In Europe and the rest of the developed world, the rise of product registries (mandatory in France, Belgium, Norway, and Denmark, and voluntary in Sweden and Italy) and legal requirements such as the European Directive on the Registration, Evaluation and Authorization of Chemicals (REACH) have the potential to affect the development, introduction, and risk assessment of nanomaterials. However, voluntary initiatives in Europe are equally relevant and influential. Recent papers in JOEH and the Annals of Occupational Hygiene have described the capability and willingness of users to apply a precautionary approach such as the Dutch Nano Reference Values and similar voluntary initiatives. Safe Work Australia has explored the feasibility of establishing group-based Australian National Exposure Standards for engineered nanomaterials and using Benchmark Exposure Levels (BELs) and control banding adapted from the British Standards Institution (BSI) publication “Nanotechnologies – Part 2: Guide to Safe Handling and Disposal of Manufactured Nanomaterials.” The Organization for Economic Cooperation and Development (OECD) collects reports on nanotechnology initiatives on its website. The OECD Working Party on Manufactured Nanomaterials has established a testing program for manufactured nanomaterials that includes links to dossiers and endpoints. Other Guidance Professional and standards-setting institutions based in the U.S. have issued other guidance as well:

REGULATIONS U.S. government agencies have produced a few traditional regulations related to nanomaterials. Under the Pre-manufacture and Significant New Use Rules of the Toxic Substances Control Act (TSCA), EPA has promulgated binding rules such as the 2014 ban on the sale of unregistered food containers containing nanosilver, and the 2015 direct final rule on graphene nanoplatelets. The most significant new regulatory activity that EPA has undertaken is the proposed TSCA Section 8(a) Recordkeeping and Reporting Rule, which would require manufacturers and importers to electronically report to EPA the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing data concerning environmental and health effects for existing nanomaterials and for new discrete nanoscale materials before they are manufactured or processed. OSHA can refer enforcement under Section 5(a)(1) of the Occupational Safety and Health Act, the “general duty clause,” which establishes a duty for each employer to “furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.” While the legal application of the general duty clause involves scrutiny of the degree to which hazards are recognized, and whether they are causing or likely to cause death or serious physical harm, we propose that a reasonable person would agree that there is a wealth of authoritative guidance based on scientifically valid research about the hazards, risks, and means of protecting workers potentially exposed to nanomaterials and other newly created substances in the workplace. Although OSHA has no mandatory requirements specifically for nanomaterials, the agency’s Web page on nanotechnology notes that existing general industry standards on personal protective equipment, hand protection, eye and face protection, respiratory protection, hazard communication, sanitation, recording and reporting of occupational injuries and illness, occupational exposure to hazardous chemicals in laboratories, and substance-specific standards “may be applicable in situations where employees are exposed to nanomaterials.” The Department of Energy Order DOE O 456.1 is an example of a governmental mandate that is enforceable within a specified set of respondents and which provides helpful, authoritative guidance for interested parties. This order is expected to be finalized in the next several months. Key elements of the DOE order include:

• Maintain a registry of all activities involving unbound engineered nanoparticles (UNP) and UNP workers in an accessible electronic database, and provide a copy to the occupational medical service provider for the DOE site.
  
• Establish safety and health policies and procedures for activities involving UNP.
  
• Provide training at initial assignment to UNP workers and their supervisors, and provide refresher training when new information and changes in requirements, policies, and procedures dictate.
  
• Conduct exposure assessments including air monitoring programs based on preliminary assessments and guidance from the AIHA publication A Strategy for Assessing and Managing Occupational Exposures.
  
• Offer baseline medical evaluation to all workers.
  
• Control exposures using a risk-based graded approach that considers available toxicological and environmental data.
  
• Post signs at entry points where UNP are handled, and label storage and transport containers.
  
• Prepare for transportation by labeling the innermost receptacle to communicate the appropriate level of caution and a description of the contents.
  
• Follow all applicable federal, state, and local waste disposal regulations for waste management and create a documented procedure for proper storage and tracking of waste including an inventory of waste shipped off-site with a description and quantity of the waste, and means and location of final disposition.
  

NANOTORTS Despite the lack of regulations, industrial hygienists and companies that manufacture or use nanomaterials should be sensitive to the potential for liability or litigation associated with alleged exposure and adverse health outcomes. These “nanotorts” may be individual personal injury claims, or they may invoke mass tort and class action. Often, these claims allege negligence and failure to warn, and include product liability claims for design or manufacturing defects. In the absence of existing disease or illness, claimants may argue for future medical monitoring. In anticipation of increasing numbers of these claims, industrial hygienists and companies using or manufacturing nanomaterials should consider proactive mitigation. These measures may include identifying and characterizing nanomaterial potential hazards, characterizing exposure potential, keeping abreast of the scientific and medical literature, implementing and updating appropriate hazard communication plans, developing nanomaterial worker exposure registries, and implementing longitudinal surveillance programs to assess potential adverse health outcomes that may be associated with long latency periods from exposure. THE PACE OF CHANGE Industrial hygienists should keep track of regulations, consensus standards, recommendations, and guidelines that apply to the regulations, consensus standards, manufacturing, importing, or processing of nanomaterials, and supplement them with authoritative guidance from trusted academic, governmental, and non-governmental organizations. By combining existing legal and regulatory requirements with the most current guidance, we can adapt to the pace of technological change. The industrial hygiene community must work with the discovery, development, manufacturing, and production communities to educate them on the best available science for hazard, risk, and good risk management. The body of knowledge related to the health, safety, and environmental aspects of nanotechnology is growing. We can help develop effective consensus standards and practices, as we have done for enzymes, absorbent gels, semiconductor reactants, active pharmaceutical compounds, and so on. Standards and best practices often precede and serve as the foundation for regulation. Translating that knowledge for consumer products, environmental health, and general public health is a skill we must learn. Finally, we need to effectively communicate best practices to policy and regulatory bodies so they can issue informed regulations. JOHN BAKER, CIH, is a senior project manager at Bureau Veritas. He can be reached at (281) 832-2894 or john.baker
@us.bureauveritas.com.
 MARTIN D. BARRIE, PhD, JD, is senior scientist in epidemiology at Oak Ridge Associated Universities. He can be reached at (865) 576-6250 or martin.barrie@orau.org.
 CHARLES L. GERACI, PhD, CIH, is associate director for nanotechnology at NIOSH and co-manager of the Nanotechnology Research Center. He can be reached at (513) 533-8339 or cgeraci@cdc.gov.
 MARK D. HOOVER, PhD, CHP, CIH, is co-director of the NIOSH Center for Direct Reading and Sensor Technologies. He can be reached at (304) 285-6374 or mhoover1@cdc.gov.