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 Information Collection Project That Will Survey Engineered Nanomaterial Occupational Safety and Health Practices

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

On April 23, 2019, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice inviting comment on a proposed information collection project entitled “Survey of Engineered Nanomaterial Occupational Safety and Health Practices.”  The goal of the project is to assess the relevance and impact of NIOSH’s contribution to guidelines and risk mitigation practices for the safe handling of engineered nanomaterials in the workplace.  According to the notice, NIOSH is in the process of procuring a contractor to perform the work, and is on schedule to award a contract by summer 2019.  The notice states that research under this project will survey companies who manufacture, distribute, fabricate, formulate, use, or provide services related to engineered nanomaterials.  Under the project, the following activities and data collections will be conducted:

  • 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.
  • 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 occupational safety and health practices concerning engineered nanomaterials.

The Office of Management and Budget (OMB) is particularly interested in comments that will help:

  1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of NIOSH, including whether the information will have practical utility;
  2. Evaluate the accuracy of NIOSH’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
  3. Enhance the quality, utility, and clarity of the information to be collected;
  4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and
  5. Assess information collection costs.

Comments are due June 24, 2019.

ACS Will Hold Free Webinar on Working Safely with Nanomaterials in the Laboratory

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

On May 16, 2019, the American Chemical Society (ACS) will hold a webinar on working safely with nanomaterials in the laboratory.  Chuck Geraci, Associate Director for Emerging Technologies at the National Institute for Occupational Safety and Health (NIOSH), will moderate a panel including:

  • Ken Kretchman, Director of Environmental Safety, NC State University;
  • Craig Merlic, Professor of Chemistry, University of California, Los Angeles (UCLA); and
  • Debbie Decker, Chemical and Laboratory Safety Officer, University of California (UC), Davis.

The panel will discuss the importance of managing products containing nanomaterials by integrating them into an existing lab safety program.  During this free interactive broadcast, they will highlight the importance of a strong safety culture that is created and maintained by bench scientists who champion appropriate safety practices.  Participants will learn:

  • How to manage nanomaterial-containing products as part of an already-existing environmental, health, and safety (EHS) program;
  • How to create and maintain a strong safety culture in a lab and the benefits of that culture; and
  • Resources that are available to laboratories, manufacturers, and processors to handle nanomaterials safely.

FDA Extends Comment Period for Proposed Rule for OTC Sunscreen Drug Products

Posted in Federal, Legal/Regulatory Issues, United States

On April 18, 2019, the Food and Drug Administration (FDA) published a Federal Register notice announcing that it is extending the comment period for its February 26, 2019, proposed rule that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.  The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded.  As reported in our February 21, 2019, blog item, “FDA Proposed Rule for OTC Sunscreen Drug Products Addresses Sunscreens Containing Nanomaterials,” FDA invites comment on the following topics:

  • Specific nanomaterials or types of nanomaterials that have been used or proposed for use in OTC sunscreen products;
  • Concerns about sunscreen product safety, effectiveness, or quality associated with the use of nanomaterials in OTC sunscreen products, with supporting data;
  • Need for, and proposals of, specifications or limitations for particular nanomaterials for use in OTC sunscreen products;
  • Any particular nanomaterials that you believe should not be permitted for use in OTC sunscreen products, along with supporting scientific information; and
  • FDA’s proposed regulatory approach and/or alternative regulatory approaches to the use of nanomaterials in OTC sunscreen products.

Comments are now due on June 27, 2019.

France Bans Titanium Dioxide Food Additive Beginning in 2020

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

On April 17, 2019, the Ministry of Ecological and Solidarity Transition issued a press release announcing that France will prohibit foods containing food additive E171 (titanium dioxide) from being placed on the market beginning January 1, 2020.  The press release cites the April 15, 2019, opinion from the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES).  The expert group established by ANSES conducted a literature review on the oral toxicity of E171, identifying 25 studies published since 2017.  ANSES concluded that it has no new information to remove the uncertainties regarding the safety of the E171 additive.  Pending a better toxicological characterization of E171 and work currently underway at the European level, ANSES reiterates its previous general recommendations on nanomaterials aimed at limiting the exposure of workers, consumers, and the environment by promoting products that are safe and equivalent products in terms of function and efficiency, without nanomaterials.  According to the Ministry’s press release, an order regarding the ban has been signed and will be published as soon as possible.  As E171 is authorized at the European Union (EU) level, France will notify the order to the European Commission and other EU Member States, which will then meet within ten days.

18th Annual NanoBusiness Conference Will Be Held in June in Washington, D.C.

Posted in Legal/Regulatory Issues, United States

The NanoBusiness Commercialization Association (NanoBCA) will hold its 18th Annual NanoBusiness Conference on June 4, 2019, in Washington, D.C.  Speakers will include:

  • Arpana Verma, Ph.D., Chief Science Officer, NanoMech Industries, Inc.;
  • Doyle Edwards, Director, Government Programs, Brewer Science;
  • Lynn L. Bergeson, Managing Director, Bergeson & Campbell, P.C.;
  • Hugues Jacquemin, Chief Executive Officer (CEO), OCSiAI LLC;
  • Paul Stimers, Partner, K&L Gates;
  • Deb Newberry, CEO, Newberry Technologies;
  • Jim Phillips, Chairman and CEO, NanoMech Corporation;
  • Penelope Salmons, President, Fibrtec Inc.;
  • Samuel Brauer, Ph.D., Principal, Nanotech Plus, LLC;
  • Anis Rahman, Ph.D., President/Chief Technology Officer, Applied Research & Photonics, Inc.;
  • Marco Curreli, Ph.D., Executive Director and Founder, Omni Nano; and
  • Vincent Caprio, Executive Director, NanoBCA.

Report Available from January 2019 Mexico-EU Workshop on Nanosafety

Posted in International, Research

On January 22-24, 2019, a Mexico-European Union (EU) workshop on nanosafety was held in Mexico.  The aim of the workshop was to establish a stronger connection between the Mexican and European research communities within the context of bringing scientific information to the risk assessment, risk management, and policy levels.  According to the workshop report, Mexico is eligible to participate in the EU’s Horizon 2020 and Ninth EU Framework Programs, and the January workshop was intended to inform Mexico and the EU with what has been achieved already and where each can benefit from the other’s knowledge and infrastructure.  The workshop report states that the following key collaborations were identified:

  1. To invite formally some of the members of EU Nanosafety Cluster (NSC) to be members of the International Advising Committee of the Sistema Nacional para la Evaluación Toxicológica de Nanomateriales (SINANOTOX);
  2. To engage SINANOTOX in NSC activities such as training schools, workshops, and annual scientific meetings;
  3. For SINANOTOX members to become members of working groups and task forces;
  4. To promote the direct contact between the SINANOTOX research groups and their European counterparts and vice versa, e.g., by involving Mexican partners in EU project proposals as Mexico is eligible for obtaining funding from the EU;
  5. To promote the student and faculty exchanges using the binational Consejo Nacional de Ciencia y Tecnología (CONACyT) funds;
  6. To promote in CONACyT the opening of a special call for nanosafety;
  7. To invite specific groups from NSC to review and enrich the toxicological assays proposed by SINANOTOX members;
  8. To connect SINANOTOX with the Malta Initiative;
  9. To share protocols and standard operating procedures;
  10. To organize a small workshop or course on data handling and analysis; and
  11. To organize a meeting to evaluate the one‐year activities and results from NSC‐SINANOTOX joint activities in January‐February 2020.

Presentations Available from EFSA Stakeholder Workshop on Nanoscience and Nanotechnology

Posted in International, Legal/Regulatory Issues

The European Food Safety Authority (EFSA) held a stakeholder workshop on April 1-2, 2019, on the implementation of its guidance on the risk assessment of applications of nanosciences and nanotechnologies in the food and feed chain.  As reported in our July 5, 2018, blog item, “EFSA Publishes New Guidance on Nanotechnologies in Food and Feed,” in July 2018, EFSA published new guidance on how to assess the safety of nanoscience and nanotechnology applications.  The guidance covers novel foods, food contact materials, food and feed additives, and pesticides, taking into account new developments that have taken place since publication of the previous guidance in 2011.  The workshop was an opportunity for stakeholders, EFSA, and its experts to have an open discussion and share their experiences on implementing the EFSA guidance, focusing on human and animal health.  The workshop was attended by 60 participants, who discussed the challenges they have faced implementing the guidance and shared examples of good practice.  Stakeholders made suggestions on some sections of the guidance, which were noted for consideration by EFSA’s Working Group on Nanotechnologies.  EFSA has posted the following presentations from the workshop:

TechConnect World 2019 Will Include Panel on Applying the Best Health, Safety, and Environment Practices to Advanced Manufacturing

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

TechConnect World Innovation Conference and Expo will be held June 17-19, 2019.  It will include the third installment of a panel started three years ago, “Tools and Techniques:  Applying the Best Health, Safety, and Environment Practices to Advanced Manufacturing.”  The Symposium Co-Chairs include:

  • Sally Tinkle, Senior Strategy and Policy Advisor, IDA/Science and Technology Policy Institute;
  • Chuck Geraci, Associate Director, National Institute for Occupational Safety and Health (NIOSH);
  • Jo Anne Shatkin, President, Vireo Advisors; and
  • Wu-Sheng Shih, Project Manager, Brewer Science Inc.

The key speakers include:

  • Michele Ostraat, Research Center Leader – Downstream, Aramco Services Company, “Advanced Manufacturing and the Fourth Industrial Revolution”;
  • Christina Agapakis, Creative Director, Ginkgo Bioworks, “What’s Happening in the Biomanufacturing Sector?”;
  • Alan J. Kennedy, Research Biologist, Engineer Research and Development Center – U.S. Army, “From Emergence to Convergence: The Growing Divide between Innovation and Risk Assessment”;
  • Kevin L. Dunn, Industrial Hygienist, Centers for Disease Control and Prevention (CDC)/NIOSH, “Additive Manufacturing: Occupational Safety Techniques and Lessons Learned from 13 NIOSH site assessments”; and
  • Wendel Wohlleben, Senior Scientist, BASF SE, Germany, “Beyond Nanotech: An International Perspective on Advanced Materials & Systems.”

ECHA PEG Reviewing Draft Appendix for Nanoforms Applicable to the Guidance on Registration and Substance Identification

Posted in International, Legal/Regulatory Issues

The European Chemicals Agency (ECHA) has posted the draft version of a guidance document, Appendix for nanoforms applicable to the Guidance on Registration and substance identification.  The draft guidance is being reviewed by a Partner Expert Group (PEG).  The draft Appendix has been developed to provide advice to registrants preparing registration dossiers that cover nanoforms.  It states that the advice provided covers nanospecific advice for issues related with registration and characterization of nanoforms.  The draft Appendix intends to provide advice specific to nanoforms and does not preclude the applicability of the general principles given in the Guidance on registration and the Guidance on Substance identification.  According to the draft Appendix, the parent guidance documents apply when no specific information for nanoforms has been given in this Appendix.  The aim of the draft Appendix is to provide guidance on how to interpret the term “nanoform” for registration purposes and provide advice on how to create “sets of nanoforms” in a registration dossier.  It also outlines what is expected in terms of characterization of the nanoforms and set of nanoforms in the registration dossier.  Section 2 of the draft Appendix explains general requirements regarding the registration of nanoforms.  Section 3 explains the concept of a nanoform, and how to distinguish a nanoform from another, and Section 4 focuses on how to create and justify sets of different nanoforms.  As reported in our December 4, 2018, blog item, the European Commission (EC) amended several Annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to clarify the information requirements for nanomaterials.  The information requirements will apply beginning January 1, 2020.

California Committee Includes Ultrafine Titanium Dioxide on Its Draft Priority 1 List for PEL Review

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

The California Division of Occupational Safety and Health’s (Cal/OSHA) Health Effects Advisory Committee (HEAC) for the Development of Permissible Exposure Limits (PEL) will meet on June 4, 2019.  According to the meeting agenda, HEAC will discuss the selection of Priority 1 substances for HEAC review.  HEAC has posted a draft 2019 Priority 1 List consisting of ten chemical substances.  The draft List includes titanium dioxide, ultrafine (<100 nanometers (nm)).  According to HEAC, the eight-hour threshold limit value is 0.3 milligrams per cubic meter (mg/m3).  Although California has adopted PELs for a number of airborne contaminants, for titanium dioxide, Table AC-1 in Section 5155 of Title 8 of the California Code of Regulations refers to particulates not otherwise regulated.  The respirable fraction for particulates not otherwise regulated is 5.0 mg/m3.  The draft Priority 1 List includes a factor for each substance that is the key consideration used for the ranking.  Titanium dioxide, ultrafine (<100 nm) is listed with a factor of 2, “[a] substantial change in the value of an [occupational exposure limit (OEL)] that could contribute to increased protection of workers if adhered to by employers.”