Premanufacture Notifications

The Toxic Substances Control Act (TSCA) was enacted in 1976 to identify and control toxic chemical ha2ards to human health and the environment. One of the main provisions of TSCA was to estabUsh and maintain an inventory of all chemicals in commerce in the United States for the purpose of regulating any of the chemicals that might pose an unreasonable risk to human health or the environment. An initial inventory of chemicals was estabhshed by requiring companies to report to the United States Environmental Protection Agency (USEPA) all substances that were imported, manufactured, processed, distributed, or disposed of in the United States. Over 50,000 chemical substances were reported. PoUowing this initial inventory, introduction of all new chemical substances requires a Premanufacturing Notification (PMN) process. To be included in the PMN are the identity of the new chemical, the estimated first year and maximum production volume, manufacture and process information, a description of proposed use, potential release to the environment, possible human exposure to the new substance, and any health or environmental test data available at the time of submission. In the 10 years that TSCA has been in effect, the USEPA has received over 10,000 PMNs and up to 10% of the submissions each year are for dyes (382)... 

The Toxic Substances Control Act (TSCA) refers to "new chemicals" as those not on the TSCA Inventory of Chemical Substances which lists about 55,000 existing commercial chemicals. All new chemicals must enter EPA s premanufacture notification program (PMN) for review before manufacture. This program is the most complete record of development of new chemicals by U.S. industry over the past 2 1/2 years. To date over 1,000 notices have been submitted, many including confidential business information (CBI). Despite the CBI, it is possible to summarize EPA s experience with new chemical substances and to evaluate the PMN program and its impact on product innovation. That is essentially the aim of this paper. 

As you heard this morning from several speakers, the premanufacture notification provision of TSCA has been in effect since July 1, 1979 and since then EPA has received over 1,000 notices of intent to manufacture and introduce new chemicals into U.S. commerce. This is the only complete and accurate record of the development and commercialization of new chemicals ever compiled and, as such, is a repository of a wealth of information. A major portion of it is classified by EPA as confidential business information - CBI in our lingo - and is closely protected against inadvertent disclosure. 

The sales of many new chemicals remain small for several years after introduction and about half of new chemicals are discontinued because they are not commercially viable. The chemical group of the Ansul Company provided a useful example in its November 1979 comments on Premanufacture Notification of how the sales volume of one of its typical chemical products grew from 1,000 pounds to only 10,000 pounds in five years ( 5). 

Council on Wage and Price Stability, "Premanufacture Notification under the Toxic Substances Control Act "... 

Reilly Tar Chemical Corporation, "Proposed Premanufacture Notification Requirements and Review Procedures. Comments for The U.S. Environmental Protection Agency", March 21, 19/9. 

Ansul Company, "Comments on EPA Reproposal of Premanufacture Notification Form and Provision of Rules", November 29, 13/9. 

Section 5 of TSCA,(4) "Manufacturing and processing notices," establishes the U.S. premanufacture notification program. Sections 3, 8(a) (b), 15-17, and 19 also are important. 

Persons and Activities Covered. TSCA 5 creates a premanufacture notification program, whereas the Sixth Amendment requires the submittal of premarket notifications. Thus, U.S. PMN s must be submitted no later than 90 days prior to the completion of R D activities, unless EPA grants permission to produce limited amounts for test marketing purposes. In contrast, companies in... 

The U.S. premanufacture notification (PMN) requirements have been in effect for approximately three years, and more than 1250 PMN s have been submitted to EPA. The EEC s premarket notification requirements took effect in September 1981,... 

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. 

Aside from the Premanufacture Notification (PMN) requirements. Section 5 rules have not been used to a great extent. Nearly all of the compliance activity since July of 1979 has been geared toward meeting PMN requirements. Whether the agency s failure to use the subsections of 5 that are designed to restrict potentially harmful substances from reaching the marketplace has resulted from lack of real necessity, a failure in the Agency s risk assessment process, or an inherent non-workability in the Law itself, remains to be seen. 

After the initial inventory reporting cutoff in May of 1978, this retrospective approach was replaced with the flow of current information. New substances, as they became commercial, had to be identified and put through a decision process as shown in Figure 2. New reports were again necessitated by the commercialization of a new substance. Since July of 1979. Section 5 Compliance has been the source of nearly all compliance activity. Input for Premanufacture Notification purposes now takes a shape similar to that previously indicated, (see Figure 2) but now incoming new product material must reach the coordinator earlier in the life of the product than at any other time in the compliance effort. This introduced a potential time delay in the commercialization process. 

Where in a product s life a regulation such as TSCA is imposed becomes important in terms of resource diversion. Ideally, imposition of Premanufacture Notification after scale-up and successful line trials would necessitate filing notifications only for those products that actually become commercial. In the usually compressed Coatings and Resins lifeline, this is not always, and in fact very seldom, possible. 

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. 

Little, Arthur D., Inc., "Impact of TSCA Proposed Premanufacturing Notification Requirements", Office of Planning and Evaluation. U.S. Environmental Protection Agency (December, 1978). 

Anon. Toxic Substances Control Premanufacture Notification Requirement and Review Procedures FR. 

Regulation of New As Well As Existing Chemicals. An evaluation of TSCA s impact would differ from that of most environmental statutes in that the former purports to regulate new as well as existing chemicals. The objective of the premanufacturing notification (PMN) system under section 5 is to permit EPA to make a reasoned evaluation of new chemicals ... 

This type of constructive impact of TSCA was viewed somewhat differently by Exxon Chemical Company s C.W. Umland. His review of nearly three years of premanufacturing notification cited evidence which suggests substantial disruption of new chemical development and introduction to the market. This disruption was traced to higher research and development costs at an economically vulnerable point in the life cycle of innovative products. A more appropriate balance between opportunity for economic viability and protection from unreasonable... 

EPA s D.G. Bannerman reviewed these impacts on the market introduction of new chemicals. He summarized EPA s experience and analyzed the classes and types of new chemicals, company size, market areas, and, among other data, the number of notified chemicals actually reported to be commercialized. He stressed a new joint industry-EPA program to assist the smaller chemical companies to comply with TSCA, especially with premanufacturing notification. This will minimize negative impacts on product innovation without reducing the effectiveness of EPA s assessment of risks of new chemicals. 

Chemical Information Rule Health and Safety Data Reporting Premanufacture Notification (and Exemptions)... 

At the heart of the TSCA is a premanufacture notification (PMN) requirement under which a manufacturer must notify the EPA at least 90 days prior to the production of a new chemical. In this context, a new chemical is a chemical that is not listed in the TSCA-based Inventory of Chemical Substances or is an unlisted reaction product of two or more chemicals. Eor chemicals already on this list, a notification is required if there is a new use that could significantly increase human or enviromnental exposure. No notification is required for... 

D. Little, Impact of TSCA Proposed Premanufacturing Notification Requirements, (25) makes three interesting findings on innovation. 

Premanufacture Notification - The Toxics Act requires chemical manufacturers to give EPA 90 days notice before commencing commercial production on any new chemical substance. Through premanufacture notification, the Agency is charged with the responsibility of regulating unreasonable risks from these new chemicals before they occur. 

The section of TSCA that will most directly effect innovation, research, and development in new chemicals is premanufacturing notification. Consequently, a more detailed description of this program would be appropriate. 

There are two aspects of this program that will effect the research and development investment decision. First, the costs of premanufacture notification (including testing costs) will increase the investment in R D necessary to develop and market new chemicals. The health and safety properties of a chemical must now be considered an intrinsic part of the new chemical development process, right alongside consideration of the substances commercial properties. Both are equal parts of the "total product". Tb the extent that this results in increased testing for health and environmental effects, the amount of investment required to achieve a given level of output from R D will also rise. 

Under the TSCA, a new chemical is a chemical substance that is not already included on the TSCA Inventory, and is intended to be used for a commercial purpose (other than as a drug or pesticide) in the USA. Section 5 of the TSCA requires manufacturers or importers of a new chemical to notify the EPA (i.e., submit a premanufacture notification, PMN) before manufacturing or importing the chemical. The EPA has only 90 days (extendable to 180 days under certain circumstances) from the time of receipt of the notification to determine if an unreasonable risk may or will be presented by any aspect of the new industrial chemical, and make risk management decisions and take action to control any unreasonable risks posed by the chemical [17]. If after 90 days the submitter of a new chemical is not notified by the EPA of any regulatory restrictions or test requirements, they can legally market or import the chemical. 

DeVito, S.C. and Farris, C.A. (1997) Premanufacture Notification Chemistry Assistance for Submitters, John Wiley Sons, Inc., New York. 

SARs have been used for decades by medicinal chemists in the design of highly efficacious drug substances [47] and by the US Environmental Protection Agency (EPA) for assessing the toxicity of new, untested commercial chemicals prior to commercialization [i.e., chemicals submitted to the EPA in the form of Premanufacture Notifications (PMNs)] [48]. However, despite the structure-activity data available for many classes of commercial chemical substances, the use of SARs has been given much less attention by chemists as a rational approach for designing new, less toxic, commercial chemical substances. 

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