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sábado, 14 de julho de 2012

Congress To FDA: Study Nano Safety

BY Gwyneth K. Shaw 
The U.S. Food and Drug Administration will soon have a new nanotechnology safety program, thanks to language tucked into a massive legislative package that’s on its way to President Obama.

U.S. Sens. Mark Pryor of Arkansas and Benjamin L. Cardin of Maryland, both Democrats, pushed for the program to be added during Senate debate last month. The revamped bill cleared the House last week and passed the Senate, 92 to 4, on Tuesday. Obama is expected to sign it.

The broader bill deals mainly with prescription drug safety and payments from pharmaceutical companies to fund the FDA’s regulatory efforts. Pryor and Cardin saw an opportunity to attach an idea they introduced last year, which had stalled.

Their proposal creates a “Nanotechnology Regulatory Science Program” within the FDA charged with scrutinizing the safety and efficacy of drugs, medical devices, cosmetics and other products that contain super-small particles. The legislation directs the FDA to both review ongoing academic research on health and safety issues, as well as conduct its own studies and work with other agencies.

“Nanotechnology is increasingly being used to improve everyday products, yet we have little independent research to show whether these products remain safe once they contain nanomaterials,” Pryor said in a statement. “This bill provides an opportunity for the FDA to focus more on these health and safety studies. With its strong record of excellence, I believe NCTR is an ideal candidate to take the lead in this arena.

Nanotechnology is a broad term that encompasses a wide variety of uses of very small materials. (A nanometer is a billionth of a meter.) These substances can make better batteries or lighter and stronger bike frames, as well as new medical instruments and medicines that can save lives. They’re increasingly common in consumer products, from “mineral-based” sunscreens to stain-repellent pants to boat paints that resist algae growth.

Nanomaterials are believed to hold great promise for a wide variety of applications. Their ultra-tiny size often gives them different properties, which is inherent to their appeal; scientists are struggling to figure out whether that can make them dangerous in the process, and how and why it happens.

The FDA is already involved in some safety and regulatory efforts through its main office in Maryland and the National Center for Toxicological Research in Arkansas. For example, FDA researchers did a study on pig skin to investigate the impact of sunscreen containing nanoscale titanium dioxide; they found that the particles didn’t penetrate intact skin very much.

In April the agency released new guidelines for manufacturers that produce nano-enabled cosmetics and food ingredients, from packaging to the edibles themselves. In those documents, the FDA effectively said that nanoscale versions of existing food additives and packaging won’t be automatically classified as “generally regarded as safe,” or GRAS. These ingredients might prompt additional testing, even if they’re already on the market, according to the proposed guidelines.
The heart of the new rules, agency officials said, is inviting manufacturers to come in and talk about what they’re putting in their products.
“We want to make the manufacturers aware that they still have a responsibility here,” said David Keefe, director of the FDA’s food additive safety office, said at the time.

But sunscreens—which are considered over-the-counter drugs by the FDA—aren’t covered under those guidelines. Neither are drugs and medical devices, which are subjected to a much more rigorous safety protocol in any form. The new safety program would push the FDA harder in those areas.

The question of whether, and how, to regulate nano-enabled products at the federal level has been a difficult one. It’s complicated by the fact that “nanotechnology” is more of a term of art than a category, including everything from carbon nanotubes to nanoclays made from shrimp shells.

Because of that broad spectrum, a variety of federal agencies have jurisdiction over these products. The Environmental Protection Agency, for example, considers nanoscale silver—increasingly used as an antimicrobial—to be a pesticide. The agency granted the first conditional approval for a nanosilver pesticide in December, a decision which drew a lawsuit from environmental advocates.

Other nanoscale substances, including carbon nanotubes, are still the EPA’s responsibility, but fall under a different law that regulates chemicals.
FDA officials, meanwhile, have to think about substances such as gold nanoparticles over a swath of uses, including anti-wrinkle creams and cancer treatments.

That’s made an overarching policy mandate hard to concoct. About a year ago, the White House, FDA and EPA released position papers that stressed the need to study safety while avoiding negative assumptions about any material. But no new rules have emerged, except the EPA’s pesticide approval, which was in the works before those documents were released.

Now, Congress has offered a nudge, at least to the FDA.

“Nanotechnology has grown to be indispensable in our daily lives but as this burgeoning technology continues to power more of our consumer products and drive job creation in America, it is essential that we fully assess, understand and address any risks that nanotechnology may pose to safety, public health and our environment,” Cardin said in a statement.

Click here for more Independent articles on nanotechnology.