NAFTA TWG Sound Science and Policy

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1 NAFTA TWG Sound Science and Policy Presentation to the NAFTA Technical Working Group on Pesticides Stakeholder-Government Meeting November 17, 2011 Dr. Peter Chan, Director General Health Evaluation Directorate Pest Management Regulatory Agency (PMRA)

2 Objectives Assessments and decisions will integrate cutting-edge science Based on approach that is rigorous and modern Identify best practices internationally in the use of alternatives to testing approaches and integrate them to the extent possible Use our current knowledge about the range of anticipated risks of pesticides to determine the evidence needed to support decision-making. Etc.. 2

3 Integrated Approaches to Testing and Assessment (IATA) WHAT IS IATA? Based on NAS Toxicity Testing in the 21 st Century a Vision and a Strategy (2007) Integrates conventional and alternative studies in WOE Alternative studies: high throughput screening (HTS) cellular/biochemical assays, omics assays,predictive models,mechanistic studies, population based studies Toxicity pathways/adverse Outcome Pathways (AOP) WHAT ARE THE GOALS OF IATA? Reduced animal usage and testing/assessment costs/times Targeted testing requirements Higher content animal testing protocols Better understanding of mechanism/mode of action Eventual replacement of conventional testing 3

4 IATA An Incremental Paradigm Shift SHORT-TERM (5-10 YRS) MEDIUM-TERM (10-20 YRS) DEVELOPMENT & APPLICATION OF IN VITRO ASSAYS (OMICS, HTS, ETC.) LONG-TERM (20 + YRS) CURRENT APPROACHES TO TESTING AND ASSESSMENT IDENTIFICATION OF ADVERSE OUTCOME PATHWAYS DEVELOPMENT & APPLICATION OF COMPUTER MODELS/DATABASES AOP BASED ASSESSMENTS POPULATION BASED STUDIES BASED ON BIOMARKERS OF EXP/EFFECT USE OF ANIMAL TESTING TESTING & ASSESSMENT RESOURCES & TIME Enhance efficiency of testing/assessment while maintaining sound science and pesticide risk assessment/risk management protective of human health and the environment 4

5 Developing and Implementing IATA Activities Frameworks/Vision: NAS Toxicity Testing in the 21 st Century 2007) + US EPA Strategic Plan for Evaluating the Toxicity of Chemicals (2009) HTS Assay/Exposure Tools: ToxCast/Tox21, ExpoCast, associated databases (e.g., ACTOR, ToxRefDB, DSSTox, etc.) Other tools existing or under development: EPISuite, ASTER, ECOSAR, AIM, Oncologic, (Q)SAR for Estrogen Receptor binding, Metapath (OECD) Proposed Regulatory Rule: 40 CFR 158W OECD: Toxicogenomics, predictive methods for Endocrine Disrupters, OECD reports/guidance docs, OECD (Q)SAR Toolbox, Metapath Stakeholder Communication: Pesticide Programme Dialogue Committee Workgroup on 21 st Century Tox Council of Canadian Academies (CCA) Assessment of Integrated Testing Strategies: Advice on Status of the Science and Public, Stakeholder and NGO concerns on use of IATA vs. existing approaches 5

6 Developmental Neurological Toxicity (DNT) Testing Objective is to develop a common standard evaluation guidance or guiding principles on DNT evaluation A Stakeholder meeting was held between PMRA, USEPA, Academia and Industry to address challenges that exist with the analysis and interpretation of DNT in March 2011 Four key priority areas were brought forward: Identify key biological hypotheses tested and determine which dependent variables are of primary interests Improve understanding of inherent variability Develop statistical approaches based n primary biological hypotheses tested Develop an integrated WOE approach as well as alternative testing strategy in future PMRA will host a second workshop in February 2012 with a focus discussion to further address these priority areas 6

7 Dermal Absorption Objective is to delineate/harmonize NAFTA countries positions regarding dermal absorption practices In 2008, the NAFTA Dermal Absorption Working Group finalized a consensus Position Paper on Use of In Vitro Dermal Absorption Data in Risk Assessment (Triple-pack approach) The NAFTA Dermal Absorption Working Group is finalizing guidance document on a streamlined dermal absorption in vivo study (nonprimate), based on existing test guidance to detail how to reduce animal use and cost This document is at the final stages of approval at the various agencies and is the final task of the NAFTA Dermal Absorption Working Group This project is considered to be completed under the NAFTA initiative 7

8 Extended One-Generation Reproduction Toxicity Study Protocol New Test Guideline (TG443) approved by OECD in November 2010 with significant input from Canada and US Was developed as an alternative to the existing two-generation reproduction toxicity study (TG416) Will provide and/or confirm information about the potential effects of chemicals on the development, integrity and performance of the adult male and female reproductive systems, and can also assess developmental neuroand immuno-toxicity The protocol, with examination of additional endpoints and animals per litter, has increased power and sensitivity to detect reproductive and developmental effects compared to TG 416, and represents a more efficient use of test animals PMRA and EPA staff are continuing to work together on applying this new test guideline to specific actives (collaboration at both study development and review levels for 4 active ingredients) as well as developing the guidance document for the EOGRTS (GD 151) 8

9 International Pollinator Activities SETAC Pellston Pollinator Workshop- Completed January 2011 International Collaboration Risk Assessment Framework Data Requirements and study protocols OECD Working Group on Pesticides: Pesticide Effects on Insect Pollinators (PEIP) Co-lead by Canada, USA, France Four Themes: Communicating Pollinator Incidents Pollinator Testing Requirements and Assessment Mitigation of Pollinator Risks Pollinator Research Database Ongoing Collaboration between International Regulatory Partners (USA, Canada, OECD partners) Joint Reviews- evaluation and risk mitigation for pollinator risks 9

10 Spray Drift Activities In March 2011, the PMRA launched the drift mitigation web pages on the PMRA, Health Canada, website. Has an online spray buffer zone modifier tool (Buffer Zone Calculator). Will provide advice on spray drift best management practices (BMP). Buffer Zone Calculator Is currently available on-line Allows for buffer zone modification based on site specific metereological conditions and equipment type PMRA is currently working on incorporating low drift nozzles into the calculator for additional options to modify buffer zones 10

11 NAFTA groundwater modelling project Intended to harmonize Canada and US groundwater modelling Common conceptual model Common numerical model (i.e. modelling program) Mostly common guidance on scenario creation and input parameter selection Joint implementation of the model and publication of a final report in late 2011/early 2012 Report will identify further areas of analysis to address sensitivity of the model to certain model processes and parameters 11

12 NAFTA Prospective Ground Water (PGW) project Establish Canada s use of US EPA Prospective Ground Water (PGW) Study Design guidance Add Canadian perspective to present guidance Identify future areas of collaboration Completion targeted for the end of

13 NAFTA Degradation Kinetics project Goal was to develop a consistent harmonized approach for characterizing pesticide degradation kinetics (both first-order and biphasic) and, when necessary, deriving first-order rate constants for modeling purposes. A guidance document will be published in late 2011/early 2012 The approach and guidance document will be revisited after one year for modification, if required. 13

14 Summary - Conclusions US EPA and PMRA continue to lead or make significant contributions to the development of IATA tools and approaches as well as other Science Projects Overall goal is to enhance the efficiency of pesticide assessments and maintain sound science that supports risk assessment/risk management actions protective of human health and the environment 14

15 Thank you for your attention Questions?

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