PMN form

These lead-based materials (PZT, PLZT, PMN) form a class of ceramics with either important dielectric, relaxor, pie2oelectric, or electrooptic properties, and are thus used for appHcations ia actuator and sensor devices. Resistive properties of these materials ia film form mirror the conduction processes ia the bulk material. Common problems associated with their use are low dielectric breakdown, iacreased aging, and electrode iajection, decreasiag the resistivity and degrading the properties. 

In my own direct contacts with industry, I have heard many times that small firms just don t have the personnel to assemble the pertinent data and fill out the PMN form for a new chemical. 

Beginning with PMN forms, our current plans are to require only that information clearly spelled out in the statute with all other information being optional. Our experience with submitters to date is that informal requests for additional information have generally proved adequate for our risk assessment needs so we will continue to rely on this approach. This should clear up the uncertainty on the PMN review process and reduce the burden on industry. 

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,... 

Presently, the cost of filling out a PMN form adds significantly to the unit cost of producing a small volume... 

Many commercial chemicals sell for under 1 per pound. At 1 per pound costs begin to escalate most rapidly under 25,000 pounds of output. An exemption, then, should not be set at less than 25,000 pounds per year to minimize the cost of PMN forms on innovative chemical products. 

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. 

Anon. Reproposal of Toxic Substances Control Act (TSCA) Premanufacture Notice (PMN) Forms and Previsions of Rules FR. 1979, 44. 59763-882. 

Several industry-sponsored studies have tried to estimate the extent to which innovation in the chemical industry has declined since passage of TSCA. The Chemical Manufacturers Association has stated, "The quantifiable costs of PMN requirements, including completing the PMN form, may themselves account for a 54 percent decline in new chemical introductions. Since a decline in new chemical introductions of between 71 and 87 percent may have aleady occurred as a result of PMN requirements, the direct costs of the PMN process are apparently having a very substantial impact and must be... 

Just as the erythrocyte provided the first homogeneous superoxide dismutase the granulocyte has been the exemplar of the cell which forms O in a controlled and apparently purposive manner. In the years following the demonstration by Babior et al. that polymorphonuclear neutrophils (PMNs) formed O when stimulated with... 

The demonstration that PMNs formed O2- in the respiratory burst necessitated the consideration of all the species which result when dioxygen is reduced one electron at a time (Fig. 1). Superoxide, the result of the reduction of dioxygen by one electron, appears to act mainly as a mild reductant in aqueous solutions. But when it coexists with H2O2, its spontaneous dismutation product, O can initiate a number of potentially injurious events [reviewed by Fridovich The primary means by which cells deal with superoxide anions appears to be through the catalysis of their dismutation by a family of metalloenzymes collectively designated superoxide dismutases. 

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. 

PMNs must be submitted on the approved EPA form 7710-25 (the PMN form), " or a copy of the PMN form generated by EPA approved commercially available software. EPA is phasing out paper fifing and has... 

The form in use as of 2003 [hereinafter PMN Form] is on the accompanying CD and can be downloaded from https //cdx.epa.gov/ssl/pmn/download.asp and http //www.epa.gov/ opptintr/newchems/pubs/pmnpartl.pdf and http //www.epa.gov/opptintr/newchems/pubs/ pmnpart2.pdf. The TSCA Hotline can also provide a copy of the PMN Form the Hotline phone number is (212) 554-1404. EPA has posted its electronic filing software at http //www. epa.gov/oppt/newchems/epmn/epmn-index.htm and plans to distribute CDs or DVDs on request. 

The PMN form requires a certification by the authorized official who signs it or submits it through CDX that ... 

If the PMN form is submitted because the submitter is applying for an LVE or LoREX exemption then the person who signs the form also takes personal responsibility for these additional certification statements ... 

The PMN form and regulations require submission of a range of available data. Although there is no requirement to develop new data to fill out the PMN form, the PMN must include conclusive identification of the subject chemical. 

All of the information required by the PMN form must be submitted if it is known or reasonably ascertainable, and this includes a significant amount of information on the PMN substance s chemistry. 

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. 

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. 

All test data in the PMN submitter s possession or control, as that term is defined in the regulations, that relate to effects on health or the environment caused by manufacturing, processing, distributing in commerce, use, or disposal of the PMN substance or any mixture, formulation, or article containing it must be submitted with the PMN form, with some limited exceptions discussed below. Note that test data must only be submitted if it is within the submitter s possession or control and there is no obligation to search for all information that a reasonable person in the same situation might be expected to know. Test data that must be submitted with a PMN includes ... 

PMN submitters have the option of submitting information on the pollution prevention benefits of the PMN substance with the PMN form. This is an opportunity to tell the EPA about the environmental benefits expected from the new chemical. These could be more efficient use of natural resources, reductions in the amount of waste generated by use of the substance, whether it can be used instead of a more toxic substance, and any other environmental advantages from use of the PMN substance. 

Chemistiy Manual, Chapter 3,98 (1997). This chapter of the Manual also provides guidance for describing the pollution prevention benefits on the PMN Form. 

The EPA will refund fees if the PMN substance is already on the Inventory, if the PMN is incomplete, if the PMN form was used for a SNUN that is not required, or if the PMN form was used for a microorganism that is not... 

The ninety day review period starts when the EPA receives a complete PMN form. The EPA assigns a receipt number, acknowledges receipt of the PMN, and informs the submitter of the date the PMN was received. If the information is not complete then the ninety day review period does not begin until the gaps are filled.If another person is supplying confidential information then the review period begins when the EPA receives all the necessary information.A Document Control Number is assigned if the PMN is complete. ... 

During its initial review of the PMN, the EPA uses the data submitted in the PMN form to assess risks associated with the entire life cycle of the subject chemical. It considers information about related chemicals and the chemistry involved in synthesizing the subject chemical as well as impurities, byproducts and degradation products. The EPA may conduct a literature search during the initial review of a PMN, but there is no requirement for it to do so. The EPA may also ask the PMN submitter questions. 

Fed. Reg. 76282 (Dec. 11. 2002). This Federal Register notice states that the PMN form must be used for TMEs, and that [i]f EPA has not taken action to deny the exemption application, under section 5(h)(1) for TMEs. .. the notice submitter may manufacture or import the new chemical substance when the respective review period for those notices expires (i.e., day 45 for TME...). W. at 76284-85. This is not consistent with statements EPA has made elsewhere about TMEs. For a discussion of TMEs see Chapter 5, PMN Exclusions and Exemptions. 

There is no personal certification on the NOC form. However, willful false statements of material facts to the U.S. government are felonies, even in the absence of the additional statements required by the certification on the PMN form. °°... 

The regulations do not impose on TME applicants the requirement to use the PMN form, as is specifically required by regulation for both the EVE and EoREX exemptions. TMEs are specifically excused from those notification requirements." The regulation governing use of the PMN form says it is only applicable to companies required to submit a notice. " The EPA, however, in some of its literature and through the EPA TSCA hotUne, does tell submitters to use that form. In other older Hterature, EPA takes the opposite position. The EPA prenotice submission office does concede that there is no statutory authority to require submitters to submit notices using the PMN form and that it is not required to be used, but does suggest that the use of the... 

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. 

Note that the PMN form contains some boxes that can be checked to indicate an agreement to manufacture the LoREX material at less than a binding volume, which would be in addition to the estimates that the regulations require. This box should not be checked, since there is no benefit to agreeing to a binding volume because the restrictions that accompany a LoREX are based on exposure. Such an agreement would only create an additional hurdle for a manufacturer should it seek to increase its volume at any time. 

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