January 9, 2018

Germany Publishes Report on Scientific Stakeholder Meeting on Nanomaterials in the Environment

The German Environment Agency (UBA) has published a report summarizing the contents and outcomes of the October 2017 scientific stakeholder meeting on nanomaterials in the environment.  The meeting focused on the relevant regulatory results of recent German and European research projects on nanomaterials in the environment.  The stakeholder meeting provided a forum for participants to present the state of the knowledge on environmental nanosafety in a regulatory context, as well as to...
January 8, 2018

EEB Finds Estonian EU Council Presidency Failed to Fill Regulatory Gaps on Nanomaterials

The European Environmental Bureau (EEB) announced on December 22, 2017, the availability of its assessment of the environmental performance of the Estonian Presidency of the European Union (EU).  The assessment is based on the results of “Ten Green Tests” laid out at the beginning of Estonia’s Presidency.  The eighth test is protecting the public from hazardous chemicals, including mercury.  The test includes encouraging the European Commission (EC) “to develop a...
January 5, 2018

B&C Publishes Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018

Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) published on January 4, 2018, their “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018.”  In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and Acta offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected...
December 29, 2017

NIOSH Plans to Support Implementation of WHO Guidelines to Protect Workers from Nanomaterials

On December 15, 2017, the National Institute for Occupational Safety and Health (NIOSH) posted a blog item entitled “WHO Guidelines to Protect Workers from Nanomaterials.”  As reported in our December 13, 2017, blog item, the World Health Organization (WHO) recently published WHO Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials.  NIOSH Director John Howard, MD, describes the WHO Guidelines as “an important step in protecting workers worldwide from the...
December 28, 2017

UNEP Report on Emerging Issues of Environmental Concern Includes Nanomaterials

In early December 2017, the United Nations Environment Program (UNEP) published Frontiers 2017:  Emerging Issues of Environmental Concern.  The report covers six key emerging issues:  the environmental dimension of antimicrobial resistance; nanomaterials; marine protected areas and sustainable development; sand and dust storms; off-grid solar solutions; and environmental displacement.  The section on nanomaterials addresses nanodimensions — new discoveries about familiar materials;...
December 18, 2017

FDA Publishes Draft Guidance on Drug Products, Including Biological Products, That Contain Nanomaterials

On December 18, 2017, the Food and Drug Administration (FDA) published a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, That Contain Nanomaterials:  Guidance for Industry.”  According to the notice, FDA developed the guidance to provide industry with its current thinking for the development of human drug products, including those that are biological products, in which a nanomaterial is present...
December 15, 2017

FDA Will Publish Draft Guidance on Drug Products, Including Biological Products, that Contain Nanomaterials

The Food and Drug Administration (FDA) is scheduled to publish a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.”  According to the pre-publication version of the notice, FDA developed the guidance to provide industry with its current thinking for the development of human drug products, including those that are biological products, that contain nanomaterials.  The...
December 14, 2017

Presentations Available from ECHA Webinar on REACH Guidance for Nanomaterials

On November 30, 2017, the European Chemicals Agency (ECHA) held a webinar to explain the support documentation available for registrants that cover nanoforms in their Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossier.  The main focus was on the registration and read-across of nanoforms, but the webinar also covered updates for information requirements for human health and the environment.  ECHA has posted the following...
December 13, 2017

WHO Publishes Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials

In December 2017, the World Health Organization (WHO) published WHO Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials.  WHO developed the Guidelines, which provide recommendations on how best to protect workers from the potential risks of manufactured nanomaterials (MNM).  According to WHO, its recommendations are intended to help policy-makers and professionals in the field of occupational health and safety in making decisions about the best...
December 12, 2017

ISO Publishes Standard on Aquatic Toxicity Assessment of Manufactured Nanomaterials in Saltwater Lakes

In November 2017, the International Organization for Standardization (ISO) published standard ISO/TS 20787:2017, “Nanotechnologies — Aquatic toxicity assessment of manufactured nanomaterials in saltwater lakes using Artemia sp. Nauplii.”  ISO/TS 20787:2017 specifies a test method, aiming to maximize repeatability and reliability of testing, to determine whether manufactured nanomaterials are toxic to aquatic organisms, specifically Artemia sp. nauplius.  ISO states that ISO/TS...