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.
Bergeson & Campbell, P.C., is pleased to announce that Managing Partner Lynn L. Bergeson and the late Michael F. Cole prepared a chapter in a new book, Biointeractions of Nanomaterials, which covers a wide range of issues associated with the safety of nanomaterials in biological systems. The book, published on July 29, 2014, by CRC Press, addresses issues related to the toxicity and safety of nanomaterials and nanosystems, and covers a range of interactions in biological systems, specifically focusing on the tools and methods used for evaluation, including in vivo and in vitro techniques.Continue Reading...