Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

NIOSH Seeks Comment on Proposed Survey of Engineered Nanomaterial OSH Practices

Posted in Federal, Occupational Health and Safety Issues, United States

The National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice on February 10, 2017, inviting comment on a proposed information collection plan, “Survey of Engineered Nanomaterial Occupational Safety and Health (OSH) Practices.”  The goal of the project is to assess the relevance and impact of NIOSH’s contribution to guidelines and risk mitigation practices for safe handling of engineered nanomaterials in the workplace.  The intended use of the data is to inform NIOSH’s research agenda to enhance its relevance and impact on worker safety and health in the context of engineered nanomaterials.  NIOSH states that it will survey companies who manufacture, distribute, fabricate, formulate, use, or provide services related to engineered nanomaterials.  After analysis, NIOSH will use the information to develop a final report.  This project will also help evaluate the influence of NIOSH products, services, and outputs on industry OSH practices.  Under this project, NIOSH will conduct the following activities and data collections:

(1)        Company pre-calls.  Sampled companies will be contacted to identify the person who will complete the survey and to ascertain whether or not the company handles engineered nanomaterials; and

(2)        Survey.  A web-based questionnaire, with a mail option, will be administered to companies.  The purpose of the survey is to learn directly from companies about their use of NIOSH materials and their OSH practices concerning engineered nanomaterials.

NIOSH would compile a sample of 600 companies from lists of industry associations, research reports, marketing databases, and web-based searches.  Of the 600 selected companies, NIOSH states that it anticipates that 500 will complete the survey.  NIOSH expects the company pre-call to require five minutes to complete, and the survey to require 20 minutes to complete, including the time it may take respondents to look-up and retrieve needed information.  NIOSH invites comment on:

  • Whether the proposed collection of information is necessary for the proper performance of the functions of NIOSH, including whether the information shall have practical utility;
  • The accuracy of NIOSH’s estimate of the burden of the proposed collection of information;
  • Ways to enhance the quality, utility, and clarity of the information to be collected;
  • Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and
  • Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.

Comments are due April 11, 2017.

Nanomaterials Inventory for Cosmetics Will Be Published “in the Next Weeks”

Posted in International, Legal/Regulatory Issues

ClientEarth published a January 11, 2017, blog item entitled “Three-year wait for nanomaterial risk data promised ‘in the next weeks.’”  Under the Cosmetics Directive, the European Commission (EC) was to publish by January 11, 2014, an inventory of nanomaterials used in cosmetic products on the European Union market.  The EC has postponed publication of the inventory several times, due to the allegedly poor quality of the information it received from industry.  ClientEarth requested access to the information in June 2014, and the EC responded that the inventory would be published “in the next few weeks.”  The non-governmental organization sent a second request in December 2016.  The EC responded:  “The catalogue of nanomaterials used in cosmetics will be published on our website . . . in the next weeks, so we kindly ask for some patience.”  ClientEarth requested clarification from the unit responsible for cosmetics.  Their answer, according to ClientEarth, was:  “There are ongoing discussions at a higher level within the Commission.  At this stage no specific date can be indicated for the publication.”

Draft REACH Guidance Documents on Nanomaterials Move to CARACAL for Review

Posted in International, Legal/Regulatory Issues

According to the European Chemicals Agency (ECHA) website, several Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) guidance documents concerning nanomaterials have moved to the next step in the consultation process.  The draft recommendations for nanomaterials applicable to the guidance on quantitative structure-activity relationships (QSAR) and grouping of chemicals was sent to the Competent Authorities for REACH and Classification, Labeling, and Packaging (CLP) (CARACAL) on January 23, 2017.  The draft guidance is intended to provide an approach on how to justify the use of hazard data between nanoforms (and the non-nanoform(s)) and within groups of nanoforms of the same substance.  On January 31, 2017, the draft appendices on recommendations for nanomaterials for environmental endpoints were sent to CARACAL:

Summaries of comments from earlier stages of the consultation process are available on ECHA’s website.

IRSST Project Measures Nanoparticle Penetration into Protective Gloves

Posted in International, Occupational Health and Safety Issues, Research

The Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) published a news item on January 16, 2017, entitled “Nanoparticles — to handle with care.”  IRSST states that although research is still in development, it appears that nanoparticles can enter the respiratory tract or penetrate through the skin and make their way to the bloodstream, which may carry the nanoparticles to various organs.  While studies have been conducted on respiratory protection equipment, IRSST notes that few have been done on skin protection and especially gloves.  IRSST is funding a research project to develop a method for measuring nanoparticle penetration into materials used to make protective gloves under conditions representative of the workplace setting.  IRSST links to a Prévention au travail article in which Ludwig Vinches, the lead researcher for the project, explains why the gloves are fragile. 

NIOSH Publishes Blog Item on Art and Science of OELs for Nanomaterials

Posted in Federal, Occupational Health and Safety Issues, United States

On February 1, 2017, the National Institute for Occupational Safety and Health (NIOSH) posted a blog item entitled “The Art and Science of OELs for Nanomaterials.”  According to the item, NIOSH searched for proposals for occupational exposure limits (OEL) for new nanomaterials as part of the development of a World Health Organization (WHO) guideline for working safely with nanomaterials.  The blog item cites the article “Occupational exposure limits for manufactured nanomaterials, a systematic review,” which Nanotoxicology published last month.  The blog item notes that the time to develop test data and the rapid increase in the number of nanomaterials can make the traditional method of quantitative risk assessment for OEL derivation difficult.  As a result, scientists have proposed other methods:

  • The properties of a new nanomaterial can be compared to an existing chemical substance with similar properties, as has been done with nanofibers and asbestos;
  • A safety factor can be applied to the nanoscale variant of existing chemicals with known toxic effects, such as cancer, as proposed by the British Standard Institute;
  • Using the knowledge available from air pollution research; and
  • Using quantitative structure-activity relationship (QSAR) modeling to predict the toxicity, although the blog item states that this approach appears not to have been used yet for nanomaterial OEL derivation.

The blog item notes that it is unclear what measurement is the best for OELs for engineered nanomaterials — mass concentration (milligrams per cubic meter), number concentration (number of particles in a cubic meter), or surface concentration (the total surface of the particles in a cubic meter).  When searching for proposed OELs, only about half were published in peer-reviewed journals, while the rest were “scattered across project reports published on the Internet only, conference abstracts or government reports.”  The OELs found varied in many cases, ranging from a factor of 50 for OELs for carbon nanotubes to even more for OELs for metallic nanomaterials.  The blog item concludes that “[t]he challenge is to find consensus on how to derive the OELs for nanomaterials and next to underpin the proposed values with more empirical research.”  According to NIOSH, at this time, “the OELs for nanomaterials are bench mark levels to which the exposure levels measured in a specific workplace can be compared.  Compared to the concentrations that have been measured in workplaces, these OEL benchmark levels are often still substantially lower and should be an incentive to reduce exposure.”

OECD Publishes Report on Alternative Testing Strategies in Risk Assessment of Manufactured Nanomaterials

Posted in OECD, Research

The Organization for Economic Cooperation and Development (OECD) published a report entitled Alternative Testing Strategies in Risk Assessment of Manufactured Nanomaterials:  Current State of Knowledge and Research Needs to Advance Their Use.  Experts from academia, industry, public interest groups, and government researched, analyzed, and discussed how alternative models could be used to advance the risk analysis of manufactured nanomaterials.  The objectives were to identify how alternative testing strategies could be used in a risk analysis context to inform human health, ecosystem health, and exposure data needs for manufactured nanomaterials in the near term and longer term, and identify research needs to support the development of these strategies in the near future.  To develop the report, a number of activities were organized, including a symposium, a case study on alternative methods in safety testing, a state-of-the-science report, and three white papers.  These results were further discussed as background materials for developing recommendations to advance knowledge and fill key gaps in understanding.  The report states that one conclusion was that alternative testing strategies are now being used for screening, and that, in the near term, alternative testing strategies could be developed for use in read-across or categorization decision making within certain regulatory frameworks.  According to the report, experts recognized that leadership is required from within the scientific community to address basic challenges, such as standardization of materials, techniques, and reporting, designing experiments relevant to realistic outcomes, and the coordination and sharing of large-scale collaborations and data.  OECD expects that the conclusions from the report can contribute to the development and implementation of relevant alternative testing strategies for manufactured nanomaterial testing that will expedite the ability to identify high-risk manufactured nanomaterials, and lead to more rapid, cost-effective, and reliable safety testing for specific risk management decision contexts.

Nano-Portal on Safe Handling of Nanomaterials Available in English

Posted in International, Occupational Health and Safety Issues

The Nano-Portal:  Safe Handling of Nanomaterials, the result of a project supported by the Deutsche Gesetzliche Unfallversicherung (DGUV) and developed by the Innovation Society, is now available in English.  The website is intended to extend knowledge about occupational safety and health in the fields of nanomaterials and nanotechnologies.  The Nano-Portal addresses:

  • Awareness of prevention and safety experts in the safe handling of nanomaterials;
  • Qualification of employees in laboratories and companies;
  • Presentation of practical protective measures and requirements for safe workplaces;
  • Description of nanomaterials and products and possible effects on health;
  • Provision of basic information on risk assessment; and
  • Support and advice to employers and executives.

While the website is aimed at prevention and safety experts, it also addresses employees without specific technical knowledge.  It includes five nanoramas in which the user enters a virtual room and can move and explore work situtations.  The 360° panorama shows products, materials, and occupational situations that deal with nanomaterials and technologies in the respective industry and in workplace areas.  The nanoramas focus on the use of nanomaterials, as well as on the appropriate workplace safety measures when handling nanomaterials.  Users can find situations and answer the questions that appear when clicking on the individual situations.  Three different interactions are possible:  (1) multiple-choice questions; (2) “traffic light“ questions; and (3) information windows.  Nanorama Laboratory and Nanorama Production are available in English, while the others (Nanorama Construction, Nanorama Laboratory, Nanorama Car Workshop, Nanorama Textile, and Nanorama Production) are available only in German at this time.

New Article Discusses TSCA Reform Provisions Pertinent to Manufacturers and Processors of Nanoscale Materials

Posted in Federal, Legal/Regulatory Issues, United States

We are pleased to announced that Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton published an article, “Practitioner Insights:  A Review and Analysis of TSCA Reform Provisions Pertinent to Manufacturers and Processors of Nanoscale Materials,” in the January 26, 2017, issue of Bloomberg BNA’s Daily Environment Report.  The article reviews and analyzes the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Pub. L. No. 114-182, and focuses narrowly on how new TSCA specifically impacts nanoscale materials.  Although new TSCA dramatically changes how the U.S. Environmental Protection Agency (EPA) evaluates and manages industrial chemicals, including nanoscale chemicals, the absence of words or phrases such as nano or nanoscale materials means that there are no specific or additional requirements that apply explicitly to such materials.  This was a significant shift from many of the earlier TSCA reform bills, which explicitly addressed nanoscale materials by proposing new definitions such as “substance characteristics” and “special substance characteristics” that included concepts such as size or size distribution; shape; surface structure; and reactivity.  New TSCA is noticeably silent on this subject and does not distinguish nanoscale materials or treat such materials differently from other chemical substances regulated under TSCA.  The article focuses on the key changes in new TSCA that could affect manufacturers and processors of nanoscale materials, and notes opportunities for stakeholders to engage in forthcoming rulemaking processes and other regulatory initiatives to ensure EPA is successful in implementing new TSCA.

KEMI Consulting on Draft Nano Register Regulation

Posted in EU Member State, International, Legal/Regulatory Issues

The Swedish Chemicals Agency (KEMI) is in the process of consulting with stakeholders on a draft regulation that would require companies to provide information on nanomaterials in chemical products to the Swedish products register by February 28, 2019.  According to KEMI, the proposal is the same as presented in its 2015 report.  Although the report is in Swedish, it includes an English summary on page 8, which states:

The Swedish Chemicals Agency proposes that those who report chemical products to the products register shall, in addition to the information that is currently reported, also provide further information regarding any nanomaterials contained in the product.  The proposal covers nanomaterials which have been intentionally added to the product, regardless of concentration.  Nanomaterials are defined in accordance with the recommended definition of the European Commission.  Although, this proposal does not cover nanomaterials that are naturally occurring or unintentionally produced.

Exemptions from the reporting requirements are proposed for companies with a turnover of less than SEK 5 million per year during a period of evaluation.  These companies should only need to tick a box if they believe that their products contain nanomaterials.  During the period of evaluation, the same exemption should also apply to nanomaterials in the form of pigment.

The product groups, which are already exempt from the reporting requirements in the Products Register, will remain exempt for any purposes of this proposal.  Those product groups are waste, food and animal feed, pharmaceuticals, cosmetics and tattoo ink.

The report states that KEMI does not propose any reporting requirements for nanomaterials in articles.  Comments are due March 24, 2017.  KEMI will review the responses and consider whether any revisions are necessary.  Once KEMI prepares a final draft, it will notify the European Commission of the regulation.

Committees Reviewing Draft Appendix on Recommendations for Nanomaterials Applicable to the Guidance on Registration

Posted in International, Legal/Regulatory Issues

On January 13, 2017, the European Chemicals Agency (ECHA) sent the draft appendix on recommendations for nanomaterials applicable to the guidance on registration to the Forum, Member State Committee, and Risk Assessment Committee for consultation.  The draft guidance outlines the minimum elements potential registrants need to consider when registering substances that fulfil the European Commission’s (EC) Recommendation for the definition of nanomaterial.  The aim of the draft guidance is to define the term “nanoform,” the minimum criteria for distinguishing between different nanoforms, and the minimum set of elements that should be reported on the characterization of nanoforms.  The draft guidance defines nanoform as a substance that meets the requirements of the EC’s Recommendation for the definition of nanomaterial and has a shape and a surface chemistry.  The three minimum elements to characterize nanoforms are:  (1) size; (2) shape; and (3) surface chemistry.  The draft guidance notes that these are the minimum elements necessary to characterize registered nanoforms in a registration dossier, and additional elements and/or additional refinement of these elements may need to be reported.  The draft guidance includes a hypothetical example of the minimum elements that would be needed to report a nanoform.