Update: US EPA will hold three webinars to discuss changes to the e-PMN submission system. More information about the webinars is available here.
In a Direct Final Rule posted to the Federal Register today
, US EPA is mandating the use of a new version of electronic reporting software (e-PMN) for businesses subject to Toxic Substances Control Act (TSCA) §5 Premanufacture and Significant New Use Notifications and other chemical reporting requirements.
In addition to making the new version of e-PMN software mandatory, the direct final rule expands the electronic reporting requirement to a new TSCA reporting element: bona fide intent to manufacture, or “bona fides.” TSCA Electronic Reporting (e-PMN) History
In 2010, US EPA issued a final rule that required chemical manufacturers, importers, and processors to submit TSCA-required reports electronically through EPA’s Central Data Exchange (CDX).
The new version of the e-PMN software is a “cloud”-based or “thin-client” system. In the past, regulated businesses downloaded the e-PMN software, prepared their reports offline, and submitted data to US EPA through CDX. By switching TSCA reporting “to the cloud,” EPA hopes to reduce reporting time and eliminate difficulties with uploading large files.
EPA provides a guide to electronic TSCA chemical data reporting here
. What About Confidential Business Information (CBI)?
In the Final Rule, EPA states that the thin-client e-PMN software will “support TSCA CBI needs by providing a secure environment that meets Federal standards.” EPA lists specific security in the Direct Final Rule
. Expanding e-Reporting to “Bona Fides”
To manufacture or import a chemical substance in the US, the manufacturer must first check EPA’s TSCA Inventory List. Generally speaking, if the chemical appears on the public TSCA Inventory, the manufacturer must notify EPA of its intent.
A portion of the TSCA Inventory is kept confidential. To know if a chemical substance appears on the confidential part of the TSCA Inventory, manufacturers must first submit a “bona fide intent to manufacture.” In the past, this notification could be prepared and submitted on paper. Under the new Final Rule, “bona fides” must be submitted through the CDX using the cloud-based e-PMN software. TSCA Regulations Online Course
Be confident you know what you must report, record, and keep on file to meet your TSCA chemical reporting and recordkeeping requirements with the easy-to-use TSCA Regulations Online Course
. Get up to speed with the latest rules and management requirements for chemical manufacturing, handling, storing, and processing chemical substances. Interactive, engaged online learning will prepare you to keep your business in compliance and avoid costly EPA civil penalties.