Nanomaterials and

Nanotechnology

Regulatory Update

Shaun F. Clancy, Ph.D.

October 21, 2015

My perspective is informed by….

• Employment by a chemical company that manufactures both

large volume and specialty materials

• Participation with peer US companies in industry activities

(ACC, SOCMA, “NANO”)

• Participation with the global industry and government

agencies in BIAC/OECD WPMN

• Participation with other diverse stakeholders in ANSI/ISO

Technical Committee 229 (Nanotechnologies)

Purpose of my presentation:

Provide a perspective on:

• Regulatory activities

• Recent and Impending regulatory activities

• Activities by non-regulatory bodies that could impact regulation

• Other relevant activities

• What is a “nanomaterial”?

Nanotechnology and Societal

Benefits - Examples

• Energy – Lighting, Batteries, Weight reduction, Fuel

efficiency

• Food & Agriculture – “Smart” Fertilizers, Improve quality,

Greater nutrition

• Healthcare – More targeted drugs, reduced toxic effects,

bone scaffolds

• Water treatment – Removal of contaminants, Desalinization

Membranes

• Information Technology – Reduction in device size

• Pollution Remediation – Elimination, Extraction

Concerns

• Hazards of Nanomaterials – Intrinsic properties

• Personal Exposures – Are nanomaterials free or are they bound in matrix?

• Environmental Exposures – Can nanomaterials get into the environment? What can happen? What does happen?

• Communication to the Public – What are the best ways to communicate with the general public information about nanomaterials? What do they want to know? What do they need to know?

Industry is already…..

Practicing responsible product development and use

• Much of the global chemical industry practices Responsible

Care, ChemStewards or equivalent

• RC requires many practices including Product Stewardship

(www.responsiblecare.org,

www.socma.com/chemstewards) that cover

nanotechnology

• Some companies have published on their nano-specific

requirements (Evonik, DuPont, BASF)

• EDF-DuPont NanoRisk Framework (2007)

Research Needs:

Hazards

Manufacturers need to provide hazard information.

Research is needed on tools and methods to evaluate the

hazards of nanomaterials that will be broadly accepted.

• Rapid screening methods are needed to quickly evaluate

materials (Academia, NIST, ISO, Industry)

• Identification and validation of existing methods that can be

used today (OECD, ISO, ASTM)

• Development of new methods to generate data where

methods are presently unavailable (OECD, ISO, Academia,

Industry)

• Increased understanding of toxicological mechanisms.

• Computational methods (TOXCAST?)

Research Needs:

Personal Exposures

• Economical Methods and Measuring Instruments are

needed to perform nanomaterial exposure measurements

in occupational settings. (NOSH Consortium, NIOSH,

NIST, Industry)

• Continued assessments of Engineering Controls and

Personal Protective Equipment for their effectiveness

(NOSH Consortium, NIOSH, OSHA, BDI, Industry)

• Standard methods to assess releases of nanomaterials

(ICON Literature Database, NanoRelease)

Research needs:

Environmental Exposures

Methods to Detect Nanomaterials in the environment

• What happens to NM intentionally released?

• What happens to NM unintentionally released?

Separation of engineered nanomaterials from naturally

occurring nanomaterials. (ISO)

Economical methods and instruments needed (ISO, EPA)

Characterization of Nanomaterials

A key issue that is often not adequately addressed in EHS studies of nanomaterials is characterization. Unlike most other subfields in Toxicology, Nanotoxicology is generally focused on the contribution of size-related elements to toxicological effects:

• Particle size – Is the stated size the actual size?

• Particle surface area – Is there a relationship to toxicity?

• Surface chemistry – Is the surface the same as the inside?

• Reactivity – Does reactivity increase as particle size decreases?

Can/Should any properties be the basis of regulation?

Size? Probably. Others? TBD

The Terminology of Nanomaterials

What is a nanomaterial?

• Particles with “size” of 1-100 nm (NNI)

• What about rod-like structures? e.g. CNT

• What about aggregates? e.g. Metal Oxides

• What about agglomerates?

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A “bottom up” example…..

Si

OH

HOOH

OH

Si

OH

HOOH

OH

Si

OH

HOOH

OH

Coalescence

Aggregation

Surface Growth

& Evaporation

Nucleation

SiCl4

H2O HCl

Flame Hydrolysis

of Silicon Tetrachloride

to Silicic Acid

Si

OH

HOOH

OH

Agglomeration

Aggregation represents fusing or sintering

including coalescence into a larger particle

Research Needs:

Communication with the Public

Nanotechnology is a very technical, scientific field.

Research is needed to improve on how to communicate to a

public where their skills and interests are in different areas.

What are the strengths and weaknesses in tools and

resources such as:

• Product labeling

• Popular media

• Government sources

What does the public want and need to know?

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Why is this research needed?

Acceptability

• Many scientists perform research and evaluations using

practices that are convenient to them. The results, while

interesting, may not be comparable or useful. Gov’t can

be an “honest broker” and can help increase certainty that

generated data will be broadly accepted and that decisions

based on the data will be based on sound science.

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Why is this research needed?

Certainty

• The development and acceptance of Nanotechnology is

negatively impacted by the perceived lack of

understanding about EHS impacts. Some claim that

technology development and implementation moves too

fast.

• This appears to have led to regulatory uncertainty

• Regulatory uncertainty can lead to delays in investment

You didn’t ask but if you did….

Short Term • Improve consistency of the use of NM terminology (ASTM,

ISO)

• Increase expectation and understanding for mimimal characterization of NM (ISO, MinChar) (www.characterizationmatters.org)

• Release of NM from coatings and food (NanoRelease)

Longer Term • Methods for rapid tox/ecotox screening of NM

• Help set direction for standardized tox methods for NM

• Detection of NM in the environment

• How can we better communicate what we learn?

• Releases of NM from “things” (NanoRelease)

Regulatory Activities

• EU Cosmetics Directive – Now in force

• EPA SNUR’s for CNT’s – New rules continue to be issued

• Canadians have issued a guidance definition of

nanomaterial. Includes 1-100 nm particles and materials

that have “nanoscale phenomena”

• Australia has issued nanomaterial regulations

• EC issued its regulatory definition (Oct 2011). It is particle

number based, not mass. JRC advised again the definition

should apply to all NM, not just man-made (Oct 2015)

• Proposed TSCA Nanomaterial SNUR – EPA would have

declared that all uses of nanomaterials not already in

practice are significant new uses. Did not get out of OMB.

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Recent Regulatory Activities

• The Regulatory Cooperation Council project on

Nanotechnology was completed and judged to be

successful

• ECHA is recommending that REACH be amended to

improve clarity on how it regulates nanomaterials.

• Canada has issued a Section 71 notice. Information due

Feb. 2016

• Proposed TSCA Section 8 rule – Contains elements of

the EPA Nanoscale Material Stewardship Program but

much more encompassing than NMSP and Section 71.

Final rule not expected until 2016.

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Regulatory Cooperation Council

US & Canadian regulatory agencies directed to identify areas

where cooperation could be improved and approaches

made more common. Stakeholder participation required.

Nanotechnology was selected for attention from EPA and

Environment/Health Canada.

Agencies worked well together and with stakeholders.

Project outcomes included common principles; more common

approaches to priority setting, risk assessment/mgmt.;

improved understanding of commercial NM.

http://nanoportal.gc.ca/default.asp?lang=En&n=5A56CB00-1

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CEPA Section 71 Survey

Requires submission of data on 206 nanomaterials with:

• Particle size or internal structure 1-100 nm and how

determined

• Quantities manufactured/imported

• Uses

• Applicable NAICS and Use codes

• Titles of published and unpublished EHS studies

Information due Feb 2016 unless extension granted.

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Proposed TSCA Section 8(a)

EPA now considering comments requested on:

• What is reportable?

• How can different forms of NM be distinguished?

• Whether there should be an ongoing reporting obligation for

nanomaterials? This would be a significant change since

8(a) reporting is normally a one-time obligation.

• Whether there should be a requirement for a “new” form of

a NM of “existing” composition (already on TSCA Inventory)

to be notified to EPA 135 days in advance of

commercialization.

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Concerns about 8(a) proposal

• Definition of reportable nanomaterial not clear. E.g. Are

aggregates >100nm of primary particles 1-100nm reportable?

• Proposed Pre-commercialization and Ongoing reporting

obligations are not consistent with the law.

• The proposed rule is not sufficiently clear to ensure that who

it applies to is understood and their obligations

• It is not as consistent with the Canadian rule as was expected

based on the RCC Nano program.

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Recent Regulatory Activities (con’t)

Nanomaterial registries created by:

• France (2013)

• Denmark (2014 – Consumer products only)

• Belgium (2015 for NM, 2016 for NM containing products.

With notable exclusions)

The French registry has shown that a limited number of NM

are available in large quantities – carbon black and silica

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Non-regulatory Activities – USG

• Executive Order from the White House directing

regulatory agencies on how to consider nanotech. Don’t

view as bad or good.

• FDA has issued a perspective on how they are already

considering nanomaterials. Because FDA regs are

application specific and each use must be approved FDA

generally feels they can catch nanomaterials during the

evaluation process and apply appropriate protective

measures.

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Activities by non-regulatory bodies

OECD WPMN

• SG 1-2 (Australia) – Created an OECD database of EHS

information

• SG 3 (Research Program – US & EU) – Wrapping up

Phase 1 of the Research Program on representative

nanomaterials. Working on initiating Phase 2

• SG 4 (Test Guidelines – US & EU) – Continuing

assessment of applicability of OECD TG to

nanomaterials. Generally, the TG’s are good but may

need to be tweaked. A few new ones may be needed.

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Activities by non-regulatory bodies

OECD WPMN (con’t)

• SG 5 (Cooperation on Gov’t Schemes)– Gov’ts sharing

info. Not shared beyond governments yet.

• SG 6 (Cooperation on Risk Assessments – Canada &

Germany) – With SG3 having generated hazard info

there is a need to put it into perspective by considering

exposure.

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Activities by non-regulatory bodies

OECD WPMN (con’t)

• SG 7 (In-vitro methods for Nanotoxicology - UK) –

Alternative non-animal-based test methods being pushed

• SG 8 (Cooperation of Exposure Assessment and

Mitigation - US) – The collection of exposure information

is not as advanced as for hazard. Could be useful for

SG6

• SG 9 (Cooperation on Sustainable Use of Nanomaterials

– US & EU) – The newest SG with a focus on topics

such as Life Cycle

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Reorganized WPMN Steering Groups

Steering Group on Testing & Assessment

• SG-TA combines the work of SG3, SG4 & SG7

Steering Group on Risk Assessment & Regulatory Programs

• SG-AP combines the work of SG5 & SG6

Steering Groups 8 (Exposure) and 9 (Sustainable Use) have

continued their work

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Research Program Dossiers

First made available in 2015

http://www.oecd.org/chemicalsafety/nanosafety/news-

nanomaterial-safety.htm

Data needs to be used with caution

ECHA promptly issued guidance to REACH registrants to

consider the impact of the WPMN dossiers on REACH

dossiers.

http://echa.europa.eu/view-article/-

/journal_content/title/oecd-releases-new-data-on-

nanomaterials-registrants-asked-to-consider-the-

information |

Activities by non-regulatory bodies

– ISO TC 229

• WG1 (Canada) – Developing terminology guidance.

Could be used by regulators.

• WG2 (Japan) – Developing metrology standards. Most

work so far has been on CNT’s but stds for nanocellulose

& graphene coming and a TR on general methods

• WG3 (USA) – Developing both guidance and standards on

a variety of EHS issues. An early standard addressed

endotoxins. Tech reports have been on the EDF-DuPont

NanoRisk Framework, SDS’s for nanomaterials, key P-

Chem/Tox parameters & labeling of Consumer products.

• WG4 (China) – Considering development of standards for

materials. Nano CaCO3 and TiO2 have been issued with

Nano Ag & Nanoclays under development. |

Activities by non-regulatory bodies

– ISO TC 229 and CEN TC 352

• A few years ago a standard was developed by BSI for how

products containing nanomaterials should be labeled.

• Later the BSI document was advanced into CEN for

consideration as a EU standard. Because of the

international implications ISO asked to participate under the

Vienna Agreement

• The draft standard was put to a vote in later 2010 and was

not approved by either CEN or ISO. ISO asked CEN to

move the project to TC 229 and an ISO Technical Report

was created in 2013.

• Awareness of actions from SDO’s is needed due to

potential global impacts.

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Other Interesting Activities

• NanoRelease Project – This project is looking to identify

methods to assess the release of nanomaterials from

articles.

• Project has stakeholders from gov’t (regulatory &

research), NGO’s, industry and from the US and Canada.

Academics have participated in NanoRelease activities.

• Wrapping up interlab testing with reports anticipated in

late 2015 or early 2016

• An ISO technical report may be created in 2016-17.

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What is a “nanomaterial”?

• There is general agreement that a discrete object with

size 1-100 nm is a nanomaterial.

• What about aggregates?

• What about agglomerates?

Agreement on terminology continues to be an issue.

A single definition may not be needed but clarity on each

definition is.

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Take aways

• There continues to be a need for clarity on terminology

• Research and Standards development is continuing at a

rapid pace. Awareness of progress is essential

• Regulatory activity is increasing. It is important to be

involved.

• Nanotechnology is providing societal benefits and more

are expected. It is essential to address concerns and

communicate effectively to ensure acceptance and

continued benefits.

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Questions? Comments?

Shaun F. Clancy, Ph.D.

Evonik Corporation

Director - Product Stewardship

North America Services

299 Jefferson Road

Parsippany, NJ 07054

USA

+1-973-929-8047

+1-973-929-8040 fax

Shaun.Clancy@evonik.com

Date | Regulation of

Nanotechnology

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