Proposed Standards for Full-Size and Non-Full-Size Cribs under Section 104 of the Consumer Product Safety Improvement Act and Related Documents — Staff Briefing Memorandum

Overview

This 91-page U.S. Consumer Product Safety Commission briefing package was transmitted to the Commission on June 30, 2010 in advance of the July 14, 2010 decision meeting on staff’s draft proposed rules for full-size (FS) and non-full-size (NFS) crib safety standards under Section 104(b) of the Consumer Product Safety Improvement Act (CPSIA). The package comprises the Office of General Counsel transmittal memorandum (Cheryl A. Falvey, Philip L. Chao, Patricia M. Pollitzer; pages 1–4), the underlying staff memorandum from the Office of Hazard Identification and Reduction and the Directorate for Engineering Sciences (Robert J. Howell, Patricia L. Edwards; pages 5–25), and an appendix of CPSC staff recommendation letters to ASTM dated September 2002, October 2007, May 2008, and August 2008 (pages 27–91). The briefing recommends Commission publication of three draft Federal Register notices: (i) an NPR proposing an FS crib mandatory standard substantially the same as ASTM F 1169-10 with one staff modification, (ii) an NPR proposing an NFS crib mandatory standard substantially the same as ASTM F 406-10 with four technical and two editorial staff modifications, (iii) a draft NPR proposing to revoke 16 CFR 1508 and 1509 once the new standards take effect, and (iv) a draft notice withdrawing the 1996 crib ANPR on slat disengagement. The package’s hazard analysis is dominated by mechanical safety issues — drop-side hardware, mattress support, slat detachment, mattress fit, climb/fall-out, and limb entrapment — and these are the hazards driving the proposed performance requirements. Heavy-metal content is confined to a single sub-section on paint/finish (§C.9) and a corresponding paragraph in the hazard-pattern identification (§B.4), both of which conclude that the existing prohibition on lead-containing surface coatings at 16 CFR 1303 — incorporated by reference into both ASTM F 1169-10 and ASTM F 406-10 — already addresses the lead-paint hazard in cribs, and that no new paint/finish performance requirements are recommended for the proposed rule.

Key numbers

Regulatory framework cited by the briefing memorandum

• Statutory authority (transmittal memorandum p. 1): Section 104(b) of the Consumer Product Safety Improvement Act (CPSIA) directs the Commission to issue safety standards for durable infant or toddler products substantially the same as, or more stringent than, applicable voluntary standards.
• Predecessor mandatory regulations recommended for revocation (staff memorandum p. 2): 16 CFR 1508 (full-size baby crib regulation, published 1973) and 16 CFR 1509 (non-full-size crib regulation, published 1976). Both regulations include warning-label requirements that direct caregivers to use a mattress of stated dimensions (“Any mattress used in this crib must be at least 27 1/4 inches by 51 5/8 inches” — 16 CFR 1508).
• Recommended new mandatory standard, full-size cribs (staff memorandum p. 3): ASTM F 1169-10 Standard Consumer Safety Specification for Full-Size Baby Crib, approved June 1, 2010. Includes incorporation of the 16 CFR 1508 requirements and the Health Canada SOR/86-962 cyclic side (shake) test and mattress-support vertical-impact test. The 2010 revision additionally added a slat strength requirement (more stringent than the 2009 version), a limitation on movable sides (drop-side), accessory testing, sharp-points/openings/scissoring general requirements, mattress-support openings requirements, and stronger warning-label emphasis on the fall hazard.
• Recommended new mandatory standard, non-full-size cribs (staff memorandum p. 4): ASTM F 406-10 Standard Consumer Safety Specification for Non-Full-Size Baby Cribs/Play Yards, approved June 1, 2010. The 2010 revision incorporates 16 CFR 1509, adds a limitation on movable sides, the Canadian cyclic side shake test, fastener-loosening prevention requirements, mis-assembly prevention, and a more stringent slat strength requirement.
• Existing lead-paint instrument incorporated by reference into both standards (staff memorandum p. 15): “Since lead based paints are already prohibited under CPSC regulation 16 CFR 1303 and by reference in both the FS and NFS crib standards, staff believes this hazard is already adequately addressed. Staff is not proposing any paint/finish-related changes to the voluntary standards at this time.”
• Two precedent international standards influential in the development of ASTM F 1169-10: Health Canada SOR/86-962 Cribs and Cradles Regulations, Schedule III — Parts 1 & 2 (December 2, 2009) and European Standard EN 716 (staff memorandum p. 4). The Canadian cyclic side (shake) test, mattress-support vertical-impact test, and slat/spindle strength test were adapted into ASTM F 1169-10; CPSC staff and the ASTM subcommittee assessed the adapted F 1169-10 performance requirements as equivalent in stringency to SOR/86-962.

CPSC Early Warning System (EWS) incident totals, November 1, 2007 – April 11, 2010

• Total crib incident reports captured in EWS during the 29-month window: 3,584 (staff memorandum p. 8). Of these, 2,395 were clearly identified as involving full-size cribs, 64 as non-full-size cribs, and 1,125 lacked sufficient information to classify by crib type.
• Fatalities: 153 total fatalities reported between November 1, 2007 and April 11, 2010 associated with all cribs (staff memorandum p. 9). 111 fatalities were unrelated to any structural failure or design flaw of the crib (cause-of-death breakdown: 65 suffocation deaths related to soft bedding in the sleep area, 18 asphyxiation deaths related to prone positioning on the sleep surface, 12 strangulation deaths related to window-blind/electrical/other cords near the crib, 16 from miscellaneous other hazards including plastic bags and other nursery accessories). 36 fatalities were attributable to structural problems/failures of cribs: 35 head/neck/body entrapments caused by detachments, disengagements, or breakages that created openings in which infants became entrapped — including the single wall-and-crib body-entrapment death where an assembly problem prevented the mattress support from being lowered sufficiently — plus 1 non-entrapment death from a screw lodged in the decedent’s throat. For 6 fatalities, no circumstance information was available. No fatalities were attributed to lead exposure or any other heavy-metal exposure pathway.
• Non-fatal injuries: 1,703 crib-related injury reports during the window (staff memorandum p. 9). The vast majority did not require hospitalization; among 48 hospitalizations, nearly half were for limb or skull fractures and other head injuries resulting from falls from cribs.
• Non-injury incidents: 1,728 of the 3,584 reports did not have any reported injury associated (staff memorandum p. 10).

Paint- and lead-related incidents (the only heavy-metal signal in the EWS dataset)

• Paint-related incident share (staff memorandum p. 11, §B.4 Hazard Pattern Identification): “Another three percent of the reports were complaints of paint-related issues. The vast majority reported concerns for a possible choking hazard or lead exposure resulting from children chewing on paint chips that came off easily from the crib surface.”
• Lead-test-positive incident count (staff memorandum p. 11, §B.4 and p. 15, §C.9 Paint/Finish): 5 incidents reported a positive lead test result. Disposition of the 5: 2 were associated with cribs that had been recalled for the presence of lead paint; 2 were unspecified lead amounts detected by consumers using home test kits; 1 reported an increased blood-lead level in a child but with no evidence linking the elevation to the crib. “There were no other reported incidents of toxic poisonings or injuries [related to paint/finish]” (p. 15).
• Lead-paint-attributable crib recalls, 2005–2010 cumulative (staff memorandum p. 15, §C.9): “Over 3,300 cribs, from two different manufacturers, have been recalled in the last five years due to excess lead levels in the paint.” The manufacturers are not named in §C.9. The appended recall list (staff memorandum pp. 16–18) identifies one of the recalls explicitly: see Recall list, below.
• Staff conclusion on the paint/finish hazard (staff memorandum p. 15, §C.9): “Since lead based paints are already prohibited under CPSC regulation 16 CFR 1303 and by reference in both the FS and NFS crib standards, staff believes this hazard is already adequately addressed. Staff is not proposing any paint/finish-related changes to the voluntary standards at this time.”

CPSC crib recall list, January 2007 – June 2010

• Cumulative crib recall scope (staff memorandum p. 16, §D Recent Compliance Activity): “Since 2007, CPSC has issued 40 recalls of over 11 million cribs. All but seven of these recalls were for product defects that created a substantial product hazard, and not for violations of the federal crib regulations.”
• Explicitly lead-related recall in the appended list (staff memorandum p. 17): “Munire Recalls ‘Newport Rubbed Black’ Cribs and Matching Furniture Due to Violation of Lead Paint Standard (December 23, 2008).” This is the only entry in the 40-recall list whose stated cause is lead paint; the remaining 39 are described as entrapment, suffocation, strangulation, fall, drop-side hardware, mattress-support collapse, and related mechanical-failure recalls. (Brand naming for a CPSC recall is permitted Exception 1, which allows brand attribution when the brand is the subject of a public-record regulatory action.)
• Hazard-pattern ranking (staff memorandum p. 12, §C Hazard Severity Summary): the 9 hazard patterns identified are ranked, with patterns where fatalities occurred listed first and non-fatal-only patterns ranked by potential severity. In descending order: (1) added soft bedding and other non-product-related issues; (2) drop-side hardware or other drop-side entrapment issues; (3) non-drop-side hardware issues, including wood screws or other fasteners; (4) mattress support hardware or other mattress support issues; (5) slat detachment or breakage, other wood issues; (6) mattress fit issues; (7) climbing and falling out of cribs; (8) limb entrapment between slats; (9) paint or other finishing issues. The paint/finish hazard pattern is ranked last (ninth) and no associated fatalities are reported in the EWS dataset.

Staff-recommended modifications to the voluntary standards (full list)

• Full-size crib standard (staff memorandum p. 19, §E): a single change recommended for incorporation into ASTM F 1169-10 as the mandatory rule — removal of the existing standard’s allowance to retighten screws between the crib side latch test and the mattress support vertical impact test. No paint/finish-related changes are recommended.
• Non-full-size crib standard (staff memorandum pp. 19–21, §F): four technical changes and two editorial changes recommended. Technical changes: (1) replace the current mattress-support vertical impact test with the FS standard’s version (adapted from Health Canada SOR/86-962); (2) replace the current crib side impact/torque tests with the FS standard’s side tests; (3) reinstate the movable side latch test that was removed from F 406-10 (carried over from F 406-09); (4) provide a specified test order matching ASTM F 1169-10 (teething rail test → cyclic side shake test → crib side latch test → mattress support system vertical impact test → mattress support system static test → crib side impact test → spindle/slat strength test). Editorial changes: exclude mesh/fabric play yard requirements from the NFS NPR (separate rulemaking forthcoming), and move recordkeeping requirements from the F 406-10 appendix into the General Requirements section. No paint/finish-related changes are recommended.
• Proposed effective date (staff memorandum p. 25): 180 days following publication of the final rule. Staff notes the Commission could elect a later effective date to allow day-care centers and other public accommodations to spread the cost of non-full-size crib replacement over a longer period.

Small-entity counts (regulatory flexibility analysis)

• Domestic and importer market size (staff memorandum p. 21, §G): approximately 68 firms known to be producing or selling FS cribs and 17 firms producing or selling NFS cribs in the United States.
• Small-firm counts under SBA definitions (staff memorandum p. 21): of the 68 FS-crib firms, 48 are small under SBA criteria (36 domestic manufacturers, 10 domestic importers, 2 firms with unknown supply sources). Of the 17 NFS-crib firms, 14 are small under SBA criteria (9 domestic manufacturers, 5 importers; 2 firms with unknown supply sources and 1 domestic manufacturer with insufficient information could not be sized).
• Compliance baseline among small firms (staff memorandum pp. 22–23): of the 36 small domestic FS-crib manufacturers, 24 are in compliance with the voluntary standard; of the 9 small domestic NFS-crib manufacturers, 5 are in compliance. Of the 10 small importers of FS cribs and 5 small importers of NFS cribs, 6 and 1 respectively are in compliance with the voluntary standard.
• Day-care and hotel use of NFS cribs (staff memorandum pp. 22, 23): approximately 58,364 small day-care firms (of 59,555 total) and 42,437 small hotel firms (of 43,303 total) use cribs and could be affected by the NFS crib rule.

Methods (brief)

This is a regulatory briefing memorandum, not a primary measurement study; the document presents no laboratory analytical methods. Incident data are drawn from the CPSC Early Warning System (EWS), in which CPSC staff each week review all incident records entered into CPSC epidemiology databases during the prior week and code each incident by failure mode or possible hazard, with referral to CPSC field staff for further investigation as needed. The 5 lead-test-positive cases identified in §B.4 / §C.9 are characterised by source as: 2 consumer-reported home-test-kit results (unspecified lead amounts), 2 cases associated with cribs recalled for the presence of lead paint, and 1 reported elevated blood-lead level in a child with no evidence linking the elevation to the crib (2 + 2 + 1 = 5). No analytical method, laboratory, or quantitative lead concentration is reported for any of the 5 cases in the briefing memorandum. The “over 3,300 cribs … recalled in the last five years due to excess lead levels in the paint” figure is reported as a cumulative count of recalled units across two manufacturers over the 2005–2010 window without a per-recall analytical-method or paint-Pb-concentration breakdown. The applicable CPSC instrument cited as the underlying regulatory threshold is 16 CFR 1303 (CPSC ban on lead-containing surface coatings), incorporated by reference into both ASTM F 1169-10 and ASTM F 406-10.

Implications

This briefing memorandum is regulatory context for the cribs and bassinets product page in three specific ways.

First, it establishes the federal regulatory architecture in force at the time of the proposed rulemaking: 16 CFR 1303 (lead-paint surface-coating ban) is the operative instrument for the heavy-metal hazard in cribs, and the proposed CPSIA §104(b) mandatory standards (ASTM F 1169-10 for FS cribs and ASTM F 406-10 for NFS cribs, with the staff modifications listed above) carry that prohibition into the new rule by reference rather than adding a parallel lead-paint requirement. This is the regulatory-record predecessor to the final FS and NFS crib safety standards eventually codified at 16 CFR 1219 (FS cribs) and 16 CFR 1220 (NFS cribs), which were promulgated in December 2010 and became effective June 28, 2011.

Second, it documents the cumulative magnitude of the lead-paint hazard in cribs in the years immediately preceding the proposed rule: over 3,300 cribs recalled for excess lead in paint across two manufacturers over 2005–2010, with one explicitly lead-paint-attributable entry (December 23, 2008) in the 40-recall, 11-million-unit cumulative recall list issued by CPSC since 2007. This is occurrence-context evidence for the cribs product row that informs assessment of how often lead-paint contamination of finished cribs reaches the consumer level despite the 16 CFR 1303 prohibition.

Related evidence

• Cribs and bassinets

Update history

The five most recent substantive edits to this page, classified major (evidence or structure moved), correction (a published value or statement was wrong and has been fixed), or minor (narrative rewritten without changing the underlying evidence). Each description is derived from what the edit did to this page; the linked commit is the authoritative record, routine regeneration passes are excluded, and the full version history lives in git.