Premanufacturing notice

Preload-venous pressure, 5 108 Premanufacture notices (PMNs), 18 542 Premarket Approval Application (PMA), 24 140... 

Figure 1. Premanufacture notices (July 1,1979-Dec. 31,1981). The total number of PMNs submitted over the 10-quarter period was 1056.

Figure 2. Premanufacture notices (July 1, 1979-Dec. 31, 1981). Key , total PMNs and , PMNs for which commercial production has commenced as of...

Section 5 deals with the notification to EPA of new substances or significant new uses of existing chemicals. Table 2 outlines the information requirements of this section. The Premanufacturing Notice (PMN) requirement of the act, as required under section 5(a)(1)(A), went into effect, as mandated by Congress, 30 days after the TSCA inventory was published, according to Section 8(b). Since taking effect on July 1, 1979, over 1250 PMN s have been submitted. This activity has been one of the top agency priorities. 

Chemical manufacturers submitted 1,031 Premanufacture Notifications in 1980 and 1981. In the same time period, they submitted 290 notifications of commencement of commercial manufacture. In other words, only 28)1 of the substances for which Premanufacturing notices were filed in the past two years of compliance have become commercial. Specifically, for the reactive polymer segment, about 29% of the reported substances have become commercial. These percentages indicate that much of what has constituted the impacts of TSCA has been "protective" filing of notifications. The length and complexity of the process mandated by TSCA has led to unnecessary resource diversion. A more liberal definition of what constitutes a commercial event could have significantly increased the percentages and reduced this type of impact, at least since July, 1979. 

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

In addition to summarizing very briefly the scope of each major section of the Act, E.H. Hurst contrasted the self-implementing sections that became effective immediately and those sections with later timetables for EPA s rule-making and implementation. In the first class are Sec. 8(e), notices of "Substantial Risks," and Sec. 5, "Premanufacturing Notices" of intent to manufacture or process a new chemical substances. Over 400 Sec. 8(e) notices and some 1200 "PMN s" under Sec. 5(e) have been sent to EPA — substantial evidence of compliance. 

The TSCA chemical substances inventory is a comprehensive list of the names of all existing chemical substances, and currently contains over 70,000 existing chemicals. Information in the inventory is updated every four years. A facility must submit a premanufacture notice (PMN) prior to manufacturing or importation for any chemical substances not on the list and not excluded by the TSCA. Examples of regulated chemicals include lubricants, paints, inks, fuels, plastics, and solvents. 

Anyone who plans to manufacture or import a new chemical substance for a nonexempt commercial purpose is required to provide US-EPA with notice before initiating the activity. This premanufacture notice, or PMN, must be submitted at least 90 days prior to the manufacture or import of the chemical. US-EPA can place restrictions up to and including a ban on production, to be placed on the use of a new chemical before it is entered into commerce (US-EPA 2003, 2006c). 

The EPA requires companies to submit premanufacturing notices (PMNs) 90 days before a chemical s manufacture is started. EPA may stop the manufacture or prohibit certain uses. The PMN must include detailed information. They were initiated in 1979. Some 1,100 were filed from 1979-1981 and the number now averages 700 new PMNs per year. About 1-7% are chemicals of concern. The PMN system has been criticized by many in the industry. There has been a 54% decline in new chemical introductions since PMNs have been initiated. Eventually it may concentrate new product development into large companies that can afford the extra testing and administrative costs. 

Lynch, D.G., N.F. Tirado, R.S. Boethling, G.R. Huse, and G.C. Thom. 1991. Performance of on-line chemical property estimation methods with TSCA Premanufacture Notice chemicals. Ecotoxicol. Environ. Saf. 22, 240-249. 

A very recent validation exercise with 305 premanufacture notice (PMN) structures, for which Organization for Economic Co-operation and Development readily biodegradable data had been submitted (Boethling et al., 2003), revealed that the overall accuracy of four of the six BIOWIN models (MITI Linear, MITI Nonlinear, Survey Ultimate, Survey Primary) was in the 80+% range... 

Boethling, R.S., Lynch, D.G., and Thom, G.C., Predicting ready biodegradability of premanufacture notice chemicals, Environ. Toxicol. Chem., 22, 837-844, 2003. 

If a business is importing chemicals or chemical-containing items into the United States, that business must determine whether or not any chemical imported in bulk or as a part of a mixture, is a TSCA chemical substance and/or a new chemical substance prior to its importation for a nonexempt commercial purpose. Under Section 5 of TSCA, persons who intend to manufacture or import a new chemical substance into the United States must seek EPA approval by submitting a premanufacture notice (PMN) to EPA at least 90 days prior to importation to enable EPA to determine whether the new chemical may present an unreasonable risk to human health or the environment. A new chemical substance is one that is not already in commerce in the United States, as determined by inclusion in the TSCA Inventory of Chemical Substances maintained by EPA. New chemical substances include certain genetically modified microorganisms. 

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. 

In the United States, companies are required to submit premanufacture notice to the U.S. EPA prior to introducing new chemicals to commerce. To encourage the application of pollution prevention principles and the development of inherently low hazard new chemicals, the U.S. EPA has instituted a pollution prevention (P2) framework as part of its Sustainable Futures program (U.S. EPA, 2004c). As part of the program, training and support are provided to companies in the evaluation of new chemicals, with limited available information, using the U.S. EPA s hazard... 

The US Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) has only a 90-day review period to issue a decision on Premanufacture Notices filed under the TSCA for any new compound to be manufactured or imported. The availability of inexpensive approaches for reliable assessment of hazard to environment and human health could be of immense value to OPPT. Likewise agencies such as the European Center for the Validation of Alternative Methods (ECVAM) aim to promote the scientific and regulatory acceptance of alternative methods... which reduce, refine, or replace the use of laboratory animals [5]. 

Lynch DG, Tirado NF, Boethhng RS, Huse GR, Thom GC. Performance of online chemical property estimation methods with TSCA premanufacture notice chemicals. Ecotox Environ Safety 1991 22 240-9. 

Manufacturers or importers of a chemical not currently on the TSCA inventory are required to notify EPA at least 90 days prior to manufacture ot importation. This premanufacture notice (PMN) must contain information on ... 

Notification of new chemical substances in the USA under the Toxic Substances Control Act (TSCA) [13] differs from other notification schemes based on the OECD MPD, in that a Premanufacture Notice (PMN) can be submitted inoMparating only the existing data on the substance. However, the EPA can require studies to be conducted if necessary for adequate evaluation of the safety of the substance. 

This is an extremely loose use of the term impurity because impurities are not subject to premanufacture notice requirements, yet the EPA said that an intermediate that is not fully consumed in the reaction process may be an impurity and must be listed on the Inventory ... 

Fed. Reg. 21726 (May 13.1983). It is clear that the EPA had a statutory prohibition against requiring premanufacture notices for substances manufactured solely for export. 

---