On March 15, 2018, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of the draft National Occupational Research Agenda for Respiratory Health for public comment. The National Occupational Research Agenda (NORA) is a partnership program created to stimulate innovative research and improved workplace practices. The draft NORA for Respiratory Health is the first NORA to address respiratory health, and it is intended to identify the research, information, and actions most needed to prevent occupational injuries. The objectives include preventing and reducing work-related interstitial/dust-induced lung diseases. This will be achieved in part by preventing and reducing coal workers’ pneumoconiosis “and other dust-induced lung diseases, including those associated with nanomaterials.” The draft NORA states: “Nanomaterials, defined as having a length scale between one and 100 nanometers, exhibit unique properties that affect physical, chemical, and biological behavior. Animal and other toxicological studies have shown adverse lung effects include inflammation and fibrosis (Maynard & Kuempel, 2005).” According to the draft NORA, since there is no known effective treatment for any of the pneumoconioses, “primary prevention to control workplace fibrogenic dust exposures, medical surveillance for early disease detection, and other interventions from across the hierarchy of controls are essential.” Comments on the draft NORA for Respiratory Health are due May 14, 2018.
As reported in our March 13, 2018, blog item, on March 9, 2018, the National Institute for Occupational Safety and Health (NIOSH) published three documents in its Workplace Design Solutions series that address nanomaterials. On March 12, 2018, NIOSH announced the availability of the new Workplace Design Solutions documents, as well as a poster, “Controlling Health Hazards When Working with Nanomaterials: Questions to Ask Before You Start.” According to NIOSH, the poster poses questions that employers and workers should consider before starting work with a nanomaterial. The poster includes questions regarding form, work activity, engineering controls, administrative controls, and personal protective equipment (PPE). For each question, the poster provides options to reduce exposures to nanomaterials based on the physical form (dry powder, suspended in liquid, or physically bound/encapsulated). NIOSH suggests that readers use the poster to see which different control and PPE options are appropriate based on the physical form of the nanomaterial. NIOSH notes that the poster can be displayed in a lab or work environment, “making it an easily accessible reminder of the important health and safety considerations for working with nanomaterials.”
The National Institute for Occupational Safety and Health (NIOSH) began its Prevention through Design (PtD) initiative in 2007. NIOSH states that its mission is to reduce or prevent occupational injuries, illnesses, and fatalities by considering hazard prevention in the design, re-design, and retrofit of new and existing workplaces, tools, equipment, and work processes. On March 9, 2018, NIOSH published three documents in its Workplace Design Solutions series. NIOSH recommends that manufacturers and downstream users of nanomaterials develop PtD strategies to protect workers during the handling of engineered nanomaterials. NIOSH states that engineering controls protect workers by removing hazardous conditions or placing a barrier between the worker and the hazard, and along with good material handling techniques, they are likely to be the most effective control strategy for nanomaterials. According to NIOSH, the identification and adoption of effective control technologies is an important first step in reducing the risk associated with worker exposure to engineered nanomaterials and associated byproducts. The publications are:
- Protecting Workers during Nanomaterial Reactor Operations: The document provides guidance on exposure control approaches for protecting workers during nanomaterial reactor operations;
- Protecting Workers during the Handling of Nanomaterials: The document provides guidance on exposure control options for protecting workers during the handling of nanomaterials; and
- Protecting Workers during Intermediate and Downstream Processing of Nanomaterials: The document provides guidance on exposure control approaches for intermediate and downstream processes commonly used after the production of nanomaterials.
On March 5, 2018, the European Commission (EC) announced the availability of a Communication to the European Parliament (EP), the Council of the European Union (EU), and the European Economic and Social Committee on the operation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The Communication includes proposals intended to facilitate further the implementation of REACH. The scope of the EC’s evaluation includes a review of the ability of REACH to “tackle” nanomaterials. According to Part 1 of the EC staff working document, although REACH is able to address emerging issues such as the risks from nanoforms of substances, the lack of specific information about nanoforms covered by REACH registration dossiers remains an issue. The document states that this is largely due to the fact that REACH does not explicitly require registrants to provide separate information for forms of a substance, including the bulk form and different nanoform(s). Furthermore, REACH does not contain a definition of nanomaterial/nanoform. The document notes that several compliance check decisions by the European Chemicals Agency (ECHA) on the registrations of substances with nanoforms were appealed to the Board of Appeal, and four were annulled. According to the document, the proposed revision of the REACH Annexes will address these shortcomings. As reported in our October 11, 2017, blog item, on October 9, 2017, the EC began a public consultation on a draft regulation that would amend several REACH Annexes to address nanoforms of substances. The EC will discuss the outcomes and follow-up actions of its REACH review with the EP, EU Member States, and stakeholders at a public conference planned for June 2018.
The U.S. Consumer Product Safety Commission (CPSC) published a Federal Register notice on March 1, 2018, announcing that it will hold a public hearing on April 11, 2018, to receive comments about CPSC’s agenda and priorities for fiscal years (FY) 2019-2020. CPSC’s Fiscal Year 2019 Performance Budget Request to Congress states that CPSC “will continue supporting nanotechnology research, coordinating with other federal agencies to extend limited agency resources by leveraging other research efforts.” As reported in our February 21, 2018, blog item, in FY 2017, CPSC established seven research collaborations on the environmental health and safety of nanomaterials. According to CPSC’s budget request, in FYs 2018 and 2019, CPSC intends to establish or maintain three collaborations with other organizations to work on nanotechnology research or issues affecting consumer products. Written comments and requests to make oral presentations at the public hearing are due March 28, 2018. CPSC seeks comment on questions such as the priorities that CPSC should consider emphasizing; activities CPSC should consider deemphasizing; and whether CPSC should consider making any changes or adjustments to its proposed or ongoing safety standards activities, regulation, and enforcement efforts in FYs 2019 and 2020.
On March 2, 2018, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) began a public consultation on its preliminary opinion on certain 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 preliminary opinion, the EC has concerns over the safety of the use of sodium styrene/acrylates copolymer (nano) and styrene/acrylates copolymer (nano) in cosmetic products. SCCS states that it cannot conclude on the safety of any of the three styrene/acrylate copolymer nano-entities submitted by the applicants. The data submitted are insufficient to evaluate possible toxicity. SCCS states that data should be provided separately for all of the three styrene/acrylate nanospheres, including any encapsulated substances. The EC asked SCCS to 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.” The deadline for comments is May 11, 2018.
On March 1, 2018, amendments to Switzerland’s Chemicals Ordinance took effect. The amendments, adopted by the Federal Council on January 31, 2018, include new disclosure requirements for synthetic nanomaterials of fibrous or tubular form. Switzerland states that the specified nanomaterials can cause lesions in the lungs if inhaled. As reported in our September 29, 2017, blog item, Switzerland notified the European Commission of the draft amendment in September 2017. The draft consultation paper released in spring 2017 included proposals to modify the definition of nanomaterial and introduce a communication requirement concerning the use of nanomaterials. Switzerland states that these proposals were withdrawn due to the comments received.
On February 26, 2018, the European Union (EU) Observatory for Nanomaterials (EUON) issued a call for study topics on nanomaterials. EUON states that it intends to conduct up to three studies annually to address knowledge gaps about nanomaterials on the EU market. The studies should be considered of interest for either a specific audience, such as regulators or researchers, but can also be for a wider use such as the general public. Proposals should address an issue/question relevant to nanomaterials on the EU market:
- Health and safety aspects of nanomaterials, including hazard and risk assessment, exposure to nanomaterials, and worker safety and protection;
- Specific issues surrounding the uses of nanomaterials by consumers or workers; and
- Markets for nanomaterials, focusing on EU markets.
The study can focus on nanomaterials in general, a specific nanomaterial, or a defined group of nanomaterials. The study should be possible to execute within three to nine months, be computer-based, and not require experimental facilities.
The U.S. Environmental Protection Agency (EPA) released its fiscal year (FY) 2019 budget proposal on February 12, 2018. According to EPA’s press release, the proposed budget will provide $6.146 billion to support EPA’s new FY 2018-2022 Strategic Plan and mission of protecting human health and the environment. EPA states that the “Back-to-Basic” agenda set out in the Strategic Plan has three over-arching goals reflecting EPA Administrator Scott Pruitt’s core philosophies: (1) refocus EPA back to its core mission; (2) restore power to the states through cooperative federalism; and (3) lead EPA through improved processes and adhere to the rule of law. Under the third goal, Objective 3.3 is to “Prioritize Robust Science: Refocus the EPA’s robust research and scientific analysis to inform policy making.” The Strategic Plan states that EPA “will evaluate and predict impacts from chemical use and disposal, and provide states and tribes with information, tools, and methods to make better informed, more timely decisions about the thousands of chemicals” in the U.S. In addition, EPA “will produce innovative tools that accelerate the pace of data-driven evaluations, enable knowledge-based decisions that protect human health, and advance the science required to anticipate and solve problems.” According to the Strategic Plan, over the next five years, EPA will “[c]onduct nanoparticle research by using life-cycle analyses, evaluating impacts on ecosystem health, and supporting the development of safer nanomaterials in private industry.”
On March 20, 2018, the American National Standards Institute (ANSI) Nanotechnology Standards Panel (ANSI-NSP) will meet at the U.S. Department of Agriculture in Washington, D.C. The focus of the meeting will be to consider the observations from the February 28, 2017, ANSI-NSP meeting on graphene standards, including the following issues:
- Characterization methods; and
- Information sharing.
Participants will discuss recommendations for future standardization activities. The meeting is open to all interested participants and is free of charge. Registration is open until March 1, 2018.