The EPA states that the purpose of this primer is to compile easy-to-use information for stakeholders potentially regulated under similar U.S. and Canadian regulations — Significant New Use Rules (SNUR) in the U.S. and Significant New Activity (SNAc) provisions in Canada. Incomplete information on risk can “prohibit or limit the manufacture, processing, or distribution in commerce of the substance.”
Last month, the US Environmental Protection Agency (EPA), Environment and Climate Change Canada (ECCC), and Health Canada (HC) published a new educational primer meant to serve as a resource to provide coordinated guidance on compliance with the United States’ Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) and Canada’s Significant New Activity (SNAc) regulation. The educational primer does not replace nor substitute for the provisions of SNUR or SNAc, but instead serves as a tool for the regulated community to aid in understanding and implementing these complex statutes.
Both SNUR and SNAc regulate the manufacture, transport and use of chemicals. SNUR permits the EPA to make a determination on whether or not a chemical substance qualifies as a “significant new use” by considering a number of factors defined in the regulation. Following notification to the EPA, if the substance and / or it’s new application are deemed to be a significant new use under the statute, the manufacturer is subject to a series of additional compliance requirements pertaining to the manufacture, distribution, and disposal of the substance. The required conditions will vary depending on the degree of risk posed by the new use. Similarly, the provisions in Canada’s SNAc regulation are triggered when a person or corporation seeks to manufacture, use or transport a substance for a significant new activity. Like the SNUR, the SNAc evaluates the level of risk that the new activity has on human or environmental health and imposes additional regulatory requirements accordingly.
At nearly 40 pages of technical information, the primer takes some time to read and understand. Here are some of the highlights of the document for those in the chemical transport industry.
Determining if SNUR or SNAc Applies to You
The SNUR and SNAc rules are triggered when a company wants to manufacture a new substance or identifies a new application for an existing substance. The educational primer discusses which substances are excluded from each set of regulations. Additionally, the document clarifies some of the ambiguity concerning the definitions of: existing use, a significant new use and a significant new activity. Understanding these concepts will aid those in the chemical industry to determine which substances are subject to these regulations, and make appropriate distribution and compliance plans in coordination with the manufacturer.
Notification Requirements for Chemical Transportation
If an individual or corporation intends on transporting a substance that meets the definition of a significant new use or a significant new activity, they are required to notify the appropriate governmental agency for their country. The notification should include information to assist the agency with understanding the type of substance, quantities, transport, disposal methods and hazard level. The agency receiving the notification will then make a determination and depending on the new use or activity, may impose additional compliance conditions on not just the manufacturer, but throughout the supply chain. The educational primer helps regulated stakeholders understand the notification requirements and the possible outcomes and requirements so that transporters can comply with the SNUR and SNAc.
Locating Additional Resources
While the educational primer provides the regulated community with a resource for making initial determinations concerning these regulations it is not comprehensive for all situations. Included in the primer is a number of additional resources that address more specific topics and situations. Section 5 of the primer contains a number of accessible resources from the EPA, ECCC, and HC to provide further assistance. This section also provides an explanation of a number of key terms and instructions on how to access various websites. Together with the educational primer, these additional resources provide more complete guidance for understanding and applying SNUR and SNAc regulations.
For additional information, The Complete Educational Primer is available here.