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White House Blocking EPA Efforts to Issue Rules on Nanomaterials, Advocates Say

Thursday, May 24, 2012

By Patrick Ambrosio and Pat Rizzuto

The White House appears to be blocking Environmental Protection Agency efforts to tighten oversight of engineered nanoscale pesticides and other chemicals, according to environmental and safety advocates.

Richard Denison, a senior scientist with the Environmental Defense Fund, told BNA May 23 that he has spoken with EPA officials who have told him they do not expect any regulations for engineered nanoscale pesticides or chemicals to be approved by the White House Office of Management and Budget.

“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,” Denison said.

Jaydee Hanson, senior policy analyst at the Center for Food Safety, said he believes OMB will not approve the agency's preferred approach to collect data on nanoscale pesticide ingredients under Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act.

“I am of the opinion that OMB has basically told the EPA, 'Don't bother' ” with a final rule, Hanson said.

Lynn Bergeson, an attorney with Bergeson and Campbell PC, told BNA she has heard that EPA's progress on an information collection policy for nanoscale pesticides has stalled. “That whole approach has died on the vine,” she said.

FIFRA Proposal.

Denison and Hanson referred to two rulemakings.

EPA published a proposed rule in June 2011 that would allow the agency to obtain information on engineered nanoscale pesticide ingredients under either Section 6(a)(2) of FIFRA or through data call-in notices authorized under Section 3(c)(2)(B) of FIFRA (35 CRR 588, 6/13/11).

In the proposal, EPA said it would prefer to collect information under Section 6(a)(2), 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.”

Hanson said he has attempted to speak with OMB and EPA officials on the status of the rule, but has been unable to obtain any official comment on it.

Neither EPA nor OMB responded to requests May 23 for information on the status of the 2011 EPA proposal on nanoscale pesticide ingredients.

TSCA Proposal.

Denison also discussed a proposed rule EPA's Office of Pollution Prevention and Toxics has developed to obtain information on engineered nanoscale chemicals after it was unable to secure information through a voluntary program. In 2009, EPA said it would be developing regulations for engineered nanoscale chemicals because industry had failed to provide information voluntarily (33 CRR 355, 4/13/09).

OPPT submitted its regulatory proposal--which combined a data collection rule authorized by Section 8(a) of the Toxic Substances Control Act with a significant new use rule (SNUR) authorized by TSCA Section 5(a)(2) for engineered nanoscale chemicals--to OMB on Nov. 22, 2010 (36 CRR 409, 4/9/12).

That proposed rule has neither been approved nor withdrawn, and OMB has remained publicly silent on its position on the rulemaking.

OMB Said to Avoid 'Stigmatizing' New Technologies.

On March 11, 2011, OMB issued guidance to federal agencies that said, “regulation and oversight should avoid unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers” (35 CRR 313, 3/21/11).

Subsequently, on June 9, 2011, the White House issued a memo encouraging federal agencies to base their decisions on nanomaterials using “the best available scientific evidence” (35 CRR 582, 6/13/11).

Denison said EPA has been trying to obtain such evidence, but its efforts have been blocked for years by some industry groups.

EPA May Move Ahead With Alternative Approach.

Hanson said EPA may move forward with an alternative approach of voluntarily asking registrants to submit data on nanoscale ingredients.

EPA has already requested additional data from the registrants of pesticide products containing nanosilver, according to Hanson.

Rosalind Volpe, executive director of the Silver Nanotechnology Working Group, an industry group, declined to comment on EPA's proposal to collect information on nanoscale ingredients in pesticides.

Hanson said voluntary data requests are unlikely to be successful because registrants are not under any legal obligation to respond.

He said businesses will be unlikely to “report on the problems of their chemical” if their competitors are not required to do the same. EPA's initial approach, to gather information under Section 6(a)(2) of FIFRA, was better because all pesticide registrants would be on the “same playing field,” Hanson said.

Denison also was skeptical of the effectiveness of any voluntary approach for pesticides, citing OPPT's failure to obtain information voluntarily.

Bergeson said she had not heard about a voluntary data call-in, but unless that is backed up with the regulation allowed under FIFRA Section 3(c)(2)(B), she is skeptical that EPA will obtain the information it is seeking.

Bergeson and the Nanobusiness Alliance, a trade association representing companies working with nanotechnologies, have consistently urged manufacturers to cooperate with EPA in its efforts to obtain information on engineered nanoscale materials to inform its regulations.

Group Weighing Legal Options.

Hanson said the Center for Food Safety is weighing its legal options related to a May 2008 petition on the use of nanosilver in consumer products.

The petition, filed by the Center for Food Safety, Beyond Pesticides, Greenpeace, Friends of the Earth, and the International Center for Technology Assessment, requested that EPA classify nanoscale silver as a pesticide, require nanosilver products to be regulated as pesticides, and take steps to ensure that retailers stop selling nanosilver products that have not been registered as pesticides (32 CRR 438, 5/5/08).

EPA has not issued a formal response to the petition, which Hanson said is “verging on an unreasonable delay.” The coalition did not file lawsuits over the EPA's failure to respond because it appeared the agency was making “good progress” by issuing proposed regulations, Hanson said.

The Center for Food Safety will have to reconsider its legal options if EPA does not proceed with formal regulation of nanoscale materials in pesticides, Hanson said.

In a separate but related development, the International Center for Technology Assessment, which works with the Center for Food Safety, is weighing its legal options to prod the Food and Drug Administration to issue regulations for engineered nanoscale ingredients in cosmetics and food (see related story).