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Response to Comments Received on EPA’s Decision Dated February 24, 2010, to Register 

Three Plant Incorporated Protectant (PIP) Products 

EPA received a number of comments on its decision to register three Bt corn PIP products. 

This document summarizes the substantive comments received and contains EPA's responses 

and reactions to those comments. 

A number of comments objected generally to genetically engineered products. Some objections, 

such regulatory policies of other federal agencies, monopoly and patent concerns are not within 

the purview of EPA’s authorities and are not further addressed here. Other objections were the 

following: potential low-level contamination of organic and non-genetically modified food, 

health risks, effects on bees, residues in soil, horizontal gene transfer, effects on biodiversity, 

food safety, human and animal health. Some comments included a reference to the 

“Precautionary Principle”. The comments did not provide data to supporting these concerns. In 

response to these objections, EPA notes that these products met the legal standards of no 

unreasonable adverse effects set forth by the Federal Insecticide Fungicide and Rodenticide Act 

(FIFRA), as amended, and safety standard set forth in the Federal Food Drug and Cosmetic Act 

(FFDCA), as amended. The science reviews supporting EPA’s determinations are available in 

the docket under the following docket ID numbers: EPA-HQ-OPP-2010-0607 and EPA HQOPP-2010-0183. 

One comment stated that Bt toxins are harmful for insects by binding to surface receptors in the 

digestive system. In response, EPA notes that this is generally recognized as the mode of action 

for the Bt incorporated into the Pioneer corn products being registered and extended in this 

action. The comment did not identify any deficiencies in the ecological risk assessment for these 

products. The risk assessments for the constituent toxins Cry1F, Cry1Ab and Cry 34/35Ab1 have 

evaluated the data for non-target insects, and have found no unreasonable adverse effects. 

One comment provided an article entitled “Transformation induced mutations in transgenic 

plants: Analysis and Biosafety Implications.” The article summarized and commented on 

numerous studies reviewing the precision of current crop plant transformation techniques. The 

article seemed directed at herbicide resistant crops, not the Pioneer Bt crops being registered in 

this action. While it did include a reference to MON810, it did not identify deficiencies in the 

risk assessment for the Pioneer products being registered. In addition, EPA notes that mutations 

in plants result from natural processes, like exposure to sunlight and ultraviolet radiation, and 

they occur routinely. There is also genetic material in plants, particularly in corn, known as 

“jumping genes” that can rearrange portions of the plant chromosome at any time. Additionally, 

conventional breeding techniques for plants commonly employ ultraviolet radiation and 

chemicals to induce mutations. It’s not clear from this article that mutations resulting from 

genetic engineering techniques are more frequent or are of greater significance than those 

resulting from natural processes or conventional breeding techniques. 

Some comments noted that in 1998 there was a report of cows’ choosing to eat non-genetically 

engineered corn over Bt corn. EPA notes that these are incidental observations, not scientifically 

derived data, and are not sufficient to justify any change to the regulatory framework supporting 

the registrations of these Bt corn products. 
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One comment noted that the docket, in posting the comment erroneously abbreviated the name 

of the organization making the comment. This error was brought to the attention of and was 

corrected by the docket staff, and no further discussion of the comment is needed.