Background - In response to concerns vigorously expressed by diverse stakeholders over the final draft of the Safer Consumer Product Alternatives (SCPA) Regulations, the California Environmental Protection Agency (CalEPA) has effectively delayed implementation of the much-anticipated regulations. The net effect of this recent development on the regulation of nanoscale materials in consumer products in California is equally uncertain and nano stakeholders should redouble their efforts to ensure nanoscale materials are not adversely and disproportionately impacted by these developments.
Scheduled to go into effect in January 1, 2011, the start date of the game changing regulations is now indeterminate. CalEPA released a widely circulated December 23, 2010, letter from Linda Adams, California’s Secretary for Environmental Protection, to Assembly Member Mike Feuer (D-LA), the author of the 2008 law (A.B. 1879) that would require regulations to address chemicals and chemical ingredients in consumer products. In the letter, Secretary Adams responded to Feuer’s December 3, 2010, letter outlining his serious concerns about the Department of Toxic Substance Control’s (DTSC) November 16, 2010, release of revisions to its SCPA regulations. A copy of the Adams letter is available at this location.
Feuer charged that the revisions both failed to address the flaws of the earlier version and 'compounds them by fundamentally altering the approach called for under legislation I authored.' In addition to Feuer’s letter, the Environmental Working Group (EWG) and 32 other organizations submitted a letter on December 14, 2010, to California Governor Schwarzenegger urging him to “take immediate action to stop implementation of the draft regulations” because of their wholesale failure to give expression to the intent of the Green Chemistry legislation.
Although A.B. 1879 expressly requires DTSC to adopt SCPA regulations by January 1, 2011, Adams stated that 'DTSC has agreed to take additional time to be responsive to the concerns raised and revisit the proposed regulations.' Instead, DTSC and its regulation development team will reconvene the California Green Ribbon Science Panel in early 2011 to address the 'programmatic issues that have been brought to our attention via the public comment process.' Adams states that “[t]his additional time and expertise will help ensure that the vision behind this component of the Green Chemistry Initiative and implementing statute AB 1879, is fully realized.”
Implications for Nanoscale Materials
Based on these developments, it would appear that changes in the revised regulations that the nano industry supported could be subject to further discussion and revision. Among these issues are the proposed exemption of nanomaterials; the decision to focus the first five years on children's products, personal care products, and household cleaning products; and the revised process by which 'chemicals of concern' and 'priority products' will be identified. Indeed, among the 'defects' identified in the EWG letter to Governor Schwarzenegger include the exemption for 'nanomaterials from regulation.'
Earlier versions of the regulations posed many challenges for the nano community. The term 'chemical' used in the SCPA included 'nanomaterial.' Nanomaterial, in turn, was defined poorly and in ways largely indifferent to the global conversation underway to define the nomenclature of nano with precision and in response to the many thoughtful global initiatives designed to avoid confusion and inspire scientific harmonization. Additionally, prioritization factors were defined in ways that would have made consumer products containing nanomaterials almost certain candidates for target lists.
Secretary Adam's decision to reconvene the Green Ribbon Science Panel is appropriate and the right decision under the circumstances. Most would agree that getting this game changing regulatory program right is vastly more important than ensuring it is timely implemented.
That said nano stakeholders will need to focus on the details of the deliberations of the Green Ribbon Science Panel and do what is needed to ensure that all things nano are given a fair shake. Certainly, some of the regulatory trends, particularly those initiated by the Office of Environmental Health Hazard Assessment (OEHHA) (nano hazard trait comes to mind) suggest that nanoscale materials will be presumptively targeted for disproportionate review.
The hope is that scientific integrity and the very bright superstars populating the Green Ribbon Science Panel (Dr. Richard Denison, for example) will prevail and ensure that nanomaterials are not treated unfairly or differently than others under the law and its implementation. The nano community will need to work hard, however, as the going forward position is that DTSC's last go around threw human health and environmental protection under the bus. Using history as our guide, the pendulum will reflexively seek to correct this perceived imbalance, potentially leaving all things nano vulnerable to regulatory overreach.