By Maria Doa, PhD, Senior Director, Chemicals Policy, and Colin Parts, Legal Fellow
NOTE: This is the fourth in a series about EPA’s regulation of new chemicals. See below under Go Deeper for links to the other blogs in the series.
What Happened?
The Environmental Protection Agency (EPA) recently proposed new regulations for its safety reviews of new chemicals under our nation’s primary chemicals law, the Toxic Substances Control Act (TSCA). One of these proposed provisions would govern how EPA can change the restricted approvals it issues for new chemicals that may pose unreasonable risks. EPA’s proposed approach would limit the type of stakeholders involved and the potential for stronger chemical regulations.
Why It Matters
The proposed changes would allow only the submitting chemical company—which has a vested interest in reducing restrictions on those who produce or import the chemical under review—to present additional information that could loosen existing prohibitions or limitations on a new chemical.
In effect, EPA is proposing to allow these submissions only if the information indicates that the chemical is less risky than previously thought and the restrictions should be loosened or eliminated.
Our Take
- This unidirectional outlook fails to account for the possibility that new data could require stronger regulations. For instance, if new testing indicates that a chemical poses greater risks to public health or the environment than initially understood, there should be mechanisms in place for tightening regulations. EPA has failed to propose any regulations that would allow it to consider this type of new information.
- The provision also falls short by failing to consider input from a broader range of stakeholders. When it comes to regulating new chemicals, many voices should be heard—not just those who produce or import the chemical. The current EPA proposal makes no mention of considering data or findings from scientific researchers, health advocates, labor unions, other governmental agencies, or the public.
- This insular approach is not just worrying—it is contrary to the principles of open governance and evidence-based policymaking. It narrows the pool of data to what is submitted by companies, who might aim to present information in a light most favorable to them.
- EPA already has the statutory authority under TSCA to modify orders to be more stringent, consistent with general agency powers recognized by courts. Therefore, it is surprising that the agency’s recent proposal does not reflect this balance. In contrast to the regulations’ one-way ratchet, the agency already uses more balanced language in its standardized approval documents, stating it may alter orders based on any “new or existing” information.
To uphold its mission, EPA must revise its proposed regulations. Specifically, it needs to expand its scope to consider data from all interested parties, not just chemical companies. It must also keep the door open for strengthening chemical regulations based on new, credible data.
EPA should also clarify the circumstances under which chemical regulations could be revised. The process must be transparent, offering public notice and an opportunity for comment. This would ensure that regulatory decisions are made on a more holistic set of information and would allow for adjustments (in either direction) that are based on the latest scientific understanding of the risks a chemical poses.
EPA should retain its focus on protecting public health and the environment, rather than accommodating industry needs. EPA has the tools and the mandate to protect the public; it should ensure its regulations are crafted to do just that.
Go Deeper
Read our blogs on improving EPA’s process for reviewing new chemicals.
Follow these links to read the other blogs in the series:
- #1: Time for a New Age for New Chemicals
- #2: EPA: Now’s Your Chance to Get Foxes Out of the Henhouse
- #3: New Chemicals Rule: EPA must require more info from industry
- #5: EPA’s New Chemical Regulations: Backtracking on PBTs
- #6: EPA’s New Chemical Review Process: A Thought Experiment
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