Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

SCCS Revised Guidance for Testing of Cosmetic Ingredients and Their Safety Evaluation Addresses Nanomaterials

Posted in International, Legal/Regulatory Issues

On November 7, 2018, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published the tenth revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation.  The guidance contains relevant information on the different aspects of testing and safety evaluation of cosmetic substances in Europe.  The document states that it is designed to provide guidance to public authorities and to the cosmetic industry to improve harmonized compliance with the current cosmetic European Union (EU) legislation.  The guidance includes a section on special consideration for certain cosmetic ingredients that discusses nanomaterials, including:

  • Definition of nanomaterial: The guidance notes that Regulation (EC) No 1223/2009 specifically covers the use of nanomaterials in cosmetic products, providing a definition of nanomaterial, as well as a mechanism for notification, labeling, and safety evaluation of cosmetic products containing nanomaterials.  The Regulation covers mainly those nanomaterials that are intentionally produced and are insoluble/poorly-soluble or biopersistent (g., metals, metal oxides, carbon materials), and not those that are either completely soluble or degraded and are not persistent in biological systems (e.g., liposomes, oil/water emulsions);
  • Potential safety issues of nanomaterials: The guidance notes that SCCS has published “a more detailed specific Guidance on Risk Assessment of Nanomaterials (SCCS/1484/12) that is now being revised, a Memorandum on the Relevance, Adequacy and Quality of the Data Expected in Safety Dossiers on Nanomaterials (SCCS/1524/13, Revision of 27 March 2014), and a checklist for the applicants submitting dossiers on nanomaterials as cosmetic ingredients (SCCS/1588/17).”  The guidance lists special features of nanomaterials and suggests how the Responsible Person can address them when testing nanomaterials; and
  • Required information for nanomaterials: The information required by SCCS for the evaluation of nanomaterials as cosmetic ingredients is described in SCCS/1588/17 and SCCS/1484/12 (under revision).  The guidance states that the following aspects deserve special attention:
    • Although most analytical methods used routinely for chemical substances have not yet been validated for nanomaterials, a careful choice of mainstream method(s) should provide sufficient means to gather adequate characterization data for nanomaterials;
    • Where there is evidence for systemic absorption, further investigations are required to confirm whether the absorbed material was in a nanoparticle form or in solubilized/ionic/metabolized form. Where the absorption of nanoparticles cannot be ruled out either by experimental measurements or justified on the basis of solubility/degradation of the nanomaterial, the SCCS may apply a default approach and assume that 100 percent of the absorbed material was in nano form;
    • Surface modification/surface coating may bring about profound changes in a nanomaterial in regard to certain physicochemical properties and potentially the toxic effects; and
    • A full dataset would be preferable. As a minimum, in addition to safety data on the core nanomaterial, the SCCS would require:  information/data on each material used for surface modification/coating of the nanomaterial to indicate that it is safe for use in the intended cosmetic product; data on physicochemical properties of the surface-modified/coated nanomaterial to show that they have not significantly changed compared to either the same material when uncoated, or with a different surface modification/coating that has already been assessed safe by the SCCS; and data on dermal penetration, stability of the surface modification/coating, and (photo)catalytic activity, where relevant.

JRC Scientists Publish Article on Inventory of Publicly Available Tools for the Safety Assessment of Nanomaterials

Posted in International, Legal/Regulatory Issues, Research

On November 5, 2018, the European Commission’s (EC) Joint Research Center (JRC) announced the availability of the NANoREG Toolbox, an inventory of publicly available tools for the safety assessment of nanomaterials.  As reported in our October 5, 2017, blog item, JRC first published the inventory as a Microsoft Excel®-based dataset.  JRC scientists have now published an article, “An inventory of ready-to-use and publicly available tools for the safety assessment of nanomaterials,” that presents a “large inventory of published and ready-to-use safety assessment tools.”  According to the JRC, the 544 tools in the inventory cover all tasks within a nanomaterial safety assessment, and the tools “are relevant and useful for similar assessments anywhere in the world.”  JRC notes that the tools also support alternative approaches to nanomaterial safety, such as safe-by-design and life cycle assessment.  JRC states that regulators, scientists, and industry use the NANoREG Toolbox as a starting point to search for available tools for specific needs.  JRC suggests that the NANoREG Toolbox could also serve as the basis for a harmonized tool database maintained by international community efforts.

B&C Launches All Things Chemical™ Podcast with Debut Episode “Animal Testing and New TSCA”

Posted in Federal, Legal/Regulatory Issues, United States

On November 1, 2018, Bergeson & Campbell, P.C. (B&C®) launched a podcast called All Things Chemical™ that will engage listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals.  B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic and international chemical regulation and provide analysis of the many intriguing and complicated issues surrounding this space.

Episode 1, “Animal Testing and New TSCA,” features a roundtable discussion about a Strategic Research Plan released by the U.S. Environmental Protection Agency (EPA) earlier this summer, outlining its approach to reduce and replace “vertebrate” testing.  In keeping with the commitment outlined in the 2016 amended Toxic Substances Control Act (TSCA), EPA proposes several so-called New Approach Methodologies, or NAMs, which it hopes will be able to replace and reduce animal testing.

Discussing and unpacking the topic are B&C Managing Partner Lynn L. Bergeson; Director of Chemistry Richard E. Engler, Ph.D.; Director of Toxicology Jane S. Vergnes, Ph.D.; and Senior Regulatory Chemist Oscar Hernandez, Ph.D.  Drs. Engler and Hernandez offer significant experience and insight on the EPA side of things, Dr. Engler as a 17-year veteran of EPA having served as senior staff scientist at the Office of Pollution Prevention and Toxics (OPPT) and leader of EPA’s Green Chemistry Program, and Dr. Hernandez as former Director of the Risk Assessment Division (RAD) in EPA’s OPPT.  Dr. Vergnes provides an invaluable real-world kind of gut-check on the proposals, drawing on her extensive experience directing corporate toxicology programs at Ashland, Texaco, and Union Carbide.

All Things Chemical Episode 1, “Animal Testing and New TSCA,” is available now on iTunes, Spotify, Stitcher, and Google Play Music.  Subscribe so you never miss an episode.  All Things Chemical is recorded and produced by Bierfeldt Audio, LLC.

Future podcasts, available approximately every two weeks, will address a host of fascinating issues, including chemical regulation in the Middle East, recent rulemakings under the Food Safety Modernization Act (FSMA), and the ever quirky and complicated area of confidential business information.  The issues that B&C pursues in its day-to-day business are unfailingly interesting and we wish to share our knowledge, our insights, and our enthusiasm for these issues with you through our All Things Chemical podcast.

EC Committee Publishes Final Opinion on Colloidal Silver (Nano)

Posted in International, Legal/Regulatory Issues

On October 26, 2018, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on colloidal silver (nano).  According to the final opinion, the EC received 63 notifications of cosmetic products containing colloidal silver in nano form.  The final opinion states that, according to the applicants, the ingredient is used in nano uncoated form both in leave-on and rinse-off oral cosmetics products, including toothpastes and skin care products, with a maximum reported concentration limit of one percent and certain specifications.  The EC asked SCCS to produce a safety assessment of the nano form of colloidal silver covered in the notifications, in the above-mentioned categories of products, taking into account the reasonably foreseeable exposure conditions.  According to SCCS, only a limited amount of data was provided by the applicants that corresponded to the SCCS Guidance on Safety Assessment of Nanomaterials in Cosmetics (SCCS 1484/12).  The provided data were also not in line with the SCCS Memorandum on Relevance, Adequacy and Quality of Data in Safety Dossiers on Nanomaterials (SCCS/1524/13).  SCCS states that although other information is available in open literature relating to the toxicity of nano silver, its relevance with respect to the materials of this submission has not been considered by the applicants.  Due to a number of major data gaps, SCCS “is not in the position to draw a conclusion on the safety of colloidal silver in nano form when used in oral and dermal cosmetic products.”  The EC also asked SCCS to address any further scientific concerns with regard to the use of colloidal silver in nano form in cosmetic products.  SCCS concluded that in addition to the safety assessment of colloidal silver in nano form, consideration should also be given to the likely presence of ionic silver in different types of final products.

Slides Available from NIOSH Webinar on Revised Draft CIB for Silver Nanomaterials

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States

On October 30, 2018, the National Institute for Occupational Safety and Health (NIOSH) held a webinar on its revised draft document entitled Current Intelligence Bulletin:  Health Effects of Occupational Exposure to Silver Nanomaterials.  The meeting agenda and slide presentation are available in the docket, as well as a list of meeting attendees.  As reported in our September 19, 2018, blog item, the revised draft Current Intelligence Bulletin (CIB) provides an updated scientific literature review of information pertaining to occupational exposure to silver nanomaterials.  The literature review includes studies on the toxicological effects of exposure to silver nanomaterials in experimental animal and cellular systems, the effect of particle size and other properties on the toxicological effects of silver, and NIOSH recommendations on the measurement and control of occupational exposures to silver and silver nanomaterials.  Based on an assessment of these data, NIOSH developed a recommended exposure limit (REL) for silver nanoparticles (<100 nanometers (nm) primary particle size) of 0.9 micrograms per cubic meter (μg/m3) as an airborne respirable eight-hour time-weighted average (TWA) concentration.  The draft REL would apply to processes that produce or use silver nanomaterials.  In addition, NIOSH continues to recommend a REL of 10 μg/m3 for total silver (metal dust, fume, and soluble compounds, as Ag).  NIOSH further recommends the use of workplace exposure assessments, engineering controls, safe work procedures, training and education, and established medical surveillance approaches to prevent potential adverse health effects from exposure to silver nanomaterials.  NIOSH proposes research needs to fill remaining data gaps on the potential adverse health effects of occupational exposure to silver nanomaterials.  The purpose of the public review of the draft CIB is to obtain comments on whether it (1) adequately and clearly describes the scientific literature on the potential adverse health effects of silver nanomaterials, and (2) demonstrates that the NIOSH recommendations on occupational exposure to silver nanomaterials are consistent with current scientific knowledge.  Comments on the draft CIB are due November 30, 2018.

JRC Posts Report on Workshop on Regulatory Preparedness for Innovation in Nanotechnology

Posted in International, Legal/Regulatory Issues

The European Commission (EC) Joint Research Center (JRC) posted a report on the October 5-6, 2017, “NanoReg2 Regulatory Preparedness for Innovation in Nanotechnology Workshop.”  Regulatory preparedness was defined at the workshop as the regulators’ timely awareness of innovations and the regulators’ actions to check whether present legislation covers all safety aspects of each innovation, including initiating revision of the legislation as appropriate.  Achieving regulatory preparedness for innovations based on nanotechnology requires a continuous proactive combination of interconnected activities:  awareness of innovations; dialogue; knowledge building; methodology enhancement and optimization; reflection; and consideration.  To implement regulatory preparedness for nanotechnology innovations as a part of the Safe Innovation Approach (SIA) pursued by NanoReg2, the following “road map” of actions of different time scales and levels of formal acceptance was outlined:

  • Near-term:
    • Acceptance of Safe-by-Design (SbD) by regulators:
      • Early engagement of regulators in product design process; and
      • Industry addresses hazard and exposure concerns early in the product design process;
    • Establishment of databases for valid (reliable) data;
    • Establishment of registries;
    • Pre-consultations with the industry (individual products);
    • Prioritization of the development of the most needed experimental protocols and guidance; and
    • Broader stakeholder meetings.
  • Mid-term:
    • Development of Organization for Economic Cooperation and Development (OECD) Test Guidelines for nanomaterials;
    • Development of other general guidance specific to nanomaterials;
    • Exploit the European Union (EU) Nanomedicine Characterization Laboratory (NCL) as a model for a (nano)innovation network:
      • Cooperation between regulators and industry;
      • Protocol development;
      • Early screening for the industry (not only medical); and
      • Open to industry use; and
    • Identification of the most promising protocols and methods in development.
  • Formal regulatory developments:
    • Moving from guidance to legislation;
    • Where required, shifts in definitions and regulatory requirements for data;
    • Finalization of protocols;
    • Validation and acceptance of alternative methods; and
    • Development of a more effective data generation process that benefits all:
      • Nanospecific tiered testing or intelligent testing strategies; and
      • Valid protocols for these strategies.

According to the report, the ideas presented at the workshop and the outcomes will feed back into the NanoReg2 project.

JRC Announces New Standardized Nanomaterial Environmental Toxicity Screening Testing Procedure

Posted in International, Research

The European Commission (EC) Joint Research Center (JRC) announced publication of a paper introducing a new standardized testing procedure for nanomaterial environmental toxicity, “Introducing a new standardized nanomaterial environmental toxicity screening testing procedure, ISO/TS 20787:  aquatic toxicity assessment of manufactured nanomaterials in saltwater lakes using Artemia sp. nauplii.”  The abstract states that the testing procedure is intended to generate more reliable and repeatable aquatic toxicity data testing manufactured nanomaterials, using Artemia sp., to evaluate their possible ecotoxicity in saltwater lake ecosystems.  The paper reviews the principles behind testing with Artemia sp. and provides an overview of research published between 2009 and 2018 in which manufactured nanomaterials were tested using Artemia sp.

Safe Work Australia Guidance Includes Advice on Fine Dusts and Nanomaterials

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues

In August 2018, Safe Work Australia (SWA) issued a national guide on classifying hazardous chemicals.  SWA intends the guidance for manufacturers and importers of substances, mixtures, and articles who have a duty under the Work Health and Safety (WHS) Act and Regulations to classify them.  SWA suggests that the guidance may also be useful for suppliers, persons undertaking business and undertakings, workers, and other persons involved with hazardous chemicals.  The guidance provides advice on specific situations, including fine dusts and nanomaterials.  The guidance states that particles in the “nano” scale (one billionth of a meter) may exhibit characteristics unlike similar materials examined at larger scales and must be appropriately classified.  According to the guidance, if the health hazards of nanoparticles are not fully characterized, it is recommended that an appropriate safety data sheet (SDS) be prepared and the container is labeled:

  • Contains engineered/manufactured nanomaterials. Caution:  Hazards unknown; or
  • Contains engineered/manufactured nanomaterials. Caution:  Hazards not fully characterized.

The guidance states that “[t]hese phrases are to be used on an interim basis only, as the manufacturer or importer has a duty to correctly classify the chemical and include information on known hazards on the label and within the SDS.”

OIRA Seeks Comment on How to Reduce Regulatory Differences between the U.S. and Canada, Including for Emerging Technologies Not Yet Regulated

Posted in Federal, Legal/Regulatory Issues, United States

The Office of Information and Regulatory Affairs (OIRA) published a request for information (RFI) on October 9, 2018, seeking comment on how the federal government, under the auspices of the Regulatory Cooperation Council (RCC), may reduce or eliminate unnecessary regulatory differences between the U.S. and Canada.  According to the RFI, this information may inform agencies’ development of regulatory reform proposals to modify or repeal existing agency requirements to increase efficiency related to economic activity with Canada, reduce or eliminate unnecessary or unjustified regulatory burdens, or simplify regulatory compliance, while continuing to meet agency missions and statutory requirements.  OIRA also seeks public comment to identify ongoing or emerging areas for which cooperation could reduce the risk of divergence between U.S. and Canadian regulations.  In 2012, Health Canada, Environment Canada, and the U.S. Environmental Protection Agency developed the Nanotechnology Work Plan, and RCC concluded its Nanotechnology Initiative in February 2014.  OIRA states in the RFI that it has identified some key topics on which stakeholder insights would be “most helpful,” although it welcomes input on opportunities for international regulatory cooperation beyond these topics, including particular sectors or issues for which the RCC should consider future regulatory cooperation or further regulatory alignment to reduce burden or other cost, including for emerging technologies that are not yet regulated.  Comments are due November 8, 2018.

EPA Posts Final Work Plan for Nanosilver Registration Review Process

Posted in Federal, Legal/Regulatory Issues, Research, United States

On October 19, 2018, the U.S. Environmental Protection Agency (EPA) posted the Final Work Plan (FWP) for the nanosilver registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FWP explains what the Office of Pesticide Programs (OPP) “knows about nanosilver generally, highlighting anticipated data and assessment needs for each unique nanosilver chemistry, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing review of the nanosilver case.” According to the FWP, EPA has identified the following use patterns to date: swimming pool/spa treatments; and material preservative products for coatings, textiles, and plastics. The FWP states that people may be exposed to nanosilver through inhalation and dermal exposures while applying the products to swimming pools and from incidental oral exposures during swimming. Further exposures may come from material preservative uses either while applying or from nanosilver that leaches out when textiles and plastics are washed. Nontarget organisms can be exposed when swimming pool water is released or when nanosilver used as a material preservative leaches. The FWP includes the following anticipated registration review schedule:

Anticipated Activity Target Date* Completion Date
Phase 1: Opening the Docket
Open Docket and 60-Day Comment Period for Preliminary Work Plan 2012-06 2012-06-07
Close Public Comment Period 2012-08 2012-06-09
Phase 2: Case Development
Issue Final Work Plan 2018-09 2018-10
Issue Data Call-In (DCI) 2018-10
Receive Data to be Considered in Risk Assessment 2020-10
Open 60-Day Public Comment Period for Preliminary Risk Assessment(s) 2021-06
Close Public Comment Period 2021-08
Phase 3: Registration Review Decision and Implementation
Open 60-Day Public Comment Period for Proposed Decision 2022-01
Close Public Comment Period 2022-03
Issue Final Decision 2022-05
Begin Post-Decision Follow-up 2022
Total (years) 10

*The anticipated schedule will be revised as necessary (e.g., need arising under the Endocrine Disruptor Screening Program with respect to the active ingredients in this case).

According to the FWP, EPA “anticipates the need to require generation and submission of human health hazard and exposure data and to conduct a human health risk assessment for nanosilver during registration review.” The FWP states that EPA plans to conduct an environmental risk assessment for the nanosilver uses, “particularly focusing on materials preservative uses, such as plastics and textiles if the particular nanosilver chemistries are shown to leach, and swimming pool uses.” Any of the other use patterns may also be subject to ecological assessment if the fate and product chemistry profiles indicate the potential for environmental exposures. According to the FWP, the risk assessment integrates the environmental fate and effects data to determine if any uses pose risks to nontarget organisms. Potential risks to fish, aquatic invertebrates, aquatic plants, and birds and mammals will be assessed after the data gaps specified in the FWP are satisfied and the relevant data are available.

EPA invites any label amendments that could be considered to eliminate the anticipated need to require certain data, reduce the possibility that EPA’s planned risk assessments overestimate risk due to reliance on conservative assumptions, and/or improve label clarity. EPA anticipates issuing in 2018 a DCI requiring the data set out in Table 7 of the FWP, “Studies Anticipated as Needed for Nanosilver Registration Review.”