The U.S. Environmental Protection Agency (EPA) announced on February 3, 2022 that it has resumed publishing notices of substantial risk provided by companies under Section 8(e) of the Control Act. of Toxic Substances (TSCA) in its ChemView database. The EPA says that as an initial phase of its efforts to develop an efficient and automated publication process, it has begun publishing notices received since the procedure expired in 2019 due to limited resources. As resources allow, EPA will “continue to make efforts” to make non-confidential business information (CBI) versions of Section 8(e) notices more quickly available to the public in ChemView. the TSCA. The EPA announcement includes the following questions and answers (Q&A):
What are TSCA Section 8(e) notices?
Section 8(e) of the TSCA states, “Any person who manufactures, imports, processes, or commercially distributes a chemical substance or mixture and obtains information that reasonably supports the conclusion that such chemical substance or mixture exhibits a substantial risk of damage to health or the environment must immediately inform the [EPA] the administrator of this information, unless that person actually knows that the administrator has been properly informed of this information. 15 U.S.C. 2607(e). EPA guidelines define “substantial risk information” as information that reasonably supports the conclusion that a chemical or mixture presents a substantial risk of harm to health or the environment and that a “substantial risk of harm to health or the environment” is a risk of very high concern because of (a) the severity of the effect and (b) the fact or likelihood of its occurrence. Substantial risk notifications under TSCA Section 8(e) must be submitted within 30 calendar days of obtaining substantial risk information.
The nature and extent of information contained in TSCA Section 8(e) notices vary widely, ranging from short memos providing limited information to fully detailed laboratory study reports. TSCA 8(e) notices can provide very preliminary data, often on substances that have not yet entered commercial production. As such, the data provided in TSCA Section 8(e) notices may be sparse, incomplete, qualitative, or quantitative, and as such may or may not lend itself to thorough examination or be suitable for investigation. use in hazard or risk assessments or regulatory decisions. manufacturing.
How are TSCA Section 8(e) notices obtained by the 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 the EPA either electronically via EPA’s Central Data Exchange (CDX) or in hard copy by 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 the 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), the National Archives and Records Administration (NARA) approved electronic 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 through an internal system, the Chemical Information System (CIS), which makes any document available to EPA staff. submitted under TSCA. EPA assessors with the required and current CBI training and authorization have access to both CBI and non-CBI versions of TSCA Section 8(e) notices as soon as they are uploaded to the CIS – the notices submitted electronically are available immediately upon receipt, and paper submissions are usually available within 2 days of receipt. TSCA Section 8(e) notices also undergo initial processing which includes entering information such as effects/endpoint, effect type, test type, dose, duration, route of administration, species tested, etc. in an internal database. When the TSCA Section 8(e) submission contains sufficient detail, EPA may ask its contractor to summarize the human health or environmental hazard information for use in the chemical assessments.
Data extracted from TSCA Section 8(e) notices may also be incorporated into several internal CBI databases and calculation tools (for exampleAnalog Identification Methodology, ECOSAR) which are also available to EPA assessors.
EPA risk assessors routinely use information included in TSCA Section 8(e) notices in new and existing TSCA chemical risk assessment activities. In the New Chemicals Program, chemicals for which toxicity information has been submitted to the Agency via TSCA Section 8(e) notices are often used as “read-across” analogs to assess potential risks for new chemicals that have similar chemical structures but lack test data. As previously described, TSCA Section 8(e) data is also incorporated into AIM or ECOSAR, calculation tools routinely used to assess the potential risks of new chemicals.
For existing TSCA Section 6 chemical risk assessments, TSCA Section 8(e) notices are an integral part of the information included in the TSCA Systematic Review Process – in the TSCA Workflow. identification and evaluation of gray literature data streams. For example, the scopes of risk assessments for the 20 high priority substances and Manufacturer Requested Risk Assessments (MRREs) currently in progress clearly show where data from TSCA Section 8(e) notices can be included. (for example, in literature inventory trees and evidence maps). In addition, data contained in TSCA Section 8(e) notices has also been used to inform the need to issue TSCA Section 4 test orders to test existing chemicals. or to fill data gaps instead of retesting.
How can the public access 8(e) notices?
Although not required by law, the EPA has a long history of making data contained in TSCA Section 8(e) substantial risk notices publicly available. From 1976 to 2017, TSCA Section 8(e) notice data was compiled in the Toxic Substances Control Act Test Submissions (TSCATS) and TSCATS2 databases. Information from the TSCATS database has also been made public through the National Library of Medicine’s (NLM) TOXNET. When NLM shut down TOXNET in December 2019, it made TSCATS data publicly available for download (https://www.nlm.nih.gov/databases/download/toxlinesubset.html).
In 2013, the EPA created its public-facing non-CBI ChemView portal and began working to transfer non-CBI electronically available versions of TSCA Section 8(e) notices and data that ‘they contain (that is to say, TSCATS and/or TOXNET databases) in ChemView. However, as of 2019, the EPA has been unable to continue regular publication of TSCA section 8(e) notices in the ChemView database. This highly manual process was carried out by a single staff member who retired in December 2018. Other unit personnel who would historically also perform this type of work were fully occupied performing other work to increase transparency associated with new TSCA chemical submissions in response to a commitment the former EPA administrator made to Sen. Carper (D-DE).
However, TSCA Section 8(e) notices continued to be publicly available through the EPA Docket Center. Anyone can request to receive non-CBI versions of TSCA Section 8(e) notices received by the agency, either in person or by email ([email protected]). Upon request and compilation (which may take time, depending on the complexity of the request), the Records Center will provide the applicant with the information by email or other electronic means (for example, CD). The public may also view hard copies of non-CBI versions of TSCA Section 8(e) notices received by the Agency in person in the Docket Center Reading Room (due to COVID, this option is currently by appointment only). Find contact information for the EPA Records Center Reading Room.