Prenotice Coordinator

It may be noted that the TSCA, unlike other Federal regulations, applies only to the manufacture and import of chemical substances. Other aspects of this Act, pertaining to administrative requirements, procedures, fees, and paperwork are beyond the scope of this book. Readers interested in obtaining further information may call the TSCA hotline at (202)-554-1404 or a PMN prenotice coordinator at (202)-260-1745 or (202)-260-3937. 

The EPA has Prenotice Coordinators who can answer questions about filing requirements and resolve ambiguities before a PMN is filed. The Prenotice Coordinators can consider the specific facts presented. They can also assist in determining which entity in the import process is responsible for filing a PMN if there is no one entity that is clearly the principal importer. ... 

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. 

If a Prenotice Coordinator has preapproved a consolidated PMN the total fee for up to six new substances described in a single consolidated PMN is 8100 for a small business and S2500 for all others. 

Telephone Interview with David Shutz, Prenotice Coordinator, EPA (Dec. 23, 2008). Mr. Shutz noted that the EPA material referred to above (Draft PMN Q8tA, 3-5, question 302-2) might need to be revised to make clear the PMN form is not required. See also 73 Fed. Reg 78261,78266 (Dec. 22,2008), the proposed rule dealing with electronic filings of PMNs, noting that applications for TMEs are not required to be on the PMN form. 

Telephone Interview with David Shutz, Prenotice Coordinator, EPA (Dec. 23, 2008). 

The EPA Web site with contact information for the Prenotice Coordinators is http //www.epa.gov/oppt/newchems/pubs/roster.htm The PMN form can be downloaded from https //cdx.epa.gov/ssl/pmn/download.asp and http //www.epa.gov/opptintr/newchems/pubs/pmnpartl.pdfand http //www.epa.gov/opptintr/newchems/pubs/pmnpart2.pdf The CDX system is described at http //www.epa.gov/cdx/index.htm The CAS Web site is http //www.cas.org... 

Step 11. The MRC shall contact an EPA Prenotice Coordinator prior to filing the PMN if the PMN is a consolidated PMN or an intermediate PMN. 

In the Coordinated Framework the EPA spells out in great detail the requirements for PMN application, and the conditions for approval. EPA expects manufacturers and importers to contact EPA well in advance of PMN submission, to allow for prenotice consultation. The Agency feels that this consultation will provide ample opportunity for the discussion and solution of any potential problems and will expedite the review. Section... 

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