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December 11, 2012

Pesticide Program Dialogue Committee Convenes Semi-Annual Meeting

Bergeson & Campbell, P.C.

On November 29-30, 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 ten substantive sessions:

  1. Update Regarding the 2013 Budget and PRIA 3
  2. Pollinator Protection
  3. Integrated Pest Management
  4. PPDC Work Group on Comparative Safety Statements
  5. Public Availability of OPP Databases
  6. PPDC Workgroup and OPP Updates
  7. 21st Century Toxicology Activities
  8. Endocrine Disruptor Screening Program
  9. Endangered Species Act Update
  10. Registration Review Update

Copies of the slides and handouts from the meeting are available on the PPDC website.

Steve Bradbury, Director, Office of Pesticide Programs (OPP), opened the meeting by reviewing the agenda, followed by an introduction of each PPDC member.

Session I. Update Regarding the 2013 Budget and PRIA 3

Marty Monell, OPP Deputy Director, gave an update on the fiscal year (FY) 2013 budget and its effect on OPP. Monell stated that with the current Continuing Resolution, OPP knows it will be funded at FY2012 levels for the first half of FY2013; that and the passage of Pesticide Registration Improvement Extension Act (PRIA 3) better enable OPP to plan its activities.

Monell provided an overview of PRIA 3. She stated that PRIA 3 expands the number of fee categories from 140 to 189. New categories now include inert ingredient approvals, Scientific Advisory Panel reviews, Human Testing Panel reviews, and exclusive use chemical reviews, among others.

Monell stated that PRIA 3 includes several set-asides to fund specific projects, such as more comprehensive electronic systems. OPP hopes to develop an electronic system that will offer several features, including: enabling a registrant/applicant to check the status of its application online; supporting the electronic review of labels; coordinating the Confidential Statement of Formula with Canada’s Pest Management Regulatory Agency (PMRA) so both offices receive the same information in the same format; and developing an electronic database for endangered species. Additionally, the incident reporting system will be upgraded to better track received information, to enable trend analysis; the data will be made publicly available.

Based on PRIA 3 authorizations, Monell stated EPA would make programmatic changes, including a technical screening review of an application prior to commencement of the review process, which must occur within 45 days of receipt for product applications with a PRIA 3 review schedule less than one year, and within 90 days for product applications with a PRIA 3 review schedule more than one year. Additionally, EPA plans to notify a registrant/applicant of necessary label changes at least two months prior to a PRIA 3 due date, to which the registrant/applicant must respond within ten days.

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 and recommendations.

The BMP subgroup’s recommendations included the following: develop a plan to coordinate and distribute BMPs, either through a national portal maintained either by EPA or the United States Department of Agriculture (USDA) or by distributing BMPs for distribution by other stakeholders; standardize training for pesticide advisors and applicators with increased information about pollinator protection; organize or identify pesticide-free non-crop refuges for pollinators; support research and initiatives that demonstrate the benefits of BMPs; support the development of additional data on residual toxicity; and support research and implementation of measures to reduce drift of dust from treated seeds.

The Labeling subgroup discussed many labeling inconsistency issues and reached a consensus on the following: the difficulty of developing pollinator protection statements and the need for cooperation among all concerned parties; a need for clearer pollinator protection statements and better defined terms used by EPA; similar restrictions for pesticides that pose similar risks to bees; and the potential utility of a source of information for local BMPs to protect bees.

The Enforcement subgroup discussed many process improvements and recommended developing the following tools: a check list and standardized training manual for how a bee kill investigation should occur; a method for tracking the activities of diverse parties who are responsible for the different aspects of an incident/investigation/enforcement action; guidance for when an incident/investigation/enforcement action should (or should not) be forwarded to EPA; procedures to make it easier for both growers and bee keepers to know when and what pesticide was used; and clarification regarding whether each state has adequate authority to obtain the information needed to conduct a proper investigation and, if not, action towards developing such authority.

Finally, the Communication, Training, and Education subgroup identified several needs and objectives, including: standardizing training to encourage a uniform and consistent message; and a centralized website in which BMPs, a glossary of terms, and training resources could be located and easily accessed by educators, pesticide applicators, beekeepers, crop advisors, and homeowners.

Session III. Integrated Pest Management

Keith Matthews, Director, Biopesticides and Pollution Prevention Division (BPPD), chaired the Integrated Pest Management (IPM) discussion. Frank Ellis, BPPD Environmental Stewardship Branch Chief, provided an overview of several EPA IPM activities, including: creation of a Center of Excellence for IPM, which will be staffed in EPA’s Region 6 offices; development of IPM for tick-borne diseases; funding a study on the use of IPM in Leadership in Energy and Environmental Design (LEED)-certified buildings; and EPA participating in an Organization for Economic Cooperation and Development (OECD) IPM meeting.

The PPDC IPM Workgroup has two subgroups that are engaged in the following ongoing efforts, respectively: (1) developing metrics to assess school IPM initiatives; and (2) considering how quantitatively to assess IPM success in agricultural, public health, and school settings. Each subgroup reported to the PPDC. In both a written document and as a PowerPoint presentation, the first subgroup provided a list of recommended metrics for EPA to use in measuring its IPM effects as well as recommendations on how to use these metrics. The second subgroup is continuing to work on its charge, but had the following set of target deliverables: recommendations on the types of data that should be considered in quantitative assessments; how quantitative assessments should be used in efforts to promote IPM; a sample flyer using quantitative assessment of IPM benefits in schools; and a comprehensive literature review of IPM benefits in schools.

Session IV. PPDC Work Group on Comparative Safety Statements

Monell chaired a discussion about several related efforts and ongoing activities that arose, according to Monell, approximately three years ago in response to requests by the regulated community for certain logos and label statements related to “green” products.

  • Design for Environment (DfE) Logo, “Dye Free,” “Fragrance Free,” and Biodegradability Label Claims: Michael Hardy, OPP, briefly recounted the history of the three-year pilot project to add the Office of Pollution Prevention and Toxics (OPPT) DfE logo to antimicrobial pesticide products, and similar pilots to permit these other label claims. Monell and Hardy explained OPP is seeking to extend these pilots by two years, as they currently are scheduled to sunset in May 2013. The pilots have succeeded with only a limited number of products, but certain hurdles have been identified as a result of the pilots that EPA hopes to address. Monell stated that EPA is considering including BPPD products in the pilots as well.
  • USDA Biobased Mark Pilot: Stephen Schaible, Registration Division, described the USDA program to review and approve products for its biobased mark and stated that a pesticide registrant had completed USDA review and approval and submitted an amendment application to add the mark to its label, a request which is currently “on hold.” Schaible stated that OPP wishes to pursue a pilot project to add the biobased mark, possibly with a disclaimer statement intended to clarify what the mark does and does not signify and where to go for more information. Schaible stated once OPP has developed the disclaimer language, it likely will invite comments on it from the PPDC and others.
  • Non-Animal Testing: Kristie Sullivan, OPP, discussed ongoing efforts to evaluate how a product might represent on its label that it has been developed without animal testing. Sullivan stated that OPP is assessing a range of related issues, including the range of data requirements for different product types, testing on active and inert ingredients, and consumer understanding of possible statements. Sullivan described a possible tiered set of statements that would describe circumstances and products ranging from no animal testing required to efforts made to avoid testing.
  • Insect Repellency Mark: Rose Kyprianou reviewed OPP’s ongoing efforts to develop an insect repellency mark that would provide a standardized graphic to identify the pests that are repelled and the duration for which they are repelled. OPP has developed draft guidance concerning the mark that it has shared with PPDC workgroups for comment; it hopes to launch a voluntary program to adopt the mark in summer 2013.

Session V. Public Availability of OPP Databases

Oscar Morales, Director, OPP Information Technology and Resources Management Division, discussed several electronic tools/efforts under development by OPP. Morales stated that PRIA 3 contained five funding set-asides for information technology (IT) development: electronic tracking of registration submissions; electronic tracking of the status of conditional registrations; enhancing the endangered species database; supporting the electronic review of labels; and supporting the capability to assess and evaluate confidential statements of formula (CSF) electronically. Morales provided an update on each of these activities.

Morales discussed efforts underway to increase pesticide-related electronic reporting through EPA’s Central Data Exchange (CDX) system. In a joint effort with Canada’s PMRA, OPP is developing an interactive electronic e-CSF application, which registrants will be able to submit through CDX. Similarly, OPP, in coordination with the EPA Office of Enforcement and Compliance Assurance, is developing an electronic submission system for registered establishment reporting.

Morales discussed several new or improved online pesticide-related databases. OPP is enhancing the Pesticide Product Label System (PPLS) to add additional search features, including text-searchable labels. OPP has created an Inert Finder tool, which allows users to determine whether inerts are approved for food, non-food, and fragrance use. OPP also has created the Chemical Search tool, which allows users to find a range of documents related to a specific pesticide chemical with one search.

Finally, Morales discussed OPP’s efforts to engage with the international community to begin to develop an infrastructure that would support global product registrations. Morales stated that such a system would allow a registrant to submit common data to multiple jurisdictions at one time, and would facilitate data sharing during joint review.

Session VI. PPDC Workgroup and OPP Updates

Eleven fact sheets/updates were distributed to the PPDC members prior to the meeting. No presentations were made on these updates though members were given time to raise specific questions for discussion. The documents are available at the PPDC link above; the document titles are as follows:

  • Soil Fumigant Mitigation Factsheet: Implementation Schedule;
  • Soil Fumigant Implementation Update for PPDC;
  • Pesticide Worker Safety Regulation Improvements, Agricultural Worker Protection Regulation;
  • NPDES Pesticide General Permit;
  • International Pesticide Registration Activities;
  • Status of Label Review Manual;
  • Role of Pesticide Usage Data in OPP;
  • Update on the Spray Drift PR Notice and Spray Drift Petitions;
  • Water Monitoring Data;
  • Web-Distributed Labeling for Pesticide Products, PPDC Update on Draft Pesticide Registration Notice; and
  • Policy Paper on Revised Risk Assessment Methods for Agriculture Workers, Children of Workers in Agriculture Fields, and Pesticides with No Food Uses.

Session VII. 21st Century Toxicology Activities

Jennifer McLain, Deputy Director, Antimicrobials Division (AD), chaired a session which provided an update on various 21st Century Toxicology-related initiatives. In particular, McLain discussed test methods and new OPP guidance documents directed at reducing animal testing while producing data to support reliable safety assessments for pesticide chemicals. McLain discussed the results of a 2009 pilot program to evaluate non-animal testing for eye irritation studies, particularly for antimicrobial products; EPA has successfully used the study results for labeling decisions and, according to McLain, AD is developing a policy to encourage the use of these non-animal testing alternatives. McLean also discussed recent guidance documents that (a) consolidate OPP guidance for registrants concerning seeking acute toxicity data waivers, and (b) provide guidance to OPP staff for conducting and evaluating open literature searches in support of risk assessments.

PPDC 21st Century Toxicology/New Integrated Testing Strategies Workgroup members reported on Workgroup activities, including:

  • Plans in spring 2013 for a workshop to explore current 21st Century toxicology tools and their potential applications in regulatory contexts.
  • A new web page with biomarker definitions, in response to PPDC’s request, in conjunction with work on pesticide biomarker research and development activities.
  • A proposal to establish and implement metrics for progress on in vitro testing and adoption of other alternative approaches.

Finally, Mary Manibusan, Director, Exposure Assessment Coordination and Policy Division, EPA Office of Science Coordination and Policy, and Joel Patterson, Canadian PMRA, discussed a new guidance document, NAFTA (Q)uantitative Structure Activity Relationship Guidance Document, that is intended to provide general/overview guidance to pesticide evaluators and other regulatory risk assessors.

Session VIII. Endocrine Disruptor Screening Program

Manibusan continued by presenting the Endocrine Disruptor Screening Program (EDSP) update. Manibusan stated that EPA continues to review submitted Tier 1 screening data and develop Tier 2 test methods. Manibusan also discussed the June 2012 Comprehensive Management Plan, which is intended to provide strategic guidance related to the EDSP to EPA staff and managers for a five-year time horizon. Manibusan discussed key 2013 activities and milestones, including: completion of data reviews of initial Tier 1 data and weight of evidence reviews; Tier 2 inter-laboratory test method validation; and issuance of List 2 chemicals and Tier 1 test orders. Finally, Manibusan discussed the Endocrine Disruptor Screening Program for the 21st Century (EDSP21) strategy document, which discusses incorporation of 21st Century toxicology methods into the EDSP testing program.

Session IX. Endangered Species Act Update

Richard Keigwin, Director, Pesticide Re-evaluation Division (PRD), provided an update regarding Endangered Species Act (ESA)-related activities. Keigwin in particular noted the following:

  • National Academy of Sciences (NAS) Review: EPA, along with USDA and the Departments of Interior and Commerce, had asked the NAS National Research Council (NRC) to review several scientific and technical issues related to ecological risk assessments conducted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and ESA. Three public meetings have already been held. A final NAS/NRC report is expected soon, in early 2013.
  • Usage Pilot Project: EPA, USDA, and the National Marine Fisheries Service (NMFS) and the U.S. Fish and Wildlife Service (FWS) (together, the Services) 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). Keigwin stated that EPA has not seen the Services’ draft biological opinions yet, so EPA does not know how the data collected during the pilot have been used in the evaluation process.
  • ESA Consultations and Registration Review: In August 2012, EPA, the Services, and USDA proposed to revise the registration review process to increase efficiencies and improve the information available for preliminary ESA assessments. In particular, PRD proposed 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. EPA received 35 comments on the proposal, which currently are under review.

Session X. Registration Review Update

Keigwin continued by providing the registration review update, focusing on the following three topics:

  • Program Accomplishments to Date: Of the 1,100 active ingredients that must be reviewed by October 2022, Keigwin stated that PRD has opened 370 cases; of those, 320 cases are past the final work plan stage, and PRD has issued 35 final decisions.
  • Focus Meetings: PRD has added Focus Meetings to the registration review process. Focus Meetings are intended to allow discussion between EPA and a registrant early to improve the efficiency of the process. Possible topics include data needs, label clarity, understanding of atypical uses, possible risk concerns, early mitigation, assumptions and uncertainties, coordination with registration actions, and data generated for registration in other countries. Keigwin stated that PRD would take a “pilot approach” to Focus Meetings, with flexibility concerning the number, timing, content, and attendance at meetings.
  • Preliminary Risk Assessments: Keigwin also stated that PRD is revising the risk assessment process to involve the Services in an informal ESA consultation earlier, as needed. Keigwin stated that the revision is being made to try to clarify pertinent uses and data earlier in the process, to support review efficiencies.