nanomaterials and nanotechnology regulatory...
TRANSCRIPT
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?
|
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?
|
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.
|
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.
|
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.
|
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
|
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.
|
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.
|
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.
|
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
|
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.
|
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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