Current status of environmental regulations for nanotechnologies
The relationship between nanotechnologies and the environment is complex and multi-faceted. On one hand, nanotechnologies already promise to offer affordable solutions to major issues which were previously considered a challenge almost beyond resolution. For example, nanotechnologies are being developed or in existence which can remove or inactivate pollutants within land, sea and air; offer more efficient use of resources, renewable energy and environmental monitoring; or provide simple and affordable solutions for water purification in third world countries. In addition, many of the nanotechnology-enabled solutions being developed for use within an environmental context promise to be cleaner and safer than the older technologies they replace. However on the other hand, the environmental impact of many nanoparticles or nanotechnology-enabled products is yet to be fully understood, and as a result many are wary of its rapid entry into the world market, fearing unforeseen detrimental outcomes or a potential public backlash. Furthermore, the scope of potential environmental impact from nanotechnologies is huge, spanning introduction to the environment throughout their lifecycle - from manufacture, through use and at disposal - all stages of which may carry different potential impacts. Based on this uncertainty, there is much debate ongoing about the requirement for specific regulation of nanotechnologies within the environment (
Reynolds, GH; 2001).
Several regulatory bodies are currently active in the investigation or in some cases regulation of nanomaterials under existing environmental regulations. These include:
- U.S. Environmental Protection Agency (EPA)
- U.K. Department for Environment, Farming and Rural Affairs (Defra)
- Environment Canada & Health Canada
A summary of the outputs from these bodies is provided in the section below, together with links to relevant further information.
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The mission of the
US EPA is to protect human health and the environment. It accomplishes this via research activities (including internal research and a grant award system), sponsorship of partnerships, and provision of education. In relation to regulation, the EPA is charged with implementation of environmental laws passed by US congress via development and enforcement of Regulations.
The main activity of EPA with regards the regulation of nanotechnolgies falls under the Toxic Substances Control Act (TSCA), which is therefore described in further detail under
Substances & Products Regulation.
The aim of Defra in relation to nanomaterials is to ensure that the benefits of nanotechnology can be realised while protecting human health and ecosystems from potential risks.
To date, there exists no nanomaterial-specific regulations within the UK. Defra has been seeking information through a Voluntary Reporting Scheme launched in 2006. However, Because of a low rate of submissions to its reporting program, no new regulations are imminent.
The UK Nanotechnologies Strategy: Small Technologies, Great Opportunities was launched on the 18th March 2010, and may be
downloaded here. This Strategy outlines how the UK Government proposed to take action to ensure that everyone in the UK could safely benefit from the societal and economic opportunities that these technologies offer, whilst addressing the challenges that they might present.
In relation to regulation, the strategy outlined that the scope of work on a scheme to succeed the pilot voluntary reporting scheme to include products as well as materials was planned. A working group comprising officials from the Department for Business, Innovation and Skills (BIS), the Department for Environment, Food and Rural Affairs (Defra), the Department of Health (DH), the Food Standards Agency (FSA) and the Health and Safety Executive (HSE) were tasked to develop a proposal.
In addition, the strategy pledged to monitor the success of implementation of amendments to novel foods and cosmetics directives with respect to nanomaterials and will influence changes made to the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (REACH) in order to ensure that nanomaterials are robustly covered within the regulatory framework. To compliment this, horizon scanning and monitoring will be performed by the Medicines and Healthcare Products Regulatory Agency (MHRA), FSA and HSE to detect necessity for amendments to legislation in the future.
Within Canada, regulation of health and the environment is implemented through the Canadian Environmental Protection Act, 1999 (CEPA), which is administered by Environment Canada and Health Canada.
In June 2007, Environment Canada released a ‘new substances program advisory’ which announced that nanomaterials will be regulated under CEPA’s new substances notification regulations (chemicals and polymers). This meant that any nanomaterials not listed on the Canadian domestic substances list (DSL), or with “unique structures or molecular arrangements” compared to their non-nano counterparts, require a new substances notification package, including a risk assessment (
Environment Canada, 2011).
Also in 2007, Environment Canada (EC) and Health Canada (HC) published a Proposed Regulatory Framework for Nanomaterials Under the Canadian Environmental Protection Act, 1999 (
Proposed Framework). As part of the framework, Environment Canada proposed conducting mandatory surveys under CEPA s. 71 on nanotechnology use in Canada. It is expected that information gathered will be used to develop the
national nanotechnology regulatory framework.
In 2010, Canadian Member of Parliament Peter Julian (NDP) proposed legislation
Bill C-494 as an amendment to CEPA. The bill includes provisions concerning adding nanomaterials to the Domestic Substances List (DSL), notification of significant new activity, risk assessment procedures, and would establish a public inventory of nanotechnology and nanomaterials in Canada.