Expert Commentary

Nanotechnology and the State of Government Regulation—Past, Present, and Future

In the context of an anticipated world market for nanomaterial-based products reaching $2.6 trillion by 2015, the advent of increased nanomaterial regulation may be fast approaching.

July 2011

Past developments have included a July 2007 Toxic Substances Control Act (TSCA) document, a January 2008 voluntary Nanoscale Materials Stewardship Program (NMSP), and September 2010 Significant New Use Rules (SNURs), all published by the Environmental Protection Agency (EPA). In May 2010, the U.S. Government Accountability Office (GAO) issued its report reviewing a number of these efforts and making predictions and recommendations for the future. More recently, the National Institute for Occupational Safety and Health (NIOSH), EPA, and the Food and Drug Administration (FDA) have published draft reports outlining recommendations on nanomaterial regulations, and they are currently considering feedback on the proposals.

Nanomaterial development, however, is fast-paced and poses challenges to regulating agencies because of its high "clock speed"; that is, nanotechnology is expanding at a faster pace than agencies have experienced previously and exhibits an exponential or quantitative rate of development, doubling or tripling within 3–4 years. Creating regulations that not only address today's concerns but are also adaptable enough to be meaningful several years from now requires near oracular foresight. Furthermore, regulatory efforts are hindered by today's current understanding of the potential hazards, exposures, and resulting risks of nanotechnology.

Specifically, a lack of research, tools, and informative methods prevents the discovery and incorporation of risk into the regulatory framework. Nevertheless, since the GAO report was issued in May 2010, a number of agencies have implemented some significant changes in nanomaterial risk management and assessment. Over the next year to year and a half, we should begin to see significant changes in how environmental and human health risks from nanomaterials are regulated in the United States.

Past Efforts

Previous results of regulatory efforts have achieved limited traction. For example, in July 2007, the EPA published the "TSCA Inventory Status of Nanoscale Substances—General Approach." This document described how the EPA would determine whether a nanomaterial is a "new" chemical under the TSCA Inventory and whether it would be subject to the premanufacture notice requirements. Following a period of scrutiny and general confusion, the EPA clarified how the document serves as general guidance and "not rules or regulations." The EPA stated specifically that guidance does not "impose legally binding requirements on EPA or the regulated community."

In January 2008, the EPA announced the final version of the NMSP, initially developed to "provide a firmer scientific foundation for regulatory decisions by encouraging submission and development of information for nanoscale materials." This announcement also encountered much public criticism, and the NMSP ended in December 2009 after compiling somewhat limited information voluntarily submitted from about 30 organizations on approximately 130 different materials.

In June 2009, the EPA published temporary SNURs for two carbon nanotubes (CNTs). The SNURs required that anyone planning to produce or process either of the two listed CNTs notify the EPA if the manufacturing process did not comply with the specified risk management conditions. This SNUR lasted approximately 2 months before being withdrawn due to the EPA's receipt of "adverse or critical comments"—a regulatory mechanism that allows temporary rules to be withdrawn if they encounter criticism prior to a formal comment period.

Current Efforts

The current focus for EPA and NIOSH includes work toward a final SNUR that would require persons who intend to manufacture, import, or process new nanoscale materials, based on chemical substances listed on the TSCA Inventory, to submit a Significant New Use Notice to the EPA at least 90 days before commencing the activity. This has been motivated by a desire to identify and prioritize nanotechnology research into predicting whether these nanoparticles pose a risk of adverse health effects and to provide guidance on controlling workplace exposures. Although no final amendments have been implemented, the EPA has identified three proposed rules affecting nanoscale materials.

First, a new rule would mirror the September 2010 SNUR for CNTs but apply to an expanded list of nanomaterials, with possible candidates including nanoscale silver, titanium dioxide, and zinc oxide.

Second, the EPA proposes to issue a data collection rule under section 8(a) of the TSCA. This rule will require that persons who manufacture certain nanomaterials must provide the EPA with specific information concerning production volumes, methods of manufacturing and processing, exposure and release information, and available health and safety data. Part of the reason for issuing this rule is the mediocre response of industry to the voluntary NMSP.

Third, the EPA is considering a test rule under section 4 of the TSCA that will require manufacturers and processors of CNTs, nanoclays, bentonite, alumina, and spray-applied nanomaterials to conduct actual testing for health effects, ecological effects, and environmental fate.1 It is believed that these products are being targeted because the requested information previously has not been provided voluntarily.

Future Efforts

The next year also may be the turning point for occupational standards. The publication of a NIOSH draft recommended exposure level (REL) for CNTs (of 7 μg/m3) in the Current Intelligence Bulletin late last year may have set the stage for the development of additional occupational exposure limits for different materials or different organizations. The CNT REL was based on sub-chronic and short-term animal toxicology data indicating early-stage fibrotic and inflammatory lung response to CNT exposure. The draft CNT REL in 2010 was followed by a final REL for nanoscale titanium dioxide (TiO2), published in the April 2011 Current Intelligence Bulletin. The published REL of 2.4 mg/m3 for fine TiO2 and 0.3 mg/m3 for ultrafine (including engineered nanoscale) TiO2 are listed as time-weighted average concentrations (for up to 10 hours per day in a 40-hour workweek), which "over a working lifetime are estimated to reduce risks of lung cancer to below 1 in 1,000." The TiO2 guidance describes recommendations regarding exposure surveillance in the workplace. For example, due to the lack of personal sampling devices capable of measuring particle surface area, NIOSH recommends mass-based airborne concentration measurements to monitor workplace exposure.

On March 7, 2011, NIOSH published a notice in the Federal Register, which stated, in pertinent part, "NIOSH would like to build on the accomplishments of ongoing research to develop strategic research goals and objectives through 2015." NIOSH has identified 10 critical research areas for nanotechnology research and communication. These 10 critical research areas are:

  1. Toxicity and internal dose
  2. Measurement methods
  3. Exposure assessment
  4. Epidemiology and surveillance
  5. Risk assessment
  6. Engineering controls and personal protective equipment (PPE)
  7. Fire and explosion safety
  8. Recommendations and guidance
  9. Communication and information
  10. Applications

NIOSH stated that it is considering focusing the overarching strategic research goals for these critical areas on five key goals:

  1. Provide guidance to protect workers.
  2. Alert workers, employers, governments, and the public about possible new hazards.
  3. Assess the hazards of nanomaterials and the risks to workers.
  4. Help workers by assessing and implementing exposure registries.
  5. Assess the level of protection practiced in US workplaces.

NIOSH sought commentary on how research in the 10 specified areas and its five goals could be further enhanced.2

Furthermore, the EPA recently announced its plan to obtain information on nanoscale materials in pesticide products.3 Under the requirements of the proposed policy, the EPA will gather information on what nanoscale materials are present in pesticide products to determine whether the registration of a pesticide may cause unreasonable adverse effects on the environment and human health. The EPA seeks comment on several possible approaches for obtaining information about what nanoscale materials are present in registered pesticides.4 Under one approach, the EPA would use section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. If the EPA adopts this approach, it would also require the inclusion of such information with any application for registration of a pesticide product that contains a nanoscale material.

Under an alternative approach, the EPA would obtain such information using Data Call-In Notices under FIFRA section 3(c)(2)(B). If the EPA adopts this alternate approach, it would also need to require the inclusion of this information with any application for registration of a pesticide product that contains a nanoscale material. FIFRA section 6(a)(2) is the EPA's preferred approach because, in the EPA's view, it is the most efficient and expedient administrative approach to obtaining information about nanoscale materials in pesticides. Further, the EPA is proposing a new approach for how it will determine on a case-by-case basis whether an active or inert nanoscale ingredient is a "new" ingredient for purposes of FIFRA and the Pesticide Registration Improvement Act, even when an identical, non-nanoscale form of the ingredient is already registered. Thus, nanosilver could potentially be considered "new" even though silver is already a registered pesticide ingredient.5

Finally, the FDA has submitted a draft guidance document considering the potential implications of regulatory status, safety, effectiveness, or public health impact that may arise with the application of nanotechnology in FDA-regulated products.6 The FDA noted specifically that it does not categorically judge all products containing nanomaterials or otherwise involving application of nanotechnology as intrinsically benign or harmful. Therefore, the document is nonregulatory and exhibits the FDA's desire to learn more about the potential role and importance of nanomaterials, with an emphasis on premarket review or consultation with the agency early in the product development process.7

Final Thoughts

In closing, the past and recent trends in the nanotechnology field suggest that the tipping point for nanomaterial regulation is fast approaching. According to EPA officials, the agency can regulate nanomaterials as it regulates other pollutants and waste under the Clean Air Act, Clean Water Act, and Resources Conservation and Recovery Act, as well as undertake cleanups of nanomaterials under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA, also known as Superfund). However, current thresholds have been a limiting factor, as the hazards posed by nanomaterials are more closely linked to size, particle count, or surface area than sheer weight. Additionally, technical limitations exist in that the EPA currently lacks the technology to monitor particles of this size. Finally, the EPA may not be able to characterize the danger of nanomaterials appropriately; for instance, the size of nanomaterials may make current landfill liners incapable of sufficiently limiting their release into groundwater or other environments.

For that reason, the majority of actions have been nonregulatory, and the various agencies have sought commentary and information before taking action. However, pressure within the regulatory bodies is building, and changes most likely to occur in the near future include the EPA's promulgation of a final SNUR, rules covering nanoscale materials under FIFRA, possible workplace exposure limits by the Occupational Safety and Health Administration, and labeling requirements by the FDA. Considering the recent closing date for commentary on the NIOSH report and the impending deadlines for commentary on the EPA SNUR and FDA documents, it seems unlikely that any official regulatory action can be taken until next year, but the writing is certainly on the wall. It is likely that 2012 will be the year we begin to see the creation of regulations aimed directly at nanotechnology.

*Abe Tran is a rising 3L at Rutgers School of Law in Camden, where he also organizes pro bono initiatives with the Association for Public Interest Law and teaches constitutional law to high school students with the Marshall Brennan Fellowship. This summer, he had the pleasure of working at Day Pitney LLP as a part of the Summer Apprenticeship program.

Dr. Marc A. Nascarella is a toxicologist at Gradient, an environmental consulting company, and specializes in comprehensive chemical evaluations and human health risk assessment. Dr. Barbara D. Beck is a toxicologist and risk assessor, and directs Gradient's nanotechnology, toxicology, and risk assessment practices. Both contributed to this article.

1U.S. Government Accountability Office, Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk (Washington, DC, May 2010), 37.

2The period for receiving comments closed on April 15, 2011.

3Environmental Protection Agency, "Pesticides; Policies Concerning Products Containing Nanoscale Materials; Opportunity for Public Comment," 76 Fed. Reg. 41178 (June 17, 2011).

4The period for receiving comments will close on July 18, 2011.

5John Bashaw. "EPA Nanomaterial Disclosure Policy Being Reviewed by White House," Day Pitney LLP website, The Nano Newswire, August 20, 2010.

6The period for receiving comments will close in August 2011.

7Additionally, the FDA has promulgated regulations, set to take effect in 1 year, regarding the labeling of sunscreen. It has received criticism for not addressing the potential risk of nanoscale materials in the new rules, and may be forced to revisit the regulations at some point in the short to medium term to address the issue.

Opinions expressed in Expert Commentary articles are those of the author and are not necessarily held by the author's employer or IRMI. Expert Commentary articles and other IRMI Online content do not purport to provide legal, accounting, or other professional advice or opinion. If such advice is needed, consult with your attorney, accountant, or other qualified adviser.

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