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.
On October 6, 2014, the U.S. Environmental Protection Agency (EPA) submitted a proposed rule to the Office of Management and Budget (OMB) entitled “Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements.” The Regulatory Agenda item linked to the proposed rule states that EPA is developing 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. In addition, EPA is developing 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. A previous proposed rule had been under OMB review since November 22, 2010. Neither proposed rule has been publicly released.
EC Scientific Committee Clarifies Meaning of "Sprayable Applications/Products" for Certain Nanomaterials
On September 30, 2014, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted a clarification on the meaning of the term “sprayable applications/products” for certain nanomaterials. According to the clarification, the EC Member States asked SCCS to clarify the meaning of the term “sprayable applications/products” in the conclusions of its safety assessments for carbon black CI 77266, titanium oxide, and zinc oxide. The clarification states:
Generally speaking, the term spray is broad and includes:
a) aerosols dispenser, for which there is the definition contained in Directive 75/324: “non-reusable containers made of metal, glass or plastic and containing a gas compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state”;
b) spray bottles containing a pump that draws a liquid up from the bottom and forces it through a nozzle generating a stream or a mist.
According to the clarification, many cosmetic products are dispensed through a mechanical pump that, instead of aerosol/nebulization, produces a single dose of cream. The SCCS acknowledges a need to clarify whether “sprayable applications/products” would also include these pump dispensers for creams. In addition, the SCCS states that, for clarity of the next scientific opinions, it could adopt a harmonized terminology with the term “spray” meaning the production of aerosols and/or nebulization, and “pump dispensers” meaning the dispensing devices for single-dose cream.
The European Commission’s (EC) Joint Research Center (JRC) has published a report entitled Towards a review of the EC Recommendation for a definition of the term “nanomaterial” -- Part 2: Assessment of collected information concerning the experience with the definition. In the report, JRC assesses information collected between August 2013 and April 2014 from scientists, research institutes, regulatory bodies, non-governmental organizations, and industry regarding implementation of the EC recommendation on the definition of nanomaterial. The report builds on the first report of the series, entitled Towards a review of the EC Recommendation for a definition of the term “nanomaterial” -- Part 1: Compilation of information concerning the experience with the definition. The report states: “Based on the feedback received regarding the current definition, compiled in the first report of the series, and its assessment, presented in this second report, the JRC is now working on a set of indications on how the definition could be modified to improve its clarity, effectiveness and implementability. These recommendations will be included in a final report (Part 3 of the series), which is expected to be released later in 2014.”
Earlier this week, Dr. John Howard, Director of the National Institute for Occupational Safety and Health (NIOSH) announced that, effective October 6, 2014, Chuck Geraci, Ph.D., CIH, has been appointed NIOSH Associate Director for Nanotechnology. NIOSH states: “As Associate Director for Nanotechnology, Dr. Geraci will ensure that NIOSH maintains its outstanding national and international reputation for scientific achievement in the emerging area of nanotechnology implications for workers. He will also develop initial strategies for NIOSH to participate scientifically in the growing areas of advanced nano-manufacturing technology, advanced nanomaterial science, and in the new challenges arising from the rapid trend of converging technologies.” Dr. Geraci first worked for NIOSH from 1975 through 1987, leaving to work in the private sector. He returned to NIOSH in 2004 from the Procter and Gamble Company and served as the Chief of the Education and Information Division (EID) Document Development Branch until he assumed his current job of Nanotechnology Research Center (NTRC) Coordinator. As Chief of the EID Document Development Branch, he was instrumental in launching several key initiatives such as Prevention-though-Design, Skin Hazard Notations, and the Immediately Dangerous to Life or Health (IDLH) derivation. Over the past three years, Dr. Geraci has represented NIOSH on two key committees with the U.S. National Nanotechnology Initiative (NNI) -- the U.S. Subcommittee on Nanoscale Science, Engineering, and Technology (NSET) and the Nanotechnology Environmental and Health Implications (NEHI) Working Group. He was instrumental in having NIOSH contributions to worker safety and health included in both the U.S. NNI Strategic Plan and the NEHI Environmental, Health, and Safety (EHS) Research Strategy. In addition to his work with the NNI, Dr. Geraci has been very successful in developing many partnerships with private companies involved in the development of nanomaterial processes and products, and extending these partnerships across NIOSH.Continue Reading...
EPA Requests Comments on Nanomaterials Manufacturing and Formulating for Effluent Guidelines Program Plan
On September 16, 2014, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing the availability of the combined Final 2012 and Preliminary 2014 Effluent Guidelines Program Plans and EPA’s 2012 and 2013 Annual Effluent Guidelines Review Reports. EPA requests comments on its Preliminary 2014 Plan, including the data and information used to support the findings, actions, and conclusions as stated in the Preliminary 2014 Plan. EPA seeks public comment and stakeholder input, data, and information on several topics, including nanomaterials manufacturing and formulating. The notice states:
EPA is collecting data and information on the potential industrial wastewater discharge hazards associated with nanomaterials manufacturing and formulating. EPA requests public comment and stakeholder input relating to any information or data available on the wastewater hazards and discharges associated with the manufacture of nanomaterials and their use in manufacturing or formulating products, as well as any other information believed to be relevant.
Comments are due November 17, 2014.
OECD Issues Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials 2010-2011
On September 16, 2014, the Organization for Economic Cooperation and Development (OECD) published a document entitled Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials 2010-2011. The Report summarizes responses to the Working Party on Manufactured Nanomaterials (WPMN) Questionnaire on Regulated Nanomaterials: 2010-2011, which was issued July 12, 2012. The Questionnaire contained four sections related to the oversight of nanomaterials in various OECD jurisdictions: regulatory updates; definitions and/or legal approaches for nanomaterials by jurisdiction; regulatory challenges; and opportunities for collaboration. Australia, Canada, Denmark, the European Union, France, Germany, Italy, Netherlands, and the U.S. submitted fourteen responses for legislation covering chemical substances and/or products, including industrial chemicals, therapeutics, foods and drugs, and biocides, as well as occupational health and safety, consumer products, packaging, and labeling. Respondents agreed on using existing regulatory frameworks to regulate nanomaterials, although some jurisdictions, such as France, have developed reporting regimes specific to nanomaterials to gather information on uses and quantities. According to the responses, developing regulatory definitions “still seems to be a fairly challenging issue for regulatory bodies; however, regulatory definitions have been developed and now are being used by some jurisdictions.” The definitions tend to consider a 1-100 nanometer (nm) size range, unique properties when outside of 1-100 nm, both internal and external structure, and have addressed ways to differentiate between materials that are engineered nanomaterials and traditional chemicals that have nanoscale components by using percentage cut-offs.
In August 2014, the Danish Environmental Protection Agency published the Guideline for the Danish Inventory of Nanoproducts, which is intended to explain how manufacturers and importers of products for consumers should use the new Inventory. The Guideline describes who has a duty to report; which products must be reported; and how to collect information and perform the actual reporting to the Inventory. The Guideline uses questions to determine whether a product must be reported, including the following:
2. Is your product covered by other regulations?
If you are a manufacturer or importer of only one or more of the following products (mixtures or articles), you are not obliged to report these (see section 3), and you do not have to do anything further:
2.1. Foodstuffs and food contact materials
2.2. Animal feed
2.3. Medicinal products
2.4. Medical devices
For manufacturers and importers that are not exempt, the Guideline includes a flow chart to help determine whether their products are nanoproducts that need to be reported to the Inventory. Manufacturers and importers of products for consumers that must be reported must report by August 30, 2015, for the period beginning June 20, 2014, and ending June 20, 2015.
The National Nanotechnology Coordination Office (NNCO) announced in the September 8, 2014, Federal Register that it will hold a technical interchange meeting entitled “Realizing the Promise of Carbon Nanotubes -- Challenges, Opportunities and the Pathway to Commercialization” on September 15, 2014. The meeting is sponsored by the National Nanotechnology Initiative (NNI) and co-sponsored by the National Aeronautics and Space Administration (NASA). According to the notice, the objectives of the meeting are to identify, discuss, and report the technical barriers preventing the production of carbon nanotube-based materials with electrical and mechanical properties approaching theoretical values, and to explore ways to overcome these barriers. The notice states that the meeting “will assemble some of the Nation’s leading experts in carbon nanotube research and development, as well as executives and experts from the Federal government, academia, and private sector.” The meeting will be held at NASA Headquarters, in Washington, D.C. Registration opens September 8, 2014, and pre-registration is required. Written comments are due September 10, 2014.
EC Publishes Responses to Public Consultation on Transparency Measures for Nanomaterials on the Market
The European Commission (EC) has posted responses received to its public consultation on transparency measures for nanomaterials on the market. The EC states that it received 202 responses -- 100 respondents submitted the questionnaire for industry stakeholders, and 102 respondents submitted the questionnaire for other stakeholders. Fourteen respondents requested that their contributions would not be published. All other contributions are available on the EC’s website. The EC notes that some contributions are published in anonymous form upon request. The EC will publish a full summary and analysis of the public consultations “in due course.”
On September 2, 2014, the U.S. Environmental Protection Agency (EPA) promulgated final significant new use rules (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 36 chemical substances that were the subject of premanufacture notices (PMN). The substances include multi-walled carbon nanotube (generic) (P-08-0392), multi-wall carbon nanotubes (generic) (P-09-257), multi-walled carbon nanofibers (generic) (PMNs P-10-115, P-10-116, P-10-117, P-10-118, P-10-119, P-10-120, P-10-121, P-10-122, P-10-123, P-10-124, P-10-125, and P-10-126), and carbide derived nanocarbon (generic) (PMN P-11-290). Persons who intend to manufacture or process any of these 36 chemical substances for an activity that is designated as a significant new use must notify EPA at least 90 days before commencing that activity. The final SNURs take effect November 3, 2014.Continue Reading...
Australian Pesticides and Veterinary Medicines Authority Will Hold Nanotechnology Regulation Symposium
The Australian Pesticides and Veterinary Medicines Authority (APVMA) will host a nanotechnology regulation symposium on October 28, 2014. APVMA states that it “has worked over many years to progressively develop a regulatory framework for nanoscale agvet chemicals and chemical products.” APVMA intends the symposium to provide industry and regulators with an opportunity for dialogue on the future regulation of nanopesticides and veterinary nanomedicines. Key topics covered will include the benefits and potential risks; definitions, metrology, properties, and manufacturing; and human health and environmental considerations. APVMA intends to publish a draft nanotechnology report in late September 2014, which will provide a basis for discussion at the symposium. According to APVMA, it will encourage participants to comment on the report, “thereby contributing to a better regulatory framework for nanomaterials.” Registration for the symposium is now open.
Fifteen European industry associations, including the Nanotechnology Industries Association (NIA) and the European Chemical Industry Council (CEFIC), have endorsed a brochure entitled “Europe needs safe and innovative nanotechnologies and nanomaterials.” According to the brochure, the associations “support the European Commission conclusion that the current European regulatory framework adequately covers nanomaterials, is science-based and proportionate.” The brochure highlights seven key points:
- Nanotechnologies provide solutions;
- Europe needs nanotechnologies to achieve the goals of the EU 2020 strategy;
- Safety is paramount;
- Openness and transparency are vital;
- The comprehensive European regulatory framework in place has the capacity to govern the production and use of nanomaterials;
- A common workable definition system for defining nanomaterials is welcome; and
- Europe cannot afford to miss out on the opportunities provided by nanotechnologies and the benefits they bring.
On July 24, 2014, the Organization for Economic Cooperation and Development (OECD) posted a report entitled Nanotechnology and Tyres: Greening Industry and Transport, which provides a risk management framework to enable site-specific or company-specific risk assessments or risk management strategies for using nanomaterials as additives in tires. OECD states that the report emphasizes the importance of:
- The policies to support research in the environmental, health, and safety risks, as well as those to support the commercialization of nanotechnology research results, for fostering responsible innovation in the tire sector;
- Using available tools to gain better insight into the socio-economic and environmental impacts of nanotechnology applications; and
- Collaboration between governments and industry to address the specific challenges raised by the introduction of new nanomaterials in different industry sectors.
The report summarizes the conclusions of a two-year project, which was originally proposed and supported by the Business and Industry Advisor Committee to the OECD through the Tyre Industry Project of the World Business Council for Sustainable Development.
On July 31, 2014, the National Nanotechnology Coordination Office (NNCO) will hold a public webinar to provide a forum to answer questions related to the federal government’s “Progress Review on the Coordinated Implementation of the National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy.” According to the July 22, 2014, Federal Register notice, discussion will focus on the research activities undertaken by the National Nanotechnology Initiative (NNI) agencies to advance the current state of the science as highlighted in the Progress Review. Representative research activities as provided in the Progress Review will be discussed in the context of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy’s six core research areas: nanomaterial measurement infrastructure; human exposure assessment; human health; the environment; risk assessment and risk management methods; and informatics and modeling. Questions on the Progress Review document may be submitted beginning July 24, 2014, through the close of the webinar. During the question-and-answer segment of the webinar, submitted questions will be considered in the order received.
EC and SCENIHR Begin Public Consultation on Preliminary Opinion on Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices
The European Commission (EC) and the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) have begun a public consultation on the preliminary opinion concerning “Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices.” The aim of the opinion is to address the use of nanomaterials in medical devices and to provide information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of nanomaterials. Guidance is provided on physico-chemical characterization of nanomaterials, the determination of hazards associated with the use of nanomaterials, and risk assessment for the use of nanomaterials in medical devices. The safety evaluation of nanomaterials used in medical devices is discussed in the context of the general framework for biological evaluation of medical devices as described in the International Organization for Standardization (ISO) 10993-30 1:2009 standard. Therefore, the risk assessment is performed taking into consideration type of device, type of tissue contact, and the duration of contact, thus identifying the specific exposure scenario. The Guidance is intended to provide information to help with safety evaluation and risk assessment of the use of nanomaterials in medical devices that should be considered in conjunction with the ISO 10993-1:2009 standard. The Guidance highlights the need for special considerations in relation to the safety evaluation of nanomaterials in view of the possible distinct properties, interactions, and/or effects that may differ from conventional forms of the same materials. For the risk evaluation of the use of nanomaterials in medical devices, a phased approach is recommended based on potential release and characteristics of the nanomaterials. SCENIHR is seeking comments on the risk assessment related to the Guidance. Comments are due October 3, 2014.
The European Commission (EC) has posted materials from its June 30, 2014, validation workshop to discuss the preliminary results of the study supporting the impact assessment on transparency measures for nanomaterials. The EC is conducting a study to evaluate existing notification systems for nanomaterials and to collect data in support of the assessment of different policy options. The EC discussed the preliminary results with stakeholders at the validation workshop and invited their input on the study and the related impact assessment. The validation workshop materials include:
- Introduction to the European Union (EU) legislative framework for nanomaterials and the study on transparency measures for nanomaterials;
- Evaluation of existing nanomaterial notification systems;
- Hazards and risks of nanomaterials and potential benefits of transparency measures;
- Nanomaterials markets (value chain characterization, growth, and innovation) and potential impacts of the transparency measures; and
- Outlook to the assessment of policy options.
The Summer 2014 issue of Canada’s Chemicals Management Plan Progress Report includes an item concerning nanomaterials. According to the article entitled “Canada Working on Nanomaterials at Home and Abroad,” Canada has endorsed a recommendation from the Organization for Economic Cooperation and Development (OECD) that its Member Countries apply existing regulatory frameworks to manage risks associated with manufactured nanomaterials. The article also states that the Canada-U.S. Regulatory Cooperation Council (RCC) Nanotechnology Initiative is complete and that the final reports will be published this summer. According to the article, the reports will include recommendations on how Canada and the U.S. can align their nanomaterial regulatory work, including the application of consistent risk assessment approaches and methodologies and identifying categories of nanomaterials.
On July 8, 2014, the U.S. Environmental Protection Agency (EPA) promulgated significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that were the subject of premanufacture notices (PMN). The rule includes two PMN substances, P-10-5 and P-11-339, that were the subject of TSCA Section 5(e) consent orders and whose reported chemical names include the term “carbon nanotube” (CNT) or “CNT.” EPA states that, because of a lack of established nomenclature for CNTs, the TSCA Inventory names for CNTs are currently in generic form, e.g., CNT, multi-walled carbon nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-walled carbon nanotube (SWCNT).
PMN Number P-10-5
Chemical Name: Single-walled carbon nanotubes (generic)
CAS Number: Claimed confidential
The PMN states that the uses of the substance will be as a component for a conductive coating using the PMN substance in a dispersion or ink, and as an additive in resins/thermoplastics/elastomers for mechanical reinforcement. The consent order requires:
- Use of personal protective equipment (PPE);
- Use of the substance only as a component for a conductive coating using the PMN substance in a dispersion or ink or as an additive in resins/thermoplastics/elastomers for mechanical reinforcement;
- Manufacture of the substance at a volume not to exceed a confidential volume specified in the consent order unless the company has submitted the results of certain health studies and physical/chemical properties data; and
- No surface water releases of the PMN substance, except for limited water releases resulting in no more than one part per billion (ppb) waste water effluent concentration determined by monitoring. The company shall analyze the concentration of the PMN substance in waste water discharged to the city sewer from the facility every year and adhere to the monitoring procedure referenced in the consent order.
The SNUR designates as a “significant new use” the absence of these protective measures.
PMN Number P-11-339
Chemical Name: Multi-walled carbon nanotubes (generic)
CAS Number: Claimed confidential
The PMN states that the use of the substance will be as an additive in resins, thermoplastics, and elastomers for mechanical reinforcement and enhanced electrical performance, as a coating on metallic foils for battery applications, or in the manufacture of fabric composites. The consent order requires:
- Use of PPE;
- Use of the substance only as an additive in resins, thermoplastics, and elastomers for mechanical reinforcement and enhanced electrical performance, as a coating on metallic foils for battery applications, or in the manufacture of fabric composites;
- Manufacture of the substance at a volume not to exceed a confidential volume specified in the consent order unless the company has submitted the results of certain health studies and physical/chemical properties data; and
- No surface water releases of the PMN substance, except for limited water releases resulting in no more than one ppb waste water effluent concentration determined by monitoring. The company shall analyze the concentration of the PMN substance in waste water discharged to the city sewer from the facility every year and adhere to the monitoring procedure referenced in the consent order.
The SNUR designates as a “significant new use” the absence of these protective measures.
The SNURs are effective on September 8, 2014. Written adverse or critical comments or notice of intent to submit adverse or critical comments, on one or more of these SNURs is due August 7, 2014. If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs, EPA will withdraw the relevant sections of the direct final rule before its effective date.
The Silver Nanotechnology Working Group (SNWG) was founded in 2009 as an industry-wide effort to advance the science and public understanding of the beneficial uses of silver nanoparticles in a wide-range of consumer and industrial products. It does this by fostering the collection of environmental, occupational and health, and consumer product data on silver nanotechnology. Since its founding, the focus of the SNWG has been to encourage the U.S. Environmental Protection Agency (EPA) and other global regulators towards a clear, responsible, and reasonable regulatory path for nanoscale silver additives in a wide variety of products. The SNWG with the help of its members, consultants, and the Silver Institute will continue to do everything possible to reach this goal as soon as possible. Membership in the SNWG is open to any entity with nanosilver interests that wishes to be updated frequently on nanosilver policy issues and be involved with influencing nanosilver regulatory policy. More information is available on the SNWG website and by contacting Rosalind Volpe, D.PH for membership details.
On June 30, 2014, the European Commission (EC) held a validation workshop to discuss the preliminary results of the study supporting the impact assessment on transparency measures for nanomaterials. As part of the workshop, the EC released the following reports:
- Study to Assess the Impact of Possible Legislation to Increase Transparency on Nanomaterials on the Market: Evaluation Report (second draft): This report is one of several outcomes of a study on regulatory oversight of nanomaterials within the European Union (EU). To date, the report states, two relevant register-like schemes -- both concerning nanomaterials and operating within the EU -- have been established: the French Notification System (FNS) and the Cosmetic Products Notification Portal (CPNP). Meanwhile, other transparency measures have been established or proposed by EU Member States.
- Study to Assess the Impact of Possible Legislation to Increase Transparency on Nanomaterials on the Market: Building Blocks Report (second draft): This report documents the findings of Task 2 (“Background information for building blocks of policy options”) and should complement the information provided in the Evaluation report (based on the findings of Task 1 (“Lessons learned from other schemes”) through the assessment of the FNS and the CPNP.
- Study to Assess the Impact of Possible Legislation to Increase Transparency on Nanomaterials on the Market: Options Assessment Report (first draft): This report documents the findings of Task 4 (“Support for the option assessment”), namely to identify the key issues that will need to be accounted for under each of the options being considered by the EC before a full impact assessment can be prepared. The report states: “It is important to emphasise that this report is intended to inform future policy development and analysis by the European Commission and is not intended to represent a definitive position of the Commission.”
The EC released a working document in May 2014 as part of its public consultation on transparency measures for nanomaterials in the market, which will end on August 5, 2014.
On June 25, 2014, the National Nanotechnology Initiative (NNI) posted Progress Review on the Coordinated Implementation of the National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy, which provides an overview of progress on the implementation and coordination of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy that was developed by the Nanoscale Science, Engineering, and Technology Subcommittee’s Nanotechnology Environmental and Health Implications (NEHI) Working Group. According to the NNI, consistent with the adaptive management process described in the Research Strategy, “the NEHI Working Group has made significant progress through the use of various evaluation tools to understand the current status of nanotechnology-related EHS (nanoEHS) research and the Federal nanoEHS research investment.” NNI states: “Most notably, the participating agencies reported to the NEHI Working Group examples of ongoing, completed, and anticipated EHS research (from FY 2009 through FY 2012) relevant to implementation of the 2011 NNI EHS Research Strategy.” Overall, according to NNI, coordination and implementation of the 2011 NNI EHS Strategy across the NEHI agencies has enabled:
- Development of comprehensive measurement tools that consider the full life cycles of engineered nanomaterials (ENM) in various media;
- Collection of exposure assessment data and resources to inform workplace exposure control strategies for key classes of ENMs;
- Enhanced understanding of the modes of interaction between ENMs and physiological systems relevant to human biology;
- Improved assessment of transport and transformations of ENMs in various environmental media, biological systems, and over full life cycles;
- Development of principles for establishing robust risk assessment and risk management practices for ENMs and nanotechnology-enabled products that incorporate ENMs, as well as approaches for identifying, characterizing, and communicating risks to all stakeholders; and
- Coordination of efforts to enhance data quality, modeling, and simulation capabilities for nanotechnology, towards building a collaborative nanoinformatics infrastructure.
On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide “greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.” One final guidance addresses FDA’s overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals, respectively. FDA notes:
The FDA does not make a categorical judgment that nanotechnology is inherently safe or harmful, and will continue to consider the specific characteristics of individual products. All four guidance documents encourage manufacturers to consult with the agency before taking their products to market. Consultations with the FDA early in the product development process help to facilitate a mutual understanding about specific scientific and regulatory issues relevant to the nanotechnology product, and help address questions related to safety, effectiveness, public health impact and/or regulatory status of the product.
The guidances are:
- Final Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology -- The guidance outlines overarching considerations for all FDA-regulated products, identifying points to consider when determining whether a product involves the use of nanotechnology. FDA intends it to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nanotechnology in FDA-regulated products;
- Final Guidance for Industry: Safety of Nanomaterials in Cosmetics -- The guidance describes FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products and encourages manufacturers to consult with FDA on test methods and data needed to support the substantiation of a product’s safety;
- Final Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives -- The guidance alerts manufacturers to the potential impact of any significant manufacturing process change, including changes involving nanotechnology, on the safety and regulatory status of food substances. The guidance also describes considerations for determining whether a significant manufacturing process change for a food substance already in the market affects the identity, safety, or regulatory status of the food substance, potentially warranting a regulatory submission to the FDA; and
- Draft Guidance for Industry: Use of Nanomaterials in Food for Animals -- The draft guidance addresses issues related to the use of nanotechnology in food ingredients intended for use in food for animals. Comments on the draft guidance are due September 10, 2014.
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) published a Federal Register notice on June 19, 2014, requesting available data and information on devices and/or technologies currently used for identifying potential inhalation hazards. According to NICEATM, it will use submitted information “to determine the technical requirements for developing effective inhalation toxicity tools to assess potential chemical or nanomaterial hazards without using animals.” NICEATM requests that respondents provide information on any activities relevant to the development and/or validation of alternatives to in vivo inhalation toxicity test methods currently required by regulatory agencies. NICEATM states that this could include submission of substance-specific data derived from non-animal tests to identify acute inhalation hazard potential. If available, NICEATM requests corresponding in vivo data for these substances, “including data from any ethical human or animal studies or accidental human exposures.” Submissions are due July 18, 2014.
On June 18, 2014, Denmark’s order concerning a nano products register entered into force. The order imposes annual reporting requirements on manufacturers and importers concerning mixtures and products containing nanomaterials. The reporting requirements apply to mixtures and articles that are intended for sale to the general public and contain nanomaterials, where the nanomaterial itself is released under normal or reasonably foreseeable use of the mixture or article, or where the nanomaterial itself is not released but substances in soluble form that are classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) or environmentally dangerous substances are released. A number of products are excluded from the reporting obligation, including food and food contact materials; feed; drugs; medical equipment; cosmetic products; pesticides; and waste. The first reports, for the period beginning June 20, 2014, and ending June 20, 2015, are due August 30, 2015. The order is available only in Danish at this time. The registration portal is available online.
On June 13, 2014, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published its final opinion on “Nanosilver: safety, health and environmental effects and role in antimicrobial resistance.” SCENIHR states that the opinion is intended “to assess whether the use of nanosilver, in particular in medical care and in consumer products, could result in additional risks compared to more traditional uses of silver and whether the use of nanosilver to control bacterial growth could result in resistance of micro-organisms.” SCENIHR states:
SCENIHR concluded that the widespread (and increasing) use of silver containing products implicates that both consumers and the environment are exposed to new sources of silver. Human exposure is direct (food, hand-to-mouth contact, skin) and may be life long; while in the environment silver nanoparticles may be a particularly effective delivery system for silver to organisms in soil, water and sediment and may act as sources of ionic silver over extended periods of time. Therefore, additional effects caused by widespread and long term use of silver nanoparticles cannot be ruled out.
Regarding the hazard associated with the dissemination of the resistance mechanism following the use of silver nanoparticles, no studies are available at this moment, representing a serious gap of knowledge. Since other nanoparticles have been shown to substantially increase the horizontal gene transfer between bacteria -- which is extremely relevant for developing resistance -- the potential of silver nanoparticles to induce similar effects should be given particular attention. More data are needed to better understand bacterial response to ionic silver and silver nanoparticles exposure. Since the mechanisms resulting in silver nanoparticles resistance are not well understood, it is not possible to estimate at this time whether or not resistance of microorganisms will increase and spread in view of a more widespread use of silver nanoparticles in products.
Last month, the National Institute for Occupational Safety and Health (NIOSH) released a report entitled The State of the National Initiative on Prevention through Design, which provides an overview of the progress and accomplishments of the Prevention through Design (PtD) initiative. The ultimate goal is to prevent or reduce occupational injuries, illnesses, or fatalities through the inclusion of prevention considerations into all designs that might impact workers. According to the report, NIOSH is planning several education modules, including one in Safe Nano Design. NIOSH intends to disseminate the modules through its stakeholders and university partners. The report notes that the NIOSH PtD Program and the NIOSH Nanotechnology Research Center (NTRC) collaborated with the State University New York at Albany, College of Nanoscale Science & Engineering to hold the “Safe Nano Design” workshop in August 2012. The purpose of the workshop was to develop guidance for the safe commercialization of nanotechnology products, resulting in guidelines for the safe synthesis of nanoparticles and associated products by means of a PtD approach. The report states that the conference “illustrated application of PtD principles at the molecular level as well as during the process phase. Nanomaterials can be designed to mitigate toxicity while maintaining functionality. At the process level various approaches can be designed in to protect workers from exposure to hazardous chemicals, including nanomaterials. Integrating the design efforts at the molecular and process levels may have an even greater impact on worker safety and health.”
The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) published on May 15, 2014, a review of the available literature on health and environmental issues relating to manufactured nanomaterials. According to ANSES, the review “will help clarify scientific understanding and demonstrate the toxic effects of some nanomaterials on living organisms and the environment.” ANSES states that it is difficult to assess the specific risks associated with nanomaterials. ANSES recommends:
- Implementing multidisciplinary projects to develop knowledge of the characteristics and hazards of nanomaterials, throughout the product life cycle;
- A strengthened regulatory framework for manufactured nanomaterials at the European level to characterize better each substance and its uses, taking into account the entire product life cycle; and
- Regulating certain nanomaterials, for which there are sufficient scientific data on toxicity, under the European Union (EU) Classification, Labeling, and Packaging (CLP) and Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations.
On May 19, 2014, the European Commission (EC) Joint Research Center (JRC) announced the availability of a report discussing labeling and reporting schemes for nanomaterials in consumer products in the European Union (EU). The JRC notes that current EU legislation requires nanomaterials to be reported in the list of ingredients, with “nano” added in brackets after the substance name, for food, cosmetics, and biocides. According to the JRC, manufacturers sometimes add voluntary “nanoclaims” indicating the presence or absence of nanomaterials. The JRC states that a product register may give a better overview of the overall application of nanomaterials and potential exposure of humans and the environment. The EC already requires mandatory reporting for cosmetic products containing nanomaterials. Some EU Member States (France, Belgium, and Denmark) have or are introducing mandatory reporting schemes for a wider range of consumer products. The JRC states that several EU Member States, including Austria, Croatia, the Czech Republic, Denmark, France, Germany, Italy, Luxembourg, the Netherlands, Spain, and Sweden would prefer a harmonized central EU nanomaterials register. The report emphasizes that “only mandatory reporting/labelling of products containing nanomaterials can assure accurate and comprehensive information. Harmonised procedures are needed to avoid trade barriers and unfair commercial practices.” The report states that a claim of the presence (or absence) of nanomaterials in products should be verifiable, and provides an overview of experimental methods available for this purpose.
As part of the Communication on the Second Regulatory Review on Nanomaterials, the European Commission (EC) announced the launch of an impact assessment intended to identify and develop the most adequate means to increase transparency and ensure regulatory oversight on nanomaterials. The EC has provided a working document, which contains a draft problem definition, policy objectives, and a description of the preliminary policy options that are under consideration. The EC will update the working document over the course of the impact assessment. In support of the impact assessment, the EC is conducting a public consultation to obtain stakeholder views on the currently available information on nanomaterials on the market, the problem definition that forms the basis of the impact assessment, as well as the potential positive and/or negative impacts of the aforementioned policy options. According to the working document, the preliminary policy options are:
0. Baseline scenario;
1. Recommendation on how to implement a “best practice model” for Member States wishing to establish a national system (soft law approach);
2. Structured approach to collect information (“Nanomaterials Observatory”);
3. Regulation creating a European Union (EU) nanomaterial registry with one annual registration per substance for each manufacturer/importer/downstream user/distributor; and
4. Regulation creating an EU nanomaterial registry with one annual registration per use (including substances, mixtures and articles with intended release).
For options 3 and 4, a number of variants, taking into account specific substances, mixtures or articles, shall be considered. Some policy options may be combined. The EC states that it will organize a validation workshop to discuss the preliminary results of the study supporting the impact assessment on transparency measures for nanomaterials with interested stakeholders. The workshop will take place on June 30, 2014, in Brussels. The public consultation will close August 5, 2014.
An International Agency for Research on Cancer (IARC) Advisory Group met on April 7-9, 2014, to recommend priorities for IARC Monographs during 2015-2019. The Advisory Group assessed the responses to a call for nominations and recommended a range of agents and exposures as high or medium priorities for assessment. According to the recommendations published in Lancet Oncology, multi-walled carbon nanotubes are a high priority for assessment -- “cancer bioassay data are available from intraperitoneal injection studies, inhalation studies are ongoing; mechanistic similarities with asbestos have been noted.” IARC’s preliminary list of agents to be reviewed at its September 30-October 7, 2014, meeting includes “carbon nanotubes.”
The European Chemicals Agency (ECHA) Biocidal Products Committee (BPC) adopted an opinion on April 10, 2014, concerning HeiQ AGS-20 (AGS-20). The European Commission (EC) requested an opinion on the following questions:
- With regard to the biocidal product AGS-20, should silver or silver adsorbed on silicon dioxide be considered as the active substance?
- Would this active substance meet the definition of a nanomaterial, as provided in Article 3(1)(z) of the Biocidal Products Regulation (BPR)?
Finally, if this active substance meets the definition of a nanomaterial what should be its specifications?
The European Chemicals Agency (ECHA) will hold a topical scientific workshop on October 23-24, 2014, on regulatory challenges in the risk assessment of nanomaterials. The workshop will bring together experts in the field of risk assessment of nanomaterials to discuss and update scientific principles and guidelines for assessing human health and environmental risks of chemicals substances in nanoform. According to ECHA, the workshop will also provide a platform for academia and regulators to address how the main long-term challenges from the regulatory perspective can be reflected and employed in the current and future research topics on nanomaterials. The workshop will cover the following topics:
- Challenges in regulatory risk assessment of nanomaterials;
- Measurement and characterization of nanomaterials;
- Metrology and dose metrics for hazard and exposure assessment throughout the life cycle;
- Environmental fate, persistence and bioaccumulation throughout the life cycle; and
- Read across and categories of nanomaterials.
Participation in the workshop will be by invitation only. Experts in the risk assessment of nanomaterials who wish to participate should express interest by May 15, 2014.
Earlier this month, the Center for International Environmental Law (CIEL) and its European partners published a position paper on the regulation of nanomaterials at a meeting of the European Union (EU) competent authorities. According to the position paper, current EU legislation “does not guarantee that all nanomaterials on the market are safe by being assessed separately from the bulk form of the substance.” The position paper asks the European Commission (EC) to produce “concrete proposals for a comprehensive revision of the existing legal framework addressing the potential risks of nanomaterials.” The position paper states that:
- Nanomaterials are different from other substances;
- Risk from nanomaterials must be assessed;
- Nanomaterials should be thoroughly evaluated;
- Information on nanomaterials must be collected and disseminated; and
- Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) enforcement activities should tackle nanomaterials.
On March 31, 2014, the U.S. Environmental Protection Agency (EPA) announced that it issued an order to Pathway Investment Corp. of Englewood, New Jersey to stop the sale of plastic food storage containers that have not been tested or registered with EPA, in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to EPA’s press release, the company’s Kinetic Go Green Premium Food Storage Containers and Kinetic Smartwist Series Containers contain nanosilver as an active ingredient, and the company markets other products as containing nanosilver, which the company claims helps reduce the growth of mold, fungus, and bacteria. EPA notes that such claims can be made only for products that have been properly tested and are registered under FIFRA. EPA states:
During a November 13, 2013 EPA inspection of the company’s facility in Englewood, New Jersey, a Pathway representative acknowledged that the company sold plastic products containing nano silver. The label for the Kinetic Go Green Premium food storage container stated that the product contained nano silver technology and that the nano-sized particles of silver helped to reduce the growth of bacteria and mold, allowing foods to stay fresh up to three times longer. In addition, the company’s product description touted the benefits of nano silver in its products and the company’s website contained several claims that describe how the nano silver particles destroy, kill or reduce the growth of mold, fungus and bacteria.
EPA states that, in addition to the order sent to Pathway, it also issued warning letters to Amazon, Sears, Wal-Mart, and other large retailers directing them not to sell these products.
ECHA Report Includes Recommendations for Exposure Assessment and Risk Characterization of Nanomaterials under REACH
On March 26, 2014, SAFENANO announced that the European Chemicals Agency (ECHA) published a report entitled Human health and environmental exposure assessment and risk characterisation of nanomaterials: Best practice for REACH registrants. The report summarizes the outcomes of the third (and last) meeting of the Group Assessing Already Registered Nanomaterials (GAARN). The September 30, 2013, meeting focused on discussing the approach and challenges faced by participant registrants when documenting the human health and environmental exposure assessment and risk characterization of their substances while registering them under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The report states that the outcomes of the discussion “can be viewed as generic recommendations for the exposure assessment and risk characterisation of NMs under REACH, while considering the present scientific knowledge on the field of nanotoxicology and practice, as well as challenges from participating registrants.” The report states that the provisions that apply to the registration of nanomaterials are the same as those for any other chemical substance, but notes that, “in line with scientific developments, there are specific considerations that registrants should report in specific endpoint sections, as this information will facilitate the evaluation of the adequacy of the tests performed and data obtained with regard to the safety assessment of NMs.” According to the report, the registration dossier should contain a comprehensive physicochemical characterization of the registered nanoform(s). Only when well-characterized nanoforms are reported in the dossier, can a read-across approach or use of existing data be considered for the purpose of hazard assessment. Registration dossiers including nanomaterials and bulk substances under the same technical dossier should include specific exposure scenarios for nanomaterials if these differ from the exposure scenarios developed for the bulk materials. The report states that, “[i]n principle, the existing risk assessment paradigm developed for traditional chemicals” should also apply to nanomaterials. According to the report, comprehensive risk assessments for nanomaterials currently present challenges both for human health and the environment. The following conclusions can be drawn:
Regarding the risk assessment for workers, due to the lack of validated modelling tools for nanomaterial exposure, field measurement data are currently preferred to support the risk assessment. If possible, the risk assessment should follow a multi-metric approach. The use of qualitative approaches is allowed to support measured or estimated exposure data. Concerning RMMs, the conventional control technologies to handle dusty materials are applicable to NMs and provide good control if implemented and maintained correctly.
With regards to the environment, the lack of specific hazard data complicates the risk assessment. Moreover, there are significant limitations in the applicability of conventional exposure assessment models. Registrants are advised to collect information on environmental release when possible (RIPoN 3). The current report proposes best practice to achieve realistic exposure data that can be used in environmental risk assessments.
In general, it is important to conclude with the reminder of the legal obligation that registration dossiers need to be updated with new nano-specific studies as scientific developments are progressing. Safe use claims under REACH should be based on explicit and transparent documentation supporting the hazard, exposure and risk assessment of NMs. Registrants are reminded that a lack of (hazard) data does not automatically mean that there is a lack of specific hazards or risks for a substance.
On March 6, 2014, Representative Eddie Bernice Johnson (D-TX), Ranking Member of the Committee on Science, Space, and Technology, introduced the America Competes Reauthorization Act of 2014 (H.R. 4159). The bill would establish, revise, and extend specified science, technology, engineering, and mathematics programs, as well as education, research, and training programs. The bill would reauthorize the National Nanotechnology Initiative (NNI) “to ensure the United States remains a leader in the development of new technologies and products based on breakthroughs in our understanding of materials at the atomic and molecular level.” Under the bill, the National Nanotechnology Coordination Office (NNCO) would develop and maintain a public database of projects funded under at least the environmental, health, and safety (EHS) program component area, or any successor program component area. The database would include a description of each project, its source of funding by agency, and its funding history. The bill states that the National Nanotechnology Program will include research on: (1) the development of instrumentation and tools required for the rapid characterization of nanoscale materials and for monitoring of nanoscale manufacturing processes; and (2) approaches and techniques for scaling the synthesis of new nanoscale materials to achieve industrial-level production rates. On March 6, 2014, the bill was referred to the House Committee on Science, Space, and Technology and to the Committee on Education and Workforce. On March 11, 2014, the bill was referred to the Science, Space, and Technology Subcommittee on Research and Technology.
Earlier this month, the German Federal Environment Agency (UBA) issued a report entitled Assessment of Impacts of a European Register of Products Containing Nanomaterials, which was intended to analyze the impacts of a European register of products containing nanomaterials (ENPR). The study identified the sectors and companies that would be affected by an ENPR, and estimated the number of notifiers and notifications, categories of substances, concerned mixtures, and articles. Based on that result, the study quantified the administrative costs for notifiers and the competent authority, and described the benefits of an ENPR for public authorities, consumers, and notifiers. The report includes a preliminary remark from Öko-Institut e.V., which performed the study. The preliminary remark notes that during the study, various difficulties occurred, resulting in a lower reliability of calculations. Complications included companies “not interested or not able to substantiate the high burden that they allocate to such a register with reliable figures,” as well as “quite a number of companies [that] do not seem to have knowledge of the possible content of nanomaterials in their products.” According to the report, “an ENPR could bring additional value for public authorities, consumers and companies involved in nanotechnology.” The report concludes that an ENPR would “help to avoid a multiplication of administrative costs” to both companies manufacturing or importing products containing nanomaterials and the national competent authorities that would be responsible for a register at the Member State level. The report states: “Finally, from a legal point of view it can be discussed whether a register is the proportionate instrument in the light of the precautionary principle to govern the safe use of nanomaterials and products containing them. However, the introduction of an ENPR is the mildest legal instrument to control the production and use of nanoproducts compared to a restriction, a ban or a moratorium on one or more of these products.”
The European Parliament (EP) passed a resolution on March 12, 2014, that objects to the European Commission’s (EC) proposed regulation that would define “engineered nanomaterials” in food. According to the EP’s press release, the EC’s proposed regulation “would grant a blanket exemption from food-labelling requirements for nano-additives already on the market.” The press release quotes EP Member Carl Schlyter, who is credited for the EP’s “scrutiny” of the proposed regulation, as stating: “The EP has repeatedly called for proper nano-labelling and it is highly surprising that the Commission even tried to weaken what has been decided by both Parliament and the Council. Consumers have the right to know and make their own choice. They do not want the Commission to do that for them. That is why today’s vote is important.” The press release states that the EC’s justification for the exemption, that consumers might assume that existing food additives being labeled as “nano” were new to the market, is “erroneous and irrelevant.”
OECD Issues Expert Meeting Report on Ecotoxicology and Environmental Fate of Manufactured Nanomaterials
On March 7, 2014, the Organization for Economic Cooperation and Development (OECD) posted a report entitled Ecotoxicology and Environmental Fate of Manufactured Nanomaterials: Test Guidelines, which provides a report of the discussion and recommendations from the January 2013 expert meeting on ecotoxicology and environmental fate. As part of OECD’s Program on the Safety of Manufactured Nanomaterials, it initiated a series of expert meetings intended to improve the applicability of the OECD Test Guidelines (TG) to nanomaterials. The main objective of the meeting was to assess the applicability of existing TGs to manufactured nanomaterials, with a view to:
- Identify the needs for updating the OECD TGs related to environmental fate and ecotoxicology, and developing new nanospecific TGs;
- Identify specific needs for developing/updating existing guidance documents, including identifying the need for additional sections for fate and ecotoxicology testing of nanomaterials; and
- Develop separate specific or adapt existing guidance documents for environmental fate and ecotoxicology testing of nanomaterials.
Meeting participants concluded that OECD TGs 201, 211, 222, 225, 305, 315, and 317 are applicable to engineered nanomaterials (ENM). According to the participants, TG 105 is not appropriate for nanomaterials, and a TG should be developed that addresses the dissolution behavior of ENMs. The participants concluded that TG 106 for measuring the adsorption and desorption behavior of a substance in soils cannot be applied for the testing of nanomaterials, since no valid differentiation between adsorbed and not adsorbed ENMs is possible. The OECD report includes specific recommendations regarding the application of each TG to ENMs and details about the data analysis, acceptable loss of the ENMs during the test, endpoints, test procedure, selection of the test media, and target organism.
On February 28, 2014, the National Nanotechnology Coordination Office (NNCO) announced the release of the 2014 National Nanotechnology Initiative (NNI) Strategic Plan. The NNI Strategic Plan represents the consensus of the participating agencies as to the high-level goals and priorities of the NNI and specific objectives for at least the next three years. It is intended to provide an integrated, interagency approach informing the nanotechnology-specific strategic plans of NNI agencies. The Strategic Plan describes the four overarching goals of the NNI, the major program component areas (PCAs) used to track the categories of investments needed to ensure the success of the NNI, and the near-term objectives that provide concrete steps toward collectively achieving the NNI vision and goals. The Strategic Plan also describes collaborative interagency activities, including Nanotechnology Signature Initiatives (NSIs), which serve as a model of specifically targeted and closely coordinated interagency, cross-sector collaboration designed to accelerate innovation in areas of national priority. The first three NSIs, launched in 2010, are focused on solar energy, sustainable manufacturing, and next-generation electronics. In 2012, two additional NSIs on informatics and sensors were introduced. The goals of the NNI are to:
- Advance a world-class nanotechnology research and development program;
- Foster the transfer of new technologies into products for commercial and public benefit;
- Develop and sustain educational resources, a skilled workforce, and a dynamic infrastructure and toolset to advance nanotechnology; and
- Support responsible development of nanotechnology.
On February 12, 2014, the European Parliament (EP) Committee on the Environment, Public Health and Food Safety rejected a proposed regulation that would define “engineered nanomaterials” in food. According to the Committee, the definition could lead to existing nanomaterials not being labeled due to an exemption provided for food additives approved on a European Union (EU) list. The Committee’s resolution notes that, under Article 18(3) of Regulation (EU) No 1169/2011 on Food Information to Consumers, “all food ingredients present in the form of engineered nanomaterials have to be clearly indicated in the list of food ingredients to ensure consumer information.” According to the Committee, the Regulation does not distinguish between existing and new nanomaterials, but “explicit[l]y requires labelling of all ingredients present in the form of engineered nanomaterials.” The resolution also criticizes the proposed regulation’s size distribution threshold of 50 percent, stating that a threshold of ten percent “would be more appropriate, subject to a review.” The EP will vote on the resolution during the February 24-27, 2014, plenary session.
The European Commission (EC) published the proposed regulation as a delegated regulation in the December 19, 2013, Office Journal of the European Union, and then, on December 20, 2013, published a notice declaring it “null and void.” The withdrawal of the amendment was the result of a procedural error by the EC.
The European Commission (EC) Scientific Committee on Consumer Safety (SCCS) has opened a call for information for a scientific opinion on the safety of silica (nano). The SCCS invites interested parties to submit any relevant information, such as identification of the type of cosmetic product using silica in nano-structured form and their concentration; protocols of applications; differences in solubility, including for surface coated materials; information on adverse health effects; results from toxicological tests with such products or ingredients contained within, including inhalation toxicity, genotoxicity/carcinogenicity/toxicokinetic studies, photocatalytic activity and phototoxic effect, or any other scientific data/publications considered relevant to assess the safety of such products. Information is due May 31, 2014.
On February 7, 2014, Belgium announced that the Council of Ministers agreed on the royal decree concerning the marketing of substances containing nanomaterials. The royal decree creates a national register of nanomaterials, requiring manufacturers to register nanomaterial substances and mixtures containing such substances. According to Belgium the register will ensure the traceability of these nanoparticles. The register will open January 1, 2016, for nanomaterial substances, and January 1, 2017, for mixtures containing nanomaterial substances. Belgium states that it will evaluate the registration of products containing nanomaterials and that they will be recorded later. The press release has not yet been posted in English.
On February 12, 2014, the U.S. Environmental Protection Agency (EPA) issued, through a direct final rule, significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 35 chemical substances that were the subject of premanufacture notices (PMN). The 35 substances include four identified as multi-walled carbon nanotubes (generic) that were the subject of a December 3, 2012, TSCA Section 5(e) consent order. The consent order requires the use of personal protective equipment (PPE); no domestic manufacture; import of the substances at a cumulative, aggregate volume not to exceed a confidential volume specified in the consent order unless the company has submitted the results of certain health studies; and no use of the substances resulting in surface water releases. The SNUR designates as a “significant new use” the absence of these protective measures. The direct final rule also includes a SNUR for infused carbon nanostructures (generic). According to EPA, no significant inhalation exposures are expected when the PMN substance is manufactured according to the process identified in the PMN, to incorporate the PMN substance into pellets. Therefore, EPA states, it has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. The direct final rule is effective on April 14, 2014. Written adverse or critical comments, or notice of intent to submit such, are due March 14, 2014.
Lynn L. Bergeson Participates in Congressionally-Requested Forum on Nanomanufacturing, Which Is Summarized in New GAO Report
On February 7, 2014, the U.S. Government Accountability Office (GAO) released a report entitled Nanomanufacturing: Emergence and Implications for U.S. Competitiveness, the Environment, and Human Health, which provides highlights from a Congressionally-requested forum on specific issues in nanotechnology manufacturing that was held July 23-24, 2013. The House Committee on Science, Space, and Technology asked the GAO and the National Academies to convene the forum and elicit the views of a group of leading experts, including Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. The report summarizes forum discussions in the following areas:
- The future of nanomanufacturing, as viewed by forum participants;
- U.S. investments in nanotechnology research and development (R&D) and current challenges to U.S. competitiveness in nanomanufacturing;
- Ways to enhance U.S. competitiveness; and
- Issues in addressing the environmental, health, and safety (EHS) implications of nanomanufacturing.
The report states that forum participants identified gaps and challenges in four key areas where they believe future action is needed: (1) international data on R&D investment; (2) international standards; (3) U.S. competitiveness; and (4) EHS issues. The report includes profiles of four nanomanufacturing industries: “Nanotechnology and the Future of the Semiconductor Industry”; “Nanotechnology and the Future of Battery-Powered Vehicles”; “Nanotechnology and the Future of Nano-Based Concrete”; and “Nanotechnology and the Future of Nanotherapeutics in Medicine.”
German Federal Environment Agency Supports Creation of EU Register of Products Containing Nanomaterials
The German Federal Environment Agency (UBA) has posted an English translation of a 2012 document entitled Concept for a European Register of Products Containing Nanomaterials. The document states that, due to the particular uncertainties concerning evaluation of the possible risks of nanomaterials for human health and the environment, UBA supports the establishment of a European register of products containing nanomaterials as a precautionary measure. The objective of the product register would be to provide an overview of products containing nanomaterials that have applications in the consumer area and in an open environment. According to UBA, this would enable public authorities to set priorities in enforcement and monitoring, to estimate exposure for humans and the environment, and, in the case of adverse effects, to ensure traceability. For actors in the supply chain, a product register would create transparency. UBA states that the establishment of the product register should take place at the European Union (EU) level and be managed centrally. UBA acknowledges that a national product register would overlap with EU legislation and obligations and regulations in individual EU Member States, which would mean increased costs for authorities and stakeholders subject to notification. Substances and mixtures (manufactured or imported) that comprise or contain nanomaterials would be subject to notification, as well as articles that intentionally or unintentionally release nanomaterials.
On January 27, 2014, the Federal Institute for Risk Assessment (BfR) posted frequently asked questions (FAQ) regarding the risk assessment of cosmetic products. BfR states that there are repeated critical public reports and discussions about several ingredients of cosmetic products, leading consumers to ask whether cosmetics pose a health risk. Several of the FAQs address nanomaterials:
Why are nanoparticles used in cosmetic products?
Nanoparticles made of titanium dioxide and/or zinc oxide are used as UV filters in suncreams to protect the skin from UV radiation. Materials produced using nanotechnology (so-called biocomposites) in toothpaste are intended to support the natural tooth repair mechanism of saliva.
Cosmetics containing ingredients in the form of nanomaterials must contain a reference to this effect in the list of ingredients in line with the EU cosmetics regulation (EC Reg. No. 1223/2009). The names of these components must be followed by the word “nano” in brackets.
What is known about the health effects of nanoparticles in cosmetic products?
Toxicological tests have already been made for several nanoparticles used in cosmetic products. Accordingly, the behaviour of nanoparticles made of titanium dioxide and zinc oxide on the skin has been well examined. It was confirmed in several experiments that these nanoparticles cannot penetrate healthy human skin cells and remain on the skin surface. They can remain on the skin for longer periods via the hair follicles, but they cannot penetrate it. Hair growth then transports them back to the skin surface.
There are currently many open questions in the assessment of the health risk of nanoparticles. The possible but not yet experimentally proven special potencies of particles in the biological system based on their nanoscalability are largely unknown, nor is much data available on the exposure of humans to nanoparticles.
Can sunscreen with nano-sized UV filters be used for babies?
Children aged under two years should not be exposed to direct sunlight because their skin has not yet developed its own protection function against solar radiation. Textile sun protection is also recommended in the shade.
If direct exposure to the sun cannot be avoided, a sunscreen product should be carefully applied to the uncovered areas of the body to prevent sunburn. Although knowledge of the possible risks of nanomaterials is still a bit sketchy in some places, the effects of nanoparticle-sized substances on human skin is comparatively well researched. As the tiny particles cannot penetrate healthy skin, their use in UV filters for sunscreen products does not pose a health risk.
On December 18, 2013, the European Commission (EC) adopted three draft proposals on animal cloning and novel food. The draft proposal concerning novel food would revise the current regulation “with a view to improving access of new and innovative food to the EU market, while still maintaining a high level of consumer protection.” An EC question and answer (Q&A) concerning the draft proposals includes the following Q&A concerning nanomaterials:
What are the requirements for nanomaterial?
Nanomaterial is materials engineered at the scale of atoms and molecules. The proposal specifies that engineered nanomaterials, as defined in the Regulation on Food Information to Consumers, require a Novel Food authorisation before being used in foodstuffs. This confirms that nanomaterials are covered by the Novel Food Regulation.
The EC’s December 18, 2013, press release states that the European Parliament and the Council will consider the draft proposal and adopt their positions “in due course.” According to the press release, the earliest the amendment would enter into force would be 2016.
Journal of Nanoparticle Research Publishes Article Describing Occupational Safety and Health Criteria for Responsible Development of Nanotechnology
On December 7, 2013, the Journal of Nanoparticle Research published online an article entitled “Occupational safety and health criteria for responsible development of nanotechnology.” The authors, who are affiliated with the National Institute for Occupational Safety and Health (NIOSH), describe five criterion actions that they believe should be practiced by decision-makers to ensure the responsible development of nanotechnology: “(1) anticipate, identify, and track potentially hazardous nanomaterials in the workplace; (2) assess workers’ exposures to nanomaterials; (3) assess and communicate hazards and risks to workers; (4) manage occupational safety and health risks; and (5) foster the safe development of nanotechnology and realization of its societal and commercial benefits.” According to the authors, because of the current “unknowns and concerns about nanomaterials,” “it is prudent to treat them as potentially hazardous until sufficient toxicology, and exposure data are gathered for nanomaterial-specific hazard and risk assessments.” The article notes: “The findings and conclusions of this report are those of the authors and do not necessarily represent the views of the National Institute for Occupational Safety and Health.”
The December 20, 2013, issue of the Official Journal of the European Union includes a corrigendum to the amendment to Regulation 1169/2011 concerning the provision of food information to consumers as regards the definition of engineered nanomaterials. The European Commission (EC) published a notice in the December 19, 2013, Official Journal of the European Union amending the food labeling regulation concerning the definition of engineered nanomaterials. The December 20, 2013, notice states: “The publication of Commission Delegated Regulation (EU) No 1363/2013 is to be considered null and void.”
EC Scientific Committee Memorandum on Relevance, Adequacy and Quality of Data in Safety Dossiers on Nanomaterials Available for Comment
The European Commission (EC) Scientific Committee on Consumer Safety (SCCS) “Memorandum on Relevance, Adequacy and Quality of Data in Safety Dossiers on Nanomaterials” is available for comment. The SCCS states that the current memorandum is intended to highlight the main considerations in relation to the relevance, adequacy, and quality of the data presented in safety dossiers on nanomaterials. The SCCS also intends the memorandum “to provide further guidance and clarity to future applicants so that preparation and evaluation of the safety dossiers can proceed without an undue burden on the part of either the applicants or the evaluators in the Committee.” The conclusion states that the relevance, adequacy, and quality of the data presented “are of utmost importance in relation to the smooth and transparent evaluation of safety of nanomaterials used in cosmetic products.” The “key message” is that the data provided “must be relevant to the types of nanomaterials under evaluation, sufficiently complete, and of appropriate standards to allow adequate risk assessment.” Comments are due February 17, 2014.
IARC has posted additional information concerning IARC Monographs Volume 111, “Some Nanomaterials and Some Fibres.” As reported previously, the Working Group will meet September 30 to October 7, 2014. The call for experts closes January 30, 2014. Requests for observer status are due June 3, 2014. The call for data closes September 3, 2014. In the call for data, IARC states that it seeks “studies that are relevant to the carcinogenicity of the agents that will be reviewed in this volume (carbon nanotubes, fluoro-edenite and silicon carbide). This includes all pertinent epidemiological studies and cancer bioassays, plus important mechanistic and other relevant data.” IARC notes that “[e]ligible studies should be published or accepted for publication in the openly available scientific literature.
On December 2-3, 2013, the U.S.-EU Communities of Research held a workshop intended to further develop and support their activities. The goal of the workshop was to publicize progress towards their goals and objectives, clarify and communicate future plans, share best practices, and identify areas of cross-Community collaboration. Participants included American and European scientists and policy makers from academia, research institutes, industry, and governments. The presentations are available online.
On December 20, 2013, the National Institute for Occupational Safety and Health (NIOSH) published a document entitled Protecting the Nanotechnology Workforce: NIOSH Nanotechnology Research and Guidance Strategic Plan, 2013-2016. NIOSH describes the document as “the roadmap being used to advance basic understanding of the toxicology and workplace exposures involved so that appropriate risk management practices can be implemented during discovery, development, and commercialization of engineered nanomaterials.” NIOSH states that, for fiscal years 2013-2016, it will continue to fill information and knowledge gaps addressing the five NIOSH Nanotechnology Research Center (NTRC) strategic goals:
- Increase understanding of new hazards and related health risks to nanomaterial workers;
- Expand understanding of the initial hazard findings of engineered nanomaterials;
- Support the creation of guidance materials to inform nanomaterial workers, employers, health professionals, regulatory agencies, and decision-makers about hazards, risks, and risk management approaches;
- Support epidemiologic studies for nanomaterial workers, including medical, cross-sectional, prospective cohort, and exposure studies; and
- Assess and promote national and international adherence with risk management guidance.
To address these strategic goals and promote the responsible development of engineered nanomaterials, NIOSH states that the strategic plan will expand research activities in ten critical areas: toxicity and internal dose; measurement methods; exposure assessment; epidemiology and surveillance; risk assessment; engineering controls and personal protective equipment (PPE); fire and explosion safety; recommendations and guidance; global collaborations; and applications.
The December 19, 2013, Office Journal of the European Union includes an amendment to Regulation 1169/2011 concerning the provision of food information to consumers as regards the definition of engineered nanomaterials. Under the regulation, all ingredients present in the form of engineered nanomaterials must be indicated in the list of ingredients. The names of such ingredients must be followed by the word “nano” in brackets. The amendment defines engineered nanomaterials as “any intentionally manufactured material, containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm to 100 nm.” Under the amendment, food additives covered by the definition “shall not be considered as engineered nanomaterials, if they have been included in the Union lists” as established by Commission Regulations (EU) No 1129/2011 and (EU) No 1130/2011. Fullerenes, graphene flakes, and single wall carbon nanotubes with one or more external dimensions below one nanometer “shall be considered as engineered nanomaterials.” “Intentionally manufactured” is defined as “the material is manufactured to perform/fulfil a specific function or purpose.”
On December 13, 2013, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) released its preliminary opinion on “Nanosilver: safety, health and environmental effects and role in antimicrobial resistance.” The opinion is intended to assess whether the use of nanosilver, in particular in medical care and in consumer products, could result in additional risks compared to more traditional uses of silver, and whether the use of nanosilver to control bacterial growth could result in resistance of micro-organisms. SCENHR states that it “concluded that the widespread (and increasing) use of silver containing products implicates that both consumers and the environment are exposed to new sources of silver.” Human exposure is direct, through food, hand-to-mouth contact, and skin, and may be life long. Silver nanoparticles “may be a particularly effective delivery system for silver to organisms in soil, water and sediment and may act as sources of ionic silver over extended periods of time.” SCENIHR thus cannot rule out “additional effects caused by widespread and long term use” of nanosilver. Regarding the hazard associated with the dissemination of the resistance mechanism following the use of nanosilver, SCENIHR notes that there is no documentation available, “representing a serious gap of knowledge.” According to SCENIHR, “[s]ince other nanoparticles have been shown to substantially increase the horizontal gene transfer between bacteria -- which is extremely relevant for developing resistance -- the potential of [nanosilver] to induce similar effects should be given particular attention.” SCENIHR states that more data are needed to understand better the bacterial response to ionic silver and nanosilver exposure. SCENIHR could not determine whether resistant microorganisms will increase and spread in view of a more widespread use of nanosilver because the mechanisms resulting in nanosilver resistance are not well understood. Comments on the preliminary opinion are due February 2, 2014.
ISO Publishes Guidance on Voluntary Labeling for Consumer Products Containing Manufactured Nano-Objects
The International Organization for Standardization (ISO) has published Technical Specification (TS) 13830:2013, “Nanotechnologies -- Guidance on voluntary labelling for consumer products containing manufactured nano-objects.” The purpose of the guidance “is to provide a framework to facilitate a harmonized approach for the voluntary provision of labelling for [consumer products containing manufactured nano-objects (PCMNO)] that may or may not exhibit or impart nanoscale phenomena.” ISO notes that the TS is a “voluntary guidance on conveying specific product information that a manufacturer may choose to disclose on product labels and is not intended to provide mandatory labelling requirements, which are established by relevant regulatory authorities.” The TS is not applicable to consumer products containing naturally occurring nano-objects that were not subjected to manufacturing processes, nor does it apply to consumer products containing nano-objects that are incidentally present. A preview of the standard is available on the ISO website, and the complete standard may be purchased online.
On November 29, 2013, the Ministry of Ecology, Sustainable Development and Energy published an initial assessment, available only in French, of the mandatory reporting of nanomaterials, which took effect January 1, 2013. 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 Ministry, as of June 30, 2013, more than 930 reporters submitted over 3,400 statements concerning substances placed on the market in France in 2012.
On November 28, 2013, the International Agency for Research on Cancer (IARC) announced that the Working Group for IARC Monographs Volume 111, “Some Nanomaterials and Some Fibres,” will meet September 30 to October 7, 2014. IARC states that “[d]etails will follow shortly.” This will include information concerning the call for data, call for experts, and request for observer status. During the meeting, the Working Group will review the latest available scientific literature and determine which classification is appropriate: Group 1, carcinogenic to humans; Group 2A, probably carcinogenic to humans; Group 2B, possibly carcinogenic to humans; Group 3, not classifiable as to its carcinogenicity to humans; and Group 4, probably not carcinogenic to humans.
A&WMA Will Hold Webinar on Nanoscale EHS: Environmental Health and Safety Essentials Every Practitioner Is Obligated to Know
On December 10, 2013, the Air & Waste Management Association (A&WMA) will hold a webinar entitled “Nanoscale EHS: Environmental Health and Safety Essentials Every Practitioner Is Obligated to Know.” The webinar description notes that possible environmental, health, and safety (EHS) implications associated with nanoscale activities are resulting in a rapidly evolving regulatory climate. The webinar will examine nanotechnology and its applications, possible EHS implications, emerging regulations, and proactive approaches to reduce potential future liability. This is the introductory webinar in the Nanoscale EHS series.
The Finnish Institute of Occupational Health released a report in October 2013 entitled Evaluation of the health effects of carbon nanotubes. According to the Institute, recent studies have suggested that some types of multiwalled carbon nanotubes (MWCNT) have similar effects as asbestos. The Institute states that the report “shows that rigid, long and needle-like MWCNTs induce inflammation and DNA damage in the lungs and in cultured cells, while flexible, long and tangled MWCNTs do not. It appears that the rigidity of MWCNTs is a key feature in triggering a specific inflammatory reaction and in causing cellular alterations involved in cancer formation.” The Institute states that this new information on the adverse effects of MWCNTs will be useful in assessing which forms of MWCNTs require regulatory attention and special safety measures in occupational settings.
On November 19, 2013, the National Science and Technology Council, Committee on Technology, and Subcommittee on Nanoscale Science, Engineering, and Technology requested public comments on the draft 2014 National Nanotechnology Initiative Strategic Plan. The Strategic Plan provides the framework within which each National Nanotechnology Initiative (NNI) agency will carry out its nanotechnology programs and is intended to sustain coordination of interagency activities. The Strategic Plan includes the following goals: (1) advance a world-class nanotechnology research and development program; (2) foster the transfer of new technologies into products for commercial and public benefit; (3) develop and sustain educational resources, a skilled workforce, and a dynamic infrastructure and toolset to advance nanotechnology; and (4) support responsible development of nanotechnology. According to the draft Strategic Plan, “success will be measured by continual and substantive progress toward the four goals.” The program component areas were revised to represent better the current state of nanotechnology, improving their alignment with the goals and objectives of the Strategic Plan. Objectives in the draft Strategic Plan were revised to reflect advances in nanotechnology and evolving stakeholder needs. Sub-objectives were assigned to each objective to improve consistency among the goals. NNI requests comments of approximately one page or less in length (4,000 characters). According to the November 19, 2013, Federal Register notice, comments are due December 17, 2013. The NNI website states that comments are due December 18, 2013, however.
In November 2013, Switzerland’s Federal Office of Public Health (FOPH) updated its precautionary matrix for synthetic nanomaterials, which industry can use to assess nano-specific health and environmental risks of nanoproducts. FOPH states that the precautionary matrix “enables the structured assessment of the ‘nano-specific need for precautions’ when handling synthetic nanomaterials.” FOPH intends the matrix to assist industry with due diligence requirements, and their “duty to exercise self-control opposite employees, consumers and the environment.” According to FOPH, the precautionary matrix can identify “potentially risky applications,” allowing the initiation of precautionary measures to protect people’s health and the environment. FOPH notes that the precautionary matrix “is upgraded in close cooperation with industry, science and trade as well as consumer and environmental organisations.”
On November 7, 2013, the U.S. Court of Appeals for the Ninth Circuit granted in part and denied in part the Natural Resources Defense Council’s (NRDC) petition for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration of HeiQ AGS-20 and AGS-20 U (collectively, AGS-20) nanosilver products. The court held that “substantial evidence” supported EPA’s decision to use the characteristics of toddlers rather than infants in determining whether AGS-20 placed consumers at risk. The court vacated EPA’s decision “insofar as it concluded that there was no risk concern requiring mitigation for short- and intermediate-term aggregate oral and dermal exposure to textiles that are surface-coated with AGS-20.” The court stated: “Our decision to grant the petition and vacate the decision in part is based solely on the fact that EPA’s own rule states that there is a risk concern requiring mitigation when the calculated MOE is less than or equal to 1,000 and, under these circumstances, the actual MOE equals 1,000. This holding does not affect any portion of EPA’s decision where the calculated MOE is greater than 1,000.” Finally, the court held that “substantial evidence supported the EPA’s decision not to consider additional sources of exposure to nanosilver other than AGS-20 in concluding that the product would not have adverse effects on consumers.”
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) posted a blog item on October 24, 2013, concerning the use of nanotechnology to develop new drugs. According to the item, “[t]here are already many products made using materials at the nanoscale, including new kinds of clothing, packaging materials, and light-weight, but strong, building materials.” CDER conducted a series of risk assessment and risk management exercises concerning drugs that contain nanomaterials to determine if its current regulatory processes are adequate to identify any potential risks and reduce those risks. CDER states that these exercises “determined that our current regulatory review processes indeed can adequately protect the public from potential risks associated with the use of nanomaterials in drug products.” CDER also identified areas that could benefit from improvement, including “increased nanotechnology regulatory science research and up-to-date training of the review staff who evaluate marketing applications for drug products developed using nanomaterials.” FDA will present the findings of these exercises at the January 14-15, 2014, workshop on “Nanomaterial Drug Products: Current Experience and Management of Potential Risks.”
On October 8, 2013, Sweden issued a report proposing a national action plan for the safe use and management of nanomaterials. The report’s recommendations, as described in the English summary, include specific actions within several categories. Of particular interest are the following categories and specific recommendations:
- Measures for the development of the European Union’s (EU) regulatory framework:
- The government and relevant agencies shall work to bring about a revision of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH):
- Nanomaterials are to be registered as a separate substance;
- The tonnage limits are reduced for nanomaterials;
- The information to be submitted when registering nanomaterials includes supplementary data on their physic-chemical properties and, when necessary, other relevant information;
- The obligation to register products containing nanomaterials is extended; and
- The rules regarding information to downstream users are to be revised so that they also include relevant details on nanomaterials.
- The government and relevant agencies shall work to bring about a revision of the European legislation on chemical substances and products:
- The regulatory frameworks ensure that the data submitted and the assessments made are relevant to the substance in the form it occurs.
- Manufacturers, importers, and distributors of products containing nanomaterials should be able to declare the preceding and subsequent links in the distribution chain.
- The proposed amendments to the regulation on novel foods, aimed at clarifying the regulations on nanomaterials, are to be adopted as soon as possible.
- The government and relevant agencies shall work to bring about a revision of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH):
- Measures to increase knowledge about nanomaterials on the market:
- The Swedish Chemicals Agency to be given the task of investigating how an obligation to submit information on the occurrence of nanomaterials when registering products in the product register might be worded.
- An inventory of products on the market that contain nanomaterials to be performed.
The Product Quality Research Institute (PQRI) will hold a January 14-15, 2014, workshop on “Nanomaterial Drug Products: Current Experience and Management of Potential Risks.” The goals and objectives of the workshop, which is co-sponsored by the United States Pharmacopeia (USP) and American Association of Pharmaceutical Scientists (AAPS) and endorsed by the Society of Toxicology (SOT) are to:
- Review analytical science and methods for characterizing nanomaterials;
- Share experiences and results using multiple formulation platforms for the same active pharmaceutical ingredient (API);
- Discuss approaches to the management of potential risks of nanomaterials in drug products starting from early drug development and throughout the product lifecycle;
- Gather input regarding the considerations for utilizing nanotechnology in pharmaceutical products;
- Present experience and perspectives from international regulatory agencies and standards setting organizations on the use of nanotechnology in pharmaceutical products; and
- Discuss areas where additional research on the effects of nanosize APIs on absorption, distribution, metabolism, elimination, and toxicity may be needed.
The expected outcomes are to establish opportunities for collaboration between academia, industry, and government-sponsored research programs and develop a summary report of the workshop discussions and recommendations.
The Air & Waste Management Association (A&WMA) recently announced the formation of an Intercommittee Task Force (ITF) on Nanoscale Science and Engineering. The ITF will span a wide array of subjects, including environmental policy, measurement, health effects, monitoring, management, and safety issues associated with the development and use of nanomaterials, nanotechnologies, and nanoscale products. Its objectives will likely be:
- To bring societal recognition, understanding, and emphasis to address rapidly developing environmental health and safety issues associated with the development and use of nanomaterials;
- To provide coordination and focus among A&WMA’s Technical Coordinating Committees (TCC) to address specific issues posed by the development and use of nanomaterials; and
- To provide leadership, a forum, and opportunity to members, regulatory agencies, industry, and the public to assess scientific, technical, and policy issues relevant to the development and use of nanomaterials.
Full participation in the ITF is typically available only to A&WMA members. The ITF is aware that members of other organizations may wish to participate, or that potential participants may be unsure whether they wish to join A&WMA at this time. Therefore, the ITF is open to non-A&WMA members.
EPA Releases Final Comprehensive Environmental Assessment Applied to MWCNTs in Flame-Retardant Coatings in Upholstery Textiles
The U.S. Environmental Protection Agency (EPA) posted on September 30, 2013, a final report entitled Comprehensive Environmental Assessment Applied to Multiwalled Carbon Nanotube Flame-Retardant Coatings in Upholstery Textiles: A Case Study Presenting Priority Research Gaps for Future Risk Assessments. The final report presents a case study of multiwalled carbon nanotubes (MWCNT) used in flame-retardant coatings applied to upholstery textiles. EPA states that the case study is organized around the comprehensive environmental assessment (CEA) framework, which structures available information pertaining to the product life cycle, environmental transport and fate, exposure-dose in receptors (i.e., humans, ecological populations, and the environment), and potential impacts in these receptors. EPA notes that the final report “is not a health, risk, or exposure assessment and as such does not draw conclusions about potential risks, or present an exhaustive review of the literature.” Instead, according to EPA, it presents the research priorities identified by experts to aid research planning. EPA states that the outcomes of these research efforts may subsequently inform long-term MWCNT assessments.
On September 3, 2013, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) posted an electronic copy of its Handbook for Notifiers, which provides guidance for importers and manufacturers of industrial chemicals in Australia. Appendix H includes guidance and requirements for notification of new chemicals that are industrial nanomaterials, and addresses the following topics:
- NICNAS working definition of industrial nanomaterial;
- Exemption categories;
- Permit categories;
- Certificate categories;
- Specified conditions for requesting additional data requirements;
- Guidance on providing additional data requirements;
- Guidance on testing health effects of nanomaterials; and
- Guidance on testing the environmental fate and effects of nanomaterials.
On September 20, 2013, the National Toxicology Program (NTP) published a Federal Register notice requesting information on 20 substances, mixtures, and exposure circumstances, including nickel nanoparticles, nominated for possible review for future editions of the Report on Carcinogens (RoC). NTP seeks information concerning: (1) data on current production, use patterns, and human exposure; (2) information about published, ongoing, or planned studies related to evaluating carcinogenicity; (3) scientific issues important for assessing carcinogenicity of the substance; and (4) names of scientists with expertise or knowledge about the substance. The 12th RoC lists nickel compounds as “known to be human carcinogens.” Metallic nickel is listed as “reasonably anticipated to be a human carcinogen.” Information on nickel nanoparticles is due October 18, 2013.
The National Nanotechnology Initiative (NNI) has posted a report on its March 2012 international “Symposium on Assessing the Economic Impact of Nanotechnology.” NNI held the symposium in conjunction with the Organization for Economic Cooperation and Development (OECD), and the American Association for the Advancement of Science (AAAS) hosted it. Participants included scientists, engineers, policy analysts, private investors, technology leaders, and the general public from both OECD and emerging economies. Participants reported on initiatives for assessing the impact of nanotechnology and other technological fields. There was a consensus that more pilot initiatives and trials are needed to gain experience and knowledge and to aid in the development of good practices or guidelines for impact assessment. The report states that the data obtained would facilitate efforts to develop robust international documentary standards, which are critical to the broad commercialization and adoption of nanotechnology. According to the report, participants drew attention to the need to obtain information about impact without greatly increasing the burden on respondents. The report notes that the symposium emphasized the importance of measuring the full range of nanotechnology’s impacts, addressing risks, costs, and benefits. Impact analyses need to be on a sound footing in order to be undertaken on a global scale and comparable, the report states, and internationally agreed upon definitions of nanotechnology are needed. The participants concluded that nanotechnology “is sufficiently mature to justify the collecting of data to support the performance of economic impact assessments.” The report provides the reasoning behind the conclusion and identifies potential challenges involved.
The Congressional Research Service (CRS) prepared an August 9, 2013, report entitled The National Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues. According to the report, from fiscal year (FY) 2001 through FY 2013, the federal government invested approximately $17.9 billion in nanoscale science, engineering, and technology through the U.S. National Nanotechnology Initiative (NNI). President Obama has requested $1.7 billion in NNI funding for FY 2014. While the 109th, 110th, and 111th Congresses considered legislation reauthorizing the NNI, none of the bills passed. The report recommends that if the 113th Congress considers legislation reauthorizing the NNI, it may wish to consider “budget authorization levels for the covered agencies; [research and development] funding levels, priorities, and balance across the program component areas; administration and management of the NNI; translation of research results and early-stage technology into commercially viable applications; environmental, health, and safety issues; ethical, legal, and societal implications; education and training for the nanotechnology workforce; metrology, standards, and nomenclature; public understanding; and international dimensions.” The report states that “[c]onsideration may also be given to the establishment of an independent review panel and to coordination of the timing for the [National Nanotechnology Advisory Panel] assessment, the [National Research Council] assessment, and the [Nanoscale Science, Engineering and Technology] Subcommittee’s strategic plan for the NNI.”
The European Commission (EC) Scientific Committee on Consumer Safety (SCCS) announced on September 4, 2013, that it has extended the deadline for comments on the opinion for titanium dioxide (nano form), addendum to the opinion on zinc oxide (nano form), and revision of the opinion on 2,2’-methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol) nano form. Comments are due September 18, 2013. The SCCS website states: “Please note that, according to the Rules of Procedure of the Scientific Committees, the opinions of the Scientific Committees on a particular subject will be considered closed and not subject to revision for a period of 3 years. Therefore, in order to most efficiently process its workload and manage its resources, the Commission does not plan to reopen a respective issue following the commenting period and the publication of the opinion.”
On August 27, 2013, the U.S. Environmental Protection Agency (EPA) announced its proposed decision to register “Nanosilva,” a nanosilver-containing antimicrobial pesticide product. According to EPA, Nanosilva is a silver-based product “used as a non-food-contact preservative to protect plastics and textiles (e.g., in household items, electronics, sports gear, hospital equipment, bathroom fixtures and accessories) from odor and stain causing bacteria, fungi, mold and mildew.” EPA states that it evaluated exposure to nanosilver from Nanosilva “using data showing that plastics and textiles treated with the product released, at most, exceedingly small amounts of silver.” EPA also reviewed other information submitted by the applicant and used data from the scientific literature to evaluate the hazard of nanosilver. Based on its evaluation, EPA determined that Nanosilva “will not cause unreasonable adverse effects on people, including children, or the environment.” As a condition of registration, EPA is requiring the company to generate additional data. Comments on the proposed decision are due September 26, 2013. More information, including the Proposed Decision Memo, is available in the online docket.
On August 24, 2013, Canada issued a significant new activity (SNAc) notice for multi-walled carbon nanotubes (MWNCT). The notice states that MWCNTs are not included on the Domestic Substances List and that “a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999.” The notice defines substance as “short tangled multi-walled carbon nanotubes” that have the following characteristics:
(a) At least 90 percent of the substance is composed of elemental carbon;
(b) The nanotubes measure from 0.09 to 10 micrometres in length, with a 1.1 micrometre average; and
(c) The diameter of the nanotubes measures from 5 to 25 nanometres, with a 12 nanometre average.
A significant new activity in relation to the substance is:
(a) Its manufacture or import in a quantity greater than 100 kilograms (kg) per calendar year when it is to be used:
(i) In consumer products as defined in Section 2 of the Canada Consumer Product Safety Act, excluding solid plastic products; or
(ii) In products intended for use by or for children from 0 to 6 years old; or
(b) In all other cases, its manufacture or import in a quantity greater than 10,000 kg per calendar year.
The notice states that despite the above restrictions, “the manufacture or import of the substance to be used to manufacture an export-only product is not a significant new activity when the manufacturing process of the product results in releases of the substance to the aquatic environment in a quantity not exceeding 1 kg per day per site after wastewater treatment.” In addition, the manufacture or import of the substance to be used as a research and development substance is not a significant new activity. Information that must be provided prior to the commencement of a proposed significant new activity includes analytical information to determine the length and diameter of the substance, as well as information describing the primary and secondary particle size, agglomeration or aggregation state, shape, chirality, surface area, and surface charge of the substance; a brief description of the manufacturing process that details precursors of the substance, reaction stoichiometry, nature (batch or continuous), and scale of the process; analytical information to determine the leachability potential of the substance and its precursors from any final product resulting from the significant new activity; and analytical information to determine the dispersibility of the substance in the most significant environmental media related to the significant new activity. If the substance will be manufactured or imported in a quantity greater than 10,000 kg per calendar, the notice specifies additional test data that must be submitted. Manufacturers or importers must identify “every government department or government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use, manufacture and import of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and risk management actions in relation to the substance imposed by the department or agency.” Finally, the notice requires submission of “all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they have access, and that are relevant to determining whether the substance is toxic or capable of becoming toxic.”
The American National Standards Institute Nanotechnology Standards Panel (ANSI-NSP) will hold a free webinar on October 10, 2013, on its new nanotechnology standards database. ANSI-NSP intends the database to be “a free, comprehensive resource for individuals and groups worldwide seeking information about standards and other relevant documents related to nanomaterials and nanotechnology.” During the webinar, ANSI-NSP will discuss how the database can be used by groups and individuals as a resource, and will provide information about the short- and long-term goals associated with the creation of the database. Advance registration for the webinar is required.
Lynn L. Bergeson Co-Authors Article on Use of Alternative Test Strategies for Nanomaterial Safety Assessment
ACS Nano has published an article entitled “A Multi-Stakeholder Perspective on the Use of Alternative Test Strategies for Nanomaterial Safety Assessment,” which is co-authored by Lynn L. Bergeson. The article presents the results of a January 2013 workshop convened at the California NanoSystems Institute of the University of California, Los Angeles (UCLA) and hosted by the University of California Center for the Environmental Implications of Nanotechnology, as well as the UCLA Center for Nanobiology and Predictive Toxicology. Using carbon nanotubes as a case study, national and international leaders from government, industry, and academia discussed the utility of alternative test strategies (ATS) for decision-making analyses of engineered nanomaterials (ENM). After discussions, participants generated a short list of generally shared viewpoints, including a general view that ATS approaches for ENMs can significantly benefit chemical safety analysis. The article is available for purchase online.
On August 7, 2013, the U.S. Environmental Protection Agency (EPA) promulgated significant new use rules (SNUR) through a direct final rule for 53 chemical substances that were the subject of premanufacture notices (PMN), including two PMN substances whose reported chemical names include the term “carbon nanotube” (CNT). Seven of the chemical substances, including the CNT substances, are subject to consent orders under Section 5(e) of the Toxic Substances Control Act. Persons who intend to manufacture or process any of the 53 chemical substances for an activity that is designated as a significant new use must notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The SNURs are effective October 7, 2013. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, are due September 6, 2013. If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, it will withdraw the relevant SNUR(s) before the effective date.
NNI Will Hold Workshop on Stakeholder Perspectives on the Perception, Assessment, and Management of the Potential Risks of Nanotechnology
The National Nanotechnology Initiative (NNI) will hold a September 10-11, 2013, workshop concerning “Stakeholder Perspectives on the Perception, Assessment, and Management of the Potential Risks of Nanotechnology.” NNI is holding the workshop to facilitate stakeholder discussion of key elements needed to assess, manage, and communicate potential risks associated with use of nanomaterials and nanotechnology-enabled products, including:
- Understanding of the state of practice for the consideration of risk used by industry, academia, and the general public;
- Analysis of the role of comparative risk assessment in these evaluations, including decision analysis tools and gap analysis tools;
- Identification, through case study presentations, of stakeholder values and risk perceptions that inform their decision making, and the potential integration of these values and perceptions into a practical framework for risk communication;
- Current risk management practices in the emerging technology communities; and
- Determination of steps to improve the linkage of risk assessment to risk management and risk communication.
The workshop will include three roundtable discussions on: the perspectives and needs of (1) small businesses and (2) large enterprises, both pertaining to the responsible development of nanotechnology, as well as a roundtable on (3) public risk perception and communication. NNI invites interested members of the general public and NNI stakeholders, including representatives from academia, industry, small business, non-governmental organizations, and government to attend. Registration is free and on a first-come, first-served basis. The main sessions will be webcast.
ITC Seeks Information to Support Investigation of How EU Trade Restrictions Affect Exports of U.S. SMEs
The U.S. International Trade Commission (ITC) published a notice in the July 30, 2013, Federal Register announcing that, following receipt of a letter from the United States Trade Representative (USTR), it instituted investigation No. 332-541, “Trade Barriers that U.S. Small and Medium-Sized Enterprises Perceive as Affecting Exports to the European Union.” According to the notice, USTR’s letter indicated that the U.S., in the Transatlantic Trade and Investment Partnership (TTIP) negotiations, “will seek to strengthen U.S.-European Union (EU) cooperation to enhance the participation of SMEs in transatlantic trade, and to address trade barriers that may disproportionately impact small businesses.” ITC will base its report on available information, including information furnished by small- and medium-sized enterprises (SME) and interested parties. ITC will address, where information is available, specific trade barriers in individual EU Member States, and provide, to the extent applicable, qualitative distinctions among the identified trade-related barriers. ITC states that it will include suggestions gathered from SMEs or the relevant literature to strengthen U.S.-EU cooperation to enhance the participation of SMEs in transatlantic trade. ITC will hold a public hearing on October 8, 2013. Requests to appear at the hearing are due September 13, 2013, and the deadline for filing pre-hearing briefs and statements is September 20, 2013. Post-hearing briefs and other written statements are due October 15, 2013. ITC will transmit its report to USTR on January 31, 2014. As nano stakeholders may be disproportionately impacted by trade barriers, this is a valuable opportunity to comment.
On July 29, 2013, the American National Standards Institute Nanotechnology Standards Panel (ANSI-NSP) announced the launch of a new database compiling information concerning nanotechnology-related standards and affiliated activities. According to ANSI-NSP, the database is part of a larger effort by ANSI-NSP and its members and partners to increase the visibility of existing and in-development nanomaterials and nanotechnology guidance documents, reference materials, and standards. The database, which does not directly host the standards and other materials, is a free resource that provides information about standards and other relevant documents related to nanomaterials and nanotechnology-related products and processes. ANSI-NSP encourages standards-developing organizations, government bodies, and other relevant organizations to contribute information about their documents and standards.
On July 26, 2013, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) posted two documents for comment. The SCCS addendum to its opinion on zinc oxide (nano form) includes the following conclusion:
The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for use on the skin as UV filter in sunscreen formulations:
- ZnO nanoparticles of purity ≥96%, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1% in total.
- ZnO nanoparticles with a median diameter (D50: 50% of the number below this diameter) of the particle number size distribution above 30 nm, and the D1 (1% below this size) above 20nm.
- ZnO nanoparticles that are either uncoated or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane, and/or coated with other cosmetic ingredients as long as these cosmetic ingredients are accepted by the regulatory authorities and/or have been demonstrated to be safe for use as cosmetic ingredient.
- ZnO nanoparticles that have a comparable solubility to that reported in the dossier, i.e. below 50 mg/L (approximately the maximum solubility of the ZnO nanomaterials for which data are provided in the dossier).
The submitted 90 days inhalation study resulted in a NOAEL of 0.3mg/m3.
However these new data do not address the concerns relating to the lung exposure and the potential manifestation of harmful effects.
The SCCS opinion on titanium dioxide (nano form) includes the following overall conclusion:
1. Does SCCS consider that use of titanium dioxide in its nanoform as an UV-filter in cosmetic products in a concentration up to maximum 25.0 % is safe for the consumers taken into account the scientific data provided?
On the basis of the available evidence, the SCCS has concluded that the use of TiO2 nanomaterials with the characteristics as indicated below, at a concentration up to 25% as a UV-filter in sunscreens, can be considered to not pose any risk of adverse effects in humans after application on healthy, intact or sunburnt skin. This, however, does not apply to applications that might lead to inhalation exposure to TiO2 nanoparticles (such as powders or sprayable products). Furthermore, this assessment applies to 13 out of the 15 TiO2 nanoparticles presented in the submission, but may also be applicable to other TiO2 nanomaterials that have a close-similarity to the parameters in Tables 1-3.
. . .
2. In order for the COM to differentiate in the regulation between materials in its nanoform and its non-nano form, can the SCCS give quantitative and qualitative guidance on how this differentiation should be given based on the particle size distribution or other parameters?
A detailed SCCS guidance on risk assessment of nanomaterials in cosmetics has recently been published (SCCS/1484/12). The guidance provides a detailed account of the important nano-related parameters that should be considered in relation to physicochemical characterisation, hazard identification, exposure assessment and risk assessment of nanomaterials.
Comments on both documents are due September 6, 2013.
The European Commission (EC) called for tenders on June 23, 2013, for a study to assess the impact of possible legislation intended to increase transparency on nanomaterials on the market. The EC states that the objective of the open call for tenders is to assist it “in the preparation of an Impact Assessment to identify and to develop the most adequate means to increase the transparency and to ensure the regulatory oversight for nanomaterials on the market (‘nano-registry’).” The EC states that the work should consider a register of nanomaterials and/or products containing nanomaterials in parallel to the existing Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) obligations. The successful contractor will gather relevant data needed for the Impact Assessment, including the costs and administrative burden of possible registration obligations to companies, the possible effects on competitiveness, the possible effects of discouraging innovation in Europe, and the potential benefits for consumers and policy makers. Tenders are due August 19, 2013.
On July 4, 2013, the Belgian Federal Public Service for Health, Food Chain Safety, and Environment notified the European Commission (EC) of a draft decree that would create a register of substances manufactured at the nanoscale based on declarations of products containing such substances by the parties placing these products on the market. Under the draft decree, substances manufactured at the nanoscale, and preparations containing them, would be declared if more than 100 grams of these substances are placed on the market per year. If Belgium believes that a substance could present a risk to human health or the environment, it could ask registrants to provide information on potential dangers, exposure, and risks. The draft decree would apply to: substances manufactured at the nanoscale; preparations containing such substances; and articles incorporating these substances. Substances manufactured at the nanoscale included within the scope of the draft decree would encompass nanomaterials as defined in the EC’s October 2011 recommendation on the definition of nanomaterials, “including the assimilation of fullerenes, graphene flakes and carbon nanotubes, but with the exception of non-chemically-modified natural substances, substances produced accidentally and substances whose fraction between one nanometer and one hundred nanomet[er]s is a by-product of human activity.” Pigments and -- concerning the declaration of articles -- carbon black, synthetic amorphous silica, and precipitated calcium carbonate used as fillers would be excluded from the scope of the draft decree. Products already subject to regulations concerning nanomaterials, such as biocides, would also be excluded. The draft decree would apply from January 1, 2015, for nanomaterials and substances containing nanomaterials, and from January 1, 2016, for articles or complex objects that contain a substance in a nanoparticle state. European Union (EU) Member States have until October 7, 2013, to submit comments on the draft decree. Belgium could then pass the draft decree, revising it as necessary based on any comments received.
On July 4, 2013, the Danish Environmental Protection Agency began a public consultation on a draft order for a nanomaterials register. The draft order would impose annual reporting requirements on manufacturers and importers concerning mixtures and products containing nanomaterials. The reporting requirements would apply to nanomaterials released during use of the product or if the nanomaterial is the reason hazardous substances are released from the product. The order would take effect January 1, 2014, and the first reports would be due no later than January 31, 2015. Comments are due August 16, 2013.
On July 3, 2013, the U.S. Environmental Protection Agency (EPA) posted its 2013 Regulatory Agenda, which includes the following item concerning nanoscale materials:
Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements; Significant New Use Rule: EPA is developing a proposal to establish reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA) for chemical substances when manufactured (defined by statute to include import) or processed as nanoscale materials. Specifically, EPA is developing a significant new use rule (SNUR) under TSCA section 5(a)(2) that would require persons who intend to manufacture, import, or process this/these chemical substance(s) 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 required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs to prevent unreasonable risk to human health or the environment. In addition, EPA is developing 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. The proposed reporting of these activities will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.
According to the Regulatory Agenda item, EPA intends to issue a notice of proposed rulemaking in August 2013.
On June 26, 2013, the U.S. Environmental Protection Agency (EPA) promulgated final significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN), including for certain carbon nanotubes. The SNURs require persons who intend to manufacture or process any of these 17 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The final rule includes EPA’s response to comments. EPA encourages any manufacturers or processors who intend to conduct testing or submit a significant new use notification (SNUN) to contact EPA prior to commencing testing to avoid duplicative testing, to identify alternative testing, and to discuss protocols and testing strategies. A commenter suggested that EPA provide mandatory nano-specific ingredient and warning labeling requirements. In response, EPA states that the SNURs and consent orders that are the basis for the SNURs do not require nano-specific labeling or warnings because: “(1) the basis for the consent orders and SNURs is not that they are nanomaterials per se, but rather is based on their specific properties and potential risks, and (2) companies that manufacture, process, and use chemical substances that are carbon nanotubes and fullerenes already clearly identify those chemical substances as nanomaterials.” The proposed SNURs would allow the submission of data in support of a new chemical exposure limit (NCEL) under 40 C.F.R. Section 721.30. EPA notes that, because of the uncertainty surrounding the National Institute for Occupational Safety and Health (NIOSH) recommended exposure limit (REL) of 1 microgram per cubic meter (µg/m3), it “will not adopt the NIOSH REL as a NCEL at this time because EPA cannot determine that at the REL the potential exposures may not present an unreasonable risk.” EPA states that it will consider the final NIOSH REL, or other alternative exposure controls for carbon nanotubes, if a submission requesting such is made under 40 C.F.R. Section 721.30. EPA states that, despite uncertainties cited by a commenter, it “believes that its assessment and risk management of nanomaterials, although sometimes hampered by a lack of submitted data, is adequate to identify and prevent potential unreasonable risks to human health or the environment from manufacturing processing, and using nanomaterials including risks to workers.” The final rule will be effective on August 26, 2013.
The National Nanotechnology Initiative (NNI) posted frequently asked questions (FAQ) for small and medium business and industry. According to NNI, the FAQs provide answers to some of the most common questions from the nanotechnology business community. The FAQs provide links to sites where a nanotechnology start-up company can obtain information about government funding opportunities; resources intended to help a small company focusing on research and development of nanotechnology-enabled products or services; and ways for a small nanotechnology business to protect intellectual property. The FAQs list U.S. government regulatory agencies that play a role in nanotechnology commercialization; links for information on meetings or workshops related to nanotechnology; ways for small nanotechnology companies to find out what the federal government is interested in buying; and a link to the Department of Commerce Bureau of Industry and Security, which is charged with the development, implementation, and interpretation “of U.S. export control policy for dual-use commodities, software, and technology.” The FAQs state that the Bureau maintains a webpage “devoted to guidance on how to comply with export control laws and regulations.”
On June 21, 2013, the European Commission (EC) began a consultation on the modification of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation annexes on nanomaterials. According to the EC, the objective of the initiative is to provide further clarity on how nanomaterials are addressed. The EC states that REACH must ensure a high level of health, safety, and environmental protection, while also permitting access to innovative products and promoting innovation and competitiveness. The EC intends to provide clearer REACH requirements for nanomaterials to ensure that industry demonstrates safe use in the registration dossiers in accordance with REACH Article 1(1). The EC expects to propose a possible amendment of the REACH annexes in 2013. Any proposed amendment would be accompanied by an impact assessment. Comments are due September 13, 2013.
On June 19, 2013, the European Agency for Safety and Health at Work (EU-OSHA) posted a fact sheet entitled “Nanomaterials in Maintenance Work: Occupational Risks and Prevention.” EU-OSHA states that the fact sheet provides a short introduction to nanomaterials and their risks to workers’ safety and health. It explains how workers may encounter nanomaterials when undertaking maintenance work and also presents information on what should be done to prevent exposures.
On June 19, 2013, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing a public meeting and opportunity for comment on a proposed NIOSH survey. The primary purpose of the survey is to evaluate the use of NIOSH guidelines and risk mitigation practices for safe handling of engineered nanomaterials in the workplace. The proposed survey will examine the extent to which NIOSH and other guidelines are implemented and the barriers to using the guidelines. According to NIOSH, information collected from the survey will be useful in future revisions of the guidelines. Registration to attend the July 31, 2013, meeting is due July 17, 2013, and will be accepted on a first come, first served basis. Public comments on the proposed survey are due September 15, 2013. A draft questionnaire is available in the docket.
The Federal Public Service Health, Food Chain Safety, and Environment (FPS), which commissioned a study on the scope of a Belgian national register for nanomaterials and products containing nanomaterials, posted the final report on June 10, 2013. According to the final report, the data collected from individual companies, in addition to market research, has shown that nanomaterials are present on the Belgian market in a large variety of products and along the entire supply chain. The report states that declaring and tracing them along their lifecycle “would result in costs that are considered too high.” The study analyzed six options, including various restrictions of the scope, and compared them with respect to the objectives of a Belgian registry and the direct costs for industry. The final report recommends a registry “with an exemption list for selected pigments and fillers, selected supply chain actors, the possibility to avoid declaration based on scientific evidence, and a rollout phase for implementation as this option achieves the register objectives in the most effective manner -- in respect to the direct costs incurred by industry and also the amount of relevant data obtained per the number of declarations that could be used for e.g. exposure and risk assessments.”
On June 11, 2013, the European Parliament adopted a resolution calling for a “new agenda for European consumer policy.” The agenda calls for “adequate consumer protection and product safety in the markets for consumer goods produced using nanotechnology or genetically modified organisms.” The agenda also “[h]ighlights the need for close cooperation between European, national and local authorities and consumer associations in order to establish consultation mechanisms and implement the measures planned in the Agenda.”
On May 31, 2013, the European Commission (EC) began a public consultation on the new European Union (EU) occupational safety and health policy framework. According to the EC, the main purpose of the consultation is to obtain comments on the results of the evaluation of the European Strategy on Safety and Health at Work 2007-2012. The EC states that “[t]his should help identify current and future challenges in the occupational safety and health area, and identify solutions to address these challenges.” The EC staff working document highlights five main challenges, including “[i]dentifying the health and safety risks of new or emergent risks. Concerns about nanomaterials, endocrine disruptors and electromagnetic field hazards have been expressed and documented.” The EC states that it particularly seeks comments from Member State public authorities, social partner organizations, and stakeholders and experts with an interest in the area of occupational safety and health. Comments are due August 26, 2013.
The European Chemicals Agency (ECHA) began a public consultation on the draft multi-annual work program for 2014-2018. According to the draft work program, ECHA will develop “more refined guidance on the registration of substances in nano-form to provide further detailed advice reflecting the state-of-the-art in regulatory science in this respect and the anticipated adaptation of information requirements for nanomaterials in the [Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)] Annexes.” ECHA states that substance evaluation “will include evaluation of substances in nano-form and thereby contribute to advancing the information and understanding of hazards and risks posed by nanomaterials.” According to the draft work program, high priority topics in regulatory science include nanomaterials. The draft work program states: “With regard to nanomaterials, ECHA aims to ensure that the regulatory requirements of REACH, [Classification, Labeling, and Packaging (CLP)], and [Biocidal Products Regulation (BPR)] can be fully implemented to address the hazards and risks of substances in nanoform.” ECHA intends to extend further “its internal capacities in the area of the characterisation, hazard and safety assessment and risk management of nanomaterials; the Agency will also enable Member States’ experts to participate in capacity building and will share experience with stakeholders.” In addition, ECHA will participate in scientific and regulatory activities at the European Union (EU) and Organization of Economic Cooperation and Development (OECD) level “with the aim of developing appropriate guidance for industry, as well as being able to evaluate registration dossiers that contain information on the hazards, risks and risk management of nanomaterials, effectively.” Comments are due July 15, 2013.
The National Nanotechnology Coordination Office (NNCO) will hold a workshop on June 11-12, 2013, to obtain input from stakeholders regarding the goals and objectives of an updated National Nanotechnology Initiative (NNI) Strategic Plan, which is currently under development and scheduled for completion by December 2013. Participants will be invited to suggest additions to and provide feedback on wording and emphasis areas in the NNI goals, the objectives that support these goals, and the Nanotechnology Signature Initiatives. Comments will also be solicited on the relationship between these topics and the revised Program Component Areas, which will be presented at the workshop. NNCO invites representatives of the U.S. research community, industry, non-governmental organizations, and interested members of the general public to offer suggestions to the U.S. government interagency group that is drafting the new plan, which is an update of the 2011 NNI Strategic Plan. The workshop will be webcast.
On May 17, 2013, the National Nanotechnology Initiative (NNI) published a report on regional, state, and local (RSL) initiatives in nanotechnology. The report is the result of a workshop, convened May 1-2, 2012, and sponsored by the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the National Science and Technology Council and the Oregon Nanoscience and Microtechnologies Institute. The goal of the workshop was to improve the outcomes of nanotechnology research, education, and business activities undertaken to advance nanotechnology. The report states that the strategy for achieving this goal is “to exploit synergies between the various initiatives, promote sharing of information and resources, and develop ongoing mechanisms for relevant interactions.” The report is not intended to be a consensus document. It states that one theme rose to the top, however: “The continuing global economic downturn after 2008 and the demise of many previously sold RSL initiatives since the third NNI RSL workshop in 2009 gave a strong sense of urgency to the participants’ requests for more Federal attention to and matching financial support of the various regional, state, and local initiatives in nanotechnology.” The report includes recommendations in the following categories: commercialization; collaboration; policy; workforce; support for RSL initiatives; and RSL roadmapping. It also includes a “’Next Steps’ category to capture activities that can be begun immediately to keep interested parties in touch with one another.”
In May 2013, the European Commission (EC) posted a January 2013 report entitled Examination and Assessment of Consequences for Industry, Consumers, Human Health and the Environment of Possible Options for Changing the REACH Requirements for Nanomaterials. According to the report, 12 of the 21 originally suggested options are considered already implemented with existing legislation and guidance. The other nine options were considered relevant for an adaptation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation and thus build the basis for the assessment. The report states that the total costs for implementing the nine options range from €11 million to €73 million as a cumulative effort for all concerned companies for a time period until 2022. These costs result from extensive application of grouping and read-across approaches under REACH. Without this approach, the costs would multiply up to €100 million and €600 million. The report states: “The overall conclusion of this impact assessment shows that additional costs for companies lead to a reduced uncertainty about potentially adverse effects of nanomaterials to human health and the environment. These may lead to considerable benefits, especially if combined with appropriate risk reduction measures.”
On May 14, 2013, COWI announced that it was commissioned by the Danish Environmental Protection Agency (EPA) to assess the impacts of nanomaterials on Denmark’s environment. According to COWI, it will perform detailed risk assessments for ten different nanomaterials, including nanotitantium dioxide, nanosilver, nanocopper, and carbon nanotubes. A spokesperson stated that COWI will chart the lifecycle of the materials and examine what substances are released into the environment during various stages. COWI will extrapolate its findings to provide an overall assessment of risks to the environment posed by nanomaterials. According to the spokesperson, at a later stage, the findings could be used as a basis for determining the need for new -risk-reduction measures. The spokesperson noted that COWI was not charged with making recommendations for legislative action, however. A separate project will examine the risks posed by nanomaterials in consumer products.
On May 9, 2013, the U.S. Environmental Protection Agency (EPA) promulgated a significant new use rule (SNUR) for premanufacture notice (PMN) substance P-12-44, which is identified as “functionalized multi-walled carbon nanotubes.” According to the Federal Register notice, “[t]he PMN states that the generic (non-confidential) use of the substance is as an additive for rubber and batteries.” EPA states that it determined that “use of the substance other than as described in the PMN; manufacturing, processing, or use in a powder form; or any use of the substance resulting in surface water releases may cause serious health effects or significant adverse environmental effects.” EPA believes the results of the following tests would help characterize the health and environmental effects of the PMN substance: (1) A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a post-exposure observation period of up to three months, bronchoalveolar lavage fluid analysis, particle size distribution information and other toxicologically relevant properties, data on histopathology of pulmonary and ex-pulmonary organs/tissues (cardiovascular, central nervous system, liver, kidney, etc.), pulmonary deposition (lung burden), clearance half-life (biopersistence) and translocation of the test material, and a determination of cardiovascular toxicity; (2) analysis by Scanning Transmission Electron Microscopy, Transmission Electron Microscopy, or Scanning Electron Microscopy of number of walls (range and average), tube ends (open, capped, circular, other), tube width/diameter (measure inner and outer diameters or range), tube length (range) including a description of any deformities found in the tubes (bumps, branching, gaps, etc.); (3) percent (range) of functional groups found on the tubes (include the method of determination); and (4) particle size determined by count not by weight or volume (preferably using Scanning Transmission Electron Microscopy). The rule is effective on July 8, 2013.
The Ministry of Ecology, Sustainable Development and Energy recently announced that it has extended the deadline for declaring substances with nanoparticle status to June 30, 2013. According to the Ministry, it received 1,991 declarations from 457 companies by the original deadline of April 30, 2013. The Ministry states that, given the “diversity of actors covered by the declaration requirement, and at the request of several industries,” for the first reporting year, it will grant a two-month extension.
On May 15, 2013, Lynn L. Bergeson will participate in a U.S. Department of Defense (DOD) webinar on “Sustainable Chemicals and Materials for Defense Forum.” Bergeson will provide an overview of the U.S. Environmental Protection Agency’s (EPA) proposed significant new use rules for carbon nanomaterials and biobased chemicals/new chemical exposure limits. The webinar is open to interested stakeholders, who should contact Joey Skoloda for more information.
On April 11-12, 2013, the Netherlands Ministry of Infrastructure and the Environment hosted an invitation-only conference entitled “Building Blocks for Completing EU Regulation of Nanomaterials.” The conference was intended to identify areas where current European Union (EU) legislation on nanomaterials is insufficient. Participants include representatives from Member States, the European Commission (EC), European Parliament (EP), industry, and a number of non-governmental organizations. According to the April 29, 2013, Chairman’s Report, during the meeting, many participants “considered that databases or registries will be indispensable for gathering the necessary information on (products with) nanomaterials.” While France has already created a national registry, and other Member States, such as Denmark and Belgium, have taken steps towards creating their own, participants “agreed that a[n] EU-registration on nanomaterials is preferred over a series of varying national databases,” which could “create more problems than solutions in improving a harmonised European policy on nanomaterials.” The Chairman’s Report states that an EC official noted that “the main problem on the table is to define the level of information on nanomaterials that is required.” According to the Report, the current EC “(which will be in office until the second half of 2014) is unlikely to take a decision on setting up a community-wide EU-database for (products with) nanomaterials.” Industry participants acknowledged that an EU-wide registry could increase public confidence in the safety of nanomaterials, but expressed their concern that a registry could also stigmatize nanoproducts and increase the costs for small- and medium-sized enterprises. The Majority Agreements states: “There is a need to further discuss the goals, costs/benefits and outcome of a register of (products with) nanomaterials. Such discussion should address:
- Public concern;
- Consumers choice;
- Information (for authorities, in the supply chain, for consumers); and
- Proportionality, etc.
On April 30, 2013, the U.S. Environmental Protection Agency (EPA) Design for the Environment (DfE) announced the availability of the final report entitled Application of Life-Cycle Assessment to Nanoscale Technology: Lithium-ion Batteries for Electric Vehicles. The life-cycle assessment (LCA) was conducted by the DfE/Office of Research and Development (ORD) Li-ion Batteries and Nanotechnology Partnership. The Partnership conducted a screening-level LCA of currently manufactured lithium-ion (Li-ion) battery technologies for electric vehicles, and a next generation battery component that uses single-walled carbon nanotube technology. EPA states that the study demonstrates how the life-cycle impacts of an emerging technology and novel application of nanomaterials (i.e., the single-walled carbon nanotube technology anode) can be assessed before the technology is mature, and provides a benchmark for future LCAs of this technology. The final report’s key results and conclusions state: “In addition, the SWCNT nanotechnology applications assessed show promise for improving the energy density and ultimate performance of the Li-ion batteries in vehicles. However, the energy needed to produce these anodes in these early stages of development is significant (i.e., may outweigh potential energy efficiency benefits in the use stage). Over time, if researchers focus on reducing the energy intensity of the manufacturing process before commercialization, the overall environmental profile of the technology has the potential to improve dramatically.”
An April 26, 2013, USA Today article entitled “CDC sets carbon nanotech safety guidelines” reports on the National Institute of Occupational Safety and Health (NIOSH) Current Intelligence Bulletin (CIB) 65, Occupational Exposure to Carbon Nanotubes and Nanofibers. The article includes comments from Andrew Maynard, Chair of Environmental Health Sciences at the University of Michigan, Todd Kuiken with the Project on Emerging Nanotechnologies at the Woodrow Wilson Center for International Scholars, and Lynn L. Bergeson, Managing Director of Bergeson & Campbell, P.C. and a board member of the NanoBusiness Commercialization Association.
On April 24, 2013, the National Institute for Occupational Safety and Health (NIOSH) released Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers, which includes a proposed recommended exposure limit (REL) that is significantly lower than that in the 2010 draft. NIOSH issues Current Intelligence Bulletins (CIB) to disseminate new scientific information about occupational hazards. CIB 65 reviews animal and other toxicological data relevant to assessing the potential non-malignant adverse respiratory effects of carbon nanotubes and carbon nanofibers; provides a quantitative risk assessment based on animal dose-response data; proposes a REL of 1.0 microgram per cubic meter (µg/m3) of elemental carbon as a respirable mass 8-hour time-weighted average concentration; and describes strategies for controlling workplace exposures and implementing a medical surveillance program. NIOSH notes that in the 2010 draft of this CIB, it indicated that “risks could occur with exposures less than 1 μg/m3 but that the analytic limit of quantification was 7 μg/m3.” Based on subsequent improvements in sampling and analytic methods, NIOSH states that, in the final CIB, it is now recommending an exposure limit at the current analytical limit of quantification of 1 μg/m3. According to NIOSH, the REL “is expected to reduce the risk for pulmonary inflammation and fibrosis. However, because of some residual risk at the REL and uncertainty concerning chronic health effects, including whether some types of [carbon nanotubes] may be carcinogenic, continued efforts should be made to reduce exposures as much as possible.” NIOSH notes that, just prior to the release of CIB 65, it reported preliminary findings from a new laboratory study in which mice were exposed by inhalation to multi-walled carbon nanotubes. NIOSH states that the results of the study indicate that multi-walled carbon nanotubes can increase the risk of cancer in mice exposed to a known carcinogen. According to the CIB, NIOSH is conducting additional research to learn more about worker exposures and the potential occupational health risks associated with exposure to multi-walled carbon nanotubes and other types of carbon nanotubes and carbon nanofibers. NIOSH states that, as results from its research become available, it will reassess its recommendations and make appropriate revisions as needed.
The National Research Council (NRC) announced on April 23, 2013, that its second triennial review of the National Nanotechnology Initiative (NNI) identified five “cross-cutting, high-priority areas for focus and improvement for NNI going forward”:
- Improve information gathering and communication at the project level;
- Develop and implement interagency plans for focused areas;
- Rework the NNI website to serve better the diversity of stakeholder groups;
- Take advantage of new technologies for data collection and analysis; and
- Identify, share, and implement best practices, especially relating to technology transfer and commercialization.
In its report, the NRC assesses NNI’s role in maximizing opportunities to transfer selected technologies to the private sector and suggests improvements and new mechanisms intended to foster technology transfer. The NRC evaluates the suitability of current procedures and criteria to determine progress toward NNI goals, and recommends “explicit definitions of success for and metrics associated with meeting those goals.” The NRC also reviews the NNI’s management and coordination of nanotechnology research across participating federal agencies.
The Swedish Chemicals Agency (KemI) published an April draft proposal to amend the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to ensure the safe handling of nanomaterials. The draft proposal would adopt the October 2011 European Commission recommendation on the definition of nanomaterial. It would require manufacturers and importers of a nanomaterial, either on its own or in one or more mixture(s), in quantities of ten kg or more per year, to register. The obligation to register on-site isolated intermediates or transported intermediates that fulfill the definition of nanomaterials would apply to any manufacturer of the nanomaterial intermediate in quantities of ten kg or more per year. Producers or importers of articles containing nanomaterials would be required to notify the European Chemicals Agency if the nanomaterial is present in those articles in quantities over ten kg per producer or importer per year.
On April 10, 2013, Senator Frank R. Lautenberg (D-NJ) reintroduced the Safe Chemicals Act (S. 696), which would reform the Toxic Substances Control Act (TSCA) and is identical to legislation (S. 847) reported favorably out of the Senate Environment and Public Works Committee on a party-line vote in the 112th Congress. While the bill does not specifically mention nanomaterials, it defines “special substance characteristic”:
(A) IN GENERAL. -- The term ‘special substance characteristic’ means a physical, chemical, or biological characteristic, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect the risks posed by substances exhibiting that characteristic.
(B) CONSIDERATIONS. -- In determining the existence of special substance characteristics, the Administrator may consider --
(i) size or size distribution;
(ii) shape and surface structure;
(iii) reactivity; and
(iv) any other properties that may significantly affect the risks posed.
It is now expected that Senator David Vitter (R-LA), ranking minority member of the Committee, will introduce his version of a TSCA reform bill, a possibility that has been discussed in the trade press for months. More information is available in Bergeson & Campbell, P.C.’s April 11, 2013, memorandum.
The Nanotechnology Industries Association (NIA) has announced that a new version of its website is now online and available at http://www.nanotechia.org. NIA redesigned the website to serve its members better while also communicating more effectively with the public about the NIA’s activities. The new website better reflects the various sectors where the NIA is present and accurately describes the services offered to members. NIA is a sector-independent, responsible voice for the industrial nanotechnologies supply chains. It supports the ongoing innovation and commercialization of the next generation of technologies and promotes their safe and reliable advancement.
USDA Withdraws Final Rule Amending Guidelines for Designating Biobased Products for Federal Procurement
The U.S. Department of Agriculture (USDA) published a notice on April 8, 2013, withdrawing its April 1, 2013, final rule concerning the designation of product categories for federal procurement. According to the USDA, it is withdrawing the final rulemaking, which amended the guidelines for designating biobased products for federal procurement, because it published the final rule prematurely “due to an oversight in the development process.” The notice states that USDA’s Office of Procurement and Property Management “anticipates republishing the rulemaking in the coming months.”
The Danish Environmental Protection Agency (EPA) published on March 20, 2013, a proposal for technical information requirements for nanomaterials. The Danish EPA states that its proposal may be used in legislation concerning nanomaterials, such as the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The Danish EPA reviewed information requirement recommendations from expert groups, associations, and authorities. According to the Danish EPA, the proposed information requirement scheme is based on the REACH methodology, i.e., a stepwise approach requiring more information at higher tonnage levels. The Danish EPA notes that the proposal “should not necessarily be seen as a proposal for updating REACH, as it could also be put forward as a stand-alone scheme for nanomaterials and used in relation to adapting other existing legislation, or it could be used for guiding.”Continue Reading...
In an April 1, 2013, final rule, the U.S. Department of Agriculture (USDA) amended the Guidelines for Designating Biobased Products for Federal Procurement. The amendments add eight sections to designate product categories within which biobased products will be afforded federal procurement preference: aircraft and boat cleaners; automotive care products; engine crankcase oil; gasoline fuel additives; metal cleaners and corrosion removers; microbial cleaning products; paint removers; and water turbine bearing oils. The amendments also add the proposed countertops subcategory to the existing composite panels product category. USDA also established minimum biobased contents for each of these product categories and subcategories. In addition, USDA is officially changing the term “item” to product category. The amendments will take effect on May 1, 2013.
On March 20, 2013, five German agencies published a report entitled Nanotechnology -- Health and Environmental Risks of Nanomaterials, which includes a joint set of recommendations for future safety assessments of nanomaterials. Under a joint research strategy set up in 2007, over 80 research projects on nanomaterials were reviewed. The report includes recommendations to:
- Develop adequate measurement methods for risk assessment;
- Develop reference materials for exposure assessment and studies into the effects of nanomaterials on humans and the environment;
- Validate and harmonize test and evaluation strategies “in a national and international context” to allow results to be compared;
- Develop screening tests for adverse health and environmental risks at an early stage of material innovation;
- Develop ideas for labeling single nanomaterials; and
- Work on grouping nanomaterials based on their properties to reduce the number of complex single investigations.
The report was prepared by the Federal Institute for Risk Assessment, Federal Environment Agency, Federal Institute for Occupational Safety and Health, Federal Institute for Materials Research and Testing, and Physikalisch-Technische Bundesanstalt.
This week, the House Energy and Commerce Committee released the first of five bipartisan white papers that explore important policy implications related to continued implementation of the Renewable Fuel Standard (RFS). The white papers are intended to solicit input and stimulate debate in several areas: infrastructure, fuel compatibility, blending, economics, and environmental issues. Each paper will provide a detailed policy analysis on one area and then outline a series of questions intended to engage key stakeholders on that issue.
This first white paper, The Blend Wall and Fuel Compatibility Issues, focuses on one of the most pressing and complicated policy challenges facing proponents and opponents of biofuels. The paper recognizes a changed fuels refining environment from 2007, where fuel demand has fallen dramatically and 10 percent ethanol blends (the conventional ethanol blend percentage) are rapidly approaching saturation in the fuel pool. It discusses various aspects of mid-level ethanol blends (E15, E85), which have the ability to introduce higher volumes of biofuels than conventional blend levels. Some key questions posed at the end of the white paper for biofuels stakeholders relate to the feasibility of mid-level ethanol blends, the marketing and mis-fueling challenges to mid-level blends, the economics of the Blend Wall, and the intersection of new Corporate Average Fuel Economy (CAFE) vehicle standards and the RFS. The Committee asks stakeholders to respond to the first paper by April 5, 2013.
Industry Consortium for Environmental Measurement of Nanomaterials Publishes Practical Nano Measurement Guide
The Industry Consortium for Environmental Measurement of Nanomaterials (ICEMN) announced today the release of a series of articles to serve as a practical guide for state and federal regulatory agencies tasked with measuring engineered nanomaterials in the environment. The articles, published in the March 2013 special issue of Environmental Engineering Sciences, were prepared by academic and industrial scientists from ICEMN and focus on the techniques and issues around nanomaterial measurement in water, air, and soil. The series of articles collates sources of primary literature and summarizes secondary literature on experimental evidence of release of nanomaterials from nano-enabled products and the capture of nanomaterials in wastewater treatment, and reviews the methodological and measurement strategy issues involved in quantifying engineered nanomaterials in the environment.Continue Reading...
The March 16, 2013, Canada Gazette includes a significant new activity (SNAc) notice for cobalt iron manganese oxide, carboxylic acid-modified, which the notice states is not included on the Domestic Substances List (DSL). The notice defines SNAc as:
(a) [A]ny use where the substance is engineered to contain particles of particle size ranging from 1 to 100 nanometres in one or more dimensions, in a quantity greater than 100 kg per calendar year other than for a use described in paragraph (b); or
(b) [T]he use as an ink additive in commercial or industrial settings where the substance is engineered to contain particles of particle size ranging from 1 to 100 nanometres in one or more dimensions, in a quantity greater than 1,000 kg per calendar year.
The notice specifies data that must be provided to Canada 90 days before commencement of the proposed SNAc. Canada notes that, under the Canadian Environmental Protection Act, 1999, in circumstances where a SNAc notice is issued for a new substance, “it is the responsibility of every person who transfers the physical possession or control of the substance to notify all persons to whom the possession or control is transferred of the obligation to comply with the Significant New Activity Notice and of the obligation to notify the Minister of the Environment of any new activity and all other information as described in the Notice.” Users are responsible for being aware of and complying with the SNAc notice and submitting a SNAc notification prior to the commencement of a SNAc associated with the substance.
On March 11, 2013, the European Union’s (EU) FP7 project on Mitigation of Risk and Control of Exposure in Nanotechnology-based Inks and Pigments (nanoMICEX) announced publication of its first newsletter. According to nanoMICEX, project participants have been working to improve the conditions for workers in the inks and pigments industry, and the newsletter describes the latest news and developments. The newsletter reports on the March 2012 kick-off meeting, where participants discussed which engineered nanoparticles to characterize, how best to carry out hazard and exposure assessments, and ways in which risks will be assessed and managed. The newsletter describes work that has been done to date, while more in-depth articles by nanoMICEX partners provide information on how the partners are ensuring the safety of workers within the industry. The newsletter includes a timeline of upcoming activities in the next six months, including publication of the next newsletter in September 2013.
On February 22, 2013, Empa announced the availability of a study prepared on behalf of Switzerland’s Federal Office for the Environment (FOEN) entitled Human and Ecotoxicity of Synthetic Nanomaterials: Initial Insights for Major Accident Prevention. The study is intended to address whether new criteria for the determination of the quantity thresholds in the Ordinance on Protection against Major Accidents (OMA) may result from the accident potential or possible new hypothetical accident scenarios related to the human and ecotoxicity of synthetic nanomaterials. According to the study, data available at the present time are very limited and are inadequate to allow general conclusions to be drawn. Nonetheless, the study states, “initial insights for major accident prevention could be won, and a perspective on important pending questions given.” FOEN’s objective is to encourage research institutions and industry to take up these questions. FOEN “will continue to follow the national and international developments in this field, to put it in a position to introduce the necessary measures when necessary.”
The United States Department of Agriculture (USDA) posted a notice on its website concerning the BioPreferred Program. According to USDA, due to the absence of funding in the Farm Bill extension legislation, USDA has suspended the processing of applications for voluntary certification of biobased products. USDA states that it “will continue limited activities related to the Federal procurement preference program, such as adding products to the BioPreferred catalog, as staff resources allow. All existing biobased product label certifications (900 'USDA Certified Biobased Products' as of December 31, 2012) are and will remain valid.” Since 2002, USDA has designated some 89 categories representing 9,000 biobased products, all of which qualify for federal sustainable procurement standards.
On February 25, 2013, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 37 chemical substances that were the subject of premanufacture notices (PMN). EPA notes that the proposed SNURs include 14 PMN substances whose reported chemical names include the term “carbon nanotube” (CNT) or “carbon nanofibers.” If issued in final, the SNURs would require persons who intend to manufacture, import, or process the chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. EPA states that the required notification would provide it with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments are due April 26, 2013.Continue Reading...
On January 23, 2013, Representative Mike Honda (D-CA) reintroduced the Nanotechnology Advancement and New Opportunities (NANO) Act (H.R.394). Honda described the Act as a comprehensive bill intended to promote the development and responsible stewardship of nanotechnology in the U.S. Honda based the legislation on the recommendations of the Blue Ribbon Task Force on Nanotechnology, a panel of California nanotechnology experts convened by Honda and then-California State Controller Steve Westly during 2005. The bill includes recommendations from the Blue Ribbon Task Force for ways to promote the development and commercialization of nanotechnology; requires the development of a nanotechnology research strategy that establishes research priorities for the federal government and industry that will ensure the development and responsible stewardship of nanotechnology; and includes a number of provisions to create partnerships, raise awareness, and implement strategic policies to resolve obstacles and promote nanotechnology. Honda introduced similar legislation in the 112th (H.R. 2749), 111th (H.R. 820), and 110th (H.R. 3235) Congresses. None of the bills made it out of subcommittee.
The Organization for Economic Cooperation and Development (OECD) published on February 14, 2013, the updated Current Developments in Delegations on the Safety of Manufactured Nanomaterials -- Tour de Table. The purpose of the Tour de Table is to allow each delegation the opportunity to describe recent or planned national initiatives and/or events related to the safety of manufactured nanomaterials. According to OECD, this will facilitate the implementation of the projects of the WPMN by allowing delegations to share their experiences and preoccupations with respect to safety, and will identify opportunities for future co-operation and co-ordination.
The European Commission (EC) announced on February 5, 2013, that it completed its five-year review of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The pre-publication version of the EC’s report states that the EC “will make an impact assessment of relevant regulatory options, in particular possible amendments of REACH Annexes, to ensure further clarity on how nanomaterials are addressed and safety demonstrated in registration dossiers. If appropriate the Commission will come forward with a draft implementing act by December 2013.” The pre-publication version of the staff working paper specifically recommends that, if REACH needs amending “for other reasons,” then “consideration should be given to the introduction of the definition of a nanomaterial in line with Recommendation 2011/696/EU.”
The Occupational Safety and Health Administration (OSHA) recently published a fact sheet entitled Working Safely with Nanomaterials. OSHA notes that workers who use nanotechnology in research or production processes may be exposed to nanomaterials through inhalation, skin contact, or ingestion. OSHA intends the fact sheet to provide “basic information to workers and employers on the most current understanding of potential hazards associated with this rapidly-developing technology and highlight measures to control exposure to nanomaterials in the workplace.” According to the fact sheet, information and training provided to workers should include:
- Identification of nanomaterials the employer uses and the processes in which they are used;
- Results from any exposure assessments conducted at the work site;
- Identification of engineering and administrative controls and personal protective equipment (PPE) to reduce exposure to nanomaterials;
- The use and limitations of PPE; and
- Emergency measures to take in the event of a nanomaterial spill or release.
OSHA states that there are few occupational exposure limits specific to nanomaterials. According to OSHA, because certain nanoparticles may be more hazardous than larger particles of the same substance, existing occupational exposure limits for a substance may not provide adequate protection from nanoparticles of the same substance. OSHA notes the following specific exposure limits:
- OSHA recommends that worker exposure to respirable carbon nanotubes and carbon nanofibers not exceed 7.0 micrograms per cubic meter (μg/m3) as an 8-hour time-weighted average, based on the National Institute for Occupational Safety and Health (NIOSH) proposed Recommended Exposure Limit (REL); and
- OSHA recommends that worker exposure to nanoscale particles of titanium dioxide (TiO2) not exceed NIOSH’s 0.3 milligrams per cubic meter (mg/m3) REL. By contrast, NIOSH’s REL for fine-sized TiO2 (particle size greater than 100 nm) is 2.4 mg/m3.
OSHA suggests that, because exposure limits for other nanomaterials do not exist yet, employers should minimize worker exposure by using the hazard control measures and best practices identified in the fact sheet and in the references noted.
The U.S. Environmental Protection Agency announced on January 31, 2013, the proposed 2013 percentage standards for four fuel categories that are part of the Renewable Fuel Standard Program. Once EPA publishes the proposed standards in the Federal Register, there will be a 45-day comment period. Under the Energy Independence and Security Act (EISA), the annual renewable fuel volume targets steadily increase to an overall level of 36 billion gallons in 2022. To meet this goal, EPA calculates a percentage-based standard, and, based on the standard, each refiner and importer determines the minimum volume of renewable fuel that it must ensure is used in its transportation fuel. The proposed 2013 overall volumes and standards are:
- Biomass-based diesel (1.28 billion gallons; 1.12 percent);
- Advanced biofuels (2.75 billion gallons; 1.60 percent);
- Cellulosic biofuels (14 million gallons; 0.008 percent); and
- Total renewable fuels (16.55 billion gallons; 9.63 percent).
EPA notes that, for 2013, it is proposing to implement EISA’s requirement to blend more than 1.35 billion gallons of renewable fuels over the amount mandated for 2012.
On January 25, 2013, the U.S. Court of Appeals for the District of Columbia Circuit vacated the U.S. Environmental Protection Agency’s (EPA) 2012 cellulosic biofuel requirements under the renewable fuel standard. American Petroleum Institute v. EPA, D.C. Cir., No. 12-1139. In its January 2012 final rule, EPA projected that 8.65 million gallons of cellulosic biofuel would be produced in 2012, and determined that a reduction in the volume of total advanced biofuels was unnecessary because other kinds of advanced biofuels could make up for the shortfall. The American Petroleum Institute (API) filed suit, challenging EPA’s 2012 projection for cellulosic biofuel and its refusal to reduce the volume of total advanced biofuels for 2012. While the court rejected API’s argument that EPA failed to justify its determination not to reduce the applicable advanced biofuels volume, the three-judge panel unanimously agreed that “because EPA’s methodology for making its cellulosic biofuel projection did not take neutral aim at accuracy, it was an unreasonable exercise of agency discretion.” The court vacated that aspect of the 2012 rule and remanded it to EPA. An EPA spokesperson stated that EPA is still reviewing the court’s decision.
Oral arguments were held on January 16, 2013, in the Natural Resources Defense Council’s (NRDC) case challenging the U.S. Environmental Protection Agency’s (EPA) conditional registration of HeiQ AGS-20, a nanosilver product. NRDC filed suit on January 26, 2012, in the U.S. Court of Appeals for the Ninth Circuit (California). During oral arguments, EPA maintained that NRDC lacks standing to challenge the conditional registration. The judges appeared to reject EPA’s argument, suggesting that NRDC could prevail because of the low bar for establishing standing to challenge a rulemaking. The judges seemed less persuaded by NRDC’s argument that EPA erred in choosing three-year-olds rather than nine-month-olds as the most vulnerable subpopulation on which to base risk values. According to NRDC, EPA should have used infants, who are more likely to chew on textiles and could have higher exposures. EPA responded that EPA has a long-standing practice of using three-year-olds in risk assessments with similar exposure patterns to AGS-20, and that its use of three-year-olds was supported by leaching studies. NRDC further argued that EPA failed to consider the risk of aggregate exposures from other nanosilver products on the market. EPA responded that it applied uncertainty factors to account for data gaps and that HeiQ must submit more data to obtain a full registration.
On January 18, 2013, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice seeking comment on the types of hazard identification and risk management research to consider in updating its fiscal years 2013-2016 nanotechnology strategic plan. NIOSH states that it wants to “build on the accomplishments of ongoing research” to “develop strategic research goals and objectives for nanotechnology occupational safety and health research through 2016.” NIOSH previously identified ten critical research areas for nanotechnology research and communication: (1) toxicity and internal dose; (2) measurement methods; (3) exposure assessment; (4) epidemiology and surveillance; (5) risk assessment; (6) engineering controls and personal protective equipment; (7) fire and explosion safety; (8) recommendations and guidance; (9) global collaborations; and (10) applications. According to the notice, NIOSH is considering focusing the research goals on five key objectives: (1) increase understanding of new hazards and related health risks to nanomaterial workers; (2) expand understanding of the initial hazard findings on engineered nanomaterials; (3) support the creation of guidance materials to inform nanomaterial workers, employers, health professionals, regulatory agencies, and decision-makers about hazards, risks, and risk management approaches; (4) support epidemiologic studies for nanomaterial workers, including medical and exposure studies; and (5) assess and promote national adherence with risk management guidance. NIOSH requests public input to address the basis or rationale for priorities that NIOSH should give for studies of toxicity evaluation and/or workplace exposure characterization for engineered nanoparticles, and what rationale can be provided for recommending needs and types of technical and educational guidance materials. Comments are due March 19, 2013.
On January 9, 2013, the Norwegian Climate and Pollution Agency (Klif) posted a notice concerning the annual update of information and mandatory reporting of quantities for chemicals for 2012 to the Norwegian Product Register. The Product Register is the central register for chemical products in Norway, and there are currently approximately 25,000 products registered. According to Klif’s notice, changes include adding a “NANO box” that registrants should mark if the chemical contains nanomaterials. The January 7, 2013, letter sent to registrants states:
Physical data that may be of significance when assessing the dangerous properties of chemicals must be declared under section 21 of the Norwegian Regulations relating to classification and labelling of dangerous chemicals. Details are given in guidelines on declaration. The definition of nano materials is given in the recommendation of the Commission by 18 October 2011. Registration of substances in nano form in the Product Register will provide better knowledge about where and how nano materials are used. The information will be used by the authorities in their work to protect human health and the environment.
For all your mandatory declared chemicals we ask you to provide information that is already known by the producer about substances on nano scale. This means that if your chemical contains a substance/substances in nano form, you should mark this in the appropriate box on the enclosed list. In addition you have to identify which constituent that is in nano form in the same box. During 2013 you will have to update the composition for all your mandatorily declared chemicals that contain substances in nano form.
Responses are due February 8, 2013.
The French Ministry of Ecology and Sustainable Development posted a January 8, 2013, memorandum (in French) concerning the annual mandatory reporting of nanomaterials, which took effect January 1, 2013. 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. The report will be due by May 1 for information about nanoparticle substances produced/imported/distributed during the prior year. A report containing 2012 data will be due by May 1, 2013. The January 8, 2013, memorandum includes a link to a new website for reporting, as well as a link to a frequently asked questions and answers document (both in French).
On November 21, 2012, Health Canada began a public consultation on a Draft: Guidance Document -- Sunscreen Monograph, which is intended to replace the existing 2006 Sunburn Protectants Monograph. The draft Monograph identifies the permitted ingredients, including nano zinc oxide and nano titanium dioxide; doses; directions and indications for use for these products, which will be required to appear on the product labels; and the recommended supporting test methods. The draft Monograph notes that license holders are expected to continue monitoring and collecting new safety data as they emerge. Applicants are required to keep information for recordkeeping purposes when nano zinc oxide and/or nano titanium dioxide are used in sunscreen products, and this information is required to be made available upon request. Comments are due February 19, 2013.
The U.S. Environmental Protection Agency (EPA) is scheduled to announce in the January 8, 2013, Federal Register the availability of its 2012 Regulatory Agenda. EPA’s Regulatory Agenda includes the following notice concerning nanoscale materials:
Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements; Significant New Use Rule: EPA is developing a proposal to establish reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA) for chemical substances when manufactured (defined by statute to include import) or processed as nanoscale materials. Specifically, EPA is developing a significant new use rule (SNUR) under TSCA section 5(a)(2) that would require persons who intend to manufacture, import, or process nanoscale materials 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 required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs to prevent unreasonable risk to human health or the environment. In addition, EPA is developing 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. The proposed reporting of these activities will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.
According to the Regulatory Agenda item, EPA intends to issue a notice of proposed rulemaking in July 2013.
On December 20, 2012, U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson signed a final rule setting forth EPA’s final decision on the issues for which it granted reconsideration pertaining to its March 21, 2011, final rule entitled “Standards of Performance for New Stationary Sources and Emissions Guidelines for Existing Sources: Commercial and Industrial Solid Waste Incineration Units.” The December 20, 2012, rule makes technical corrections to the March 21, 2011, final rule, including clarifying the definition of clean cellulosic biomass (revisions are in red):
Clean cellulosic biomass means those residuals that are akin to traditional cellulosic biomass, including, but not limited to: agricultural and forest-derived biomass (e.g., green wood, forest thinnings, clean and unadulterated bark, sawdust, trim, tree harvesting residuals from logging and sawmill materials, hogged fuel, wood pellets, untreated wood pallets); urban wood (e.g., tree trimmings, stumps, and related forest-derived biomass from urban settings); corn stover and other biomass crops used specifically for the production of cellulosic biofuels (e.g., energy cane, other fast growing grasses, byproducts of ethanol natural fermentation processes); bagasse and other crop residues (e.g., peanut shells, vines, orchard trees, hulls, seeds, spent grains, cotton byproducts, corn and peanut production residues, rice milling and grain elevator operation residues); wood collected from forest fire clearance activities, trees and clean wood found in disaster debris, clean biomass from land clearing operations, and clean construction and demolition wood. These fuels are not secondary materials or solid wastes unless discarded. Clean biomass is biomass that does not contain contaminants at concentrations not normally associated with virgin biomass materials.
The amended definition will be effective 60 days after publication in the Federal Register.
The National Institute for Occupational Safety and Health (NIOSH) is scheduled to publish in the December 19, 2012, Federal Register a request for information and comment on silver nanoparticles. According to the notice, NIOSH has initiated an evaluation of the scientific data on silver nanoparticles “to ascertain the potential health risks to workers and to identify gaps in knowledge so that appropriate laboratory and field research studies can be conducted.” NIOSH has identified a number of “relevant publications” on silver nanoparticles, and this listing will be available in Docket CDC-2012-0014, at http://www.regulations.gov, once the Federal Register notice is published. NIOSH requests additional information concerning:
- Published and unpublished reports and findings from in vitro and in vivo toxicity studies with silver nanoparticles;
- Information on possible health effects observed in workers exposed to silver nanoparticles;
- Information on workplaces and products in which silver nanoparticles can be found;
- Description of work tasks and scenarios with a potential for exposure;
- Information on measurement methods and workplace exposure data; and
- Information on control measures (e.g., engineering controls, work practices, personal protective equipment) that are being used in workplaces where potential exposures to silver nanoparticles occur.
Comments will be due 60 days after the notice is published in the Federal Register.
U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson signed on November 30, 2012, a supplemental rule associated with the Renewable Fuel Standard (RFS) Program. The final rule contains a lifecycle greenhouse gas (GHG) analysis for grain sorghum ethanol and a regulatory determination that grain sorghum ethanol qualifies as a renewable fuel under the RFS Program. According to the rule, EPA’s analysis indicates that ethanol made from grain sorghum at dry mill facilities that use natural gas for process energy meets the lifecycle GHG emissions reduction threshold of 20 percent compared to the baseline petroleum fuel it would replace, and therefore qualifies as renewable fuel. The rule also includes EPA’s regulatory determination that grain sorghum ethanol produced at dry mill facilities, using specified forms of biogas for both process energy and most electricity production, has lifecycle GHG emission reductions of more than 50 percent compared to the baseline petroleum fuel it would replace, and that such grain sorghum ethanol qualifies as an advanced biofuel under the RFS Program. The rule will take effect when it is published in the Federal Register.
In a November 21, 2012, Canada Gazette notice, Canada amended the Domestic Substances List (DSL). The amendments include the addition of cellulose, hydrogen sulphate, sodium salt, obtained from sulphuric acid hydrolysis of the bleached pulp, with the substance having the following characteristics:
- (a) Nominal length of 100 ± 50 nanometres;
- (b) Cross section dimension less than or equal to 10 nanometres; and
- (c) Sulphur content of greater than or equal to 0.5 percent and less than or equal to 1.0 percent by weight.
Canada added the substance with substance identity number 91343, rather than a Chemical Abstracts Service (CAS) Registry Number. Substances on the DSL do not require notification unless they are proposed for a significant new activity (SNAc) as indicated on the DSL. Substances not appearing on the DSL are considered to be new to Canada and are subject to notification.
Environmental Law Network International’s (ELNI) recent issue of elni Review includes an article entitled “Law and innovation in the context of nanomaterials: Barriers to sustainable development? Results of an empirical study,” which examines to what degree the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation promotes innovations for sustainability through nanomaterials. The authors surveyed 37 companies based in Germany that manufacture and/or use nanomaterials to determine how REACH affected their approach. Issues addressed included the relationships between substance risks and innovation and between REACH and innovation. The authors determined that REACH does not offer sufficient incentives to register nanomaterials and to apply nano-specific safety assessment procedures. In addition, according to the authors, the lack of specific provisions within REACH concerning nanomaterials results in uncertainties in the interpretation of legal concepts and obligations. The authors offer preliminary conclusions for a possible adaptation of the legal framework for nanomaterials.Continue Reading...
The European Food Safety Authority (EFSA) published in the October 10, 2012, Official Journal of the European Union a call for tender to prepare a background document on the current knowledge in the field of nanotechnology and prepare an inventory of food additives/food contact materials/feed additives applications of nanotechnologies currently used and/or reasonably foreseen to be used. According to the tender specifications, the tasks will include:
- Performing an extensive literature search to summarize the knowledge in the field of nanotechnology applied to food and feed;
- Producing inventory lists for each type of application (e.g., food additives, enzymes, flavorings, food contact material, novel foods, feed additives, and pesticides), including at least one inventory list for food additives, one for food contact materials, and one for feed additives applications of nanotechnologies currently used and/or reasonably foreseen to be used;
- Reviewing the existing non-European Union (EU) legislation on the authorization of food additives/food contact materials/feed additives application in the area of nanotechnology; and
- Preparing a final report.
The length of the contract will be one year and is not renewable. Responses were due November 23, 2012. EFSA estimates that the contract will be completed in January 2014.
On November 28, 2012, the Canada-U.S. Regulatory Cooperation Council (RCC) held a webinar to discuss its RCC Nanotechnology Work Plan. Canada and the U.S. created the RCC to align better their regulatory approaches in a number of areas, including nanotechnology. According to information presented during the webinar, while the U.S. has received 137 notifications concerning nanomaterial substances, Canada has received only 16. While most of the nanomaterial substances notified in the U.S. were inorganic carbon, most of those notified in Canada were mixed metal oxides. During the webinar, both Canadian and U.S. spokespersons noted the difficulty in sharing information, due to confidential business information (CBI) claims. The RCC would like to be able to share information to inform better their regulatory programs and risk assessment/management approaches. This would include:
- General Substance Information: Substance name, company, applications, volumes; and
- Technical Substance Specific Information: Physchem properties, technical studies, and use pattern information.
The RCC requested that industry provide more information on the commercial distribution of nanomaterials, as well as more transparency by claiming confidentiality of only that information absolutely critical to market advantage.Continue Reading...
On November 20, 2012, Lux Research Inc. released a report entitled Bridging the Divide between Demands and Bio-Based Materials, in which the properties and commercial attractiveness of 38 applications and 21 conventional and bio-based polymers were assessed on 13 criteria, with three demand areas promising opportunity, according to Lux. Lux states that materials that fail to connect with end-user demands never reach the commercialization stage. Lux recommends that developers target large, addressable markets, among which the biggest are composites and coatings, industrial manufactured intermediates, and packaging. Lux notes that developers must offer bio-based alternatives at cost parity, offer more bio-based drop-in monomers, and continue to close performance gaps on temperature distortion and brittleness, as well as advance bio-based polymers beyond their reputation as merely “disposable.” Lux urges developers to meet or exceed expectations on cost and performance and be smart during roll-out. Kalib Kersh, a Lux analyst, stated that the U.S. Department of Agriculture (USDA) would expand the market for biobased chemicals if it fulfills its pledge to certify intermediates through its BioPreferred Program. During a recent conference held by the Society for the Commercial Development of Industrial Biotechnology, a USDA spokesperson stated that USDA intends to cover intermediates in its Program.
The American Fuel & Petrochemical Manufacturers (AFPM) petitioned the U.S. Court of Appeals for the District of Columbia Circuit on November 21, 2012, for review of the U.S. Environmental Protection Agency’s (EPA) 2013 biomass-based diesel renewable fuel requirements. Under EPA’s September 27, 2012, final rule, EPA increased the volume of biomass-based diesel from 1.0 billion to 1.28 billion gallons for calendar year 2013. According to AFPM, a number of factors have surfaced since EPA issued the rule that could result in unintended consequences adversely impacting the domestic refining industry and U.S. consumers. AFPM states that the increase could reduce investment in advanced biofuels that compete with biodiesel and increase carbon emissions. In addition, AFPM notes, the increase could negatively impact the price and supply of agricultural commodities, since additional biodiesel feedstocks, such as soybean oil, would be required under the rule.
The presentations from the August 14-16, 2012, “Safe Nano Design: Molecule » Manufacturing » Market” workshop are now available. The National Institute for Occupational Safety and Health (NIOSH) Prevention through Design Program and Nanotechnology Research Center held the workshop, during which participants provided input into the safe commercialization of nano products resulting in the development of guidelines for the safe synthesis of nanoparticles and associated products, using a Prevention-through-Design approach. The workshop focused on efforts to develop safer nano molecules that have the same functionality; process containment and control, based on the considerations of risk of exposure to workers; and the management system approaches for including occupational safety and health into the nanoparticle synthetic process, product development, and product manufacture. A summary of all of the outcomes from each panel discussion is in development. Lynn L. Bergeson was on the Planning Committee for the workshop, and presented remarks.
The Center for International Environmental Law (CIEL), ClientEarth, and Friends of the Earth Germany (BUND) released on November 13, 2012, a proposal for European Union (EU) legislation to address the risks of nanomaterials. CIEL states that the non-governmental organizations’ (NGO) proposal was prompted by the European Commission’s (EC) October 3, 2012, Communication on the Second Regulatory Review on Nanomaterials. The Communication describes the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program as “the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures” and notes that “more specific requirements for nanomaterials within the framework have proven necessary.” The NGOs maintain that further regulatory action is necessary, and recommend a “nano patch” for REACH, including an obligation for all nanomaterials to be considered distinct from their non-nanoscale counterparts and substantially lower volume thresholds for registration of nanoscale substances. The NGOs also call for an EU-wide registry for all nanomaterials and products on the market.Continue Reading...
BP announced on October 25, 2012, that it canceled its plans to build a commercial-scale cellulosic ethanol plant in Highlands County, Florida, and would instead refocus its U.S. biofuels strategy on research and development and licensing its biofuels technology. BP states that when it announced its plans to build the facility, in 2008, it intended to turn “thousands of acres of energy crops into 36 million gallons per year of cellulosic ethanol.” BP intends to continue to invest in and operate its biofuels research facility in San Diego, California, and a demonstration plant in Jennings, Louisiana, to develop next generation cellulosic biofuel technologies and license them for commercial use. Under the Energy Independence and Security Act of 2007, one billion gallons of cellulosic biofuel must be included in the U.S. fuel supply in 2013, and 16 billion gallons must be produced by 2022. The statute requires EPA to set the cellulosic biofuel standard each year based on the volume projected to be available during the following year, using Energy Information Administration projections and assessments of production capability from industry. For 2012, EPA projected there would be only 8.65 million gallons of cellulosic biofuel available, short of the 500 million gallons required. EPA has not yet set the standard for 2013.
On October 19, 2012, the European Comission (EC) began a public consultation on a preliminary opinion entitled Addressing the New Challenges for Risk Assessment. The Inter-Committee Coordination Group of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Scientific Committee on Consumer Safety (SCCS), and Scientific Committee on Health and Environmental Risks (SCHER) established a joint working group to review risk assessment procedures and new challenges for risk assessment, taking into account both fundamental and practical considerations, and to provide a scientific discussion paper on the issue. According to the preliminary opinion, a number of additional factors, including the need to assess more complex products and processes, e.g., products of nanotechnologies, make a thorough examination of current and potential future methods particularly timely. The preliminary opinion states that research is needed for developing models suitable for predicting the fate of nanomaterials. Fully new approaches need to be developed, conceptually different from the traditional molecular-based models. The preliminary opinion states that SCENIHR, SCCS, and SCHER “are aware that the most of the proposals described in this discussion paper are not realistically suitable for amending, in the short term, risk assessment procedures for regulatory purposes. However, this discussion paper highlights needs and priorities for research in order to get the objective of higher precision, accuracy and transparency in risk assessment for protecting human and environmental health." Comments are due November 30, 2012.
On October 22, 2012, Safe Work Australia announced the availability of a report entitled Human Health Hazard Assessment and Classification of Carbon Nanotubes, as well as an information sheet on the report. The report recommends that multi-walled carbon nanotubes should be classified as hazardous unless toxicological or other data for specific types imply otherwise. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) prepared the report in support of Safe Work Australia’s Nanotechnology Work Health and Safety Program. NICNAS extensively reviewed the published literature on the toxicity of carbon nanotubes, and concluded that multi-walled carbon nanotubes may cause damage to lungs through prolonged or repeated inhalation exposure. The report recommends classification as hazardous for repeated or prolonged inhalation exposure and for carcinogenicity. For all other endpoints, NICNAS found that carbon nanotubes either were not classified as hazardous, or cannot be classified as insufficient data are available. The information sheet summarizes the key findings from the report and discusses implications for manufacturers, importers, persons in control of a business or undertaking, and workers manufacturing or using products containing carbon nanotubes.
ECHA Will Hold Webinar on REACH Registration Dossiers for Nanomaterials and Creates Nanomaterials Working Group
On October 30, 2012, the European Chemicals Agency (ECHA) will hold a webinar entitled “How to ensure the safe use of nanomaterials under REACH Part I: Characterisation of nanoforms of substances in registration dossiers.” According to ECHA, the webinar will provide information to registrants on the type of information to be included in a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossier for a substance with nanoform(s). In addition, on October 17, 2012, ECHA announced publication of a new web page on nanomaterials under REACH and the Classification, Labeling, and Packaging (CLP) regulation. According to ECHA, the page “will provide advice to registrants that wish to register nanomaterials and inform about” ECHA’s latest activities concerning nanomaterials. The web page states that, in October 2012, ECHA created a nanomaterials working group “to discuss scientific and technical questions relevant to REACH and CLP processes and to provide recommendations on strategic issues.” The working group is an informal advisory group consisting of experts from Member States, the European Commission, ECHA, and accredited stakeholder organizations, “with the mandate to ‘Provide informal advice on any scientific and technical issues regarding implementation of REACH and CLP legislation in relation to nanomaterials.’” ECHA states that the working group also “aims to facilitate discussions with industry regarding its experience gained in documenting intrinsic properties of the nano-forms of substances using recent methodologies and its obligations towards fulfilling REACH requirements.”
On October 5, 2012, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) for potassium titanium oxide, which was previously the subject of a consent order under Section 5(e) of the Toxic Substances Control Act (TSCA). EPA states that, based on test data on the premanufacture notice (PMN) substance and structure activity relationship analysis of test data on analogous respirable, poorly soluble particulates (subcategory titanium dioxide), EPA “identified concerns for lung toxicity and fibrosis in workers exposed to the PMN substance by the inhalation route.” EPA issued the consent order based on a finding that the substance may present an unreasonable risk of injury to human health. The conditions required by the consent order include “[n]o manufacture of the PMN substance with a particle size less than 100 nanometers.” The final SNUR designates as a significant new use the absence of the protective measures required by the consent order. According to the SNUR, EPA determined that a 90-day inhalation toxicity test with special attention to histopathology of the lung tissues and to various parameters of the broncoalveolar lavage fluid would help characterize the human health effects of the PMN substance. The SNUR will be effective on December 4, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, are due November 5, 2012.
The Canada-U.S. Regulatory Cooperation Council (RCC) will hold a webinar on November 28, 2012, on its RCC Nanotechnology Work Plan. Canada and the U.S. created the RCC to align better their regulatory approaches in a number of areas, including nanotechnology. According to the U.S. Environmental Protection Agency (EPA), the purpose of the RCC’s nanotechnology initiative is to increase, where possible, regulatory transparency and coordination between the U.S. and Canada respecting nanomaterials. The Nanotechnology Work Plan includes specific objectives, deliverables, and milestones for tangible progress within the RCC’s two-year mandate. During the November 28, 2012, webinar, RCC will provide additional background information, as well as updates on ongoing activities under the Nanotechnology Work Plan. Stakeholders should confirm their webinar attendance no later than October 25, 2012.Continue Reading...
ICCM3 Adds Measures Concerning Nanotechnologies And Manufactured Nanomaterials To Global Plan Of Action
During the Third International Conference on Chemicals Management (ICCM3), which was held September 17-21, 2012, participants agreed to add the measures concerning nanotechnologies and manufactured nanomaterials to the Strategic Approach to International Chemicals Management (SAICM) Global Plan of Action. The measures include “exploring the development of registers/inventories and/or market assessment activities of manufactured nanomaterials,” and “promoting the availability of information on the presence of manufactured nanomaterials within the product supply chain and throughout the life cycle, which could include possible labelling, consistent with relevant international obligations, and/or other forms of guidance relating to consumer products containing manufactured nanomaterials.” Participants also agreed to a resolution to continue work on manufactured nanomaterials as an “emerging policy issue” under SAICM, and to develop international technical and regulatory guidance and training materials for their sound management. The Resolution invites the United Nations (UN) Committees of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) to review the applicability of the GHS criteria to manufactured nanomaterials and, if necessary, to prepare a work plan for adapting them.
On October 3, 2012, the European Commission (EC) announced its adoption of a Communication on the Second Regulatory Review on Nanomaterials, which assesses the adequacy and implementation of European Union (EU) legislation for nanomaterials, indicates follow-up actions, and responds to issues raised by the European Parliament (EP), EU Council, and the European Economic and Social Committee. The Communication concludes that “nanomaterials are similar to normal chemicals/substances in that some may be toxic and some may not.” Since possible risks are related to specific nanomaterials and specific uses, nanomaterials should be assessed on a case-by-case basis. The Communication states: “Current risk assessment methods are applicable, even if work on particular aspects of risk assessment is still required.” According to the Communication, the EC “remains convinced that REACH sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures but more specific requirements for nanomaterials within the framework have proven necessary. The Commission envisages modifications in some of the REACH Annexes and encourages ECHA to further develop guidance for registrations after 2013.” To improve the availability of information, the EC states that it “will create a web platform with references to all relevant information sources, including registries on a national or sector level, where they exist. In parallel, the Commission will launch an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight, including an in-depth analysis of the data gathering needs for such purpose. This analysis will include those nanomaterials currently falling outside existing notification, registration or authorisation schemes.”Continue Reading...
Tom Vilsack, Secretary of Agriculture, spoke at the 2012 GreenGov Symposium on September 25, 2012. According to Vilsack, the United States Department of Agriculture (USDA) is working to support the manufacturing industry by increasing the number of biobased products approved for federal purchase. Currently, there are approximately 9,300 BioPreferred products, and USDA intends to make 18,000 BioPreferred products available. Under Executive Order 13,514, federal agencies are required to ensure that 95 percent of new contracts use biobased products when available. Under a February 21, 2012, Presidential Memorandum, the USDA is directed to increase the number of categories of biobased products available for purchase by 50 percent by February 21, 2013. There were 64 categories of biobased products available in February 2012, and Vilsack stated that USDA has increased the number of categories to 77, including lotions and moisturizers, leather, vinyl, rubber care products, and shaving products.
The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) has posted an opinion on zinc oxide, nano-form. SCCS approved the opinion for adoption and it is now open for comment by applicants, national authorities, and other interested parties. SCCS considered whether zinc oxide in its nano-form is safe for use as a UV-filter with a concentration up to 25 percent in cosmetic products. SCCS concluded, on the basis of available evidence, that the use of zinc oxide nanoparticles with the indicated characteristics, at a concentration up to 25 percent as a UV-filter in sunscreens, “can be considered not to pose a risk of adverse effects in humans after dermal application.” SCCS notes that this does not apply to other applications that might lead to inhalation exposure to zinc oxide nanoparticles, such as sprayable products. SCCS states that the use of larger (non-nano) forms of zinc oxide as a UV-filter with a concentration up to 25 percent, as stated in its 2009 clarification, is safe and is not of any additional safety concern compared to the nano-forms assessed in the opinion. Regarding whether SCCS has any further scientific concern about the use of zinc oxide in cosmetic products, SCCS states: “In view of the lung inflammation induced by ZnO particles after inhalation exposure, the use of ZnO in cosmetic products which may result in inhalation is of concern.” SCCS also notes: “Any cosmetic products containing ZnO particles (nano or non-nano) with coatings that can promote dermal penetration will also be of concern.” Comments are due October 22, 2012.
Under a draft amendment to the Danish Chemicals Act, the Minister of the Environment would have the authority to write a detailed order establishing the rules for a national database of mixtures and articles containing or releasing nanomaterials. The order would also require producers and importers to report products containing or releasing nanomaterials. The information in the database is intended to form the basis of an evaluation of whether the content of nanomaterials in products on the Danish market poses a risk for consumers and the environment. The Ministry plans for the first reports to be due in early 2014.
On September 11, 2012, the Organization for Economic Cooperation and Development (OECD) posted a brochure entitled “Six Years of OECD Work on the Safety of Manufactured Nanomaterials: Achievements and Future Opportunities.” The brochure notes that “[a]fter six years of work, the OECD and its member countries have come to the conclusion that the approaches for the testing and assessment of traditional chemicals are in general appropriate for assessing the safety of nanomaterials, but may have to be adapted to the specificities of nanomaterials.” According to the brochure, knowing that the testing and assessment approaches for traditional chemicals are generally appropriate for assessing nanomaterials, OECD intends to focus on the specific aspects of manufactured nanomaterials that require the adaptation and/or development of specific testing methods used for assessing human health and environmental safety and on developing guidance documents for assessing manufactured nanomaterials adapted to their specificities. OECD states that this will include guidance on estimating exposure on how to use results on physicochemicals endpoints in exposure assessment and mitigation measures to reduce exposure to safe levels. The brochure highlights OECD’s activities concerning manufactured nanomaterials since 2006, including its Sponsorship Programme for the Testing of Manufactured Nanomaterials and development of guidance on exposure measurement and on exposure mitigation.
On September 5, 2012, the National Research Council (NRC) released a pre-publication version of a report entitled Science for Environmental Protection: The Road Ahead. The U.S. Environmental Protection Agency (EPA) asked NRC to assess EPA’s overall capabilities “to develop, obtain, and use the best available scientific and technologic information and tools to meet persistent, emerging, and future mission challenges and opportunities.” The report discusses nanotechnology as an example of using emerging science to address regulatory issues and support decision-making. The Committee states that, to have the capacity to address emerging tools, technologies, and challenges, EPA “will need to have enough internal expertise to identify and collaborate with the expertise of all of its stakeholders in order to ask the right questions; determine what existing tools and strategies can be applied to answer those questions; determine the needs for new tools and strategies; develop, apply, and refine the new tools and strategies; and use the science to make recommendations based on hazards, exposures, and monitoring.” According to the report, the example of engineered nanomaterials “illustrates some of the problems and pitfalls of current approaches to emerging technologies.” While EPA provided early funding regarding the use of nanotechnology in remediation, the report states that it missed the opportunity to support research addressing the environmental health and safety of nanomaterials, pollution prevention in the production of nanomaterials, and the use of nanotechnology to prevent pollution. The reasons for the delay in early intervention include “insufficient federal agency leadership, emphasis, and policy regarding proactive rather than reactive approaches to safer design.” If EPA intends to promote and guide early intervention in the design and production of emerging chemicals, materials, and products, the report states, “it will need to commit to this effort beyond its regulatory role.”
On August 31, 2012, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) issued a call for experts on the safety assessment of nanomaterials in cosmetic products. Under Article 16 of the Cosmetic Regulation EC No 1223/2009, any cosmetic product containing nanomaterials must be notified to the EC six months prior to being placed on the market. In case of concern, the EC will request SCCS to provide an opinion. According to the EC website, to meet the expected demand for safety assessments, the Commission Health and Consumers Directorate General intends to identify relevant experts who will assist the work of the SCCS. The Working Group is looking for experts with knowledge in relation to nanomaterials, particularly those used in cosmetic products, in the following areas:
- Systemic toxicity;
- Human exposure (including inhalation);
- In vitro and alternative methods; and
- Risk assessment for human health.
The deadline for submission for the call for experts is October 15, 2012.
ISO Preparing Labeling Guidance for Manufactured Nano-Objects and Products Containing Manufactured Nano-Objects
The International Organization for Standardization (ISO) Technical Committee (TC) 229 on nanotechnologies is preparing guidance on the format and content of voluntary labeling for manufactured nano-objects (MNO) and products, preparations, and mixtures containing MNOs. According to ISO, the guidance, ISO/TS 13830:2011, would also address the use of the term “nano” in product labeling. The European Committee for Standardization (CEN) was initially developing the guidance and, under CEN, the guidance would have included business-to-employee and business-to-business communications. During a June 2012 meeting, TC 229 decided to focus the guidance on consumer labeling, however. Other ISO guidance documents will address other kinds of business communications.
Lynn L. Bergeson Will Chair Session at Newly-Organized Sustainable Nanotechnology Organization Conference
Lynn L. Bergeson will chair a session of the first Sustainable Nanotechnology Organization (SNO) conference, which will be held November 4-6, 2012, in Arlington, Virginia. The conference will address the critical aspects of sustainable nanotechnology, including lifecycle assessment, green synthesis, green energy, food and agriculture, nanomedicine, industrial nanotechnology, environmental and biological fate, and the overall sustainability of engineered nanomaterials. Bergeson will chair a session on “Legal Aspects/Policy Considerations,” on November 5, 2012.Continue Reading...
The French Ministry of Ecology and Sustainable Development published an order in the August 10, 2012, Journal Officiel de la République Française concerning the content and submission requirements for the annual declarations of information relating to nanoparticle substances, as substances or as part of a mixture. The order comes into force on January 1, 2013, and provides details on how companies should meet the mandatory declaration obligations.
EU-OSHA Posts Literature Review on Risk Perception and Communication on Nanomaterials in the Workplace
On June 20, 2012, European Agency for Safety and Health at Work (EU-OSHA) posted a new literature review entitled Risk perception and risk communication with regard to nanomaterials in the workplace, which found “serious gaps in our awareness of the potential risks involved in handling nanomaterials at work, and serious shortcomings in the way that those risks are communicated to workplaces.” The review intends to:
- Summarize the general principles and theories of risk perception and communication, referring to relevant trends and current guidance on these topics;
- Identify the stakeholders involved in risk perception and communication for nanomaterials in the workplace, and appraise relevant research, studies, surveys, and risk communication initiatives that have been done to date at national and international levels; and
- Consider the gaps in knowledge and limitations of the risk communication initiatives in this area, and suggest ways these might be addressed, with a view to proposing how to communicate with workers and employers on the potential risks of nanotechnologies and highlighting the difficulties involved.
EU-OSHA states that risk communication strategies need to help employers make informed decisions about their workplaces and put adequate prevention measures in place, and to empower individual workers to take personal control of their own situations to protect themselves adequately.
SCENIHR Issues Call for Information and Experts on Health Effects of Nanomaterials Used in Medical Devices
On August 8, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a request it received from the EC for a scientific opinion on the safety of medical devices containing nanomaterials. According to the request, Notified Bodies have identified the following cases of alleged use of nanomaterials:
- Carbon nanotubes in bone cements;
- Nanopaste hydroyapatite powder for bone void filling;
- Polymer setting material with nanoparticles in dental cements;
- Polycrystalline nanoceramics in dental restorative materials;
- Nanosilver or other nanomaterials used as coatings on implants and catheters; and
- Nanosilver used as an antibacterial agent.
The EC states that, in addition, there are reports of iron-oxide nanoparticles injected into tumor cells to be heated-up by radiation or an external magnetic field, although this use has not yet been attributed clearly to the legislation on medicines or the to the legislation on medical devices.
The Pace Environmental Law Review (PELR) will publish a themed issue this winter concerning issues in the development and regulation of nanotechnology and biotechnology. Articles or essays should discuss the intersection between nanotechnology and/or biotechnology and environmental issues. PELR encourages submitters to take an interdisciplinary approach to nanotechnology and/or biotechnology from legal and other perspectives, including technology, science, public health, economics, or policy. Authors should send an abstract and cover letter to email@example.com. The deadline for submissions of article proposals is September 30, 2012.
On August 1, 2012, the U.S. Environmental Protection Agency (EPA) posted a final report entitled Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray, which EPA states “is intended to be used as part of a process to identify what is known and, more importantly, what is not yet known that could be of value in assessing the broad implications of certain nanomaterials.” According to EPA, “[t]he complex properties of various nanomaterials make evaluating them in the abstract or with generalizations difficult if not impossible.” EPA notes that the case study does not represent a completed, or even preliminary, assessment of nanosilver. Instead, it and other similar case studies are intended to support research planning efforts for nanomaterials. The case study is organized around the comprehensive environmental assessment (CEA) framework, which structures available information pertaining to the product lifecycle, transport, transformation and fate processes in environmental media, exposure-dose in receptors, and potential impacts in these receptors. If information is available, the case study also includes other direct and indirect ramifications of both primary and secondary substances or stressors associated with a nanomaterial. Through a structured collective judgment method, expert stakeholders used EPA’s draft case study to identify and prioritize research gaps that could inform future assessments and risk management efforts. Some of the research gaps pertain to nanosilver in disinfectant spray; others to nanosilver irrespective of its application, and still others to nanomaterials in general.
On July 25, 2012, the Senate Committee on the Environment and Public Works approved Senator Frank Lautenberg’s (D-NJ) amended Safe Chemicals Act of 2011 (S. 847) in a 10-8 partisan vote. While the bill does not explicitly mention nano, potentially relevant provisions remain in the amended text. These include the bill granting the Administrator the ability to determine that a variant of a chemical substance that exhibits one or more special substance characteristics either “is a use that is separate from any use of the chemical substance that does not exhibit the special substance characteristics” or is a distinct chemical substance. In the event that a chemical substance exhibiting special substance characteristics is considered to be a variant that is a separate use, the manufacturer or processor will be required to satisfy conditions that are established by the Administrator. In the event that a chemical substance exhibiting special substance characteristics is considered to be a distinct chemical substance, and is not listed on the active inventory of chemicals manufactured or processed in the U.S., the manufacturer or processor would be required to submit data. This measure could have a significant impact on nanoscale chemical substances.
On July 9, 2012, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (P.L. 112-144). The Act authorizes the U.S. Food and Drug Administration (FDA) to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biologics. It also includes a section concerning nanotechnology, directing the Secretary of Health and Human Services to “intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under the Federal Food, Drug, and Cosmetic Act” or other statutes administered by FDA. The Secretary may:
- Assess scientific literature and data on general nanomaterials interactions with biological systems and on specific nanomaterials of concern to FDA;
- In cooperation with other federal agencies, develop and organize information using databases and models that will facilitate the identification of generalized principles and characteristics regarding the behavior of classes of nanomaterials with biological systems;
- Promote FDA programs and participate in collaborative efforts to further the understanding of the science of novel properties of nanomaterials that might contribute to toxicity;
- Promote and participate in collaborative efforts to further the understanding of measurement and detection methods for nanomaterials;
- Collect, synthesize, interpret, and disseminate scientific information and data related to the interactions of nanomaterials with biological systems;
- Build scientific expertise on nanomaterials within FDA, including field and laboratory expertise, for monitoring the production and presence of nanomaterials in domestic and imported products regulated under the Act;
- Ensure ongoing training, as well as dissemination of new information within the FDA centers, and more broadly across FDA, to ensure timely, informed consideration of the most current science pertaining to nanomaterials;
- Encourage FDA to participate in international and national consensus standards activities pertaining to nanomaterials; and
- Carry out other activities that the Secretary determines are necessary and consistent with the purposes described above.
According to a July 10, 2012, memorandum added to the registration review docket for nanosilver, the Federal Register notice announcing the opening of the docket erroneously listed the comment period end date as August 19, 2012. The U.S. Environmental Protection Agency (EPA) memorandum states that the comment period has been extended to September 10, 2012, “to allow for a full 60-day comment period [that] is standard for registration review docket openings.”
The British Standards Institution (BSI) announced on July 9, 2012, the availability of three new standards and the development of a fourth standard intended to help mitigate the risks involved in manufacture and disposal of nanotechnology products. The three new Publicly Available Specifications (PAS) are:
- PAS 134:2012 -- Terminology for carbon nanostructures, 2nd edition: Revised to help ensure the use of a consistent language across the disparate industries and technologists involved in this area;
- PAS 138:2012 -- Guide to the disposal of manufacturing process waste containing manufactured nano-objects: Provides guidance regarding the disposal of manufactured nanomaterials and objects and will support manufacturers and others in making decisions as to the most appropriate way to dispose of their process waste; and
- PAS 139:2012 -- Detection and characterization of manufactured nano-objects in complex matrices: Provides guidance concerning the detection and characterization of nano-objects and to those who want to understand their impacts on human and environmental health.
Additionally, BSI is developing a fourth PAS:
- PAS 137:2012 -- Nanomaterials and nanotechnology-based products -- Guide to regulations and standards: Provides guidance for United Kingdom (UK) organizations (including small- and medium-sized enterprises (SME)) by signposting regulation and standards relevant to the importation, manufacture, processing, distribution, and sale of nanomaterials and nanotechnology-based products, thereby assisting organizations in their business development and commercial success.
The July 3, 2012, edition of the National Institute for Occupational Safety and Health (NIOSH) eNews includes a nanotechnology update, which states that the critical question to address is whether nanomaterials pose health or safety risks to workers employed in their manufacture and industrial use. The update includes the following “notable recent findings and areas of research”:
- A peer-reviewed paper recently published by NIOSH researchers addressing five areas to help focus action to protect workers:
- Review of the current evidence on the carcinogenic potential of carbon nanotubes (CNT), based on laboratory studies;
- The role of physical and chemical properties related to cancer development;
- CNT doses associated with changes to or damages in genes in laboratory animals and human tissue specimens;
- Workplace exposures to CNT; and
- Specific risk management actions needed to protect workers.
- A study linking nanoparticle exposure to cellular responses associated with autoimmune risks. In laboratory studies, exposures to certain types of nanoparticles produced cellular changes that are associated with risks for disorders of the autoimmune system such as rheumatoid arthritis.
- A recent paper highlighting the findings from an evaluation of the quality and completeness of information of nanomaterial safety data as it pertains to hazard identification, exposure controls, personal protective equipment, and toxicological information being communicated about the engineered nanomaterial. The study determined that the majority of the safety data sheets obtained in 2010-2011 provided insufficient data for communicating the potential hazards of engineered nanomaterials.
- In a paper published in June, NIOSH researchers scrutinize the “oxidative stress paradigm,” a widely accepted scientific model for understanding the processes that in general are associated with cellular damage, to better understand the processes that can occur from reactions to nanoparticles. The answer to this question will have important ramifications for the development of strategies for mitigation of potential adverse effects of nanoparticles.
- Recent findings indicating that improperly designed, maintained, or installed engineering controls may not be completely effective in controlling releases of nanomaterials into the workplace. Unprotected skin exposure to carbon nanofibers was noted in two instances and indicated the need for educating workers on the use of personal protective equipment.
- A summary of emission data collected at four facilities that volunteered to serve as test sites. The measurements indicated that specific tasks can release engineered nanomaterials into the workplace atmosphere and that traditional controls such as ventilation can be used to limit exposure. Much research is still needed to understand the impact of nanotechnology on health, and to determine appropriate exposure monitoring and control strategies.
The Netherlands National Institute for Public Health and the Environment (RIVM) published on June 29, 2012, a report entitled Interpretation and implications of the European Commission Recommendation on the definition of nanomaterial. The Dutch ministries requested RIVM to interpret the meaning and implications of the European Commission’s (EC) recommendation from a scientific perspective and to consider the implications for use in legislation. RIVM intends the report to provide the basis for discussions by policy makers and stakeholders on the use and further implementation of the recommended definition in national and international legal frameworks. RIVM concludes that, while the EC’s recommendation contains the relevant aspects, further guidance is necessary to ensure the definition is interpreted consistently. According to RIVM, the next step is to incorporate the definition into legal frameworks regarding the interpretation of the term nanomaterial. RIVM states that this will lead to the collection of “nano-specific” data, contributing to further insight into the “nano-specific” properties and the fate, kinetics, and effects of nanomaterials. This will help focus on the specific needs for risk assessment and risk management of nanomaterials.
On July 6, 2012, the U.S. Environmental Protection Agency (EPA) announced the establishment of a registration review docket for nanosilver. EPA states that registration review is its “periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment.” Registration review dockets include information intended to assist the public in understanding the types of information and issues that EPA may consider during the course of registration reviews. According to the preliminary work plan, EPA has information that there are silver-based pesticide products that were registered without the registrant disclosing to EPA the presence or characteristics of the nanosilver in their products. EPA sent a letter in August 2009 to each registrant with silver-based products requesting a statement as to whether their products contained any amount of silver in any form having a dimension that measures between 1 and approximately 100 nanometers. Four registrants responded that their products, which were registered using data for conventional silver, contain nanosilver. In the preliminary work plan, EPA states it is identifying several other products, registered using data for silver chloride, as potentially containing nanosilver. The registration review for nanosilver includes these products, as well as the two HeiQ nanosilver products conditionally registered in December 2011. According to the preliminary work plan, EPA believes that additional data are needed to determine whether the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) standard for maintaining these registrations is met “due to nanosilver’s unique physical and chemical properties, and thus nanosilver’s potentially different health and safety properties as compared to silver.”Continue Reading...
On July 4, 2012, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted its Guidance on the safety assessment of nanomaterials in cosmetics. The EC requested the SCCS develop guidance on the elements that would be required in a manufactured nanomaterial safety dossier. The SCCS states that the Guidance is intended to provide information to help compliance with the requirements for the safety assessment of nanomaterials intended for use in cosmetic products. The Guidance describes the need for special considerations in relation to the safety of nanomaterials, in view of the possible distinct properties, interactions, and/or effects that may differ from the conventional form of the same materials. The Guidance includes the main elements of risk assessment of nanomaterials in relation to possible use as cosmetic ingredients, i.e., general safety considerations, material characterization, exposure assessment, hazard identification and dose-response characterization, and risk assessment. The Guidance notes that the Cosmetics Regulation No 1223/2009 defines nanomaterial as “an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm,” and that this definition could be revised in light of the EC’s October 2011 Recommendation on the definition of a nanomaterial. According to the Guidance, if the Cosmetics Regulation definition were aligned to the Recommendation, it would provide further information on whether a material falls under the definition of a nanomaterial.
The United Nations (UN) Food and Agriculture Organization (FAO) and World Health Organization (WHO) have released a draft paper entitled State of the art on the initiatives and activities relevant to risk assessment and risk management of nanotechnologies in the food and agriculture sectors for comment. FAO and WHO commissioned the paper with the objective of summarizing and analyzing the information that has become available since their 2009 expert meeting and determining possible courses of action. The draft paper reviews national and international activities on the risk analysis of nanomaterials in the food and agriculture sectors that have been carried out since the meeting. It presents national and international risk assessment and risk management approaches that identify and implement strategies to address potential hazards associated with the use of nanotechnology-related products or techniques. Information on relevant regulations and risk assessment activities was gathered from the websites of 16 national and international institutions, organizations, and governments. Information on actual and planned uses of nanomaterials resulting in human exposure through food or food packaging/contact materials since 2009 was collected from a variety of sources, including the scientific literature, websites, patent databases, market analysis reports, and material presented at conferences, workshops, and symposia. Comments are due November 30, 2012.
EPA Nanomaterial Case Study Compares Multiwalled Carbon Nanotube and Decabromodiphenyl Ether Flame-Retardant Coatings Applied to Upholstery Textiles
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.
The National Institute for Occupational Safety and Health (NIOSH) Prevention through Design Program and Nanotechnology Research Center will hold an August 14-16, 2012, workshop entitled “Safe Nano Design: Molecule » Manufacturing » Market.” NIOSH states that participants will provide input into the safe commercialization of nano products resulting in the development of guidelines for the safe synthesis of nanoparticles and associated products, using a Prevention-through-Design approach. The workshop will focus on efforts to develop safer nano molecules that have the same functionality; process containment and control, based on the considerations of risk of exposure to workers; and the management system approaches for including occupational safety and health into the nanoparticle synthetic process, product development, and product manufacture. Lynn L. Bergeson is on the Planning Committee for the workshop. Registration is open until July 13, 2012.
On April 16, 2012, the Natural Resources Defense Council (NRDC) filed its brief in its lawsuit against the U.S. Environmental Protection Agency (EPA) concerning EPA’s conditional registration for HeiQ AGS-20, an end-use product containing nanosilver. NRDC filed suit on January 26, 2012, in the U.S. Court of Appeals for the Ninth Circuit (California) against EPA, seeking to limit public exposure to the nanosilver’s use in clothing, baby blankets, and other textiles and prevent EPA “from allowing nanosilver on the market without the legally-required data about its suspected harmful effects on humans and wildlife.”Continue Reading...
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.
The European Chemicals Agency (ECHA) recently held a two-day workshop concerning its first experiences with nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, with an emphasis on the evaluation process. ECHA, Member State Competent Authorities (MSCA), accredited stakeholders, and the European Commission (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.
On May 25, 2012, the European Chemicals Agency (ECHA) published three new appendices, updating Chapters R.8, R.10, and R.14 of the Guidance on Information Requirements and Chemical Safety Assessment. ECHA updated the guidance based on the outcome of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Projects on Nanomaterials (RIP-oN) 3, which concerned aspects such as occupational exposure estimation and dose-response characterization for human health and for environment. According to ECHA, the updated appendices “will further enhance the advice to registrants of substances in the nanoform a full year in advance of the next REACH registration deadline,” May 31, 2013.
The International Organization for Standardization (ISO) has published a Technical Report (TR) providing guidance on the physicochemical characterization of manufactured nano-objects prior to toxicological assessment. ISO states that TR 13014:2012, Nanotechnologies -- Guidance on physicochemical characterization of engineered nanoscale materials for toxicologic assessment, “is intended to assist health scientists and experts to understand, plan, identify, and address relevant physicochemical characteristics of nano-objects before conducting toxicological tests on them.” ISO Technical Committee (TC) 229 Working Group (WG) 3, Health, Safety, and Environmental Aspects of Nanotechnologies, prepared the TR. The U.S. Technical Advisory Group (TAG) to ISO TC 229, which is accredited and administered by the American National Standards Institute (ANSI), is open to all materially affected U.S. national interested parties. The U.S. TAG formulates positions and proposals on behalf of the U.S. with response to ISO standardization activities, and provides the delegates and experts who represent the U.S. at meetings of the respective ISO TCs, subcommittees, and WGs.
On March 27-28, 2012, the Organization for Economic Cooperation and Development (OECD), in collaboration with the National Nanotechnology Initiative (NNI), and hosted by the American Association for the Advancement of Science (AAAS) held an International Symposium on Assessing the Economic Impact of Nanotechnology. The objective of the symposium was to explore systematically the need for and development of a methodology to assess the economic impact of nanotechnology across whole economies, factoring in many sectors and types of impact, including new and replacement products and materials, markets for raw materials, intermediate and final goods, and employment and other economic impacts. Lynn L. Bergeson was on the Steering Committee and presented at the symposium. The presentation slides and plenary videos are now available online.
Federal Advisory Council on Occupational Safety and Health Considers Dispersible Engineered Nanomaterials
The Federal Advisory Council on Occupational Safety and Health (FACOSH) met on May 3, 2012, during which it discussed the use of occupational exposure levels (OEL) by the federal government. Because the Occupational Safety and Health Administration’s (OSHA) permissible exposure limits (PEL) have remained unchanged since their adoption on May 29, 1971, and do not account for advances in technology or the latest data, FACOSH asked its Emerging Issues Subcommittee to analyze federal agencies’ use of PELs. As part of its review, the Subcommittee identified other issues of interest, including dispersible engineered nanomaterials (DENM). A document entitled “Recommendations for Consideration by the U.S. Secretary of Labor on the Adoption and Use of Occupational Exposure Limits by Federal Agencies” includes the following text concerning DENMs:
- OSHA defines nanomaterials as, “materials that have been purposefully manufactured, synthesized, or manipulated to have a size with at least one dimension in the range of approximately 1 to 100 nanometers and that exhibit unique properties determined by their size.”
- Published scientific studies have indicated that at least some DENMs are biologically active, have produced toxicological reactions in the lungs of exposed experimental animals, and may readily penetrate intact human skin. While DENMs are truly an emerging issue and published results are not plentiful, scientists and federal agencies, such as NIOSH, continue to conduct research to understand fully the potential health effects of exposure.
- Currently, both scientists and federal agencies agree that DENM toxicity depends heavily on the physical and chemical properties of the nanoparticles, such as particle size and size distribution, agglomeration state, shape, crystal structure, chemical composition, surface area, surface chemistry, surface charge, and porosity, and that these properties may differ substantially from those of the same material in macro-scale form.
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.”
The U.S. delegation to the July 4-6, 2012, meeting of the United Nations (UN) Subcommittee of Experts on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) is considering presenting an information paper on how to classify nanomaterials under the GHS. According to Kathy Landkrohn, Occupational Safety and Health Administration (OSHA) Directorate of Standards and Guidance, the paper would be presented under a work group examining the types of physical and chemical properties listed on safety data sheets (SDS). Landkrohn stated that a lack of data has impeded the work group’s ability to create a separate hazard class for nanomaterials.
On May 14, 2012, the U.S. Environmental Protection Agency (EPA) and the Department of Commerce announced efforts to launch an environmental technology initiative intended to help create American jobs in the growing environmental industry. EPA released a document entitled Technology Innovation for Environmental and Economic Progress: An EPA Roadmap, which states that EPA “will undertake policy, regulatory, financial, and voluntary actions, grounded in science, that will promote innovation along the entire continuum of technology development and deployment.” Specifically, according to the Roadmap, EPA “will advocate more cost-effective, innovative solutions that eliminate, or significantly reduce, adverse impacts to natural resources in a manner that promotes healthy, productive communities.” EPA states that its initial efforts will focus on four broad actions:
- Designing EPA policies, regulations, standards, permits, and procedures to leverage technology innovation;
- Catalyzing technology design, development, finance, commercialization, and adoption through partnerships with stakeholders;
- Stimulating cross-Agency consideration, development, commercialization, and adoption of breakthrough technologies; and
- Developing a new relationship with the investment community. EPA will take a number of steps to build relationships and improve communication.
On May 14, 2012, the agencies participating in the National Nanotechnology Initiative (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. NKI identifies four areas that will benefit from focused attention:
- A diverse collaborative community of scientists, engineers, and technical staff to support research, development, and applications of nanotechnology to meet national challenges;
- An agile modeling network for multidisciplinary intellectual collaboration that effectively couples experimental basic research, modeling, and applications development;
- A sustainable cyber-toolbox to enable effective application of models and knowledge to nanomaterials design; and
- A robust digital nanotechnology data and information infrastructure to support effective data sharing, collaboration, and innovation across disciplines and applications.
The Strategic Approach to International Chemicals Management (SAICM) Secretariat is expected to publish this month comments on Switzerland’s proposal that activities relating to nanotechnology be added to the SAICM Global Plan of Action. The proposal would include a new work area on nanotechnologies and manufactured nanomaterials, with corresponding activities, actors, and targets. The Secretariat will compile the comments to inform discussion at the third International Conference on Chemicals Management (ICCM3), which will be held September 17-21, 2012. The Nanotechnology Industries Association (NIA) submitted detailed comments on the proposal.
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.”
On May 1, 2012, President Barack Obama signed an Executive Order (EO) entitled “Promoting International Regulatory Cooperation,” which is intended to ensure that differing regulatory approaches taken by foreign governments do not unnecessarily limit the ability of American businesses to export and compete internationally. EO 13563, which Obama signed on January 18, 2011, states that the U.S. regulatory system must protect public health, welfare, safety, and the environment while promoting economic growth, innovation, competitiveness, and job creation. The May 1, 2012, EO calls for the Regulatory Working Group established by Executive Order 12866, and reaffirmed by EO 13563, to serve as a forum to discuss, coordinate, and develop a common understanding among agencies of U.S. government positions and priorities with respect to: international regulatory cooperation activities that are reasonably anticipated to lead to significant regulatory actions; efforts across the federal government to support significant, cross-cutting international regulatory cooperation activities; and promotion of good regulatory practices internationally, as well as the promotion of U.S. regulatory approaches, as appropriate.Continue Reading...
Representatives Bill Pascrell, Jr. (D-NJ) and Brian Bilbray (R-CA) introduced on April 26, 2012, the Qualifying Renewable Chemical Production Tax Credit Act of 2012 (H.R. 4953), which would amend the Internal Revenue Code to provide a credit for the production of renewable chemicals. The credit would be equal to $0.15 per pound of eligible content of renewable chemical produced during the taxable year. Eligible content would mean the biobased content percentage of the total mass of organic carbon in such chemical. Renewable chemical would mean any chemical produced in the U.S. from renewable biomass that is sold or used for the production of polymers, plastics, or formulated products, or as polymers, plastics, or formulated products, and is not sold or used for the production of any food, feed, or fuel. Chemicals would be excluded if the biobased content percentage is less than 25 percent; 10,000,000 pounds or more of such chemical was produced in 2000 from renewable biomass; the chemical is neither the product of nor reliant upon, biological conversion, thermal conversion, or a combination of biological and thermal conversion, of renewable biomass; or the chemical is composed of renewable chemicals that are eligible for a credit under the bill. The total number of credits under the program would be limited to $500,000,000, and no taxpayer may receive more than $25,000,000 in any taxable year. The program would end five years after the date of enactment of the bill. The bill was referred to the House Committee on Ways and Means.
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.
On April 27, 2012, the President’s Council of Advisors on Science and Technology (PCAST) released the Report to the President and Congress on the Fourth Assessment of the National Nanotechnology Initiative, which is a Congressionally mandated biennial review of the National Nanotechnology Initiative (NNI). PCAST found that the NNI, which has provided $16 billion to date in investments by 26 federal agencies, “has had a ‘catalytic and substantial impact’ on the growth of the U.S. nanotechnology industry and should be continued.” PCAST states that, in large part due to the NNI, the U.S. “is today, by a wide range of measures, the global leader in this exciting and economically promising field of research and technological development.” The Obama Administration has proposed $1.8 billion in funding for fiscal year 2013 for 15 agencies with budgets dedicated to nanotechnology research and development (R&D).Continue Reading...
On April 26, 2012, the Obama Administration released its National Bioeconomy Blueprint, which is intended to provide a comprehensive approach to harnessing innovations in biological research to address national challenges in health, food, energy, and the environment. In coordination with the release of the National Bioeconomy Blueprint, the Secretary of Health and Human Services Kathleen Sebelius and the Secretary of Agriculture Tom Vilsack announced commitments supportive of the Blueprint’s goals. These include initiatives to encourage federal procurement of an expanded range of biobased products; take better advantage of large pharmaceutical data sets to speed drug development; apply the latest genomics discoveries to identify quickly emerging microbial threats; and accelerate research on non-embryonic stem cells as possible treatments for blood-related and neurological diseases.Continue Reading...
On April 18, 2012, the United States Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA) promulgated a final rule amending the Federal Acquisition Regulation (FAR) to implement changes due to the Farm Security and Rural Investment Act that require contractors to report the biobased products purchased under service and construction contracts. According to the Federal Register notice, the reporting will enable agencies to monitor compliance with the federal preference for purchasing biobased products. The information reported by prime contractors will enable federal agencies to report annually information concerning actions taken to implement the preference for biobased products, and assess compliance and measure progress in carrying out the preference for biobased products. Where information on the biobased nature of products is not already available, the notice states that contractors may need to create an inventory management system to track the product types and dollar value of United States Department of Agriculture (USDA)-designated biobased products purchased for each contract. DoD, GSA, and NASA expect that the impact will be minimal, however, because the existing clause already requires contractors to make maximum use of biobased products. The final rule will be effective May 18, 2012.
On April 20, 2012, the U.S. Food and Drug Administration (FDA) announced the availability of two draft guidance documents addressing the use of nanotechnology, “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives,” and “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.” FDA states that the food draft guidance describes factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may:
- Affect the identity of the food substance;
- Affect the safety of the use of the food substance;
- Affect the regulatory status of the use of the food substance; or
- Warrant a regulatory submission to FDA.
The cosmetic product draft guidance discusses the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products. Key points include:
- The legal requirements for cosmetics manufactured using nanomaterials are the same as those for any other cosmetics. While cosmetics are not subject to premarket approval, companies and individuals who market cosmetics are legally responsible for the safety of their products and they must be properly labeled; and
- To conduct safety assessments for cosmetic products containing nanomaterials, standard safety tests may need to be modified or new methods developed.
FDA notes that both guidance documents encourage manufacturers to consult with it before taking their products to market. According to FDA, this consultation can help FDA experts address questions related to the safety or other attributes of nanotechnology products, or answer questions about their regulatory status. Comments will be due 90 days after FDA announces their availability in the Federal Register.
The European Chemicals Agency (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). The draft appendices are available at:
- R.8 -- http://echa.europa.eu/documents/10162/13643/appendix_to_r8_clean_en.pdf;
- R.10 -- http://echa.europa.eu/documents/10162/13643/appendix_to_r10_clean_en.pdf; and
- R.14 -- http://echa.europa.eu/documents/10162/13643/appendix_to_r14_clean_en.pdf.
EU OSHA Announces French Report on Feasibility of Epidemiological Surveillance System for Workers Exposed to Engineered Nanomaterials
The European Agency for Safety and Health at Work (EU OSHA) posted an item 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. While the French report is dated 2011, an English summary is dated 2012.
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.
In an April 4, 2012, final rule, the U.S. Department of Agriculture (USDA) amended the Guidelines for Designating Biobased Products for Federal Procurement to add 13 sections to designate product categories within which biobased products will be afforded federal procurement preference. USDA also established minimum biobased contents for each of these product categories. The 13 categories are: air fresheners and deodorizers; asphalt and tar removers; asphalt restorers; blast media; candles and wax melts; electronic components cleaners; floor coverings (non-carpet); foot care products; furniture cleaners and protectors; inks; packing and insulating materials; pneumatic equipment lubricants; and wood and concrete stains. USDA has determined that each of these product categories meets the necessary statutory requirements; that they are being produced with biobased products; and that their procurement will carry out the following objectives of Section 9002 of the Farm Security and Rural Investment Act of 2002, as amended by the Food, Conservation, and Energy Act of 2008: to improve demand for biobased products; to spur development of the industrial base through value-added agricultural processing and manufacturing in rural communities; and to enhance the nation’s energy security by substituting biobased products for products derived from imported oil and natural gas. With the designation of these specific product categories, USDA invites the manufacturers and vendors of qualifying products to provide information on the product, contacts, and performance testing for posting on its BioPreferred website. The final rule will be effective May 4, 2012.
On April 10, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) invited interested parties to submit any relevant information that could assist it with its assessment of the safety, health, and environmental effects of nanosilver. In particular, SCENIHR states, it is interested in receiving any scientific information related to the “nano” forms of silver. The EC requested on December 9, 2011, that SCENIHR prepare a scientific opinion on the safety, health, and environmental effects and role in antimicrobial resistance of nanosilver. The EC requested SCENIHR “to assess whether the use of nanosilver, in particular in medical care and in consumer products could result in additional risks compared to more traditional uses of silver,” and “to assess whether the use of nanosilver to control bacterial growth could result in resistance of micro-organisms.” The deadline for SCENIHR’s opinion is early 2013. All information submitted to SCENIHR is considered public unless otherwise stated by the provider. Information is due to SCENIHR by June 4, 2012.
Bergeson & Campbell, P.C. (B&C) and The Acta Group, L.L.C. (Acta) will hold a complimentary webinar on April 18, 2012, from 1:30 to 3:30 p.m. (EDT) on the Occupational Safety and Health Administration's (OSHA) final rule revising the OSHA Hazard Communication Standard (HCS) issued on March 26, 2012. The final rule aligns the HCS with the United Nations' Globally Harmonized System for Chemical Classification and Labeling (GHS). OSHA estimates the rule is expected to impact some five million U.S. workplaces and have an annual cost of approximately $97 million.Continue Reading...
On April 4, 2012, the U.S. Environmental Protection Agency (EPA) promulgated, through a direct final rule, significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). This includes a SNUR for “infused carbon nanostructures (generic).” According to EPA, the PMN states that the generic (non-confidential) use of the substance is as an additive to provide conductive properties to reinforcements used in composites. EPA states that, based on available information on analogous chemical substances, the PMN substance may cause lung effects. For the use described in the PMN, however, no significant inhalation exposures are expected, and EPA “has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk.” EPA notes that it has determined, however, that a manufacturing process other than as described in the PMN may cause serious health effects. Based on this information, EPA states the PMN substance meets the concern criteria at 40 C.F.R. Section 721.170(b)(3)(ii). EPA determined that the results of the following information would help characterize the health effects of the PMN substance: the dimensions, characteristics, and physical-chemical properties of the carbon nanostructures. Under the SNUR, these properties should be determined once a year for three consecutive years. The direct final rule is effective on June 4, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, are due May 4, 2012.
Background Papers Available from the International Symposium on Assessing the Economic Impact of Nanotechnology
On March 27-28, 2012, the Organization for Economic Cooperation and Development (OECD), in collaboration with the National Nanotechnology Initiative (NNI), and hosted by the American Association for the Advancement of Science (AAAS) held an International Symposium on Assessing the Economic Impact of Nanotechnology. The objective of the symposium was to explore systematically the need for and development of a methodology to assess the economic impact of nanotechnology across whole economies, factoring in many sectors and types of impact, including new and replacement products and materials, markets for raw materials, intermediate and final goods, and employment and other economic impacts. Lynn L. Bergeson was on the Steering Committee and presented at the symposium. NNI has posted the following background papers:
- Challenges for Governments in Evaluating Return on Investment from Nanotechnology and its Broader Economic Impact;
- Finance and Investor Models in Nanotechnology;
- The Economic Contributions of Nanotechnology to Green and Sustainable Growth; and
- Models, Tools and Metrics Available to Assess the Economic Impact of Nanotechnology.
The B&C Consortia Management, L.L.C. (BCMM) is pleased to announce that the UCLA Center for Environmental Implications of Nanotechnology will be hosting a workshop that will be sponsored by The California Nanotechnology Industry Network (CalNIN) on Challenges and Opportunities for Businesses Engaged in Nanotechnology on September 25, 2012.
Planned topics include:
- Nanotechnology industry in California;
- Regulatory initiatives;
- Concerns with nanomaterials in the environment;
- Programs, resources, and research opportunities;
- Federal programs; and
- Educational needs and opportunities.
Registration opens on May 15, 2012.
Stay tuned for additional details on the workshop!
On May 9-11, 2012, the Organization for Economic Cooperation and Development (OECD) and Germany’s Federal Ministry of Environment, Nature Conservation and Nuclear Safety (BMU) will hold a workshop entitled “Safe Management of Nanowaste.” According to the draft agenda, the objectives of the workshop are to get a better understanding of the potential risks posed by nanowaste and waste containing nanomaterials; to exchange information about existing initiatives/approaches addressing nanowaste management; and to identify what OECD and member country governments can do to ensure safe management of such materials. After the workshop, the OECD Secretariat will prepare a report on the discussions and conclusions of the workshop, for submission to the next meeting of the Working Party on Resource Productivity and Waste in November 2012. The report will include proposals for further work and potential role of OECD in this area. Because space is limited, OECD’s Business and Industry Advisory Committee (BIAC) has been invited to nominate up to three participants. Interested persons should contact BIAC by April 11, 2012. Participation will be subject to confirmation, and interested persons should wait for formal confirmation before making travel arrangements.
On March 27, 2012, the European Commission (EC) posted a request to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) for a scientific opinion on the health effects of nanomaterials used in medical devices. According to the EC’s request, in the field of medical devices, the following cases of alleged use of nanomaterials have been identified by Notified Bodies:
- Carbon nanotubes in bone cements;
- Nanopaste hydroyapatite powder for bone void filling;
- Polymer setting material with nanoparticles in dental cements;
- Polycrystalline nanoceramics in dental restorative materials;
- Nanosilver or other nanomaterials used as coatings on implants and catheters; and
- Nanosilver used as an antibacterial agent, for example in wound dressings.
Furthermore, according to the request, there are reports on iron-oxide nanoparticles injected into tumor cells to be heated-up by radiation or an external magnetic field. The EC states that, when assessing nanomaterials for medical applications, the risk assessor should be aware of the specific characteristics of nanomaterials to obtain appropriate information to be able to do the risk assessment of the application of nanomaterials in a medical technology. According to the request, the EC is currently preparing a proposal for a revision of the medical devices directives. The proposal might include provisions on the risk classification, the labeling, and the instructions for use of medical devices containing nanomaterials. The deadline for SCENIHR’s opinion is March 2013.
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.
S.B. 533, which was prepared for the Joint Legislative Council’s Special Committee on Nanotechnology, was introduced in the Wisconsin Senate on February 29, 2012, by the Joint Legislative Council. The bill directs the University of Wisconsin System Board of Regents to maintain a nanotechnology information hub, for at least five years, to promote the development of nanotechnology businesses in Wisconsin, and gather and disseminate information about environmental health and workplace safety related to nanotechnology. The hub is directed to report to the legislature on emerging nanotechnology health and safety information, and at the direction of the nanotechnology council, identify needed legislation relating to nanotechnology safety and development. The nanotechnology council, which would be created by the bill, would set policies and priorities for the nanotechnology information hub and make grants for research and development related to nanotechnology, subject to the availability of funding. The bill does not appropriate any funds for grants but rather directs the nanotechnology hub to seek and compete for federal, state, or other funding to support its activities and to be used by the nanotechnology council to make grants.Continue Reading...
On February 29, 2012, the European Chemicals Agency (ECHA) announced the first Community Rolling Action Plan (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.”Continue Reading...
The National Institute for Occupational Safety and Health (NIOSH) Prevention through Design Program and Nanotechnology Research Center will hold an August 14-16, 2012, workshop entitled “Safe Nano Design: Molecule » Manufacturing » Market.” NIOSH states that participants will provide input into the safe commercialization of nano products resulting in the development of guidelines for the safe synthesis of nanoparticles and associated products, using a Prevention-through-Design approach. The workshop will focus on efforts to develop safer nano molecules that have the same functionality; process containment and control, based on the considerations of risk of exposure to workers; and the management system approaches for including occupational safety and health into the nanoparticle synthetic process, product development, and product manufacture. Lynn L. Bergeson is on the Planning Committee for the workshop.
WHO Background Document on Guidelines on Protecting Workers from Manufactured Nanomaterials Available for Comment
The World Health Organization (WHO) released a draft background document proposing content and focus for Guidelines on “Protecting Workers from Potential Risks of Manufactured Nanomaterials.” According to WHO, the Guidelines will aim to facilitate improvements in occupational health and safety of workers potentially exposed to nanomaterials in a broad range of manufacturing and social environments. The Guidelines will incorporate elements of risk assessment and risk management and contextual issues, and provide recommendations to improve occupational safety and protect the health of workers using nanomaterials in all countries, especially in low- and middle-income countries. The WHO Guideline Development Group will use the background document to identify key questions to be addressed by the Guidelines. WHO asks commenters to note that key questions to be addressed by the Guidelines “should be answerable, their number should be manageable and answers to the key questions should be useful to the target audience of these Guidelines.” Comments are due March 31, 2012.
President Obama signed a February 21, 2012, memorandum entitled “Driving Innovation and Creating Jobs in Rural America through Biobased and Sustainable Product Procurement.” The BioPreferred Program, which was established by the Farm Security and Rural Investment Act of 2002 (2002 Farm Bill) and amended by the Food, Conservation and Energy Act of 2008 (2008 Farm Bill), is intended to increase federal procurement of biobased products, which will promote rural economic development, create new jobs, and provide new markets for farm commodities. According to the memorandum, the federal government, with leadership from the United States Department of Agriculture (USDA), has made significant strides in implementing the BioPreferred Program. The goal of the Presidential memorandum is to ensure that agencies effectively execute federal procurement requirements for biobased products.
On February 22, 2012, the European Chemicals Agency (ECHA) issued a press release announcing that it is currently preparing an update of its Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA) based on the European Commission’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIP-oN). Because the next registration deadline of May 31, 2013, is approaching quickly, ECHA “will facilitate compliance of all potential registrants well in advance.” ECHA intends to update the Guidance on IR & CSA later in 2012, in line with the outcomes of RIP-oNs 2 and 3. ECHA states that registrants may already find it useful to refer to the RIP-oN reports when preparing registration dossiers covering nanomaterials. ECHA reminds registrants, however, “to ensure that safe use of their substance should be demonstrated in the registration dossier, and hence that the data of the submitted properties as well as related risk assessment and management information should be applicable and appropriate for the nanoforms covered by the registration.” According to ECHA, the RIP-oN 1 report on the substance identification of nanomaterials also contains useful information that can be integrated into the IUCLID 5 manuals. Because the experience in addressing characterization of nanoforms is still developing, ECHA states it will not revise the current guidance on substance identity. Furthermore, ECHA notes, “for other areas it is clear that further scientific development and research are still necessary before providing definitive guidance updates.”
The U.S. Environmental Protection Agency (EPA) announced in a February 13, 2012, Federal Register notice the availability of its Fall 2011 Regulatory Agenda. EPA’s Regulatory Agenda includes several notices concerning nanoscale materials:
- Test Rule for Certain Nanoscale Materials -- EPA states that it is developing a test rule under Section 4(a) of the Toxic Substances Control Act (TSCA) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in March 2012.
- Significant New Use Rule (SNUR) -- EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2). The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. In addition, according to the notice, EPA is developing 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. The notice regarding a TSCA Section 8(a) rulemaking was previously separate, but EPA states “those two efforts were combined into a single rulemaking.” EPA submitted a proposed rule regarding TSCA Section 8(a) reporting to the Office of Management and Budget (OMB) for review on November 22, 2010, where it remains. According to the notice, EPA intends to publish an NPRM in March 2012.
The Center for International Environmental Law (CIEL) published a report on February 6, 2012, entitled Just Out of REACH: How REACH Is Failing to Regulate Nanomaterials and How It Can Be Fixed. According to CIEL, there are four key gaps in the registration phase of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation:
- REACH does not define nanomaterials, and contains no nano-specific provisions;
- Most nanomaterials evade registration until 2018, yet they can still enter the European Union (EU) market;
- REACH’s schedule for registration hinges on the number of tonnes of a chemical, essentially missing all nanomaterials, which are generally produced in far smaller quantities; and
- REACH test guidelines fail to consider the special properties of nanomaterials.
CIEL proposes stand-alone regulation, aligned with REACH, but specifically tailored to nanomaterials. CIEL states that such a regulation “would establish clear, legally binding provisions for nanomaterials and create a transparent and predictable legal environment for the safe production and use of nanomaterials in the EU.”
On February 9, 2012, the U.S. Environmental Protection Agency (EPA) posted a summary report on its January 2011 workshop on nanoscale silver. The workshop was the second in a series conducted by the National Center for Environmental Assessment (NCEA) to further the development of a research strategy for completing comprehensive environmental assessments of nanomaterials. The basis of the workshop was the report Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray. According to the summary report, the outcomes of this and future workshops in the series -- prioritized information gaps and risk tradeoffs -- will be used in developing and refining a long-term research strategy to assess potential human health and ecological risks of nanomaterials and to manage associated risks of specific nanomaterials.Continue Reading...
The U.S. Environmental Protection Agency (EPA) has announced that, in response to public comments, it will provide the public more time to comment on the December 28, 2011, proposed significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). Of particular interest, seven of the PMN substances’ reported chemical names include the term “carbon nanotube” (CNT) or “CNT.” EPA states “the comment period is being reopened until 45 days following publication of the new notice (until approximately mid-March).” Importantly, the docket reveals that requests for extension were submitted by the International Center for Technology Assessment (ICTA), the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), the United Automobile, Aerospace & Agricultural Implement Workers of America (UAW), and the United Steelworkers Union (USW). The USW comment specifically asserts that the “specific protection measures required for individual PMN substances indicate that personal protective equipment, including gloves and respirators, should be the first line of defense to protect workers. These requirements do NOT follow occupational health and safety best practices” (emphasis in original). The comment then goes on to cite the ANSI/AIHA Z10 2005 standard and the Occupational Safety and Health Administration (OSHA) standards as best practices.
This is an important perspective in the ongoing worker protection debate and the requests for comment deadline extension suggest that the unions are likely to become more engaged in this discussion.
International Symposium on Assessing the Economic Impact of Nanotechnology Will Be Held in March 2012
On March 27-28, 2012, the American Association for the Advancement of Science (AAA) will host the “International Symposium on Assessing the Economic Impact of Nanotechnology.” The Working Party on Nanotechnology (WPN) of the Organization for Economic Cooperation and Development (OECD), in collaboration with the U.S. National Nanotechnology Initiative (NNI), organized the Symposium. Lynn L. Bergeson is on the Steering Committee and will speak at the Symposium. The objective of the Symposium is to explore systematically “the need for and development of a methodology to assess the economic impact of nanotechnology across whole economies, factoring in many sectors and types of impact, including new and replacement products and materials, markets for raw materials, intermediate and final goods, and employment and other economic impacts.” Participants will address the scope of economic impacts of nanotechnology; input and output factors; metrics for other technological assessments; consideration of the appropriateness of these metrics for nanotechnology materials and products; the role of research funding portfolios; intellectual property frameworks; venture capital; public-private partnerships; state and local initiatives; international cooperation; and metrics such as private sector and industry investments, patents and publications, and the development of a technologically-educated workforce as metrics for nanotechnology. Attendees are being invited from a broad spectrum of backgrounds and expertise, including technology leaders, key decision makers, economists, investors, policy analysts, scientists and engineers from industry, business, government, academia, and the general public. Registration will open February 10, 2012, and will be on a first-come, first-served basis until the capacity is met. Positions are expected to fill quickly.
On January 26, 2012, the Natural Resources Defense Council (NRDC) filed a lawsuit in the U.S. Court of Appeals for the Ninth Circuit against the U.S. Environmental Protection Agency (EPA) concerning its conditional registration of a pesticide product containing nanosilver as a new active ingredient for use as a preservative for textiles. NRDC states that it seeks to limit public exposure to the nanosilver’s use in clothing, baby blankets, and other textiles. On December 1, 2011, EPA announced its conditional approval of HeiQ AGS-20. As a condition of registration, EPA is requiring HeiQ to conduct a number of studies within four years, which EPA chose to allow time for protocol reviews prior to initiation of the studies, completion of the studies, and its review of the study results. NRDC states that it seeks to block EPA “from allowing nanosilver on the market without the legally-required data about its suspected harmful effects on humans and wildlife.”
NRC Publishes A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials
On January 25, 2012, the National Research Council (NRC) posted the pre-publication version of its report entitled A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials. The U.S. Environmental Protection Agency (EPA) asked NRC to perform an independent study to develop and monitor the implementation of an integrated research strategy to address the environmental, health, and safety (EHS) aspects of engineered nanomaterials (ENM). NRC convened the Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials, which concluded that there is need for a research strategy that is independent of any one stakeholder group, has human and environmental health as its primary focus, builds on past efforts, and is flexible in anticipating and adjusting to emerging challenges.Continue Reading...
Lynn L. Bergeson will participate in a February 7, 2012, Bloomberg BNA webinar entitled “The Greening of Consumer Products: Legal, Regulatory, and Strategic Considerations.” Bloomberg BNA states that the webinar is intended to help users:
- Identify the core concepts of green product development and the maturation of conventional environmental protection themes on which green product steward concepts rely;
- Describe the diversity of legal and regulatory authorities, domestic and international, that are relevant to chemical, industrial, and consumer product manufacturers from a legal compliance perspective;
- Analyze the role of private party standards and evolving concepts of product stewardship in product design and management;
- Address the trends and emerging themes embedded in the commercial value chain that must be monitored to be competitive and successful;
- Explore the challenges and value of green product marketing; and
- Develop basic strategies for legal compliance and commercial success in green product marketing.
The NanoBusiness Commercialization Association, North Carolina Department of Commerce, and Center of Innovation for Nanobiotechnology will co-host the Nanotech Commercialization Conference on April 4-5, 2012, in Research Triangle, North Carolina. Lynn L. Bergeson will speak at the Conference, which will include:
- National-level keynote speakers;
- Sessions, workshops, and exhibits showcasing the latest advances in the field;
- Discussions on financing, licensing, and business development geared toward the nanotech entrepreneur;
- Sessions and exhibits showcasing cutting-edge research, products, and technologies; and
- Networking opportunities with connected professionals.
On December 30, 2011, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled EPA Needs to Manage Nanomaterial Risks More Effectively. According to OIG, the purpose of its review was to determine how effectively EPA is managing the human health and environmental risks of nanomaterials. OIG states that it found “that EPA does not currently have sufficient information or processes to effectively manage the human health and environmental risks of nanomaterials.” According to OIG, although EPA has the statutory authority to regulate nanomaterials, it “currently lacks the environmental and human health exposure and toxicological data to do so effectively.” EPA proposed a policy, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), that would identify new pesticides being registered with nanoscale materials. After “minimal industry participation” in EPA’s Nanoscale Materials Stewardship Program (NMSP), a voluntary data collection program, EPA has chosen to propose mandatory reporting rules for nanomaterials under FIFRA, and is developing proposed rules under the Toxic Substances Control Act (TSCA).Continue Reading...
As You Sow, a non-governmental organization (NGO), has published a framework providing guidelines intended for food and food packaging companies to assess exposure to and potential risks from food and food packaging products containing nanomaterials. According to As Your Sow, more than a dozen food companies, scientific organizations, and investor groups reviewed the framework, including: Kraft, McDonald’s, PepsiCo, Whole Foods, and Yum! Brands; the Center for Food Safety, Consumers Union, Project on Emerging Nanotechnology, International Center for Technology Assessment, Natural Resources Defense Council, and the Technical University of Denmark; As You Sow, Calvert Investments, and the Investor Environmental Health Network. The framework offers tiered recommendations of steps companies should take and information they should obtain from their suppliers regarding the safety testing of nanomaterials and products containing nanomaterials. As You Sow recommends that, until there are “firm regulatory requirements and/or a central repository for safety data on nanomaterials, information requested in this framework should be provided to food and food packaging companies by their suppliers.”Continue Reading...
A coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the U.S. District Court for the Northern District of California on December 21, 2011. The coalition is led by the International Center for Technology Assessment (ICTA), and includes Friends of the Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group, and the Institute for Agricultural and Trade Policy. ICTA states that its lawsuit “demands” FDA respond to the coalition’s 2006 petition. The 2006 petition requested FDA take several actions, including requiring specific product labeling and health and safety testing; analyzing the environmental and health impacts of nanomaterials in products approved by FDA; and regulating sunscreens containing nanomaterials. In the December 21, 2011, complaint, the coalition states that, since 2006, “nanomaterial consumer products have continued to proliferate without oversight.” The coalition asks the court to order FDA to respond to its 2006 petition without further delay.
The U.S. Environmental Protection Agency (EPA) published on December 28, 2011, proposed significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). Of particular interest, seven of the PMN substances’ reported chemical names include the term “carbon nanotube” (CNT) or “CNT.” EPA states that because of a lack of established nomenclature for CNTs, the Toxic Substances Control Act (TSCA) Inventory names for CNTs are currently in generic form, e.g., “carbon nanotube (CNT), multi-walled carbon nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-walled carbon nanotube (SWCNT).” EPA uses the specific structural characteristics provided by the PMN submitter to characterize more specifically the TSCA Inventory listing for an individual CNT. According to EPA, all submitters of new chemical notices for CNTs have claimed those specific structural characteristics as confidential business information (CBI). The proposed rule includes the generic chemical name along with the PMN number to identify that a distinct chemical substance was the subject of the PMN without revealing the confidential chemical identity of the PMN substance. Comments are due January 27, 2012.Continue Reading...
Japan’s Ministry of Economy, Trade and Industry (METI) established a Committee on Safety Management for Nanomaterials, which was scheduled to hold its first meeting on December 2, 2011. METI states that it established the Committee “on the basis of the results obtained from the project ‘Research and Development of Nanoparticle Characterization Methods’ commissioned by the New Energy and Industrial Technology Development Organization (NEDO) and the latest scientific knowledge.” The Committee will focus on risks caused by nanomaterials, and study appropriate management procedures for nanomaterials considering the actual usage and life cycles. According to Japan’s November 30, 2011, press release, the Committee will compile an interim report “around spring to summer in 2012.”
On November 23, 2011, the European Union (EU) Council’s committee of the permanent representatives of each member state (COREPER) approved the compromise agreement on the proposed EU biocidal products regulation that would repeal and replace the biocidal products Directive 98/8/EC. Under the compromise reached by the EU Council and the European Parliament (EP), biocides would be reviewed regularly, with approvals or renewals valid for a maximum of ten years, and less for “problematic” substances. The proposed legislation states that there is “scientific uncertainty” about the safety of nanomaterials, and “to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials, if possible based on the work of appropriate international fora, and to specify that the approval of an active substance does not include the nanomaterial form unless explicitly mentioned.” The proposed legislation calls on the European Commission (EC) to “regularly review the provisions on nanomaterials in the light of scientific progress.”Continue Reading...
The European Commission (EC) requested on December 9, 2011, that the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) prepare a scientific opinion on the safety, health, and environmental effects and role in antimicrobial resistance of nanosilver. According to the EC, while recent review papers suggest that nanosilver may not be hazardous to humans, data are insufficient to carry out a full risk assessment. The EC states that indirect adverse effects on human health may occur via an increasing resistance of micro-organisms against silver, including nanosilver and silver-based compounds, which could limit the usefulness of nanosilver in medical devices and other medical applications. Furthermore, the EC states, silver can be present in different forms, and it is not clear how these different forms of silver influence its antimicrobial properties, a possible increase of antimicrobial resistance, and the healing process. The EC notes that recent reviews and publications proposed to use a combination of nanosilver and the “usual antibiotics” for the treatment of specific infectious diseases caused by resistant bacteria. The EC requests SCENIHR “to assess whether the use of nanosilver, in particular in medical care and in consumer products could result in additional risks compared to more traditional uses of silver,” and “to assess whether the use of nanosilver to control bacterial growth could result in resistance of micro-organisms.” The deadline for SCENIHR’s opinion is early 2013.
The U.S. Environmental Protection Agency (EPA) announced on December 1, 2011, that it is conditionally registering a pesticide product containing nanosilver as a new active ingredient. HeiQ AGS-20 is a silver-based antimicrobial pesticide product approved for use as a preservative for textiles. The final registration is not yet in the docket. We believe, but cannot confirm, the final registration is largely similar to the draft proposed registration issued last year. As members of the nano community know well, this is very good news and demonstrates that EPA is prepared to make regulatory decisions involving nanotechnology, even where, as here, they are likely to inspire controversy.Continue Reading...
ObservatoryNANO posted on November 24, 2011, a report on the nanotechnology environment, health, and safety (EHS) landscape. ObservatoryNANO, which is funded by the European Commission, intends to support European policy makers by providing scientific and economic analysis of nanoscience and nanotechnology developments. ObservatoryNANO notes that activity concerned with the EHS aspects of nanotechnologies has been growing for a decade. ObservatoryNANO states that the aim of the EHS landscaping report is to provide a map and overview of key organizations and their activities within the field worldwide in relation to nano-EHS. ObservatoryNANO intends the landscaping document to support communication of efforts, outlining those key initiatives, activities, and projects within the field. According to ObservatoryNANO, because of the challenge of keeping track of the rapidly changing field, the landscaping document provides only a snapshot of efforts ongoing within 2011, and will change with time.Continue Reading...
On November 15, 2011, the Congressional Nanotechnology Caucus will host a briefing on the impact of nanotechnology on job creation. Topics to be addressed include the best ways to encourage private/public partnerships; what kind of jobs nanotechnology investment can create; and where private capital is investing money in nanotechnology. Guest speakers will include:
- Robert D. “Skip” Rung, President and Executive Director, Oregon Nanoscience and Microtechnologies Institute;
- Doug Jamison, Chief Executive Office, Harris & Harris; and
- Hilary Flynn, Lux Research.
The briefing will begin at 3:00 p.m. in Room 385 of the Russell Senate Office Building. To RSVP, please contact Matt Bormet.
The Nanotechnology Industries Association (NIA) will hold a workshop on November 30, 2011, entitled “Defining Nano!? Compliance Requirements & Market Impact of the EU Definition of ‘Nanomaterials.’” The workshop, which will be held in Brussels, Belgium, is intended to answer questions such as which market sectors will be affected by additional regulatory compliance, the economic impact on current and future applications of nanotechnologies, how the European Union (EU) definition will be implemented in European legislation and in EU member states, and what companies can do in the short-term to offset the cost of long-term compliance.
The U.S. Environmental Protection Agency (EPA) published in an October 26, 2011, Federal Register notice its final 2010 Effluent Guidelines Program Plan, which includes a request for comment and information for its 2011 annual reviews. EPA requests information on a number of topics, including discharges of nanosilver from industrial manufacturing. EPA cites nanosilver’s use as an active pesticide ingredient, an antimicrobial in fabric; a preservative in textile products, and coating in drums in washing machines. EPA states that, since many of these uses have the potential to create a source of silver in wastewater discharges, it “is interested in gathering as much information as possible on the fate, transport and effects of nanosilver on the aquatic environment and human health.” Comments on EPA’s 2011 reviews are due November 25, 2011.Continue Reading...
The Nanotechnology Caucus will hold a briefing on November 15, 2011, at 3:00 p.m. concerning jobs and nanotechnology. The briefing will focus on how targeted federal investments can lead to jobs down the road. More details will be forthcoming.
On November 3, 2011, the European Chemicals Agency (ECHA) began a consultation on a testing proposal for multi-wall carbon nanotubes, synthetic graphite in tubular shape. Under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, manufacturers and importers must obtain information on toxic effects of substances. REACH requires that new testing of a substance involving vertebrate animals be carried out only as a last resort, however. ECHA states that, to ensure that the best use has been made of existing information, it publishes all test proposals involving vertebrate animals for endpoints specified in Annexes IX and X under REACH. After a testing proposal has been published, third parties have 45 days to submit “scientifically valid information and studies that address the relevant substance and hazard endpoint, relating to the testing proposal.” The hazard endpoint for which vertebrate testing was proposed is long-term toxicity to fish. The deadline for submitting information is December 19, 2011. ECHA will consider any scientifically valid information and studies that address the relevant substance and hazard endpoint. ECHA publishes its responses to these contributions for the testing proposals after adoption of the related final decision.
The European Commission (EC) began in 2009 a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIPoN), which it intended to provide advice on key aspects of the implementation of REACH with regard to nanomaterials. The EC recently posted final reports concerning nanomaterials and information requirements (RIPoN 2) and chemical safety assessment (RIPoN 3). The EC states that, based on the scientific and technical state of the art with regard to nanomaterials, the reports were developed so that the advice on specific issues related to nanomaterials can be integrated into the existing REACH guidance documents. The EC notes that “inclusion of any of the advice from the reports into the [European Chemicals Agency (ECHA)] guidance is exclusively the responsibility of ECHA. The presented reports do not represent ECHA guidance.” Nevertheless, the EC states, “while awaiting the official guidance up-date, companies are invited to consult the two reports and take the recommendations into account as appropriate when preparing or updating REACH registration dossiers and evaluating hazard information for potential classification under CLP.” The EC also posted a third report on substance identity. The EC cautions, however, that since it was not possible to reach consensus amongst the experts on the recommendations in the third report, “further work of the Commission, in collaboration with CARACAL, is required before recommendations can be forwarded to ECHA.”
The U.S. Environmental Protection Agency (EPA) posted a September 2011 guidance document entitled Guidance to Facilitate Decisions for Sustainable Nanotechnology, which was prepared by the National Risk Management Research Laboratory of the Office of Research and Development. EPA states that it developed the guidance to assist in assessing the sustainability of nanoproducts, and it is intended “to lay the groundwork for developing a decision-support framework through continual updates as research in this area progresses.” The foundation of EPA’s approach, according to the guidance, is to consider existing standards and methods for environmental, economic, and social assessments using a life cycle perspective and offer guidance by relaying first-hand knowledge of applying assessment tools to nanotechnologies, whenever possible. The guidance includes overviews of various assessment methodologies to help stakeholders make informed choices when selecting tools appropriate for their