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