ECHA Planning Workshop on Regulatory Challenges in the Risk Assessment of Nanomaterials

The European Chemicals Agency (ECHA) will hold a topical scientific workshop on October 23-24, 2014, on regulatory challenges in the risk assessment of nanomaterials.  The workshop will bring together experts in the field of risk assessment of nanomaterials to discuss and update scientific principles and guidelines for assessing human health and environmental risks of chemicals substances in nanoform. According to ECHA, the workshop will also provide a platform for academia and regulators to address how the main long-term challenges from the regulatory perspective can be reflected and employed in the current and future research topics on nanomaterials. The workshop will cover the following topics:

  • Challenges in regulatory risk assessment of nanomaterials;
  • Measurement and characterization of nanomaterials;
  • Metrology and dose metrics for hazard and exposure assessment throughout the life cycle;
  • Environmental fate, persistence and bioaccumulation throughout the life cycle; and
  • Read across and categories of nanomaterials.

Participation in the workshop will be by invitation only. Experts in the risk assessment of nanomaterials who wish to participate should express interest by May 15, 2014.

 

EPA Awards Grant to Study the Life Cycle of Nanomaterials

The U.S. Environmental Protection Agency (EPA) has awarded a $5 million, four-year grant to investigators led by Arizona State University to study the life cycle of nanomaterials. According to EPA’s description of the award, the project involves an interdisciplinary team of chemists, toxicologists, scientists, engineers, and social scientists to evaluate the trade-offs between intended function of nanomaterials in products and risks to humans and the environment across their life cycle from creation, through use and disposal. The description states that researchers will evaluate four product lines expected to have variable nanomaterial release rates (i.e., dispersed in liquids used in industrial manufacturing (e.g., polishing agents), dispersed in products (e.g., foods), embedded in composite polymers (e.g., thermoplastics, membranes for water filtration), and coated on the surfaces of flexible polymeric materials (e.g., textiles) using four high-volume nanomaterials (titanium dioxide, silicon dioxide, nanosilver, and multi-wall carbon nanotubes) that exhibit properties unique from each other and properties similar to other emerging nanomaterials.  The description states that the results are expected to:

  1. Reduce uncertainty in risks from nano-enabled products for the public, manufacturing communities, and regulatory agencies;
  2. Provide the framework for existing and future nano-enabled product designs that preserve commercial value while minimizing adverse environmental health and safety effects;
  3. Train a diverse group of undergraduate, graduate, and post-doctoral scientists to work as a network and produce integrated research products; and
  4. Educate the public on the importance of the life cycle perspective for maximizing the benefits of nano-enabled products.

European NGOs Publish Position Paper on the Regulation of Nanomaterials

Earlier this month, the Center for International Environmental Law (CIEL) and its European partners published a position paper on the regulation of nanomaterials at a meeting of the European Union (EU) competent authorities. According to the position paper, current EU legislation “does not guarantee that all nanomaterials on the market are safe by being assessed separately from the bulk form of the substance.” The position paper asks the European Commission (EC) to produce “concrete proposals for a comprehensive revision of the existing legal framework addressing the potential risks of nanomaterials.” The position paper states that:

  1. Nanomaterials are different from other substances;
  2. Risk from nanomaterials must be assessed;
  3. Nanomaterials should be thoroughly evaluated;
  4. Information on nanomaterials must be collected and disseminated; and
  5. Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) enforcement activities should tackle nanomaterials.

EPA Stops Sale of Unregistered Food Containers Containing Nanosilver

On March 31, 2014, the U.S. Environmental Protection Agency (EPA) announced that it issued an order to Pathway Investment Corp. of Englewood, New Jersey to stop the sale of plastic food storage containers that have not been tested or registered with EPA, in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to EPA’s press release, the company’s Kinetic Go Green Premium Food Storage Containers and Kinetic Smartwist Series Containers contain nanosilver as an active ingredient, and the company markets other products as containing nanosilver, which the company claims helps reduce the growth of mold, fungus, and bacteria. EPA notes that such claims can be made only for products that have been properly tested and are registered under FIFRA. EPA states:

During a November 13, 2013 EPA inspection of the company’s facility in Englewood, New Jersey, a Pathway representative acknowledged that the company sold plastic products containing nano silver. The label for the Kinetic Go Green Premium food storage container stated that the product contained nano silver technology and that the nano-sized particles of silver helped to reduce the growth of bacteria and mold, allowing foods to stay fresh up to three times longer. In addition, the company’s product description touted the benefits of nano silver in its products and the company’s website contained several claims that describe how the nano silver particles destroy, kill or reduce the growth of mold, fungus and bacteria.

EPA states that, in addition to the order sent to Pathway, it also issued warning letters to Amazon, Sears, Wal-Mart, and other large retailers directing them not to sell these products.

ECHA Report Includes Recommendations for Exposure Assessment and Risk Characterization of Nanomaterials under REACH

On March 26, 2014, SAFENANO announced that the European Chemicals Agency (ECHA) published a report entitled Human health and environmental exposure assessment and risk characterisation of nanomaterials: Best practice for REACH registrants. The report summarizes the outcomes of the third (and last) meeting of the Group Assessing Already Registered Nanomaterials (GAARN). The September 30, 2013, meeting focused on discussing the approach and challenges faced by participant registrants when documenting the human health and environmental exposure assessment and risk characterization of their substances while registering them under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The report states that the outcomes of the discussion “can be viewed as generic recommendations for the exposure assessment and risk characterisation of NMs under REACH, while considering the present scientific knowledge on the field of nanotoxicology and practice, as well as challenges from participating registrants.” The report states that the provisions that apply to the registration of nanomaterials are the same as those for any other chemical substance, but notes that, “in line with scientific developments, there are specific considerations that registrants should report in specific endpoint sections, as this information will facilitate the evaluation of the adequacy of the tests performed and data obtained with regard to the safety assessment of NMs.” According to the report, the registration dossier should contain a comprehensive physicochemical characterization of the registered nanoform(s).  Only when well-characterized nanoforms are reported in the dossier, can a read-across approach or use of existing data be considered for the purpose of hazard assessment.  Registration dossiers including nanomaterials and bulk substances under the same technical dossier should include specific exposure scenarios for nanomaterials if these differ from the exposure scenarios developed for the bulk materials.  The report states that, “[i]n principle, the existing risk assessment paradigm developed for traditional chemicals” should also apply to nanomaterials.  According to the report, comprehensive risk assessments for nanomaterials currently present challenges both for human health and the environment.  The following conclusions can be drawn:

Regarding the risk assessment for workers, due to the lack of validated modelling tools for nanomaterial exposure, field measurement data are currently preferred to support the risk assessment.  If possible, the risk assessment should follow a multi-metric approach.  The use of qualitative approaches is allowed to support measured or estimated exposure data.  Concerning RMMs, the conventional control technologies to handle dusty materials are applicable to NMs and provide good control if implemented and maintained correctly.

With regards to the environment, the lack of specific hazard data complicates the risk assessment. Moreover, there are significant limitations in the applicability of conventional exposure assessment models. Registrants are advised to collect information on environmental release when possible (RIPoN 3).  The current report proposes best practice to achieve realistic exposure data that can be used in environmental risk assessments.

In general, it is important to conclude with the reminder of the legal obligation that registration dossiers need to be updated with new nano-specific studies as scientific developments are progressing.  Safe use claims under REACH should be based on explicit and transparent documentation supporting the hazard, exposure and risk assessment of NMs.  Registrants are reminded that a lack of (hazard) data does not automatically mean that there is a lack of specific hazards or risks for a substance.

NNI Publishes Supplement to President's 2015 Budget

On March 25, 2014, the National Nanotechnology Initiative (NNI) published a supplement to President Obama’s 2015 budget request submitted to Congress on March 4, 2014.  The supplement provides a description of the activities underway in 2013 and 2014 and planned for 2015 by the federal government agencies participating in the NNI, primarily from a programmatic and budgetary perspective.  NNI states that it is based on the NNI Strategic Plan and reports actual investments for 2013, estimated investments for 2014, and requested investments for 2015 by Program Component Area (PCA). NNI states that the President’s 2015 budget provides over $1.5 billion for NNI, “reflect[ing] nanotechnology’s potential to significantly improve our fundamental understanding and control of matter at the nanoscale and to translate that knowledge into solutions for critical national issues.” According to NNI, the investments in 2013 and 2014 and proposed for 2015 “continue the emphasis on accelerating the transition from basic R&D to innovations that support national priorities, while maintaining a strong base of foundational research, to provide a pipeline for future nanotechnology-based innovations.”

NanoDiode Survey Seeks European Citizens' Views on Nanotechnologies

NanoDiode is conducting a survey concerning Europeans’ preferences for nanotechnologies. According to NanoDiode, the results will be used “to inspire policy makers, researchers and companies across Europe.” NanoDiode states that stakeholder engagement and dialogue is essential to the responsible development of nanotechnologies in Europe, and invites lay consumers to participate in the survey. NanoDiode, which is funded by the European Union, establishes a coordinated program for outreach and dialogue throughout Europe.  It integrates engagement activities along the innovation value chain by combining “upstream” public engagement (by way of dialogues that integrate societal needs and expectations into the policy debate) with “midstream” engagement (by organizing open innovation workshops at the level of research and development) and “downstream” strategies for education and communication.

America Competes Reauthorization Act Would Reauthorize NNI

On March 6, 2014, Representative Eddie Bernice Johnson (D-TX), Ranking Member of the Committee on Science, Space, and Technology, introduced the America Competes Reauthorization Act of 2014 (H.R. 4159). The bill would establish, revise, and extend specified science, technology, engineering, and mathematics programs, as well as education, research, and training programs.  The bill would reauthorize the National Nanotechnology Initiative (NNI) “to ensure the United States remains a leader in the development of new technologies and products based on breakthroughs in our understanding of materials at the atomic and molecular level.” Under the bill, the National Nanotechnology Coordination Office (NNCO) would develop and maintain a public database of projects funded under at least the environmental, health, and safety (EHS) program component area, or any successor program component area. The database would include a description of each project, its source of funding by agency, and its funding history. The bill states that the National Nanotechnology Program will include research on: (1) the development of instrumentation and tools required for the rapid characterization of nanoscale materials and for monitoring of nanoscale manufacturing processes; and (2) approaches and techniques for scaling the synthesis of new nanoscale materials to achieve industrial-level production rates. On March 6, 2014, the bill was referred to the House Committee on Science, Space, and Technology and to the Committee on Education and Workforce. On March 11, 2014, the bill was referred to the Science, Space, and Technology Subcommittee on Research and Technology.

EU NanoSafety Cluster Begins Database Survey

The European Union (EU) NanoSafety Cluster announced on March 18, 2014, the availability of an online nanosafety database survey. According to the EU Nanosafety Cluster, this is the first survey in a biannual effort to collect, organize, and share up-to-date information about nanosafety-related databases worldwide. The EU NanoSafety Cluster will continuously update the list of databases “with new valuable insight along its development.” The objective is to help owners and administrators of nanosafety-related databases increase awareness of their databases and to ensure interoperability of data. Reponses to the survey are due April 18, 2014.

Germany Releases Study Assessing Impacts of European Register of Products Containing Nanomaterials

Earlier this month, the German Federal Environment Agency (UBA) issued a report entitled Assessment of Impacts of a European Register of Products Containing Nanomaterials, which was intended to analyze the impacts of a European register of products containing nanomaterials (ENPR).  The study identified the sectors and companies that would be affected by an ENPR, and estimated the number of notifiers and notifications, categories of substances, concerned mixtures, and articles.  Based on that result, the study quantified the administrative costs for notifiers and the competent authority, and described the benefits of an ENPR for public authorities, consumers, and notifiers. The report includes a preliminary remark from Öko-Institut e.V., which performed the study. The preliminary remark notes that during the study, various difficulties occurred, resulting in a lower reliability of calculations.  Complications included companies “not interested or not able to substantiate the high burden that they allocate to such a register with reliable figures,” as well as “quite a number of companies [that] do not seem to have knowledge of the possible content of nanomaterials in their products.” According to the report, “an ENPR could bring additional value for public authorities, consumers and companies involved in nanotechnology.” The report concludes that an ENPR would “help to avoid a multiplication of administrative costs” to both companies manufacturing or importing products containing nanomaterials and the national competent authorities that would be responsible for a register at the Member State level. The report states: “Finally, from a legal point of view it can be discussed whether a register is the proportionate instrument in the light of the precautionary principle to govern the safe use of nanomaterials and products containing them.  However, the introduction of an ENPR is the mildest legal instrument to control the production and use of nanoproducts compared to a restriction, a ban or a moratorium on one or more of these products.”