The US EPA’s recent changes to the information that must be submitted under TSCA Section 5, including information required in a Premanufacture Notice (PMN), are intended to help ensure that EPA is provided with the best available information on which to base its risk assessment. These changes extend to EPA’s CDX system, which is used to complete the required PMN form electronically. While most of the changes simply ensure greater uniformity in the information being provided, some are of greater consequence. For example, for required information, submitters will no longer be able to simply leave the field blank and skip to the next item without first affirming (by check box) that the information is not known to the submitter or reasonably ascertainable. This allows EPA to push the submission back to the end of the line if later you provide additional information in support of your submission that could have, or should have, been available to you. This will, in effect, restart EPA’s 90-day clock without the submitter’s cooperation to suspend the review. In short, long gone are the days when your R&D chemist can just haphazardly fill out the PMN form and submit it to EPA with the expectation to commence manufacture 90 days later. Instead, for a PMN to be successful, submitters need to understand the inner workings of EPA’s risk assessment process to anticipate and provide the information EPA will need to review your new chemical with as few “worst-case” assumptions as possible. This is not a one-size-fits-all exercise because each new chemical has a unique set of uses, exposures, and potential for release and, thus, has a unique set of information that needs to be submitted.
For details regarding our Chemical Registration and Notification Services, including help filing PMNs, visit our webpage: Chemical Registrations & Notifications – Experien Health Sciences
More details about the changes to Section 5 notices can be found here: Federal Register :: Updates to New Chemicals Regulations Under the Toxic Substances Control Act (TSCA)
