The US EPA has identified a total of five persistent, bioaccumulative and toxic chemical substances that must be assessed for their impact to human health and the environment, based upon their intended, known or “reasonably foreseen” conditions of use, per the authority granted under the Toxic Substances Control Act (TSCA), Section 6(h). The outcome of the eventual determination will then be used to potentially impose further regulation on these so-called “PBT” substances. In the meantime, EPA is accepting public comment to help shape their decision, and recently extended the submission deadline to January 12, 2018.
Whether you manufacture, import, process or formulate products using one of the five listed PBTs flagged for expedited risk assessment under TSCA 6(h), the impact to your operation, as well as to product labels and Safety Data Sheets (SDS) may be significant, if EPA determines that further risk management is necessary. Because EPA is now considering not only the effects of exposure to general users of the substance but also reasonably foreseen effects on special populations, such as those “potentially exposed” and those identified as particularly “susceptible” (e.g. infants or pregnant women)—further risk management appears likely.
In its most severe form, further risk management by EPA could lead to phase-outs or a ban on the use of the PBT substances under review; less severe outcomes include new use restrictions and controls to limit exposure. New use restrictions and controls, while a more facile outcome, will likely impact product labeling and SDSs, requiring significant new language on each, as well as the resources necessary to implement these changes. Automated software-driven solutions will play a key role in helping enterprises prepare to address these seemingly imminent changes.
Consult with our compliance experts for more information.