REGULATORY MEMORANDUM

EPA Issues TSCA Section 4 Test Orders for Nine Chemicals Undergoing Risk Evaluation

The U.S. Environmental Protection Agency (EPA) announced on January 15, 2021, that it has issued test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on nine of the next 20 chemicals undergoing risk evaluation. EPA states that after reviewing the available data on these chemicals, it needs additional data and is using its TSCA test order authority to require companies to develop and submit information on environmental hazard and inhalation and dermal exposures for workers. According to EPA, companies subject to the test orders may provide EPA with existing data or conduct new tests. Companies may also form consortia to consolidate costs and burden and to avoid unnecessary duplication of testing.

EPA notes that this action marks the second time it 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. According to EPA, the test orders “are the result of a lengthy Agency analytical process to identify the data needed to evaluate these nine chemicals. The information obtained through these orders will help ensure EPA’s risk evaluations for these chemicals are robust, credible, and use the best available data.” EPA first used its TSCA Section 4 testing authority for C.I. Pigment Violet 29 (PV29). After EPA received additional data on PV29 in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer, it issued a revised draft risk evaluation. According to EPA, these new data led it to revise its analytical approach for evaluating the potential exposure and health effects of PV29.

EPA has created a web page listing chemicals subject to TSCA Section 4 test orders. The nine chemicals are:

Chemical Name Docket Number Test Order and Effective Date Testing Required
1,1,2-Trichloroethane EPA-HQ-OPPT-2018-0421 January 19, 2021 Environmental Hazard Testing (OECD 233), and facility-specific Occupational Exposure Testing (NIOSH Method 1003; OECD 428; Dermal Hand Wipe Sampling)
1,1-Dichloroethane EPA-HQ-OPPT-2018-0426 January 19, 2021 Environmental Hazard Testing (OECD 233), and facility-specific Occupational Exposure Testing (NIOSH Method 1003; OECD 428; Dermal Hand Wipe Sampling)
1,2-Dichloroethane EPA-HQ-OPPT-2018-0427 January 19, 2021 Facility-specific Occupational Exposure Testing (NIOSH Method 1003; OECD 428; Dermal Hand Wipe Sampling)
1,2-Dichloropropane EPA-HQ-OPPT-2018-0428 January 19, 2021 Environmental Hazard Testing (OECD 233), and facility-specific Occupational Exposure Testing (NIOSH Method 1003; OECD 428; Dermal Hand Wipe Sampling)
4,4’-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA) EPA-HQ-OPPT-2018-0462 January 19, 2021 Environmental Hazard Testing (OCSPP 850.4400; OECD 225; OECD 233), and facility-specific Occupational Exposure Testing (Inhalation Monitoring; Dermal Hand Wipe Sampling; OECD 428)
o-Dichlorobenzene EPA-HQ-OPPT-2018-0444 January 19, 2021 Environmental Hazard Testing (OPPTS 850.1735; OECD 233) and facility-specific Occupational Exposure Testing (NIOSH Method 1003; OECD 428; Dermal Hand Wipe Sampling)
p-Dichlorobenzene EPA-HQ-OPPT-2018-0446 January 19, 2021 Environmental Hazard Testing (OPPTS 850.1735; OECD 233), and facility-specific Occupational Exposure Testing (NIOSH Method 1003; OECD 428; Dermal Hand Wipe Sampling)
Phosphoric acid, Triphenyl Ester (TPP) EPA-HQ-OPPT-2018-0458 January 19, 2021 Environmental Hazard Testing (OCSPP 850.4400; OCSPP 850.4500; OECD 225; OECD 233; OECD 222), and facility-specific Occupational Exposure Testing (Inhalation Monitoring; Dermal Hand Wipe Sampling; OECD 428)
trans-1,2-Dichloroethylene EPA-HQ-OPPT-2018-0465 January 19, 2021 Facility-specific Occupational Exposure Testing (NIOSH Method 1003; OECD 428; Dermal Hand Wipe Sampling)

EPA states that the orders and any data submitted in response to the orders will be made publicly available on EPA’s website and in applicable dockets on www.regulations.gov.

Commentary

EPA is continuing to employ its new test order authority to fill gaps in data that EPA has identified as necessary for the risk evaluations for the “next 20” substances undergoing risk evaluation under TSCA. EPA’s 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 may already be available. EPA is also requiring testing for TPP on aquatic plant species.

In addition to the ecotoxicity testing, the test orders require in vitro skin absorption in all nine substances along with workplace monitoring testing. The test orders include facility-specific workplace inhalation monitoring and dermal hand wipe sampling. The skin absorption and hand wipe sampling will give EPA a much better picture of dermal exposures in the workplace and the potential for risk to workers from dermal exposures. The inhalation monitoring testing will provide a clearer picture of inhalation exposures than EPA’s standard models.

The test order recipients are certain manufacturers (including importers) and processors of the nine substances. As stated by EPA in Enclosure D to the orders, all manufacturers and importers included on the “Final Lists of Manufacturers Subject to Fees for the 20 High Priority Substances Undergoing TSCA Risk Evaluations” (final lists) are among the recipients of the orders. Certain manufacturers and importers were excused from the obligation to pay fees associated with the EPA-initiated risk evaluations for the 20 high-priority substances undergoing risk evaluation (including the nine substances covered by the subject orders) and are thus, in general, not on the final lists. These companies were excused from the obligation to pay fees where their manufacturing or importing activities fell solely within one or more classes of companies excluded by EPA from the obligation to pay fees as described in EPA’s “No Action Assurance” (i.e., companies that produce a covered substance as a byproduct, produce or import the substance as an impurity, or import the substance as part of an article) or import a substance in small quantities for research and development. See 85 Fed. Reg. 55283, 55285 (Sept. 4, 2020). Additionally, according to EPA, test order recipients include companies that reported as “processors” of the substances to the 2019 Toxics Release Inventory before September 1, 2020, unless they reported as processing the substance only as an impurity.

Companies subject to the test orders may provide EPA with existing data that satisfy the data needs or conduct the tests required under the orders. Companies may also form consortia to consolidate costs and burden and to avoid unnecessary duplication of testing. The manufacturers and importers covered by the test orders must also pay a fee associated with the submission of information. The total fee associated with 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, and certain of them are are for the subject orders as described above, under the TSCA Fees Rule, they are not subject to fee payment for the submission of information under test orders -- unless it is in association with the submission of a significant new use notification required under a TSCA significant new use rule. The applicable fee is due no later than 120 days after the effective date of the order. See 40 C.F.R. § 700.45.

Companies covered by an order must, within 45 calendar days of the effective date of the order, respond to the order through EPA’s CDX portal informing the Agency which of five options it has chosen 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. These options are described more fully in Part IV of each order.

Companies should expect such test orders to become routine as EPA works its way through the remaining Work Plan chemicals and the rest of the existing chemicals listed as active on the TSCA Inventory. Manufacturers and processors will need to be sure to engage with EPA regarding data gaps and how to best fill those gaps -- whether that is through testing or read-across from related substances.

 
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