EPA Finalizes New Chemical Data Reporting Rule Under TSCA
On March 17, 2020, EPA finalized the “TSCA Chemical Data Reporting Revisions Under TSCA Section 8(a)” rule (CDR Rule), which amends requirements related to Chemical Data Reporting under the Toxic Substances Control Act (TSCA). The CDR Rule finalizes changes EPA proposed on April 25, 2019, and the new rule becomes effective on May 11, 2020, thirty days after its publication in the Federal Register on April 9, 2020. Manufacturers and importers of chemical substances listed on the TSCA Inventory will likely be impacted by changes to Chemical Data Reporting. The changes implemented under the CDR Rule impact processing and use codes, confidentiality claims, and reporting on chemical byproducts and chemicals removed from waste streams, among other impacts.
In tandem with the finalization of the CDR Rule, EPA has extended the submission deadline for the 2020 Chemical Data Reporting submission period from September 30, 2020, to November 30, 2020. This one-time extension gives submitters additional time to conform their reporting with the changes in the CDR Rule.
Chemical Data Reporting under TSCA requires U.S. manufacturers and importers of certain chemicals listed on the TSCA Inventory to report to EPA every four years certain information about chemical substances manufactured or imported during the prior four years (i.e., 2016, 2017, 2018, and 2019). Generally, manufacturers and importers must report information concerning listed chemical substances whose production volumes are 25,000 pounds or more at a single site during any reportable calendar year, although lower thresholds apply for certain chemicals. Domestic manufacturers and importers of chemical substances are required to report information such as production volumes, chemical-exposure related information associated with manufacturing the chemical, and certain processing and use information. Certain chemical reporting information may also be claimed as confidential.
The proposed changes to Chemical Data Reporting stem from amendments to TSCA in 2016 under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Amendments), and from EPA’s stated motivation to collect information that is better tailored to meet EPA’s information needs. Among other changes, the Lautenberg Amendments changed requirements associated with confidentiality claims, including identifying information eligible for confidentiality claims and when substantiality of claims is required. Additionally, EPA has sought better informational alignment with its specific needs for chemical substance prioritization and risk evaluation under Section 6 of TSCA.
As noted above, one of the more significant changes implemented by the CDR Rule concerns changes to the use of processing and use codes. The CDR Rule replaces CDR industrial function and commercial/consumer product codes with function, product, and article use codes used by the Organisation for Economic Co-operation and Development (OECD), and adds OECD function categories for commercial/consumer products. Currently, EPA requires the reporting of function categories for chemical substances used in industrial products but does not require the reporting of a chemical substance’s function for commercial/consumer products. The CDR Rule requires reporting of function use categories for both industrial and commercial/consumer products, and to adopt the OECD functional use categories.
EPA believes that using OECD codes will expand the utilization of applicable use and exposure-related information from international sources to support EPA risk evaluation and risk assessment activities for new and existing chemicals. It would also provide industry with international uniformity in use and exposure information reporting. The final CDR Rule phases-in the implementation of the OECD-based codes, such that reporting during the 2020 CDR submission period for chemicals designated as a high priority for risk evaluation must use OECD-based codes, but reporting for all other chemical substances may report using either the OECD-based codes or the current CDR codes. Reporting using the OECD-based codes for all other chemical substances will be required during the 2024 CDR submission period.
Another significant change implemented by the CDR Rule concerns the requirements for claiming confidentiality in reporting. The Lautenberg Amendments mandated new procedural requirements for the submission and EPA management of confidential business information (“CBI”) claims. Consistent with those changes, the CDR Rule requires substantiation of all CBI claims at the time of CBI assertion except for information exempt under Section 14(c)(2) of TSCA. The substantiation questions are similar to questions previously posed to CBI claimants, and generally inquire about the impact of disclosure on the submitter’s competitive position, whether information has been made available to others, and the controls used to protection the confidential information. Additional questions target more specific data elements, including chemical substance identity, chemical processing and use, and technical contact. Data elements that cannot be claimed as CBI include “general description” information directly related to how the chemical is used and whether the chemical is used in industrial, commercial, or consumer products.
Additional changes in the CDR Rule include the following:
- Requiring CDR submitters to report the 6-digit NAICS code that best describes the manufacturing activities conducted at the reporting site. Inclusion of the NAICS codes allows EPA to use such information in its analysis of the reported manufacturing-related information to better analyze the data by industry sector.
- Removing the terms “remanufactured, reprocessed, and reused” from the recycled chemical substances reporting requirement. Submitters have been required to identify whether their reportable chemical substance is “recycled, remanufactured, reprocessed, reused, or otherwise used for a commercial purpose” instead of being disposed of as a waste or included in a waste stream. EPA has removed the above terms because it believed they may be interpreted to apply too broadly, and that the terms are not synonymous with “recycle.”
- Adding a voluntary reporting element for the percent total production volume for a chemical substance that is a byproduct. With this information, EPA believes it will better understand the manufacturing of byproduct chemical substances and the impact of current or potential future exemptions to reporting. The final CDR Rule changed the proposed CDR Rule by making this reporting element voluntary instead of required.
- Requiring the secondary submitter of a joint submission to report the chemical-specific function of an imported product or mixture, along with information on chemical composition. Currently, the importer identifies the function of the imported product, which in some circumstances can be applied to the specific chemical substance. In the circumstance where the imported product is a multi-component mixture, however, applying the function of the imported product to each component of the mixture can result in identifying a function for an individual chemical substance that is not appropriate.
- Changing reporting associated with parent companies by adding a requirement to report a foreign parent company in addition to a U.S. parent company when the ultimate parent company is located outside the U.S., and to change its regulatory definition of “parent company” to both account for the reporting of foreign parent companies and to offer guidelines for different company structures. Currently, submitters are only required to report their U.S. parent company.
- Exempting the reporting of specific byproducts that are recycled onsite by Portland cement manufacturers and manufacturers using Kraft pulping process. Specifically, the manufacture of cement kiln dust by Portland cement manufacturers and sulfite liquors, cooking liquors, and Carbonic acid calcium salt from the Kraft pulping process are exempt from reporting, provided that these substances are recycled or otherwise used to manufacture another chemical substance in an enclosed system. Additionally, byproducts manufactured through processes that are not integral to the production process are exempt from reporting.
If you have any questions or concerns regarding the CDR Rule, please contact Todd Kantorczyk at (484) 430-2359, Zach Koslap at (484) 430-2330 or MGKF technical consultant Michael Nines at (484) 430-2350.
Alert updated April 9 to include effective date of new rule.