Safety Standard for Bedside Sleepers, 73345-73354 [2012-29583]

Download as PDF Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Proposed Rules at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425–227–1221. (l) Other FAA AD Provisions The following provisions also apply to this AD: (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Dan Rodina, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, Washington 98057– 3356; telephone (425) 227–2125; fax (425) 227–1149. Information may be emailed to: 9ANM-116-AMOC-REQUESTS@faa.gov. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/ certificate holding district office. The AMOC approval letter must specifically reference this AD. (2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service. mstockstill on DSK4VPTVN1PROD with (k) Parts Installation Prohibition As of the effective date of this AD, no person may install a SOGERMA pilot or copilot seat having P/N 2510112 series, or P/N 2510113 series, on any airplane unless it has passed the tensile test required by paragraph (i) of this AD, or has been replaced or modified as required by paragraph (j) of this AD. [FR Doc. 2012–29710 Filed 12–7–12; 8:45 am] (m) Related Information (1) Refer to Mandatory Continuing Airworthiness Information European Aviation Safety Agency, Airworthiness Directive 2012–0102, dated June 8, 2012, and the service information specified in paragraphs (m)(1)(i) and (m)(1)(ii) of this AD, for related information. (i) Airbus Alert Operators Transmission A300–A25W001–12, dated June 6, 2012. (ii) EADS SOGERMA Service Bulletin 2510112–25–898, dated April 25, 2012. (2) For Airbus service information identified in this AD, contact Airbus SAS— EAW (Airworthiness Office), 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email account.airwortheas@airbus.com; Internet https:// www.airbus.com. For EADS SOGERMA service information identified in this AD, contact EADS SOGERMA, Zone Industrielle de l’Arsenal, CS. 60109, 17303 Rochefort, Cedex France; phone: 33 5 46 82 84 84; fax: 33 5 46 82 88 13; email: SCOD1@sogerma.eads.net; Internet: https:// www.sogerma.eads.net. You may review copies of the referenced service information VerDate Mar<15>2010 16:22 Dec 07, 2012 Jkt 229001 Issued in Renton, Washington, on November 30, 2012. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. BILLING CODE 4910–13–P CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1112 and 1222 [Docket No. CPSC–2012–0067] Safety Standard for Bedside Sleepers Consumer Product Safety Commission. ACTION: Notice of proposed rulemaking. AGENCY: The Danny Keysar Child Product Safety Notification Act, Section 104 of 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 bedside sleepers in response to the direction under Section 104(b) of the CPSIA. DATES: Submit comments by February 25, 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–2012–0067, 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 SUMMARY: PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 73345 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 proposed 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–2012–0067, into the ‘‘Search’’ box and follow the prompts. FOR FURTHER INFORMATION CONTACT: Douglas A. Lee, Project Manager, Directorate for Engineering Sciences, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone 301–987–2073; email dlee@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 E:\FR\FM\10DEP1.SGM 10DEP1 73346 Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Proposed Rules mstockstill on DSK4VPTVN1PROD with 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. In this document, the Commission is proposing a safety standard for bedside sleepers. Bassinets and cradles are specifically identified in section 104(f)(2)(L) as durable infant or toddler products. Bedside sleepers are similar to bassinets, and many bedside sleepers also function as bassinets. In addition, some beside sleepers are accessories to play yards/non-full-size baby cribs. On October 3, 2012, the Commission approved a notice of proposed rulemaking (NPR) for a Safety Standard for Bassinets and Cradles (https:// www.cpsc.gov/library/foia/foia12/brief/ bassinetnpr.pdf). The Commission has issued a Safety Standard for Play Yards, codified at 16 CFR part 1221. Recently the Commission has proposed specific language to address hazards due to misassembly of play yard bassinet accessories in a notice of proposed rulemaking (77 FR 52272, August 29, 2012). This proposed rule, if finalized, would amend the Safety Standard for Play Yards. The proposed rule for beside sleepers would adopt many of the requirements in the proposed NPR for bassinets, as well as address the hazards associated with the use of bassinet play yard accessories that can be assembled with missing key structural requirements for bedside sleeper play yard accessories. 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 F2906–12, ‘‘Standard Consumer Safety Specification for Bedside Sleepers’’ (ASTM F2906–12), with additions to make the standard more stringent. The ASTM standard is copyrighted, but it 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 F2906–12 defines ‘‘bedside sleeper’’ as ‘‘a rigid frame assembly that may be combined with a fabric or mesh assembly, or both, used to function as VerDate Mar<15>2010 16:22 Dec 07, 2012 Jkt 229001 sides, ends, or floor or a combination thereof, and that is intended to provide a sleeping environment for infants and is secured to an adult bed.’’ A ‘‘multimode product’’ is ‘‘a unit that is designed and intended to be used in more than one mode (for example, a play yard, bassinet, changing table, hand held carrier, or bedside sleeper).’’ A bedside sleeper is intended to be secured to an adult bed that permits newborns and infants to sleep close by an adult without being in the adult bed. In current products, the horizontal sleep surface is typically 1 inch to 4 inches below the level of the adult bed’s mattress. The side of the bedside sleeper that is adjacent to the adult bed can usually be lowered, thereby differentiating bedside sleepers from bassinets, where all four sides of a bassinet are the same height. Bedside sleepers are intended for use with children up to the developmental stage where they can push up on hands and knees (about 5 months). This is the same developmental range for the intended users of bassinets. Current bedside sleepers range in size from about 35″ x 20″ to 40″ x 30.″ They may have rigid sides, but they are most commonly constructed with a tube frame covered by mesh or fabric. Freestanding bassinets are not covered under the proposed standard for bedside sleepers. They are covered under ASTM F2194–12a, ‘‘Standard Consumer Safety Specification for Bassinets and Cradles.’’ Several manufacturers produce multiuse (or multimode) bedside sleeper products that convert into bassinets and/or play yards. Most bedside sleeper products can be converted into a bassinet by raising the lowered side to have four equal-height sides, and a few also convert into a bassinet and play yard. Some play yards include bedside sleeper accessories which, when attached, convert the play yard into a bedside sleeper; and some bassinets convert into bedside sleepers. All of the tube-framed products that have been evaluated by CPSC staff may be collapsed for storage and transport. A bedside sleeper that can be used in additional modes would need to meet each applicable standard. For example, a bedside sleeper product that converts into a play yard and a bassinet would have to meet: ASTM F2906 bedside sleeper requirements, ASTM F2194 bassinet requirements (except for height of the fourth lowered side for bedside sleepers) and sections of the ASTM F406 play yard requirements applicable to bassinets when in the bedside sleeper mode; ASTM F406 play yard requirements when in play yard use PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 mode; and ASTM F2194 bassinet requirements and applicable sections of ASTM F406 play yard requirements when in bassinet mode. To ensure consistency with the existing and proposed standards for bassinets and play yards, the Commission is proposing additions to the scope and performance requirements of a bedside sleeper, as discussed below. C. The Voluntary Standard—ASTM F2906 ASTM first published a voluntary standard for bedside sleepers, ASTM F2906–11, in December 2011. It required bedside sleepers to meet the voluntary standard requirements of the product upon which it was based, either a play yard/non-full-size baby cribs, ASTM F406 (play yard standard) or a bassinet, ASTM F2194 (bassinet standard). The standard also addressed hazards specific to bedside sleeper products. It addressed incidents involving the creation of a hazardous gap between the product and an adult mattress, by requiring the successful completion of three disengagement tests. The tests ensured that the securing components can withstand forces that may be exerted on the product by either the child or an adult, while sleeping. The gap must be no more than 0.5 in. when the product is installed to the adult bed, per manufacturer’s directions. When a 25-lb. horizontal force is applied near the attachment system or corners, the gap may not exceed 1.0 in. And, to simulate an adult rolling into a bedside sleeper while sleeping, a gap greater than 1.0 in. may not be created after the application and release of a 50-lb. horizontal force to the bedside sleeper’s corners. The inclusion of these anti-gap requirements served to mitigate the foreseeable head and neck entrapment hazards posed by bedside sleepers. The standard requires a minimum 4-inch lowered side height over which a child is unlikely to be able to roll. In addition, latching and locking devices are evaluated to prevent unintentional movement of the side that lowers and to ensure overall product integrity. In 2012, the standard for bedside sleepers was changed from meeting either ASTM F406 (play yard standard) or ASTM F2194 (bassinet standard), to require all products to meet ASTM F2194 only. The bassinet minimum side-height requirement (the upper surface of the non-compressed mattress of a bassinet/cradle must be at least 7.5 inches lower than the upper surface of the lowest side in all intended bassinet/ cradle use positions) is also required for E:\FR\FM\10DEP1.SGM 10DEP1 mstockstill on DSK4VPTVN1PROD with Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Proposed Rules beside sleepers, with the exception of a lowered side rail (the height of the side rail in the lowest position shall be no less than 4 inches when measured from the top of the uncompressed bedside sleeper mattress to the top of the lowered side rail, when the mattress support is in its highest position.) Bedside sleepers and bassinets share a significant number of hazard patterns because they are used by children with the same developmental abilities and for the same purpose. Many bedside sleepers also function as bassinets. By requiring beside sleepers to be tested to ASTM F2194 (bassinets) rather than to ASTM F406 (play yards), ASTM made the bedside sleeper standard more stringent because there are bedside sleeper hazards covered by the bassinet standard but that are not covered by the play yard standard. Additionally, ASTM F406 requires a bassinet accessory on a play yard structure to meet the applicable sections of the play yard voluntary standard. These changes were incorporated into ASTM F2906–12, ‘‘Standard Consumer Safety Specification for Bedside Sleepers,’’ in July 2012. CPSC staff also reviewed mandatory and voluntary international standards in Canada, the European Union, Australia, and New Zealand. There are some international standards governing safe sleep products for infants; however, there are no specific requirements that address the hazards unique to bedside sleeper products. Canada has a mandatory standard for cribs, cradles, and bassinets, SOR/2010–26; the European Union uses EN 1130 Cribs and Cradles and EN 12790 Child Care Articles—Reclined Cradles to assess and market various design elements and structures in bedside sleeper products. In Australia and New Zealand, several standards exist for safe sleep products– AS/NZS 2172:2003 Cots (full-size and non-full-size cribs that do not fold); AS/ NZS 2195:1999 Folding Cots (play yards and folding cribs of any size); AS/NZS 4385:1996 Infants’ Rocking Cradles (cradles and bassinets that tilt.) The Juvenile Products Manufacturers Association (JPMA) has a certification program for a variety of juvenile products, including bassinets and play yards. Manufacturers that voluntarily obtain JPMA certification submit products to an independent test laboratory for conformance testing to the most recent version of the voluntary standard. Manufacturers have 6 months after publication of a new or revised standard to certify products to the new requirements. Currently, JPMA does not have a certification program for bedside sleepers, and no firm claims to meet the VerDate Mar<15>2010 16:22 Dec 07, 2012 Jkt 229001 ASTM voluntary standard, ASTM F2906–12. However, three firms supply multimode products, where one mode is compliant with the associated ASTM voluntary standard. Two firms claim compliance with the ASTM standard for bassinets; one firm is JPMA-certified as compliant, and the other claims compliance with the ASTM bassinet standard. A third firm supplies play yards that are JPMA-certified as compliant with the ASTM play yard/ non-full-size crib standard. D. Incident Data CPSC staff identified 40 cases of bedside sleeper-related incidents from 2001 to 2011. The CPSC databases searched were the In-Depth Investigation database, the Injury or Potential Injury Incident database, and the Death Certificate file. National estimates of bedside sleeper productrelated injuries are not available because the National Electronic Injury Surveillance System (NEISS) data does not allow for clear identification of bedside sleepers. Therefore, the risk of injury associated with the number of products in use cannot be calculated. CPSC staff is aware of four fatalities and 36 nonfatal incidents (with and without injuries) related to bedside sleepers that were reported from January 2001 through December 2011. Bedside sleepers have been on the market since 1997. During this time, there have been two recalls for product defects that created a substantial product hazard. One recall involved four deaths, three from head entrapment and one from suffocation, and several complaints on the same entrapment hazard from a bedside sleeper with a bassinet base. This recall involved 3-in-1 and 4-in-1 convertible bassinets that contained metal bars covered by an adjustable fabric flap, attached with Velcro,® that folded down when the bassinet was converted into a bedside sleeper. If the Velcro® was not resecured properly when the flap was adjusted, an infant could slip through the opening and become entrapped in the metal bars and suffocate. Because of additional incidents, this recall was re-announced three times. There were 900,000 units recalled. The second recall involved a bedside sleeper with a play yard base. There were 10 reports of infants falling from the mattress into the bottom of a bedside sleeper or becoming entrapped between the edge of the mattress and the side of the bedside sleeper. There were 76,000 units recalled. Details of the recalls can be found on the cpsc.gov Web site. PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 73347 1. Fatalities All four reported fatalities involved the same brand of recalled bedside sleeper/bassinet. In all four cases, the product was being used in the bassinet mode, with the adjustable side raised at the time of the incident. Three of the deaths were due to entrapment and/or hanging, which resulted after an infant’s body, but not head, slipped through the fabric covering and underlying structural components of a particular brand of bedside sleeper. In two of these three fatalities involving a 4-month-old and a 6-month-old decedent, the infant’s head was entrapped between the lower horizontal bars (of the adjustable side) and the top of the mattress. The fabric flap designed to cover the metal bars was not in place. In the third fatality, the fabric flap covering the adjustable side was not secured to the permanent fabric siding, and the horizontal bars of the adjustable side were broken/ missing. As a result, the 6-month-old decedent’s body slipped out through an opening in the fabric siding, but her chin/throat got caught on a lower crossbar. The fourth death occurred when an infant moved into a corner where the fabric covering the adjustable side was not secured by the Velcro® strip and the bassinet was also missing the lower rail. This created a pocket between the side and bassinet floor. The infant was found with their head in the pocket and face against the side of the bassinet, resulting in suffocation. 2. Nonfatal Incidents Of the 36 nonfatal incidents, there were three reported injuries involving infants, none hospitalized, during the use of a bedside sleeper. All of the injured infants were under 5 months of age, which is within the ASTM recommended user age range. Two of the infants suffered bruising when they were entrapped between the metal rungs of the same product that had caused three of the fatalities described in the previous section. The third injury occurred when the infant rolled into a position where his neck was hyperextended into a non-breathable corner of the product, and he suffered respiratory difficulties. In all three cases, the caregiver was nearby to prevent any serious consequences. The remaining 33 reports indicated that no injury occurred or provided no information about any injury. However, many of the descriptions in the reports indicated the potential for a serious injury, or even death, in bedside sleepers. In cases where victim age was reported, six reported ages between 6 E:\FR\FM\10DEP1.SGM 10DEP1 73348 Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Proposed Rules months and 8 months old; the other infants were under 5 months of age. mstockstill on DSK4VPTVN1PROD with 3. Hazard Pattern Analysis CPSC staff considered all 40 incident reports to identify the hazard patterns associated with bedside sleeper-related incidents. The hazard scenarios in 24 of the 40 incidents (60 percent) reported were attributed to some sort of failure/ defect or a potential design flaw in the product. This category includes the four fatalities and three non-hospitalized injuries. Listed below are the reported problems, beginning with the most frequently reported concerns: • A problem with the adjustable fabric cover over the horizontal metal bars on the side that lowers in the bedside sleeper mode was responsible for nine of the reported incidents. These included all four fatalities and two of the injuries. All of these incidents involved one particular manufacturer’s bedside sleeper/convertible bassinet product, which was recalled in 2008. Two of the fatalities occurred before the CPSC recall; the third, which involved a secondhand product in poor condition, occurred after the 2008 recall, but prior to the 2009 recall (which was an expansion of the 2008 recall). Between the two injuries, one occurred prior to the 2008 recall, while the other occurred after that recall. Neither of the post-recall incident reports indicated whether the consumers were aware of the recall. • Issues with assembly instructions were identified in six reported incidents. In all of these reports, the consumer had misassembled the product but reported the product as being faulty. None of the incidents resulted in any injury or fatality. All but one of these incidents involved one particular manufacturer’s bedside sleeper, which was recalled in 2011. • Miscellaneous other product-related issues, such as non-levelness of the product (two reports), instability of leg extensions (two reports), poor design (two reports), broken component (one report), failure of the attachment (to adult bed) mechanism (one report), and unclear age labeling (one report) were reported in the remaining incident reports. One incident reported an injury associated with poor product design. • In response to CPSC recall notices, there were 16 non-incident reports of concerns or complaints. In these reports, the consumer either sought advice on options regarding a bedside sleeper product they owned that had been recalled, or they inquired about whether the product they owned was within the scope of the recall. VerDate Mar<15>2010 16:22 Dec 07, 2012 Jkt 229001 E. Proposed Changes to ASTM F2906– 12 CPSC staff identified 24 incidents due to defect or potential design flaws in the product. The hazards associated with these incidents included: Issues with the adjustable fabric cover over the metal bars on the side that lowered in the bedside sleeper mode (9 incidents); poor assembly instruction (6 incidents); and miscellaneous other product-related issues (9 incidents). To address these incidents, the Commission proposes to adopt by reference, ASTM International’s voluntary standard, ASTM F2906–12, Standard Consumer Safety Specification for Bedside Sleepers, with a few additions to strengthen the standard. Section 5 (Performance Requirements) of ASTM F2906–12 requires that in addition to the tests provided in ASTM F2906–12, the bedside sleeper must be tested to the bassinet standard (ASTM F2194). Specifically, section 5.1 provides that: Prior to or immediately after testing to this consumer safety specification, the bedside sleeper must be tested to Consumer Safety Specification F2194. Multi-mode products must also be tested to each applicable standard. When testing to Consumer Safety Specification F2194 the unit shall be free standing, and not be secured to the test platform as dictated elsewhere in this standard. Because bedside sleepers already are required to be tested to the applicable bassinet standard requirements, and multimode products, to each applicable standard, the Commission proposes in this rule to add clarifying language to ensure that the requirements that are not yet included in an existing standard or proposed in an NPR (i.e., ASTM F406– 12a (play yards) and ASTM F2194–12 (bassinets)) are also included in ASTM F2906–12 (bedside sleepers). 1. Fabric-Sided Enclosed Openings The current version of ASTM F2194– 12a (bassinets) contains a Fabric-Sided Enclosed Openings’ performance requirement for bassinets. This requirement prohibits completely bounded openings large enough to permit passage of an infant’s torso. The hazard scenarios addressed by this requirement encompass the three strangulation deaths described above and a related, foreseeable suffocation hazard. These hazards occur when a child passes through an opening, either becomes trapped between the liner and mattress pad and suffocates, or becomes suspended by the neck, and then strangles. This hazard, associated with a recall of 900,000 units, led to three of the four fatalities on a bassinet that converts to a bedside sleeper. The PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 bassinet test procedure (ASTM F2194– 12a, section 7.8) attempts to push a torso probe the size of a 5th percentile infant through bounded openings with 20 lbs of force. The test is first performed with product assembled per the manufacturer’s instructions. If the product has a removable cover, it is performed a second time after all fasteners or snaps are unfastened, but the removable cover left in place. In doing so, the test intentionally replicates the incorrectly secured fabric liner hazard scenario of the fatal incidents. A manufacturer’s bedside sleeper accessory exhibited this hazard, which led to its recall in 2011. The recall was initiated in response to incident reports in which the bedside sleeper accessory’s removable cover (liner or shell) was either not used, or was present but not secured to the play yard frame. This bedside sleeper accessory can also be used as a play yard, or a bassinet accessory to a play yard. When in the bassinet accessory position, the front side of the product can be lowered, transforming it into the beside sleeper mode. A 11⁄2 year-old unused sample of this product was recently retested by CPSC staff, confirming that it fails the ASTM F2194 fabric-sided enclosed opening requirement. However, a new sample of a similar model from the same manufacturer passed this test. Staff identified two possible reasons for testing variances. One explanation is that the fit of the shell to the play yard frame becomes looser with repeated assembly and disassembly. The other reason is that the seam joining the mesh and fabric part of the liner may be in a slightly different location on some models. The seam may cause sufficient friction on the torso test probe during force testing on some models. Accordingly, minor changes in materials or construction may not be sufficient to remedy the hazard presented by the fabric-sided, bounded opening hazard. Under section 6.7 of ASTM F2194–12, for bassinets/cradles with fabric sides, a completely bounded opening may not be created that allows the complete passage of the torso probe (based on a torso diameter of a 5th percentile 0 to 2-month-old infant) when tested in accordance with the fabric release test methods for enclosed openings. However, the test does not apply to play yard bassinets or play yard accessories. Bassinets accessories to play yards (that cannot be converted to bedside sleepers) are usually held in place by fasteners that clip to the top of the play yard’s railing. If the fasteners were left unclipped, the bassinet would fall, rendering the product untestable, due to E:\FR\FM\10DEP1.SGM 10DEP1 mstockstill on DSK4VPTVN1PROD with Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Proposed Rules the complete collapse of the bassinet attachment; test labs would likely consider that a failure. However, for bassinets that convert to a bedside sleeper with a lowered side, CPSC staff determined that all bedside sleeper play yard accessories should be subject to the requirements of the ASTM F2194–12 bassinet standard’s section 6.7 FabricSided Enclosed Opening without the exemption for bassinet play yard accessories, given the demonstrated hazards presented when a bedside sleeper’s removable cover (liner or shell) is either not used, or not secured properly. The Commission proposes additional language for the ASTM F2906 bedside sleeper standard to add a new definition for ‘‘bedside sleeper accessory’’ and eliminate the fabric-sided bounded opening performance requirement exemption currently granted to play yard bassinet accessories. Unlike bassinet play yard accessories, bedside sleeper (or a bassinet that is converted into a bedside sleeper) play yard accessories could have fasteners left unclipped (through the detachment of snaps/Velcro) where the bedside sleeper with the lowered side does not completely collapse. Because the bedside sleeper could still appear functional, the Commission proposes to add language under Section 3 (Terminology) of ASTM F2906–12. The new proposed section 3.1.8 would state: ‘‘bedside sleeper accessory, n—an elevated sleep surface that attaches to a non-full-size crib or play yard, designed to convert the product into a bedside sleeper intended to have a horizontal sleep surface while in a rest (nonrocking) position.’’ The Commission also proposes to add a new proposed section 5.7, stating: ‘‘a Bedside Sleeper Accessory Fabric-Sided Enclosed Openings—A bedside sleeper accessory shall meet the F2194 performance requirement ‘‘Fabric-Sided Enclosed Openings.’’ Under new proposed section 5.7.1, bedside sleeper accessories would be exempt from this requirement if either of the following two conditions were met after disengaging all fasteners between the accessory and the non-full-size crib or play yard base to which it is assembled: (1) The bedside sleeper accessory collapses under its own weight, such that any part of the mattress pad contacts the bottom floor of the non-fullsize crib or play yard (5.7.1.1); or (2) the bedside sleeper accessory’s sleep surface tilts by more 30 degrees (5.7.1.2). These requirements are also consistent with the proposed requirements in the NPR for the Safety VerDate Mar<15>2010 16:22 Dec 07, 2012 Jkt 229001 Standard for Play Yards for play yard bassinet accessory misassembly provisions, which require all key structural elements to be attached permanently to the bassinet shell. The second method of compliance is to meet a catastrophic failure test, where a missing key structural element makes the product collapse completely or tilt more than 30 degrees. 77 FR 52273. 2. Consumer Misassembly With Missing Components The Commission proposed a requirement to address consumer misassembly of key structural elements for bassinet accessories to play yards in the NPR for the Safety Standard for Play Yards, 77 FR 52272. However, the NPR for play yards did not include specific language for bedside sleeper play yard accessories. Although section 5 (Performance Requirements) of ASTM 2906–12 provides that bedside sleepers must be tested to ASTM F2194 (bassinets), and multimode products must also be tested to each applicable standard, the Commission proposes to add language to ASTM 2906–12 (bedside sleepers) to make explicit that the requirements for addressing consumer misassembly of key structural elements is required for bedside sleeper play yard accessories in addition to bassinet play yard accessories. As described at length in the NPR for the Safety Standard for Play Yards, 77 FR 52272, omission of key structural elements of a bassinet assembly (such as rods, tubes, bars, and hooks that keep the sleep surface flat and level) could result in a tilt in the sleeping surface and put the infant in a position where he or she is unable to breathe and is at risk of suffocation. This hazard is magnified should these misassembled products be used as an unsupervised sleep environment, another reasonably foreseeable scenario. Similarly, a misassembled bedside sleeper play yard accessory may not be readily apparent or obvious to the consumer. If the misassembled accessory supports an infant without a catastrophic and obvious change to the sleep surface, a consumer may continue to use the misassembled accessory and inadvertently place a child in danger. Bedside sleeper accessories and bassinet accessories incorporate very similar designs and manufacturing processes (because many bedside sleepers also function as bassinets), and many of the same performance requirements are applicable to both products. Accordingly, in order to ensure that all of the hazards associated with bedside sleeper play yard accessories and bassinet play yard accessories that can PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 73349 be assembled missing key structural elements are addressed, the Commission proposes to add under section 5 (Performance Requirements) to ASTM F2906–12, new proposed section 5.8 Bedside Sleeper Play Yard Accessories Missing Key Structural Elements. The new section 5.8 will provide: A bedside sleeper accessory shall meet the F406 general requirement, ‘‘Bassinet/Cradle Accessories Missing Key Structural Elements.’’ 3. New Requirements for Bassinets ASTM F2906–12 already requires bedside sleepers to meet the requirements of the bassinet standard, ASTM F2194 ‘‘Standard Consumer Product Safety Specification for Bassinets and Cradles,’’ with the exception of the height of the lowered fourth side. Most bedside sleepers also function as bassinets. The intended users are identical, and the majority of the hazards are identical. The Commission’s proposed modifications to address bassinet hazards in ASTM F2194–12 have been discussed in great detail in the NPR and in the Bassinet NPR staff briefing package. Specifically, the Commission proposed four changes to the ASTM bassinet standard. Three of those proposed changes to the bassinet standard would also be applicable to bedside sleepers. The fourth proposed change would update the scope and corresponding terminology specific to bassinets under ASTM F2194, and it is not applicable to bedside sleepers. Three of the proposed requirements that would apply to bedside sleepers include: (1) Segmented Mattress Flatness Requirement and Test Method; (2) Removable Bassinet Bed Stability; and (3) Stability Test Dummy. Because bedside sleepers are already required to be tested to the bassinet standard, ASTM F2194, there is no need to add language to the bedside sleeper standard proposing these requirements and test methods. Accordingly, if the proposed changes to ASTM F2194 are finalized, bedside sleepers will also be required to meet the following requirements and test methods in addition to all other applicable requirements in ASTM F2194. The following proposed changes to the bassinet standard would also be applicable to bedside sleepers: A. Proposed Segmented Mattress Flatness Requirement and Test Method (Sections 6.9 and 7.10 of ASTM F2194– 12a) In order to address the hazard of suffocation/positional asphyxia due to an excess mattress pad angle, the Commission proposed performance requirements and a test method for the E:\FR\FM\10DEP1.SGM 10DEP1 73350 Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Proposed Rules minimum flatness of mattress surfaces. This requirement would apply to segmented mattresses, such as those seen in a bassinet accessory to a play yard. The Commission proposed 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. This performance requirement and test method would also apply to a segmented mattress used in a bedside sleeper accessory to a play yard. mstockstill on DSK4VPTVN1PROD with B. Proposed 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 of ASTM F2194–12a) In order to address hazards associated with misassembly of removable bassinet beds, the Commission proposed performance requirements and a test method for products that have bassinet beds that attach to an elevated stand. The requirements would apply to removable bassinet beds that are designed to separate from the stand/base without the use of tools. The Commission proposed 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. These requirements are equally applicable to removable bedside sleepers that are designed to separate from the stand/base without the use of tools. C. Proposed Revised Test Procedure for Bassinet Stability (Sections 2.3 and 7.4.4 of ASTM F2194–12a) During evaluations of the test methods for removable bassinet beds, CPSC staff made comparisons of the stability of products weighted with the newborn CAMI dummy (7.45 lbs) as VerDate Mar<15>2010 16:22 Dec 07, 2012 Jkt 229001 opposed to the infant CAMI dummy (17.5 lbs). ASTM F 2194–12 contains a stability requirement that uses the heavier infant CAMI dummy. 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. Accordingly, the Commission proposed a revised test procedure for bassinet stability that uses a newborn CAMI instead of an infant CAMI. This test procedure is equally applicable to removable beside sleepers that are designed to separate from the stand/base without the use of tools because they too are intended for use with newborns. F. 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 bedside sleepers 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 bedside sleeper manufacturers to come into compliance with the rule. G. Regulatory Flexibility Act 1. 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 must describe the impact of the proposed rule on small entities and identify any alternatives that may reduce the impact. Specifically, the initial regulatory flexibility analysis 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 PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 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 initial regulatory flexibility analysis 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. 2. The Market Typically, bedside sleepers are produced and/or marketed by juvenile product manufacturers and distributors. Currently, there are at least five known manufacturers supplying bedside sleepers to the U.S. market. Four are domestic manufacturers, including one manufacturer that dominates the market. The fifth is a foreign manufacturer who ships products directly to the United States. There may be additional unknown small manufacturers and importers operating in the U.S. market as well. Under U.S. Small Business Administration (SBA) guidelines, a manufacturer of bedside sleepers is small if it has 500 or fewer employees, and an importer is considered small if it has 100 or fewer employees. Based on these guidelines, all four domestic manufacturers known to be supplying the U.S. market are small. The Juvenile Products Manufacturers Association (JPMA), the major U.S. trade association that represents juvenile product manufacturers and importers, runs a voluntary Certification Program for several juvenile products. Under this program, products voluntarily submitted by manufacturers are tested against the appropriate ASTM standard, and only passing products are allowed to display JPMA’s Certification Seal. Currently, JPMA does not have a Certification Program for bedside sleepers, and no firm claims to meet the ASTM bedside sleeper voluntary standard. However, three firms supply multimode products where one mode is compliant with the associated ASTM voluntary standard. Two firms claim compliance with the ASTM standard for bassinets; one firm is JPMA-certified as compliant, and the other claims compliance with the ASTM bassinet standard. A third firm supplies play yards that are JPMA-certified as compliant with the ASTM play yard/ non-full-size crib standard. E:\FR\FM\10DEP1.SGM 10DEP1 Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Proposed Rules mstockstill on DSK4VPTVN1PROD with National estimates of bedside sleeper product-related injuries are not available because the National Electronic Injury Surveillance System (NEISS) data does not allow for clear identification of bedside sleepers. Therefore, the risk of injury associated with the number of products in use cannot be calculated. 3. Compliance Requirements of the Proposed Rule Although all bedside sleepers currently on the market will require some modification in order to meet the voluntary standard, several of these requirements would impose little to no burden on manufacturers because firms also must comply with similar requirements in existing voluntary standards. Several modifications of the product may be required. The lowered side of the bedside sleeper must be 4 inches. The height requirement for sides that cannot be lowered is identical to that of bassinets, 71⁄2 inches. This requirement is not expected to pose a substantial cost for firms. However, it is possible that a few firms will need to modify their product in order to comply. Some products will need to add a permanent fourth side, and some may need to raise the fourth side so that it meets the minimum 4-inch side height. ASTM F2906–12 requires that the gap between the bedside sleeper and adult bed should not be more than a 1⁄2 inch when the bedside sleeper is secured to the bed. Firms may need to modify the attachment system to meet the minimum requirement by adjusting the anchor and/or straps to reduce stretching and to limit slippage. Alternatively, firms may opt to redesign their attachment system. Cost should be minimal if no new materials are used. Some products will require some modification in order to meet the two proposed bedside sleeper accessory requirements. The Commission proposes that the bedside sleeper accessory would be required to meet the (1) fabric sided opening requirement and (2) consumer misassembly requirement. In order to comply with the fabric opening requirement, the bedside sleeper accessory must pass the torso probe test. Alternatively, when the fabric-sided liner is unsecured, the bedside sleeper accessory should either collapse under its own weight or the sleep surface should tilt by more than 30 degrees. The proposed consumer misassembly requirement is identical to the play yard bassinet misassembly requirement proposed in the NPR for the Safety Standard for Play Yards. The Commission proposes that a bedside VerDate Mar<15>2010 16:22 Dec 07, 2012 Jkt 229001 sleeper accessory that can be assembled and attached to the play yard with any of the key structural elements missing must either: (1) Have all key structural components permanently attached or (2) be obviously unusable when attached to the play yard with any key structural element removed. The bedside sleeper accessory, if misassembled, should provide visual cues, such as the mattress pad contacts the bottom floor of the non-full-size crib or play yard, or the sleep surface angle tilts by more than 30 degrees to indicate misassembly. The actual cost of meeting these proposed requirements to manufacturers is unknown, but it could be minimal, primarily involving additional stitching, rivets, and other methods of attachment. However, if product redesign is required, the costs could be significant. The proposed bassinet requirements that are also applicable to bedside sleepers—mattress and stability requirements—are expected to have little to no incremental impact on firms. These requirements are identical to requirements in the bassinet NPR for Safety Standard for Bassinets and Cradles and the cost of meeting those requirements was accounted for in the bassinet NPR. If these requirements are finalized as proposed, a manufacturer who produces a bedside sleeper and a bassinet combination product would already need to meet these requirements and would have incurred the associated costs under the bassinet standard. As a consequence, meeting the same requirements under a bedside sleeper standard would impose no additional burden. Most bedside sleeper manufacturers produce such a combination product. In addition, firms would need to revise current warning labels to include a description of correct assembly and conversion modes. This represents a minor modification. 4. 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. 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 PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 73351 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 bedside sleepers 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. 5. Impact on Small Businesses There are five firms known to be marketing bedside sleepers in the United States. One is a foreign manufacturer. The analysis applies to the four domestic firms, all of which are small. The impact of the standard on manufacturers depends on two factors: (1) Whether their products are multiuse products and are already in compliance with one or more existing voluntary (or mandatory) standards; and (2) the proportion of their total sales or revenue that bedside sleepers constitute. Three of the four domestic manufacturers produce a multiuse product, or a product that may be used as a bedside sleeper, as well as a play yard or bassinet. These multiuse products are already in compliance with an existing standard, and there is significant overlap between standards. It is likely that manufacturers will need to make only slight, if any, modifications to comply with the bedside sleeper standard. The three producers of multiuse products are unlikely to experience a significant impact. Two of the domestic manufactures rely almost solely on the sales of bedside sleepers as their revenue source. One of the firms produces a multiuse product that is in compliance with an existing voluntary standard, as described above, and should not experience a significant impact. The other firm, however, produces a product that serves only as a bedside sleeper. The costs of compliance for this firm are unknown but could be significant if a complete product redesign is required. In addition, the impact could be magnified because most of this firm’s revenues are due to the sales of bedside sleepers. All manufacturers will need to modify existing warning labels. A new warning label poses a small burden because it represents a minor modification. Costs associated with the new warning label would be low because no new materials are used. Once the final rule and notice of requirements are in effect, all manufacturers will be subject to third E:\FR\FM\10DEP1.SGM 10DEP1 73352 Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Proposed Rules party testing and certification requirements. proposed rule falls within the categorical exemption. 6. Alternatives I. 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 Bedside Sleepers. Description: The proposed rule would require each bedside sleeper to comply with ASTM F2906–12, Standard Consumer Safety Specification for Bedside Sleepers. Sections 7.1, 8.1, and 8.2 of ASTM F2906–12 contain requirements for marking, labeling, and instructional literature that are disclosure requirements, thus falling within the definition of ‘‘collections of information’’ at 5 CFR 1320.3(c). Section 7.1 of ASTM F2906–12 requires that all bedside sleeper products meet with the 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. Adopting the current voluntary standard without any changes potentially would reduce costs for manufacturers. Three of the four small manufacturers who are already compliant with a voluntary standard would have a reduced burden. However, all firms still require some product changes in order to meet the voluntary standard. Because the staff’s proposed changes add little to the overall burden, adopting the voluntary standard with no changes will not significantly offset the burden. A second alternative would be to set an effective date later than the staffrecommended 6 months. This would allow suppliers additional time to modify and/or develop compliant bedside sleepers and spread the associated costs over a longer period of time. H. 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 marking and labeling instructions of ASTM F2194, Standard Consumer Safety Specification for Bassinets and Cradles. Section 8.1 of ASTM F2194–12 requires: • The name and the place of business (city, state, mailing address including Zip code) or telephone number of the manufacturer, importer distributor, or seller; and • A code mark or other means that identifies the date (month and year as a minimum) of manufacture. Section 8.1 of ASTM F2906–12 requires that all bedside sleeper products comply with the instructional literature requirements of ASTM F2194, Standard Consumer Safety Specification for Bassinets and Cradles. Section 9.1 of ASTM F2194–12a requires all firms supplying bedside sleepers to provide easy-to-read and understand instructions regarding assembly, maintenance, cleaning, operating, and adjustments, where applicable. Section 8 of ASTM F2906–12 also requires that the instructions cover correct assembly of product and use of attachment system, and conversion, as well as alert consumers that they should read all instructions and keep the instructions for future use. 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 bedside sleepers. Estimated Burden: We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN Number of respondents Frequency of responses Total annual responses Hours per response Total burden hours 1222 ..................................................................................... mstockstill on DSK4VPTVN1PROD with 16 CFR Section 5 2 10 1 10 Our estimates are based on the following: There are five known firms supplying bedside sleepers to the U.S. market. All five firms are assumed to use labels on both their products and their packaging already, 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 of these firms supplies an average of two different models of bedside sleepers; therefore, the estimated burden hours associated with labels is 1 hour × 5 firms × 2 models per firm = 10 annual hours. Sections 8.1 and 8.2 of ASTM F2906– 12 require instructions to be supplied VerDate Mar<15>2010 16:22 Dec 07, 2012 Jkt 229001 with the product. This is a practice that is customary with bedside sleepers. Bedside sleepers are products that generally require some installation and maintenance instructions, and any products sold without such information would not be able to compete successfully with products that provide this information. Therefore, because the CPSC is unaware of bedside sleepers that: (a) Generally require some installation, but (b) lack any instructions to the user about such installation, there are no burden hours associated with the instruction requirement in sections 8.1 and 8.2 because any burden associated with supplying instructions with PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 bedside sleepers would be ‘‘usual and customary’’ and not within the definition of ‘‘burden’’ under the OMB’s regulations. We estimate that hourly compensation for the time required to create and update labels is $27.64 (U.S. Bureau of Labor Statistics, ‘‘Employer Costs for Employee Compensation,’’ June 2012, Table 9, total compensation for all sales and office workers in goodsproducing private industries: https:// www.bls.gov/ncs/). Therefore, the estimated annual cost associated with the proposed requirements is $276 ($27.64 per hour × 10 hours = $276). In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. E:\FR\FM\10DEP1.SGM 10DEP1 Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Proposed Rules 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 January 9, 2013, 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. mstockstill on DSK4VPTVN1PROD with J. 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. K. 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 VerDate Mar<15>2010 16:22 Dec 07, 2012 Jkt 229001 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 1222, ‘‘Safety Standard for Bedside Sleepers,’’ 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 a proposed rule in the Federal Register titled, ‘‘Requirements Pertaining to Third Party Conformity Assessment Bodies,’’ 77 FR 31086, which, when finalized, would establish the general requirements and criteria concerning testing laboratories under 16 CFR part 1112. 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 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 bedside sleeper 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 bedside sleepers 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 1222, Safety Standard for Bedside Sleepers, included in its scope of accreditation of CPSC safety rules listed for the laboratory on the CPSC Web site at: www.cpsc.gov/labsearch. CPSC staff conducted an analysis of the potential impacts on small entities of the proposed rule establishing accreditation requirements, as required by the Regulatory Flexibility Act, and prepared an Initial Regulatory Flexibility Analysis (IRFA). Requirements Pertaining to Third Party PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 73353 Conformity Assessment Bodies. 77 FR 31086, 31123–26. The IRFA concluded that the requirements would not have a significant adverse impact on a substantial number of small laboratories because no requirements are imposed on laboratories that do not intend to provide third party testing services under Section 14(a)(2) of the CPSA. The only laboratories that are expected to provide such services are those that anticipate receiving sufficient revenue from providing the mandated testing to justify accepting the requirements as a business decision. Laboratories that do not expect to receive sufficient revenue from these services to justify accepting these requirements would likely not pursue accreditation for this purpose. Similarly, amending the rule to include the NOR for the bedside sleeper standard would not have a significant adverse impact on small laboratories. Moreover, based upon the number of laboratories in the United States that have applied for CPSC acceptance of the accreditation to test for conformance to other juvenile product standards, we expect that only a few laboratories, perhaps fewer than 6, will seek CPSC acceptance of their accreditation to test for conformance with the bedside sleeper standard. Most of these laboratories already will have been accredited to test for conformance to other juvenile product standards, and the only cost to them would be the cost of adding the bedside sleeper standard to their scope of accreditation. As a consequence, the Commission could certify that the proposed NOR for the bedside sleeper standard will not have a significant impact on a substantial number of small entities. 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 bedside sleepers and the test methods incorporated within that standard. The Commission may recognize limited circumstances in which it will accept certification based on product testing conducted before the Commission’s acceptance of accreditation of laboratories for testing bedside sleepers (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 bedside sleepers and the accompanying proposed NOR. L. Request for Comments This proposed rule begins a rulemaking proceeding under section 104(b) of the CPSIA to issue a consumer product safety standard for bedside sleepers. We invite all interested E:\FR\FM\10DEP1.SGM 10DEP1 73354 Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Proposed Rules persons to submit comments on any aspect of the proposed rule. 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 1222 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 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. Amend Part 1112.15 by adding paragraph (b)(34) 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) The CPSC has published previously, or in the cases of 16 CFR parts 1221, 1223, and 1224, and ASTM F 963–11 for the first time, the requirements for accreditation for third party conformity assessment bodies to assess conformity with the following CPSC rules and/or test methods: * * * * * (34) 16 CFR part 1222, Safety Standard for Bedside Sleepers. 3. Add part 1222 to read as follows: PART 1222—SAFETY STANDARD FOR BEDSIDE SLEEPERS mstockstill on DSK4VPTVN1PROD with Sec. 1222.1 1222.2 Scope. Requirements for Bedside Sleepers. Authority: The Consumer Product Safety Improvement Act of 2008, Pub. L. 110–314, § 104, 122 Stat. 3016 (August 14, 2008); Pub. L. 112–28, 125 Stat. 273 (August 12, 2011). § 1222.1 Scope. This part establishes a consumer product safety standard for bedside sleepers. VerDate Mar<15>2010 16:22 Dec 07, 2012 Jkt 229001 § 1222.2 Requirements for Bedside Sleepers. ‘‘Bassinet/Cradle Accessories Missing Key Structural Elements.’’ (a) Except as provided in paragraph (b) of this section, each bedside sleeper must comply with all applicable provisions of ASTM F2906–12, Standard Consumer Safety Specification for Bedside Sleepers, 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_federalregulations/ ibr_locations.html. (b) Comply with the ASTM F2906–12 standard with the following additions: (1) In addition to complying with section 3.1.7 of ASTM F2906–12, comply with the following: (i) 3.1.8 ‘‘bedside sleeper accessory, n—an elevated sleep surface that attaches to a non-full-size crib or play yard, designed to convert the product into a bedside sleeper intended to have a horizontal sleep surface while in a rest (non-rocking) position.’’ (ii) [Reserved] (2) In addition to complying with section 5.6 of ASTM F2906–12, comply with the following: (i) 5.7 Bedside Sleeper Accessory Fabric-Sided Enclosed Openings—A bedside sleeper accessory shall meet the F2194 performance requirement, ‘‘Fabric-Sided Enclosed Openings.’’ (A) 5.7.1 Bedside sleeper accessories are exempt from this requirement if either of the following two conditions is met after disengaging all fasteners between the accessory and the non-fullsize crib or play yard base to which it is assembled: (B) 5.7.1.1 The bedside sleeper accessory collapses under its own weight, such that any part of the mattress pad contacts the bottom floor of the non-full-size crib or play yard. (C) 5.7.1.2 The bedside sleeper accessory’s sleep surface tilts by more than 30 degrees. (ii) 5.8 Bedside Sleeper Play Yard Accessories Missing Key Structural Elements: A bedside sleeper accessory shall meet the F406 general requirement Dated: December 3, 2012. Todd A. Stevenson, Secretary, Consumer Product Safety Commission . PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 [FR Doc. 2012–29583 Filed 12–7–12; 8:45 am] BILLING CODE 6355–01–P CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1112 and 1225 [CPSC Docket No. CPSC–2012–0068] RIN 3041–AD16 Safety Standard for Hand-Held Infant Carriers Consumer Product Safety Commission. ACTION: Notice of Proposed Rulemaking. AGENCY: The Danny Keysar Child Product Safety Notification Act, Section 104(b) of the Consumer Product Safety Improvement Act of 2008 (CPSIA) requires the United States Consumer Product Safety Commission (Commission, CPSC, or we) 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 handheld infant carriers in response to the direction under Section 104(b) of the CPSIA. The proposed rule would incorporate ASTM F2050–12 by reference, with two modifications. DATES: Submit comments by February 25, 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 mailed to: oira_submission@omb.eop.gov. Other comments, identified by Docket No. CPSC-2012-0068, 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 SUMMARY: E:\FR\FM\10DEP1.SGM 10DEP1

Agencies

[Federal Register Volume 77, Number 237 (Monday, December 10, 2012)]
[Proposed Rules]
[Pages 73345-73354]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29583]


=======================================================================
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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112 and 1222

[Docket No. CPSC-2012-0067]


Safety Standard for Bedside Sleepers

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Danny Keysar Child Product Safety Notification Act, 
Section 104 of 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 bedside sleepers in response to the direction under 
Section 104(b) of the CPSIA.

DATES: Submit comments by February 25, 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-2012-0067, 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 proposed 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-2012-0067, into the ``Search'' box and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Douglas A. Lee, Project Manager, 
Directorate for Engineering Sciences, Consumer Product Safety 
Commission, 5 Research Place, Rockville, MD 20850; telephone 301-987-
2073; email cpsc.gov">dlee@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

[[Page 73346]]

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.
    In this document, the Commission is proposing a safety standard for 
bedside sleepers. Bassinets and cradles are specifically identified in 
section 104(f)(2)(L) as durable infant or toddler products. Bedside 
sleepers are similar to bassinets, and many bedside sleepers also 
function as bassinets. In addition, some beside sleepers are 
accessories to play yards/non-full-size baby cribs. On October 3, 2012, 
the Commission approved a notice of proposed rulemaking (NPR) for a 
Safety Standard for Bassinets and Cradles (https://www.cpsc.gov/library/foia/foia12/brief/bassinetnpr.pdf). The Commission has issued a Safety 
Standard for Play Yards, codified at 16 CFR part 1221. Recently the 
Commission has proposed specific language to address hazards due to 
misassembly of play yard bassinet accessories in a notice of proposed 
rulemaking (77 FR 52272, August 29, 2012). This proposed rule, if 
finalized, would amend the Safety Standard for Play Yards. The proposed 
rule for beside sleepers would adopt many of the requirements in the 
proposed NPR for bassinets, as well as address the hazards associated 
with the use of bassinet play yard accessories that can be assembled 
with missing key structural requirements for bedside sleeper play yard 
accessories.
    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 F2906-12, ``Standard Consumer Safety 
Specification for Bedside Sleepers'' (ASTM F2906-12), with additions to 
make the standard more stringent. The ASTM standard is copyrighted, but 
it 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 F2906-12 defines ``bedside sleeper'' as ``a rigid frame 
assembly that may be combined with a fabric or mesh assembly, or both, 
used to function as sides, ends, or floor or a combination thereof, and 
that is intended to provide a sleeping environment for infants and is 
secured to an adult bed.'' A ``multi-mode product'' is ``a unit that is 
designed and intended to be used in more than one mode (for example, a 
play yard, bassinet, changing table, hand held carrier, or bedside 
sleeper).'' A bedside sleeper is intended to be secured to an adult bed 
that permits newborns and infants to sleep close by an adult without 
being in the adult bed. In current products, the horizontal sleep 
surface is typically 1 inch to 4 inches below the level of the adult 
bed's mattress. The side of the bedside sleeper that is adjacent to the 
adult bed can usually be lowered, thereby differentiating bedside 
sleepers from bassinets, where all four sides of a bassinet are the 
same height. Bedside sleepers are intended for use with children up to 
the developmental stage where they can push up on hands and knees 
(about 5 months). This is the same developmental range for the intended 
users of bassinets. Current bedside sleepers range in size from about 
35'' x 20'' to 40'' x 30.'' They may have rigid sides, but they are 
most commonly constructed with a tube frame covered by mesh or fabric.
    Freestanding bassinets are not covered under the proposed standard 
for bedside sleepers. They are covered under ASTM F2194-12a, ``Standard 
Consumer Safety Specification for Bassinets and Cradles.''
    Several manufacturers produce multiuse (or multimode) bedside 
sleeper products that convert into bassinets and/or play yards. Most 
bedside sleeper products can be converted into a bassinet by raising 
the lowered side to have four equal-height sides, and a few also 
convert into a bassinet and play yard. Some play yards include bedside 
sleeper accessories which, when attached, convert the play yard into a 
bedside sleeper; and some bassinets convert into bedside sleepers. All 
of the tube-framed products that have been evaluated by CPSC staff may 
be collapsed for storage and transport. A bedside sleeper that can be 
used in additional modes would need to meet each applicable standard. 
For example, a bedside sleeper product that converts into a play yard 
and a bassinet would have to meet: ASTM F2906 bedside sleeper 
requirements, ASTM F2194 bassinet requirements (except for height of 
the fourth lowered side for bedside sleepers) and sections of the ASTM 
F406 play yard requirements applicable to bassinets when in the bedside 
sleeper mode; ASTM F406 play yard requirements when in play yard use 
mode; and ASTM F2194 bassinet requirements and applicable sections of 
ASTM F406 play yard requirements when in bassinet mode.
    To ensure consistency with the existing and proposed standards for 
bassinets and play yards, the Commission is proposing additions to the 
scope and performance requirements of a bedside sleeper, as discussed 
below.

C. The Voluntary Standard--ASTM F2906

    ASTM first published a voluntary standard for bedside sleepers, 
ASTM F2906-11, in December 2011. It required bedside sleepers to meet 
the voluntary standard requirements of the product upon which it was 
based, either a play yard/non-full-size baby cribs, ASTM F406 (play 
yard standard) or a bassinet, ASTM F2194 (bassinet standard). The 
standard also addressed hazards specific to bedside sleeper products. 
It addressed incidents involving the creation of a hazardous gap 
between the product and an adult mattress, by requiring the successful 
completion of three disengagement tests. The tests ensured that the 
securing components can withstand forces that may be exerted on the 
product by either the child or an adult, while sleeping. The gap must 
be no more than 0.5 in. when the product is installed to the adult bed, 
per manufacturer's directions. When a 25-lb. horizontal force is 
applied near the attachment system or corners, the gap may not exceed 
1.0 in. And, to simulate an adult rolling into a bedside sleeper while 
sleeping, a gap greater than 1.0 in. may not be created after the 
application and release of a 50-lb. horizontal force to the bedside 
sleeper's corners. The inclusion of these anti-gap requirements served 
to mitigate the foreseeable head and neck entrapment hazards posed by 
bedside sleepers. The standard requires a minimum 4-inch lowered side 
height over which a child is unlikely to be able to roll. In addition, 
latching and locking devices are evaluated to prevent unintentional 
movement of the side that lowers and to ensure overall product 
integrity.
    In 2012, the standard for bedside sleepers was changed from meeting 
either ASTM F406 (play yard standard) or ASTM F2194 (bassinet 
standard), to require all products to meet ASTM F2194 only. The 
bassinet minimum side-height requirement (the upper surface of the non-
compressed mattress of a bassinet/cradle must be at least 7.5 inches 
lower than the upper surface of the lowest side in all intended 
bassinet/cradle use positions) is also required for

[[Page 73347]]

beside sleepers, with the exception of a lowered side rail (the height 
of the side rail in the lowest position shall be no less than 4 inches 
when measured from the top of the uncompressed bedside sleeper mattress 
to the top of the lowered side rail, when the mattress support is in 
its highest position.) Bedside sleepers and bassinets share a 
significant number of hazard patterns because they are used by children 
with the same developmental abilities and for the same purpose. Many 
bedside sleepers also function as bassinets. By requiring beside 
sleepers to be tested to ASTM F2194 (bassinets) rather than to ASTM 
F406 (play yards), ASTM made the bedside sleeper standard more 
stringent because there are bedside sleeper hazards covered by the 
bassinet standard but that are not covered by the play yard standard. 
Additionally, ASTM F406 requires a bassinet accessory on a play yard 
structure to meet the applicable sections of the play yard voluntary 
standard. These changes were incorporated into ASTM F2906-12, 
``Standard Consumer Safety Specification for Bedside Sleepers,'' in 
July 2012.
    CPSC staff also reviewed mandatory and voluntary international 
standards in Canada, the European Union, Australia, and New Zealand. 
There are some international standards governing safe sleep products 
for infants; however, there are no specific requirements that address 
the hazards unique to bedside sleeper products. Canada has a mandatory 
standard for cribs, cradles, and bassinets, SOR/2010-26; the European 
Union uses EN 1130 Cribs and Cradles and EN 12790 Child Care Articles--
Reclined Cradles to assess and market various design elements and 
structures in bedside sleeper products. In Australia and New Zealand, 
several standards exist for safe sleep products- AS/NZS 2172:2003 Cots 
(full-size and non-full-size cribs that do not fold); AS/NZS 2195:1999 
Folding Cots (play yards and folding cribs of any size); AS/NZS 
4385:1996 Infants' Rocking Cradles (cradles and bassinets that tilt.)
    The Juvenile Products Manufacturers Association (JPMA) has a 
certification program for a variety of juvenile products, including 
bassinets and play yards. Manufacturers that voluntarily obtain JPMA 
certification submit products to an independent test laboratory for 
conformance testing to the most recent version of the voluntary 
standard. Manufacturers have 6 months after publication of a new or 
revised standard to certify products to the new requirements. 
Currently, JPMA does not have a certification program for bedside 
sleepers, and no firm claims to meet the ASTM voluntary standard, ASTM 
F2906-12. However, three firms supply multimode products, where one 
mode is compliant with the associated ASTM voluntary standard. Two 
firms claim compliance with the ASTM standard for bassinets; one firm 
is JPMA-certified as compliant, and the other claims compliance with 
the ASTM bassinet standard. A third firm supplies play yards that are 
JPMA-certified as compliant with the ASTM play yard/non-full-size crib 
standard.

D. Incident Data

    CPSC staff identified 40 cases of bedside sleeper-related incidents 
from 2001 to 2011. The CPSC databases searched were the In-Depth 
Investigation database, the Injury or Potential Injury Incident 
database, and the Death Certificate file. National estimates of bedside 
sleeper product-related injuries are not available because the National 
Electronic Injury Surveillance System (NEISS) data does not allow for 
clear identification of bedside sleepers. Therefore, the risk of injury 
associated with the number of products in use cannot be calculated.
    CPSC staff is aware of four fatalities and 36 nonfatal incidents 
(with and without injuries) related to bedside sleepers that were 
reported from January 2001 through December 2011. Bedside sleepers have 
been on the market since 1997. During this time, there have been two 
recalls for product defects that created a substantial product hazard. 
One recall involved four deaths, three from head entrapment and one 
from suffocation, and several complaints on the same entrapment hazard 
from a bedside sleeper with a bassinet base. This recall involved 3-in-
1 and 4-in-1 convertible bassinets that contained metal bars covered by 
an adjustable fabric flap, attached with Velcro,[supreg] that folded 
down when the bassinet was converted into a bedside sleeper. If the 
Velcro[supreg] was not resecured properly when the flap was adjusted, 
an infant could slip through the opening and become entrapped in the 
metal bars and suffocate. Because of additional incidents, this recall 
was re-announced three times. There were 900,000 units recalled. The 
second recall involved a bedside sleeper with a play yard base. There 
were 10 reports of infants falling from the mattress into the bottom of 
a bedside sleeper or becoming entrapped between the edge of the 
mattress and the side of the bedside sleeper. There were 76,000 units 
recalled. Details of the recalls can be found on the cpsc.gov Web site.

1. Fatalities

    All four reported fatalities involved the same brand of recalled 
bedside sleeper/bassinet. In all four cases, the product was being used 
in the bassinet mode, with the adjustable side raised at the time of 
the incident. Three of the deaths were due to entrapment and/or 
hanging, which resulted after an infant's body, but not head, slipped 
through the fabric covering and underlying structural components of a 
particular brand of bedside sleeper. In two of these three fatalities 
involving a 4-month-old and a 6-month-old decedent, the infant's head 
was entrapped between the lower horizontal bars (of the adjustable 
side) and the top of the mattress. The fabric flap designed to cover 
the metal bars was not in place. In the third fatality, the fabric flap 
covering the adjustable side was not secured to the permanent fabric 
siding, and the horizontal bars of the adjustable side were broken/
missing. As a result, the 6-month-old decedent's body slipped out 
through an opening in the fabric siding, but her chin/throat got caught 
on a lower crossbar. The fourth death occurred when an infant moved 
into a corner where the fabric covering the adjustable side was not 
secured by the Velcro[supreg] strip and the bassinet was also missing 
the lower rail. This created a pocket between the side and bassinet 
floor. The infant was found with their head in the pocket and face 
against the side of the bassinet, resulting in suffocation.

2. Nonfatal Incidents

    Of the 36 nonfatal incidents, there were three reported injuries 
involving infants, none hospitalized, during the use of a bedside 
sleeper. All of the injured infants were under 5 months of age, which 
is within the ASTM recommended user age range. Two of the infants 
suffered bruising when they were entrapped between the metal rungs of 
the same product that had caused three of the fatalities described in 
the previous section. The third injury occurred when the infant rolled 
into a position where his neck was hyperextended into a non-breathable 
corner of the product, and he suffered respiratory difficulties. In all 
three cases, the caregiver was nearby to prevent any serious 
consequences.
    The remaining 33 reports indicated that no injury occurred or 
provided no information about any injury. However, many of the 
descriptions in the reports indicated the potential for a serious 
injury, or even death, in bedside sleepers. In cases where victim age 
was reported, six reported ages between 6

[[Page 73348]]

months and 8 months old; the other infants were under 5 months of age.

3. Hazard Pattern Analysis

    CPSC staff considered all 40 incident reports to identify the 
hazard patterns associated with bedside sleeper-related incidents. The 
hazard scenarios in 24 of the 40 incidents (60 percent) reported were 
attributed to some sort of failure/defect or a potential design flaw in 
the product. This category includes the four fatalities and three non-
hospitalized injuries. Listed below are the reported problems, 
beginning with the most frequently reported concerns:
     A problem with the adjustable fabric cover over the 
horizontal metal bars on the side that lowers in the bedside sleeper 
mode was responsible for nine of the reported incidents. These included 
all four fatalities and two of the injuries. All of these incidents 
involved one particular manufacturer's bedside sleeper/convertible 
bassinet product, which was recalled in 2008. Two of the fatalities 
occurred before the CPSC recall; the third, which involved a secondhand 
product in poor condition, occurred after the 2008 recall, but prior to 
the 2009 recall (which was an expansion of the 2008 recall). Between 
the two injuries, one occurred prior to the 2008 recall, while the 
other occurred after that recall. Neither of the post-recall incident 
reports indicated whether the consumers were aware of the recall.
     Issues with assembly instructions were identified in six 
reported incidents. In all of these reports, the consumer had 
misassembled the product but reported the product as being faulty. None 
of the incidents resulted in any injury or fatality. All but one of 
these incidents involved one particular manufacturer's bedside sleeper, 
which was recalled in 2011.
     Miscellaneous other product-related issues, such as non-
levelness of the product (two reports), instability of leg extensions 
(two reports), poor design (two reports), broken component (one 
report), failure of the attachment (to adult bed) mechanism (one 
report), and unclear age labeling (one report) were reported in the 
remaining incident reports. One incident reported an injury associated 
with poor product design.
     In response to CPSC recall notices, there were 16 non-
incident reports of concerns or complaints. In these reports, the 
consumer either sought advice on options regarding a bedside sleeper 
product they owned that had been recalled, or they inquired about 
whether the product they owned was within the scope of the recall.

E. Proposed Changes to ASTM F2906-12

    CPSC staff identified 24 incidents due to defect or potential 
design flaws in the product. The hazards associated with these 
incidents included: Issues with the adjustable fabric cover over the 
metal bars on the side that lowered in the bedside sleeper mode (9 
incidents); poor assembly instruction (6 incidents); and miscellaneous 
other product-related issues (9 incidents). To address these incidents, 
the Commission proposes to adopt by reference, ASTM International's 
voluntary standard, ASTM F2906-12, Standard Consumer Safety 
Specification for Bedside Sleepers, with a few additions to strengthen 
the standard. Section 5 (Performance Requirements) of ASTM F2906-12 
requires that in addition to the tests provided in ASTM F2906-12, the 
bedside sleeper must be tested to the bassinet standard (ASTM F2194). 
Specifically, section 5.1 provides that:

    Prior to or immediately after testing to this consumer safety 
specification, the bedside sleeper must be tested to Consumer Safety 
Specification F2194. Multi-mode products must also be tested to each 
applicable standard. When testing to Consumer Safety Specification 
F2194 the unit shall be free standing, and not be secured to the 
test platform as dictated elsewhere in this standard.

Because bedside sleepers already are required to be tested to the 
applicable bassinet standard requirements, and multimode products, to 
each applicable standard, the Commission proposes in this rule to add 
clarifying language to ensure that the requirements that are not yet 
included in an existing standard or proposed in an NPR (i.e., ASTM 
F406-12a (play yards) and ASTM F2194-12 (bassinets)) are also included 
in ASTM F2906-12 (bedside sleepers).

1. Fabric-Sided Enclosed Openings

    The current version of ASTM F2194-12a (bassinets) contains a 
Fabric-Sided Enclosed Openings' performance requirement for bassinets. 
This requirement prohibits completely bounded openings large enough to 
permit passage of an infant's torso. The hazard scenarios addressed by 
this requirement encompass the three strangulation deaths described 
above and a related, foreseeable suffocation hazard. These hazards 
occur when a child passes through an opening, either becomes trapped 
between the liner and mattress pad and suffocates, or becomes suspended 
by the neck, and then strangles. This hazard, associated with a recall 
of 900,000 units, led to three of the four fatalities on a bassinet 
that converts to a bedside sleeper. The bassinet test procedure (ASTM 
F2194-12a, section 7.8) attempts to push a torso probe the size of a 
5th percentile infant through bounded openings with 20 lbs of force. 
The test is first performed with product assembled per the 
manufacturer's instructions. If the product has a removable cover, it 
is performed a second time after all fasteners or snaps are unfastened, 
but the removable cover left in place. In doing so, the test 
intentionally replicates the incorrectly secured fabric liner hazard 
scenario of the fatal incidents.
    A manufacturer's bedside sleeper accessory exhibited this hazard, 
which led to its recall in 2011. The recall was initiated in response 
to incident reports in which the bedside sleeper accessory's removable 
cover (liner or shell) was either not used, or was present but not 
secured to the play yard frame. This bedside sleeper accessory can also 
be used as a play yard, or a bassinet accessory to a play yard. When in 
the bassinet accessory position, the front side of the product can be 
lowered, transforming it into the beside sleeper mode. A 1\1/2\ year-
old unused sample of this product was recently retested by CPSC staff, 
confirming that it fails the ASTM F2194 fabric-sided enclosed opening 
requirement. However, a new sample of a similar model from the same 
manufacturer passed this test. Staff identified two possible reasons 
for testing variances. One explanation is that the fit of the shell to 
the play yard frame becomes looser with repeated assembly and 
disassembly. The other reason is that the seam joining the mesh and 
fabric part of the liner may be in a slightly different location on 
some models. The seam may cause sufficient friction on the torso test 
probe during force testing on some models. Accordingly, minor changes 
in materials or construction may not be sufficient to remedy the hazard 
presented by the fabric-sided, bounded opening hazard.
    Under section 6.7 of ASTM F2194-12, for bassinets/cradles with 
fabric sides, a completely bounded opening may not be created that 
allows the complete passage of the torso probe (based on a torso 
diameter of a 5th percentile 0 to 2-month-old infant) when tested in 
accordance with the fabric release test methods for enclosed openings. 
However, the test does not apply to play yard bassinets or play yard 
accessories. Bassinets accessories to play yards (that cannot be 
converted to bedside sleepers) are usually held in place by fasteners 
that clip to the top of the play yard's railing. If the fasteners were 
left unclipped, the bassinet would fall, rendering the product 
untestable, due to

[[Page 73349]]

the complete collapse of the bassinet attachment; test labs would 
likely consider that a failure. However, for bassinets that convert to 
a bedside sleeper with a lowered side, CPSC staff determined that all 
bedside sleeper play yard accessories should be subject to the 
requirements of the ASTM F2194-12 bassinet standard's section 6.7 
Fabric-Sided Enclosed Opening without the exemption for bassinet play 
yard accessories, given the demonstrated hazards presented when a 
bedside sleeper's removable cover (liner or shell) is either not used, 
or not secured properly.
    The Commission proposes additional language for the ASTM F2906 
bedside sleeper standard to add a new definition for ``bedside sleeper 
accessory'' and eliminate the fabric-sided bounded opening performance 
requirement exemption currently granted to play yard bassinet 
accessories. Unlike bassinet play yard accessories, bedside sleeper (or 
a bassinet that is converted into a bedside sleeper) play yard 
accessories could have fasteners left unclipped (through the detachment 
of snaps/Velcro) where the bedside sleeper with the lowered side does 
not completely collapse. Because the bedside sleeper could still appear 
functional, the Commission proposes to add language under Section 3 
(Terminology) of ASTM F2906-12. The new proposed section 3.1.8 would 
state: ``bedside sleeper accessory, n--an elevated sleep surface that 
attaches to a non-full-size crib or play yard, designed to convert the 
product into a bedside sleeper intended to have a horizontal sleep 
surface while in a rest (non-rocking) position.'' The Commission also 
proposes to add a new proposed section 5.7, stating: ``a Bedside 
Sleeper Accessory Fabric-Sided Enclosed Openings--A bedside sleeper 
accessory shall meet the F2194 performance requirement ``Fabric-Sided 
Enclosed Openings.'' Under new proposed section 5.7.1, bedside sleeper 
accessories would be exempt from this requirement if either of the 
following two conditions were met after disengaging all fasteners 
between the accessory and the non-full-size crib or play yard base to 
which it is assembled: (1) The bedside sleeper accessory collapses 
under its own weight, such that any part of the mattress pad contacts 
the bottom floor of the non-full-size crib or play yard (5.7.1.1); or 
(2) the bedside sleeper accessory's sleep surface tilts by more 30 
degrees (5.7.1.2). These requirements are also consistent with the 
proposed requirements in the NPR for the Safety Standard for Play Yards 
for play yard bassinet accessory misassembly provisions, which require 
all key structural elements to be attached permanently to the bassinet 
shell. The second method of compliance is to meet a catastrophic 
failure test, where a missing key structural element makes the product 
collapse completely or tilt more than 30 degrees. 77 FR 52273.

2. Consumer Misassembly With Missing Components

    The Commission proposed a requirement to address consumer 
misassembly of key structural elements for bassinet accessories to play 
yards in the NPR for the Safety Standard for Play Yards, 77 FR 52272. 
However, the NPR for play yards did not include specific language for 
bedside sleeper play yard accessories. Although section 5 (Performance 
Requirements) of ASTM 2906-12 provides that bedside sleepers must be 
tested to ASTM F2194 (bassinets), and multimode products must also be 
tested to each applicable standard, the Commission proposes to add 
language to ASTM 2906-12 (bedside sleepers) to make explicit that the 
requirements for addressing consumer misassembly of key structural 
elements is required for bedside sleeper play yard accessories in 
addition to bassinet play yard accessories.
    As described at length in the NPR for the Safety Standard for Play 
Yards, 77 FR 52272, omission of key structural elements of a bassinet 
assembly (such as rods, tubes, bars, and hooks that keep the sleep 
surface flat and level) could result in a tilt in the sleeping surface 
and put the infant in a position where he or she is unable to breathe 
and is at risk of suffocation. This hazard is magnified should these 
misassembled products be used as an unsupervised sleep environment, 
another reasonably foreseeable scenario. Similarly, a misassembled 
bedside sleeper play yard accessory may not be readily apparent or 
obvious to the consumer. If the misassembled accessory supports an 
infant without a catastrophic and obvious change to the sleep surface, 
a consumer may continue to use the misassembled accessory and 
inadvertently place a child in danger. Bedside sleeper accessories and 
bassinet accessories incorporate very similar designs and manufacturing 
processes (because many bedside sleepers also function as bassinets), 
and many of the same performance requirements are applicable to both 
products. Accordingly, in order to ensure that all of the hazards 
associated with bedside sleeper play yard accessories and bassinet play 
yard accessories that can be assembled missing key structural elements 
are addressed, the Commission proposes to add under section 5 
(Performance Requirements) to ASTM F2906-12, new proposed section 5.8 
Bedside Sleeper Play Yard Accessories Missing Key Structural Elements. 
The new section 5.8 will provide: A bedside sleeper accessory shall 
meet the F406 general requirement, ``Bassinet/Cradle Accessories 
Missing Key Structural Elements.''

3. New Requirements for Bassinets

    ASTM F2906-12 already requires bedside sleepers to meet the 
requirements of the bassinet standard, ASTM F2194 ``Standard Consumer 
Product Safety Specification for Bassinets and Cradles,'' with the 
exception of the height of the lowered fourth side. Most bedside 
sleepers also function as bassinets. The intended users are identical, 
and the majority of the hazards are identical. The Commission's 
proposed modifications to address bassinet hazards in ASTM F2194-12 
have been discussed in great detail in the NPR and in the Bassinet NPR 
staff briefing package. Specifically, the Commission proposed four 
changes to the ASTM bassinet standard. Three of those proposed changes 
to the bassinet standard would also be applicable to bedside sleepers. 
The fourth proposed change would update the scope and corresponding 
terminology specific to bassinets under ASTM F2194, and it is not 
applicable to bedside sleepers. Three of the proposed requirements that 
would apply to bedside sleepers include: (1) Segmented Mattress 
Flatness Requirement and Test Method; (2) Removable Bassinet Bed 
Stability; and (3) Stability Test Dummy. Because bedside sleepers are 
already required to be tested to the bassinet standard, ASTM F2194, 
there is no need to add language to the bedside sleeper standard 
proposing these requirements and test methods. Accordingly, if the 
proposed changes to ASTM F2194 are finalized, bedside sleepers will 
also be required to meet the following requirements and test methods in 
addition to all other applicable requirements in ASTM F2194. The 
following proposed changes to the bassinet standard would also be 
applicable to bedside sleepers:
A. Proposed Segmented Mattress Flatness Requirement and Test Method 
(Sections 6.9 and 7.10 of ASTM F2194-12a)
    In order to address the hazard of suffocation/positional asphyxia 
due to an excess mattress pad angle, the Commission proposed 
performance requirements and a test method for the

[[Page 73350]]

minimum flatness of mattress surfaces. This requirement would apply to 
segmented mattresses, such as those seen in a bassinet accessory to a 
play yard. The Commission proposed 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. This performance requirement and test method 
would also apply to a segmented mattress used in a bedside sleeper 
accessory to a play yard.
B. Proposed 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 of 
ASTM F2194-12a)
    In order to address hazards associated with misassembly of 
removable bassinet beds, the Commission proposed performance 
requirements and a test method for products that have bassinet beds 
that attach to an elevated stand. The requirements would apply to 
removable bassinet beds that are designed to separate from the stand/
base without the use of tools. The Commission proposed 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.
    These requirements are equally applicable to removable bedside 
sleepers that are designed to separate from the stand/base without the 
use of tools.
C. Proposed Revised Test Procedure for Bassinet Stability (Sections 2.3 
and 7.4.4 of ASTM F2194-12a)
    During evaluations of the test methods for removable bassinet beds, 
CPSC staff made comparisons of the stability of products weighted with 
the newborn CAMI dummy (7.45 lbs) as opposed to the infant CAMI dummy 
(17.5 lbs). ASTM F 2194-12 contains a stability requirement that uses 
the heavier infant CAMI dummy. 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. Accordingly, 
the Commission proposed a revised test procedure for bassinet stability 
that uses a newborn CAMI instead of an infant CAMI. This test procedure 
is equally applicable to removable beside sleepers that are designed to 
separate from the stand/base without the use of tools because they too 
are intended for use with newborns.

F. 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 bedside sleepers 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 
bedside sleeper manufacturers to come into compliance with the rule.

G. Regulatory Flexibility Act

1. 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 
must describe the impact of the proposed rule on small entities and 
identify any alternatives that may reduce the impact. Specifically, the 
initial regulatory flexibility analysis 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 initial regulatory flexibility analysis 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.

2. The Market

    Typically, bedside sleepers are produced and/or marketed by 
juvenile product manufacturers and distributors. Currently, there are 
at least five known manufacturers supplying bedside sleepers to the 
U.S. market. Four are domestic manufacturers, including one 
manufacturer that dominates the market. The fifth is a foreign 
manufacturer who ships products directly to the United States. There 
may be additional unknown small manufacturers and importers operating 
in the U.S. market as well.
    Under U.S. Small Business Administration (SBA) guidelines, a 
manufacturer of bedside sleepers is small if it has 500 or fewer 
employees, and an importer is considered small if it has 100 or fewer 
employees. Based on these guidelines, all four domestic manufacturers 
known to be supplying the U.S. market are small.
    The Juvenile Products Manufacturers Association (JPMA), the major 
U.S. trade association that represents juvenile product manufacturers 
and importers, runs a voluntary Certification Program for several 
juvenile products. Under this program, products voluntarily submitted 
by manufacturers are tested against the appropriate ASTM standard, and 
only passing products are allowed to display JPMA's Certification Seal.
    Currently, JPMA does not have a Certification Program for bedside 
sleepers, and no firm claims to meet the ASTM bedside sleeper voluntary 
standard. However, three firms supply multimode products where one mode 
is compliant with the associated ASTM voluntary standard. Two firms 
claim compliance with the ASTM standard for bassinets; one firm is 
JPMA-certified as compliant, and the other claims compliance with the 
ASTM bassinet standard. A third firm supplies play yards that are JPMA-
certified as compliant with the ASTM play yard/non-full-size crib 
standard.

[[Page 73351]]

    National estimates of bedside sleeper product-related injuries are 
not available because the National Electronic Injury Surveillance 
System (NEISS) data does not allow for clear identification of bedside 
sleepers. Therefore, the risk of injury associated with the number of 
products in use cannot be calculated.

3. Compliance Requirements of the Proposed Rule

    Although all bedside sleepers currently on the market will require 
some modification in order to meet the voluntary standard, several of 
these requirements would impose little to no burden on manufacturers 
because firms also must comply with similar requirements in existing 
voluntary standards.
    Several modifications of the product may be required. The lowered 
side of the bedside sleeper must be 4 inches. The height requirement 
for sides that cannot be lowered is identical to that of bassinets, 
7\1/2\ inches. This requirement is not expected to pose a substantial 
cost for firms. However, it is possible that a few firms will need to 
modify their product in order to comply. Some products will need to add 
a permanent fourth side, and some may need to raise the fourth side so 
that it meets the minimum 4-inch side height.
    ASTM F2906-12 requires that the gap between the bedside sleeper and 
adult bed should not be more than a \1/2\ inch when the bedside sleeper 
is secured to the bed. Firms may need to modify the attachment system 
to meet the minimum requirement by adjusting the anchor and/or straps 
to reduce stretching and to limit slippage. Alternatively, firms may 
opt to redesign their attachment system. Cost should be minimal if no 
new materials are used.
    Some products will require some modification in order to meet the 
two proposed bedside sleeper accessory requirements. The Commission 
proposes that the bedside sleeper accessory would be required to meet 
the (1) fabric sided opening requirement and (2) consumer misassembly 
requirement. In order to comply with the fabric opening requirement, 
the bedside sleeper accessory must pass the torso probe test. 
Alternatively, when the fabric-sided liner is unsecured, the bedside 
sleeper accessory should either collapse under its own weight or the 
sleep surface should tilt by more than 30 degrees. The proposed 
consumer misassembly requirement is identical to the play yard bassinet 
misassembly requirement proposed in the NPR for the Safety Standard for 
Play Yards. The Commission proposes that a bedside sleeper accessory 
that can be assembled and attached to the play yard with any of the key 
structural elements missing must either: (1) Have all key structural 
components permanently attached or (2) be obviously unusable when 
attached to the play yard with any key structural element removed. The 
bedside sleeper accessory, if misassembled, should provide visual cues, 
such as the mattress pad contacts the bottom floor of the non-full-size 
crib or play yard, or the sleep surface angle tilts by more than 30 
degrees to indicate misassembly. The actual cost of meeting these 
proposed requirements to manufacturers is unknown, but it could be 
minimal, primarily involving additional stitching, rivets, and other 
methods of attachment. However, if product redesign is required, the 
costs could be significant.
    The proposed bassinet requirements that are also applicable to 
bedside sleepers--mattress and stability requirements--are expected to 
have little to no incremental impact on firms. These requirements are 
identical to requirements in the bassinet NPR for Safety Standard for 
Bassinets and Cradles and the cost of meeting those requirements was 
accounted for in the bassinet NPR. If these requirements are finalized 
as proposed, a manufacturer who produces a bedside sleeper and a 
bassinet combination product would already need to meet these 
requirements and would have incurred the associated costs under the 
bassinet standard. As a consequence, meeting the same requirements 
under a bedside sleeper standard would impose no additional burden. 
Most bedside sleeper manufacturers produce such a combination product. 
In addition, firms would need to revise current warning labels to 
include a description of correct assembly and conversion modes. This 
represents a minor modification.

4. 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. 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 bedside sleepers 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.

5. Impact on Small Businesses

    There are five firms known to be marketing bedside sleepers in the 
United States. One is a foreign manufacturer. The analysis applies to 
the four domestic firms, all of which are small. The impact of the 
standard on manufacturers depends on two factors: (1) Whether their 
products are multiuse products and are already in compliance with one 
or more existing voluntary (or mandatory) standards; and (2) the 
proportion of their total sales or revenue that bedside sleepers 
constitute.
    Three of the four domestic manufacturers produce a multiuse 
product, or a product that may be used as a bedside sleeper, as well as 
a play yard or bassinet. These multiuse products are already in 
compliance with an existing standard, and there is significant overlap 
between standards. It is likely that manufacturers will need to make 
only slight, if any, modifications to comply with the bedside sleeper 
standard. The three producers of multiuse products are unlikely to 
experience a significant impact.
    Two of the domestic manufactures rely almost solely on the sales of 
bedside sleepers as their revenue source. One of the firms produces a 
multiuse product that is in compliance with an existing voluntary 
standard, as described above, and should not experience a significant 
impact. The other firm, however, produces a product that serves only as 
a bedside sleeper. The costs of compliance for this firm are unknown 
but could be significant if a complete product redesign is required. In 
addition, the impact could be magnified because most of this firm's 
revenues are due to the sales of bedside sleepers.
    All manufacturers will need to modify existing warning labels. A 
new warning label poses a small burden because it represents a minor 
modification. Costs associated with the new warning label would be low 
because no new materials are used. Once the final rule and notice of 
requirements are in effect, all manufacturers will be subject to third

[[Page 73352]]

party testing and certification requirements.

6. 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. Adopting the current voluntary standard without any 
changes potentially would reduce costs for manufacturers. Three of the 
four small manufacturers who are already compliant with a voluntary 
standard would have a reduced burden. However, all firms still require 
some product changes in order to meet the voluntary standard. Because 
the staff's proposed changes add little to the overall burden, adopting 
the voluntary standard with no changes will not significantly offset 
the burden.
    A second alternative would be to set an effective date later than 
the staff-recommended 6 months. This would allow suppliers additional 
time to modify and/or develop compliant bedside sleepers and spread the 
associated costs over a longer period of time.

H. 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.

I. 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 Bedside Sleepers.
    Description: The proposed rule would require each bedside sleeper 
to comply with ASTM F2906-12, Standard Consumer Safety Specification 
for Bedside Sleepers. Sections 7.1, 8.1, and 8.2 of ASTM F2906-12 
contain requirements for marking, labeling, and instructional 
literature that are disclosure requirements, thus falling within the 
definition of ``collections of information'' at 5 CFR 1320.3(c). 
Section 7.1 of ASTM F2906-12 requires that all bedside sleeper products 
meet with the marking and labeling instructions of ASTM F2194, Standard 
Consumer Safety Specification for Bassinets and Cradles. Section 8.1 of 
ASTM F2194-12 requires:
     The name and the place of business (city, state, mailing 
address including Zip code) or telephone number of the manufacturer, 
importer distributor, or seller; and
     A code mark or other means that identifies the date (month 
and year as a minimum) of manufacture.
    Section 8.1 of ASTM F2906-12 requires that all bedside sleeper 
products comply with the instructional literature requirements of ASTM 
F2194, Standard Consumer Safety Specification for Bassinets and 
Cradles. Section 9.1 of ASTM F2194-12a requires all firms supplying 
bedside sleepers to provide easy-to-read and understand instructions 
regarding assembly, maintenance, cleaning, operating, and adjustments, 
where applicable. Section 8 of ASTM F2906-12 also requires that the 
instructions cover correct assembly of product and use of attachment 
system, and conversion, as well as alert consumers that they should 
read all instructions and keep the instructions for future use. 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 
bedside sleepers.
    Estimated Burden: We estimate the burden of this collection of 
information as follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of       Frequency of     Total annual      Hours per       Total burden
                           16 CFR Section                              respondents       responses        responses         response          hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1222...............................................................               5                2               10                1               10
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Our estimates are based on the following:
    There are five known firms supplying bedside sleepers to the U.S. 
market. All five firms are assumed to use labels on both their products 
and their packaging already, 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 of these firms 
supplies an average of two different models of bedside sleepers; 
therefore, the estimated burden hours associated with labels is 1 hour 
x 5 firms x 2 models per firm = 10 annual hours.
    Sections 8.1 and 8.2 of ASTM F2906-12 require instructions to be 
supplied with the product. This is a practice that is customary with 
bedside sleepers. Bedside sleepers are products that generally require 
some installation and maintenance instructions, and any products sold 
without such information would not be able to compete successfully with 
products that provide this information. Therefore, because the CPSC is 
unaware of bedside sleepers that: (a) Generally require some 
installation, but (b) lack any instructions to the user about such 
installation, there are no burden hours associated with the instruction 
requirement in sections 8.1 and 8.2 because any burden associated with 
supplying instructions with bedside sleepers would be ``usual and 
customary'' and not within the definition of ``burden'' under the OMB's 
regulations.
    We estimate that hourly compensation for the time required to 
create and update labels is $27.64 (U.S. Bureau of Labor Statistics, 
``Employer Costs for Employee Compensation,'' June 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 associated with the proposed requirements is $276 ($27.64 
per hour x 10 hours = $276).
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.

[[Page 73353]]

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 January 9, 2013, 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.

J. 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.

K. 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 1222, ``Safety Standard for Bedside Sleepers,'' 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 a proposed rule in the 
Federal Register titled, ``Requirements Pertaining to Third Party 
Conformity Assessment Bodies,'' 77 FR 31086, which, when finalized, 
would establish the general requirements and criteria concerning 
testing laboratories under 16 CFR part 1112. 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 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 bedside sleeper 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 bedside 
sleepers 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 1222, Safety Standard for Bedside 
Sleepers, included in its scope of accreditation of CPSC safety rules 
listed for the laboratory on the CPSC Web site at: www.cpsc.gov/labsearch.
    CPSC staff conducted an analysis of the potential impacts on small 
entities of the proposed rule establishing accreditation requirements, 
as required by the Regulatory Flexibility Act, and prepared an Initial 
Regulatory Flexibility Analysis (IRFA). Requirements Pertaining to 
Third Party Conformity Assessment Bodies. 77 FR 31086, 31123-26. The 
IRFA concluded that the requirements would not have a significant 
adverse impact on a substantial number of small laboratories because no 
requirements are imposed on laboratories that do not intend to provide 
third party testing services under Section 14(a)(2) of the CPSA. The 
only laboratories that are expected to provide such services are those 
that anticipate receiving sufficient revenue from providing the 
mandated testing to justify accepting the requirements as a business 
decision. Laboratories that do not expect to receive sufficient revenue 
from these services to justify accepting these requirements would 
likely not pursue accreditation for this purpose. Similarly, amending 
the rule to include the NOR for the bedside sleeper standard would not 
have a significant adverse impact on small laboratories. Moreover, 
based upon the number of laboratories in the United States that have 
applied for CPSC acceptance of the accreditation to test for 
conformance to other juvenile product standards, we expect that only a 
few laboratories, perhaps fewer than 6, will seek CPSC acceptance of 
their accreditation to test for conformance with the bedside sleeper 
standard. Most of these laboratories already will have been accredited 
to test for conformance to other juvenile product standards, and the 
only cost to them would be the cost of adding the bedside sleeper 
standard to their scope of accreditation. As a consequence, the 
Commission could certify that the proposed NOR for the bedside sleeper 
standard will not have a significant impact on a substantial number of 
small entities.
    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 bedside sleepers and the test methods 
incorporated within that standard. The Commission may recognize limited 
circumstances in which it will accept certification based on product 
testing conducted before the Commission's acceptance of accreditation 
of laboratories for testing bedside sleepers (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 bedside sleepers and the accompanying proposed NOR.

L. Request for Comments

    This proposed rule begins a rulemaking proceeding under section 
104(b) of the CPSIA to issue a consumer product safety standard for 
bedside sleepers. We invite all interested

[[Page 73354]]

persons to submit comments on any aspect of the proposed rule. 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 1222

    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 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. Amend Part 1112.15 by adding paragraph (b)(34) 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) The CPSC has published previously, or in the cases of 16 CFR 
parts 1221, 1223, and 1224, and ASTM F 963-11 for the first time, the 
requirements for accreditation for third party conformity assessment 
bodies to assess conformity with the following CPSC rules and/or test 
methods:
* * * * *
    (34) 16 CFR part 1222, Safety Standard for Bedside Sleepers.
    3. Add part 1222 to read as follows:

PART 1222--SAFETY STANDARD FOR BEDSIDE SLEEPERS

Sec.
1222.1 Scope.
1222.2 Requirements for Bedside Sleepers.

    Authority: The Consumer Product Safety Improvement Act of 2008, 
Pub. L. 110-314, Sec.  104, 122 Stat. 3016 (August 14, 2008); Pub. 
L. 112-28, 125 Stat. 273 (August 12, 2011).


Sec.  1222.1  Scope.

    This part establishes a consumer product safety standard for 
bedside sleepers.


Sec.  1222.2  Requirements for Bedside Sleepers.

    (a) Except as provided in paragraph (b) of this section, each 
bedside sleeper must comply with all applicable provisions of ASTM 
F2906-12, Standard Consumer Safety Specification for Bedside Sleepers, 
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_federalregulations/ibr_locations.html.
    (b) Comply with the ASTM F2906-12 standard with the following 
additions:
    (1) In addition to complying with section 3.1.7 of ASTM F2906-12, 
comply with the following:
    (i) 3.1.8 ``bedside sleeper accessory, n--an elevated sleep surface 
that attaches to a non-full-size crib or play yard, designed to convert 
the product into a bedside sleeper intended to have a horizontal sleep 
surface while in a rest (non-rocking) position.''
    (ii) [Reserved]
    (2) In addition to complying with section 5.6 of ASTM F2906-12, 
comply with the following:
    (i) 5.7 Bedside Sleeper Accessory Fabric-Sided Enclosed Openings--A 
bedside sleeper accessory shall meet the F2194 performance requirement, 
``Fabric-Sided Enclosed Openings.''
    (A) 5.7.1 Bedside sleeper accessories are exempt from this 
requirement if either of the following two conditions is met after 
disengaging all fasteners between the accessory and the non-full-size 
crib or play yard base to which it is assembled:
    (B) 5.7.1.1 The bedside sleeper accessory collapses under its own 
weight, such that any part of the mattress pad contacts the bottom 
floor of the non-full-size crib or play yard.
    (C) 5.7.1.2 The bedside sleeper accessory's sleep surface tilts by 
more than 30 degrees.
    (ii) 5.8 Bedside Sleeper Play Yard Accessories Missing Key 
Structural Elements: A bedside sleeper accessory shall meet the F406 
general requirement ``Bassinet/Cradle Accessories Missing Key 
Structural Elements.''

    Dated: December 3, 2012.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission .
[FR Doc. 2012-29583 Filed 12-7-12; 8:45 am]
BILLING CODE 6355-01-P
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