By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on February 3, 2022, that it has resumed publishing notices of substantial risks provided by companies under Section 8(e) of the Toxic Substances Control Act (TSCA) to its ChemView database. EPA states that as the initial phase of its effort to develop an efficient and automated publication process, it started publishing notices received since the procedure lapsed in 2019 due to resource limitations. As resources allow, EPA will “continue to strive” to make non-confidential business information (CBI) versions of TSCA Section 8(e) notices publicly available in ChemView more quickly. EPA’s announcement includes the following questions and answers (Q&A):
What are TSCA section 8(e) notices?
Section 8(e) of TSCA states that “Any person who manufactures, imports, processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the [EPA] Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information.” 15 U.S.C. 2607(e). EPA guidance defines the term substantial-risk information as information which reasonably supports the conclusion that a chemical substance or mixture presents a substantial risk of injury to health or the environment and ‘‘substantial risk of injury to health or the environment’’ as a risk of considerable concern because of (a) the seriousness of the effect and (b) the fact or probability of its occurrence. Substantial Risk Notifications under TSCA section 8(e) should be submitted within 30 calendar days of obtaining substantial risk information.
The nature and extent of information in TSCA section 8(e) notices varies greatly, ranging from short memos providing limited information to fully detailed laboratory study reports. TSCA 8(e) notices may provide very preliminary data, often on substances that have not yet made it into commercial production. As such, the data provided in TSCA section 8(e) notices can be sparse, incomplete, qualitative or quantitative, and as such, may or may not be amenable to robust review or suitable for use in hazard or risk assessments or regulatory decision-making.
How are TSCA section 8(e) notices obtained by EPA?
TSCA section 8(e) notices (and related “FYI” notices) -- those containing confidential business information (CBI) and non-CBI versions -- are submitted by companies to EPA either electronically via EPA’s Central Data Exchange (CDX) or in hard copy via mail. For more information on submitting TSCA section 8(e) notices: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/reporting-tsca-chemical-substantial-risk-notice[.]
What does EPA do when it receives a TSCA section 8(e) notice?
Upon receipt of a TSCA section 8(e) notice, these notices are uploaded to the internal Chemical Information System (CIS), EPA’s National Archives and Records Administration (NARA) approved e-record keeping system for TSCA records, including TSCA section 8(e) notices.
How do EPA Risk Assessors Access and Use TSCA section 8(e) notices?
TSCA section 8(e) notices are available to OPPT chemical risk assessors via an internal system, the Chemical Information System (CIS), that makes available any document that is submitted under TSCA to EPA staff. EPA assessors with requisite and up-to-date CBI training and clearance have access to both the CBI and non-CBI versions of TSCA section 8(e) notices as soon as they are uploaded to CIS -- electronically submitted notices are available immediately upon receipt, and paper submissions are typically available within 2 days of receipt. TSCA section 8(e) notices also undergo initial processing which includes entry of information such as effects/endpoint, type of effect, type of test, dose, duration, route of administration, species tested, etc. into an internal database. When the TSCA section 8(e) submission contains sufficient detail, EPA may task its contractor to summarize the human health or ecological hazard information for use in chemical assessments.
Data extracted from TSCA section 8(e) notices may also be incorporated into several internal CBI databases and computational tools (e.g., Analog Identification Methodology, ECOSAR) that are also available to EPA assessors.
EPA risk assessors routinely use the information included in TSCA section 8(e) notices in both TSCA new and existing chemical risk assessment activities. In the new chemicals program, chemicals with toxicity information that was submitted to the Agency via TSCA section 8(e) notices are often used as analogs to “read-across” to assess potential risks to new chemicals that have similar chemical structures but that lack test data. As described previously, TSCA section 8(e) data is also incorporated into AIM or ECOSAR, computational tools used routinely to assess potential risks of new chemicals.
For TSCA section 6 existing chemical risk evaluations, TSCA section 8(e) notices are an integral part of the information included within the TSCA Systematic Review process -- in the gray literature data stream identification and evaluation workflow. For example, the scopes of the risk evaluations for the 20 high priority substances and Manufacturer Requested Risk Evaluations (MRREs) currently underway clearly demonstrate where data from TSCA section 8(e) notices may be included (e.g., in the literature inventory trees and evidence maps). In addition, data contained in TSCA section 8(e) notices have also been used to inform the need for issuance of TSCA section 4 test orders to conduct testing of existing chemicals or to fill data gaps in lieu of conducting new testing.
How can the public access 8(e) notices?
Although not required by statute, EPA has a long history of making data contained in TSCA section 8(e) substantial risk notices publicly available. From 1976-2017, data from TSCA section 8(e) notices were compiled into the TSCATS (Toxic Substances Control Act Test Submissions) and TSCATS2 databases). The TSCATS database information was also made publicly available via the National Library of Medicine (NLM)’s TOXNET. When NLM discontinued TOXNET in December 2019, it made the TSCATS data publicly available for download (https://www.nlm.nih.gov/databases/download/toxlinesubset.html).
In 2013, EPA established its public-facing non-CBI ChemView portal, and began efforts to transfer electronically available non-CBI versions of TSCA section 8(e) notices and the data contained within them (i.e., from the TSCATS databases and/or TOXNET) into ChemView. However, beginning in 2019, EPA was not able to continue the regular publication of TSCA section 8(e) notices to the ChemView database. This heavily manual process was conducted by a single staff person who retired in December 2018. Other staff within the unit that would historically also do this type of work were fully occupied conducting other work to increase transparency associated with TSCA new chemicals submissions in response to a commitment made by the past EPA Administrator to Senator Carper (D-DE).