2. Overview of the CPSC Directorate for Health Sciences * Mary Ann Danello, Ph.D. Associate Executive Director * The views expressed in this presentation are those of the staff, have not been reviewed or approved by, and may not represent the views of the U.S. Consumer Product Safety Commission.

3. DETERMINE IF THERE IS A HUMAN HEATH EFFECT: * TOXICOLOGICAL ASSESSMENT (EXPOSURE AND RISK ASSESSMENT) * PHARMACOLOGICAL ASSESSMENT (RISK TO CHILDREN) * PHYSIOLOGICAL/MEDICAL ASSESSMENT (SEVERITY AND LIKELIHOOD OF INJURY) REGULATORY DEVELOPMENT NO RULE DEVELOPMENT OF RULE COMPLIANCE ACTIVITY NO COMPLIANCE ACTIONCOMPLIANCE ACTION NO RISK RISK

4. – Pharmacology Acute toxicity Poison prevention – Physiology Choking, suffocation, strangulation, and burn hazards Head injury Other traumatic injuries (eye, ear, intestinal, etc) – Toxicology and Risk Assessment Chronic and acute health effects-cancer, developmental and reproductive toxicity, neurotoxicity, immunotoxicity/chemical sensitization, inhalation Exposure and risk assessment International harmonization Alternatives to animal testing

5.  Evaluate potential human health effects and hazards of consumer products during reasonably foreseeable uses  Perform exposure and risk assessments for product-related hazards  Provide scientific advice and expertise for policy development and implementation of CPSC statutes  Provide expertise to Office of Compliance to support enforcement and compliance actions

6.  Provide advice on international activities and support the development of international standards  Support development of voluntary and mandatory product safety performance standards and test methods  Develop testing procedures to identify product- related hazards  Respond to consumer inquiries on product safety

7. Hazard Identification and Reduction - Projects - Petitions - Emerging Hazards Compliance - CR-packaging and CR-lighter assessments - Drug toxicity assessments - Household chemical safety assessments - Product safety assessments - Small parts choking hazard assessments

8. – Staff participate on interagency committees developing U.S. positions for harmonization of: – OECD test guidelines – OECD guidance documents – Globally Harmonized System for the classification and labeling of chemicals – Approaches to reducing use of animals in testing (through ICCVAM ) – Staff participation in international cooperative activities related to nanotechnology (through the National Nanotechnology Initiative) – Staff assessment of GHS for possible implementation