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?
A bottom up example.. OH Flame Hydrolysis of Silicon Tetrachloride to Silicic Acid SiCl 4 H 2 O HO OH Si OH OH HCl HO OH HO Si Si OH OH Surface Growth & Evaporation HO OH OH OH Si OH OH Nucleation Coalescence Aggregation 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 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://www.oecd.org/chemicalsafety/nanosafety/newsnanomaterial-safety.htm http://echa.europa.eu/view-article/- /journal_content/title/oecd-releases-new-data-onnanomaterials-registrants-asked-to-consider-theinformation
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 CaCO 3 and TiO 2 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 Shaun.Clancy@evonik.com
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