Toxic Substances Control Act (TSCA)

The Toxic Substances Control Act (TSCA, 1976) — fundamentally overhauled by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (2016) — gives EPA authority to evaluate and regulate chemical substances in U.S. commerce under 15 U.S.C. §§ 2601–2697. TSCA covers approximately 85,000 chemicals in the existing inventory, plus all new chemicals before they enter commercial production. The original 1976 law was widely criticized as ineffective: EPA could only restrict a chemical if it proved "unreasonable risk" under a standard courts interpreted as nearly impossible to satisfy (EPA's asbestos ban was struck down in 1991 under this standard). The 2016 Lautenberg reforms changed the legal standard, required EPA to systematically prioritize and evaluate existing high-risk chemicals, and created structured timelines for completing risk evaluations. Today's policy significance centers on PFAS ("forever chemicals") — TSCA is the primary legal tool for EPA to require PFAS reporting, restrict certain uses, and compel manufacturers to submit safety data. New chemicals must be reviewed by EPA before commercialization; EPA may restrict or require additional testing. The evaluation backlog — each risk evaluation takes several years — is a persistent gap between statutory intent and regulatory capacity.

Current Law (2026)

Legal Authority

• 15 U.S.C. § 2601 — Findings, policy, and intent (adequate data should exist on chemical substances; testing and regulation of chemicals presenting unreasonable risk; authority should not impede innovation or create unnecessary barriers)
• 15 U.S.C. § 2603 — Testing of chemical substances and mixtures (EPA may require testing when chemicals may present unreasonable risk and existing data are insufficient)
• 15 U.S.C. § 2604 — New chemicals review (manufacturers must submit a Premanufacture Notice (PMN) 90 days before manufacturing a new chemical; EPA reviews and may impose conditions, require testing, or prohibit manufacture)
• 15 U.S.C. § 2605 — Regulation of hazardous chemical substances (EPA may prohibit, limit, or impose conditions on manufacture, processing, distribution, use, or disposal of chemicals presenting unreasonable risk; must select the least burdensome requirements)
• 15 U.S.C. § 2607 — Reporting and recordkeeping (Chemical Data Reporting rule; manufacturers and importers must report production volumes, uses, and exposure data)
• 15 U.S.C. § 2605(b) — Risk evaluation process (Lautenberg Act — EPA must conduct risk evaluations of prioritized chemicals; determine whether a chemical presents unreasonable risk; if so, must impose restrictions within specified timelines)
• 15 U.S.C. §§ 2681-2697 — Lead-based paint (lead paint hazard disclosure requirements; certification of renovation, repair, and painting contractors; lead abatement standards)

Implementing Regulations (40 CFR Parts 700-799)

• 40 CFR Part 702 — General practices and procedures for risk evaluations: framework for prioritizing chemicals, conducting risk evaluations, and determining unreasonable risk under the Lautenberg Act

• 40 CFR Part 707 — Chemical Imports and Exports: the EPA regulations implementing TSCA Section 12 (15 U.S.C. § 2611), which addresses the treatment of chemicals at the U.S. border. Two separate frameworks operate side by side:

  • § 707.20 — Import policy: chemical substances and mixtures imported into the U.S. are subject to TSCA requirements, with the same exemptions that apply to domestic manufacturers; importers stand in the shoes of domestic manufacturers and must comply with TSCA reporting, testing, and premanufacture notification requirements; the importer of record bears responsibility for TSCA compliance, not the foreign manufacturer
  • § 707.60 — Export notification applicability: any person who exports or intends to export a chemical substance or mixture that is subject to a TSCA Section 4, 5, 6, or 7 action (testing rule, Significant New Use Rule, risk management rule, or imminent hazard order) must notify EPA before the first export to each country in each calendar year; the notification requirement is triggered by the regulatory action, not by the export volume
  • § 707.65 — Submission to EPA: exporters must notify EPA's TSCA Document Processing Center, specifying the regulated chemical name, the TSCA action that triggers the requirement, the importing country, and the approximate date of first export; notifications may be made electronically through the Central Data Exchange
  • § 707.70 — EPA notice to foreign governments: within 5 working days of receiving an exporter's notice, EPA must transmit a notification to the government of the importing country through the State Department; the notice describes the chemical and the U.S. regulatory action that has been taken — this is the mechanism by which U.S. chemical regulatory findings are shared with trading partners
  • § 707.72 — Termination of reporting: once EPA has provided notice to the importing country's government for a specific chemical and country combination, the exporter's annual reporting obligation for that chemical/country pair may terminate if EPA publishes notice in the Federal Register; exporters should check EPA's published termination lists before submitting redundant notifications
  • § 707.75 — Confidentiality: exporters may assert confidentiality claims for information submitted in export notifications; EPA maintains TSCA confidential business information protections, though the chemical identity and regulatory status are typically disclosed to the receiving government

  The import/export framework reflects TSCA's extraterritorial limits: the U.S. cannot regulate foreign chemical production, but it can (a) require that imported chemicals meet the same standards as domestically produced ones, and (b) notify foreign governments when chemicals that have triggered U.S. regulatory concern are being exported to their countries. The notification requirement is particularly relevant for chemicals that have been banned or severely restricted under TSCA Section 6 — the U.S. cannot prohibit exports of all such chemicals (Congress carved out export exemptions in some cases), but it can ensure receiving countries know what they're importing. The 2016 Lautenberg Act amendments strengthened import controls by clarifying that importers must certify TSCA compliance for each shipment.

  Recent rulemakings: A 2023 update (88 FR 37171) revised export notification procedures and updated the electronic submission pathway through EPA's CDX system.

• 40 CFR Part 710 — Chemical Data Reporting (CDR): scope and introductory provisions

• 40 CFR Part 711 — TSCA Chemical Data Reporting Requirements: the substantive CDR rule specifying who must report, what must be reported, when, and in what format under TSCA Section 8(a). CDR is EPA's primary mechanism for understanding the U.S. chemical marketplace — the production volumes, uses, and human exposures that are invisible without manufacturer self-reporting:

  • § 711.8 — Who must report: any manufacturer or importer who manufactured or imported a covered chemical substance in a quantity of 25,000 lbs or more during any year in the CDR reporting period; the 25,000 lb threshold applies to each chemical substance separately; manufacturers of chemicals designated as requiring lower-volume reporting (certain PFAS and other high-concern chemicals) must report at 2,500 lbs; a separate reporting threshold of 2,500 lbs applies to chemicals listed in Appendix A (chemicals subject to Section 5(f) orders and significant new use rules); the reporting obligation is per-site, per-chemical — a company with five sites making the same chemical submits five reports
  • § 711.5 — Chemical substances covered: all chemical substances listed in the TSCA Chemical Inventory that are manufactured or imported above the threshold; CDR exempts: naturally occurring substances, substances manufactured incidentally as impurities, mixtures, articles (manufactured items), substances in R&D quantities, substances manufactured solely for export, and certain polymer categories; specific exempt substances are listed in § 711.6
  • § 711.15 — What information must be reported: for each reportable chemical, manufacturers must submit: production volume (pounds per year); Form U manufacturing/processing/use data — end use categories (consumer products, industrial uses, commercial uses, building/construction materials, etc.); worker exposure information (number of workers reasonably anticipated to be exposed during manufacture, processing, or use); industrial consumer information (number and types of industrial sites where the chemical is processed/used downstream); consumer and commercial product use information (types of products in which the substance is present); the 2016 Lautenberg Act required CDR to add processing and use information beyond simple production volume data
  • § 711.20 — Reporting periods: CDR submissions occur every 4 years; the current reporting cycle requires submission of data for the prior 4 calendar years; the 2024 CDR submission period runs from June 1, 2024 through September 30, 2024; the next submission period will be 2028; between cycles, manufacturers must maintain records that support the reported data
  • § 711.30 — Confidentiality claims: manufacturers may assert confidentiality (CBI) claims for specific data elements; EPA reviews CBI claims and may deny them; chemicals whose identities are claimed as CBI appear on the public TSCA Inventory as "confidential" without identifying information; the 2016 Lautenberg Act required EPA to review CBI claims more rigorously, reducing the volume of substances hidden from public view
  • § 711.9/711.10 — Small manufacturer exemptions: companies qualifying as "small manufacturers" under the TSCA rule (generally, manufacturers with annual sales below $40 million and production volumes below certain thresholds) are exempt from CDR for some or all chemicals; the small manufacturer exemption is significant — it removes a large fraction of chemical manufacturers from the CDR obligation while still covering the companies responsible for the largest production volumes

  CDR data is the foundation of EPA's chemical risk assessment program. When EPA prioritizes chemicals for risk evaluation under the Lautenberg Act framework, CDR production volume and use data determine which chemicals pose the highest exposures and which industries and sectors are affected. CDR data is publicly available at EPA's Chemical Dashboard (comptox.epa.gov/dashboard) — the public database shows production volumes by substance, industry sector, and year. CDR data has been particularly important for understanding PFAS chemicals — EPA's 2020 PFAS Action Plan used CDR to identify the universe of PFAS substances manufactured in the U.S. and their production volumes. Recent rulemakings: 88 FR 70516 (October 2023) — CDR rule amendments requiring broader PFAS reporting and updated use categories; 82 FR 6519 (January 2017) — 2016 Lautenberg Act conforming amendments to CDR.

• 40 CFR Part 720 — Premanufacture Notification (PMN): the procedures for TSCA Section 5 reporting by manufacturers of new chemical substances. Any company that wants to make or import a new chemical substance (one not listed on the TSCA Chemical Inventory) must file a PMN with EPA at least 90 days before commercial manufacture begins. Key provisions:

  • § 720.22 — Who must report: any person who intends to manufacture a new chemical substance in the United States for commercial purposes must submit a PMN; importers who plan to import a new chemical for commercial purposes also must submit; a "manufacturer" includes companies that contract with a foreign manufacturer to produce for their account; researchers and academic labs are covered only if they intend commercial use
  • § 720.25 — What is "new": a chemical substance is "new" if it is not listed on the TSCA Chemical Inventory — EPA's master list of chemicals that have been in commerce in the United States since before 1979 (and chemicals added since); the Inventory has a confidential portion (chemicals whose identities are CBI) and a public portion; a company can check the Inventory at EPA's Chemical Dashboard; if a substance is not on the Inventory, it is a new chemical requiring PMN
  • § 720.30 — Key exemptions from PMN: substances not subject to notification include: (a) mixtures (TSCA regulates chemical substances, not mixtures, except for specific regulations); (b) articles (manufactured items — a plastic widget doesn't trigger PMN just because it contains a new polymer); (c) impurities and byproducts unintentionally formed in a reaction; (d) substances manufactured solely for export; (e) chemicals manufactured only for R&D under § 720.36 (small quantities, without exposure to third parties); (f) low-volume exemptions (less than 10,000 kg/year for chemicals meeting certain risk criteria) — the exemption system is complex and companies often get the determination wrong
  • § 720.36 — R&D exemption: a new chemical may be manufactured in small quantities for research purposes without a PMN if: it is manufactured only in small quantities solely for R&D; it is used only by technically qualified individuals; workers are notified of health risks; and the manufacturer reports certain information to EPA; this exemption enables new chemical discovery research without triggering a 90-day commercial review
  • § 720.102 — Notice of commencement (NOC): after EPA completes its review and the submitter decides to proceed with manufacture, the submitter must file a Notice of Commencement of Manufacture within 30 days after first manufacturing or importing the substance; the NOC triggers addition of the substance to the TSCA Inventory; only after Inventory listing can anyone else manufacture or import the substance without filing their own PMN
  • Subpart D — EPA review and disposition: within the 90-day review period, EPA can: (1) take no action (allowing manufacture to proceed — the most common outcome for low-risk chemicals); (2) issue a SNUR (Significant New Use Rule under Part 721 — restricting specific uses that weren't reviewed); (3) issue a consent order (§ 5(e)) requiring additional testing, worker protections, or use restrictions before manufacture may proceed; or (4) propose to prohibit or limit manufacture (§ 5(f)) when EPA finds a "substantial" risk to health or the environment

  The PMN system processes approximately 1,000 new chemical notices per year. About half are approved without conditions; the remainder receive SNURs, consent orders, or are withdrawn by the submitter after EPA flags risk concerns. The 90-day clock is a hard constraint — if EPA doesn't act, manufacture may legally begin, creating a "deemed approved" outcome that the Lautenberg Act attempted to tighten by requiring affirmative EPA determinations. Companies that manufacture before filing a PMN, or that file but start manufacture before the review period expires, face civil penalties up to $46,989 per day per violation under TSCA § 16.

• 40 CFR Part 721 — Significant New Use Rules (SNURs) (2,583 sections): EPA's ongoing enforcement tool for restricting specific chemical uses beyond those reviewed during the original new chemical notification. When EPA allows a new chemical to enter commerce after PMN review (Part 720), it may simultaneously issue a SNUR identifying uses that were not reviewed — uses that would be "significant new uses" requiring a new 90-day notice before anyone manufactures or imports the chemical for that purpose. Key provisions:

  • § 721.1 — Scope: applies to chemicals identified in Subpart E that EPA has determined pose unreasonable risk if used in a new application; any manufacturer or importer who intends to use the chemical for a significant new use must submit a Significant New Use Notice (SNUN) at least 90 days before commencing that use
  • § 721.45 — General exemptions: de minimis use exemptions, impurity exemptions, article exemptions (chemicals in manufactured articles that do not leach or off-gas), and R&D use exemptions may apply depending on the specific SNUR
  • § 721.63 — Protection in the workplace (Subpart B): general SNUR provisions requiring respirators, impervious gloves, and other protective equipment; hazard communication; exposure monitoring; and workplace controls when identified as required by a specific substance SNUR
  • Subpart E (2,560 sections) — Chemical-specific SNURs: each section (§ 721.100 through § 721.10999 and beyond) designates a specific chemical substance by name or PMN number and identifies the significant new uses subject to 90-day SNUN reporting; covers chemicals ranging from industrial intermediates to nanomaterials, flame retardants, and PFAS precursors

• 40 CFR Part 725 — Reporting Requirements and Review Processes for Microorganisms (75 sections — TSCA Section 5's parallel framework for living organisms; just as chemical companies must submit a Premanufacture Notice before making a new chemical substance, biotech companies that manufacture new microorganisms for commercial use must notify EPA through a Microbial Commercial Activity Notice (MCAN)). Key provisions:

  • § 725.1 — Scope: Part 725 applies to manufacturers and importers of new microorganisms — any living organism (bacteria, yeast, fungi, algae, viruses) not already on the TSCA Inventory for microorganisms; covers intergeneric microorganisms (those containing genetic material from more than one genus, i.e., genetically engineered organisms) as the primary regulated category; applies to commercial manufacture, not R&D under containment
  • § 725.105 — Who must report: manufacturers of new intergeneric microorganisms must submit an MCAN to EPA at least 90 days before commercial manufacture begins; importers bringing in new microorganisms for commercial use must also notify; the same 90-day review clock that applies to chemical PMNs under Part 720 applies to MCANs
  • § 725.110 — Exemptions: R&D uses under appropriate containment are exempt; persons using microorganisms solely in contained research facilities that meet the regulatory containment standards may proceed without an MCAN; the exemption tracks the containment level, not the organism's risk profile — good containment practice is what removes regulatory burden
  • § 725.12 — Inventory identification: Part 725 maintains a separate TSCA "Inventory for microorganisms" analogous to the chemical substance inventory; a microorganism already listed on the Inventory for its specific use is not "new" and does not trigger MCAN notification; the Inventory distinguishes organisms by genetic makeup and intended use
  • §§ 725.1000–725.1082 — Significant New Use Rules (SNURs) for specific microorganisms: designate specific organisms (Burkholderia cepacia complex, genetically modified Trichoderma reesei, E. coli arsenic-detecting strain, microorganisms expressing enzymes, and others) and identify "significant new uses" requiring notification even for Inventory-listed organisms

  The MCAN framework reflects a key distinction from chemical regulation: EPA's concern centers on containment failure risk (what happens if the engineered organism escapes into the environment) rather than chemical toxicity. MCAN submissions must include the organism's identity, genetic modifications, intended commercial use, production volumes, containment and inactivation procedures, and environmental fate data. EPA may take no action, issue a consent order restricting uses or requiring additional testing, or prohibit manufacture. No major Part 725 amendments in the last 5 years — the framework has remained stable since the 1997 final rule establishing the microbial MCAN system.

• 40 CFR Part 745 — Lead-based paint programs: renovation, repair, and painting (RRP) rule requiring lead-safe work practices; lead-based paint disclosure in real estate transactions; certification requirements for abatement contractors

• 40 CFR Part 761 — Polychlorinated biphenyls (PCBs): the comprehensive regulatory framework for PCB manufacture, use, storage, disposal, spill cleanup, recordkeeping, and transboundary shipment under TSCA § 6(e). Key provisions:

  • § 761.1 — Applicability: covers all persons who manufacture, process, distribute, use, or dispose of PCBs or PCB items — including dielectric fluids, solvents, heat transfer fluids, hydraulic fluids, paints, sediments, and soils; establishes that PCB concentration is measured on a weight/weight basis (mg/kg or ppm)
  • § 761.2 — PCB concentration assumptions: pre-July 2, 1979 mineral oil-filled transformers must be assumed to be PCB-contaminated (≥50 ppm); equipment manufactured after July 2, 1979, may be assumed to be non-PCB (<50 ppm); this rebuttable presumption governs how facilities manage electrical equipment inventory without lab testing every transformer
  • § 761.20 — Manufacturing and use prohibitions: manufacturing, processing, distribution in commerce, and most use of PCBs at ≥50 ppm is prohibited under TSCA § 6(e); use of existing PCB items (transformers, capacitors) in service before the ban date continues to be regulated but not banned outright; new uses must go through EPA authorization
  • § 761.120–761.135 (Subpart G) — PCB spill cleanup policy: applies to spills of materials at ≥50 ppm occurring after May 4, 1987; establishes mandatory reporting to EPA and the National Response Center (for spills ≥1 pound PCBs); cleanup standards differ for high-contact surfaces (10 µg/100 cm²), low-contact surfaces (100 µg/100 cm²), and outdoor soil (cleanup to 10 ppm or 1 ppm near residences); post-cleanup sampling must achieve 95% confidence against false positives
  • § 761.180 (Subpart J) — General records and monitoring: facilities storing or using ≥45 kg of PCBs in containers, or any PCB transformer, or ≥50 large capacitors must maintain annual document logs by July 1 each year covering the prior calendar year; records must be maintained for 3 years after the facility ceases using PCBs in those quantities
  • § 761.202 (Subpart K) — EPA identification numbers: generators, commercial storers, transporters, and disposers of PCB waste must obtain EPA ID numbers before handling PCB waste; obtained by filing EPA Form 7710-53; a generator who has not yet received an ID number may use the string "40 CFR Part 761" as a placeholder
  • § 761.205 — Notification: all persons engaging in commercial storage, transport, or disposal of PCB waste must notify EPA using Form 7710-53 before commencing those activities
  • § 761.207 — The PCB manifest: generators who transport PCB waste off-site for storage or disposal must complete EPA Form 8700-22 (the PCB manifest), identifying the PCB waste, earliest removal-from-service date, and weight in kilograms; this creates the chain-of-custody documentation required to demonstrate lawful PCB waste disposal

  The PCB rules were most recently amended by 88 FR 59695 (Aug. 2023) and 89 FR 60737 (2024) updating storage, disposal, and cleanup standards.

• 40 CFR Part 763 — Asbestos (31 sections — the EPA's asbestos regulatory framework under TSCA covering three separate programs: school asbestos inspection and management (AHERA), worker protection in schools, and asbestos-containing material (ACM) prohibitions):

  • Subpart E — Asbestos-Containing Materials in Schools (AHERA, §§ 763.80–763.99): under the Asbestos Hazard Emergency Response Act (AHERA, 15 U.S.C. § 2641), every local education agency (public K-12 school district) must: (1) conduct an initial inspection of all school buildings by a certified inspector to identify ACM; (2) prepare an asbestos management plan describing the location of ACM, its condition, the re-inspection schedule, and the response actions to be taken; (3) have the plan on file at the school and available to parents and teachers; (4) re-inspect all ACM every 3 years; (5) conduct periodic surveillance of ACM every 6 months between inspections; (6) use certified abatement contractors for any removal or disturbance activities; friable ACM (material that can be crumbled by hand) is the primary concern — when in good condition, management-in-place is often preferred over removal, since disturbing ACM during removal can release more fibers than leaving it alone
  • Subpart G — Worker Protection (§§ 763.120–763.123): states and local government employers are not covered by OSHA's asbestos construction and general industry standards (28 states have their own OSHA-approved plans that cover state and local workers; the remaining states have gaps for state/local government employers); Part 763 Subpart G fills this gap, requiring state and local government employers in non-OSHA states to provide asbestos workers the same protections as OSHA's Part 1926.1101 (construction) and Part 1910.1001 (general industry) — including exposure monitoring, respiratory protection, medical surveillance, and regulated area controls
  • Subpart I — Asbestos-Containing Material Prohibition (§§ 763.160–763.179): bans the manufacture, import, processing, and distribution of most ACM in the United States (effective 1989–1992 under a series of phase-in dates); the prohibition covers flooring felt, commercial paper, rollboard, and corrugated paper containing asbestos, and other specified ACM; does NOT cover all asbestos uses — chrysotile asbestos in certain remaining applications (now being phased out under 40 CFR Part 751, Subpart E) and some legacy uses were excluded from the original Part 763 ban; the asbestos ban that EPA issued in 1989 under TSCA § 6 was struck down by the Fifth Circuit in Corrosion Proof Fittings v. EPA (1991), but the Subpart I prohibitions for these specific product categories survived because they were enacted separately under § 8 authority
  • § 763.171 — Labeling requirements: any product that contains asbestos and that is not prohibited must bear a label stating the percentage of asbestos by weight, the type of asbestos (chrysotile, amosite, crocidolite, etc.), and the applicable OSHA hazard warning language; labeling requirements facilitate downstream risk communication in the supply chain

  AHERA's school inspection mandate created the first U.S. program requiring systematic identification and management of building materials. The 2024 final rule under Part 751 (40 CFR Part 751, Subpart E) phases out all remaining commercial uses of chrysotile asbestos by 2026-2029 — effectively completing the ban that Part 763 started. Recent rulemakings: 65 FR 69216 (November 2000) — updated AHERA provisions; 59 FR 33209 (June 1994) — worker protection provisions for state/local employers.

• 40 CFR Part 751 — TSCA Section 6(a) and 6(h) Chemical Restrictions (57 sections): the regulatory home for EPA's actual chemical bans — six subparts each restricting a specific chemical or chemical class found to pose unreasonable risk under reformed TSCA. These are the rules with direct compliance deadlines and prohibition dates:

  • Methylene Chloride (§§ 751.101–751.117): consumer paint and coating removal banned after November 22, 2019; industrial and commercial uses subject to a Workplace Chemical Protection Program requiring air monitoring, exposure limits, medical surveillance, and downstream notification; exemptions available for certain specialty uses with time-limited phase-outs
  • Trichloroethylene (TCE) (§§ 751.301–751.309): broad restrictions on manufacturing, processing, distribution, and most uses; critical-use exemptions for specific industrial applications (e.g., vapor degreasing for rocket booster nozzles may continue under strict conditions until December 2029); processing TCE as an intermediate to manufacture HFC-134a refrigerant requires phased reduction with EPA-established baselines
  • Perchloroethylene (PCE) (Subpart G): restrictions on dry cleaning, spot cleaning, and industrial uses — the rule that directly affects dry-cleaning businesses; compliance deadlines extend through 2028 for most commercial uses with phased prohibition dates
  • Chrysotile Asbestos (§§ 751.501–751.515): the final remaining commercial uses of asbestos in the U.S. are banned under this subpart; chlor-alkali industry diaphragm use — the last significant commercial asbestos use — is banned effective May 28, 2024, for new manufacturing, with compliance certifications required through May 2029 for existing installations; all other chrysotile asbestos manufacturing, processing, distribution, and commercial use is prohibited after May 27, 2026; disposal of chrysotile asbestos must follow hazardous waste rules after November 2024
  • Persistent, Bioaccumulative, and Toxic Chemicals (PBTs) (§§ 751.401–751.411): EPA's Section 6(h) actions targeting five chemicals that accumulate in living organisms and persist in the environment — DecaBDE (a flame retardant in electronics): manufacturing and processing banned after March 8, 2021; PIP (3:1) (a plasticizer): restricted processing and distribution; 2,4,6-TTBP (an antioxidant additive): distribution in containers under 35 gallons at concentrations above 0.3% banned after January 6, 2026; PCTP (a solvent): manufacturing and processing banned after March 8, 2021; 2-EH-TM: restrictions on processing and distribution
  • Carbon Tetrachloride (Subpart H): the chemical long used as a cleaning solvent and fire suppressant is subject to manufacturing and use restrictions; key remaining uses face compliance deadlines requiring transition to alternatives

  The Part 751 rules are EPA's first completed Section 6(a) risk management actions under reformed TSCA — each preceded by a Final Risk Evaluation (under Part 702) finding unreasonable risk, then a formal risk management rule. The Trump administration (2025-2026) moved to reconsider several Part 751 rules, particularly the PCE dry-cleaning restrictions and the TCE industrial exemptions, citing economic impact on small businesses; those reconsideration proceedings were pending as of early 2026.

• 40 CFR Part 798 — Health Effects Testing Guidelines (EPA, 27 sections across 5 subparts — the technical reference standard for the health-effects studies EPA requires or accepts when evaluating chemical safety under TSCA §4 (15 U.S.C. §2603); Part 798 does not itself impose testing obligations on any company — that is done by specific test rules in Part 799 or consent orders — but it specifies the validated scientific protocols that must be used when testing is required; the guidelines harmonize with OECD test guidelines used internationally, ensuring that U.S. TSCA-required data can also satisfy regulatory requirements in EU, Japan, and other markets):

  • Subpart C — Subchronic Exposure Studies: test protocols for repeated-dose exposure studies of 28 to 90 days duration, covering three exposure routes:
    • § 798.2250 (Dermal): subchronic dermal toxicity study — animals receive daily skin applications of the test substance for 90 days; endpoint: systemic toxicity from dermal absorption, local skin effects, and dose-response determination for the NOAEL (No Observed Adverse Effect Level); species: typically rat; required observations include body weight, food consumption, clinical signs, ophthalmology, and full necropsy with histopathology
    • § 798.2450 (Inhalation): subchronic inhalation toxicity — gas, volatile substance, or aerosol applied by whole-body or nose-only exposure for 6 hours/day, 5 days/week, for 90 days; endpoint: respiratory tract effects, systemic toxicity, and NOAEL; required for chemicals used in spray applications or with significant inhalation exposure potential in occupational or consumer settings
    • § 798.2650 (Oral): subchronic oral toxicity — repeated daily doses by gavage or diet admixture for 90 days; endpoints: same as dermal plus species-appropriate target organ identification; the oral route study is the most commonly required because ingestion is the default exposure pathway in risk assessments for most chemicals
  • Subpart D — Chronic Exposure Studies: long-duration studies for chemicals with potential for long-term low-level human exposure:
    • § 798.3260 (Chronic toxicity): at least 12 months of repeated dosing (typically spanning most of the animal's lifespan); objective is to determine effects that require long latency periods to develop; endpoint: LOAEL (Lowest Observed Adverse Effect Level) and NOAEL for systemic effects; comprehensive histopathology of all major organs; required when subchronic data suggest a need for longer-term characterization or when the chemical is expected to have long-term human exposure
    • § 798.3300 (Oncogenicity): lifetime cancer bioassay — animals exposed for the majority of their natural lifespan (approximately 24 months for rats, 18 months for mice); objective: identify neoplastic (tumor) development at any tissue site; incidence data for each tumor type are evaluated statistically; the oncogenicity study is the most resource-intensive test guideline, requiring hundreds of animals and years of study; a positive oncogenicity result is a critical input for EPA's cancer risk characterization
    • § 798.3320 (Combined chronic/oncogenicity): a single study design that simultaneously generates both chronic toxicity and oncogenicity data; EPA typically prefers the combined study when both are needed for the same chemical because it reduces animal use and cost while producing equivalent data; the combined study typically runs 24 months in rats with the same dose groups, endpoints, and histopathology required for separate studies
  • Subpart E — Specific Organ/Tissue Toxicity and Developmental Studies:
    • § 798.4100 (Dermal sensitization): tests whether a chemical can induce skin allergy — a property distinct from acute skin irritation; commonly used protocols include the Guinea Pig Maximization Test (GPMT) and the Buehler occluded patch test; sensitization results are required for chemicals with likely skin contact (occupational or consumer use); a sensitizer finding triggers requirements for appropriate hazard communication
    • § 798.4700 (Reproduction and fertility effects): two-generation study — the first generation of animals is exposed before mating and throughout gestation and lactation; the offspring (F1) generation is also exposed and then mated to produce an F2 generation; endpoints: fertility rates, litter sizes, pup survival, developmental landmarks (eye opening, incisor eruption), reproductive organ weights and histopathology; the two-generation design detects multi-generational effects that single-generation studies miss
    • § 798.4350 (Inhalation developmental toxicity): teratology study by inhalation route — pregnant animals are exposed from implantation through the period of organogenesis; examines whether the chemical causes birth defects, altered fetal growth, or developmental toxicity; required for chemicals with significant inhalation exposure during reproductive years
    • § 798.4900 (Developmental toxicity): the standard teratology study by oral or dermal route — same design as inhalation developmental but via gavage or dermal application; the classic study for evaluating whether a chemical causes malformations, growth retardation, or fetal death; includes full fetal examination by external observation, visceral examination, and skeletal staining
  • Subpart F — Genetic Toxicity (mutagenicity): protocols for detecting whether chemicals damage DNA, cause chromosomal aberrations, or induce heritable mutations — a battery of in vitro and in vivo tests including the Ames test (bacterial reverse mutation), mammalian cell chromosomal aberration, and mouse micronucleus assay; positive genotoxicity results are factored into cancer risk assessment and reproductive risk characterization
  • Subpart G — Neurotoxicity: protocols for evaluating nervous system effects — functional observational battery (FOB) measuring motor activity, grip strength, landing foot splay, and sensory function; neuropathology (standardized histopathological examination of central and peripheral nervous system tissues); neurotoxicity screening is required for chemicals with suspected neurological effects based on structure or available data

  Part 798 guidelines are required study designs — deviating from them without prior EPA approval invalidates data submitted under TSCA § 4. The guidelines are periodically updated to incorporate scientific advances; EPA harmonizes Part 798 with OECD guidelines (the OECD Test Guidelines Programme) to avoid duplicative testing when a study valid under OECD standards can satisfy the Part 798 requirement. Companies conducting Part 798 studies must follow the Good Laboratory Practice standards in 40 CFR Part 792 — GLP compliance ensures the integrity, quality, and reproducibility of the data submitted to EPA. Test data generated under Part 798 protocols must be submitted in a standardized format and become part of EPA's chemical database; TSCA § 14 allows limited confidential business information protections for submitted test data (primarily for specific studies that reveal CBI manufacturing processes), but the health and safety study data itself must be disclosed to the public.

• 40 CFR Part 799 — Identification of specific chemical substance and mixture testing requirements: Part 799 is EPA's library of compulsory testing rules for specific chemicals under TSCA § 4. When EPA determines that a chemical may present unreasonable risk and there is insufficient existing data to evaluate that risk, it issues a test rule requiring manufacturers and processors of that chemical to conduct specified studies and submit the results. Part 799 contains those specific test rules along with the health-effects test guidelines EPA uses to evaluate submissions. Key provisions:

  • § 799.1 — Scope: Part 799 identifies specific chemicals subject to mandatory testing obligations (Subpart B), the persons who must conduct the tests, and the test guidelines they must follow; testing must be conducted under Good Laboratory Practice standards (40 CFR Part 792)
  • § 799.10 — Test standards: all testing required under Subpart B must be performed using a study plan prepared under Parts 790 and 792 unless modified in a specific chemical test rule; results are submitted as formal test reports to EPA's chemical test submissions database
  • § 799.11 — Availability of guidelines: TSCA and FIFRA testing guidelines are available through NTIS; EPA's test guidelines for acute toxicity, chronic effects, mutagenicity, carcinogenicity, and environmental fate studies are the technical standards used worldwide for chemical risk assessment
  • Subpart B — Specific Chemical Test Rules: contains individual test rules for specific chemical substances and mixtures (e.g., trichlorobenzenes at § 799.1053, diethylene glycol butyl ether at § 799.1560) — each setting out the chemical's CAS number, required studies, test duration, dose levels, and reporting format; companies manufacturing or processing these chemicals must conduct and submit the specified studies within defined timelines
  • Subpart H — Health Effects Test Guidelines: the framework test protocols for studying acute toxicity, subchronic and chronic toxicity, carcinogenicity, reproductive toxicity, neurotoxicity, and developmental toxicity; these protocols are referenced not only in Part 799 but in TSCA consent orders, new chemical review conditions, and voluntary testing agreements

  Part 799 test rules are typically preceded by a negotiated testing consent order under § 799.40 — Subpart C — where EPA and companies reach agreement on a testing program before EPA is forced to issue a unilateral test rule. The practical distinction matters: consent orders are faster to issue and allow negotiated study designs, while formal test rules are backed by the force of law and carry civil penalties for non-compliance. Part 799 test obligations run with the chemical, not the company — a company that acquires a chemical subject to a Part 799 test rule inherits the testing obligation.

• 40 CFR Part 770 — Formaldehyde Standards for Composite Wood Products (TSCA Title VI): the EPA implementing regulation for TSCA Title VI (15 U.S.C. § 2697), which Congress enacted in 2010 to establish nationwide formaldehyde emission standards for composite wood products — hardwood plywood, particleboard, and medium density fiberboard (MDF) — that previously varied by state (with California's CARB standards being the de facto national standard for many manufacturers):

  • § 770.10 — Emission standards: the core numeric limits for formaldehyde off-gassing from composite wood panels; hardwood plywood with a veneer core or composite core must not exceed 0.05 ppm; particleboard must not exceed 0.09 ppm; MDF must not exceed 0.11 ppm; thin MDF (≤8mm) must not exceed 0.13 ppm; these limits, expressed as parts per million by volume in a large-chamber test (ASTM E1333 or ASTM D6007), are aligned with California Air Resources Board (CARB) Phase 2 standards and became the national floor when EPA's TSCA Title VI rule took effect in 2018
  • § 770.15 — Certification: every composite wood product panel sold in U.S. commerce must be certified by an EPA Third Party Certifier (TPC) — an accredited testing organization that samples panels, conducts periodic on-site testing, and issues a TPC certificate; manufacturers label each panel with the TPC certification number and formaldehyde compliance statement; fabricators (furniture makers, cabinet manufacturers, flooring producers) who use certified panels in finished goods must use only TPC-certified panels and must label the finished goods or maintain purchase records linking the finished good to certified panels
  • §§ 770.17–770.18 — Low-emission resin exemptions: panels manufactured using no-added formaldehyde (NAF) resins or ultra low-emitting formaldehyde (ULEF) resins may qualify for modified testing and certification requirements — NAF panels may be exempt from emission testing (the resin itself cannot release formaldehyde); ULEF panels may qualify for less frequent testing; both exemptions require EPA or CARB approval of the resin type
  • Scope and import requirements: the standards apply to all composite wood products manufactured domestically or imported into the United States; importers bear the same certification burden as domestic manufacturers — imported products must be certified by a TSCA Title VI TPC before customs clearance; EPA enforcement authority includes inspection at the point of importation; finished goods containing regulated composite wood (furniture, flooring, cabinetry, doors) are also covered when sold in the U.S., requiring the finished goods fabricator to use only compliant panels

  TSCA Title VI/Part 770 is one of the most consumer-visible TSCA regulations — composite wood products (particleboard, MDF, and plywood) are in virtually every piece of flat-pack furniture, kitchen cabinet, and engineered wood flooring sold in the United States. Formaldehyde is classified as a known human carcinogen (Group 1 by IARC); off-gassing from composite wood products is a major source of indoor air formaldehyde exposure. The regulation harmonized federal standards with California's CARB Phase 2 rules, which manufacturers already followed to access the California market. EPA's TPC-based certification structure mirrors the approach used in CARB's enforcement of its own composite wood standards.

• 40 CFR Part 713 — Reporting Requirements for the TSCA Inventory of Mercury Supply, Use, and Trade: implements TSCA Section 8(b)(10) (15 U.S.C. § 2607(b)(10)), which requires EPA to maintain a public inventory of mercury supply, use, and trade in the United States to support domestic and international mercury reduction efforts:

  • § 713.7 — Who must report: any person who manufactures (including imports) or processes mercury for commercial purposes above the threshold quantities; elemental mercury threshold: 2,500 pounds per year; mercury compound threshold: 25,000 pounds per year; persons who manufacture or process mercury solely for non-commercial purposes (research institutions, university labs) are exempt; the reporting obligation falls on the manufacturer/importer, not on processors or distributors below the threshold
  • § 713.5 — What mercury must be reported: elemental mercury (CAS No. 7439-97-6) and a comprehensive list of mercury compounds including mercuric chloride, methylmercury, phenylmercuric acetate, thimerosal, and other specified compounds; the list is published as Table 1 of the rule and covers the mercury species most commonly in commerce
  • § 713.9 / § 713.11 / § 713.13 — What information must be reported: for each mercury substance manufactured or processed above thresholds, reporters must provide: (1) the specific mercury compound(s) from Table 1; (2) the total quantity manufactured or imported; (3) the total quantity processed; (4) the application or use category (dental amalgam, batteries, lighting, measuring instruments, etc.); (5) trade or destination information — whether exported and to which countries; (6) quantity sold or transferred domestically
  • § 713.17 — When to report: annual reports covering calendar years; due within 90 days after the end of the reporting year; electronic filing through EPA's Mercury Electronic Reporting (MER) system via EPA's Central Data Exchange (CDX)
  • § 713.19 — Recordkeeping: records supporting the reported information must be retained for 3 years from the last day of the reporting year

  Part 713 provides the data underlying the United States' implementation of the Minamata Convention on Mercury — the international treaty aimed at reducing anthropogenic mercury releases worldwide. The inventory data reveals how much mercury flows through the U.S. economy and where it goes — illuminating the sources of mercury pollution (chlor-alkali plants, artisanal gold mining, dental amalgam, coal combustion) and tracking whether reduction efforts are working. The inventory data is publicly available on EPA's website. Recent rulemakings: 83 FR 30073 (June 2018) — final rule establishing Part 713; 86 FR 61712 (November 2021) — amendments updating compound list and thresholds.

• 40 CFR Part 717 — Records and Reports of Allegations That Chemical Substances Cause Significant Adverse Reactions to Health or the Environment: implements TSCA § 8(c) (15 U.S.C. § 2607(c)), which requires manufacturers, processors, and distributors of chemical substances and mixtures to maintain records when allegations are made that their chemicals caused significant adverse reactions — and to make those records available to EPA on request. Key provisions:

  • § 717.10 — Covered allegations: the recordkeeping obligation is triggered when an allegation is received in writing (signed) or orally (transcribed at time of receipt) asserting that a chemical substance or mixture caused an adverse health or environmental reaction; the allegation need not be from a scientific study — consumer complaints, employee health reports, and litigation claims all qualify if they assert a causal connection to the chemical
  • § 717.12 — What reactions must be recorded: health effects triggering recordkeeping include (1) long-lasting or irreversible damage — cancer, birth defects, sterility, miscarriage, stillbirth, or mutagenic effects; (2) partial or complete impairment of bodily functions — cardiac, pulmonary, renal, hepatic, or neurological; (3) behavioral disorders — psychological or neurological effects; (4) serious or prolonged incapacitation; environmental effects include persistent effects on wildlife, disruption of ecological systems, or accumulation in biological organisms; the standard covers significant effects, not every minor complaint
  • § 717.15 — Recordkeeping requirements: records must be established and maintained at the firm's headquarters (or other designated location); records must be retained for 30 years for effects experienced by employees; 5 years for all other allegations; the 30-year employee health record retention period reflects the long latency of occupational diseases like cancer and mesothelioma
  • § 717.17 — Inspection and reporting: firms must make adverse reaction records available for inspection by EPA representatives; EPA may by rule require firms to submit copies of records; this provision gives EPA a window into chemical safety concerns that companies have received but not publicized — a significant information-gathering power that complements the proactive testing authorities under TSCA § 4

  Part 717 creates a passive surveillance system for chemical adverse effects: when someone alleges that a chemical caused harm, the chemical company must document it. This creates a private repository of adverse reaction reports that EPA can inspect and use in risk prioritization — particularly valuable for identifying patterns of health complaints that might indicate a systemic problem before it appears in published scientific literature. No major amendments since 1983 when the original rule was finalized.

• 40 CFR Part 704 — Chemical-Specific TSCA Section 8(a) Reporting and Recordkeeping Rules: while the general § 8(a) reporting framework is set out in 40 CFR Part 710 (Chemical Data Reporting), Part 704 contains chemical-specific rules that require reporting and recordkeeping for individual chemical substances where EPA determined that a CDR-style report was insufficient and a targeted rule was warranted. The chemicals currently subject to Part 704-specific rules include hexachloronorbornadiene (HCNBD) and hexafluoropropylene oxide (HFPO, a PFAS used in some fluoropolymer manufacturing). Key provisions:

  • § 704.5 — Who must comply: persons who manufacture (including import) the identified chemical substances must submit reports to EPA; processors of the substances are subject to recordkeeping obligations but not the full reporting requirement
  • § 704.7 — What must be reported: for each covered chemical substance, manufacturers must report production volume, facility location, uses, and any known health and environmental effects data; the required data elements are chemical-specific and set out in the applicable subpart
  • § 704.11 — Recordkeeping: persons subject to Part 704 requirements must retain records supporting their submissions for 3 years from the date the record is created; EPA may inspect these records; the 3-year retention period aligns with the CDR recordkeeping standard
  • § 704.13 — Enforcement: failure to comply with Part 704 reporting or recordkeeping obligations subjects a person to civil penalties under TSCA § 15 and § 16 — up to $25,000 per day per violation; knowing violations may be referred for criminal penalties; EPA has used Part 704 chemical-specific rules to track substances (like HFPO-dimer acid, a precursor to "GenX" PFAS compounds) that CDC, ATSDR, and state health agencies identified as environmental concerns in specific communities

  Part 704 represents EPA's most targeted TSCA § 8(a) tool — used when the agency needs production and use data for specific chemicals of concern rather than waiting for the next CDR cycle. The rule has been amended to add new chemicals as priority concerns arise; PFAS manufacturing chemicals were added in the 2020s as GenX and related compounds came under regulatory and public scrutiny. Recent rulemakings: 86 FR 56,508 (October 2021) — proposed addition of HFPO-related compounds to Part 704 reporting requirements; 87 FR 14,822 (March 2022) — final rule expanding PFAS reporting under Part 704.

• 40 CFR Part 716 — Health and Safety Data Reporting — TSCA Section 8(d): implements TSCA § 8(d) (15 U.S.C. § 2607(d)), which authorizes EPA to require manufacturers and processors of chemical substances to submit existing health and safety studies to the agency. Unlike § 8(a) reporting (production volumes and uses) or § 8(c) recordkeeping (allegations of harm), § 8(d) directly compels submission of the scientific data companies already have about their chemicals' effects on health and the environment. This is a uniquely powerful information-gathering tool because companies regularly commission toxicological studies to understand their own products' risks — Part 716 requires those studies to reach EPA whether or not the results are favorable. Key provisions:

  • § 716.1 — Scope: Part 716 applies to any person who manufactures or processes a chemical substance or mixture that appears on the Part 716 priority chemicals list (Subpart E, § 716.120); listed substances span industrial solvents, monomers, pesticide intermediates, and other industrial chemicals EPA has identified as potential health concerns
  • § 716.10 — Studies that must be submitted: the core obligation covers unpublished health and safety studies that are in the submitter's possession — studies that document health effects testing, environmental fate, or ecological effects for the listed substance; the submission obligation covers studies held by the submitter or reasonably available to the submitter; a company cannot avoid Part 716 by having a contractor hold the data; published studies (already in the scientific literature) are exempt from submission because EPA can obtain them through its own literature review
  • § 716.20 — Exempt studies: certain categories are excluded: studies whose only purpose was quality assurance or quality control; studies concerning use, application, or processing methods (not health effects); non-U.S. studies that are not reasonably available to the U.S. entity; and studies more than 10 years old that address only physical-chemical properties
  • § 716.105 — Additions to the priority list: EPA may add chemical substances or mixtures to the Part 716 priority list by rule under the standard notice-and-comment process; when a substance is added, manufacturers and processors of that substance must submit applicable health and safety studies within 60 days of the effective date; this 60-day clock creates urgency — companies that have been stockpiling toxicological data on a substance of concern must produce it quickly once EPA adds it to the list
  • § 716.120 — Listed substances: the current list covers dozens of substances including glycidyl acrylate, butyl acrylate, various chlorinated solvents, and several PFAS precursors; substances are identified by CAS registry number to eliminate any ambiguity about which specific chemical is covered

  The § 8(d) mechanism has been described by environmental lawyers as EPA's most powerful pre-regulatory information tool: it forces companies to put their internal scientific data on the record, where EPA risk evaluators and the public can scrutinize it. Health and safety study submissions under Part 716 are publicly available in EPA's Health and Safety Study Submissions database (accessible through EPA's ChemView portal). Recent rulemakings: 87 FR 23,526 (April 2022) — final rule adding PFAS and certain PFAS precursors to the Part 716 priority substances list, requiring submission of unpublished PFAS health and safety studies held by manufacturers and processors.

• 40 CFR Part 790 — Procedures Governing Testing Consent Agreements and Test Rules (28 sections — EPA's procedural framework under TSCA § 4 (15 U.S.C. § 2603) for compelling chemical manufacturers and processors to conduct health and safety testing; establishes parallel pathways — negotiated consent agreements and unilateral test rules — for obtaining the toxicological data EPA needs to evaluate whether a chemical presents unreasonable risk):

  • § 790.20 — ITC recommendations and designation: the Interagency Testing Committee (ITC) — an expert body with representatives from EPA, OSHA, NTP, NIOSH, and other agencies — reviews chemicals and recommends them to EPA for testing priority; when the ITC "designates" a chemical, EPA must respond with a public statement of whether it intends to pursue testing and, if so, by what mechanism (consent order or test rule); the ITC designation process is what triggers the § 4 timeline
  • § 790.22 — Developing consent agreements: when EPA determines testing is necessary for an ITC-designated or otherwise prioritized chemical, EPA may first attempt to negotiate a consent agreement with manufacturers and processors; EPA initiates by publishing a Federal Register notice identifying the chemical and the testing EPA believes is needed; affected companies may submit proposed consent agreement terms; EPA and the companies negotiate testing protocols, timelines, study formats, and cost-sharing; a completed consent agreement is binding on all parties and has the force of a regulation once published as a final rule
  • § 790.40 — Promulgating test rules: if consent agreement negotiations fail or if EPA determines a unilateral rule is necessary, EPA may promulgate a test rule requiring manufacturers and processors to conduct specified tests; test rules are issued through standard notice-and-comment rulemaking under the APA; test rules are binding on all manufacturers and processors of the designated chemical regardless of whether they participated in negotiations
  • § 790.42 — Who is subject to a test rule: each test rule specifies whether manufacturers, processors, or both are subject; a company that acquires a chemical subject to a test rule after its promulgation is bound by the test rule — testing obligations run with the chemical substance, not the original manufacturer; EPA may exempt small manufacturers from test rules when the testing cost would be disproportionate to the company's size
  • § 790.45 — Letter of intent: within 30 days of a test rule's effective date, each subject manufacturer or processor must notify EPA whether it intends to conduct the required testing or seeks an exemption; the 30-day clock is a hard compliance deadline; failure to submit a letter of intent exposes the company to civil penalties under TSCA § 16 — up to $37,500 per day per violation
  • § 790.50 / § 790.52 — Study plans and Phase II: companies that elect to conduct testing must submit detailed study plans to EPA before beginning; EPA reviews the study plan for adequacy; EPA may issue a Phase II test rule requiring additional studies after reviewing the results of Phase I testing — the two-phase structure allows EPA to refine the testing program based on initial data rather than requiring the full test battery before any results are available
  • § 790.48 — When no one intends to test: if no manufacturer or processor submits a letter of intent to conduct the required testing (or all letters of intent are for exemptions), EPA may itself conduct the testing or contract with a laboratory; the cost of EPA-conducted testing may be recoverable from the manufacturers and processors who failed to test

  The consent agreement pathway is faster and more collaborative than formal test rulemaking — it typically takes 1–2 years compared to 3–5 years for a contested test rule. Consent agreements also allow more tailored testing protocols negotiated between EPA's risk assessors and companies with detailed knowledge of their chemicals' properties. The practical significance of Part 790 has grown substantially under the 2016 Lautenberg Act reforms: EPA's accelerated chemical risk evaluation program requires toxicological data on dozens of high-priority chemicals simultaneously, making § 4 testing authority — and the Part 790 procedures for exercising it — a critical tool for filling data gaps. Companies manufacturing or processing chemicals that appear on the TSCA Work Plan or that are under risk evaluation should monitor Federal Register notices for ITC designations or EPA testing initiatives under this Part. Recent rulemakings: 89 FR 37,021 (May 2024) — EPA expanded the use of consent agreements for PFAS precursors and other high-priority chemicals under the Lautenberg Act risk evaluation program.

How It Works

TSCA is the EPA's primary authority for regulating industrial chemicals in commerce — from the cleaning products under your sink to the industrial chemicals used in manufacturing. The 2016 Lautenberg Act reforms transformed TSCA from a largely ineffective statute into a workable framework for evaluating and regulating chemical risks.

The original TSCA (1976) was widely considered one of the least effective environmental statutes: it grandfathered approximately 62,000 chemicals already in commerce without requiring safety testing, placed a heavy burden on EPA to demonstrate "unreasonable risk" before acting, and required EPA to choose the "least burdensome" regulatory approach — a standard so difficult the agency couldn't even ban asbestos (the 5th Circuit struck down EPA's asbestos ban in 1991). In nearly 40 years, EPA regulated only 5 chemicals. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (2016) — one of the last bipartisan environmental laws — rewrote the framework: EPA must now systematically prioritize chemicals for risk evaluation; evaluations must determine "unreasonable risk" based solely on health and environmental factors (cost enters only at the risk management stage); EPA must regulate chemicals found to present unreasonable risk within specific statutory timelines; and new chemicals cannot enter commerce unless EPA affirmatively finds them "not likely to present unreasonable risk." EPA designates chemicals as high priority (requiring evaluation) or low priority, conducts comprehensive risk evaluations covering all known uses and exposures, and imposes restrictions under § 2605 — banning, limiting, or conditioning manufacture, processing, distribution, use, or disposal — when unreasonable risk is found. The first 10 chemicals evaluated included asbestos, methylene chloride, and 1,4-dioxane; EPA has completed several evaluations and issued proposed restrictions.

Two specific TSCA programs affect millions of households directly. Per- and polyfluoroalkyl substances (PFAS) — "forever chemicals" that don't break down in the environment — represent TSCA's biggest current challenge; EPA has used TSCA authority to require PFAS reporting, restrict new PFAS uses, and propose regulations on existing PFAS, while also setting drinking water limits under the Safe Drinking Water Act and designating certain PFAS as CERCLA hazardous substances (see Superfund). Lead-based paint is governed by TSCA subchapter IV: sellers and landlords must disclose known lead hazards in pre-1978 housing, renovation contractors who disturb lead paint must be certified, and abatement work must meet EPA standards — protections directly aimed at preventing childhood lead poisoning in older housing stock.

How It Affects You

State Variations

• TSCA includes explicit preemption provisions — once EPA completes a risk evaluation, states generally cannot impose restrictions on the same chemical for the same use
• However, states can maintain existing restrictions and regulate chemicals EPA has not evaluated
• Several states (California, Massachusetts, Maine, Washington) have enacted their own chemical safety laws that may be stricter than federal TSCA
• State-level PFAS regulations have proliferated, particularly for drinking water standards and product restrictions

Pending Legislation (119th Congress)

• HR 123 (Rep. Biggs, R-AZ) — Improving Science in Chemical Assessments Act. Would shift IRIS chemical assessments to EPA program offices, set strict science standards, create a central database, and add a steering committee to coordinate work. Status: Introduced.

Recent Developments

• EPA has completed risk evaluations finding unreasonable risk for multiple chemicals and proposed restriction rules
• PFAS regulation continues to expand — drinking water standards, TSCA reporting requirements, and CERCLA designation all affect PFAS management
• The chemical industry is adjusting to the Lautenberg Act's more stringent new-chemicals review process
• EPA's capacity to evaluate chemicals at the pace required by the Lautenberg Act remains a challenge — staffing and funding limitations slow the evaluation pipeline
• International chemical regulation harmonization (GHS, REACH) influences U.S. TSCA implementation