Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

NIOSH One-Pager Includes Accomplishments and Next Steps for Nanotechnology Research Center

Posted in Federal, Occupational Health and Safety Issues, United States

On July 9, 2018, the National Institute for Occupational Safety and Health (NIOSH) published a one-page document on its Nanotechnology Research Center (NTRC), which conducts research to understand the potential effects on human health of exposure to engineered nanomaterials and develops methods to control or eliminate exposures.  NTRC’s accomplishments include:

NTRC’s next steps include:

  • Publishing “Current Intelligence Bulletin: Health Effects from Occupational Exposure to Silver Nanomaterials”;
  • Evaluating biomarkers, cardiovascular toxicity, and pulmonary exposure to nanoclays and boron nitride nanotubes; and
  • Completing peer and stakeholder review of the draft “Current Intelligence Bulletin: Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials.”

OECD Report Presents Findings from Survey Aimed at Investigating Different Types of Risk Assessment

Posted in International, Legal/Regulatory Issues, OECD

The Organization for Economic Cooperation and Development (OECD) published a July 4, 2018, report entitled Investigating the Different Types of Risk Assessments of Manufactured Nanomaterials:  Identifying Tools Available for Risk Management Measures and Uncertainties Driving Nano-Specific Data Needs.  The report presents the findings from a survey conducted in 2016 that aimed at investigating the different types of risk assessment.  The survey was conducted to gather the following information concerning risk assessments in different member countries:

  • Different types of risk assessment used by jurisdictions, such as:
    • Screening (e., risk and hazard prioritization) level versus a more detailed risk assessment;
    • Level of detail in the assessment; and
    • Jurisdictions that emphasize hazard more than risk/exposure;
  • Levels of uncertainties/assumptions used in these risk assessments;
  • Risk management measures and other outcomes of the assessment; and
  • Risk assessment process(es) used when evaluating manufactured nanomaterials, including uncertainties, data requirements, and characterization/identification.

OECD states that the outcome of the project is an increased understanding of the details and scope of different regulatory risk assessments for manufactured nanomaterials by comparing and contrasting the conditions, assumptions, and levels of uncertainties of approaches used in different jurisdictions.  Best practices could be identified that could be adopted by other countries.  A majority of survey participants identified the following recommendations:

  • There is further need for validated exposure/release scenarios and assessment for nanomaterials;
  • The utility of specific physical-chemical properties to predict environmental fate and hazard must be validated to agree to a set of required characterization parameters, which will likely be specific to the type of nanomaterial being assessed;
  • It is essential to improve the ability to use read-across/grouping/screening tests to assess nanomaterials; and
  • There needs to be continued development of validated test guidelines specific to nanomaterials.

NanoReg2 and Gracious Will Hold Scientific Workshop on Grouping of Nanomaterials in September

Posted in International, Legal/Regulatory Issues, OECD, Research

The NanoSafety Cluster announced that its projects NanoReg2 and Gracious, which focus on grouping, have come together with the Organization for Economic Cooperation and Development (OECD) Working Party for Manufactured Nanomaterials (WPMN) to host a two-day conference in Paris on September 12-13, 2018.  The “Scientific workshop on Grouping of Nanomaterials” will immediately follow the September 11, 2018, WPMN meeting on physico-chemical parameters framework for the risk assessment of nanomaterials, which will bring together international experts to review the outcomes of two joint projects on physico-chemical properties of nanomaterials and their measurement.  According to the NanoSafety Cluster, the NanoReg2 and Gracious workshop will build upon the OECD meeting, “with synergies between the grouping approaches taken by both projects and the physico-chemical parameters and their measurement and reporting that will be covered as part of the OECD meeting.”  Session topics will include:

  • Grouping of nanomaterials: Principles, history, and context of grouping activities;
  • Over-arching grouping schemes;
  • Grouping in practice: Connecting to test methods and strategies; and
  • Development of grouping recommendations and next steps.

The NanoSafety Cluster states that workshop outcomes will include recommendations on nanomaterials grouping that can support global regulations and standards development.  The workshop invites participation from stakeholders experienced in nanomaterials grouping and physico-chemical and hazard assessment.  Stakeholders from industry and regulatory backgrounds are especially welcome.  Participation in the workshop will be free, with delegates covering their own travel and subsistence costs.  Places are limited and potential participants are required to provide a short summary of their relevant expertise to allow the organizers to ensure representation from a diverse range of stakeholders.

EFSA Publishes New Guidance on Nanotechnologies in Food and Feed

Posted in International, Legal/Regulatory Issues

The European Food Safety Authority (EFSA) issued a July 4, 2018, press release announcing the availability of new guidance on how to assess the safety of nanoscience and nanotechnology applications.  The guidance covers novel foods, food contact materials, food and feed additives, and pesticides, taking into account new developments that have taken place since publication of the previous guidance in 2011.  Potential future developments suggested in the scientific literature include nanoencapsulated delivery systems and nanocomposites in applications such as novel foods, food/feed additives, biocides, pesticides, and food contact materials.  Therefore, EFSA states, the guidance has taken account of relevant new scientific studies that provide more insights to physicochemical properties, exposure assessment, and hazard characterization of nanomaterials.  It specifically elaborates on the physicochemical characterization of nanomaterials in terms of how to establish whether a material is a nanomaterial, the key parameters that should be measured, the methods and techniques that can be used for characterization of nanomaterials, and their determination in complex matrices.  The guidance also details the aspects relating to exposure assessment and hazard identification and characterization.  In particular, the guidance discusses nanospecific considerations relating to in vivo/in vitro toxicological studies, and outlines a tiered framework for toxicological testing.  It describes in vitro degradation, toxicokinetics, and genotoxicity, as well as general issues relating to testing of nanomaterials.  Depending on the initial tier results, EFSA states that studies may be needed to investigate reproductive and developmental toxicity, immunotoxicity, allergenicity, neurotoxicity, effects on gut microbiome, and endocrine activity.  The guidance also discusses the possible use of read-across to fill data gaps, as well as the potential use of integrated testing strategies and the knowledge of modes/mechanisms.  The guidance proposes approaches to risk characterization and uncertainty analysis, and provides recommendations for further research in this area.  EFSA notes that the guidance is intended for all interested parties — in particular risk assessors, risk managers, and applicants.  According to EFSA, the guidance will now enter a pilot phase, with a final guidance envisioned by the end of 2019.  EFSA will develop a second guidance in 2019 focusing on the environmental risk assessment of nanoscience and nanotechnology applications in the food and feed chain.

EU-Funded Researchers Testing Nano-Based Food Packaging

Posted in International, Research

The European Commission (EC) announced on June 15, 2018, that researchers from the European Union (EU)-funded NANOPACK project found a solution for extending food shelf-life by using smart antimicrobial surfaces applied to active food packaging.  According to the EC, the researchers are now running five pilot production runs of the new polymer composite, based on tiny nanotube formations, to test its technical, industrial, and commercial viability.  The researchers “form tiny materials based on natural ‘halloysite nanotubes’ (HNTs), which act as reliable and safe carriers that can deliver minute amounts of an EU-approved bioactive agent or oil to stop food from going bad or becoming mouldy.”  The EC states that due to their “minuscule size,” HNTs are unable to migrate from the food packaging into food itself, making them a “safe and natural preservative.”  The EC notes that the project is also considering legal, safety, and environmental aspects, as well as consumer and retailer acceptance of the new nanotech-inspired packaging.

NanoMONITOR Available for Testing at Facilities

Posted in International, Legal/Regulatory Issues, Research

NanoMONITOR announced on June 25, 2018, that the NanoMONITOR Monitoring Station is available upon request to use in facilities to obtain robust data on the concentration of engineered nanomaterials.  NanoMONITOR’s brochure states that access is provided on a transnational basis with no charge to the user.  According to NanoMONITOR, by developing a real-time information and monitoring system, NanoMONITOR supports the risk assessment of nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  This is intended to help to improve the use of environmental monitoring data to support REACH implementation and promote the protection of human health and the environment when dealing with engineered nanomaterials.  Interested users should complete the expression of interest form.  NanoMONITOR states that its management will only use the information provided to enable its technical experts to discuss the feasibility of proposed activities.

EC Committee Publishes Final Opinion on Nano Styrene/Acrylates and Sodium Styrene/Acrylates Copolymers

Posted in International, Legal/Regulatory Issues

On June 25, 2018, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on styrene/acrylates copolymer (nano) and sodium styrene/acrylates copolymer (nano).  The EC received eight notifications of cosmetic ingredients containing the copolymers in nano forms.  According to the applicants, the ingredients are used in nano-coated form in leave-on cosmetic products with maximum reported concentration limits of 0.06 percent.  According to the opinion, the EC has concerns over safety of the use of sodium styrene/acrylates copolymer (nano) and styrene/acrylates copolymer (nano) in cosmetic products.  The EC requested that SCCS give its opinion on the safety of the nanomaterial styrene/acrylates copolymer and sodium styrene/acrylates copolymer when used in leave-on cosmetics products with a maximum concentration limit of 0.06 percent, taking into account the “reasonably foreseeable exposure conditions.”  In the final opinion, SCCS states that it cannot conclude on the safety of any of the three styrene/acrylate copolymer nano-entities submitted by the applicants.  According to SCCS, the data submitted are insufficient to evaluate possible toxicity.  Regarding use, it was reported that the nano-entities, as present in Nanospheres 100 Theophyllisilane C (SA), were used for encapsulation of a slimming agent Theophyllisilane C.  SCCS notes that according to the information provided by the applicants, the formulation might be used in health products like milks, emulsions, creams, lotions, and solutions.  No data on the use frequency were provided, however, so the potential exposure could not be estimated based on a use scenario.  In addition, SCCS states, the submitted information was based on a (nearly) finished product consisting of a nanomaterial shell (Nanosphere 100) and encapsulated active ingredients (Theophyllisilane C and Algisium C2 (SA) methylsilanol mannuronate).  For the formulation Nanospheres 100 D.S.H. C.N (SA), no information on composition was submitted.  Data should be provided separately for all of the three styrene/acrylate nanospheres, including any encapsulated substances.  The EC requested that SCCS also address any further scientific concerns with regard to the use of styrene/acrylates copolymer and sodium styrene/acrylates copolymer in nano form in cosmetic products.  SCCS states:  “For applications as evaluated in this Opinion, it is imperative that the safety assessment not only considers safety of the individual components (e.g. the encapsulating material and the encapsulated contents), but also the safety of all the components when put together in the form of a nano-sized entity.”

Second Workshop on Quantifying Exposure to Engineered Nanomaterials from Manufactured Products Will Be Held in October

Posted in Federal, International, Legal/Regulatory Issues, United States

The “2nd Quantifying Exposure to Engineered Nanomaterials from Manufactured Products (QEEN II) Workshop” will be held October 9-10, 2018, in Washington, D.C.  Sponsored by the Consumer Product Safety Commission (CPSC) and co-hosted by the National Nanotechnology Initiative (NNI), the Workshop will highlight new research on the tools and methods available to characterize and quantify effective population exposures, as well as the presence and release potential of nanomaterials.  The two-day technical Workshop builds on key themes that emerged from the first QEEN workshop in 2015.  According to NNI, the program will address the progress in integrating exposure, hazard, and risk to reduce uncertainties in nanomaterial environmental, health, and safety (EHS) assessments.  The Workshop goals include the identification of priorities and options for cross-disciplinary research collaborations.  NNI states that the intended audience includes academics, federal representatives, and manufacturers and distributors of nanotechnology-enabled products, as well as communities seeking to understand exposure science related to engineered nanomaterials.  The Workshop is free and open to the public with registration on a first-come, first-served basis.  Registration will open on July 9, 2018, and will be capped at 180 attendees.  The 2018 U.S.-European Union (EU) “Bridging Nanotechnology EHS (NanoEHS) Research Efforts” joint workshop will also be held in Washington, D.C., on October 11-12, 2018.  It will be the seventh event in a series of joint nanoEHS workshops organized by NNI and the European Commission (EC).

EUON Updates Website, Adds Two Searchable Databases

Posted in International, Legal/Regulatory Issues, Research

On June 11, 2018, the European Observatory for Nanomaterials (EUON) announced that its website now features the following two searchable databases, NanoData and eNanoMapper:

  • NanoData: Contains data on different products, research projects, publications, patents, and companies, and helps users to visualize statistics through built-in charts and graphs.  The data can also be filtered by different sectors and geographic location.  The database can be used for example by consumers interested in finding out about products that use nanotechnology.
  • eNanoMapper: Gives access to one of the largest data sources currently available on the toxicological properties of nanomaterials.  The data originates from several research projects, including the results of the European Union (EU)-funded NanoREG project.  The eNanoMapper can be used to find toxicological data on specific nanomaterials.

EUON states that it has also revamped its home page with more dynamic content, including the latest news on nanomaterials and nanotechnology from the web.  The update includes new information about nanomaterials within the EU regulatory framework, how they are used in different sectors, such as food, medicine, and environmental research, and how to use nanomaterials safely at work.

New York Household Cleansing Product Disclosure Program Will Require Disclosure of Nano Ingredients

Posted in Legal/Regulatory Issues, State

As reported in our June 7, 2018, memorandum, the New York State Department of Environmental Conservation (NYSDEC) on June 6, 2018, released its final policy and form for manufacturer disclosures under the Household Cleansing Product Information Disclosure Program.  The Household Cleansing Product Information Disclosure Program requires manufacturers of cleaning products sold in New York to disclose chemical ingredients and identify any ingredients that appear on authoritative lists of chemicals of concern on their websites.  According to the Household Cleansing Product Information Disclosure Program Certification Form and Program Policy, for each ingredient that is a nanoscale material, a term describing the nanoscale material should be disclosed.  For example, if the nanoscale material is carbon, the disclosure should use the term “nanoscale” carbon.  NYSDEC’s Program Policy states that a nanoscale material “is a chemical substance that meets the [Toxic Substances Control Act (TSCA)] definition of a reportable chemical substance manufactured or processed at the nanoscale.  That definition provides, in part, that a ‘reportable chemical substance is a chemical substance as defined in Section 3 of TSCA that is solid at 25° C and standard atmospheric pressure, that is manufactured or processed in a form where any particles, including aggregates and agglomerates, are in the size range of 1-100 nanometers in at least one dimension, and that is manufactured or processed to exhibit unique and novel properties because of its size.  A reportable chemical substance does not include a chemical substance that is manufactured or processed in a form where less than 1% of any particles, including aggregates, and agglomerates, measured by weight are in the size range of 1-100 nanometers.’”

According to the response to comments, a commenter suggested that NYSDEC delete the definition of nanomaterial, as “no unified determination of the definition of nanomaterial exists.”  NYSDEC responded that the U.S. Environmental Protection Agency (EPA) “requires disclosure of nanoscale materials under TSCA.  In doing so, they have created a definition for what is considered a nanoscale material.”  NYSDEC updated the Program Policy “to harmonize with this EPA definition.”  Another commenter stated that the requirement to disclose nanomaterials should be removed, and that NYSDEC should rely on TSCA/the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  NYSDEC responded that “[t]he requirement to disclose nanoscale materials is important as the potential human health and environmental effects of such substances are not yet fully understood.  However, the disclosure of this information is subject to [confidential business information (CBI)] claims.”

NYSDEC has mischaracterized EPA’s one-time reporting rule as a disclosure program, and suggested that the definition used by EPA for the purposes of this one-time reporting rule applies to other TSCA regulations.  As noted in our memorandum, the scope of the New York Cleansing Products Disclosure Program may be just the beginning of many more product lines to be subject to disclosure.  That these “ingredient disclosure” programs are beginning to populate the commercial landscape is likely to be cause for concern by product manufacturers.  New York may simply be the first state to use the TSCA Section 8(a) reporting rule’s definition of a reportable chemical substance for its own purposes.