Chemicals, Regulatory Developments

EPA Publishes New TSCA Data Reporting Regulation

On June 29, 2021, the EPA published a final rule under the Toxic Substances Control Act (TSCA) and the TSCA Health and Safety Data reporting rule, requiring manufacturers (including importers) of 50 specified chemical substances to report certain lists and copies of unpublished health and safety studies to the EPA.

“Section 8(d) of the Toxic Substances Control Act (TSCA) had been effectively a dead provision of TSCA for over a decade,” according to a Lexology article by Beveridge & Diamond. “EPA has just revived it by adopting an immediate final rule mandating the submission of health and safety studies on 50 chemical substances by September 27, 2021. The rule applies to chemical manufacturers (and importers) of the 50 substances, as well as petroleum refiners. The 50 substances are the 20 High-Priority Substances for which EPA is conducting risk evaluations and 30 organohalogen flame retardants for which [the Consumer Product Safety Commission (CPSC)] has requested testing.”

The EPA has not added a Section 8(d) rule since it added lead in children’s products in 2008, meaning impacted industry may not be familiar with the requirements of Section 8(d). Those impacted are advised to closely review 8(d) regulations in 40 CFR 716, along with the new final rule, according to Beveridge & Diamond.

The main points for industry about the new rule are:

  • “The rule applies only to chemical manufacturers and petroleum refiners (i.e., entities covered by NAICS codes 325 and 324110). Companies in other industries are not covered by the rule.
  • The rule applies to former manufacturers in the affected NAICS codes who ceased manufacture of a listed substance since July 27, 2011.
  • The rule has no exemption for articles, byproducts, impurities, test marketing, or R&D, and it has no de minimis threshold.
  • Persons subject to the rule must conduct an ‘adequate’ file search, then submit both copies of all unpublished studies on the 50 substances in their possession and lists of such studies.
  • The required studies include monitoring data that have been aggregated and analyzed, as well as specified toxicology and ecotoxicology studies.
  • Reporting is due by September 27, 2021. Requests for extensions must be submitted by September 5, 2021.
  • All submissions must be made through the CISS tool on CDX.” (For more information, see the EPA website on TSCA electronic reporting.)

The regulations under 40 CFR 716 provide the EPA with the authority to issue immediate final rules requiring manufacturers to submit studies and lists for substances added to the Priority Testing List by the Interagency Testing Committee (ITC). The ITC report, published by the EPA in April 2021, marks the first time since 2012 substances have been added to the Priority Testing List, Beveridge & Diamond says.

In addition to published studies, the regulations state that manufacturers and importers of the listed substances must submit the following, as applicable to the listed substances:

  • Lists and copies of unpublished health and safety studies for all high-priority substances identified by the rule;
  • All unpublished studies on environmental effects, environmental fate, and physical-chemical properties, if performed, as described in 40 CFR 716.50;
  • All unpublished studies on occupational (both users and nonusers), general population, consumer, and environmental exposure;
  • Studies showing any measurable content of the high-priority substance in the tested substance; and
  • Studies previously submitted to the EPA under TSCA.

For more specifics on reporting requirements under TSCA Section 8(d), see the EPA Health Safety Data Reporting User Guide.