Agreeing on a legal definition of nanomaterials that satisfies food manufacturers, regulators, enforcement bodies and consumers will be hugely challenging, according to experts gathered at a nanotechnology workshop in Leatherhead, UK, last week.
Currently, the only legal definition for nanomaterials in the EU is in the Cosmetics Regulation (EC 1223/2009), which defines nanomaterials (for labelling purposes) as "insoluble or biopersistent and intentionally manufactured... with one or more external dimensions or an internal structure on the scale of 1-100 nanometres".
A second definition - which focuses on "intentionally-produced materials in the order of 100-nanometres or less" is included in the latest draft of the revised Novel Food Regulation.
A third definition that appears to focus more on size than functionality is being developed by the European Commission's independent Scientific Committee for Emerging and Newly Identified Health Risks.
However, all of the above definitions are problematic, according to scientists and legal experts at last week's workshop, which was organised by Leatherhead Food Research, NanoCentral and the UK's Nanotechnology Knowledge Transfer Network (NanoKTN).
The National Institute for Occupational Safety and Health (NIOSH) and a university-based nanotechnology research center today announced a formal partnership that will provide companies with practical research and guidance to promote occupational health and safety in nanotechnology.
Under the agreement, NIOSH will partner with the National Science Foundation (NSF) Center for High-rate Nanomanufacturing (CHN) - a collaboration of the University of Massachusetts Lowell, Northeastern University and the University of New Hampshire - in research to identify and address potential occupational health and safety concerns related to the nanotechnology industry.
Further details available here .
The Organization for Economic Development and Co-Operation (OECD) has published a brief summary of information, reported to it by its US representatives. concerning the latest developments in research and regulation of the health and environmental impacts of manufactured nanomaterials in the United States.
OECD US update
The United States Government Accountability Office (GAO) recently issued its Report to the Chairman of the Committee on Environment and Public Works, US Senate, concerning US Environmental Protection Agency (EPA) initiatives to regulate nanomaterials.
In summary the GAO recommended to the EPA to:
- complete its plan to issue a Significant New Use Rule (SNUR) for nanomaterials;
- modify the US Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) pesticide registration guidelines to require applicants to identify nanomaterial ingredients in pesticides;
- complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new;
- complete its plan to use data gathering and testing authorities under the US Toxic Substances Control Act (TCSA) to gather information on nanomaterials including production volumes, methods of manufacture and processing, exposure and release, as well as available health and safety studies; and
- use information-gathering provisions of the US Clean Water Act to collect information about potential discharges containing nanomaterials.
Finally, it recommended that the Administrator of EPA should consider revising the Inventory Update under TSCA so that it will capture information on the production and use of nanomaterials and so that the agency will receive periodic updates on this material.
A subsequent written response from EPA indicated that it broadly agreed with all of GAO's recommendations.
Source: Nanotechnology Law Report
Nanomaterials exhibit various physical, chemical, mechanical, optical, magnetic and biological properties, as well as different internal/external structures, and are used in a wide range of applications. There are now many divergent understandings and assumptions associated with emerging scientific concepts in this area leading to poor communication, lack of interoperability among systems and duplication of efforts. For nanotechnology to develop to its full potential there is therefore a strong need for a logical classification of nanomaterials.
In response to this need, the International Organization for Standardization (ISO) has published a new technical report, ISO/TR 11360:2010, Nanotechnologies - Methodology for the classification and categorization of nanomaterials, providing a comprehensive, globally harmonised methodology for classifying nanomaterials.
ISO/TR 11360 introduces a system called a "nano-tree", which places nanotechnology concepts into a logical context by indicating relationships among them as a branching out tree. The most basic and common elements are defined as the main trunk of the tree, and nanomaterials are then differentiated in terms of structure, chemical nature and other properties.
The document will be useful to a wide range of scientific and engineering disciplines engaged in research, industry and government.
ISO Catalogue page
The US Environmental Protection Agency (EPA) has published a draft case study of engineered nanoscale silver (nano-Ag) as used in a number of disinfectant sprays for which it invites comments by 27 September 2010.
The case study is organised around a comprehensive environmental assessment (CEA) framework, which combines a product life-cycle perspective with a risk assessment paradigm. The document does not draw conclusions about potential risks. Instead, it is intended to be used as part of a process to identify what is known and unknown about nano-Ag in a selected application and as a starting point to identify and prioritise possible research directions to support future assessments of nanomaterials.
Each chapter includes lists of questions that reflect information gaps in that portion of the document. Some of these knowledge gaps or research needs are specific to the use of nano-Ag in disinfectant sprays; others may relate more broadly to nano-Ag irrespective of its application, while still others may apply more widely to nanomaterials in general. Readers are encouraged to consider the questions listed throughout the document and offer specific comments on how individual questions or research needs might be better expressed.