This optional, pre-conference workshop will provide a detailed, comprehensive and practical look at the major changes to the Toxic Substances Control Act (TSCA) since its revision in 2016.
The passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act by the US House of Representatives on 24 May 2016 (subsequently passed by the US Senate and signed into law by President Obama on 22 June 2016) profoundly alters the regulation of industrial chemicals in the US under TSCA. All chemical stakeholders doing business in the US, as well as foreign entities with business interests in the US, will need to understand the fundamental shifts in requirements and the new concepts and approaches that are introduced by the law.
Chemical Watch is pleased to have assembled an impressive faculty of TSCA experts to dig deep into the revisions of the law and offer practical advice and solutions to the understanding of this complex regulation. Using a mix of presentations, discussions and exercises, this workshop will provide attendees with the information they need to ensure they can manage the regulatory inspection process with confidence.
Book this workshop by clicking on 'Book now' and selecting the workshop on its own or alongside your tickets for the main conference.
Workshop leaders include:
Pillsbury Winthrop Shaw Pittman LLP
Reza Zarghamee, Special Counsel
Matthew Morrison, Partner
Bick Law LLP
Corrie Plant, Partner
Elaine Freeman, Managing Scientist
Jane Stavely, Senior Managing Scientist
William Goodfellow, Principal Scientist & Practice Director
- Session 1: TSCA 101
• TSCA's overarching goal and how it works
• Scope of regulation and key definitions
• The heart of the statute: Sections 4, 5, 6, and 8
• Export/import considerations: Sections 12 and 13
• PCBs (40 CFR Part 761), LBP (Title IV), and asbestos
• How TSCA fits in with other environmental and safety laws
(Pillsbury Winthrop Shaw Pittman LLP and Bick Law LLP)
TSCA Section 5 – Emphasizing the PMN Process
• What information and analysis is necessary to obtain EPA approval for PMNs and other Section 5 applications?
• New standard for affirmative approval under the 2016 Amendments
• Basic types of toxicity and ecological fate and transport studies; how much do they cost? How long do they take to perform?
• Practical tips re: advance planning and pre-submission meeting with EPA
• Worker exposure now as a susceptible population and influence on new chemical assessments
• Low Volume Exemption and Test Marketing Exemption applications
• 5(e) orders
(Pillsbury Winthrop Shaw Pittman LLP and Exponent)
- Session 2: TSCA 201
TSCA Reform: How to Better Regulate Existing Chemicals
• TSCA Inventory Reset Rule
• Prioritization Process Rule
• Guidance for Risk Evaluations conducted by industry
• How changes in definition of susceptible populations to include workers will affect TSCA risk evaluations
• Changes to scientific standards
(Pillsbury Winthrop Shaw Pittman LLP/ Exponent)
Detailed Discussion of What Constitutes “Sound Science”
• Best available science
• Weight of evidence
• Risk evaluations - incorporating both hazard and exposure
• Use of modeling and surrogates in lieu of testing
• TSCA penalty provisions
• Functional changes to self-disclosures
• What to expect from the Trump Administration
• Broader EPA trends
(Pillsbury Winthrop Shaw Pittman LLP)
State Law Considerations
• State pre-emption in TSCA reform
• California's Proposition 65
• Green Chemistry
• Other state law issues
Questions and Answers
• Anticipated rule makings and legal challenges
• What can companies do to ensure compliance and stay abreast of developments?
Close of workshop