Unpublished Health and Safety Studies

TSCA Section 8(d) Revisions (PDF format)

Key elements of these revisions are:

persons who must report (unless otherwise specified) include chemical producers and importers under the NAICS Codes Subsection 325 (chemical manufacturing and allied products) and Industry Group 32411 (petroleum refiners).
reporting period is one-time with a 60 day reporting period (in certain circumstances, a chemical may remain listed for a longer period but not longer than 2 years).
studies to be reported will be specified by EPA to include the specific type(s) of health and safety data needed; the chemical grade/purity of the test material (studies involving mixtures are not required unless otherwise specified).
initiated studies are reportable only for study initiation that occurs during the 60 day reporting period.
adequate file searches encompass reportable information dated on or after January 1, 1977 (unless otherwise specified).

Under TSCA Section 8(d), EPA has the authority to promulgate rules to require producers, importers, and processors to submit lists and/or copies of ongoing and completed, unpublished health and safety studies. EPA's TSCA Section 8(d) "Health & Safety Data Reporting Rule" was developed to gather health and safety information on chemical substances and mixtures needed by EPA to carry out its TSCA mandates (e.g., to support OPPT's Existing Chemicals Program and Chemical Testing Program and to set priorities for TSCA risk assessment/management activities). EPA has also used its TSCA Section 8(d) authority to gather information needed by other EPA Program Offices and other Federal Agencies. Chemicals that are designated or recommended for testing by the TSCA Interagency Testing Committee (ITC) may be added to the rule via immediate final rulemaking (up to 50 substances/year). Non-ITC chemicals can be added to the Section 8(d) rule via notice and comment rulemaking. Further information available under 40 CFR Part 716.

Persons who must report under the TSCA Section 8(d) rule include:

Current as well as prospective producers, importers, and (if specified) processors of the subject chemical(s); and
Persons who, in the 10 years preceding the effective date that a substance or mixture is added to the rule, either had proposed to produce, import, or (if specified) process, or had produced, imported, or processed (if specified) the substance or listed mixture.

Once a chemical substance or mixture is added to the rule, reporting obligations terminate (i.e., sunset) no later than 2 years after the effective date of the listing of the substance or mixture, or on the removal of the substance or mixture from the rule.

Unpublished studies on listed substances or mixtures are potentially reportable (i.e., studies may be subject to either copy submission requirements or listing requirements). Generally, copies of studies possessed at the time a person becomes subject to the rule must be submitted, and the following categories of studies must be listed:

Studies ongoing as of the date a person becomes subject to the rule (copies must be submitted when completed);
Studies initiated after the date a person becomes subject to the rule (copies must be submitted when completed);
Studies which are known as of the date a person becomes subject to the TSCA Section 8(d) rule, but not possessed; and
Studies previously sent to U.S. Government Agencies without confidentiality claims.

The term "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;

Unpublished Health and Safety Studies

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