TSCA New Chemicals Coalition
The TSCA New Chemicals Coalition (NCC) is a forum of company representatives that have come together to share experiences and/or concerns related to new chemical notifications under the amended Toxic Substances Control Act (TSCA). The NCC’s primary goals are: to identify areas in which industry-wide advocacy efforts are needed; and to work collaboratively with the U.S. Environmental Protection Agency (EPA) to address those issues.
New chemical issues are often managed singularly between EPA and the company submitting the notification. While the need for strict confidentiality is essential, this format also places the submitter at a potential disadvantage, since it is advocating policy issues on its own and in a contextual vacuum. The submitter, for example, may have no idea if any particular policy position that is being advanced by EPA is being applied to other similarly situated submitters, if its case is unique, or if other broader considerations are at play. By working together within the NCC, companies can communicate and coordinate as needed on consequential evolving EPA policies, practices, and procedures and will engage in pursing advocacy positions with EPA that have the benefit of informed discussion with other notifiers and EPA staff. NCC is currently working with EPA on its evolving guidance document on points to consider for Section 5 submissions.
Section 5 of TSCA addresses new chemical notifications and, as such, is chemical innovation’s regulatory gatekeeper. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) dramatically amends Section 5. EPA’s interpretation of these amendments has changed significantly the Section 5 review process in ways that none of us fully anticipated; the numbers speak for themselves. Under old TSCA, approximately 90 percent of new chemical notifications entered commerce without restriction. Since Lautenberg, this number is in the 10-20 percent range, a remarkable change given the absence of clear Congressional intent fundamentally to amend the new chemicals program.
The nature of the New Chemicals Program is that there is little, if any, line-of-sight on decisions on individual submissions. EPA makes its determinations based on the factual information set forth in a premanufacture notice (PMN) and additional modeling and assumptions. Given the prevalence of confidential business information (CBI) in new chemical submissions, there is no way, however, for submitters to determine whether EPA’s determinations are consistent. Similarly, it is difficult to discern common approaches to regulation that EPA might be pursuing among structurally similar substances.
A coalition of submitters is far better situated to discuss critical issues and common themes without discussing specific details. These discussions will provide greater insight into EPA’s approaches and offer an opportunity to engage with EPA to find workable solutions that meet TSCA’s statutory obligations without causing avoidable commercial disruption or imposing unnecessary testing burdens.
Bergeson & Campbell, P.C. (B&C®) provides legal counsel to the TSCA NCC. B&C’s staff, unique in the depth and breadth of its TSCA experience, includes highly experienced TSCA experts, both former EPA officials and other experts, who have made a career in TSCA implementation in areas including chemical nomenclature and TSCA Inventory issues, risk assessment, risk management, and other TSCA-related issues. The Board of Directors, comprised of official TSCA NCC representatives, one from each member company/organization, sets priorities for the coalition; a B&C Consortia Management, L.L.C. (BCCM) Manager serves as the TSCA NCC Executive Director.
Membership in the coalition is available for an annual fee of $1,000. Membership is open to individual chemical companies with a vested interest in the EPA new chemical notification process due to commercial impacts related to past, existing, or future new chemical notifications.