UNITED STATES CONSUMER PRODUCT SAFETY COMMISSION 4330 EAST WEST HIGHWAY BETHESDA, MD 20814

DATE:

BALLOT VOTE SHEET

TO: The Commission Todd A. Stevenson, Secretary

THROUGH: Mary T. Boyle, General Counsel Patricia H. Adkins, Executive Director

FROM: Patricia M. Pollitzer, Assistant General Counsel Mary A. House, Attorney, OGC

SUBJECT: Petition CP 15-2: Petition Requesting Ban on Supplemental for Play Yards with Non-Rigid Sides

BALLOT VOTE DUE ______

CPSC staff is forwarding a briefing package to the Commission regarding a petition requesting a ban on supplemental mattresses for play yards with non-rigid sides, which are currently marketed to be used with non-full-size cribs, play yards, portable cribs, and play pens (petition). The petition was submitted by Joyce Davis, president of Keeping Babies Safe (KBS) (petitioner). Petitioner contends that supplemental mattresses for play yards that are thicker than 1.5 inches create a suffocation hazard. CPSC staff recommends that the Commission defer the petition so that staff can work with stakeholders on several voluntary standards committees to improve safety for all aftermarket mattresses intended to be used with play yards.

Please indicate your vote on the following options:

I. Grant the petition and direct staff to begin developing a notice of proposed rulemaking or an advance notice of proposed rulemaking.

(Signature) (Date)

CPSC Hotline: 1-800-638-CPSC(2772) CPSC's Web Site: http://www.cpsc.gov

Page 1 of 2 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1)

II. Defer the petition and direct the staff to work through the voluntary standards process to improve the safety of aftermarket mattresses sold for use in play yards.

(Signature) (Date)

III. Deny the petition and direct staff to draft a letter of denial to the petitioner.

(Signature) (Date)

IV. Take other action. (Please specify.)

(Signature) (Date)

Attachment: Staff Briefing Package for Petition CP 15-2: Petition Requesting Rulemaking on Supplemental Mattresses for Play Yards with Non-Rigid Sides

Page 2 of 2

THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1)

Staff Briefing Package

Petition CP 15-2: Petition Requesting Rulemaking on Supplemental Mattresses for Play Yards with Non-Rigid Sides

May 10, 2017

Hope E J. Nesteruk, Children’s Program Manager Division of Mechanical and Combustion Engineering Directorate for Engineering Sciences U.S. Consumer Product Safety Commission

The contents of this package have not been reviewed or approved by the Commission and do not necessarily represent its views.

THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) I. TABLE OF CONTENTS

EXECUTIVE SUMMARY ...... III

BRIEFING MEMORANDUM...... V

I. INTRODUCTION...... 1

II. HAZARD INFORMATION ...... 4

III. VOLUNTARY STANDARDS...... 8

IV. ECONOMIC CONSIDERATIONS ...... 13

V. PUBLIC COMMENTS ...... 14

VI. STAFF CONCLUSION ...... 21

VII. COMMISSION OPTIONS ...... 22

VIII. OPTIONS ...... 23

IX. STAFF RECOMMENDATION ...... 24

TAB A: PETITION FOR A BAN ON SUPPLEMENTAL MATTRESSES FOR PLAY YARDS WITH NON-RIGID SIDES ...... 25

TAB B: FATALITIES INVOLVING AFTERMARKET MATTRESSES FOR PLAY YARDS WITH NON-RIGID SIDES . 32

TAB C: HUMAN FACTORS ASSESSMENT OF PLAY YARDS WITH NON-RIGID SIDES AND THE USE OF

AFTERMARKET MATTRESSES ...... 41

TAB D: HEALTH SCIENCES STAFF REVIEW OF THE MECHANISMS OF DEATH ASSOCIATED WITH USE OF

AFTERMARKET MATTRESSES IN PLAY YARDS...... 51

TAB E: MECHANICAL ENGINEERING ASSESSMENT FOR PETITION CPSC-2015-0020, PETITION

REQUESTING THE BAN OF SUPPLEMENTAL MATTRESSES FOR PLAY YARDS WITH NON-RIGID SIDES ...... 58

TAB F: PETITION REQUESTING A BAN ON SUPPLEMENTAL MATTRESSES FOR PLAY YARDS WITH NON-

RIGID SIDES – ECONOMIC CONSIDERATIONS ...... 68

ii THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) Executive Summary On June 16, 2015, the president of Keeping Babies Safe (KBS) and the mother of a child that died in an incident involving an aftermarket , petitioned the CPSC requesting a ban on supplemental mattresses for play yards with non-rigid sides, which are currently marketed to be used with non-full-size cribs, play yards, portable cribs, and play pens. In addition, KBS stated that they did not intend their petition to cover mattresses sold by the play yard manufacturer as a replacement part. Specifically, the petitioner contended that the supplemental mattresses are thicker than the 1.5 inches allowed for mattresses supplied with a play yard pursuant to the mandatory standard for play yards, codified at 16 C.F.R. part 1221. In addition, the petitioner alleges that “thicker mattresses create a suffocation hazard because they create a gap between the sides and the side of the portable crib where a baby can suffocate when the baby’s head falls in such gap while lying in the prone position.” Furthermore, the petitioner concluded that “no feasible consumer product safety standard would adequately protect babies from the unreasonable risk of injury and death associated with the product.”

CPSC staff analyzed potentially relevant play yard entrapment fatalities between 2000 and 2016 and identified 14 incidents involving or potentially involving a mattress other than the original mattress used in a play yard with non-rigid sides. Of the 14 incidents, nine incidents involved a child entrapped within a pocket formed between the mattress and the non-rigid side of a play yard. These incidents involved mattresses other than the original mattress, but included incidents involving a mattress that was used alone, as well as incidents involving a mattress that was used on top of an original mattress (a “supplemental mattress”). Although a ban on the product category would keep supplemental mattresses off the market, staff’s analysis of additional play yard suffocation-related incident data, online product reviews, and data from the Durable Nursery Product Exposure Study suggest that if supplemental mattresses are not available, other soft may be used to increase the child’s actual or perceived comfort.

In 2014, the ASTM International (ASTM) F15.66 Crib Mattress subcommittee formed a task group and is actively working through ballot proposals to incorporate requirements for aftermarket mattresses into a voluntary standard. Recently, ASTM F15.66 passed a ballot that broadens the scope of the voluntary standard for crib mattresses, ASTM F2933, to include aftermarket play yard and non-full-size crib mattresses. ASTM F2933 will require aftermarket mattresses to meet the same thickness, support system, and attachment requirements as the original mattress included with the specific play yard for which the mattress is intended to fit and to carry additional warning messages. ASTM’s intent appears to be to ensure that aftermarket mattresses are virtually identical to the original mattress. However, ASTM defined an “aftermarket mattress” to be a mattress “intended to replace” the original mattress. Such definition arguably excludes mattresses that can be used on top of an original mattress. Thus, ASTM’s current effort will improve safety, but staff concludes that to improve safety for all

iii THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) mattresses intended for use in a play yard, ASTM should also address safety requirements for “supplemental mattresses” that consumers currently use along with an original mattress.

The ASTM F15.18 subcommittee for non-full-size cribs and play yards has considered the issue of mattress thickness and softness for original play yard mattresses several times over the past 20 years. Currently, the mattress entrapment issue is addressed in ASTM F406 by requiring play yards to be sold with a mattress that is no more than 1.5 inches thick. Internationally, the standard for play yard products (folding cots) in Australia and New Zealand address mattress entrapment using a performance test to assess the entrapment potential between the side of a mattress and a non-rigid side. This international standard suggests the possibility of also creating a performance test for entrapment in play yards.

Because incident data demonstrate that consumers perceive play yard mattresses to be uncomfortable, and then place additional soft bedding in infant sleep environments, CPSC staff does not recommend banning supplemental mattresses. Instead, CPSC staff recommends that the Commission defer its decision on the petition and direct staff to work with standards development organizations, their relevant subcommittees, and stakeholders to address consumer concerns while increasing the safety of all aftermarket mattresses. Staff plans to work with the ASTM F15.66 Crib Mattress Subcommittee on the ASTM F2933 voluntary standard to expand the requirements for aftermarket play yard mattresses to include all aftermarket mattresses. In addition, staff plans to work with the ASTM F15.18 Play Yards Subcommittee on the ASTM F406 voluntary standard to assess whether the standard for play yard mattresses can address consumers’ perceived comfort concerns, without compromising safety. For example, CPSC staff and the voluntary standards organization could assess options, such as developing a performance test for mattress fit, adjusting the thickness requirement to include a minimum and a maximum, or standardizing play yard sizes so that well-fitting mattresses are available. If the Commission votes to defer its decision, staff will provide the Commission with an update on the progress of efforts made in the relevant voluntary standards. Thereafter, the Commission could make a determination on how to proceed with the petition.

iv THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) Briefing Memorandum

v THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1)

UNITED STATES CONSUMER PRODUCT SAFETY COMMISSION 4330 EAST WEST HIGHWAY BETHESDA, MARYLAND 20814

Memorandum

Date: May 10, 2017

TO: The Commission Todd A. Stevenson, Secretary

THROUGH: Patricia H. Adkins, Executive Director DeWane Ray, Deputy Executive Director for Safety Operations Mary T. Boyle, General Counsel

FROM: George A. Borlase, Assistant Executive Director Office of Hazard Identification and Reduction

Hope E J. Nesteruk, Children’s Program Manager General Engineer, Directorate for Engineering Sciences

SUBJECT: Petition CP 15-2: Petition Requesting Rulemaking on Supplemental Mattresses for Play Yards With Non-Rigid Sides

I. INTRODUCTION

U.S. Consumer Product Safety Commission (CPSC or Commission) staff prepared this briefing package in response to a petition requesting that the Commission use its authority under section 8 of the Consumer Product Safety Act (CPSA) (15 U.S.C. § 2057) to initiate rulemaking to ban supplemental mattresses for play yards with non-rigid sides, which are currently marketed to be used with non-full-size cribs, play yards, portable cribs, and play pens. This memorandum includes a review of the public comments received in response to the Federal Register notice, current status of voluntary standards, and a discussion of options to respond to this petition for Commission consideration.

A. PRODUCT DESCRIPTION

No statute, regulation, or voluntary standard defines the term “supplemental mattress.” Therefore, for the purposes of this petition, CPSC staff considered a supplemental mattress to be a mattress sold for use in a non-rigid sided non-full-size crib, play yard, or portable crib, but not packaged with the crib or play yard and not sold by the original manufacturer as a replacement part. Staff considers an “aftermarket” mattress to be any mattress for a play yard other than a

CPSC Hotline: 1-800-638-CPSC(2772) CPSC's Web Site: http://www.cpsc.gov

THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) mattress produced and sold as a replacement part by an original equipment manufacturer (OEM). Supplemental mattresses, as considered by CPSC staff, are used by consumers either instead of, or in addition to, the original play yard mattress. Staff will refer to the products covered in this petition as “aftermarket mattresses” because the term more clearly indicates any mattress sold independently that can be used in a play yard, whether used alone or with the original mattress.

B. PETITION SUMMARY

On June 16, 2015, Joyce Davis (the petitioner), president of Keeping Babies Safe (KBS), petitioned the CPSC requesting a ban on “supplemental mattresses for play yards with non-rigid sides, which are currently marketed to be used with non-full-size cribs, play yards, portable cribs, and play pens.” CPSC’s Office of the General Counsel docketed1 the request for rulemaking as Petition CP 15-2, under provisions of the CPSA. A copy of the petition can be found in Tab A. On August 11, 2015, the Commission published a notice in the Federal Register (80 Fed. Reg. 48,043) requesting public comments. Later in this memorandum, we summarize the comments received and staff’s responses.

The petitioner provided a list of 15 incidents that purportedly occurred in domestic settings2 between 2000 and 2013 that the petitioner believed involved a supplemental mattress in a play yard or portable crib. The incidents allegedly involved a child becoming entrapped in gaps created when a supplemental mattress was placed in a play yard or non-rigid-sided portable crib as the primary sleeping surface. Specifically, the petitioner contended that supplemental mattresses that are thicker than the 1.5 inches allowed for mattresses supplied with a play yard pursuant to the mandatory standard for play yards, codified at 16 C.F.R. part 1221, create a suffocation hazard for infants placed in play yards. Petitioner alleged that “thicker mattresses create a suffocation hazard because they create a gap between the mattress pad sides and the side of the portable crib where a baby can suffocate when the baby’s head falls in such gap while lying in the prone position.” Furthermore, the petitioner concluded that “no feasible consumer product safety standard would adequately protect babies from the unreasonable risk of injury and death associated with the product.”

C. EXISTING REGULATIONS AND STANDARDS IN THE UNITED STATES

The petition focuses on mattresses sold for use in soft-sided play yards. The Commission has a mandatory rule for play yards issued under the Danny Keysar Child Product Safety Notification

1 https://www.cpsc.gov/s3fs- public/pdfs/CP152PetitionRequestingRulemakingSupplementalMattressesPlayYardswithNonRigidSides072915.pdf. 2 The petitioner also mentioned “6 incidents that occurred in a child care setting,” but these incidents were not included with the petition.

2 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) Act, section 104 of the Consumer Product Safety Improvement Act of 2008 (CPSIA). The safety standard for play yards is codified at 16 C.F.R. part 1221, and incorporates by reference applicable provisions of ASTM F406-13, Standard Consumer Safety Specification for Non-Full- Size Baby Cribs/Play Yards, as the mandatory standard.3 Play yards are framed enclosures, less than 35 inches in height, with a floor made for the purpose of providing sleeping and playing accommodations for a child who cannot climb out. Play yards, by definition, have non-rigid fabric or mesh side panels. Unlike non-full-size crib requirements in ASTM F406, the play yard requirements do not include a test to ensure mattress fit. Rather, the play yard standard requires that each product include a mattress at the point of sale, and that total mattress thickness shall not exceed 1 ½ inches, with the filling material limited to 1 inch.

Mattresses intended for a play yard, but not included with a play yard purchase, currently are not addressed by any rule or voluntary standard. However, ASTM International publishes a voluntary standard for crib mattresses, ASTM F2933 – 13, Standard Consumer Safety Specification for Crib Mattresses, which covers “full-size and non-full-size crib mattresses.” As described in this briefing package, the ASTM F2933 subcommittee has recently been working to address aftermarket mattresses for non-full-size cribs and play yards in this voluntary standard (see section III). On the most recent ballot, however, ASTM defined an “aftermarket mattress” to include only those mattresses that are “intended to replace” an original play yard mattress. Arguably, this definition can be read to exclude mattresses that consumers use in addition to the original mattress provided with a play yard.

The petitioner identified “supplemental mattresses” as mattresses “currently marketed to be used with non-full-size cribs, play yards, portable cribs, and play pens.” However, staff notes that “non-full-size cribs” and “portable cribs,” by definition, are rigid-sided products under the mandatory rule for non-full-size cribs and portable cribs, codified at 16 C.F.R. part 1220.4 Part 1220 incorporates by reference an earlier version of the same voluntary standard that addresses play yards, ASTM F406.5

3 ASTM has one standard (F406) that covers both play yards and full size cribs; however, the Commission has separate standards for these products. 4 Portable cribs are considered a subset of non-full size cribs by 16 C.F.R. part 1220 and ASTM F406. 5 Part 1220 regulates non-full-size cribs and incorporates by reference the applicable provisions of ASTM F406-10a, Standard Consumer Safety Specification for Non-Full-Size Baby Cribs/Play Yards. Part 1221 regulates play yards and incorporates by reference the applicable provisions of the 2013 version of the same voluntary standard, ASTM F406-13.

3 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) II. HAZARD INFORMATION

A. INCIDENT DATA

As discussed in Tab B, CPSC staff’s review of the incidents cited in the petition shows that two of the 15 incidents may have involved an aftermarket mattress in a non-rigid-sided play yard, and only one of the incidents clearly involved an entrapment. The remaining incidents involved products designed for purposes other than play yard mattresses (e.g., , foam ) added to a play yard as a sleeping surface, which staff finds are outside the scope of the petition.

CPSC staff conducted a separate data search for incidents relevant to the petition. Staff’s data search focused on fatalities of young children in non-rigid-sided play yards due to the use of aftermarket mattresses that occurred between January 1, 2000 and December 31, 2016. Staff’s chosen timeframe ensured that all incidents cited in the petition were within the search time period. Staff identified 14 fatalities that involved, or may have involved, an aftermarket mattress used in a non-rigid-sided play yard. None of incidents cited in the petition is included in the 14 incidents staff identified because none of the petition incidents clearly involved aftermarket mattresses used in a non-rigid-sided play yard.

Twelve of the reported fatal incidents most likely involved the use of an aftermarket mattress in a non-rigid-sided play yard. Seven of the fatalities involved children less than 5 months old who became entrapped between the mesh side of a play yard and the aftermarket mattress, which is the primary hazard pattern identified by the petitioner. The remaining five fatal incidents involved an aftermarket mattress, but staff could not determine whether the suffocation was related solely to entrapment. In these incidents, the presence of soft bedding, extraneous items in the play yard, or prone positioning, were confounding factors.

Two additional incidents did not report sufficient detail for staff to conclusively determine the use of an aftermarket mattress; however, both incidents involved entrapment in a gap or pocket formed between a mesh side play yard and a mattress.

BEHAVIORAL ANALYSIS

In Tab C, staff of CPSC’s Directorate for Engineering Sciences, Division of Human Factors (ESHF), analyzed the human-product system involved in play yard use.

1. Child development

Of the 12 fatalities identified by EPHA staff involving an aftermarket mattress used within a play yard, the infants ranged in age from 2 months old to 6 months old, and 7 of the 12 incidents involved positional asphyxia between a thick mattress and the mesh play yard side. Additional

4 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) incidents of the general hazard pattern (thick sleeping surface and a mesh side wall) involved children as old as 10 months. The hazard pattern is likely related to a child becoming entrapped in a position from which they are unable to extract themselves.

Infants in the age range associated with fatal incidents, i.e., between 2 and 6 months, develop new skills, such as rolling over and crawling, in stages. According to Bayley (1969), several developmental milestones occur within the first 6 months of life; some notable motor skills typically achieved are turning from side to back (average age: 1.8 months old), turning from back to side (average age: 4.4 months old), and turning from back to stomach (average age: 6.4 months old). Children as young as 8 to 12 weeks are likely to move around a play yard, including moving to the edge and possibly into vulnerable situations, such as falling into a pocket between mattress and mesh wall. However, children may not be able to remove themselves by reversing their actions because they may not have developed the skill.

2. Caregiver perceptions

In reviewing the large set of play yard-related, positional asphyxia incidents to identify those associated with aftermarket mattresses, ESHF staff noted incidents involving infants ranging from 1 to 10 months old that did not involve an aftermarket mattress, but did involve the addition of a mattress-like product, such as foam, , and sofa . In addition, in the online product reviews for aftermarket mattresses that were included with the petition, caregivers expressed concern for infants sleeping on hard surfaces. ESHF staff concluded that extra bedding is used as a way to increase perceived comfort for the infant. Staff’s conclusion regarding extra bedding is supported by CPSC’s Durable Nursery Product Exposure Survey (DNPES), which found that about 75 percent of play yard users replace or add soft items to the original play yard mattress.

INJURY MECHANISMS ANALYSIS

In Tab D, Directorate for Health Sciences staff explored the incidents submitted by the petitioner and those from CPSC staff’s analysis. In each case, the cause of death was listed as positional asphyxia, a form of asphyxia associated with an abnormal body position that prevents adequate gas exchange or direct obstruction of the airways (e.g., smothering by an object). An excessive gap between a mattress edge and the play yard wall is a recognized entrapment hazard that can cause death by positional asphyxia/suffocation. Infants found in this compromised position, with their nose and mouth pressed against the mattress or play yard side are likely to remain in this position and experience compromised airflow.

Decreased oxygen levels in the blood can further impair the ability of the infant to respond to a compromised breathing situation, such as an entrapment. If uninterrupted, a cycle of decreased

5 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) heart and respiration rate develops that eventually leads to cessation of breathing and may become fatal. Unlike adults, the limited physical and developmental capabilities of infants render them susceptible to suffocation in certain sleeping environments. Physiological abnormalities and delays in the development of vital systems can further hamper an infant’s ability to react to a hazardous condition. Infants in the first few months of life (less than 6 months) and premature babies who are particularly vulnerable to low oxygen levels, are the most at risk due primarily to an immature breathing control system in the first few months of life.

Thick mattresses, multiple mattresses, and additional bedding used to raise the level of the sleeping surface can pose additional risks by increasing the chances of forming a larger pocket between the edge of a mattress and the side wall of a play yard. Thus, a child can roll into the mesh side wall of a play yard and become wedged or entrapped face down in a depression formed in the play yard floor in areas that are not covered by the mattress. As discussed above, infants younger than 6 months of age may be particularly at risk because they may be developmentally capable of moving around during sleep, but may not be able to reverse actions and extract themselves from a hazardous situation.

PRODUCT EVALUATION

As identified in the user behavior and injury mechanism analysis, the two aspects of mattress design that relate directly to entrapment between the mattress and a non-rigid sided play yard are mattress fit and mattress thickness.

Fit General guidance on safe sleep environments and fit guidance for rigid-sided infant sleep products, e.g., full-size and non-full size cribs, suggests that proper fit of mattresses for play yards and non-full-sized cribs means that when the mattress is placed in the center of the product, there should be less than ½ inch between the mattress and the side walls of the product. In Tab E, Directorate for Laboratory Sciences staff reviewed online information for five models of aftermarket mattresses and physically examined three aftermarket mattress models available in CPSC’s sample inventory. Information on the length, width, and height of each aftermarket mattress was then compared to two typical mesh-sided play yards available in CPSC inventory. Based on the measurements, none of the mattresses would fit properly into one play yard, and only one of the eight mattresses would fit properly into the second play yard.

Thickness As discussed in the existing standard summary (section I. part C.), play yard mattress thickness is limited to 1 ½ inches in the mandatory standard for play yards. Of the eight aftermarket mattresses assessed in Tab E, only one mattress would potentially meet the 1 ½-inch requirement that applies to play yards, although the exact thickness of the filling, which is limited to 1inch, was not clear. The remaining seven mattresses ranged between 2 and 3 inches thick.

6 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1)

B. HAZARD EVALUATION AND ILLUSTRATION

The hazard of entrapment within the mesh sides of a play yard has been known to the Commission for more than 30 years. In August 1985, the CPSC issued a warning6 that “[c]hildren may asphyxiate or suffocate in the loose mesh of the lowered side.” While that warning was specifically related to play yards with sides that lowered, allowing fabric to loosen and form a pocket to the side of the play yard floor, the mechanics of the hazard are similar to the entrapment described by the petition. Specifically, if an aftermarket mattress does not fit properly, a similar pocket may be formed between the edge of the mattress, the floor of the play yard, and the mesh side of the play yard. Depending on the size of this pocket, it may be large enough to entrap a child on its own, or the pocket may grow in size because of the non-rigid mesh sides, as shown in the figures below. In the first set of photos (Figure 1), a typical play yard mattress is shown with a gap along the side, but the thickness of the mattress does not create a deep enough gap to form an entrapment pocket. However, Figure 2 and Figure 3 show how a 1- inch gap with a thicker mattress can expand to the width of an infant’s head and form an entrapment pocket. Additional photos and discussion can be found in Tab C.

Figure 1. Typical mesh-side play yard and original 1-inch mattress

6 https://www.cpsc.gov/Recalls/1985/Mesh-Sided-Crib--Playpen-Warning.

7 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) Figure 2. Typical mesh-side play yard and aftermarket mattress approximately 3 inches thick

Figure 3. Illustration of gap expansion

III. VOLUNTARY STANDARDS

In Tab E, CPSC Laboratory Sciences staff identified two U.S. voluntary standards relevant to infant mattresses and one international standard relevant to mattress fit in a play yard environment.

8 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) ASTM F406-15: Standard Consumer Safety Specification for Non-Full-Size Baby Cribs/Play Yards (16 C.F.R. part 1220 and 16 C.F.R. part 12217).

ASTM F406 establishes performance requirements for rigid and mesh/fabric-sided non-full-size cribs/play yards. Each product must be sold with a mattress included.

Non-rigid-sided products (play yards) ASTM F406 does not contain dimensional or thickness requirements for mattresses in non-rigid- sided (i.e., mesh or fabric) products. The only performance requirements for non-rigid-sided product mattresses are that (1) the mattress must be provided with the product, and (2) the filling material of the mattress, e.g., as foam, fiberfill, etc., shall not exceed 1 inch in thickness, while 1 the total thickness of the mattress shall not exceed 1 /2 inches. The thickness requirement for play yard mattresses has existed since the 1980s, and it is intended to prevent entrapment of an infant in a pocket that could be created between the mattress and the play yard.8 Although the subcommittee has revisited the thickness in recent years (e.g., a 2014 task group), the only change to the thickness requirements was made in 1999, when the thickness allowance was increased from 1 inch to 1.5 inches to allow for a rigid base beneath the mattress pad. In addition, play yards must carry a warning that addresses “Use ONLY mattress/pad provided by the manufacturer.”

Rigid-sided products (non-full-size cribs) Although rigid-sided products are outside the scope of the petition, the requirements for a non- full-size crib mattress demonstrate one method of defining mattress fit and mattress thickness. ASTM F406 Section 5.17 contains requirements for thickness and dimensions (i.e., fit) for mattresses for rigid-sided products. Specifically, the dimensions of the mattress supplied with a 1 non-full-size crib shall not leave a gap of more than /2 inch at any point between the perimeter of the mattress and the perimeter of the crib. In addition, when the mattress is placed against a side of the crib the resulting gap on the other side shall not exceed 1 inch. Mattress thickness must be at least 2 inches, but is determined by the height of the side of a non-full-size crib side. For stationary-sided9 cribs, the mattress must provide a minimum effective crib-side height dimension:

• When the mattress is in the lowest adjustable position, at least:

7 Although the products share a voluntary standard, the Commission has separate mandatory standards for play yards and non-full-size cribs that incorporate by reference the relevant parts of ASTM F406. 8 March 1996 ASTM meeting minutes, which include the following rationale: “Limit the thickness of pads to prevent entrapment of an infant in a recess that could be created between the mattress and the play yard. Mesh/fabric side could deform to create a pocket between the sides and mattress.” 9 There are additional requirements for non-full-sized cribs with a moveable side; however, this is an artifact from drop-sided cribs that remains in the standard.

9 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) o 20 inches from the sleeping surface to upper surface of each side panel, and o 22 inches from the mattress support structure to upper surface of each side panel • When the mattress is in the lowest adjustable position, at least: o 9 inches from the sleeping surface to upper surface of each side panel.

ASTM F2933 – 13: Standard Consumer Safety Specification for Crib Mattresses

ASTM F2933 – 13 is a voluntary standard that establishes design requirements, testing requirements and methods, and requirements for labeling for full-size and non-full-size crib mattresses.

Full-size cribs ASTM F2933 – 13 requires the minimum dimensions of the mattress supplied with a full-size 1 5 crib to be 27 /4 x 51 /8 inch. Because the standard for full-size cribs (16 C.F.R. part 1219/ASTM F1169-13) specifies rigid dimensions of a full-size crib to be 28 ± 5/8 inches wide and 52 3/8 ± 5/8 inches long, a crib mattress that meets F2933 would not create a gap between the side of the crib and mattress greater than 1.375 inches. In addition, cribs must have an on- product warning statement that specifies the minimum dimensions of a mattress used to be 27 1/4 x 51 5/8 inches, with a thickness not exceeding 6 inches.

Rigid-sided non-full-size cribs ASTM F2933 – 13 requires that the dimensions of the mattress supplied with a non-full-size crib 1 shall not leave a gap of more than /2 inch at any point between the perimeter of the mattress and the perimeter of the crib. When the mattress is placed flush against a side of the crib, the resulting gap on the other side shall not exceed 1 inch. In addition, ASTM F2933 – 13 contains the same thickness requirements as ASTM F406, which are based on effective side height.

Non-rigid-sided products (play yards) Currently, ASTM F2933 does not contain any requirements for mattresses used with non-rigid- sided products. However, modifications to the F2933 standard to expand the scope to include aftermarket non-full-size crib and play yard mattresses are under consideration by the ASTM F15.66. In a recent ballot, issued February 28, 2017, ASTM defined “aftermarket mattress” as a mattress that is intended to replace the original mattress sold with a play yard or non-full sized crib. The item, as balloted, did not pass, and thus, is subject to additional review and discussion by the ASTM subcommittee. As balloted, the change in scope would include aftermarket mattresses intended for use alone, but arguably could exclude some supplemental mattresses that are specifically designed and marketed to be placed on top of an existing mattress. Although a new standard that includes aftermarket mattresses has not been published, the subcommittee appears to be moving in the direction of requiring aftermarket mattresses to be similar in size, support structure, and attachment methods as a mattress that is originally sold with a play yard.

10 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) In addition, aftermarket play yard mattresses would also need to meet requirements contained in the mattress (§5.16), mattresses for rigid-sided products (§5.17), and mattress vertical displacement (§7.6) sections of ASTM F406. In essence, an “aftermarket mattress,” per ASTM’s proposed definition, would need to be virtually identical to the mattress it is intended to replace, and it must meet the specifications stated in ASTM F406 when tested with each brand and model of the product it is intended to replace. In addition, an aftermarket mattress would carry its own suffocation warning label that communicates the hazards of poor fit and mattress height.

Recent activities by the F15.66 subcommittee include:

• December 2016: Ballot F15 (16-11) Item 7. This item was proposed to “Add test and warnings standard for mattresses marketed as replacement for Non-Full-Size Baby Cribs and Play Yards” and was applied to “Mattresses marketed as replacement for Non-Full-Size Baby Cribs and Play Yards.” The item received eight negative votes and was withdrawn for further task group work. CPSC staff submitted an abstention with comment10 on this ballot item because staff felt that “marketed as replacement” tied the requirements to the marketing information, rather than the foreseeable use of the products. Specifically, CPSC staff suggested:

that the phrase, “sold independently,” in lieu of, “marketed as replacement,” would more clearly identify the mattresses that the subcommittee intends to address. One method to accomplish this is to define ‘aftermarket’ in section 3, and then the proposed section 5.8 would apply to “Aftermarket mattresses for non-full-sized cribs and play yards.”

• March 2017: Ballot F15 (17-02) Items 9, 10, and 12. These items are the outcome of task group work in January and February 2017. Staff did not comment on the ballot items because of ongoing work with this petition response. Staff anticipates that requiring an aftermarket mattress to meet the same requirements as original play yard mattresses and including fit requirements would address the hazards identified by the petitioner.

o Item 9: Proposal to add “after-market mattresses for play yards and non-full size cribs” to the scope of F2933. This item passed with no negatives and one editorial comment. The subcommittee considered the one comment at the April 3, 2017 meeting.

10 https://www.regulations.gov/document?D=CPSC-2015-0020-0124.

11 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) o Item 10: Proposal to define “aftermarket mattress” as “A mattress that is intended to replace the original mattress sold with a play yard or non-full sized crib” while excluding “a replacement mattress provided or sold by the original manufacturer for their own product.” The item received four negative votes. The negative votes centered on the exclusion and asked that that the exemption be limited to those that do not differ in dimensions or structure. The subcommittee found the negatives persuasive and withdrew the item for further task group work to address the concerns.

o Item 12: Proposal to add performance and hazard communication requirements to aftermarket mattresses. The item received seven negative votes, six affirmative with comments, and one abstention with comments. Negative votes regarding the lack of formatting requirements were withdrawn with the understanding that the subcommittee was preparing to address warning formatting for all warnings in the standard. Four negative votes focused on several issues, such as:

. That the ballot item would prevent aftermarket manufacturers from producing mattresses that are thicker than the original mattress, even if the original mattress is thinner than the 1.5 inches allowed by F406, . That the ballot item would require the same mattress support structure, even if the original mattress used a segmented support structure and the aftermarket mattress would have used a solid support structure, and . That the ballot item was related to the petition under consideration by the Commission and the subcommittee should wait.

The subcommittee found all four negative votes non-persuasive – a decision that will be balloted for the F15 committee to uphold. In addition, the subcommittee formed a task group to address the issue raised about the requirement to match the support structure.

Of the seven comments, three were addressed editorially or by answering the commenter’s question. The remaining four were position statements supporting a ban, but indicating this change would be beneficial.

Specifically, under item 12, aftermarket mattresses would be required to:

. be virtually identical in thickness, floor support structure, and attachment method to the original mattress;

12 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) . meet the requirements in the mattress (§5.16), mattresses for rigid-sided products (§5.17), and mattress vertical displacement (§7.6) sections of F40611; . have all markings, such as warnings and instructions, that were on the original mattress; . include the suffocation warning below to address ill-fitting mattresses, stacking mattresses, and how to check the fit of an aftermarket mattress: o Suffocation Hazard Babies have suffocated:

• In gaps between wrong-size mattress and side walls of product. • Between the side walls and extra padding, such as stacked mattresses.

ALWAYS check mattress fit by pushing mattress tight to one corner. Look for any gaps between the mattress and the side walls. If this gap is larger than 1 inch the mattress does not fit and should NOT be used. NEVER stack with another mattress. Use only ONE mattress.

AS/NZS 2195:1999 Australian/New Zealand Standard: Folding Cots – Safety Requirements

The Australia and New Zealand standard for folding cots, which are the same type of products referred to as play yards in the United States, specifies that no gap should exist between the flexible sides of the folding cot and the mattress because a “child’s head could become entrapped causing a suffocation hazard.” The mattress complying with the recommended size on the cot’s warning labels shall touch the cot on all sides, i.e., “fit snugly.” In addition, an entrapment hazard test aims to prevent a child’s head from becoming entrapped between the mattress and flexible sides by applying a force of 50 Newton (11.2 pounds-force) to a 95 millimeter (3.74 inch) diameter probe between the mattress and the side wall. In addition, AS/NZS 2195 requires warning labels that address the length, width, and height of an appropriately sized mattress.

IV. ECONOMIC CONSIDERATIONS As discussed in the memorandum from the Directorate for Economic Analysis (Tab F), staff identified 22 firms supplying aftermarket mattresses to the U.S. marketplace. Three of the firms are foreign manufacturers, and one is a large domestic retailer, most likely importing aftermarket mattresses. Based on U.S. Small Business Administration guidelines, the remaining 18 domestic

11 Note that only the mattress (section 5.16) section applies to play yard mattress.

13 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) firms are small: 11 manufacturers, 4 importers, 1 retailer, and 2 firms with unknown supply sources.

Staff found no annual sales information available for aftermarket mattresses, but found that approximately 12 percent of the play yards in use have aftermarket mattresses, according to CPSC’s Durable Nursery Product Exposure Survey (DNPES).12 According to the DNPES, only about 25 percent of play yard users do not place anything other than the original mattress under their child. Most caregivers use one or more other types of soft bedding in a play yard.

Although staff identified at least 12 incidents that involved aftermarket mattresses over a 17-year period, these data were reported to CPSC through the Consumer Product Safety Risk Management System (CPSRMS), which cannot be extrapolated to the population at large, unlike data from the National Electronic Injury Surveillance System (NEISS). Therefore, CPSC staff cannot derive national estimates of the deaths associated with aftermarket mattresses from the incident data or estimate the annual cost to society of the hazards associated with aftermarket mattresses used in play yards.

Staff cannot state what effect a ban on “supplemental mattresses” (as defined by KBS) would have on play yard deaths. While a ban would eliminate all aftermarket mattresses, regardless of whether they necessarily pose a hazard, it may be possible to make an aftermarket mattress that fits a particular play yard properly and also meets the mattress requirements in the voluntary and mandatory play yard standards (ASTM F406-15 and 16 C.F.R. part1220, respectively). The requested ban would also eliminate the utility that consumers derive from aftermarket mattresses that they use in rigid-sided products. As discussed above, ASTM is working to address aftermarket mattresses in ASTM F2933.

V. PUBLIC COMMENTS

CPSC received 120 comments on regulations.gov in response to a Federal Register notice requesting comments on the petition. Overall, 108 commenters supported the petition, 9 commenters disagreed with banning supplemental mattresses, and 3 commenters expressed no opinion. CPSC staff broke the comments into five general areas:

• A form letter or a minor variation of the form letter that supported the petition and contained six specific, numbered points; • Support for the petition, but without substantive comment;

12 Melia, K.L. and J.L. Jenkins (November 2014). Durable Nursery Products Exposure Survey (DNPES): Final Summary Report. U.S. Consumer Product Safety Commission, prepared by Westat.

14 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) • Support for the petition, with one or more additional specific comments; • Opposition to the petition for a variety of reasons; • Information from comments, such as incident descriptions and international standards.

Form Letters

Seventy commenters submitted a form letter than contained the following six specific points.

1. Stores sell supplemental mattresses for play yards even though the voluntary standard warns that consumers shouldn’t use them. Staff response: Staff agrees this is a statement of fact.

2. The sale of supplemental mattresses undermines the strength of the warning labels on play yards. Staff response: 16 C.F.R. part 1221, which references ASTM F406 – 1313, requires the following suffocation warning for play yards:

WARNING Infants can suffocate • In gaps between a mattress too small or too thick and product sides. • On soft bedding NEVER add a mattress, pillow, , or padding.

In addition, the following message is required on “products that have a separate mattress that is not permanently fixed in place,” which would include play yards with removable mattresses. • Use ONLY mattress/pad provided by the manufacturer

Rigid-sided products with removable mattresses would be required to add the following statement after “provided by the manufacturer”: (which must be at least X in. long by Y in. wide and not more than Z in, thick.).

While staff agrees that the commenters’ contention on the first two points is possible, other factors contribute to the credibility and effectiveness of a warning. Generally, for a warning to be effective, the consumer must notice, read, and heed a warning. A breakdown in any of these three factors will prevent a warning from being effective.

13 The current published version of the voluntary standard is ASTM F406 – 15; however, CPSC’s standard incorporates by reference ASTM F406 – 13. ASTM has not notified CPSC of revisions under the process established in section 104(a)(4) of the CPSIA. The warning statements referenced between the two published versions are the same.

15 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) Thus, an effective warning must be carefully written, designed, and placed in ways that will increase the likelihood that consumers will notice, read, and heed the warning. When personal experience conflicts with a warning message, it is generally the warning message that is discredited and ignored (Ayers, Gross, Wood, Horst, Beyer, and Robinson, 1986). Therefore, personal experience and the recommendations of others, including stores that market aftermarket mattresses and online reviews of the products, can influence behavior.

3. There is clear evidence that children are suffocating. Staff response: Staff researched the incidents cited by the petitioner and also conducted a search for incidents that involved aftermarket mattresses. The full results of this analysis are found in Tab B. CPSC staff found seven fatal suffocation incidents where a child was entrapped between an aftermarket mattress and a non-rigid-sided play yard, and an additional two fatal entrapments where an aftermarket mattress may have been used. However, the majority of fatal play yard suffocation incidents involved extra bedding, pillows, or other soft materials that were not marketed and sold as an aftermarket mattress.

4. Play yards are sold with minimal padding for a reason. Staff response: Commenters did not state the reason play yard mattresses are sold with minimal padding. From work with the ASTM F15.18 voluntary standard committee over the years, staff is aware that the thickness requirement for play yard mattresses has existed since the 1980s, and is intended to prevent entrapment of an infant in a pocket that could be created between the mattress and the play yard. The issue first arose with ASTM in response to incidents involving play yards with a mesh sidewall that could be lowered,14 and the subcommittee chose to limit the thickness of the mattress as a means to address the hazard. Mattress thickness was limited to 1 inch from the mid-1980s until 1999, when it was increased to 1.5 inches to allow for a rigid base while the filling remained limited to 1 inch. However, some play yard mattresses may be thinner than 1.5 inches based on a manufacturer’s design choice, such as to accommodate folding the play yard unit for storage or for the mattress to also fit within a attachment. Play yards on the market today must meet performance requirements that prevent the sides from lowering unexpectedly and forming the loose material that formed the entrapment pocket, such as in the figure below.

14 https://www.cpsc.gov/Recalls/1985/Mesh-Sided-Crib--Playpen-Warning.

16 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) Figure A1.5 in ASTM F406-15

5. Supplemental mattresses are commonly marketed with soft-sided play yards, creating the belief that they can be used together. Staff response: Staff is unaware of any play yards that are marketed with an aftermarket mattress, and the commenters did not provide examples or evidence of co-marketing. The commenters may be describing how aftermarket mattresses are placed in a store near play yards (e.g., in the same store aisle), rather than alleging that the two products are being marketed and sold together as one package. However, staff agrees with the general concept that products that are marketed for use in a play yard would lead consumers to believe that they are safe to be used in play yards.

6. Banning the sale of supplemental mattresses for play yards with non-rigid sides is the most effective way to prevent the suffocation hazard posed by the use of these mattresses. Staff response: As described in this memorandum and subsequent supporting memoranda, staff believes that a performance standard for aftermarket mattresses is feasible and will reduce the risk of suffocation. Banning the sale of aftermarket mattresses is unlikely to resolve caregiver behavior of placing thicker or softer, more cushiony materials in a play yard because caregivers perceive that play yard mattresses are uncomfortable. If aftermarket mattresses are unavailable, consumers may continue to place hazardous soft bedding in a play yard.

Based on the information in this briefing package, staff concludes that proper fit of a mattress is essential to avoid creating a hazardous gap, and will likely reduce the risk of injury associated with aftermarket mattresses. CPSC staff believes that addressing aftermarket mattresses through the efforts of the voluntary standards for crib mattresses and play yards will likely adequately address the hazard associated with play yard mattresses, based on the incident data. However, CPSC staff anticipates that while the required suffocation warning proposed in the voluntary standard for crib mattresses may help to reduce the risk of caregivers placing additional soft bedding in play yards, staff is unclear whether such labeling will be sufficient to change consumer behavior.

Support for the petition

Twenty-two comments expressed general support for the petition without specific reasons. Fifteen additional support comments listed one or more reasons to support the petition. Most of these comments spoke to some, but not all, of the six reasons included in the form letter. For

17 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) example, one comment stated, “When stores sell soft supplemental mattresses along with these play yards parents think they are safe. They think they are choosing a product that will make their baby more comfortable when in fact, they are choosing a potentially dangerous product that has resulted in preventable infant deaths.” Other comments included items from the form letter verbatim. Issues raised by the supportive comments that varied significantly from the form letter include:

• Comments about warnings, such as “Warning labels are not enough,” and “target consumer is a busy, tired parent - who just needs a good night sleep for her precious baby - reading a warning label doesn't always happen.”

• Comments about marketing and sales, such as “When stores sell soft supplemental mattresses along with these play yards parents think they are safe,” and “i saw this item being sold in a store even with the JPMA warning on a play yard.”

• Comments about child development, such as “[infant babies] can not [sic] move or pickup their heads when in the corner of the crib.”

• “Anything that can help to protect a baby from an unsafe sleep environment is critical.”

• “Parents look to the government to help protect their babies from potential danger that can ultimately cause death.”

Staff Response: Staff appreciates the comments received. Because these comments are general comments or personal experience, staff is not responding to each one. However, the comments informed staff’s briefing package and provided input into the issues staff researched and considered in its analysis. In general, staff agrees that child development contributes to many of the recommendations for safe sleeping environment – such as the “Back to Sleep” and “Bare is Best” information and education campaigns. In addition, staff generally recommends designing the hazard out of a product or guarding the consumer from the hazard, rather than relying only on warnings, because a warning’s effectiveness depends on persuading consumers to alter their behavior in some way to avoid the hazard.

Against the petition

Eight comments opposed the petition. One of these comments was simply the word “AGAINST,” while the others addressed a wide variety of opinions. We discuss the key points from each commenter below.

One commenter suggested allowing supplemental mattresses for older children, giving an example of her 16-month-old son that still sleeps in a play yard occasionally, and suggesting “If the child is old enough to turn over, they are old enough to move away if they are caught in a situation when they are having trouble breathing.”

Staff response: Staff agrees that older children are at less risk than young infants; however, staff disagrees that rolling over is the appropriate developmental milestone. Of the fatalities involving an aftermarket mattress used within a play yard, the infants ranged in age from 2 months old to 5

18 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) months old. Several developmental milestones occur within the first 6 months of life; some notable motor skills achieved within 6 months of life are turning from side to back (average age: 1.8 months old), turning from back to side (average age: 4.4 months old), and rolling from back to stomach (average age: 6.4-months old). These motor milestones may allow infants to achieve a position that may pose a suffocation risk, but the child may not be able to extract themselves. Limited physical and developmental capabilities of these infants render them susceptible to dangers from suffocation in certain settings. Young infants are unlikely to have developed the arousal and cardiovascular control mechanisms that would wake them in life-threatening circumstances. As such, a very young sleeping infant is unable to arouse itself when air supply to the lungs is compromised (Blair et al., 2006; Kattwinkel et al., 2000; Nakamura et al., 1999; and Wanna-Nakamura, 2008, 2010).

One commenter suggested “[s]ubject[ing] supplemental mattresses to the same set of requirements from the F406 standards as the primary mattress, which includes mattress thickness, mattress dimensions, floor strength, and mattress vertical displacement.”

Staff response: Staff agrees that requiring aftermarket mattresses to meet the same requirements as mattresses sold in conjunction with a play yard would likely address the issue of mattresses that are too thick for a mesh-sided play yard. The ASTM F15.44 subcommittee on crib mattresses is currently proceeding with task groups to address aftermarket play yard mattresses in way that is similar to the commenter’s suggestion. Staff remains concerned about the overall fit of a mattress, but believes that by working with the ASTM standards committee, this issue can be addressed.

One commenter stated that their purchase of a supplemental mattress was “safer than using pillows and .”

Staff response: Staff agrees that the use of pillows and blankets to soften the sleep surface is generally considered to be an unsafe sleep practice; however, staff does not have the data to support a claim that use of any aftermarket mattress is a “safer” sleep environment than with the use of pillows and blankets. For example, raising the height of a sleeping surface in a mesh side play yard increases the risk of entrapment between the mesh side wall and the sleeping surface, especially when the edge of the sleeping surface does not remain flush with the non-rigid sidewall. This entrapment hazard remains regardless of whether the increased height of the sleep surface is achieved by using an aftermarket mattress or by using a pillow.

One commenter suggested performing a root-cause analysis and focusing on caregiver expectations and education. In addition, the commenter questioning if play yards are intended for “sleeping unsupervised” and suggested that similar death has occurred in cribs with “solid slats.”

Staff response: Staff agrees with the request to do a root-cause analysis, and believes that this briefing package explores the causes of the reported incidents. CPSC staff appreciates the concerns raised and considered them in our analysis. However, with respect to the specific question regarding unsupervised sleep, the Commission does consider a play yard to be a sleeping environment. The voluntary standard for play yards, ASTM F406 – 13, Standard

19 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) Consumer Safety Specification for Non-Full-Size Baby Cribs/Play Yards, which has been promulgated as 16 C.F.R. 1221, defines a “play yard” as:

3.1.21 play yard (aka playpen), n—framed enclosure that includes a floor and has mesh or fabric sided panels primarily intended to provide a play or sleeping environment for children.[emphasis added]

One commenter, representing the juvenile product industry, wrote that they are “actively working with the voluntary standards setting process to determine the best and next course of action for this product category” and requested “that the Commission evaluate all data, solicit comments, and work with industry to address those concerns addressed within the petition rather than simply banning the use of the product category in question”

Staff response: Staff appreciates the effort that the ASTM voluntary standards subcommittees and task groups, including members from the juvenile product industry, have made in evaluating and responding to the issue of entrapment associated with aftermarket mattresses. We have reviewed the comments in response to the petition, evaluated existing data with respect to the issue, and participated in voluntary standards activities to address the hazard associated with the use of aftermarket mattresses. Staff’s efforts have informed the recommendation contained in this briefing package.

One commenter submitted two comments including an incident review that they asserted “point to a variety items other than commercially produced supplemental play yard mattress as cause of death.” In summary, the commenter stated that “The evidence demonstrates that even with the warnings, consumers continue to use soft bedding and other unsafe items to augment their play yard mattresses. It is frightening to imagine how many more consumers would turn to such proven dangerous items if the safer alternative supplemental play yard mattresses are taken off the market as this petition proposes.” One additional commenter submitted an identical incident review, and requested “further research be conducted before imposing any legal restrictions on the retail sale of supplemental play yard mattresses.”

Staff response: As documented in Tabs B and D, staff agrees that the incidents submitted by the petitioner were not limited to “supplemental mattresses.” Staff believes that this briefing package and its recommendations respond to the commenter’s request for further research and consideration of the issue of caregivers using soft bedding in infant sleep environments.

No Opinion

Three comments stated no opinion on the petition. One said “Thank you, CPSC, for considering this important, life-saving petition,” another was essentially blank, and the third provided information related to actions in France related to “additional mattresses” used in play yards (called folding cots in Europe).

Staff Response: Staff greatly appreciates the information on the actions in France. The information contained in the documents was used to inform the development of this briefing package. Specifically, the information about the efforts in France to add hazard communication

20 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) requirements to address incidents of children that suffocated in a play yard when an additional mattress was added to a play yard. This warning under consideration with the ASTM F15.66 subcommittee would specifically address stacking additional mattresses in a play yard.

VI. STAFF CONCLUSION

The petitioner asked the CPSC to initiate a rulemaking to ban supplemental mattresses for play yards with non-rigid sides that are currently marketed to be used with non-full-size cribs, play yards, portable cribs, and play pens. Staff reviewed the incident data submitted by the petitioner, conducted a separate incident search and analysis, researched child development data, analyzed caregiver perceptions, investigated the hazard pattern, reviewed mandatory and voluntary standards, participated in ASTM task group work, and conducted a preliminary market analysis. Through this process, staff concluded that the key components of entrapment prevention between the mattress edge and non-rigid play yard sides are mattress fit and mattress thickness. Additionally, staff concluded that the data demonstrate that caregivers introduce additional hazards into the sleep environment, by using soft bedding in play yards, believing that the OEM mattress that comes with a play yard is uncomfortable for infant sleep. Because of this perception, staff does not believe that banning aftermarket mattresses will have the intended effect of preventing infant deaths and that caregivers will continue to place soft bedding in play yards, even if aftermarket mattresses are banned. In addition, staff is concerned that banning all aftermarket mattresses for use in play yards may be ineffective because similar products may continue to be available for use in rigid-sided products. Thus, consumers may continue to use or misuse supplemental mattresses in play yards. Staff’s recommendation is to address the safety of all aftermarket mattresses.

Because few mattresses are marketed as “supplemental mattresses” and the petitioner did not define a “supplemental mattress,” staff anticipates that addressing requirements for all aftermarket mattresses for play yards will capture the supplemental mattresses of concern in the petition, along with other types of replacement mattresses. Recent activity by the ASTM F15.66 subcommittee for crib mattresses suggests that the subcommittee is committed to including aftermarket play yard mattresses within the scope of F2933. The current proposal is for aftermarket mattresses that replace original mattresses to have the same thickness, support structure, and attachment method as the original mattress; meet the same mattress requirements as required by ASTM F406; and carry a suffocation hazard warning label about height and fit of aftermarket mattresses. The subcommittee has balloted and passed these requirements, although a definition clarification and some administrative procedures remain before the standard is approved and published. Staff believes that requiring all aftermarket mattresses to meet the same requirements as original play yard mattresses will address the petition; however, the work of ASTM should be expanded to address all aftermarket mattresses intended for use in a play yard,

21 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) not just those specifically intended to replace an original play yard mattress. If the Commission decides to defer the petition, staff will work with ASTM to that end.

As discussed above, staff concludes that the issues of fit and thickness associated with play yard mattresses can be addressed by working with ASTM to address the issue within the ASTM F15.18 play yard subcommittee. Staff suggests that ASTM evaluate whether play yard mattresses can be made to be thicker or softer, without compromising safety to infants, to address consumer perception of inadequate comfort of the play yard mattresses. Possible strategies to achieve “better” mattresses include standardizing play yard size or developing a soft-sided entrapment test, such as the test used in Australia. Because the F15.66 subcommittee on mattresses is addressing aftermarket mattresses through reference to the requirements in F406, any changes made to the mattress requirements for play yards should be carried over to aftermarket play yard mattresses. Additionally, if the Commission finds that changes to F406 improve the safety of play yards, the Commission can incorporate by reference the new version of such voluntary standard as the mandatory standard for play yards through the update procedures in section 104 of the CPSIA.

VII. COMMISSION OPTIONS A. BASIS FOR CONSIDERATION The Commission’s regulations on petitions state that when considering whether to grant or deny a petition, the Commission considers:

(1) Whether the product that is the subject of the petition presents an unreasonable risk of injury; (2) Whether a rule is reasonably necessary to eliminate or reduce the risk of injury; (3) Whether failure to initiate rulemaking would expose the petitioner or others to the risk of injury the petitioner alleges the product presents; and (4) If the petition seeks a ban, whether the product is being or will be distributed in commerce and whether a feasible consumer product safety standard would adequately protect the public from the risk of injury.

The petition regulations also state that when considering these factors, the Commission will consider the petition in relation to the agency’s priorities, as stated in the CPSC’s Policy on Establishing Priorities and the Commission’s resources available for rulemaking. 16 C.F.R. § 1051.9(a).

Staff agrees with the petitioner that a gap formed between a thick aftermarket mattress and the side of a non-rigid-sided play yard creates an entrapment risk for infants, and can present a suffocation hazard if it’s large enough to form a pocket. However, based on incident data and

22 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) staff’s analysis, staff does not conclude that banning aftermarket mattresses is necessary to eliminate or reduce this entrapment risk. Rather, staff believes a feasible solution to reduce the risk of injury is to strengthen the requirements for aftermarket mattresses to include all aftermarket mattresses and require those mattresses to meet the same requirements as original play yard mattress. Staff’s review of information demonstrates that consumers perceive play yard mattresses to be uncomfortable and that caregivers add soft bedding to infant sleep environments to increase comfort. Accordingly, banning aftermarket mattresses may encourage caregivers to use other soft bedding, such as pillows, cushions, blankets, or foam pads, the safety of which cannot be addressed through voluntary or mandatory standards. Because of this caregiver behavior, failure to initiate rulemaking to ban aftermarket mattresses may not expose infants to an increased suffocation risk. Moreover, because aftermarket mattresses are marketed for use with play yards and non-full-size cribs, banning the product is unlikely to be feasible. Even if sufficient data were available to ban aftermarket mattresses for use in play yards, staff is unclear whether the Commission would have sufficient data to ban aftermarket mattresses for use in non- full-size cribs. Accordingly, unless the product could be banned for all uses, aftermarket mattresses would remain available for consumer use and misuse.

Staff’s recommendation is to work through the ASTM process to strengthen the requirements for all aftermarket mattresses for use in play yards to encourage use of appropriate bedding and reduce fatalities associated with aftermarket mattresses and soft bedding. ASTM is currently revising the voluntary standard for crib mattresses to address some aftermarket mattresses. If the voluntary standard for crib mattresses requires aftermarket mattresses to meet the same requirements as original play yard mattresses, ASTM should also assess requirements for mattresses that are included with a play yard to explore if the existing method of limiting thickness remains the only practical solution to address the entrapment hazard.

In addition, the CPSA states that the Commission may not deny a petition on the basis of a voluntary standard, unless:

(1) The Commission determines that the voluntary standard is likely to result in the elimination or adequate reduction of the risk of injury identified in the petition, and (2) It is likely that there will be substantial compliance with the voluntary standard.

If the Commission defers the petition, staff will provide, subject to available resources, an assessment of the relevant voluntary standards in a future briefing package, after ASTM has concluded updates to address aftermarket mattresses for play yards.

VIII. OPTIONS

Options for Commission action to address the petition include:

23 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION. UNDER CPSA 6(b)(1) 1. Grant the Petition

If, based on the information contained in this briefing package, the Commission concludes that aftermarket mattresses may present an unreasonable risk of injury or death and that a ban (or mandatory standard) may be reasonably necessary to eliminate or adequately reduce that risk, the Commission may grant the petition and direct staff to develop an advance notice of proposed rulemaking (ANPR) or a notice of proposed rulemaking (NPR) under the authority of the Consumer Product Safety Act (CSPA) to ban, or issues a mandatory standard for, aftermarket mattresses.

2. Deny the Petition

If the Commission concludes that the available information does not indicate that aftermarket mattresses present an unreasonable risk of injury or death, or that addressing the hazard does not necessitate banning or issuing a mandatory standard for aftermarket mattresses, the Commission may deny the petition.

3. Defer Decision on the Petition

If the Commission concludes that there is insufficient information to make a decision on the petition and that staff could obtain such information, or concludes that voluntary standards requirements could be developed that would address the issue under consideration, the Commission could defer its decision and direct staff to obtain the additional information and/or continue to work on the voluntary standards.

IX. STAFF RECOMMENDATION

Based on the information contained in this briefing package, CPSC staff recommends that the Commission defer its decision on the petition and direct staff to work with standards development organizations, their relevant subcommittees, and stakeholders to address consumer concerns while increasing the safety of all aftermarket mattresses. Staff plans to work with ASTM F15.66 Crib Mattress Subcommittee on the ASTM F2933 voluntary standard to finalize requirements for all aftermarket play yard mattresses. In addition, staff plans to work with the ASTM F15.18 Play Yards Subcommittee on the ASTM F406 voluntary standard to evaluate whether the standard for play yards should address mattress fit, and whether the thickness requirement for play yard mattresses is the only way to address potential entrapment. If the Commission votes to defer its decision, staff will provide the Commission with an update on the progress of voluntary standards activities after the voluntary standard publishes a new standard. At that time, the Commission could make a determination to continue to defer its decision on the petition and proceed with the voluntary standards process or pursue other Commission action.

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TAB A: Petition for a Ban on Supplemental Mattresses for Play Yards with Non-Rigid Sides

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CPSC Hotline: 1-800-638-CPSC(2772) CPSC's Web Site: http://www.cpsc.gov

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Petition and all attachments also available online at: https://www.cpsc.gov/s3fs- public/pdfs/CP152PetitionRequestingRulemakingSupplementalMattressesPlayYardswithNonRig idSides072915.pdf.

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TAB B: Fatalities Involving Aftermarket Mattresses for Play Yards with Non-Rigid Sides

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UNITED STATES CONSUMER PRODUCT SAFETY COMMISSION 4330 EAST WEST HIGHWAY BETHESDA, MARYLAND 20814

Memorandum

Date: Feb 10, 2017

TO Hope E J. Nesteruk Project Manager, Supplemental Mattresses Petition Division of Mechanical and Combustion Engineering, Directorate for Engineering Sciences

THROUGH Kathleen Stralka Associate Executive Director Directorate for Epidemiology

Stephen Hanway Director, Division of Hazard Analysis Directorate for Epidemiology

FROM Risana Chowdhury Division of Hazard Analysis Directorate for Epidemiology

SUBJECT Fatalities Involving Aftermarket Mattresses for Play Yards with Non-Rigid Sides∗

I. Introduction

Keeping Babies Safe (KBS) filed a petition requesting that the Consumer Product Safety Commission (CPSC) promulgate a mandatory rule to ban the sale of supplemental mattresses for play yards with non-rigid sides (Petition). According to the Petition, these mattresses are currently marketed to be used with non-full-size cribs, play yards, and portable cribs. The Petition cites incident data (obtained from CPSC databases) to demonstrate that no feasible

∗This analysis was prepared by CPSC staff. It has not been reviewed or approved by, and may not necessarily reflect the views of, the Commission.

CPSC Hotline: 1-800-638-CPSC(2772) CPSC's Web Site: http://www.cpsc.gov

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consumer product safety standard would adequately protect babies from the unreasonable risk of injury and death associated with these supplemental mattresses. The Petition clarifies that the proposed ban would not include mattresses offered for sale by manufacturers of play yards as replacements for mattresses that originally came with the play yards.

CPSC staff conducted two data searches. First, staff identified the incidents cited in the Petition from the CPSC databases to obtain all available information for each case and confirm their relevance to the Petition. Next, staff conducted a separate data search and completed a detailed analysis of all fatal incidents associated with the use of aftermarket mattresses in play yards with non-rigid sides. This memorandum summarizes the findings from that effort.

II. Incidents Cited in the Petition

Staff searched CPSC databases for the incidents cited in the Petition to verify that the incidents were indeed associated with the use of aftermarket mattresses in non-rigid-sided play yards. Staff located all incidents cited in CPSC’s databases. Staff also located all corroborating information from other reporting sources to facilitate a more complete assessment of each incident cited in the Petition. Staff reviews each incident below, following the order cited in the Petition.

Incident 1 (from 2000; IDI15 000222HCC3166): This child was found prone on top of a plastic- wrapped adult pillow in a play yard. The pillow was being used as the mattress and was on top of two , two folded sheets, a , and three receiving blankets. No available information on this incident mentions or suggests that a commercially available aftermarket mattress was involved.

Incident 2 (from 2001; IDI 020517HCC1537): A full-size crib mattress, not an aftermarket mattress, was added to the play yard. The mattress, which was too long for the play yard, was bent into an “L” configuration, with part of the mattress sticking out of the play yard. No available information mentions or suggests that an aftermarket mattress was involved.

Incident 3 (from 2003; IDI 040107CCC2251): A 5-inch-thick couch cushion was being used at the bottom of a play yard as a mattress. No available information on this incident mentions or suggests that a commercially available aftermarket mattress was involved.

Incident 4 (from 2003; IDI 040517HCC3305): A twin mattress was placed on top of a play yard to prevent a 15-month-old child from climbing out. The child managed to dislodge the mattress enough to get her head over the play yard rail, but then became trapped between the rail and the

15 IDI stands for In-Depth Investigation.

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mattress. No available information mentions or suggests that an aftermarket mattress was involved.

Incident 5 (from 2004; document number 0448151934): A 4-inch-thick foam pad was being used as a mattress in the play yard. No available information on this incident mentions or suggests that a commercially available aftermarket mattress was involved.

Incident 6 (from 2004; document number X0473332A): A was found wrapped tightly around the child, with the child’s face in the mattress. The type of mattress, whether aftermarket or not, was not mentioned, nor was there any mention of entrapment because of an ill-fitting mattress.

Incident 7 (from 2005; IDI 050615HCC1856): This incident narrative, as submitted in the Petition, appears to be fragments of multiple-incident narratives pieced together. The narrative mentions an entrapment between a 4-inch-thick foam pad and the end of a play yard; a child’s head was trapped between a sofa cushion and the side of a play yard; as well as a blanket wrapped around the child’s head and neck. Staff cannot determine which parts of the narrative describe the incident to which the petitioner referred. Nevertheless, staff does not consider any of the items described, a foam pad, sofa cushion, or a blanket, to be an aftermarket mattress. CPSC staff identified a 2005 death of a child trapped in a gap between a 4-inch-thick foam pad and a play yard. Again, however, a foam pad is not an aftermarket mattress for purposes of the Petition.

Incident 8 (from 2006; IDI 080221HCC1438): Similar to incident 2 above, a crib mattress was added to a play yard. Because the mattress was longer than the play yard, it was bent into an L- shaped configuration with part of the mattress sticking out and over the top of the play yard. No available information mentions or suggests that an aftermarket mattress was involved.

Incident 9 (from 2006; IDI 071004HCC3024): In this incident, a child was found wedged and prone between a removable changing table cushion and the railing of a wooden crib, not a non- rigid-sided play yard. This incident does not mention or suggest the use of an aftermarket mattress.

Incidents 10 & 11(from 2007; document numbers N07C0163A, 0720023850): These two incident narratives refer to the same incident. The 2-year-old child was in a play yard, with a twin mattress on top. The child’s head/neck became wedged over the rail of the play yard but under the mattress. An aftermarket mattress was not involved in the incident.

Incident 12 (from 2008; IDI 090317HCC1502): A 6-month-old child was placed prone on two sofa cushions that were placed side-by-side at the bottom of a play yard. The child was found

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face down in a gap between the edge of one of the sofa cushions and the side of the play yard. An aftermarket mattress was not involved in this incident.

Incident 13 (from 2008; IDI 090213HCC1421): In this incident, the baby was face down on top of the original mattress of a play yard’s bassinet attachment. The non-flatness in the crease (where the mattress folds) of the mattress was believed to be a contributing factor in this death. An aftermarket mattress was not involved in this case.

Incident 14 (from 2009; IDI 090805HCC1935): In this incident, the decedent was on an adult- sized , co-sleeping with a parent and sibling. At some point, the child rolled off the air mattress onto the mesh siding of a play yard, which was positioned next to the air mattress, and became entrapped. The child was not in a play yard, and an aftermarket mattress was not involved.

Incident 15 (from 2010; document number 1037040644): Little information was available on this incident. The child was reported to be entrapped between a mattress and a portable crib. Assuming that the child was inside the portable crib, the mattress may have been the original or an aftermarket mattress. The portable crib may have been a play yard or a non-full-sized crib (both are often referred to as portable cribs in the CPSC databases when sufficient information is unavailable). If it was a wood or metal non-full-sized crib, then it would have been rigid-sided as well. Given the lack of information, it is not certain whether this case is relevant to the Petition.

Based on the description of the products considered in-scope by the Petition, CPSC staff’s review of the incidents cited in the Petition shows that, at most, two incidents (incidents 6 and 15) may have involved an aftermarket mattress in a non-rigid-sided play yard, and only one of those (incident 15) clearly involved an entrapment. However, incomplete information on these incidents prevents CPSC staff from concluding whether an aftermarket mattress was associated with the incidents.

III. Incident Data Review16 for Aftermarket Mattresses in Non-Rigid-Sided Play Yards or Bassinet Attachments of Play Yards

16 The CPSC database searched was the Consumer Product Safety Risk Management System (CPSRMS). The reported deaths in this database do not provide a complete count of all that occurred during the time period of interest. However, they do provide a minimum number for the deaths occurring during this time period and illustrate the circumstances involved in the incidents.

Data have been extracted in three stages. On 1/20/16, all fatality data coded under product codes 1513 (Playpens and play yards), 1529 (Portable cribs), and 1542 (Baby mattresses or pads) were extracted; on 3/2/16, a second extraction included fatality data coded under product code 1537( or cradles) to ensure all incidents

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CPSC staff conducted an independent data search for incidents relevant to the Petition. To be consistent with the requested ban on supplemental mattresses as described in the Petition, staff considered a “supplemental mattress” to be a commercially available mattress intended to be used with a non-rigid play yard or play pen, but the definition excluded mattresses or pads sold with the play yard or sold as replacements by the play yard’s manufacturer. CPSC staff’s data search focused on fatalities suffered by young children in non-rigid-sided play yards resulting from the use of aftermarket mattresses that occurred between January 1, 2000, and December 31, 2016. The chosen timeframe ensured that all incidents cited in the Petition were considered.

CPSC staff identified 12 reported fatal incidents that likely involved the use of an aftermarket mattress in a non-rigid-sided play yard. Two additional incidents did not report sufficient detail for staff to determine conclusively the use of an aftermarket mattress. The incidents and the hazards leading to the deaths will be discussed individually, in chronological order, within subgroups decided via team consensus.

a. Entrapment in a Gap

Incident 1 (from 2000; IDI 010327HCC0417): “A four month old died of asphyxiation after he was put to sleep in a play yard containing a smaller than original replacement mattress of another brand than the play yard itself. The infant was found with his face in the space created between the mattress and the nylon wall of the play yard.” Although the mattress is referred to as a “replacement mattress” in the report, the mattress is a 2.75-inch-thick mattress pad that likely falls under the definition of an “aftermarket mattress,” as described in the Petition. The child’s death occurred when the child became entrapped in the gap created between the edge of the mattress and the side of the play yard.

Incident 2 (from 2001; IDI 020516HCC1532): “A 3 month old female, left to sleep in a portable playpen/crib, was found dead, her face wedged between the mattress and the mesh siding of the product.” The official report indicated that the additional mattress used in this incident was 2 to 3 inches thick and there was a 2 to3-inch gap between the edge of the mattress and the mesh siding of the play yard where the child was found wedged.

involving bassinet attachments of play yards are also reviewed. On 1/13/17, another search was conducted, using the same product codes noted above, to identify any new fatality reports received since the prior extractions and to extend the covered timeframe through 12/31/16. In all cases, the age of the victim was capped at 24 months or under. CPSC staff members from multiple directorates jointly reviewed the data to identify the potentially in-scope cases. To prevent any double-counting, when multiple reports of the same incident were identified, they were consolidated and counted as one incident.

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Incident 3 (from 2003; IDI 040316HCC2389): “A four month old female was placed by her mother in a playpen to go to . One hour later, the victim was found with her face and head wedged between the side of the playpen and mattress. Cause of death was ruled as Position Asphyxia. The mattress was purchased separately and left a three inch gap on both sides where the victim was found wedged.” The child was entrapped in a gap created by the edge of the mattress and the side of the play yard. However, based on the little additional information available on the mattress, CPSC staff believes that this most likely was a non-full-size crib mattress.

Incident 4 (from 2003; IDI 051110CCC3100): “A three-month-old female died in a portable crib due to positional asphyxiation. Two mattresses were being used in the crib and one did not come all the way to the edge of the crib.” In this incident, the parent had added a second, smaller mattress (dimensions unknown), which left a gap between the sides of the play yard and the mattress. The child was found on her side in the corner of the play yard. This scenario is very similar to the incidents described above, except that the ill-fitting aftermarket mattress was on top of a properly fitted bottom mattress, instead of a floor board.

Incident 5 (from 2005; IDI 060814HCC1695): “The grandmother of the four month old female infant had placed two mattress pads in the play yard and covered them with an infant mattress cover and sheet. When one of the parents went into the bedroom they found the infant wedged between the mattress pads and the side of the play yard. The victim expired three days later.” According to the investigation report, the mattresses were not intended for the play yard; they were 2 feet x 3 feet and approximately 1.5 to 2.0 inches thick. They appeared to fit firmly at the top and bottom ends, but had an approximate gap of 2.5 inches on one side. The victim rolled into this gap face down and suffocated.

Incident 6 (from 2014; IDI 150407HCC1448): “The two month old male victim was found unresponsive wedged between the end of a playpen and a mattress that was placed in the playpen. The victim was transported to the hospital where he was pronounced deceased due to suffocation.” According to official reports, the mattress (not original) that lined the bottom of the play yard left uncovered a space of approximately 5 to 7 inches on one side of the play yard. A depressed surface, created between two metal support beams in the bottom of the play yard, was left exposed by the mattress. The child was found lying face down in that depressed area. The report contains no information on mattress thickness.

Incident 7 (from 2015; IDI 160812HCC2772): “A four month old male was placed face down in a play yard and discovered unresponsive approximately ninety minutes later. Law enforcement determined the mattress in the play yard was not original to the play yard and an approximate

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one inch gap existed between the mattress and the side of the play yard. The victim was found face down with the side of his cheek against the play yard side.” In this incident, the victim’s family was visiting relatives out of state. The victim’s mother could not affirm or deny that the mattress used was original to the play yard, but had believed that the fit was fine. No additional information was available on the thickness of the mattress.

b. Multiple Contributory Factors, with No Entrapment

For the following five incidents, CPSC staff determined conclusively that an aftermarket mattress was in use, but staff analysis of available evidence indicates that entrapment was not an issue. Staff was unclear if and how the mattresses contributed to the fatalities because of the presence of other confounding factors, such as soft bedding, additional items in the play yard, and prone sleeping position. As such, it is unclear whether the following five incidents are in- scope for the Petition.

Incident 8 (from 2002; document no: X0262839A): “A male infant, age 2 month, was found unresponsive face down in the mattress in a playpen with the two adult pillows slightly apart. Cause of death asphyxia.” The report describes two pillows placed on top of a blanket, which was on top of a sheet that covered a 4-inch-thick aftermarket mattress. The medical examiner’s report indicated suffocation on excessive bedding.

Incident 9 (from 2011; IDI 110325HCC2399): “A five month old male was placed to sleep in a play yard/bassinet combo, face down with loose bedding. The infant was found unresponsive and pronounced dead the next morning.” In this incident, the child was put to sleep face down in a sagging bassinet attachment of a play yard, on top of bedding stacked 8-inches high. The bedding consisted of a floor pad, an , a folded comforter, and two mattress pads.

Incident 10 (from 2011; IDI 110617HCC3844): “A four month old infant was found unresponsive in a playpen. The childcare provider stated she left the infant in the playpen swaddled in a blanket and on her left side. When she found the infant there was nothing blocking her face. The cause of death was ruled SIDS.” An aftermarket mattress was being used in this incident; however, there was nothing blocking the child’s mouth or nose.

Incident 11 (from 2014; IDI 151002CCC2005): “A 31 year old mother placed her 2 month old son to sleep on his back in a play yard. When she woke up to check on the baby, he was face

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down. He was cold to the touch. All efforts to revive the baby were unsuccessful and the baby died of asphyxia.” A pillow, a stuffed animal, and a blanket were also inside the play yard. The mattress, which was smaller than the play yard, was covered with a loosely fitted sheet. There was inconsistency between the reported positions (middle of the mattress versus corner of the mattress) in which the decedent was discovered.

Incident 12 (from 2015; IDI 161019HCC3063): “A 2-month old male was found unresponsive and not breathing after being removed from a playpen at an unlicensed daycare facility located in a personal residence. There was no indication of any item obstructing the child's breathing; however, the medical examiner concluded that the cause of death was suffocation.” There was conflicting information in the official reports about the mattress pad. According to a police report, the mattress pad was not an aftermarket product; the fabric and pattern on the pad matched the rest of the playpen. According to the medical examiner, the decedent was face down in an unsafe environment with a mattress that was non-standard for the playpen he was in, non- fitted sheets, and blankets. Based on the photo evidence, CPSC staff also concludes that the mattress pad was not original.

c. Uncertain If Aftermarket Mattress

Incident 13 (from 2009; IDI 110923CCC2993): “Several hours after being put to bed for the night in a playpen, a 3-month-old female was found unresponsive and not breathing, reportedly in a 4-inch gap between the playpen and a mattress in the playpen. After unsuccessful attempts to resuscitate the victim, emergency medical personnel declared her dead at the scene.” Both the investigation and coroner reports used the terms “mattress” and “cushion” interchangeably; with no additional information available on the mattress, staff is unable to determine conclusively whether the product was an aftermarket mattress.

Incident 14 (from 2014; IDI 161027CCC1134): “A six month old female victim was found unresponsive in her playpen wedged between the mattress and the fabric/mesh side wall of the playpen. The cause of death is listed as positional asphyxia.” Staff is unable to determine conclusively the type of mattress that was involved in the incident due to lack of information.

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TAB C: Human Factors Assessment of Play Yards with Non-Rigid Sides and the Use of Aftermarket Mattresses

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United States Consumer Product Safety Commission Rockville, MD 20850

Memorandum

APRIL 25, 2017 To: Hope E J. Nesteruk Project Manager, Supplemental Mattresses Petition Division of Mechanical and Combustion Engineering Directorate for Engineering Sciences

Through: Joel R. Recht, Ph.D., Associate Executive Director, Directorate for Engineering Sciences

From: Sarah B. Newens, Human Factors Engineer, Division of Human Factors, Directorate for Engineering Sciences

Rana Balci-Sinha, Ph.D., Director, Division of Human Factors, Directorate for Engineering Sciences

Subject: Human Factors Assessment of Play Yards with Non-Rigid Sides and the Use of Aftermarket Mattresses∗

BACKGROUND

On June 16, 2015, Keeping Babies Safe petitioned the Consumer Product Safety Commission (CPSC) to ban the sale of supplemental mattresses for play yards with non-rigid sides. Supplemental mattresses are currently marketed for use within non-full size cribs, play yards, and portable cribs. The petition provided incident data to demonstrate unreasonable risk of injury and death associated with these supplemental mattresses.

∗This analysis was prepared by the CPSC staff. It has not been reviewed or approved by, and may not necessarily reflect the views of, the Commission.

CPSC Hotline: 1-800-638-CPSC(2772) CPSC's Web Site: http://www.cpsc.gov

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This memorandum, prepared by staff of CPSC’s Directorate for Engineering Sciences, Division of Human Factors (ESHF), discusses child development and consumer behavior as it pertains to play yards, non-full size cribs, and portable cribs and the current product design and requirements that may influence consumer behavior. The ESHF memorandum also addresses current and proposed warning requirements for non-full size cribs and play yards, and aftermarket mattresses, which are equivalent to the petitioner’s definition of “supplemental mattresses.”

PRODUCT AND APPLICABLE STANDARDS

An “aftermarket” or “supplemental mattress,” as defined by the petition, is a “mattress for play yards with non-rigid sides which are currently marketed to be used with non-full size cribs, play yards, portable cribs and play pens and, available for sale whether new and/or available for resale.” The petition would exclude mattresses or pads sold with the play yard, or original equipment manufacturer (OEM) mattresses, meant to replace the original mattress included with the product. Typically, a play yard mattress sold with the product also serves the purpose of securing the play yard when it is in the collapsed state and allows easy transportation by the consumer.

SUMMARY OF ASTM VOLUNTARY STANDARDS

The current voluntary standard for non-full size baby cribs/play yards, F406-15 Standard Consumer Safety Specifications for Non-Full-Size Baby Cribs/ Play Yards, includes requirements for mattresses provided with a play yard and has been promulgated as 16 C.F.R. part 1220 and 16 C.F.R. part 1221 under section 104 of the Consumer Product Safety Improvement Act of 2008 (CPSIA). Section 3.1.14 of ASTM F406-15 defines a “mattress” as “a pad with a fabric, vinyl, or other material case filled with resilient material (such as cotton, foam fiberfill, etc.) used as or on the floor of the unit.” Section 5.12.1 requires products that meet the requirement for non-full size baby cribs and play yards to be sold with a mattress when they are intended for sleep.

For rigid-sided products, the standard requires that the dimensions of the mattress supplied with 1 a non-full-size crib shall not leave a gap of more than /2 inch at any point between the perimeter of the mattress and the perimeter of the crib. For mesh/fabric products, the standard requires that the filling material of the mattress such as foam, fiberfill, etc., shall not exceed 1 inch in 1 thickness, and the total thickness of the mattress shall not exceed 1 /2 inches. ASTM F406-15 has included a thickness requirement for play yard mattresses since the 1980s and is intended to

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prevent entrapment of an infant in a pocket that could be created between the mattress and the play yard.17 However, the standard does not contain a gap requirement for mesh/fabric products.

ASTM F406-15 requires a warning label on the top rail of a play yard that informs consumers of the suffocation hazard posed by soft bedding and gaps between an ill-fitting mattress and the product side. However, the standard does not contain specific instructions for consumers on how to confirm a proper fit of a mattress within the play yard. To reduce the likelihood of suffocation with additional materials on a play yard, the warning instructs consumers to “NEVER add a mattress, pillow, comforter, or padding.”

Currently, there are no published voluntary standards or performance requirements for aftermarket mattresses as defined in the petition. Recently, the ASTM subcommittee for crib mattresses, F15.66, formed a task group to develop requirements for play yard mattresses. The task group and subcommittee are working to address aftermarket play yard mattresses in ASTM F2933, Standard Consumer Safety Specification for Crib Mattresses, by requiring the aftermarket mattress to meet the same requirements as those in ASTM F406-15. In addition, the subcommittee has balloted and passed a warning specific to aftermarket mattresses, similar to the suffocation hazard warning on play yards, but with specific hazard avoidance behaviors related to mattress fit.18 Unlike full-size cribs and crib mattresses, non-full-size cribs and play yards are not required to be standard sizes. For full-size cribs, consumers typically purchase the crib and crib mattress separately. Because the two corresponding standards for cribs and crib mattresses work together, consumers are able to ensure that mattresses have a snug fit.19 Given that there are no standardized dimensions for non-full-size cribs and play yards, ASTM F406-15 requires that the manufacturer provide the mattress. Accordingly, in the case of aftermarket mattresses for play yards, instructing consumers to check for proper fit between the mattress and the play yard becomes paramount to prevent an entrapment hazard.

HAZARD DESCRIPTION AND DEVELOPMENTAL COMPONENTS

17 March 1996 ASTM meeting minutes, which include the following rationale: “Limit the thickness of pads to prevent entrapment of an infant in a recess that could be created between the mattress and the play yard. Mesh/fabric side could deform to create a pocket between the sides and mattress.” 18 Revision Of F2933-2016 Consumer Safety Specification for Crib Mattresses WK58012, Item 12.

19 In order to “prevent head entrapment and suffocation between the mattress and crib sides, a mattress used in a full-size crib must be at least 27 1/4 inches x 51 1/4 inches, with a thickness not exceeding 6 inches. The assembly instructions, the retail carton for the crib, and the crib itself must contain a specific warning statement that notes these dimensions.” Retrieved from http://www.cpsc.gov/en/Business--Manufacturing/Business-Education/Business- Guidance/Full-Size-Baby-Cribs/

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INCIDENTS INVOLVING AN AFTERMARKET MATTRESS

CPSC’s Directorate for Epidemiology identified 14 fatal incidents that involved or may have involved an aftermarket mattress in a non-rigid-sided play yard. Seven of the incidents involved a child entrapped between the mesh side wall of the play yard and a poorly fitting aftermarket mattress. Two incidents of the 14 incidents involved a fatal entrapment in the mesh side walls of a play yard, but staff was unable to conclusively identify whether the sleeping surface involved an aftermarket mattress. All victims were less than 7 months old.

ENTRAPMENT AND CHILD DEVELOPMENT

Infants between 2 and 6 months old are developing new skills in stages, such as rolling over and crawling. According to Bayley (1969), several developmental milestones occur within the first 6 months of life; some notable motor skills typically achieved are turning from side to back (average age: 1.8 months old), turning from back to side (average age: 4.4 months old), and turning from back to stomach (average age: 6.4 months old). Children as young as 8 to 12 weeks are likely to move around a play yard, including moving to the edge and possibly moving into vulnerable situations. However, children may not be able to remove themselves by reversing their actions because they may not have developed the skill.

ENTRAPMENT SCENARIO The hazard of entrapment within the pocket formed by the mesh side of a play yard has been known to the Commission for more than 30 years. In August 1985, the CPSC issued a warning20 that “[c]hildren may asphyxiate or suffocate in the loose mesh of the lowered side.” While that warning was specifically related to play yards with sides that lowered, allowing fabric to loosen and form a pocket to the side of the play yard floor, the mechanics of the hazard are similar to the entrapment described by the petition. Specifically, if an aftermarket mattress does not fit properly, a similar pocket may be formed between the edge of the mattress, the floor of the play yard, and the mesh side of the play yard. Depending on the size of this pocket, the gap created may be large enough to entrap a child, or the pocket may grow in size because of the non-rigid mesh sides, as shown in the figures below. As described above, children that roll into a pocket or gap may be unable to extract themselves.

The figures below illustrate the potentially hazardous pocket or gap created between an ill-fitting aftermarket mattress and the side of a non-rigid play yard. In the first set of photos (Figure 4), a typical play yard mattress is shown with a gap along the side, but because the mattress is not thick, the gap created is not deep enough to form a pocket entrapment hazard. Figure 5 and Figure 6 show how using a thicker aftermarket mattress in a play yard with a 1-inch gap between

20 https://www.cpsc.gov/Recalls/1985/Mesh-Sided-Crib--Playpen-Warning.

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the mattress and the play yard side expands the gap to engulf the width of an infant’s head. Depending on development, many infants would not be able to extricate themselves from this position to restore airflow. Figure 4 also shows an entrapment pocket formed by an ill-fitting aftermarket mattress.

Figure 4. Typical mesh-side play yard and original 1-inch-thick mattress Depth too shallow to form a pocket

Figure 5. Typical mesh-side play yard and supplemental mattress approximately 3 inches thick

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Figure 6. Illustration of pocket expansion

Figure 7. Poorly Fitting Supplemental Mattress

MATTRESS FIT ISSUES OBSERVED BY CONSUMERS

An ill-fitting aftermarket mattress within the play yard is likely to be noticed by some consumers as demonstrated by staff’s review of consumer comments on various retailers’ websites. Staff believes that some consumers may perceive the gap as a risk and attempt to reduce the risk with make-shift solutions, such as filling the gap with additional materials. Other consumers may ignore the gap believing that the gap is not large enough to accommodate their child. Regardless, an ill-fitting mattress may lead to hazardous situations with or without consumer action. Some of the consumer comments are listed below: • “… it fits nicely except for maybe like and [sic] inch gap but I put a rolled blanket in there.” • “…this does not fit snugly and there would be room for her to get stuck between the mattress and the side of the playard which is a suffocation hazard.” • “It fits, kind of, but it is not a perfect fit. Without pushing the mattress off to the sides, there is a gap around the edges of the mattress and the sides of the playard. Since the sides of the playard are flexible, you can’t really measure the width of the gap. Around 2”

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if you don’t force it. 4” if you do. So the gap is not big enough for a baby to fall into and get stuck, but it is definitely not snug like a crib mattress is to a crib…. there’s a giant warning tag on the playard that warns not to use any mattress that did not come with it.” • “There was about 1.5 inch gap on one side. It is too big of a gap for me to feel safe putting my baby to sleep in it… double check your specific playard brand/model measurements before ordering instead of going by the compatibility mentioned in the description.” • “there is now a 2” gap running along the length and a 1” gap along the width from the sides of the play yard to the mattress…. Probably end up just stuffing it with towels or something.”

CAREGIVER COMFORT PERCEPTIONS

INCIDENTS INVOLVING SOFT BEDDING

In order to identify fatal incidents within the scope of the petition, team members conducted an interdisciplinary review of fatal suffocation incidents involving play yards that occurred between January 1, 2000 and December 31, 2016. Although this incident review was intended to identify fatalities associated with aftermarket mattress, ESHF staff also noted other incidents, not involving an aftermarket mattress, where it appeared that caregivers had added items to a play yard in order to soften the sleeping surface, such as foam, couch cushions, egg crate foam, and pillows.

Eight example incidents are described below involving victims between 1 to 10 months old. • A 10-month-old became wedged between mesh side of playpen and its mattress (foam placed under the mattress) (IDI#010328HCC3231). • An 8-month-old was found face down wedged against mattress (IDI#120611CCC1731). • A 3-month-old was found wedged between a playpen mattress and the sidewall (IDI#140702CCC3689). • A 5-month-old became wedged between a cushion and a play yard (IDI#150903CCC2790). • A 6-week-old girl found face-down in the corner of a pack-n-play… makeshift mattress made from two pieces of foam padding (IDI#150810CCC1817). • A 5-month-old infant placed in a play yard with a self-made foam pad, covered in a fitted sheet (IDI#110815HCC3054). • A 2-month-old found in a playpen with two adult pillows slightly apart (Doc#X0262839A). • A 5-month-old placed in a playpen overnight that maintained numerous bedding items including two large pillows, two thin mattresses, a stuffed animal, and a sheet (IDI#151002CCC2005)

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CAREGIVER MOTIVATION

According to CPSC’s Durable Nursery Product Exposure Survey (DNPES), 12.04 percent [95% confidence interval: 1.49-22.59] of caregivers use an aftermarket mattress and that the majority of caregivers place a pillow, blanket, or quilt under their child when sleeping in a play yard (Melia and Jenkins, 2014, Jenkins, 2017). To understand caregiver motivations, ESHF staff reviewed Exhibit 5 of the petition, which included online reviews for certain aftermarket mattresses, and the public comments received in response to the petition (see Appendix). Several examples of consumer comments are also shown in the Appendix. From the DNPES and the consumer comments reviewed, ESHF staff concludes that many parents believe that the OEM play yard mattress is not comfortable for their child.

CONCLUSIONS

The CPSC was petitioned to ban the sale of supplemental mattresses for play yards with non- rigid sides. ESHF staff evaluated the reported incidents where an aftermarket mattress or other added items were a contributing factor in a fatality; entrapment in the pocket formed by the mesh side of a play yard and an aftermarket mattress was associated with seven incidents. Evaluation of products in CPSC inventory show that if there is a gap between the mattress and the side wall of a play yard, a pocket may form that may entrap a child.

In addition, the current play yard mattress requirements allow 1-inch filler material and a total depth of 1½ inches, including the base structure. Consumers expressed concern with the hardness of provided mattresses, which led them to purchase an aftermarket mattress or to place added cushioning items in the play yard, such as pillows, comforters, crib mattresses, and other items. Given the perceived hardness of mattresses included with play yards, ESHF staff concludes that the use of aftermarket mattresses and other cushioning items as a play yard sleeping surface is a foreseeable caregiver behavior.

REFERENCES

Bayley, N. (1969). Manual for the Bayley Scales of Infant Development. New York: The Psychological Corporation.

Jenkins, J.L. (2017). Petition Requesting a Ban on Supplemental Mattresses for Play Yards with Non-Rigid Sides – Economic Considerations. CPSC Memorandum to H. Nesteruk, Project Manager for the Supplemental Mattress Petition, U.S. Consumer Product Safety Commission, Bethesda, MD.

Melia, K.L. and Jenkins, J.L. (November 2014). Durable Nursery Products Exposure Survey (DNPES): Final Summary Report. U.S. Consumer Product Safety Commission, prepared by Westat.

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APPENDIX

Example reviews in Example public comments Example comments retrieved petition exhibit 5 from various retailers’ websites “I needed more comfort for my “My son is 16 months and still “I wanted something more 9 months old.” sleeps in a playpen when comfortable…other than the visiting and vacationing and a hard cardboard and thin little extra comfort goes a long mattress which came with the way when trying to get him to play yard.” rest.” (CPSC-2015-0020-0035) “It is great quality and “… parents and caregivers “This mattress is much better comfortable.” perceived lack of comfort in the than the one that comes with the portable play yard mattresses pac-n-play especially for sold with play yards.” (CPSC- sleeping.” 2015-0020-0108) “I was worried about the hard “I purchased a supplemental “…so that my infant daughter foundation… I was seriously mattress and it made it safer would have a more comfortable considering modifying a foam than using pillows and bed. The mattress that comes ‘egg crate’ mattress pad to fit.” blankets.” (CPSC-2015-0020- with the playard is fairly hard.” 0115) “An added benefit is that I am “I bought this as a more short and the three inches this comfortable surface as well as a raises the bottom up makes it more stable platform…” easier for me to put the baby down…” “Because the base page that come with [the product] is so hard, I didn’t think my son would sleep through the night…” “… turn a playard into an inviting, comfy little nook – much more suitable for napping than the thin pad it comes with.” “the ‘mattress’ that the playard comes with is think and very board-like and not comfortable.”

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TAB D: Health Sciences staff review of the mechanisms of death associated with use of aftermarket mattresses in play yards.

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UNITED STATES CONSUMER PRODUCT SAFETY COMMISSION 4330 EAST WEST HIGHWAY BETHESDA, MARYLAND 20814

Memorandum

Date: April 25, 2017

TO Hope E J. Nesteruk Project Manager, Supplemental Mattresses Petition Division of Mechanical and Combustion Engineering Division of Mechanical Engineering, Directorate for Engineering Sciences

THROUGH Alice Thaler, D.V.M., MS Bioethics, Associate Executive Director Directorate for Health Sciences Jacqueline Ferrante, Ph.D., Division Director Division of Pharmacology and Physiology Directorate for Health Sciences

FROM Suad Wanna-Nakamura Ph.D., Physiologist Division of Pharmacology and Physiology Directorate for Health Sciences

SUBJECT Health Sciences staff review of the mechanisms of death associated with use of aftermarket mattresses in play yards.

Introduction and Background

On June 16, 2015, Keeping Babies Safe (KBS or petitioner) petitioned the Consumer Product Safety Commission (CPSC or Commission) to ban supplemental mattresses for play yards with non-rigid sides, which are currently marketed for use in non-full-size cribs, portable cribs, and play yards. The Commission docketed the petition (CP 15-2) on August 11, 2015. The petitioners: (1) clarified that the proposed ban is not intended to include replacement mattresses offered for sale by manufacturers of play yards; and (2) cited 15 CPSC incidents that occurred between 2000 and 2014 to support the request for a ban on supplemental mattresses. This memorandum reviews the mechanisms and severity of injuries associated with use of aftermarket, which staff considers equivalent to supplemental, mattresses in play yards for incidents reported to CPSC from January 1, 2000 through December 31, 2016.

CPSC Hotline: 1-800-638-CPSC(2772) CPSC's Web Site: http://www.cpsc.gov

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Directorate for Epidemiology staff conducted two database searches: (1) a preliminary search of all the incidents cited in the Petition to confirm their relevance; and (2) an independent search of CPSC databases, (Tab. B) from January 1, 2000 through December 31, 2016, to identify fatal incidents relevant to the petition.

(1) Petitioner Incident Data: To evaluate the incidents cited by the petitioner, CPSC staff matched each cited incident with its corresponding document number in the CPSC databases. Although the petitioner did not include CPSC case numbers, and provided limited information on the incident and victim’s age, staff was able to identify the incidents by comparing the incident summaries in the petition with narratives of case records retrieved by CPSC staff. In most cases, the incidents cited were based on verbatim or near-verbatim text extracts from case summaries in CPSC Epidemiological databases. Accordingly, staff was able to match with confidence all 15 reported incidents (Table A). Also, EPHA staff determined that the incident narratives for case numbers 10 and 11 belonged to the same case, bringing the total number of unique incidents reported in the petition to 14.

In 12 of the 14 cases cited by the petitioner, the cause of death was listed as positional asphyxia. The age of the victims ranged from 1 month to 9 months. The two remaining incidents were ruled as mechanical asphyxiation. These two incidents involved older children (15 months and a 2-year-old) who became entrapped at the neck between the play yard railing and a twin size mattress that had been placed on top of a play yard to prevent the children from climbing out. The children were able to partially dislodge the mattress allowing their heads to extend over the play yard rail and become trapped at the neck. Sustained pressure on the neck by the weight of the mattress can lead to asphyxia by strangulation1, 2. None of the 14 incident deaths involved the use of an aftermarket mattress, with the exception of one, which involved an entrapment between a mattress and the side of a “portable crib.” Because of the limited information in the death certificate, staff is unsure whether the “portable crib” was a play yard or a non-full-sized crib. Therefore, staff cannot be certain if this incident is within the petition’s scope.

(2) Incidents Identified by CPSC Staff: From 2000-2016, CPSC staff identified 14 incidents associated with the use of aftermarket mattresses in play yards. Thirteen of these reported positional asphyxia as the cause of death seven of which were due to entrapment between the play yard mattress and the side of the play yard. In one of the seven incidents the entrapment was in a depression between the metal support beams not covered by the mattress. According to the sheriff’s report, the mattress was not the original mattress and was much smaller than the play yard floor exposing an area that measured approximately 5 - 7 inches along the side. The remaining incident was characterized by the medical examiner (ME) as “asphyxia in a prone placement.” For those 7 incidents associated with a poor fitting mattress, the size of the space between the edge of the mattress and the play yard side varied in width from 2 to 7 inches. The

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age of the victims ranged from two to six months, which are all within the at risk age group for suffocation and sudden infant death syndrome (SIDS).

Pathophysiology of Positional Asphyxia/Suffocation

Directorate for Health Sciences (HS) staff further reviewed all 28 incidents (14 reported by the petitioner and the 14 separate incidents retrieved by CPSC staff) to identify the hazard pattern and the cause of death. This was done using the available case documents from In-Depth Investigation (IDI), death scene investigations, autopsies, caregivers, police reports, and death certificates (DTHS). HS staff identified positional asphyxia/suffocation as a risk factor associated with play yard deaths, which was primarily due to unsafe sleep settings such as entrapment gaps and pockets caused by an ill-fitting mattress. The incident reports also describe scenarios of infants being placed to sleep on one or more items of bedding that included adult size pillows, cushions, foam mats, folded , etc. that had been used to soften the sleep surface. In all of 28 cases, the cause of death was listed as positional asphyxia, a form of asphyxia associated with an abnormal body position, which prevents adequate gas exchange or causes direct obstruction of the airways (e.g., smothering by an object). An excessive gap is a recognized entrapment hazard that can cause death by positional asphyxia/suffocation. Infants found in this compromised position, with their nose and mouth pressed against the mattress or play yard side are likely to remain in this position and experience compromised airflow.

Once an infant’s airflow is compromised, decreased levels of oxygen in the blood can further impair the ability of the infant to respond to the situation. If an infant cannot respond, a vicious circle of decreased heart and respiration rate develops that can eventually lead to cessation of breathing and may become fatal if uninterrupted3. Unlike adults, the limited physical and developmental capabilities of infants render them susceptible to danger from suffocation in certain sleeping environments. Physiological abnormalities and delays in the development of vital systems can further hamper an infant’s ability to react to a hazardous condition. According to the “Back to Sleep” recommendation4, 5, vulnerable populations not placed to sleep in the supine position are especially at risk for suffocation. Infants in the first 4-6 months of life and premature babies who are particularly vulnerable to low oxygen levels, are the most at risk due primarily to developmental delays and an immature breathing control system in the first few months of life. This age group is also at risk for SIDS, which appears to be related to the development and maturity of the respiratory system4-7.

The prognosis for hypoxic victims due to smothering depends primarily on the extent of oxygen deprivation, the duration of unconsciousness, and the speed of resuscitation. Rapid reversal of the hypoxic state is essential to prevent or limit the development of pulmonary and cerebral edema. Thus, victims who are oxygen deprived for short durations or quickly receive cardiopulmonary resuscitation to reestablish air flow have the most favorable prognosis for

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recovery8,9. Because these types of entrapment incidents often happen while an infant has been left alone to sleep, the likelihood of the parent/caregiver becoming aware of the event and rescuing the child is often low. The severity of oxygen deprivation ultimately governs the victim’s chance for survival and the degree of neurological damage. Inadequate supply of oxygen to the brain can lead to loss of consciousness and death.

Conclusion

According to a recent CPSC staff annual report entitled Nursery Product-Related Injuries and Deaths Among Children Under the Age of Five (2016) and published reports on safe sleep10-14, the vast majority of infant deaths in play yards and cribs are attributable to suffocation in an unsafe sleep setting due to a crowded sleep area and the use of adult size pillows, a known high risk factor for suffocation when placed under the infant. In addition, the use of multiple mattresses raises the level of the sleeping surface, which can pose additional risks by increasing the chances to form of larger gap between the mattress and side railing as illustrated in (Figure 1.) when the child rolls into the mesh side wall and the infant can become wedged

Figure 1. Images showing head entrapment in gap between a mattress approximately 3 inches thick and mesh side play yard of the play yard

Infants under six months of age may be at particular risk because they may be developmentally capable of moving around in the sleep environment and putting themselves in a vulnerable situation such as getting wedged in a gap (Tab. C), but not yet have the capability to extricate themselves.

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References

1. Camps FE and Hunt AC. Pressure on the neck. J Forensic Med 6:116, 1959. 2. Iserson, K.V. Strangulation: A review of ligature, manual and postural neck compression injuries. Ann. Emerg. Med. 13:179185, 1984. 3. Gordon I, Shapiro HA. Deaths usually initiated by hypoxia or anoxic anoxia. In: Gordon I, Shapiro HA, editors. Forensic medicine: 2nd ed. Edinburgh, UK: Churchill Livingstone, 1982; 95–129. 4. AAP American Academy of Pediatrics, Policy Statement (Organizational Principles to Guide and Define the Child Health Care System and/or Improve the Health of All Children).Task Force on Sudden Infant Death Syndrome. The Changing Concept of Sudden Infant Death Syndrome: Diagnostic Coding Shifts, Controversies Regarding the Sleeping Environment, and New Variables to Consider in Reducing Risk. Pediatrics. 2005;116:1245-1255 5. Task Force on Infant Positioning and SIDS. Positioning and infant death syndrome (SIDS): update Arch Pediatr Adolesc Med. 1996;150:834-837 6. Dwyer T, Ponsonby A-L, Blizzard L, Newman NM, Cochane JA. The contribution of changes in prevalence of prone sleeping position to the decline in sudden infant death syndrome in Tasmania. JAMA. 1995;273:783-789 7. Ponsonby AL, Dwyer T, Gibbons LE, Cochrane JA, Wang Y-G. Factors potentiating the risk of sudden infant death syndrome associated with prone position. N Engl J Med. 1993;329:377-382 8. Polson CJ. Hanging In: Polson CJ and Gee DJ (eds.) Essentials of forensic medicine Oxford England, 1973 371-404. 9. Spitz WU. Asphyxia. In: Spitz WU, Spitz DJ, editors. Spitz and Fisher’s medico-legal investigation of death: guidelines for the application of pathology to crime investigation, 4th edn. 8. Smialek, JE, Smialek, PZ and Spitz, WU. Accidental bed deaths in infants due to unsafe sleeping situations. Clinical Pediatrics 1977; 15 (11):1031-1035 9. Wanna-Nakamura, S. Hazards associated with pillows and crowded sleep spaces a look beyond the safety standards. Abstract presented at the 2010 American Academy of Pediatrics (AAP) National Conference and Exhibition to be held in San Francisco, CA, October 2-5, 2010 Section on Injury, Violence & Poison Prevention 10. Wanna-Nakamura S. White Paper – Unsafe Sleep Settings: Hazards associated with the infant sleep environment and unsafe practices used by caregivers: a CPSC staff perspective.

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11. Gilbert-Barnes, E, Hegstrand L Chandra S, Emery J, Barnes LA, Franciosi R, and Huntington R. Hazards of mattresses, bed and bedding in deaths of infants. Amer J Forensic Med and Pathol 1991; 12(1):27-32. 12. Hauck FR, Herman SM, Donovan M, et al. "Sleep Environment and the Risk of Sudden Infant Death Syndrome in an Urban Population: The Chicago Infant Mortality Study." Pediatrics 2003; (111): 1207-1214 13. Byard RW, Beal S and Bourne AJ. Potentially dangerous sleeping environment and accidental asphyxia in infancy and early childhood. Arch Dis Child 1994; 71: 497-500. 14. Fleming PJ, Blair PS, Bacon C, et al. Environment of infants during sleep and risk of the sudden infant death syndrome: results of 1993-5 case-control study for confidential inquiry into stillbirths and deaths in infancy. BMJ. 1996;313:191-195

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TAB E: Mechanical Engineering Assessment for Petition CPSC-2015-0020, Petition Requesting the Ban of Supplemental Mattresses for Play Yards with Non-Rigid Sides

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UNITED STATES CONSUMER PRODUCT SAFETY COMMISSION 4330 EAST WEST HIGHWAY BETHESDA, MARYLAND 20814

Memorandum

DATE: April 25, 2017

TO: Hope E J. Nesteruk Supplemental Mattress Project Manager Directorate for Engineering Sciences

THROUGH: Michael Nelson Director, Division of Mechanical Engineering Directorate for Laboratory Sciences

FROM: Maxwell Sanborn Mechanical Engineer Directorate for Laboratory Sciences

SUBJECT: Mechanical Engineering Assessment for Petition CPSC-2015-0020, Petition Requesting the Ban of Supplemental Mattresses for Play Yards with Non-Rigid Sides

I. Introduction

This memorandum provides CPSC staff’s assessment of existing standards and practices related to mattresses for non-full-sized cribs, and play-yards. In addition, staff analyzed the dimensions of various on-the-market play yards and aftermarket mattresses and assessed ongoing work on voluntary standards.

II. Background

The petition addresses products known as “supplemental mattresses,” sold and marketed directly to the public, which are to be used with non-full-size cribs, play yards/pens and portable cribs. The petition stated that these supplemental mattresses should be deemed banned hazardous products because they present an unreasonable risk of injury and death to infants, and that no consumer product safety standard could adequately protect infants from the unreasonable risk of injury and death associated with the product. The petitioners cited infant deaths from positional

CPSC Hotline: 1-800-638-CPSC(2772) CPSC's Web Site: http://www.cpsc.gov

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asphyxiation purportedly caused by entrapment between ill-fitting supplemental mattresses and the sides of a play yard. CPSC staff used the following definitions in this assessment:

• Non-full-size crib – as defined in 16 CFR 1220, is (1) designed to provide sleeping accommodations for infants; (2) intended for use in or around the home, for travel and other purposes and; (3) has an interior length dimension either greater than 55 in. or 5 smaller than 49 ¾ in., and/or an interior width dimension greater than 30 /8 in., or smaller 3 than 25 /8 in. Dimensions outside of these ranges would result in either an oversize crib or an undersized crib. Non-full-size cribs do not include mesh/net/screen cribs or other non-rigidly constructed cribs.

Oversize crib – is a non-full-size crib with an interior length dimension greater o 5 than 55 in., and/or an interior width dimension greater than 30 /8 in.

Undersize crib – is a non-full-size crib with an interior length dimension smaller o 3 than 49 ¾ in., and/or an interior width dimension smaller than 25 /8 in.

• Play yard/pen (play pen) – as defined in 16 CFR 1221, is a framed enclosure that includes a floor and has mesh or fabric sided panels primarily intended to provide a play area or sleeping environment for children.

• Aftermarket mattress for play yard or non-full-size crib – is a third-party mattress that is intended to replace the original mattress sold with a play yard or non-full sized crib. This definition is analogous to supplemental mattresses, as defined in the petition.

Play yards, by definition, have fabric or mesh side panels (non-rigid) while non-full size cribs and portable cribs typically have rigid sides, but may also have non-rigid sides.

III. Existing Standards and Practices

Currently, there are no federal regulations or voluntary standards pertaining to aftermarket play yard mattresses. However, CPSC has mandatory regulations for non-full-size cribs and play yards, which place certain requirements on mattresses used and sold with these products. Additionally, ASTM developed a voluntary standard for crib mattresses. Staff also reviewed and summarized an international standard. See sections III a. through III d. below:

1. 16 CFR 1220: Safety Standard for Non-Full-Size Baby Cribs & 16 CFR 1221: Safety Standard for Play Yards

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Based on ASTM F406-15, these rules establish performance requirements for rigid and non-rigid side non-full-size cribs and play yards. Each product must be sold with a mattress included.

Rigid-sided products Although rigid sided products are not within the scope of the petition, the requirements for non- full-size crib mattress demonstrate one method of defining mattress fit and thickness. Section 5.17 contains requirements for thickness and dimensions (i.e., fit) for mattresses for rigid-sided products. Specifically, for rigid-sided products, the dimensions of the mattress supplied with a 1 non-full-size crib shall not leave a gap of more than /2 inch at any point between the perimeter of the mattress and the perimeter of the crib. When the mattress is placed against a side of the crib, the resulting gap on the opposite side of the mattress shall not exceed 1 inch. Mattress thickness must be at least two inches, but is determined limited by non-full-size crib side height. For stationary-sided21 cribs, the mattress must provide a minimum effective crib-side height dimension: • When the mattress is in the lowest adjustable position, at least: o 20 inches from the sleeping surface to upper surface of each side panel, and o 22 inches from the mattress support structure to upper surface of each side panel • When the mattress is in the lowest adjustable position, at least: o 9 inches from the sleeping surface to upper surface of each side panel.

Non-rigid-sided products For non-rigid side play yards, the only performance requirements are that (1) the mattress must be provided with the product and (2) the filling material of the mattress such as foam, fiberfill, etc. shall not exceed 1 inch in thickness and the total thickness of the mattress shall not exceed 1 1 /2 inch. There are no size or gap requirements that exist for non-rigid side products.

A thickness requirement for play yard mattresses has existed since the 1980s, and is intended to aid in the prevention of entrapment of an infant in a pocket that could be created between the mattress and the play yard. 22 Although the subcommittee has revisited the thickness in recent years, including the 2014 task group, the only change to the thickness requirements was made in 1999, and increased the thickness allowance from 1 inch to 1.5 inches to allow for a rigid base.

All products

21 There are additional requirements for non-full-sized cribs with a moveable side; however, this is an artifact from drop-sided cribs that remains in the standard. 22 March 1996 ASTM meeting minutes, which include the following rationale: “Limit the thickness of pads to prevent entrapment of an infant in a recess that could be created between the mattress and the play yard. Mesh/fabric side could deform to create a pocket between the sides and mattress.”

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The rules also require manufacturers to affix suffocation warning labels along the top rail on opposite sides of the product, which state that infants can suffocate in gaps between a mattress and product sides, on soft bedding such as a pillow, comforter, or padding. For products that have a removable mattress, the warning must also state to only use a mattress provided by the manufacturer. Rigid-sided products must also include “which must be at least X in. long by Y in. wide and not more than Z in. thick,” where X, Y, and Z refer to specific dimensions based on the manufacturer’s specifications.

2. ASTM F2933-13: Standard Consumer Safety Specification for Crib Mattresses

This consumer safety specification establishes design requirements for full-size and non-full-size crib mattresses.

Full-size cribs mattresses The standard requires the minimum dimensions of the mattress supplied with a full-size crib to 5 1 be 51 /8 inch by 27 /4 inch. Because the standard for full-size cribs (16 C.F.R. 1219/ASTM F1169-13) specifies dimensions of a full-size crib to be 28 ± 5/8 inches wide and 52 3/8 ± 5/8 inches long, a crib mattress that meets F2933 would not create a gap between the side of the crib and mattress greater than 1 3/8 inches. In addition, cribs must have an on-product warning statement that specifies the minimum dimensions of a mattress used to be 27 1/4 by 51 5/8 inches with a thickness not exceeding 6 inches.

The standard also requires manufacturers to affix suffocation warning labels to the product that address: . that infants can suffocate on soft bedding and to never place pillows or comforters under sleeping infants, . not to cover the baby’s head or “over bundle” in clothing or blankets, 5 . to not use a specific mattress in cribs with interior dimensions exceeding 28 /8 by 53 inch, and . only use sheets and mattress pads designed for crib mattresses.

Non-full-sized crib mattresses According to F2933, the dimensions of the mattress supplied with a non-full-size crib shall not 1 leave a gap of more than /2 inch at any point between the perimeter of the mattress and the perimeter of the crib. When the mattress is placed flush against a side of the crib the resulting gap on the other side shall not exceed 1 inch.

The standard also requires manufacturers to affix suffocation warning labels to the product that address:

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. that infants can suffocate on soft bedding and to never place pillows or comforters under sleeping infants, . not to cover the baby’s head or “over bundle” in clothing or blankets, and . only use sheets and mattress pads designed for the same size mattress.

Play yard mattresses Currently, ASTM F2933 does not contain any requirements for mattresses used with non-rigid sided products. However, the ASTM F15.66 subcommittee for crib mattresses is in the process of modifying the standard to include aftermarket mattresses for play yards and non-full-size cribs, which staff believes are equivalent to supplemental mattresses as defined in the petition. Although a new standard that includes aftermarket mattresses has not been published, the subcommittee appears to be moving in the direction of requiring aftermarket mattresses to be similar in size, support structure, and attachment methods as a mattress that is sold with a play yard. In addition, aftermarket play yard mattress would also need to meet requirements of the mattress (§5.16); mattresses for rigid sided products (§5.17); mattress vertical displacement requirements (§7.6) sections of ASTM F406. In essence, an aftermarket mattress, by ASTM’s definition, would need to be virtually identical to the mattress it is intended to replace and to meet the specifications stated in ASTM F406 when tested with each brand and model of the product it is intended to replace. In addition, an aftermarket mattress would carry its own suffocation warning label that communicates the hazards of poor fit and mattress height. Recent activities by the F15.66 subcommittee include:

• December 2016: Ballot F15 (16-11) Item 7. This item was proposed to “Add test and warnings standard for mattresses marketed as replacement for Non-Full-Size Baby Cribs and Play Yards” and was applied to “Mattresses marketed as replacement for Non-Full-Size Baby Cribs and Play Yards.” CPSC staff submitted an abstention with comment on this ballot item because staff felt that “marketed as replacement” tied the requirements to the marketing information rather than the foreseeable use of the products. The item received eight negative votes and was withdrawn for further task group work.

• March 2017: Ballot F15 (17-02) Items 9, 10 and 12. These items are the outcome of task group work in January and February 2017. Staff did not comment on the ballot items because of ongoing work with this petition response. Staff anticipates that requiring an aftermarket mattress to meet the same requirements as original play yard mattresses and including fit requirements would address the hazards identified by the petitioner. o Item 9: Proposal to add “after-market mattresses for play yards and non-full size cribs” to the scope of F2933. This item passed with no negatives and one comment. The one comment was considered by the subcommittee at the April 3, 2017 meeting.

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o Item 10: Proposal to define aftermarket mattress as “A mattress that is intended to replace the original mattress sold with a play yard or non-full sized crib” while excluding “a replacement mattress provided or sold by the original manufacturer for their own product.” The item received four negative votes. The negative votes centered on the exclusion and asked that it be limited to those that do not differ in dimensions or structure. The subcommittee found the negatives persuasive and withdrew the item for further task group work to address the concerns.

o Item 12: Proposal to add performance and hazard communication requirements to aftermarket mattresses. The item received seven negative votes, six affirmative with comments, and one abstention with comments. Negative votes regarding the lack of formatting requirements were withdrawn with the understanding that the subcommittee was preparing to address warning formatting for all warning in the standard. Four negative votes focused around issues, such as: . The ballot item that would prevent aftermarket manufacturers from producing mattresses that were thicker than the original mattress, even if the original mattress was thinner than the 1.5 inches allowed by F406, . the ballot item required the same mattress support structure, even if the original mattress used a segmented support structure and the aftermarket mattress would have used a solid support structure, and . the ballot item was related to the petition under consideration by the Commission and the subcommittee should wait. The subcommittee found all four negative votes non-persuasive – a decision that will be balloted for the F15 committee to uphold. In addition, the subcommittee formed a task group to address the issue raised about the requirement to match the support structure.

Of the seven comments, three were addressed editorially or by answering the commenter’s question. The remaining four were position statements supporting a ban, but indicating this change would be beneficial.

Specifically, under item 12, aftermarket mattresses would be required to: . to be virtually identical in thickness, floor support structure, and attachment method to the original mattress; . to pass the mattress, mattresses for rigid sided products, and mattress vertical displacement sections of F406;23 . have all markings, such as warnings and instructions, that were on the original mattress;

23 Note that only the mattress (section 5.16) section applies to play yard mattress.

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. include the suffocation warning below to addresses ill-fitting mattresses, stacking mattresses, and how to check the fit of an aftermarket mattress. Suffocation Hazard Babies have suffocated: • In gaps between wrong-size mattress and side walls of product. • Between the side walls and extra padding, such as stacked mattresses. ALWAYS check mattress fit by pushing mattress tight to one corner. Look for any gaps between the mattress and the side walls. If this gap is larger than 1 inch the mattress does not fit and should NOT be used. NEVER stack with another mattress. Use only ONE mattress.

3. AS/NZS 2195:1999 Australian/New Zealand Standard: Folding Cots – Safety Requirements

This standard specifies safety requirements for folding cots, which are the same type of products considered play yards according to U.S. terminology. The standard specifies that no gap should exist between the flexible sides of the folding cot and the mattress as a “child’s head could become entrapped causing a suffocation hazard.” The mattress complying with the recommended size on the cot’s warning labels (measured horizontally) shall touch the cot on all sides, i.e., fit snugly. In addition, the entrapment hazard test, cited in Clause 10.2, aims to ensure a child’s head cannot become entrapped between the mattress and flexible sides. This is accomplished by determining if a 95 mm (3.74 inch) diameter probe can penetrate a gap with a force of 50 N (11.2 lbf) applied. Warning labels are required to be affixed to the product and include the following:

This cot is made to use a mattress which is XX mm wide YY mm long and no more than ZZ mm thick. Using the wrong size mattress may create hazardous gaps that could result in suffocation or could reduce the side height of the cot, which may result in a child falling out.

The mattress for this cot should be XX mm wide YY mm long and no more than ZZ mm thick. Using the wrong size or thickness of mattress may create hazardous gaps that could result in suffocation or reduce the height of the cot, which may result in a child falling out.

If the cot is supplied with a mattress, do not add an extra mattress as this may cause suffocation due to a child’s head becoming wedged between the mattress and the cot side. Do not use this cot if any part is broken, torn or missing. Only use accessories that are recommended by the Manufacturer.

Before each use, make sure that the cot is correctly assembled and that the locking device(s) are fully engaged.

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IV. Evaluation of Existing Aftermarket Mattresses and Play Yards

LSM staff conducted an inquiry online, and documented the dimensions for five models of aftermarket mattresses, and physically examined three samples in CPSC inventory. Similarly, LSM staff measured and recorded the internal dimensions of two play yards currently in CPSC inventory. See Table 2.

Table 1: Play Yard Mattress Dimensions

Sample Length (in) Width (in) Height (in) 1 1* 37 /2 25 ½ 3 2* 38 24 2 3* 38 26 1 ½ 4* 29 19 ½ 3 5* 39 28 2 3 3 3 6** 37 /8 23 /8 2 /4 3 7 7** 37 ¼ 25 /8 2 /8 1 7 8** 37 /8 25 ¼ 2 /8 *Dimensions reported by manufacturer. **Dimensions physically measured by staff.

Table 2: Play Yard Dimensions Sample Length (in) Width (in) A 39 ¼ 27 ¼ B 38 ½ 27

As noted in Section III, a mattress used inside a play yard must have no more than a one inch gap on any side when placed in the play yard. None of the mattresses listed in Table 1 meet the requirements for use in play yard A listed in Table 2, as the gaps created exceed 1 in. See Table 3. Mattress 5 may meet the requirements for use in play yard A and B, if the mattress can be compressed to fit in the smaller crib area. Mattress 8 packaging indicated it was compatible with play yard B, but staff found it does not meet the requirements of less than a 1 inch gap.

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Table 3: Dimensional Differences Between Mattresses and Play Yards Play Yard A B Length Width Length Width

1 1 ¾ 1 ¾ 1 1 ½ 2 1 ¼ 3 ¼ ½ 3 3 1 ¼ 1 ¼ ½ 1 4 10 ¼ 7 ¾ 9 ½ 7 ½ 5* ½ - ¾ - ½ -1

7 7 1 5 6 1 /8 3 /8 1 /8 3 /8 7 5 7 2 1 /8 1 ¼ 1 /8 1 3 8 2 /8 2 1 /8 1 ¾ Mattress * Mattress 5 is larger than the play yard (negative numbers shown). It may possible to compress the mattress to fit snugly Green ≤ 1 inch Red > 1 in Black = N/A (<0)

V. Conclusion

Currently, no standards exist that apply specifically to aftermarket play yard mattresses; however, standards and guidelines do exist for mattresses sold with play yards. ASTM is currently in the process of updating F2933: Standard Consumer Safety Specification for Crib Mattresses to include aftermarket mattress requirements. CPSC staff has researched various play yard mattresses and found that they have a range of dimensions which would result in some leaving overly large gaps if placed in certain play yards. Currently, it is the responsibility of the consumer to determine the dimensional compatibility of aftermarket mattresses with play yards. It is possible that a consumer may purchase a mattress that would leave a gap in excess of 1 inch. This can lead to an infant exposed to an entrapment/suffocation hazard as described by Tabs C and D in this briefing package.

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TAB F: Petition Requesting a Ban on Supplemental Mattresses for Play Yards with Non-Rigid Sides – Economic Considerations

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Memorandum

Date: April 25, 2017

TO : Hope E J. Nesteruk Project Manager for the Supplemental Mattress Petition Program Manager for Children’s Hazards Division of Mechanical Engineering and Combustion Directorate for Engineering Sciences

THROUGH : Gregory B. Rodgers, Ph.D. Associate Executive Director Directorate for Economic Analysis

Robert L. Franklin Senior Staff Coordinator Directorate for Economic Analysis

FROM : Jill L. Jenkins, Ph.D., Economist Directorate for Economic Analysis

SUBJECT : Petition Requesting a Ban on Supplemental Mattresses for Play Yards with Non-Rigid Sides – Economic Considerations

Introduction

Keeping Babies Safe (KBS) has petitioned the Consumer Product Safety Commission (CPSC or Commission) to ban “supplemental mattresses” marketed for use with non-full-size cribs, play yards, portable cribs, and play pens. The petitioner bases their petition on the potentially hazardous gaps that can be created when “supplemental mattresses” are used in play yards with non-rigid sides. The petitioner specifically requested that mattresses offered for sale by the original play yard’s manufacturer as a replacement not be included in the ban.

This memorandum provides information on the market for aftermarket mattresses, as well as some discussion of the deaths associated with aftermarket mattresses.

The Market

As defined by KBS, “supplemental mattresses” are essentially mattresses marketed and sold for use with non-full-size cribs, play yards, portable cribs, and play pens that are not supplied by the original manufacturer. In the petition, KBS focused on the fit issue, whereby gaps between an CPSC Hotline: 1-800-638-CPSC(2772) CPSC's Web Site: http://www.cpsc.gov

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ill-fitting mattress and the soft sides of a play yard can create a potential entrapment and suffocation hazard for infants. Based on the information in the petition and staff discussion of the issue, the market research focused on aftermarket mattresses sold or marketed for use with non- full-size cribs, play yards, portable cribs, and play pens. Mattresses marketed and sold for full- size cribs, bassinets, or cradles were not included. Also not included were mattresses marketed and sold exclusively for a particular non-full-size crib, play yard, portable crib, or play pen.

“Supplemental mattresses,” as defined by KBS, are also called pads by some suppliers. Other firms reserve the term “pad” for extremely thin mattress covers/protectors with some quilting. Staff determined that the latter type of pad is not of concern for the petition, as the thinness of the product is insufficient to create a hazardous gap. Therefore, products that appeared to be less than a quarter inch in thickness were not included (these products were typically so thin that a thickness measurement was not provided by the supplier).

Staff identified 22 firms that supply aftermarket mattresses currently marketed and sold in the U.S. marketplace. Three of the firms are foreign manufacturers and 19 firms are domestic. Based on U.S. Small Business Administration guidelines, 18 of the domestic firms are small: 11 manufacturers, 4 importers, 1 retailer, and 2 firms with unknown supply sources. The one large domestic firm is a retailer, most likely importing their aftermarket mattresses.

Sales and Number in Use

We have not found any sales information for the aftermarket mattresses identified by the petition. However, according to data collected as part of CPSC’s Durable Nursery Product Exposure Survey (DNPES), 12.0 percent of play yard users use an aftermarket mattress under their child.24 That translates into about 700,000 aftermarket mattresses being used in play yards in U.S. households with children under age 6.25 In comparison, the same survey found that 26.1 percent (95% confidence interval (CI), 12.1 percent to 40.1 percent) of play yard users typically place a pillow under the child and 62.3 percent (95% CI, 47.6 percent to 77.1 percent) of play yard users typically place a blanket/quilt under the child. Based on the data collected, it appears that only about 25 percent of play yard users do not place anything other than the original mattress under their child. Most seem to use one or more other products. This is consistent with the discussion in the memorandum from the Division of Human Factors (HF): consumers appear

24 Melia, K.L. and J.L. Jenkins (November 2014). Durable Nursery Products Exposure Survey (DNPES): Final Summary Report. U.S. Consumer Product Safety Commission, prepared by Westat. The 95% confidence interval is between 1.49 percent and 22.59 percent. 25 5,834,519 play yards in use * 12.0 percent of play yards used with aftermarket mattresses = 700,142. The 95% confidence interval for play yards in use is between about 4,940,000 and 6,728,000. Taking both confidence intervals into account, staff can say with 95% certainty that the number of aftermarket mattresses being used with play yards to be between about 73,000 and 1,520,000.

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to add soft bedding items to play yards to alleviate what they perceive as a hard original sleeping surface.26

Societal Costs

Although staff identified at least 12 incidents that involved aftermarket mattresses over a 17 year period, this data was reported to CPSC through the Consumer Product Safety Risk Management System (CPSRMS). Unlike data from the National Electronic Injury Surveillance System (NEISS), data from CPSRMS cannot be extrapolated to the population at large. Therefore, CPSC cannot derive national estimates of the deaths associated with aftermarket mattresses from the incident data or estimate the annual cost to society of the hazards associated with aftermarket mattresses used in play yards.

CPSC staff cannot determine what effect a ban on “supplemental mattresses” (as defined by KBS) would have on play yard deaths. However, a ban would eliminate all aftermarket mattresses, regardless of whether they pose a hazard; it is possible to make a supplemental mattress that fits a particular play yard properly and also meets the mattress requirements in the voluntary and mandatory play yard standards (ASTM F406-15 and 16 C.F.R. 1220, respectively). The requested ban would include aftermarket mattresses sold for use with rigid- sided products, such as non-full-size cribs and portable cribs, products that do not exhibit the hazard pattern of concern to the petitioner (i.e., hazardous gaps). Therefore, the requested ban would eliminate the utility that consumers derive from aftermarket mattresses that they use in rigid-sided products with no hazard reduction.

As discussed in the HF memorandum, ASTM is working to address aftermarket mattresses in ASTM F2933.27 Staff believes that this approach can effectively address the hazard pattern associated with aftermarket mattresses found in the data without reducing the utility consumers derive from their use in rigid-sided products.

26 Memorandum from Sarah B. Newens and Rana Balci-Sinha, Division of Human Factors, Directorate for Engineering Sciences, dated April 25, 2017, Subject: Human Factors Assessment of Play Yards with Non-Rigid Sides and the Use of Supplemental Mattresses. 27 Newens and Balci-Sinha (2017).

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Addendum

Table A referenced in Tab D

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# Year Age IDIs # and Related Narrative as Cited in the Petition Incident Narrative CPSC records Docs 1 2000 1 m ID000222HCC3166 Anoxia when child placed prone on a plastic A 1-month-old female suffered anoxia when her wrapped adult pillow in play yard, found lifeless mother placed her in a prone position on a plastic on large comforter in play yard, asphyxia after wrapped full-sized adult pillow located within a put to sleep with replacement mattress that bassinet1. The infant died as a result of accidental was too small and child found in space between asphyxia caused by mechanical suffocation. mattresses and play yard (occurred in 2000) 2 2001 4 m 020517HCC1537, Baby wedged between improperly fitted Baby wedged between improperly fitted mattress 0151026474, mattress and side of playpen (occurred in 2001) and side of playpen - traumatic asphyxia by 133534. smothering - autopsy yes. 3 2003 3 m 040107CCC2251, Child found with blanket twisted around him- A three-month-old male died from positional 1008050, 696472 suffocated, pinned between the end of the asphyxia when he got pinned between the end of a playpen and a 5 inch couch cushion placed in mesh-sided playpen and a five-inch thick couch playpen as a mattress (occurred in 2003). cushion that had been placed in the bottom of the playpen as a mattress. The incident occurred in a bedroom of the victim's grandmother’s house. 4 2003 15 m 040517HCC3305 Head caught between playpen and mattress- Head caught between playpen & mattress - 0308019616, (occurred in 2003). mechanical asphyxiation - autopsy yes. 152265. 5 2004 8 m 0448151934, Suffocated due to blankets and pillows in Infant was put to bed in play pen with 4 inch foam 161901 playpen, found between 4 inch foam pad and pad that had 3 inch play from side to side. Baby was side of playpen (occurred in 2004). between the foam pad and side of play pen - suffocation - autopsy yes. 6 2004 9 m X0473332A, A female infant, age 9 month, was found A female infant, age 9 month, was found deceased 711926. deceased with her face on the playpen with her face on the playpen mattress & a blanket mattress and a blanket wrapped tightly around wrapped tightly around her. The incident occurred at her (occurred in 2004). her caretaker's home. 04-3000. 7 2005 1 m 050615HCC1856, Child trapped in gap between end of 4 inch Infant found in playpen with head between sofa 244933, 742993 foam and end of playpen, head between sofa cushion & play pen side - mechanical positional 0526058559, cushion and playpen side, found with blanket asphyxia - autopsy yes. 161923. wrapped around child's head and neck,

1 The term “bassinet” used in the narrative summary refers to a “play yard” as detailed in the IDI

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(occurred in 2005).

8 2006 3 m 080221HCC1438, A three month-old child died of positional A three month-old child died of positional asphyxia 1020491, 171012 asphyxia when his head became entrapped when his head became entrapped between a between a mattress and mesh side of a play mattress and mesh side of a playpen. The mattress pen. The mattress was crib sized and was not was crib sized and was not intended for use in the intended for use in the playpen and did not fit playpen and did not fit into it properly. it did not fit into it properly. It did not fit flush to the sides flush to the sides and one end extended up and over and one end extended up and over the top of the top of one side of the playpen. one side of the playpen.(occurred in 2006) 9 2006 5 m 071004HCC3024, Became wedged prone between playpen and became wedged prone between playpen and 0648104452, mattress- (occurred in 2006). mattress - positional asphyxia - autopsy yes 170501 10 2007 2 y 172763, A 2 year old child was found dead in a play pen. A 2 year old child was found dead in a playpen. The 071210HWE71312 The toddler became wedged between the toddler became wedged between the playpen's playpen's mattress and frame (Occurred in mattress and frame. 2007). 11 2007 2 y 07200238502 Found with head/ neck wedged between rail of Found with head / neck wedged between rail of 840390, playpen and twin mattress- (occurred in 2007). playpen and twin mattress - asphyxia; compression of N07C0163A the neck - autopsy yes. 12 2008 6 m 090317HCC1502, A 6 month old male was placed face-down for a A 6 month old male was placed face-down for a nap 1024046, 175954 nap on two sofa cushions placed on the bottom on two sofa cushions placed on the bottom of a play of a play yard (occurred in 2008). yard. After approximately 2-1/2 hours, his father went into the room to wake the child and found him with his face between the cushions and the side of the play pen and cold to the touch. The child was pronounced at the scene. An autopsy indicated that the infant died as a result of positional asphyxia.

2 These four Doc #s refer to one incident, the incident location Wichita, KS was incorrectly entered in the CPSC database as Augusta GA in Docs #s 840390, N07C0163A, although the news source was Wichita Kansas news.com

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13 2008 3 m 090213HCC1421, A 3 month and 26 day old male victim was A 3 month and 26 day old male victim was found 1023749, 891124. found deceased inside a play yard. The ME deceased inside a play yard. The ME determined that determined that the cause of the death was the cause of the death was asphyxia. The victim was asphyxia. The victim was found face down in a found face down in a crease produced by the crease produced by the mattress. He was mattress. He was pronounced deceased at the pronounced deceased at the hospital (occurred hospital. in 2008). 14 2009 5 m 090805HCC1935, 5 month old male decedent was found wedged 5 month old male decedent was found wedged X0970122A, between the mattress & the playpen in his between the mattress & the playpen in his home. 912527 home (occurred in 2009). Cause of death: asphyxia.

15 2010 3 m 1037040644, Doc A 3 mom infant suffocation; A 3 mom infant - suffocation; wedging/entrapment # 1203266 wedging/entrapment between mattress & side between mattress & side of portable crib - autopsy of portable crib (occurred in 2010). yes.

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