TSCA Resources

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 and high-level leadership experience at EPA.

In 2021 and beyond, engagement on TSCA issues will become increasingly important as new evaluations, regulations, orders, and policies emerge. This Resource Page is offered to help you stay current with the changing landscape. In addition, we have included selected references that we find especially useful in our TSCA work on behalf of clients. To subscribe to our complimentary Alerts, please click here.

Contact Us

Martha E. Marrapese 202.719.7156 mmarrapese@wiley.law	Erik C. Baptist 202.719.7540 ebaptist@wiley.law

Existing Chemical Risk Evaluations

• Chemicals Currently Undergoing Risk Evaluation Under TSCA

• The Continued Challenge Presented by Exposure Considerations in EPA Risk Evaluations

• The Future of Chemical Risk Evaluations Under TSCA

• Procedures for Chemical Prioritization under TSCA – Final Rule

• Procedures for Chemical Risk Evaluations under TSCA – Final Rule

• Designation of First 10 Substances

• EPA Risk Evaluation Submission Guidance

Fees and Enforcement

• Proposed Revisions to TSCA Fees Rule (Dec. 2020)

• No Action Assurance for TSCA Fees Rule

• Request for No Action Assurance for TSCA Fees Rule

• Frequently Asked Questions on Fees Rule

• 2018 Fees – Final Rule

• 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 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

• Notice of Intent to File Suit For Greater Disclosure Under Section 5

• EPA Prioritization and Risk Evaluation Case: Safer Chemicals, Healthy Families et al. v. EPA (9^th Decision, Nov. 14, 2019)

New Chemicals Program

• A New World for New Chemicals

• EPA TSCA Recent Activities Announcement Page

• New Chemicals Working Approach to Determinations Under TSCA Section 5

• Regulated Chemical Categories Identified by EPA

• EPA Statistics for New Chemical Program

• Chemistry Assistance Manual for Premanufacture Notification Submitters

• Polymer Exemption Guidance Manual

• TSCA Contained R&D Checklist for Intergeneric Microorganisms

• TSCA and New Industrial Biotech Submissions Overview

• EPA Points to Consider in Preparing Microbial Submissions

• EPA Announcement on Two New Tier I 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

• EPA Section 5 Order Template For a New Chemical Substance

• Questions & Answers for the New Chemicals Program (Q&A)

PBT Chemicals and PFAS

• EPA Readies Final PBT Rules As Industry Braces For Stringent Limits

• Now Is the Time for Companies to Prepare for EPA’s Final Rules to Restrict Certain PBT Chemicals

• Phenol Isopropylated Phosphate (3:1) – Final Rule

• Decabromodiphenyl Ether (DecaBDE) – Final 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

• Compliance Guidance for Long Chain PFAS SNUR for Articles

• A Critical Review of the Application of Polymer of Low Concern and Regulatory Criteria to Fluoropolymers

• Short Chain PFAS Toxicology Considerations Part I

• Short Chain PFAS Toxicology Considerations Part II

• Science Considerations for Fluoropolymers (Jan. 21, 2021)

CBI

• 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

• EPA’s Frequently Asked Questions About CBI Protection

• EPA’s CBI Review Statistics

• EPA Substantiation Templates

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

Additional Resources

• TSCA as Amended by the 2016 Lautenberg Chemical Safety Act of the 21^st 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)