Thursday, May 18, 2006

NANOTECH: Enviro petition likely to face Data Quality Act challenge

Lauren Morello, Greenwire reporter

A petition by environmentalists seeking stronger federal regulation of sunscreens and other cosmetics that contain nanomaterials could face a challenge under the Information Quality Act.

In an e-mail sent to about a dozen nanotechnology firms following news of the Food and Drug Administration petition Tuesday, the industry-backed Center for Regulatory Effectiveness solicited help challenging the environmentalists' filing under the data law.

The controversial statute, which is also known as the Data Quality Act, requires agencies to ensure the integrity of the information they use and distribute. The law allows outside parties to petition to force the correction of information they believe is wrong.

"FDA adoption of the [environmentalists'] petition will seriously curtail U.S. nanotech programs," says CRE board member Jim Tozzi in the e-mail. "The Center for Regulatory Effectiveness will invoke the recent Data Quality Act to oppose the petition. ... If you are interested in participating in the formulation and implementation of CRE's strategy, please contact me."

Tozzi, a Reagan administration official who helped craft the Data Quality Act, said in an interview today his e-mail had received a surprising amount of interest in a short time. "We've got way more than we thought we'd ever get in 24 hours," he said. "Generally, something like that takes a few weeks for people to respond."

While Tozzi would not name companies that received the e-mail, he did note they were "major, but unusual." Only one is a group that deals with nanotechnology for personal products, while most are Defense Department contractors interested in nanotech, he said.

Casting such a broad net was justified because the petition filed by Friends of the Earth and the International Center for Technology Assessment (ICTA) could force FDA regulatory action that "could set a negative precedent," Tozzi added.

When informed of the CRE e-mail, a spokesman for the environmental groups said the quick industry reaction demonstrated the strength of the case for new nanotech regulation.

"CRE is in cahoots with industry to try and control the [FDA's] response to the petition," said George Kimbrell of ICTA. "It shows they are worried about it and we certainly hit a nerve."

But Kimbrell said that the e-mail seemed to mischaracterize how a challenge could affect the petition's consideration at FDA.

"My understanding is that they can use the [Information Quality Act] to attempt to control the agency's response to the petition. They cannot negate the agency's duty to give us a response to the petition," Kimbrell said, though he noted any challenge would "certainly be a delaying tactic."

Under the Administrative Procedure Act, FDA has 180 days to respond to the petition. Friends of the Earth and ICTA are prepared to take the agency to court if they do not get the "timely response" guaranteed under the APA, Kimbrell said.

According to Tozzi, if CRE files an Information Quality Act challenge to the petition that FDA determines has merit, the agency could not adopt the measures urged by the environmentalists.

CRE has not begun formulating the strategy for its challenge, Tozzi said, acknowledging that the environmentalists' document "is pretty well-written."

Still, Tozzi said, "whether all the science [they cite] is going to make it [past an Information Quality Act challenge], I don't know."

Details of the enviro petition

The environmentalists' petition seeks to force FDA to formulate regulations specific to products containing engineered nanomaterials.

"Engineered nanoparticles have fundamentally different properties from their bulk material counterparts -- properties that also create unique human health and environmental risks -- which necessitate new health and safety testing paradigms," the petition reads. "Yet [FDA] has taken no regulatory steps to formally recognize the inherent differences of nanomaterials and begin to address their associated new risks."

The petition's 80 pages include more than 200 footnotes that reference "pretty much every well-known study" on nanotechnology safety and potential risks to human health and the environment, Kimbrell said.

The filing focuses on sunscreens because FDA classifies and regulates them as human drugs, unlike most other cosmetics.

"We're asking them to consider the [nano-]sunscreens as new drug products for which manufacturers would have to file new product applications," Kimbrell said.

The environmentalists also are seeking the recall of nanotechnology-enabled sunscreens from consumer markets until that testing is completed, he said.

Click here to view the environmentalists' petition.