The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on December 4, 2018, withdrawing significant new use rules (SNUR) promulgated under the Toxic Substances Control Act (TSCA) for 26 chemical substances, including carbon nanomaterial (generic), that were the subject of premanufacture notices (PMN). As reported in our October 2, 2018, blog item, EPA issued the SNURs through a direct final rule on October 3, 2018. EPA states that it received adverse comments regarding the SNURs identified in the direct final rule, and is withdrawing them. On October 3, 2018, EPA also issued proposed SNURs covering these 26 chemical substances. EPA states that it will address all adverse public comments in a subsequent final rule, based on the proposed SNURs.
The Swedish National Platform for Nanosafety (SweNanoSafe) has posted a report on the European Chemicals Agency’s (ECHA) November 8-9, 2018, workshop on the upcoming Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) information requirements for nanomaterials. As reported in our April 26, 2018, blog item, the European Commission (EC) REACH Committee voted on April 26, 2018, to amend several REACH Annexes to clarify the registration requirements for nanomaterials. The workshop was a preparatory step before the formal start of the update of ECHA’s guidance documents for nanomaterials through the Partner Expert Group (PEG). The formal start date depends on the publication of the revised REACH Annexes for nanomaterials in the Official Journal of the European Union, which is expected before the end of 2018. According to the report, around 55 delegates representing different stakeholders such as industry, European Union (EU) Member State authorities, and non-governmental organizations (NGO) participated at the workshop. The report states that four main areas need new guidance:
- Guidance on nanoforms — registration and Substance IDentification (SID) issues;
- Guidance on grouping and read-across;
- Guidance on Information Requirements (IR) — environmental endpoints; and
- Guidance on Information Requirements (IR) — human health endpoints
PEG members may be officially nominated by industrial associations, Member State Competent Authorities, or NGOs. Once the PEGs are established, ECHA will develop a draft proposal document for each area and circulate it for discussion and revision by the PEGs. Typically this process would include several comment and revision rounds, including several virtual and face-to-face meetings. The timeframe for the work will be short as the finally agreed proposals should be adopted by the EC around November 2019. Thereafter, ECHA will publish the updated nanomaterial guidance on their homepage for immediate use.
The European Union (EU) released the EU US Roadmap Nanoinformatics 2030 on November 15, 2018. The Roadmap, developed by scientists from the EU, U.S., and a few other countries, is a compilation of state-of-the-art commentaries from multiple interconnecting scientific fields, combined with issues involving nanomaterial risk assessment and governance. The Roadmap states that in bringing these issues together into a coherent set of milestones, the authors address three recognized challenges facing nanoinformatics: (1) limited data sets; (2) limited data access; and (3) regulatory requirements for validating and accepting computational models. According to the Roadmap, it is also recognized that data generation will progress unequally and unstructured if not captured within a nanoinformatics framework based on harmonized, interconnected databases and standards. The implicit coordination efforts within such a framework ensure early use of the data for regulatory purposes, e.g., for the read-across method of filling data gaps. The Roadmap expects readers to be experts in specialized fields interested in understanding developments in nanoinformatics, and the authors have written the Roadmap to be understandable by a broad audience. The Roadmap consists of three sections: an administrative section (executive summary, definitions and context, objectives); a technically oriented informatics section (informatics, materials modeling, statistical computation, omics bioinformatics), and a community of practice section (stakeholders, database projects, initiatives, and milestones and pilot projects).
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.
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.
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.
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.
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.
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:
- 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.
- Acceptance of Safe-by-Design (SbD) by regulators:
- 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.
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.