The June 2016 Lautenberg amendments to the Toxic Substances Control Act (TSCA) required EPA to improve the TSCA Inventory by identifying which "chemical substances" are actively in commerce in the United States, allowing the agency to better prioritize its chemical safety research. This has been implemented by performing an "inventory reset" that assigned an Active or Inactive status to every substance already on the Inventory.
Those that were known to the agency to be actively in commerce were automatically set to Active status. This included all substances in Chemical Data Reporting (CDR) submissions from 2006 to 2016, as well as all substances which were added to the TSCA Inventory during the lookback period. Substances could also be set to Active status by submitting special one-time Notice of Activity reports during the transition period, which is nearly complete. On May 15, 2019, EPA promulgated a Notice of Availability of the updated Inventory that started a 90-day clock with important and widespread impacts. At the end of that 90-day period (August 5, 2019), it will be a TSCA violation to manufacture, import, or process any chemical substance if it is not listed on the TSCA Inventory and with Active status.
Historically, a similar usage restriction existed, but as the Active/Inactive status distinction had yet not been created, it was only required to ensure the substance was listed on the Inventory before commencing manufacture, import, or use. Furthermore, there were widespread false perceptions of the TSCA Inventory-related requirements, such as:
- They only applied to manufacturers and importers (not users).
- Users of substances did not have TSCA compliance responsibilities if they bought them from domestic sources.
- An importer's TSCA responsibilities could be fulfilled by obtaining a Safety Data Sheet (SDS) or other certification from their supplier, stating that all components of the material were listed on the TSCA Inventory.
The new regulations to support maintaining the Active/Inactive categorization in the Inventory are now completely clear that these responsibilities apply to manufacturers, importers, and users equally. Recent precedents also indicate that supplier certifications are not sufficient protection for an importer or user of a substance; it is their responsibility to obtain comprehensive information on product formulation and independently verify correct Inventory status for each ingredient before importing or using.
This situation is problematic for importers and users. Many facilities import or use formulated products in some way without awareness of the full composition. For example, some substances may not be listed as an ingredient on a product's SDS due to the ingredient being either nonhazardous, confidential, or both. Despite the limitations of SDSs and issues up to, and including, the outright refusal of suppliers to disclose complete formulation information, it is the responsibility of the manufacturer, importer, and user of every substance to know its identity and validate its status on the Inventory.
As part of the Inventory Reset process, EPA has become much more aware of these false perceptions, and that many substances were being imported to the U.S. without being on the Inventory because the importer was relying on an SDS certification from a supplier. These certifications have been falsified in some cases, and incorrect in many cases - oftentimes due to the supplier having confirmed correct Inventory status only for those ingredients explicitly listed on the SDS. As such, Trinity Consultants expects EPA will significantly increase its TSCA auditing and enforcement activities in the coming years.
In related TSCA news, additional compliance activities are also on the horizon because 2020 is a reporting year for the CDR. Although significant time remains before the CDR submission deadline, the user registration, data gathering, and data reporting process can be very slow and difficult. Because this four-year lookback can require extensive information about the downstream use(s) of each substance manufactured or imported, substantial lead time may be needed to request and understand the situation for each substance. Confidentiality concerns, and requirements for substantiation of confidentiality claims can also add to the complexity of these reports. EPA has also not left the 2016 CDR rules alone and recently proposed amendments to the regulation. The comment period for this ends June 24th, and we anticipate that many of these amendments will be added to the reporting requirements for 2020.
To support the regulated community prepare for these new and upcoming TSCA compliance needs, Trinity Consultants is offering a complimentary webinar on July 24, 2019 at 12:00pm (Central Time).