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

methods 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 barriers to alternative method adoption were discussed, and include the difficulties of data 

sharing among companies, international harmonization, and the assurance of acceptance of submitted 

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 development/ improvement 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 OPP category system and use of the mixtures equation for formulations.

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 management 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 group will put together 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 AgroSciences)

Tamika Sims (CropLife 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 Hastings (BASF), Susanne Kolle (BASF)

Judy Strickland (ILS, Inc.)

Dave Allen (ILS Inc.) 

Kristie Sullivan (PCRM), 

Catherine Willet (HSUS)

Bill McCormick (Clorox), Patrick Elias (Clorox) 

Erik Janus (M3

)

Nathan Pechacek (Ecolab), Tim O’Brian (Ecolab) 

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