Biocides Panel

AMERICAN CHEMISTRY COUNCIL

BIOCIDES PANEL

Record of Meeting

Date: April 8, 2009 Time: 8:30 a.m. – 3:00 p.m. Eastern Time Place: American Chemistry Council 1300 Wilson Blvd. Arlington, VA 22209

List of Participants: Lisa Amadio JohnsonDiversey Inc. Dale Bauer* Kemira Chemicals, Inc. Crystal Brown* Buckman Laboratories International Elizabeth Brown Steptoe & Johnson Heather Collins* LANXESS Corporation Sue Crescenzi Steptoe & Johnson Jan Dhonau* Procter & Gamble, Chemicals Division Elisa Estremera* Clorox Services Company Susan Feeser* Alco Chemical Corporation Bernie Franc BASF Corporation Noe Galvan* Clorox Services Company Seth Goldberg Steptoe & Johnson William Goodwine Janssen Pharmaceutica Jennifer Gregg* Milliken Chemical Kate Ingram* Ashland Inc. Tom Isaac* Stepan Company Liane Jenkins* Reckitt Benckiser Luanne Jeram* LANXESS Corporation Mark Jernigan* Chemtura Mike Kelley ToXcel LLC (for Verichem) Larry Kesler* Clariant Corporation Sangeeta Khattar International Specialty Products Judith Kranetz* Rhodia Inc. Adrian Krygsman Troy Corporation David Lewis Lewis Harrison (on behalf of S.C. Johnson & Son) Kevin Manning* GE Betz, Inc. William McCormick Clorox Services Company Keena McCurn Arch Chemicals, Inc. Michael Meadows* Milliken Chemical Eileen Moyer Reckitt Benckiser Sue Price* 3M Biocides Panel April 8, 2009 Record of Meeting Page 2 of 5

Pat Quinn The Accord Group for Procter & Gamble Jamie Quon* Clorox Services Company David Rickard* Dial Corporation Lisa Sandoval Steptoe & Johnson Rhonda Schulz* Ecolab Inc. Bob Sloan* Lonza Inc. Judy Smith* ICL-IP America, Inc. Harvey Steinberg* AEGIS Environments Elizabeth Tannehill Mason Chemical Company Abby Trueblood Dow Chemical Company Deborah Vercek* LANXESS Corporation Jim Westerhaus* Ecolab Inc. John Wood* Ecolab Inc. Gary Wright* Chemtura Has Shah American Chemistry Council * Participated via conference call

1.0 Introductions and ACC Antitrust Guidelines

Participants introduced themselves. The ACC Antitrust Guidelines were in effect for the duration of the meeting.

2.0 Approval of February 5, 2009 Record of Meeting

The Record was approved as written.

3.0 Review of Comments on the 158W Antimicrobial Pesticide Data Requirements Proposed Rule

3.1 Brief Overview of Comments

The significant effort by numerous Panel members was acknowledged. High level overviews of each appendix were provided. Coordination and joint activities with CSPA were discussed, along with outreach to other stakeholders.

3.2 Next Steps

The rulemaking process with regard to Agency responses to public comments was discussed. Has Shah will contact Joan Harrigan-Farrelly, Antimicrobials Division (AD) Director, to request a briefing for AD and OPP management on the comments submitted by the Panel. The goal is that this meeting would be followed by follow-up discussions on specific issues, particularly those already identified as priorities within AD. These latter meetings would be coordinated with CSPA. Dr. Shah will schedule a conference call of Bill McCormick, Adrian Krygsman, Eileen Moyer, Lisa Amadio, a Dow or Rohm & Haas person, an Biocides Panel April 8, 2009 Record of Meeting Page 3 of 5

Ecolab person, and either Luann Jeram or Stan Oslosky to develop an agenda and discussion material for meeting with EPA, possibly on June 3, 2009.

The possibility of meeting with the Office of Management and Budget also was discussed. The objective would be to inform OMB about areas of concerns. A final decision on this option was tabled pending a meeting with EPA.

4.0 Development of Benefits of Antimicrobials Document

Members have developed drafts for two areas (manufacture of leather and metalworking fluids) to serve as possible examples. The need to incorporate economic information into the benefits was emphasized. Dr. Shah will route the list of volunteers developed at the February 8, 2009 meeting along with a request for additional volunteers. Dr. Shah also will contact CSPA and request information they already have developed that could form the basis for the institution use area. Each group will be requested to have a draft version available for discussion at the June 4, 2009 Panel meeting.

5.0 Discussion of Revised Draft Ninth Antimicrobial Workshop Agenda

The most current draft, developed following a meeting with AD on April 1, was discussed. Dr. Shah will seek clarification on AD’s proposal to include acute inhalation toxicity waivers and bridging in session on AD policies; it is unclear whether that should reference waivers and bridging for all acute toxicity endpoints, as was proposed in the Panel’s white paper. There was a suggestion to include a session on the pilot project to evaluate non-animal testing for eye irritation hazard. The Panel also recommends a session on Antimicrobial Reregistration and Registration Review to include the current DCI schedule and a refresher on responding to data call-ins.

Dr. Shah and Adrian Krygsman will work on developing topics for PMRA to discuss at the Workshop. Other interested members should contact Dr. Shah. An invitation to serve as luncheon speaker will be sent to the assistant administrator for OPPTS after the nominee for that position has been confirmed.

6.0 Review of 2009 Operating Plan

Members will review the plan and provide any comments to Dr. Shah.

7.0 Update on PPDC Work Group Activities

7.1 21st Century Toxicology

Elizabeth Brown will participate in a brief panel discussion during the full PPDC meeting in April to identify communication issues of interest and will continue to participate during the monthly meetings of the work group at the Panel’s request. Presentations on the ongoing activities are available on the work group website. Biocides Panel April 8, 2009 Record of Meeting Page 4 of 5

7.2 Web-Distributed Labeling

Implementation issues continue to be a major topic of discussion but without resolution. Because EPA identified that the proposed system would not be compatible with supplemental distributor labels, antimicrobial pesticides would not fit into the system. The Panel concurred that antimicrobials need to be excluded.

7.3 Comparative Safety Statements for Pesticide Product Labeling

It will be approximately 12-18 months until the proposed pilot project between OPP and OPPTS/DfE will be completed. The pilot project currently is restricted to hard surface disinfectants. Consideration may be given in the future to expanding the program beyond those. Following significant efforts to obtain broad stakeholder consensus, a subgroup has developed a proposal for allowing factual, non-pesticidal statements on pesticide product labels. It is expected that this proposal will be presented to the full PPDC.

8.0 Update on Pesticide Registration Improvement Act Issues

8.1 PRIA Category on Refined Environmental Risk Assessment

Industry representatives have concurred that this category is intended to request a more refined environmental risk assessment when only a screening level assessment has been done previously. The more refined assessment could allow severe limitations to be removed from labels but would need to be associated with a specific regulatory action requested by the applicants.

8.2 Inert Ingredients

The new process announced by OPP was discussed. In essence, no application for a product should be submitted to EPA in which the product contains an inert that is not already approved by the Agency. Members rose questions regarding the process and concerns about the lack of information on whether risk assessments are available for all inert ingredients and, if so, for what uses. Dr. Shah will follow up with the Inerts Assessment of EPA on issues that were raised about a year ago and still remain unaddressed. A work group was formed to compile a list of questions, issues, and concerns to be addressed by EPA at the Ninth Antimicrobial Workshop. Volunteers for the work group include Lisa Amadio, Liz Tannehill, Bill Goodwine, and Sue Crescenzi.

9.0 Discussion of HVAC Labeling Issues Biocides Panel April 8, 2009 Record of Meeting Page 5 of 5

A revised draft proposal to EPA was reviewed and discussed. Dr. Shah will contact HVAC trade organizations and discuss their willingness to take an active role in educating HVAC product applicators and to support the Panel’s general approach to respond to issues raised in EPA’s draft PR Notice.

10.0 Update on Thresholds of Toxicological Concerns Project

The ILSI Research Foundation has established a Steering Committee to guide the project. Members of the Steering Committee are Steve Olin (ILSI), Susan Felter (Proctor & Gamble), Troy Seidle (Humane Society of the US), Mitchell Cheeseman (FDA/CFSAN), and Vicki Dellarco (EPA/OPP).

11.0 Brief Updates

11.1 EPA’s Antimicrobial Testing Program

EPA’s intent to post the results of the testing program was discussed. The details are not yet clear, but the posting is expected to show whether products passed and whether a regulatory or enforcement path was taken for those that failed.

11.2 Status of Submission of Synovate Survey Data and Protocol to EPA to Determine the Validity of IDREAM

The draft report with all raw data is available and is being prepared in the 86-5 format for submission to EPA.

11.3 Upcoming Container Labeling Deadlines

Members noted the August 2010 deadline for compliance with the amended final rule and the likely need for antimicrobial product labeling to be submitted as amendments due to the need for modified wording. It was noted that EPA has been developing and accepting modified wording for antimicrobials, since the preexisting wording is not well suited to antimicrobials. While EPA has plans to post agreements on modified wording on its website, that likely will not occur for several months.

11.4 Registration and Reregistration Issues

Ms. Crescenzi will summarize issues identified in registration review documents, for discussion at the next meeting.

Hasmukh Shah Manager, Biocides Panel