Posted: July 28, 2008

EPA Nanotechnology Voluntary Program risks becoming a 'black hole'

(Nanowerk News) Six months after launching its voluntary nanotechnology reporting program for nanomaterial producers, EPA has made virtually no information public about the limited number of submissions it has received. As a result, the public can have little confidence that the program is providing the information the Agency will need to protect citizens, consumers, workers and the environment from the potential risks of nanotechnology, according to Environmental Defense Fund (EDF).

The EPA intended its Nanoscale Materials Stewardship Program (NMSP) to provide both EPA and the public with a better understanding of what nanomaterials are being produced, how they’re being used and what their producers know about them.

“EPA not only appears to have received limited information, but worse, EPA is saying almost nothing about it. The information being received appears to be entering a ‘black hole,’”said Richard A. Denison, Ph.D., EDF Senior Scientist. “Limited participation, some company submissions covering only a single nanomaterial, ignorance as to the extent of information being provided, and an almost total lack of public transparency are not a good recipe for a program that was supposed to help restore the public’s trust.”

The only information EPA has provided on its website is a list of companies that have made submissions (nine companies as of today) or said they intend to (11 companies as of today). The nine submissions equal the number received under the United Kingdom’s nanomaterial voluntary reporting scheme (See www.defra.gov.uk/ENVIRONMENT/nanotech/index.htm).  All of these companies have or intend to volunteer under the “basic” program component, which calls on companies to report only information they already possess on the identity, properties, production and management of their nanomaterials. Two of these companies have also volunteered for the “in-depth” program component, which could entail new testing.

To put these numbers into perspective: When it launched the NMSP, EPA said it expected to receive 240 submissions from 180 companies under the basic program, and to attract 15 participants in the in-depth program (See EPA’s “Supporting Statement for an Information Collection Request (ICR),” pp. 13-15 and 19, available at www.epa.gov/oppt/nano/nmsp-icr-supportingstatement.pdf). EPA based its projections on an estimate that, in 2005, more than 600 companies were manufacturing and applying nanotechnology, a number that has surely grown since then.

“EPA was unwilling to include in the program meaningful ways to measure how complete or representative the information being submitted is,” said Denison. “For example, EPA didn’t ask companies to tell them how many nanomaterials they produce, or even require them to indicate whether the information they’re submitting on a given nanomaterial is complete or not.”

Through inquiries to EPA, EDF has managed to discern that:

A number of the submissions received to date provide data only for a single nanomaterial, despite the strong likelihood that most or all submitting companies are engaged with multiple nanomaterials; EPA’s website notes that the submissions cover 68 nanoscale materials, but does not indicate how many were submitted by each company -- a single company apparently accounts for the vast majority of these materials, all of them metal-based; An unknown number of the submissions have been claimed by the submitter to be confidential business information (CBI), including in one case the identity of the company itself; EPA has no immediate plans to make public even the non-CBI submissions it receives.

Equally important is what EPA has not made public and EDF has not been able to find out:

What nanomaterials the submissions cover; The extent of information provided for each nanomaterial; Whether each submitter provided all or only part of the requested information it possesses on its volunteered nanomaterial; Whether any health and safety studies were provided (which are ineligible to be claimed as CBI under the Toxic Substances Control Act); Whether those claiming their submissions as CBI did so for all or part of their submissions; Whether EPA has reviewed or plans to review CBI claims to verify their legitimacy.

“At the time EPA launched the NMSP, EDF warned that it would likely yield a selective and skewed picture of the state of nanomaterial production and use in the United States,” concluded Denison. “Because of flaws in the design of the NMSP, not even EPA – let alone the public – has any idea whether a given submission represents all or only a small portion of the information a company has on its nanomaterials.”

Environmental Defense Fund, a leading national nonprofit organization, represents more than 500,000 members. Since 1967, Environmental Defense Fund has linked science, economics, law and innovative private-sector partnerships to create breakthrough solutions to the most serious environmental problems. For more information, visit www.edf.org.

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