“Principles” Issued

After a long stretch of silence, the White House and two federal agencies recently offered a glimpse — albeit a small one — of where federal policy involving the growing field of nanotechnology might go.

There are no regulations, or even proposed laws, in the three documents, issued on the same day earlier this month. The White House offered a set of ​“principles” to help guide agencies as they consider the implications of these super-small materials. The Food and Drug Administration essentially reiterated what it’s been saying for several years, that nano-aided drugs and other products should be treated as new.

The Environmental Protection Agency’s missive is drawing the most attention from industry supporters, academics and others who follow nano-related policy.

On its face, the EPA document basically tells manufacturers of pesticides containing nanoparticles that the agency wants to know more about what they’re putting in their products, and discusses a couple of different ways to hold those talks. The agency is also signaling its intent to potentially reopen the approval process for some substances that are already on the market, an unusual move.

“It’s a definite shift, and definitely a new phase in this entire process. So it’s certainly being viewed that way within the field,” said R. Paul Stimers, a lobbyist at the Washington law firm of K&L Gates who works with nano-related clients and a policy advisor to the NanoBusiness Commercialization Association. “I think the White House and the agencies in coordinating this intended it that way.”

Nanotechnology leverages the often-unique properties of super-small particles to create products with amazing qualities. These materials 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 paints.

These nanomaterials are believed to hold great promise for a wide variety of applications. But shrinking these substances can change their properties, and scientists are struggling to figure out whether, how and why that shift can make them dangerous in the process.

Some studies raise serious questions. Nanosilver, for example, is turning up in sewage sludge. Fiber-like carbon nanotubes can cause inflammation in the lungs of mice, leading to comparisons to asbestos.

As researchers race to keep up, the U.S. government and its international counterparts are grappling with how to protect people, animals and the environment without strangling the nascent nano industry in the crib. Consumer and environmental advocates are pushing for rules that specifically address nanomaterials; industry is wary of restrictions when so much remains uncertain. As a result, there’s lots of meetings and research going on—and plenty of money being spent—but few concrete answers.

That’s probably as it should be, said Michael Fitzpatrick, the associate administrator at the federal Office of Management and Budget’s Office of Information and Regulatory Affairs, or OIRA. He was involved in putting together the recently released guidelines (click here to read the full document), which complement a similar document that came out in March.

“This is going to involve a careful, careful balancing,” Fitzpatrick said. ​“Any time you have an emerging technology, you’re going to have this ramp-up time when the science and the understanding is trying to catch up with this new technology.”

The White House guidelines shy away from a formal definition of a nanoparticle, which has been a contentious issue for regulators around the world. Instead, it notes that the National Nanotechnology Initiative considers anything that’s 1 nanometer to 100 nanometers in size to be a ​“nanoscale” material. That’s become the rough standard in the field.

But the document goes on to say that for probing safety, size isn’t the only thing that matters. For regulatory purposes, it says, ​“the critical issue is whether and how such new or altered properties and phenomena emerging at the nanoscale create or alter the risks and benefits of a specific application. A focus on novel properties and phenomena observed in nanomaterials may ultimately be more useful than a categorical definition based on size alone.”

The principles stress, above all things, making decisions based on scientific evidence, urging agencies to separate ​“purely scientific judgments from judgments of policy to the extent feasible.” They emphasize transparency and communication, with both the public and the industry, as well as solid evaluation of what the actual risk involved with a particular material.

“Nanomaterials should not be deemed or identified as intrinsically benign or harmful in the absence of supporting scientific evidence,” the document says, pointing out that ​“where there is evidence of either safety or likely harm, the corresponding regulatory actions are usually clear.”

Industry Cheered

That language is particularly cheering for industry, Stimers said.

“One of the things that we’re concerned about is we don’t want it to be a regulatory process that just as a matter of its architecture is geared toward assertions that there’s a harm,” Stimers said. ​“That’s not a level playing field.”

Fitzpatrick said it’s important for the government to refrain both from boosterism and creating a sense that all nanoparticles are bad. Take chemicals, for example: there are plenty of them out there, and some are harmful, while others aren’t. The U.S. regulatory system aims to minimize exposure to the former without labeling all chemicals as dangerous.

“There’s a lot of ongoing effort inside the government to study this,” Fitzpatrick said. ​“It’s very hard to just decide to take action … you have to accept some level of uncertainty for some time.”

People should be assured, however, that ​“the government is on the case,” he said.

“You’re seeing an increased focus, and an increased set of research and attention being paid to the science,” Fitzpatrick said. ​“It’s received the appropriate level of attention, which is a lot of attention.”

Too Slow?

Consumer and environmental advocates, however, say the government has moved far too slowly in setting up rules for nano-enabled products. Jaydee Hanson, policy director at the International Center for Technology Assessment, said he thought the latest steps were in part a response to threats of a lawsuit. The ICTA, in concert with other advocacy groups, has petitioned both the FDA and EPA to start regulating products that contain nanomaterials.

It’s been just over three years since the groups demanded that the EPA use its power to regulate pesticides that use nanosilver, which is prized for its antibacterial properties. Hanson said the lack of movement doesn’t surprise him, although it is disappointing.

“We live in a country where the EPA doesn’t have enough data to ban asbestos,” Hanson said, despite decades-old evidence that the substance causes major lung disease.

Hanson said Europe is moving ahead of the U.S. in terms of nano-related policy, in part because there’s a willingness for everyone — regulators, industry and consumer groups — to share data and collaborate on solutions.

“Our contentious process just gets everybody digging their heels in,” he said.

John C. Monica Jr., a partner at the Porter Wright Morris & Arthur law firm who works on nanotechnology issues, said the linchpin of the White House principles — that science should drive any policy changes — isn’t new. But for the White House to say it explicitly is ​“helpful,” he said. It’s also notable that the document defers to the laws currently on the books.

“I think the document refers nine times to the sufficiency of existing regulations,” Monica said. ​“I think they were trying to make a statement there.”

Fitzpatrick said the administration stressed that point in order to defer to Congress, which ultimately makes the laws. There are a handful of initiatives on Capitol Hill that would impact the nanotechnology industry, particularly an effort to overhaul the Toxic Substances Control Act, or TSCA. But it’s unclear whether any of them have legs in the current political environment.

Andrew Maynard, director of the University of Michigan Risk Science Center and expert on risk and emerging technologies, said the recent moves are an interesting start. At issue now, he said, is what happens over the next year, as ongoing efforts inside the federal agencies moves ahead.

“My sense is that at the White House level, yes, there is something afoot,” Maynard said. ​“What is less clear is what it happening at the agency level.”

That’s where the FDA and EPA documents come in. The FDA’s portion, touted as ​“guidance for industry,” basically sets out some standards for deciding whether a product — be it a drug, cosmetic or other application — can be considered to contain nanomaterials. It also declines to set a formal definition for ​“nanoscale,” but it says the agency will take into account not just size, but the properties and behavior of an ingredient, up to 1 micrometer, which is 1,000 nanometers.

Fitzpatrick said the administration’s decision not to focus exclusively on size came because research has increasingly shown that it’s not always determinative.

“It’s much more the characteristic of the phenomena, and that application of the material,” he said.

Hanson said he had heard from a top FDA official that the agency plans to weigh in specifically on food safety sometime soon, although he didn’t get a firm timetable. Nanomaterials are reportedly turning up in produce coatings, if not inside your soup can. The super-tiny substances are also coveted in the world of food packaging, where they’re envisioned as a way to keep food fresher and kill bacteria.

Whether it’s safe is another matter, sure to become another front in the tug-of-war between innovation and health. 

There’s more meat on the EPA’s plan, although it’s also nonbinding. The agency is telling manufacturers that it wants more information about nano-size ingredients, and intends to use its powers under the Federal Insecticide, Fungicide and Rodenticide Act, or FIFRA. It proposes two methods, but the key difference is whether two words — ​“adverse effects” — should be included.

An EPA spokesman said the agency prefers the option that uses those words, which are part of one provision of FIFRA, ​“because it imposes less burden on the regulated community, is faster, and will ensure that EPA gets the most accurate and complete information on what nanoscale materials are in pesticide products.” Using the second option, known as a data call-in, would require repeated queries to manufacturers. 

EPA has issued carefully-controlled permits for the production of some types of nanomaterials, including specific carbon nanotube products. It’s also considering whether to offer a tentative approval to a nanosilver-based pesticide that’s used as an antimicrobial ingredient in athletic apparel — a process that began a year ago.

In addition, the EPA has extensively studied other nanomaterials, including titanium dioxide. It’s also working on a separate track, using TSCA, to enact other reporting rules for nanoscale chemicals. 

But the latest missive, even if it’s preliminary, is the agency’s biggest step forward to date.

“This announcement proposes, for the first time, a plan that will allow EPA to effectively review and regulate nanoscale pesticides,” the agency spokesman said.

Already-Approved Pesticides Included

What’s interesting about the EPA’s plans is that they potentially include pesticides that have already been approved by the agency, because they contain a nano-sized version of a chemical or substance that’s allowed. Silver, for example, is approved for use as a pesticide, including for water treatment, regardless of its size.

“It’s a bold step forward, because it means that anything that comes out is going to be retroactive,” Maynard said.

Hanson predicted a fight over the EPA decisions — one that he said the ICTA and others will be watching, with lawsuits a possibility if the process stalls.

“We think that the EPA already has the legal authority to regulate these nanochemicals as new chemicals,” Hanson said. ​“It’s moving in the right direction, but if it doesn’t keep moving in that direction, we would seek other remedies.”

Stimers and Monica said they also expect there to be strong pushback from the industry on some of the ideas.

“EPA has done a reasonably good job of reaching out to industry and working with industry to understand more about nanoparticles and nanoregulation, but it’s an ongoing process and its a process where EPA has a very large capability to really … create an environment that’s very, very difficult for businesses almost without trying, and so we’re concerned especially in the current economy that that not happen,” Stimers said.

“Really, the fundamental course that the nanotechnology field is trying to chart is one between overregulation on one hand and killing off companies before they get off the ground on the other hand, and no regulation on the other hand,” Stimers said. ​“The goal is to find the middle path where people an be confident that they’re getting safe products, but at the same time the regulations involved are not onerous and are actually doing some good.”

Monica said he’s sure ​“a lot of people were disappointed by” the documents, especially advocates who’ve pushed for new regulations to specifically address the challenges posed by nanomaterials. But he praised the administration for being cautious while trying to be proactive.

“I think it’s inevitable that it’s going to be slow, and there’s only really so much you can do,” Monica said. ​“There’s no way the toxicology science can catch up with what’s already out there, much less what’s being invented every day.”

Hanson, though, said there’s enough evidence to start making decisions.

“The nice thing about this technology is … parts of this work, and parts of it are very powerful and will be very helpful,” Hanson said. ​“But we want to separate those parts from the parts of it that are going to be very harmful.”