Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Lynn L. Bergeson Will Speak at 17th NanoBusiness Commercialization Association Conference

Posted in United States

The NanoBusiness Commercialization Association (NanoBCA) will hold its 17th annual conference on June 14, 2018, in Washington, D.C.  Speakers will include Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C., as well as:

  • Jim Phillips, Chairman and Chief Executive Officer (CEO), NanoMech Corporation;
  • Doyle Edwards, Director, Government Programs, Brewer Science;
  • Marco Curreli, Ph.D., Executive Director and Founder, Omni Nano;
  • Lisa Friedersdorf, Director, National Nanotechnology Coordination Office;
  • Penelope Salmons, President, Fibrtec Inc.;
  • Carleton JC Hsia, Ph.D., Chairman and CEO, AntiRadical Therapeutics LLC;
  • Anis Rahman, Ph.D., President/Chief Technology Officer CTO, Applied Research & Photonics, Inc.; and
  • A representative from the Federal Bureau of Investigation (FBI).

Registration is available online.

Abstracts for 2018 ICOH Congress Include Several Regarding Nanomaterials

Posted in International, Occupational Health and Safety Issues, Research

The 32nd Triennial Congress of the International Commission on Occupational Health (ICOH) was held April 29 through May 4, 2018, in Dublin, Ireland.  Occupational and Environmental Medicine (OEM) has published the abstracts for the Congress online, including the following ones concerning nanomaterials:

Belgium Finds Quality of Nanoregistrations Can Be Improved

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

The Belgian Federal Public Service for Public Health, Food Chain Safety and Environment has published the first annual report for nano substances registered for placement on the market in 2016.  Although the report is available only in French and Dutch at this time, each contains an executive summary in English.  Of the 475 registrations submitted, importers submitted 56 percent of the registrations, distributors 22 percent, and manufacturers 11 percent.  The rest were submitted by formulators or “others.”  According to the executive summary, NACE(BEL) Code 20, manufacture of chemicals and chemical products, was used most often to describe the economic activity at the level of the company.  At the level of the registrations, Code 20160, manufacture of plastics in primary forms, was used most frequently.  In 2016, 57,550 tons of substances in nanoparticular state were imported, 16,947 tons were manufactured, and 13,815 tons were distributed.  Substances registered in quantities greater than 1,000 tons include amorphous silica, calcium carbonate, calcium carbonate treated with stearic acid, carbon black, diiron trioxide, iron hydroxide oxide yellow, and silicon oxide.  About half of the submitted registrations reported quantities below one ton.  The executive summary states that evaluation of the submitted registrations shows that the quality of the registrations can be further improved.  It also suggests the possibility that not all potential registrants are aware of the May 27, 2014, Royal Decree and the obligation to register.  The nominative list of the substances registered for 2016 is presented in an annex to the report.  Based on the Chemical Abstracts Service (CAS) number, about 150 different chemical substances were identified.  The executive summary notes that the chemical identification makes no distinction between the possible differences in the physico-chemical properties of the nanosubstances.

Germany’s Federal Environment Ministry Holds NanoDialog on Nano-In-Vivo

Posted in International, Research

On April 23-24, 2018, the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU) held a NanoDialog to discuss “Nano-In-Vivo,” a long-term research project intended to close existing data gaps concerning the safety of nanomaterials.  BMU, the Federal Environment Agency (UBA), the Federal Institute for Occupational Safety and Health (BAuA), and BASF SE, with the participation of the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) and the Federal Institute for Risk Assessment (BfR), launched the joint project in 2013.  Using rat organisms, the project is studying the potential long-term effects of nanomaterials on the lungs and other organs.  In particular, the tests are examining the impacts that low exposure levels have over a long period of time to identify the chronic effects of nanomaterials in the low-dose range.  During the NanoDialog, meeting participants discussed the early study results.  According to BMU, the study results will feed into ongoing work at the Organization for Economic Cooperation and Development and discussion within the European Union on the risk assessment of nanomaterials.  The study results are expected to be published at the end of 2018.

Nanotech Entrepreneurs Will Share Commercialization Challenges and Successes in NNCO Webinar

Posted in Federal, Research, United States

The National Nanotechnology Coordination Office (NNCO) will hold the first in its series of free webinars for the nanotechnology entrepreneurship community on May 21, 2018, at 2:00 p.m. (EDT).  NNCO states that the webinar will feature stories from entrepreneurs that have transitioned their university-based nanotechnology research through commercialization.  Participants will share lessons learned, technological challenges faced, and how their university entrepreneurial ecosystem supported their efforts.  Panelists will include:

  • Angelique C. Johnson, founder and Chief Executive Officer of MEMStim LLC;
  • Christopher Schuh, Chief Scientist of Xtalic Corporation; and
  • Gleb Yushin, co-founder and Chief Technology Officer of Sila Nanotechnologies.

Registration is now open.

AIHA® Fact Sheet Addresses National Security Implications of Export-Import Activities Concerning Nanomaterials

Posted in Federal, International, United States

The American Industrial Hygiene Association (AIHA®) announced the availability of a nanomaterial product stewardship fact sheet sponsored by the AIHA® Nanotechnology Working Group.  The fact sheet, “Nanomaterial Product Stewardship:  National Security Implications of Export-import Activities,” authored by C.R. Knezevich, CIH, provides a thorough and helpful overview of export-import regulations affecting nanomaterials, reviews U.S. export regimes, and includes recommended practices and resources related to export-import activities.  The purpose of the fact sheet is to give product safety specialists and industrial hygienists an overview of export-import requirements for nanomaterials and is not intended to be a regulatory compliance guide.  The fact sheet states that nanotechnology “is a rapidly changing field with significant health, safety, environmental, and product stewardship considerations” and notes that the export of nanomaterials “presents additional global product stewardship challenges.”  According to the fact sheet, these challenges require the cooperation of several departments within a business organization, including industrial hygienists, who “contribute technical, ethical, and critical-thinking skills to global business teams.”  The fact sheet is a must read for nano enthusiasts and others engaged in export-import activities.

EPA Continues to Investigate Engineered Nanomaterials in Industrial Wastewater Discharge

Posted in Federal, Research, United States

On May 2, 2018, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing publication of its Final 2016 Effluent Guidelines Program Plan.  The Plan describes EPA’s Clean Water Act rulemakings and other actions intended to control industrial wastewater pollution.  According to the Plan, EPA continued several ongoing investigations, including one on the manufacture and processing of engineered nanomaterials as a potential new source of industrial wastewater discharge.  The Plan states that based on the information gathered during this current review, research continues to suggest that engineered nanomaterials “are used in a wide range of industrial applications and domestic products, but little is known about production quantities, waste management practices, or the potential for release of [engineered nanomaterials] from most industrial wastestreams.”  Incremental progress has been made to date towards developing analytical methods for detecting and quantifying nanomaterials in complex media, including industrial wastewater.  According to the Plan, EPA will continue to look for opportunities to inform current data gaps, including:

  1. Potential sources, quantities, and types of engineered nanomaterials in industrial wastewater discharge;
  2. Fate, transformation, and treatment of engineered nanomaterials in industrial wastewaters, including their potential impact to municipal wastewater treatment plants that may receive industrial wastewater discharges; and
  3. The development of analytical methods to detect and quantify engineered nanomaterials. Filling these data gaps will enable EPA to assess more fully the potential presence and impact of engineered nanomaterials in industrial process water.

JRC Extends Call to Access Its Nanobiotechnology Laboratory

Posted in International, Research

As reported in our February 16, 2018, blog item, the European Commission (EC) Joint Research Center (JRC) has opened a call to access its Nanobiotechnology Laboratory.  The Nanobiotechnology Laboratory features state-of-the-art equipped facilities designed to foster interdisciplinary studies.  Offering access to the Nanobiotechnology Laboratory is part of JRC’s strategy to enhance dissemination of scientific knowledge; boost competiveness; bridge the gap between research and industry; and provide training and capacity building.  To be eligible, the lead user institution and user institutions must be from a European Union (EU) Member State, candidate country, or country associated with the EU Research Program Horizon 2020.  The lead user institution must be from a university, research, or public institution, or from a small- or medium-sized enterprise (SME).  The call to access the JRC Nanobiotechnology Laboratory will close May 25, 2018.

REACH Committee Approves Draft Regulation to Amend the REACH Annexes to Address Nanomaterials

Posted in International, Legal/Regulatory Issues

The European Commission (EC) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Committee voted on April 26, 2018, to amend several REACH Annexes to clarify the registration requirements for nanomaterials.  According to the European Chemicals Agency’s (ECHA) press release, the amendments address the knowledge gap regarding which substances registered under REACH are placed on the market as nanomaterials and in what quantities.  ECHA states that the amendments will allow both companies and authorities to know more about the characteristics of nanomaterials, how they are used, how they are handled safely, what risks they potentially pose to health and the environment, and how these risks are controlled.  The draft regulation is now subject to scrutiny by the European Parliament and Council for a period of three months before being adopted by the EC.  ECHA states that it will begin to assess the need to update existing guidance or issue new guidance to support registrants in complying with the new requirements.  As soon as the amendments are formally adopted, ECHA encourages registrants of nanoform substances to familiarize themselves with the amendments and assess what actions they need to take to comply.  The EC held a public consultation in 2017 on a draft regulation that would amend the Annexes.  More information on the draft regulation and public consultation is available in our blog items, “EC Proposes to Amend REACH Annexes to Address Nanomaterials” and “EC Posts Comments Received on Draft Regulation to Amend REACH Annexes to Address Nanomaterials.”

European Parliament Approves New Law on Organic Production and Labeling of Organic Products

Posted in International, Legal/Regulatory Issues

On April 19, 2018, the European Parliament (EP) approved a regulation on organic production and labeling of organic products.  Under the regulation, the production of processed organic food will be based on several specific principles, including the exclusion of food containing or consisting of engineered nanomaterials.  The regulation defines engineered nanomaterial as defined in the 2011 regulation on the provision of food information to consumers as amended in 2015 by the novel foods regulation.  According to the EP’s April 19, 2018, press release, one of the features of the regulation is to ensure the high quality of organic food through “strict, risk-based checks” that will take place along the supply chain.  In addition, imports will have to comply with European Union (EU) standards.  The press release states that the current “equivalence” rules, requiring non-EU countries to comply with similar but not identical standards, will be phased out within five years.  The Council of the EU must formally approve the text of the regulation before it can enter into force.  It shall apply beginning January 1, 2021.