• Any risk management actions would apply only to the condition(s) of use that EPA found to present an unreasonable risk in the final risk evaluation.
• When EPA grants an exemption, it must publish its analysis of the need for the exemption, and also must establish a time limit on the exemption.

There are several actions the Environmental Protection Agency (EPA) can take to address unreasonable risks. These actions, alone or in combination, may include:

• Prohibiting or otherwise restricting, or limiting the manufacture, processing, or distribution in commerce of the substance or mixture.
• Prohibiting or otherwise restricting, or limiting the manufacture, processing, or distribution in commerce of the substance or mixture for a particular use or above a set concentration for a particular use.
• Requiring adequate minimum warnings and instructions with respect to its use, distribution in commerce, or disposal.
• Requiring recordkeeping, monitoring, or testing by manufacturers and processors.
• Prohibiting or regulating the manner or method of commercial use.
• Prohibiting or regulating the manner or method of disposal.
• Directing manufacturers/processors to give notice of the determination of risk to distributors and users and replacing or repurchasing.

Any risk management actions would apply only to the condition(s) of use that EPA found to present an unreasonable risk in the final risk evaluation. Those that EPA found do not present an unreasonable risk will not be subject to risk management.

Exemptions from rules

As amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) of 2016, section 6(g) of the Toxic Substances Control Act (TSCA) authorizes EPA to grant exemptions from rules promulgated under section 6(a). EPA may grant an exemption if the agency finds that:

• An exemption would be necessary to maintain critical or essential uses of a chemical; or
• An exemption would be necessary to avoid significant disruption to the national economy, security, or critical infrastructure; or
• A specific condition of use provides substantial benefits to health, environment, or public safety despite risks associated with the chemical.

Additionally, EPA must exempt replacement parts for “complex durable goods” and “complex consumer goods” designed prior to a rule’s publication in the Federal Register unless the agency finds that such replacement parts contribute significantly to unreasonable risks identified in a risk evaluation. When EPA grants an exemption, it must publish its analysis of the need for the exemption and establish a time limit on the exemption.

EPA rulemakings

Regarding rulemakings, Section 6 directs EPA to:

• Promulgate one or more of the seven regulatory requirements in accordance with the Administrative Procedure Act’s (APA’s) provisions governing agency rulemaking.
• Adhere to additional procedural requirements, such as considering the chemical’s risks and benefits, “reasonably ascertainable economic consequences” of the requirements on the chemical, and alternative regulatory actions.
• Propose a rule not later than one year after publishing the final risk evaluation and finalize the rule not later than two years after publishing the final risk evaluation.
  • Note: EPA may extend these time frames up to two years for chemicals the agency has not already identified as persistent and bioaccumulative.
• Establish mandatory compliance dates that are as soon as practicable but not later than five years after promulgation of the rule, except for uses being exempted.
  • Note: EPA may vary the mandatory compliance dates for different affected persons (e.g., chemical manufacturers, processors, and distributors).
• Issue rules that provide for a reasonable transition period before the mandatory compliance dates become effective.
  • Note: If EPA determines that the manufacture, processing, distribution, use, or disposal of a chemical is likely to present an unreasonable risk before the effective date, EPA may declare a proposed rule to be effective to protect the public interest, in which case compliance with the proposed requirements is mandatory upon the proposed rule’s publication in the Federal Register until the proposed rule is finalized or revoked.

After the enactment of the LCSA, the first EPA rule to prohibit the manufacture, processing, and distribution of a chemical occurred in March 2019. EPA issued a final rule to prohibit the manufacture, processing, and distribution of methylene chloride in all paint and coating removers for consumer use.