TSCA: Pre-Manufacture Notification and Review

TSCA reform promises to significantly alter the chemical marketplace. Contemplated changes will have a profound impact on all industries that manufacture, distribute, modify or utilize chemicals, articles or mixtures. Recognizing the magnitude of this potential impact, Science News & Views intends to provide substantive monitoring and analysis as the legislative process proceeds. Today, we will examine the current and proposed system of pre-manufacture notification and review of chemicals, a controversial aspect of the existing statute.

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Section 5 of existing TSCA prohibits the manufacture, processing, or import of a “new chemical substance” or “significant new use” of an existing substance unless a pre-manufacture notification (PMN) is submitted to EPA at least 90 days in advance.

Section 5 does not currently require a submitter to conduct testing before submitting a PMN, but merely to provide any information on health or environmental effects that are in its possession. During the 90-day review period, EPA is to utilize this and other information to determine whether the chemical “may present an unreasonable risk of injury to health or the environment,” and if so, to request more data, prohibit or limit manufacture, or halt the review process. In practice, the dearth of data accompanying submissions impairs the agency’s ability to make informed judgments about the safety of a given compound. Reform advocates cite this as a key weakness of the existing statute.

The proposed bills would toughen the Section 5 PMN and review process. Both the House and Senate would subject new chemicals and uses under Section 5 (as well as existing chemicals under Section 6) to the requirement of a “minimum data set.” This data set would consist of the chemical’s identity, physical characteristics, toxicological properties, hazard, exposure and use, along with other information that EPA establishes by rule. Indications are that the agency will require data on both traditional endpoints such as carcinogenesis and mutagenicity, and also emerging concerns such as bioaccumulation, environmental persistence and endocrine disruption.

The current presumption that a chemical is appropriate for the marketplace in the absence of an “unreasonable risk” or “insufficient data” finding will be inverted. Instead, a six-month to one-year review of the application will be triggered unless EPA affirmatively finds that the chemical is “reasonably anticipated” to meet safety standards.

Manufacturers and processers will have the responsibility of identifying or generating research needed to complete the data set for a new chemical or new chemical use, effectively shifting the “burden of proof” to them. They would also be responsible for updating data submissions to reflect new information. Both bills would give EPA the power to compel testing by administrative order and to specify appropriate methodologies. The House bill would allow the agency to to assess fines for non-compliance.

The PMN and minimum data set provisions will likely be the subject of debate and modification, particularly the timetables for implementation. Recent changes to chemical regulation in Europe help illustrate this point. The REACH law imposed similarly aggressive benchmarks for generation and submission of test data. This approach has proved to be impractical, time-consuming and expensive to implement.

Are we on a similar path with a new TSCA?

Clearly early engagement with legislators to help craft a smart and effective chemical regulation, one that protects human health and the environment in a cost-effective, rational manner, is critical.