In 2016, after decades without any changes, Congress amended the Toxic Substances Control Act (the “TSCA”) with an eye towards updating and modernizing the regulatory regime for chemical substances. One of the elements of the amendments was to require the Environmental Protection Agency (EPA) to update the TSCA Inventory, a list of all chemical substances that are manufactured, processed,1 or imported into the United States. Part of the update requirement was to identify which chemical substances are active in commerce or “commercialized.” In order to facilitate updating the TSCA Inventory, the EPA required manufacturers and importers to report those chemicals manufactured or imported into the United States for 10 years prior to June 21, 2016. The EPA also allowed processors of chemicals to report on the same lookback period. Submissions were due from parties in 2018, and the EPA used the submissions to prepare and publish the initial list of “active” chemical substances on February 19, 2019. The updated TSCA Inventory includes approximately 40,665 active chemical substances, as well as approximately 45,573 inactive chemical substances. These numbers include the approximately 7,757 active and approximately 10,463 inactive chemical substances designated as confidential business information and therefore not specifically identified on the publicly available TSCA Inventory.
The TSCA Inventory designations are significant because certain reporting requirements apply under the TSCA Inventory Notification (Active-Inactive) Rule once a chemical substance is listed as “inactive” on the TSCA Inventory. Under the Active-Inactive Rule, EPA publication of the initial TSCA Inventory triggered a 90-day review window of those chemicals listed as “inactive” chemical substances because identifications do not become effective or “designated” until 90 days after the inventory is published. This 90-day period allows industry time to respond to the new inactive designations, and gives industry 90 days to file a Notice of Activity Form B (“NOA Form B”)2 before the inactive chemical substance designation becomes final. Note that the TSCA Inventory only publishes nonconfidential chemical substances. If a manufacturer, importer or processor has reason to believe that a substance may have been reported as active, but may have been reported as confidential business information, it may ask the EPA to search the Confidential Inventory for a specific chemical substance by submitting a bona fide intent request (“BFI Request”).
The EPA’s February 19, 2019, publication of the initial Active TSCA Inventory is available through the EPA’s website here. This article originally noted that the 90-day clock for industry to submit an NOA Form B to continue manufacturing, processing or importing an initially listed inactive chemical substance began to run following the EPA’s informal February 19, 2019, publication of the initial Active TSCA Inventory and expired on May 20, 2019. However, on May 6, 2019, the EPA announced the “Availability of a Signed Action Identifying Chemical Substances for Inactive Designation” (the “Signed Action”).3 This Signed Action was a companion to the first version of the TSCA Inventory published on the EPA’s website on February 19, 2019, and made no changes to listings designated as active or inactive. The purpose of the Signed Action, dated May 6, 2019, and published in the Federal Register on May 15, 2019, was to formally initiate the 90-day period after which substances identified as inactive will be designated as inactive. As a result, industry now has until August 5, 2019, to submit an NOA Form B to continue manufacturing, processing or importing an initially listed inactive chemical substance.4
Therefore, if a company is currently manufacturing, importing or processing, or anticipates that before August 5, 2019, it will manufacture, import or process a chemical substance listed as inactive on the February 2019 initial TSCA Inventory, it must submit an NOA Form B to the EPA before August 5, 2019, in order to continue that activity without disruption. If a manufacturer, importer or processor waits until after August 5, 2019, it must stop the manufacturing, importing and processing of the designated inactive chemical substance until the NOA Form B is properly filed. Such forms are required to be filed with the EPA not more than 90 days prior to its planned manufacture, importation or processing.
The EPA has provided the following guidance as to when filing an NOA Form B would be required:
Information about how to prepare and submit the NOA Form B is available on the EPA’s website. In order to ensure that there is no disruption to manufacturing, processing or importing of a chemical substance, it is prudent to confirm that any chemical substances being, or expected to be, manufactured, processed or imported by August 5, 2019, are not listed as inactive. If they are, the appropriate filing of an NOA Form B prior to August 5, 2019, will prevent business disruption.
* This client alert is an update to our April 9, 2019, update on the same subject that has been revised to reflect EPA’s updated deadlines for the TSCA Active/Inactive list
1TSCA defines processing as: “the preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce (1) in the same form or physical state as, or in a different form or physical state from, that in which it was received by the person so preparing such substance or mixture, or (2) as part of a mixture or article containing the chemical substance or mixture.” 40 C.F.R. § 720.2(aa).
2The NOA Form B can found in EPA’s Central Data Exchange (“CDX”), available through: https://cdx.epa.gov/
4When filing the NOA Form B, industry may protect the chemical substance information as Confidential Business Information (“CBI”). However, this must be substantiated either at the time of the NOA Form B application, or within 30 days after application submittal. 40 C.F.R. § 710.37. Note that on April 26, 2019, the U.S. Court of Appeals for the District of Columbia Circuit ordered the EPA to address substantiation questions regarding reverse engineering applicable to persons claiming a specific chemical identity as CBI. This decision may be viewed here.