December 10, 2019
Sr. Manager, Regulatory Affairs
My name is Jared Rothstein, and I am Senior Manager of Regulatory Affairs at SOCMA, the specialty chemical association. We appreciate the opportunity to make this statement regarding EPA’s efforts to implement the New Chemicals program under amended TSCA.
SOCMA acknowledges and is grateful for EPA’s ongoing work to resolve the backlog of new chemical notices, to streamline the review process for submissions, and to adopt more realistic assumptions about workplace protections. However, we continue to hear from our members that the current program still lacks predictability and transparency. Submitters continue to face the dilemma of being asked by the Agency to suspend the statutory review deadline for their application. Their only choice is to agree to the suspension request or to withdraw their submission entirely. SOCMA members report that EPA often provides no guidance regarding the basis of the suspension, leaving submitters unable to expedite review or resolve concerns with their specific case.
Altogether, these practices are greatly impeding the introduction and commercialization of new chemicals, and therefore impeding innovation. Companies always face some commercial risk that a new chemistry will not turn an adequate profit. The uncertainties and delays created by the new chemicals program only increase that risk and lead many companies to forego opportunities to create new substances. Their customers, and our economy, also lose in these cases.
The problems I have described also afflict EPA’s review of low volume exemption requests, thus bottling up a historically important pathway to the marketplace for new chemistries. In fact, the LVE review process has disproportionately suffered, as EPA has shifted staff focus on PMNs.
SOCMA strongly urges the agency to return to a screening level risk assessment of new chemical applications and continue to work toward ensuring all PMNs and LVEs complete review by the applicable deadline.