TSCA 30/30: PMN Review and Review Period Issues
Hosted by Keller and Heckman LLP
Location, or Event type: Online
TSCA 30/30: PMN Review and Review Period Issues
Webinar, Hosted By Keller and Heckman LLP
Wednesday, October 12, 2016 - 7:00 AM
Section 5 of TSCA has changed! Before a new substance is allowed onto the market EPA must now make "an affirmative finding of safety" under a new risk-based safety standard. EPA must also consider “conditions of use,” and “potentially exposed or susceptible subpopulations," but not cost, availability of alternatives, or other non-risk factors. Since the changes in the law, many new substances will be cleared only after issuance of section 5(e) orders, which may impose restrictions on manufacture / import volume, water release, and occupational safety and health practices. As before, the Agency will make conservative assumptions in predicting toxicity and exposure, necessitating a more strategic approach to PMN management and chemical risk assessment including identification of existing data and more accurate descriptions of applications and uses and filling data gaps using read-across approaches or development of new toxicological data. Topics will include:
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Changes to the New Chemical Review Process
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The New Standard of Review
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New Data Requirements
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More Surprises to Come
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What Manufacturers Should Do