Chemical Registrations & Notifications

U.S. TSCA Section 5 Notices (PMNs, SNUNs, LVEs, & LoREX)

Experien Health Sciences staff have more than 50 years of combined experience preparing and filing TSCA Pre-Manufacture Notices (PMNs), Significant New Use Notices (SNUNs), Low Volume Exemptions (LVEs), and Low Environmental Release and Human Exposure (LoREX) exemptions for Class I and Class II chemical substances and for polymers that don’t qualify under EPA’s polymer exemption. Under TSCA, the U.S. EPA regulates all chemicals in commerce, regardless of volume and with few exceptions, and importers are held to the same standards as domestic manufacturers. But much has changed since congress passed The Frank R. Lautenberg Chemical Safety for the 21st Century Act. No longer can the R&D chemist just fill-in the PMN form, submit it to EPA, and hope for the best. Now, EPA is required to make an affirmative finding on every PMN that the new chemical either is “not likely to present an unreasonable risk” or “presents and unreasonable risk” or “may present an unreasonable risk” and, although EPA has specific deadlines for reaching their conclusion, they effectively have unlimited ability to extend those deadlines to complete a thorough review of your case. It’s just too risky and potentially costly to your business to leave anything to chance. You need a partner who understands exactly how EPA will evaluate your new substance and a partner who can devise a submission strategy that helps to ensure your PMN will pass through with the least amount of resistance possible. While submissions with no data are still possible and are still sometimes successful, that decision can only be made by trying to anticipate and address EPA’s concerns before the notice is filed. Failure to do so can result in costly delays and overly burdensome Consent Orders and/or Significant New Use Rules (SNUR).

Trust our team to help with the following:

• Name your Class I or Class II chemical substance or polymer using EPA’s preferred method of submitting it for review by Chemical Abstract Services (CAS) Inventory Expert Services (IES) and obtain a CAS No. if so desired.
• Determine the status of your chemical substance or polymer as either a new or existing substance.
• File a Bona fide Intent to Manufacture to EPA to determine if your substance is on the confidential portion of the TSCA Inventory.
• Determine if EPA’s polymer exemption rules or Significant New Use Rules (SNUR) apply., and determine if your business would benefit by filing a PMN, SNUN, LVE, or LoREx is required before you can begin to manufacture or import the substance.
• Evaluate your substance and its uses to determine what test data, if any, will yield the best value for a successful submission. This often involves the use of the same QSAR and exposure modeling software that EPA uses and will help to anticipate what EPA’s concerns will be when they perform their evaluation.
• Assist with securing the necessary physical-chemical, toxicological, eco-toxicological, and environmental fate data to support your notice, whether through testing using qualified laboratories or by identifying analog or read-across data to include in your submission.
• Prepare and file the notice using EPA’s CDX system and ensure your Confidential Business Information (CBI) is protected under EPA’s complex CBI rules.
• File the required Notice of Commencement to get your chemical substance or polymer listed on the TSCA Inventory.

Work with EPA to resolve questions/concerns that may arise during the review of your notification.