FDA to potential ‘nano' tech users: ‘Call us'

By Sara Wyant

© Copyright Agri-Pulse Communications, Inc.

WASHINGTON, May 2, 2012 -A recently released draft guidance document from FDA addressing the use of nanotechnology in food production suggests that companies using the technology in food and packaging manufacturing should consult with the agency.

The FDA describes nanotechnology as “an evolving technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers - particles so small that they cannot be seen with a regular microscope.” Potential applications include altering substances at a “nano” scale to improve food packaging, food nutrition and food safety.

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The nanometer scale is as small as 1/100,000 the width of a human hair. Manufacturers in several industries use it to develop advanced products including lighter, stronger airplane propellers; self-cleaning, hydrophilic windows; and stain-resistant pants.

According to the Project on Emerging Nanotechnologies, “an estimated global research and development investment in nanotechnology of nearly $9 billion per year is anticipated to lead to new medical treatments and tools; more efficient energy production, storage and transmission; better access to clean water; more effective pollution reduction and prevention; and stronger, lighter materials.” Merchandise listed in market inventories includes cosmetics, athletic equipment, clothing and electronics.

Additional uses are showing up in the food, medical and cosmetic industries. Nanotechnology has the potential to alter the nanoparticles of certain food substances so they can indicate when they are past a safe consumption date, improve resistance to harmful bacteria or alter nutritional content, according to the Woodrow Wilson International Center for Scholars.

University of Michigan Risk Science Center Director Andrew Maynard said although the scientific potential is vast, there are no known food substances currently on the market that list nanomaterials as ingredients. He said some known materials on the market have nanotech packaging, such as plastic beer bottles, but that it often is not cost-effective for companies to develop plastics at the “nano” scale.

“There was a lot of optimism, but then the industry became cautious, largely driven from fear of consumer backlash,” Maynard said.

Maynard explained that, along with the scientific and societal benefits, “scale unique risks” are associated with nanotechnology, meaning that nanoparticles can behave in different ways than “conventional” particles.

The FDA guidance, which is open for a 90-day public comment period, is a voluntary guideline, but states that “any manufacturing change has the potential to be significant, and this remains true for changes or novel products, involving nanotechnology.”

One of the biggest challenges is that no food industry market data exists on which materials involve nanotech production, said Research Foundation of the International Life Science Institute (ILSI) Center for Human Health Risk Assessment Director Richard Canady.

“Food companies are just uncertain as to how difficult it would be to get a nanotech material on the market,” he said. “We're listing everything we've heard about, trying to identify where there may be concerns.”

Canady said he is involved in a project to be released within the next couple of months that will provide a list of what materials are known to benefit from nanotechnology and might exist on, or potentially reach, the market. He said the FDA, Health Canada and Consumers Union are some of the project's sponsors.

While no scientific evidence demonstrates a negative impact on human health from the use of nanotechnology in food production, materials at the “nano” scale can pose unique safety issues, states the FDA.

“We are taking a prudent scientific approach to assess each product on its own merits and to not make broad, general assumptions about the safety of nanotechnology products,” said FDA Commissioner Margaret Hamburg.

The draft proposal describes factors manufacturers should consider when determining whether changes in manufacturing processes involving nanotechnology create a significant change that may affect the identity of the food substance; affect the safety of the use of the food substance; affect the regulatory status of the use of the food substance; or warrant a regulatory submission to FDA.


Original story printed in May 2nd, 2012 Agri-Pulse Newsletter.

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