Ramping up the EPA’s Nanoscale Materials Stewardship Program

09/01/2007

The highly anticipated Concept Paper-for what is likely to be the EPA’s primary nano-focused tool-has drawn cheers and jeers. Whichever side you’re on, you’re sure to feel its impact

BY JOHN C. MONICA, JR.

The U.S. Environmental Protection Agency’s proposed Nanoscale Materials Stewardship Program (NMSP) presents great opportunities, but also has some major obstacles to overcome.

The agency’s long-awaited Concept Paper for Nanoscale Materials Stewardship Program Under TSCA, published in July, provides a broad outline of how the NMSP will likely be structured once it’s finalized. (You can download the 21-page document at http://epa.gov/oppt/nano/nmspfr.htm.) A public meeting the EPA hosted on August 2 to discuss the paper drew about 150 of people, mostly from government and industry, and generated conversation that highlighted some of the program’s challenges.

Here’s the program

The NMSP is completely voluntary, but the EPA is encouraging all manufacturers, users, and importers of nanoscale materials to participate to jumpstart “responsible development” of nanotechnology. The agency expects the program will foster the openness and transparency that many in the public and certain non-governmental organizations believe is crucial to the success of any regulatory program.

NMSP asks participants to take two actions:

1. Implement a nanotechnology environmental, health, and safety (“EHS”) risk management program; and
2. Submit nano-related information for use in the EPA’s future regulatory decisions.

Implementation and information

Implementation of a nano-EHS risk management program would ideally consider relevant input from the EPA and then report back regarding its efficacy. The EPA intends to base its program on the results of an October 2006 scientific consultation that resulted in a comprehensive, 70-page report suggesting ways to manage potential nano-EHS risks. Thus, while the Concept Paper does not provide specifics for developing a nano-EHS risk-management program, ample resources are available to assist the effort. It is difficult, however, to predict whether companies will voluntarily embrace this portion of NMSP without knowing more.

Participants are also asked to provide information regarding their current use of engineered nanoscale materials under two reporting levels. The EPA intends to use this information to determine “how and whether certain nanoscale materials or categories may present risks to human health and the environment,” and to identify any existing data gaps, prioritize nanomaterials for further research, and develop risk mitigation techniques.

The EPA believes most companies already have this first, basic level of information involving materials characterization, hazard data, use information, potential exposure data, and existing risk-management practices. These broad topics, of course, have many subtopics. In fact, the EPA’s draft questionnaire for this “basic” information is 25 pages long and is based on the Toxic Substances Control Act’s (“TSCA”) new chemical questionnaire.

Beyond this, interested companies can participate in a second, “in-depth” level, which involves partnering with the EPA to collect additional data on a specific, limited number of nanomaterials of greatest potential concern. Participants will jointly review existing data, conduct preliminary assessments, identify any additional data needs, and develop an action plan for cooperatively gathering the needed data. Joint research topics include “characterizing the physical/chemical properties of the material; testing for health and environmental hazards; monitoring or estimating exposures and releases; determining fate and transport characteristics; evaluating the effectiveness of protective equipment or engineering controls; developing a model worker education program; and other evaluations agreed to under the plan of action.”

EPA envisions some companies taking a direct role in level-two research, while others may choose to work in loosely formed coalitions. After they complete the research, there will be a final joint risk assessment for each material studied, and any additional actions/steps will be considered on a case-by-case basis.

Reality check

While much needed, it is difficult to see how all of the in-depth information can be created and collected in the short- or mid-term for even a modest subset of the 1,700 currently catalogued nanoscale materials. This is especially true, given NMSP’s voluntary nature and the large amount of time, money, and effort it will require to conduct the research and gather the data. While the goal is a good one, some might judge this portion of NMSP as overly optimistic.

Those concerned with confidentiality will want to know that all information collected under NMSP will be treated as formally submitted under TSCA. Companies can designate certain portions of their submissions as confidential business information (CBI), which provides all existing TSCA non-disclosure protections. The substantiation requirements for CBI claims are extensive, however, and there are penalties for erroneous claims in certain instances. Thus, nano-companies using the CBI provisions should make sure their claims are appropriate, given their specific circumstances.

Further, participation in the voluntary program is a concern. The EPA is asking the public for ideas on incentives to induce company participation. At the same time, the agency says participation will not “relieve or replace” existing TSCA requirements that are otherwise applicable to each specific manufacturer and nanomaterial.

Above all else, NMSP’s success depends on participation. A similar two-year voluntary program initiated in the U.K. in September 2006 contained few incentives for participation and as of June 2007, had drawn submissions from only seven companies. Unless the EPA does something different with NMSP, it is likely to see an equally poor response rate.

As expected

Comments at the EPA’s August 2 public meeting were not surprising. Nanoscale material manufacturers, chemical associations, and business interests largely embraced NMSP and felt the EPA has done a good job of crafting the program without rushing to judgment on nano-related EHS issues. Some were concerned about when the program will be up and running and how long information will be collected under each tier. Others encouraged the EPA to make sure it is actually requesting all of the data it needs to properly move the program forward.

On the other hand, environmental and consumer groups were generally skeptical of NMSP. Environmental Defense announced it does not support NMSP because of how long it has taken to come to fruition, its lack of compliance deadlines, and lack of a mandatory regulatory complement to ensure increased industry participation. Similarly, Consumers Union criticized the NMSP because of its voluntary nature and concern that companies will selectively report information. Terry Davies of the Woodrow Wilson International Center for Scholars also advocated pairing NMSP with a mandatory regulatory backstop to ensure increased participation.

The success of NMSP is important. It may be the only nano-specific initiative under TSCA forthcoming from the EPA for the next three to five years. The EPA recently confirmed that it will not treat engineered nanoscale materials as “new chemical substances” subject to TSCA’s premanufacturing notice requirements unless their molecular identities differ from existing chemical substances. Likewise, for better or worse there is little reason to believe EPA will treat nanomaterials any differently when it is deciding whether they constitute “significant new uses” under TSCA.

Thus, NMSP is likely to be EPA’s primary nano-focused tool under TSCA for the foreseeable future.

Whether you choose to participate in NMSP or not, you should be concerned with “institutional inertia.” It is easy to imagine NMSP ultimately resulting in significant nano-focused regulation-regardless of scientific efficacy-if for no other reason than the tremendous amount of time, effort, and money the EPA is investing to create and implement the program.

John C. Monica, Jr. is a partner at Porter Wright Morris & Arthur LLP, and is a specialist on nanotechnology product liability issues. He can be contacted at [email protected].