Entities That Must File PMNs

Entities That Must File PMNs A. Manufacturers and Importers 

Manufacturers and importers of new chemical substances are required to follow premanufacture notification procedures before manufacturing or importing those new chemicals.  

Importers are not specifically mentioned in the statutory or regulatory statements of the PMN requirement, but in both the statute and the regulations manufacture is defined to include both manufacture and import and so all of the premanufacture notification rules that apply to manufacturers also apply to importers. Importers do not need to ensure that substances in articles are on the Inventory because articles are exempt from the PMN process. However, it is important to review the definition of article to check that all of the substances in the article meet the definition. Importers must file PMNs on all new chemicals that they import in bulk or as part of a mixture.  

In the context of the PMN program processing is a subset of use, because the EPA took the position in a Q A that a person processing an illegally manufactured new chemical substance would not be in violation of TSCA unless the person knew or had reason to know that the substance had been illegally manufactured. See 15(2) of TSCA. If processing were not a subset 

See Chapter 2, TSCA s Scope for a discussion of the term article.  

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If no entity clearly meets the definition of principal importer, the EPA will designate the company that must file the PMN, with all its attendant responsibilities/ ... 

This is a joint submission by the entities that are supplying the information needed for the PMN submission, and each joint submitter must sign the certifications on the PMN form. ° A foreign manufacturer can file a joint submission with an importer who is filing a PMN, or it can write a letter of support to the EPA. The suppHer of a reactant used in making the PMN substance can write a letter of support to provide the confidential information to the EPA. 

The regulations spell out a detailed set of conditions a polymer must meet in order to be exempt from the PMN process. The conditions are that the substance must meet the definition of a polymer, it must not be specifically excluded, it must meet specific chemical criteria, and the entity manufacturing or importing the substance must file reports and keep records. Some of these conditions overlap. 

SNURs are issued for substances that are either on the TSCA Inventory, or for which a PMN has been filed. The EPA can restrict the uses that the PMN submitter engages in by entering into a consent order imder TSCA 5(e) with that entity. However, a 5(e) consent order is only binding on the one entity that signs it with the EPA. In order to make the restrictions in the 5(e) consent order binding on aU of the regulated industry, the EPA must... 

Until the EPA issues its proposed rule, a company engaged in such a business transaction must look at other sources to decide how to manage these issues. The EPA has taken the position that when it approves an exemption from the PMN requirements of TSCA 5, that approval is unique to the company that sought the exemption, and must be formally transferred if a buyer is to have the benefit of it. The EPA also takes the position that the same entity that filed the PMN must file the NOG to put the substance on the Inventory. The EPA based its logic on TSCA 5(a)(1) and on the regulations ... 

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