Intertek has solutions for all your complex, chemical regulatory Section 5 needs to comply with the TSCA.

US TSCA Chemical Regulatory Services – Section 5: PMN, BFI and NOC

Our Intertek team of energetic, experienced regulatory specialists, chemists, toxicologists, engineers and lawyers is here to guide you through the evolving Section 5 of the Toxic Substances Control Act (TSCA), as new details are revealed in the implementation of the Lautenberg Chemical Safety for the 21st Century Act (LCSA). Working with our team may be the most cost-effective way to ensure your compliance needs are met and 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 the chemical.

Although PMN submission does not require the generation of new test data, there is a great deal of information to be managed, including:
  • Formal chemical identity
  • Production volumes
  • Byproducts
  • Use details
  • Human and environmental exposure
  • Any existing available test data

It is critical to provide as much information as possible, because under the changes implemented by LSCA, EPA must make a positive determination as to whether the chemical is likely to present an unreasonable risk. If it is determined that unreasonable risk exists or may exist, EPA may issue a Consent Order or SNUR, the contents of which will be heavily influenced by the details you provide.

Intertek can help you gather and analyze all available data, develop supporting material if needed and prepare all necessary information in a clear and concise manner to ensure a smooth submission process.

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 (“bona fide notice”) to request written confirmation from the EPA.

Intertek can work with you to compile and submit all of the required information, including:

  • Formal chemical identity (a Chemical Abstracts Index name)
  • Intended manufacture / import details
  • Any confidential information that may be required from a supplier

Notice of Commencement

A critical but often forgotten piece of the TSCA New Chemicals process is the Notice of Commencement (NOC) of Manufacture or Import.  Without this, your substance will not be added to the TSCA Inventory and your submission is technically incomplete. 

As part of Intertek’s services, we will aid you in completing and submitting an NOC to EPA within 30 calendar days of the date your substance is first manufactured or imported. Your substance will be added to the TSCA Inventory and you will be free to import and/or manufacture.

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