Welcome
Nidia Mariana Calvo Mendez, Enhesa Product
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Agenda
Session one: Assessing and managing chemicals under TSCA
High level overview
- Basics of TSCA and the Lautenberg Amendments
- Review of key sections of the law
- Issues to watch in 2024
Kelly Franklin, Chemical Watch News & Insight, By Enhesa
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, Office of Chemical Safety and Pollution Prevention, EPA
Q&A
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, Baker Botts
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, Intertek
Q&A
Break
Session two: PFAS Reporting Rule and CDR Reporting
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, Steptoe
Chemical Data Reporting (CDR) Rule
- Entities subject to reporting
- Substances subject to reporting
- Summary of reporting requirements
John J. Kowalski, UL Solutions
Q&A
Lunch
Enhesa Product service presentation and platform demo
Session three: Risk Management Proposals and Test Orders
Afternoon moderator
Melanie Rybar, Enhesa Product
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, Squire Patton Boggs
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, and Principal, Sussman and Associates, United States
Test orders
- TSCA test order update: Are we having fun yet"
- Common challenges
- Strategies for addressing test rules
Lynn L. Bergeson, Bergeson & Campbell, United States
Q&A
Break
Session four: TSCA hot topics
New chemicals: an overview of updates
Kimberly Wise White, American Chemistry Council (ACC)
New chemicals: an industry case study
Robert F. Helminiak, Society of Chemical Manufacturers & Affiliates (SOCMA)
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, Ramboll US Corporation