect-resistant corn event MON 88017 and the availability of APHIS' 
written decision.

    Authority:  7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR 
2.22, 2.80, and 371.3.

    Done in Washington, DC, this 8th day of August 2005 .
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-4384 Filed 8-11-E5; 8:45 am]
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