The Role of Research in the Business of the Environmental Protection Agency Steven Bradbury, Director Environmental Fate & Effects Division Office of Pesticide Programs ORD Managers Workshop March 2007

Is it a business? buying and selling; trade; dealings, especially of a commercial nature a commercial firm (Oxford American Dictionary of Current English) Protecting Human Health and the Environment

Gateway to pesticide market; sales over $11 B/yr. Gateway to pesticide market; sales over $11 B/yr. Approximately 1,100 active ingredients and 19,000 products (agricultural pesticides, antimicrobial and consumer products, ‘inert’ ingredients). Approximately 1,100 active ingredients and 19,000 products (agricultural pesticides, antimicrobial and consumer products, ‘inert’ ingredients). Evaluation of new pesticides and reevaluation of existing pesticides on regular, statutory and litigation-driven schedules, with finite resources. Evaluation of new pesticides and reevaluation of existing pesticides on regular, statutory and litigation-driven schedules, with finite resources. Over 5,000 regulatory decisions annually with many possible outcomes. Over 5,000 regulatory decisions annually with many possible outcomes. National Pesticide Program

Protecting Human Health and the Environment Is it a business? regular occupation, trade, profession a thing that is one’s [or society’s] concern a task or duty a serious activity a difficult matter (Oxford American Dictionary of Current English)

Best possible regulatory decisions to protect public health, non–target species, and the environment Public expectations for scientific soundness, transparency, and timeliness Human Health and Environmental Protection

Use of best available data; availability and quality of data varies extensively New risk assessment/management challenges always arise Science increasingly complex and changing

How does the public and our stakeholders visualize EPA and its business? How do we in EPA visualize ourselves and the business of health and environmental protection? How is ORD perceived within EPA? How does ORD visualize itself in the business of human health and environmental protection?

Research & Development in EPA’s Business Critical to meeting EPA’s goals Unique among other Federal research missions EPA implements statutes Unique compared to the academic mission Federal research is long-term, high risk Unique compared to the industrial mission EPA’s statutory-based, risk/risk-benefit charge Complement unique role with partners

Examples of ORD’s Role in EPA’s Business Pre-manufacturing notification program under the Toxic Substances Control Act Ambient water quality criteria under the Clean Water Act Approaches to assess cumulative health risks under the Food Quality Protection Act Assessing regulatory performance under the Clean Air Act and the Clean Water Act

ORD’s Role in EPA’s Business EPA implemented the Nation’s statutes ORD’s people were part of the EPA teams resolving protection challenges. ORD’s products were intimately integrated into EPA’s business. EPA could not have met its challenges without ORD. EPA’s research was longer-term, higher risk, but ORD partners understood the regulatory challenge and how uncertainty played into decision-making. Incremental advancements were planned and realized; perfection was not the enemy of the good. Evolution in the science complemented advances in regulatory programs; ORD, as part of the EPA teams, played key roles in stakeholder dialogue.

Challenges for the Future Establishing an Integrated Toxicology, Testing and Risk Assessment Paradigm Advancing Approaches for Assessing and Managing Spatially-Explicit Risks to Humans and Wildlife Documenting Environmental and Human Health Outcomes Derived from Regulatory Programs

The New Hypothesis-Driven Risk Assessment Paradigm Mortality Systemic Toxicity Disease Cancer Developmental Impairment Terato Prenatal Deficits Reproductive Fitness Viable Offspring Fertility Molecular Interactions Biochemical Responses Cellular Responses Tissue/Organ Function Chemical Inventories C 2 Cl 3 Cl C C 2 Cl 3 Cl C C 2 Cl 3 Cl C ClCl ClCl ClCl ClCl OH Existing data; In silico and In vitro Prioritization; Screening Adverse Outcomes; Dosimetry Efficient, Focused In vivo Animal Testing; Exposure Assessment

Spatially-Explicit Risk Assessments Vulnerable ground water exposure sites N-methyl Carbamate Cumulative Assessment Drinking Water Exposure

Spatially-Explicit Risk Assessments Use area (orange), highly permeable soils (blue) and potential high GW exposure areas (dark color).

Placed-Based Regulatory Implementation (4)

REGULATORY GOALS - PROTECTION OUTCOMES SPATIALLY, TEMPORALLY EXPLICIT RISK ASSESSMENTS Human Health and Environmental Outcomes MEASURING ACHIEVEMENT OF ENVIRONMENTAL PROTECTION GOALS SPATIALLY, TEMPORALLY EXPLICIT RISK MANAGEMENT DECISIONS

Research and Development in the Business of the EPA Can EPA meet the future protection challenges without ORD? What are the unique talents and attributes that only ORD can provide to meet the challenges? Are ORD’s people part of the existing and emerging cross-EPA teams trying to resolve protection challenges? How are ORD’s products envisioned to be intimately integrated into EPA’s business over time?

Protecting Human Health and the Environment