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.
EPA released on June 1 the “problem formulation” documents for the first 10 chemicals for which risk evaluations are being conducted under the amended Toxic Substances Control Act (TSCA). (See: https://www.epa.gov/newsreleases/epa-takes-three-important-steps-ensure-chemical-safety-under-lautenberg-act-proposes.) The documents describe the chemical use and exposure scenarios that the agency expects to examine, as well as the hazards, exposures, conditions of use, and exposed populations (e.g., workers, consumers, bystanders) that will be considered as EPA conducts the risk evaluations. Companies that manufacture or use products containing these chemicals should review the scoping documents and assess whether the use and exposure scenarios identified by EPA are accurate with respect to the products that they make or utilize in their production processes. EPA is taking comments for 45 days upon publication in the Federal Register.
For example, the scoping documents rely in part on 2012 and 2016 Chemical Data Reporting to identify potential consumer or commercial exposures for various uses of a chemical that may be outdated or which may have been phased out. If so, companies may wish to submit comments to EPA clarifying the nature and extent (or lack) of exposure to the chemical of interest. Such comments could help avoid any inappropriate or misleading associations of risk that could result from the EPA evaluation.
The 10 chemicals, for which risk evaluations must be completed by December 2019, are: Asbestos, 1-Bromopropane, Carbon Tetrachloride, 1,4-Dioxane, Cyclic Aliphatic Bromide Cluster (HBCD), Methylene Chloride, n-Methylpyrrolidone (NMP), Perchloroethylene, C.I. Pigment Violet 29, and Trichloroethylene (TCE).
As part of the continuing implementation of the 2016 amendments to the Toxic Substances Control Act (TSCA), EPA is moving rapidly to complete designation of chemicals in commerce that are considered “active.” This “Reset” effort is a first step in helping the agency pare down the thousands of chemicals listed on the TSCA Inventory and identify a subset for possible evaluation under the new chemical prioritization and risk evaluation requirements.
While seemingly mundane, this is important stuff: chemicals that are classified as “inactive” will not be able to be manufactured or imported into the U.S. without going through EPA’s pre-manufacture notice (PMN) and review process. PMN is something to avoid, particularly after the 2016 amendments shifted the burden of proof to require that EPA now make an affirmative finding that the substance does not pose an unreasonable risk to health or the environment before allowing it on the market.
On April 12, EPA released an updated public version of the TSCA Chemical Substance Inventory, which for the first time includes the “active” designations. The updated Inventory can be accessed here. (https://www.epa.gov/tsca-inventory/how-access-tsca-inventory) . The agency also released an updated list of substances reported as “active” during the current notification process pursuant to the “TSCA Inventory Notification (Active-Inactive) Rule.” (https://www.epa.gov/tsca-inventory/list-substances-reported-under-tsca-inventory-notification-active-inactive-rule). Under this program, manufacturers (including importers) were to notify EPA by February 7, 2018, of substances they currently manufacture or import, and which therefore should be deemed “active.” Fortunately, EPA also exempted from reporting, and automatically identified as “active,” substances reported under the 2012 and 2016 Chemical Data Reporting rule periods (as well as naturally occurring substances). So long as a substance is either notified to EPA by at least one company or considered exempt from reporting, then the substance is classified as “active.” At latest report, approximately 35,000 substances, or about half of the chemicals on the current TSCA Inventory, are listed as “active.”
“Processors” of chemicals – in essence, companies that use chemicals or incorporate them into their products – are now eligible to notify EPA by October 5, 2018, of any substances that have yet to be designated as “active” but which they currently use. Companies should compare their internal list of chemicals they manufacture or use with the EPA exempt list and the newly released list of already notified chemicals. If a chemical does not appear on those lists, the company should notify EPA.