Nanoscale Materials Data Collection Rule Guidance Coming

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By Pat Rizzuto

Draft EPA guidance to help companies making and processing nanoengineered chemicals understand how to comply with a final rule requiring them to submit existing production, use and other information will be issued for comment May 16, according to an advance copy of the Environmental Protection Agency notice.

The final rule (RIN:2070-AK39) is effective on Aug. 17 thanks to a three-month delay the agency announced in a May 12 Federal Register notice (82 Fed. Reg. 22,088). The rule applies to existing chemicals designed in the range of 1 to 100 nanometers to have special strength, electrical or other properties they would not have when made in larger dimensions. A nanometer is about the size of a virus.

BASF, the Dow Chemical Co., Dupont, NanoHorizons, Inc., Pyrograf Products, Inc. and Zyvex Technologies, Inc. are among the hundreds of companies that make or process nanoengineered chemicals. Such chemicals are used to make a wide variety of industrial and consumer products including specialized paints, memory chips, airplane parts, tennis rackets and solar panels. The forthcoming guidance and delay in the rule’s effective date are good news for companies that make and process nanoengineered chemicals, Martha Marrapese, a partner with Wiley Rein LLP’s Washington office, told Bloomberg BNA. Such companies needed help answering questions such as how much re-engineering of an existing nanoscale chemical would transform it into a new, nanoengineered substance subject to the rule’s data-collection requirements, said Marrapese, who also serves as general counsel for the Nanomanufacturing Association, which was among the groups that asked the EPA to delay the rule’s effective date until the implementation guidance was issued.

Companies have provided the EPA questions they hope its guidance will address, she said.

One aspect of the final rule, however, still may warrant repeal or further delay, Marrapese said.

Two Requirements

The rule requires companies making or processing nanoengineered chemicals to provide the EPA already known or reasonably attainable manufacturing methods, production volume, use, exposure, release, health and safety and other information. Companies don’t have to generate any new information to comply with the rule, which the EPA issued using the authorities of a data-collection provision—Section 8(a)—of the Toxic Substances Control Act.

The data will be collected in two ways, under the rule.

First, companies that have made or processed a discrete form of a nanoengineered chemical substance during the three years preceding the rule’s effective date—any time between Aug. 17, 2014 and Aug. 17, 2017—have a one-time reporting obligation. They have to submit known or readily available information to the EPA by Aug. 17, 2018.

Second, the rule has an ongoing reporting obligation. If a company in the future intends to make or process a new discrete, nanoengineered form of existing chemical, it must provide the agency the same types of information at least 135 days before manufacture or processing commences.

Delay May Lead to Repeal

Richard Denison, lead senior scientist with the Environmental Defense Fund, described the final rule’s delay as “an annoying addition to the ridiculously long time course for this rule.” The group has urged the EPA to regulate nanoengineered chemicals for more than 10 years.

“Some in industry are seeking a wholesale repeal [of the rule],” Denison said. “It remains to be seen whether this delay is part of a strategy to allow those industry voices time to prevail.”

He described the EPA’s rationale for not proposing and taking comment about a possible delay as “pathetic.” The agency waited until the week before the final rule was scheduled to go into effect to delay the regulation and then claimed it didn’t have time to allow for public notice and comment about the delay, Denison said.

“This is an increasingly common tactic under this administration,” he said, adding that the tactic undermines public trust.

Guidance’s Effectiveness Critical

Lynn Bergeson managing partner of Bergeson & Campbell, P.C. told Bloomberg BNA the EPA’s decision to delay the rule’s effective date until after it issues the draft guidance mutes the complaint that companies wouldn’t know how to comply. It doesn’t mean, however, that the guidance will be sufficient to answer companies’ questions, she said by email.

“Whether the guidance that has yet to be issued provides the requisite level of detail to facilitate effective reporting remains to be seen,” she said.

If the guidance is inadequate, flawed or still confusing when issued as final, some parties may argue the rule needs further to be further delayed or suspended indefinitely, Bergeson said. “But that is by no means clear.”

“It does up the stakes for EPA to prepare and issue final guidance that silences concerns raised by many, many detractors, which is a tall order,” Bergeson said.

Marrapese said the Nanomanufacturing Association hopes the administration will still consider repealing or delay the ongoing reporting obligation to provide information for nanoengineered chemicals companies may make or work with in the future, until it has evaluated the value of the information it will receive from the one-time reports due in 2018.

Not a Broader Signal

Christopher Bell, an attorney with the Washington, D.C. office of Greenberg Traurig, LLP, said EPA’s decision to delay the effective date of the nanoengineered chemicals rule shouldn’t be seen as a signal the agency’s approach to overseeing these or other chemicals has changed.

The new administration has said it will stop, look and listen before proceeding with rules, and it is doing so, Bell said.

The delay slightly slows down a data-gathering process that wasn’t going to produce results in the near term anyhow, he said.

The agency’s decision on this rule doesn’t offer any insight into how the agency may address three final rules it is crafting to restrict the uses of certain solvents, Bell said.

The solvent restriction rules raise very different questions about how the EPA and the Occupational Safety and Health Administration will jointly oversee worker safety, he added.

To contact the reporter on this story: Pat Rizzuto in Washington at

To contact the editor responsible for this story: Paul Connolly at

For More Information

A prepublication copy of the EPA's draft guidance notice is available at

EPA's notice delaying the data collection rule is available at .

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