TSCA 2.0: Are Comparisons to Pesticide Regulation Instructive?

There is a widely-shared criticism of how new chemicals are regulated under TSCA. TSCA Section 5 requires a Pre-Manufacturing Notice (PMN) for both new chemicals and proposed new uses of chemicals already on the market. The PMN need not be accompanied by comprehensive health data on the compound, merely that information already in the possession of the applicant. This leaves industry without a strong incentive to compile a robust data set, and the resulting information gaps impair EPA’s ability to make informed judgments about the safety of a given chemical.

Both the House and Senate TSCA bills would substantially toughen PMN and review, requiring applicants to provide a "minimum data set" about the chemical and potential health and environmental impacts. Manufacturers and processers would for the first time have the responsibility of identifying or generating research needed to complete this data set or risk losing access to the marketplace.

Proponents of the bill argue that stringent data collection and review of new chemical products have been features of federal pesticide regulation for decades, and that this has not unduly burdened the crop protection industry or the agriculture sector. This analogy was made by Rep. Frank Pallone (D-NJ) at the July 29 subcommittee hearing on H.R. 5820.

The pre-market screening of pesticides under the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) and related statutes is undoubtedly stringent. Registrants must be prepared to provide studies on carcinogenic, neurological, developmental and reproductive effects, as well as information on fate and transport, persistence, and metabolic byproducts. Another essential element of the petition is an assessment of exposure to humans and other non-target organisms.

In light of these requirements, the agency itself acknowledges that “depending on the class of pesticide and the priority assigned to it, the review process can take several years.” Despite this, U.S. regulation of pesticides is generally viewed as a success, a point often made by those drawing comparisons to TSCA modernization.

But is this comparison apt? Pesticides present a relatively contained range of exposure scenarios, including exposed agricultural workers, contaminated groundwater, and pesticide residues on crops.

In contrast, the chemicals that would be governed by a revised TSCA present multiple routes of exposure, and the interaction of these various exposures must be modeled and aggregated to make meaningful decisions about chemical use. Further, a reworked TSCA is virtually certain to require modeling of exposures by vulnerable populations such as children and the elderly, something that is not required for pesticides.

The net result could be a registration process with a complexity that resembles REACH rather than FIFRA, one that will delay market access for some chemicals by years, and discourage others from being commercialized at all. Such an outcome might be tolerable for some mundane products and uses. But for components of lifesaving technologies such as medical devices and time-to-market critical products like smartphones, is our society prepared to accept such a delay?