Premanufacture notification substances

Farris, C.A., Podall, H.E., and Anastas, P.T., Alternative Syntheses and Other Source Reduction Opportunities for Premanufacture Notification Substances at the U.S. Environmental Protection Agency, in Benign by Design, Alternative Synthetic Design for Pollution Prevention, Anastas, P.T. and Farris, C.A., Eds., American Chemical Society, Washington, DC, 1994, 156. 

Alternative Syntheses and Other Source Reduction Opportunities for Premanufacture Notification Substances at the U.S. Environmental Protection ency... 

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. 

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

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. 

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

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... 

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. 

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. 

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. 

Section 5(a) requires premanufacture notification (PMN) to be submitted by an operator at least 90 days before a new substance is produced or imported or before an existing substance is used in what has been determined by an EPA rule to be a... 

Mixtures or solutions composed of two or more substances The making available of the substance to third parties Notification of New Substances European Inventory of Existing Chemical Substances European List of Notified Chemical Substances Premanufacturing notification (USA)... 

For chemicals that do not appear on the U.S. EPA list of Chemical Substances in Commerce, it is necessary to submit a Premanufacture Notification (PMN) to the EPA before making the new material for commercial purposes. The EPA approval is based on adequate documentation of planned manufacturing procedures, anticipated by-products, health and environmental effects test data, and procedures for safe use, handling, and disposal. 

The Toxic Substance Control Act (TSCA) was passed in 1976 and is contained in 15 USC 2601 et seq. It regulates toxic substances, other than wastes, that are not adequately covered by other statutes. Promulgation of TSCA gave the EPA the authority to manage chemicals from production to final disposal. In fact, if a compound (e.g., carbon tetrachloride) is found to pose unreasonable risk to human health or the environment, the EPA can immediately remove it from commerce. The TSCA s requiring a premanufacture notification (PMN) 90 days prior to manufacture has minimized the occurrence of immediate emergency removal of toxic chemicals. The PMN contains information on the physical/chemical properties, health... 

This evaluation can also address several general drawbacks in the procedure, for instance improving solvent recovery, increasing yield, or reducing excess of unrecoverable substances. Even these statements are not intended to provide details about how the improvement can be achieved they are helpful for designing of the entire process in an ecological manner and help to understand the EPAs process of reviewing premanufacture notifications. 

Chemical substances not included on the TSCA inventory are considered new chemical substances, with some exemptions, and require compliance with premanufacturing notification requirements set forth under Section 5(a)(1)(A) of... 

I have included in today s presentation three of these issues first, the distinction between a "new" and a "naturally occurring" chemical substances for the purpose of the applicability of the premanufacture notification (PMN) requirement of TSCA second, the scope of the research and development exemption from the PMN requirements, and its implication for open field testing of microorganisms and third the type and amount of information that EPA might need for risk/benefit analyses of new microorganisms. I will also briefly mention some technical areas in which further research would greatly facilitate the processes of risk/benefit assessment. 

For biotechnology, the most important provision of TSCA is the section 5(a) requirement that companies notify EPA at least 90 days before beginning to manufacture or import a "new chemical substance" for commercial purposes. This reporting requirement is known as premanufacture notification or PHN. Any substance that is not listed by name on EPA s Chemical Substances Inventory or that is not "naturally occurring" is defined as "new" and therefore subject to PMN requirements. 

New substances may be added to the TSCA Inventory through the Premanufacture Notification (PMN) process, which typically adds... 

The Environmental Protection Agency (EPA) explained the conventions applied to listings of polymeric chemical substances for purposes of Premanufacture Notification (PMN) reporting and the TSCA Inventory. The principal guidance document in which the conventions are explained is titled Toxic Substances Control Act Inventory Representation for Polymeric Substances, which was published on 29 March 1995. This discussion of polymer nomenclature conventions under TSCA begins with general guidelines, followed by a discussion of how polymers are identified... 

---