TSCA and the Proposed Chemical Safety Improvement Act

The majority of chemicals in use today have not been screened for safety or regulated under the Toxic Substances Control Act (TSCA), making the Act considered to be largely ineffective. The proposed Chemical Safety Improvement Act (CSIA) would revamp and modernize TSCA by requiring all existing and new chemicals to be screened for safety and then regulated if necessary. Introduced by the late Senator Lautenberg (D-NJ) and Senator Vitter (R-LA), the CSIA appears to have considerable bipartisan support, having won praise from both industry and environmental advocates. Although the CSIA is viewed by many as an improvement over TSCA, some argue that the bill does not go far enough to protect human health and the environment. TSCA was enacted in 1978 to provide the Environmental Protection Agency (EPA) with the authority to examine the risks a chemical poses before it enters the market and to regulate those chemicals that present an “unreasonable” risk of harm to human health or the environment. Yet TSCA empowers EPA to call for safety testing and subsequent regulation only after evidence surfaces demonstrating that a chemical may pose a risk of unreasonable harm. As a result, EPA has only required testing for roughly 200 of the more than 84,000 chemicals currently registered in the U.S. The agency has banned only five substances since TSCA was first enacted (PCBs, CFCs, dioxin, asbestos, and hexavalent chromium). Under the CSIA, however, EPA would be required to publish a list of active chemicals and then conduct a prioritization screening of all active chemicals, designating each substance as a “high” or “low” priority. High priority chemicals have the potential to be particularly hazardous or widespread, while low priority chemicals are likely to meet the CSIA “safety standard.” During the prioritization phase, EPA cannot require manufacturers to submit relevant data, a decision some stakeholders criticize because they believe it hinders accurate prioritization. Yet unlike TSCA, which treats the lack of data as supporting a presumption of a chemical’s safety, limited data could be a reason under the CSIA to give a chemical a high priority designation. The CSIA would require EPA to conduct a “safety assessment” of all high-priority substances and make a “safety determination” as to whether the substance poses an unreasonable risk of harm to human health or the environment. This safety standard appears similar to the TSCA standard, but TSCA requires EPA to conduct a cost-benefit analysis in applying the standard, whereas the CSIA would require the assessment to be risk-based only. In conducting the assessment, EPA would retain the authority to require testing of a substance through rulemaking, as well as through an order or consent agreement under the CSIA. The use of orders and consent agreements will make it easier for EPA to require testing of a chemical substance, and could lead to more frequent testing. Similar to TSCA, the CSIA would give EPA a toolbox of options with which to regulate a substance once it determines that a substance does not meet the safety standard. Options include labeling requirements, production limits, or an outright ban. Yet under the CSIA, EPA would no longer be restricted to the least burdensome option if it decides to regulate a substance. Only if the Agency seeks to ban or phase out a chemical does it need to conduct a cost-benefit analysis. The CSIA would largely retain TSCA’s procedures for reviewing new substances, with one primary difference. Under TSCA, if EPA does not take action within 90 days of a pre-manufacturing notice or significant new use notice (which manufacturers must file before they manufacture a new chemical or manufacture an active chemical for a significant new use), a manufacturer can commence production. But under CSIA, a manufacturer would need an affirmative decision from EPA that the substance is “likely” to meet the safety standard before it could bring the substance to market. As under TSCA, manufacturers who want certain information to be confidential—namely the safety assessment or health data of a chemical—would be allowed to submit a claim justifying why the company is entitled to confidentiality. Yet the CSIA would require that manufacturers substantiate their claims by showing that the company has taken reasonable measures to protect the information and that information disclosure would likely cause substantial competitive harm. This substantiation requirement may make it more difficult for manufacturers to obtain confidentiality. The CSIA also would significantly expand EPA’s preemption of state chemical regulation. Under TSCA, a state is preempted from regulating a chemical that EPA has required testing for or has regulated. Since EPA did not test or regulate many chemicals under TSCA, states have had room to regulate chemicals. But the CSIA would preempt state and local regulation of chemicals that EPA has screened for prioritization, which will include all active chemicals in the market. This preemption expansion is disconcerting to critics who point out that the CSIA does not have specific timeliness requirements. Those critics argue that states will be unable to step in and enact regulation if EPA does not take meaningful action on a high priority substance for some time. Other critics of the CSIA charge that the bill fails to mention environmental justice or emphasize the disproportionate exposure of certain individuals, including pregnant woman, children, minorities, and low-income communities. The CSIA would give EPA greater authority to regulate chemicals. Under the proposed regime, EPA must screen all chemicals for safety, conduct a risk-based assessment of high-priority chemicals, and regulate chemicals which do not meet the safety standard. However, critics raise concerns about the bill given its expansive preemption, lack of timeliness requirements, and failure to emphasize environmental justice. At the least, this bill shows that the U.S. chemical industry recognizes the need for more effective chemical regulation, and stakeholders on all sides are working towards that end