TSA Chemical Review
All nine chemicals to be tested received their test orders effective January 19, 2021
Background
The orders mark the second time the EPA has used this authority, added to TSCA by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), to inform the TSCA risk evaluation process. The EPA first used its Section 4 testing authority for C.I. Pigment Violet 29 (PV29). After the agency received additional data on PV29 in response to testing, it issued a revised draft risk evaluation. The new data led the EPA to change its analytical approach for evaluating the potential exposure and health effects of PV29.
Discussion
The EPA is continuing to employ its new test order authority to fill gaps in data, as Congress envisioned. Its most recent orders obligate testing for effects on soil- and sediment-dwelling terrestrial and aquatic invertebrates for a number of the nine substances. Such tests are commonly required for higher-tonnage substances manufactured in the European Union and China, so data already may be available.
In addition to the ecotoxicity testing, the test orders require in vitro skin absorption in all nine substances along with workplace monitoring testing. The orders include facility-specific workplace inhalation monitoring and dermal hand wipe sampling. The skin absorption and hand wipe sampling will give the EPA a clearer picture of dermal exposures in the workplace and the potential for risk to workers. The inhalation monitoring testing will provide a clearer picture of inhalation exposures than EPA’s standard models.
Companies subject to testing may provide existing data that satisfy the request or conduct the tests. They may also form consortia to consolidate costs and burden and to avoid unnecessary duplicate testing. The manufacturers and importers covered by the test orders must also pay a fee associated with the submission of information. The total fee for each order, expected to be allocated among those manufacturers and importers covered, is $9,800 ($1,950 if only “small business concerns” are covered). Although processors can be covered by TSCA test orders, under the TSCA Fees Rule, they are not subject to fees for submitting information under test orders — unless it is in association with submitting a required TSCA significant new use notification. The applicable fee is due no later than 120 days after the effective date of the order.
Subjected companies must, within 45 calendar days of the effective date of the order, respond through the EPA’s Central Data Exchange (CDX) portal and select one of five options to comply with the order. Those options are: develop the information required under the order; submit existing information; request an exemption; claim you are not subject to the order; or cease the manufacture and/or processing of the chemical.
Companies should expect such test orders to become routine as the agency works its way through the remaining chemicals and the rest of the existing chemicals listed as active on the TSCA Inventory. The new EPA Administration can be expected to issue far more testing orders in the next four years than in the preceding four years. Manufacturers and processors will need to engage with the EPA regarding data gaps and how to best fill those gaps — whether that is through testing or read-across from related substances.
