A first-ever federal nanoscale chemical rule will require manufacturers and companies that import or process nanomaterials, now and in the future, to report certain information to the EPA.
These substances are nano-sized versions of chemicals and are now subject to EPA regulation under the Toxic Substances Control Act.
The rule, finalized yesterday, defines reportable chemical substances as those that are:
- solids at 25 degrees Celsius at standard atmospheric pressure;
- manufactured or processed in a form where any particles, including aggregates and agglomerates, are between 1 and 100 nanometers (nm) in at least one dimension; and
- manufactured or processed to exhibit one or more unique and novel property.
The rule does not apply to chemical substances manufactured or processed in forms that contain less than 1 percent by weight of any particles between 1 and 100nm.
It also imposes one-time reporting and recordkeeping requirements on nanoscale chemical substances. It requires companies to notify the EPA of:
- specific chemical identity;
- production volume;
- methods of manufacture; processing, use, exposure, and release information; and,
- available health and safety data.
Companies also must keep records of this information for three years.
The agency says it will use the information gathered to determine if any further action under the Toxic Substances Control Act, including additional information collection, is needed. It expects the new rule to cost companies about $27.79 million in total in the first year and $3.09 million in subsequent years, requiring about 360,000 in the first year and 40,100 hours thereafter. The agency notes that this is a conservative estimate.
Attorney James Votaw, an environmental partner at Manatt, Phelps & Phillips, said the final rule, six years in the making, is controversial because the EPA’ s 2015 proposal was criticized by industry as being too broad in its coverage and stigmatizing nanoscale materials.
“Industry asked EPA to reopen the dialog on the proposal to resolve these and other issues,” Votaw said in an email. “EPA declined. The final rule addresses some of those concerns, but has created new ones, in part because EPA has included wholly new terms in the final rule that were not subject to prior public review and comment and which in some cases are flawed or unworkable and which may be the basis for legal challenges.”