Premanufacture notification orders

Unfortunately, EPA initially proposed ambitious regulations that could have expanded premanufacture notification ("PMN") requirements well beyond the limits embodied in the statute. For example, EPA had testified in Congress that manufacturers would merely be required to complete and submit a two-page PMN form. But the PMN that EPA proposed in January of 1979 was an extremely detailed form which called for nearly 40 pages of mandatory information, and 20 more pages of optional information. CMA, and other industry commenters, urged drastic modifications in EPA s proposal in order to conform to the terms of the statute and lessen the burden on innovation. In particular, CMA developed and provided to EPA, a draft PMN form which called for much less information, but would still be adequate to facilitate EPA s review function under Section 5. 

It is generally not necessary to make an exposure estimate for every chemical/exposure source combination since many will be of such low significance that they can be neglected. For those chemical/exposure source combinations that could be near the top of the priority list, the exposure estimate is probably not needed beyond an order of magnitude. Methods for making this type of estimate have been developed by the EPA for the purpose of evaluating Premanufacturing Notifications (PMNs). 

The EPA notes in the action plan for chlorinated paraffins that some of the chemicals in this class that are currently manufactured in or imported into the United States are not on the Inventory, and their manufacturers and importers must submit premanufacture notifications (PMNs). °° Section 5(e) orders may result from the PMN process for those chemicals. EPA is considering issuing a finding under TSCA 6(a) that short-chain chlorinated paraffins present or will present an unreasonable risk, and is also considering bans or restrictions under 6 ° ... 

Section 15 of TSCA, entitled Prohibited Acts, enumerates the acts that violate TSCA. It says, somewhat obviously, that a violation of any reporting obligation, any test rule, or any other requirement of 4 or 5 is a violation. Similarly, it is a TSCA violation to fail to maintain required records or allow the EPA to inspect a facility. It adds a very critical dimension to the list of violations by stating that using a substance that was manufactured in violation of TSCA is itself a violation of TSCA. The most significant language is that it shall be unlawful for any person to. .. (2) use for commercial purposes a chemical substance or mixture which such person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of the 5 and premanufacture notification (PMN) rules, a ban or restriction under TSCA 6 or 7, or a rule or order under those sections. 

Many countries have adopted chemical substance inventories in order to monitor use and evaluate exposure potential and consequences. In the case of essential oils used in many fragrance applications, these oils must be on many of these lists, New essential oils used in fragrances are subject to premanufacturing or premarketing notification (PMN). PMN... 

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