Nanoscale Materials Stewardship Program--RELEASED

The ink isn't dry yet, and we haven't had a chance to go through it in detail, but be aware that US EPA has officially released its Nanoscale Materials Stewardship Program.  Details on the program can be found here, and prior discussion can be found here

The Federal Register notice on the program's release is here (73 FR 4861), and addresses the comments submitted by interested parties during the draft phase.

More information will come as we have a chance to parse the material.

NIOSH Urges EPA to Treat All Nanoscale Materials as New Chemical Substances Under TSCA

New chemical substances that are not on EPA's existing Toxic Substances Control Act (TSCA)chemical inventory are subject to premanufacturing notice and approval requirements.  Many NGOs have urged EPA to treat all nanoscale materials as new chemical substances under TSCA because of potential environmental, health, and safety concerns shown in laboratory settings.  Such treatment would trigger TSCA's premanufacturing notice and approval requirements.  This past July, EPA indicated it did not currently intend to accept this approach because it considers "new" chemicals as those that have molecular identities that are not reflected on the inventory.

 

On September 7, the National Institute of Occupational Health and Safety (NIOSH) submitted written comments on EPA's new Nanoscale Materials Stewardship Program in which it urged EPA to change its position and treat all nanoscale materials as new chemical substances under TSCA. In support of its position, NIOSH suggested that "EPA consider particle size . . . in its decision criteria for determining if a nanoscale material is considered a new chemical for the TSCA Inventory. Reducing the particle size to the nanoscale can result in unique or enhanced properties of the nanoscale substance, which can also alter or increase the biological activity and potential toxicity. Thus, the hazard potential of a nanoscale form of a substance may differ substantially (qualitatively and/or quantitatively) from the parent/bulk material that may be listed on the Inventory."
This sets up a possible showdown between EPA and NIOSH on the future treatment of nanomaterials under TSCA. Stay tuned.

EPA's Stewardship Program in Jeopardy?

Information out of Europe suggests that the U.S. EPA's Nanoscale Materials Stewardship Program, when finally launched, may not be as successful as the Agency hopes.

A similar program in the United Kingdom, the Voluntary Reporting Scheme for Engineered Nanoscale Materials, administered by the Department for Environment, Food & Rural Affairs (DEFRA), has received lukewarm responses at-best.

A report issued on March 22, 2007 by DEFRA states that it received only six submissions to the Voluntary Reporting Scheme: four by industry and two by academia.  The Scheme started in September 2006, and DEFRA will not give more information about the submissions due to concerns of releasing otherwise confidential information.  The report cites concerns and questions of Respondees, including confusion over who the Scheme applies to, when data should be submitted, which materials are covered, and the format of submissions.  The next report on the Scheme is due in June 2007.

The U.S. EPA's program is similar, due to its voluntary nature, to the U.K's Scheme that is getting off to a slow start.  EPA's program, while announced, is under Office of Management and Budget review, making a launch date uncertain. 

MEH: The Stewardship Program is an important tool for EPA to close the data-gap that currently exists between information an effective regulation.  EPA should heed the warnings coming out of the UK and refine its program as needed to create further incentives and protections to industries and researchers if it wants a significant response to its call for data.