The Role of Research in the The Role of Research in the Business of theBusiness of the

Environmental Protection Environmental Protection AgencyAgency

Steven Bradbury, Director

Environmental Fate & Effects DivisionOffice of Pesticide Programs

ORD Managers Workshop

March 2007

Is it a business?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 EnvironmentProtecting 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 Approximately 1,100 active ingredients and 19,000 products (agricultural pesticides, antimicrobial and products (agricultural pesticides, antimicrobial and consumer products, ‘inert’ ingredients). consumer products, ‘inert’ ingredients).

Evaluation of new pesticides and reevaluation of existing Evaluation of new pesticides and reevaluation of existing pesticides on regular, statutory and litigation-driven pesticides on regular, statutory and litigation-driven schedules, with finite resources.schedules, with finite resources.

Over 5,000 regulatory decisions annually with many Over 5,000 regulatory decisions annually with many possible outcomes.possible outcomes.

National Pesticide ProgramNational Pesticide Program

Protecting Human Health and the EnvironmentProtecting Human Health and the EnvironmentIs it a business?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 Human Health and Environmental ProtectionProtection

Human Health and Environmental Human Health and Environmental Protection 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 Research & Development in EPA’s BusinessBusiness

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 Examples of ORD’s Role in EPA’s Business 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 BusinessORD’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 FutureChallenges 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 The New Hypothesis-Driven Risk Assessment ParadigmAssessment 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

C2Cl3

ClClC

C2Cl3

ClClC

C2Cl3

ClClC

Cl

ClClCl

Cl

Cl

ClCl

ClCl

Cl

Cl

ClClCl

Cl

Cl

ClCl

ClCl

Cl

Cl

ClOHOH

OH

Existing data; In silico and

In vitro Prioritization;

Screening

Adverse Outcomes;Dosimetry

Efficient, Focused In vivo Animal Testing;

Exposure Assessment

Spatially-Explicit Risk AssessmentsSpatially-Explicit Risk Assessments

Vulnerable ground water exposure sites

N-methyl Carbamate Cumulative AssessmentDrinking Water Exposure

Spatially-Explicit Risk AssessmentsSpatially-Explicit Risk Assessments

Use area (orange), highly permeable soils (blue) and potentialhigh GW exposure areas (dark color).

Placed-Based Regulatory ImplementationPlaced-Based Regulatory Implementation

(4)

REGULATORY GOALS -

PROTECTION OUTCOMES

SPATIALLY,TEMPORALLY

EXPLICIT RISK

ASSESSMENTS

Human Health and Environmental OutcomesHuman Health and Environmental Outcomes

MEASURING ACHIEVEMENT OFENVIRONMENTAL PROTECTION

GOALS

SPATIALLY,TEMPORALLY

EXPLICIT RISK

MANAGEMENTDECISIONS

Research and Development in the Research and Development in the Business of the EPABusiness 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 EnvironmentProtecting Human Health and the Environment