Soft Law and ​​​​Nanote​chnology
Sources of Guidance for Risk Management
BY JOHN BAKER, MARTIN D. BARRIE, CHARLES L. GERACI, AND MARK D. HOOVER
At AIHce 2015 in Salt Lake City, attorney Lynn Bergeson gave a presentation on the legal and regulatory issues related to the environmental health and safety aspects of nanotechnology. Not surprisingly, Bergeson told attendees that many holes exist in the patchwork of regulations. “Governance frameworks are always out of date,” she said. “They can never keep up with the speed of innovation. We want people to know what they’re dealing with [so they] have a solid basis to make informed judgments about risk.” What should industrial hygienists do when the legislative and regulatory process can’t keep pace with technology? Our profession is charged with protecting workers and public health. The industrial hygienists’ Code of Ethics provides guidance that must be supplemented by new knowledge. If we act only when regulations are issued, we would be doing very little to promote safe and responsible development of the technology. This is especially true for an evolving and rapidly expanding field like nanotechnology. This article reviews current standards of behavior, guidance, regulations, and “soft law” related to nanomaterials.
STANDARDS OF BEHAVIOR
Influential initiatives related to the manufacture, use, and ultimate disposition of manufactured nanomaterials do exist (see Figure 1). Many of these initiatives are in the form of “adaptive governance,” an approach to risk management that anticipates emerging technological advances and related regulatory or governance challenges. Adaptive governance implies managing changes through existing governance frameworks. The related term “soft law,” which has been used in the context of congressional practices, securities law, healthcare reform, and environmental law, can also apply to nanotechnology. As the law professor Timothy F. Malloy explains in the journal
Jurimetrics
, the concept of soft law encompasses establishing standards of behavior that are influential but not legally binding. ​
Figure 1. Sources of nanotechnology guidance, regulations, and requirements.
RESOURCES
Journal Publications:
  • Annals of Occupational Hygiene
    : “Exposure Limits for Nanoparticles: Report of an International Workshop on Nano Reference Values” (July 2012).
  • JOEH: “Achieving Control of Occupational Exposures to Engineered Nanomaterials” (August 2015).
  • JOEH: “Characterizing Adoption of Precautionary Risk Management Guidance for Nanomaterials, an Emerging Occupational Hazard” (January 2015).
  • JOEH: “Exposure Limit Values for Nanomaterials—Capacity and Willingness of Users to Apply a Precautionary Approach” (January 2013).
  • Jurimetrics
    : “Soft Law and Nanotechnology: A Functional Perspective” (Spring 2012).
Other publications:
NIOSH:
  • Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials (
    PDF
    , March 2009)
  • Current Strategies for Engineering Controls in Nanomaterial Production and Downstream Handling Processes (
    PDF
    , November 2013)
  • General Safe Practices for Working with Engineered Nanomaterials in Research Laboratories (
    PDF
    , May 2012)
  • Interim Guidance for Medical Screening of Workers Potentially Exposed to Engineered Nanoparticles (
    PDF
    , February 2009)
  • Nanotechnology
    website

  • Occupational Exposure to Carbon Nanotubes and Carbon Nanofibers (
    PDF
    , April 2013)
  • Occupational Exposure to Fine and Ultrafine Titanium Dioxide (
    PDF
    , April 2011)
Department of Energy: Food and Drug Administration: Non-Governmental and Other Organizations:
​Thankfully, there is no shortage of authoritative guidance that can form the basis of a soft-law approach to nanomaterials. Several useful initiatives are summarized in this article. For a comprehensive list of sources related to nanotechnology, see the Resources list at the end of this article.

National Nanotechnology Initiative
The
National Nanotechnology Initiative
(NNI) is the overarching federal coordination effort that provides a framework for research and development programs with participating agencies. NNI works toward a “shared vision of a future in which the ability to understand and control matter at the nanoscale leads to a revolution in technology and industry that benefits society.” In July 2015, NNI held a joint workshop with the Consumer Products Safety Commission on quantifying exposure to engineered nanomaterials from manufactured products. Presentations from this workshop are available
online
.
NIOSH
NIOSH has been the principal source of authoritative health and safety research and guidance including Current Intelligence Bulletins containing recommended exposure limits for fine and ultrafine titanium dioxide and for carbon nanotubes and nanofibers, and recently released a Bulletin on silver nanomaterials for public review. NIOSH has published guidance on exposure assessment, medical screening of workers potentially exposed to engineered nanoparticles, and safe practices for working with nanomaterials in research laboratories and in production and downstream manufacturing processes. These and other excellent documents are available from the NIOSH nanotechnology
website
. A paper in the January 2015 issue of the
Journal of Occupational and Environmental Hygiene
(JOEH) describes the degree to which U.S. companies have implemented precautionary control methods for nanomaterials. NIOSH staff observed use of PPE at 89 percent of 46 companies dealing with a wide variety of nanomaterials where the agency conducted on-site visits. Use of containment-based engineering controls for at least some processes was observed on site at 83 percent of visited companies. According to the JOEH paper,
more than 90% of the 16 engineered carbonaceous nanomaterial companies that responded to a nationwide survey were observed (on site) to be using engineering controls and PPE as reported or more stringently than reported. Since PPE use was slightly more prevalent than engineering controls, better communication may be necessary to reinforce the hierarchy of controls.
OSHA
The OSHA fact sheet “Working Safely with Nanomaterials” summarizes and provides references to related NIOSH guidance. In 2013, the agency issued a technical amendment to the Non-Mandatory Appendix A of 29 CFR 1910.1450 on
Occupational Exposure to Hazardous Chemicals in Laboratories
that included a paragraph on nanoparticles and nanomaterials from the 2011 revision of
Prudent Practices in the Laboratory: Handling and Management of Chemical Hazards
, a publication of the National Academies.
Food and Drug Administration
FDA has issued non-binding guidance on whether an FDA-regulated product involves the application of nanotechnology and on specific topics such as the use of nanomaterials in food for animals and the safety of nanomaterials in cosmetic products. In 2015, FDA adopted three nanotechnology standards as part of a major update to its List of Recognized Standards. These include Technical Specification ISO/TS 14101,
Surface Characterization of Gold Nanoparticles for Nanomaterial Specific Toxicity Screening: FT-IR Method
; ASTM E2490,
Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)
; and ASTM E2535,
Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings
.
International Guidance
The Quebec-based
Institut de recherché Robert-Sauvé en santé et en sécurité du travail
(IRSST) recently published a second edition of
Best Practices Guidance for Nanomaterial Risk Management in the Workplace
, which incorporates new information available from the scientific literature, and includes appendices that describe examples of at-risk situations; preventive measures and data on their relative efficacy; and the implementation of measures to control exposure.

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
.


The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the National Institute for Occupational Safety and Health.
Nanotechnology and Law at AIHce

AIHA’s Legal and Regulatory Affairs Committee and Nanotechnology Working Group are presenting a roundtable on legal issues affecting nanotechnology at AIHce 2016 in Baltimore, Md. This roundtable will discuss insurance coverage issues and mass torts, the development and implementation of workplace management programs, and the use of biological monitoring in the risk management process.
See links to resources at the end of this article.
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