EPA considers program to report voluntarily on nanomaterials

By Elizabeth Gardner

On the principle that it should understand something before it tries to regulate it, the U.S. Environmental Protection Agency is considering a proposal to encourage companies to volunteer information about nanomaterials that they manufacture or use in their products.

The Nanomaterials Voluntary Program, or NVP, would cover materials now being used commercially, or those due to come out of the laboratory soon. The EPA would use the resulting information to figure out the potential risks of the materials, how they differ from the risks for non-nanomaterials and how best to regulate their manufacture and use.

“I don’t think anyone believes that existing regulations, completely untouched, are likely to be sufficient,” said Richard Denison, a senior scientist at Environmental Defense, a New York City-based environmental group interested in the potential impact of nanomaterials. “The debate is on whether tweaks would be enough, or whether a whole new set of regulations is needed.”

Just one example is the current exemption from certain regulations for materials that are manufactured or released in very low volume. The current low-volume threshold is 10,000 kilograms, or about 22,000 pounds. “That’s a lot for nanomaterials,” Denison said.

Participants in the Nanomaterials Voluntary Program would provide the Environmental Protection Agency with information about nanomaterials that are in, or are poised to enter, the marketplace. The information may help the EPA assess risks and determine what, if any, regulations may be needed. Here’s a proposed timeline for the project.
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A program proposal is circulating within the EPA, developed by an ad hoc working group of the EPA’s National Pollution Prevention and Toxics Advisory Committee. The group included EPA scientists and representatives from industry and environmental organizations. The proposal was submitted to the EPA director in late November.

“Theoretically we could accept it verbatim or ignore it,” though most of the basics will probably be retained, said Jim Alwood of the EPA’s Chemical Control Division. He is shepherding the proposal through the approval process. He declined to put a timeframe on the program’s development, but said he hoped to have a version out for public comment before the end of the summer.

The proposal outlines a two-tiered program. All participants in the basic program would be required to:

  • Report all the existing information they have about the characteristics of each material they make or use (including risks associated with making it or using it) and the risk management practices they have in place.
  • Do whatever research is necessary to fill in gaps in basic information about a material’s characteristics.
  • Implement basic risk management practices.

Participants in the in-depth program would do all of the above, plus generate new or more detailed information about certain nanoscale materials, at the request of the EPA. They would also institute risk management practices identified by the EPA, and monitor nanomaterials in the workplace and in the environment.

The program would run for some specific period of time (the proposal recommends 24 months), at which point the EPA would evaluate the information received and decide whether the program was worth continuing.

The basic program covers information that many companies, especially larger ones, may already have compiled for their own internal use, and they may even have done some of the work covered in the in-depth program, said Bill Gulledge, manager of the nanotechnology panel of the industry group American Chemistry Council (ACC). “A lot of our members are interested in participating because it gets them in on the ground floor to develop a regulatory framework for nanomaterials.” Representatives of the ACC participated on a committee that developed the program proposal.

Gulledge said that smaller companies may need incentives to participate, and will have to be assured that the confidentiality of their trade secrets won’t be breached. The EPA already is required to keep trade secrets confidential for other substances that it regulates.

The proposal includes several suggestions for encouraging companies to participate. The agency might fast-track participants’ applications for permission to manufacture nanomaterials covered by the program. Companies might be allowed to promote their participation in the voluntary program in their corporate materials (though as of now not on individual products). With public concern growing about the safety of nanomaterials, evidence of good corporate citizenship might have some market value. The EPA might also list participants on its Web site.

PPG Industries Corp. in Pittsburgh has several materials on its roster that would fall under the NVP, especially in the area of coatings, said Paul Ziegler, global director of product compliance assurance. “We’re probably going to participate in the program even if there’s not something in it for us, because we do act as a responsible company,” he said. “We try to develop the information and understand the hazards already.”

Concerns that still need addressing

A number of unresolved issues are listed in the nanomaterials proposal, including:

  • How to distinguish between new and existing nanoscale materials.
  • Whether the EPA should publish an inventory of nanoscale materials.
  • How much of the data should be available to the public.
  • Whether the EPA should develop special data sheets for existing chemicals that are re-engineered into a nanoscale format.
  • Whether businesses should be compensated for some types of data collection and whether small businesses should receive special assistance.
  • Whether nanomaterials should automatically be treated as hazardous until complete information is available on potential risks, from manufacture to disposal.


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