(Beyond Pesticides, May 29, 2012) An industry newsletter has quoted representatives from two Washington, DC-based environmental organizations working on nanotechnology policy who blame the Obama Administration for impeding oversight of the largely unregulated technology. On May 23, Chemical Regulation Reporter quoted Richard Denison, PhD, a senior scientist with the Environmental Defense Fund, and Jaydee Hanson, senior policy analyst at the Center for Food Safety, as stating that two pending nanotechnology regulations have been placed on hold by the Office of Management and Budget (OMB). The delayed regulations involve separate proposed rules issued by the U.S. Environmental Protection Agency (EPA) that address engineered nanoparticles used as pesticides and chemicals, respectively.
The article reported that Dr. Denison had spoken with EPA officials who told him that they do not expect any regulations for engineered nanoscale pesticides or chemicals to be approved by OMB. OMB is a powerful agency within the Executive Office of the President of the United States which exercises final authority for approving all significant regulatory actions initiated by Cabinet departments. “My understanding is that there is a view in some circles in the White House that they do not want to stigmatize nanomaterials nor stifle the technology even by requiring the reporting of information that EPA needs to make judgments as to whether there are risks,” Dr. Denison said.
EPA published a proposed rule in June 2011, citing existing authority under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) that would allow the agency to obtain information on engineered nanoscale pesticide ingredients. In the proposal, EPA said it would prefer to collect information under Section 6(a)(2) of FIFRA, which requires registrants to inform the agency of additional information related to “unreasonable adverse effects on the environment,” because it is “the most efficient and expedient administrative approach.”
The Chemical Regulation Reporter article cited Mr. Hanson from the Center for Food Safety as saying that OMB will not approve EPA’s preferred approach. It quoted Mr. Hanson as saying that, “I am of the opinion that OMB has basically told the EPA, ‘Don’t bother’”‰” with a final rule. Mr. Hanson further stated that EPA may move forward with an alternative approach of asking registrants to submit data voluntarily on nanoscale ingredients, but that voluntary data requests are unlikely to be successful because registrants are not under any legal obligation to respond.
EPA has already granted a conditional registration to a pesticide product containing nanosilver as a new active ingredient. The antimicrobial pesticide product, HeiQ AGS-20, a silver-based product for use as a preservative for textiles to help control odors, is being granted registration despite a long list of outstanding studies that have yet to be submitted and reviewed by EPA. As a testament to EPA’s flawed registration process, the agency will now require additional data on the product after it has entered the marketplace to confirm its assumption that the product will not cause ”˜unreasonable adverse effects tp human health or the environment,’ the general standard for registration under the FIFRA.
The article also reported that a separate proposed rule from EPA’s Office of Pollution Prevention and Toxics (OPPT), which was developed to obtain information on engineered nanoscale chemicals, is stalled at OMB. In 2009, EPA said it would be developing regulations for engineered nanoscale chemicals because industry had failed to provide information voluntarily. Based on EPA’s authority under the Toxic substance Control Act, OPPT submitted its regulatory proposal to OMB on Nov. 22, 2010. That proposed rule has neither been approved nor withdrawn, and OMB has remained publicly silent on its position on the rulemaking.
The two proposed rules purportedly being held up at OMB are separate from rulemaking actions applicable to the use of nanoparticles used in sunscreens, cosmetics, and drugs. A coalition of six consumer safety groups filed suit against the U.S. Food and Drug Administration (FDA) on December 21, 2011, citing FDA’s chronic failure to regulate nanomaterials used in these products. The lawsuit demands that FDA respond to a May 2006 petition that the coalition filed calling for regulatory actions, including nano-specific product labeling, health and safety testing, and an analysis of the environmental impacts of nanomaterials in products regulated by FDA. After years of no federal regulatory oversight, FDA in April 2012 issued two draft guidance documents addressing the use of nanotechnology by the food and cosmetics industries. The documents “encourage” safety assessments for cosmetic products containing nanomaterials, including the need for modification or development of new methods for standardized safety tests. The new guidelines for the first time show the FDA believes nanomaterials deserve greater scrutiny
Source: Chemical Regulation Reporter
All unattributed positions and opinions in this piece are those of Beyond Pesticides.