Danish EPA Releases Report on Environmental & Health Risks for Selected Nanoparticles

Denmark's Environmental Protection Agency (DEPA)  recently released "Survey on basic knowledge about exposure and potential environmental and health risks for selected nanoparticles". The survey was written by Sonja Hagen Mikkelsen, Erik Hansen and Trine Boe Christensen of COWI A/S, Anders Baun and Steffen Foss Hansen of DTU Environment and Mona-Lise Binderup of DTU Food, all working under contract with DEPA.

Noting that "There is no single source of information that provides an overview of nanomaterials and products in Denmark or in the EU for that matter",

DEPA has therefore initiated this project to provide an overview of the existing knowledge about seven of the most common nanomaterials, their environmental and health properties, the use of those nanomaterials and the possibility of exposure of humans and the environment.

The seven nanomaterials selected as the focus of the survey are

1 - Titanium dioxide

2 - Cerium dioxide

3- Fullerenes (aka carbon balls or 'buckeyballs")

4- Nanosilver

5- Zero-valent iron

6 - Silicium dioxide

7 - Nanoclay

These nanomaterials were selected based on

1- Application volums

2- Potential human exposure

3- Potential direct discharge into the environment

4 - Expected biological effect (human and/or environment), persistence or bioaccumultion

The authors of the survey developed "profiles" for the nanomaterials, focusing on " the general characteristics and manufacture of the nanomaterial, their current uses (mainly focused at consumer products) and hazard profiles (ecotoxicity and human toxicity) . . . . The profiles included sections discussing relevant exposures from consumer products and considerations regarding the related risk."

The first two chapters of the survey, "Introduction" and "Nanomaterials Survey" discuss the nature of the nanomaterials, their use in industries, general availability of products incorporating the nanomaterials and brief summaries of earlier studies. Chapters 3-9 focus on the individual nanomaterials selected for this survey, discussing the general characteristics of a specific nanomaterial, how it is manufactured, which consumer products available in Denmark, either via a website or a bricks and mortor shop, review of toxicity studies, possible scenarios where humans and the environment might be exposed to the nanomaterials, ranging from disposal of products containing nanomaterials in landfills to the use of nanomaterial ensconced cosmetics, such as sunscreens containing titanium dioxide, and brief discussions of "risk profiles" for the selected nanomaterials. Summary sheets are found at the end of the chapters.

Chapter 10, "Exposure and risk potential", raises a point that critics of this survey will note:

. . . the range of toxicological and ecotoxicological studies available is not sufficient to allow firm conclusions with regard to the toxicity of the nanoparticles compared to their bulk counterparts. . . (emphasis added)

As one might then expect, the authors of this survey come to the conclusion that, in order to answer the questions regarding nanomaterials and risk more information and research is needed.

New Nanoscale Carbon Website -- CNT Report

Readers may be interested in learning about a new subscription website devoted to nanoscale carbon -- CNT Report

CNT Report is dedicated to bringing its readers the most recent news concerning important issues affecting nanoscale carbon research, development, and commercialization.  CNT Report closely covers all forms of nanoscale carbon in development on the global stage, including CNTs, graphene, fullerenes, specialty fibers, and all else in-between.  CNT Report's primary focus is on new scientific research developments, practical applications, finance, legal and regulatory issues, and general commercialization.   CNT Report publishes news in several broad categories including: Business, Commercialization,  Finance & Deals, Insurance, Intellectual Property, International Laws & Regulations, Policy, Standards, States, Science, Applications, Current Research, and Environmental, Health and Safety.

CNT Report also accepts press releases, research results, financial news, or any other news item related to nanoscale carbon which it then makes available to all of its subscribers.  CNT Report welcomes timely contributions from its readers and makes sure that their articles receive proper attribution and credit.

 

An Industry-Driven Approach to EHS Issues

My new Nanotechnology Law & Business article -- "An Industry Driven Approach to EHS Issues: 'The NanoSafety Consortium for Carbon'" -- can be found here.  The abstract follows.

The NanoSafety Consortium for Carbon (NCC) is an industry-driven group formed to proactively address potential environmental, health, safety, and regulatory concerns related to the commercia-lization of its members’ nanoscale carbon products. NCC was formed to take advantage of an offer by the EPA for a consortium of companies to providing testing regarding carbon nanotube toxicity. This article provides background on NCC’s activities, purpose, and goals.

Nanoscale Carbon: In Vivo Tox Bibliography

The NanoSafety Consortium for Carbon has recently posted a bibliography of in vivo tox studies on its website.  The bibliography is (obviously) a work in progress.  We would greatly appreciate it if our readers would bring to our attention any pertinent articles that are not already on the bibliography.  The articles will be used to inform and guide our attempt in crafting a representative toxicity testing regime with US EPA.  Many thanks in advance for your input.

Registration of Carbon Nanoscale Materials Required Under REACH

The EC's 2006 Registration, Evaluation, Authorisation and Registration of Chemicals ("REACH") regulations place "the responsibility for the management of the risks of [chemical] substances with. . .[the companies that] manufacture, import, place on the market or use [the] substances in the context of their professional activities."  Guidance on Registration, Guidance for the Implementation of REACH, European Chemicals Agency, Version 1.3, May 2008, at p. 12.  

To this end, REACH requires companies manufacturing or importing chemical substances in quantities greater than one ton per year to register those substances before they "can be manufactured, imported or placed on the market."  As part of these requirements, "manufacturers and importers need to collect or generate data on the substances and assess how risks to human health and environment can be controlled by applying suitable risk management measures."  This can often be an expensive and time consuming process.

Providing some relief in certain circumstances, Article 2(7)(a) of Regulation (EC) No 1907/2006 provides that certain substances are exempt from registration under REACH because "sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties." These substances are listed in REACH Annex IV.

On October 8, 2008, the EC removed carbon and graphite from Annex IV "due to the fact that the concerned Einecs and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in" Annex IV.   We first posted on this possibility last June.

Commission Regulation (EC) NO 987/2008 of 8 October 2008 Amending Regulation (EC) No 1907/2006 of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V.

This decision is consistent with the U.S. Environmental Protection Agency's reasoning that nanoscale substances with new molecular identities -- such as fullerenes and carbon nanotubes -- are considered new chemical substances for purposes of premanufacturing notice submissions under the Toxic Substances Control Act.
 

Nanotechnology Law Report -- June 2008

Nanotechnology Law Report -- June 2008