UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

OFFICE OF PESTICIDE PROGRAMS

MEMORANDUM

August 8, 2014

To: Katherine St. Clair, CRM and Tom Myers, Team Leader

Pesticide Re

- evaluation Division

From: Jane Robbins s igned 8/8/14

Pesticide Re

- evaluation Division

Thru: Michael Goodis, Associate Director s igned 8/13/14

Pesticide Re

- evaluation Division

S ubject: Transmittal of response to comments on EDSP related the Flume t sulam

Registration Review docket.

Dow AgroSciences (DAS) submitted comments “reiterating the key points” of concern related to the endocrine disruptor program in the context of the flumetsulam registration r eview. 1

According to DAS, these comments had been submitted to the Endocrine Disruptor Screening Program (EDSP) second list of chemicals docket [EPA

- HQ

- OPPT

- 2009

- 0477

- 0015] which were responded to by the Agency in that same docket.

DAS Summarized Comments:

DAS requested that flumetsulam should not be prioritized on the second list for EDSP screening, that it is a lower priority because it has 1) a “very low toxicity”; 2) an extensive data base from which to evaluate the endocrine disrupting pote ntial; and 3) low exposure. Also, this chemical is part of a family of chemicals, the triazolopyrimidine sulfonamides, of which only flumetsulam is on any EDSP list for screening. The “family of herbicides”, should be a lower priority, and if
screened, s hould be conducted as a family rather than chemical by chemical and after Registration Review is completed on Flumetsulam . DAS also claimed that some of the EDSP tier 1 assays used for list 1 chemicals are “inappropriate” because they have performance iss ues that should be resolved before EDSP orders are issued for the second list of chemicals. DAS is concerned that some of the assays would be considered non

- essential after screening has commenced, at potentially, great expense to the order recipients.

1 Flumetsulam, Preliminary Risk Assessment (PRA) Docket #: EPA

- HQ

- OPP

- 2008

- 0625, comment period closed November, 26, 2013

.EP A Response:

Flumetsulam was selected for EDSP testing based on its timing with regards to Registration Review. In the Agency response to comments 2 received on the second list of chemicals we

stated that “... the List 2 effort provides an opportunity to incl ude the FY07/08 registration

review chemicals [which includes flumetsulam] in an attempt to begin addressing the early Registration Review chemicals. ” We also stated that “... the Agency undertakes a comprehensive review of each new registration and, in reaching its decisions regarding registration eligibility considers a wide range of toxicity studies that provide information on

endocrine

- related effects, including: the rat 2

- generation reproduction study (or the Extended 1

- generationreproduction study) , mammalian subchronic bioassays (in rats and dogs), mammalian chronic bioassays (in rats and dogs), cancer bioassays (in rats and mice), mammalian prenatal developmental studies (usually in rats and rabbits), the developmental neurotoxicity study (in rats), fish development and reproduction studies (usually in fathead minnow and rainbow trout), avian reproduction studies (usually in bobwhite quail and mallard duck), and an estuar ine/marine invertebrate life cycle study (usually in daphnid or mysid shrimp). The Agency will continue to use the best available science, as it evolves (such as through the work on EDSP21), to assess the potential risks posed by pesticides and will modif y its assessment methodologies, as appropriate.” Further, “t he Agency is working toward integrating the EDSP and the Registration Review program, aligning the business processes involved with the programs so that the agency no longer uses a fixed list appr oach for pesticide active ingredients .”

In 2006, the Agency published the “Pesticides: Procedural Regulations for Registration Review; Final Rule” where the Agency states that it intends on “incorporating evolving or new programs into registration review ...such as, endocrine disruptor screening and testing...” 3 (August 9, 2006 [71 FR 45720][FRL

- 8080

- 4]) (page 45726).

This being said, and in light of current budget and personnel constraints, the Agency is particularly interested in efficiencies. The Agen cy is actively pursuing new and different methods for prioritizing chemicals for endocrine screening to enhance efficiency in the future, including, possibly, your suggestion to evaluate “families of chemicals”, rather than just following the current appro ach of chemical by chemical. ( See www.epa.gov/endo for the latest Agency approaches and advances for addressing prioritization and the EDSP. ) Lastly, the Agency does not intend to issue more EDSP orders requiring Tie r 1 screening until all of the data received in response to the EDSP orders for the list 1 chemicals have been fully evaluated and the practical utility of the Tier 1 battery of screens is evaluated in light of those

data.

2 Second list of EDSP chemicals for Screening, Response to comments document, docket number EPA

- HQ

- OPPT

2009

- 0477

3 Federal Register notice, Pesticides: Procedural Regulations for Registration Review; Final Rule”, [71 FR
45720][FRL

- 8080

- 4]) page 45726, da ted August 9, 2006.