May 14, 2012
On May 3-4, 2012, the Pesticide Program Dialogue Committee (PPDC) convened its semiannual meeting in the U.S. Environmental Protection Agency (EPA) offices in Arlington, Virginia. This memorandum summarizes the presentations and topics discussed during the meeting, which were organized into 13 sessions:
Copies of most slides and handouts from the meeting are available on the PPDC website.
Session I. Update Regarding Strategic Plans, Budget, and PRIA 3
Steve Bradbury, Director, Office of Pesticide Programs (OPP), opened the meeting and provided comment regarding OPP's strategic planning, which he stated would be influenced by changes in information technology, scientific knowledge, and available resources. Bradbury noted that OPP must be able to receive and manage submissions and other information electronically, and incorporate advancing science and new risk assessment tools into OPP's risk assessments. Bradbury stated that budget constraints will require changes in the organization to increase efficiency. Finally, Bradbury stated that he has established a work group to begin work in these areas.
Marty Monell, OPP Deputy Director, gave an update on the fiscal year (FY) 2012 budget and its impact on OPP. From the FY 2011 budget, the FY 2012 budget appropriation has reductions of $9.2 million and 16 Full Time Employees (FTE). Monell stated that because OPP has been funded since October 2011 under continuing resolutions, which allowed spending at the FY 2011 level, OPP now must adjust its programs to comport with the final FY 2012 budget. Additionally, the maintenance and registration fees collected for FY 2012 are lower than had been projected. To support ongoing OPP activities, Monell stated that a larger portion of Pesticide Registration Improvement Renewal Act (PRIA 2) fees will be used, at the expense of outside contracts. One goal is to cover the budget reductions by having EPA scientific personnel, rather than contractors, conduct product chemistry and primary data reviews.
Monell also gave a short update on negotiations for reauthorization of PRIA (PRIA 3). Current authorization (PRIA 2) ends in September 2012. Monell stated EPA has provided cost information use in developing a new fee structure. Monell stated that OPP is reviewing many registration program elements for increased efficiencies and/or funds, including: the decision times to obtain a final approved label; inert ingredient compensation; application screening process; electronic submissions; and a maintenance fee increase. Monell stated there likely will be increases in both the number of PRIA 3 categories and fees.
The constraints imposed by diminishing resources was a recurring theme noted throughout the meeting.
Session II. Pollinator Protection
Richard Keigwin, Director, Pesticide Re-evaluation Division (PRD), and Donald Brady, Director, Environmental Fate and Effects Division (EFED), chaired the Pollinator Protection session. A PPDC Pollinator Protection Workgroup was formed in 2011 with goals of protecting pollinators through improved product label language, training, and promotion of best management practices (BMP). The Workgroup has formed several subgroups to address issues related to: labeling; BMP; training; and enforcement. During the session, each subgroup provided a status report of ongoing efforts. Each subgroup emphasized common points, including the need for: consistent labeling; standardized definitions and training manuals; and cooperation between beekeepers and pesticide users. Additional needs and related follow-up were discussed, including:
The Workgroup's efforts are ongoing in an area acknowledged by all as challenging. During additional comments at the beginning of the meeting's second day, Keigwin reported that the Workgroup would work out discrete action items and time frames to implement the following four next steps: (1) document and disseminate case studies of success stories and associated BMPs; (2) consider how to incorporate a pollinator segment into every current appropriate training course; (3) develop specialized training for inspectors for reported incidents; and (4) draft standardized pollinator protection language and include eventually in the Label Review Manual.
Session III. Integrated Pest Management
Keith Matthews, Director, Biopesticides and Pollution Prevention Division (BPPD), chaired the Integrated Pest Management (IPM) discussion, and covered the following topics:
During ensuing discussion, comments were wide ranging and included:
Session IV. Endocrine Disruptor Screening Program
Karen Whitby, Acting Director, Health Effects Division, and Mary Manibusan, Director, Exposure Assessment Coordination and Policy Division, Office of Science Coordination and Policy, chaired this session and provided an update on EPA's ongoing Endocrine Disruptor Screening Program (EDSP). Highlighted points included:
In response to questions, Whitby and Manibusan stated that EPA does not intend to release Data Evaluation Records (DER) for Tier 1 studies in a piecemeal fashion or without context, and also stated that positive Tier 1 results are not definitive.
Session V. PPDC Workgroup and OPP Program Updates
In a session filled with updates about several initiatives, the following points were made:
Session VI. Economic Definition of Minor Use
Jack Housenger, Director, Biological and Economic Analysis Division, chaired a session discussing guidance that EPA is developing to assess when a pesticidal use qualifies as a minor use because there is insufficient economic incentive to support the use (and the other statutory criteria are met). Housenger stated that the guidance will be published on EPA's website for public comment. During the presentation, various issues and considerations were discussed. Industry PPDC members, following the presentation, stated that registrants engage in similar analyses regularly to make business decisions; while such analyses typically contain confidential business information, registrants may be willing to discuss case studies individually with EPA to assist in the guidance development.
Session VII. Spray Drift and Drift Reduction Technology
Jay Ellenberger, Associate Director, FEAD, and William Jordan, OPP, chaired a session on Spray Drift issues. Ellenberger discussed efforts related to encouraging adoption of Drift Reduction Technology (DRT), including:
Separately, Jordan stated the final Pesticide Registration Notice for spray drift continues to undergo internal EPA review.
Session VIII. Endangered Species Act Update
Brady and Keigwin chaired this session, which provided an update on Endangered Species Act (ESA) initiatives, specifically:
Session IX. Registration Review and Water Quality -- Process Improvements
Keigwin and Brady also chaired this session, and discussed OPP's efforts to integrate water quality considerations into the registration review process. According to a presentation given by Mark Corbin, EFED, and Tracy Perry, PRD, OPP wishes to work with the Office of Water to reduce and prevent impairment of receiving water bodies by pesticides. Based on a 2006 state-requested pilot project, OPP developed a process for facilitating access by OPP to state-held water monitoring data (2007 SOP). While many registration review cases open with requests for water monitoring data, little has been received, according to the presentation. Accordingly, the current effort is intended to 'reinvigorate' the 2007 SOP. During and following the presentations, there was significant discussion about the appropriate uses of modeling and monitoring data and the appropriate ways the two should be used together.
Session X. PPDC Work Group on 21st Century Toxicology
Jennifer McLain, Deputy Director, Antimicrobials Division, chaired a session which provided an update on various initiatives related to 21st Century Toxicology initiatives across the Office of Chemical Safety and Pollution Prevention (OCSPP).
Workgroup subgroups proposed various projects to the PPDC, including:
Jeff Morris, Deputy Director for Programs, Office of Pollution Prevention and Toxics (OPPT), discussed coordination efforts related to 21st Century Toxicology initiatives among the OCSPP Offices, with international efforts such as those by the Organization for Economic Cooperation and Development (OECD), and with stakeholders. Morris stated that based on received feedback, stakeholders in particular are interested in how developed data will be made available in a useful form and in context. Morris invited and pledged cooperation and coordination with the PPDC.
Session XI. Regulatory Cooperation Council
Kimberly Nesci, Registration Division, and Jerry Baron, Executive Director, IR-4, chaired the session discussing the 2011 U.S.-Canada Regulatory Cooperation Council's (RCC) Joint Action Plan on Regulatory Cooperation, and in particular the initiative related to crop protection products. Nesci reviewed a detailed handout, which outlines the action times and schedule for implementation to identify mechanisms to encourage registrants to submit applications for joint review that include increased numbers of minor uses. According to the presentation, the goal is to facilitate access to effective means of pest control in both countries, as well as to align Maximum Residue Levels whenever possible.
Session XII. Sustainability and EPA
Michael McDavit, Associate Director, BPPD, provided background on a request by EPA to the NRC to develop an operational framework for integrating sustainability within EPA's responsibilities. McDavit announced the publication of NRC's report, Sustainability and the U.S. EPA (2011) and reviewed its conclusions, as well as sustainability efforts underway within OPP. The report can be reviewed and ordered online.