On April 19, 2018, the European Parliament (EP) approved a regulation on organic production and labeling of organic products. Under the regulation, the production of processed organic food will be based on several specific principles, including the exclusion of food containing or consisting of engineered nanomaterials. The regulation defines engineered nanomaterial as defined in the 2011 regulation on the provision of food information to consumers as amended in 2015 by the novel foods regulation. According to the EP’s April 19, 2018, press release, one of the features of the regulation is to ensure the high quality of organic food through “strict, risk-based checks” that will take place along the supply chain. In addition, imports will have to comply with European Union (EU) standards. The press release states that the current “equivalence” rules, requiring non-EU countries to comply with similar but not identical standards, will be phased out within five years. The Council of the EU must formally approve the text of the regulation before it can enter into force. It shall apply beginning January 1, 2021.
The National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice on April 24, 2018, announcing the availability of a draft research plan entitled Continuing to Protect the Nanotechnology Workforce: NIOSH Nanotechnology Research Plan for 2018-2025 for public comment. The draft Nanotechnology Research Plan presents the Nanotechnology Research Center (NTRC) strategic plan for fiscal years (FY) 2018-2025, highlighting how the critical research and guidance efforts of NIOSH align with and support the comprehensive Environmental, Health, and Safety (EHS) Research Strategy needs of the National Nanotechnology Initiative (NNI). For the period FY2018-2025, NIOSH states that it will continue to fill information and knowledge gaps that address the five NIOSH NTRC strategic goals first defined in the 2013 strategic plan. The proposed research focuses on specific research needs to fill the knowledge gaps and the NNI EHS priority research needs:
- Strategic Goal 1: Increase understanding of new hazards and related health risks to nanomaterial workers:
- Intermediate Goal 1.1: Authoritative groups will use NIOSH research to create standards and develop interventions to protect workers from exposures to new, novel engineered nanomaterials.
- Strategic Goal 2: Expand understanding of the initial hazard findings of engineered nanomaterials:
- Intermediate Goal 2.1: Authoritative groups will issue guidance based on NIOSH research to prevent pulmonary toxicity from carbon nanotubes and nanofibers, metal, and metal oxides;
- Intermediate Goal 2.2: Medical professionals and researchers will use NIOSH information on biomarkers to conduct screening tests to evaluate worker response to inhalation of engineered nanomaterials;
- Intermediate Goal 2.3: Manufacturers will issue recommendations to protect the health and safety of workers along the product lifecycle of engineered nanomaterials;
- Intermediate Goal 2.4: Health and safety professionals will use standardized measurement methods for evaluating workplace exposure to engineered nanomaterials;
- Intermediate Goal 2.5: Manufacturers will provide information on the potential fire and explosion safety hazards of engineered nanomaterials on safety data sheets (SDS) and product labels; and
- Intermediate Goal 2.6: Nanomaterial researchers will use informatics to process and communicate information.
- Strategic Goal 3: Support the creation of guidance materials to inform nanomaterial workers, employers, health professionals, regulatory agencies, and decision makers about hazards, risks, and risk management approaches:
- Intermediate Goal 3.1: Authoritative groups will use NIOSH-recommended categorical and specific exposure limits;
- Intermediate Goal 3.2: Employers will adopt NIOSH recommendations for engineering controls and personal protective equipment (PPE) for use with engineered nanomaterials and additive manufacturing processes;
- Intermediate Goal 3.3: Employers will incorporate Prevention through Design (PtD) into engineered nanomaterial health and safety programs; and
- Intermediate Goal 3.4: International groups such as the World Health Organization (WHO) and the Organization for Economic Cooperation and Development (OECD) will include NIOSH research in the collection, management, and dissemination of relevant information to protect engineered nanomaterial workers.
- Strategic Goal 4: Support epidemiologic studies for nanomaterial workers, including medical, cross-sectional, prospective cohort, and exposure studies:
- Intermediate Goal 4.1: Employers, unions, and workers handling engineered nanomaterials will participate in epidemiologic research and medical surveillance.
- Strategic Goal 5: Assess and promote national adherence with risk management guidance:
- Intermediate Goal 5.1: Nanomaterial industry will incorporate good risk management guidance for engineered nanomaterials.
NIOSH states that it is seeking stakeholder input on the draft Nanotechnology Research Plan to ensure that the program is meeting the needs of the stakeholders, and to identify ways in which it can be improved to increase its impact on the safety and health of nanomaterial workers across the U.S. Comments are due June 25, 2018.
On April 16, 2018, the European Food Safety Authority (EFSA) published a report entitled “EU Insights — Consumer perceptions of emerging risks in the food chain.” To understand better the views of European Union (EU) consumers on food-related emerging risks, EFSA surveyed 25 EU countries using three examples of emerging risks: green smoothies, plastic rice, and nanoparticles. According to the report, the study found that consumers tended to be more concerned about established risks than about emerging risks. The report states that the study documented a lack of knowledge about the emerging risks used in the survey. The perceptions of the risks posed by nanoparticles used in food were mixed overall, with a similar proportion of participants perceiving high risks (27 percent) and low risks (31 percent). Communicating information about the nature of the risk and the level of uncertainty that surrounds it “may have a significant impact on risk perception, pointing to the malleability of perceptions of emerging risks.”
On April 4, 2018, the European Chemicals Agency (ECHA) announced that it has launched a public consultation on its draft Strategic Plan for 2019-2023. ECHA states that by 2023, it “aims to become the main source of scientific knowledge and technical know-how on chemicals, serving a wide range of [European Union (EU)] policies and stakeholders.” The draft Strategic Plan lists three strategic priorities that are to be achieved with a set of enabling components:
- Identification and risk management of substances of concern;
- Safe and sustainable use of chemicals by industry; and
- Sustainable management of chemicals through the implementation of EU legislation.
Activities intended to achieve the first strategic priority include:
- Concerted regulatory action;
- Enhanced mapping and prioritization of substances, including developing regulatory strategies and assessment methods for specific (groups of) chemicals or effects, such as nanomaterials and endocrine disruptors, supporting the development of alternative methods to animal testing, and exploring how these can be used in risk assessment; and
- Inducing faster action by industry.
Once final, the Strategic Plan will become the multi-annual part of the Programming Documents of ECHA for 2019-2021 and beyond. Steered by the strategy, ECHA will establish annual Work Programs containing specific actions and outputs planned for each year. The areas of operation in the Strategic Plan per each strategic objective and the enabling components aim to provide a framework for the annual Work Programs and are thus more generic. Comments on the draft Strategic Plan are due May 4, 2018.
Effective April 15, 2018, Chuck Geraci, Ph.D., CIH, will be the National Institute for Occupational Safety and Health (NIOSH) Associate Director for Emerging Technologies. As Associate Director for Emerging Technologies, Dr. Geraci will be responsible for the planning, direction, and execution of emerging technology research activities at NIOSH, advising the NIOSH Director. Emerging technologies with potential to impact the U.S. workplace include the evolution of advanced and nano materials and manufacturing, advanced biotechnology, robotics, digital manufacturing, and new work organizational models. These responsibilities extend to nationally based projects and programs within NIOSH, and to international interactions that promote worker protection. Dr. Geraci will also assist in the formation of the Emerging Technologies Branch in the Education and Information Division (EID), where he will serve as Acting/Interim Chief. In that capacity, he will continue to provide management direction to the Nanotechnology Research Center and will develop a project portfolio focused on addressing workplace challenges of key emerging technologies. Dr. Geraci has served as NIOSH Associate Director for Nanotechnology since October 2014.
In April 2018, the International Standardization Organization (ISO) published standard ISO 19007:2018, “Nanotechnologies — In vitro MTS assay for measuring the cytotoxic effect of nanoparticles.” The standard specifies a method for evaluating the effects of nano-objects and their aggregates and agglomerates on cellular viability using the MTS assay. The assay design includes performance requirements and control experiments to identify and manage variability in the assay results. In general, according to ISO, changes in absorption intensity are directly proportional to cell number although assay conditions that alter reductase activity or reagent availability can result in colourmetric changes that are not directly due to changes in cell viability (i.e., cell number). ISO states that the MTS reagents are directly added to cell culture well, allowing for rapid evaluation of potential intrinsic toxicity of nanoparticles. Due to the potential interference effects that can occur with nanoparticles and colourmetric assays, ISO notes that it is important control experiments with the nanoparticles and the MTS reagents are performed before the assay results are accepted. Direct microscopic observation of cells after treatment also provides an orthogonal method to validate an MTS assay result. According to ISO, the normalized protocol presented here is limited to adherent cell types, but it could be modified to be used with suspension cells.
The May 13-16, 2018, TechConnect World Innovation Conference and Expo will include a panel discussion on “Safety in Advanced Manufacturing: A Profit Maker or a Profit Taker?” as part of the advanced manufacturing symposium. The panel discussion, which will be held on May 16, 2018, will provide a forum to examine existing health and safety approaches that enable Industry 4.0 and the advanced manufacturing ecosystem. It will consider the challenges and opportunities to incorporate new safety paradigms into business operations, and explore options for flexibility and scalability of a health and safety program for startups through small, medium, and large corporations. Following brief presentations, there will be small group discussions that address critical questions, and an interactive closing panel discussion that incorporates the small groups’ discussions and considers advanced manufacturing workplace safety as a profit maker or profit taker. The session Co-Chairs include Chuck Geraci, Ph.D., CIH, Associate Director for Nanotechnology, National Institute for Occupational Safety and Health (NIOSH); Sally Tinkle, Ph.D., Senior Strategy and Policy Advisor, IDA/Science and Technology Policy Institute, and former Deputy Director of the National Nanotechnology Coordination Office; and Michael Fancher, Director, New York State Center for Advance Technology in Nanomaterials and Nanoelectronics, Associate Professor, SUNY Polytechnic Institute. The topics for panel discussion include:
- Hazard determination and exposure assessment in the advanced manufacturing workplace;
- New opportunities for building safety into processes: automation, robotics, and other emerging technologies;
- New models of occupational safety and health practice and program management during scale up;
- Methods and models for risk assessment and risk management across the advanced manufacturing life cycle; and
- Creating partnerships to share best practices for managing advanced manufacturing safety challenges.
On March 26, 2018, the Swedish National Platform for Nanosafety (SweNanoSafe) launched a new website intended to facilitate communication and knowledge exchange on the safety aspects of nanomaterials. According to the press release, the website is targeted toward regulators, scientists, industry, non-governmental organizations, and other stakeholders interested in nanotechnology. The website provides information on how nanomaterials are regulated in various areas, including work environment, chemicals, and cosmetics. It also contains information about research on the environmental, health, and safety aspects of nanomaterials. The website includes a knowledge bank, questions and answers, a calendar, and links to other sources of nanosafety information. The press release states that the website “is an important part of Swetox commission from the Swedish government to create a national platform for nanosafety. The site has been developed, and will continue to be developed, in collaboration with the SweNanoSafe Cooperation Council and Expert Panel.”
On March 13, 2018, the European Commission (EC) Ombudsman issued its recommendation in a case concerning the EC’s refusal to grant access to its catalog of nanomaterials used in cosmetics, as well as to related notification from cosmetics manufacturers. As reported in our August 8, 2017, blog item, ClientEarth announced on July 31, 2017, that it filed a complaint with the Ombudsman about the EC’s “unlawful handling of a long-delayed list of nano-chemicals in cosmetics.” As reported in our June 19, 2017, blog item, the EC published on June 15, 2017, a catalog of nanomaterials used in cosmetic products on the European Union (EU) market. ClientEarth criticized the catalog, stating that it “does not let people identify which cosmetics contain potentially harmful nanomaterials, or assess the threat they may pose to human health.” ClientEarth called on the EC Ombudsman to “open an investigation into these acts of maladministration and hold the Commission to account for frustrating consumers’ and civil society’s rights to know about the risks of products people use every day.”
The EC Ombudsman found that while the final version of the catalog had not been published when the complainant made its access request, the EC failed to consult ClientEarth as to whether it would want access to any of the existing draft versions. The Ombudsman states that “[t]his constituted maladministration.” The Ombudsman also found that some of the notifications could have been extracted from the EC’s database. Concerning the other notifications, according to the Ombudsman, the EC failed to look for a solution in consultation with ClientEarth. “These failures also constituted maladministration.” The EC Ombudsman recommends that the EC “grant the complainant access to those notifications that can be extracted from its database and that it [try] to find a solution regarding the others.” As the catalog of nanomaterials used in cosmetics has been published, “the Ombudsman does not consider it necessary to recommend the disclosure of any drafts.” ClientEarth’s March 23, 2018, press release states: “We welcome this support from the European Ombudsman and expect the Commission to fully comply with the recommendations and restore trust.” The EC’s opinion on the Ombudsman’s recommendation is due June 15, 2018.
The Organization for Economic Cooperation and Development (OECD) has published a March 23, 2018, report entitled Evaluation of in vitro methods for human hazard assessment applied in the OECD Testing Programme for the Safety of Manufactured Nanomaterials. The Testing Program for the Testing of Manufactured Nanomaterials tested 11 manufactured nanomaterials to generate information, including their physico-chemical properties, environmental fate, and environmental and mammalian toxicity. The purpose of the evaluation was to review the Testing Program dossiers and evaluate which of the existing in vitro OECD Test Guidelines (TG) were used, what other non-guideline methods were applied, and what were the potential limitations of each assay used for testing manufactured nanomaterials. The report lists the following general observations:
- A number of in vitro methods were used in the OECD Testing Program to assess manufactured nanomaterials, however, many in vitro data reported were not generated using OECD TGs;
- A number of in vitro endpoints have been assessed, but a full set of in vitro assays for a specific manufactured nanomaterial is not available;
- The existing in vitro TGs have not been used extensively (g., skin sensitization and irritation);
- There are many inconsistencies and omissions within the dossiers related to the use of existing OECD TGs, representation of dose and dose metrics, physico-chemical parameters assessed, consideration of manufactured nanomaterial interference with assay parameters, and protocols used, including inconsistencies in reporting;
- Characterization of manufactured nanomaterials in in vitro conditions (g., in culture media) and cellular uptake have not been reported; and
- No in vitro data based on TGs have been reported for nanoclay and dendrimers and no in vitro cytotoxicity data has been reported for silver and nanoclay within the Testing Program.
The report identifies the following potential next steps:
- Based on TG 428 and the reported studies, there is no apparent limitation in the application of the TG 428 to manufactured nanomaterials. Some critical factors for the evaluation of skin absorption tests with nanomaterials were not addressed in detail in these studies, however, and might need to be further explored. Applicability of TG 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis Test Method) should be further discussed;
- Applicability of TG 437 (Bovine Corneal Opacity and Permeability Test Method) should be further discussed. Literature findings indicate that nanomaterials can aggregate/agglomerate in the suspension or can absorb the dispersant and the dye, causing possible artefacts. Also, some nanomaterials present in opacity measurements may affect the result;
- TG 471 (Bacterial Reverse Mutation Test) may be amended with the acknowledgement that it is not applicable for most types of manufactured nanomaterials (no uptake into the bacteria);
- Modification of TG 487 (In Vitro Micronucleus Assay) should be considered to include specific recommendations regarding addition of cytochalasin B when testing manufactured nanomaterials and the verification of intracellular uptake of manufactured nanomaterials;
- Since several genotoxicity assays were applied in the Testing Program, it might be most efficient to consult the expert group on genotoxicity to prioritize the assays for further harmonization; and
- In addition to the work that is currently underway at the OECD Working Party on Manufactured Nanomaterials (WPMN) and International Organization for Standardization (ISO) Technical Committee (TC) 229 to develop standards and guidance for some cytotoxicity assays, the Testing Program should consider evaluation and further development of the assays that are routinely used to test manufactured nanomaterials. For instance, the assays used to determine the potential of manufactured nanomaterials to cause oxidative stress and those used to assess endpoints specific to immunological implications of exposure to manufactured nanomaterials.