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John DiLoreto

The most important chemical substance regulatory statute in the U.S. is now facing challenges in many ways and some are wondering if nanotechnology is fueling the fire for change. The Environmental Protection Agency has moved beyond voluntary programs and took several regulatory enforcement actions which portend an even more aggressive approach toward the regulation of nanomaterials in 2010.

March 28th, 2010

The Intersection of Nanotechnology and Chemical Regulatory Policy

With the implementation of REACH in Europe and anticipated changes to the Toxic Substances Control Act (TSCA) in the U.S., the regulatory climate for producers and users of nanomaterials could become increasingly difficult and far more costly. In the United States, Environmental Protection Agency (EPA) Administrator Lisa Jackson recently revealed a framework for TSCA reform and announced plans to strengthen the Agency's ability to address chemicals that could pose a risk to the public.

New or Existing Chemical Substances?

For decades the chemical industry worked within the TSCA regulatory structure and many became comfortable with a framework that originally became law in 1976. The emergence of nanotechnology exposed the difficulty the Agency has in mandating the submission of the data needed for risk determinations in addition to challenging the very foundation of Agency enforcement capability by making new forms of existing substances that don't fall neatly into the definitions of new or existing substances.

While it was easy for the EPA to declare carbon nanotubes new substances, it was more difficult to address the prospective hazards of existing substances like titanium dioxide with regard to safety. These substances are "existing" because they are already on the TSCA inventory and the data submission requirements generally must be driven by determinations that there is a significant new use.

It can be said that the EPA can always require data on new and existing substances but the existing regulatory procedures can make it difficult to do so in a timely manner. Ultimately, many products can enter the marketplace with little safety data being submitted to the Agency.

Jackson's speech to the Commonwealth Club of San Francisco in September did not specifically mention nanomaterials but a press release on the speech highlighted difficulties associated with the regulation of nanoscale materials.

"An additional focus will be accelerating efforts to gather the critical information from industry that the agency needs to make chemical risk determinations. This will include filling the current gaps in health and safety data on high production volume chemicals; enhanced, transparent, and more current reporting of use and exposure information; and a number of requirements for increased reporting on nanoscale chemical materials. In addition, EPA is reviewing how nanoscale materials are managed under TSCA. EPA is also reviewing ways to increase the public's access to information about chemicals."

For years some have feared even the slightest suggestion to change TSCA but most people in industry have come to recognize the inevitability of such a change and are, at least publicly, embracing the change with some describing it as "modernization."

Regulatory Enforcement is Already Underway

One of the enforcement tools currently in favor for nanomaterials at the EPA is the use of Significant New Use Rules (SNURs). The Agency is also considering additional actions under its existing TSCA authority including Section 4 test rules, Section 5 fines and additional reporting under section 8. Under Section 5 of TSCA, when the EPA identifies a "significant new use" that could result in exposures to, or releases of, a substance of concern, the Agency publishes a rule in the Federal Register requiring the manufacturer to provide notification prior to initiating production of the substance.

Following close on the heels of the EPA's clarification of carbon nanotubes as a "new substance" under TSCA, the agency exerted its regulatory authority on November 5, 2008 by promulgating SNURs for two nanoscale materials. It was the first time the action was ever taken on a substance identified specifically as a nanoparticle. Expressing concern for "lung effects" for siloxane-modified silica nanoparticles and siloxane-modified alumina nanoparticles, the EPA "has determined that a 90-day inhalation toxicity test would help characterize the human health effects" of the substance.

Direct final SNURs for two single- and multi-walled carbon nanotubes were published in the Federal Register on June 24, 2009. They were ultimately withdrawn when the EPA received a notice of intent to submit adverse comments. The substances were already subject to consent orders which required a 90-day inhalation toxicity study in rats with a post-exposure observation period of up to 3 months, material characterization data and a limitation on production volumes and production time limits until testing is completed.

On February 3, 2010, the EPA published another proposed rule specifically for multi-walled carbon nanotubes (MWCNTs) described in premanufacture notice (PMN) P08-199. The SNUR "will require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of the specific multi-walled carbon nanotubes identified by the notice for any activity designated by this SNUR as a significant new use. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs."

In the basis for action in the latest federal register notice the "EPA identified concerns for lung effects, immunotoxicity, and mutagenicity from exposure to the PMN substance." In addition, the EPA notice establishes a requirement for: A bacterial reverse mutation test in vitro; a mammalian erythrocyte micronucleus test in vivo, in bone marrow, by the intraperitoneal route; an immunotoxicity test; and a 90-day inhalation toxicity test, including a post-exposure observation period of up to 3 months.

The Future for Nanotechnology Regulatory Enforcement is Now

SNURs can be an effective enforcement tool but they are generally specific to a Premanufacture Notice submission by a single manufacturer. A more far-reaching tool available to the EPA is the TSCA section 4(a) test rule which can impact all producers and importers of nanomaterials. It is mandatory and can be both costly and time-consuming given the length of time needed to conduct toxicity studies.

In the spring 2009 Unified Agenda the Agency indicated the test rule may be needed to determine the health effects of multiwalled carbon nanotubes. While the use of test rules and SNURs as regulatory tools can help accomplish the goal of "understanding the health effects of the substance to manage/minimize any potential risk and exposure," it is expected that TSCA "modernization" can be used to enhance existing enforcement capabilities and add new regulatory enforcement capabilities for nanoscale materials.

The EPA has always been pressed by industry to make regulatory determinations based on sound science but the lack of significant hazard data on nanomaterials has put the policymakers in a difficult position. The Nanoscale Materials Stewardship Program was intended to provide data to better understand the potential risks associated with nanomaterials but many of those following the voluntary program point to the failure of the effort as an example of the need for reform of chemical regulatory policy in the U.S.

While it's doubtful that those calling for nano-specific regulations will be successful, there seems to be little doubt that TSCA changes are in the air. It's only a matter of time before Congress turns its attention away from the more compelling issues of the day and begins to address chemical regulatory policy. Nanomaterial producers would be wise to form coalitions to help shape the mandatory testing that will inevitably be required in order to minimize costs and help shape the upcoming TSCA "modernization" in ways which will continue to spur nanotechnology advances without stifling innovation.

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