Premanufacturing Review Program

While debate over the merits of its proposed regulations has continued, EPA has simultaneously received and reviewed almost 2,000 PMNs. The Agency s premanufacture review program has been shaped by the explicit requirements of the statute, supplemented by informal Agency guidance, and thus has provided an opportunity to test the industry position that Section 5 can be implemented effectively without detailed regulations. 

EPA is conducting an extensive study in order to more fully understand the impact of the premanufacturing review program on innovation in new chemicals. Although the lack of data in this area is discouraging, we are doing the best we can to quantitatively evaluate the effect on both the input (in terms of R D dollars) and the output (in terms of new chemical substances) of the innovative process. 

In this respect, it is one of the goals of the premanufacture review program to improve the quality of output of the innovative process. 

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. 

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. 

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. 

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