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Transcript of The Role of Research in the Business of the Environmental Protection Agency Steven Bradbury,...
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).
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?