“Now this is not the end; it is not even the beginning of the end. But it is, perhaps, the end of the beginning.” —Winston Churchill
Passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act brings significant revisions to the Toxic Substances Control Act (TSCA) — the framework for managing and reviewing chemicals intended for use in commerce in the United States. This was the first substantive amendment to TSCA since it passed in 1976, and it is a significant step in revitalizing a chemicals management program that was widely viewed as outdated and ineffective.
As with much legislation, the devil is in the details, and passage of this legislation does not mark the completion of TSCA reform. The U.S. Environmental Protection Agency (EPA) is now tasked with a prescriptive and aggressively timed “to do” list. How the agency manages and accomplishes its new mandates is the next big step, inviting close scrutiny and regular engagement with the regulated community over the next several years. All companies that manufacture, use, process, import, export or sell products containing chemicals need to understand the new TSCA landscape and evaluate the requirements and potential opportunities that come with it.
So what does TSCA reform entail and what is going to be happening at EPA and in the regulated community as it is implemented?
While there are numerous changes and revisions under TSCA reform, they can be viewed broadly today as: chemicals management and administrative changes. The following is an overview these key changes, including key implementation milestones, and a description of TSCA funding.
Chemicals Management Changes
Under the new guidelines, the EPA must now review every chemical in commerce. The concept of “grandfathering in” chemicals has been retired and the entire TSCA chemical inventory will now be reset. The focus of the chemical review is on intended use and risk of exposure. This revamped chemicals management program will entail:
- Inventory Reset
- Risk Evaluation, including screening assessment and detailed risk reviews
- Risk Management measures
The inventory reset is meant to result in an up-to-date inventory of all chemicals in active commerce and will be built from industry-supplied data. Chemical manufacturers must and processors may report to EPA all chemicals manufactured or processed in the 10 years preceding passage of TSCA reform (back to June 2006). This requirement also covers importers. The EPA has until June 2017 to issue a final rule establishing procedures for the inventory reset. While this final rule will not be finalized until next year, this is an area where companies can begin compiling initial lists and information in advance. It should also be noted that the EPA’s current TSCA Inventory chemical reporting is still in place and is still due between June 1 and September 30, 2016.
Risk evaluation will be conducted in two steps for all chemicals on the reset TSCA inventory. This evaluation will be based on the health, hazard, use and exposure information provided by industry, interested parties and in the information in EPA’s possession. An initial screening assessment to determine whether a chemical may present an unreasonable risk due to potential hazard and potential exposure will be conducted by the EPA. Chemicals will be classified as either low priority and not subject to further regulation, or as high priority and subject to additional risk evaluation. Following the more detailed risk evaluation of high-priority chemicals, those evaluated to “present an unreasonable risk of injury” will be subject to risk management measures such as use restrictions or bans. It should be noted that manufacturers will have the option to conduct and submit their own draft risk evaluations for the EPA’s consideration.
The EPA is required to establish this risk screening, evaluation and management process by June 2017. In addition, the EPA is also required to issue guidance for manufacturers who are planning to conduct their draft risk evaluations by June 2017. The EPA’s likely starting point for these rules and guidance may be its TSCA Work Plan.
TSCA reform also includes a number of administrative changes to the program. Two key items that were long sore points under the old TSCA have been addressed, namely: Confidential Business Information (CBI) and Preemption of state laws. Under the old TSCA, an organization could claim a variety of information in the chemical reporting process as CBI. This designation protects certain proprietary information from disclosure, such as the technical chemical name and the process used to manufacture the chemical. CBI claims under the old TSCA could be broad, did not require significant substantiation and had an unlimited timeframe. However, under TSCA reform, CBI claims will require initial substantiation of the claim (even for chemicals previously claimed as CBI) and must be renewed every ten years. All CBI claims will be reviewed by the EPA one year after the inventory is reset. Another new aspect is that information previously protected can be disclosed to state lawmakers and emergency personnel in the event that it would protect human health and the environment. A key point of consideration for CBI is to understand how the CBI process will be linked to the inventory reset and to be prepared to determine what will be claimed as CBI and how it will be substantiated.
Under the old TSCA, in the absence of explicit federal chemical rules, states developed their own chemical management regulations; some more stringent than others. This resulted in a patchwork of state chemical regulation programs. Part of what held up meaningful reform to TSCA (and why it almost stalled at the last minute) was how to respect states’ rights. State and local preemption under TSCA reform likely halts the growth of this patchwork of different state chemical regulations, while respecting existing programs. Any state action taken before April 22, 2016, is not subject to preemption. In addition, any information collection and reporting requirements, and any action taken according to a state law that was in effect on August 31, 2003 (California’s Prop 65, e.g.), is not subject to preemption. States may still take action up until the EPA publishes the scope of a chemical’s risk assessment. Further, states cannot establish or enforce regulations that would restrict a chemical the EPA has determined does not pose an unreasonable risk.
With those changes in mind, what lies ahead and how will it be funded?
Key Timelines and Milestones
After President Obama signed the law, TSCA reform took effect immediately. Specific timeframes have been set for the EPA regarding implementation. These timeframes are also critical for industry to track closely and impact required review periods and action timeframes on submittals to the EPA.
Key highlights include:
- By December 2016, the EPA must designate ten chemicals to study, and submit a report to Congress with their perceived capacity for risk evaluation and risk management.
- By June 2017, the EPA must:
- Establish a final rule the for the risk evaluation process, including criteria for classifying chemicals as high or low priority.
- Establish a final rule on the TSCA inventory reset
- Establish the Science Advisory Committee on Chemicals (SACC), which will include industry members
- Develop guidance for interested parties to conduct their own risk evaluations
- By June 2018, the EPA must develop policies, procedures and guidelines and determine ways to reduce or replace vertebrate animal testing
- For Pre-manufacture Notices (PMN) and Significant New Use Notices (SNUNs), EPA will have 90-180 days to make an affirmative finding on whether or not the new chemical or use presents an unreasonable risk. During that time period, the chemical cannot enter commerce. If the agency fails to make an assessment in the timeframe, user fees are refunded, but assessment must still be completed
The EPA has expanded authority to collect fees under TSCA reform. These are to be reasonable and specifically used to cover a portion of TSCA costs to the agency. The fees will apply to chemical manufacturers and processors who are submitting data under Sections 4 and 5 of TSCA. However, the fee structure has not yet been established. No fees can be collected until the EPA has consulted with the parties subject to the fees and established the fees by rule. This will require public notice and comment periods. In the short term, the EPA administrator has been granted the authority to redirect FY 2016 budget to support TSCA reform. Over the longer term, it will be important to track future EPA budgets for TSCA implementation, as well as the new fee setting process. With aggressive deadlines and significant technical work tied to TSCA reform, following the money and related critical staff additions will be an important part of evaluating TSCA reform implementation and its impact on the regulated community.
So, say goodbye to a 40-year-old set of regulations that, by the end of its time, had probably outlived its effectiveness. At the same time, say hello to a new way of regulation that has just begun to evolve into a 21st century approach to thoughtful chemical management.
For more information about how TSCA reform could affect your company, download NAEM’s webinar “What You Need to Know about the TSCA Reform Bill”, featuring Amy Duvall, Sr. Director of Federal Affairs for the American Chemistry Council, Mark Heaney, Vice President of Alter Echo and Josh Shear, Regulatory Analyst with Alter Echo. This webinar is a free benefit of NAEM membership.