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:

• Changes to the New Chemical Review Process

• The New Standard of Review

• New Data Requirements

• More Surprises to Come

• What Manufacturers Should Do