On December 4, the U.S. Environmental Protection Agency (EPA) finalized amendments to the regulations that govern the Agency’s review of new chemicals under the Toxic Substances Control Act (TSCA). The Agency aims to ensure new per- and polyfluoroalkyl substances (PFAS) and persistent, bioaccumulative, and toxic (PBT) chemicals with potential for human exposure are subject to the full safety review process before manufacture. Under TSCA, EPA reviews the potential risks of new chemicals before they can enter U.S. commerce and, when necessary, putting safeguards in place to protect human health and the environment.
Final Rule Eliminates PFAS and PBT Exemptions
The final rule eliminates eligibility for a low volume exemption (LVE) or low release and exposure exemption (LoREX). Existing regulations allow EPA to grant safety review exemptions for the manufacturing of chemicals with low production quantities, environmental releases or human exposures. These exemptions allowed the chemicals, some of which historically have included some PFAS, to undergo a shorter review instead of the full, robust review prior to manufacture.
Align Federal Regulations with Existing Law
Under TSCA, manufacturers (including importers) and processors must submit premanufacture notices (PMNs) for new chemical substances, significant new use notices (SNUNs) for significant new uses, and microbial commercial activity notices (MCANs) for microorganisms with commercial applications. Prior to the 2016 amendments, EPA only made formal safety determinations on approximately 20% of new chemical submissions.
The new law requires EPA to make one of five possible safety determinations on 100% of new chemical submissions before they can enter the market. If EPA determines…
ONE: a new chemical substance or significant new use presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation under the conditions of use, the Agency must take action under section 5(f) to protect against the unreasonable risk.
TWO: the available information is insufficient to allow the Agency to make a reasoned evaluation of the health and environmental effects of the new chemical substance or significant new use, EPA must issue an order under section 5(e). A section 5(e) order prohibits or limits the manufacture, processing, distribution in commerce, use, or disposal to the extent necessary to protect against an unreasonable risk, and may include testing requirements.
THREE: in the absence of sufficient information, the manufacture, processing, distribution in commerce, use or disposal of the chemical may present an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the EPA Administrator, EPA must issue an order under section 5(e). A section 5(e) order prohibits or limits the manufacture, processing, distribution in commerce, use, or disposal to the extent necessary to protect against an unreasonable risk, and may include testing requirements.
FOUR: the substance is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the substance, EPA must issue an order under section 5(e). A section 5(e) order prohibits or limits the manufacture, processing, distribution in commerce, use, or disposal to the extent necessary to protect against an unreasonable risk, and may include testing requirements.
FIVE: a new chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation under the conditions of use, the Agency will notify the submitter and the submitter may commence manufacture of the chemical or manufacture or processing for a significant new use notwithstanding any remaining portion of the 90-day review period. EPA will notify the submitter of its decision and publish its findings in a statement in the Federal Register.
This rule amends the regulations by specifying that EPA must make one of the five specified statutory determinations on each PMN, SNUN, and MCAN received before the submitter may commence manufacturing or processing the new chemical substance. The rule also updates the regulations to list the actions required in association with each of those determinations.
The Agency feels these amendments align the regulations with TSCA section 5 requirements to reflect the full extent of new chemicals review, providing consistency and transparency in new chemicals review processes.
Change to Chemicals Review Process
The final rule also makes several other changes to the new chemicals review process, including clarifying the level of detail needed in new chemical notices and amending the procedures for EPA’s review of notices that have errors or are incomplete. EPA is changing its longstanding practice of accepting amended notices that contain information that was known or reasonably ascertainable at the time of the original submission and then accepting a request to suspend the review period. Instead, EPA will now exercise its authority under the regulations to declare the original submission incomplete and restart the review period when the completed submission is received.
Industry will provide complete submissions for review through a new set of information “pick-lists” that will be incorporated into the application form located in EPA’s Central Data Exchange in a phased approach. EPA feels this will help submitters provide all the necessary information, so that EPA can assess risk more quickly and accurately.
This rule will go into effect 30 days after publication in the Federal Register. A prepublication version of the rule is available here.
