Under New Safety Law, 20 Toxic Chemicals EPA Should Act On Now: What the New Chemical Safety Law Will Do
By Melanie Benesh, Legislative Attorney
The nation’s new chemical safety law promises to make big changes in the way the Environmental Protection Agency regulates existing chemicals. But the devil will be in the details.
When Congress enacted the Toxic Substances Control Act in 1976, it grandfathered in more than 60,000 known chemicals already in commerce. The law exempted the substances on this list, known as the TSCA inventory, from any initial EPA review and from the requirement that chemical makers notify the EPA when they begin manufacturing or importing a new chemical.
Once a new chemical has gone through the notification process, it is added to the TSCA inventory, now numbering about 85,000 chemicals, many of which are no longer in use.
Chemicals on the TSCA inventory are regulated under TSCA Section 6, a weak and ineffectual part of the law rarely invoked by regulators. Since TSCA was passed, the agency has used its authority to attempt to ban or restrict only five grandfathered substances, on account of their danger to human health and the environment: asbestos, polychlorinated biphenyls, chlorofluorocarbons, one member of the dioxin family and hexavalent chromium. In four of these cases, the EPA achieved some restrictions under TSCA or other environmental laws.
In the fifth case, that of asbestos in 1991, the U.S. Court of Appeals for the Fifth Circuit overturned the EPA’s ban of the cancer-causing substance on grounds that compliance would be too costly for the industry. This case set a dangerous precedent, requiring the EPA to find the “least burdensome” solution for the industry and undertake onerous cost-benefit calculations before issuing regulations. The agency stopped trying to regulate existing chemicals under Section 6 until recently.
The new law, The Frank R. Lautenberg Chemical Safety for the 21st Century Act, takes the unprecedented step of requiring the EPA to evaluate the safety of chemicals already on the TSCA inventory. A new Section 6 lays out this review process in four phases: prioritization, risk evaluation, risk management and implementation.
The prioritization section requires the EPA to designate chemicals as either high or low priority. The agency must give high priority to chemicals that could pose an unreasonable risk to Americans' health or to the environment. It can assign chemicals less likely to meet its safety criteria. lower priority. To determine priority, the EPA must consider:
- Does the chemical build up in people’s bodies or persist in the environment?
- Are vulnerable populations like children, pregnant women, the elderly and workers exposed?
- Is the chemical stored near significant sources of drinking water?
- How is the chemical used, and in what volume?
- What is the hazard and exposure potential?
The substances most likely to be investigated first are the 90 chemicals on the EPA’s TSCA Work Plan, a priority list of substances that known to pose risks. Within that list, EPA must give special priority to chemicals that build up in people’s bodies and persist in the environment, are known human carcinogens, or have high acute and chronic toxicity. Half of all the chemicals EPA designates as high priority must come from the TSCA Work Plan.
Once the EPA begins to consider whether a chemical is high or low priority, it has nine to 15 months to decide if the chemical could pose an unreasonable risk to the public or the environment. If the agency gives the chemical low priority, it does not have to take further action. If it gives the chemical high priority, it must launch a risk evaluation.
Evaluations of risks and regulations
Within 180 days of the new law’s effective date – June 22 – the EPA must have chosen 10 Work Plan chemicals for risk evaluation. After three and a half years, EPA should be in the process of evaluating 20 high-priority chemicals, and must have relegated 20 more chemicals to the low-priority list.
What we don’t know is how the EPA will conduct its risk evaluations: The law says the agency must establish the process through rulemaking within one year. Each time the EPA starts a risk evaluation, it must define within six months the hazards, exposures, conditions of use and potentially exposed vulnerable populations to be considered. The EPA has three years to complete each risk assessment, with a possible six-month extension.
If the risk assessment process concludes that a chemical meets the EPA’s safety threshold, the agency won’t issue regulations. But if it does not meet that threshold, the EPA is required to draft regulations restricting that chemical’s use. The EPA has one year to propose regulations and two years to finalize them, with a possible two-year extension only for chemicals not on the Work Plan.
The EPA must then publish a statement that addresses the health and environmental effects of the proposed rule, the magnitude of exposure, benefits for various uses and the “reasonably ascertainable” economic consequences of restrictions.
To determine the economic effects, the law says the EPA must look at effects on the national economy, small businesses, technological innovation, the environment and public health, as well as the costs and benefits and cost-effectiveness of both the proposed regulation and at least one other alternative regulation. The EPA must consider whether there are “technically and economically feasible” alternatives to the proposed regulation.
The final phase of the process is implementation. Each regulation promulgated under Section 6 is supposed to take effect as soon as practicable, but within five years at most. The law makes an exception, however, for the most draconian proposals, which would to ban or phase out chemicals entirely. Because taking a chemical off the market can be complicated, the law allows the EPA to start the process within five years but does not set a deadline for a ban.
Persistent bioaccumulative chemicals
So-called PBTs – Work Plan chemicals that are persistent, bioaccumulative and toxic – get more aggressive treatment. EPA must propose regulations for these chemicals within three years of the law’s enactment. The law gives the agency 18 months to seek comment and finalize a regulation. After that, it gets five years to implement the new regulation. If the agency is proposing to ban or phase out the chemical, it gets an indefinite window in which to act.
The new law should mean federal regulation of more chemicals. But there's a tradeoff: EPA action on a chemical could prevent states and local governments from adopting their own regulations. In the past, frustrated with the slow pace of EPA action, some states took the lead in restricting or banning harmful chemicals. State regulations in place before the new federal law took effect will remain in force. In the future, once the EPA begins reviewing a chemical and has defined the scope of review a state cannot take action until EPA’s risk evaluation is complete, although it can seek a waiver allowing state and local level regulation.