Daily Rules, Proposed Rules, and Notices of the Federal Government
The Consumer Product Safety Improvement Act of 2008, (CPSIA, Pub. L. 110-314), was enacted on August 14, 2008. Section 104(b) of the CPSIA, part of the Danny Keysar Child Product Safety Notification Act, requires the Commission to: (1) Examine and assess the effectiveness of voluntary consumer product safety standards for durable infant or toddler products, in consultation with representatives of consumer groups, juvenile product manufacturers, and independent child product engineers and experts, and (2) promulgate consumer product safety standards for durable infant and toddler products. These standards are to be “substantially the same as” applicable voluntary standards or more stringent than the voluntary standard if the Commission concludes that more stringent requirements would further reduce the risk of injury associated with the product. The term “durable infant or toddler product” is defined in section 104(f)(1) of the CPSIA as a durable product intended for use, or that may be reasonably expected to be used, by children under the age of 5 years. Bassinets and cradles are specifically identified in section 104(f)(2)(L) as a durable infant or toddler product.
In April 2010, the Commission issued a notice of proposed rulemaking (NPR) for bassinets and cradles. (75 FR 22303, April 28, 2010). Through ongoing consultation and assessment of the standard, both the ASTM standard and the Commission's proposals have evolved since publication of the April 2010 NPR, such that the Commission believes a supplemental notice and opportunity for the public to comment would be beneficial. Thus, in this document, the Commission is proposing a safety standard for bassinets and cradles in a supplemental notice of proposed rulemaking. Pursuant to Section 104(b)(1)(A), the Commission consulted with manufacturers, retailers, trade organizations, laboratories, consumer advocacy groups, consultants, and members of the public in the development of this proposed standard, largely through the ASTM process. The proposed standard is based on the voluntary standard developed by ASTM International (formerly the American Society for Testing and Materials), ASTM F2194-12, “Standard Consumer Safety Specification for Bassinets and Cradles” (ASTM F2194-12), with additions and modifications to strengthen the standard. The ASTM standard is copyrighted but can be viewed as a read-only document, only during the comment period on this proposal, at:
ASTM F2194-12 defines a “bassinet/cradle” as a “small bed designed exclusively to provide sleeping accommodations for infants supported by free standing legs, a wheeled base, a rocking base, or which can swing relative to a stationary base” and provides that a bassinet/cradle is “intended to provide sleeping accommodations only for an infant up to approximately 5 months in age or when the child begins to push up on hands and knees, whichever comes first.” ASTM F2194-12 defines a “bassinet/cradle accessory” as “a supported sleep surface that attaches to a crib or play yard designed to convert
The voluntary standard for bassinets and cradles was first approved and published by ASTM in 2002, as ASTM 2194,
1. Compliance with CPSC's regulations at 16 CFR part 1303 (ban of lead in paint), 16 CFR 1500.48 and 16 CFR 1500.49 (sharp points and sharp edges), and 16 CFR part 1501 (small parts), both before and after the product is tested according to the standard.
2. Exposed wood parts on bassinet/cradles, prior to testing, must be smooth and free of splinters.
3. Bassinets/cradles must not present scissoring, shearing, or pinching hazards.
4. Requirements and test method to prevent unintentional folding.
5. Requirements for the permanency of labels and warnings.
6. Prohibition against using wood screws in the assembly of any components that must be removed by the consumer in the normal disassembly of a bassinet/cradle.
7. Limits on how far a corner post assembly may extend.
8. Prohibition against containing an occupant restraint system when the product is used in the bassinet/cradle mode.
9. Performance requirements for the spacing of rigid sided bassinet/cradle components.
10. Performance requirements for the openings of mesh/fabric sided bassinet/cradles to prevent entrapment.
11. Performance requirements and test methods for static load and stability of the bassinet/cradle.
12. Requirements regarding the thickness and dimensions of the sleeping pad.
13. Requirements for the side height of the bassinet/cradle.
14. Requirements and test method for protective components of bassinet/cradle.
15. Fabric-sided enclosed openings requirement and test method involving a torso probe to protect against entrapment in bounded openings in the bassinet/cradle.
16. Performance requirements and test methods for the rock/swing feature of bassinets or cradles.
17. Marking, labeling, and instructional literature requirements.
The CPSC's Directorate for Epidemiology reports that there have been 335 incidents reported to the Commission regarding bassinets/cradles from November 2007 through December 2011. The data is drawn from the CPSC's “Early Warning System” (EWS), a pilot project initiated in 2007, which draws all data entered into the CPSC's epidemiology databases on a weekly basis. The 335 incidents involved 94 fatalities and 241 nonfatal incidents. (Because the number of emergency department-treated injuries associated with bassinets and cradles was insufficient to derive any reportable national estimates, injury estimates are not presented separately but are instead included within the category “nonfatal incidents.”).
A total of 94 bassinet-related fatalities have been reported from early November 2007 through December 2011. Eight of the 94 deaths are associated with the design aspects of the product. Three of these deaths were due to entrapment and/or hanging that resulted after an infant's body, but not head, slipped through the fabric covering and underlying structural components of a particular brand of convertible bassinets/bedside sleeper that was subsequently recalled for this defect. Two of these three infants were 6 months old, while the third infant was a 4-month-old. Three of the eight deaths are associated with problems dealing with the flatness of the mattress pads used in a bassinet accessory of a play yard. All three of these decedents were 5 months old or younger. One of the three decedents suffocated in the corner of the bassinet when he rolled into that position due to the unlevel mattress pad; the other two decedents were found face down in a dip in the center of the unlevel mattress pad. The rocking feature of a bassinet, which contributed to its non-level resting position, was associated with an additional suffocation death of a 1-month-old infant. The remaining fatality associated with the design of the product occurred when the bassinet bed fell off its stand and allowed the 3-month-old decedent to get pinned between the bassinet and a nearby dresser.
Eighty-two of the deaths were asphyxiations due to the presence of soft or extra bedding in the bassinet, prone placement of the infant, and/or the infant getting wedged between the side of the bassinet and an added mattress or pillow. All but two of the 82 decedents were 5 months old or younger in age; one infant was 7 months old and another was 8 months old. There were four fatalities with not enough information to allow the CPSC to determine the hazard scenario.
A total of 241 bassinet-related, nonfatal incidents were reported from November 2007 through December 2011. Fifty-two of these incidents reported an injury to an infant using the bassinet or cradle. The majority of the injuries (30 out of 52), were identified as resulting from falls out of the bassinets. Because 28 of the 30 falls were reported through the emergency department-treated injury surveillance system, little or no circumstantial information is available on how the fall occurred. However, the reports do indicate that 76 percent of the injured infants who fell out of bassinets were older than the ASTM-recommended maximum age limit of 5 months, with four infants as old as 9 months of age falling out of bassinets. All of the falls resulted in head and facial injuries.
Overall, there were six bassinet-related injuries that reportedly required hospitalization. Four of them, all serious head injuries, resulted from a fall out of the bassinet. One injury, a leg fracture, resulted from a caregiver unknowingly attempting to lift an infant out of the bassinet while the infant's leg was caught in a structural opening. The remaining hospitalized injury was due to a moldy bassinet pad that caused respiratory illness to the infant.
Two additional serious injuries were reported, but neither of these infants was hospitalized. There was a report of a second-degree burn suffered by an infant from the bassinet's overheated mobile and a report of an arm fracture from an infant's arm getting caught in the bassinet. The remaining injuries were limited mostly to contusions and abrasions.
The remaining 189 reports either indicated that no injury had occurred or provided no information about any injury. However, many of the
Based on the incident data, the Commission identified hazard patterns associated with bassinet and cradle incidents. The incidents were grouped into four broad categories:
• Product-related issues;
• Non-product-related issues;
• Recalled product-related issues; and
• Miscellaneous other issues.
• Lack of
• Reports of infants
• Problems with
• Problems with
• Problems with
• Problems with bassinet
In summary, there are five product-related issues associated with incident deaths and/or significant injuries:
• Structural integrity/instability,
• Mattress flatness,
• Falling or climbing out, and
• Entrapment in fabric sided products (recalled product-related).
There have been a total of five consumer-level recalls involving bassinets from October 2006 through June 2012.
One recall, involving 46,000 bassinets manufactured from July 2008 through May 2010, pertained to the latching system between the bassinet bed and the frame/stand. The latches that attach the bassinet bed onto the metal frame/stand could appear to be locked in place but still remain unlocked. This allowed the bassinet bed to become detached from the metal frame/stand, causing the bassinet bed to fall and the infant to be injured. There were seven incidents reported to CPSC and the manufacturer. One infant received a bruised cheek when the bassinet bed detached from the metal frame/stand and landed sideways on the floor with the infant inside. (The proposed Removable Bassinet Bed Attachment test, discussed in Sections F and G, would address this hazard.)
Another recall, conducted on February 16, 2011, involved all bassinets manufactured by the company before June 2010. The cross-bracing rails on the bassinet stands were misinstalled, and thus, were not fully locked into position, resulting in the bassinet collapsing, which caused the infant to fall to the floor or fall within the bassinet and suffer injuries. The manufacturer received 10 reports of incidents in which two infants received minor injuries as a result of the collapses, including bruises to the head and shoulder. Consumers were supplied with better instructions and guidance on how to install the cross-braces properly. This was a very design-specific hazard, and CPSC staff has not seen similar incidents from other manufacturers.
The third recall was conducted in December 2009 and involved five models that were bassinet accessories to play yards. This recall involved metal bars used to support the floorboard of the bassinet accessory that came out of the fabric sleeves and created an uneven sleeping surface, posing a risk of suffocation or positional asphyxiation. The manufacturer received no reports of injuries. (The proposed mattress flatness requirement, discussed in Sections F and G, would address this hazard.)
A fourth recall, conducted in May 2009 by the same manufacturer as in the third recall, also involved portable play yards. The convertible play yard included a bassinet accessory and changing station feature and was manufactured before December 1, 2008. This recall involved the play yard's rocking bassinet accessory that was tilting, even when secured by straps in the non-rocking mode, or that stayed tilted without returning to a level sleeping surface while in the rocking mode. These conditions could cause an infant to roll to the corner or side of the bassinet and become wedged in the corner or pressed against the side or bottom of the bassinet, posing a risk of suffocation or positional asphyxiation. The manufacturer and CPSC received 10
The fifth recall, conducted in September 2008, involved 3-in-1 and 4-in-1 convertible bassinets that contained metal bars covered by an adjustable fabric flap attached with Velcro®. The fabric was folded down when the bassinet was converted into a bedside sleeper position. If the Velcro® was not resecured properly when the flap is adjusted, an infant could slip through the opening and become entrapped in the metal bars and suffocate. CPSC learned that on August 21, 2008, a 6
In April 2010, the Commission approved a proposed rule on bassinets/cradles that referenced the requirements specified in ASTM F2194-07a
• Updated warnings;
• Stability requirements;
• Performance requirements for fabric-sided products to address entrapment incidents;
• Performance requirements to limit the rocking/swinging angle to 20 degrees and the rest angle of certain rocking/swinging cradles to 5 degrees;
• Requirement to eliminate active restraints;
• Changes to scope and terminology; and
• Performance requirements specifying a mattress flatness angle of 5 degrees to address suffocation incidents on segmented mattresses.
Many of the changes proposed in the April 2010 NPR have been incorporated in some capacity into ASTM F2194-12. Other changes to ASTM F 2194-12 have come about in response to comments to the April 2010 NPR. The Commission proposes to revise two of the proposed changes to the 2010 NPR (involving hammocks and the mattress-flatness requirement), based on review of public comments, further testing and analysis, and discussions with the ASTM task group on bassinets.
The 2010 NPR proposed to prohibit bassinets with restraints that require action on the part of the caregiver to secure the restraint. A commenter requested that bassinets be allowed to have restraints and provided several reasons why they should be allowed. The primary reason that the Commission believes restraints should not be allowed in bassinets is that most bassinet uses do not require a restraint, so consumers have a strong motivation to avoid using restraints, if they are provided. When unused, restraints have been known to entrap and strangle children in similar products, like swings, handheld infant carriers, and bouncers. While none of the bassinet incidents was associated with restraint harness strangulation, this is probably due to the fact that restraints are rare on bassinets and not because they would not pose a hazard if they were present.
The 2012 version of F2194 contains a stronger requirement than that proposed in the April 2010 NPR that prohibits
The 2010 NPR proposed a stronger warning label to address suffocation hazards. The current ASTM standard for bassinets, F2194-12, includes an enhancement of the soft bedding warnings by: (1) Increasing the font size for the suffocation warning label to 0.4 inches or higher; and (2) adding emphasis by stating that “Infants have suffocated * * *,” rather than stating “Infants can suffocate * * *.”
The Commission's 2010 NPR proposed a maximum rock/swing angle of 20 degrees and a maximum rest angle of 5 degrees for rocking cradles. Several commenters recommended a maximum rock/swing angle of 20 degrees and a maximum rest angle of 7 degrees for rocking cradles. The 5-degree angle was based on the Australian standard for rocking cradles. In the Australian standard, the angle is measured with the CAMI infant dummy placed in the center of the cradle. The intent is to ensure that the rocking cradle returns to a level position and provides a flat sleeping surface for the infant. In ASTM F2194-12, the angle is measured with the CAMI dummy placed to one side of the cradle. The Commission believes that the placement of the CAMI to one side results in a more stringent requirement than the Australian standard. For this reason, a 7-degree rest angle is a reasonable and achievable requirement for bassinets that will address suffocation hazards associated with an angled sleep surface. Therefore, the Commission is not making any recommendations with respect to this issue.
The performance requirements for fabric-sided products included in F2194-12 to address entrapment incidents are the same as in the 2010 NPR, except for editorial changes made to clarify the requirement and test procedure.
The stability requirements are intended to ensure that the product does not tip over when pulled on by a 2-year-old male. The 2010 NPR clarified that the stability requirement applies to all manufacturer-recommended use positions, including the position where the locks are engaged to prevent rocking/swinging motion. ASTM incorporated this change in ASTM F2194-11; therefore, it is included in the latest version, ASTM F2194-12.
In response to the 2010 NPR, one commenter noted that because “bassinets provide an important tool for parents to monitor premature babies,” a target age range for infant occupants may be necessary to enhance the understanding of the developmental milestones used in the warnings. They also suggested that if there is “a size at which a bassinet becomes unsafe for a baby,” then that factor should be listed in the product's instructions and warnings.
The 2012 version of the ASTM standard includes a reference to the maximum recommended weight in the FALL HAZARD warning label. The Commission supports this addition to the standard.
The static load test is intended to ensure structural integrity even when a child three times the recommended (or 95th percentile) weight uses it. This has been modified following publication of the April 2010 NPR to also test play yard bassinet accessories at all four corners to ensure structural integrity of the product.
This requirement, which is intended to prevent falls, was added to F2194-12 in response to comments to the 2010 NPR. The side height requirement in F2914-12 requires that the bassinet/cradle side height be at least 7
The Commission's 2010 NPR proposed to include infant hammocks in the scope of the standard. The voluntary standard for bassinets and cradles does not state explicitly whether infant hammocks are included within the scope of the standard. However, the Juvenile Products Manufacturers Association (JPMA) historically has certified some infant hammocks to the bassinet standard because there was not a separate standard for infant hammocks and other inclined sleep products. Including infant hammocks in the scope would effectively ban most infant hammocks currently on the market because, by their nature, they would be unable to meet the performance criteria in the bassinet standard addressing rest angle, segmented mattress flatness angle, and rock/swing angle.
Several comments were received regarding the inclusion of infant hammocks and other inclined sleeping products in the scope of the 2010 NPR. The comments were universally against such inclusion, asserting that this would effectively ban a product that has utility. The comments also opined that banning them might increase hazardous sleeping arrangements, causing consumers to resort to a substitute product such as a car seat or makeshift soft bedding to prop up an infant. The Commission agrees that alternative products or makeshift products would present additional hazards if consumers chose to use them instead of cribs, bassinets, or other common juvenile products intended for sleep.
An inclined sleeper differs from a bassinet in that it is intended to have an inclined sleep surface and it conforms to the contour of the occupant. Most hammocks have mattresses that are also inclined in a manner that elevates the head, as well as conforming to the body contours of the infant. They are also intended to allow swinging or bouncing motions. These special features, especially elevating the head, are sometimes intended to help prevent reflux. Features that allow head elevation, swinging, and bouncing motions distinguish these products from common bassinets and cradles, which generally have flat mattresses with solid or fabric-covered framed sides. The Commission believes that a separate standard targeted specifically to these products will more effectively address any hazards associated with them. Due to the significant progress in the development of a separate voluntary standard to address hammocks and inclined sleeping products, the Commission is not including them within the scope of this proposed rule.
In the 2010 NPR, a mattress flatness performance test for all types of bassinets and cradles was included. The performance requirement specified a mattress flatness angle of 5 degrees to address suffocation incidents on mattresses. The mattress flatness performance requirement that the Commission is proposing in this document only applies to segmented mattresses because the CPSC's review of the data showed that only segmented mattresses used in play yards were involved in incidents. In addition, the Commission determined that an angle of 10 degrees or less would still provide protection; allow for testing variances; and also address design and manufacturability concerns with segmented mattress pads. The Commission's new proposal has additional requirements for two-occupant bassinets. The test method now uses a rigid cylinder to simulate the infant, rather than a soft/deformable CAMI dummy. This change provides more consistent test results. The mattress flatness test is discussed in more detail in Section F.
The Commission believes that ASTM F2194-12 addresses many of the general hazards associated with durable nursery products, such as lead in paints, sharp edges/sharp points, small parts, wood part splinters, scissoring/shearing/pinching, openings/entrapments, warning labels, and toys. The standard also includes specific requirements for tip stability, unintentional folding of the product, and static load.
From the incident data and hazard patterns associated with bassinets and cradles (as discussed in Section C), the Commission identified six addressable hazards: (1) Suffocation due to the addition of soft bedding; (2) suffocation/positional asphyxia due to excess mattress pad angle; (3) entrapments in fabric-sided openings; (4) suffocation due to excess rock/swing angles; (5) misassembly of removable bassinet beds; and (6) falls and climb-outs. Following is an analysis of the adequacy of ASTM F2194-12 in addressing these hazards.
1. Suffocation Due to the Addition of Soft Bedding. The majority of the deaths associated with bassinets and cradles were asphyxiations due to the presence of soft or extra bedding in the bassinet, prone placement of the infant, and/or the infant getting wedged between the side of the bassinet and an added mattress or pillow.
As mentioned in Section E of this preamble, since publication of the 2010 NPR, ASTM F2194 has been revised to strengthen the suffocation warning. Specifically, ASTM F2194-12, includes an enhancement of the soft bedding warnings by: (1) Increasing the font size for the suffocation warning label to 0.4 inches or higher; and (2) adding emphasis by stating: “Infants have suffocated * * *,” rather than indicating: “Infants can suffocate * * *.”
The Commission supports the strengthening of the suffocation warning label as included in the latest revision of the ASTM voluntary standard and does not believe that there are additional requirements that can be put in place in the standard to address unsafe sleep environments and unsafe sleep practices. The Commission will continue information and education efforts, such as the Safe Sleep campaign, to address suffocation and other serious sleep hazards.
2. Suffocation/Positional Asphyxia Due to Excess Mattress Pad Angle. Bassinets that are commonly sold as accessories to play yards use the floor of the play yard (a segmented mattress pad) as the floor of the bassinet. Seams between segments of folding play yard bassinet accessory mattress pads have been known to create a valley shape in a bassinet sleeping surface in the crease between adjoining segments of the mattress.
An inclined sleeping surface (on a product not intended to provide a contour or other means to contain the child) can contribute to an infant rolling, increasing the likelihood that they will be found face down and become trapped in a significant V-shaped crease. When lying prone in a valley (or V-shaped crease), infants may have more difficulty keeping their airways unobstructed than they would on a flat surface because their faces are trapped in the juncture between adjacent surfaces. Their heads cannot rotate to the side as much as when the sleeping surface is flat. Immature head control and weak neck muscles may not allow them to free their airways. Thus, infant sleeping surfaces need to be as firm, flat, and level as possible because soft, uneven and non-level surfaces may create a higher risk of suffocation than a level surface.
The Commission has identified incidents associated with a sleeping surface (segmented mattress) that is not level or flat. The data include fatal and nonfatal incidents involving play yard attachment bassinets with insufficient mattress support.
In one in-depth investigation (IDI), the product was apparently assembled without two key structural support bars beneath the mattress pad of a bassinet accessory that was intended by the manufacturer to be mounted from the top rails of the play yard. The incident summary states:
In another IDI, the victim was in a bassinet accessory to a play yard that was also misassembled. The incident summary states:
A third fatality involved a victim with serious physical challenges who was placed face down to sleep (both of these are additional risk factors) and was found in a sagging bassinet accessory to a play yard. The incident report states:
In the fourth incident involving a fatality, a baby died in the corner of a tilted bassinet accessory on a play yard. A rod intended to be placed in a pocket at the end of the accessory was left out. When a clip on the corner of the bassinet came off for unknown reasons, the sleeping surface tilted downward, allowing the infant's head to become entrapped. While the incident was included in data used for the final rule briefing package for play yards, it is included here because the manner of death is related to a non-level, segmented mattress.
In addition to the fatal incidents, a nonfatal incident was found to be associated with the same hazard. In this incident, a child in a bassinet accessory of a play yard was observed rolling into seams on the sleep surface, but the child was not injured. The incident report states:
There is no requirement for mattress flatness in ASTM 2194. The 2010 NPR proposed a mattress flatness requirement that specified a 5-degree maximum tilt angle for segmented sleeping surfaces, like those found in play yard bassinet accessories. The ASTM subcommittee for bassinets believed that the 5-degree maximum angle was not achievable within the tolerances necessary to manufacture play yard bassinet accessories; accordingly, they considered alternative test methods and requirements for sleeping surface flatness in products with segmented mattresses.
In lieu of the 5 degrees proposed in the 2010 NPR for segmented mattresses, the ASTM subcommittee sent out to ballot a requirement that allowed up to 14 degrees on either side of a valley formed at a seam, with higher inclines possible if the sum of the two angles on either side of the valley did not exceed 28 degrees in total. The 14-degree angle was based on an extrapolation of angles formed by dimensions of
The Commission is uncomfortable using the
In August 2012, ASTM reballoted the mattress flatness test. Several modifications were made to the test procedure, and CPSC staff was involved throughout the development of this requirement. The actual test procedure that was reballotted by ASTM is identical to the Commission's recommendation. However, the test requirement (the pass/fail criteria) is different. In the test procedure, a measurement is taken on each side of each seam of the mattress (for a total of 6 or 8 measurements per bassinet). As mentioned, the Commission is proposing a test requirement of 10 degrees maximum for each measurement taken. Under the ASTM ballot, 10 degrees or less for all measurements would pass, more than 14 degrees for one or more measurements would fail, and any angle measurements between 10 and 14 degrees would require a two-step process where the test lab would take two additional measurements, average them, and then use 10 degrees as the final pass/fail delineator.
With regard to the test method itself, the 2010 NPR's method for testing flatness used a CAMI dummy to weight the surface prior to measuring the side angles of the valley formed in the sleeping surface. However, the CPSC and the ASTM subcommittee prefer a rigid cylinder to help increase the reliability of the test across test laboratories. This is because CAMI dummies tend to vary slightly with age because of the nature of their construction. CPSC staff tested a variety of cylinder diameters and lengths and found that small differences in the footprint of the test cylinder were not critical to differentiating hazardous from nonhazardous products. The most critical factor was the design of the mattress support structure. An exact replica of the human form is not necessary for this type of screening, and the benefits of using standardized, readily available test methods are appreciated by industry. As previously mentioned, the test procedure that the Commission is proposing is identical to what ASTM recently balloted.
3. Entrapments in fabric-sided openings. Three deaths associated with bassinets and cradles were due to entrapment and/or hanging that resulted after an infant's body, but not head, slipped through the fabric covering and underlying structural components of a particular brand of convertible bassinets/bedside sleepers of a particular brand of convertible bassinets/bedside sleepers. These incidents occurred in one manufacturer's bassinet that was recalled on August 28, 2008.
As discussed in Section E, since publication of the 2010 NPR, ASTM has revised the bassinet standard to include a fabric-sided enclosed openings test. The test, as added to the 2012 version of the standard, is very close to what was included in the 2010 NPR. Thus, the Commission is not recommending any further changes relating to this hazard.
4. Suffocation due to excess rock/swing angles. Bassinets and cradles with locking or tilting issues that caused the infant to roll/press up against the side/corner of the product pose a suffocation hazard. There have been several nonfatal incidents and one fatality associated with a rocking bassinet. In the fatal incident, a 1-month-old was found pressed up against the fabric side of a bassinet. It is not known whether the lock, which was designed to prevent rocking, was engaged properly, or wasn't functioning correctly.
As discussed in Section E, since publication of the Commission's 2010 NPR, ASTM has included a rock/swing angle requirement in its standard. The requirement specifies a maximum of 20 degrees for the swing angle and 7 degrees for the rest angle. The Commission believes that this requirement adequately addresses the hazard. Thus, the Commission is not proposing any further changes to the standard relating to this hazard.
5. False latching/stability of removable bassinet beds. The Commission is aware of several incidents involving bassinets beds that were designed to be removed from their stand, four of which have IDIs. During the incidents, the bed portion of the unit was not completely locked or properly attached to its stand. The bed portion of the unit appeared to be stable, giving the caregivers a false sense of security. For various reasons, the bed portion fell or tilted off of its stand. In one case, a 3-month-old infant was killed. The Commission was also informed by Health Canada of a second death. In email correspondence from Health Canada staff, the following was reported:
There have also been nonfatal incidents involving bassinet beds that tipped over or fell off their base/stand when they were not properly locked/latched to their base/stand, or the latch failed to engage as intended. In May 2012, there was a recall of 46,000 bassinets that could appear to latch to the stand when they actually had not latched. (
The reason that removable bassinet designs need inherent stability (or obvious instability) is consumers will sometimes avoid activating lock or latch mechanisms if it appears that the bassinet bed is stable when placed on its stand/base. Consumers may do this because the locks or latches seem redundant or because they are worried about making noise when activating locks or latches around a sleeping infant. Locks and latches also accidentally may give feedback that they are locked when they are not. This constitutes a “false latching” situation. Because of these foreseeable use patterns, this requirement will make bassinets with a removable bed portion inherently stable or have visible indicators to show when the bassinet bed is not properly attached to the stand.
Commission staff has been actively involved in an ASTM task group that is currently developing requirements to address the hazards associated with bassinets with removable bed portions. To date, the language that the task group drafted has yet to be balloted. The Commission proposes adding a new requirement for the NPR, based on what the ASTM task group has developed to date. The proposed requirement allows multiple options to pass. These options will either ensure that the bed portion of the unit is inherently stable when it is placed on the stand unlatched, or it will give obvious feedback that the unit is not latched or stable. One option allows the unit to give an extreme appearance of instability by being tilted 20 degrees or more. The 20-degree
In addition to the aforementioned options, a bassinet that has a removable bed would also pass the requirement if it has a visual indicator to alert a caregiver that the bassinet bed is not properly locked onto the stand. Or, the bassinet would also pass the requirement if it can pass the standard's stability test while in an unlocked position.
6. Falls and Climb-Outs. The majority of the nonfatal injuries (30 out of 52, or 58 percent) were identified as falls from the bassinets. Because 28 of the 30 falls were reported through the emergency department-treated injury surveillance system, little or no information is available on how the falls occurred. However, the reports do indicate that 76 percent of the injured infants who fell out of bassinets were older than the ASTM-recommended maximum age limit of 5 months, with four infants as old as 9 months of age. All of the falls resulted in head and facial injuries.
The Commission believes the new side height requirement in ASTM F2194-12, which requires a bassinet side to be at least 7.5 inches above the mattress surface, as well as the proposed removable bassinet requirements, will help address fall hazards.
In addition to the requirements for mattress flatness and removable bassinet bed attachments, the Commission is proposing changes to the scope of the standard and a revised test method for stability.
In order to clarify which products are covered under the scope of the proposed standard and to ensure more complete coverage of sleep products, the Commission is proposing the following with respect to the scope of the ASTM standard. The scope would encompass products with an incline of 10 degrees or less, but not products with a greater than 10-degree angle. This would include cradle swings within the scope, which, by definition, recline less than 10 degrees. The Commission proposes including products that can be supported by a stationary frame/standard, such as carriage attachments to strollers and Moses baskets, only when they are used with a stationary or rocking stand. (A Moses basket is a portable cradle, typically made from wicker or cloth, with no legs or a stand.) Finally, the Commission proposes to specify that the standard covers products
During evaluations of the test methods for removable bassinet beds, Commission staff made comparisons of the stability of products weighted with the newborn CAMI dummy (7.45 lbs) as opposed to the infant CAMI dummy (17.4 lbs). ASTM F2194-12 contains a stability requirement that uses the heavier infant CAMI dummy. There is no rationale included in the ASTM standard for why the heavier dummy was specified in the stability requirement. Use of the newborn CAMI, which is readily available to test labs and represents the 50th percentile newborn, would result in a more conservative stability test. In addition, bassinets are intended for use with newborns. For these reasons, the Commission is proposing a revised test procedure for bassinet stability, which uses a newborn CAMI instead of an infant CAMI.
The Commission reviewed Canadian, European, and Australian standards for bassinets and/or cradles. Many of the requirements found in the 2012 ASTM standard can also be found in some of these international standards.
The European Standard, EN 1130-1: 1996, “Furniture—Cribs and Cradles for Domestic Use,” has several requirements not found in ASTM F2194-12. Most of these additional requirements address hazards associated with cribs intended for use with older children (in excess of the 5-month recommended maximum age for bassinets). Thus, they are not applicable to bassinets.
The scope of the European Standard, EN 12790-2009, “Child Use and Care Articles—Reclined Cradles,” includes inclined bassinets/cradles, car seat carriers, hammocks, and bouncers. Some of the general requirements could apply, but because the scope of the product is not the same, most of the requirements are not applicable to bassinets.
The Australian/New Zealand standard (AS/NZS 4385:1996) contains requirements for rocking and swinging angles that were used to develop some of the requirements in ASTM F2194. The ASTM rock/swing rest angle performance requirement, while based on AS/NZS 4385:1996, contains a more severe test method than that in AS/NZS 4385:1996, due to the placement of the CAMI dummy. This is discussed more fully in Section E.
The Canadian standard (SOR 86-962: 2010) includes requirements for cribs and non-full-size cribs. This standard does not distinguish between a bassinet and non-full-size cribs. As a result, many of the requirements are not applicable for this NPR. However, the Canadian standard was used to develop the ASTM requirement for bassinet side height.
The Commission believes that the current ASTM F2194-12 standard is the most comprehensive of the standards to address the incident hazards. There are some individual requirements in various foreign standards that are more stringent than ASTM; however, many of these requirements do not address the identified hazards in the incident data reported to the CPSC.
The proposed rule would create a new part 1218 titled, “Safety Standard for Bassinets and Cradles.” The proposal would establish ASTM F2194-12, “Standard Consumer Safety Specification for Bassinets and Cradles,” as a consumer product safety standard, but with certain changes. These proposed changes include a revision to an existing test method (the bassinet stability test method), two additional new requirements and associated test methods (for mattress flatness and removable bassinet bed attachments), and a revised scope and associated definitions or references to support these additions. They are detailed herein.
The Commission is proposing to revise the scope of ASTM F2194-12 and corresponding terminology to better define which products fall within or outside the scope of the standard. The current text of ASTM F2194-12 provides that the “consumer safety performance specification covers products intended to provide sleeping accommodations only for an infant up to approximately 5 months in age, or when the child begins to push up on hands and knees, whichever comes first.” The Commission is proposing to change the scope and definition of a “bassinet/cradle”—from products meant exclusively for sleeping—to those intended
The Commission is also proposing to amend the definitions of “bassinet/cradle” and “bassinet/cradle accessories” to specify that the sleeping surface of these products, while in a rest (non-rocking or swinging) position, is intended to be less than or equal to 10 degrees from horizontal. This change would complement the definition of “inclined sleeper” in the draft ASTM inclined sleeper standard, which defines the “inclined sleeper” as having more than a 10-degree sleep surface incline. Thus, the following are covered under the standard: Cradle swings with inclines less than or equal to 10 degrees from horizontal while in rest position; carriage baskets/bassinets that are removable from the stroller base, when the carriage basket/bassinet meets the definition of “bassinet/cradle” found in the standard; bassinet/cradle attachments to cribs or play yards, when in bassinet/cradle-use mode. The following would not fall under the scope of the bassinet/cradle standard: Products used in conjunction with an inclined infant swing or stroller and products that are intended to provide an inclined sleep surface (defined as greater than 10 degrees from horizontal while in the rest (non-rocking) position).
In order to address the hazard of suffocation/positional asphyxia due to an excess mattress pad angle, the Commission is recommending performance requirements and a test method for the minimum flatness of segmented mattress surfaces. This requirement applies only to segmented mattresses, such as those seen in a bassinet accessory to a play yard. The Commission recommends that the segmented mattresses commonly used in play yards shall not create an angle greater than 10 degrees when tested using a 17-pound cylinder to simulate the weight of a 6-month-old infant.
In order to address hazards associated with misassembly of removable bassinet bed and falls, the Commission is recommending performance requirements and a test method for products that have bassinet beds that attach to an elevated stand. The requirements apply to removable bassinet beds that are designed to separate from the stand/base without the use of tools. The Commission is proposing that if a removable bassinet bed is not properly attached or assembled to its base, it must meet one of the following requirements:
• The base/stand shall not support the bassinet (
• The lock/latch shall automatically engage under the weight of the bassinet bed (without any other force or action); or
• The stand/base shall not be capable of supporting the bassinet bed within 20 degrees of horizontal; or
• The bassinet shall contain a visual indicator mechanism that shall be visible on both sides of the product; or
• The bassinet bed shall not tip over and shall retain the CAMI newborn dummy when subjected to the stability test outlined in the standard.
For the reasons described in the previous Section, the Commission is proposing a revised test procedure for bassinet stability that uses a newborn CAMI instead of an infant CAMI.
The Administrative Procedure Act (APA) generally requires that the effective date of the rule be at least 30 days after publication of the final rule. 5 U.S.C. 553(d). To allow time for bassinets and cradles to come into compliance, the Commission proposes that the standard would become effective 6 months after publication of a final rule in the
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires agencies to consider the impact of proposed rules on small entities, including small businesses. Section 603 of the RFA requires that the Commission prepare an initial regulatory flexibility analysis and make it available to the public for comment when the notice of proposed rulemaking is published. The initial regulatory flexibility analysis (IRFA) must describe the impact of the proposed rule on small entities and identify any alternatives that may reduce the impact. Specifically, the IRFA must contain:
• A description of, and where feasible, an estimate of the number of small entities to which the proposed rule will apply;
• A description of the reasons why action by the agency is being considered;
• A succinct statement of the objectives of, and legal basis for, the proposed rule;
• A description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities subject to the requirements, and the type of professional skills necessary for the preparation of reports or records; and
• An identification, to the extent possible, of all relevant federal rules that may duplicate, overlap, or conflict with the proposed rule.
In addition, the IRFA must contain a description of any significant alternatives to the proposed rule that would accomplish the stated objectives of the proposed rule and, at the same time, reduce the economic impact on small businesses.
Bassinets and cradles are typically produced and/or marketed by juvenile product manufacturers and distributors, or by furniture manufacturers and distributors, some of which have separate divisions for juvenile products. The Commission believes that there are currently at least 55 suppliers of bassinets and/or cradles to the U.S. market; 24 are domestic manufacturers, and 11 are domestic importers. An additional 14 domestic firms have unknown bassinet/cradle supply
Bassinets and cradles from 12 of the 55 firms have b