Small bites, bigger questions

Jennifer Kuzma

by Gweyneth K. Shaw, New Haven Independent

One problem is that a lot more money is being spent on development than on safety research. Another is that the safety studies that are done tend to be narrowly focused: for example, dosing a zebrafish embryo with high levels of one nanomaterial might not offer a lot of insight about the impact of a consumer product.

For example, Suppan said, you could probably eat as much nanoclay as you want without any real problem. But nanoclay is almost certainly going to be paired with other super-small substances, such as silica and metallic oxides, in products. And nobody really knows what the interactions might do. He said he’d asked a prominent toxicologist why there weren’t studies looking at the impact of nanoparticles on the gastrointestinal track, which is obviously a hot spot for determining food safety. The answer: those are expensive, and difficult to do.

On the other hand, Suppan said, using nanotechnology to help detect food contamination—in the form of exceptionally small and sensitive monitors—is a potentially low-risk, high-reward application.

“One thing that’s so irritating about nanotechnology is the way it’s marketed is kind of a unified technology, it doesn’t discriminate between trivial and potentially dangerous applications and relatively low-risk applications that could be socially useful,” Suppan said.

Food packaging does seem to be at the forefront right now in terms of development, he said, and it’s a focus of the FDA as well. Packaging may also be the most benign use of nanomaterials, since it seems that substances embedded in packaging are less likely to migrate into the food they’re covering. The FDA is moving more slowly than the EPA, Suppan said, in part because the agency has a much broader authority—over everything from drugs to medical devices to food and cosmetics.

“We’ll get, I think, some indication of just how much well there is to regulate when we see what happens to the response to the EPA guidance,” Suppan said.

The EPA has essentially proposed two ways of collecting the information it wants from manufacturers: one is voluntary, the other mandatory. Industry representatives are urging the agency to adopt the voluntary scheme, while environmental groups and consumer advocates are pushing for the compulsory system. If the EPA bows to industry lobbying to make reporting voluntary, Suppan said, that will be an indicator that the federal government won’t have a particularly strong weapon in overseeing development of nano-products.

Politics, and the economy, play a role, too. Suppan said in conversations with international regulators, they’ve described being hamstrung because politicians have spent time touring factories and touting the potential benefits of nano-enabled products, and have bought into the idea that nanotechnology is a cure-all for ongoing economic woes.

“They’re hoping this is going to save their bacon,” he said. “Let’s not investigate health and environmental safety issues too closely, lest we scare off investors.”

It’s not just consumers who need protection, and information.

“My personal view is that the clear and present danger that I should think both industry and government should be concerned about regarding food packaging with nanomaterials is in the manufacturing process itself, and exposure to workers,” Suppan said.

Kuzma said she had been critical in the past of the FDA and EPA for not moving forward, but that she is encouraged by what was released last summer and now has more confidence in the agencies.

“You see these tiny, like baby steps almost,” she said.

She said she’s comfortable with the decision, at least for now, not to nail down a completely specific definition of “nanomaterial,” which is the subject of a fierce international debate. But efforts to gather information about what’s going into products needs to be compulsory, she said.

“(This) seems to me to be a sane approach, but it’s not really a mandatory approach now,” she said. “It’s not necessarily a bad approach, but I think there needs to be perhaps one more incremental step in that you say, ‘you must come to us.’‘’

Lynn Bergeson, a lawyer at the Washington firm Bergeson & Campbell who works with nanotechnology companies on navigating the regulatory process, said she too is less critical of the FDA than she might have been in the past. Bergeson said she’s encouraged by the appointment last year of Michael Taylor to be deputy commissioner for food at the agency, and thought the draft guidance issued by the agency last summer reflected a new focus on nano inside the FDA.

Taylor, who authored a report on nanotechnology and food in 2008 for the Woodrow Wilson International Center for Scholars’ Project on Emerging Nanotechnologies, knows where the gaps are, Bergson said. She called him and another key appointee, Jesse Goodman, “nano-smart, nano-savvy and nano-sensitive.”

Whether they—or anyone—can fill those gaps in the current Washington budget environment remains unlikely, she said.

“Nobody …can do much about the very serious shortfall of resources that all of these agencies are enduring now, and will continue to endure,” she said. “That’s not a failure of policy and it’s not a failure of commitment, it’s a failure of resources, and it’s not going to improve.”

Bergeson, who also writes a nano-law blog, is a booster of nanotechnology. She’s worked with the American Bar Association and other projects aimed at demystifying the nano world. Her personal opinion, she said, is that industry could be doing more to inform the public as companies develop new nano products and bring them to market, and not just in the food sector.

“We have not done enough to telegraph what these concerns might be, how they are being addressed, and how the commercialization of nanotechnology really should be not a source of tremendous concern,” she said. “That public dialogue has really not reached the pitch that it should reach.”

After packaging, Kuzma said she thinks the early frontier in nano-based food products will probably be in the vitamins and supplements area, and in efforts to enhance flavor through engineering. Given the lack of regulation and transparency, she said, people should proceed cautiously.

“What I do as a consumer is, sometimes I hear that something has special new properties and i immediately think nano, so even though it doesn’t have a nano label,” she said.

“If something says, ‘a new way to deliver vitamins to you,’ or offers orders of magnitude of improvement,” that’s a place where nanomaterials might be inside a product, she said.

Suppan said he suspects that companies would try new ideas first on imported produce and other items, because the U.S. enforcement system is weak in that area. Just as nano-based pesticides, such as nanosilver, expose the broader problems with the laws that EPA uses to govern them, nano food products showcase the already gaping holes in America’s food safety system.

“The technology is not going to fix the regulatory breakdown,” he said.

And despite the assurances of industry that they’re interested in managing the risks of nano products—as much from a business standpoint as a safety one—Suppan remains skeptical. It seems foolish to risk hurting people in order to make creamier ice cream with fewer calories, but many companies seem reluctant to put the money into safety testing, especially if it means exposing flaws in a variety of products.

“That’s a pretty shaky defense of the next industrial revolution,” Suppan said. “I am for what is by all accounts supposed to be a revolutionary technology. I just can’t see why they wouldn’t try to ensure the viability of that revolution with really relatively small investments in the regulatory structure and policy. Why not take a couple of years to safety-proof your products?”