888.656.EXPO | [email protected]| www.exponent.com “New TSCA” Rules Provide Opportunities for Proactive Companies to Help Shape Initial Outcomes __________________________________________________________________________________________________________ Environmental Perspectives Newsletter – June 2017 Authors – Michael W. Kierski, Ph.D., Jane P. Staveley, M.S.P.H., Elaine L. Freeman, M.S. DABT, and Angelina Duggan, Ph.D. The U.S. Environmental Protection Agency (EPA) proposed three new rules in January 2017 that address some of the key legislative requirements of “New TSCA.” By understanding how these rules work, and how they work together, companies affected by these new rules can work proactively with EPA to shape initial outcomes related to the chemicals they manufacture. Under the recently reformed Toxic Substances Control Act, or “New TSCA” (known formally as the Frank R. Lautenberg Chemical Safety for the 21st Century Act, or LCSA), EPA mandates new guidance for regulating existing chemicals in commerce. “New TSCA” requires EPA to identify which chemicals must be considered as a first step, and then prioritize those that require further risk evaluation as a second step. If EPA finds a chemical to be “high risk” as part of the risk evaluation process (third step), there are a number of possible ramifications for manufacturers of that chemical, including the possibility of restricting or banning the chemical. The two initial steps, as outlined in the Inventory and Prioritization Rules recently proposed by EPA, present companies with opportunities to work with EPA by providing information to the Agency up front, potentially avoiding the need for further evaluation using the proposed formal Risk Evaluation Rule process. Under the “New TSCA,” EPA’s three new proposed rules related to existing chemicals in the marketplace are: • Inventory Rule 40 (40 CFR Part 710 [EPA–HQ–OPPT–2016–0426; FRL–9956–28]; RIN 2070–AK24) • Prioritization Rule (40 CFR Part 702 [EPA–HQ–OPPT–2016–0636; FRL–9957–74]; RIN 2070–AK23) • Risk Evaluation Rule (40 CFR Part 702 [EPA-HQ-OPPT-2016-0654; FRL-9957-75]; RIN 2070-AK20) Figure 1 depicts how the three proposed rules would work together in practice. The Inventory Rule explains the process EPA will use to determine which of the existing chemicals in commerce need to be evaluated for their relative risk under the “New TSCA.” The Prioritization Rule outlines the process EPA proposes for ranking the relative risk of chemicals currently used in commerce. A chemical identified as high risk under the Prioritization Rule will require a formal evaluation to determine whether the chemical presents an unreasonable risk to human health and the environment based on its use. The prepublication copy of the Risk Evaluation Rule explains the process EPA is proposing to determine if a chemical is associated with an unreasonable level of risk.
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“New TSCA” Rules Provide Opportunities for Proactive Companies to Help Shape Initial Outcomes __________________________________________________________________________________________________________
Environmental Perspectives Newsletter – June 2017 Authors – Michael W. Kierski, Ph.D., Jane P. Staveley, M.S.P.H., Elaine L. Freeman, M.S. DABT, and Angelina Duggan, Ph.D. The U.S. Environmental Protection Agency (EPA) proposed three new rules in January 2017 that address some of the key legislative requirements of “New TSCA.” By understanding how these rules work, and how they work together, companies affected by these new rules can work proactively with EPA to shape initial outcomes related to the chemicals they manufacture. Under the recently reformed Toxic Substances Control Act, or “New TSCA” (known formally as the Frank R. Lautenberg Chemical Safety for the 21st Century Act, or LCSA), EPA mandates new guidance for regulating existing chemicals in commerce. “New TSCA” requires EPA to identify which chemicals must be considered as a first step, and then prioritize those that require further risk evaluation as a second step. If EPA finds a chemical to be “high risk” as part of the risk evaluation process (third step), there are a number of possible ramifications for manufacturers of that chemical, including the possibility of restricting or banning the chemical. The two initial steps, as outlined in the Inventory and Prioritization Rules recently proposed by EPA, present companies with opportunities to work with EPA by providing information to the Agency up front, potentially avoiding the need for further evaluation using the proposed formal Risk Evaluation Rule process. Under the “New TSCA,” EPA’s three new proposed rules related to existing chemicals in the marketplace are:
• Inventory Rule 40 (40 CFR Part 710 [EPA–HQ–OPPT–2016–0426; FRL–9956–28]; RIN 2070–AK24)
• Prioritization Rule (40 CFR Part 702 [EPA–HQ–OPPT–2016–0636; FRL–9957–74]; RIN 2070–AK23)
• Risk Evaluation Rule (40 CFR Part 702 [EPA-HQ-OPPT-2016-0654; FRL-9957-75]; RIN 2070-AK20)
Figure 1 depicts how the three proposed rules would work together in practice. The Inventory Rule explains the process EPA will use to determine which of the existing chemicals in commerce need to be evaluated for their relative risk under the “New TSCA.” The Prioritization Rule outlines the process EPA proposes for ranking the relative risk of chemicals currently used in commerce. A chemical identified as high risk under the Prioritization Rule will require a formal evaluation to determine whether the chemical presents an unreasonable risk to human health and the environment based on its use. The prepublication copy of the Risk Evaluation Rule explains the process EPA is proposing to determine if a chemical is associated with an unreasonable level of risk.
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Companies can work with EPA in advance by providing them with the most complete information available so that EPA can more accurately apply the processes in the Inventory and Prioritization Rules to rank the relative risk of chemicals and determine which ones require further evaluation using the Risk Evaluation Rule process. A proactive company can also work through the rule process themselves to gain insights on their own chemicals ahead of EPA’s review, so they can make more informed risk management decisions about the chemicals they manufacture. Inventory Rule Process – The Inventory Rule process is analogous to the Step 1 process implemented by EPA in the TSCA Work Plan document published in February 2012, which lays out a process to determine which chemicals must be evaluated further in terms of their relative risk (Figure 2). Specific exclusion criteria are used to remove some chemicals from further consideration. These include chemicals that do not meet the intent of the prioritization criteria (e.g., chemicals considered as generally safe, such as common oils or fats or simple plant extracts), that were not subject to action under the former TSCA, or that were already the subject of former TSCA action. Since EPA’s focus for existing chemicals is on those whose manufacture and sales will continue, companies can help to shape the list of chemicals under consideration by providing EPA with up-to- date information about the chemicals they produce. The proposed Inventory Rule provides a process to reset the former TSCA inventory list of chemicals, including both a retrospective 10-year look back from June 21, 2016, to determine what chemicals are being actively manufactured, and should therefore be on the “New TSCA” inventory list as active, and a forward-looking component to determine which chemicals currently listed as inactive or not listed should be added to the “New TSCA” inventory list because of plans for future manufacturing. Chemicals on the “New TSCA” inventory list need further consideration under the proposed Prioritization Rule. Providing EPA with the most accurate information on chemical production can allow EPA to delist chemicals they may now still consider candidates for evaluation under the Prioritization Rule if manufacturing is no longer planned. It will also allow EPA to add other chemicals to the “New TSCA” inventory list that may have otherwise been excluded because of misinformation or lack of information on the manufacturing of the chemical. It is important that processors ensure chemicals vital to their businesses remain on the Active Inventory so they are evaluated as required by “New TSCA.”
Figure 1. Flow chart showing how the three new rules—Inventory, Prioritization, and Risk Evaluation—work together.
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Figure 2. Inventory Rule – Conceptual Overview of Process (aka TSCA Work Plan Step 1 Process) Prioritization Rule Process - The risk prioritization process ranks a chemical as high, medium, or low risk based on metrics of hazard and exposure. The Prioritization Rule process as embodied in the TSCA Work Plan document (Feb. 2012) uses a three-metric process (hazard, exposure, and persistence/bioaccumulation scores) to evaluate the relative risk of chemicals. Figure 3 presents a conceptual overview of this relative risk ranking process. The process considers exposure as a critical component to the relative risk of a chemical. Even if a chemical has a high hazard, it will not necessarily be scored high risk if the exposure to the chemical is very low. The Prioritization Rule that EPA will use to determine chemical risk rank is not new; the guidelines for the Prioritization Rule Process are presented in the TSCA Work Plan document, which is available now. Companies can apply the Prioritization Rule process themselves to determine the relative risk rank (high, medium, or low) their chemical might receive from EPA. The application of the Prioritization Rule process provides meaningful information to support the sustainable production of your chemicals. For example, the process can identify data gaps that may need to be filled to address the relative risk of some of your chemicals. It may also provide information that can help you determine if the continued production of certain chemicals is in the company’s best interest. Importantly, lack of data will increase the relative risk rank of a chemical in EPA’s process; therefore, identifying and addressing data gaps regarding your chemicals upfront is critical before EPA proceeds with the prioritization process.
Figure 3. Prioritization Rule – Conceptual Overview of Prioritization Process (aka TSCA Work Plan Step 2 Risk Prioritization Process)
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How Exponent Can Assist
Exponent’s multi-disciplinary scientific and regulatory consultants have extensive experience in all aspects of product stewardship for chemical manufacturing companies. We are well versed in the development of relative risk ranking systems for portfolios of chemicals that incorporate both tailored exposure and hazard assessments, and we have gained valuable expertise through client work related to chemical inventory evaluations and chemical exposure assessments. Exponent can help you evaluate your chemicals to determine if significant data gaps exist that may prevent risk ranking, evaluate the potential for chemical exposure, and determine the probable relative risk rank of your chemicals under “New TSCA.”
