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 Directorate-General for the Environment (commonly referred to as DG Environment) is one of the more than 40 Directorates-General and services that make up the European Commission. The objective of the Directorate-General is to protect, preserve and improve the environment for present and future generations. To achieve this it proposes policies that ensure a high level of environmental protection in the European Union and that preserve the quality of life of EU citizens.
In 2011, as part of the second review of regulatory aspects of nanomaterials, DG Environment commissioned a "Review of Environmental Legislation for the Regulatory Control of Nanomaterials" which was conducted by Milieu. The objective of the study was to review environmental legislation for waste, water and other relevant acts as regards their legal coverage of nanomaterials and, where possible, implementation on the ground. The second objective was to identify and describe legislative and implementation gaps in environmental legislation, including details on whether gaps relate to a lack of legal coverage, limitations in technical capacities or dependences on other legislation. In terms of the level of coverage afforded to nanomaterials, the report concludes that all the legislation reviewed could be considered to address nanomaterials in principle. However, several pieces of legislation were found to have some limitations in the coverage of nanomaterials, resulting generally from a lack of knowledge and technical capacity (in particular monitoring and detection techniques) and in some cases from the inapplicability of existing legal mechanisms (such as concentration thresholds to control the presence of pollutants). Further details are provided in the full report, which can be downloaded here
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.
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.
Nanotechnology is identified by the EPA
as a topic that cuts across various environmental laws, regulations, or programs. The regulatory issues identified as particularly relevant for nanotechnology are:
- Control of Nanoscale Materials Under the Toxic Substances Control Act; and
- Regulating Pesticides that Use Nanotechnology.
TSCA is described in detail under the Substances & Products Regulation
In relation to pesticides, EPA states that FIFRA and EPA's implementing regulations provide an effective framework for regulating pesticide products that contain a nanoscale material. However, given the potential for nanoscale materials to pose different risks than their larger-sized counterparts, the EPA intends to obtain information on what nanoscale materials are present in pesticide products. The Agency are making available a notice announcing our proposed plan for gathering information on nanoscale materials contained in pesticide products. This document, which will be published in the Federal Register in the near future, describes several possible approaches for obtaining certain additional information on the composition of pesticide products. Further information on this new policy, as well as how to register a product that may contain nanomaterials, is available on the EPA website
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.
for further information from the Government of Canada.