### Determination of Nonregulated Status for Monsanto Company MON 88701 Cotton

In response to petition 12-185-01p from Monsanto Company (hereinafter referred to as Monsanto), the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA) has determined that Monsanto dicamba and glufosinate herbicide-resistant MON 88701 cotton (hereinafter referred to as MON 88701 cotton) and progeny derived from it are not likely to pose a plant pest risk and are no longer to be considered regulated articles under APHIS' Biotechnology Regulations at Title 7 of the Code of Federal Regulations, part 340 (7 CFR part 340). Since APHIS has determined that MON 88701 cotton is unlikely to pose a plant pest risk, APHIS will approve the petition for nonregulated status of MON 88701 cotton. Therefore, APHIS approved permits or acknowledged notifications that were previously required for environmental release, interstate movement, or importation under these regulations will no longer be required for MON 88701 cotton and its progeny. Importation of MON 88701 cotton seeds and other propagative material will still be subject to APHIS foreign quarantine notices at 7 CFR part 319 and Federal Seed Act Regulations at 7 CFR parts

201 and 361.

This Determination of nonregulated status for MON 88701 cotton is based on APHIS' analyses of field and laboratory data submitted by Monsanto, references provided in the petition, peer-reviewed publications, and other relevant information as described in the Plant Pest Risk Assessment (PPRA) for MON 88701 cotton.

The PPRA conducted on MON 88701 cotton concluded that it is unlikely to pose a plant pest risk and should no longer be subject to the regulations at 7 CFR part 340 for the following reasons:

(1) No plant pest risk was identified from the transformation process, the insertion and/or expression of new genetic material, or from changes in metabolism in

MON 88701 cotton.

(2) Disease and pest incidence and/or damage were not observed to be significantly increased or atypical in MON 88701 cotton compared to the nontransgenic counterpart or other comparators in field trials conducted in growing regions representative of where MON 88701 cotton is expected to be grown. Observed agronomic traits also did not reveal any significant differences that would indirectly indicate that MON 88741 cotton is more susceptible to pests or diseases. Therefore no plant pest effects are expected on these or other agricultural products and no impacts are expected to APHIS pest control

programs.(3) Based on an evaluation of the gene products, donor organisms, chemical composition of MON 88701 cotton plants, and arthropod abundance in field trials of MON 88701 cotton, exposure to and/or consumption of MON 88701 cotton are unlikely to adversely impact nontarget organisms beneficial to agriculture.

(4) MON 88701 cotton is no more likely to become weedier or more difficult to control as a weed than conventional varieties of this crop based on its observed agronomic characteristics, weediness potential of the crop and current management practices available to control the MON 88701 cotton as a weed.

(5) MON 88701 cotton is not likely to increase the weed risk potential of other species with which it can interbreed in the U.S. or its territories. Gene flow, hybridization and/or introgression of inserted genes from MON 88701 cotton to other sexually compatible relatives with which it can interbreed may occur. These compatible relatives are not considered weedy or invasive. The new phenotype conferred by genetic engineering is not likely to increase the weediness of these compatible relatives or affect the current ability to control these relatives should they become weedy or invasive.

(6) Significant changes to agricultural or cultivation practices (e.g. pesticide applications, tillage, irrigation, harvesting, etc.) from adoption of MON 88701 cotton are expected, but are not likely to increase plant diseases or pests or compromise their management.

(7) Horizontal gene transfer of the new genetic material inserted into the GE plant to other organisms is highly unlikely, and is not expected to lead directly or indirectly to disease, damage, injury or harm to plants, including the creation of new or more virulent pests, pathogens, or parasitic plants.

APHIS also concludes in its PPRA that new varieties derived from MON 88701 cotton are unlikely to exhibit new properties substantially different from the ones observed for MON 88701 cotton, or those observed in other cotton varieties not considered regulated articles under 7 CFR part 340, that would pose a plant pest risk.

Prior to this Determination of nonregulated status, APHIS completed a Final Environmental Impact Statement (FEIS) which explored the potential environmental impacts that a determination of nonregulated status for MON 88701 cotton and its progeny would have on the quality of the human environment. The FEIS concluded, among other things, that a determination of nonregulated status for MON 88701 cotton and its progeny will have no effect on federally-listed threatened and endangered species, species proposed for listing, or their designated or proposed critical habitats. APHIS also concludes with its Determination of nonregulated status, based upon its PPRA and informed by the completion of the FEIS and the Record of Decision that was issued for the.FEIS, that new varieties derived from MON 88701 cotton are unlikely to exhibit new properties substantially different from the ones observed for MON 88701 cotton, or those

2observed for other cotton varieties not considered regulated articles under 7 CFR part

340, that would pose a plant pest risk.

Based on my full and complete review and consideration of all the scientific and environmental data, analyses and information ; the input from the public involvement process, the conclusions of the PPRA, the FEIS and its Record of Decision, and my knowledge and experience as the APHIS Deputy Administrator for Biotechnology Regulatory Services, I have determined and decided that this Determination of nonregulated status for MON 88701 cotton is the most scientifically sound and appropriate regulatory decision.

Michae Firko, Ph.D.

APHIS Deputy Administrator Biotechnology Regulatory Services Animal Plant Health Inspection Service U.S. Department of Agriculture Date

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