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Unpublished Health and Safety Studies


December 4, 2013 - A new EPA rule requires electronic reporting of certain TSCA information. Learn more.

  TSCA Section 8(d) Revisions (PDF format)

Key elements of these revisions are:

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rules to require producers, importers, and processors to submit lists and/or copies of ongoing and completed, unpublished health and safety studies.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:

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Unpublished studies on listed substances or mixtures are potentially reportable (i.e., studies may be subject to either copy submission requirements or listing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:

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:

Cadmium in Consumer Products, Especially Toy Metal Jewelry

On December 14, 2012, EPA informed the regulated community that the Agency decided to withdraw the immediate final health and safety data reporting rule for cadmium due to questions and concerns raised about the scope and extent of the rule that indicate that there is significant confusion and uncertainty within certain industrial sectors concerning the rule. EPA intends to publish a Federal Register notice announcing this decision no later than the January 2, 2013 effective date of the immediate final. EPA will be considering the questions and concerns raised in response to the immediate final and next steps with regard to this rule. EPA will also continue to work with the Consumer Product Safety Commission (CPSC) to reduce exposure to cadmium in consumer products generally, and especially those consumer products used by or around children, such as children's metal jewelry.

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