A New World for New Chemicals
Yesterday, the U.S. Environmental Protection Agency (EPA) announced a major change in its approach to reviewing new chemical submissions. This seismic shift will likely lead to the vast majority of premanufacture notification (PMN) submissions receiving orders from EPA under Section 5 of the Toxic Substances Control Act (TSCA). Chemical manufacturers and their downstream users should prepare for the new world that they are about to encounter.
EPA’s announcement identified two specific changes that will overhaul how EPA reviews, approves, and regulates new chemicals.
First, EPA unequivocally stated that it will issue orders when EPA lacks sufficient information to determine whether a new chemical is likely to present an unreasonable risk and when a new chemical may present an unreasonable risk. No longer will EPA rely on proposed Significant New Use Rules (SNURs) as a basis to conclude that these uses are not likely to present unreasonable risks, thereby rendering orders unnecessary. EPA had previously deployed non-order SNURs when the PMN submitter lacked information on reasonably foreseen conditions of use and could not include data to support a “not likely” determination on these uses. Because EPA is likely to take an expansive interpretation of “reasonably foreseen,” submitters should anticipate that EPA will consider any conceivable use of a chemical to be “reasonably foreseen.” Combining this broad interpretation of “reasonably foreseen” with EPA’s intention to use orders when it lacks sufficient information, it is safe to say that there will be a dramatic shift in the proportion of orders that EPA will issue. We may see a return to the early days of 2016 Lautenberg Act implementation where 80-90% of PMNs received orders. But it does not end here.
Second, EPA also announced that it will simply no longer assume that companies will protect their workers with the appropriate personal protective equipment (PPE)—even if the submitter already uses such PPE and failure to do so would violate the Occupational Safety and Health Administration’s regulations. This means that if EPA determines that a new chemical would present an unreasonable risk to workers in the absence of PPE, EPA will now issue an order requiring the submitter to provide prescribed levels of PPE to its workers and subsequently will promulgate a SNUR to apply to all other entities that manufacture or use the chemical. Therefore, EPA’s new assumption—that companies might not adequately protect their workers, regardless of whether they actually provide the requisite PPE—will increase the number of orders even more.
Finally, it is important to keep in mind EPA’s desire and ability to issue unilateral orders. EPA’s announcement mentioned that the agency “remains committed to meeting statutory deadlines for review and determinations on new chemical submissions.” In isolation, this would have been welcomed news. In light of the other changes in the announcement, however, this statement could translate into unilateral orders if submitters are not willing sign consent orders within the statutory 90-day deadline for EPA to make a final determination.
If unilateral orders become more prevalent, submitters may be left with no other recourse than filing lawsuits to challenge EPA’s determinations under TSCA Section 5. They could also try to sue EPA over this policy announcement—before receiving an adverse Section 5 order. Notably, a reviewing court may be persuaded by the fact that no one has been able to demonstrate that EPA’s now-rescinded approaches ever undermined environmental protection or public health. If anything, they strengthened it. Therefore, the courts may be willing to right the ship on EPA’s announced actions, which threaten to undermine TSCA’s express policy of removing unnecessary economic barriers to technological innovation and encouraging the use of safer chemicals.