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Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)

Regulatory Determinations made under Section 5 of the Toxic Substances Control Act (TSCA)

EPA Review and Determination 

TSCA requires EPA to review submitters' section 5 notices and make an affirmative finding on the safety of new chemical substances or significant new uses of chemicals (identified by EPA in rulemaking) submitted under section 5(a) of TSCA before they can proceed to the marketplace.  The law sets forth five possible determinations under section 5 with related actions:

  • If EPA determines a new chemical substance or significant new use presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation under the conditions of use, the Agency must take action under section 5(f) to protect against the unreasonable risk.
  • If EPA determines that the available information is insufficient to allow the Agency to make a reasoned evaluation of the health and environmental effects of the new chemical substance or significant new use, EPA must issue an order under section 5(e).  A section 5(e) order prohibits or limits the manufature, processing, distribution in commerce, use, or disposal to the extent necessary to protect against an unreasonable risk, and may include testing requirements.
  • If EPA determines that, in the absence of sufficient information, the manufacture, processing, distribution in commerce, use or disposal of the chemical may present an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the EPA Administrator, EPA must issue an order under section 5(e).  A section 5(e) order prohibits or limits the manufacture, processing, distribution in commerce, use, or disposal to the extent necessary to protect against an unreasonable risk, and may include testing requirements.
  • If EPA determines that the substance is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the substance, EPA must issue an order under section 5(e).  A section 5(e) order prohibits or limits the manufacture, processing, distribution in commerce, use, or disposal to the extent necessary to protect against an unreasonable risk, and may include testing requirements.
  • If EPA determines that a new chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation under the conditions of use, the Agency will notify the submitter and the submitter may commence manufacture of the chemical or manufacture or processing for a significant new use notwithstanding any remaining portion of the 90-day review period. EPA will notify the submitter of its decision and publish its findings in a statement in the Federal Register.

If EPA fails to make a determination by the end of the review period and the notice has not been withdrawn by the submitter, EPA must refund the submitter all applicable fees charged for review of the notice, but the Agency must still make the determination. A refund of applicable fees will not be made if the submitter has not provided information required or has otherwise unduly delayed the process such that EPA is unable to render a determination within the applicable review period.

Note: No person may manufacture a new chemical substance or manufacture or process a chemical substance for a significant new use until EPA makes a determination as described in section 5(a) and takes any required action.

Learn more about EPA’s Decision-Making Framework and EPA Actions Following a Section 5 Determination.

TSCA Section 5(h)(4) Exemption Categories

EPA has made some categories of chemical substances 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 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) (under the requirements at 40 CFR 723.50),
  • Chemical substances with low release to the environment and low human exposure (Low Release/Low Exposure, LoREX) and which have been reviewed by the New Chemicals Program (under the requirements at 40 CFR 723.50).
  • Chemicals that are manufactured (including imported) for test marketing (Test Marketing Exemption) (under the requirements at 40 CFR 720.38 and 720.78).
  • Chemical substances manufactured or processed only in small quantities and for research and development (under the requirements at 40 CFR 720.36 and 720.78).

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.

Learn more about Biotechnology under TSCA.