A new framework of fees to cover the costs of implementing the provisions of the 2016 amendments to the Toxic Substances Control Act (TSCA) will go into effect October 1st, under a final rule issued yesterday by EPA. The fees are designed to collect $20 million annually from chemical manufacturers, importers, and processors, or about 25% of the expected agency costs of implementing the new mandates of TSCA, including chemical prioritization and risk evaluation tasks, as well as review of toxicity and exposure data submitted under an EPA test order.
These fees are intended to achieve the goals articulated by Congress by providing a sustainable source of funds for EPA to fulfill its legal obligations to conduct activities such as designating applicable substances as High- and Low-Priority, conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, requiring testing of chemical substances and mixtures, and evaluating and reviewing new chemical submissions, as required under TSCA sections 4, 5 and 6, as well as and collecting, processing, reviewing, and providing access to and protecting information about chemical substances from disclosure as appropriate under TSCA section 14.
Examples of some of the fees manufacturers (and sometimes processors) would pay include:
• $1.3 million for agency-initiated chemical risk evaluations;
• $2.5 million for manufacturer-requested risk evaluations for chemicals not on EPA’s 2014 TSCA Work Plan list, and $1.25 million for chemicals on the list;
• Between $9,800 and $22,800 for EPA review of toxicity, exposure, and other information companies submit in response to an EPA order, regulation, or negotiated agreement;
• $16,000 for EPA review of new chemicals (or certain new uses).
The final rule largely adopts the user fee program as proposed in February, with certain modifications to the procedures for identifying manufacturers subject to the fees, the fee calculation for chemical reviews requested by manufacturers (which are substantially higher than the fees for agency-initiated reviews), and the standard for identifying “small businesses” subject to fee reductions of approximately 80%.
The fee rule is the fourth and final of EPA’s “framework rules” for implementing the 2016 TSCA amendments. The first three rules addressed chemical prioritization for risk assessment; the process for conducting risk evaluation; and update of the TSCA existing chemical inventory.