Daily Rules, Proposed Rules, and Notices of the Federal Government
The Consumer Product Safety Improvement Act of 2008 (CPSIA, Pub. L. 110-314) was enacted on August 14, 2008. Section 104(b) of the CPSIA requires the Commission to promulgate consumer product safety standards for durable infant and toddler products. These standards are to be “substantially the same as” applicable voluntary standards or more stringent than the voluntary standard if the Commission concludes that more stringent requirements would further reduce the risk of injury associated with the product. The term “durable infant or toddler product” is defined in section 104(f)(1) of the CPSIA as a durable product intended for use, or that may be reasonably expected to be used, by children under the age of 5 years. Play yards are one of the products specifically identified in section 104(f)(2)(F) as a durable infant or toddler product.
The ASTM subcommittee on play yards developed a newer edition of this standard, ASTM F406-12a, which includes the three clarifications we proposed in the NPR. ASTM F406-12a also contains two clarifications that were suggested in comments we received from the public in response to the NPR. Those two clarifications: (1) Added a preload to the mattress vertical displacement test; and (2) exempted from the top rail configuration requirement play yards with upward-folding top rails.
In this document, we are issuing a safety standard for play yards, which incorporates by reference ASTM F406-12a and provides a 6-month (from the date of publication) effective date for the mandatory play yard standard.
ASTM F406-12a defines a “play yard” as a “framed enclosure that includes a floor and has mesh or fabric sided panels primarily intended to provide a play or sleeping environment for children. It may fold for storage or travel.” Play yards are intended for children who are less than 35 inches tall, who cannot climb out of the product. Some play yards include accessory items that attach to the product, including mobiles, toy bars, canopies, bassinets, and changing tables.
The preamble to the NPR (76 FR 58168) summarized the data for incidents related to play yards reported to us from early November 2007 through early April 2011. The final rule is based on the data provided in the NPR, as well as updated data on incidents related to play yards reported to us from April 2011 through December 31, 2011.
From April 10, 2011, through December 31, 2011, we received information on 41 play yard-related incidents. Fifteen of the 41 incidents were fatal. Of the remaining 26 incidents, eight resulted in injuries to the child.
Eleven of the 15 fatal incidents are attributable to an unsafe sleep environment, such as the presence of soft bedding. For one fatality, very little information was supplied to us and, we were unable to determine the cause of the death. Three of the 15 fatalities were play yard related. One child died when the bassinet accessory being used as a sleep environment was assembled without key structural elements, which resulted in a dangerous tilt of the sleep surface. The child slid into the corner of the bassinet and suffocated. In another incident, a child was attempting to climb out of a play yard and, while holding onto a separate bassinet nearby, the canopy of the bassinet fell forward and caught him on the back of the neck, suffocating him. A third child suffocated when he got his head stuck in a torn opening between the floor and the mesh side of the play yard.
The recent incidents have hazard patterns similar to those reported in the NPR, and include:
• Eleven incidents, all resulting in fatalities, were the result of unsafe sleep environments and unsafe sleep practices.
• Ten incidents were caused by broken or detached component parts, such as loose wheels and loose hardware, which resulted in the instability or collapse of the product. There were three injuries reported in this category.
• Five incidents were related to the mesh or fabric sides of the play yard, such as stitching that unraveled, tears in the fabric, and mesh holes that were too large. There were two injuries and one fatality reported in this category.
• Four incidents were caused by hazardous accessories, such as broken or detached components from a mobile or a tent accessory. There was one injury reported in this category.
• Three incidents were related to the mattress pad or floor of the play yard, including reports that the fasteners designed to keep the floor board in place failed. There were no injuries reported in this category.
• Three incidents were due to the side rail of the play yard collapsing. There were no injuries in this category.
• Two incidents were the result of the child being able to climb out of the play yard. There was one injury and one fatality reported in this category.
• One incident, which resulted in a fatality, can be attributed to assembly issues in the bassinet accessory of a play yard. In this incident, the bassinet was missing key structural elements meant to support the accessory. The sleep surface of the bassinet tilted, and the child slid into the corner and suffocated.
• One incident was the result of a child nearly choking on a sticker that was a component of the play yard.
• For one reported fatality associated with a play yard, there was insufficient information to determine the cause.
The preamble to the NPR invited comments concerning all aspects of the proposed rule. We received comments from 23 individuals or organizations. Many of the comments contained more than one issue. Thus, we organized our responses by issue, rather than responding to each individual commenter. Each comment and response is numbered below to help distinguish between different comments. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance, or the order in which it was received. All of the comments can be viewed on:
However, we also used market research—conducted independently—to perform the regulatory flexibility analysis. This research provided information on the number of firms supplying play yards to the U.S. market, their type, their size, and their location. We also researched, independently, the number of products supplied by each firm, each firm's compliance with the voluntary standard, as well as details about accessories sold with each play yard. It is this information, along with input from our staff and play yard manufacturers, which led to the conclusions of the initial regulatory flexibility analysis.
The initial regulatory flexibility analysis recognized that the impact on firms that supply noncompliant play yards to the U.S. market potentially could be significant. However, because the CPSIA requires that we promulgate a mandatory standard that is substantially the same as, or more stringent than, the voluntary standard, the CPSC is limited in how it can minimize the economic impact on small firms that are not in compliance with the standard.
One commenter, representing several consumer advocacy groups, recommends: “an effective date of 90 days after publication in the
We share concerns about noncompliant products being available for years beyond the effective date. However, the number and severity of play yard incidents does not seem to warrant a shorter effective date than that used for other durable infant products, particularly given that ongoing compliance activities would continue to be used to pull unsafe play yards from the market.
It is possible that the omission of key structural elements initially may not be visually evident to the consumer. If the misassembled accessory supports an infant without a catastrophic and obvious change to the sleep surface, then a consumer may continue to use the accessory and place a child in danger inadvertently.
We considered adding a provision to the play yard final rule to address the hazards associated with play yard bassinet accessories that can be assembled while missing key structural elements. However, we have chosen, instead, to publish an NPR in today's issue of the
We have been unable to identify a performance requirement for inclusion in the play yard standard that would effectively reduce incidents of children climbing out of play yards without simultaneously introducing other potential hazards. The current ASTM standard contains a warning advising parents to stop using the product once a child can climb out of the play yard. We feel that this is the most effective way to prevent injuries associated with children being able to climb out of play yards.
We identified five incidents where the attachment points of a play yard bassinet accessory failed. None of the incidents resulted in an injury to the child. Three incidents were caused by weak fabric or poor stitching. These hazards are addressed in the ASTM standard for play yards at sections 7.7 and 7.8, which address the durability of fabric and the strength of seams. The other two incidents were caused by separated hook-and-loop (Velcro) closures. On one, the closure failed to secure during the consumer's first use of the product and permitted the sleep surface to tilt slightly. The consumer noticed the problem immediately. We have evaluated the incident and determined that it can be attributed, most likely, to poor quality control in the manufacturing process. In the other incident, the hook-and-loop closure, used as a back-up means of attachment, wore out over time. The concern is that if the primary attachment were to fail, the worn hook-and-loop closure might permit the sleep surface to tilt. However, in this case, because the hook-and-loop closure was a secondary means of attachment, the product did not cause an injury or incident.
We share the commenter's concern about the robustness of bassinet and cradle attachments, but we do not agree that requiring cyclic testing for the attachment points will address those concerns. At this point, we cannot recommend a performance requirement and test method that would reduce the risk of injury associated with this hazard. Incoming data will be monitored to ensure that any emerging trends are identified.
For the play yard final rule, we are incorporating by reference ASTM F406-12a. The final rule excludes sections of ASTM F406-12a that apply to non-full-size cribs exclusively. In this section, we: (1) summarize the requirements of ASTM F406-12a; and (2) describe the final rule, listing the excluded provisions of ASTM F406-12a that only apply to non-full-size cribs.
In the NPR (76 FR 58169 through 58170), we described, in detail, the key provisions of ASTM F406-11 that apply to play yards. ASTM F406-12a differs from ASTM F406-11 in the following ways:
• It includes the three changes to the play yard standard we proposed in the NPR, specifically two clarifications to the testing method used to measure the strength of the play yard floor, and one change to the Top Rail to Corner Post
• On its own initiative, the ASTM committee clarified the Top Rail to Corner Post Attachment Test, as well as the accompanying explanatory graphics. By incorporating by reference ASTM F406-12a, we support the inclusion of these clarifications in the play yard mandatory standard.
• A preload was added to the Mattress Vertical Displacement Test in order to improve testing consistency by ensuring that free movement of fabric is taken up before establishing the initial clamp position reference point. We also received a comment to the NPR suggesting this change. By incorporating by reference ASTM F406-12a, we support the inclusion of this clarification in the play yard mandatory standard.
• An exemption was included in the Top Rail Configuration requirement to exclude play yards with side rails that fold upward. The side rails of most play yards move downward vertically. If the side rail latch mechanisms are not locked properly, they can form a dangerous V-shape. If the child's neck is caught in the V-shape, the child could suffocate. Play yards with side rails that fold upward, however, do not create this risk. We also received a comment to the NPR suggesting this change. By incorporating by reference of ASTM F406-12a, we support the inclusion of this clarification in the play yard mandatory standard.
The final play yard rule incorporates by reference ASTM F406-12a, with several exclusions for provisions that apply to non-full-size cribs only. In the
• Section 5.17 of ASTM F406-12a, containing the requirements for mattresses in rigid-sided products;
• Section 5.19 of ASTM F406-12a, containing a provision to prevent misassembly in non-full-size cribs;
• Section 5.20 of ASTM F406-12a, containing record keeping requirements for non-full-size cribs;
• The entirety of section 6 of ASTM F406-12a, containing the performance requirements for rigid-sided products;
• Sections 8.1 through 8.10.5 of ASTM F406-12a, containing the test methods for rigid-sided products;
• A portion of section 188.8.131.52 of ASTM F406-12a, containing warning label requirements for nonrectangular cribs; and
• Section 10.1.1.1 of ASTM F406-12a, containing instructional literature requirements for non-full-size cribs.
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).
We are providing a 6-month effective date, as proposed in the NPR. This will give suppliers sufficient time to come into compliance with the mandatory standard.
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-605, requires that final rules be reviewed for their potential economic impact on small entities, including small businesses. Section 604 of the RFA requires that we prepare a final regulatory flexibility analysis when promulgating final rules. The final regulatory flexibility analysis must describe the impact of the rule on small entities and identify any alternatives that may reduce the impact. Specifically, the final regulatory flexibility analysis must contain:
1. A succinct statement of the need for, and objectives of, the rule;
2. A summary of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a summary of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments;
3. A description of, and an estimate of, the number of small entities to which the rule will apply, or an explanation of why no such estimate is available;
4. A description of the projected reporting, recordkeeping, and other compliance requirements of the rule, including an estimate of the classes of small entities that will be subject to the requirement, and the type of professional skills necessary for preparation of the report or record; and
5. A description of the steps that the agency has taken to minimize the significant economic impact on small entities, consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule, and why each one of the other significant alternatives to the rule considered by the agency that affect the impact on small entities was rejected.
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.
The Juvenile Products Manufacturers Association (JPMA) runs a voluntary certification program for juvenile products. Certification under the JPMA program is based on the most recent ASTM voluntary play yard standard, typically with a 6-month delay. Six of the nine small manufacturers produce play yards that are certified as compliant with the ASTM voluntary play yard standard by the JPMA. Of the importers, three import play yards that have been certified as compliant with the ASTM voluntary standard. One additional importer claims compliance with the ASTM standard but is not JPMA certified.
The extent to which each firm will be impacted by the play yard mandatory standard depends upon whether the firm's play yards currently comply with the ASTM voluntary standard. Small firms whose play yards already comply with the voluntary standard will not incur any new costs. Many of these firms are active in the ASTM standard development process, and compliance with the voluntary standard is part of an established business practice. Thus, it is
Six of the small manufacturers produce play yards known to comply with the voluntary standard. Small firms whose play yards already comply with the voluntary standard will not incur any new costs. For the three manufacturing firms whose play yards may not be compliant with the voluntary standard, the costs could be more significant. Meeting the existing voluntary standard could require manufacturers to redesign their product. The impact on manufacturers who produce noncompliant play yards may be mitigated if the costs are treated as new product expenses and amortized over time.
This scenario also assumes that the three firms whose play yards are not JPMA certified do not meet the voluntary standard. In fact, we have identified many instances in which a juvenile product not certified by the JPMA complies with the ASTM voluntary standard. To the extent that these firms already may supply play yards that meet the ASTM voluntary standard, the costs incurred would be lower.
Four of the 10 small importers produce play yards known to comply with the voluntary standard. Three are certified by the JPMA, and one additional firm claims compliance with the ASTM standard. Small firms whose play yards already comply with the voluntary standard will not incur any new costs.
The costs to the six importers whose play yards may not be compliant with the voluntary standard could be more significant. Importers of play yards would need to find an alternate source if their existing supplier does not come into compliance with the standard. Purchasing compliant, higher quality play yards could increase the cost of the product.
This will not be an option for two of the noncompliant play yard importers because they specialize in the importation of play yards from a specific foreign company. Thus, finding an alternative supply source is probably not an option for them. These firms could respond to the rule by discontinuing the import 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.
As with manufacturers, to the extent that some of the firms believed to supply noncompliant play yards actually may supply play yards that meet the ASTM voluntary standard, the costs incurred would be lower.
An alternative that could minimize the economic impact on small business is providing an effective date longer than 6 months. However, the JPMA, which represents many play yard manufacturers, felt that a 6-month effective date was adequate to allow suppliers to come into compliance with the mandatory standard. We agree. Therefore, we have chosen a 6-month effective date for the play yard mandatory standard.
We received several comments from the public in response to the initial regulatory flexibility analysis, including comments regarding the use of market data, the impact on small businesses, and the appropriate effective date. A summary of those comments and our responses can be found in part D of this preamble, titled, “Response to Comments on the Proposed Rule.”
The impact of the final play yard rule on firms supplying non-ASTM-compliant play yards could be significant. However, the requirements of the final rule address known play yard hazard patterns and will help reduce injuries and deaths. We are providing a 6-month effective date as proposed in the NPR. This will give suppliers sufficient time to come into compliance with the mandatory standard and spread the costs over a longer period of time.
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, 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.
This 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. The preamble to the proposed rule (76 FR 58173 through 58174) discussed the information collection burden of the proposed rule and specifically requested comments on the accuracy of our estimates. Briefly, sections 9 and 10 of ASTM F406-12a contain requirements for marking, labeling, and instructional literature. These requirements fall within the definition of “collection of information,” as defined in 44 U.S.C. 3502(3).
OMB has assigned control number 3041-0152 to this information collection. We did not receive any comments regarding the information collection burden of this proposal. However, the final rule makes modifications regarding the information collection burden because the number of estimated suppliers subject to the information collection burden is now estimated to be 24 firms rather than the nine firms initially estimated in the proposed rule.
Accordingly, the estimated burden of this collection of information is modified as follows:
There are 24 known firms supplying play yards to the U.S. market. All 24 firms are assumed to use labels already on both their products and their packaging, but they might need to make some modifications to their existing
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), we have submitted the information collection requirements of this final rule to the OMB.
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 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 the rule becomes effective.
Once in effect, the final rule on play yards will make it unlawful for anyone to manufacture, distribute, or import a play yard into the United States that is not in conformity with the standard. 15 U.S.C. 2068(1). Pursuant to section 14(a)(2) of the CPSA, play yards must be certified by the manufacturer to the final standard based on testing conducted by a CPSC-accepted third party conformity assessment body. The third party testing and certification requirement for play yards will not be in effect until we issue a final notice of requirements (NOR). The final NOR establishes requirements for how third party conformity assessment bodies can become accepted by us to test play yards to the final rule. A proposed NOR for play yards was published in the
Consumer protection, Imports, Incorporation by reference, Infants and children, Labeling, Law enforcement, Safety and toys.
Therefore, the Commission amends Title 16 of the Code of Federal Regulations by adding part 1221 to read as follows:
The Consumer Product Safety Improvement Act of 2008, Pub. L. 110-314, section 104, 122 Stat. 3016 (August 14, 2008).
This part establishes a consumer product safety standard for play yards manufactured or imported on or after February 28, 2013.
(a) Except as provided in paragraph (b) of this section, each play yard must comply with all applicable provisions of ASTM F406-12a, Standard Consumer Safety Specification for Non-Full-Size Baby Cribs/Play Yards, approved on May 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;
(b) Comply with the ASTM F406-12a standard with the following exclusions:
(1) Do not comply with section 5.17 of ASTM F406-12a.
(2) Do not comply with section 5.19 of ASTM F406-12a.
(3) Do not comply with section 5.20 of ASTM F406-12a.
(4) Do not comply with section 6, Performance Requirements for Rigid-Sided Products, of ASTM F406-12a, in its entirety.
(5) Do not comply with sections 8.1 through 8.10.5 of ASTM F406-12a.
(6) Instead of complying with section 184.108.40.206 of ASTM F406-12a, comply with only the following:
(i) 220.127.116.11 For products that have a separate mattress that is not permanently fixed in place: Use ONLY mattress/pad provided by manufacturer.
(7) Do not comply with section 10.1.1.1 of ASTM F406-12a.