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TSCA Section 4 Test Rules

Announcement

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

40 CFR Parts 790 through 799

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):

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.

All test rule or enforceable consent agreement (ECA) submissions to EPA under TSCA section 4 must bear the Code of Federal Regulations (CFR) citation for the test rule or the title of the ECA. All submissions should also bear the docket number for the test rule or ECA. All submissions using the U.S. Postal Service (including those submissions containing confidential business information (CBI)) must be addressed to:

Document Control Office (DCO) (7407M)
Office of Pollution Control and Toxics (OPPT)
U.S. Environmental Protection Agency (EPA)
1200 Pennsylvania Ave., NW
Washington, D.C. 20460-0001
Attn: TSCA Section 4
40 CFR __.__ (Docket # EPA-HQ-OPPT-__-__)

Submissions may be hand-delivered to:

Document Control Office (DCO) (7407M)
Office of Pollution Control and Toxics (OPPT)
U.S. Environmental Protection Agency (EPA)
EPA East Building, Room E6428 (202-564-8930)
1201 Constitution Ave., NW
Washington, D.C. 20460
Attn: TSCA Section 4
40 CFR __.__ (Docket # EPA-HQ-OPPT-__-__)


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