Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

FDA Proposed Rule for OTC Sunscreen Drug Products Addresses Sunscreens Containing Nanomaterials

Posted in Federal, Legal/Regulatory Issues, United States

The Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.  The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded.  FDA notes that it has not established regulatory definitions of nanotechnology, nanomaterial, nanoscale, or other related terms.  As described in FDA’s guidance for industry “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” at this time, when considering whether an FDA-regulated product involves the application of nanotechnology, FDA asks:

  1. Whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately one nanometer (nm) to 100 nm).

In addition, because materials or end products can also exhibit related properties or phenomena attributable to a dimension(s) outside the nanoscale range of approximately one nm to 100 nm that are relevant to evaluations of safety, effectiveness, performance, quality, public health impact, or regulatory status of products, the proposed rule states that FDA will also ask:

  1. Whether a material or end-product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer (μm) (1,000 nm).

According to the notice, FDA “will apply these considerations broadly to all FDA-regulated products, including sunscreen products.”  For the purpose of the proposed rule, FDA uses the term “nanomaterial” generally to refer to materials falling within either point 1 or 2 above.

FDA notes that nanomaterial forms of the active ingredients zinc oxide and titanium dioxide have been used in marketed OTC sunscreens.  In addition to nanomaterial forms of zinc oxide and titanium dioxide, other nanomaterials are also reported to have been used, or promoted or studied for possible use, in sunscreen products.  FDA states that, “having examined the scientific information in the record, including for nanomaterial forms of zinc oxide and titanium dioxide, FDA is not now proposing conditions of use for these two active ingredients under the sunscreen monograph that distinguish nanomaterials from other forms of these ingredients.”  FDA “also does not propose to categorically classify sunscreen products that are manufactured using nanotechnology or contain nanomaterials as GRASE or not, solely on that basis.”  Manufacturers of products containing nanomaterials marketed under the OTC sunscreen monograph remain responsible for ensuring that the product satisfies all applicable legal requirements.  FDA “encourages manufacturers of such products to consult with FDA to facilitate a mutual understanding of specific scientific or regulatory issues relevant to their product.”

FDA invites comment on the following topics:

  • Specific nanomaterials or types of nanomaterials that have been used or proposed for use in OTC sunscreen products;
  • Concerns about sunscreen product safety, effectiveness, or quality associated with the use of nanomaterials in OTC sunscreen products, with supporting data;
  • Need for, and proposals of, specifications or limitations for particular nanomaterials for use in OTC sunscreen products;
  • Any particular nanomaterials that you believe should not be permitted for use in OTC sunscreen products, along with supporting scientific information; and
  • FDA’s proposed regulatory approach and/or alternative regulatory approaches to the use of nanomaterials in OTC sunscreen products.

In 2011, FDA published an advance notice of proposed rulemaking (ANPR) that identified sunscreen dosage forms considered either eligible or ineligible for inclusion in the sunscreen monograph, and specifically requested comments on the safety and efficacy of spray sunscreens.  FDA notes in the forthcoming proposed rule that several comments on the ANPR “expressed concern about the potential inhalation risk from exposure to spray sunscreens that contain nanomaterials (as both active and inactive ingredients).”  One comment also recommended that FDA require the presence of such ingredients to be disclosed on spray sunscreen labels.  FDA states that it “is not now proposing conditions of use, including labeling, for spray sunscreens that distinguish based on the presence of nanomaterials because we are proposing that any sunscreen spray that contains any particles smaller than 5 μm when it is dispensed from the consumer container would not be GRASE.” With respect to nanomaterials in spray sunscreens, FDA notes that “the primary determinant of inhalation risk is the size of the particles in emitted sprays, which may be larger than individual formulation components.  Nanoscale ingredients would not pass the particle size limitations for spray sunscreens; therefore, if they were to be detected when sprayed from the consumer container during particle size testing, the sunscreen could not be marketed under the OTC monograph.”  Publication of the proposed rule in the Federal Register will begin a 90-day comment period.

EU NanoSafety Cluster Announces Its Support of the Malta Initiative

Posted in International, Research

On February 18, 2019, the European Union (EU) NanoSafety Cluster (NSC) announced that it is supporting the Malta Initiative by linking various projects with activities developed within the Malta Initiative.  According to NSC’s website, the Malta Initiative began in 2017, when Germany approached the EU Directorate-General (DG) for Research and Innovation to request political and financial support to develop and amend Organization for Economic Cooperation and Development (OECD) Test Guidelines and Guidance Documents to ensure that nano-specific issues for fulfilling regulatory requirements are addressed.  It is a self-organized group without any legally binding status.  In line with existing OECD procedures, any country or organization with expertise interested in working on adapting existing OECD Test Guidelines or developing new OECD Test Guidelines and/or Guidance Documents is welcome to become an active contributor.  The activities of the Malta Initiative are supported through national, international, and EU resources by means of direct funding, in-kind contributions, or providing expertise.  Austria, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland, the United Kingdom, the European Chemicals Agency (ECHA), the European Commission (EC), and OECD’s Business and Industry Advisory Committee (BIAC) currently support the Malta Initiative.

The Malta Initiative Board was formed to facilitate and steer the activities of the Malta Initiative.  Board members were selected to represent EU Member States, EC DGs and agencies, NSC, and industry (notably through BIAC).  Furthermore, according to NSC, members have been selected “to include renowned experts from three relevant fields of expertise, namely:  physical-chemical characterization; environmental and biotic effects; and human health effects.”  The board members also have strong links to various OECD working parties and other groups are familiar with OECD working practices and procedures.  Members (sorted by last name) include:

  • Flemming Cassee (deputy Eugenia Valsami-Jones), NSC (EU);
  • Emeric Frejafon, Institut national de l’environnement industriel et des risques (France);
  • Monique Groenewold (deputy Eric Bleeker), National Institute for Public Health and the Environment (RIVM) (The Netherlands);
  • Elisabeth Heunisch, Federal Institute for Occupational Safety and Health (BAuA) (Germany);
  • Jenny Holmqvist (deputy Celia Tanarro), ECHA (EU);
  • Anke Jesse, Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU) (Germany) — chair;
  • Thomas Kuhlbusch, BAuA (Germany);
  • Juan Riego-Sintes (deputy Kirsten Rasmussen), EC (Joint Research Center-Ispra) (EU);
  • Kathrin Schwirn (deputy Doris Völker), German Environment Agency (UBA) (Germany);
  • Jacques-Aurélien Sergent (deputy Karin Wiench), BIAC; and
  • Anne Mette Zenner Boisen, Ministry of Environment and Food of Denmark (Denmark).

Case Study Demonstrates Successful Application of ECHA’s Read-Across Guidance to Multi-Walled Carbon Nanotubes

Posted in International, Legal/Regulatory Issues, Research

The February 2019 issue of Computational Toxicology includes an article entitled “Grouping of multi-walled carbon nanotubes to read-across genotoxicity:  A case study to evaluate the applicability of regulatory guidance.”  The article describes a case study, performed by scientists at the European Commission’s (EC) Joint Research Center (JRC), to explore and illustrate read-across of genotoxicity data by following the “Recommendations for nanomaterials applicable to the Guidance on QSARs and Grouping” developed by the European Chemicals Agency (ECHA).  The grouping hypothesis was supported by the use of chemoinformatics techniques such as hierarchical clustering and principal components analysis.  The uncertainties of the present case study were evaluated using the Read-Across Assessment Framework (RAAF) developed by ECHA.  The abstract notes that while the aim of the study was not to conduct a hazard assessment, the study data chosen for illustrative purposes suggest that the multi-walled carbon nanotube analogues selected are not genotoxic.  The abstract states:  “No (major) differences between the analogues were observed which could be attributed to differences in physicochemical properties such as length, diameter or rigidity/straightness.  Such properties, however, may have an impact on other hazard endpoints such as carcinogenicity.”  According to the abstract, the study shows the practical application of the ECHA framework for grouping of nanomaterials, as well as use of the ECHA RAAF for nanomaterials, and how this can be supported by chemoinformatics techniques.  The article suggests some adaptations to the workflow for a more practical and straightforward narrative in the reporting.  The European Union (EU) Observatory for Nanomaterials (EUON) issued a February 15, 2019, press release, stating that the study “successfully demonstrates the applicability of this guidance to such materials.”

JRC Publishes Overview of Concepts and Terms Used in the EC’s Definition of Nanomaterial

Posted in International, Legal/Regulatory Issues

The European Commission’s (EC) Joint Research Center (JRC) published on February 13, 2019, a report entitled An overview of concepts and terms used in the European Commission’s definition of nanomaterial.  The report supports the implementation of the EC’s Recommendation on a definition of nanomaterial (2011/696/EU).  It addresses the definition’s key concepts and terms and discusses them in a regulatory context.  Corresponding to the broad scope of the definition, the report states that its considerations can be applied across all relevant legislative areas; they are not specific to any particular piece of legislation.  The report provides recommendations for a harmonized and coherent implementation of the nanomaterial definition in any specific regulatory context at the European Union (EU) and national level.

ECHA Proposes to Restrict Intentionally Added Microplastics

Posted in International, Legal/Regulatory Issues

The European Chemicals Agency (ECHA) announced on January 30, 2019, that it has submitted a restriction proposal for microplastic particles that are intentionally added to mixtures used by consumers or professionals.  According to ECHA, if adopted, the restriction could reduce the amount of microplastics released to the environment in the European Union (EU) “by about 400 thousand tonnes over 20 years.”  ECHA states that its assessment found that intentionally added microplastics are most likely to accumulate in terrestrial environments, as the particles concentrate in sewage sludge that is frequently applied as fertilizer.  A much smaller proportion of these microplastics is released directly to the aquatic environment.  Once released, they can be extremely persistent in the environment and practically impossible to remove.  ECHA states:  “Due to their small size, microplastics and nanoplastics — even smaller particles that are created from the further degradation of microplastics — may be readily ingested and thereby enter the food chain.”  ECHA’s proposed restriction targets intentionally added microplastics in products from which they will inevitably be released to the environment.  The proposed restriction would cover small, typically microscopic, synthetic polymer particles that resist (bio)degradation.  The scope would cover a wide range of uses in consumer and professional products in multiple sectors, including cosmetic products, detergents and maintenance products, paints and coatings, construction materials, and medicinal products, as well as various products used in agriculture and horticulture and in the oil and gas sectors.

EFSA Will Hold Stakeholder Workshop on Nanoscience and Nanotechnology

Posted in International, Legal/Regulatory Issues

The European Food Safety Authority (EFSA) will hold a stakeholder workshop on nanoscience and nanotechnology on April 1-2, 2019, in Parma, Italy.  As reported in our July 5, 2018, blog item, “EFSA Publishes New Guidance on Nanotechnologies in Food and Feed,” in July 2018, EFSA published 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.  During the April 1-2, 2019, workshop, applicants can raise specific issues, give and follow presentations, and discuss with EFSA scientists their experiences in implementing the guidance.  EFSA intends the workshop for all applicants with expertise and interest in the area of risk assessment of nanoscience and nanotechnology applications in the food and feed chain.  EFSA particularly encourages stakeholders that are using nanoscience and nanotechnologies and intend to submit dossiers to attend the event.  The meeting can accommodate a maximum of 60 participants, including speakers and other experts identified by EFSA.  EFSA states that a “post-registration selection” will ensure there is a sufficient representation of the various fields of expertise and sectors, as well as geographical balance.  Registration will close on February 28, 2019.  After closure of registration, EFSA will inform potential participants whether they have been selected for participation.

Stakeholders Have Opportunity to Provide Feedback on EUON

Posted in International, Legal/Regulatory Issues

The European Union (EU) Observatory for Nanomaterials (EUON) provides information on nanomaterials to a wide audience on subjects including safety, innovation, and research.  It also covers the existing EU legislation on nanomaterials and the presence and uses of specific substances on the EU market.  EUON is currently conducting a survey to allow stakeholders to express their views on how EUON is performing and how it could be developed to meet their needs better.  EUON is funded by the European Commission (EC).  It is hosted and maintained by the European Chemicals Agency (ECHA).

ACGIH® TLV®-CS Committee Seeks Information on Carbon Nanotubes

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States

The American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee has included carbon nanotubes on its 2019 list of chemical substances and other issues under study.  Being placed on the under study list indicates that the TLV®-CS Committee has selected carbon nanotubes for development of a threshold limit value (TLV®).  ACGIH® describes TLVs® as health-based values representing the opinion of the scientific community that exposure at or below the level of the TLV® does not create an unreasonable risk of disease or injury.  The TLV®-CS Committee seeks substantive data and comments, and will consider only those addressing issues of health and exposure, not economic or technical feasibility.  ACGIH® will update the under study list into a two-tier list by July 31, 2019:

  • Tier 1 entries indicate the chemical substances and physical agents that may move forward as a notice of intended change (NIC) or notice of intent to establish (NIE) in the upcoming year, based on their status in the development process; and
  • Tier 2 consists of those chemical substances and physical agents that will not move forward, but will either remain on, or be removed from, the under study list for the next year.

If the Committee decided to proceed with a proposed TLV® for carbon nanotubes, the ACGIH® Board of Directors would first ratify the proposed value and it would be published as an NIE in the 2019 annual report of the TLV®-CS Committee.  The Committee included carbon nanotubes on its 2018 list of chemical substances and other issues under study.

NIOSH Publishes Nanotechnology Research Plan for 2018-2025

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States

On January 24, 2019, the National Institute for Occupational Safety and Health (NIOSH) published a document entitled Continuing to Protect the Nanotechnology Workforce:  NIOSH Nanotechnology Research Plan for 2018-2025.  NIOSH is using the Nanotechnology Research Plan for fiscal years (FY) 2018-2025 as a roadmap to advance:  (1) understanding of nanotechnology-related toxicology and workplace exposures; and (2) implementation of appropriate risk management practices during the discovery, development, and commercialization of engineered nanomaterials along their product lifecycle.  According to the Research Plan, the proposed NIOSH Nanotechnology Research Center (NTRC) research goals for FYs 2018-2025 focus on specific research needs to fill knowledge gaps and the Environmental, Health, and Safety (EHS) priority research needs of the National Nanotechnology Initiative (NNI).  The goals also align with the NIOSH Strategic Plan for FYs 2019-2023.  The Nanotechnology Research Plan’s Strategic Goals include:

  1. Increase understanding of new nanomaterials and related health risks to nanomaterial workers;
  2. Build upon initial data and information to further increase understanding of the initial hazard findings of engineered nanomaterials;
  3. Build upon initial guidance materials to further 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, cross-sectional, prospective cohort, and exposure studies; and
  5. Assess and promote national and international adherence with risk management guidance.

Each Strategic Goal includes intermediate and activity goals.  Based on burden, need, and impact, the Nanotechnology Research Plan states that the following goals are the top three priorities for the NTRC:

  • Priority 1 — Strategic Goal 1: Increase understanding of new nanomaterials and related health risks to nanomaterial workers.  Impact:  This research will contribute to the body of knowledge about the adverse health effects in animals exposed to various engineered nanomaterials. The findings will have a direct impact on the risk assessment of potential outcomes for exposed workers; contribute to epidemiologic research; and provide background that can be used to create guidance on control technologies and medical surveillance.
  • Priority 2 — Strategic Goal 3: Build upon initial guidance materials to inform nanomaterial workers, employers, health professionals, regulatory agencies, and decision-makers about hazards, risks, and risk management approaches.  Impact:  Various target audiences such as nanotechnology workers and employers, occupational safety and health professionals, policy-makers, decision-makers, and/or the scientific community in research, manufacturing, construction, mining, oil and gas, and healthcare will begin or continue to apply NIOSH guidance to develop, handle, and commercialize engineered nanomaterials responsibly.  Through strategic planning, research, partnering with stakeholders, and making information widely available, the NTRC will continue supporting the responsible development of nanotechnology by translating research into effective risk management guidance and practices across the lifecycle of engineered nanomaterial-enabled products.
  • Priority 3 — Activity/Output Goal 3.1.3:  Use a nanomaterial hazard banding classification scheme to group engineered nanomaterials.  Impact:  This research will investigate the evidence for developing predictive algorithms of structure-activity relationships and comparative toxicity for use in quantitative risk assessment.  Findings from this research will provide the scientific basis for developing occupational exposure limits for individual nanomaterials or groups of nanomaterials.

New York Delays Enforcement of Household Cleansing Product Information Disclosure Program

Posted in Legal/Regulatory Issues, State, United States

On January 9, 2019, the New York State Department of Environmental Conservation (NYSDEC) announced a three-month delay in its enforcement of the Household Cleansing Product Information Disclosure Program (Disclosure Program), from July 1, 2019, to October 1, 2019.  NYSDEC published its announcement in the January 9, 2019, Environmental Notice Bulletin.  As reported in our June 8, 2018, blog item, the 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 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.’”

More information regarding the Disclosure Program and the enforcement delay is available in Bergeson & Campbell, P.C.’s January 14, 2019, memorandum, “NYDEC Delays for Three Months Enforcement of its Household Cleansing Product Information Disclosure Program