EPA's Voluntary Program for Nanomaterials Still Too Little, Too Late

January 28, 2008



Sharyn Stein, sstein@environmentaldefense.org, 202-572-3396

Sean Crowley, scrowley@environmentaldefense.org, 202-572-3331

(Washington, DC – January 28, 2008) The U.S. Environmental Protection Agency’s (EPA) long-awaited voluntary reporting program for engineered nanomaterials will not deliver critically needed information and serves only to postpone key decisions on how best to mitigate nanotechnology’s potential risks to human health and the environment, according to Environmental Defense. The group harshly criticized the EPA’s new Nanoscale Materials Stewardship Program, which is described in a notice published in today’s Federal Register

“EPA is simply ‘kicking the can down the road’ by shunning approaches that could have delivered needed information faster, and by opting instead to pursue an open-ended approach with no end in sight,” said Richard A. Denison, Ph.D., Environmental Defense Senior Scientist.
Nanomaterials – measuring in billionths of a meter – are already showing up in hundreds of consumer products, ranging from paints to cosmetics to stain-resistant treatments for clothing. Initial studies show that some of them may be able to enter the body and even individual cells and, once there, cause damage.
“While EPA has added a few new specifics to its July 2007 proposal, the lack of clear ground rules governing what information volunteers will be called on to provide means that – even after the initial two-year program runs its course – EPA will still likely have only a partial understanding of what nanomaterials are in production and use, and what is known and unknown about their hazards and the nature of exposures to them,” Denison noted.
The United Kingdom launched a similar program 16 months ago, which still has attracted only seven companies to volunteer.  The loose design and open-ended timing of the EPA program is likely to yield similarly disappointing participation, resulting in a very selective and skewed picture of the state of nanotechnology.
Among the deficiencies Environmental Defense has identified in EPA’s program are:
  • Despite inclusion of a six-month “target” date by which EPA “encourages” participants to submit already available information, the basic program will actually run for two years before EPA decides what to do next – which EPA indicates may be only a further extension of the voluntary program. Environmental Defense considers six months to be more than ample for submission of already available information, and believes that EPA’s approach serves only to invite delay on the part of potential participants and to put off its determination of the needed next steps.
  • EPA also apparently intends to defer any decision as to whether even to initiate development of mandatory reporting rules until the initial program has run its course.  Simultaneous development of such rules as a “backstop” for the voluntary program was recommended by EPA’s federal advisory committee more than two years ago.
  • For each nanomaterial enrolled in the program, EPA will not require participants to:
    • submit all of the information they have for each of the information elements specified by EPA; or
    • identify – and justify – cases where they possess requested information but opt not to submit it; or
    • indicate where they do not possess the requested information.
  • These features invite partial or selective reporting and also mean that EPA will not know the actual extent of information that is either available to companies or not known to them.
  • EPA apparently intends to initiate the in-depth program only after reviewing the results of the basic program’s first phase, leading to further delays in developing essential data on nanomaterial hazards and exposures.
  • EPA helpfully clarifies that it will not exempt any participant in the voluntary program from having to comply with requirements applicable to producers of engineered nanomaterials under the Toxic Substances Control Act.  However, EPA appears to be adopting an unacceptably lax approach to exercising its statutory authorities or enforcing these requirements:
    • EPA states that where submitted information provides evidence of risk, EPA “may work with the participant to determine possible actions” it could take.
    • If EPA finds that a participant should have but did not comply with requirements to notify EPA prior to manufacture of a new nanomaterial, EPA will merely “inform the participant of that situation.”
“We are deeply disturbed by EPA’s failure to use the full range of authorities available to it to ensure that the rapid development of nanotechnology does not present undue risks to health and the environment,” said Denison.
Environmental Defense has been working since 2003 to ensure that the potential risks of nanoscale materials are identified and mitigated.  The organization has advocated for more federal funding for health and environmental risk research and is the only U.S. environmental NGO active at the international level in efforts to address nanoscale material risks.  For more information, see www.environmentaldefense.org/nano.