Berkeley Nanotech Ordinance Underscores Need For Uniform Regs – Experts

A regulatory framework for nanotechnology that is harmonized on both the national and international level is needed in order to promote health and environmental safety and to provide a "climate of trust for the consumer," according to Christoph Meili, Ph.D., consultant with The Innovation Society.

"I think the biggest risk is not over-regulation but under-regulation," Meili said during an interview with "The Tan Sheet." Although industry normally seeks minimal regulation for its products, in the case of nanotechnology, "it's the other way around," he said. "I think regulatory framework gives sort of a safety and security framework for these products."

Meili's comments come in response to an ordinance recently passed in Berkeley, Calif., that requires facilities to disclose toxicology and procedural information related to nanotechnology materials under their control. The ordinance, which was approved unanimously by the Berkeley City Council Dec. 5 and enacted Dec. 15, amends Title 15 of the city's Municipal Code.

The ordinance states: "All facilities that manufacture or use manufactured nanoparticles shall submit a separate written disclosure of the current toxicology of the materials reported, to the extent known, and how the facility will safely handle, monitor, contain, dispose, tract inventory, prevent releases, and mitigate such materials .... All manufactured nanoparticles defined as a particle with one axis less than 100 nanometers in length, shall be reported in the disclosure plan."

The ordinance is "a very dangerous development," according to Meili, "because if you tend to regulate nanotechnology like this you will have a chaotic system of very, very different regulatory frameworks."

"If every community has another regulatory framework, I think this is the worst" possible scenario, he added.

The Berkeley council's initiative represents the first time a city has established its own regulatory requirements for the nanotechnology industry. Cambridge, Mass. - home to the Massachusetts Institute of Technology and Harvard University - is now also considering implementation of ¹ nanotechnology regulation.

Such initiatives by individual cities raise the question of whether changes are needed at the federal level.

In general, FDA considers the Food, Drug and Cosmetic Act "sufficient to be able to support the use of new technologies without creating new regulations," according to Director of the Office of Cosmetics and Colors Linda Katz, M.D. Whether that will be the case for nanotechnology "remains to be seen," she said while speaking at the "Regulations for Nanotechnology in Consumer Products" conference in Washington Feb. 9.

Attorney John C. Monica of Porter Wright Morris & Arthur (Washington) agrees that a host of different regulatory schemes for the nanotechnology industry is not desirable.

Installing pre-emptive legislation to regulate nanomaterials is premature and may cause more harm than good in the long term, he said.

Monica, who is also an associate editor on the journal Nanotechnology Law & Business, says in an e-mail the Berkeley ordinance is "unnecessary because it is virtually impossible to comply with in its current form."

He cited several other problems with the ordinance, including that it does not provide a set definition of "nanoparticle." FDA also lacks a standard definition for the words "nanotechnology" and "nanoparticle," Katz added.

The National Nanotechnology Initiative defines nanotechnology as "the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications."

Monica also took issue with the Berkeley ordinance because of its use of the phrase "manufactured nanoparticles."

"Why only 'manufactured' nanoparticles?" he asked. He described the definition in the ordinance as a "broad" one, given that particles may also be natural, incidental or engineered.

In addition, Monica said a requirement to report on the toxicology of nanomaterials is unreasonable, because their toxicology is largely unknown.

George Kimbrell, staff attorney for the International Center for Technology Assessment, takes the opposite point of view when it comes to toxicology testing.

"The releases are happening now," he said at the nanotech conference. "We have consumer products out on the market that are releasing environmentally through manufacture, through transportation, through use and through disposal, so that's a problem."

"We lack the technologies that we need to - once these things get out into the environment - monitor them, control them, remove them, to detect them, to track them," he said.

Kimbrell says nanotechnology toxicology currently falls under the purview of existing U.S. environmental laws, such as the Toxic Substances Control Act.

"The underlying principle of many of these environmental laws has been talked about before and that's the conventional hazard risk assessment paradigm, which in many ways is inadequate alone for nanomaterials," he said.

Monica also questions why the Berkeley ordinance seeks toxicology reports and what types of toxicology the city council is looking for, such as an exposure route or a subspecialty.

Because toxicology is relatively unknown, facilities will be unable to describe how they will handle the nanomaterials, since such decisions cannot be made without full comprehension of the safety of the materials, Monica said.

In dealing with the toxicology, "all 'manufactured nanoparticles' have not been labeled as 'hazardous,' nor is there any current scientific consensus that they all should be," Monica asserts. "Most scientists say more research is still needed and it will take several years."

Although many agree more research is needed, the question of who will conduct the research still remains.

Federal agencies are funding nano-related environmental, health, and safety research, requesting approximately $44 million in the 2007 budget, Monica says. "On the other hand, the federal government takes the position that manufacturers are primarily responsible for the research necessary to ensure the safety of their nano-products."

Kimbrell said industry should be devoting more money to environmental health and safety studies.

Industry's focus "is on applications," he said. "I think it needs to be much more on implications here if they want this to succeed."

Monica notes product liability law imposes the burden on manufacturers, requiring them to "ultimately bear the social and financial burden of any liability."

"I believe manufacturers should plan accordingly," he said. "However, my personal belief as a policy matter is that manufacturers and the federal government have equal responsibility," he added.

Additionally, Monica said the responsibility falls to the federal government to "take the lead" in labeling any material or chemical as hazardous.

"Personally, I don't think city governments are well-equipped to analyze these issues. Thus, I would always consider municipal regulations of this specific type to be pre-emptive and ill-advised."

Noting that the federal government is looking closely at environmental health safety issues related to nanomaterials, Monica recommends "leav[ing] the decision to them as to whether or not to label a nanomaterial as 'hazardous' and all the burdens that come with that label."

Whether this could spawn litigation or put a damper on business development remains to be seen, Monica says. Depending on what mode of dissemination the city chooses, the burden falls on the companies to provide the required toxicology information, he adds.

If Berkeley requires a literature search - the most likely outcome - then "reviewing the universe of existing toxicology studies and then reporting/summarizing them to the city is a very expensive prospect," Monica says. In the less-likely event that new toxicology research is required, "then that is a whole different - greater - level of expense," he adds.

Once the toxicology issue has been resolved, companies can anticipate additional expenses associated with implementing the materials handling requirement. "Of course, this is hard to estimate without having the toxicology part nailed down," Monica said.

- Rebekah Moan ([email protected]) and Melina Vissat ([email protected])