EPA Stakeholder Meeting on Acute Testing Non

- Animal Alternatives October 8, 2015

The EPA Office of Pesticide Programs is advocating for speedier adoption of non

- animal acute test
method s for pesticides (acute 6 pack) by industry and regulatory agencies

. This meeting was convened

to discuss the need for and barriers to that progress with invested stakeholders ( attendee list attached)

.

General b arriers to alternative method adoption were discussed, and include the difficulties of d ata sharing among comp anies , international harmonization, and the assurance of a cceptance of s ubmitted

non

- animal tests by EPA

. Updates on alternative approaches to each type of study in the acute 6 pack

was discussed in brief

.

Potential solutions to these barriers were also examined. In particular, the use of GHS categories instead
of established OPP categories was identified as a potential step towards greater international

harmonization and accelerating progress

. In addition, use of the GHS dose additive mixtures equation

was discussed as an alternative to animal testing of pesticide formulations . The need for additional EPA staff training and develop ment/ improve ment of Standard Evaluation Procedures for alternative assays

was also discussed. We also identified the need for data that companies have collected on their active ingredients and formulations to support the analysis of alternatives.

The Agency committed to following up on the identified areas: evaluate the potential for use of GHS categories in lieu of the O PP category system and use of the mixture s equation for formulation s

.

EPA is willing to lead the adoption of alternative methods for pesticides, with the anticipation that other regulatory agencies will eventually follow. EPA will facilitate project manag ement to keep the process moving forward but robust industry participation and support from other groups (animal welfare, IIVS,

NIEHS

- NICEATM, Canada PMRA, environmental & worker protection groups, etc) is needed for success.

Next steps

o Dow AgroSciences will circulate their existing data spreadsheet on skin sensitization to facilitate data sharing

.

o CropLife America and member companies will continue progress towards collecting eye irritation data for expansion to agricultural pesticides of the Alternate Testing Framework for Classification of Eye Irritation guidance

.

o EPA will scope out resources, project milestones, delegation of responsibilities, timelines and

serve as project lead . EPA will set up a follow

- on conference call to discuss progress

.

o The g roup will put t ogether a map of where to target efforts in state and national jurisdictions to
advance harmonization

.Stakeholder Attendees : Kim Nemeth (Proctor & Gamble), Espe Troyano (Proctor & Gamble) Amy Clippinger (PETA), Patricia Bishop (PETA) Erin Hill (IIVS), Roger Curren (IIVS), Hans Raabe (IIVS), Gertrude Emilia Costin (IIVS) Sean Gehen (Dow AgroS ciences )

Tamika Sims (CropL ife America) Steve Smith (S.C. Johnson) , Edward Whittle (S.C. Johnson) Hal Ambuter (Reckitt Benckiser), Michael Maynard (Reckitt Benckiser), Diana Boesenberg (Reckitt Benckiser) Patrick Quinn (Accord Group) Karin Bently (DuPont), Chuck Hasting s (BASF) , Susanne Kolle (BASF) Judy Strickland (ILS, Inc. ) Dave Allen (ILS Inc.) Kristie Sullivan (PCRM),

Catherine Willet (HSUS)

Bill McCormick (Clorox), Patrick Elias (C lorox) Erik Janus (M 3 )

Nathan Pechacek (Ecol ab), Tim O’ Brian (Ecol ab) Sarah Willems (Sealed Air) Sheryl Beauvais (CDPR)

, Peter Leung (CDPR), Tom Moore (CDPR), Tom Kellner (CDPR), Neelima Mehta (CDPR), John Corlett (CDPR), Mike Guo (CDPR), Mark Hansen (CDPR)

EPA Attendees : Anna Lowit , Steve Knizner, Susan Lewis, Jennifer McLain, PV Shah, Jack Housenger, John Redden, Elissa Reaves, Karen Hicks, Garland Waleko