Premanufacture notification filing

Where in a product s life a regulation such as TSCA is imposed becomes important in terms of resource diversion. Ideally, imposition of Premanufacture Notification after scale-up and successful line trials would necessitate filing notifications only for those products that actually become commercial. In the usually compressed Coatings and Resins lifeline, this is not always, and in fact very seldom, possible. 

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. 

The purpose of the SMART module in GCES is to help chemical manufacturers to review their processes and to perform similar analyses during the course of process development prior to filing a premanufacture notification with the EPA. The SMART assessment techniques are applicable to both new and existing manufacturing processes. 

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). 

Importers are not specifically mentioned in the statutory or regulatory statements of the PMN requirement, but in both the statute and the regulations manufacture is defined to include both manufacture and import and so all of the premanufacture notification rules that apply to manufacturers also apply to importers. Importers do not need to ensure that substances in articles are on the Inventory because articles are exempt from the PMN process. However, it is important to review the definition of article to check that all of the substances in the article meet the definition. Importers must file PMNs on all new chemicals that they import in bulk or as part of a mixture. ... 

To demonstrate the concept, consider the seemingly simple requirement of TSCA that only chemicals on the TSCA Inventory, or that are exempt from the requirements of being on the TSCA Inventory, can be manufactured, processed, used in, or imported into, the United States. If a chemical is not otherwise exempt from the TSCA Inventory requirements, and is not on the TSCA Inventory, a premanufacture notification must be filed prior to introducing it into commerce. The task here is to identify those business processes in the company where new chemicals can enter the company, and then decide how best to control those entry points to ensure no new chemicals are... 

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... 

Step 5. The ITS obtains and sends chemical identity or composition to the Manager, Product Compliance (MPC) for those chemicals for which there is no blanket TSCA certification on file for the current year or for which other regulatory classification is needed. The MPC provides product regulatory data such as TSCA certifications, harmonized tariff system (HTS) numbers, transportation classifications, and ascertains whether or not the shipment is in connection with a cleared Premanufacturing 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-... 

Chris supervises a unit that has begun making a new chemical (one not on the list) and becomes aware that a premanufacturing notification has not been filed. 

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