Regulatory Developments

Pesticide Program Dialogue Committee Convenes Semi-Annual Meeting

May 14, 2012 PRINT

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 12 sessions:

  1. Update Regarding Strategic Plans, Budget, and PRIA 3
     
  2. Pollinator Protection
     
  3. Integrated Pest Management
     
  4. Endocrine Disruptor Screening Program
     
  5. PPDC Workgroup and OPP Program Updates
     
  6. Economic Definition of Minor Use
     
  7. Spray Drift and Drift Reduction Technology
     
  8. Endangered Species Act Update
     
  9. Registration Review and Water Quality -- Process Improvements
     
  10. PPDC Work Group on 21st Century Toxicology
     
  11. Regulatory Cooperation Council
     
  12. Sustainability and EPA

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 BMP subgroup identified a need to communicate success stories to pesticide users.
     
  • The Labeling subgroup identified a need for simplified as well as consistent labeling.
     
  • The Enforcement subgroup identified the following needs: better record keeping; improved bee kill incident reporting; and clarification of the states' authority to obtain incident data.

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:

  • PPDC IPM Workgroup Report: According to Workgroup members, two subgroups are engaged in two ongoing efforts: (1) develop metrics to assess school IPM initiatives; and (2) consider how quantitatively to assess IPM success in agricultural, public health, and school settings. According to the presentations, the subgroups are identifying and reviewing existing metrics, data, and tools; compiling case studies to assess what has worked and why; and assessing barriers to IPM adoption.
     
  • School IPM: Matthews discussed EPA's ongoing efforts to increase IPM implementation in schools and specifically plans for the next three FYs. Among the initiatives discussed in two handouts, Matthews highlighted (1) six grants to school districts totaling more than $1 million, and (2) creation of a national Center of Expertise for School IPM, which will be part of BPPD's Environmental Stewardship Branch but located in EPA Region 6's Dallas, TX, office.
     
  • USDA Natural Resources Conservation Service (NRCS) Programs: A U.S. Department of Agriculture (USDA) NRCS presentation concerning NRCS IPM techniques, tools, and practices was distributed and briefly discussed.

During ensuing discussion, comments were wide ranging and included:

  • If IPM adoption is low, perhaps focus should be given to how to increase adoption, including training, partnerships within the private sector, better access to tools, and other incentives.
     
  • For IPM adoption in schools, demand should be developed by educating parents and Parent-Teacher Associations, and finding incentives other than funding given tight budgets, such as net savings from reduced pesticide and maintenance costs.
     
  • Among available resources, USDA has four regional IPM centers that have distributed grants and resources since 2000. County health agencies often have environmental health specialists that are available to support school IPM efforts.
     
  • EPA may wish to look to incidents reports to target IPM efforts where there is the greatest need.
     
  • Regarding IPM and pollinator protection, the Conservation Reserve Program, which takes land out of production, helps provide habitat for pollinators.

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:

  • EPA began receiving Tier 1 data for List 1 EDSP chemicals in October 2011 and expects to continue receiving data through 2013; these data are undergoing EPA review.
     
  • In November 2010, EPA proposed List 2, which contains 134 chemicals; EPA received and is reviewing more than 600 comments on the list. EPA hopes to issue the list in final sometime in 2013 but does not have a more specific target at this time.
     
  • EPA also has proposed and is in the process of validating Tier 2 tests.
     
  • EPA is exploring computational tools to support more targeted testing strategies and hopes eventually to replace Tier 1 testing with these tools.

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:

  • PPDC Public Health Workgroup: Susan Jennings, OPP, discussed ongoing efforts to expedite review of product applications for urgent public health needs, development of efficacy protocols for bed bugs, and development of an inventory to improve access to tools to combat pests of public health significance.
     
  • PPDC Workgroup -- Comparative Safety Statements: Monell provided an update, stating that EPA has registered products under the current pilot project with the Design for the Environment (DfE) logo and dye-free and fragrance-free claims, as well as with website addresses to corporate commitment statements. According to Monell, EPA is working through issues in the context of two pending applications for biodegradability claims. Finally, Monell stated that EPA is focusing on criteria for when to allow the claim "botanical" as well as "biobased," the latter to allow products to be listed as part of the USDA's program and meet a federal mandate to increase purchase of biobased products
     
  • Insect Repellency Mark: Rose Kyprianou, Field and External Affairs Division (FEAD), discussed a voluntary program for registrants of skin-applied insect repellent products to adopt an EPA-developed graphic to provide standardized information about how long the product repels ticks and/or mosquitoes. The program is under development; EPA intends to launch it in early 2013.
     
  • Rulemaking: Bob McNally, Director, FEAD, discussed several ongoing rulemaking initiatives, including: (1) an update to the Worker Protection Standard -- a proposal is expected in 2012; (2) two efforts affecting Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b) products -- (a) a rulemaking which is "coming soon" to make changes such as requiring Chemical Abstracts Service (CAS) registry numbers for active ingredients, and (b) further consideration of requiring submission of efficacy data to EPA for review for insect repellent products, including a Scientific Advisory Panel meeting in the first half of FY 2013; (3) further consideration of inerts disclosure, which, according to McNally, is expected to be a "formal, lengthy process"; (4) a revision to the FIFRA Section 6(a)(2) rules to facilitate electronic reporting and address non-aggregate reporting; and (5) further work related to the 2011 petition from farm worker interest groups requiring bilingual (English and Spanish) labeling and the more than 200 public comments received.

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:

  • EPA's and USDA Agricultural Research Service's (ARS) efforts to develop test protocols for DRT and work with technology manufacturers to test the DRT. EPA intends to post information about verified DRT on its web site, with a 1- to 4-star rating system similar to one currently used in the United Kingdom.
     
  • A voluntary program expected to begin approximately by August 2012 to modify labels to encourage the use of verified DRT. According to the presentation, use of DRT will be credited in registration review risk reduction analyses if product labels are modified to encourage its use. Ellenberger stated EPA hopes to have modified labels with DRT language available by Spring 2013.

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:

  • National Academy of Sciences (NAS) Review: EPA, along with USDA and the Departments of Interior and Commerce, have asked the NAS National Research Council (NRC) to review several scientific and technical issues related to ecological risk assessments conducted under FIFRA and ESA. Three public meetings have already been held. A final NAS/NRC report is expected in early 2013.
     
  • Usage Pilot Project: EPA, USDA, and National Marine Fisheries Service (NMFS) are working together on a pilot project to increase information available to the risk assessment process regarding actual product use rates (rather than just maximum use rates).
     
  • ESA Consultations and Registration Review: Starting in Fall 2012, PRD intends to insert a Focus Meeting early in the registration review process, during which OPP and affected registrants would meet. The objective is to focus review on applicable issues and better tailor the process. One intended benefit is to integrate ESA-related issues earlier in the process than is currently done.

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:

  • A project to identify how existing data relevant to diagnosing overexposure to pesticides can be made more accessible to clinicians to better identify worker and children overexposure in particular, as well as identify additional pertinent information needs.
     
  • A project to develop a priority list of candidate pesticides to explore how to develop human health pesticide biomarkers for research and clinical application.

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.


 
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