Premanufacture notification information

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. 

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. 

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

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... 

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. 

Currently, we are evaluating the public comments that we received on the December 31 FEDERAL REGISTER notice. We are using these and information compiled from panels of scientific and technical experts as a basis for the formulation of a revised statement of policy on biotechnology. I ve hinted today at some of the directions being considered for the key issues of what is "new" and therefore what products are subject to premanufacture notification. 

If a submitter obtains possession, knowledge, or control of new information relevant to the chemical substance, the submitter must submit that information within ten days of receipt, but no later than five days before the end of the review period. If the new information becomes available during the last five days of the notice review period, the submitter must immediately inform its EPA contact by telephone. 40 C.F.R. 723.50(i). This obligation is similar to the obhgation imposed on a submitter of a PMN. which is discussed in Chapter 4, Premanufacture Notifications. 

The notice of inspection may limit the inspection to one TSCA program. For example, the inspection could be limited to compliance with 8(e) requirements to submit notices of significant risk information, it could be directed to the premanufacture notification requirements of 5, or it could cover all TSCA requirements. The letter will typically specify the kinds of documentation that the inspectors will want to inspect. It is advisable to review these materials in advance to see exactly what the inspector will see, and avoid the element of surprise if there is a violation on the face of a document. It will often be possible to refute any inference of a violation, and all the arguments should be marshaled at this point. For example, if the inspection notice states that all notices of export under 12(b) should be assembled, and a quick review shows that some letters were not submitted until after the export may have taken place, it may be possible to gather documentation showing that the exports occurred later than expected and the notices were indeed timely. 

Depending on the international structure of the acquiring corporation, the acquired business may need to change its practices and search the records of any new foreign parent company when it gathers information in response to a rule under TSCA 8(d) or when it submits prior studies as part of a premanufacture notification under TSCA 5. ... 

The Production Manager shall inform the MRC immediately upon completion of manufacture of the first batch of product made for commercial use other than research and development. The MRC shall file a Notice of Commencement with the United States Environmental Protection Agency in accordance with Procedure Number Reg. Aff. 2 Premanufacture Notifications and Notices of Commencement... 

Inventory it is now possible to determine if the chemical in question is produced for commercial purposes and the level of its production. The TSCA Inventory, however, is only a one-time information collection effort by EPA. It does not provide historical production information, and its update depends on the Premanufacture Notification (PMN) and the Significant New Use Regulations (SNUR), which are under development by EPA. The PMN regulation will provide for addition of new compounds to the inventory. The form of the SNUR regulation is not yet clear, but we can expect that manufacturers will be required to report significant new uses for chemicals already listed on the inventory, along with production figures. 

Although Neely and Blau (87) used direct laboratory measurements to develop rate constants, there are a few mathematical representations of environmental pathways which provide similar kinetics information (Table XV). Unfortunately, only a few of these pathways can currently be modeled based solely on physical/ chemical properties (e.g., volatilization from water and bioaccumulation). For some pathways (such as those describing atmospheric deposition and washout, biodegradation, and oxidation), adequate mathematical representations are not currently available. Other mathematical representations require either laboratory kinetics data (e.g., photodegradation and hydrolysis) or empirical data for model chemicals or environmental media (e.g., soil evaporation, adsorption, and leaching). Therefore, kinetics/rates models require more data as input than are likely to be available at the time of premanufacture notification. 

TSCA (Section 5) also provides EPA with the authority to regulate and control the introduction of new chemicals either through manufacture or import, or the processing of an existing chemical for a significant new use. Such manufacturers and importers must file a Premanufacture Notification (PMN) 90 days before producing or importing the chemical. Once a PMN is filed, EPA assesses the information and determines if the chemical poses an unreasonable risk of injury to health or the environment. An additional 90 days may be re-... 

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. 

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