By MATEUSZ PERKOWSKI
Food manufacturers shouldn't assume that nano-sized versions of regulator-approved ingredients are also safe, according to the federal government.
When materials are manipulated on an extremely small nanometer scale, they can take on novel properties that serve specific functions.
Nanomaterials are expected to have important implications for the food and agriculture industries, potentially killing microbial pathogens and improving the efficiency of fertilizers and pesticides.
However, the unusual qualities of nanomaterials have also sparked concerns about their health and environmental effects.
The U.S. Food and Drug Administration is now advising food companies to study substances that have undergone major manufacturing changes -- like the use of nanotechnology -- to determine if they should be subject to additional regulations.
Ingredients deemed "generally recognized as safe," or GRAS, by the agency do not have to clear regulatory hurdles for food additives.
"In the specific instance of nanotechnology, a food substance manufactured for the purpose of creating very small particles with new functional properties likely would not be covered by an existing GRAS determination," the FDA said in a draft guidance document.
Such nanoparticles may have to be reevaluated to see if they can also be considered "generally recognized as safe," the agency said. If insufficient data exists to make that conclusion, the substance may be subject to "premarket review and approval" as a food additive.
It's possible food products already on the market have incorporated nanoparticles, which could prompt companies to seek FDA's advice and make new regulatory filings, said Lynn Bergeson, an attorney specializing in chemicals and nanoparticles.
"The fact they're already on the market does not mean this guidance doesn't apply," Bergeson said.
Though the FDA's guidance isn't binding, ingredients that are considered unsafe could by subject to recalls and enforcement actions by the agency, she said.
"When in doubt, the FDA is saying come on in and talk to us," Bergeson said.
The Institute for Agriculture and Trade Policy, a nonprofit that has called for stronger federal oversight of nanotechnology, is heartened by the FDA's draft guidance.
"This has been a long time coming," said Steve Suppan, senior policy analyst for the group. "The guidance is a small step in the direction of regulation."
The institute is worried that nanoparticles could be used for fruit and vegetable coatings or similar products, with potentially hazardous effects if they accumulate within the body.
Last year, the group joined in a lawsuit against the FDA, claiming the agency unlawfully ignored a petition to regulate nanomaterials and study their environmental impacts. The litigation is pending before a federal court in California.
Suppan said the FDA's draft guidance is unlikely to make the lawsuit moot, since it doesn't directly address the increased scrutiny demanded by the group's petition.
Even so, it is significant the FDA said the safety of nanomaterials shouldn't be assumed, he said. It will likely prompt the nanotechnology industry to think about moving forward with a regulatory process for such substances.
"They're basically forewarning them that they carry the burden of proof of safeness," he said.
