by John J. Kowalski, CHMM
Despite the ongoing pandemic, the U.S. Environmental Protection Agency (EPA or the Agency) has been very busy implementing the Toxic Substances Control Act (TSCA), as amended. Some of its recent actions are briefly summarized below.
On March 6, 2020, EPA published a final rule to establish confidential business information (CBI) substantiation requirements for manufacturers and processors who claimed specific chemical identities as CBI in Notice of Activity (NOA) Form A’s previously filed in accordance with the TSCA Inventory Notification (Active-Inactive) Requirements rule. The final rule published on March 6th also amends the existing CBI substantiation requirements for manufacturers and processors who have filed or will file NOA Form B’s. Manufacturers and processors who previously provided substantiations in NOA Form A or Form B for CBI claims for specific chemical identities will be required to supplement those substantiations to include responses to two new questions related to a specific chemical identity’s susceptibility to reverse engineering.
The final rule also describes EPA’s plan for reviewing certain CBI claims for specific chemical identities. The Agency’s plan sets out the review criteria and related procedures that EPA will use to complete the reviews within the five-year timeframe set forth in TSCA.
On March 11, 2020, EPA released an update to the public version of the TSCA Inventory. UL has already updated its LOLI® Chemical Regulatory Database based upon this update. With this update, the Inventory now includes a total of 86,405 chemical substances, of which 41,484 are designated as active in U.S. commerce.
Under TSCA Section 5, companies must notify EPA before manufacturing or importing a substance that is not listed on the Inventory for a non-exempt, commercial purpose subject to regulation under TSCA. Under TSCA Section 8, companies must notify EPA before manufacturing, importing, or processing a substance that is designated as inactive for a non-exempt, commercial purpose subject to regulation under TSCA.
Chemical Data Reporting
On March 17, 2020, EPA Assistant Administrator Alexandra Dapolito Dunn signed two final rules to amend the Chemical Data Reporting (CDR) requirements under TSCA Section 8(a) and to extend the submission deadline for 2020 reports from September 30, 2020 to November 30, 2020. According to EPA, the amendments will reduce the reporting burden for certain submitters, improve the quality of CDR data collected, and align reporting requirements with the 2016 amendments to TSCA.
The Agency is also working on a separate rule to update the definition of small entities for purposes of CDR. As of March 26, 2020, the two rules signed on March 17th had not yet been published in the Federal Register.
Risk Evaluation Fees
On March 25, 2020, EPA announced a plan to consider potential exemptions to the TSCA Fees Rule in response to stakeholder concerns about certain implementation challenges. More specifically, the Agency plans to initiate a new rulemaking process to consider exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that:
- import the chemical substance in an article;
- produce the chemical substance as a byproduct; and
- produce or import the chemical substance as an impurity.
EPA stated its intention to issue proposed amendments to the current fees rule later this year, with the goal of finalizing the amendments in 2021.
In addition, the Agency issued a “No Action Assurance” for the three categories of manufacturers subject to TSCA fee requirements for 20 chemical substances subject to EPA-initiated risk evaluations. With this action, EPA exercised its enforcement discretion regarding the self-identification requirement for those three categories of manufacturers, consistent with its intended regulatory action.
Recommended Action Items
- Review the documents to which links are provided within this article; and,
- Continue to watch this space, as we frequently post articles regarding significant new developments under TSCA.
Environmental Protection Agency. “Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory” Federal Register 85 (6 March 2020): 13062-13069. https://www.govinfo.gov/content/pkg/FR-2020-03-06/pdf/2020-03868.pdf
United States, EPA, TSCA, CBI, TSCA Inventory, CDR, Fees
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