1 Response to Comments Received on EPA’s D ecision 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 comm ents received and contains EPA's responses

and reactions to those comments.

A number of comments objected generally to gene tically engineered products. Some objections, such regulatory policies of othe r federal agencies, monopoly and pa tent concerns are not within the purview of EPA’s authorities and are not fu rther addressed here. Ot her objections were the following: potential low-level contamination of organic and non-genetically modified food, health risks, effects on bees, re sidues 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 Fede ral 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 sup porting EPA’s determinations are available inthe 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, EP A notes that this is generally recognized as the mode of action

for the Bt incorporated into the Pioneer corn produc ts being registered and extended in this action. The comment did not identify any deficienci es in the ecological risk assessment for these products. The risk assessments for the constitu ent toxins Cry1F, Cry1Ab and Cry 34/35Ab1 have evaluated the data for non-targ et insects, and have found no unreasonable adverse effects.

One comment provided an article entitled “Trans formation induced mutations in transgenic plants: Analysis and Biosafety Implications.” The article summarized and commented on numerous studies reviewing the precision of cu rrent crop plant transformation techniques. The

article seemed directed at herbicid e 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 regi stered. In addition, EP A notes that mutations in plants result from natural pr ocesses, like exposure to sunli ght and ultraviolet radiation, and they occur routinely. There is also genetic mate rial in plants, particul arly 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 si gnificance than those resulting from natural processes or conventional breed ing 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 incide ntal observations, not scientifically derived data, and are not sufficient to justify any change to the regul atory framework supporting the registrations of these Bt corn products.2 One comment noted that the docket, in posting the comment erroneously abbreviated the name of the organization making the comment. This e rror was brought to the attention of and was corrected by the docket staff, and no furt her discussion of the comment is needed.