relevance of california s safer consumer products

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 ?

Art

work

by J

ean H

enri

Gasto

n G

iraud

(1938-2

012)

3

Two Regulatory Tools

California’s Chemical Data Call-in (AB 289)

California’sSaferConsumerProductsRegulation(AB 1879 & SB 509)

Artwork by Jean Henri Gaston Giraud

4

Presentation Overview:

Nanomaterials Data Call-in

California’s Green Chemistry Initiative – Intent & History

California’s Safer Consumer Products Regulations (SCPR)

Art

work

by J

ean

Henri G

asto

n G

irau

d

5



California’s Green Chemistry Initiative –

Intent & History


6

Art

work

by J

ean H

enri G

asto

n G

iraud

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

Art

work

by J

ean H

enri G

asto

n G

iraud

California’s Chemical Data Call-in is really asking manufacturers and importers..

WHAT do you know about your product ?8

Art

work

by J

ean H

enri G

asto

n G

iraud

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)

9

Art

work

by J

ean H

enri G

asto

n G

iraud

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

Art

work

by J

ean H

enri G

asto

n G

iraud

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?)

11

Art

work

by J

ean H

enri G

asto

n G

iraud

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

Art

work

by J

ean H

enri G

asto

n G

iraud

Questions for Manufacturers, Importers, and Researchers

Call-in questions + form

.

13

Art

work

by J

ean H

enri G

asto

n G

iraud

Sample Response*

* All responses are available at www.dtsc.ca.gov/pollutionprevention/chemical_call_in.cfm

14

Art

work

by J

ean H

enri G

asto

n G

iraud

Sample Response*

* All responses are available at www.dtsc.ca.gov/pollutionprevention/chemical_call_in.cfm

15

Art

work

by J

ean H

enri G

asto

n G

iraud

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

16

Art

work

by J

ean H

enri G

asto

n G

iraud



California’s Green Chemistry Initiative –Intent & History


17

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

18

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

19



California’s Green Chemistry Initiative – Intent & History


20

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


•Statutory Date

•Administration Policy

2012 Draft Regulations


•Administration Support

•Expanded Use of Experts

•Scientific Peer Review

2013

Safer Consumer Product

Regulations

AB 1879/ SB 509

Statutory Authority

21

SCPR requires product

manufacturers to ask:

Is It Necessary?

22https://upload.wikimedia.org/wikipedia/commons/6/66/Jean-Bernard_Restout_-

_Diogenes_Asking_for_Alms.jpg

Safer Consumer Products Regulations

Mandates the question, BUT

does not dictate the answer.

http://www.neurosciencemarketing.com/blog/wp-content/uploads/2011/02/choice.jpg

23

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

26

27

Art

work

by J

ean H

enri G

asto

n G

iraud

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

28

Art

work

by J

ean H

enri G

asto

n G

iraud

“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.

29

•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

work

by J

ean H

enri G

asto

n G

iraud

30

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


DTSC attempted size-centric solution(s)… many watched… and objected…

Art

work

by J

ean H

enri G

asto

n G

iraud

32

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..”

33

Art

work

by J

ean H

enri G

asto

n G

iraud

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

34

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

35

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

36

How did it get on theCandidate Chemicals List ?

37

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?

38

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

39

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 ?

http://www.wayfaring.info/images/how_far_is_haha.jpg

43

http://www.luxresearchinc.com/index.php

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

44

Art

work

by J

ean H

enri G

asto

n G

iraud

Based upon “reliable information”

45

Candidate Chemical List

Chemical of Concern

Priority Products

Alternative Analysis

Regulatory Response

1

2

3

4

htt

p:/

/im

g.s

park

note

s.c

om

/conte

nt/

spark

life

/spark

talk

/people

watc

hin

g_Larg

e.jpg

Does it have a “hazard trait?”

Does it have an “adverse impact?”

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

47

Art

work

by J

ean H

enri G

asto

n G

iraud

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

48

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

51

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.

52

• 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…

53


Thank you !

54

relevance of california s safer consumer products

Documents