Proposed Regulatory Amendment to the Cribs and Cradles Regulations

The online consultation is now closed. Comments and suggestions received during the public consultation period are being considered in the finalization of this document. The final report will be made available as soon as possible.

Purpose

To provide information concerning an initiative that relates to the safety of cribs, cradles and bassinets, including proposed requirements addressing traditional drop-side cribs, and to solicit input with respect to this proposal. Comments received from this consultation will be taken into consideration as the Department prepares a formal regulatory proposal for publication in Part I of the Canada Gazette. At that time, there will be a formal comment period, which is typically 75 days.

Background

Under the authority of the Hazardous Products Act (HPA), the Cribs and Cradles Regulations were introduced in 1974 as a measure to reduce deaths and injuries associated with the use of these products. Canada's requirements for cribs and cradles are among the most stringent in the world. However, Health Canada has recently identified safety concerns associated with crib drop-sides. In addition, crib, cradle and bassinet manufacturers have historically requested greater alignment of the Canadian Cribs and Cradles Regulations with other recognized international standards, specifically those of ASTM International (originally known as the American Society for Testing and Materials).

To help further protect the safety of infants and children, Health Canada is launching this public consultation on potential amendments to the Regulations.

The U.S. Consumer Product Safety Commission (U.S. CPSC) has committed to introducing a revised mandatory federal safety standard for cribs this year in connection with section 104 (b) of the Consumer Product Safety Improvement Act (CPSIA), which requires the U.S. CPSC to issue safety standards for infant and toddler products. The advance notice of proposed rulemaking (ANPR) for cribs issued on June 30, 2010 by the U.S. CPSC proposes adopting the revised voluntary industry standard (ASTM F 1169-10) for full-size cribs as law. The U.S. CPSC also issued a notice of proposed rulemaking (NPR) for cradles and bassinets on March 10, 2010. The NPR for cradles and bassinets proposes adopting the voluntary standard for cradles and bassinets (ASTM F2194-07ae1) with some revisions.

The revised ASTM F1169-10 standard for full-size cribs, which the U.S. CPSC proposes adopting as law, includes several new provisions, such as a ban on crib sides that are not rigidly attached to the crib ends (the traditional style of crib drop-sides). Despite this new restriction, the standard allows for the uppermost portion of the side to fold, pivot or move with respect to the frame in order to provide easier access to the occupant. Due to this new voluntary industry standard, many manufacturers have already stopped selling drop-side cribs in the U.S. and Canada.

Between September 2008 and July 14, 2010, in collaboration with a number of manufacturers, Health Canada issued twelve voluntary recalls relating to the safety of crib drop-sides. Drop-side cribs generally have a tendency to be less structurally sound than cribs with four fixed sides because of the additional stress caused by the repeated raising and lowering of the drop-side. The hardware on these cribs could break or deform. If the drop-side hardware breaks or deforms, the drop-side could detach from the crib in one or more corners and create a space between the drop-side and the crib mattress. The bodies of infants and toddlers could become entrapped in this space, which could lead to suffocation. Complete detachment of the drop-side from the crib could lead to falls. Therefore, the Department is proposing to align with the ASTM F1169-10's requirements regarding drop-side cribs.

The revised ASTM F1169-10 crib standard features Health Canada's shake test for crib sides (Schedule III, Sections 3 and 4 of the current Cribs and Cradles Regulations) and a modified version of the Department's mattress support vertical impact test for cribs (Schedule III, Section 1 of the current Regulations). The Department has consulted with the U.S. CPSC and an agreement regarding a common set of test requirements for both countries has been reached. These testing specifications closely resemble the Canadian method, but alignment between the Canadian requirements and the proposed American requirements would involve amending certain parameters, such as the cycle frequency, in the current Regulations to allow for greater repeatability of the test. Health Canada is proposing to align with the ASTM F1169-10's modified version of the mattress support vertical impact test.

Additionally, the new version of the ASTM F1169-10 crib standard revises the slat strength test such that it is more stringent. In Canada, the Cribs and Cradles Regulations currently contain strict requirements relating to slats. Schedule V of the Regulations requires that a torque test be performed on each slat, as well as the application of a vertical upward force to the crib's top rail. Following these tests, the slats must not turn, disengage, deform, deflect or become damaged. Despite these strict requirements, Health Canada continues to receive reports of slats breaking or disengaging. As a result, the Department is proposing to align with ASTM F1169-10's slat strength test.

Health Canada has received reports of incidents associated with the mis-assembly of cribs. Crib mis-assembly has the potential to result in serious injury or death. As such, the Department proposes to align with the new requirement in ASTM F1169-10 that stipulates crib designs must only allow assembly of key structural components in accordance with the manufacturer's instructions or have permanent markings that indicate the proper orientation of the component. The markings must be conspicuous in any mis-assembled state.

The Department has also received reports of incidents associated with accessories, such as change table and bassinet attachments, that are intended to be affixed to a playpen. Due to its structure, location, movement or failure, a playpen accessory may expose a playpen's occupant to a number of possible hazards, including openings that present an entrapment hazard. Although accessories that attach to cribs are not currently prevalent on the market, they present the same set of hazards as accessories that attach to playpens. Therefore, Health Canada is proposing that the Cribs and Cradles Regulations be amended to include the new requirements for crib accessories found in ASTM F1169-10.

The potential for serious injury or death is present when infants and young children are not placed to sleep on a firm and flat sleeping surface. To limit the potential for suffocation or entrapment, the U.S. CPSC is proposing a maximum allowable rest angle (for rocking and swinging bassinets) of 5° and a maximum allowable 5° mattress angle for all rocking and non-rocking bassinets. The 5° recommendation for the mattress flatness angle and the rest angle is based on the Australian study, "The Danger of Freely Rocking Cradles" by S. M. Beal et al, Journal of Pediatric Child Health (1995) and AS/NZS 4385: 1996, the Australian/New Zealand standard for infant's rocking cradles. Health Canada is proposing to align with the U.S. CPSC's proposed maximum mattress flatness angle and rest angle for bassinets.

Health Canada has received reports of incidents in which an infant either became entrapped between, or fell through, the structural members of the side of a bassinet. These structural members became exposed when the product's fabric cover had become unfastened. The existing Cribs and Cradles Regulations include a requirement intended to ensure that the product does not have any hazardous openings in which a child could become entrapped or fall through. The U.S. CPSC is proposing additional requirements that specify cradles and bassinets are to be tested with the fabric on the product, but without the snaps, zippers, etc. fastened. Health Canada is proposing a clarification to the Regulations with respect to the completely bounded openings requirements for cribs, cradles and bassinets. This will ensure that hazardous openings in the product's frame are not present.

Please note that proposed amendments to the Cribs and Cradles Regulations of the HPA were published in the Canada Gazette, Part I on April 11, 2009. This proposed regulatory amendment included a number of modifications to the Regulations, such as including requirements for stand-alone bassinets. Health Canada is aiming to move forward with the next steps in this process later this year. However, this previous regulatory amendment does not propose regulatory changes related to the safety of crib drop-sides. A new regulatory proposal, which is the subject of this pre-consultation, may be developed to address the safety hazards related to crib drop-sides.

Proposed Changes to the Regulations

It is proposed that the Cribs and Cradles Regulations of the HPA be amended to both enhance safety and further align Canada's safety requirements with those recently proposed in the U.S. This would be accomplished by:

• including a requirement that only the uppermost portion of a crib side may fold, pivot or move with respect to the frame in order to provide easier access to the occupant;
• amending the test method for the impacting of cribs and cradles such that it is more repeatable, which would align with the crib requirements proposed by the U.S. CPSC;
• adding a performance requirement and test method, from the crib requirements proposed by the U.S. CPSC, for slat strength;
• including a requirement, from the crib requirements proposed by the U.S. CPSC, to further safeguard against incorrect assembly of key components;
• including performance requirements and test methods, from the crib requirements proposed by the U.S. CPSC, for accessories, such as bassinets or changing tables, that attach to cribs;
• including performance requirements and test methods for the maximum rest angle and maximum flatness angle of bassinets, which would align with the proposed U.S. CPSC requirements, and;
• clarifying the performance requirement and test method relating to completely bounded openings for fabric sided cribs, cradles and bassinets.

Incidents

Crib Drop-Sides

Between January 2000 and mid-August 2010, Health Canada received 93 complaints involving crib drop-sides in Canada. The 93 reported drop-side complaints were associated with 84 non-injury related complaints, seven reports of bumps and bruises, one report of a concussion and one death. However, this death occurred in a crib where the original drop-side hardware had been replaced with parts that were not supplied by the manufacturer. The crib was also in a general state of disrepair.

Crib Slat Breakage and Disengagement

Between January 2000 and mid-August 2010, Health Canada received one report of crib slats deforming and deflecting, five reports of crib slats breaking and 19 reports of crib slats disengaging. One of the reports resulted in a minor injury - scratches from a broken slat. The remaining 24 reports did not result in any injuries.

Accessories

Between 1996 and 2009, Health Canada received eight complaints related to playpen accessories, including three deaths. In 2005, a one year old baby died when its head became trapped between the top rail of a playpen and the bottom rail of a change table that was attached to the playpen. In 2008, a seven week old infant died after being placed to sleep on a playpen change table accessory. In 2009, a two month old infant died in a bassinet accessory in which the child had been placed to sleep with blankets and a stuffed toy. Other reported incidents included falls from bassinet accessories.

Fabric Sided Cradles and Bassinets

Between January 2000 and mid-August 2010, Health Canada received one report of an infant becoming entrapped between the bars of the bassinet's metal frame and one report of the infant falling through the bars of the bassinet's frame. Both of these incidents occurred when the frame was exposed as a result of the fabric cover becoming unfastened.

Regulatory Options

The Department has identified the following regulatory options to address the current safety concerns related to crib drop-sides:

• Maintain the status quo.
• Amend the Cribs and Cradles Regulations to introduce requirements that would align the Canadian requirements more directly with those in the U.S. This would include eliminating crib sides that are not rigidly attached to the crib ends while allowing for the uppermost portion of the crib side to fold, pivot or move with respect to the frame.
• Prohibit the sale, advertisement and importation of all types of movable crib sides in Canada.

Health Canada considers the second option to be preferable as it would increase the level of harmonization with the U.S. and address important safety issues that have specifically been identified with crib drop-sides. These safety issues would be addressed by ensuring that the crib side is rigidly attached to the crib ends. This would eliminate the potential for the crib side to separate from the crib ends creating a gap between the crib side and the mattress in which a child could become entrapped. The second option also allows for the uppermost portion of the crib side to fold, pivot or move with respect to the frame. This would facilitate access to the occupant without allowing for the entire side to move.

Comments

The Government of Canada is committed to providing the Canadian public and other stakeholders with the opportunity to participate in the development of regulatory initiatives. You are invited to provide Health Canada with comments on the proposed options for regulatory action regarding cribs, cradles and bassinets, or any other suggestions. As applicable, please supply evidence to support your comments.

Please provide your comments no later than December 15, 2010. Comments may be submitted by mail, e-mail or fax to the following coordinates.

• Mail:
  Cribs, Cradles and Bassinets Consultation
  Mechanical & Electrical Hazards Division
  Consumer Product Safety Bureau
  Health Canada
  123 Slater Street, 4^th floor, Address Locator: 3504D
  Ottawa, Ontario
  K1A 0K9
• E-mail: M&E@hc-sc.gc.ca
• Fax: 613-952-9138, Attention: Mechanical & Electrical Hazards Division

Stay Informed

Please refer to the Consumer Product Safety section of the Health Canada Web site to stay informed of this initiative.

Additionally, you may wish to subscribe to the Consumer Product Safety electronic newsletter so that you will receive the latest news and information about Health Canada's work in the area of consumer product safety.