One of the hallmarks of the 2016 United States TSCA reform bill was the creation of a risk evaluation process for certain chemical substances.  To implement this risk evaluation process, EPA promulgated regulations regarding the prioritization of chemical substances and conduct of risk evaluations, which includes self-identification by companies and cost sharing for the risk evaluations. 

In December of 2019, EPA announced a list of twenty high-priority substances that would undergo risk evaluation (for easy reference, the list is copied below that is organized by types of substance and common applications).  Companies that manufacture these high-priority substances in the United States or import them into the United States, even as part of an article, are required to self-identify to the EPA by May 27, 2020, and will be required to share in the estimated $1,350,000 cost of the risk evaluation.  We previously circulated information on the process and the high-priority substance listing in this client alert.   

EPA Intends to Exempt Certain Classes of Manufacturers and Importers

On March 25, 2020, EPA announced that it intends to propose exemptions from the self-identification requirement for three classes of manufacturers and importers: (1) importers of articles containing one of the twenty high-priority substances; (2) producers of one of the twenty high-priority substances as a byproduct; and (3) producers or importers of one of the twenty high-priority substances as an impurity.  This would have the effect of exemption a large numbers of manufacturers and importers from the self-identification and risk evaluation process. 

EPA has indicated that they will propose the amendments later this year, with the intent of finalizing them in 2021. Typically, this would mean that unless and until EPA finalized the rules, these three classes of manufacturers/importers would still be subject to the self-identification and fee requirements. And, since the self-identification deadline falls before EPA has indicated an intent to finalize the regulatory amendments, these three classes of manufacturers/importers would still be required to self-identify. However, to address this gap associated with the rulemaking timeline, EPA’s Office of Enforcement and Compliance Assurance also announced a “No Action Assurance.” In this assurance, OECA indicated that it would exercise enforcement discretion regarding the self-identification obligation and not enforce the rule against the three classes of importers and manufacturers.  This “No Action Assurance” provides these manufacturers and importers the comfort they need to not self-identify by May 27, 2020, while EPA modifies the rules to more clearly exempt them from the risk evaluation process. 

What Do I Need To Do Now?

• If you believe that your company falls within the relevant three classes of importers and manufacturers for a high-priority substance, we recommend that you document for your internal file that your manufacturing or import falls within one of the three classes.
• If you were on EPA’s preliminary list of subject manufacturers and importers but fall into one of these three categories, you still need to certify in EPA’s CDX software that you are in one of the three exempt classes by May 27, 2020.
• If you already self-identified but fall into one of these three categories, you need to go into EPA’s CDX system and modify your response prior to May 27, 2020.
• The No Action Assurance and forthcoming regulatory exemptions will be specific to each high-priority substance.  So, if you fall within the three categories for high-priority substance X but not for high-priority substance Y, you will still need to self-identify and participate in the risk evaluation process for high-priority substance Y.

December 2019 List of Twenty TSCA High-Priority Substances

1)  Formaldehyde (commonly used in building products, pressed wood products, fabrics, insulation materials, paper product coatings, and as a preservative);

2 – 6)  BBP, DBP, DEHP, DIBP, and DCHP (phthalates or plasticizers in products such as roofing membranes, children’s toys such as rubber ducks, food packaging, cosmetics, and medical devices);

7)  Phthalic anhydride (a chemical used to make phthalates); 

8 – 10) TBBPA, TPP, and TCEP (halogenated flame retardants); 

11)  Ethylene dibromide (additive in leaded gasoline, insect extermination, nonflammable solvent for dyes, resins, gums, and waxes);

12)  HHCB, also known as Galaxolide (additive in perfumes, cosmetics, detergents and fabric softeners, air fresheners);

13 – 19) Certain chlorinated solvents (used in plastic and vinyl products, degreasers, insecticide sprays, cleaning solutions, paint thinners, and glues); and 

20)  1,3-Butadiene (used in synthetic rubber/ plastics and acrylics).

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