The EPA released a proposed rule for procedures for verifying certain claims of confidentiality for chemical identity and the processes for EPA review of those claims. The goal of the proposed rule is to ensure that when a company asserts the identity of a chemical as confidential business information (CBI), it conforms to the criteria for CBI under the Toxic Substances Control Act (TSCA).
The proposed rule pertains to CBI claims for particular chemicals determined as “active” pursuant to the TSCA Inventory Notification Rule. The TSCA Inventory Notification Rule mandated that companies notify the EPA about the chemicals on the TSCA Inventory that were active in U.S. markets, which refers to those that were manufactured or processed during the 10-year period ending June 21, 2016. The Rule also allowed companies to declare the confidentiality of a specific identity for the active chemicals, but those claiming confidentiality must verify those claims through certain processes.
The proposed rule, and the amended TSCA provision requiring the adoption of such a rule, reflect a longstanding tension between protecting sensitive information from public disclosure and ensuring transparency regarding matters pertaining to the protection of human health and the environment. On the one hand, protection of sensitive information helps incentivize innovation, by ensuring that such information does not fall into the hands of domestic or foreign competitors. On the other hand, lack of access to such information can mean that members of the general public are prevented from fully voicing legitimate concerns about the safety of chemicals.
The 2016 TSCA amendments attempted to resolve this tension. The EPA is required to issue a CBI rule pursuant to TSCA section 8(b)(4)(c) to enact a plan to review all CBI claims to safeguard the chemical identities of chemical substances on the confidential section of the TSCA Inventory. The EPA has reported that of the 40,655 chemicals that are active in commerce, over 80 percent are not classified as CBI while fewer than 20 percent (or 7,757) are identified as CBI. Meanwhile, other types of CBI claims are not included in the review plan under TSCA Section 8(b)(4)(c).
The rule must be finalized no later than one year after the publication of the first TSCA Inventory with “active” substance labels. Under TSCA, the EPA must also enact a CBI review plan to evaluate CBI claims no later than five years after the publication of the TSCA Inventory. The deadline for issuing a final rule is February 19, 2020, and the deadline for reviewing the CBI claims is February 19, 2024. The EPA may take advantage of a two-year extension under TSCA which would push the deadline for completing the reviews to February 19, 2026.
Grimaldi Law Offices has been advising clients for over 20 years on chemical and product law. For knowledgeable advice and in-depth analysis of your chemical regulatory compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at [email protected].