Hazardous substances act pdf

This guidance page provides information on only certain portions of the FHSA and does not cover all requirements. For guidance on FHSA requirements outside of those below, check out our Business Guidance Library.

Cautionary Labeling of Hazardous Substances

Enacted in 1960, the FHSA requires precautionary labeling of hazardous substances to help consumers safely store and use those products and to give them information about immediate first aid steps to take if an accident occurs. Additional information for the FHSA, including Commission determinations that certain substances are hazardous substances, is found at 16 C.F.R. Subchapter C (parts 1500 to 1513).

Section 2(f)(1)(A) of the FHSA, 15 U.S.C. § 1261(f)(1)(A), defines a hazardous substance as any substance or mixture of substances which meets both of the following criteria:

1. Is toxic; is corrosive; is an irritant; is a strong sensitizer; is flammable or combustible; or generates pressure through decomposition, heat, or other means (see definitions of individual hazards below); and
2. May cause substantial personal injury or illness during customary or reasonably foreseeable handling or use (including reasonably foreseeable ingestion by children).

The definition of a hazardous substance subject to cautionary labeling under the FHSA excludes:

• Pesticides subject to the Federal Insecticide, Fungicide, and Rodenticide Act; visit the U.S. Environmental Protection Agency’s (EPA) page for more information
  • Additionally, please see information from the EPA related to the Toxic Substances Control Act (TSCA) that may be helpful

  The definitions of listed hazards are found at 16 C.F.R. § 1500.3, and restated below:

  • Toxic means a substance (other than a radioactive substance) which has the capacity to produce personal injury or illness to man through ingestion, inhalation, or absorption through any body surface. 16 C.F.R. §§ 1500.3(c)(1) and 1500.3(c)(2) contain certain tests on animals to determine whether a product can cause immediate injury. In addition, a product is toxic if it can cause long-term chronic effects like cancer, birth defects, or neurotoxicity. 16 C.F.R. § 1500.3(c)(2)(ii) and the Chronic Hazard Guidelines (57 FR 46626, and supplemented at 89 FR 30326), summarized at 16 C.F.R. § 1500.135, provide information on how to evaluate products for chronic hazards.
    • Highly toxic means a substance which falls within any of the following categories:
      • Produces death within 14 days in at least half of a group of 10 or more laboratory white rats each weighing 200-300 g, at a single orally administered dose of 50 mg or less per kg of body weight
      • Produces death within 14 days in at least half of a group of 10 or more laboratory white rats each weighing 200-300 g, when inhaled continuously for a period of 1 hour or less at an atmospheric concentration ≤ 200 ppm by volume of gas or vapor or ≤ 2 mg/L by volume of mist or dust, provided such concentration is likely to be encountered by a consumer when the substance is used in any reasonably foreseeable manner
      • Produces death within 14 days in at least half of a group of 10 or more rabbits tested in a dosage of 200 mg or less per kg of body weight, when administered by continuous contact with the bare skin for 24 hours or less
      • Extremely flammable: flashpoint ≤ 20 °F (-6.7 °C)
      • Flammable: flashpoint between 20 °F (-6.7 °C) and 100 °F (37.8 °C), exclusive
      • Combustible: flashpoint between 100 °F (37.8 °C) and 150 °F (65.6 °C), inclusive
      • Extremely flammable solid: ignites and burns at an ambient temperature of 80 °F or less when subjected to friction, percussion, or electrical spark
      • Flammable solid: ignites and burns with a self-sustained flame at a rate greater than one-tenth of an inch per second along its major axis
      • Extremely flammable contents of self-pressurized container: flashback is obtained at any degree of valve opening and flashpoint < 20 °F (-6.7 °C)
      • Flammable contents of self-pressured container: flame projection exceeding 18 inches is obtained at full calve opening, or a flashback is obtained at any degree of valve opening
      • Explodes when subjected to an electrical spark, percussion, or the flame or a burning paraffin candle for 5 seconds or less
      • Expels the closure of its container, or bursts its container, when held at or below 130 °F for 2 days or less
      • Erupts from its opened container at a temperature of 130 °F for 2 days or less
      • Comprises the contents of a self-pressurized container

      Note that neither the FHSA nor the regulations issued thereunder require animal testing to determine whether a hazard exists. Under the FHSA animal testing is one possible option that can be used to determine the biological response and appropriate cautionary labeling. The Commission's policy is to find alternatives to traditional animal testing that replace animals, reduce the number of animals tested, and decrease the pain and suffering in animals associated with testing household products. To that end, CPSC is a member of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) which works to facilitate the development, validation, and regulatory acceptance of test methods that replace, reduce, or refine the use of animals. More information on CPSC and ICCVAM can be found on our page on animal testing as well as 16 C.F.R. § 1500.232, including information about tests that may be used in place of the laboratory animal tests defined at 16 C.F.R. § 1500.3.

      Products that meet the definition of “hazardous substance” must bear certain precautionary information that meets the labeling requirements outlined at 16 C.F.R. § 1500.121. The immediate container (and any outer packaging, if the labeling on the immediate container is not visible) must bear the following information in English:

      • Signal word (POISON, DANGER, WARNING, CAUTION)
      • Statement(s) of the principal hazard(s) (e.g., FLAMMABLE, VAPOR HARMFUL, CAUSES BURNS)
      • Common/usual or chemical name of the substance(s) responsible for the hazard(s)
      • Precautionary measures describing the action to be followed or avoided
      • First-aid treatment instructions, when necessary or appropriate
      • Handling and storage instructions for packages which require special care
      • “Keep out of reach of children” or its practical equivalent, or adequate directions for protection of children for hazardous substances intended for children
      • Name and place of business of the manufacturer, packer, distributor, or seller

      16 C.F.R. § 1500.122 prohibits the use of deceptive disclaimers that negate or disclaim any of the statements required by the FHSA. Examples of such disclaimers would be packages of hazardous substances advertising that they are harmless or safe around pets.

      Section 3(a) of the FHSA, 15 U.S.C. § 1262(a), allows the Commission to mandate specific labeling (partial or complete) for products. Such products, prerequisites, and the specific labeling requirements are listed at 16 C.F.R. § 1500.14. One of the listed products is art materials; information specific to labeling of art materials is available on our art materials business guidance page.

      Substances named in the Federal Caustic Poison Act are required to bear the signal word “POISON.” The substances and the amount which would trigger the use of the signal word “POISON” are listed at 16 C.F.R. § 1500.129.

      Section 2(q)(1)(B) of the FHSA, 15 U.S.C. § 1261(q)(1)(B), allows the Commission to ban certain products that are so dangerous, or the nature of the hazard is such that precautionary labeling is not adequate to protect consumers. Such products are listed at 16 C.F.R. § 1500.17.

      Petitions for exemptions from full labeling requirements or classification as a banned hazardous substance can be submitted per 16 C.F.R. § 1500.82. Granted exemptions from full labeling are listed at 16 C.F.R. § 1500.83, and granted exemptions from classification as a banned hazardous substance are listed at 16 C.F.R. § 1500.85. Note that these exemptions are typically both product and hazard specific; general exemptions, such as exemptions for all small packages, do not exist. Petitions must be made in accordance with the guidance provided at 16 C.F.R. part 1051.

      Section 2(q)(1) of the FHSA, 15 U.S.C. § 1261(q)(1), includes in its definition of a “banned hazardous substance” any children’s product that is or contains a hazardous substance. Certain children’s products, such as chemistry kits, are exempt from the classification of a banned hazardous substance if certain requirements are met. See 16 C.F.R. § 1500.85 for a list of such exemptions.

      Reimbursement

      Per 16 C.F.R. § 1500.267, CPSC will provide reimbursement for import samples that are collected and found to be compliant with the applicable requirements under the FHSA. Firms should contact the CPSC staff who collected the sample, typically found at the bottom of the CPSC Form 163 “Receipt for Samples”, and provide the following:

      • Documentation indicating compliance with the FHSA (usually a CPSC Form 179 “Results of Sample Analysis Reports”)
      • Invoice for the wholesale cost of the samples that were collected (may include any additional prorated costs)

      Additional Information from CPSC

      • Cautionary Labeling FAQs
      • CPSC Business Education | FHSA General Requirements Webinar (youtube.com)
      • CPSC’s chronic hazard guidelines (57 FR 46626, and supplemented at 89 FR 30326)

      Additional Information from Other Federal Agencies

      The following information from other federal agencies may assist firms with the determination of a hazardous substance under the FHSA; however, it is important to note that the hazards identified on these pages may not necessarily align with the hazard classifications defined under the FHSA:

      • PubChem (nih.gov)
      • NIST Chemistry WebBook
      • Summary of the Toxic Substances Control Act | US EPA
      • Occupational Chemical Database | Occupational Safety and Health Administration (osha.gov)

      Contact

      For more information, please contact the Small Business Ombudsman (SBO) team:

      • SBO contact form
      • Toll-free: (888) 531-9070
      • Email: SBO@cpsc.gov