Agenda

Timings listed in EST (Washington DC)

  1. Welcome

    Nidia Mariana Calvo Mendez Nidia Mariana Calvo Mendez
    Americas Managing Analyst, Enhesa Product Intelligence
  2. Session one: Assessing and managing chemicals under TSCA
  3. High level overview

    • Basics of TSCA and the Lautenberg Amendments
    • Review of key sections of the law
    • Issues to watch in 2024
    Kelly Franklin Kelly Franklin
    North America Managing Editor, Chemical Watch News & Insight - by Enhesa, USA
  4. Keynote: Update from the EPA

    • Historical perspective on chemical innovation and regulation
    • Accomplishments under TSCA in the past year
    • Future of TSCA implementation
    Michal Ilana Freedhoff Michal Ilana Freedhoff
    Assistant Administrator for OCSPP, Office of Chemical Safety and Pollution Prevention, EPA
  5. Q&A

  6. Risk evaluation framework rule

    • Overview of EPA’s 2023 proposal to revise its 2017 rule for conducting risk evaluations of existing chemicals under TSCA Section 6
    • How EPA will incorporate transparency, flexibility, and science into the rule
    • Updates to the Manufacturer Requested Risk Evaluation process
    • Business and environmental group reactions to EPA’s proposal 
    Alexandra Dapolito Dunn Alexandra Dapolito Dunn
    Partner, Baker Botts
  7. PBT rules

    • Proposed (as of November 2023) PBT Rules for PIP (3:1) and DecaBDE
    • PBT activities of the First Quarter 2024 looking at strategies and timelines for compliance
    Rose Passarella Rose Passarella
    Director - Chemicals Group, Intertek Assuris, USA
  8. Q&A

  9. Break

  10. Session two: PFAS Reporting Rule and CDR Reporting
  11. PFAS Reporting Rule

    • This presentation will summarize the regulatory requirements of the TSCA § 8(a)(7) PFAS Reporting and Recordkeeping Rule, including its statutory basis, the persons and substances subject to the rule, the reportable data elements, and the timeline to report.
    • In addition, the presentation will discuss the “known to or reasonably ascertainable by” legal standard for reporting information under the rule.
    Michael Boucher Michael Boucher
    Partner, Steptoe
  12. Chemical Data Reporting (CDR) Rule

    • Entities subject to reporting
    • Substances subject to reporting
    • Summary of reporting requirements
    John J. Kowalski John J. Kowalski
    Regulatory Affairs Lead, UL Solutions, USA
  13. Q&A

  14. Lunch

  15. Enhesa Product service presentation and platform demo

  16. Session three: Risk Management Proposals and Test Orders
  17.  

    Afternoon moderator

    Melanie Rybar Melanie Rybar
    Regulatory and Compliance Analyst, Enhesa Product Intelligence, USA
  18. Risk management proposals

    • Risk evaluations development; proposed framework rule 
    • Highlights of first four proposed risk management rules 
    • Major issues that will be presented in litigation 
    W. Caffey Norman W. Caffey Norman
    Senior Partner, Squire Patton Boggs
  19. NGO response to risk management proposals

    • EPA has now proposed several risk management rules on the first 10 chemicals receiving risk evaluations under TSCA
    • In the coming weeks and months, we will start to see the first final rules, a major milestone in implementing the 2016 TSCA
    • Based on the proposals we’ve seen, these rule will be impactful and significantly affect the continued manufacture and use of established commodity chemicals
    • This presentation will discuss the key factors that are driving EPA’s design of these rules, the major issues raised by the stakeholders and amendments  
    Bob Sussman Bob Sussman
    Counsel, Safer Chemicals Healthy Families, and Principal, Sussman and Associates, United States
  20. Test orders

    • TSCA test order update: Are we having fun yet? 
    • Common challenges 
    • Strategies for addressing test rules 
    Lynn L. Bergeson Lynn L. Bergeson
    Managing Partner, Bergeson & Campbell, USA
  21. Q&A

  22. Break

  23. Session four: TSCA hot topics
  24. New chemicals: an overview of updates

    Kimberly Wise White Kimberly Wise White
    Vice President, Regulatory and Scientific Affairs, American Chemistry Council (ACC)
  25. New chemicals: an industry case study

    Robert F. Helminiak Robert F. Helminiak
    Vice President of Legal and Government Relations, Society of Chemical Manufacturers & Affiliates (SOCMA), USA
  26. NAMs Developments

    • Overview of OPPT’s strategic plan on the use of Alternative Test Methods / New Approach Methods
    • Description of Proof-of-Concept Case Study on Integrating Publicly Available Information to Screen Candidates for Chemical Prioritization under TSCA
    • Examples of frequently used data sources on the TSCA NAMs list
    Harvey Clewell Harvey Clewell
    Principal Consultant, Ramboll US Corporation
  27. Q&A

  28. Close of virtual conference