Inventory notification

SPC on manufactured products SQC on laboratory operations communicate with corporate CIM system improved QA/QC on products reduced testing costs correlate laboratory analyses and process measurements faster solutions to production problems tested in laboratory faster notification of backlog problems improved electronic data interchange capabiUties automated communication with inventory, ordering, and materials planning systems... 

All eight PMBs are Hsted on the U.S. EPA s TSCA Inventory (May 1, 1994 ed.) and on the European Communities EINECS inventory (June 15, 1990). All but pentamethylbenzene are Hsted on the Canadian Domestic Substances List (DSL) (Apr. 6, 1994). Pentamethylbenzene is Hsted on the Canadian Nondomestic Substances List (NDSL) (Apt. 6, 1994) and as of July 1, 1994 was subject to New Substance Notification if manufactured in or imported into Canada. 

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)... 

Delivery advice notes will be needed to match shipments to inventory and to trace problems should the need arise. A shipment notification system similar to that which you need to have with your customer will also be necessary in order to alert you to any shipment difficulties. A simple database to record planned deliveries against actual deliveries and incidents of premium freight usage may suffice. However, you will need to take account of changes in planned deliveries and therefore you will need to link the notification system with the recording system so that the two are compatible at all times. 

Requires a federal inventory of existing chemicals in commerce, notification for hsting of new chemicals or new uses for existing chemicals, and can require testing of chemicals for toxicity prior to approval for listing. 

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. 

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. 

The author feels it his responsibility at this point to apprise the reader of the fact that there is little "hard" data on corporate responses to TSCA, especially at the management level. Hence, this paper has taken the role of an overview and qualitative look at corporate responses to TSCA rather than a quantitative document based on estimated numbers of personnel added and other costs of complying with TSCA. Such "hard" data approaches on various specific aspects of TSCA such as pre-manufacturing notification and inventory have been attempted with some successes and some failures. At this overview level,... 

A conflict clearly exists between permanent confidentiality, available under the system of U.S. laws, and the eventual disclosure of identities of specialized chemical substances which had heretofore been undisclosed, but which are now affected by EINECS or by EEC s premarketing notification system. The rules are different the assumptions regarding disclosure are different. Perhaps the best solution a lawyer could offer is that member states should be willing to adjudicate individual cases of specific confidentiality needs. Inventories of existing substances are rules, adopted prospectively to announce to the world both the existence of a material and its regulatory status. Those rules can operate to accommodate both public and private needs. 

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. 

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... 

At the same time, however, development of a new apphcation or new formulation of preparations on the basis of the available inventory of substances are important examples of innovation with a high added value in the chemical industry. In this irrstance many SMEs are active in developing new recipes or in adapting existing ones to specific customer reqrrirements. This means that the abihty to be irmovative in the domain of chemicals cannot be illustrated solely by the number of newly registered substances. Or to say it in another way sim-plify ing notification of New Substances is not the sole and maybe not even the essential factor for the ability to be irmovative. 

The contract can specify the amount of time the client needs to remove its materials from the toller s facility and lays out notification procedures for dissolving the contract. Chapter 6, Closure and Audit, Example 6-1 is a sample contract termination checklist. It is an illustration of one company s inventory list for closing out a tolling project. It addresses material, financial, legal and environmental considerations. 

In 1979 the sixth amendment to the dangerous substances directive (79/831/ EEC) introduced a notification system for new substances and made provision for the publication of an inventory of existing substances, the latter being those substances on the European market by 18 September 1981. The European Inventory of Existing Commercial Substances (EINECS) was published in 1990 and lists 100,106 substances (SLIM, 1999). A decade later some 30,000 or so of these substances were thought to be marketed in volumes of above 1 tonne per year, these accounting for more than 99 per cent of the total volume of all substances on the EU market (CEC, 2001, p6). 

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. 

FDA Inventory of GRAS Notifications. Department of Health and Human Services. Food and Drug Administration, August 2004 (available from http //www.cfsan.fda. gov/ rdb/opa-gras.html). 

Many countries have adopted chemical substance inventories in order to monitor use and evaluate exposure potential and consequences. In the case of essential oils used in many fragrance applications, these oils must be on many of these lists, New essential oils used in fragrances are subject to premanufacturing or premarketing notification (PMN). PMN... 

In Japan there is no specific regulation for biocides, and new substances are regulated under the Industrial Chemical Control Law (ICCL). The scheme is based on an inventory for existing substances and notification for new substances. The fact that three different agencies are involved slows down the approval system considerably (28). 

In 1979, almost 62000 chemical substances were reported to be in commerce in the United States, and these were grandfathered into the Toxic Substances Control Act s inventory of existing industrial chemicals. Chemicals not in this list were to be considered new substances, and more than 43 000 new chemical notifications have been submitted by industry for assessment since July 1979. Via inclusion of about 13 000 new industrial chemicals that have been assessed for risk and are now in commerce, the TSCA inventory has now increased to more than 75000 substances, with a total production and import of 2.7 trillion tonnes per year in 1989. However, the total produced in and/or imported into the United States in 1989 was larger than this... 

The Australia inventory is the Australian Inventory of Chemical Substances (AICS).1516 It was established for the purpose of implementing the Industrial Chemicals (Notification and Assessment) Act 1989. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) operates under the Act for the notification and assessment of industrial chemicals and is administered by the National Occupational Health and Safety Commission (NOHSC). The list contains over 40,000 substances which gets added to regularly. 

The European Inventory of Existing Commercial Chemical Substances (EINECS) consists of substances on the market in the European Community between 1971 and 1981.19 These substances may be imported or manufactured without further notification. The list of 100,106 substances was published in 1990, and the contents are fixed. All chemicals that will be marketed after the September 18,1981 are not placed on the EINECS. These chemicals have to be notified before they will be placed on the market according to the sixth Amendment of Directive 67/548/EEC, Directive 79/831/EEC. Once assessed, these new chemicals are listed on the European List of New Chemical Substances (ELINCS).20 These substances must be notified by each new importer/manufacturer (although sometimes reduced notification packages may be accepted if the substance has already... 

The primary objective of the TSCA Inventory is to define what chemical exist in U.S. commerce for purposes of implementing the Toxic Chemicals Control Act. Specifically, chemicals not included on the Inventory are considered to be new chemicals under TSCA and are subject to the premanufacture notification (PMN) requirements stipulated under section 5 (a) of TSCA. The purpose of the TSCA Inventory is to identify those chemicals that exist in U.S. commerce, which have commercial applications that are not specifically addressed under other existing environmental legislation. 

Under Section 5, the EPA has the authority to require notification before any person manufactures or imports a chemical not on the TSCA inventory or manufactures or processes a chemical for a use the administrator has determined to be a significant new use. The former falls under the PMN requirement and the latter under SNUR. There are R D exemptions under this section for small quantities of material to be used under controlled conditions by technically competent individuals. 

Existing substances are defined as those substances in use within the EU before September 1981 and listed in EINECS (European Inventory of Existing Commercial Chemical Substances). Accordingly, substances not listed in EINECS are regarded as new substances and subject to a notification procedure (Section 2.2.2). 

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)... 

Not surprisingly, there are many synthetic chemicals and formulations commercially available. In Europe alone more than 100000 chemicals (not formulations) are on the European Inventory of Existing Commercial Chemical Substances (EINECS), which lists chemicals on the market before September 1981. This list differentiates between existing and all new chemicals produced since 1981 that have to be notified. During the period between 1981 and 2000 more than 2700 new substances were notified in Europe (Figure 1.3). For new substances, the obligatory notification system requires the manufacturer or importer to provide information suitable for risk assessment to be submitted to the competent authorities. The details required are dependent on the production volume or import quantities of the chemical. 

Manufacture and use of chemicals is nowadays tightly regulated around the globe and not limited to the industrialized countries. Prior to marketing every producer or importer has to comply with a general chemical regulation that asks either for a notification of new substances and/or products or compliance with existing chemicals inventories, e.g., in EU [8], the USA [9], Japan [10], Canada [11], Australia... 

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