First-Ever Nanoscale Chemicals Data Collection Rule Imminent

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By Pat Rizzuto

Industry and environmental health advocates plan to scrutinize a forthcoming final Environmental Protection Agency rule that for the first time would collect available industry information about nanoscale chemicals.

The White House Office of Management and Budget cleared the final rule (RIN:2070-AJ54) on Dec. 28 after nearly 11 years of back and forth with EPA and regulatory reviewers.

The EPA will release the final rule after the New Year, the agency told Bloomberg BNA Dec. 29 by e-mail.

Two attorneys representing companies that make and use nanoscale chemicals along with scientists working for environmental organizations that fought for more than 10 years in support of the rule told Bloomberg BNA they are anxious to see the provisions of the rule.

Proposed Rule’s Provisions

The proposed rule, released April 6, 2015, (80 Fed. Reg. 18,330) would have:

  •  defined nanoscale chemicals, or “materials";
  •  established a one-time reporting obligation during which companies that make or use nanoscale chemicals would provide the EPA available information they have about their chemical’s form, size, shape and other properties; and
  •  established a 135-day notification requirement triggered by a manufacturer’s or processor’s use of a new form of a nanoscale chemical.

Rule Said Not Economically Significant

According to OMB, the rule is not economically significant, meaning it is unlikely to have an annual effect on the economy of $100 million or more, but the proposed rule was a “significant regulatory action,” meaning the White House review was needed because it raised “novel legal or policy issues.”

When released, this will be the EPA’s first regulation concerning nanoscale chemicals generally. The agency’s new chemicals program has allowed hundreds of individual, new nanoengineered molecules to enter commerce.

“At long last, EPA is expected to promulgate its rule to gather risk-relevant information on nanoscale materials,” Richard Denison, lead senior scientist for the Environmental Defense Fund, told Bloomberg BNA. Denison was among three environmental organization officials who resigned from an EPA advisory committee in 2006, saying the committee and agency had been unwilling to consider their proposals on issues such as requiring companies to submit data on nanoscale chemicals.

Rule Has Taken 11 Years

“This rule, significantly scaled back from earlier efforts, comes fully 11 years after it was first called for by a multi-stakeholder EPA advisory group in 2005,” Denison said by e-mail.

Among the many obstacles the rule faced was chemical manufacturers reluctance to voluntarily submit information through a voluntary data-collection effort the EPA made.“Progress was stymied at every step by myopic opposition coming from both industry and other parts of the federal government, [which] failed to recognize that the biggest threat nanomaterial producers and users face is a government oversight system starved of even a basic understanding of the nature and extent of nanomaterial use and what is known and not known about their potential risks,” he said.

“This is a new frontier for reporting—across the board—for nanoscale chemicals,” Martha Marrapese, an attorney with the Washington, D.C., office of Keller and Heckman LLP, told Bloomberg BNA.

By “new frontier,” Marrapese said she referred to the EPA’s request for types of information companies may have never previously provided for any kind of chemical.

Data Sought by EPA

The information the EPA would like to obtain—if companies already have it—includes up to 43 physical and chemical properties such as porosity, crystal structure, surface area, surface charge, particle shape, particle size distribution and surface chemical composition.

The EPA proposed to obtain the data from manufacturers, importers and processors simultaneously even though some companies, such as processors, have far less experience providing the agency chemical data, Marrapese said.

In addition, the 135-day notification period the EPA proposed to require for the manufacture or use of a new form of a nanoscale chemical was egregious, she said.

That requirement would have “unreasonably exceeded” the authority Congress gave the EPA under Section 8 of both the original or amended Toxic Substances Control Act, Marrapese said. EPA’s proposed rule was based on TSCA Section 8, which provides the agency a variety of authorities it can use to collect chemical data.

Expanded Exemptions?

Companies hope the final rule will expand the types of nanoscale materials exempted from it, Marrapese said.

Jennifer Sass, a senior scientist with the Natural Resources Defense Council, told Bloomberg BNA the council hopes the final rule reduces the proposed exemptions.

“We disagree with EPA’s proposal to exclude from the requirements of this rule nanoclays, zinc oxide, and chemical substances manufactured at the nanoscale as part of a film on a surface,” Sass and Elizabeth Crowe, co-director of an environmental justice organization called Coming Clean, told OMB in a Dec. 12 letter.

Lynn Bergeson, managing partner of Bergeson & Campbell, P.C. in Washington, D.C., told Bloomberg BNA she anticipates some of the more vigorously opposed provisions of the proposed rule may be scaled back or eliminated.

This includes the 135-day notification period, she said.

Legal Challenges to Come?

“The big question is, of course, what’s in the final rule?” Bergeson said.

Depending upon its scope, any number of entities could be expected to review it, and some may legally challenge it, she said. Nanoscale chemicals are processed by and used in a wide variety of products.

Marrapese said companies may sue if they conclude the agency exceeded its statutory authority.

Bergeson said, “None of these options is a sure thing, and stakeholders need to read the rule and be prepared to comply with it unless and until intervening circumstances dictate otherwise.”

Denison and Sass declined to comment on whether their organizations would consider suing the agency if they find the final regulation deficient.

Public Access to Data Sought

The Environmental Defense Fund is, however, prepared to ensure the agency’s information collection efforts are as robust and expeditious as possible and that the public is provided maximum access to risk-relevant information on nanoscale materials that are already in or are about to enter commerce, Denison said.

Sass said public access to the data EPA collects is critical. Nanoscale chemicals are used in so many products that it’s essential that consumers and manufacturers be able to evaluate them, she said.

“EPA’s rule is an important tool to gather relevant data on nanomaterials to inform hazard assessment, regulatory decisions, and industrial product design and development,” Sass wrote in a recent blog.

To contact the reporter on this story: Pat Rizzuto in Washington, D.C., at prizzuto@bna.com

To contact the editor responsible for this story: Larry Pearl at lpearl@bna.com

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