• In implementing the 2016 TSCA amendments, EPA has considerably slowed the Pre-Manufacture Notice (PMN) and Significant New Use Notice (SNUN) review processes.
• The PMN and SNUN review processes now result in an exceptional number of Notice submitters being asked to “voluntarily” suspend the review process to respond to EPA information and data requests, often times seeking information heretofore not necessary for the Agency to conduct its assessment under Section 5 of TSCA.
• Such delays have made the review process unpredictable, untimely, and unnecessarily restrictive, yet without clearly enhancing public safety nor reducing environmental risk.
• With time, the unpredictable and unnecessarily restrictive nature of EPA’s New Chemicals Program review process will inhibit chemical innovation in the US and encourage offshore manufacturing and processing, depriving American citizens of important new technologies and eventually jobs.
• Newer chemical specialty products often represent innovative new chemistries that are produced using improved manufacturing and processing techniques that reduce risks, exposures and energy use. Discouraging the introduction of these new products by delaying market entry and imposing unnecessary testing costs will impede commercial use of such risk-reducing products and their methods of manufacture and processing in the US.
EPA can implement changes to its New Chemicals Program review process that will avoid delays resulting from its implementation of the program while still permitting EPA to meet deadlines and the requirement to make a finding pursuant to Section 5(a)(3) with respect to a PMN or a SNUN which is under review. The changes would involve: a) encouraging PMN submitters to use the “Binding Option” box on the PMN Form, and b) EPA timely issuing “short form” Section 5(e) Consent Orders if necessary, which can be enhanced through the use of “follow-on Significant New Use Rules” (SNURs).
ACI supports the Agency’s efforts to review new chemical substances and significant new uses in accordance with the amended Section 5 of TSCA. To address delays, ACI recommends the Agency commits the focus of the statutory 90-day review period to assessing and reaching a determination based on the intended conditions of use described in the Section 5 Notice EPA receives.