CERM provides regulatory services for both new and existing chemical substances, whether your needs are in the U. S. or global. In the United States as defined under the Toxic Substances Control Act (TSCA), a New Chemical may be considered to be one that is not listed on the TSCA Inventory. This definition, and the requirements for new chemical notification, varies within foreign countries; however, CERM has extensive understanding and experience with a many international chemical regulatory agencies.
In addition, the Occupational Safety and Health Administration (OSHA) has a variety of regulations that chemical producers and users must comply with. CERM can help your company navigate through the difficult area of global new product notifications and chemical regulation.
CERM has extensive capabilities to assist companies in compliance with TSCA through its knowledge and experience in making complex nomenclature interpretations and determinations as to whether a chemical substance in on the TSCA Inventory; in the preparation of Premanufacture Notifications (PMNs) including pre-assessment of the likelihood that EPA will regulate the chemical by conducting P2 Sustainable Futures (SF) assessments prior to submission of the PMN; negotiation of 5(e) consent order restrictions in order to minimally impact marketability of such products; and compliance with various reporting responsibilities under TSCA including the new Inventory Update Rule (IUR).
For more information, please contact Peter Ranslow.