Congressional Research Service (CRS)
The Congressional Research Service (CRS) published an April 13, 2012, document entitled Nanotechnology: A Policy Primer that provides an overview of federal research and development (R&D) in nanotechnology, U.S. competitiveness, environmental, health, and safety (EHS) concerns, nanomanufacturing, and public understanding of and attitudes toward nanotechnology. CRS states that, since the launch of the National Nanotechnology Initiative (NNI) in 2000 through fiscal year (FY) 2012, Congress has appropriated approximately $15.6 billion for nanotechnology R&D, including approximately $1.7 billion in FY 2012. President Obama has requested $1.8 billion in NNI funding for FY 2013. More than 60 nations have established similar programs, and, according to CRS, in 2010, the total global public R&D investments were approximately $8.2 billion, complemented by an estimated private sector investment of $9.6 billion. Based on the data on inputs (e.g., R&D expenditures) and non-financial outputs (e.g., scientific papers, patents), the U.S. appears to be the overall global leader in nanotechnology, though CRS cautions that some believe the U.S. lead "may not be as large as it was for previous emerging technologies." According to CRS, some research has raised concerns about the safety of nanoscale materials, and "[t]here is general agreement that more information on EHS implications is needed to protect the public and the environment; to assess and manage risks; and to create a regulatory environment that fosters prudent investment in nanotechnology-related innovation." The CRS report is available online.
Environmental Protection Agency (EPA)
The U.S. Environmental Protection Agency (EPA) announced on July 2, 2012, the availability of an external review draft document entitled Nanomaterial Case Study: A Comparison of Multiwalled Carbon Nanotube and Decabromodiphenyl Ether Flame-Retardant Coatings Applied to Upholstery Textiles (EPA/600/R-12/043A). EPA states that the draft document “does not draw conclusions regarding potential environmental risks or hazards of multiwalled carbon nanotubes (MWCNT); rather, it aims to identify what is known and unknown about MWCNT to support future assessment efforts.” On October 29, 2012, EPA will hold a public information exchange meeting to: (1) receive comments and questions on the draft document; and (2) provide information on the draft EPA nanomaterial case study and the workshop process that the draft document will be used in for identifying and prioritizing research gaps that could support future assessment and risk management efforts for MWCNT. Following the conclusion of the October 29 meeting, RTI International, an EPA contractor, will conduct a separate meeting on the “Nanomaterial Case Study Workshop Process: Identifying and Prioritizing Research for Multiwalled Carbon Nanotubes”' in the same location. EPA states that the workshop will be conducted independently by RTI International, with a set of invitee-only expert participants selected by RTI International, and will use a “structured decision science process” similar to the process used in previous workshops on nanoscale titanium dioxide in water treatment and in topical sunscreen and nanoscale silver in disinfectant spray. The RTI workshop will be open to public observers. Written comments on the draft document are due August 31, 2012. Registration for the public information exchange meeting will close on October 15, 2012. Space is limited, and reservations will be accepted on a first-come, first-served basis.
National Instutue for Occupational Safety and Health (NIOSH)
NIOSH Releases Guidance On General Safe Practices For Working With Engineered Nanomaterials In Research Laboratories: NIOSH has posted a document entitled General Safe Practices for Working with Engineered Nanomaterials in Research Laboratories, which contains recommendations on engineering controls and safe practices for handling engineered nanomaterials in laboratories and some pilot scale operations. According to NIOSH, it designed the guidance "to be used in tandem with well-established practices and the laboratory's chemical hygiene plan." The guidance notes that experimental animal studies indicate that potentially adverse health effects may result from exposure to nanomaterials, and that the routes of exposure include inhalation, dermal exposure, and ingestion. The guidance concludes that "[t]he full range of occupational hygiene controls will be necessary to limit exposures to nanomaterials as a means to prevent adverse health outcomes in the research community. Engineering and administrative controls can eliminate or minimize the amount of nanomaterials that will be present in workplace air or settled on surfaces. Personal protective equipment can be used where other types of controls are not available or practical." The guidance is available online.
National Nanotechnology Initiative (NNI)
President's Council of Advisors on Science and Technology (PCAST) Releases Fourth Assessment of the National Nanotechnology Initiative.
NNI Agencies Announce New Nanotechnology Signature Initiative: On May 14, 2012, the agencies participating in the NNI announced the fourth Nanotechnology Signature Initiative, "Nanotechnology Knowledge Infrastructure: Enabling National Leadership in Sustainable Design" (NKI). According to a press release issued by the National Nanotechnology Coordination Office (NNCO), this signature initiative will stimulate the development of models, simulation tools, and databases to enable the prediction of specific properties and characteristics of nanoscale materials. This will then accelerate commercialization of nanotechnology innovations that maximize benefits to humans and the environment while minimizing risks.
Organization for Economic Cooperation and Development (OECD)
The Organization for Economic Cooperation and Development (OECD) recently published a new document in its series on the safety of manufactured nanomaterials, Important Issues on Risk Assessment of Manufactured Nanomaterials. The document was prepared by Steering Group Six of the Working Party on Manufactured Nanomaterials (WPMN), which is leading the project on cooperation on risk assessment, and was endorsed at the ninth meeting of the WPMN in December 2011. The document provides the current practices, challenges, and strategies for assessing risk in circumstances where data are limited, and there is a necessity for more research on specific risk assessment issues. OECD cautions that it is not to be construed to imply scientific and/or policy endorsement of any specific risk assessment methods or models, however. OECD notes that "this document is a living document," and was current at the time of WPMN's ninth meeting in December 2011. The document is subject to amendment and refinement as research affords further understanding of how to assess and manage nanomaterials. The document is available online.
Senate Science and Space Subcommittee Holds Hearing on National Nanotechnology Investment
American Chamber of Commerce to the European Union (AmCham EU) position statement on nanomaterials
Australia Announces New Guidance on the Safe Handling and Use of Carbon Nanotubes.
On March 5, 2012, Safe Work Australia announced the release of an information sheet on the safe handling and use of carbon nanotubes in the workplace and a document entitled Safe Handling and Use of Carbon Nanotubes. The information sheet provides an overview of risk management for carbon nanotubes, while Safe Handling and Use of Carbon Nanotubes describes two approaches to managing the risks: risk management with detailed hazard analysis and exposure assessment, and risk management by using control banding. Either or both of these methods may be used, depending on the circumstances. Safe Work Australia states that the guidance is applicable to other forms of carbon nanofibers, such as carbon nanorods and carbon nanowires. It is also applicable to products containing carbon nanotubes and other forms of carbon nanofibers where these nanomaterials may be released during handling. Safe Work Australia has commissioned a human health hazard assessment and classification of carbon nanotubes, and it expects to publish the findings in mid-2012.
Council of the European Union
EU Biocides Regulation Addresses Nanomaterials: On May 10, 2012, the Council of the European Union (EU) announced the adoption of a regulation concerning the placing on the market and use of biocidal products, which include insecticides, disinfectants, and repellents, but not medicines or agricultural pesticides. The regulation will take effect September 1, 2013, with a transitional period for certain provisions. The regulation incorporates the European Commission's (EC) recommendation on the definition of a nanomaterial, and requires that, where nanomaterials are used in a product, the risk to the environment and to health be assessed separately. Labels would be required to include the name of all nanomaterials contained in biocidal products, followed by the word "nano" in brackets. The regulation states that "approval of an active substance shall not cover nanomaterials except where explicitly mentioned." More information is available online.
European Chemicals Agency (ECHA)
ECHA Forwards Draft Guidance Concerning Nanomaterials to CARACAL. ECHA sent three new draft appendices to Chapters R.8, R.10, and R.14 of the guidance on information requirements and chemical safety assessment concerning recommendations for nanomaterials to the Competent Authorities for Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) (CARACAL). The draft appendices are based on the results of the REACH Implementation Project on Nanomaterials (RIPoN).
Community Rolling Action Plan (CoRAP) notes nano concerns for two substances. The first CoRAP, which includes 90 substances that Member States will evaluate under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) substance evaluation process. For each substance, ECHA notes the initial grounds for concern. For two substances, silicon dioxide and silver, the initial grounds for concern are “Substance characterization/Nanoparticles, toxicity of different forms of the substance.” Silicon dioxide is scheduled to be evaluated in 2012, by the Netherlands, and silver is scheduled to be evaluated in 2013, also by the Netherlands. ECHA notes that, when the substances are included in the CoRAP, “they have yet not been evaluated and thus the concern is indicative and not exhaustive or conclusive.”
ECHA Announces Updated Guidance For Registering Nanomaterials. On April 30, 2012, the European Chemicals Agency (ECHA) announced the availability of three appendices, updating Chapters R.7a, R.7b, and R.7c of the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA). ECHA prepared a draft revision of the Guidance, based on the outcome of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Projects on Nanomaterials (RIP-oN) 2 final report. ECHA updated the Guidance via a fast-track procedure, and states that this was justified on the basis that the final RIP-oN 2 report had already been the subject of consultation with relevant stakeholders. Its content could, therefore, be considered as reflecting a consensus. Furthermore, according to ECHA, the update "needed to be made urgently in order to allow publication of the guidance as soon as possible and well in advance of the next REACH registration deadline," May 30, 2013. The updated Guidance provides tailored advice to prepare registrations for substances in the nanoform. More information is available online.
ECHA Will Create Working Group On Nanomaterials: ECHA recently held a two-day workshop concerning its first experiences with nanomaterials under REACH, with an emphasis on the evaluation process. ECHA, Member State Competent Authorities (MSCA), accredited stakeholders, and the EC discussed how nanomaterials in general have been characterized in registration dossiers. Currently, according to ECHA, the scope of the registration (i.e., whether and how many nano-forms are included) is often unclear and the level of nano-specific information provided (e.g., substance characterization, hazards, exposure, and risks) shows "significant room for improvement." ECHA agreed with MSCA representatives on a common approach to addressing the current information requirements in nanomaterial dossiers, taking into account the scientific uncertainties and legislative framework provided by REACH. ECHA states that it will implement the EC's recommendation on the definition of a nanomaterial as a benchmark in assessing substances, and "invites registrants to proactively characterise their substances in light of this definition." Workshop participants discussed creating a working group on nanomaterials that would provide advice on scientific and technical principles related to nanomaterials under REACH. The working group on nanomaterials would act independently, but report to the relevant ECHA committees. According to ECHA, the mandate of this working group will be further consolidated with the MSCAs. In addition, ECHA intends to disseminate the best practices that it has collected from relevant stakeholders that registered nanomaterials and that were discussed in the first "Group Assessing Already Registered Nanomaterials" meeting prior to the workshop. ECHA intends to post the best practices on its website by this summer. More information is available online.
European Agency for Safety and Health at Work (EU OSHA)
The European Agency for Safety and Health at Work (EU OSHA) posted a notice on April 16, 2012, concerning a French report on the feasibility of an epidemiological surveillance system for workers exposed to engineered nanomaterials. EU OSHA notes that the French Health and Occupational Ministries asked the French Institute for Public Health Surveillance (InVS), supported by a multidisciplinary working group convened by the Institute for Public Health Research, to assess the feasibility of an epidemiological surveillance system of workers likely to be exposed to engineered nanomaterials. The resulting report "draws up an inventory of the numerous uncertainties inherent to this field such as the question of definition, the wide range of nanomaterials, the identification of health events that could be monitored, the registration and collaboration of companies and workers likely to be concerned by nanomaterials and the metrological issues." According to EU OSHA, InVS suggests the implementation of a double surveillance system with a prospective cohort study and repeated cross-sectional studies. The repeated cross-sectional studies would include all kinds of nanomaterials, while the cohort study would focus on a few. In conclusion, EU OHSA states, the report gives some recommendations for epidemiological research. The EU OSHA item is available online. While the French report is dated 2011, an English summary is dated 2012. The English summary is available online.
International Cooperation on Cosmetic Regulation (ICCR) initiative Report of the ICCR Joint Ad Hoc Working Group on Nanotechnology in Cosmetic Products: Criteria and Methods of Detection.
On July 3, 2012, the National Institute of Public Health and the Environment (RIVM) of the Netherlands published a report entitled “Interpretation and implications of the European Commission Recommendation on the definition of nanomaterial.” The report examines the European Commission’s (EC) recommended definition of “nanomaterial.” The report suggests the EC recommended definition is a good basis for use in regulations, however, additional work addressing the size range (1-100 nm) and the requirement that at least 50 percent of the particles be in this range is needed before the definition is incorporated into legislation. The complete report can be downloaded online.
Health Council Of The Netherlands Proposes Registry For Worker Exposure To Engineered Nanoparticles: The Health Council of the Netherlands announced on May 22, 2012, the availability of a draft report proposing the implementation of an exposure registry and a system of health monitoring when working with engineered nanoparticles. The draft report states that, due to the concerns and lack of knowledge, the Health Council "considers it prudent" to create an exposure registry. The Health Council recommends that the exposure registry be created for "insoluble and poorly in water soluble nanoparticles in any composition or physical structure, including nanoparticles that are present in solid materials." The draft report acknowledges that, if solid materials are in good condition, "scarcely any nanoparticles will be released, but due to wear and tear and handling, such as drilling and sanding, it cannot be excluded that such particles can be released with all the associated risks." The draft report concludes that, "[f]rom the point of view of health, it is best to also register the solid materials." Data submitted to the registry would need to include chemical and physical properties, determinants of emission and exposure, and exposure concentrations. Regarding medical surveillance, the draft report concludes that implementation of a passive system is the best option. While a passive system would not provide answers quickly on whether health risks exist when working with nanoparticles, and if so, which type of health effects, when combined with other activities, such as targeted scientific research, it "may give a valuable contribution in the future to providing insight in the potential health risks due to exposure to nanoparticles." Comments on the draft report, which was presented to experts of employer's organizations and trade unions, are due August 10, 2012. According to the Health Council, it will consider comments when preparing the final report, which will be presented to the State Secretary of Social Affairs and Employment. More information is available online.