Richard Denison, Ph.D., is a Lead Senior Scientist.
Nearly 4 years ago, EPA sent to the White House Office of Management and Budget (OMB) a pair of draft proposed rules that would require reporting of certain information by makers of nanomaterials. The proposed rules under the Toxic Substances Control Act (TSCA) seemed by all measures to have fallen into a black nano-hole.
But earlier this week, a smidgen of movement was discernible on the EPA regulatory tracker entry for this long-dormant activity. What appears to have happened is that EPA has withdrawn the original proposed rules and resubmitted one of them to OMB. Dropped, apparently, is the proposed significant new use rule (SNUR), which would have required companies proposing to commercialize a nanomaterial for a new use to first notify EPA so that it could conduct a safety review. Retained is the other half of the original pair of proposed rules, an information reporting rule under the authority of section 8(a) of TSCA. While details are not yet available, that proposal would require companies currently making nanomaterials to report basic information to EPA.
The long, sad history of the effort to develop these rules is something I blogged about nearly 4 years ago. While the development of reporting rules was first called for by an EPA advisory committee way back in 2005, EPA instead spent several years developing and carrying out a voluntary reporting program that produced minimal information. Indeed, in the description of section 8(a) proposed rule in its Fall 2010 regulatory agenda, EPA described the outcome of that voluntary program as follows:
EPA identified data gaps for existing nanoscale material production, uses, and exposures, based on the information EPA received prior to January 2009. For example, EPA estimated that companies provided information on only about 10 percent of the nanomaterials that may be commercially available.
Finally, in November 2010, EPA sent drafts of the proposed SNUR and section 8(a) reporting rule to OMB for its regulatory review. And there they have sat. And sat. And sat.
(A third proposed test rule for certain nanomaterials under section 4 of TSCA was reportedly developed by EPA but never sent to OMB because of the quagmire into which the first two proposed rules had fallen. It’s especially sad to note that EPA’s own webpage describing these proposed rules still states: “EPA anticipates proposing the SNUR, section 8(a) and section 4 rules by the end of 2010.”)
While there was some industry push-back against these modest rules (see here and here), the word on the street for some time has been that even more resistance came from within the Administration – from groups and individuals that have had as their mission for many years the promotion of nanotechnology. These folks apparently have viewed even the mildest regulation – requirements merely to report available health and safety information or notify EPA prior to market entry – as “stigmatizing” nanomaterials. The counterargument – that responsible development of nanotechnology would be aided by ensuring regulatory agencies have adequate information on nanomaterials that are already on or are about to enter the market to be able to identify and address any potential risks – fell on deaf ears.
This potential for a conflict of interest between the parts of the federal government that are promoting the development and commercialization of nanotechnology and those parts charged with understanding and addressing nanomaterials’ potential risks has been raised in recent reviews by the National Academy of Sciences of the National Nanotechnology Initiative; see here and here.
It’s not clear what has changed, if anything, to finally loosen the reins on one of these proposed rules. But it appears a deal was reached that involves EPA holding back on the SNUR requiring notification of new uses of nanomaterials and moving forward on mandatory reporting of information on nanomaterials and uses already in commerce.
Ironically, the SNUR was made necessary largely as a result of a bad policy decision by EPA in 2007 that declared nano forms of existing chemicals to be existing rather than new chemicals, thereby removing the only means under TSCA by which EPA could have reviewed such nanomaterials before they entered commerce and taken any steps needed to protect the public or the environment. Enter the SNUR: By requiring notification to EPA of new uses of existing nanomaterials, the SNUR would have gone far toward addressing the regulatory gap. In its absence, EPA will be unable to effectively keep up with the large and growing number of nanomaterials and associated uses that are coming onto the market.
Even for the scaled back rulemaking, there is still a long row to hoe. EPA’s regulatory tracker estimates the rule won’t even be proposed until March 2015. It would then undergo public comment, redrafting and another round of OMB and interagency review before being finalized and starting a process that many of us think will by then be more than a decade overdue.