Page 2 of 3 The Physicians Committee f or Responsible Medicine (PCRM) ha s submitted a response to the Bensulfuron

- methyl d ocket ( Docket ID: EPA

- HQ

- OPP

- 201 1

- 0 663 ) regarding HED’s human health risk assessment scoping document. While the PCRM response included information pertaining to environmental fate and effects, this document addresses only those comments pertinent to human health aspects of the preliminary work plan (PWP ) for bensulfuron

- methyl
. CONCLUSIONS/RECOMMENDATIONS The Agency thanks The Physicians Committee f or Responsible Medicine for their comments regarding bensulfuron

- methyl . The Agency will consider these comments , along with any responses from the registr ant, during the development of the final work plan for bensulfuron

methyl registration review
. DETAILED CONSIDERATI ONS The Physicians Committee f or Responsible Medicine to the Office of Pesticide Programs (OPP) Regu latory Public Docket (7502P). Registration Review docket for Chlor imuron ethyl Docket Opened for Review and Comment. Docket Number: Docket ID: EPA - HQ OPP - 201 1 - 0 663 . The Physicians Committee f or Responsible Medicine’s comment : 1. We also wish to comment on the 21/28 day dermal toxicity study (870.3250). The study, as proposed by the Agency, will eliminate uncertainty in the direction of a less conservative risk assessment. Given the low dermal toxicity as found in the rabbit stud y discussed in the Human Health Scoping Document, a finding of low dermal absorption can be reasonably inferred to predict low systemic toxicity by the dermal route. This could be assessed using in

- vitro or in

- silico dermal penetration models (see OECD Te st Guideline 428, for example) to assess the extent of dermal penetration likely for Bensulfuron methyl. 2. Finally, we wish to comment broadly on the proposed Acute and Subchronic Neurotoxic i ty (870.6200(a)(b)) and Immunotoxicity (870.7800) studies. Bensu lfuron

- methyl shows no indication of neurotoxicity or immunotoxicity. Requesting these studies is a check

- the

- box exercise and not in line with the Agency’s stated priority to minimize animal testing and conduct targeted testing. The Agency should not re quire these focused studies for specific mechanisms of action for all pesticides, without justification based on existing data or information indicating potential concern for neuro

- or immunotoxicity. HED’s Response : 1. The Agency currently utilizes in

- vitro dermal penetration models in conju n ction with in

- vivo dermal absor ption data. HED will consider the comments from the PCRM as the risk assessment is developed for bensulfuron

- methyl registration review. Although we will accept studies using OECD guidelines, at present OPP does not use in

- vitro studies alone to estimate dermal absorption. An in

- vi vo dermal absorption study is needed as well
.Page 3 of 3 2. Although there was no evidence of neurotoxicity or immunotoxici ty in the bensulfuron

methyl toxicology database, the submitted studies are not designed to specifically assess neurotoxicity parameters and histopathology or to assess functions of the immu ne system . Further, the acute / subchronic neurotoxicity and immuno toxicity studies are considered to be required studies under the updated Part 158 Toxicology Data Requirement s for conventional pesticides. Nonetheless, HED will consider the comments from the PCRM as risk assessment is developed for bensulfuron

- methyl re gistration review. T he Agency is currently working on a retrospective analysis to determine whether or not these studies will be required and the decision may affect Bensulfuron's registration review.