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Why pay more than necessary? This isn’t rocket-science after all!
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Our team of highly experienced regulatory specialists, chemists, toxicologists and engineers are here to guide you through Section 5 of EPA’s Toxic Substances Control Act (TSCA). By engaging with Reddwall Solutions for these services, you gain the most cost-effective means of ensuring compliance while assuring that your New Chemical submission goes smoothly from beginning to end.
Section 5 of TSCA, EPA’s New Chemicals program, manages potential risk to human health and the environment from chemicals that are new to the marketplace. Anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose is required to provide EPA with notice before initiating the activity. This Premanufacture Notice (PMN) must be submitted at least 90 days prior to the manufacture or import of a New Chemical Substance (NCS).
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Pre-Manufacture and Pre-Import Notices
Although PMN submissions don’t require generation of new test data, there is a great deal of information that needs to be managed, including:
- Chemical name & CAS #
- Physicochemical properties
- Precursors and impurities
- Anticipated production
- Manufacturing processes
- Downstream Processing
- Consumer applications
- Occupational exposures
- Environmental releases
- Available test data
It is critical to provide as much information as possible because EPA is required to make a positive determination as to whether the chemical is likely to present an unreasonable risk. If it is determined that an unreasonable risk exists or may exist, EPA could potentially issue a Consent Order or Significant New Use Rule (SNUR), the contents of which will be heavily influenced by those details you provide.
Reddwall Solutions will assist you with gathering and analyzing available data, develop supporting material where needed and in preparing all necessary information in a clear and concise manner to ensure smooth submission processes.
Reddwall Solutions has the experience needed to simplify TSCA Section 5 mandates and to accommodate navigation of your filings through the complex CDX framework
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Bona Fide Intent to Manufacture or Import Notice
If you have plans to manufacture or import a substance and you think it may already be listed on the confidential portion of the TSCA Inventory, it is possible to submit a Bona Fide Intent to Manufacture or Import Notice (BFI) to request written confirmation from the EPA. To facilitate this request, however, the submitter must assure EPA of their intent to manufacture or import. The entity must also have a US-based address, phone and business registration. In support of these requirements, Reddwall Solutions is prepared to assist in facilitating this requirement by offering its subsidiary company (RWS Chemical Holdings, LLC) as the US-based entity responsible for the filing. Once complete and with approvals in hand, the authorizations are transferred back to the client via EPA’s Successor-In-Interest program whereby the originating company takes possession of the New Chemical Substance.
Reddwall Solutions can work with you to compile and submit the information needed for EPA-TSCA approval.