• EPA’s 90-day new chemicals review process for active cases under review includes eight key stages, from pre-submission to final determination.
• If EPA fails to make a determination, fees may be refunded.

The PMN Program to review new chemicals under the Toxic Substances Control Act (TSCA) has evolved into an efficient mechanism for identifying those new chemicals which are of greatest concern early on in the 90-day review process. A detailed analysis is focused on these cases with the ultimate goal of identifying and controlling unreasonable risks.

EPA uses an integrated approach that draws on knowledge and experience across disciplinary and organizational lines to identify and evaluate concerns regarding health and environmental effects, exposure and release, and economic impacts. EPA’s new chemicals review process for active cases under review includes the following key stages:

1. Pre-submission — Companies are encouraged to contact EPA’s new chemicals program to set up a “pre-notice consultation” to discuss their new chemical submission and understand the agency’s review process. EPA has developed a “Points to Consider When Preparing TSCA New Chemical Notifications” document to assist submitters with the preparation of their submissions. EPA’s predictive tools and models are publicly available and used to estimate releases to the environment, environmental fate, exposures to workers and the general population, and hazards. These models and user manuals explain the procedures and provide the default parameters when notices do not provide specific information.
2. Incoming cases — A pre-screen occurs before risk assessment begins. During this step, submissions are reviewed for administrative completeness and to ensure that all required technical information concerning chemical identity has been submitted. EPA has issued regulations at 40 CFR 720.45 and 720.50, which describe the specific information that must be included in the notice form. EPA will check if the notice is required, is incomplete and/or contains errors pursuant to regulations at 720.62 and 720.65. Failure to include the specific information required by the regulations may result in EPA declaring the submission incomplete and suspending its review. EPA may declare a submission incomplete at any time during the review period where the circumstances warrant doing so under these regulations.
3. Risk assessment — EPA conducts a full life-cycle risk assessment of the substance. Chemistry, environmental fate, exposure, and hazard (human and ecological) assessments are performed and integrated to determine whether the chemical poses an unreasonable risk to human health or the environment under the conditions of use. For case counting purposes, the submission is included as a “Risk Assessment” case during this step.
4. Risk characterization — EPA chemical program managers advise submitters of the initial risk assessment findings. Submitters may elect to provide clarifying information to EPA and/or to amend their PMN if risks have been identified in the risk assessment stage. When this happens, a case may change status from Risk Characterization back to Risk Assessment. EPA uses any additional information provided by submitters, where appropriate, to revise the initial risk assessment. During this step, for case counting purposes, the submission is still included as a “Risk Characterization” case if EPA is working on the assessment. However, the submission is included as an “Awaiting Submitter Information” case if EPA is waiting for submitter action.
5. Awaiting submitter information/action — If EPA is waiting for information for more than seven days, the submission will be included as an “Awaiting Submitter Information” case. This category includes, but is not limited to, cases for which the submitter is conducting toxicity testing or fate determinations, clarifying manufacturing or processing information, or conducting analytical measurements.
6. Regulatory decision and action development — EPA makes an affirmative determination on whether the new chemical substance or use is likely to present an unreasonable risk to human health or the environment in the regulatory decision and action development stage. The decision is documented in the risk determination document for “Not likely to Present Unreasonable Risk” or an Order for all other cases. This determination is made publicly available. The submission is included as a “Regulatory Decision and Action Development” case during this step. In some instances, submitters may provide additional or clarifying information at this stage that could affect the regulatory decision, and a case may change status from Regulatory Decision and Action Development to Risk Characterization or Risk Assessment.
7. Awaiting submitter signature on consent order — EPA generally works with submitters to develop orders that protect human health and the environment and meet the statutory requirements of TSCA.
8. Final determination — EPA posts the final determination in the status tables for section 5 notices reviewed under TSCA. These are posted on EPA’s “Premanufacture Notices (PMNs) and Significant New Use Notices (SNUNs) Table” webpage. Possible determinations include:
   • Allowed to commercialize without restrictions;
   • Allowed to commercialize with restrictions pending information development, if applicable;
   • Not allowed to commercialize pending development of information;
   • Prohibited from commercializing; or
   • Case withdrawn by submitter.

If EPA fails to make a determination, fees may be refunded; however, nothing relieves EPA of its obligation to make a determination.