Editor's Note: One session of the Educational Speaker Showcases at SOCMA's 95th Annual Dinner will focus on Toxic Substances Control Act (TSCA) Implementation for the C-Suite. Below SOCMA Government Relations Senior Manager Dan Newton shares insight into the types of issues specialty chemical manufacturers may face under the new law.
We have all had those aha moments….and, they can run the gamut. But for science geeks like chemists, it may be a new application for an existing chemical in commerce, or a completely new substance or formulation that has amazing functionality. Whatever it may be, for anyone who wants to get into the business of chemistry he/she will likely need to be familiar with the new Toxic Substances Control Act (TSCA), the Lautenberg Act, and be prepared to navigate a much more rigorous regulatory paradigm. Since TSCA is the default statute covering just about all chemical applications that are not covered by more narrowly focused ones like the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) or the Federal Food, Drug, and Cosmetic Act (FFDCA), there is a good chance the latest and greatest chemistry idea will fall under the purview of TSCA.
Now that the Environmental Protection Agency (EPA) has enhanced authority to regulate chemicals in commerce, it has taken a much more precautionary approach with new chemical submissions. Getting a new chemical into commerce may not be quite like it used to be, at least that’s the way it seems since enactment of the new TSCA law on June 22, 2016. It would be very unfortunate if the new chemicals program, commonly known as the Pre-manufacture Notification (PMN) process, gets hamstrung since this is the part of TSCA that stakeholders, including EPA, agreed had worked so well over many years. It is also where greener chemistries have emerged. If there becomes a bias towards existing chemicals, the success of new TSCA could arguably become questionable. EPA should be reminded that it has many more tools available to address existing chemicals, and it could be disincentivizing the development of greener and safer chemistries by making it harder to enter the market. If there was ever a time to be more precautionary with new chemicals, it was before TSCA reform, before it had the tools to address existing chemicals.
Perhaps on the flip side of things, if one is able to get into the market under EPA’s more precautionary approach, the higher barrier to entry could spell higher rewards. But, that makes it harder for small businesses and this is where so much innovation occurs. The growth of a company oftentimes depends on developing new chemicals, and new chemical development involves the proper timing of release and market opportunities. More than ever companies must be aware of the new process and procedures required by new TSCA. One of the most significant of these requirements has proven to be the EPA’s new chemical notification process.
If EPA continues to implement the new chemicals section as it has been over the past five months, there could be a dramatic impact in the business of chemistry and the ability for entrepreneurs and small businesses to enter the market.
For better or for worse, time will tell how implementation plays out, and SOCMA plans on sharing experiences and comments with the agency as it hones its new process. EPA is forging ahead on new turf, so stakeholders need to be engaged. There is a learning curve for everyone involved, and nothing has been set in stone, yet. SOCMA sent a letter to EPA outlining some concerns with the new process and plans to attend a public stakeholder meeting the agency is convening on December 14, 2016. Chemical manufacturers are encouraged to attend.
To learn more about TSCA implementation, we also invite you to attend the Educational Speaker Showcase at SOCMA’s 95th Annual Dinner. Jamie Conrad, Founder and Attorney with Conrad Law and Policy Counsel, and Beth Bosley, President of Boron Specialties, Inc., will discuss TSCA Implementation for the C-Suite. Anyone interested in meeting the decision-makers in the specialty chemical sector should register to attend.