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  2. Chemicals under the Toxic Substances Control Act (TSCA)

Second Set of Draft Scope Documents for Chemicals Undergoing Risk Evaluation Available for Public Comment

For Release: April 17, 2020

EPA is asking for public input on the draft scope documents for the remaining seven of the 20 chemicals designated as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA). These chemicals were designated as a high priority for risk evaluation in December 2019, and seeking public input on the conditions of use to be included in the risk evaluations for these chemicals is the next step in the process outlined in TSCA. It is important to note that being designated as a high-priority chemical does not mean that a chemical is high risk.

The draft scope documents include the proposed conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations EPA expects to consider in the risk evaluations. The documents also include: a description of the reasonably available information and the science approaches that the agency plans to use, a conceptual model that outlines the potential hazards and exposures throughout the life cycle of the chemical, an analysis plan to identify the approaches and methods EPA plans to use to assess health and environmental factors, and a potential plan for peer review.

One of the draft scope documents released today is for formaldehyde, a chemical that has been studied by the agency for many years. Work done under EPA’s Integrated Risk Information System (IRIS) program was used to select this chemical as a high priority for risk evaluation, and today’s action represents the next step in the process required by TSCA. Moving forward, the work done for IRIS will also be used to inform the formaldehyde risk evaluation.

Upon publication of the Federal Register notice, EPA will accept comments on these seven draft scopes for 45 days. Comments may be submitted to the docket relevant to this action (EPA-HQ-OPPT-2019-0131), or to the individual dockets for each of the chemicals. EPA will use feedback received from the public comment process to inform the final scope documents.

View the list of chemicals undergoing risk evaluation under TSCA and related documents: Ongoing and Completed Chemical Risk Evaluations under TSCA.

Background

TSCA required EPA to designate 20 chemicals as a high-priority for risk evaluation. EPA finalized this list of 20 chemicals in December 2019. Finalizing this list of high-priority chemicals for risk evaluation was the final step in the prioritization process outlined in TSCA. The next steps for these chemicals are outlined in TSCA’s process for risk evaluation and include taking public comment on scope documents for each of these 20 chemicals.  

EPA published the draft scope documents for 13 of the 20 high-priority chemicals on April 6, 2020. The draft scope documents for the following seven chemicals are being released today:

  1. Butyl benzyl phthalate (BBP) (1,2-Benzenedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester), CASRN 85-68-7, Docket ID Number EPA-HQ-OPPT-2018-0501
  2. Dibutyl phthalate (DBP) (1,2-Benzenedicarboxylic acid, 1,2-dibutyl ester), CASRN 84-74-2, Docket ID Number EPA-HQ-OPPT-2018-0503
  3. Dicyclohexyl phthalate (1,2-Benzenedicarboxylic acid, 1,2-dicyclohexyl ester), CASRN 84-61-7, Docket ID Number EPA-HQ-OPPT-2018-0504
  4. Di-ethylhexyl phthalate (DEHP) (1,2-Benzenedicarboxylic acid, 1,2-bis(2-ethylhexyl) ester), CASRN 117-81-7, Docket ID Number EPA-HQ-OPPT-2018-0433
  5. Di-isobutyl phthalate (DIBP) (1,2-Benzenedicarboxylic acid, 1,2-bis(2-methylpropyl) ester), CASRN 84-69-5, Docket ID Number EPA-HQ-OPPT-2018-0434
  6. Formaldehyde, CASRN 50-00-0 (including CASRN 30525-89-4), Docket ID Number EPA-HQ-OPPT-2018-0438
  7. Phthalic anhydride (1,3-Isobenzofurandione), CASRN 85-44-9, Docket ID Number EPA-HQ-OPPT-2018-0459

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Last updated on March 26, 2025
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