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 |
CBI
- EPA Substantiation Templates
- EPA’s Frequently Asked Questions About CBI Protection
- EPA’s CBI Review Statistics
- EPA Notice of Post-Lautenberg CBI and Need for Up-Front Substantiation – 2017 Notice
- Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory – Final Rule
- Policy on Notices of Deficiency Announcement
Enforcement
- EPA Audit Policy
- EPA New Owner Audit Policy
- EPA Small Business Compliance Policy
- EPA Audit Policy Questions and Answers (January 2021)
- Notice of eDisclosure Portal Launch: Modernizing Implementation of EPA’s Self-Policing Incentive Policies
- 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 Training Materials
- TSCA Training Materials on New Chemical Substances and Premanufacture Notice Process
- TSCA Training Materials on Inventory, Nomenclature and Bona Fide Process
- TSCA Training Materials on New Chemical Risk Assessment
- TSCA Training Materials on New Chemical Risk Management Actions, Section 5 orders, and Significant New Use Rules
- TSCA Transparency and Reduce Rework Initiative
- TSCA New Chemical Engineering Outreach Initiative
Existing Chemical Risk Evaluations
- EPA June 30, 2021 Press Release Announcing New Whole Chemical Approach
- EPA’s Explanation of a Whole Chemical Approach as Articulated in the Carbon Tetrachloride Risk Evaluation Draft Revision, pp 52768-52770
- EPA June 30, 2021 Press Release Announcing New Personal Protective Equipment Policy Update
- EPA’s Explanation of its PPE Policy as Articulated in the Carbon Tetrachloride Risk Evaluation Draft Revision, pp 52770 – 52771
- EPA Updates Test Orders Policy for TSCA Section 4(a) Testing
- EPA Updates Test Orders Policy for TSCA Section 4(a)(2)
- List of Existing Chemicals Undergoing Risk Evaluations Subject to Section 4 Test Orders
- March 2022 EPA Overview of Activities Involved in Issuing a TSCA Test Order
- Status of Chemicals Currently Undergoing Risk Evaluation Under TSCA
- Procedures for Chemical Prioritization under TSCA – Final Rule
- Procedures for Chemical Risk Evaluations under TSCA – Final Rule
- EPA Risk Evaluation Submission Guidance
- EPA Prioritization and Risk Evaluation Case: Safer Chemicals, Healthy Families et al. v. EPA (9th Decision, Nov. 14, 2019)
Fees
- 2018 Fees – Final Rule
- Fee Payments
- Frequently Asked Questions on Fees Rule
- No Action Assurance for TSCA Fees Rule
- Proposed Revisions to TSCA Fees Rule (Dec. 2020)
- Request for No Action Assurance for TSCA Fees Rule
- TSCA Fees Table
New Chemicals Program
- EPA Discontinues the Use of Exposure Modeling Thresholds in New Chemical Reviews
- Integrated Approach for Biofuel Premanufacture Notices
- Applicability of TSCA to Chemicals Made from Petroleum and Renewable Sources Used as Fuels and Fuel Additives and Distillates
- Applicability of TSCA to Mixed Metal Oxides, including CAMs and Modified CAMs
- EPA Policy Announcement on Integrated Approach for Mixed Metal Oxides in the New Chemicals Review
- New Chemicals Working Approach to Determinations Under TSCA Section 5
- EPA Section 5 Order Template For a New Chemical Substance
- Chemistry Assistance Manual for Premanufacture Notification Submitters
- EPA Statistics for New Chemical Program
- Questions & Answers for the New Chemicals Program (Q&A)
- General Background on the TSCA Low Volume Exemption
- Regulated Chemical Categories Identified by EPA
- Polymer Exemption Guidance Manual
- TSCA and New Industrial Biotech Submissions Overview
- 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
- EPA Link for Accessing the TSCA Inventory
- Active-Inactive Inventory Reset - Final Rule
- TSCA Inventory Notification (Active-Inactive) Rule Questions and Answers
- 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
PBT Chemicals and PFAS
- Phenol Isopropylated Phosphate (3:1) – Final Rule – Date Extension to October 31, 2024
- Phenol Isopropylated Phosphate (3:1) – Final Rule – Date Extension to March 8, 2022
- Decabromodiphenyl Ether (DecaBDE) – Final Rule
- Lawsuit Against EPA Regarding TSCA Rule on DecaBDE
- Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances – Proposed Rule
- Premanufacture Notification Exemption for Polymers; Amendment of Polymer Exemption Rule to Exclude Certain Perfluorinated Polymers – 2010 Rule
- 2,4,6 tris(tert-butyl)phenol (246-TTBP) – Final Rule
- Pentachlorothiophenol (PCTP) – Final Rule
- Hexachlorobutadiene (HCBD) – Final Rule
- Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances – Final Significant New Use Rule
Statutory Resources
- TSCA as Amended by the 2016 Lautenberg Chemical Safety Act of the 21st Century Act
- Democrat Intent Statements on H.R. 2576 (June 7, 2016)
- Republican Intent Statements on H.R. 2576 (June 7, 2016)
- The Lautenberg Bill as Passed by Congress on June 6, 2016 (H.R. 2576)
- House Committee Report on H.R. 2576 (June 23, 2015)
- Senate Committee Report on S. 697 (June 18, 2015)
Various Reporting
- 2020 Update to Chemical Data Reporting – Final Rule
- 2020 Update to Chemical Data Reporting – Response to Comments
- Nanoscale Substances On-Going Reporting – Final Rule
- EPA Section 8(e) Reporting Guidance
- TSCA Section 13 Import Compliance Checklist
- Introduction to the Chemical Import Requirements of the Toxic Substances Control Act