In the Development of Industrial Chemical Substances

Prior to 1976, in total contrast to the extensive testing and other pre-market approval requirements established under the FFDCA for new substances intended to be marketed as drugs, and under the FIFRA for new substances intended to be marketed as pesticides, there were no pre-market statutory requirements for new industrial chemicals to protect human health and the environment from the risks posed by such substances. In the USA, chemical manufacturers could produce and market any new industrial chemical at will and without notifying the EPA. 

In 1976, the Toxic Substances Control Act (TSCA) was enacted, in part to (1) require chemical manufacturers to notify the EPA of their intent to introduce a new chemical into commerce, (2) enable the EPA to determine whether the new chemical poses unreasonable risks to human health or the environment, and (3) enable the EPA to 

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. 

U nlike submissions of new drug applications or new pesticide registrations, there is no burden of proof on the part of the submitter of a PMN to show that the new chemical is safe or, for that matter, efficacious. In fact, in reality, in order for the EPA to impose regulatory restrictions on a new chemical submitted under Section 5 of the TSCA, the onus is on the EPA to justify the restrictions. More simply, the submitter of a PMN is not required to prove or provide evidence that the chemical is safe, but the EPA would have to have some basis for concluding that the new chemical substance is not or may not be safe in order to regulate it. 

Less than half of the new chemical submissions received by the EPA contain any kind of test data. The EPA can obtain and review whatever toxicity or physical data on the new chemical happen to be available, such as data from literature sources, but usually there are none. For most new chemical submissions, measured values for chemical, toxicological, or environmental fate properties are not available for the E PA to use to make decisions regarding hazards or risks that the chemical may pose to human health or the environment, or its global impact. 

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