Services

• European REACH Legislation
• Food Contact / Food Packaging
• U.S. TSCA Pre-Manufacture Notice (PMN)
• Canadian New Substance Notifications
• Regulatory Toxicology & Risk Assessment
• Occupational Health / Industrial
  Hygiene
• Product Safety / Product Stewardship
• Modeling & Measurement of Exposure / Release Factors
• Exposure Limit Services
• Qualitative Exposure Assessment
• Safety & Environmental Services
• Safety Data Sheet Authoring (global)

U.S. TSCA Pre-Manufacture Notice (PMNs)

Experien Health Sciences staff has more than 50 years of combined experience preparing and filing TSCA PMNs. But much has changed since the passing of 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 a conclusion, they effectively have unlimited ability to extend those deadlines unless you are willing to accept a finding that is not in your favor. Given these new procedures, it’s just too risky and 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. Such strategies may include targeted human health or eco-toxicity testing, environmental fate testing, or providing specific information regarding the uses, exposures, and releases of the substance so that EPA does not have to rely on worst-case assumptions and to avoid even more costly testing mandated by EPA. While submissions with no data are still possible and are still sometimes successful, those are the now the exception and are far more likely to result in a Consent Order and/or Significant New Use Rule. Trust our team to help with the following:

• Review your substance and its uses to determine what test data, if any, will provide the best value for a successful PMN submission to EPA. This often involves the use of the same QSAR and exposure modeling software that EPA will use when they evaluate your PMN and doing so serves to anticipate what their concerns will be.
• Assist with securing the necessary physical-chemical, toxicological, eco-toxicological, and environmental fate data to support your PMN, whether through testing using qualified laboratories or by identifying analog or read-across data to include in your submission.
• Prepare the PMN form using the CDX system required by EPA.
• Work with EPA to resolve questions/concerns that may arise during the review of your PMN.