Filing a PMN

RRS assessed the cost of completing the PMN form by examining the costs that companies actually incurred in performing this task. RRS sent a questionnaire to all companies known to have filed a PMN form. In addition, RRS examined EPA s public files on the PMNs it has received. Average costs are shown in Table II,... 

A substance that is not on the TSCA Inventory and is manufactured, imported, processed, or distributed for export only may be used for research and development purposes without filing a PMN, provided that the requirements for that exemption from the PMN requirements are met." " ... 

Fluid and particle are critical undefined terms in 40 C.F.R. 720.3(c). Fluids and particles cannot themselves be articles, so they must be on the Inventory, or be part of an article from which they are not intended to be released, or else the manufacturer needs to file a PMN. It is not clear if there is any size Emit on a particle, although the typical dictionary definition implies that particles must be minute. 

The nomenclature papers all provide guidance in interpreting the chemical names on the Inventory so that prospective manufacturers and importers can determine if they must file a PMN before they commence manufacturing or importation. They also assist PMN filers with selecting the proper name of their chemicals. 

When a manufacturer or importer files a PMN for a polymer, all of the starting materials must be described on the PMN form. The manufacturer must also list the percent by weight of each reactant. However, when the polymer is listed on the Inventory, it will only be listed by reference to the reactants that are either charged to the reaction vessel or incorporated into the final polymer at greater than two percent by weight unless the submitter chooses to list the reactants that are used at two percent or less. 

Since R8cD substances cannot be put on the Inventory, there is no reason to file a PMN for them. 

A proposed manufacturer or importer only needs to file a PMN after it has answered aU of these questions ... 

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. ... 

Although as a general rule no new information is required to file a PMN, the PMN cannot be filed without basic information on the substance s chemical identity. The substance s chemical identity must be described in Part I of the PMN form. The requirements for describing the chemical identity vary depending on whether the PMN substance can be categorized as a Class 1 substance, a Class 2 substance, or a polymer. Class 1 substances are chemicals that can be represented by a complete chemical structure diagram, and Class 2 substances are chemicals that can not be represented by a complete chemical structure diagram. 

If a supplier will not divulge confidential information to a person who intends to file a PMN, the supplier can submit the confidential information directly to the EPA. ° That way the PMN submitter will not learn any of the trade secrets of its supplier, but can still put its substances on the Inventory. 

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 fees for filing PMNs are straightforward. Small business concerns, defined as people or entities that together with any parent entities had sales of less than 840,000,000 in the prior fiscal year, pay SlOO for filing a PMN. All other entities pay 82500. ... 

After the PMN period has expired, manufacturers and importers who have filed a PMN must notify the EPA within thirty calendar days of commencing manufacture or import of the PMN substance. The notification must be made on the NOC form, which is EPA form 7710-56. The thirty day period begins to run on completion of manufacture of the first amoimt of the PMN substance made for a nonexempt purpose, i.e., when it is made for commercial purposes and not for research and development, test marketing, or another purpose exempt from the PMN filing requirements. For an import, the thirty day period begins to run after the PMN substance has cleared U.S. Customs. ... 

One hypothetical will illustrate the application of the 5 ERP. Assume a company manufactured substance A for four years without filing a PMN and substance A is not on the Inventory, is not excluded from TSCA, and does not qualify for an exemption from the PMN requirements. In each of 2006,... 

If a manufacturer, importer, or processor wants to use surplus R D material for a non-R D purpose, it may file a PMN, a Low Volume Exemption or a LoREX exemption application. Interestingly, the substance will not be put on the Inventory unless it is manufactured or imported subsequently for a non-exempt purpose because no Notice of Commencement (NOC) can be filed for a batch that was manufactured for R D purposes. ... 

Polymers that have elements outside of ranges in 40 C.F.R. 723.250(d)(2) are excluded from the polymer exemption, and anyone who is going to manufacture them or import them must file a PMN if they are not already on the Inventory. This exclusion requires that a polymer that qualifies for the polymer exemption must ... 

Even if a polymer does degrade, it can stfll qualify for the polymer exemption if the manufacturer can restrict the uses to those where degradation will not take place. The EPA addressed an example of a polymer that has two uses in one use it breaks down in water, but in the other use it is incorporated into a solid article that is not expected to break down. The EPA said that if the manufacturer can ensure that the polymer is only used as part of an article that is not expected to break down, then the polymer will qualify for the polymer exemption. As a practical matter, if the manufacturer is distributing the polymer to other end users, it is probably relatively more burdensome to enter into and enforce contracts restricting the use of the polymer than it would be to file a PMN. Filing a PMN certainly exposes the manufacturer to less risk of violating the TSCA regulations. 

While a company is evaluating whether a polymer quaUfies for the polymer exemption, the company must follow the rules for the R D exemption from premanufacure notice requirements if it has not filed a PMN and an NOG... 

It is always worthwhile analyzing whether it makes more sense to rely on the polymer exemption or file a PMN. The answer will depend on the specific polymer, and how likely it is that the manufacturer or importer will change the process or tweak the polymer to enhance its properties. 

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