1. The Role of Physiology in Hazard determinations Suad Wanna-Nakamura, Ph. D. U.S. Consumer Product Safety Commission* OAS-PAHO-CPSC Capacity Building Project for Latin America and the Caribbean CSHN Course: Product Safety Training for Health and Consumer Protection Authorities of the Americas February 28 – March 04 2011 Washington, DC * 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.

2. Physiologist Functions Evaluate potential health effects and hazards of consumer products. Provide expertise to Office of Compliance to support enforcement and compliance actions. Provide scientific advice and expertise for development of mandatory or voluntary standards.

3. Compliance Activities Product Safety Assessments: –Evaluate potential health effects and hazards of consumer products already on the market Provide expertise to Office of Compliance to support enforcement and compliance actions Small parts choking, aspiration and ingestion hazard assessments

4. Small Parts Hazard Determinations Before sample products are forwarded to CPSC Health Sciences (HS) staff for “small parts hazard determinations”, they are first subject to age-grading by CPSC Human Factors staff. If the products are age-graded for children up to 3 years, Laboratory Sciences staff examine additional samples to determine if “small parts” are –present as received, or –were generated during age-appropriate use and abuse tests

5. Small Parts Hazard Determinations Test reports that include photographs of the small parts are forwarded to HS staff HS physiologists examine and measure the dimensions of the small parts Data is entered on a special form

6. Small Part Form Contains description of the small part –shape –material –dimensions

7. Product Attributes that Contribute to Choking and Aspiration Hazards

8. Small Part Assessment HS staff determines the severity and likelihood that the small part can be a choking, aspiration, or an ingestion hazard. The Small Part Hazard Determination Form is then forwarded to a Compliance Officer.

9. "Copyright, GASNet, Inc. Adapted with permission“ Reference:http://gasnet.med.yale.edu/airway/anat05.htm Tongue Oropharynx Esophagus Epiglottis Trachea

10. Pharynx The pharynx connects the mouth and esophagus and is a common passageway for air, food and liquids. The pharynx shown on the previous slide as “oropharynx” is a muscular structure surrounded by two layers of constrictor muscles, external circular muscles and inner longitudinal muscle.

11. Facts Food is moved along the digestive tract by a series of alternate waves of contraction and relaxation of the throat muscles. In fact, the waves are so powerful that food and fluids will reach the stomach even if you stand on your head. Throat muscles can constrict around a rigid object securing it more tightly.

12. Choking Occurs when: –A foreign object obstructs the airway and compromises the oxygen supply to the lungs. –A foreign object completely obstructs the airway at, or above, the level of the trachea.

13. Protective reflexes The cough reflex. The gag reflex.

14. Cough Reflex An airway protection mechanism. Air is brought in to force an object out of the airway.

15. Gag Reflex A gastrointestinal protective mechanism. Reverse of the swallowing reflex. Prevents ingestion of unpalatable foods/objects. Affords protection for the common GI/airway opening. Forces objects back into the mouth.

16. Characteristics of objects that are choking hazards Size: Small objects that can fit into the throat. 1-3 cm or 0.5-1.25 inches Shape: Spherical/rounded objects. Consistency of material: compressible material. Texture: Smooth pliable.

17. Reasons Roll to back of throat. Less irritating to tactile sensors in the mouth. Unlikely to elicit the gag reflex. Very difficult to remove.

18. Consequences of choking Objects can cause death either by completely or partially blocking the air passage into the lungs. This leads to irreversible brain damage and/or death within minutes.

19. Aspiration Hazards Size, weight and shape determine the location of the object in the larynx, trachea, lung. Light weight cylindrical shaped objects with tapered ends i.e. bullet-shaped objects and beads that are less than 1cm in diameter, are typically considered an aspiration hazard.

20. Consequences of Aspiration Lower airway obstruction Symptoms of incomplete obstruction –Coughing, wheezing, stridor, pneumonia, & lung collapse –Symptoms may easily be mistaken for inflammatory airway diseases Upper airway obstruction Acute respiratory distress, an immediate threat to life.

21. How have choking hazards been addressed 16 C.F.R. § 1500.18 (a) (9) Toys and related articles intended for use by children under 3 years. 16 C.F.R. § 1500.18 (a) (17) regulations ban small balls in toys intended for children under 3 years. 16 C.F.R. § 1500.19 requires choking hazard warning labels on toys and games that are intended for children 3-5 years.

22. Section 15(b) of the CPSA Requires manufacturers, importers, distributors, and retailers to report to the Commission when they obtain information from consumers that a product (1) contains a defect which could create a substantial product hazard described in subsection (a) (2); or (2) creates an unreasonable risk of serious injury or death