Premanufacture notification activities

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... 

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. 

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. 

Before a company files an EUP it may research the pesticidal properties of a chemical substance. In those cases, if the R D activities are focused on investigating substances potential for use as pesticides, then the company does not need to comply with TSCA s restrictions on managing of R D chemicals. If the company does other types of research in addition to research on pesticides, then it must show by some affirmative evidence that its only intent with respect to the chemical at issue is to develop it as a pesticide. As a consequence, pesticides can be exempted from the premanufacture notification requirements of TSCA 5 even before an EUP is filed, but the substance will be subject to other TSCA requirements, such as reporting significant adverse effects under TSCA 8(e). 

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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