Section 8 of the Toxic Substances Control Act (TSCA) compels manufacturers (including importers) to provide the U.S. Environmental Protection Agency (EPA) with information on the production and use of chemicals in commerce. The last Chemical Data Reporting (CDR) cycle was in 2016, so TSCA stakeholders have been gearing up for this quadrennial reporting obligation in 2020. This column provides an overview of changes since 2016.
Congress amended the TSCA in 2016, and the EPA has revised the CDR to reflect legislative changes. On March 17, 2020, the EPA released a new final CDR rule. The revisions lessen the burden for certain CDR reporters, improve the quality of CDR data collected, and align reporting requirements with the 2016 TSCA amendments. The EPA also extended the reporting period from September 30, 2020 to November 30, 2020, to provide additional time for the regulated community to familiarize themselves with the amendments and the updated public version of the reporting tool. Key changes include:
Confidentiality: Amendments for making confidentiality claims include identifying when upfront substantiation is required, updating the substantiation questions, and identifying data elements that can’t be claimed as confidential business information (CBI).
Use codes: The final rule replaces certain processing and use codes (industrial function and commercial/consumer product uses) with ones based on functional use and product and article use codes of the Organization for Economic Cooperation and Development (OECD). The new codes will be placed in the Code of Federal Regulations rather than listed in guidance. Codes associated with non-TSCA uses will be folded into the overarching non-TSCA use code. The OECD-based codes will be required during the 2020 CDR submission period for the chemical substances designated in 2019 as a high priority for risk evaluation, and for all chemical substances during the 2024 CDR submission.
North American Industrial Classification System (NAICS): Entities must report the NAICS code(s) for the site of manufacture. The final rule also modifies the requirement to indicate whether a chemical is removed from the waste stream and recycled, remanufactured, reprocessed or reused. Manufacturers now must indicate whether a chemical is removed from the waste stream and recycled only. Both these revisions are being made as proposed.
Voluntary data element: The final rule adds a voluntary data element to identify the percent total production volume of a chemical substance that is a byproduct. The EPA modified the proposed rule by including that percent byproduct reporting be in ranges and making the reporting voluntary. In the final rule, the secondary submitter of a joint submission must report the specific function of the chemical along with the percentage of the chemical in the imported product.
Parent company: The final rule modifies the reporting of “parent company” to require the use of a naming convention; add the requirement to report a foreign parent company, when applicable; and codify reporting scenarios in a new definition for “highest-level parent company.” The EPA notes these definitions, requirements and reporting scenario codifications are modified from the proposed rule. The final rule simplifies the process by providing two reporting mechanisms for co-manufacturers by enabling a multi-reporter process for entities separately to report directly to the EPA within the e-CDR web reporting tool.
New exemptions: The final rule adds these exemptions: 1) for specifically identified byproducts that are recycled in a site-limited, enclosed system (which is being adopted as proposed with the addition of another chemical substance); and 2) for byproducts manufactured as part of non-integral pollution control and boiler equipment (implemented as proposed).
The EPA, recognizing that certain changes such as the adoption of the OECD function codes, could result in additional burden for companies hoping to rely on codes used during the latest reporting cycle, is commendable. Requiring new codes for the 20 high-priority chemicals and allowing voluntary reporting for other chemicals is a reasonable and pragmatic approach. The adjustments in the CBI substantiation requirements will likely be the biggest change from 2016 and one that is necessary to comply with the new TSCA. As is always the case, the sooner entities get started and complete their CDR reporting obligations, the better off each will be.
LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at [email protected]
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006). The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.