The EPA has published preliminary lists of manufacturers (including importers) that will need to pay fees to defray the costs of risk evaluations the Agency must perform on 20 substances that have been designated high priorities under Section 6 of the Toxic Substances Control Act (TSCA). Each of the 20 high-priority substances has been matched with a preliminary list of manufacturers of that substance.
The Agency says it developed each preliminary list using the “most up-to-date information available, including information submitted to the Agency (e.g., information submitted under TSCA section 8(a) (including the Chemical Data Reporting (CDR) Rule) and section 8(b), and to the Toxics Release Inventory (TRI)).” Withing 60 days following publication of the fee notice, manufacturers that are not on the list must self-identify to the EPA that they manufacture a high-priority substance irrespective of whether they are included on a preliminary list. In addition, entities may certify that they do not manufacture or have ceased manufacture of a high-priority substance.
The EPA expects to publish final lists of manufacturers subject to fees no later than concurrently with the publication of the final scope document for risk evaluations of the 20 high-priority substances.
The 2016 amendments to TSCA authorize the EPA to establish fees to defray a portion of the costs of administering TSCA Sections 4, 5, and 6 and collecting, processing, reviewing, providing access to, and protecting information about chemical substances from disclosure as appropriate under TSCA Section 14. The EPA established eight distinct fee categories: (1) test orders, (2) test rules, and (3) enforceable consent agreements—all under TSCA Section 4; (4) notices and (5) exemptions, both under TSCA Section 5; and (6) EPA-initiated risk evaluations, (7) manufacturer-requested risk evaluations for chemicals on the TSCA Work Plan, and (8) manufacturer-requested risk evaluations for chemicals not on the TSCA Work Plan—all under TSCA Section 6.
The EPA has estimated the annual Agency costs of carrying out TSCA Sections 4, 5, and 6 and of collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under TSCA Section 14 information on chemical substances under TSCA at $80.2 million per year for 2019, 2020, and 2021. Based on the mandatory 25% cap on cost recovery, the Agency also anticipates collecting approximately $20 million annually in fees not associated with manufacturer-requested risk evaluations. Specifically, for EPA-initiated risk evaluations for each high-priority substance, the total fee has been set at $1,350,000.
Payment of fees is due within 120 days following the publication of the final scope of a chemical risk evaluation. Manufacturers may form a consortium to pay fees. The consortium must notify the EPA that a consortium has formed within 60 days of the publication of the final scope of a risk evaluation. Once established, the consortium would determine how the fee would be split among the members and ultimately paid to the Agency.
Entities will have the opportunity to certify as to whether they meet the definition of a small business concern as defined in the fees rule and qualify for a reduced fee amount. Under the fee rule, an entity in any of 33 industry sectors is considered a small business concern if the entity has fewer than a specific number of employees for its sector. For example, a petroleum refinery qualifies as a small business concern if it has 1,500 employees or fewer; an ethyl alcohol manufacturer is a small business concern if it has 1,000 employees or fewer.
Manufacturers on the preliminary lists have an opportunity to certify through the Agency’s Central Data Exchange (CDX) that:
- They have already ceased manufacturing before the defined cutoff dates and will not manufacture (including import) for 5 years; or
- They have not manufactured the chemical substance in the 5-year period preceding the publication of the preliminary lists.
For the current group of 20 chemicals, the cutoff date for ceasing manufacture or import of a chemical substance is March 20, 2019, which is the day before initiation of the prioritization process for the applicable designated high-priority substance. If the EPA receives such a certification statement from a manufacturer, then the manufacturer will not be obligated to pay the fee.
The preliminary lists are available at https://www.regulations.gov in docket EPA–HQ–OPPT–2019–0677. Each list is provided in two formats: a searchable Excel file and in two PDF files—the first file presenting manufacturers in parent company name order and the second file presenting manufacturers in parent company Dun & Bradstreet Number order. Instructions for using the searchable Excel file are presented in the READ ME FIRST tab. Instructions for accessing the TSCA Section 6 User Fees application through CDX are also provided in the READ ME FIRST tab and at the top of the PDF files.