Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

NIEHS-Funded Center Will Assess Safety of Engineered Nanomaterials

Posted in Federal, Research, United States

The National Institute of Environmental Health Sciences (NIEHS) is funding a new interdisciplinary Nanosafety Research Center at the T.H. Chan Harvard School of Public Health (HSPH).  The main focus of the new HSPH-NIEHS Center is to bring together scientists from across disciplines — material science, chemistry, exposure assessment, risk assessment, nanotoxicology, and nanobiology — to assess the potential environmental health and safety implications of engineered nanomaterials.  According to an August 16, 2016, news article, the Center will focus on building a fundamental understanding of why some engineered nanomaterials are potentially more harmful than others.  The Center will also establish a “reference library” of engineered nanomaterials, each with slightly varied properties, which will be used in nanotoxicology research to assess safety.  This will allow researchers to pinpoint exactly what aspect of an engineered nanomaterials’ properties may impact health.  The researchers will also work to develop standardized methods for nanotoxicology studies evaluating the safety of nanomaterials.

U.S. Army ERDC Conducting Survey to Inform Risk Management Tool for Developing Nano-Enabled Products and Nanomaterials

Posted in Federal, Legal/Regulatory Issues, United States

The U.S. Army Engineer Research and Development Center (ERDC) is developing a web-enabled information and screening tool intended to help small businesses integrating or developing nanoscale materials address uncertainty related to regulatory compliance and environment, health, and occupational safety (EHOS) risks.  To that end, ERDC is conducting a brief survey to identify resources, regulations, and risks that are most important to companies and other organizations involved in product and material development.  According to ERDC, the insights provided through the survey will help develop user requirements for a tool that can address future EHOS and regulatory needs in nanotech development.  ERDC is a member agency of the National Nanotechnology Initiative through its affiliation with the Department of Defense, and it has produced many tools and publications in this research area.  ERDC is partnering with the Jordan Valley Innovation Center at Missouri State University on this effort to augment EHOS expertise with its knowledge of emerging trends in the nanomaterial space.  All responses will be held in confidence by researchers at the ERDC, and will be used primarily for the purpose of developing a tool to help businesses that use or are considering use of nanoscale materials account for relevant risks and regulations.  The survey will take about ten minutes to complete.  Responses are due August 31, 2016.  Any questions or comments should be directed to Matthew D. Wood, ERDC.

Review Published of Nanomaterials for Products and Application in Agriculture, Feed, and Food in the European Union

Posted in International, Research

The European Food Safety Authority (EFSA) requested a review of the already marketed and in-development applications of nanomaterials in the agri/feed/food sectors.  The results of the review are published in the August 2016 issue of Trends in Food Science & Technology in an article entitled “Nanomaterials for products and application in agriculture, feed and food.”  The article highlights include:

  • Nanotechnology is applied in agricultural production, animal feed, food processing, additives, and food contact materials;
  • Nano-encapsulates, silver, titanium dioxide, and silica are the most often mentioned nanomaterials in the literature;
  • A comparison between marketed and in-development applications indicates a trend moving from inorganic to organic nanomaterials; and
  • Nanotechnology is an enabling technology, therefore product description should contain the function of a nanomaterial in the product.

Two Workshops Will Be Held Before October 2016 OpenTox Euro Conference

Posted in International, Research

Two workshops, a European Union (EU)-U.S. Nano Environmental and Health Safety (NanoEHS) workshop and a nano modeling workshop, will be held in advance of the October 2016 OpenTox Euro Conference.  The EU-U.S. NanoEHS workshop, “Enabling a Sustainable Harmonized Knowledge Infrastructure Supporting NanoEHS Assessment,” will be held October 24, 2016.  The objective of the workshop is to facilitate networking, knowledge sharing, and idea development on the requirements and implementation of a sustainable knowledge infrastructure for nanoEHS assessment and communications.  The workshop will also facilitate active discussions and identify potential partners for future EU-U.S. cooperation on the development of knowledge infrastructure in the nanoEHS field.  The nano modeling workshop will be held October 25, 2016.  The objectives are to:  (1) give the opportunity to research groups working on computational nanotoxicology to disseminate their modeling tools based on hands-on examples and exercises; (2) present a collection of modeling tools that can span the entire lifecycle of nanotox research, starting from the design of experiments until use of models for risk assessment in biological and environmental systems; and (3) engage workshop participants in using different modeling tools and motivate them to contribute and share their knowledge. The OpenTox Euro Conference, “Integrating Scientific Evidence Supporting Risk Assessment and Safer Design of Novel Substances,” will be held October 26-28, 2016.  The current topics for the Conference include:  (1) computational modeling of mechanisms at the nanoscale; (2) translational bioinformatics applied to safety assessment; (3) advances in cheminformatics; (4) interoperability in action; (5) development and application of adverse outcome pathways; (6) open science applications showcase; (7) toxicokinetics and extrapolation; and (8) risk assessment.

CEN Committee Seeks Responses to Survey on Disposal Practices for Manufactured Nano-Objects in Waste

Posted in International, Legal/Regulatory Issues

Under European Commission (EC) funding, the European Committee for Standardization Technical Committee (CEN/TC) 352 — Nanotechnologies is developing guidelines relating to the safe waste management and disposal of deliberately manufactured nano-objects. The TC seeks responses from companies manufacturing or processing manufactured nano-objects by September 5, 2016, to an online questionnaire relating to current disposal practices for manufactured nano-objects in waste. The guidelines are intended to provide guidance for all waste management activities from the manufacturing and processing of manufactured nano-objects.  The TC has a separate online questionnaire for waste disposal companies.

Canada Begins Consultation on Proposed Prioritization Approach for Nanoscale Forms of DSL Substances

Posted in International, Legal/Regulatory Issues

On July 27, 2016, Environment and Climate Change Canada (ECCC) and Health Canada (HC) began a consultation on a proposed prioritization approach for nanoscale forms of substances on the Domestic Substances List (DSL).  Canada will use the proposed approach to:  (1) establish a list of existing nanomaterials in Canada for prioritization; (2) identify how the information available will be used to inform prioritization of nanomaterials for risk assessment; and (3) outline the proposed outcomes of the prioritization process.  In 2015, Canada conducted a mandatory survey under Section 71 of the Canadian Environmental Protection Act, 1999 (CEPA).  The survey applied to persons who manufactured or imported any of 206 nanomaterials at a quantity greater than 100 kilograms (kg) during the 2014 calendar year.  Based on the results of the survey, ECCC and HC will prepare a final list of confirmed existing nanomaterials in Canada and will use the list for subsequent prioritization.  ECCC and HC propose that, where possible, the substances identified via the survey be “rolled up into” their broader parent nanomaterial groups for the purposes of prioritization.  According to ECCC and HC, this will allow, when possible, a more robust look at the hazard, volume, and use data as appropriate, rather than considering an individual substance-by-substance approach.  ECCC and HC state that further consideration for sub-grouping (such as by use, unique property, or functionalization) may need to be considered for prioritization and/or risk assessment.  The 21 possible nanomaterial groupings, based on parent substance, include:

Aluminum oxide

Iron (II)/(II/III) oxide

Modified silica

Bismuth oxide

Magnesium oxide

Silicon oxide

Calcium carbonate

Manganese (II & III) oxide

Silver

Cerium oxide

Nanocellulose

Titanium dioxide

Cobalt (II) oxide

Nanoclays

Yttrium oxide

Copper (II) oxide

Nickel (II) oxide

Zinc oxide

Gold

Quantum dots

Zirconium oxide

To prioritize the nanomaterials, ECCC and HC will consider multiple sources of information, including volume and use pattern information from the survey, routes of exposure, and scientific information on hazard.  ECCC and HC will determine human and ecological exposure separately using information obtained from the survey such as information on volume, sector (based on reported North American Industry Classification System (NAICS) codes), and use (based on reported substance function code).  ECCC and HC state that nanomaterials that were not reported during the survey and received no voluntary submissions of information will be considered as not in commerce and no further action will be taken on these nanomaterials as a result of prioritization.  Direct human exposure will be ranked as:

  • Low: Substances with only industrial and/or commercial applications (e., no consumer use) or substances contained in manufactured items, but not subject to leaching;
  • Moderate: Substances contained in manufactured items subject to possible leaching during normal use; or
  • High: Substances directly used by consumers, contained in consumer products, or in manufactured items intended for use by or for children.

Prioritization for ecological exposure will be based on information reported through the survey, including consideration of the volumes used in Canada, and on three possible types of environmental exposures scenarios:

  1. Manufacturing of the nanomaterial;
  2. Manufacturing the final end-use product; and/or
  3. Use of the end-use product.

To rank the potential hazards to human health and the environment, ECCC and HC will consider information from a variety of sources, including peer-reviewed literature, information available from other government of Canada activities (e.g., Chemicals Management Plan (CMP)) and international reports and activities (e.g., Organization for Economic Cooperation and Development dossiers).  ECCC and HC will rank the human health hazard by considering the properties of the nanomaterial as well as any available information on toxicological effects of the nanomaterial itself (e.g., outcomes of available toxicological studies).  ECCC and HC will rank the ecological hazard by looking at the most sensitive endpoint across all compartments (e.g., soil, sediment, air, and water), species, and exposure durations, using studies that conform to standardized and accepted test guidelines.  The results of prioritization will be no further action at this time; nanomaterials prioritized for risk assessment; and nanomaterials that will be set aside for future consideration due to insufficient information.  Comments on the proposed prioritization approach are due September 25, 2016.

White Paper Describes Nanotechnology-Inspired Grand Challenge for Future Computing

Posted in Federal, Research, United States

The White House Office of Science and Technology Policy (OSTP) announced on July 29, 2016, that federal agencies released a white paper describing the collective federal vision for the emerging and innovative solutions needed to realize the Nanotechnology-Inspired Grand Challenge for Future Computing announced in October 2015.  The white paper, a collaboration by the U.S. Department of Energy (DOE), National Science Foundation (NSF), Department of Defense (DOD), National Institute of Standards and Technology (NIST), and the intelligence community, describes the interagency technical priorities, highlights the challenges and opportunities associated with these priorities, and presents a guiding vision for the research and development needed to achieve key technical goals for the challenge.  According to the white paper, “[b]y coordinating and collaborating across multiple levels of government, industry, academia, and nonprofit organizations, the nanotechnology and computer science communities can look beyond the decades-old approach to computing based on the von Neumann architecture and chart a new path that will continue the rapid pace of innovation beyond the next decade.”  As reported in our October 20, 2015, blog item, the Grand Challenge is to “[c]reate a new type of computer that can proactively interpret and learn from data, solve unfamiliar problems using what it has learned, and operate with the energy efficiency of the human brain.”  The new computing capabilities envisioned in the Grand Challenge might address issues such as delivering individualized treatments for disease, allowing advanced robots to work safely alongside people, and proactively identifying and blocking cyber intrusions.

Comments on 2011 Proposed SNURs Prompt Proposal Regarding Hierarchy of Controls

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

On July 28, 2016, the U.S. Environmental Protection Agency (EPA) proposed changes to the existing regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) to align these regulations with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS), as well as changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals.  One of the proposed changes would be to make it a significant new use not to implement a hierarchy of controls to protect workers.  Persons subject to applicable significant new use rules (SNUR) would be required to determine and use appropriate engineering and administrative controls before using personal protective equipment (PPE) for worker protection, similar to the requirements in the OSHA standards at 29 C.F.R. Section 1910.134(a)(1) and guidance in Appendix B to Subpart I of 29 C.F.R. Part 1910.  According to EPA, this change is being proposed partly due to comments received on recently promulgated SNURs.  As reported in our December 28, 2011, blog item, EPA proposed on December 28, 2011, SNURs for 17 chemical substances that were the subject of premanufacture notices (PMN).  Of particular interest, seven of the chemical substances were multi-walled carbon nanotubes, while six were fullerenes, and the proposed SNURs prompted significant comment.  In the July 28, 2016, proposed rule, EPA states that in response to the December 28, 2011, proposed SNURs, it received comments from 26 public submissions.  According to EPA, each of the comments generally stated that EPA’s approach of exclusively identifying the absence of adequate PPE as a significant new use instead of engineering and administrative controls is not following the best occupational health and safety practices.  The commenters suggested approaches that EPA could adopt.  Several commenters identified the industrial hygiene “hierarchy of controls” approach for workplace health and safety, where elimination, substitution, engineering controls, and workplace or administrative controls should be implemented before use of PPE for worker protection.  Several commenters stated that persons subject to SNURs should follow the OSHA requirements to use controls that are higher in the hierarchy of controls before requiring employees to use PPE.  Some commenters suggested that EPA should specifically incorporate the OSHA requirements at 29 C.F.R. Section 1910.134(a)(1) into each SNUR or modify standard requirements for SNURs at 40 C.F.R. Section 721.63 to require a hierarchy of controls.  EPA promulgated final SNURs on June 26, 2013, and responded to the comments, agreeing that a hierarchy of controls should be applied and that PPE should be the last option to control exposures.  Below is a sample of comments on the December 28, 2011, proposed SNURs:

Under TSCA, EPA requires manufacturers of new chemical substances, including new nanomaterials, to submit PMNs.  EPA’s web page on the control of nanoscale materials under TSCA lists actions EPA has taken to control and limit exposures to new nanoscale materials, including requiring the use of PPE and engineering controls.  In light of EPA’s proposed rule, however, and the influence comments on EPA’s December 28, 2011, proposed SNURs have had, manufacturers of new nanomaterials should implement a hierarchy of controls whenever possible.  More information on EPA’s July 28, 2016, proposed rule will be available in Bergeson & Campbell, P.C.’s forthcoming memorandum, which will be posted online.

Canadian Parliament Holds First Reading of Bill to Create Framework to Regulate Nanotechnology

Posted in International, Legal/Regulatory Issues

On June 8, 2016, the House of Commons held its first reading of an Act to amend the Canadian Environmental Protection Act, 1999 (CEPA) (nanotechnology) (C-287).  The bill would add Part 6.1 to CEPA primarily to implement procedures for the investigation and assessment of nanomaterials.  Member Peter Julian, New Democratic Party of Canada (NDP) House Leader, issued a June 8, 2016, press release stating that he first introduced the bill in 2010 and is “pleased to see that some of the aspects of this Bill are being considered by Health Canada and Environment Canada, such as the development of a registry for nanomaterials in commerce and use in Canada.”  According to the press release, the bill would establish a “balanced approach ensuring the responsible development of nanotechnology and the safe use off [sic] nanomaterials in Canada.”  The bill would define nanomaterial as any manufactured substance or product or any component material, ingredient, device or structure that:  (a) is within the nanoscale (one nanometer (nm) up to and including 100 nm), in at least one external dimension; or (b) if it is not within the nanoscale, exhibits one or more properties that are attributable to the size of a substance and size effects.  The bill mandates a risk assessment process to identify the potential benefits and possible risks of nanotechnologies before nanoproducts enter the market.  It would also create a national inventory regarding nanotechnology, including nanomaterials and nanoparticles, using information collected under CEPA Sections 46 and 71 and “any other information to which the Ministers have access.”  As reported in our July 27, 2015, blog item, on July 25, 2015, Canada published a notice announcing a mandatory survey under CEPA Section 71(1)(b) with respect to certain nanomaterials in Canadian commerce.  Julian first introduced similar legislation in 2010.  Previous versions of the bill did not make it past the first reading in the House of Commons.

EC Amends Cosmetics Regulation to Allow Use of Titanium Dioxide (Nano) as UV Filter

Posted in International, Legal/Regulatory Issues

The European Commission (EC) published on July 14, 2016, a regulation in the Official Journal of the European Union that amends Annex VI, the list of ultraviolet (UV) filters allowed in cosmetic products, of the cosmetics regulation.  Under the amendment, the entry for titanium dioxide is revised to state that the combined use of titanium dioxide and titanium dioxide (nano) must not exceed 25 percent maximum concentration in ready-for-use preparation.  The amendment also adds an entry for titanium dioxide (nano), stating that it must not exceed 25 percent maximum concentration in ready-for-use preparation.  Titanium dioxide (nano) is not to be used in applications that may lead to exposure of the end user’s lungs by inhalation.  Only nanomaterials having the following characteristics are allowed:

  • Purity ≥ 99 percent;
  • Rutile form, or rutile with up to 5 percent anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes;
  • Median particle size based on number size distribution ≥ 30 nanometers (nm);
  • Aspect ratio from 1 to 4.5, and volume specific surface area ≤ 460 square meters per cubic meter (m2/cm3);
  • Coated with silica, hydrated silica, alumina, aluminum hydroxide, aluminum stearate, stearic acid, trimethoxycaprylylsilane, glycerin, dimethicone, hydrogen dimethicone, or simethicone;
  • Photocatalytic activity ≤ 10 percent compared to corresponding non-coated or non-doped reference, and
  • Nanoparticles are photostable in the final formulation.