On January 13, 2017, the Environmental Protection Agency published a proposed rule to “reset” the TSCA Inventory, as required by the recent Lautenberg amendments to the Toxic Substances Control Act. Comments on the proposed rule must be submitted by March 14, 2017.
EPA is proposing the rule under TSCA Section 8(b), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act passed on June 22, 2016, which amended and modernized TSCA. The amended Section 8(b) requires EPA to designate chemicals on the TSCA Inventory as “active” or “inactive” chemicals. The “active” and “inactive” designations will allow EPA to focus and prioritize its regulatory scrutiny of existing chemicals.
The proposed rule closely aligns to the requirements of amended Section 8(b). In a retrospective review of manufacturing and importation of existing chemicals, manufacturers (including importers) will be required to notify EPA, using a specified form to be submitted electronically, of those chemical substances in the TSCA Inventory that have been manufactured or imported for non-exempt commercial purposes during the period June 21, 2006 through June 21, 2016. Processors also may submit such notifications.
Notified chemicals shall be designated as “active” chemicals on the TSCA Inventory. Those chemicals for which no notification has been received shall be designated as “inactive” chemicals. Substances added to the TSCA Inventory on or after June 22, 2016 are automatically designated as “active.”
Only “active” chemicals may be manufactured, imported or processed for non-exempt commercial purposes. Acknowledging that business operations may change and evolve over time, and consistent with amended Section 8(b), the proposed rule provides for forward-looking notifications by manufacturers, importers and processors, whereby “inactive” chemicals may become designated “active” chemicals. Put another way, manufacturers/importers will be prohibited from manufacturing or importing inactive chemicals for non-exempt commercial purposes unless they first notify EPA pursuant to the procedures established by the new rule. Similarly, processors will be prohibited from processing inactive chemicals for non-exempt commercial purposes without prior notification to EPA. Upon such notifications, EPA will designate such inactive chemicals as “active.”
Manufacturer and importers would be required to submit retrospective notifications no later than 180 days after the date the final rule is published; processors making the retrospective notifications would have 360 days. Forward-looking notifications would be required to be submitted not more than 30 days prior to the actual manufacture, import or processing. For both retrospective notifications and forward-looking notifications, records documenting the basis of the notifications would have to be maintained for five years. It is unclear, however, exactly what kind of documentation would be required to support a notification.
The proposed rule also allows notifying entities to submit claims of confidentiality to protect the submitted information from public disclosure. Entities would be required to substantiate those claims by responding to a list of questions probing the basis of the confidentiality claim, just like for submission of confidentiality claims under the Chemical Data Reporting Rule. EPA will strictly scrutinize claims of confidentiality for chemical identity information.
Under Lautenberg, EPA must finalize this Inventory “reset” rule by June 2017. Manufacturers, importers and importers should expect the finalized rule to look very similar to the proposed rule. Such entities also should be mindful of the deadlines for notifications as they plan their business operations, since failure to meet those deadlines could result in severe business disruption as well as potential TSCA violations. In particular, processors should be reaching out to their suppliers to understand whether those suppliers intend to submit the required notifications. Finally, as manufacturers and importers get ready to submit notifications, they should be aware that, as a collateral effect of this new requirement, preparing the required notifications may trigger the discovery of inadvertent violations of the Section 5 Pre-Manufacture Notice requirement — and they should be ready to deal with that as well.
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