Daily Rules, Proposed Rules, and Notices of the Federal Government
On June 27, 2012, the Commission voted unanimously to approve publication in the
In August 2011, we received a report of an infant fatality in the bassinet accessory of a play yard. The child died when the sleeping surface of the bassinet tilted, causing the child to slip into the corner where she suffocated. A review of the In-Depth Investigation Report (IDI) 110825CAA2853, as well as our tests on an exemplar model of the bassinet accessory and play yard involved in the fatality, led us to conclude that the incident was caused by the omission of key structural elements.
Many play yards are sold with accessories that attach to the product, such as bassinets, changing tables, and mobiles. Bassinet accessories are unique among play yard accessories because they are intended to be used as a sleeping environment, and infants are meant to be left unsupervised in them for extended periods of time. Serious injuries or fatalities can result if a play yard bassinet accessory has been assembled without key structural elements, such as rods, tubes, bars, and hooks, which keep the sleep surface flat and level. A tilt in the sleeping surface of the bassinet can result in an infant getting into a position where he or she is unable to breathe and is at risk of suffocation.
As seen in the IDI, it is possible that the omission of key structural elements may not initially be visually evident 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 accessory and inadvertently place a child in danger. If the bassinet's
Initially, the IDI completed for the fatality in August 2011 indicated that the tilt in the sleeping surface was caused by the detachment of plastic clips attached to the bassinet shell that secured the shell to the side rails of the play yard. Sometime after the child was placed in the bassinet accessory, one of the plastic clips detached. However, our testing indicates that detachment of one of the plastic clips is not enough to cause the tilt in the sleeping surface that led to the fatality. Indeed, the plastic clips caused the consumer to
The requirement we are proposing here will address this hazard. Manufacturers will be given two ways to comply. The first way to comply prevents misassembly by requiring that all key structural elements be attached permanently to the bassinet shell. The second method of compliance is designed to alert consumers if a key structural element is missing by requiring that the removal of even one key structural element results in a catastrophic failure of the bassinet. The test for this method of compliance is referred to as the “catastrophic failure test” in this document.
Most bassinet accessories consist of a fabric shell that is attached to the side rails of the play yard. The shell is supported by rods, tubes, bars, or hooks. The segmented mattress pad that is used on the floor of the typical play yard is inserted into the bassinet shell.
The requirement we are proposing offers two avenues for compliance. First, the bassinet accessory would meet the requirement if all of the key structural elements are attached permanently to the bassinet accessory. Thus, manufacturers who attach the support rods, tubes, bars, or hooks permanently into the bassinet shell would not need to have their product tested to this requirement.
If a manufacturer chooses not to permanently attach key structural elements to the bassinet, the bassinet would have to be tested by removing each key structural element and numbering them from 1 through
The requirement is meant to ensure that the omission of a key structural element is so visually obvious that the consumer will not use the product and place the child in danger inadvertently. It should be noted that in order to
Most manufacturers will use rods, tubes, bars, or hooks to support the bassinet shell. Thus, the mattress pad is not a key structural element under this provision, unless the manufacturer chooses to stiffen the mattress pad itself in order to provide structural support to the bassinet. If the mattress pad provides the structural support for the bassinet, it becomes a key structural element and must either be attached permanently to the bassinet or designed in such a way that omission of the mattress pad causes the bassinet to become obviously unusable.
In addition to the performance requirement and test method, we are also proposing to modify one definition, add one definition, and include several graphics in the mandatory play yard standard in order to ensure that this requirement is clear to play yard suppliers and testing laboratories. We are modifying the definition of “key structural elements” to include “the components that provide the supporting frame and/or means of attachment for a bassinet/cradle accessory.” We are also proposing to add a new term, “bassinet/cradle accessory,” defined as “a supported sleep surface that attaches to a non-full-size crib or play yard designed to convert the product into a bassinet/cradle intended to have a horizontal sleep surface while in a rest (non-rocking) position.”
We are proposing to include four new graphics that will assist stakeholders in understanding the new requirement. The first is a figure of the “CAMI Newborn Dummy” that will be used in the bassinet misassembly test method. In other ASTM standards, the reference to a CAMI Dummy is included at the beginning of the standard in a section titled, “Referenced Documents.” Consistent with ASTM custom, we are adding the CAMI Newborn Dummy to this section, accompanied by a footnote to indicate that the figure we are using is copied from a drawing provided by the U.S. Department of Transportation.
We are also proposing to include three other graphics to illustrate: (1) examples of bassinet/cradle key structural elements; (2) the infant CAMI dummy positioned for the bassinet/cradle accessory sleep surface test; and (3) the bassinet/cradle accessory sleep surface test angle measurement.
The requirement we are proposing was created with the assistance of key stakeholders, such as manufacturers, third party test laboratories, consumer advocates, and CPSC staff. In early 2012, we approached the ASTM Play Yard subcommittee and asked that the infant fatality reported to us in August 2011 be reviewed, and, if possible, a requirement be developed to address injuries and fatalities that can result from play yard bassinet accessories that are assembled incorrectly. The subcommittee formed a task group, which met six times from January through April 2012, and was comprised of major stakeholders, including manufacturers, third party test laboratories, consumer advocates, and CPSC staff.
The result of the task group's efforts is the language proposed here and is intended to address the specific hazard that resulted in the death of the infant. The requirement and test method apply only to bassinet accessories, and only address hazards associated with assembling the bassinet without key structural elements.
The Administrative Procedure Act (APA) generally requires that the effective date of a rule be at least 30 days after publication of the final rule. 5 U.S.C. 553(d). To allow time for play yard manufacturers to come into compliance, we recommend that this proposed amendment to the play yard standard become effective 6 months after the publication of the final rule in the
The Regulatory Flexibility Act (“RFA”), 5 U.S.C. 601-612, requires agencies to consider the impact of proposed rules on small entities, including small businesses. Section 603 of the RFA requires us to prepare an initial regulatory flexibility analysis and make it available to the public for comment when the NPR is published. The initial regulatory flexibility analysis must describe the impact of the proposed rule on small entities. In addition, it must identify any significant alternatives to the proposed rule that would accomplish the stated objectives of the rule and, at the same time, reduce the economic impact on small businesses. 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
• Identification, to the extent possible, of all relevant federal rules that may duplicate, overlap, or conflict with the proposed rule.
There are 21 domestic firms known to be producing or selling play yards in the United States. Ten are domestic manufacturers, and 11 are domestic importers. Under the U.S. Small Business Administration (SBA) guidelines, a manufacturer of play yards 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, nine domestic manufacturers and 10 domestic importers known to supply play yards to the U.S. market are small businesses. The remaining domestic entities are one large manufacturer and one large importer. There are also three foreign firms supplying play yards to the U.S. market. There may be additional unknown small manufacturers and importers operating in the U.S. market.
Not every play yard manufacturer makes a bassinet accessory for their product. However, the majority of known small play yard manufacturers have a least one model that includes a bassinet accessory. For these firms, in order to meet this proposed requirement, they will have to: (1) Modify their existing designs in order to attach key structural elements to the bassinet accessory permanently, or (2) design the accessory such that it is obviously unusable when any one key structural element is left out.
It is likely that most suppliers will choose to comply with this requirement by attaching key structural elements to the bassinet accessory permanently. We know of one manufacturer who produces a play yard with a bassinet accessory that is already compliant with this requirement. Several of the firms impacted by this new requirement were involved in the ASTM language development process and have indicated that they are moving toward attaching key structural elements to play yard bassinet accessories permanently. The cost to manufacturers who elect to meet the requirement in this way is expected to be minimal, primarily involving additional stitching, rivets, or other methods of attachment.
At least one manufacturer anticipates meeting the requirement by designing the accessory such that it is obviously unusable when key structural elements are left out. This approach is likely to be more costly than permanently attaching key structural elements because, currently, no design has been identified by manufacturers that would succeed in failing visibly when each key structural element is removed individually.
The impact on small importers will be similar. If an importer's existing supplier is not willing to comply with the bassinet misassembly provision, the importer would need to find an alternate source. If that is not possible, these firms could respond to the rule by discontinuing the importation of play yards. The impact of this decision could be mitigated by replacing play yards with a different infant or toddler product. Deciding to import an alternative infant or toddler product would be a reasonable and realistic way to offset any lost revenue.
Setting an effective date longer than 6 months could reduce the impact. This would allow small manufacturers additional time to make necessary changes to their product, and it would allow small importers more time to find alternative sources. It would also allow entities to spread costs over a longer period of time.
It is possible that the proposed amendment, if finalized, could have a significant impact on some small businesses. For manufacturers, the extent of these costs could entail expensive product redesign. Importers may need to find alternative sources of play yards or replace play yards with another infant or toddler product.
We invite comments describing:
• The possible impact of this rule on small manufacturers and importers; and
• 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.
ASTM F406-12a, which is incorporated by reference into the play yard standard codified at 16 CFR part 1221, requires labels and instructions be supplied with the product. The PRA requirements for the play yard standard codified at 16 CFR part 1221 have been submitted to the Office of Management and Budget (OMB), and OMB has assigned control number 3041-0152 to the information collection. We estimate that there are no additional burden hours associated with this proposed amendment.
The Commission's regulations address whether we are required to prepare an environmental assessment or an environmental impact statement. Our rules generally have “little or no potential for affecting the human environment,” and therefore, they are exempt from any requirement to prepare an environmental assessment or impact statement. 16 CFR 1021.5(c)(1). This rule falls within the categorical exemption.
Section 26(a) of the Consumer Product Safety Act (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 establish or continue in effect a requirement dealing with the same risk of injury, unless the state's requirement is identical to the federal standard. Section 26(c) of the CPSA also provides that states or
Pursuant to section 14(a)(2) of the CPSA, play yards must be certified by the manufacturer to the mandatory standard based on testing conducted by a CPSC-accepted third party conformity assessment body. The third party testing and certification requirement for this proposed amendment to the play yard standard will not be in effect until the proposal is final and effective, and we issue a final notice of requirements (NOR). The NOR establishes requirements for how third party conformity assessment bodies can become accepted by us to test play yards. Play yard manufacturers will be required to certify products to the play yard standard, including this proposed amendment if it is finalized, based on third party testing once we have accepted the accreditation of such laboratories.
We invite all interested persons to submit comments on any aspect of the proposed rule. Comments should be submitted in accordance with the instructions in the
Specifically, we invite comments on the following:
• Whether this proposed requirement and test method will address the hazards associated with play yard bassinet accessories that can be assembled with missing key structural elements, and if not, what alternative requirements and test methods would address this hazard;
• Whether the second avenue of compliance, referred to as the “catastrophic failure test” is necessary, or if manufacturers should be required to attach all key structural elements permanently;
• Whether the CAMI Newborn Dummy, weighing 7.5 pounds, is appropriate to use for the catastrophic failure test, and if it is not, what should be used;
• Whether the language of the proposed requirements and test methods should be changed in order to improve repeatability and clarity, and if so, what those changes should be;
• Whether 6 months is an appropriate effective date for this provision; and
• Descriptions of the possible impact of this proposed requirement on small manufacturers and importers, as well as 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.
Consumer protection, Imports, Incorporation by reference, Infants and children, Labeling, Law enforcement, Safety, and Toys.
Therefore, the Commission proposes to amend 16 CFR part 1221 as follows:
1. The authority citation for part 1221 continues to read as follows:
The Consumer Product Safety Improvement Act of 2008, Pub. L. 110-314, section 104, 122 Stat. 3016 (August 14, 2008).
2. Add § 1221.3 to read as follows:
(a) In addition to complying with section 2.4 of ASTM F406-12a, comply with the following, along with the accompanying footnote:
(b) Instead of complying with section 3.1.9 of ASTM F406-12a, comply with the following:
(c) In addition to complying with section 3.1.26 of ASTM F406-12a, comply with the following:
(d) Instead of complying with section 5.19 of ASTM F406-12a, comply with the following:
(2) 5.19.1Bassinet/cradle accessories that have all key structural elements attached permanently to the bassinet/cradle accessory, or by any permanent means, prohibiting their removal from the bassinet/cradle accessory, are exempt from the following key structural element requirements. For the purpose of this section, a mattress pad without key structural elements attached permanently is not considered a key structural element.
(3) 5.19.2Bassinet/cradle accessories that require consumer assembly of key structural element(s), and can be assembled and attached to the product with any key structural element(s) missing, shall meet either 22.214.171.124, or 126.96.36.199 when each key structural element not attached permanently is removed. For the purpose of this section, a mattress pad without key structural elements attached permanently is not considered a key structural element.
(4) 188.8.131.52The bassinet/cradle accessory shall collapse, such that any part of the mattress pad contacts the bottom floor of the play yard, or is not able to support the newborn CAMI dummy when tested to 8.31.
(5) 184.108.40.206The bassinet/cradle accessory sleep surface shall tilt by more than 30 degrees when tested to 8.31.
(e) In addition to complying with 8.30 of ASTM F406-12a, comply with the following:
(1) 8.31Bassinet and Cradle Accessory Sleep Surface Collapse/Tilt.
(2) 8.31.1Determine the number of removable (
(3) 8.31.2Assemble the bassinet/cradle accessory to the product according to manufacturer's instructions.
(4) 8.31.3Establish a horizontal reference plane by placing an inclinometer on the floor of the testing area, and then zero the inclinometer.
(5) 8.31.4Remove key structural element #1 used in the assembly of the bassinet/cradle accessory, and attempt to assemble the accessory back onto the product.
(6) 220.127.116.11If the accessory can be assembled onto the product without element #1, proceed to 8.31.5.
(7) 18.104.22.168If the accessory cannot be assembled onto the product without element #1, the accessory shall be considered to meet 5.19.2. Proceed to 8.31.7.
(8) 8.31.5Place a newborn CAMI dummy in the center of the sleep surface, oriented parallel to the longest side of the bassinet/cradle accessory. (See Fig. A1.40.) Determine visually whether the bassinet/cradle accessory collapses or it no longer supports the newborn CAMI within 2 seconds.
(9) 8.31.6If collapse does not occur, measure the sleep surface's angle of incline relative to the horizontal plane established in 8.31.3 at the location(s) most likely to meet the angle requirement in 22.214.171.124. Record this angle. (See Fig. A1.41.)
(10) 8.31.7Replace the removed key structural element.
(11) 8.31.8Repeat 8.31.4-8.31.7 removing and replacing each key structural element (identified in 8.31.1) one at a time, starting with #2 through
(f) In addition to Figure A1.37 of ASTM F406-12a, use the following: