Regulating Engineered Nanomaterials in California: No Small Issue

Engineered Nanomaterials Workshop October 2018 Sacramento, CA

Jeffrey Wong, Ph.D.

Very Retired

1

Disclaimer

Opinions presented today are those of the presenter.

The policy approach of the DTSC Safer Products & Workplaces Program continues to evolve through sustained data collection and evaluation, stakeholder input, constant policy review and existence as learning organization.

Therefore, what you hear today may not represent a final position, policy or approach of the Administration.

2

Presentation Outline

Overview: Past efforts by DTSC

DTSC Nanomaterials Data Call-in

DTSC Safer Consumer Products Regulations (SCPR):

• Nanomaterials: Candidate Chemical?

• Nanomaterial enabled products: Priority Product?

Thoughts about nanomaterial regulation

3

Are you ready… ?

What do you know?• Is what you know useful?

• Is what you know relevant?

• Is what you know current?

Does what you know actually help you or someone else?

4

Gunfighting, and Other Thoughts….By CR Williams.Amazon Digital Services LLC ASINB00LXKOQQK. 2014.

Nanomaterial Value Chain

Two Regulatory Tools

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

California’sSaferConsumerProductsRegulation(AB 1879 & SB 509) H&S Code

Sections 25252-25257

(AB 1879) / H&S Code

Section 25251(SB 509)Artwork by Jean Henri Gaston Giraud

6

Neither process is nanomaterial focused or limited !

H&S Code 57018-

57020

California’s Chemical Data Call-in

Assembly Bill (AB) 289 key points:

• Sponsored by Assembly Member Wilma Chan

• Signed in law by the Governor 9.29.2006

o California H&S Code 57018-57020

• Authorization to request a manufacturer of a chemical to provide the State with specific information regarding the chemical.

• DTSC used this authority to request information on nanomaterials.

• Authority not limited to nano-materials

7

California’s Nanomaterials Data Call-in Goals

Get more information into the marketplace.

Establish what is known & determine “data gaps.”

Create strategic partnerships with the stakeholders that will fill “data gaps.”

Use strategic partnership with the University of California, Stanford and other academic institutions to fill “data gaps” through the coordinated pursuit of federal support.

Create strategic, coordinated and transparent partnership with the Federal Government. 8

Call-in Questions to be answered in 365 days!(actually a two year process)

Detection and Measurement: What sampling, detection & measurement methods are you using to monitor the presence of your chemical in the workplace & the environment? Provide a full description of all required sampling, detection, measurement and verification methodologies.

Environmental Fate and Transport: What is your knowledge about the current and projected presence of your chemical in the environment that results from manufacturing, distribution, use, and end-of-life disposal?

Public Health & Environmental Impacts: What is your knowledge about the safety of your chemical in terms of occupational safety, public health and the environment?

Occupational Safety: What methods are you using to protect workers in the research, development and manufacturing environment?

9

What do you know about your product?

Sample 1 AB 289 Response

10

Sample 2 AB 289 Response

11

California’s Nanomaterials Data Call-in: Best Tool?

Get more information into the marketplace. Tried.. Marketplace needed to own more data. Need better tools for gathering data.

Establish what is known & determine “data gaps.” Needed “heavier hand.”

Create strategic partnerships with the stakeholders that will fill “data gaps.” Hard. California businesses “small.”

Use strategic partnership with the University of California, Stanford and other academic institutions to fill “data gaps” through the coordinated pursuit of federal support. Partnered w/ UCLA, UCSB, Stanford. Tried to partner w/ NIOSH.

Create strategic, coordinated and transparent partnership with the Federal Government. Tried. Partnered w/ US EPA on symposiums but under TSCA California not CBI cleared. Addressed PCAST on NNI.

12

2014 California’s Safer Consumer Products Regulation (SCPR) Health and Safety Code section 25252

Drive markets to make safe chemistry fundamental to product design.

o Reduce exposure

o Reduce or eliminate chemical hazards

o Look at full product lifecycle

o Encourage reformulation/innovation

o Avoid regrettable substitutes

Asks questions?

• Is this chemical necessary?

• Is there a safer alternative?

13

AB 1879

Assembly Member Michael Feuer,

42nd District

SCP Regulations: Four-Step Process

Chemical Abstracts Service (CAS) leads to some confusion.

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 macro-scale counterparts.

Cannot rely upon CAS Numbers:

15

Definition by size wasn’t working…

16

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.

One size… defines all ?

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 %.

17

18

“Nanomaterials…” are “chemicals!”

“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.

Regulations Text

DIVISION 4.5, TITLE 22, CALIFORNIA CODE OF REGULATIONS

CHAPTER 55. SAFER CONSUMER PRODUCTS

DEPARTMENT OF TOXIC SUBSTANCES CONTROL REFERENCE NUMBER: R-2011-02

OFFICE OF ADMINISTRATIVE LAW NOTICE FILE NUMBER: Z-2012-0717-04

All of the text in these regulations is new language added to the California Code of

Regulations.

Page 1 of 72

No explicit inclusion or exclusion of nanomaterials..

So no need to define.. !

“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.

• Distinguish between macro-scale & nano-scale.

•Address future novel materials in the marketplace.

19

(17) “Atmospheric oxidation rate” means the rate of change or degradation of a

chemical through the interaction with oxygen in the atmosphere. (18) “Bioaccumulation” means the bioaccumulation hazard trait, as specified in

section 69405.2. (19) “Candidate Chemical” means a chemical that is a candidate for designation as a

Chemical of Concern, and that is identified as a Candidate Chemical under section 69502.2.

(20)

(A) “Chemical” means either of the following: 1. An organic or inorganic substance of a particular molecular identity,

including any combination of such substances occurring, in whole or in part, as a result of a chemical reaction or occurring in nature, and any element, ion or uncombined radical, and any degradate, metabolite, or reaction product of a substance with a particular molecular identity; or

2. A chemical ingredient, which means a substance comprising one or more substances described in subparagraph 1.

(B)

“Molecular identity” means the substance’s properties listed below: 1. Agglomeration state; 2. Bulk density; 3. Chemical composition, including surface coating; 4. Crystal structure; 5. Dispersability; 6. Molecular structure; 7. Particle density; 8. Particle size, size distribution, and surface area; 9. Physical form and shape, at room temperature and pressure;10. Physicochemical properties; 11. Porosity; 12. Solubility in water and biologically relevant fluids; 13. Surface charge; and 14. Surface reactivity.

mical of Concern” means a Candidate Chemical that has been design Chemical of Concern under section 69503.5(b)(2)(B).

(21) “Che ated

as a (22) “Chemical Removal Intent Notification” and “Chemical Removal Confirmation

Notification” mean the notifications submitted to the Department under section 69505.2(a)(1)(A)1.

(23)

(A) “Component” means a uniquely identifiable homogeneous material, part, piece, assembly, or subassembly that is a necessary or intended element of a consumer product.

(B) “Homogeneous material” means either of the following: 1. One material of uniform composition throughout; or 2. A material, consisting of a combination of materials, that cannot be

readily disjointed or separated into different materials by

Candidate Chemical List

Added by New Regulations

Hazard Trait

20

A “chemical” gains DTSC’s attention by..

Authoritative List(Hazard Traits)

• 5 Major Hazard Trait Categories

o Toxicological: Carcinogenic, Developmental &

Reproductive

o Other Toxicity: Organ, Tissues

o Environmental: Domestic, Wild Life, Sewage

Treatment

o Exposure Potential: Ozone, Bioaccumulative,

Mobility

o Physical: Flammability

21

Hazard Traits and Endpoints

Evolution in Regulatory Approach:Consideration of “Hazard”

22

Ultrafine TiO2: IARC 2B Carcinogen

Authoritative List

Inhalation Route

23

Titanium Dioxide (TiO2)Potential Policy Considerations for Spray sunscreen, spray hair dye

Pros Inhalation (aerosols) most

significant exposure pathway

Clear respiratory effects

Listed carcinogen

Enters WWTP, may not be fully removed

• Found in high levels at downstream rivers

High exposure to children

High use of sunscreen every day

Cons Toxicity varies for fine particles

versus nanoparticles

Coatings, size, shape of particles affect toxicity

Limited number of inhalation animal studies, scarce human data

FDA Approval

• Sunscreen (limit 25%) Most are between 2-15%

• Approved food additive

Is SCPR enough?

Nanomaterials as chemicals or products can be regulated under the SCPR.

The SCPR adds additional design requirements for potential nano-enabled products – performance plus safety throughout the lifecycle.

Flexible process that allows for a product-chemical specific approach.

Incomplete data will not prevent decisions.

25

Getting ready….

26

Sustainable Interagency teams and/or taskforce?

Coordinated use of multiple regulatory authorities?

Ingredient disclosure requirements? Enforceable data call-ins?

Regulatory consortiums with other States or?

Work with local agencies?

Partnerships w/ stakeholders?

What do you know?

• Is what you know useful?

• Is what you know relevant?

• Is what you know current?

Does what you know actually help you or someone else?

Jean Henri Gaston Giraud

• Dr. Meredith Williams & DTSC Staff SP&WP Program

• Professor Tim Malloy; UCLA Law• Professors Andre Nel, Hillary Godwin, Arturo Keller, Barbara Harthorn; UCLA/UCSB • Dr. Joseph Guth and Dr. Michael Wilson; UC Berkeley• Dr. Richard Denison; EDF• Terry Medley, J.D. & Thomas Jacob; DuPont

Acknowledgments

27

Thanks to Drs. R. Kreutzer, G. Windgasse and the ENM Workshop Planning Team

DTSC Nanomaterials Team

Stanley Phillippe, M.S., PE

Bill Ryan, P.E.

Suzanne Davis

Hai-Yong Kang, Ph.D.

Thomas Booze, Ph.D.

Neena Sahasrabudhe, Ph.D.

Gwen Chen

Sho Takatori (Ph.D.)

Cathy Cooke