New chemical review: What are the 5 possible results?
Before a new chemical substance can enter the marketplace, it first travels through the New Chemicals Review Program. Section 5 of the Toxic Substances Control Act (TSCA) requires the Environmental Protection Agency (EPA) to review new chemicals for any unreasonable risk of injury they may pose to human or environmental health. The agency determines (a) whether the substances can enter the marketplace and (b) if they require restrictions to manage any unreasonable risk.
To manufacture (including import) a chemical for commercial purposes that’s not on the TSCA Chemical Substance Inventory (i.e., a new chemical), you have to submit a premanufacture notice (PMN) to EPA. In December 2024, EPA finalized the new chemicals review rule. It clarifies that when you submit a PMN, you may not manufacture the new chemical substance until the agency issues a safety determination and completes any associated actions (like developing rules to limit its use).
Start the PMN process by conducting your own review! Evaluate and prepare for the possible determinations EPA will make for your new chemical substance.
Safety determinations
Submitting a PMN sparks the beginning of the new chemicals review process. EPA completes the review process by making one of five possible safety determinations for the new chemical.
It’s important to note that three types of determinations fall under the scope of Section 5(e) actions. If EPA makes any determination under Section 5(e), it must issue a Section 5(e) order with requirements that limit or ban the manufacture, processing, distribution in commerce, use, or disposal of the new chemical. Examples include toxicity testing, personal protective equipment for exposed workers, and environmental release restrictions.
Let’s take a look at each one.
Section 5(a)(3)(C): Not likely to present an unreasonable risk
In the most straightforward scenario, EPA can find that the new chemical isn’t likely to pose an unreasonable risk.
In this case, the agency will notify you and publish its findings in the Federal Register. Once you receive the Section 5(a)(3)(C) notice from EPA, you may begin manufacturing the new chemical substance, even if the applicable review period isn’t over.
Section 5(f): Presents an unreasonable risk
The agency may find that a new chemical presents an unreasonable risk of injury.
It will use Section 5(f) to limit or ban the manufacture, processing, distribution in commerce, use, or disposal of the new chemical through either:
- A proposed rule that takes immediate effect, or
- An issued order.
Section 5(e): Insufficient information
The agency may determine that it doesn’t have enough information to make a “reasoned evaluation” of the new chemical’s impact on health and the environment.
EPA will issue a Section 5(e) order with restrictions to mitigate or eliminate the unreasonable risk.
Section 5(e): May present an unreasonable risk
If EPA doesn’t have enough information, it can alternatively determine that the new chemical poses an unreasonable risk due to insufficient information.
The agency will issue a Section 5(e) order with restrictions to mitigate or eliminate the unreasonable risk.
Section 5(e): Presents unreasonable risk due to quantity
On the other hand, EPA may determine that the new chemical will be produced in substantial quantities that could (a) be released in large amounts to the environment or (b) result in significant human exposure.
EPA will issue a Section 5(e) order with restrictions to mitigate or eliminate the unreasonable risk.
Regulatory action
In December 2024, EPA finalized changes to the rule for new chemical reviews. It clarifies that the agency must make one of five statutory determinations for each PMN, significant new use notice, and microbial commercial activity notice it receives.
The final rule also:
- Eliminates full review exemptions for per- and polyfluoroalkyl substances (or PFAS) as well as for persistent, bioaccumulative, and toxic (PBT) chemicals if environmental releases of or potentially unreasonable exposures to PBT chemicals are expected;
- Clarifies the information required in new chemical notices;
- Changes EPA’s procedures for reviewing notices with incomplete information or errors;
- Updates the application form on the EPA Central Data Exchange; and
- Streamlines the suspension request process for submitters.
Key to remember: EPA reviews each new chemical and makes one of five possible safety determinations that dictate both if and how the substance can enter the marketplace.