The U.S. Senate and House of Representatives have passed the long-pending Toxic Substances Control Act (TSCA) reform legislation, which will bolster the government’s power to regulate a wide variety of chemicals. The bill amends TSCA for the first time in 40 years to ensure that only human and environmental health are considered in assessing the safety of chemicals. Under the new bill, known as the Frank R. Lautenberg Chemical Safety for the 21st Century Act, all chemicals in commerce will be reviewed by U.S. EPA to consider—without regard to cost or benefits—their health and safety impact. The legislation also shifts the burden and cost of evaluating and regulating chemicals to manufacturers, along with imposing new fees. EPA’s oversight of chemicals manufactured, sold or distributed in the U.S. will be greatly expanded, as will be the processes by which chemicals may be approved. The reform legislation will now be sent on to President Obama, with every expectation he will sign it.
So what does this mean to manufacturers? First, the bill establishes for the first time a mandate for EPA to review the risks of chemicals in active commerce, eliminating the grandfathering-in of chemicals then in use without a risk review. The regulation of existing chemicals will be bifurcated into two steps: (1) risk evaluation of a chemical and (2) risk management of chemicals found to be problematic. The first step in deciding whether regulation is warranted is to conduct a scientific evaluation of the risks without regard to cost or benefits. If EPA concludes the chemical’s use presents an “unreasonable risk,” EPA is required to issue a risk management rule. The rule may range from requiring labeling or notice requirements to putting into effect an outright ban on the use of the chemical. To the extent practicable, the cost and benefits of the rule and the cost effectiveness of the regulation must be considered as a factor, but is not determinative.
In identifying high priority chemicals, EPA will give preference to chemicals that are persistent and bioaccumulative and those that are known human carcinogens, as well as chemicals stored near significant sources of drinking water.—Sandra A. Edwards
For new chemicals, EPA will be required to review and make an affirmative finding about the level of risk posed without regard to cost. And indeed, the chemical may not be commercially produced until EPA rules on it, and it cannot be produced without being in compliance with EPA restrictions on that chemical. EPA must make a determination about, and choose the regulation for, a chemical within 90 days, but no later than 180 days if more time is needed.
The essential steps of the review process are:
- Companies will be required to identify all chemicals they are currently making or processing.
- EPA will establish the priority of active chemicals.
- High priority chemicals – those EPA determines present an unreasonable risk – will undergo full safety assessment and safety determinations. For any chemical that does not meet the safety standard, EPA must impose restrictions sufficient for the chemical to meet the safety standard; where restrictions cannot ensure the safety standard will be met, EPA must ban or phase out the chemical.
- In identifying high priority chemicals, EPA will give preference to chemicals that are persistent and bioaccumulative and those that are known human carcinogens, as well as chemicals stored near significant sources of drinking water.
- To the extent sufficient information exists, EPA may conclude a chemical is likely to meet the safety standard, and is therefore a “low priority” chemical.
The legislation requires EPA to collect fees for both new and existing chemicals, and those designated as high priority. Companies will pay 100% of the costs of risk evaluations they request, and the fees will go into a TSCA Implementation Fund and directly to EPA.
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Notably, the bill will allow EPA to issue an order requiring testing, rather than having to promulgate a rule, avoiding the multi-year process typically associated with rulemaking. Testing authority applies to both new and existing chemicals, and in limited instances may also be applicable to the prioritization process. Historically, the rule making and consent agreement processes were lengthy and slow, so that EPA is likely, going forward, to simply order a test.
Several provisions of the bill also alter the handling of Confidential Business Information (CBI) in ways that will impact manufacturers. Companies seeking to protect the specific chemical identity of a chemical substance will be required to submit a notice to EPA substantiating the confidentiality of the chemical compound, and substances for which no notification of CBI are received will be placed on the non-confidential portion of EPA’s §14 database list of regulated chemicals. The bill requires EPA to develop a retroactive review plan for evaluating whether chemicals on the existing list require CBI protection, or whether they can be placed on the non-confidential portion of the list.
The issue of preemption was one of the sticking points in the effort to reform TSCA. The result, and one way in which the new legislation differs from the existing TSCA, is that if EPA decides a chemical does not present an unreasonable risk and requires no regulatory action, that decision preempts state laws that may contradict that finding. Preemption of state and local law begins when EPA defines the scope of a risk evaluation, and ends either 30 months later or when the risk evaluation is completed, whichever is earlier. This does not restrict the state from enforcing a law enacted prior to risk evaluation, and federal preemption applies only to the scope of the risk evaluation and to the significant new uses under Section 5 of the Act. There are additional exceptions for, among other things, existing state laws and regulations.
Until the legislation is signed into new law, there may be further changes to the bill. I will provide a further update once the final legislation is released.
