• Manufacturers and processors of the chemical substances and mixtures subject to a TSCA section 8(d) rulemaking must submit lists and copies of health and safety studies relating to the health and/or environmental effects of the chemical substances and mixtures.
• All studies submitted to EPA will be verified and the contents of the submissions recorded and inspected for the inclusion of CBI.
• EPA will make non-confidential versions of the health and safety studies available via its publicly available ChemView online database.

Toxic Substances Control Act (TSCA) section 8(d) authorizes the Environmental Protection Agency (EPA) to promulgate rules requiring certain persons who manufacture, process, or distribute in commerce (or propose to manufacture, process, or distribute in commerce) chemical substances and mixtures, to submit to EPA lists and copies of health and safety studies in their possession with respect to such chemical substances and mixtures.

Health and safety study is intended to be interpreted broadly and means “any study of any effect of a chemical substance or mixture on health or the environment or on both,” including but not limited to:

• Epidemiological or clinical studies,
• Studies of occupational exposure,
• In vivo and in vitro toxicological studies, and
• Ecotoxicological studies.

Data items

These rules, which are codified in 40 CFR 716, require the manufacturers and processors of the chemical substances and mixtures subject to a TSCA section 8(d) rulemaking to submit lists and copies of health and safety studies relating to the health and/or environmental effects of the chemical substances and mixtures. All submitted studies must be accompanied by a cover letter that contains the following data:

• Name;
• Job title;
• Address;
• Telephone numbers of the submitting official;
• Name and address of the manufacturing or processing establishment on whose behalf the submission was made;
• Identity of any impurity or additive known to have been present in the substance or listed mixtures as studied, unless so noted in the study; and
• Indication that the study is being submitted under Part 716.

List of studies shall include:

• Ongoing health and safety studies conducted by or initiated by respondents — For these studies, the list should include the following data: beginning date of the study, purpose of the study, types of data to be collected, anticipated date of completion, and name and address of the laboratory conducting the study.
• Studies respondents know about but do not have copies of — For these studies, the list should include the name and address of a person known to them that possess a copy of the study.
• Studies that have been sent to another federal agency with no claims of confidentiality — For these studies, the list should include the following data: title of the study, name and address of the person to whom the study was sent, and month and year in which the study was submitted.

Compliance steps

EPA amends the list of subject chemicals in 40 CFR 716 periodically to add chemical substances and mixtures. The listed chemical substances and mixtures include chemicals recommended for testing under TSCA section 4 by the Interagency Testing Committee (ITC) and other chemical substances that EPA, or other federal agencies, choose to assess for health or environmental effects.

Reporting of information is only required when the subject matter information is available. Availability of study reports on the list may occur after the established reporting period for the list and must still be submitted when they become available. Studies previously submitted to EPA are exempt.

To comply, respondents must search their records to identify any health and safety studies in their possession, copy and process relevant studies, list studies that are currently in progress, and submit this information to EPA. Specifically, a representative respondent would engage in the following activities in order to produce the lists of studies and required data:

1. Determine whether the firm may be required to report. If so, review the rule in more detail;
2. Conduct a corporate review to identify which firm sites must be searched to locate the appropriate health and safety studies;
3. Search the files at appropriate sites to locate relevant studies;
4. Compile and transcribe lists of studies being submitted, ongoing studies, newly initiated studies, studies known to exist but not known to be in the respondent’s possession, and studies previously submitted to other federal agencies without confidentiality claims;
5. Photocopy or prepare electronic versions of the studies;
6. Voluntarily prepare robust summaries of the studies;
7. Review the responses for possible confidential business information and prepare information to substantiate a claim of confidentiality; and
8. Submit the studies to EPA electronically, and, after initial study submissions, notify EPA when other studies are initiated; submit studies completed after the reporting period.

Reporting is mandatory. However, respondents may claim all or part of a response confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR 2.

What happens to the submitted data?

All studies submitted to EPA will be verified and the contents of the submissions recorded and inspected for the inclusion of confidential business information (CBI). EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14, 40 CFR 2, and 40 CFR 703.

Copies of the documents will then be prepared and distributed, based on the associated chemical identity, to program offices at EPA and/or to other federal agencies for scientific analysis. A coding form will be completed to capture certain descriptive information such as identity, document control number, confidentiality indicator, document title, document date, receipt date, and chemical identity. The document will be stored electronically for archival purposes. In addition, EPA will make non-confidential versions of the health and safety studies available via its publicly available ChemView online database.

EPA uses this information to support its investigation of the risks posed by the chemical substance in question and construct a complete picture of the known effects of the chemical substance. This will support the agency’s decisions on whether to require additional test data be submitted under TSCA section 4.