Intermediate PMNs

The second situation is when the end product and the intermediate chemicals used in synthesizing the end product are new chemicals. In this case each substance requires its own PMN, but all of the PMNs can be submitted together to enable the EPA to achieve economies of scale and get a better idea of the risks posed by the manufacturing process as a whole. The PMNs for the intermediates are referred to as intermediate PMNs. Reduced fees are available only for large businesses. 

A hybrid consohdated and intermediate PMN is possible if there are up to six related new chemical end products (D), together with new chemicals used in their synthesis (A, B, and C). The EPA gives the example of four closely related syntheses ... 

PMN Instruction Manual, 14-15. Note that this is primarily an issue of applying the fee for intermediate PMNs instead of consolidated PMNs. 

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. 

Intermediates don t often reach the marketplace but do require a PMN under TSCA. Similarly, many chemicals apparently had PMNs filed to be ready for manufacture/marketing but then failed to make it through the business decision process for other reasons. 

Mean Total Filing Cost Economic Burden of Intermediates Economic Burden of Adverse PMNs... 

The Chemical Manufacturers Association (CMA) had reached similar conclusions about a year ago and filed a petition with EPA suggesting that there was a strong case to be made for exemptive relief under Section 5 (h)(4) of TSCA for many polymers, site-limited intermediates, and chemicals produced in volumes of less than 25,000 pounds per year. (An examination of the effect of PMN costs at various prices and levels of production reveals that the PMN cost, as a percentage of total cost per pound of product, generally rises most rapidly as output falls below 25,000 pounds. See the Appendix for a more detailed discussion.) It is CMA s firm belief that exemption could be granted in terms that would operate to assure "no unreasonable risk" to the public in terms of either health or the environment. 

Because the Sixth Amendment itself exempts most of the chemicals that are subject to EPA s current rulemaking, In general the Commission does not need to commence any exemption activities analogous to EPA s efforts. Thus, the EEC s premarket program covers only those new polymers that contain 2% or more of a monomer(s). (Any new monomer iis subject to the notification requirements.) Further, because PMN s must be submitted only for new substances that are "placed on the [Community] market," the EEC s PMN requirements generally do not apply to the manufacture and use of intermediates (or of any other new substances, for that matter) by one company at one site.(13)... 

Formation of taurine chloramines and of other small-molecular-weight amines accounts for 90% of all chloramine output in stimulated PMNs (G24). Chloramine synthesis efficiency approaches 100% of the stoichiometic amount of HOC1 employed (W5). Though HOC1 reacts spontaneously, with taurine as a chlorine donor, taurine chloramine production in the presence of MPO is one order of magnitude faster than the spontaneous one (k = 4.4 x 105 versus k = 2.8 x 106 M-1s-1). This indicates that the MPO-mediated taurine chlorination reaction may involve an enzyme intermediate species rather then free HOC1. 

Substances not on the Inventory or are not otherwise excluded or exempt are considered new and are subject to a premanufacture notice (PMN). Examples of exclusions would include mixtures, substances subject to another statute, impurities, by-products and nonisolated intermediates. Additional exemptions also include test marketing products, low volume products, polymer exemptions, LoREX (low release and exposure exemption), and R D substances. By statute, chemical manufacturers must notify the Agency at least 90 days before manufacturing a chemical substance that is not listed on the TSCA Chemical Substance Inventory. However, TSCA does not empower the US EPA to require routine testing of new chemicals to permit a valid evaluation of the potential risks. This has been a limitation in the overall effectiveness of the PMN process. Erequently, very little data accompanies the PMN (50% of submissions present no safety data and 90% have only an LD50 and an Ames test) however, the EPA must decide within 90 days if the submitted chemical will pose a health or environmental hazard. 

Small volume chemicals for research and development and non-isolated chemical intermediates are automatically exempt from notification. The EPA may also grant exemption by rule for substances not presenting unreasonable risk to health or the environment or used only for test marketing. PMN exemption is available for low volume chemicals which are supplied at 1 tonne a, but an exemption notice must be submitted 21 d before manufacture or import begins. Certain polymers are exempt from full PMN, and instead a limited PMN is submitted 21 d before manufacture or import begins. 

Letter from Edwin F. Tinsworth, Acting Director of Office of Toxic Substances, EPA to Geraldine V. Cox, captioned Nonisolated Intermediate Definition (undated) [hereinafter Tinsworth Letter] see also Draft PMN Q A, 2-4, question 203-2. 

The word use is not defined in the PMN regulations, but the definition of manufacture or import for commercial purposes gives two examples of activities that are considered to be use. A substance is used for product research and development. An intermediate is used, and intermediate is defined as either a catalyst or as any chemical substance that is consumed, in whole or in part, in chemical reactions used for the intentional manufacture of another chemical substance(s) or mixture(s). ... 

PMNs are only required for substances that are manufactured or imported for commercial purposes, which is defined in the regulations to mean to import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer or importer. Any amount of manufacture or import, no matter how small, can be for a commercial purpose if it is for commercial distribution, test marketing, product research and development, or use as an intermediate. Byproducts and impurities that have no commercial value are made or imported for a commercial purpose if they are made with or present in a product with commercial value that was made or imported for a commercial advantage," " although they may qualify for exemptions from PMN and SNUR requirements. 

If PMNs cover one or more intermediates and the end product, small businesses must pay 8100 for each substance. Large businesses must pay 82500 for the end product and SIOOO for each intermediate. 

An example of a substance exempted by the (h)(5) exemption is the chemical reaction product that is formed when paint dries. That same chemical would be subject to PMN regulations if it were intentionally made as a commercial product for distribution as a chemical product or an intermediate, but not when it is formed as a result of the use of paint. If the paint is applied to an article, then the chemicals formed on use of the paint are also exempt from the premanufacture notification requirements under the (h)(6) exemption. 

The team, in conjunction with a representative of the Regulatory Affairs Department, addresses any appropriate toxicological/Responsible Care issues required. The MRC shall advise the Product Team as early as possible during Phase 4 whether any imported raw materials, isolated intermediates manufactured during the production process, or the candidate product itself must be the subject of a premanufacture notice (PMN) prior to commercialization of the candidate product. If so, the Product Team shall estabhsh a timeline for gathering information required for submission of a PMN and for filing the PMN at least ninety days prior to anticipated commercial manufacture of the candidate product. If the MRC concludes that the PMN review period is likely to exceed ninety days, or that the candidate product is likely to... 

The MRC shall inform the Director of the appropriate Business Center and the Resource Manager when the PMN review period has expired for each isolated intermediate in the production process and each constituent of the product, if they are subject to the PMN process. The product maybe manufactured only after the PMN review period has expired for each such substance. 

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