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 signed 8/8/14

Pesticide Re-evaluation Division

Thru: Michael Goodis, Associate Director signed 8/13/14

Pesticide Re-evaluation Division

Subject: Transmittal of response to comments on EDSP related the Flumetsulam 

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 review.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 potential; 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, should 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 issues 

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.
EPA Response:

Flumetsulam was selected for EDSP testing based on its timing with regards to Registration 

Review. In the Agency response to comments2received on the second list of chemicals we 

stated that “...the List 2 effort provides an opportunity to include 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 estuarine/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 modify its assessment methodologies, as 

appropriate.” Further, “the 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 approach 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 Agency 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 approach 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 Tier 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-OPPT2009-0477

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

45720][FRL-8080-4]) page 45726, dated August 9, 2006.