Legal aspects regulatory controls

To learn about regulatory and legal aspects of quality assurance and quality control. 

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. 

Regulatory Authority A national body with legal responsibility for aspects of the control of chemicals. 

For a more detailed discussion of legal regulation in relation to safety-critical systems see D. Rowland, Regulatory issues in Safety Aspects of Computer Control, P.Beimett (ed.) (Butterworth-Heinemann, 1993). 

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