As a part of the amended Toxic Substances Control Act (TSCA), the U.S. Environmental Protection Agency (EPA) has the authority to charge fees to chemical manufacturers and importers for the risk evaluations of chemicals in commerce. In late 2019, EPA designated as final 20 high-priority chemicals which now move directly into the risk evaluation process. These chemicals are:
|Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester)||84-74-2|
|Butyl benzyl phthalate (BBP) - 1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester||85-68-7|
|Di-ethylhexyl phthalate (DEHP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester)||117-81-7|
|Di-isobutyl phthalate (DIBP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester)||84-69-5|
|4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA)||79-94-7|
|Tris(2-chloroethyl) phosphate (TCEP)||115-96-8|
|Phosphoric acid, triphenyl ester (TPP)||115-86-6|
|1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB)||1222-05-5|
You can view more information on the preliminary list here.
If your company imports or manufactures any of these chemicals, you will be responsible for a portion of the overall fee payment for the chemical. The total fee payment for an EPA-initiated risk evaluation is $1,350,000. The fee payment will be determined by the number of participating businesses and how many of those are small businesses. Small businesses will receive an 80% fee discount.
Comments are due on March 27, 2020. Prior to that date, companies have the opportunity to self-identify as a manufacturer/importer or to certify out from the fee payment if they have not imported/manufactured the product as of March 20, 2019, and agree not to import/manufacture the product for a period of five years.
This opportunity to certify out of fee payment is called “certification of cessation” in the final fees rule. The cutoff date for certifying out of fee payment is defined as the day prior to the initiation of the prioritization process for the chemical undergoing the risk evaluation. For the group of 20 chemicals at issue, prioritization was initiated March 21, 2019. In other words, those entities that can certify they ceased the manufacture/import activity as of March 20, 2019, and certify they won’t resume the manufacture/import activity for five years into the future can avoid paying the TSCA fees. EPA’s CDX system has been set up to facilitate this process.
Following the publication of the final list of manufacturers/importers, EPA expects to begin sending invoices in August 2020. Payments will be due in October 2020.
EPA has allowed for the creation of consortia to organize the payment of fees and respond to EPA throughout the risk evaluation process. NACD has no current plans to administer consortia for the 20 chemicals in question. The American Chemistry Council has established consortia for several of the chemicals. If you consider joining a consortium, be aware that consortia are not required to give small business members the 80% discount.
Simultaneous to the fee payment process, EPA will publish a draft and final scope of each chemical outlining the conditions of use that the agency will consider in the risk evaluation. The conditions of use for each chemical will inform the ultimate risk management actions the agency will require.
It’s critical that NACD members review the preliminary and final lists of manufacturers and importers to verify that they will be charged correctly. For more information on fees, please see NACD’s TSCA User Fees Regulatory Report.
Please contact Allison Tuszynski with questions.
Update: On March 25, 2020, EPA announced that it is considering a proposed rule looking at potential exemptions to the TSCA Fees Rule in response to stakeholder concerns about implementation challenges.
The agency is considering exemptions for importers of articles containing one of the twenty high-priority substances; producers of one of the twenty high-priority substances as a byproduct; and producers or importers of one of the twenty high-priority substances as an impurity. Due to the pending rulemaking, EPA is no longer expecting these three categories of “manufacturers” of one of the twenty high-priority substances to self-identify under the TSCA fees rule.