On December 20, 2019, the U.S. Environmental Protection Agency (EPA) released an updated “Working Approach” document that builds upon its November 2017 version. The EPA states that the updated version, “TSCA New Chemical Determinations: A Working Approach for Making Determinations under TSCA Section 5,” explains its approach for making affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA). This article highlights key changes in the document.
When Congress amended TSCA in 2016, it modified the review process for introducing new industrial chemicals into commerce. Previously, the EPA had the legal burden of demonstrating that a new chemical substance presents an unreasonable risk. Most new chemicals reviewed escaped regulation, and the review was generally completed within the statutory 90-day window. Under the new TSCA, the EPA must make one of five determinations:
• The chemical presents an unreasonable risk of injury to health or the environment;
• Available information is insufficient to make a reasoned evaluation of the health and environmental effects associated with the chemical;
• In the absence of sufficient information, the chemical may present an unreasonable risk of injury to health or the environment;
• The chemical 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 chemical; or
• The chemical is not likely to present an unreasonable risk of injury to health or the environment.
The updated document reflects on a 2017 public meeting, comments and the EPA’s further experience implementing the 2016 amendments. It includes additional clarification and detail throughout, general guiding principles and concepts for making determinations, and decision-making logic and key questions the EPA must address.
The document accurately reflects the EPA’s current approach to reviewing new chemicals and is a significant improvement over the earlier version. The EPA has reiterated that its decisions are and will continue to be based on risk, without consideration of cost or other non-risk factors, rather than only hazard. In response to stakeholder requests, the EPA includes a detailed explanation of how it determines conditions of use as intended, known and reasonably foreseeable. This explanation gives submitters more clarity to the EPA’s thinking, and provides the EPA a system to justify and document its views.
In addition, the agency expands on how it interprets “sufficient information.” The document states required testing will be “structured to reduce and replace vertebrate animal testing to the extent practicable and scientifically justified.” The EPA also confirms it will continue to take a tiered testing approach, following the standard practice for risk assessments. Some stakeholders criticized the EPA’s move from requiring testing in every order it issued in 2016–2017 to rarely requiring testing in 2019. The current practice of including “potentially useful” information in orders or significant new use rules (SNUR) represents an appropriate balance between the EPA’s requirement to make a determination on the unreasonable risk for permissible conditions of use and its likely need for additional information to inform a determination for the conditions of use prohibited by the order or SNUR.
The EPA also explains its approach to worker protection. In reviewing a premanufacture notice (PMN), the EPA considers worker exposures, including considerations of engineering controls, and calculates potential worker exposures absent personal protective equipment (PPE). If the EPA finds potential unreasonable risk without PPE, then it evaluates whether PPE would sufficiently mitigate exposures so as to pose no unreasonable risk. The EPA then relies upon the Occupational Safety and Health Administration (OSHA) to compel employers to inform employees of the hazards, train those employees in proper PPE use, and require that employees take the steps necessary to protect themselves. As OSHA violations for gloves, goggles or general dermal protection are quite rare (less than 1% of violations) among the 12 million violations OSHA has issued, the EPA seems to agree this meets the statutory criteria of “not likely to present unreasonable risk under the [reasonably foreseeable] conditions of use.”
The EPA’s efforts to ensure transparency in its policies and practices is commendable. All TSCA stakeholders benefit in understanding more clearly the agency’s approach.
LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at [email protected]
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006). The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.