The Ministry of Ecology, Sustainable Development, and Energy published a report, available only in French, concerning the second round of mandatory reporting of nanomaterials. Under Decree No. 2012-232, companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in an amount of at least 100 grams per year must submit an annual report with substance identity, quantity, and use information. According to the report, 10,417 declarations were submitted by June 1, 2014, compared to 3,409 declarations submitted as of July 1, 2013.
The European Parliament (EP) Committee on Environment, Public Health, and Food Safety (ENVI) has posted a study entitled ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP). The study analyzes the main differences between European Union (EU) and U.S. legislation in eight areas: human medicines and medical devices; cosmetics; food and nutrition; sanitary and phyto-sanitary; nanomaterials; cloning; raw materials and energy; and motor vehicles. According to the study, while nanomaterials are regulated under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation in the EU and the Toxic Substances Control Act (TSCA) in the U.S., “REACH is much more stringent than TSCA.” Under REACH, all chemicals on the EU market must be registered, which includes the submission of safety data. Under TSCA, the submission of safety data is required only in particular cases, and chemicals on the market before 1976 can remain on the market without any testing or registration requirements. In addition, the study states, fewer restrictions on chemicals are imposed in the U.S., “where a large amount of information on chemicals may be kept confidential.” While there are currently no nanomaterial labeling policies in the U.S., several EU regulations require the labeling of nanomaterials contained in specific products, in particular cosmetics and food. According to the study, specific legislation dedicated to nanomaterials is still under development in the EU and U.S. The study states that, in addition to explicit rules for nanomaterials, “a definition of [nanomaterials] should be agreed at international level to enhance the dialogue between stakeholders from different countries or sectors and thus the harmonisation of legislation related to [nanomaterials].”
Australian Pesticides and Veterinary Medicines Authority Hosts Symposium on Nanotechnology Regulation
On October 28, 2014, the Australian Pesticides and Veterinary Medicines Authority (APVMA) held a nanotechnology regulation symposium on developing a regulatory framework for nanotechnologies in Australian agriculture and animal husbandry. The program was based on a draft report entitled Regulatory Considerations for Nanopesticides and Veterinary Nanomedicines. The report addresses relevant aspects of nanotechnology, including definitions, metrology, physicochemical properties, manufacture, and the potential impacts on human health and the environment. The draft report suggests that “a pragmatic approach, based on the durability of formulated product, may be the way forward.” According to the draft report, nanoparticles require a very different approach for fate and effect assessment to that for conventional agricultural and veterinary (AgVet) chemicals. The report recommends a minimum set of characterization criteria for nano-AgVet chemicals. APVMA intends to release a final document by the end of January 2015.
During the Sustainable Nanotechnology Organization’s (SNO) 2014 Conference, held November 2-4, 2014, in Boston, Massachusetts, Lynn L. Bergeson presented the session “Current Developments in Nanotechnology Law and Policy.” SNO, a non-profit, international professional society dedicated to advancing sustainable nanotechnology through education, research, and promotion of responsible development of nanotechnology, intended the conference to bring together scientific experts from academia, industry, and government agencies to present and discuss current research findings on the subject of nanotechnology and sustainability. The conference emphasized not only the environmental aspects of sustainability, but also the societal and economic sustainability issues. The conference program addressed the critical aspects of sustainable nanotechnology, such as life cycle assessment, green synthesis, green energy, industrial partnerships, environmental and biological fate, and the overall sustainability of engineered nanomaterials. SNO, together with Sustainable Nanotechnologies (SUN) and GUIDENANO, two large European Union FP7 nanosafety projects, will hold the SUN-SNO-GUIDENANO Sustainable Nanotechnology Conference 2015 on March 9-11, 2015, in Venice, Italy. The conference program will address the critical aspects of sustainable nanotechnology such as life cycle thinking; environmental release and fate of engineered nanomaterials (ENM); environmental, occupational, and consumer exposure to ENMs; environmental and human health impacts of ENMs; safe production, handling, and disposal of ENMs; regulatory and industrial decision support for sustainable nanotechnology; nanotechnology applications for sustainability; societal implications of nanotechnology; and curriculum and training for sustainable nanotechnology.
The International Agency for Research on Cancer (IARC) Working Group met on September 30-October 7, 2014, to review the carcinogenicity of fluoro-edenite, silicon carbide (SiC) fibers and whiskers, and carbon nanotubes (CNT). A summary of the evaluations has now been published in The Lancet Oncology. The summary states:
Fluoro-edenite fibrous amphibole was classified as carcinogenic to humans (Group 1) on the basis of sufficient evidence in humans that exposure to fluoro-edenite causes mesothelioma. Sufficient evidence of carcinogenicity was also reported in experimental animals, with increased incidences of mesotheliomas observed in one study in male and female rats given fibrous fluoro-edenite by intraperitoneal or intrapleural injection. The results of the few available mechanistic studies were consistent with proposed mechanisms of fibre carcinogenicity.
According to the summary, SiC particles are manufactured mainly by the Acheson process, with SiC fibers being unwanted byproducts. The summary states:
Occupational exposures associated with the Acheson process were classified as carcinogenic to humans (Group 1) on the basis of sufficient evidence in humans that they cause lung cancer. Since the correlation between exposures to SiC fibres and cristobalite made it difficult to disentangle their independent effects, the Working Group concluded that fibrous SiC is possibly carcinogenic to humans (Group 2B) based on limited evidence in humans that it causes lung cancer. No data on cancer in humans exposed to SiC whiskers were available. In experimental animals, there was sufficient evidence for the carcinogenicity of SiC whiskers, with mesotheliomas observed in three studies in female rats treated by intrapleural implantation, intrapleural injection, or intraperitoneal injection, and in one inhalation study in rats that did not include concurrent controls. Although not unanimous, the Working Group classified SiC whiskers as probably carcinogenic to humans (Group 2A) rather than possibly carcinogenic to humans (Group 2B), on the basis that the physical properties of the whiskers resemble those of asbestos and erionite fibres, which are known carcinogens. In addition, the results of available mechanistic studies were consistent with proposed mechanisms of fibre carcinogenicity. The majority of the Working Group considered that differences in the nature of SiC fibres and SiC whiskers warranted separate evaluations.
The Working Group reviewed single-walled CNTs (SWCNT) and multi-walled CNTs (MWCNT). The summary states that no human cancer data were available, “indicating inadequate evidence for the carcinogenicity of CNTs in humans.” The Working Group reviewed studies in rodents and in cultured human lung or mesothelial cells. The summary states:
As a whole, the Working Group acknowledged that the above mechanisms are all relevant to humans. However, a majority did not consider the mechanistic evidence for carcinogenicity -- especially concerning chronic endpoints -- to be strong for any specific CNT. Furthermore, the lack of coherent evidence across the various distinct CNTs precluded generalisation to other types of CNTs. Thus, MWCNT-7 was classified as possibly carcinogenic to humans (Group 2B); and SWCNTs and MWCNTs excluding MWCNT-7 were categorised as not classifiable as to their carcinogenicity to humans (Group 3).
The Center for Research on Ingredient Safety (CRIS), which was established at Michigan State University (MSU) in partnership with the Grocery Manufacturers Association in April 2014, will hold its first open house on November 20-21, 2014. Members and prospective members will have the opportunity to meet MSU President Lou Anna K. Simon, hear presentations, and participate in round table discussions. CRIS will be modeled after already existing centers of expertise at other academic institutions, which focus on allergen and microbiological safety. As an independent, academic, science-based center, CRIS will serve as a reliable and unbiased source for information, research, training, and analysis on the safe use of chemical ingredients in consumer packaged goods, including foods, beverages, cosmetics, and household consumer products. Founding members of CRIS include Cargill, Kellogg’s, Unilever, ConAgra Foods, Campbell’s, McCormick, General Mills, Hormel Foods, PepsiCo, Hershey’s, Coca-Cola, EcoLab, Bumble Bee Foods, LLC, Mondelēz International, Kraft Foods, and Bush’s Best. Registration for the open house will close November 14, 2014.
On October 27, 2014, the U.S. Environmental Protection Agency (EPA) promulgated significant new use rules (SNUR) for 52 chemical substances, including “functionalized carbon nanotubes (generic).” According to the Federal Register notice, the premanufacture notice (PMN) states that the substance will be used as a thin film for electronic device applications. The notice states that, as described in the PMN, EPA “does not expect significant occupational exposures due to the use of impervious gloves, where there is potential for dermal exposure, and because the PMN is used in liquid form and is not spray applied.” In addition, EPA does not expect environmental releases during the use identified in the PMN submission. EPA states that it has determined, however, “that any use of the substance without the use of impervious gloves, where there is a potential for dermal exposure; manufacturing the PMN substance for use other than as a thin film for electronic device applications; manufacturing, processing, or using the PMN substance in a form other than a liquid; use of the PMN substance involving an application method that generates a mist, vapor, or aerosol; or any release of the PMN substance into surface waters may cause serious health effects or significant adverse environmental effects.” The rule is effective on December 26, 2014. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, must be received by November 26, 2014.
The Belgian Royal Decree Regarding the Placement on the Market of Substances Manufactured at the Nanoscale, a Report to the King, and the Opinion of the Council of State were published in the September 24, 2014, issue of the Official Gazette. Substances defined as nanomaterials, and mixtures containing them, must be registered by the Belgian Federal Public Service for Health, Food Chain Safety and the Environment if at least 100 grams of the substance or mixture is placed on the market during the year covered by the registration, and if the entity putting the substance on the market produced this substance or mixture, or puts it on the market for professional users only. Biocidal products, medicines, food and feed, food contact materials, and pigments are excluded from the scope of the Royal Decree. Nanomaterials subject to declaration requirements must be registered by January 1, 2016, if they are already on the market by this date. After January 1, 2016, all nanomaterials concerned must be registered before being placed on the market. Mixtures subject to declaration requirements must be registered by January 1, 2017, if they are already on the market by this date. After January 1, 2017, all mixtures concerned must be registered before being placed on the market.
On October 10, 2014, the Office of Science and Technology Policy (OSTP) announced that the President’s Council of Advisors on Science and Technology (PCAST) released the Report to the President and Congress on the Fifth Assessment of the National Nanotechnology Initiative, which concludes that the nanotechnology community is at an important turning point. PCAST recommends that the federal government accelerate its activities aimed at facilitating the commercialization of federally sponsored research, “thereby enabling the Nation to reap the benefits of this investment.” To help focus the commercialization process, PCAST calls for the nanotechnology community to take on a series of national nanotechnology Grand Challenges. Specific nanotechnology Grand Challenges would provide a way to turn scientific advances into products that leverage existing opportunities and meaningfully address existing needs. In the report, PCAST recommends that the federal government establish and execute a process for engaging the nanotechnology community to identify specific Grand Challenges that best support these goals. PCAST also provides some specific recommendations regarding the formulation of the Grand Challenges and innovation prizes and public-private partnerships to support them, as well as a focus on manufacturing challenges. Finally, the report details several program management updates to leadership initiatives, advisory input, evaluation metrics, and other areas to ensure the continuing success of the National Nanotechnology Initiative.
After submitting a proposed rule concerning nanoscale materials to the Office of Management and Budget (OMB) on October 6, 2014, the U.S. Environmental Protection Agency’s (EPA) Spring 2014 Regulatory Agenda item concerning nanoscale materials has been revised. The Regulatory Agenda item posted online in May 2014 referred to the development of a significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) that would require persons who intend to manufacture, import, or process these chemical substances for an activity that is designated as a significant new use by the proposed rule to notify EPA at least 90 days before commencing that activity. The Regulatory Agenda item now includes no reference to the SNUR, but describes only a proposal to require reporting and recordkeeping under TSCA Section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data.