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SCIENCE-POLICY MASH UP
T i mo t h y F. Ma l l oy
UCL A Sch o ol o f L a w
UC Cen t er Fo r E n vi r o nment al Imp l i cat ions o f Na n ot echnol ogy
UCL A Sus t a i nable Tech n o logy a n d Po l icy Pr o g r am
September 28, 2013
YOUR TIME IN VENTURA
• Coffee:
• Palermo’s
• The Sandbox
• Chocolate:
• Trufflehounds
• Pizza:
• Sicily
THE LONG AND WINDING ROAD
• Myth Busters: Do We Know What We Think We
Know?
• Into the Weeds: Policies, Mechanisms and
Tools
• Concluding Thoughts
NANOMATERIALS ARE NOT SUBJECT TO
COMPREHENSIVE REGULATION
INFORMATION DISCLOSURE:
CALIFORNIA STYLE
CALIFORNIA COVERAGE OF ENGINEERED NANO
MATERIALS (ENM)
AND THOSE OTHER GUYS
• EPA
• TSCA Consent Orders/ SNURs
• FIFRA Registration/ Registration Review
• FDA
• European Union
• France, Norway, Belgium, Denmark
• Japan
• Canada
• Berkeley, CA
THERE IS NOT ENOUGH “GOOD SCIENCE” TO
PERFORM RISK ASSESSMENTS ON ENM’S
RISK ASSESSMENT MANIA
• It IS being done • EPA
• NIOSH
• European Union
• What “it” is not an absolute
THE STATE OF CALIFORNIA HAS NO
AUTHORITY TO REQUIRE TESTING OF ENM
ALTERNATIVE TESTING METHODS ARE NOT
YET READY FOR REGULATORY PRIME TIME
CALIFORNIA COVERAGE OF ENGINEERED NANO
MATERIALS (ENM)
EPA RELIANCE ON
ALTERNATIVE TESTING
• Issuance of Test Rules
• Review of PMNs
THE PRIMARY BARRIER TO REGULATION OF
ENM’S IS LACK OF DATA/ INFORMATION
INTO THE WEEDS . . . .
Tort
THE STATE OF THE DISCOURSE:
THE POLICY MILIEU
POLICY
Information
Disclosure
Best
Practices Direct
Regulation
Bonding
Insurance
Self-
Regulation
TORT LIABILITY: MODE OF ACTION
• Retrospective in nature—after the fact
• Provides for compensation to those harmed by
actions of others
• Also prospective—future-looking
• Specific deterrence
• General deterrence
“If you or a loved one has suffered from exposure to nanoparticles or other nano-materials, you may qualify for damages or remedies that may be awarded in a possible class action lawsuit. Please click the link below to submit your complaint and we will have a lawyer review your Nanotechnology complaints.”
www.lawyersandsettlements.com/case/nanotechnology.html
TYPES OF TORTS
• Negligence
• Failure to use due care in business operations
• “Due care” will depend upon
• existing regulation and
• Best practices in the industry
• Strict Liability
• Design defect
• Manufacturing defect
• Failure to warn
OBSTACLES TO TORT RECOVERY
• Latency
• Proving causation
• Level of evidence
• Transaction costs
INFORMATION FLOW
Nanomaterial
Manufacturer
Nanomaterial
Distributor
Nanomaterial
Int. User
Nanomaterial
Commercial End-
user
•Info
•Training
Hazard
Handling
Hazard
Handling
Hazard
Handling •Info
•Training
Use/Exp.
Use/Exp.
Use/Exp. Hazard
Handling
Gov’t
•Info
•Training
Information Gaps/
Asymmetry
Info Collection/
Processing by
Firm
Info Receipt and
Processing by the
Recipient
Change in Info
Recipient
Behavior
Change in Firm
Behavior
Reflexive
Function
Deterrent
Function
Enhancement
Function
Mechanisms of Information Disclosure
MECHANISMS OF ACTION:
DIRECT REGULATION
• Deterrent Function
• Reflexive Function
• Normative Function
DIRECT REGULATION: AB 1879
Direct Regulation: Classic
ALTERNATIVES ANALYSIS
DECISION FRAMEWORK
Economic Impact
Technical Performance
Environmental Impact
Human Health Impact
Ecological Impact
DECISION NEEDS
Inventory of Types/Applications / Volumes
Releases/ Fate/Exposures
Toxicity/Hazard Testing
Prioritization Methods
Trade Off Analysis Risk Assessment
Economic Analysis
Diffusion Analysis
Consumer Behavior/Perception
IDENTIFYING MOCS, THEIR USES AND
FATE
• Experimental Studies of ENM-specific releases from particular applications
• Development of application-specific ENM release models
• Development of life cycle release models from various applications
• Development of ENM fate and transport models to determine exposure concentrations
Keller, et al, 2013
TOXICITY/HAZARD TESTING
• Predictive Toxicology: A toxicological approach in which non-animal testing results, such as chemical structure (for quantitative structure-activity relationships) or in vitro screening of biological effects or toxicity at the cellular or biomolecular level is used to predict the likelihood of an adverse health outcome in animals and/or humans
• Regulatory Implementation
• Validation
• Scope of Use (Prioritization vs. Risk Assessment)
• Breadth of Reach (Pathways vs. Endpoints)
DECISION-MAKING:
PRIORITIZING MOCS & EVALUATING PRODUCTS
• Verbal Argumentative Approach
• Decision Analytic Approach: MCDA
• Probabilistic Approaches: Bayesian
Networks.
CONCLUDING THOUGHTS
• Integration of Policy/ Translation of Scientific
Advances
• Design vs. Evaluation
• Future of Legal Evolution
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