Regulation of Chemicals under Section 6(a) of the Toxic Substances Control Act
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Section 6 of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, provides EPA with the authority to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of a chemical if EPA evaluates the risk and concludes that the chemical presents an unreasonable risk to human health or the environment.
, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which updates the Toxic Substances Control Act was signed into law.
The law authorizes EPA to issue regulations requiring one or more of the following actions to the extent necessary so that the chemical substance no longer presents an unreasonable risk:
- Prohibit or otherwise restrict manufacture, processing, or distribution in commerce;
- Prohibit or otherwise restrict for a particular use or above a set concentration;
- Require minimum warnings and instructions with respect to use, distribution in commerce, or disposal;
- Require recordkeeping or testing;
- Prohibit or regulate any manner or method of commercial use;
- Prohibit or regulate any manner or method of disposal; and/or
- Direct manufacturers or processors to give notice of the unreasonable risk to distributors and replace or repurchase products if required.
EPA must issue these regulations within specific timelines and in accordance with additional requirements laid out in TSCA section 6(c) (15 U.S.C. §2605).
In addition, EPA is also authorized to regulate under section 6 of TSCA:
- Chemicals defined under section 6(h) of TSCA.
- These are certain chemicals that meet the statutory criteria for persistent, bioaccumulative, and toxic chemicals as described in section 6(h) (15 U.S.C. §2605). EPA identified five chemicals meeting these criteria.
- These chemicals are candidates for regulatory action, with a statutory requirement for a proposed rule no later than 3 years after June 22, 2016.
§ 6 Rules Under Amended TSCA
- Chloride: On March 15, 2019, EPA issued a final rule under Section 6 of TSCA to address the unreasonable risks presented by methylene chloride in paint and coating removal for consumer use.
- Amended Procedural Rule: On December 21, 2016, EPA issued a direct final rule removing portions of outdated procedural regulations promulgated under the old version of TSCA specifying certain procedural requirements for rulemaking under section 6, including the requirement for a hearing from part 750 of the Code of Federal Regulations. The old procedures are not consistent with the timelines and requirements of TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. As amended, TSCA no longer mandates an informal hearing and instead mandates certain timeframes for taking regulatory action on identified unreasonable risk after a chemical has undergone risk evaluation. This final rule also makes minor conforming changes to the procedural rules for exemptions from the prohibitions in TSCA section 6(e) applicable to PCBs.
Rules Under Development
- TCE Use in Aerosol Degreasing and for Spot Cleaning at Dry Cleaning Facilities: EPA issued a proposed rule under section 6 of TSCA to address the unreasonable risks presented by TCE use in commercial and consumer aerosol degreasing and for spot cleaning at dry cleaning facilities.
- TCE Use in Vapor Degreasing: EPA issued a proposed rule under section 6 of TSCA to address the unreasonable risks presented by TCE use in vapor degreasing.
- N-Methylpyrrolidone (NMP) in Paint and Coating Removal: EPA issued a proposed rule under Section 6 of TSCA to address the unreasonable risks presented by methylene chloride and NMP in commercial and consumer paint and coating removal.
- in Commercial Paint and Coating Removal: On March 27, 2019 EPA issued an advance notice of proposed rulemaking for commercial uses of methylene chloride in paint and coating removal.
§ 6 Rules Prior to June 2016
Some Section 6 actions have led to ongoing programs relating to chemical substances of national concern, such as asbestos and polychlorinated biphenyls (PCBs). Others – such as acrylamide – were withdrawn when the circumstances that led to the proposal of the rule changed, enabling the risk to be reduced without rulemaking.
- Polychlorinated biphenyls (PCBs): Manufacturing, Processing, Distribution in Commerce and Use Prohibitions.
EPA formalized the statutory ban contained in section 6(e) of TSCA in final regulations issued on May 31, 1979, 44 FR 31542. Subsequently, EPA has taken numerous actions to regulate PCB uses and disposal.
- Metalworking Fluids: Specific Use Requirements for Certain Chemical Substances
EPA took three actions to limit certain uses of metalworking fluids:
- Water Treatment Chemicals: Air Conditioning and Cooling Systems
- Hexavalent chromium-based water treatment chemicals in cooling systems at 40 CFR 749.68
- Asbestos Worker Protection
EPA issued asbestos worker protection rules extending the Occupational Safety and Health Administration (OSHA) Asbestos standards in 29 CFR 1910.1001 and 29 CFR 1926.1101 to certain state and local government employees.
- Prohibition of the Manufacture, Importation, Processing and Distribution in Commerce of Certain Asbestos-Containing Products; Labeling Requirements
EPA’s ban on existing uses of asbestos, known as the Asbestos Ban and Phaseout Rule, was remanded in the Corrosion Proof Fittings v. EPA case (947 F.2d 1201). Learn more.
- EPA’s ban on new uses of asbestos remains in effect. Read the regulations at 40 CFR Part 763 Subpart I.