EPA has been considering a voluntary program for the collection of health, safety and risk mitigation measures of engineered nanoscale materials for several years.

On Jan. 28, 2008, the U.S. Environmental Protection Agency (EPA) pulled the trigger on its much-anticipated new voluntary Nanoscale Materials Stewardship Program (NMSP), under the Toxic Substances Control Act (TSCA). EPA hopes and expects the NMSP to "complement and support its new and existing chemical efforts on nanoscale materials" under TSCA.

In the last decade, EPA has opted to pursue voluntary programs of one form or another to obtain information it believes is critical to its ability to provide effective oversight on particular issues. The High Production Volume Challenge Program, for example, enabled chemical manufacturers to provide information and develop new information on chemicals manufactured in large amounts. The Voluntary Children’s Chemical Evaluation Program also is a voluntary program that assessed the hazards of certain chemicals and determined whether any might pose a disproportionate risk to infants and children.

Voluntary programs offer significant value. They are much faster to implement than measures requiring federal rulemaking, and enable stakeholders to work collaboratively with EPA and others on issues of shared concern.

Some argue voluntary programs are less effective than rulemakings in that they are voluntary and lack the force and effect of enforceable federal rules. Additionally, not everyone volunteers, which means the burden of a particular issue falls disproportionately on a subset of industry members that, some believe, is inequitable and perhaps unwise. Despite this debate, EPA’s use and reliance on voluntary programs is strong, and there is no end in sight.

NMSP Participants
EPA has been considering a voluntary program for the collection of health, safety and risk mitigation measures of engineered nanoscale materials for several years. EPA states in the notice that the NMSP encompasses participants “who manufacture, process, use or import nanoscale materials for commercial purposes.” This includes those who  manufacture or import engineered nanoscale materials; physically or chemically modify or process an engineered nanoscale material; physically or chemically modify or process a non-nanoscale material to create an engineered nanoscale material; or use engineered nanoscale materials in the manufacture of a product.   

EPA states that others, including researchers who develop or study engineered nanoscale materials, may also participate. According to the notice, both new and existing chemical substances (as determined by the status of the substance on the TSCA inventory of chemical substances) can be included in the NMSP, regardless of whether they qualify for exemptions from TSCA’s new chemical reporting. In the notice, EPA also reminds participants that “participation in the program does not relieve or replace any requirements under TSCA that a manufacturer, importer, processor or user of nanoscale materials may otherwise have.”

Program Components
EPA will implement the NMSP in two parts: (1) a basic program, where participants report all known or reasonably ascertainable information regarding specific nanoscale materials, including risk management practices; and (2) an in-depth program, where participants commit to develop data. Under the basic program, participants should forward available data on nanoscale materials to EPA within six months. Participants in the basic program may continue to submit new data that becomes available on any nanoscale material reported to EPA during the initial six-month period.   

Under the in-depth program, participants would develop a plan and submit data over a longer period of time yet to be determined. EPA says it intends to conduct both the basic and in-depth programs for the next two years, “although it may make adjustments or decide on future steps or direction of the program at an earlier point as sufficient experience is gained.” As soon as EPA identifies potential sponsors, it will coordinate the process for in-depth data development.

EPA recognizes the NMSP involves voluntary submissions of information, and that the application of TSCA to all the data submitted in connection to the NMSP cannot be determined in advance. Because of this, EPA advises participants that submission of information under the NMSP “will constitute consent for the agency to treat this information as if it had been submitted under TSCA.”

EPA invites each participant in the basic program to submit available data on risk management practices for nanoscale materials it manufactures, imports, processes or uses. EPA also asks participants who have already developed a risk management plan to include the plan as part of their submission under the basic program.

EPA Use of the Data
EPA states it will use data from the NMSP “to gain a better understanding of the nature of nanoscale materials that are produced; the quantities in which they are produced; how they are or will be used; any hazards, exposures, or releases associated with those materials; and how these hazards are being addressed.” In addition, EPA scientists will use the data to aid in determining how certain nanoscale materials may present risks to human health and the environment.   

EPA states that if the hazard, exposure and fate data submitted by a participant indicate potential risks may exist for a specific nanoscale material, “EPA may work with the participant to determine possible actions to avoid, reduce or mitigate potential risks.” If the data submitted by a participant indicate the participant is manufacturing a nanoscale material that is reportable under TSCA Section 5 as a new chemical substance, “EPA will inform the participant of that situation, the applicable TSCA requirements and the TSCA [S]ection 5 enforcement policy.”

EPA “encourages manufacturers, importers and processors of nanoscale materials to consult with EPA regarding questions of the TSCA inventory status of such materials before beginning commercial activity.” EPA says it will work with NMSP participants who also have reporting requirements under TSCA Section 5 “to minimize or eliminate duplicative reporting of the same information.”

Other Important Documents
On July 12, 2007, EPA released several documents for public review and comment:  Concept Paper for the Nanoscale Materials Stewardship Program under TSCA; and the TSCA Inventory Status of Nanoscale Substances – General Approach. EPA received several suggestions of changes to the concept paper, including definitions, materials that should or should not be included, types of participants and additional data elements that could be reported under the NMSP. EPA says, “[r]ather than revise the concept paper, EPA will continue to use it as a description of who EPA envisions participating and what nanoscale materials they would report.”   

EPA states the information provided by commenters did not “compel modification of the basic approach described in the TSCA inventory paper as previously issued for comment. Therefore, this approach will remain unchanged.”

The NMSP is a vitally important program, and robust participation in it is essential to the responsible development of nanotechnology. Manufacturing Today readers are urged to assess whether they are eligible for participation in the NMSP and to volunteer to participate if the answer is yes.

Lynn L. Bergeson is a managing director of Bergeson & Campbell P.C., a Washington, D.C., law firm focusing on chemical, pesticide and other specialty chemical product approval and regulation, environmental health and safety law, chemical product litigation and associated business issues. She is also president of The Acta Group L.L.C. and The Acta Group EU Ltd. with offices in Washington, D.C., and Manchester, UK. Bergeson is legal counsel to the American Chemistry Counsel Nanotechnology Panel. She can be reached at 202-557-3800.