It has been just over three months since the Frank R. Lautenberg for Chemical Safety for the 21st Century Act, or what some are calling the new Toxic Substances Control Act (TSCA), was enacted. Upon enactment on June 22, 2016, the Environmental Protection Agency (EPA) immediately started carrying out some of its mandates.
For one, EPA started using new criteria prescribed by law on new chemical pre-manufacture notices (PMNs), which now require an affirmative finding of safety. This also included PMNs that were submitted prior to enactment, but pending expiration of the 90-day review period. The new law requires an affirmative review and determination of whether a new chemical presents, may present, or is unlikely to present an unreasonable risk of injury to health or the environment. Manufacturers can expect increased delays, at least in the short term, and potentially more consent orders and significant new use rules (SNURs).
EPA is also taking a closer look at what constitutes confidential business information (CBI). The new law requires EPA to review all chemical identity (CBI), and 25 percent of most other CBI, and then make a determination as to whether the claims are valid. Manufacturers will continue to get default CBI protection on their new chemical notices until they decide to commence manufacture. But, at that point, EPA will be taking a closer look at the claims. Manufacturers should be prepared to defend them. There are a number of questions companies will have to answer, and they will have to certify their substantiations are accurate.
Furthermore, EPA has already started developing rules on processes for prioritization and risk-evaluation of existing chemicals, a new fee structure and an inventory reset. Proposed rules are expected to come out in mid to late December with final rules expected in June 2017.
As EPA continues to implement the new TSCA, much of how its success or failure will depend on resources and how they are allocated. Some of the resources will come from industry. Twenty-five percent, or $25 million of program costs, whichever is the lower, will come from industry. Industry stakeholders should expect EPA to attempt to recover $25 million since program costs and overhead are expected to exceed $100 million in the years to come. The fees will be used for section 4, 5, 6 and 14 activities, but there likely will be increased pressure on companies subject to actions under Sections 5 and 6 to generate much of the $25 million.
This creates somewhat of a dilemma. If EPA puts too much focus on section 5 new chemicals and attempts to get smaller businesses to foot more of the bill, innovation could be negatively impacted. We could see a significant decline in the number of new chemicals introduced, particularly by smaller companies. This is a direction we do not want to go. But, EPA will need adequate resources to review chemicals in commerce expeditiously, which should, over time, enhance public confidence.
Balancing the fee structure will be no easy task, but SOCMA is confident EPA will pay close attention to small business concerns and consider incentives for innovation and come up with an equitable structure that gets them the resources they need to carry out the law.
Stay tuned for more on TSCA implementation in SOCMA’s blogs and webinars. Be sure to participate in the upcoming Chemical Risk Management Committee meeting on November 1 and the SOCMA Annual Dinner on December 5. Also, stay tuned for more on GlobalChem 2017, the premier chemical regulations conference.
For more information on TSCA implementation, contact Dan Newton at email@example.com, or (202) 721-4158.