Under the Toxic Substances Control Act (TSCA), The US Environmental Protection Agency (EPA) requires newly manufactured or imported chemicals to be on the TSCA inventory.. Inventory listing is accomplished through submission of a Premanufacture Notification (PMN) to the EPA. There are some narrow exceptions which allow the use of unlisted substances to be used exclusively for research and development (R&D) activities. These activities must be conducted under the provisions of the R&D exemption found in 40 CFR 720.36. PLEASE BE ADVISED THAT THE PRODUCT(S) YOU ARE PURCHASING FROM THE NATIVE ANTIGEN COMPANY MAY CONTAIN INGREDIENTS THAT ARE NOT ON THE TSCA INVENTORY. We claim R&D exemption status under TSCA for all products, unless otherwise marked, including those labeled “Research Use Only” or “RUO”. This labeling means that you may only use the products exclusively for research and development (R&D) activities.
It is very important to understand the activities that you are permitted to conduct under the R&D exemption. Failure to follow TSCA’s stipulations regarding the R&D exemption could result in substantial penalties. For informational purposes only, some of the requirements to qualify for the R&D exemption include:
- The material is used solely for R&D purposes.
- The activities must be conducted under the direct supervision of a technically qualified person, who can understand and relate the exposure risks associated with the material.
- Any unused material is disposed of according to local regulations.
Additional information and guidance can be obtained from the EPA publication, New Chemical Information Bulletin: Exemptions for Research and Development and Test Marketing. You can obtain this bulletin by calling the TSCA information Service (202) 554-1404.
For our products we supply a Material Safety Data Sheet (MSDS). Please review the MSDS for risks and handling precautions believed to be associated with this material. Electronic copies of our MSDSs can be found online.
Thank you for your continued support. Please contact us with any questions or concerns (firstname.lastname@example.org).
THE NATIVE ANTIGEN COMPANY