Relevance of California’s Safer Consumer Products Regulations to Nanomaterials
Jeffrey Wong, Ph.D. Chief Scientist & Acting Deputy Director for Safer Products & Workplaces Program (retired)
Department of Toxic Substances ControlCalifornia Environmental Protection Agency
Presentation for theSustainable Nanotechnology Organization
Santa Barbara, CANovember 2013
http://www.ci.berkeley.ca.us/ContentPrint.aspx?id=11244
Disclaimer
Opinions presented today are those of
the presenter.
The policy approach of the California Green
Chemistry Initiative, Safer Consumer Products
Regulations & the California chemical data
call-in is still evolving through stakeholder
input, the California Administrative
Procedures Act and constant policy review.
Therefore, what you hear today
may not represent a final position,
policy or approach of the
Administration.2
Prevention or Cure ?
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Two Regulatory Tools
California’s Chemical Data Call-in (AB 289)
California’sSaferConsumerProductsRegulation(AB 1879 & SB 509)
Artwork by Jean Henri Gaston Giraud
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Presentation Overview:
Nanomaterials Data Call-in
California’s Green Chemistry Initiative – Intent & History
California’s Safer Consumer Products Regulations (SCPR)
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Presentation Overview:
Nanomaterials Data Call-in
California’s Green Chemistry Initiative –
Intent & History
California’s Safer Consumer Products Regulations (SCPR)
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California’sChemical Data Call-in:(starting with nanomaterials)
California H&S Code 57018-57020 Signed into law by Governor Schwarzzenger in 2006.
AB 289 Wilma Chan (Section 57018-57020 of California Health & Safety Code).
Provided the Cal/EPA with authority to request a manufacturer/importer of a chemical to provide the State with specific information regarding that chemical.
DTSC has used this authority to request information on nanomaterials.7
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California’s Chemical Data Call-in is really asking manufacturers and importers..
WHAT do you know about your product ?8
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Purpose:
Get more info into marketplace.
Identify and fill in info gaps.
Form partnerships with stakeholders and academic institutions.
Round ONE: Carbon Nanotubes.
Round TWO: Nano Metal Oxides and Quantum. Dots
NO Round THREE – resources focused on SCPR
Resulting Partnerships
DPR, CDPH, US EPA & UCLA, UCSB, UCR, Stanford, others.
Chemical Information Call-in(focusing on nanomaterials)
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Authority to Request
• The information requests may include, but is NOT limited to:
• An analytical test method for that chemical.
• Information on the fate and transport of chemical.
• Information on environmental health and safety
of chemical.
• Information on workers safety.10
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Physical properties, including: size shape surface area (including biologically
available surface area) solubility surface chemistry size distribution Particle and bulk density surface reactivity Porosity Surface charge
Commercial names Common form(s) Chemical composition Molecular structure Purity Adhesion, diffusion, agglomeration, and
aggregation behavior Dispersability
Dose-response and toxicological modes of action
Routes of exposure into the body Octanol-water partition coefficient Bio-concentration factor for humans Metabolism, including but not limited to
bioaccumulation sites Analytical test methods, including methods for
metabolites and degradation products Workplace detection and monitoring Environmental monitoring Effectiveness of personal protection
equipment Fate and transport Physicochemical properties for
characterization to enable prediction for bio-interactions
Stability in liquid and solid matrices, particularly those in commercial use
Life-cycle and Waste handling
Information Needs (who, what, where, and where?)
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How do you know & find your products? (recent call-in for nanometals and oxides…)
Detection in environment ?
Detection in body ?
How will measurement be made?
What isolation methodology will be used?
How to determine identity/form of chemical ?
12http://worthpix.com/files/funzug/imgs/informative/aircraft_detection_b4radar_12.jpg
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Questions for Manufacturers, Importers, and Researchers
Call-in questions + form
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Sample Response*
* All responses are available at www.dtsc.ca.gov/pollutionprevention/chemical_call_in.cfm
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Sample Response*
* All responses are available at www.dtsc.ca.gov/pollutionprevention/chemical_call_in.cfm
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NO ANALYTICAL METHODS
• The data call-in needs more efficient process and resources. Questions need to be focused/formatted.
•Do not perceive industry self-regulation, organization or coordination. Need better view of nanomaterial ecosystem.
•Many are small start-ups with investor funding only.
• Need bite behind bark! (21 of 45 letters unanswered in second round with nanometals and oxides).
• Need more resources (not what you think): CUPA
Lessons Learned
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Presentation Overview:
Nanomaterials Data Call-in
California’s Green Chemistry Initiative –Intent & History
California’s Safer Consumer Products Regulations (SCPR)
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California leadership in innovation, use, and manufacture of safer, ever more environmentally benign chemicals and products.
– Honor original Green Chemistry principles
– Use GC as a symbol of broad policy objectives
– Producer Responsibility
– Create incentives in marketplace with information about products
Green Chemistry Initiative
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California’s Green Chemistry Report: Six Policy Recommendations
Develop a 21st Century Green Chemistry Workforce
Accelerate the Quest for Safer Products
Expand Pollution Prevention
Move toward aCradle-to-CradleEconomy
Create On-line Product Ingredient Network
Create an Online Toxics Information
Clearinghouse
December 2008
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Presentation Overview:
Nanomaterials Data Call-in
California’s Green Chemistry Initiative – Intent & History
California’s Safer Consumer Products Regulations (SCPR)
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Safer Consumer Products Regulations(1st GC symposium Fall 2006, Start of GCI April 2007, SCPR adopted Oct 2013)
Green Chemistry Report
•Scientific Symposiums
•Science Advisory Panel
•Green Ribbon Science Panel
Green Chemistry Options
•Stakeholder Forums
•Web
•Outreach
•2008 Options Report
Policy Thinking
•Stakeholder Input
2010 Draft Regulations
•Stakeholder Input
•Statutory Date
•Administration Policy
2012 Draft Regulations
•Stakeholder Input
•Administration Support
•Expanded Use of Experts
•Scientific Peer Review
2013
Safer Consumer Product
Regulations
AB 1879/ SB 509
Statutory Authority
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SCPR requires product
manufacturers to ask:
Is It Necessary?
22https://upload.wikimedia.org/wikipedia/commons/6/66/Jean-Bernard_Restout_-
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Safer Consumer Products Regulations
Mandates the question, BUT
does not dictate the answer.
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Step 1: Identify Chemicals
Initial Candidate Chemicals List within 30 days of Regulations taking effect
List drawn from 23 authoritative body lists
Ongoing: Chemicals Can Be Added or Deleted - > Petition Process
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We don’t make “chemical(s).”
“Chemical” = any organic or
inorganic substance of a particular molecular identity, including any combination of such substances occurring, in whole or part, as a result of a chemical reaction or occurring in nature, or any element, ion, or uncombined radical.
Chemical Abstracts Service (CAS) is not keeping up !
Carbon black (1333-86-4) and fullerene (C60) (99685-96-8) each given different CAS #’s from that of elemental carbon (7440-44-0).
BUT
Nano-Ag, nano-TiO2, and nano ZnO given same CAS #’s as their macroscale counterparts.
Chemical(s) have CAS Numbers:Chemical Registries and Nanomaterials
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“Nanomaterials” Definition?
Definitions often identify whether or not a class of material is regulated.
Consequences of falling within the definition are clear and substantial.
A triggering mechanism.
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•U.S. EPA has traditionally interpreted TSCA definition of “chemical” to be about chemical structure.
•Unable to distinguish between nano-scale & macro-scale materials.
•Need to consider more than just chemical structure.
TSCA sees…Art
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Proposed EC Definition
European Commission (EC), Public consultation document. Commission recommendation of (...) on the definition of the term "nanomaterial".(2011).
"Nanomaterial" means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.
Arbitrary thresholds with no scientific evidence.31
Artwork by Jean Henri Gaston Giraud
DTSC attempted size-centric solution(s)… many watched… and objected…
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How Will Regulations on Nanomaterials Be Enacted?By Dexter Johnson Posted 8 Sep 2010 | 13:27 GMT
It is in California where the regulations look to be the most advanced. The most controversial bits of California’s regulatory project have been the definition of
nanomaterials offered by California’s Department of Toxic Substances Control (DTSC), which considers “materials under 1,000 nm to be nanoscale rather than the more commonly accepted 100 nm.” When this definition is coupled with the view of California’s Office of
Environmental Health Hazard Assessment (OEHHA) that “all nanomaterials will be considered hazardous” the broad range of regulations that could come forth is staggering.
The prospect of states determining the regulations of nanomaterials on a state-by-state basis, which in turn will decide the fate of nanomaterials’ commercial prospects, seems as though it should be a somewhat scarier proposition for producers
“…commonly accepted..”
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Wait!! Stop!! It’s 101 nm!!!
“Molecular Identity”!
“Molecular identity” = the physical and chemical characteristics of the substance, including its chemical structure and composition, size and size distribution, shape and surface structure, reactivity, and any other properties that may be relevant to whether the substance is a potential chemical of concern.
• Goes beyond SIZE.
• Able to distinguish between macroscale and nanoscale materials.
• In terms of regulatory approaches: useful beyond nano to other future novel materials in the marketplace. Artwork by Jean Henri Gaston Giraud
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Benchmark Information
From presentation by Dr. Richard Denison, Environmental Defense @ DTSC’sNanotechnology II Symposium, 3 October 2007
Particle Size
Size Distribution
Surface-Area
Particle Density
Solubility
Dispersability
Bulk Density
Agglomeration State
Chemical Reactivity
Surface Reactivity
Porosity
Surface Charge
Technical Name
Commercial Name
Common Form
Chemical
Composition
Molecular Structure
Crystal Structure
Physical Form
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It’s a chemical.. but does it have a Hazard Trait?
(36)"Hazard trait" means any hazard trait specified or
defined in chapter 54.
(e) “Hazard traits” are properties of chemicals that fall
into broad categories of toxicological, environmental,
exposure potential and physical hazards that may
contribute to adverse effects in exposed humans,
domesticated animals, wildlife, or in ecological
communities, populations or ecosystems
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How did it get on theCandidate Chemicals List ?
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Initial Candidate
Chemical List
• From 23 Authoritative Bodies
• Meeting one-time hazard and exposure criteria
Revisions to Candidate
Chemical List• Hazard criteria only
Revised List
How does the Candidate Chemicals List Change?
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Initial Candidate
Chemical List• From 23 Authoritative Bodies
Revisions
• Nominations through Petitions-Rule Making
• State added-Rule Making
• Changes in Dynamic List-No Rule Making
• Changes in Dated List-Rule Making
Revised List
Evolution in Regulatory Approach:Consideration of Hazard
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Terminology: Adverse Impacts
(5) “Adverse impacts” means adverse public
health impacts and/or adverse environmental
impacts.
(6) “Adverse public health impacts” means any of
the toxicological effects on public health specified
in article 2 or article 3 of chapter 54, or
exceedance of an enforceable California or
federal regulatory standard relating to the
protection of public health. Public health includes
occupational health.41
Step 2: Identify Priority Products
Process.
Proximate.
Policy.
Politics.
42 https://upload.wikimedia.org/wikipedia/commons/1/11/Choosing_the_Wedding_Gown_vicar_of_wakefield_mulready.jpg
Where to start ?
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Prioritization Factorsfor Priority Products
Adverse Impacts and Exposures:
Potential Hazards posed by chemicals in the products
Potential Exposure with special focus on:
Sensitive Subpopulations
Environmentally Sensitive Habitats
Endangered and Threatened Species
Impaired Environments - designated by California
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Based upon “reliable information”
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Candidate Chemical List
Chemical of Concern
Priority Products
Alternative Analysis
Regulatory Response
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3
4
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Does it have a “hazard trait?”
Does it have an “adverse impact?”
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Step 3. Alternative Analyses:“A-M” Criteria
a. Product function/performance
b. Useful life
c. Materials/Resource consumption
d. Water conservation
e. Water quality impacts
f. Air emissions
g. Prod., use, transp. energy inputs
h. Energy efficiency
i. Greenhouse gas emissions
j. Waste and end-of-life
disposal.
k. Public health impacts: sensitive sub-populations
l. Environmental impacts
m. Economic impacts
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Alternative Analyses
Phased process – notification, preliminary report, final report
Flexibility – format & timing
Notification options in lieu of AA– chemical removal, product removal, product-chemical replacement, and alternatives analysis threshold exemption
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Step 4. Regulatory Response
Additional information to DTSC
Additional information to consumers
Use restrictions
Sales prohibitions
Additional safety measures / controls
End-of-life product stewardship
Research funding50
Comparison of California, REACH & EPA TSCA
CaliforniaSCPR
REACH U.S. EPA TSCA U.S. EPA Workplan
Scope 1200 Chemicals 30,000 chemicals
82,000 Chemicals on TSCA Inventory
83 WorkplanChemicals
Priority 3-5 consumer products initially
Chemicals > 1 million tons
1.RiskAssessments2.Increasing Information3.Safer Products
Conduct initial assessments on 23 chemicals
Chemical or Product SafetyFocus
Both Chemical Safety Chemical Safety Chemical Safety. SomeProduct Safety
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Comparison of SCPR, REACH & EPA TSCA (cont’d)
CaliforniaSCPR
REACH U.S. EPA TSCA U.S. EPA Workplan
Alternative and/or Risk Assessments
Yes, AAs for products.
No for both. Yes, Risk Assessments
Both AA’s and RA’s
Who Provides Data
Business. Business. EPA collects available info. Limited testing authority.
EPA collects available info. Limited testing authority.
Info for Consumers Yes. Yes. Limited.
Info Portal soon.Limited.Info Portal soon.
Regulatory Actions
Various. Various. Limited. Limited.
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• DTSC AB 289 Team & SCPR Team
• Professor Tim Malloy; UCLA Law• Professors Adre Nel, Hillary Godwin, Arturo Keller; UCLA/UCSB CEIN• Dr. Joseph Guth; UC Berkeley• Dr. Richard Denison; EDF•Terry Medly & Tom Jacob; DuPont
Acknowledgments to those on the leading edge…
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Artwork by Jean Henri Gaston Giraud
Thank you !
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