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Making a Finding on Unreasonableness of Risk

The term "unreasonable risk" is not defined in the Toxic Substances Control Act (TSCA). The legislative history, however, indicates that unreasonable risk involves the balancing of the probability that harm will occur and the magnitude and severity of that harm against the effect of a proposed regulatory action on the availability to society of the expected benefits of the chemical substance. In the context of the New Chemicals Program, EPA considers unreasonableness of risk both in the context of individual chemical substances and in considering whether to exempt categories of chemical substances.

Individual Substance

EPA's determination that manufacture, processing, use, distribution in commerce, or disposal of an individual substance which has been the subject of a notice under section 5 of the TSCA may present an unreasonable risk of injury to human health or the environment is based on consideration of (i) the size of the risks identified by EPA; (ii) limitations on risk that would result from specific safeguards (generally, exposure and release controls) sought based on Agency review and (iii) the benefits to industry and the public expected to be provided by new chemical substances intended to be manufactured after Agency review. In considering risk, EPA considers factors including environmental effects, distribution, and fate of the chemical substance in the environment, disposal methods, waste water treatment, use of protective equipment and engineering controls, use patterns, and market potential of the chemical substance.

Category of Substance

There is a substantial discussion of unreasonableness of risk as applied to categories of substances at 60 FR 16328. Categories of chemical substances EPA has made eligible for exemption, and the sections of the Code of Federal Regulations (CFR) at which they are described include: some polymers (under the requirements at 40 CFR section 723.250), chemical substances with production volumes less than or equal to 10,000 kilograms/year and which have been reviewed by the New Chemicals Program (Low Volume Exemption, LVE under the requirements at 40 CFR section 723.50), and those with low human exposure and low release to the environment (Low Release/ Low Exposure, LoREX, also under requirements at 40 CFR section 723.50), and which have been reviewed by the New Chemicals Program. EPA has determined that these are appropriate categories under TSCA sections 26(c) and 5(h)(4). For each of these categories EPA has made a finding that new chemical substances eligible for the exemptions will not present an unreasonable risk of injury to human health or the environment when manufactured, processed, used, distributed in commerce, or disposed of under the terms of the exemptions, including EPA's 30-day review.


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