BRIEFING PACKAGE: CPSC Staff Response to the Record of Commission Action on Crib Bumpers September 9, 2016 For additional information, contact: Timothy P. Smith Project Manager, Crib Bumpers Project Division of Human Factors Directorate for Engineering Sciences U.S. Consumer Product Safety Commission 5 Research Place, Rockville, MD 20850 301-987-2557, [email protected] The contents of this package have not been reviewed or approved by the Commission and do not necessarily represent its views. THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) CONTENTS Executive Summary ....................................................................................................................... iii I. Introduction .............................................................................................................................1 II. Background .............................................................................................................................1 A. JPMA Petition ................................................................................................................1 B. The Product and Market.................................................................................................2 C. Relevant U.S. Standards and Legislative Activities ......................................................3 III. Update and Review of Reported Incidents ............................................................................4 A. Reported Nonfatal Incidents ..........................................................................................5 B. Reported Fatal Incidents ................................................................................................6 C. Other Bumper-Related Incident Data Reviews............................................................13 IV. Safety Benefits of Bumpers ..................................................................................................13 V. Effectiveness of ASTM F1917 .............................................................................................15 A. Adequacy of Performance Requirements ....................................................................16 B. Adequacy of Warning Requirements ...........................................................................21 C. Voluntary Standard Conformance ...............................................................................21 D. Fatalities Over Time ....................................................................................................22 VI. Preliminary Estimate of Societal Costs ................................................................................23 VII. CPSC Request for Information .............................................................................................24 A. Hazardous Bumper Features ........................................................................................25 B. Safety Benefits of Bumpers .........................................................................................25 C. Standards and Requirements for Bumpers ...................................................................25 D. “Breathability” and Bumper Alternatives ....................................................................26 VIII. Regulatory Options ...............................................................................................................26 A. Mandatory Rule under CPSIA Section 104 .................................................................27 B. Mandatory Rule under CPSA or FHSA .......................................................................27 C. Ban Under CPSA .........................................................................................................28 IX. Staff Conclusions ..................................................................................................................28 X. References .............................................................................................................................30 Tab A: 2013 Record of Commission Action Regarding Crib Bumpers. Tab B: Memorandum from Samantha Li and Mark Bailey, Directorate for Economic Analysis, “Economic Considerations Related to Crib Bumpers.” June 1, 2016. Tab C: Memorandum from Adam Suchy, Mathematical Statistician, Hazard Analysis Division, Directorate for Epidemiology, “Overview of Crib Bumper Incidents Reported From January 1, 1990 to March 31, 2016.” April 22, 2016. THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) Tab D: Tables of Fatal Incidents. Tab E: Memorandum from Suad Wanna-Nakamura, Ph. D., Directorate for Health Sciences, “Analysis of Deaths Citing Crib Bumpers Reported from January 1, 1990 to March 31, 2016.” June 22, 2016. Tab F: Memorandum from Timothy P. Smith, Senior Human Factors Engineer, Division of Human Factors, Directorate for Engineering Sciences, “Human Factors Assessment of Warning Requirements for and Safety Benefits of Crib Bumpers.” May 6, 2016. Tab G: Memorandum from John Massale, Mechanical Engineer, Laboratory Sciences Directorate, Mechanical Division, “Existing Voluntary Standards and Testing Methods Associated with Crib Bumpers.” June 20, 2016. ii THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) EXECUTIVE SUMMARY In this briefing package, staff of the U.S. Consumer Product Safety Commission (CPSC or “Commission”) updates the Commission on the status of staff activities in response to the Commission’s 2013 Record of Commission Action for Crib Bumpers. Specifically, staff has: • evaluated updated incident data involving crib bumpers; • assessed the potential addressability of these incidents by Commission action; • described the potential safety benefits of bumpers; • discussed the effectiveness of current voluntary standard requirements pertaining to bumpers, as well as the likely effectiveness of more stringent requirements; and • identified the regulatory options the Commission may consider to address the risk of infant suffocation associated with crib bumpers. A search of CPSC data sources identified 107 fatal incidents that were reported to CPSC from January 1, 1990, to March 31, 2016, in which a crib bumper was present in the sleep environment, in addition to 282 nonfatal incidents or reported concerns associated with bumpers during the same timeframe. Thirty-one of the 107 reported fatalities had no evidence of bumper contact or involvement and, therefore, were classified as “incidental.” An additional five reported fatalities involved bumper contact outside a crib, which staff considered out of scope in the original 2013 Petition Briefing Package. Of the remaining 71 reported fatalities, 41 involved entrapment or wedging scenarios, such as the infant becoming entrapped or wedged between the bumper and another object inside the crib, or becoming entrapped or wedged in the perimeter of the crib, between the mattress and the crib side. These latter fatality reports consistently involved incidents of broken cribs or older cribs that likely did not meet current crib slat and mattress spacing requirements. In addition to classifying the reported fatalities into hazard patterns, staff attempted to assess the likely addressability of these fatalities through Commission action. Staff concluded that such an assessment was necessary to enable staff to assess the voluntary standard and to evaluate regulatory options. Staff made this assessment by examining the information available in the incident reports to determine whether the fatality still would have occurred if the bumper were not present in the sleep environment. Staff chose this approach because fatalities that would have occurred even if the bumper were removed are incidents in which the bumper likely did not increase the risk of injury, and for which improved performance requirements, or even a ban, would likely have had no effect. The primary difficulties in making such assessments are that all of the incidents were unwitnessed, and incident reports varied in the type and amount of information available or provided when describing the incident scenario. In addition, most cases included other confounding factors, such as the child having a medical condition or illness at the time of the incident, the child being in a prone sleep position, the presence of pillows and other suffocation hazards, and the presence of specialized infant products and other clutter that tend to crowd the sleeping area and contribute to entrapment hazards. Nevertheless, staff believed that attempting to make such an assessment was the best way to determine the likely contribution of the crib bumper to the fatality, and to avoid giving undue weight to incidents in which the contribution of the bumper appeared unfounded. iii THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) Based on the available information, staff concluded that 72 of the 107 reported fatal incidents, which include the 31 incidental cases described above, are unlikely to be addressable by Commission action. Thus, improved performance requirements, or even a ban, are unlikely to have had an effect on these deaths. In contrast, 9 of the 107 reported fatalities are likely to be addressable to some degree. The incident reports for the remaining 26 fatalities lacked sufficient details to determine whether the crib bumper