Safety Standard for Bassinets and Cradles, 64055-64076 [2012-24896]

Download as PDF Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules WA. For information on the availability of this material at the FAA, call 425–227–1221. Issued in Renton, Washington, on October 5, 2012. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 2012–25673 Filed 10–17–12; 8:45 am] BILLING CODE 4910–13–P CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1112 and 1218 [CPSC Docket No. CPSC–2010–0028] RIN 3041–AC81 Safety Standard for Bassinets and Cradles Consumer Product Safety Commission. ACTION: Supplemental notice of proposed rulemaking. AGENCY: The Consumer Product Safety Improvement Act of 2008 (CPSIA requires the United States Consumer Product Safety Commission (Commission or CPSC) to promulgate consumer product safety standards for durable infant or 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 Commission is proposing a safety standard for bassinets and cradles in response to the CPSIA. This constitutes a second round of notice and comment, or supplemental notice of proposed rulemaking, for bassinets and cradles. DATES: Submit comments by January 2, 2013. ADDRESSES: Comments related to the Paperwork Reduction Act aspects of the marking, labeling, and instructional literature of the proposed rule should be directed to the Office of Information and Regulatory Affairs, OMB, Attn: CPSC Desk Officer, FAX: 202–395–6974, or emailed to oira_submission@omb.eop.gov. Other comments, identified by Docket No. CPSC–2010–0028, may be submitted electronically or in writing: Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: https:// www.regulations.gov. Follow the instructions for submitting comments. To ensure timely processing of mstockstill on DSK4VPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 comments, the Commission is no longer directly accepting comments submitted by electronic mail (email), except through www.regulations.gov. The Commission encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above. Written Submissions: Submit written submissions in the following way: Mail/ Hand delivery/Courier (for paper, disk, or CD–ROM submissions), preferably in five copies, to: Office of the Secretary, Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504–7923. Instructions: All submissions received must include the agency name and docket number for this rulemaking. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to https://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If furnished at all, such information should be submitted in writing. Docket: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov, and insert the docket number, CPSC 2010–0028, into the ‘‘Search’’ box and follow the prompts. FOR FURTHER INFORMATION CONTACT: Patricia Edwards, Project Manager, Directorate for EngineeringSciences, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone 301–987–2244; email pedwards@cpsc.gov. SUPPLEMENTARY INFORMATION: A. Background and Statutory Authority 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 PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 64055 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: https://www.astm.org/ cpsc.htm, by permission of ASTM. B. The Product 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 E:\FR\FM\18OCP1.SGM 18OCP1 64056 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules the product into a bassinet/cradle intended to have a horizontal sleep surface while in a rest (non-rocking) position.’’ The Commission is proposing modifications to the scope and definition of a bassinet/cradle and bassinet/cradle accessory, as further discussed herein. mstockstill on DSK4VPTVN1PROD with PROPOSALS C. The Voluntary Standard—ASTM F2194 The voluntary standard for bassinets and cradles was first approved and published by ASTM in 2002, as ASTM 2194, Standard Consumer Safety Specification for Bassinets and Cradles. The standard has been revised a number of times since then. The Commission’s April 2010 NPR assessed the effectiveness of ASTM F2194–07aε1. Since publication of the 2010 NPR, the standard has been revised three times: In 2010, 2011, and, most recently, in 2012. The 2012 version, ASTM F2914– 12, was approved on June 1, 2012. The 2012 voluntary standard contains requirements addressing a number of hazards. The requirements include: 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. VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 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. D. Incident Data 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.’’). 1. Fatalities 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 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 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. 2. Nonfatal Injuries 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 bassinetrelated 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 E:\FR\FM\18OCP1.SGM 18OCP1 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules descriptions indicated the potential for a serious injury or even death. mstockstill on DSK4VPTVN1PROD with PROPOSALS 3. Hazard Analysis 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. (1) Product-related issues: The hazard scenarios in 209 of the 335 incidents (62 percent) reported were attributed to some sort of failure/defect or a potential design flaw in the product itself. This category includes five fatalities and 46 injuries, five of which involved hospitalization. Listed below are the reported problems, beginning with the most frequently reported concerns: • Lack of structural integrity, which includes issues such as instability, loose hardware, collapse of the product, and loose wheels. This issue was reported in 64 (about 19 percent) of the incidents. One death is associated with this issue. • Reports of infants falling or climbing out of bassinets/cradles. This category accounted for most of the bassinet-related injury reports that were received from emergency departments around the United States. While little product-/scenario-specific information was available in these reports, a majority indicated that the victims were over the ASTM-recommended upper age limit of 5 months. This issue was reported in 32 (about 10 percent) of the incidents. • Problems with mattress flatness in bassinet attachments to play yards. Examples include mattresses that would not remain level horizontally because of poorly designed metal rods/other structures that are meant to be positioned underneath the mattress; lack of rigid mattress support; and failure of straps/hooks/bars designed to hold the bassinet attachment inside the play yard. This issue was reported in 31 (about 9 percent) of the incidents and was associated with three deaths. • Problems with rocking bassinets and cradles, with locking or tilting issues that caused the infant to roll/ press up against the side/corner of the product and posed a suffocation hazard. This issue was reported in 23 (about 7 percent) of the incidents, including one death. • Problems with packaging of the product that resulted in broken/ damaged products during delivery. This issue was reported in 19 (about 6 percent) of the incidents. VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 • Problems with bassinet mobiles, where components overheated, smoked, or sparked. This issue was reported in 13 (about 4 percent) of the incidents. • Miscellaneous other product-related problems, ranging from a tear in the bassinet fabric, to odors, to product assembly/quality issues. Twenty-seven (about 8 percent) of the incidents reported these issues. (2) Non-product-related issues: Eighty-three of the 335 reports (25 percent) were about incidents that involved no product defect or failure. This category consisted of 82 fatalities, most of which were associated with the use of soft/extra bedding or prone positioning. There was also one nonfatal injury incident that did not involve any product-related issues. (3) Recalled product-related issues: There were 26 reports (8 percent) that involved recalled products. Some of the reports were received by CPSC staff prior to the recalls being published. There were three fatalities and two injuries due to entrapment and/or hanging of an infant between structural components of the bassinet. Most of the remaining reports were complaints or inquiries from consumers regarding a recalled product. (4) Miscellaneous other issues: The remaining 17 (5 percent) incident reports were related to miscellaneous other or unspecified issues. Some of these reported concerns from consumers about perceived safety hazards; others described incidents with insufficient specificity for CPSC staff to identify the hazard scenario. There were four fatalities (unknown circumstances) and three injuries, including a hospitalized injury, reported in this category. In summary, there are five productrelated issues associated with incident deaths and/or significant injuries: • Structural integrity/instability, • Mattress flatness, • Rocking, • Falling or climbing out, and • Entrapment in fabric sided products (recalled product-related). In addition, there are multiple deaths associated with the use of soft/extra bedding or prone positioning of the child that are considered non-product related. 4. Recalls 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 PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 64057 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 E:\FR\FM\18OCP1.SGM 18OCP1 64058 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules reports of infants rolling to one side, including six that had their faces pressed against the side or the bottom of the bassinet. One child reportedly was turning purple and was out of breath when discovered. No other injuries were reported. (The rock/swing angle test, proposed in the 2010 NPR and added to the ASTM standard in its 2012 iteration, would address this hazard.) The fifth recall, conducted in September 2008, involved 3-in-1 and 4in-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 61⁄2month-old girl died when she became entrapped and strangled between the bassinet’s metal bars. This is the second strangulation death that the CPSC learned of involving the co-sleeper bassinets. On September 29, 2007, a 4month-old girl became entrapped in the metal bars of the bassinet and died. (The fabric-sided openings test, proposed in the 2010 NPR and added to the ASTM standard in its 2012 iteration, would address this hazard.) mstockstill on DSK4VPTVN1PROD with PROPOSALS E. April 2010 NPR and Subsequent Changes to the ASTM Voluntary Standard In April 2010, the Commission approved a proposed rule on bassinets/ cradles that referenced the requirements specified in ASTM F2194–07aε1 as a mandatory standard for bassinets and cradles, with several modifications to further reduce injuries and deaths. The modifications and edits included the following: • 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. The April 2010 NPR also proposed to include hammocks within in the scope of the standard. VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 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. 1. Proposed Changes in April 2010 NPR Incorporated Into ASME F2194–12 Restraints 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 all restraints in bassinets. The Commission supports this change to the standard, and notes that it is more conservative than the restraints requirement proposed in the 2010 NPR. The Prominence of Warnings About Soft Bedding 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 * * *.’’ Maximum Rock/Swing and Rest Angles 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 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 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. Fabric-Sided Enclosed Openings Test 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. Stability The stability requirements are intended to ensure that the product does not tip over when pulled on by a 2-yearold 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. 2. Changes to ASTM F2194 That Arose Out of a Response to Comments Received on the April 2010 NPR Baby Size Limits 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. E:\FR\FM\18OCP1.SGM 18OCP1 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules 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. Static Load 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. Side Height Requirement 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 71⁄2; inches from the top of the uncompressed mattress surface. 3. Revisions to Proposed Changes in 2010 NPR mstockstill on DSK4VPTVN1PROD with PROPOSALS Hammocks 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 VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 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. Mattress Flatness 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 twooccupant 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. F. Assessment of ASTM Voluntary Standard and International Standards The Commission believes that ASTM F2194–12 addresses many of the general hazards associated with durable nursery products, such as lead in paints, sharp PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 64059 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. E:\FR\FM\18OCP1.SGM 18OCP1 64060 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules 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 Vshaped 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: mstockstill on DSK4VPTVN1PROD with PROPOSALS A 3 month and 26 day old male victim was found deceased inside a play yard. The ME determined that the cause of the death was asphyxia. The victim was found face down in a crease produced by the mattress. He was pronounced deceased at the hospital. The Commission notes that requirements to ensure that key structural supports are properly installed by consumers would have helped prevent this incident from occurring. The Bassinet Misassembly Provision NPR, published on August 29, 2012, is a Commission-directed NPR to amend the play yard mandatory standard to include a provision to address the hazards associated with play yard bassinet accessories that can be misassembled. (77 FR 52272). However, there has never been a requirement for sleeping surfaces to be flat or even nearly flat, which is the critical feature of the product that constitutes a hazard. A play yard could be designed to position the occupant in a valley, and it would still pass the play yard standard and the misassembly provision. The Commission believes both requirements are necessary to address these hazards: (1) A missing VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 component requirement to prevent installation/use of a bassinet accessory that has a key component missing; and (2) a flatness requirement to ensure segmented mattresses, like those found in bassinet accessories, are flat when assembled according to manufacturer’s instructions. In another IDI, the victim was in a bassinet accessory to a play yard that was also misassembled. The incident summary states: A two month old male was found unresponsive in his * * * play yard with no signs of trauma. The child had rolled in the bassinet section causing his face to be placed in the corner of the bassinet. He was lying on a blanket with another blanket on top of him. Investigators who initially measured the bassinet at the scene reported that one side was five inches higher than the other. I observed during my investigation that depending on weight and movement that there will be a variance in height within the unit. Other risk factors also may have contributed to the incident (e.g., the placement of the infant to sleep in the prone position and the presence of a blanket under the infant), but the case nonetheless illustrates the potential for non-level sleeping surfaces to contribute to bassinet occupants getting into fatal positions from which they may not be able to remove themselves. 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: The mother was using the elevated playpen platform for her 5 month old male baby’s sleeping area. He was born with multiple physical complications including the inability to swallow and would drool constantly. The parents placed the infant in the playpen at night face down and awoke to find he had expired in the middle of the night. The playpen elevated platform showed sagging in the center possibly due to incorrect assembly of the playpen. 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 PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 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: No injury occurred to a five-month-old female, who while asleep in the bassinet section of a portable and collapsible play yard rolled into a seam of the removable changing pad used with the bassinet. The mother of the five-month old noticed that the five month old had a tendency to roll into seams of the mattress pad when it was used with the bassinet. 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 average infant faces. By combining an infant’s mandible width with dimensions of nasal protrusion, an isosceles triangle can be created that represents a crosssection of the volume of space beneath the nose. From this cross-section, one can extrapolate both the angle of the valley and the angle of the incline of the surface that would contact a prone infant’s face. The angle resulting from the combination of the average facial dimensions is 15 degrees, from which the ASTM subcommittee subtracted a single degree for a factor of safety. This ASTM ballot item received many negative votes and was not approved for the standard. The Commission is uncomfortable using the average infant facial dimension as the basis for this requirement. A product that has a 14degree angle in the valley formed at the seam of the mattress would leave about one-half of the potential occupant population unprotected from suffocation. While the ASTM Committee used an angle resulting from E:\FR\FM\18OCP1.SGM 18OCP1 mstockstill on DSK4VPTVN1PROD with PROPOSALS Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules the combination of average facial dimensions, the Commission generally recommends using the smallest users’ anthropometrics for justifying requirements of this nature. If the facial measurements of the smallest (5th percentile) infants are used to form the isosceles triangle, the resulting valley is 158 degrees, which yields an 11-degree angle of sleep surface incline from the horizontal on each side. If a single degree is subtracted from this incline angle for a minor factor of safety, the requirement becomes a 10-degree maximum incline from the horizontal. In the Commission’s proposed test, each seam of a folding bassinet sleeping surface is tested with a pass/fail criterion of 10 degrees maximum for either side of the valley formed by a weighted cylinder. 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 VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 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 PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 64061 various reasons, the bed portion fell or tilted off of its stand. In one case, a 3month-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: It strongly appears the bassinet was not attached to the base when the infant was put down for a nap. When the infant was found, the bassinet was perpendicular to the base and had fallen into the base opening at an angle suspending the infant. The straps and hooks attaching the bassinet to the base were not snapped in. 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. (https://www.cpsc.gov/cpscpub/ prerel/prhtml12/12173.html). 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 E:\FR\FM\18OCP1.SGM 18OCP1 mstockstill on DSK4VPTVN1PROD with PROPOSALS 64062 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules minimum is twice the allowable deviation from horizontal that staff recommends for sleeping surface flatness. This angle was extrapolated from an IDI report involving a caregiver who noticed that a bassinet was tilted. From photographs of the incident product, the ASTM task group assigned to examine the problem estimated that the unit produced about a 17-degree angle, which they felt would be reasonable to round up to 20 degrees for the standard. A sleeping surface at 20 degrees from the horizontal seems severe enough that consumers would notice that it was not level. This proposed requirement is slightly less than the angle proposed to address similar hazards in the play yard standard (i.e., 30 degrees from the horizontal), but the ASTM subcommittee reasoned that bassinets are different in structural design and materials and will appear to be misassembled more easily than the suspended and segmented mattress supports used in play yards. 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. Scope In order to clarify which products are covered under the scope of the proposed VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 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 primarily used to provide sleeping accommodations. This would expand the scope beyond products only used to provide sleeping accommodations. This would ensure, for example, that a bassinet sold with a toy mobile that is meant to entertain an infant who is lying in the bassinet would still fall within the scope of the standard. Stability Test Dummy 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. International Standards 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 PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 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. G. Description of Proposed Changes to ASTM Standard 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. E:\FR\FM\18OCP1.SGM 18OCP1 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules 1. Clarifying the Scope of the Standard and Associated Definitions (Sections 1.3, 3.1.1, and 3.1.2) mstockstill on DSK4VPTVN1PROD with PROPOSALS 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 primarily for sleeping. This would ensure that a bassinet sold with a toy mobile that is meant to entertain an infant who is lying in the bassinet, for instance, would still fall within the scope of the standard. 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). 2. Segmented Mattress Flatness Requirement and Test Method (Sections 6.9 and 7.10) 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 VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 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. 3. New Performance Requirement and Associated Definitions To Address Hazards Associated With the Stability of Removable Bassinet Beds (Sections 3.1.3, 3.1.17, 3.1.18, 3.1.19, 3.1.20, 6.10, 7.11) 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 (i.e., the bassinet bed falls from the stand so that it is in contact with the floor); or • 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. 4. Revised Test Procedure for Bassinet Stability (Sections 2.3 and 7.4.4) 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. H. Effective Date 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 PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 64063 final rule in the Federal Register. The Commission invites comment on how long it will take bassinet and cradle manufacturers to come into compliance with the rule. I. Regulatory Flexibility Act Introduction 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. The Market 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 E:\FR\FM\18OCP1.SGM 18OCP1 64064 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS sources; three of those firms are retailers and nine specialize in bedding, some of which is sold with bassinets or cradles. There are also six foreign firms supplying the U.S. market: Five manufacturers and one importer who imports from foreign companies and distributes from outside of the United States. Bassinets and cradles from 12 of the 55 firms have been certified as compliant by the JPMA, the major U.S. trade association that represents juvenile product manufacturers and importers. Firms supplying bassinets or cradles would be certified to the ASTM voluntary standard F2194–10, while firms supplying play yards with bassinet/cradle attachments would also have to meet F406–11b. Nine additional firms claim compliance with the relevant ASTM standard for at least some of their bassinets and cradles. According to a 2005 survey conducted by the American Baby Group (2006 Baby Products Tracking Study), 64 percent of new mothers own bassinets; 18 percent own cradles; and 39 percent own play yards with bassinet attachments. Approximately 50 percent of bassinets, 56 percent of cradles, and 18 percent of play yards were handed down or purchased second-hand. Thus, about 50 percent of bassinets, 44 percent of cradles, and 82 percent of play yards were acquired new. This suggests annual sales of about 1.3 million bassinets (.5 × .64 × 4.1 million births per year); 325,000 cradles (.44 × .18 × 4.1 million); and 1.3 million play yards with bassinet attachments (.82 × .39 × 4.1 million). This yields a total of approximately 3 million units sold per year that could be affected by the proposed bassinet/cradle standard. Reason for Agency Action and Legal Basis for Proposed Rule. The Danny Keysar Child Product Safety Notification Act, section 104 of the CPSIA, requires the CPSC to promulgate a mandatory standard for bassinets/cradles that is substantially the same as, or more stringent than, the voluntary standard. CPSC worked closely with ASTM to develop the new requirements and test procedures that have been added to the voluntary standard since 2010. These new requirements address several known hazard patterns that will help to reduce injuries and deaths in bassinets and cradles, and they have resulted in the current voluntary standard, F2194–12, upon which the proposed rule is based. However, the Commission proposes adding two new requirements to F2194– 12, as well as modifying the scope and the test CAMI dummy used in the VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 existing stability test. The first new requirement would address suffocation and positional asphyxia hazards that have occurred as a result of problems with segmented mattress flatness in play yard bassinet accessories. The second would address the stability of bassinets with removable bassinet beds, particularly the attachment mechanisms. The Commission also proposes modifying the scope (and some of the terminology) to ensure that inclined sleepers (including infant hammocks) would no longer be covered under the bassinet/cradle standard, unless they recline to 10 degrees or less. The expanded scope would also include Moses baskets and stroller carriage accessories when used in conjunction with a stationary stand. These modifications would also help eliminate gaps in product coverage (i.e., most products that may be used for infant sleep will be included under at least one durable nursery product standard). Finally, the Commission proposes that the CAMI newborn dummy be used for stability testing because it more closely resembles the characteristics of bassinet users than the CAMI infant dummy in F2194–12. 4. Requirements of the Proposed Rule The Commission proposes adopting the voluntary ASTM standard for bassinets and cradles (F2194–12) with a new mattress flatness requirement, a new stability requirement for bassinets with removable beds, a revised scope, and a modified CAMI dummy for the existing stability requirement. Some of the more significant requirements of the current voluntary standard for bassinets and cradles (ASTM F2194–12) are listed below. The requirements that were added to the ASTM voluntary standard or modified since the 2010 NPR are italicized. • Spacing of rigid-side components— intended to prevent child entrapment between both uniformly and nonuniformly spaced components, such as slats. This has been modified for clarity to remove duplicative test references. • Openings for mesh/fabric— intended to prevent the entrapment of children’s fingers and toes, as well as button ensnarement. • Static load test—intended to ensure structural integrity even when a child three times the recommended (or 95th percentile) weight uses it. This has been modified to also test play yard bassinets in all four corners. • Stability requirements—intended to ensure that the product does not tip over when pulled on by a 2-year-old male. ASTM adopted the revised test requirements included in the 2010 NPR PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 (includes testing with locks/latches engaged). • Sleeping pad thickness and dimensions—intended to minimize gaps and the possibility of suffocation due to excessive padding. F2194–12 allows thicker mattresses for rigid-sided products because a thicker mattress does not pose the same suffocation hazard when used in rigid-sided, rather than soft-sided, products. • Tests of locking and latching mechanisms—these are intended to prevent unintentional folding while in use. • Suffocation warning label— intended to help prevent soft bedding incidents. F2194–12 requires the warning to use a larger font than the 2010 NPR. • Fabric-sided openings test— intended to prevent entrapments. This test was included in the 2010 NPR and has been adopted in F2194–12 with a few editorial changes. • Rock/swing angle requirement— intended to address suffocation hazards that can occur when latch/lock problems and excessive rocking or swinging angles press children into the side of the bassinet/cradle. The 2010 NPR recommended a maximum rocking angle of 20 degrees and a maximum rest angle of 5 degrees. ASTM F2194–12 adopts the maximum deflection angle of 20 degrees, but includes a maximum rest angle of 7 degrees with a more severe test condition where the CAMI doll is positioned at the side, rather than the center, of the bassinet/cradle. • Occupant restraints—intended to prevent incidents where unused restraints have entrapped and strangled children. The 2010 NPR proposed that only passive restraints be allowed. ASTM F2194–12 is even stricter, allowing no restraints to be used in a bassinet/cradle configuration. • Side height requirement—intended to prevent falls. This requirement, which is new to F2194–12, arose from the comments to the 2010 NPR. A bassinet/ cradle side height of 71⁄2 inches from the top of the uncompressed mattress is now required. The voluntary standard also includes: (1) Torque and tension tests to ensure that components cannot be removed; (2) requirements for several bassinet/cradle features to prevent entrapment and cuts (minimum and maximum opening size, small parts, hazardous sharp edges or points, and edges that can scissor, shear, or pinch); (3) requirements for the permanency and adhesion of labels; (4) requirements for instructional literature; and (5) corner post extension requirements intended to prevent E:\FR\FM\18OCP1.SGM 18OCP1 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS pacifier cords, ribbons, necklaces, or clothing that a child may be wearing from catching on a projection. The Commission proposes modifying the scope, using the more appropriate infant CAMI dummy for stability testing, and adding new mattress flatness and attachment of removable bassinet bed requirements to ASTM F2194–12. As part of these changes, there would also be several new or revised definitions, including ‘‘bassinet/ cradle,’’ ‘‘bassinet/cradle accessory,’’ and ‘‘bassinet bed.’’ Following is a discussion of the impact of each of these changes. a. Scope There are three major proposed changes to the scope of the bassinet/ cradle standard: 1. Specification that it is to cover products primarily used to provide sleeping accommodations. This expands the scope beyond products only used to provide sleeping accommodations. 2. Products with an incline of 10 degrees or less would be included, while products with a greater than 10 degree incline would not. ASTM and CPSC have developed this demarcation across product standards to help ensure complete coverage of sleep products. This would include cradle swings which, by definition, recline less than 10 degrees from horizontal. 3. Specification that it includes products that can be supported by a stationary frame/stand. This would bring in carriage attachments to strollers and Moses baskets only when used with a stationary or rocking stand. These scope changes may affect suppliers in several ways. First, they would provide additional clarity to suppliers regarding which products would be covered under what standards. Reduced confusion means less time reviewing, testing, and making necessary modifications. Second, ‘‘cradle swings,’’ defined by the infant swings standard, F2088–11a, as an infant swing intended for use by a child lying flat (i.e., horizontal), would be covered under both the bassinet standard and the infant swings standard. The Commission believes that cradle swings currently on the market should be able to meet the proposed standard for bassinets without additional modifications. Third, Moses baskets and carriage attachments to strollers would now be subject to the bassinet/cradle standard when used in conjunction with a separate stand. However, this would apply only to Moses baskets and carriages that are produced and sold by the same company that makes the stand, and VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 64065 therefore, are intended to be used together. Firms that supply bassinet/ cradle stands, as well as either Moses baskets or carriage attachments for strollers, would need to ensure that their Moses baskets and/or carriage attachments meet the bassinet/cradle standard when attached to the stand(s). This would likely require some redesign, most notably to meet the side height and stability requirements, and it would affect 10 known firms. Alternatively, they could stop supplying the stands. example, by retrofitting their play yard bassinets to use longer rods or a betterfitting mattress shell. The cost of such a retrofit is unknown and would likely vary from product to product; however, it should be less expensive than a product redesign. Based on this information, it appears that at least a few play yard bassinets may require modifications, which could include product redesign. However, it is believed that most firms would opt for the less expensive option of retrofitting their existing designs. b. Stability Testing With Newborn CAMI Dummy Because bassinets and cradles are intended to be used by very young children, it is appropriate that the smaller newborn CAMI dummy be used for stability testing. The heavier (17.5 pound) infant CAMI currently used for stability testing in F2194–12 could make these products more stable when tested than they actually would be in a realworld situation. Based on preliminary Commission testing, it appears that most bassinet/cradles will be able to pass this revised test procedure without modification. However, at least one product failed stability testing with the newborn CAMI and passed with the infant CAMI. It is possible that a few products may require modifications to meet the revised stability test procedure. It is likely to affect only a few manufacturers, but it is unlikely to require product redesign. Affected firms would most likely increase the stability of their product by widening the structure, making the bassinet bed deeper, or making the base heavier. If meeting the modified requirement necessitates a change to the hard tools used to manufacture the bassinet, the cost could be more significant. d. Removable Bassinet Beds Finally, the Commission proposes adding a new requirement and test method to address the attachment of removable bassinet beds. There are several manufacturers with bassinet designs that allow for the bassinet bed to be removed from the stand easily (i.e., without the use of tools) and used separately. In many cases, the bassinet bed sits securely on the stand without any attachment mechanism. In other cases, clips or locks may be used to ensure that the stand retains the bassinet bed during use. Incidents have arisen where the attachments have either failed or have not been used, rendering the bassinet bed unstable. Therefore, CPSC, in conjunction with an ASTM task group, has developed a requirement and test methods to address the potential instability of some removable bassinet beds when used with a stand. There are several firms supplying bassinets with removable bassinet beds to the U.S. market. The majority will not need modifications to meet the proposed requirement. However, at least four firms will need to make changes to one or more of their bassinets. Essentially, the products will need to be modified so that they are either inherently stable (automatically lock or stable even without the locks) or obviously unstable (unsupportable or obviously tilted without locks or a visual indicator that locks not in use). There are numerous ways that firms could meet this new requirement if their product(s) required modification, including redesigning the product entirely. However, it seems likely that many firms would opt for less expensive alternatives, such as more sensitive locks that activate with little pressure (i.e., with just the weight of the bassinet). c. Mattress Flatness The Commission is proposing the addition of a mattress flatness requirement and test method to the standard, as well. The mattress flatness requirement is primarily aimed at incidents involving bassinet/play yard combination products that tend to use segmented mattresses. These incidents suggest that products with mattresses that have multiple seams could pose a suffocation hazard. Based on Commission testing, it appears that the play yard bassinet attachments of many suppliers (both compliant and noncompliant with F2194–10) would pass this requirement without any modifications. Those that do require modifications would need to increase the mattress support in their bassinets. This could be accomplished, for PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 Other Federal or State Rules The Commission is in the process of implementing sections 14(a)(2) and 14(i)(2) of the Consumer Product Safety Act (CPSA), as amended by the CPSIA. E:\FR\FM\18OCP1.SGM 18OCP1 64066 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS Section 14(a)(2) of the CPSA requires every manufacturer of a children’s product that is subject to a children’s product safety rule to certify, based on third party testing, that the product complies with all applicable safety rules. Section 14(i)(2) of the CPSA requires the Commission to establish protocols and standards (i) for ensuring that a children’s product is tested periodically and when there has been a material change in the product, (ii) for the testing of representative samples to ensure continued compliance, (iii) for verifying that a product tested by a conformity assessment body complies with applicable safety rules, and (iv) for safeguarding against the exercise of undue influence on a conformity assessment body by a manufacturer or private labeler. Because bassinets/cradles will be subject to a mandatory standard, they will also be subject to the third party testing requirements of section 14(a)(2) of the CPSA when the mandatory standard and the notice of requirements become effective. Impact on Small Businesses There are approximately 55 firms currently known to be marketing bassinets and/or cradles in the United States. Under U.S. Small Business Administration (SBA) guidelines, a manufacturer of bassinets or cradles is small if it has 500 or fewer employees, and importers and wholesalers are considered small if they have 100 or fewer employees. Based on these guidelines, 38 are small firms—19 domestic manufacturers, 8 domestic importers, and 11 firms with unknown supply sources (including 9 specializing in bedding). The remaining firms are five large domestic manufacturers, three large domestic importers, three large retailers with unknown supply sources, and six foreign firms. There may be additional unknown small bassinet/ cradle suppliers operating in the U.S. market. Small manufacturers. The expected impact of the proposed standard on small manufacturers will differ based on whether their bassinets/cradles are already compliant with F2194–10. Firms whose bassinets and cradles meet the requirements of F2194–10 are likely to continue to comply with the voluntary standard as new versions are published. In addition, they are likely to meet any new standard within 6 months because this is the amount of time JPMA allows for products in their certification program to shift to a new standard. Many of these firms are active in the ASTM standard development process, and compliance with the voluntary VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 standard is part of an established business practice. Therefore, it is likely that firms supplying bassinets and cradles that comply with ASTM F2194– 10 (which went into effect for JPMA certification purposes in November 2010) would also likely comply with F2194–12 by January 2013, even in the absence of a mandatory standard. It is possible that the direct impact for manufacturers whose products are likely to meet the requirements of ASTM F2194–12 (10 of 19 firms) could be significant for one or more firms if they must redesign their bassinets to meet the proposed rule. While none of these manufacturers would be newly covered due to the proposed change in scope, seven would be affected by the mattress flatness requirement (i.e., they produce play yards with bassinet attachments), and at least two (and possibly four) may be affected by the removable bassinet bed stability requirement. For the most part, the bassinets/cradles and bassinet cradle attachments supplied by these firms will be able to meet the staffrecommended changes to ASTM F2194– 12, without modification. In cases where modifications are necessary, they would most likely opt to retrofit their products, rather than undertake an expensive redesign. However, it is possible that some products may require redesign, particularly to meet the new removable bassinet bed stability requirement; therefore, costs could be significant in some cases. Meeting ASTM F2194–12’s requirements could necessitate product redesign for at least some bassinets/ cradles that are believed not to be compliant with F2194–10 (9 of 19 firms). Two of these firms produce either Moses baskets or carriage stroller attachments along with separate stands, and therefore, they are included only because of the proposed change in scope. (Since no Moses baskets or carriage attachments for strollers are currently tested to the ASTM bassinets/ cradles standard, it is assumed that none would meet ASTM F2194–12 without modifications). The remaining seven firms could require redesign, regardless of the staff-recommended modifications. A redesign would be minor if most of the changes involve adding straps and fasteners or using different mesh or fabric, but it could be more significant if changes to the frame are required, including changes to side height. One manufacturer estimated that a complete play yard redesign, including engineering time, prototype development, tooling, and other incidental costs, would cost approximately $500,000. The PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 Commission believes that a bassinet redesign would tend to be comparable. Consequently, the proposed rule could potentially have a significant direct impact on small manufacturers whose products do not conform to F2194–10. However, any direct impact might be mitigated if costs are treated as new product expenses that can be amortized. It is possible that some firms supply bassinets/cradles that are compliant with F2194–10, even though they are not certified or marketed as compliant. The Commission has identified many such cases with other products. To the extent that some of these firms may supply compliant bassinets/cradles and have developed a pattern of compliance with the voluntary standard, the direct impact of the proposed standard will be less significant than described above. There are also two small firms with unknown supply sources, none of which appear to comply with F2194–10 (one is covered by the proposed rule due to the expanded scope). If these firms are manufacturers, they may also require redesign to meet the proposed standard. In addition to the direct impact of the proposed standard described above, there are indirect impacts. These impacts are considered indirect because they do not arise directly as a consequence of the bassinet/cradle rule’s requirements. Nonetheless, they could be significant. Once the rule becomes final and the notice of requirements is in effect, all manufacturers will be subject to the additional costs associated with the third party testing and certification requirements. This will include any physical and mechanical test requirements specified in the final rule; lead and phthalates testing is already required, and hence, not included here.1 One manufacturer estimated that testing to the ASTM voluntary standard runs around $1,000 per model sample, although they noted that the costs could be lower for some models where the primary difference is fabric rather than structure. Testing overseas could potentially reduce some testing costs, but this may not always be practical. On average, each small domestic manufacturer supplies eight different models of bassinets/cradles and/or play yards with bassinet/cradle accessories to the U.S. market annually. Therefore, if third party testing were conducted every year on a single sample for each model, third party testing costs for each 1 Bassinet and cradle suppliers already must third party test their products to the lead and phthalate requirements. Therefore, these costs are left out of the analysis above. E:\FR\FM\18OCP1.SGM 18OCP1 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS manufacturer would be about $8,000 annually. Based on a review of firm revenues, the impact of third party testing to ASTM F2194–12 is unlikely to be significant if only one bassinet/cradle sample per model is required. However, if more than one sample would be needed to meet the testing requirements, third party testing costs could have a significant impact on a few of the small manufacturers. Small Importers As with manufacturers of compliant bassinets/cradles, the four small importers of bassinets/cradles currently in compliance with F2194–10 could experience significant direct impacts as a result of the proposed rule, if product redesign is necessary. In the absence of regulation, these firms would likely continue to comply with the voluntary standard as it evolves and likely the final mandatory standard as well. Any increase in production costs experienced by their suppliers may be passed on to them. Importers of bassinets/cradles would need to find an alternate source if their existing supplier does not come into compliance with the requirements of the proposed rule, which may be the case with the four importers of bassinets/ cradles believed not to be in compliance with F2194–10 (two of which are covered by the proposed rule due to the expanded scope). Some could respond to the rule by discontinuing the import of their noncompliant bassinets/cradles, possibly discontinuing the product line altogether. However, the impact of such a decision could be mitigated by replacing the noncompliant bassinets/ cradles with compliant bassinets/ cradles. Deciding to import an alternative product would be a reasonable and realistic way to offset any lost revenue. As is the case with manufacturers, all importers will be subject to third party testing and certification requirements, and consequently, they will experience costs similar to those for manufacturers if their supplying foreign firm(s) does not perform third party testing. The resulting costs could have a significant impact on a few small importers who must perform the testing themselves if more than one sample per model were required. Bedding Suppliers. There are nine known small firms specializing in the supply of bedding, including bedding for bassinets and cradles. Each firm sells basic bassinet or cradle shells, covered with their bassinet and cradle bedding. While it is clear that these firms do not manufacture the structural parts of the bassinets or cradles themselves, it is VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 unclear whether they purchase them domestically or overseas. Regardless, these firms will be affected by the proposed rule in a manner similar to importers. Because none of these firms is believed to supply bassinets or cradles in compliance with F2194–10, they would need to find an alternate source if their existing supplier does not come into compliance with the requirements of the proposed rule. Unlike most importers, however, they would not have the option of replacing a noncompliant bassinet/cradle with another product. While they could opt to sell the bedding without the associated bassinet/cradle, this is the standard method of sale, and it might make it more difficult to compete in the bassinet/cradle market. As with manufacturers and importers, these firms will also be subject to third party testing and certification requirements, and they will experience costs similar to those for manufacturers if their supplying firm(s) does not perform third party testing. The resulting costs could have a significant impact on some of these small bassinet/ cradle suppliers who must perform the testing themselves. Alternatives Under the Danny Keysar Child Product Safety Notification Act, section 104 of the CPSIA, one alternative that would reduce the impact on small entities is to make the voluntary standard mandatory with no modifications. Doing so would eliminate the impact on the six small firms that would be newly covered under the bassinet/cradle standard due to the proposed change in scope. These firms all supply Moses baskets or carriages, along with stationary stands; the Commission believes that these products require additional safety features when used for sleeping purposes. Adopting the voluntary standard without modifications could also reduce the impact on other small manufacturers and importers whose ASTM-compliant bassinets/cradles would require modifications due to the proposed changes. However, because of the severity of the incidents associated with instability and mattress tilt, the Commission does not recommend this alternative. A second alternative would be to set an effective date later than the proposed 6 months that is generally considered sufficient time for suppliers to come into compliance with a proposed rule. Setting a later effective date would allow suppliers additional time to modify and/or develop compliant PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 64067 bassinets/cradles and spread the associated costs over a longer period of time. The Commission invites comments describing the possible impact of this rule on manufacturers and importers, as well as comments containing other information describing how this rule will affect small businesses. J. Environmental Considerations The Commission’s regulations address whether we are required to prepare an environmental assessment or an environmental impact statement. If our rule has ‘‘little or no potential for affecting the human environment’’ it will be categorically exempted from this requirement. 16 CFR 1021.5(c)(1). The proposed rule falls within the categorical exemption. K. Paperwork Reduction Act This proposed rule contains information collection requirements that are subject to public comment and review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3521). In this document, pursuant to 44 U.S.C. 3507(a)(1)(D), we set forth: • A title for the collection of information; • A summary of the collection of information; • A brief description of the need for the information and the proposed use of the information; • A description of the likely respondents and proposed frequency of response to the collection of information; • An estimate of the burden that shall result from the collection of information; and • Notice that comments may be submitted to the OMB. Title: Safety Standard for Bassinets and Cradles. Description: The proposed rule would require each bassinet and cradle to comply with ASTM F 2194–12, ‘‘Standard Consumer Safety Specification for Bassinets and Cradles.’’ Sections 8 and 9 of ASTM F 2194–12 contain requirements for marking, labeling, and instructional literature. These requirements fall within the definition of ‘‘collection of information,’’ as defined in 44 U.S.C. 3502(3). Description of Respondents: Persons who manufacture or import bassinets/ cradles. Estimated Burden: We estimate the burden of this collection of information as follows: E:\FR\FM\18OCP1.SGM 18OCP1 64068 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN Number of respondents Frequency of responses Total annual responses Hours per response Total burden hours 1218 ..................................................................................... mstockstill on DSK4VPTVN1PROD with PROPOSALS 16 CFR Section 55 5 275 1 275 Our estimates are based on the following: Section 8.1.1 of ASTM F 2194–12 requires that the name of the manufacturer, distributor, or seller and either the place of business (city, state, and mailing address, including zip code) or telephone number, or both, be marked clearly and legibly on each product and its retail package. Section 8.1.2 of ASTM F 2194–12 requires a code mark or other means that identifies the date (month and year, at a minimum) of manufacture. There are 55 known entities supplying bassinets to the U.S. market. All 55 firms are assumed to use labels already on both their products and their packaging, but they might need to make some modifications to their existing labels. The estimated time required to make these modifications is about 1 hour per model. Each entity supplies an average of eight different models of bassinets; therefore, the estimated burden associated with labels is 1 hour per model × 55 entities × 5 models per entity = 275 hours. We estimate the hourly compensation for the time required to create and update labels is $27.55 (U.S. Bureau of Labor Statistics, ‘‘Employer Costs for Employee Compensation,’’ March 2012, Table 9, total compensation for all sales and office workers in goods-producing private industries: https://www.bls.gov/ ncs/). Therefore, the estimated annual cost to industry associated with the labeling requirements is $7,576.25 ($27.55 per hour × 275 hours = $7,576.25). There are no operating, maintenance, or capital costs associated with the collection. Section 9.1 of ASTM F2194–12 requires instructions to be supplied with the product. Bassinets and cradles are products that generally require assembly, and products sold without such information would not be able to compete successfully with products supplying this information. Under the OMB’s regulations (5 CFR 1320.3(b)(2)), the time, effort, and financial resources necessary to comply with a collection of information that would be incurred by persons in the ‘‘normal course of their activities’’ are excluded from a burden estimate, where an agency demonstrates that the disclosure activities required to comply are ‘‘usual and customary.’’ VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 Therefore, because we are unaware of bassinets or cradles that generally require some installation, but lack any instructions to the user about such installation, we tentatively estimate that there are no burden hours associated with section 9.1 of ASTM F2194–12 because any burden associated with supplying instructions with bassinets and cradles would be ‘‘usual and customary’’ and not within the definition of ‘‘burden’’ under the OMB’s regulations. Based on this analysis, the proposed standard for bassinets would impose a burden to industry of 275 hours at a cost of $7,576.25 annually. In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. § 3507(d)), we have submitted the information collection requirements of this rule to the OMB for review. Interested persons are requested to submit comments regarding information collection by November 19, 2012, to the Office of Information and Regulatory Affairs, OMB (see the ADDRESSES section at the beginning of this notice). Pursuant to 44 U.S.C. 3506(c)(2)(A), we invite comments on: • Whether the collection of information is necessary for the proper performance of the CPSC’s functions, including whether the information will have practical utility; • The accuracy of the CPSC’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; • Ways to enhance the quality, utility, and clarity of the information to be collected; • Ways to reduce the burden of the collection of information on respondents, including the use of automated collection techniques, when appropriate, and other forms of information technology; and • The estimated burden hours associated with label modification, including any alternative estimates. L. Preemption Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a consumer product safety standard is in effect and applies to a product, no state or political subdivision of a state may either establish or continue in effect a requirement dealing with the same risk PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 of injury, unless the state requirement is identical to the federal standard. Section 26(c) of the CPSA also provides that states or political subdivisions of states may apply to the Commission for an exemption from this preemption under certain circumstances. Section 104(b) of the CPSIA refers to the rules to be issued under that section as ‘‘consumer product safety rules,’’ thus implying that the preemptive effect of section 26(a) of the CPSA would apply. Therefore, a rule issued under section 104 of the CPSIA will invoke the preemptive effect of section 26(a) of the CPSA when it becomes effective. M. Certification and Notice of Requirements (NOR) Section 14(a) of the CPSA imposes the requirement that products subject to a consumer product safety rule under the CPSA, or to a similar rule, ban, standard, or regulation under any other act enforced by the Commission, must be certified as complying with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a). Section 14(a)(2) of the CPSA requires that certification of children’s products subject to a children’s product safety rule be based on testing conducted by a CPSCaccepted third party conformity assessment body. Section 14(a)(3) of the CPSA requires the Commission to publish a notice of requirements (NOR) for the accreditation of third party conformity assessment bodies (or laboratories) to assess conformity with a children’s product safety rule to which a children’s product is subject. The proposed rule for 16 CFR part 1218, ‘‘Safety Standard for Bassinets and Cradles,’’ when issued as a final rule, will be a children’s product safety rule that requires the issuance of an NOR. On May 24, 2012, the Commission published in the Federal Register the proposed rule, Requirements Pertaining to Third Party Conformity Assessment Bodies, 77 FR 331086, which, when finalized, would establish the general requirements and criteria concerning testing laboratories. These include the requirements and procedures for CPSC acceptance of the accreditation of a laboratory to test children’s products in support of the certification required by section 14(a)(2) of the CPSA. The proposed rule at 16 CFR part 1112, E:\FR\FM\18OCP1.SGM 18OCP1 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS Requirements Pertaining to Third Party Conformity Assessment Bodies, lists the children’s product safety rules for which the CPSC has published NORs for laboratories. In this document, the Commission is proposing to amend the list in 16 CFR part 1112, once that rule becomes final, to include the bassinet standard, once finalized, along with the other children’s product safety rules for which the CPSC has issued NORs. Laboratories applying for acceptance as a CPSC-accepted third party conformity assessment body to test to the new standard for bassinets and cradles would be required to meet the third party conformity assessment body accreditation requirements in 16 CFR part 1112, Requirements Pertaining to Third Party Conformity Assessment Bodies, once that rule becomes final. When a laboratory meets the requirements as a CPSC-accepted third party conformity assessment body it can apply to the CPSC to have 16 CFR part 1218, Safety Standard for Bassinets and Cradles included in its scope of accreditation of CPSC safety rules listed for the laboratory on the CPSC Web site at www.cpsc.gov/labsearch. The final NOR will base the CPSC laboratory accreditation requirements on the performance standard set forth in the final rule for the safety standard for bassinets and cradles and the test methods incorporated within that standard. The Commission may recognize limited circumstances in which the Commission will accept certification based on product testing conducted before the Commission’s acceptance of accreditation of laboratories for testing bassinets and cradles (also known as retrospective testing) in the final NOR. The Commission seeks comments on any issues regarding the testing requirements of the proposed rule for bassinets and cradles and the accompanying proposed NOR. N. Request for Comments This proposed rule is part of a rulemaking proceeding under section 104(b) of the CPSIA to issue a consumer product safety standard for bassinets and cradles. We invite all interested persons to submit comments on any aspect of the proposed rule. In particular, the Commission invites comments regarding the reliability of proposed 16 CFR 1218.2(b)(7)(ii)(C) (allowing the option of making the sleep surface of the bassinet bed at least 20 degrees off from a horizontal plane when the bassinet bed is in an unlocked position as a means of meeting the stability requirement) with respect to notifying consumers that the bassinet VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 bed is dangerously unstable as opposed to intentionally designed to rest at an angle. Comments should be submitted in accordance with the instructions in the ADDRESSES section at the beginning of this notice. List of Subjects 16 CFR Part 1112 Administrative practice and procedure, Audit, Consumer protection, Reporting and recordkeeping requirements, Third party conformity assessment body. 16 CFR Part 1218 Consumer protection, Imports, Incorporation by reference, Infants and Children, Labeling, Law Enforcement, and Toys. For the reasons discussed in the preamble, the Commission proposes to amend Title 16 of the Code of Federal Regulations Chapter II as follows: PART 1112—REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY ASSESSMENT BODIES 1. The authority citation for part 1112 continues to read as follows: Authority: Pub. L. 110–314, section 3, 122 Stat. 3016, 3017 (2008); 15 U.S.C. 2063. 2. In § 1112.15, add paragraph (b)(33) to read as follows: § 1112.15 When can a third party conformity assessment body apply for CPSC acceptance for a particular CPSC rule and/or test method? * * * * * (b) * * * (33) 16 CFR part 1218, Safety Standard for Bassinets and Cradles. 3. Add part 1218 to read as follows: PART 1218—SAFETY STANDARD FOR BASSINETS AND CRADLES Sec. 1218.1 Scope. 1218.2 Requirements for bassinets and cradles. Authority: The Consumer Product Safety Improvement Act of 2008, Pub. L. 110–314, section 104, 122 Stat. 3016 (August 14, 2008). § 1218.1 Scope. This part establishes a consumer product safety standard for bassinets and cradles. § 1218.2 Requirements for bassinets and cradles. (a) Except as provided in paragraph (b) of this section, each bassinet and cradle must comply with all applicable provisions of ASTM F 2194–12, Standard Consumer Safety Specification for Bassinets and Cradles, approved on PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 64069 June 1, 2012. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from ASTM International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428; https:// www.astm.org/cpsc.htm. You may inspect a copy at the Office of the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814, telephone 301–504–7923, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: https://www.archives.gov/ federal_register/code_of_federal regulations/ibr_locations.html. (b) Comply with the ASTM F 2194– 12 standard with the following additions or exclusions: (1) Instead of complying with section 1.3 of ASTM F 2194–12, comply with the following: (i) 1.3 This consumer safety performance specification covers products primarily intended to provide sleeping accommodations 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. Products used in conjunction with an inclined infant swing or stroller, or products that are intended to provide an inclined sleep surface (head-to-toe direction) of greater than 10° from horizontal, while in the rest (nonrocking) position, are not covered by this specification. Note to Paragraph (b)(1)(i): Cradle swings, with an incline less than or equal to 10° from horizontal while in the rest (non-rocking) position, are covered under the scope of this standard. A sleep product that has an inclined sleeping surface (intended to be greater than 10° from horizontal while in the rest (non-rocking) position) does not fall under the scope of this standard. Strollers that have a carriage/bassinet feature are covered by the stroller/carriage standard when in the stroller use mode. Carriage baskets/bassinets that are removable from the stroller base are covered under the scope of this standard when the carriage basket/ bassinet meets the definition of a bassinet/ cradle found in 3.1.1. Bassinet/cradle attachments to cribs or play yards, as defined in 3.1.2 or 3.1.12, are included in the scope of the standard when in the bassinet/cradle use mode. (ii) [Reserved] (2) Add ‘‘CAMI Newborn Dummy (see Fig. 1A). Drawing numbers 126–0000 through 126–0015 (sheets 1 through 3), 126–0017 through 126–0027, a parts list entitled ‘‘Parts List for CAMI Newborn Dummy,’’ and a construction manual entitled ‘‘Construction of the Newborn E:\FR\FM\18OCP1.SGM 18OCP1 64070 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules Street SW., Room 5109, Washington, DC, or at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC.’’ to ‘‘2.3 Other References’’ and use the following figure: (3) Instead of complying with section 3.1.1 of ASTM F 2194–12, comply with the following: (i) 3.1.1 Bassinet/cradle, n—small bed designed primarily to provide sleeping accommodations for infants, supported by free-standing legs, a stationary frame/stand, a wheeled base, a rocking base, or which can swing relative to a stationary base; while in a rest (non-rocking or swinging) position, a bassinet/cradle is intended to have a sleep surface less than or equal to 10° from horizontal. (ii) [Reserved] (4) Instead of complying with section 3.1.2 of ASTM F 2194–12, comply with the following: (i) Bassinet/cradle accessory, n—a supported sleep surface that attaches to a crib or play yard designed to convert the product into a bassinet/cradle intended to have a sleep surface less than or equal to 10° from horizontal while in a rest (non-rocking or swinging) position. (ii) [Reserved] (5) Instead of complying with section 3.1.3 of ASTM F 2194–12, comply with the following: (i) 3.1.3 conspicuous, adj—describes a label or indicator that is visible, when the bassinet/cradle is in a manufacturer’s recommended use position, to a person standing near the bassinet/cradle at any one position around the bassinet/cradle but not necessarily visible from all other positions. (ii) [Reserved] (6) In addition to complying with section 3.1.16 of ASTM F 2194–12, comply with the following: (i) 3.1.17 bassinet bed, n—the sleeping area of the bassinet, containing the sleep surface and side walls. (ii) 3.1.18 removable bassinet bed, n—A bassinet bed that is designed to separate from the base/stand without the use of tools. (iii) 3.1.19 false lock/latch visual indicator, n—a warning system, using contrasting bright colors, lights, or other similar means designed to visually alert caregivers when a removable bassinet bed is not properly locked onto its stand/base. (iv) 3.1.20 intended use orientation, n—The bassinet bed orientation (i.e., the position where the head and foot ends of the bassinet bed are located), with respect to the base/stand, as recommended by the manufacturer for intended use. (7) In addition to complying with section 6.8 of ASTM F 2194–12, comply with the following: (i) 6.9 Segmented Mattress Flatness—If the bassinet or bassinet accessory has a folding and/or segmented mattress, any angle when measured in section 7.10 shall be less than or equal to 10 degrees. (ii) 6.10 Removable Bassinet Bed Attachment—Any product containing a removable bassinet bed with a latching or locking device intended to secure the bassinet bed to the stand/base, shall comply with 6.10.1, 6.10.2, 6.10.3, 6.10.4 or 6.10.5 when tested in accordance with 7.11. (A) 6.10.1 The base/stand shall not support the bassinet bed (i.e., the bassinet bed collapses from the stand and contacts the floor). (B) 6.10.2 The lock/latch shall automatically engage under the weight of the bassinet bed (without any other force or action). (C) 6.10.3 The sleep surface of the bassinet bed shall be at least 20° off from a horizontal plane when the bassinet bed is in an unlocked position. (D) 6.10.4 The bassinet shall provide a false latch/lock visual indicator(s) that is conspicuous, at a minimum, on the two longest sides of the product. (E) 6.10.5 The bassinet bed shall not tip over and shall retain the CAMI newborn dummy. (8) Instead of complying with section 7.4.4 of ASTM F 2194–12, comply with the following: (i) 7.4.4 Place the CAMI Newborn Dummy on the sleeping pad in the center of the product face up with the arms and legs straightened. (A) Rationale. The newborn CAMI dummy represents a 50th percentile newborn infant, which is a more appropriate user of a bassinet than the CAMI infant dummy, which represents a 50th percentile 6-month-old infant. (B) [Reserved]. (ii) [Reserved]. (9) In addition to complying with section 7.9 of ASTM F 2194–12, comply with the following: (i) 7.10 Segmented Mattress Flatness Test. (A) 7.10.1 Angle measurement for bassinets intended for a single occupant. (B) 7.10.1.1 Establish a horizontal reference plane by placing an inclinometer, with an accuracy capable of 0.5° minimum resolution, on the floor of the testing area and zeroing it. (C) 7.10.1.2 Assemble the product according to the manufacturer’s instructions. If the product has more than one mode, assemble in the bassinet mode(s). Disable the rocking/swinging feature if the product is equipped with such a feature. (D) 7.10.1.3 Place the infant test cylinder, as shown in Fig. 13, in the center of the 1st seam (the seam VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 E:\FR\FM\18OCP1.SGM 18OCP1 EP18OC12.003</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS Infant Dummy’’ (July 1992). Copies of the materials may be inspected at NHTSA’s Docket Section, 400 Seventh Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules between an end panel and its adjacent panel), as shown in Fig. 14, and allow the cylinder to come to rest in the seam. 64071 Note to Paragraph (b)(9)(i)(D): If the cylinder begins to roll out of the seam, place a stop(s) on the mattress surface against the cylinder to prevent movement. The stop(s) shall not influence the angle measurement and shall have a total weight no greater than 0.25 lbs. for placement of the steel block in front of the cylinder, move the cylinder off center, enough to allow placement of the block, as outlined above in 7.10.1.4. (I) 7.10.1.5 Place the inclinometer in the center of the block, and measure the angle formed with the horizontal along the line that is perpendicular to the longitudinal axis of the cylinder, as shown in Fig. 16. Ensure the inclinometer does not touch the mattress surface. Note to Paragraph (b)(9)(i)(I): If needed, an additional level block of negligible mass, no greater than 0.2 lb, may be placed atop the steel block in order to elevate the inclinometer, such that it does not touch the mattress surface. (E) Figure 13. Infant Test Cylinder. (G) 7.10.1.4 Place a 6″ x 4″ x 1⁄2″ (152 x 101.6 x 12.7 mm) nominal thickness steel block weighing 3.3 lbs. (+/¥ 0.2 pounds) on the mattress panel in front of the cylinder with the 6″ length of the block in line with the center line of the cylinder as shown in Fig. 15. Place the block within 1⁄2″; (12.7 mm) of the cylinder. If the block slides and touches the cylinder, this is allowable. (H) 7.10.1.4.1 Where the play yard bassinet size constraints do not allow VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 (J) Figure 15. Steel block in front of the cylinder for a single occupant bassinet. E:\FR\FM\18OCP1.SGM 18OCP1 EP18OC12.004</GPH> EP18OC12.005</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS (F) Figure 14. Cylinder placement on mattress seam. 64072 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules (K) Figure 16. Inclinometer on steel block in front of the cylinder for a single occupant bassinet. VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 (P) 7.10.2 Angle measurement for bassinets intended for two occupants: (Q) 7.10.2.1 Establish a horizontal reference plane by placing an inclinometer, with an accuracy capable of 0.5° minimum resolution, on the floor of the testing area and zeroing it. (R) 7.10.2.2 Place one at a time, two identical newborn test cylinders (A and B), as shown in Fig. 17 in the occupant PO 00000 Frm 00020 Fmt 4702 Sfmt 4702 retention areas, as shown in Fig. 18, and allow them to come to rest in the seam. Note to Paragraph (b)(9)(i)(R): If the cylinder begins to roll out of the seam place a stop(s) on the mattress surface against the cylinder to prevent movement. The stop(s) shall not influence the angle measurement and shall have a total weight no greater than 0.25 lbs. (S) Figure 17. Newborn Test Cylinder E:\FR\FM\18OCP1.SGM 18OCP1 EP18OC12.006</GPH> EP18OC12.007</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS (L) 7.10.1.6 Record the angle measurement. (M) 7.10.1.7 Repeat 7.10.1.4–7.10.1.5 on the opposite side of the seam and record the measurement. (N) 7.10.1.8 Remove the cylinder from the bassinet. (O) 7.10.1.9 Repeat 7.10.1.3–7.10.1.8 on each remaining seam of the mattress and record the angles. Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules 64073 (T) Figure 18. Placement of cylinders for a 2 occupant bassinet. VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 cylinder. If the block slides and touches the cylinder, this is allowable. (W) 7.10.2.4.1 Where the play yard bassinet size constraints do not allow for placement of the steel block in front of the cylinder, move the cylinder off center enough to allow placement of the block as outlined above in 7.10.2.4. (X) 7.10.2.5 Place the inclinometer on the block, and measure the angle formed with the horizontal along the line that is perpendicular to the PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 longitudinal axis of cylinder A, as shown in Fig. 20. Ensure that the inclinometer does not touch the mattress surface. Note to Paragraph (b)(9)(i)(X): If needed, an additional level block of negligible mass, no greater than 0.2 lb, may be placed atop the steel block in order to elevate the inclinometer, such that it does not touch the mattress surface. (Y) Figure 19. Steel block in front of the cylinder for a 2-occupant bassinet. E:\FR\FM\18OCP1.SGM 18OCP1 EP18OC12.008</GPH> EP18OC12.009</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS (U) 7.10.2.3 Apply a 10.0 ± 0.5 lb compression force simultaneously with a force gauge onto the center of each cylinder, and hold for 10 seconds. (V) 7.10.2.4 Place a 6″ x 4″ x 1⁄2″ (152 x 101.6 x 12.7 mm) nominal thickness steel block weighing 3.3 lbs. (+/¥ 0.2 pounds) on the mattress panel in front of cylinder A with the 6″ length of the block in line with the center line of the cylinder, as shown in Fig. 19. Place the block within 1⁄2″ (12.7 mm) of the 64074 Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules (Z) Figure 20. Inclinometer on Steel block in front of the cylinder for a 2occupant bassinet. a force gauge onto the center of each cylinder and hold for 10 seconds. (FF) Figure 21. Two cylinders (A and B) in contact with the inside wall. EP18OC12.012</GPH> (DD) 7.10.2.9 Remove both cylinders and then place them in the occupant retention areas such that the side of the cylinders are in contact with the inside wall as shown in Fig. 21. (EE) 7.10.2.10 Apply a 10.0 ± 0.5 lb compression force simultaneously with VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 PO 00000 Frm 00022 Fmt 4702 Sfmt 4725 E:\FR\FM\18OCP1.SGM 18OCP1 EP18OC12.010</GPH> EP18OC12.011</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS (AA) 7.10.2.6 Record the angle measurement. (BB) 7.10.2.7 Repeat 7.10.2.4– 7.10.2.5 on the opposite side of the cylinder and record the measurement. (CC) 7.10.2.8 Repeat the angle measurements 7.10.2.4–7.10.2.7 for cylinder B and record the measurement. Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules (GG) 7.10.2.11 Place 6″ x 4″ x 1⁄2″ (152 x 101.6 x 12.7 mm) nominal thickness steel block weighing 3.3 lbs. (+/¥ 0.2 pounds) on the mattress panel on one side perpendicular to the longitudinal axis of the cylinder, with the centerline of the block adjacent to the midpoint of the cylinder. Place the block within 1⁄2″ (12.7 mm) of the cylinder. If the block slides and touches either the inside wall or the cylinder, this is allowable. (HH) 7.10.2.12 Place the inclinometer in the center of the block, 64075 and measure the angle formed with the horizontal along the line that is perpendicular to the longitudinal axis of cylinder A as shown in Fig. 22. (II) 7.10.2.13 Record the angle measurement. (JJ) 7.10.12.14 Place a 6″ x 4″ x 1⁄2″ (152 x 101.6 x 12.7 mm) nominal thickness steel block weighing 3.3 lbs. (+/¥ 0.2 pounds) on the mattress panel on one side perpendicular to the longitudinal axis of the cylinder, with the centerline of the block adjacent to the midpoint of the cylinder. Place the block within 1⁄2″ (12.7 mm) of the cylinder. If the block slides and touches the cylinder, this is allowable. (KK) 7.10.12.15 Place the inclinometer in the center of the block, and measure the angle formed with the horizontal along the line that is perpendicular to the longitudinal axis of cylinder B, as shown in Fig. 23. (LL) 7.10.2.16 Record the angle measurement. (MM) Figure 22. Angle measure in front of Cylinder A. (10) In addition to the changes to ASTM F 2194–12 in paragraph (b)(10) of this section comply with the following: (i) 7.11 Removable Bassinet Bed Attachment Tests. (A) 7.11.1 Assemble the bassinet/ cradle base/stand only, in accordance with manufacturer’s instructions. (B) 7.11.2 Place the base/stand in one of the manufacturer’s recommended use positions. (C) 7.11.3 Place the base/stand and the inclinometer on a flat level horizontal surface (0 +/¥ 0.5°) to establish a test plane. Zero the inclinometer. (D) 7.11.4 Remove the mattress pad from the bassinet bed. Note to Paragraph (b)(10)(i)(D): For mattresses that are integral with the mattress support, do not remove the mattress and perform all angle measurements for 7.11 on a 6 by 6 by 3⁄8-in. nominal aluminum block placed on the center of the mattress. (OO) Rationale. (1) The cylinder used in 7.10.1 was copied from a European standard for baby walkers (EN 1273:2005) and appears to be based on the weight and torso dimensions of a child between 6 and 8 months old. This represents the heaviest intended occupant, which will result in a more conservative test. (2) Because bassinet accessories intended for multiple births will have a shorter useful range of utility, the larger cylinder used in 7.10.2 was too heavy to represent the intended user population. The smaller cylinder used in 7.10.2 was based on the weight of an infant, matched to the height of the test cylinder in 7.10.1. (ii) [Reserved]. VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 (E) 7.11.5 Place the bassinet bed on the base/stand in the intended use orientation without engaging any latch or lock mechanism. If the bassinet bed can rest on the base/stand in its intended use orientation in more than one lateral unlocked position (see Figure 24), the unit shall be evaluated in the lateral position most likely to fail the requirements outlined in 6.10. (F) Figure 24: Bassinet Bed Resting on Stand, Showing Possible Alternate Lateral Positions. E:\FR\FM\18OCP1.SGM 18OCP1 EP18OC12.013</GPH> EP18OC12.014</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS (NN) Figure 23. Angle measure in front of Cylinder B. Federal Register / Vol. 77, No. 202 / Thursday, October 18, 2012 / Proposed Rules (G) 7.11.5.1 If the base/stand supports the bassinet bed, place the inclinometer on the mattress support at the approximate center of the mattress support. Care should be taken to avoid seams, snap fasteners, or other items that may affect the measurement reading. Record the angle measurement. (H) 7.11.5.2 If the base/stand supports the bassinet bed and the angle of the mattress support surface is less than 20 degrees of horizontal, evaluate whether the bassinet has a visual indicator per 6.10.4. (I) 7.11.5.3 If the base/stand supports the bassinet bed, and the angle of the mattress support surface is less than 20 degrees of horizontal, and the bassinet does not contain a false latch/ lock indicator, test the unit in accordance with sections 7.4.2–7.4.7. (J) 7.11.6 Repeat 7.11.3 through 7.11.5.3 for all of the manufacturer’s base/stand positions. (K) 7.11.7 If the product design allows, repeat 7.11.2 through 7.11.6 with the bassinet bed rotated 180° from the normal use orientation. (1) Rationale. This test requirement addresses fatal and 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. Products that appear to be in an intended use position VerDate Mar<15>2010 17:51 Oct 17, 2012 Jkt 229001 when the lock or latch is not properly engaged can create a false sense of security by appearing to be stable. Unsecured or mis-aligned lock/latch systems are a hidden hazard because they not easily seen by consumers due to being located beneath the bassinet or covered by decorative skirts. In addition, consumers will avoid activating lock/latch mechanisms for numerous reasons if a bassinet bed appears stable when placed on a stand/ base. Because of these foreseeable use conditions, this requirement has been added to ensure that bassinets with a removable bassinet bed feature will be inherently stable or it is obvious that they are not properly secured. (2) Section 6.10 allows bassinet bed designs that: (i) Cannot be supported by the base/ stand in an unlocked configuration, (ii) Automatically lock and cannot be placed in an unlocked position on the base/stand, (iii) Are clearly and obviously unstable when the lock/latch is misaligned or unused, (iv) Provide a visual warning to consumers when the product is not properly locked onto the stand/base, or (v) Have lock/latch mechanisms that are not necessary to provide needed stability. (ii) [Reserved]. PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 Dated: October 4, 2012. Todd A. Stevenson, Secretary, Consumer Product Safety Commission. [FR Doc. 2012–24896 Filed 10–17–12; 8:45 am] BILLING CODE 6355–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 161 [Docket No. USCG–2011–1024] RIN 1625–AB81 Vessel Traffic Service Updates, Including Establishment of Vessel Traffic Service Requirements for Port Arthur, Texas and Expansion of VTS Special Operating Area in Puget Sound Coast Guard, DHS. Proposed rule; correction. AGENCY: ACTION: This document contains a correction to the notice of proposed rulemaking published in the Federal Register on September 10, 2012 (77 FR 55439), which proposes to revise and update the Vessel Traffic Service regulations in 33 CFR part 161. DATES: Comments and related material must either be submitted to our online SUMMARY: E:\FR\FM\18OCP1.SGM 18OCP1 EP18OC12.015</GPH> mstockstill on DSK4VPTVN1PROD with PROPOSALS 64076

Agencies

[Federal Register Volume 77, Number 202 (Thursday, October 18, 2012)]
[Proposed Rules]
[Pages 64055-64076]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24896]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112 and 1218

[CPSC Docket No. CPSC-2010-0028]
RIN 3041-AC81


Safety Standard for Bassinets and Cradles

AGENCY: Consumer Product Safety Commission.

ACTION: Supplemental notice of proposed rulemaking.

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SUMMARY: The Consumer Product Safety Improvement Act of 2008 (CPSIA 
requires the United States Consumer Product Safety Commission 
(Commission or CPSC) to promulgate consumer product safety standards 
for durable infant or 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 Commission is proposing a safety 
standard for bassinets and cradles in response to the CPSIA. This 
constitutes a second round of notice and comment, or supplemental 
notice of proposed rulemaking, for bassinets and cradles.

DATES: Submit comments by January 2, 2013.

ADDRESSES: Comments related to the Paperwork Reduction Act aspects of 
the marking, labeling, and instructional literature of the proposed 
rule should be directed to the Office of Information and Regulatory 
Affairs, OMB, Attn: CPSC Desk Officer, FAX: 202-395-6974, or emailed to 
oira_submission@omb.eop.gov.
    Other comments, identified by Docket No. CPSC-2010-0028, may be 
submitted electronically or in writing:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: https://www.regulations.gov. Follow the 
instructions for submitting comments. To ensure timely processing of 
comments, the Commission is no longer directly accepting comments 
submitted by electronic mail (email), except through 
www.regulations.gov. The Commission encourages you to submit electronic 
comments by using the Federal eRulemaking Portal, as described above.
    Written Submissions: Submit written submissions in the following 
way: Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions), preferably in five copies, to: Office of the Secretary, 
Consumer Product Safety Commission, Room 820, 4330 East West Highway, 
Bethesda, MD 20814; telephone (301) 504-7923.
    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. All comments received may be 
posted without change, including any personal identifiers, contact 
information, or other personal information provided, to https://www.regulations.gov. Do not submit confidential business information, 
trade secret information, or other sensitive or protected information 
that you do not want to be available to the public. If furnished at 
all, such information should be submitted in writing.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov, and insert the 
docket number, CPSC 2010-0028, into the ``Search'' box and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Patricia Edwards, Project Manager, 
Directorate for EngineeringSciences, Consumer Product Safety 
Commission, 5 Research Place, Rockville, MD 20850; telephone 301-987-
2244; email pedwards@cpsc.gov.

SUPPLEMENTARY INFORMATION: 

A. Background and Statutory Authority

    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: https://www.astm.org/cpsc.htm, by permission of ASTM.

B. The Product

    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

[[Page 64056]]

the product into a bassinet/cradle intended to have a horizontal sleep 
surface while in a rest (non-rocking) position.'' The Commission is 
proposing modifications to the scope and definition of a bassinet/
cradle and bassinet/cradle accessory, as further discussed herein.

C. The Voluntary Standard--ASTM F2194

    The voluntary standard for bassinets and cradles was first approved 
and published by ASTM in 2002, as ASTM 2194, Standard Consumer Safety 
Specification for Bassinets and Cradles. The standard has been revised 
a number of times since then. The Commission's April 2010 NPR assessed 
the effectiveness of ASTM F2194-07a[epsiv]\1\. Since publication of the 
2010 NPR, the standard has been revised three times: In 2010, 2011, 
and, most recently, in 2012. The 2012 version, ASTM F2914-12, was 
approved on June 1, 2012. The 2012 voluntary standard contains 
requirements addressing a number of hazards. The requirements include:
    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.

D. Incident Data

    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.'').

1. Fatalities

    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.

2. Nonfatal Injuries

    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

[[Page 64057]]

descriptions indicated the potential for a serious injury or even 
death.

3. Hazard Analysis

    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.

    (1) Product-related issues: The hazard scenarios in 209 of the 335 
incidents (62 percent) reported were attributed to some sort of 
failure/defect or a potential design flaw in the product itself. This 
category includes five fatalities and 46 injuries, five of which 
involved hospitalization. Listed below are the reported problems, 
beginning with the most frequently reported concerns:
     Lack of structural integrity, which includes issues such 
as instability, loose hardware, collapse of the product, and loose 
wheels. This issue was reported in 64 (about 19 percent) of the 
incidents. One death is associated with this issue.
     Reports of infants falling or climbing out of bassinets/
cradles. This category accounted for most of the bassinet-related 
injury reports that were received from emergency departments around the 
United States. While little product-/scenario-specific information was 
available in these reports, a majority indicated that the victims were 
over the ASTM-recommended upper age limit of 5 months. This issue was 
reported in 32 (about 10 percent) of the incidents.
     Problems with mattress flatness in bassinet attachments to 
play yards. Examples include mattresses that would not remain level 
horizontally because of poorly designed metal rods/other structures 
that are meant to be positioned underneath the mattress; lack of rigid 
mattress support; and failure of straps/hooks/bars designed to hold the 
bassinet attachment inside the play yard. This issue was reported in 31 
(about 9 percent) of the incidents and was associated with three 
deaths.
     Problems with rocking bassinets and cradles, with locking 
or tilting issues that caused the infant to roll/press up against the 
side/corner of the product and posed a suffocation hazard. This issue 
was reported in 23 (about 7 percent) of the incidents, including one 
death.
     Problems with packaging of the product that resulted in 
broken/damaged products during delivery. This issue was reported in 19 
(about 6 percent) of the incidents.
     Problems with bassinet mobiles, where components 
overheated, smoked, or sparked. This issue was reported in 13 (about 4 
percent) of the incidents.
     Miscellaneous other product-related problems, ranging from 
a tear in the bassinet fabric, to odors, to product assembly/quality 
issues. Twenty-seven (about 8 percent) of the incidents reported these 
issues.
    (2) Non-product-related issues: Eighty-three of the 335 reports (25 
percent) were about incidents that involved no product defect or 
failure. This category consisted of 82 fatalities, most of which were 
associated with the use of soft/extra bedding or prone positioning. 
There was also one nonfatal injury incident that did not involve any 
product-related issues.
    (3) Recalled product-related issues: There were 26 reports (8 
percent) that involved recalled products. Some of the reports were 
received by CPSC staff prior to the recalls being published. There were 
three fatalities and two injuries due to entrapment and/or hanging of 
an infant between structural components of the bassinet. Most of the 
remaining reports were complaints or inquiries from consumers regarding 
a recalled product.
    (4) Miscellaneous other issues: The remaining 17 (5 percent) 
incident reports were related to miscellaneous other or unspecified 
issues. Some of these reported concerns from consumers about perceived 
safety hazards; others described incidents with insufficient 
specificity for CPSC staff to identify the hazard scenario. There were 
four fatalities (unknown circumstances) and three injuries, including a 
hospitalized injury, reported in this category.
    In summary, there are five product-related issues associated with 
incident deaths and/or significant injuries:
     Structural integrity/instability,
     Mattress flatness,
     Rocking,
     Falling or climbing out, and
     Entrapment in fabric sided products (recalled product-
related).

In addition, there are multiple deaths associated with the use of soft/
extra bedding or prone positioning of the child that are considered 
non-product related.

4. Recalls

    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

[[Page 64058]]

reports of infants rolling to one side, including six that had their 
faces pressed against the side or the bottom of the bassinet. One child 
reportedly was turning purple and was out of breath when discovered. No 
other injuries were reported. (The rock/swing angle test, proposed in 
the 2010 NPR and added to the ASTM standard in its 2012 iteration, 
would address this hazard.)
    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[supreg]. The fabric was 
folded down when the bassinet was converted into a bedside sleeper 
position. If the Velcro[supreg] 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\1/2\-month-old girl died when she became entrapped and 
strangled between the bassinet's metal bars. This is the second 
strangulation death that the CPSC learned of involving the co-sleeper 
bassinets. On September 29, 2007, a 4-month-old girl became entrapped 
in the metal bars of the bassinet and died. (The fabric-sided openings 
test, proposed in the 2010 NPR and added to the ASTM standard in its 
2012 iteration, would address this hazard.)

E. April 2010 NPR and Subsequent Changes to the ASTM Voluntary Standard

    In April 2010, the Commission approved a proposed rule on 
bassinets/cradles that referenced the requirements specified in ASTM 
F2194-07a[epsiv]\1\ as a mandatory standard for bassinets and cradles, 
with several modifications to further reduce injuries and deaths. The 
modifications and edits included the following:
     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.

The April 2010 NPR also proposed to include hammocks within in the 
scope of the standard.
    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.

1. Proposed Changes in April 2010 NPR Incorporated Into ASME F2194-12

Restraints
    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 all restraints in 
bassinets. The Commission supports this change to the standard, and 
notes that it is more conservative than the restraints requirement 
proposed in the 2010 NPR.
The Prominence of Warnings About Soft Bedding
    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 * * 
*.''
Maximum Rock/Swing and Rest Angles
    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.
Fabric-Sided Enclosed Openings Test
    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.
Stability
    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.

2. Changes to ASTM F2194 That Arose Out of a Response to Comments 
Received on the April 2010 NPR

Baby Size Limits
    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.

[[Page 64059]]

    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.
Static Load
    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.
Side Height Requirement
    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\1/2\; inches from the top of the uncompressed mattress 
surface.

3. Revisions to Proposed Changes in 2010 NPR

Hammocks
    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.
Mattress Flatness
    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.

F. Assessment of ASTM Voluntary Standard and International Standards

    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.

[[Page 64060]]

    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:

    A 3 month and 26 day old male victim was found deceased inside a 
play yard. The ME determined that the cause of the death was 
asphyxia. The victim was found face down in a crease produced by the 
mattress. He was pronounced deceased at the hospital.

The Commission notes that requirements to ensure that key structural 
supports are properly installed by consumers would have helped prevent 
this incident from occurring. The Bassinet Misassembly Provision NPR, 
published on August 29, 2012, is a Commission-directed NPR to amend the 
play yard mandatory standard to include a provision to address the 
hazards associated with play yard bassinet accessories that can be 
misassembled. (77 FR 52272). However, there has never been a 
requirement for sleeping surfaces to be flat or even nearly flat, which 
is the critical feature of the product that constitutes a hazard. A 
play yard could be designed to position the occupant in a valley, and 
it would still pass the play yard standard and the misassembly 
provision. The Commission believes both requirements are necessary to 
address these hazards: (1) A missing component requirement to prevent 
installation/use of a bassinet accessory that has a key component 
missing; and (2) a flatness requirement to ensure segmented mattresses, 
like those found in bassinet accessories, are flat when assembled 
according to manufacturer's instructions.

    In another IDI, the victim was in a bassinet accessory to a play 
yard that was also misassembled. The incident summary states:

    A two month old male was found unresponsive in his * * * play 
yard with no signs of trauma. The child had rolled in the bassinet 
section causing his face to be placed in the corner of the bassinet. 
He was lying on a blanket with another blanket on top of him. 
Investigators who initially measured the bassinet at the scene 
reported that one side was five inches higher than the other. I 
observed during my investigation that depending on weight and 
movement that there will be a variance in height within the unit.

Other risk factors also may have contributed to the incident (e.g., the 
placement of the infant to sleep in the prone position and the presence 
of a blanket under the infant), but the case nonetheless illustrates 
the potential for non-level sleeping surfaces to contribute to bassinet 
occupants getting into fatal positions from which they may not be able 
to remove themselves.

    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:

    The mother was using the elevated playpen platform for her 5 
month old male baby's sleeping area. He was born with multiple 
physical complications including the inability to swallow and would 
drool constantly. The parents placed the infant in the playpen at 
night face down and awoke to find he had expired in the middle of 
the night. The playpen elevated platform showed sagging in the 
center possibly due to incorrect assembly of the playpen.

    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:

    No injury occurred to a five-month-old female, who while asleep 
in the bassinet section of a portable and collapsible play yard 
rolled into a seam of the removable changing pad used with the 
bassinet. The mother of the five-month old noticed that the five 
month old had a tendency to roll into seams of the mattress pad when 
it was used with the bassinet.

    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 
average infant faces. By combining an infant's mandible width with 
dimensions of nasal protrusion, an isosceles triangle can be created 
that represents a cross-section of the volume of space beneath the 
nose. From this cross-section, one can extrapolate both the angle of 
the valley and the angle of the incline of the surface that would 
contact a prone infant's face. The angle resulting from the combination 
of the average facial dimensions is 15 degrees, from which the ASTM 
subcommittee subtracted a single degree for a factor of safety. This 
ASTM ballot item received many negative votes and was not approved for 
the standard.
    The Commission is uncomfortable using the average infant facial 
dimension as the basis for this requirement. A product that has a 14-
degree angle in the valley formed at the seam of the mattress would 
leave about one-half of the potential occupant population unprotected 
from suffocation. While the ASTM Committee used an angle resulting from

[[Page 64061]]

the combination of average facial dimensions, the Commission generally 
recommends using the smallest users' anthropometrics for justifying 
requirements of this nature. If the facial measurements of the smallest 
(5th percentile) infants are used to form the isosceles triangle, the 
resulting valley is 158 degrees, which yields an 11-degree angle of 
sleep surface incline from the horizontal on each side. If a single 
degree is subtracted from this incline angle for a minor factor of 
safety, the requirement becomes a 10-degree maximum incline from the 
horizontal. In the Commission's proposed test, each seam of a folding 
bassinet sleeping surface is tested with a pass/fail criterion of 10 
degrees maximum for either side of the valley formed by a weighted 
cylinder.
    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:

    It strongly appears the bassinet was not attached to the base 
when the infant was put down for a nap. When the infant was found, 
the bassinet was perpendicular to the base and had fallen into the 
base opening at an angle suspending the infant. The straps and hooks 
attaching the bassinet to the base were not snapped in.

    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. (https://www.cpsc.gov/cpscpub/prerel/prhtml12/12173.html).
    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

[[Page 64062]]

minimum is twice the allowable deviation from horizontal that staff 
recommends for sleeping surface flatness. This angle was extrapolated 
from an IDI report involving a caregiver who noticed that a bassinet 
was tilted. From photographs of the incident product, the ASTM task 
group assigned to examine the problem estimated that the unit produced 
about a 17-degree angle, which they felt would be reasonable to round 
up to 20 degrees for the standard. A sleeping surface at 20 degrees 
from the horizontal seems severe enough that consumers would notice 
that it was not level. This proposed requirement is slightly less than 
the angle proposed to address similar hazards in the play yard standard 
(i.e., 30 degrees from the horizontal), but the ASTM subcommittee 
reasoned that bassinets are different in structural design and 
materials and will appear to be misassembled more easily than the 
suspended and segmented mattress supports used in play yards.
    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.
Scope
    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 primarily used to provide sleeping 
accommodations. This would expand the scope beyond products only used 
to provide sleeping accommodations. This would ensure, for example, 
that a bassinet sold with a toy mobile that is meant to entertain an 
infant who is lying in the bassinet would still fall within the scope 
of the standard.
Stability Test Dummy
    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.
International Standards
    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.

G. Description of Proposed Changes to ASTM Standard

    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.

[[Page 64063]]

1. Clarifying the Scope of the Standard and Associated Definitions 
(Sections 1.3, 3.1.1, and 3.1.2)

    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 
primarily for sleeping. This would ensure that a bassinet sold with a 
toy mobile that is meant to entertain an infant who is lying in the 
bassinet, for instance, would still fall within the scope of the 
standard.
    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).

2. Segmented Mattress Flatness Requirement and Test Method (Sections 
6.9 and 7.10)

    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.

3. New Performance Requirement and Associated Definitions To Address 
Hazards Associated With the Stability of Removable Bassinet Beds 
(Sections 3.1.3, 3.1.17, 3.1.18, 3.1.19, 3.1.20, 6.10, 7.11)

    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 (i.e., the 
bassinet bed falls from the stand so that it is in contact with the 
floor); or
     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.

4. Revised Test Procedure for Bassinet Stability (Sections 2.3 and 
7.4.4)

    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.

H. Effective Date

    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 
Federal Register. The Commission invites comment on how long it will 
take bassinet and cradle manufacturers to come into compliance with the 
rule.

I. Regulatory Flexibility Act

Introduction

    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.

The Market

    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

[[Page 64064]]

sources; three of those firms are retailers and nine specialize in 
bedding, some of which is sold with bassinets or cradles. There are 
also six foreign firms supplying the U.S. market: Five manufacturers 
and one importer who imports from foreign companies and distributes 
from outside of the United States.
    Bassinets and cradles from 12 of the 55 firms have been certified 
as compliant by the JPMA, the major U.S. trade association that 
represents juvenile product manufacturers and importers. Firms 
supplying bassinets or cradles would be certified to the ASTM voluntary 
standard F2194-10, while firms supplying play yards with bassinet/
cradle attachments would also have to meet F406-11b. Nine additional 
firms claim compliance with the relevant ASTM standard for at least 
some of their bassinets and cradles.
    According to a 2005 survey conducted by the American Baby Group 
(2006 Baby Products Tracking Study), 64 percent of new mothers own 
bassinets; 18 percent own cradles; and 39 percent own play yards with 
bassinet attachments. Approximately 50 percent of bassinets, 56 percent 
of cradles, and 18 percent of play yards were handed down or purchased 
second-hand. Thus, about 50 percent of bassinets, 44 percent of 
cradles, and 82 percent of play yards were acquired new. This suggests 
annual sales of about 1.3 million bassinets (.5 x .64 x 4.1 million 
births per year); 325,000 cradles (.44 x .18 x 4.1 million); and 1.3 
million play yards with bassinet attachments (.82 x .39 x 4.1 million). 
This yields a total of approximately 3 million units sold per year that 
could be affected by the proposed bassinet/cradle standard.

Reason for Agency Action and Legal Basis for Proposed Rule.

    The Danny Keysar Child Product Safety Notification Act, section 104 
of the CPSIA, requires the CPSC to promulgate a mandatory standard for 
bassinets/cradles that is substantially the same as, or more stringent 
than, the voluntary standard. CPSC worked closely with ASTM to develop 
the new requirements and test procedures that have been added to the 
voluntary standard since 2010. These new requirements address several 
known hazard patterns that will help to reduce injuries and deaths in 
bassinets and cradles, and they have resulted in the current voluntary 
standard, F2194-12, upon which the proposed rule is based.
    However, the Commission proposes adding two new requirements to 
F2194-12, as well as modifying the scope and the test CAMI dummy used 
in the existing stability test. The first new requirement would address 
suffocation and positional asphyxia hazards that have occurred as a 
result of problems with segmented mattress flatness in play yard 
bassinet accessories. The second would address the stability of 
bassinets with removable bassinet beds, particularly the attachment 
mechanisms. The Commission also proposes modifying the scope (and some 
of the terminology) to ensure that inclined sleepers (including infant 
hammocks) would no longer be covered under the bassinet/cradle 
standard, unless they recline to 10 degrees or less. The expanded scope 
would also include Moses baskets and stroller carriage accessories when 
used in conjunction with a stationary stand. These modifications would 
also help eliminate gaps in product coverage (i.e., most products that 
may be used for infant sleep will be included under at least one 
durable nursery product standard). Finally, the Commission proposes 
that the CAMI newborn dummy be used for stability testing because it 
more closely resembles the characteristics of bassinet users than the 
CAMI infant dummy in F2194-12.

4. Requirements of the Proposed Rule

    The Commission proposes adopting the voluntary ASTM standard for 
bassinets and cradles (F2194-12) with a new mattress flatness 
requirement, a new stability requirement for bassinets with removable 
beds, a revised scope, and a modified CAMI dummy for the existing 
stability requirement. Some of the more significant requirements of the 
current voluntary standard for bassinets and cradles (ASTM F2194-12) 
are listed below. The requirements that were added to the ASTM 
voluntary standard or modified since the 2010 NPR are italicized.
     Spacing of rigid-side components--intended to prevent 
child entrapment between both uniformly and non-uniformly spaced 
components, such as slats. This has been modified for clarity to remove 
duplicative test references.
     Openings for mesh/fabric--intended to prevent the 
entrapment of children's fingers and toes, as well as button 
ensnarement.
     Static load test--intended to ensure structural integrity 
even when a child three times the recommended (or 95th percentile) 
weight uses it. This has been modified to also test play yard bassinets 
in all four corners.
     Stability requirements--intended to ensure that the 
product does not tip over when pulled on by a 2-year-old male. ASTM 
adopted the revised test requirements included in the 2010 NPR 
(includes testing with locks/latches engaged).
     Sleeping pad thickness and dimensions--intended to 
minimize gaps and the possibility of suffocation due to excessive 
padding. F2194-12 allows thicker mattresses for rigid-sided products 
because a thicker mattress does not pose the same suffocation hazard 
when used in rigid-sided, rather than soft-sided, products.
     Tests of locking and latching mechanisms--these are 
intended to prevent unintentional folding while in use.
     Suffocation warning label--intended to help prevent soft 
bedding incidents. F2194-12 requires the warning to use a larger font 
than the 2010 NPR.
     Fabric-sided openings test--intended to prevent 
entrapments. This test was included in the 2010 NPR and has been 
adopted in F2194-12 with a few editorial changes.
     Rock/swing angle requirement--intended to address 
suffocation hazards that can occur when latch/lock problems and 
excessive rocking or swinging angles press children into the side of 
the bassinet/cradle. The 2010 NPR recommended a maximum rocking angle 
of 20 degrees and a maximum rest angle of 5 degrees. ASTM F2194-12 
adopts the maximum deflection angle of 20 degrees, but includes a 
maximum rest angle of 7 degrees with a more severe test condition where 
the CAMI doll is positioned at the side, rather than the center, of the 
bassinet/cradle.
     Occupant restraints--intended to prevent incidents where 
unused restraints have entrapped and strangled children. The 2010 NPR 
proposed that only passive restraints be allowed. ASTM F2194-12 is even 
stricter, allowing no restraints to be used in a bassinet/cradle 
configuration.
     Side height requirement--intended to prevent falls. This 
requirement, which is new to F2194-12, arose from the comments to the 
2010 NPR. A bassinet/cradle side height of 7\1/2\ inches from the top 
of the uncompressed mattress is now required.

The voluntary standard also includes: (1) Torque and tension tests to 
ensure that components cannot be removed; (2) requirements for several 
bassinet/cradle features to prevent entrapment and cuts (minimum and 
maximum opening size, small parts, hazardous sharp edges or points, and 
edges that can scissor, shear, or pinch); (3) requirements for the 
permanency and adhesion of labels; (4) requirements for instructional 
literature; and (5) corner post extension requirements intended to 
prevent

[[Page 64065]]

pacifier cords, ribbons, necklaces, or clothing that a child may be 
wearing from catching on a projection.
    The Commission proposes modifying the scope, using the more 
appropriate infant CAMI dummy for stability testing, and adding new 
mattress flatness and attachment of removable bassinet bed requirements 
to ASTM F2194-12. As part of these changes, there would also be several 
new or revised definitions, including ``bassinet/cradle,'' ``bassinet/
cradle accessory,'' and ``bassinet bed.'' Following is a discussion of 
the impact of each of these changes.
a. Scope
    There are three major proposed changes to the scope of the 
bassinet/cradle standard:
    1. Specification that it is to cover products primarily used to 
provide sleeping accommodations. This expands the scope beyond products 
only used to provide sleeping accommodations.
    2. Products with an incline of 10 degrees or less would be 
included, while products with a greater than 10 degree incline would 
not. ASTM and CPSC have developed this demarcation across product 
standards to help ensure complete coverage of sleep products. This 
would include cradle swings which, by definition, recline less than 10 
degrees from horizontal.
    3. Specification that it includes products that can be supported by 
a stationary frame/stand. This would bring in carriage attachments to 
strollers and Moses baskets only when used with a stationary or rocking 
stand.
    These scope changes may affect suppliers in several ways. First, 
they would provide additional clarity to suppliers regarding which 
products would be covered under what standards. Reduced confusion means 
less time reviewing, testing, and making necessary modifications. 
Second, ``cradle swings,'' defined by the infant swings standard, 
F2088-11a, as an infant swing intended for use by a child lying flat 
(i.e., horizontal), would be covered under both the bassinet standard 
and the infant swings standard. The Commission believes that cradle 
swings currently on the market should be able to meet the proposed 
standard for bassinets without additional modifications. Third, Moses 
baskets and carriage attachments to strollers would now be subject to 
the bassinet/cradle standard when used in conjunction with a separate 
stand. However, this would apply only to Moses baskets and carriages 
that are produced and sold by the same company that makes the stand, 
and therefore, are intended to be used together. Firms that supply 
bassinet/cradle stands, as well as either Moses baskets or carriage 
attachments for strollers, would need to ensure that their Moses 
baskets and/or carriage attachments meet the bassinet/cradle standard 
when attached to the stand(s). This would likely require some redesign, 
most notably to meet the side height and stability requirements, and it 
would affect 10 known firms. Alternatively, they could stop supplying 
the stands.
b. Stability Testing With Newborn CAMI Dummy
    Because bassinets and cradles are intended to be used by very young 
children, it is appropriate that the smaller newborn CAMI dummy be used 
for stability testing. The heavier (17.5 pound) infant CAMI currently 
used for stability testing in F2194-12 could make these products more 
stable when tested than they actually would be in a real-world 
situation. Based on preliminary Commission testing, it appears that 
most bassinet/cradles will be able to pass this revised test procedure 
without modification. However, at least one product failed stability 
testing with the newborn CAMI and passed with the infant CAMI. It is 
possible that a few products may require modifications to meet the 
revised stability test procedure. It is likely to affect only a few 
manufacturers, but it is unlikely to require product redesign. Affected 
firms would most likely increase the stability of their product by 
widening the structure, making the bassinet bed deeper, or making the 
base heavier. If meeting the modified requirement necessitates a change 
to the hard tools used to manufacture the bassinet, the cost could be 
more significant.
c. Mattress Flatness
    The Commission is proposing the addition of a mattress flatness 
requirement and test method to the standard, as well. The mattress 
flatness requirement is primarily aimed at incidents involving 
bassinet/play yard combination products that tend to use segmented 
mattresses. These incidents suggest that products with mattresses that 
have multiple seams could pose a suffocation hazard. Based on 
Commission testing, it appears that the play yard bassinet attachments 
of many suppliers (both compliant and noncompliant with F2194-10) would 
pass this requirement without any modifications. Those that do require 
modifications would need to increase the mattress support in their 
bassinets. This could be accomplished, for example, by retrofitting 
their play yard bassinets to use longer rods or a better-fitting 
mattress shell. The cost of such a retrofit is unknown and would likely 
vary from product to product; however, it should be less expensive than 
a product redesign. Based on this information, it appears that at least 
a few play yard bassinets may require modifications, which could 
include product redesign. However, it is believed that most firms would 
opt for the less expensive option of retrofitting their existing 
designs.
d. Removable Bassinet Beds
    Finally, the Commission proposes adding a new requirement and test 
method to address the attachment of removable bassinet beds. There are 
several manufacturers with bassinet designs that allow for the bassinet 
bed to be removed from the stand easily (i.e., without the use of 
tools) and used separately. In many cases, the bassinet bed sits 
securely on the stand without any attachment mechanism. In other cases, 
clips or locks may be used to ensure that the stand retains the 
bassinet bed during use. Incidents have arisen where the attachments 
have either failed or have not been used, rendering the bassinet bed 
unstable. Therefore, CPSC, in conjunction with an ASTM task group, has 
developed a requirement and test methods to address the potential 
instability of some removable bassinet beds when used with a stand.
    There are several firms supplying bassinets with removable bassinet 
beds to the U.S. market. The majority will not need modifications to 
meet the proposed requirement. However, at least four firms will need 
to make changes to one or more of their bassinets. Essentially, the 
products will need to be modified so that they are either inherently 
stable (automatically lock or stable even without the locks) or 
obviously unstable (unsupportable or obviously tilted without locks or 
a visual indicator that locks not in use). There are numerous ways that 
firms could meet this new requirement if their product(s) required 
modification, including redesigning the product entirely. However, it 
seems likely that many firms would opt for less expensive alternatives, 
such as more sensitive locks that activate with little pressure (i.e., 
with just the weight of the bassinet).

Other Federal or State Rules

    The Commission is in the process of implementing sections 14(a)(2) 
and 14(i)(2) of the Consumer Product Safety Act (CPSA), as amended by 
the CPSIA.

[[Page 64066]]

Section 14(a)(2) of the CPSA requires every manufacturer of a 
children's product that is subject to a children's product safety rule 
to certify, based on third party testing, that the product complies 
with all applicable safety rules. Section 14(i)(2) of the CPSA requires 
the Commission to establish protocols and standards (i) for ensuring 
that a children's product is tested periodically and when there has 
been a material change in the product, (ii) for the testing of 
representative samples to ensure continued compliance, (iii) for 
verifying that a product tested by a conformity assessment body 
complies with applicable safety rules, and (iv) for safeguarding 
against the exercise of undue influence on a conformity assessment body 
by a manufacturer or private labeler.
    Because bassinets/cradles will be subject to a mandatory standard, 
they will also be subject to the third party testing requirements of 
section 14(a)(2) of the CPSA when the mandatory standard and the notice 
of requirements become effective.

Impact on Small Businesses

    There are approximately 55 firms currently known to be marketing 
bassinets and/or cradles in the United States. Under U.S. Small 
Business Administration (SBA) guidelines, a manufacturer of bassinets 
or cradles is small if it has 500 or fewer employees, and importers and 
wholesalers are considered small if they have 100 or fewer employees. 
Based on these guidelines, 38 are small firms--19 domestic 
manufacturers, 8 domestic importers, and 11 firms with unknown supply 
sources (including 9 specializing in bedding). The remaining firms are 
five large domestic manufacturers, three large domestic importers, 
three large retailers with unknown supply sources, and six foreign 
firms. There may be additional unknown small bassinet/cradle suppliers 
operating in the U.S. market.
    Small manufacturers. The expected impact of the proposed standard 
on small manufacturers will differ based on whether their bassinets/
cradles are already compliant with F2194-10. Firms whose bassinets and 
cradles meet the requirements of F2194-10 are likely to continue to 
comply with the voluntary standard as new versions are published. In 
addition, they are likely to meet any new standard within 6 months 
because this is the amount of time JPMA allows for products in their 
certification program to shift to a new standard. Many of these firms 
are active in the ASTM standard development process, and compliance 
with the voluntary standard is part of an established business 
practice. Therefore, it is likely that firms supplying bassinets and 
cradles that comply with ASTM F2194-10 (which went into effect for JPMA 
certification purposes in November 2010) would also likely comply with 
F2194-12 by January 2013, even in the absence of a mandatory standard.
    It is possible that the direct impact for manufacturers whose 
products are likely to meet the requirements of ASTM F2194-12 (10 of 19 
firms) could be significant for one or more firms if they must redesign 
their bassinets to meet the proposed rule. While none of these 
manufacturers would be newly covered due to the proposed change in 
scope, seven would be affected by the mattress flatness requirement 
(i.e., they produce play yards with bassinet attachments), and at least 
two (and possibly four) may be affected by the removable bassinet bed 
stability requirement. For the most part, the bassinets/cradles and 
bassinet cradle attachments supplied by these firms will be able to 
meet the staff-recommended changes to ASTM F2194-12, without 
modification. In cases where modifications are necessary, they would 
most likely opt to retrofit their products, rather than undertake an 
expensive redesign. However, it is possible that some products may 
require redesign, particularly to meet the new removable bassinet bed 
stability requirement; therefore, costs could be significant in some 
cases.
    Meeting ASTM F2194-12's requirements could necessitate product 
redesign for at least some bassinets/cradles that are believed not to 
be compliant with F2194-10 (9 of 19 firms). Two of these firms produce 
either Moses baskets or carriage stroller attachments along with 
separate stands, and therefore, they are included only because of the 
proposed change in scope. (Since no Moses baskets or carriage 
attachments for strollers are currently tested to the ASTM bassinets/
cradles standard, it is assumed that none would meet ASTM F2194-12 
without modifications). The remaining seven firms could require 
redesign, regardless of the staff-recommended modifications. A redesign 
would be minor if most of the changes involve adding straps and 
fasteners or using different mesh or fabric, but it could be more 
significant if changes to the frame are required, including changes to 
side height. One manufacturer estimated that a complete play yard 
redesign, including engineering time, prototype development, tooling, 
and other incidental costs, would cost approximately $500,000. The 
Commission believes that a bassinet redesign would tend to be 
comparable. Consequently, the proposed rule could potentially have a 
significant direct impact on small manufacturers whose products do not 
conform to F2194-10. However, any direct impact might be mitigated if 
costs are treated as new product expenses that can be amortized.
    It is possible that some firms supply bassinets/cradles that are 
compliant with F2194-10, even though they are not certified or marketed 
as compliant. The Commission has identified many such cases with other 
products. To the extent that some of these firms may supply compliant 
bassinets/cradles and have developed a pattern of compliance with the 
voluntary standard, the direct impact of the proposed standard will be 
less significant than described above. There are also two small firms 
with unknown supply sources, none of which appear to comply with F2194-
10 (one is covered by the proposed rule due to the expanded scope). If 
these firms are manufacturers, they may also require redesign to meet 
the proposed standard.
    In addition to the direct impact of the proposed standard described 
above, there are indirect impacts. These impacts are considered 
indirect because they do not arise directly as a consequence of the 
bassinet/cradle rule's requirements. Nonetheless, they could be 
significant. Once the rule becomes final and the notice of requirements 
is in effect, all manufacturers will be subject to the additional costs 
associated with the third party testing and certification requirements. 
This will include any physical and mechanical test requirements 
specified in the final rule; lead and phthalates testing is already 
required, and hence, not included here.\1\
---------------------------------------------------------------------------

    \1\ Bassinet and cradle suppliers already must third party test 
their products to the lead and phthalate requirements. Therefore, 
these costs are left out of the analysis above.
---------------------------------------------------------------------------

    One manufacturer estimated that testing to the ASTM voluntary 
standard runs around $1,000 per model sample, although they noted that 
the costs could be lower for some models where the primary difference 
is fabric rather than structure. Testing overseas could potentially 
reduce some testing costs, but this may not always be practical.
    On average, each small domestic manufacturer supplies eight 
different models of bassinets/cradles and/or play yards with bassinet/
cradle accessories to the U.S. market annually. Therefore, if third 
party testing were conducted every year on a single sample for each 
model, third party testing costs for each

[[Page 64067]]

manufacturer would be about $8,000 annually. Based on a review of firm 
revenues, the impact of third party testing to ASTM F2194-12 is 
unlikely to be significant if only one bassinet/cradle sample per model 
is required. However, if more than one sample would be needed to meet 
the testing requirements, third party testing costs could have a 
significant impact on a few of the small manufacturers.

Small Importers

    As with manufacturers of compliant bassinets/cradles, the four 
small importers of bassinets/cradles currently in compliance with 
F2194-10 could experience significant direct impacts as a result of the 
proposed rule, if product redesign is necessary. In the absence of 
regulation, these firms would likely continue to comply with the 
voluntary standard as it evolves and likely the final mandatory 
standard as well. Any increase in production costs experienced by their 
suppliers may be passed on to them.
    Importers of bassinets/cradles would need to find an alternate 
source if their existing supplier does not come into compliance with 
the requirements of the proposed rule, which may be the case with the 
four importers of bassinets/cradles believed not to be in compliance 
with F2194-10 (two of which are covered by the proposed rule due to the 
expanded scope). Some could respond to the rule by discontinuing the 
import of their noncompliant bassinets/cradles, possibly discontinuing 
the product line altogether. However, the impact of such a decision 
could be mitigated by replacing the noncompliant bassinets/cradles with 
compliant bassinets/cradles. Deciding to import an alternative product 
would be a reasonable and realistic way to offset any lost revenue.
    As is the case with manufacturers, all importers will be subject to 
third party testing and certification requirements, and consequently, 
they will experience costs similar to those for manufacturers if their 
supplying foreign firm(s) does not perform third party testing. The 
resulting costs could have a significant impact on a few small 
importers who must perform the testing themselves if more than one 
sample per model were required.
    Bedding Suppliers. There are nine known small firms specializing in 
the supply of bedding, including bedding for bassinets and cradles. 
Each firm sells basic bassinet or cradle shells, covered with their 
bassinet and cradle bedding. While it is clear that these firms do not 
manufacture the structural parts of the bassinets or cradles 
themselves, it is unclear whether they purchase them domestically or 
overseas. Regardless, these firms will be affected by the proposed rule 
in a manner similar to importers.
    Because none of these firms is believed to supply bassinets or 
cradles in compliance with F2194-10, they would need to find an 
alternate source if their existing supplier does not come into 
compliance with the requirements of the proposed rule. Unlike most 
importers, however, they would not have the option of replacing a 
noncompliant bassinet/cradle with another product. While they could opt 
to sell the bedding without the associated bassinet/cradle, this is the 
standard method of sale, and it might make it more difficult to compete 
in the bassinet/cradle market.
    As with manufacturers and importers, these firms will also be 
subject to third party testing and certification requirements, and they 
will experience costs similar to those for manufacturers if their 
supplying firm(s) does not perform third party testing. The resulting 
costs could have a significant impact on some of these small bassinet/
cradle suppliers who must perform the testing themselves.

Alternatives

    Under the Danny Keysar Child Product Safety Notification Act, 
section 104 of the CPSIA, one alternative that would reduce the impact 
on small entities is to make the voluntary standard mandatory with no 
modifications. Doing so would eliminate the impact on the six small 
firms that would be newly covered under the bassinet/cradle standard 
due to the proposed change in scope. These firms all supply Moses 
baskets or carriages, along with stationary stands; the Commission 
believes that these products require additional safety features when 
used for sleeping purposes. Adopting the voluntary standard without 
modifications could also reduce the impact on other small manufacturers 
and importers whose ASTM-compliant bassinets/cradles would require 
modifications due to the proposed changes. However, because of the 
severity of the incidents associated with instability and mattress 
tilt, the Commission does not recommend this alternative.
    A second alternative would be to set an effective date later than 
the proposed 6 months that is generally considered sufficient time for 
suppliers to come into compliance with a proposed rule. Setting a later 
effective date would allow suppliers additional time to modify and/or 
develop compliant bassinets/cradles and spread the associated costs 
over a longer period of time.
    The Commission invites comments describing the possible impact of 
this rule on manufacturers and importers, as well as comments 
containing other information describing how this rule will affect small 
businesses.

J. Environmental Considerations

    The Commission's regulations address whether we are required to 
prepare an environmental assessment or an environmental impact 
statement. If our rule has ``little or no potential for affecting the 
human environment'' it will be categorically exempted from this 
requirement. 16 CFR 1021.5(c)(1). The proposed rule falls within the 
categorical exemption.

K. Paperwork Reduction Act

    This proposed rule contains information collection requirements 
that are subject to public comment and review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3521). In this document, pursuant to 44 U.S.C. 
3507(a)(1)(D), we set forth:
     A title for the collection of information;
     A summary of the collection of information;
     A brief description of the need for the information and 
the proposed use of the information;
     A description of the likely respondents and proposed 
frequency of response to the collection of information;
     An estimate of the burden that shall result from the 
collection of information; and
     Notice that comments may be submitted to the OMB.
    Title: Safety Standard for Bassinets and Cradles.
    Description: The proposed rule would require each bassinet and 
cradle to comply with ASTM F 2194-12, ``Standard Consumer Safety 
Specification for Bassinets and Cradles.'' Sections 8 and 9 of ASTM F 
2194-12 contain requirements for marking, labeling, and instructional 
literature. These requirements fall within the definition of 
``collection of information,'' as defined in 44 U.S.C. 3502(3).
    Description of Respondents: Persons who manufacture or import 
bassinets/cradles.
    Estimated Burden: We estimate the burden of this collection of 
information as follows:

[[Page 64068]]



                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of       Frequency of     Total annual      Hours per       Total burden
                           16 CFR Section                              respondents       responses        responses         response          hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1218...............................................................              55                5              275                1              275
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Our estimates are based on the following:
    Section 8.1.1 of ASTM F 2194-12 requires that the name of the 
manufacturer, distributor, or seller and either the place of business 
(city, state, and mailing address, including zip code) or telephone 
number, or both, be marked clearly and legibly on each product and its 
retail package. Section 8.1.2 of ASTM F 2194-12 requires a code mark or 
other means that identifies the date (month and year, at a minimum) of 
manufacture.
    There are 55 known entities supplying bassinets to the U.S. market. 
All 55 firms are assumed to use labels already on both their products 
and their packaging, but they might need to make some modifications to 
their existing labels. The estimated time required to make these 
modifications is about 1 hour per model. Each entity supplies an 
average of eight different models of bassinets; therefore, the 
estimated burden associated with labels is 1 hour per model x 55 
entities x 5 models per entity = 275 hours. We estimate the hourly 
compensation for the time required to create and update labels is 
$27.55 (U.S. Bureau of Labor Statistics, ``Employer Costs for Employee 
Compensation,'' March 2012, Table 9, total compensation for all sales 
and office workers in goods-producing private industries: https://www.bls.gov/ncs/). Therefore, the estimated annual cost to industry 
associated with the labeling requirements is $7,576.25 ($27.55 per hour 
x 275 hours = $7,576.25). There are no operating, maintenance, or 
capital costs associated with the collection.
    Section 9.1 of ASTM F2194-12 requires instructions to be supplied 
with the product. Bassinets and cradles are products that generally 
require assembly, and products sold without such information would not 
be able to compete successfully with products supplying this 
information. Under the OMB's regulations (5 CFR 1320.3(b)(2)), the 
time, effort, and financial resources necessary to comply with a 
collection of information that would be incurred by persons in the 
``normal course of their activities'' are excluded from a burden 
estimate, where an agency demonstrates that the disclosure activities 
required to comply are ``usual and customary.'' Therefore, because we 
are unaware of bassinets or cradles that generally require some 
installation, but lack any instructions to the user about such 
installation, we tentatively estimate that there are no burden hours 
associated with section 9.1 of ASTM F2194-12 because any burden 
associated with supplying instructions with bassinets and cradles would 
be ``usual and customary'' and not within the definition of ``burden'' 
under the OMB's regulations.
    Based on this analysis, the proposed standard for bassinets would 
impose a burden to industry of 275 hours at a cost of $7,576.25 
annually.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
Sec.  3507(d)), we have submitted the information collection 
requirements of this rule to the OMB for review. Interested persons are 
requested to submit comments regarding information collection by 
November 19, 2012, to the Office of Information and Regulatory Affairs, 
OMB (see the ADDRESSES section at the beginning of this notice).
    Pursuant to 44 U.S.C. 3506(c)(2)(A), we invite comments on:
     Whether the collection of information is necessary for the 
proper performance of the CPSC's functions, including whether the 
information will have practical utility;
     The accuracy of the CPSC's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used;
     Ways to enhance the quality, utility, and clarity of the 
information to be collected;
     Ways to reduce the burden of the collection of information 
on respondents, including the use of automated collection techniques, 
when appropriate, and other forms of information technology; and
     The estimated burden hours associated with label 
modification, including any alternative estimates.

L. Preemption

    Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a 
consumer product safety standard is in effect and applies to a product, 
no state or political subdivision of a state may either establish or 
continue in effect a requirement dealing with the same risk of injury, 
unless the state requirement is identical to the federal standard. 
Section 26(c) of the CPSA also provides that states or political 
subdivisions of states may apply to the Commission for an exemption 
from this preemption under certain circumstances. Section 104(b) of the 
CPSIA refers to the rules to be issued under that section as ``consumer 
product safety rules,'' thus implying that the preemptive effect of 
section 26(a) of the CPSA would apply. Therefore, a rule issued under 
section 104 of the CPSIA will invoke the preemptive effect of section 
26(a) of the CPSA when it becomes effective.

M. Certification and Notice of Requirements (NOR)

    Section 14(a) of the CPSA imposes the requirement that products 
subject to a consumer product safety rule under the CPSA, or to a 
similar rule, ban, standard, or regulation under any other act enforced 
by the Commission, must be certified as complying with all applicable 
CPSC-enforced requirements. 15 U.S.C. 2063(a). Section 14(a)(2) of the 
CPSA requires that certification of children's products subject to a 
children's product safety rule be based on testing conducted by a CPSC-
accepted third party conformity assessment body. Section 14(a)(3) of 
the CPSA requires the Commission to publish a notice of requirements 
(NOR) for the accreditation of third party conformity assessment bodies 
(or laboratories) to assess conformity with a children's product safety 
rule to which a children's product is subject. The proposed rule for 16 
CFR part 1218, ``Safety Standard for Bassinets and Cradles,'' when 
issued as a final rule, will be a children's product safety rule that 
requires the issuance of an NOR.
    On May 24, 2012, the Commission published in the Federal Register 
the proposed rule, Requirements Pertaining to Third Party Conformity 
Assessment Bodies, 77 FR 331086, which, when finalized, would establish 
the general requirements and criteria concerning testing laboratories. 
These include the requirements and procedures for CPSC acceptance of 
the accreditation of a laboratory to test children's products in 
support of the certification required by section 14(a)(2) of the CPSA. 
The proposed rule at 16 CFR part 1112,

[[Page 64069]]

Requirements Pertaining to Third Party Conformity Assessment Bodies, 
lists the children's product safety rules for which the CPSC has 
published NORs for laboratories. In this document, the Commission is 
proposing to amend the list in 16 CFR part 1112, once that rule becomes 
final, to include the bassinet standard, once finalized, along with the 
other children's product safety rules for which the CPSC has issued 
NORs.
    Laboratories applying for acceptance as a CPSC-accepted third party 
conformity assessment body to test to the new standard for bassinets 
and cradles would be required to meet the third party conformity 
assessment body accreditation requirements in 16 CFR part 1112, 
Requirements Pertaining to Third Party Conformity Assessment Bodies, 
once that rule becomes final. When a laboratory meets the requirements 
as a CPSC-accepted third party conformity assessment body it can apply 
to the CPSC to have 16 CFR part 1218, Safety Standard for Bassinets and 
Cradles included in its scope of accreditation of CPSC safety rules 
listed for the laboratory on the CPSC Web site at www.cpsc.gov/labsearch.
    The final NOR will base the CPSC laboratory accreditation 
requirements on the performance standard set forth in the final rule 
for the safety standard for bassinets and cradles and the test methods 
incorporated within that standard. The Commission may recognize limited 
circumstances in which the Commission will accept certification based 
on product testing conducted before the Commission's acceptance of 
accreditation of laboratories for testing bassinets and cradles (also 
known as retrospective testing) in the final NOR. The Commission seeks 
comments on any issues regarding the testing requirements of the 
proposed rule for bassinets and cradles and the accompanying proposed 
NOR.

N. Request for Comments

    This proposed rule is part of a rulemaking proceeding under section 
104(b) of the CPSIA to issue a consumer product safety standard for 
bassinets and cradles. We invite all interested persons to submit 
comments on any aspect of the proposed rule. In particular, the 
Commission invites comments regarding the reliability of proposed 16 
CFR 1218.2(b)(7)(ii)(C) (allowing the option of making the sleep 
surface of the bassinet bed at least 20 degrees off from a horizontal 
plane when the bassinet bed is in an unlocked position as a means of 
meeting the stability requirement) with respect to notifying consumers 
that the bassinet bed is dangerously unstable as opposed to 
intentionally designed to rest at an angle. Comments should be 
submitted in accordance with the instructions in the ADDRESSES section 
at the beginning of this notice.

List of Subjects

16 CFR Part 1112

    Administrative practice and procedure, Audit, Consumer protection, 
Reporting and recordkeeping requirements, Third party conformity 
assessment body.

16 CFR Part 1218

    Consumer protection, Imports, Incorporation by reference, Infants 
and Children, Labeling, Law Enforcement, and Toys.

    For the reasons discussed in the preamble, the Commission proposes 
to amend Title 16 of the Code of Federal Regulations Chapter II as 
follows:

PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY 
ASSESSMENT BODIES

    1. The authority citation for part 1112 continues to read as 
follows:

    Authority:  Pub. L. 110-314, section 3, 122 Stat. 3016, 3017 
(2008); 15 U.S.C. 2063.

    2. In Sec.  1112.15, add paragraph (b)(33) to read as follows:


Sec.  1112.15  When can a third party conformity assessment body apply 
for CPSC acceptance for a particular CPSC rule and/or test method?

* * * * *
    (b) * * *
    (33) 16 CFR part 1218, Safety Standard for Bassinets and Cradles.
    3. Add part 1218 to read as follows:

PART 1218--SAFETY STANDARD FOR BASSINETS AND CRADLES

Sec.
1218.1 Scope.
1218.2 Requirements for bassinets and cradles.

    Authority:  The Consumer Product Safety Improvement Act of 2008, 
Pub. L. 110-314, section 104, 122 Stat. 3016 (August 14, 2008).


Sec.  1218.1  Scope.

    This part establishes a consumer product safety standard for 
bassinets and cradles.


Sec.  1218.2  Requirements for bassinets and cradles.

    (a) Except as provided in paragraph (b) of this section, each 
bassinet and cradle must comply with all applicable provisions of ASTM 
F 2194-12, Standard Consumer Safety Specification for Bassinets and 
Cradles, approved on June 1, 2012. The Director of the Federal Register 
approves this incorporation by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. You may obtain a copy from ASTM 
International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, 
PA 19428; https://www.astm.org/cpsc.htm. You may inspect a copy at the 
Office of the Secretary, U.S. Consumer Product Safety Commission, Room 
820, 4330 East West Highway, Bethesda, MD 20814, telephone 301-504-
7923, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: https://www.archives.gov/federal_register/code_of_federal regulations/ibr_locations.html.
    (b) Comply with the ASTM F 2194-12 standard with the following 
additions or exclusions:
    (1) Instead of complying with section 1.3 of ASTM F 2194-12, comply 
with the following:
    (i) 1.3 This consumer safety performance specification covers 
products primarily intended to provide sleeping accommodations 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. Products used in 
conjunction with an inclined infant swing or stroller, or products that 
are intended to provide an inclined sleep surface (head-to-toe 
direction) of greater than 10[deg] from horizontal, while in the rest 
(non-rocking) position, are not covered by this specification.

    Note to Paragraph (b)(1)(i): Cradle swings, with an incline less 
than or equal to 10[deg] from horizontal while in the rest (non-
rocking) position, are covered under the scope of this standard. A 
sleep product that has an inclined sleeping surface (intended to be 
greater than 10[deg] from horizontal while in the rest (non-rocking) 
position) does not fall under the scope of this standard. Strollers 
that have a carriage/bassinet feature are covered by the stroller/
carriage standard when in the stroller use mode. Carriage baskets/
bassinets that are removable from the stroller base are covered 
under the scope of this standard when the carriage basket/bassinet 
meets the definition of a bassinet/cradle found in 3.1.1. Bassinet/
cradle attachments to cribs or play yards, as defined in 3.1.2 or 
3.1.12, are included in the scope of the standard when in the 
bassinet/cradle use mode.

    (ii) [Reserved]
    (2) Add ``CAMI Newborn Dummy (see Fig. 1A). Drawing numbers 126-
0000 through 126-0015 (sheets 1 through 3), 126-0017 through 126-0027, 
a parts list entitled ``Parts List for CAMI Newborn Dummy,'' and a 
construction manual entitled ``Construction of the Newborn

[[Page 64070]]

Infant Dummy'' (July 1992). Copies of the materials may be inspected at 
NHTSA's Docket Section, 400 Seventh Street SW., Room 5109, Washington, 
DC, or at the Office of the Federal Register, 800 North Capitol Street 
NW., suite 700, Washington, DC.'' to ``2.3 Other References'' and use 
the following figure:
[GRAPHIC] [TIFF OMITTED] TP18OC12.003

    (3) Instead of complying with section 3.1.1 of ASTM F 2194-12, 
comply with the following:
    (i) 3.1.1 Bassinet/cradle, n--small bed designed primarily to 
provide sleeping accommodations for infants, supported by free-standing 
legs, a stationary frame/stand, a wheeled base, a rocking base, or 
which can swing relative to a stationary base; while in a rest (non-
rocking or swinging) position, a bassinet/cradle is intended to have a 
sleep surface less than or equal to 10[deg] from horizontal.
    (ii) [Reserved]
    (4) Instead of complying with section 3.1.2 of ASTM F 2194-12, 
comply with the following:
    (i) Bassinet/cradle accessory, n--a supported sleep surface that 
attaches to a crib or play yard designed to convert the product into a 
bassinet/cradle intended to have a sleep surface less than or equal to 
10[deg] from horizontal while in a rest (non-rocking or swinging) 
position.
    (ii) [Reserved]
    (5) Instead of complying with section 3.1.3 of ASTM F 2194-12, 
comply with the following:
    (i) 3.1.3 conspicuous, adj--describes a label or indicator that is 
visible, when the bassinet/cradle is in a manufacturer's recommended 
use position, to a person standing near the bassinet/cradle at any one 
position around the bassinet/cradle but not necessarily visible from 
all other positions.
    (ii) [Reserved]
    (6) In addition to complying with section 3.1.16 of ASTM F 2194-12, 
comply with the following:
    (i) 3.1.17 bassinet bed, n--the sleeping area of the bassinet, 
containing the sleep surface and side walls.
    (ii) 3.1.18 removable bassinet bed, n--A bassinet bed that is 
designed to separate from the base/stand without the use of tools.
    (iii) 3.1.19 false lock/latch visual indicator, n--a warning 
system, using contrasting bright colors, lights, or other similar means 
designed to visually alert caregivers when a removable bassinet bed is 
not properly locked onto its stand/base.
    (iv) 3.1.20 intended use orientation, n--The bassinet bed 
orientation (i.e., the position where the head and foot ends of the 
bassinet bed are located), with respect to the base/stand, as 
recommended by the manufacturer for intended use.
    (7) In addition to complying with section 6.8 of ASTM F 2194-12, 
comply with the following:
    (i) 6.9 Segmented Mattress Flatness--If the bassinet or bassinet 
accessory has a folding and/or segmented mattress, any angle when 
measured in section 7.10 shall be less than or equal to 10 degrees.
    (ii) 6.10 Removable Bassinet Bed Attachment--Any product containing 
a removable bassinet bed with a latching or locking device intended to 
secure the bassinet bed to the stand/base, shall comply with 6.10.1, 
6.10.2, 6.10.3, 6.10.4 or 6.10.5 when tested in accordance with 7.11.
    (A) 6.10.1 The base/stand shall not support the bassinet bed (i.e., 
the bassinet bed collapses from the stand and contacts the floor).
    (B) 6.10.2 The lock/latch shall automatically engage under the 
weight of the bassinet bed (without any other force or action).
    (C) 6.10.3 The sleep surface of the bassinet bed shall be at least 
20[deg] off from a horizontal plane when the bassinet bed is in an 
unlocked position.
    (D) 6.10.4 The bassinet shall provide a false latch/lock visual 
indicator(s) that is conspicuous, at a minimum, on the two longest 
sides of the product.
    (E) 6.10.5 The bassinet bed shall not tip over and shall retain the 
CAMI newborn dummy.
    (8) Instead of complying with section 7.4.4 of ASTM F 2194-12, 
comply with the following:
    (i) 7.4.4 Place the CAMI Newborn Dummy on the sleeping pad in the 
center of the product face up with the arms and legs straightened.
    (A) Rationale. The newborn CAMI dummy represents a 50th percentile 
newborn infant, which is a more appropriate user of a bassinet than the 
CAMI infant dummy, which represents a 50th percentile 6-month-old 
infant.
    (B) [Reserved].
    (ii) [Reserved].
    (9) In addition to complying with section 7.9 of ASTM F 2194-12, 
comply with the following:
    (i) 7.10 Segmented Mattress Flatness Test.
    (A) 7.10.1 Angle measurement for bassinets intended for a single 
occupant.
    (B) 7.10.1.1 Establish a horizontal reference plane by placing an 
inclinometer, with an accuracy capable of 0.5[deg] minimum resolution, 
on the floor of the testing area and zeroing it.
    (C) 7.10.1.2 Assemble the product according to the manufacturer's 
instructions. If the product has more than one mode, assemble in the 
bassinet mode(s). Disable the rocking/swinging feature if the product 
is equipped with such a feature.
    (D) 7.10.1.3 Place the infant test cylinder, as shown in Fig. 13, 
in the center of the 1st seam (the seam

[[Page 64071]]

between an end panel and its adjacent panel), as shown in Fig. 14, and 
allow the cylinder to come to rest in the seam.

    Note to Paragraph (b)(9)(i)(D): If the cylinder begins to roll 
out of the seam, place a stop(s) on the mattress surface against the 
cylinder to prevent movement. The stop(s) shall not influence the 
angle measurement and shall have a total weight no greater than 0.25 
lbs.

    (E) Figure 13. Infant Test Cylinder.
    [GRAPHIC] [TIFF OMITTED] TP18OC12.004
    
    (F) Figure 14. Cylinder placement on mattress seam.
    [GRAPHIC] [TIFF OMITTED] TP18OC12.005
    
    (G) 7.10.1.4 Place a 6'' x 4'' x \1/2\'' (152 x 101.6 x 12.7 mm) 
nominal thickness steel block weighing 3.3 lbs. (+/- 0.2 pounds) on the 
mattress panel in front of the cylinder with the 6'' length of the 
block in line with the center line of the cylinder as shown in Fig. 15. 
Place the block within \1/2\''; (12.7 mm) of the cylinder. If the block 
slides and touches the cylinder, this is allowable.
    (H) 7.10.1.4.1 Where the play yard bassinet size constraints do not 
allow for placement of the steel block in front of the cylinder, move 
the cylinder off center, enough to allow placement of the block, as 
outlined above in 7.10.1.4.
    (I) 7.10.1.5 Place the inclinometer in the center of the block, and 
measure the angle formed with the horizontal along the line that is 
perpendicular to the longitudinal axis of the cylinder, as shown in 
Fig. 16. Ensure the inclinometer does not touch the mattress surface.

    Note to Paragraph (b)(9)(i)(I):  If needed, an additional level 
block of negligible mass, no greater than 0.2 lb, may be placed atop 
the steel block in order to elevate the inclinometer, such that it 
does not touch the mattress surface.

    (J) Figure 15. Steel block in front of the cylinder for a single 
occupant bassinet.

[[Page 64072]]

[GRAPHIC] [TIFF OMITTED] TP18OC12.006

    (K) Figure 16. Inclinometer on steel block in front of the cylinder 
for a single occupant bassinet.
[GRAPHIC] [TIFF OMITTED] TP18OC12.007

    (L) 7.10.1.6 Record the angle measurement.
    (M) 7.10.1.7 Repeat 7.10.1.4-7.10.1.5 on the opposite side of the 
seam and record the measurement.
    (N) 7.10.1.8 Remove the cylinder from the bassinet.
    (O) 7.10.1.9 Repeat 7.10.1.3-7.10.1.8 on each remaining seam of the 
mattress and record the angles.
    (P) 7.10.2 Angle measurement for bassinets intended for two 
occupants:
    (Q) 7.10.2.1 Establish a horizontal reference plane by placing an 
inclinometer, with an accuracy capable of 0.5[deg] minimum resolution, 
on the floor of the testing area and zeroing it.
    (R) 7.10.2.2 Place one at a time, two identical newborn test 
cylinders (A and B), as shown in Fig. 17 in the occupant retention 
areas, as shown in Fig. 18, and allow them to come to rest in the seam.

    Note to Paragraph (b)(9)(i)(R):  If the cylinder begins to roll 
out of the seam place a stop(s) on the mattress surface against the 
cylinder to prevent movement. The stop(s) shall not influence the 
angle measurement and shall have a total weight no greater than 0.25 
lbs.

    (S) Figure 17. Newborn Test Cylinder

[[Page 64073]]

[GRAPHIC] [TIFF OMITTED] TP18OC12.008

    (T) Figure 18. Placement of cylinders for a 2 occupant bassinet.
    [GRAPHIC] [TIFF OMITTED] TP18OC12.009
    
    (U) 7.10.2.3 Apply a 10.0  0.5 lb compression force 
simultaneously with a force gauge onto the center of each cylinder, and 
hold for 10 seconds.
    (V) 7.10.2.4 Place a 6'' x 4'' x \1/2\'' (152 x 101.6 x 12.7 mm) 
nominal thickness steel block weighing 3.3 lbs. (+/- 0.2 pounds) on the 
mattress panel in front of cylinder A with the 6'' length of the block 
in line with the center line of the cylinder, as shown in Fig. 19. 
Place the block within \1/2\'' (12.7 mm) of the cylinder. If the block 
slides and touches the cylinder, this is allowable.
    (W) 7.10.2.4.1 Where the play yard bassinet size constraints do not 
allow for placement of the steel block in front of the cylinder, move 
the cylinder off center enough to allow placement of the block as 
outlined above in 7.10.2.4.
    (X) 7.10.2.5 Place the inclinometer on the block, and measure the 
angle formed with the horizontal along the line that is perpendicular 
to the longitudinal axis of cylinder A, as shown in Fig. 20. Ensure 
that the inclinometer does not touch the mattress surface.

    Note to Paragraph (b)(9)(i)(X): If needed, an additional level 
block of negligible mass, no greater than 0.2 lb, may be placed atop 
the steel block in order to elevate the inclinometer, such that it 
does not touch the mattress surface.

    (Y) Figure 19. Steel block in front of the cylinder for a 2-
occupant bassinet.

[[Page 64074]]

[GRAPHIC] [TIFF OMITTED] TP18OC12.010

    (Z) Figure 20. Inclinometer on Steel block in front of the cylinder 
for a 2-occupant bassinet.
[GRAPHIC] [TIFF OMITTED] TP18OC12.011

    (AA) 7.10.2.6 Record the angle measurement.
    (BB) 7.10.2.7 Repeat 7.10.2.4-7.10.2.5 on the opposite side of the 
cylinder and record the measurement.
    (CC) 7.10.2.8 Repeat the angle measurements 7.10.2.4-7.10.2.7 for 
cylinder B and record the measurement.
    (DD) 7.10.2.9 Remove both cylinders and then place them in the 
occupant retention areas such that the side of the cylinders are in 
contact with the inside wall as shown in Fig. 21.
    (EE) 7.10.2.10 Apply a 10.0  0.5 lb compression force 
simultaneously with a force gauge onto the center of each cylinder and 
hold for 10 seconds.
    (FF) Figure 21. Two cylinders (A and B) in contact with the inside 
wall.
[GRAPHIC] [TIFF OMITTED] TP18OC12.012


[[Page 64075]]


    (GG) 7.10.2.11 Place 6'' x 4'' x \1/2\'' (152 x 101.6 x 12.7 mm) 
nominal thickness steel block weighing 3.3 lbs. (+/- 0.2 pounds) on the 
mattress panel on one side perpendicular to the longitudinal axis of 
the cylinder, with the centerline of the block adjacent to the midpoint 
of the cylinder. Place the block within \1/2\'' (12.7 mm) of the 
cylinder. If the block slides and touches either the inside wall or the 
cylinder, this is allowable.
    (HH) 7.10.2.12 Place the inclinometer in the center of the block, 
and measure the angle formed with the horizontal along the line that is 
perpendicular to the longitudinal axis of cylinder A as shown in Fig. 
22.
    (II) 7.10.2.13 Record the angle measurement.
    (JJ) 7.10.12.14 Place a 6'' x 4'' x \1/2\'' (152 x 101.6 x 12.7 mm) 
nominal thickness steel block weighing 3.3 lbs. (+/- 0.2 pounds) on the 
mattress panel on one side perpendicular to the longitudinal axis of 
the cylinder, with the centerline of the block adjacent to the midpoint 
of the cylinder. Place the block within \1/2\'' (12.7 mm) of the 
cylinder. If the block slides and touches the cylinder, this is 
allowable.
    (KK) 7.10.12.15 Place the inclinometer in the center of the block, 
and measure the angle formed with the horizontal along the line that is 
perpendicular to the longitudinal axis of cylinder B, as shown in Fig. 
23.
    (LL) 7.10.2.16 Record the angle measurement.
    (MM) Figure 22. Angle measure in front of Cylinder A.
    [GRAPHIC] [TIFF OMITTED] TP18OC12.013
    
    (NN) Figure 23. Angle measure in front of Cylinder B.
    [GRAPHIC] [TIFF OMITTED] TP18OC12.014
    
    (OO) Rationale. (1) The cylinder used in 7.10.1 was copied from a 
European standard for baby walkers (EN 1273:2005) and appears to be 
based on the weight and torso dimensions of a child between 6 and 8 
months old. This represents the heaviest intended occupant, which will 
result in a more conservative test.
    (2) Because bassinet accessories intended for multiple births will 
have a shorter useful range of utility, the larger cylinder used in 
7.10.2 was too heavy to represent the intended user population. The 
smaller cylinder used in 7.10.2 was based on the weight of an infant, 
matched to the height of the test cylinder in 7.10.1.
    (ii) [Reserved].
    (10) In addition to the changes to ASTM F 2194-12 in paragraph 
(b)(10) of this section comply with the following:
    (i) 7.11 Removable Bassinet Bed Attachment Tests.
    (A) 7.11.1 Assemble the bassinet/cradle base/stand only, in 
accordance with manufacturer's instructions.
    (B) 7.11.2 Place the base/stand in one of the manufacturer's 
recommended use positions.
    (C) 7.11.3 Place the base/stand and the inclinometer on a flat 
level horizontal surface (0 +/- 0.5[deg]) to establish a test plane. 
Zero the inclinometer.
    (D) 7.11.4 Remove the mattress pad from the bassinet bed.

    Note to Paragraph (b)(10)(i)(D): For mattresses that are 
integral with the mattress support, do not remove the mattress and 
perform all angle measurements for 7.11 on a 6 by 6 by \3/8\-in. 
nominal aluminum block placed on the center of the mattress.

    (E) 7.11.5 Place the bassinet bed on the base/stand in the intended 
use orientation without engaging any latch or lock mechanism. If the 
bassinet bed can rest on the base/stand in its intended use orientation 
in more than one lateral unlocked position (see Figure 24), the unit 
shall be evaluated in the lateral position most likely to fail the 
requirements outlined in 6.10.
    (F) Figure 24: Bassinet Bed Resting on Stand, Showing Possible 
Alternate Lateral Positions.

[[Page 64076]]

[GRAPHIC] [TIFF OMITTED] TP18OC12.015

    (G) 7.11.5.1 If the base/stand supports the bassinet bed, place the 
inclinometer on the mattress support at the approximate center of the 
mattress support. Care should be taken to avoid seams, snap fasteners, 
or other items that may affect the measurement reading. Record the 
angle measurement.
    (H) 7.11.5.2 If the base/stand supports the bassinet bed and the 
angle of the mattress support surface is less than 20 degrees of 
horizontal, evaluate whether the bassinet has a visual indicator per 
6.10.4.
    (I) 7.11.5.3 If the base/stand supports the bassinet bed, and the 
angle of the mattress support surface is less than 20 degrees of 
horizontal, and the bassinet does not contain a false latch/lock 
indicator, test the unit in accordance with sections 7.4.2-7.4.7.
    (J) 7.11.6 Repeat 7.11.3 through 7.11.5.3 for all of the 
manufacturer's base/stand positions.
    (K) 7.11.7 If the product design allows, repeat 7.11.2 through 
7.11.6 with the bassinet bed rotated 180[deg] from the normal use 
orientation.
    (1) Rationale. This test requirement addresses fatal and 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. Products that appear 
to be in an intended use position when the lock or latch is not 
properly engaged can create a false sense of security by appearing to 
be stable. Unsecured or mis-aligned lock/latch systems are a hidden 
hazard because they not easily seen by consumers due to being located 
beneath the bassinet or covered by decorative skirts. In addition, 
consumers will avoid activating lock/latch mechanisms for numerous 
reasons if a bassinet bed appears stable when placed on a stand/base. 
Because of these foreseeable use conditions, this requirement has been 
added to ensure that bassinets with a removable bassinet bed feature 
will be inherently stable or it is obvious that they are not properly 
secured.
    (2) Section 6.10 allows bassinet bed designs that:
    (i) Cannot be supported by the base/stand in an unlocked 
configuration,
    (ii) Automatically lock and cannot be placed in an unlocked 
position on the base/stand,
    (iii) Are clearly and obviously unstable when the lock/latch is 
misaligned or unused,
    (iv) Provide a visual warning to consumers when the product is not 
properly locked onto the stand/base, or
    (v) Have lock/latch mechanisms that are not necessary to provide 
needed stability.
    (ii) [Reserved].

    Dated: October 4, 2012.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2012-24896 Filed 10-17-12; 8:45 am]
BILLING CODE 6355-01-P
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