Dioxin: Legislative DevelopmentsJuly 20, 2016 | |
Updated Toxic Substances Control Act Will Have Broad Impact on Chemical Manufacturers, Other Businesses, and Consumers
An update to the federal law known as the Toxic Substances Control Act has been passed by Congress and signed into law by President Obama. Among other things, the new law, known as the Frank R. Lautenberg Chemical Safety Act for the 21st Century, is intended to make it easier for the federal Environmental Protection Agency (“EPA”) to review chemicals already on the market, as well as new chemicals, focusing on the risks they present to health.
The Toxic Substances Control Act (the “TSCA”), which was enacted in 1976, is the fundamental federal law regulating the manufacture, processing, distribution in commerce, use, and disposal of chemical substances. It gives the EPA the authority to review new chemicals before they are manufactured, to gather information on existing chemicals in commerce, and to regulate unreasonable risks to health and the environment from industrial chemicals in commerce.
Over the years, many in the chemical industry, the business community, consumers, and legislators became disenchanted with certain provisions of the TSCA and with its implementation.
The new law is named for the late Frank Lautenberg, the former Senator from New Jersey who introduced TSCA reform legislation in five consecutive Congresses and who was an ardent proponent of modifications to the TSCA during his lifetime.
The legislative history indicates that Congress intends that the new law “enhance confidence in the federal chemical regulatory system, provide EPA the authority necessary for efficient and effective regulation of chemical risks, and foster safety and innovation in commercial chemistry.”
According to the legislative history, the new law was “designed to ensure that the competitive advantage of the U.S. chemical industry is not eroded by regulatory mandates and that industry is subject to a more consistent set of regulations that equally protect citizens across the nation.” It “reauthorize[s]” and “modernize[s]” the TSCA.
The significance of the new law cannot be overstated. It applies to chemicals that are used in everything from automobiles, cleaning agents, and fabrics to plastics and paint thinners.
The law’s major provisions:
- Require the EPA to develop policies, procedures, and guidance to address the process for testing and evaluating the safety of chemical substances;
- Authorize the EPA to obtain new information on chemical substances from manufacturers and processors at all stages of the safety evaluation process;
- Require the EPA to establish and implement a risk-based prioritization process to screen all chemicals now in use;
- Address when federal actions under the TSCA preempt requirements of state and local governments related to restricting and banning chemical substances;
- Require the EPA to update its process for reviewing industry requests that information submitted to the agency be kept confidential; and,
- Require the EPA to establish a new schedule for charging fees to chemical manufacturers that are required to submit data to the agency or that request that the EPA assess certain chemicals that are not yet prioritized for review by EPA.
The new law introduces a number of important new terms to the TSCA, including “conditions of use.” This term, used throughout the new law, means the “intended, known, or reasonably foreseeable circumstances” under which a chemical substance is manufactured, processed, distributed in commerce, used or disposed of. The term does not include “intentional misuse” of chemicals.
Under the new law, in the context of a safety assessment (that is, an assessment of the risk posed by a chemical substance under the conditions of use that must precede the EPA’s safety determination) and safety determination, if conditions of use suggest differential exposures to one or more groups of individuals or the conditions of use impact individuals who are more susceptible, the EPA must take those exposures into account and establish risk management measures necessary and sufficient to protect those populations.
Importantly, the definition does not mean that in applying the safety standard, the EPA is required to protect each susceptible “individual” in the population or groups of individuals in all safety assessments and determinations. Rather, in safety assessments and determinations in which a population is relevant, the EPA is to protect that population as well as the population as a whole from “unreasonable risk.”
Moreover, the new law requires the EPA to consider reasonably available information about potential hazards and exposures of a chemical substance under the conditions of use when making decisions under the TSCA. It also gives the EPA the authority to require testing when needed to ensure decisions are based on sufficient information.
The new law also provides the EPA with broad authority to obtain new information on chemical substances at all stages of the safety review and evaluation process (for new chemicals; in limited circumstances for prioritization; for safety assessments and safety determinations of existing chemicals; and for any necessary risk management rulemaking) and for export notification purposes.
The Chemical Review Process
A new section of the TSCA modifies the new chemical review process by requiring that the EPA make the determination that a new chemical substance or a significant new use is likely to meet the safety standard before it can be commercially manufactured or processed. The new section also prohibits manufacture or processing of a new chemical or significant new use found not likely to meet the safety standard except in compliance with any conditions or restrictions imposed by the EPA sufficient to ensure likely safety.
Under the TSCA before its amendment, the EPA’s authority to find unreasonable risk and regulate a chemical substance has been interpreted to require the consideration of cost and benefits as part of fundamental decisions on safety. The new law requires that the EPA conduct a risk-based safety assessment and make a risk-based safety determination of each high-priority substance – without taking into consideration costs or other non-risk factors. In other words, the EPA must determine that a chemical substance meets the safety standard, or not, based solely on risk to human health and the environment – the integration of hazard and exposure information about a chemical – and not on the basis of other factors such as consideration of the costs or benefits of the substance or of possible restrictions on the substance.
Confidential Business Information
The new law amends the TSCA to make several important modifications to the process by which confidential business information (“CBI”) can be protected against disclosure or disclosed. In general, the law balances the need for protection from disclosure for information qualifying under the exemption in the Freedom of Information Act (“FOIA”) for “trade secrets and commercial or financial information obtained from a person and privileged or confidential” with the needs to ensure access to such information under appropriate conditions by those who need it to perform their duties, and to maximize public availability of health and environmental information relating to chemical substances in commerce.
The law alters current preemption rules in a number of ways, while making clear that preemption under the new law does not apply to tort claims. Now, state actions regarding testing, the notification of significant new uses, and the restriction of high-priority substances for which the EPA has completed a safety determination and either has found that the substance meets the safety standard, or has found that it does not meet the safety standard and has completed a final risk management rule, are preempted, to the extent the same uses and conditions of use are included in the scope of the EPA action. For example, if the EPA has completed a safety assessment and safety determination for a chemical substance and finds the chemical substance meets the safety standard, that action preempts state restrictions on that substance only for the uses and/or conditions of use included in the EPA review. If the EPA implements risk management requirements on a chemical substance, that action also would preempt state restrictions on that chemical substance, but only those state restrictions that apply to the same uses or conditions of use addressed by the EPA’s rule.
Under the new law, states must notify the EPA when they propose or take administrative action or enact a law to prohibit or restrict a chemical that the EPA has not designated as a high-priority. If certain conditions are met, the EPA must conduct a prioritization screening for the substance.
Finally, the new law imposes a number of deadlines on the EPA. For example, it must establish an initial list of at least 10 high and 10 low priority substances within 180 days of enactment. Within three years of enactment, the EPA must have designated additional high-priority substances sufficient to ensure that at least a total of 20 high-priority substances have undergone or are undergoing safety assessments, and additional low-priority substances sufficient to ensure that at least a total of 20 low-priority substances have been so designated. These numbers are to increase to at least 25 high- and low-priorities no later than five years after enactment.
The new law also requires the EPA to develop any necessary policies, procedures, and guidance not later than two years after the law’s enactment and requires that the EPA review its policies, procedures, and guidance every five years and update them to reflect emerging science. It also establishes a new Scientific Advisory Committee on Chemicals to provide the EPA with independent scientific advice.
Less specifically, the EPA now is required to “strive” to complete the prioritization process of all chemicals in active commerce in a “timely manner,” taking into account the resources available to complete safety assessments and determinations.