In a blunt new report, the U.S. Environmental Protection Agency’s internal watchdog finds that the agency lacks both the data and the administrative ability to effectively deal with the challenge posed by super-small materials that are increasingly finding their way into consumer products.
The report, released late last week by the EPA’s inspector general, raises few new issues. But it makes plain the difficulties facing a host of federal agencies as they try to ensure safety without stifling innovation in the ever-broadening field of nanotechnology. While a growing body of evidence suggests there are real questions about the impact of nanomaterials on people, animals and the environment, there are few absolutes in this arena.
As scientists — both inside and outside the federal government — struggle to catch up, more and more products are coming on the market.
“If these challenges are not resolved, EPA will continue to lack assurance that it is making effective nanomaterial management decisions,” the report concludes.
EPA Photo
EPA Inspector General Arthur A. Elkins Jr.
The report from Inspector General Arthur A. Elkins Jr. (pictured) notes the EPA’s ongoing efforts to retool its regulatory scheme to tackle nanomaterials, the boldest of which are stalled at the White House Office of Management and Budget. And while the report highlights the yawning data gaps that are hampering regulatory efforts, it also acknowledges that the EPA is certainly not alone in this situation.
Read any serious take on nanotechnology and safety — from the U.S., or various countries around the world — and the lack of solid toxicological testing is the biggest complaint. The IG report mentions the costs, both in terms of time and resources, associated with generating the needed results, and questions whether the agency can do it with its existing budget.
By leveraging the often-amazing properties of ultra-tiny materials, nanotechnology can make airplane wings stronger and help cancer treatments ruthlessly target the bad cells. As nano-enabled products proliferate, however, there’s a big gap between what’s possible and what’s been tested for safety. The smaller size of these materials can sometimes change the way they interact with the world around them, raising serious questions about their impact on health and the environment.
The report takes on an area where the EPA is in control: Its administrative structure. The inspector general found that the agency isn’t doing enough to share the information on nanomaterials that it does have, making a tough scenario more difficult. In its response to the report, EPA officials said a more centralized approach is coming soon.
It also raps the agency for not doing a better job of explaining potential risks to the public. While the EPA maintains web pages detailing the hazards associated with lead exposure and hydraulic fracturing, or “fracking,” the report notes that there’s no corresponding information on the agency’s website about the implications of nanomaterials. Instead, details are sprinkled among several pages that deal with different types of nanomaterials.
In its response to the report, the EPA says it’s working hard to close the data gaps, outlining a series of steps agency officials have taken. Chief among them is a transition from an earlier, voluntary program aimed at drawing data out of manufacturers toward a system with more teeth. These changes involve the two laws that the EPA uses to govern nanomaterials: The Toxic Substances Control Act, or TSCA, and the Federal Insecticide, Fungicide and Rodenticide Act, or FIFRA.
New proposals under TSCA, which would require companies to report new substances containing nanomaterials to the EPA for testing before manufacturing, were submitted to the OMB in October 2010, the agency told the IG. A proposed FIFRA rule, which could lead to compulsory reporting on nanoscale ingredients from pesticide manufacturers, was released in draft form last June, and a final version was “recently submitted” to the OMB, according to the agency.
The EPA also granted conditional approval to a nanopesticide for the first time in December, a decision that was stalled for more than a year.
Richard Denison, a senior scientist with the Environmental Defense Fund who follows regulatory efforts involving nanotechnology, said the IG report didn’t place enough responsibility on the OMB for holding up the proposals.
“Today is day 408, and they are still sitting at OMB, with no end in sight,” Denison said. “I think those rules would go a long way to at least closing some of the data gaps that are mentioned in this report.”
Without that basic information, he added, it’s probably going to be difficult for the EPA to address the larger concerns.
Manufacturers are anticipating the EPA’s eventual decisions as eagerly as consumer and environmental advocates. In private conversations across the spectrum of academics, watchdogs and industry representatives, there is rampant speculation but no firm answers as to why the OMB has held up the proposals for so long.
Another problem that garners essentially no mention in the IG report, Denison said, is the legal and cultural barriers to sharing information from manufacturers. The Toxic Substances Control Act, or TSCA, protects many details of chemicals as “confidential business information,” and the EPA takes that mandate seriously — perhaps too seriously, Denison said. That can raise hurdles to wide discussions unless everyone involved is cleared to hear the protected information, he said.
It also affects the ability to share information with the public. Sifting through EPA announcements of permits and registrations granted to various manufacturers, it’s often impossible to tell exactly what products the agency is approving, or even which companies are involved.
In its response, the EPA defends its outreach efforts, and its general work on nanomaterials.
“EPA has been committed for several years to developing and taking action to ensure the safe use of nanoscale materials, and to engaging and informing our stakeholders and the public on these actions,” says the EPA response, which is attributed to Assistant Administrator Stephen A. Owens.
The OMB’s foot-dragging, coupled with the slow-moving effort in Congress to revamp TSCA, the EPA is in a difficult spot, Denison said. While it’s fine to point out the problems, he said, it’s not totally fair to lay the blame solely at the agency’s feet.
“Both of those are issues that are kind of out of the EPA’s control,” he said.