The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 15, 2019, announcing the availability of a signed action identifying chemical substances for inactive designation according to the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements rule. 84 Fed. Reg. 21772. The signed action, dated May 6, 2019, initiated a 90-day period after which substances identified as inactive will be designated as inactive. Inactive designations for chemical substances on the TSCA Chemical Substance Inventory are effective on Monday, August 5, 2019. Beginning August 5, 2019, manufacturers and processors will be required to notify EPA before reintroducing into commerce a substance currently identified as inactive on the TSCA Inventory. Manufacturers and processors can notify EPA via a Notice of Activity (NOA) Form B, found in EPA’s Central Data Exchange (CDX). Upon receiving such notification, EPA will change the designation of substances from inactive to active.
To help manufacturers and processors prepare for the inactive designations taking effect, EPA has posted materials about NOA Form B reporting. These materials include:
- TSCA Active-Inactive Webinar Slides from March 13, 2019; and
- TSCA Active-Inactive NOA Form B Questions and Answers (Q&A).
The webinar provided an overview of filing an NOA Form B and provided a demonstration of the electronic reporting application in CDX. The Q&A includes common questions related to the reporting requirements and the electronic reporting application.
Most companies have completed review of their supply chains to ensure that all substances manufactured, processed, or used for non-exempt TSCA purposes are listed on the TSCA Inventory as active. For these companies, the August 5 deadline simply adds an additional check when evaluating new substances for use in a supply chain. In the past, a company would have to ensure that a substance is listed on the TSCA Inventory and research whether any TSCA regulations apply (such as a Significant New Use Rule or test rule). Now, the search of the Inventory must also include a check to confirm the substance is listed with its commercial status as “active.”
Companies that are still seeking certification from suppliers that wish to maintain trade secrets related to the identity or presence of certain substances should maintain records of such efforts to be able to demonstrate to EPA that the company has performed its due diligence for ensuring that substances in its supply chain are listed on the Inventory as active.
If a company needs to change the status of a substance from inactive to active, all that is required is for the company to submit to EPA an NOA Form B prior to undertaking that commercial activity. Some reports have suggested that a Section 5 notice (e.g., a premanufacture notice) is required to reactivate the listing. This is not the case. Form B is very simple to prepare: it includes certain basic information, including the submitter’s name, the substance identity, whether the submitter seeks to maintain the substance identity as confidential if the substance is listed on the confidential portion of the Inventory, and the anticipated date of activity. There is no minimum time in advance that the Form B must be submitted, only that it must occur in advance of the activity. Conversely, there is a maximum time in advance that the Form B may be submitted: a company may not submit a Form B more than 90 days in advance of the anticipated commercial activity.
The active/inactive status of a substance does require a minor amount of additional effort in screening substances prior to introduction into a company’s supply chain, but “inactive” status should not be viewed as a significant barrier to commercial activity. As long as a company is aware of a substance’s inactive status, a Form B can be prepared and submitted in a matter of minutes and commercial activity can proceed forthwith.