PMNs on Related Substances

There are two situations in which the EPA will review several new chemicals together. The first is when up to six substances have similar chemistry, toxicology, uses, and expected manufacturing or importation quantities. The EPA will accept a single consohdated PMN that covers all of the substances, provided a Prenotice Coordinator has eigreed that the substances are sufficiently similar. There are reduced filing fees for consolidated PMNs. Consolidated PMNs can be filed on two related polymers, one with a specific monomer or other reactant above the two percent rule level so that monomer or reactant is part of the polymer s chemical identity and the other with the same monomer or other reactant below the two percent rule level so that monomer or reactant is excluded from the polymer s chemical identity. 

The second situation is when the end product and the intermediate chemicals used in synthesizing the end product are new chemicals. In this case each substance requires its own PMN, but all of the PMNs can be submitted together to enable the EPA to achieve economies of scale and get a better idea of the risks posed by the manufacturing process as a whole. The PMNs for the intermediates are referred to as intermediate PMNs. Reduced fees are available only for large businesses. 

A hybrid consohdated and intermediate PMN is possible if there are up to six related new chemical end products (D), together with new chemicals used in their synthesis (A, B, and C). The EPA gives the example of four closely related syntheses  

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