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 

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observed 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 

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