TSCA Section 4 Test Rules

TSCA Section 4 test rules are created through a formal rulemaking process that requires public notice/comment.

EPA must make a statutory TSCA Section 4 "A" (Hazard) finding and/or a TSCA Section 4 "B" (Exposure) finding for all TSCA Section 4 test rules.

Because an "A" (Hazard) finding-based Section 4 Test Rule is risk based and chemical exposure is a component of risk, some possibility of exposure must be demonstrated by EPA. However, EPA can rely on inference to establish the possibility of exposure as long as the available evidence (including information obtained from industry) indicates that the probability of exposure is more than just theoretical; exposure component can also be based on non-recurrent or brief exposure if the available evidence indicates that such exposure may pose an unreasonable risk of injury to health or the environment [Note: The 1988 D.C. Circuit Court decision on 2-ethylhexanoic acid TSCA Section 4 Final Test Rule provided guidance to EPA for making the required "A" findings (CMA v. EPA, 859 F.2d 977, D.C. Cir. 1988)]

In 1990, the 5th Circuit Court remanded the TSCA Section 4 Final Test Rule on cumene back to EPA to articulate the criteria the Agency uses to make "B" findings (CMA v. EPA, 899 F.2d 344, 5th Cir. 1990). In response, EPA published the following criteria that form the basis for EPA's policy for making "B" (Exposure)-based findings (58 FR 28736; May 14, 1993):

Substantial production/importation (1 million pounds), and;
Substantial release (1 million pounds or 10% of production/importation), or;
Substantial human exposure (1,000 workers or 10,000 consumers or 100,000 general population), or;
Significant human exposure (Determined on a case-by-case basis)

EPA must make statutory TSCA Section 4 "data inadequacy" and "testing is necessary" findings.

TSCA Section 4 testing must be conducted via EPA-approved test methods/guidelines.

TSCA Section 12(b) export notice requirements are triggered by TSCA Section 4 test rules.

TSCA Section 4 Test Rules

Local Navigation