Procedure Number Reg. Aff. 2, Premanufacture Notifications and Notices of Commencement

Procedure Number Reg. Aff. 2, Premanufacture Notifications and Notices of Commencement  

The statute and regulations exclude numerous substances from the definition of chemical substance and these excluded substances are not subject to the PMN requirements and are not the subject of this Procedure. 

Additional substances qualify for exemptions from the PMN requirements. The EPA s PMN form is also used for certain exemption applications and other notifications. The exemption applications that must use the PMN form are the Low Volume Exemption and Low Release and Exposure Exemption. Use of the PMN form is optional for applying for a Test Marketing Exemption. 

The PMN form is also used for Significant New Use Notices (SNUNs), and for so-called mock PMNs, which are submissions in the context of enforcement proceedings. Note that requirements for the SNUNs are not the same as for PMNs., and are addressed in Procedure Number Reg. Aff. 7, Procedure for SNUNs. 

This Procedure does not apply to research and development substances that are made, imported, or handled solely by laboratories or facilities in compliance with either Procedure Number Lab. 11, Qualifyingfor the R D Exemption at Laboratories or Procedure Number Pilot Plant 11, Qualifyingfor the R D Exemption at Pilot Plants. 

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The Production Manager shall inform the MRC immediately upon completion of manufacture of the first batch of product made for commercial use other than research and development. The MRC shall file a Notice of Commencement with the United States Environmental Protection Agency in accordance with Procedure Number Reg. Aff. 2 Premanufacture Notifications and Notices of Commencement... 

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