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Data Development (Testing)

EPA Agreement Requires Siloxane Environmental Testing Data from Chemical Manufacturers

April 3, 2014 - EPA has entered into an Enforceable Consent Agreement with five manufacturers of octamethylcyclotetrasiloxane (also called D4), which is widely used as a chemical intermediate and component of personal care products. Learn more. Read the Federal Register notice.

As stated in Section 2 of the Toxic Substances Control Act (TSCA), "It is the policy of the United States that adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment and development of such data be the responsibility of those who manufacture and those who process such chemicals and mixtures."

Section 4 of TSCA gives EPA the authority to require chemical manufacturers and processors to test existing chemicals. Under Section 4, EPA can by rule require testing after finding that (1) a chemical may present an unreasonable risk of injury to human health or the environment, and/or the chemical is produced in substantial quantities that could result in significant or substantial human or environmental exposure, (2) the available data to evaluate the chemical are inadequate, and (3) testing is needed to develop the needed data. The Chemical Testing Program in EPA's Office of Pollution Prevention and Toxics (OPPT) also works with members of the U.S. chemical industry to develop needed data via TSCA Section 4 Enforceable Consent Agreements (ECAs) and Voluntary Testing Agreements (VTAs). ECAs and VTAs are usually less resource intensive than formal TSCA rule-making and allow EPA to consider agreed-upon pollution prevention and other types of product stewardship initiatives by the chemical industry as a possible substitute for or adjunct to certain types of needed testing.

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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