In July, the U.S. Environmental Protection Agency (EPA) published a proposed test rule under Section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA) that would require manufacturers, importers and processors of certain high-production volume (HPV) chemicals to conduct testing. That EPA is renewing its focus on chemical testing, and use of its authority under TSCA Section 4 is noteworthy for the majority of the manufacturing industry.

Chemical Testing
Under TSCA Section 4, EPA can require manufacturers, importers, and in some cases processors of chemical substances to conduct testing of any chemical substance or mixture for which EPA makes certain findings. Under the law, EPA must find that “there are insufficient data and experience upon which the effects of [the] manufacture, distribution in commerce, processing, use or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted,” and testing is necessary to develop the data.

EPA must also find that the chemical substance or mixture may present “an unreasonable risk” to human health or the environment or that it is produced in substantial quantities that could result in substantial or significant human exposure or environmental release.

While Manufacturing Today readers in all cases may not be subject to this TSCA Section 4 test rule or any others, your company may distribute and/or use a chemical substance or mixture included within the scope of this rule, and others like it expected in the future. It is, therefore, important to be mindful of the implications of a TSCA Section 4 test rule, none of which are particularly favorable.

In general terms, once EPA has made a TSCA “finding,” inferences adverse to the chemical substance and, potentially, to industrial and consumer products made from the chemical substance, may follow. Certainly, if the chemical is used in industrial settings, worker exposure, health and safety implications can be expected to arise. If the chemical substance is a component of consumer products, it is reasonable to assume concerns with potential consumer exposures to the chemical substance will follow.  All such concerns are at the expense of the commercial vitality of the chemical substance.

Depending on the nature of the concerns underlying the need for additional data and thus the issuance of the TSCA Section 4 test rule, there are several possibilities. Identified data needs may be relatively specific and finite, and the manufacturers will satisfy them without much fanfare.

If more robust data needs are involved, manufacturers may seek to persuade EPA that development of only some data is needed and agree to develop those data, and be excused from other data requirements. In other situations, manufacturers may be unwilling or unable to develop the data EPA believes are necessary, decline to develop the data and decide to withdraw from the market. If others in the value chain decline to step up and develop the data, the chemical substance may simply vanish from the domestic market. Downstream users in all these circumstances had better be prepared for whatever option proves to be the controlling one.

Proposed Rule
According to the notice, EPA has preliminarily determined that each of the 19 chemicals included in the proposed rule is produced in substantial quantities and that there is or may be substantial human exposure to each of them; there are insufficient data to determine reasonably or predict the effects on health or the environment of the manufacture, distribution in commerce, processing, use or disposal of the chemicals, or of any combination of these activities; and the testing program proposed is necessary to develop such data. EPA states that data developed under the proposed rule “will provide critical information about the environmental fate and potential hazards associated with these chemicals which, when combined with information about exposure and uses, will allow the agency and others to evaluate potential health and environmental risks and to take appropriate follow-up action.” Persons who export or intend to export any chemical substance included in the final rule would be subject to the export notification requirements in TSCA Section 12(b)(1) and at 40 C.F.R. Part 707, Subpart D.