EPA has begun promulgating regulations to implement the Frank R. Lautenberg Chemical Safety for the 21st Century Act of 2016 (Act), legislation that makes significant changes to the Toxic Substance Control Act (TSCA). EPA recently finalized regulations requiring covered manufacturers, importers, and processors to notify EPA over the next six to 14 months regarding whether registered chemicals are “active” (currently being manufactured or processed) or “inactive” (no longer being manufactured or processed).
TSCA Chemical Registration
Pursuant to Section 5 of TSCA, a company may not manufacture or import a chemical for commercial purposes unless the chemical is listed on the TSCA Chemical Substance Inventory. There are a number of exceptions to the registration requirement, such as chemicals that are mixtures, are polymers, or are manufactured in small quantities for R&D purposes. Some of the exceptions are subject to notification and risk assessment requirements.
Over the years, the TSCA Inventory has become clogged with chemicals registered, but never used. “This rule will enable EPA to… designate chemical substances on the [TSCA] Inventory as active or inactive in U.S. Commerce.” 82 Fed. Reg. at 37522. The designation of a substance as active or inactive is relevant to EPA’s prioritization of substances for risk evaluations under the Act. A substance posing an unacceptable risk may be banned from use after risk evaluations are complete.
Notification Requirements
Certain “manufacturers” and “processors” of chemical substances listed on the TSCA Inventory that are distributed in commerce in the United States are covered by the rule. The term “manufacturer” includes importers, so a company that imports chemicals for distribution or use may be subject to the rule. The phrase “process for commercial purposes” means to prepare any amount of chemical substance “for the purpose of obtaining immediate or eventual commercial advantage” and includes mixtures and impurities. Therefore, most manufacturers and distributors will be required to file a notification.
Manufacturing or processing a chemical listed on the TSCA Inventory solely for an exempt commercial purpose is not subject to the rule. The list of exempt activities includes manufacturing or processing of:
Where an “equivalent notice” has been provided to EPA, notification under the rule is not required. Such prior notice may have been received as part of the interim list of active substances, chemical substances for which TSCA registration by Notice of Commencement occurred after June 21, 2006, but before June 21, 2016, and those for which notification is made by another manufacturer.
The notification requirements are straight-forward. A covered facility must notify EPA of the activity and use of each chemical substance manufactured, imported, or processed at the facility. Retrospective reporting applies to chemical substances listed on the TSCA Inventory and manufactured during the 10-year period ending on June 21, 2016. This 10-year period is referred to as the “look-back period” in the Act. If a chemical substance has not been manufactured, imported, or processed during the look-back period, the facility need not file an applicable form, but further use of that chemical substance is prohibited without a forward-looking Form B submission.
EPA developed two versions of forms to be filed: Notice of Activity Form A and Notice of Activity Form B. Form A is to be used by those facilities reporting retrospective chemical activity, while Form B is to be used by those wishing to “reintroduce into… commerce” an inactive substance.
Information required under Form A must be reported electronically and include the following for each reportable chemical:
Co-manufacturers and co-processors should determine among themselves which entry complies with the rule, but both remain liable if a notification required under the regulation is not submitted.
Notification Deadlines
Deadlines for filing the electronic Form A and Form B differ for the type of manufacturer or processor involved. Each timeframe for reporting is discussed below based on the type of operation.
Form A notification of retrospective use of a chemical substance must be filed during the applicable submission period. Manufacturers and importers must file between August 11, 2017, and February 7, 2018. Processors are subject to a submission period commencing August 11, 2017, and ending October 5, 2018, which provides time for the processor to determine whether a Form A notification was filed by the manufacturer.
Notification triggered by Form B (re-activation of an inactive substance) must be submitted at least 90 days prior to manufacturing or processing the inactive substance.
Electronic Filing
EPA restricts Form A and Form B notifications to electronic filing though EPA’s CDX system: https://cdx.epa.gov or 1-888-890-1995 (Help Desk). Confidentiality claims are made through the electronic filing process, but will require that certain substantiation questions be completed.
Conclusion and Recommended Action
Companies manufacturing, importing, or processing a TSCA chemical must file a Form A for that substance by February 7, 2018, or cease manufacturing, importing or processing that chemical and file a Form B 90 days prior to future use. The filing must be in EPA’s CDX system.
To comply with the new notification program, it is recommended that each manufacturer, importer and processor of a TSCA chemical undertake the following steps to comply with the regulation:
82 Fed. Reg. 37520 (August 11, 2017).