Steven Bradbury,Director Environmental Fate and Effects Division Office of Pesticide Programs US Environmental Protection Agency National Pesticide Program A New Toxicology Testing Paradigm: Meeting Common Needs National Pesticide Program MISSION Best Possible Regulatory Decisions to Protect Public Health and the Environment Rely on All Available and Relevant Scientifically Sound Information
1 National Pesticide Program A New Toxicology Testing Paradigm: Meeting Common Needs Steven Bradbury, Director Environmental Fate and Effects Division Office of Pesticide Programs US Environmental Protection Agency 2 • Best Possible Regulatory Decisions to Protect Public Health and the Environment • Rely on All Available and Relevant Scientifically Sound Information National Pesticide Program MISSION
National Pesticide Program OPP AT A GLANCE Gateway to pesticide market,where sales over $11 B/yr Over 5,000 regulatory decisions annually Approximately 1,100 active ingredients and 19,000 products Reevaluation of existing pesticides on a regular schedule to ensure safety standards continue to be met National Pesticide Program OPP AT A GLANCE Safety Evaluation Done for all Pesticide Chemicals -Agricultural chemicals -Antimicrobials and Consumer products -Inert ingredients Data Availability/Quality Varies Extensively New Risk Assessment/Management Challenges Always Arise
2 3 • Gateway to pesticide market, where sales over $11 B/yr • Over 5,000 regulatory decisions annually • Approximately 1,100 active ingredients and 19,000 products • Reevaluation of existing pesticides on a regular schedule to ensure safety standards continue to be met National Pesticide Program OPP AT A GLANCE 4 National Pesticide Program OPP AT A GLANCE • Safety Evaluation Done for all Pesticide Chemicals – Agricultural chemicals – Antimicrobials and Consumer products – Inert ingredients • Data Availability/Quality Varies Extensively • New Risk Assessment/Management Challenges Always Arise
National Pesticide Program CHALLENGES Science Increasingly Complex and Changing Large Number of Chemicals to Review with Many Possible Adverse Outcomes Finite Resources and Time Sufficient,Credible Information to Make a Decision, not an Overwhelming Amount of Information Public Expectations for Scientific Soundness, Transparency,and Timeliness National Pesticide Program Vision for a New Toxicology Testing and Assessment Paradigm ·Integrative ·Hypothesis-Driven ·Efficient
3 5 National Pesticide Program CHALLENGES • Science Increasingly Complex and Changing • Large Number of Chemicals to Review with Many Possible Adverse Outcomes • Finite Resources and Time • Sufficient, Credible Information to Make a Decision, not an Overwhelming Amount of Information • Public Expectations for Scientific Soundness, Transparency, and Timeliness 6 • Integrative • Hypothesis-Driven • Efficient National Pesticide Program Vision for a New Toxicology Testing and Assessment Paradigm
Why a Shift in Paradigm? ·b8ee8bt88emg5R6mesomcn Increase efficiency by focusing the regulated ific effec to assess and manage risks appropriately e8Cga8a9Rg8t8esw6es8g on all possible adverse outcomes Why a Shift in Paradigm? Lower the costs for the government and taxpavers because the Agency could avoid reviewing unnecessary fests Eliminate complex and expensive in vivo testing for the pesticide-producing industry Reduce the use of animals in testing
4 7 Why a Shift in Paradigm? • Improve ability to carry out EPA mission of protecting public health and the environment • Increase efficiency by focusing the regulated community, government, and interested parties on a pesticide’s most likely hazards of concern Determine what specific effects data for each chemical and exposure situation are essential to assess and manage risks appropriately Use screening and priority setting to eliminate the need for requiring a battery of tests focused on all possible adverse outcomes 8 Why a Shift in Paradigm? • Lower the costs for the government and taxpayers because the Agency could avoid reviewing unnecessary tests • Eliminate complex and expensive in vivo testing for the pesticide-producing industry • Reduce the use of animals in testing
Current Paradigm Risk Managers Focus on Potential Adverse Outcomes Mortality Reproductive Developmental Fertility BATTERY of Animal Testing (Part 158) Current Toxicology Testing Paradigm Generates In Vivo Animal Data for all Possible Outcomes to Determine which of all Possible Effects are Relevant Implementing Change Development and implementation of a new,integrated approach to the testing and assessment of pesticides will be a challenge and will take place over the next 10 years .Scientific tools and knowledge must be 8iae86R8beee6eegdngana National Academy of Science study 、分
5 9 Mortality •Systemic Toxicity •Disease •Cancer Reproductive Fitness •Viable Offspring •Fertility Developmental Impairment •Terato •Prenatal Deficits Current Paradigm • Risk Managers Focus on Potential Adverse Outcomes • Current Toxicology Testing Paradigm Generates In Vivo Animal Data for all Possible Outcomes to Determine which of all Possible Effects are Relevant BATTERY of Animal Testing (Part 158) 10 Implementing Change • Development and implementation of a new, integrated approach to the testing and assessment of pesticides will be a challenge and will take place over the next 10 years • Scientific tools and knowledge must be advanced and public understanding and confidence must be developed • National Academy of Science study