The Center for Research on Ingredient Safety (CRIS), which was established at Michigan State University (MSU) in partnership with the Grocery Manufacturers Association in April 2014, will hold its first open house on November 20-21, 2014. Members and prospective members will have the opportunity to meet MSU President Lou Anna K. Simon, hear presentations, and participate in round table discussions. CRIS will be modeled after already existing centers of expertise at other academic institutions, which focus on allergen and microbiological safety. As an independent, academic, science-based center, CRIS will serve as a reliable and unbiased source for information, research, training, and analysis on the safe use of chemical ingredients in consumer packaged goods, including foods, beverages, cosmetics, and household consumer products. Founding members of CRIS include Cargill, Kellogg’s, Unilever, ConAgra Foods, Campbell’s, McCormick, General Mills, Hormel Foods, PepsiCo, Hershey’s, Coca-Cola, EcoLab, Bumble Bee Foods, LLC, Mondelēz International, Kraft Foods, and Bush’s Best. Registration for the open house will close November 14, 2014.
On October 27, 2014, the U.S. Environmental Protection Agency (EPA) promulgated significant new use rules (SNUR) for 52 chemical substances, including “functionalized carbon nanotubes (generic).” According to the Federal Register notice, the premanufacture notice (PMN) states that the substance will be used as a thin film for electronic device applications. The notice states that, as described in the PMN, EPA “does not expect significant occupational exposures due to the use of impervious gloves, where there is potential for dermal exposure, and because the PMN is used in liquid form and is not spray applied.” In addition, EPA does not expect environmental releases during the use identified in the PMN submission. EPA states that it has determined, however, “that any use of the substance without the use of impervious gloves, where there is a potential for dermal exposure; manufacturing the PMN substance for use other than as a thin film for electronic device applications; manufacturing, processing, or using the PMN substance in a form other than a liquid; use of the PMN substance involving an application method that generates a mist, vapor, or aerosol; or any release of the PMN substance into surface waters may cause serious health effects or significant adverse environmental effects.” The rule is effective on December 26, 2014. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, must be received by November 26, 2014.
The Belgian Royal Decree Regarding the Placement on the Market of Substances Manufactured at the Nanoscale, a Report to the King, and the Opinion of the Council of State were published in the September 24, 2014, issue of the Official Gazette. Substances defined as nanomaterials, and mixtures containing them, must be registered by the Belgian Federal Public Service for Health, Food Chain Safety and the Environment if at least 100 grams of the substance or mixture is placed on the market during the year covered by the registration, and if the entity putting the substance on the market produced this substance or mixture, or puts it on the market for professional users only. Biocidal products, medicines, food and feed, food contact materials, and pigments are excluded from the scope of the Royal Decree. Nanomaterials subject to declaration requirements must be registered by January 1, 2016, if they are already on the market by this date. After January 1, 2016, all nanomaterials concerned must be registered before being placed on the market. Mixtures subject to declaration requirements must be registered by January 1, 2017, if they are already on the market by this date. After January 1, 2017, all mixtures concerned must be registered before being placed on the market.
On October 10, 2014, the Office of Science and Technology Policy (OSTP) announced that the President’s Council of Advisors on Science and Technology (PCAST) released the Report to the President and Congress on the Fifth Assessment of the National Nanotechnology Initiative, which concludes that the nanotechnology community is at an important turning point. PCAST recommends that the federal government accelerate its activities aimed at facilitating the commercialization of federally sponsored research, “thereby enabling the Nation to reap the benefits of this investment.” To help focus the commercialization process, PCAST calls for the nanotechnology community to take on a series of national nanotechnology Grand Challenges. Specific nanotechnology Grand Challenges would provide a way to turn scientific advances into products that leverage existing opportunities and meaningfully address existing needs. In the report, PCAST recommends that the federal government establish and execute a process for engaging the nanotechnology community to identify specific Grand Challenges that best support these goals. PCAST also provides some specific recommendations regarding the formulation of the Grand Challenges and innovation prizes and public-private partnerships to support them, as well as a focus on manufacturing challenges. Finally, the report details several program management updates to leadership initiatives, advisory input, evaluation metrics, and other areas to ensure the continuing success of the National Nanotechnology Initiative.
After submitting a proposed rule concerning nanoscale materials to the Office of Management and Budget (OMB) on October 6, 2014, the U.S. Environmental Protection Agency’s (EPA) Spring 2014 Regulatory Agenda item concerning nanoscale materials has been revised. The Regulatory Agenda item posted online in May 2014 referred to the development of a significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) that would require persons who intend to manufacture, import, or process these chemical substances for an activity that is designated as a significant new use by the proposed rule to notify EPA at least 90 days before commencing that activity. The Regulatory Agenda item now includes no reference to the SNUR, but describes only a proposal to require reporting and recordkeeping under TSCA Section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data.
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.