This is Part I of a two-part series looking at the recent changes to the TSCA legislation. This article will explore the changes introduced by the Act. A follow-up article will explore the EPA’s recently released plan for implementing these changes.
On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the “Act”), which significantly amended the Toxic Substances Control Act (“TSCA”). See https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act. As has been widely reported in the press, the Act significantly enhances TSCA and gives EPA additional authority to regulate chemicals in commerce.
Evaluation of Chemicals
For the first time, EPA must make an affirmative finding on the safety of a new chemical or significant new use of an existing chemical before the chemical (or new use) is allowed in the marketplace. EPA can impose restrictions as a condition for approval or prohibit the manufacture, processing, or distribution of the chemical altogether.
Existing chemicals will be prioritized (high priority and low priority) based on risk to human health or the environment, including to susceptible populations. This categorization cannot consider cost or other non-risk factors. High priority chemicals will then need to undergo a risk evaluation. Low priority chemicals do not need to be evaluated unless the manufacturer requests it.
To determine if there is an unreasonable risk to human health (including to susceptible populations) or the environment, chemicals will be evaluated against a new risk-based safety standard. This evaluation cannot consider cost or other non-risk factors. EPA can request testing as part of the prioritization or evaluation process without first having to demonstrate the presence of an unreasonable risk.
Addressing Unreasonable Risk
If unreasonable risks are identified, EPA must take a final risk management action (e.g., ban, phase-outs, or other restrictions). In choosing what actions to take, EPA can consider cost and availability of alternatives, but the agency is no longer required to choose the least burdensome action.
Confidential Business Information
The Act makes it harder to obtain and keep protection for Confidential Business Information (CBI). For example, claims of confidentiality must be substantiated and certified. EPA is required to review all new requests for protection from disclosure of the specific chemical identity of a chemical substance, as well as at least 25% of all other requests for disclosure protection. EPA also is required to review certain past claims to determine if CBI protection is still warranted. CBI protection expires after 10 years, at which time the manufacturer must re-substantiate its claim. CBI protection generally does not apply to chemicals for which the agency issues a ban or phase-out.
Other Changes
- More stringent requirements and deadlines put in place for chemicals considered to be Persistent Bioaccumulative Toxics.
- New reporting requirement for chemicals in commerce for the last 10 years so that EPA can classify chemicals in TSCA inventory as active or inactive.
- Funding for implementation provided via new fees associated with reviews, notices, and evaluations.
- Existing state requirements (prior to 4/22/16) are grandfathered. State action allowed if EPA has not addressed the specific chemical, but preempted once EPA finds that the specific chemical is safe or takes final action to address risks. States can ask for exemption to preemption.
- The Act creates additional requirements for mercury export and disposal.
- The Act increases the monetary amount of civil and criminal penalties. The Act also adds criminal liability for knowing endangerment.
Many of these changes will require further rulemaking before they are fully implemented. Therefore, the full impact on regulated entities will not be known until the agency proposes specific rules. Part II of this series will explore EPA’s immediate plan for implementation of these changes.
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