Overview
At Wiley, we provide effective regulatory strategies and legal advocacy on behalf of our clients before the U.S. Environmental Protection Agency (EPA) and the federal courts on matters under the Toxic Substances Control Act (TSCA). Our clients attribute their success to Wiley’s unparalleled substantive depth on TSCA. The Resource Page includes selected references that we find especially useful in TSCA work. To subscribe to our complimentary Alerts, please click here.
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Martha E. Marrapese | Sara Beth Watson | Sarah E. Amick |
Resource Sections
- PFAS Reporting
- PFAS PMNs and SNURs
- TSCA Existing Chemicals
- Section 21 Petitions
- PBT Chemicals
- Formaldehyde in Composite Wood Products
- TSCA New Chemicals Program
- Fees
- Enforcement
- TSCA Testing
- TSCA Reporting
- Export and Import Obligations
- Confidential Business Information (CBI)
- Statutory Resources
PFAS Reporting
- PFAS Data Reporting and Recordkeeping Under TSCA; Change to Submission Period and Technical Correction
- PFAS TSCA Section 8(a)(7) Reporting and Recordkeeping Rule – Final Rule
- PFAS TSCA Section 8(a)(7)Final Rule Response to Comments
- EPA’s Public List of PFAS for TSCA 8(a)(7) Reporting
- TSCA Section 8(a)(7) PFAS Reporting Rule Frequently Asked Questions
- Wiley Commentary: EPA’s Mandatory PFAS Reporting Rule Under TSCA Includes Thousands of Products, No Exemptions for Impurities or Imported Articles
PFAS PMNs and SNURs
- Updates to New Chemicals Regulations Under TSCA making certain PFAS Ineligible for LVE and LoREX exemptions (December 2024)
- Framework for TSCA New Chemicals Review of PFAS Premanufacture Notices (PMNs) and Significant New Use Notices (SNUNs)
- Premanufacture Notification Exemption for Polymers; Amendment of Polymer Exemption Rule to Exclude Certain Perfluorinated Polymers – 2010 Rule
- Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances – Final Significant New Use Rule (LCPFAC SNUR)
- Inhance Technologies v. EPA, No. 23-60620 (5th Cir. 2024)
TSCA Existing Chemicals
- Spreadsheet Tracking EPA’s Activities Regarding Existing Chemicals
- TSCA Work Plan for Chemical Assessments: 2014 Update
- Procedures for Chemical Prioritization under TSCA – Final Rule
- Initiation of Prioritization Under TSCA; Notice of Availability (December 2024)
- Procedures for Chemical Risk Evaluation Under TSCA (2024 TSCA Risk Evaluation Rule)
- EPA Prioritization and Risk Evaluation Case: Safer Chemicals, Healthy Families et al. v. EPA (9th Decision, Nov. 14, 2019)
- EPA Submission Guidance for Manufacturer Sponsored Risk Evaluations
- Risk Management for Asbestos, Part 1: Chrysotile Asbestos – Final Rule
- Risk Management for Carbon Tetrachloride – Final Rule
- Risk Management for Perchloroethylene (PCE) – Final Rule
- Risk Management for Trichloroethylene (TCE) - Final Rule
- Risk Management for Methylene Chloride – Final Rule
- EPA Compliance Guide for Final Methylene Chloride Risk Management Rule
Section 21 Petitions
- EPA Response to Grant TSCA Section 21 Petition for 6PPD in Tires
- EPA Grants Petition on Three PFAS Found in Fluorinated Plastic Containers
- TSCA Fluoride District Court Findings of Fact and Law (2024) (Food and Water Watch et al. v. United States Environmental Protection Agency et al.(2024))
- TSCA Fluoride Order re: Whole Chemical Approach (2017) (Food and Water Watch et al. v. United States Environmental Protection Agency et al. (2017))
- Wiley Commentary: Fluoride Ruling Charts Path to Bypass EPA Risk Evaluations
PBT Chemicals
- Decabromodiphenyl Ether (decaBDE) and Phenol, Isopropylated Phosphate (PIP 3:1); Revision to the Regulation of Persistent, Bioaccumulative, and Toxic Chemicals under TSCA – Final Rule
- Decabromodiphenyl Ether (DecaBDE); Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h) – Final Rule 2021
- Phenol, Isopropylated Phosphate (3:1) (PIP 3:1); Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h) – Final Rule 2021
- 2,4,6 tris(tert-butyl)phenol (246-TTBP) – Final Rule
- Pentachlorothiophenol (PCTP) – Final Rule
- Hexachlorobutadiene (HCBD) – Final Rule
Formaldehyde in Composite Wood Products
- Formaldehyde Emission Standards for Composite Wood Products – Final Rule
- TSCA Title VI - Formaldehyde Standards for Wood Products (15 U.S. Code § 2697)
TSCA New Chemicals Program
- TSCA Inventory Representation for Products Containing Two or More Substances: Formulated and Statutory Mixtures
- TSCA Inventory Representation for Combinations of Two or More Substances: Complex Reaction Products
- TSCA Inventory Representation for Chemical Substances of Unknown or Variable Composition, Complex Reaction Products and Biological Materials
- TSCA Chemical Substance Inventory - SDA Substance Identification Procedure
- New Chemicals Working Approach to Determinations Under TSCA Section 5
- Questions & Answers for the New Chemicals Program (Q&A)
- EPA Statistics for New Chemical Program
- New Chemicals Division Reference Library
- Instruction Manual for Reporting under TSCA Section 5 New Chemicals Program
- Chemistry Assistance Manual for Premanufacture Notification Submitters
- EPA Section 5 Order Template for a New Chemical Substances
- Guidance Documents and Sample Forms for Central Data Exchange (CDX) Registration and e-PMN Software
- New Approach for Evaluating the Bioaccumulation Potential of Metals in the New Chemicals Division
- Applicability of TSCA to Mixed Metal Oxides, including CAMs and Modified CAMs
- Fluorinated Products of Incomplete Combustion in EPA’s New Chemicals Program
- General Background on the TSCA Low Volume Exemption
- Polymer Exemption Guidance Manual
- Exemptions for Research and Development and Test Marketing
- Toxic Substances Control Act (TSCA) Research and Development (R&D) Exemption for New Chemicals
- TSCA Contained R&D Checklist for Intergeneric Microorganisms
- EPA Points to Consider in Preparing Microbial Submissions
- EPA Announcement on Two New Tier I Exemption Strains
- Wiley Commentary: TSCA and New Industrial Biotech Submissions Overview
- Nanoscale Substances on the TSCA Inventory
- Control of Nanoscale Materials under the Toxic Substances Control Act
Fees
- Fees for the Administration of the Toxic Substances Control Act (TSCA) (2024)
- Frequently Asked Questions on Fees Rule
- Fee Payments (40 CFR 700.45)
Enforcement
- EPA ECHO – Enforcement and Compliance History Online
- EPA Administrative Enforcement Dockets
- Enforcement Response Policy for Test Rules Under Section 4 of TSCA
- Enforcement Response Policy for Section 5 of TSCA
- Amendment to the TSCA Section 5 Enforcement Policy - Penalty Limit for Untimely NOCs
- Enforcement Response Policy for TSCA Section 8, 12, and 13
- EPA Audit Policy
- EPA New Owner Audit Policy
- EPA Audit Policy Questions and Answers (January 2021)
- EPA Small Business Compliance Policy
- Notice of eDisclosure Portal Launch: Modernizing Implementation of EPA’s Self-Policing Incentive Policies
- Civil Monetary Penalty Inflation Adjustment (2025)
- Interim Consolidated Enforcement Response and Penalty Policy (CERPP) for the TSCA New and Existing Chemicals Program
TSCA Testing
- EPA Overview of Activities Involved in Issuing a TSCA Section 4 Test Order
- User Guides on Test Order Reporting via CDX
- Test Orders Under TSCA Section 4: Questions and Answers
- EPA Presentation on TSCA Section 4 Test Orders (2021)
- Policies Regarding Manufacturers and Processors Subject to TSCA Section 4(a) Testing
- Vinyl Institute v. EPA DC Circuit Test Order Case (2024)
TSCA Reporting
- Certain Existing Chemicals; Request to Submit Unpublished Health and Safety Data Under the Toxic Substances Control Act (TSCA); Extension of Submission Deadline (March 2025)
- Certain Existing Chemicals; Request To Submit Unpublished Health and Safety Data for 16 Substances under TSCA Section 8(d)
- 2020 Update to Chemical Data Reporting – Final Rule
- 2020 Update to Chemical Data Reporting – Response to Comments
- Instructions for Reporting 2024 TSCA Chemical Data Reporting (CDR)
- 2024 Chemical Data Reporting Questions and Answers
- Quick Reference Guides for CDR Reporting in CDX
- Reporting a TSCA Chemical Substantial Risk Notice (TSCA Section 8(e) General Information)
- EPA Section 8(e) Reporting Guidance
- TSCA Section 8(e): Frequently Asked Questions
- Nanoscale Substances On-Going Reporting – Final Rule
- Draft Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce (December 2024)
- Wiley Commentary: EPA Issues Final Guidance on Nanotechnology Reporting Rule on Same Date the Rule Takes Effect
Export and Import Obligations
- List of Chemicals Subject to TSCA 12(b) Export Notification Requirements
- TSCA Section 12(b) Requirements for Exporting Chemicals
- TSCA Section 13 Import Compliance Checklist
- Introduction to the Chemical Import Requirements of the Toxic Substances Control Act
Confidential Business Information (CBI)
- EPA Substantiation Templates
- CBI Claims Under TSCA – Final Rule (June 2023)
- CBI Claims Under TSCA – Final Rule - Response to Comments Document (May 2023)
- Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory – Final Rule (2020)
- TSCA Review of CBI Claims for the Identity of Chemicals in the TSCA Inventory; Extension of Review Period (2025)
- EPA’s Frequently Asked Questions About CBI Protection
- Appellate Court Decision Upholding CBI Rule
Statutory Resources
- TSCA as Amended by the 2016 Lautenberg Chemical Safety Act of the 21st Century Act
- The Lautenberg Bill as Passed by Congress on June 6, 2016 (H.R. 2576)
- Democrat Intent Statements on H.R. 2576 (June 7, 2016)
- Republican Intent Statements on H.R. 2576 (June 7, 2016)
- House Committee Report on H.R. 2576 (June 23, 2015)
- Senate Committee Report on S. 697 (June 18, 2015)
- National Defense Authorization Act for Fiscal Year 2020 (adding Section 8(a)(7) to TSCA)
