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Assessing and Managing Chemicals under TSCA

Toxic Substances Control Act Section 8(e): Frequent Questions

Definition of Substantial Risk

Reporting Procedures and Responsibilities

Persons Subject to TSCA §8(e) Reporting

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Information "Known to the Administrator"

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Health and Environmental Effects

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Health and Safety

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Environmental Contamination

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Reporting of Modeling and Risk Assessment Studies

  • Q.37. Companies often perform air dispersion, groundwater migration or other types of modeling to estimate the magnitude and extent of a chemical's presence in environmental media following its release from a manufacturing, processing, or disposal facility. Under what circumstances are the results of such modeling subject to TSCA §8(e) reporting?

    Modeling information alone is not reportable under TSCA §8(e), but it is often useful in interpreting measured data obtained from monitoring or other sources to determine TSCA §8(e) reportability. For example, reporting of non-emergency situations of environmental contamination may be warranted where modeling results reliably support available information that the contamination involves widespread and previously unsuspected distribution in the environment of a chemical known to cause serious adverse effects to humans or non-human organisms at projected exposure levels.

  • Q.38. Should risk assessments conducted under California's Proposition 65 be considered for TSCA §8(e) reporting?

    In cases where the risk assessment relies on actual data showing that widespread and previously unsuspected environmental distribution and exposure to a chemical known to cause serious adverse effects has occurred or is substantially likely to occur, submission of the exposure data underlying the assessment should be considered for TSCA §8(e) reporting. However, to the extent that Proposition 65 triggers are based on conservative safety factors and exposure scenarios, the applicability of such requirements may not necessarily coincide with TSCA §8(e) reporting criteria. If exposure data underlying the assessment are reported, the assessment itself may be submitted as supplementary information, but its submission is not required.

  • Q.39. Would industrial hygiene assessments need to be considered for TSCA §8(e) reporting?

    Typically no. Such assessments are often conducted in situations where potential exposure to the chemical has already been identified. For example, contamination of workplace air or surfaces by substances known to the manufacturer and EPA, such as Occupational Safety and Health Administration (OSHA) regulated substances, would not need to be examined for §8(e) reporting under Part V. (b)(1) of the TSCA Section 8(e) Reporting Guidance because they are not "previously unsuspected." However, information should be considered for reporting if it reasonably supports a conclusion of substantial risk (combination of toxicity and exposure) that was previously unknown. In order for workplace situation to be reportable under TSCA §8(e), it would need to be previously unsuspected and involve serious toxic effects. Also, a sudden release of a large quantity of an OSHA regulated substance may need to be considered for TSCA §8(e) reporting as an emergency incident of contamination, depending on the quantity and toxic properties of the substance.

Example of "previously unsuspected" contamination

Risk assessments and TSCA §8(e)

  • Q.41. Is there an obligation to conduct risk assessments under TSCA §8(e)?

    No. Preparation of a qualitative or quantitative risk assessment based on new toxicity or exposure data is not required under §8(e). However, in cases where the risk assessment relies on actual data showing that widespread and previously unsuspected environmental distribution and exposure to a chemical known to cause serious adverse effects has occurred or is substantially likely to occur, submission of the exposure data underlying the assessment should be considered for TSCA §8(e) reporting.

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CBI Claims

  • Q.42. How will EPA treat a confidential business information (CBI) claim for a chemical name and other chemical identity information associated with a health and safety study submitted under TSCA §8(e) where the chemical name is listed on the non-confidential portion of the TSCA Chemical Substance Inventory at the time of the TSCA §8(e) submission?

    EPA intends to review §8(e) submissions for confidential business information (CBI) claims regarding chemical identities that are publicly available on the TSCA Chemical Substance Inventory. EPA expects to find that a chemical name or CAS Registry Number associated with a health and safety study in a §8(e) filing, where the substance is already listed on the public portion of the Inventory, clearly is not entitled to confidential treatment. Where the Agency determines information clearly is not entitled to confidential treatment, any confidentiality claims for that information will be addressed in a manner consistent with provisions at 40 CFR § 2.204(d)(2).

    As a general rule, TSCA §14(b)(2) provides that health and safety studies and information from health and safety studies are not entitled to confidential treatment, with an exception for information that “discloses processes used in the manufacturing or processing of a chemical substance or mixture,” or, in the case of a mixture, where release of the data discloses the portion of a mixture comprised by a particular substance. Chemical identity is part of a health and safety study. As such, chemical identity associated with a health and safety study submitted under §8(e) is not entitled to confidential treatment unless it falls into one of the exemptions under TSCA §14(b)(2). Where the identity of a chemical substance is already contained on the public portion of the TSCA Chemical Substance Inventory, the identity itself, as well as any information that might conceivably be derived from it about processes or portions, has already been disclosed.

    EPA recognizes that companies may at times desire to protect the relationship between the substance and the submitting company. Some companies in this situation may believe they have a basis to claim the company name as confidential rather than the chemical identity. In those instances where a company’s name or other company identifier would not be considered health and safety data, and where that information would qualify for protection under Exemption 4 of the Freedom of Information Act, the company identity may be eligible for confidential treatment. Nonetheless, EPA requests confidentiality claims be made sparingly because of the importance of public availability of such data. EPA may review incoming claims and determine whether or not the information is entitled to confidential treatment.

    This confirms EPA’s long held position that, when a health and safety study is submitted to EPA, chemical identity is part of, or underlying data to, the health and safety study. Therefore, the chemical identity itself would be covered by the term ‘‘health and safety study’’ as defined in §3(6) of TSCA and as used in the disclosure provisions contained in TSCA §14.

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