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Consumer Product Safety Commission
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Staff Briefing Package Recommendations on Baby Bath Seats
Introduction
Consumers Union (CU) appreciates the opportunity comment on Consumer Product Safety Commission (CPSC)’s staff recommendations on baby bath seats. These recommendations come in response to the May 2001 CPSC vote – with all three commissioners in support – to initiate rulemaking for baby bath seats. The Commission took up this issue in response to the Consumer Federation of America’s petition July 2000 petition to ban baby bath seats, a petition that argued that they pose an unreasonable risk of death and injury to children. This is a position CU supports and this is why we joined CFA’s petition urging the Commission to ban baby seats.
Scenarios in Which Babies Have Drown Using Bath Seats:
The Baby Bath Seats Rulemaking Options Briefing Package (hereinafter “Briefing Package”) provides a comprehensive look at the ways in which babies have been injured or died using a baby bath seat. CPSC to date has reports of 96 drownings and 153 non-fatal incidents involving bath seats that occurred from January 1983 to December 2002.
The children who have drowned using bath seats have done so in one of the three scenarios listed in the Briefing Package and set out:
1) Tip-Over: the bath seat tipped over while in use, submerging or trapping the child or allowing the child to escape the seat.
2) Entrapment and submersion: The bath seat remained upright and the child became submerged and/or entrapped.
3) Coming out: The bath seat remained upright and the child came out of the bath seat.
History of Voluntary Standard Setting for Baby Bath Seats:
No where is the failure of the regulatory process to effectively address a child safety hazard more graphically illustrated than in the regulatory history of baby bath seats. And the unwitting victims of this regulatory malaise are the children that have drowned or been seriously injured using a bath seat.
The Briefing Package states that ASTM “first initiated” the development of a voluntary safety standard for baby bath seats in October of 1994. The Briefing Paper fails to mention that at the Commission’s urging – after CPSC had reports that 19 children had died – that ASTM formed a committee to develop a voluntary standard for baby bath seats. Among the issues to be addressed by the committee for voluntary standards were requirements for stability, suction cup integrity, static load, latching/locking mechanisms, restraint systems, leg opening sizes and other requirements commonly found in juvenile product standards.
Paul Ware, vice president of quality assurance for Safety 1st, the dominant manufacturer in the bath seat market, chaired the committee that began work on setting voluntary standards on bath seats in 1994. During the committee’s five year process, the CPSC pressed the standard-setting committee to address the size of the leg openings and the durability and strength of the suction cups. CPSC wanted a maximum leg opening dimension added to the standard. The commission also noted the problems with suction cups: they came off too easily and, with non-skid bathtub surfaces, the suction cups didn’t always stick to the bottom.(1) The Commission wanted this issue addressed as well.
A full five years later, a voluntary standard took effect that included marking, label and literature requirements as well as performance requirements addressing some of the issues mentioned above, but did not address leg opening sizes and suction cup integrity.(2)
ASTM balloted a new requirement for suction cup integrity and a durability requirement for latching/locking mechanisms and published the standard in June 2001.(3)
In March 2003, ASTM balloted yet another set of five revisions to ASTM F 1967-01, including a test procedure and warning label change, the addition of a performance requirement for the size of the leg openings and occupant seating space to address entrapment and submersion incidents.
Bath Seat Manufacturers’ Slow Pace
While we lament the CPSC’s inability to either mandate criteria for safer bath seat designs or ban the product from the marketplace in the face of mounting fatalities, we are even more critical of bath seat manufacturers’ lack of urgency in addressing safety problems.
In a deposition in 1999, Safety 1st Vice President Paul Ware admitted he was well aware of CPSC research indicating that parents were more likely to leave a child alone if a bath seat is present in the tub. The company did little to act on this knowledge.(4)
Six months after the CPSC voted unanimously in May of 2001 for an Advanced Notice of Proposed Rulemaking (ANPR) on bath seats, Safety 1st showed off a prototype of a safer seat.(5) Did Safety 1st rush the new model to the market? No. They told USA Today in January of this year that it would not be out until the fall of this year. In the period since the CPSC’s ANPR and today, the Commission has reports of at least 10 more infant deaths. During this period, there have been no public warnings from manufacturers nor has CPSC made an effort to recall the bath seats currently on the market.
Given the all-too-clear and continuing pattern of deaths and injuries, we would expect manufacturers to intensify their efforts to make a product that is intended for use by babies as safe as possible. But it seems Safety 1st took a less forceful path: Ken Mitchell of Safety 1st was quoted recently as saying only, “We do not in any way claim it’s a safety device. It’s a convenience device.”(6) In our view, product claims do not balance out product performance. The pattern of infant death and injury continued unabated – regardless of how the product was presented to consumers.
CU’s History on Baby Bath Seat Safety
In October of 2001, CU submitted comments in response to the Advanced Notice of Proposed Rulemaking (ANPR) relating to baby bath seats and rings (66 Fed.Reg. 39692, August 1, 2001). CU recommended to the CPSC that it issue a rule declaring baby bath seats to be “banned hazardous substances(7) ” under the Federal Hazardous Substances Act (FHSA), 15 U.S.C. 1261 et seq.
CU stated in its October 2001 comments that:
[u]sing baby bath seats and rings encourages caregivers to leave children alone in the bathtub – a ‘misuse’ of the product. . . Parents and caregivers using these products develop a false sense of security because the products appear to be able to hold a child upright, and in place. In addition, these products pose a hazard even when used in a manner consistent with their purpose as a bath aid – evidence collected by the CPSC reveals three deaths have been reported where a caregiver was present in the bathroom. In addition, 41 non-fatal incidents have been reported with the products while the caregiver was present.
We agreed with the Commission’s findings contained in the August 2001 ANPR on baby bath seats: “The Commission has reason to believe that baby bath seats and rings, as currently designed, may present an unreasonable risk of injury.” At the time, the Commission noted that it was “aware of 78 deaths and 110 non-fatal incidents and complaints from January 1983 through May 2001 involving baby bath seats and rings. Forty-one of these non-fatal incidents complaints occurred when a caregiver was present.”
(CU notes that since the previous March 2001 briefing package, the Commission received reports of 29 non-fatal incidents of bath seats tipping over, 22 of those incidents occurred when the caregiver was present and bathing the child.)
We reiterate our earlier comments, and can only lament that three years after the CFA’s petition, we find ourselves in the midst of yet another round of debate and discussion on what to do about this inherently hazardous baby product.
Since the August 1, 2001 ANPR posting in the Federal Register, 18 more children have died using baby bath seats and 43 additional non-fatal incidents have been reported. Consumers Union finds these long delays between the petitioning process and agency action intolerable. While the administrative wheels grind slowly along, babies continue to die. The luckier ones are involved in such serious near-misses with bath seats that the event is reported to the CPSC, either because medical care is needed and the CPSC reporting system is triggered, or their parents or caregivers are so concerned they take the unusual step of calling in reports of close calls to the CPSC. We urge the Commission to take decisive action to protect the public from this unreasonable risk.
Consumer Reports’ position on baby bath seats
Consumer Reports “Guide to Baby Products,” published in July of 2001, warned parents to avoid baby bath seats:
There is one baby-bathing product that should be avoided. A bath seat, or bath ring, is a plastic baby seat made with suction cups on the bottom that attach the unit to a regular bathtub. Bath seats are supposed to make it easier to handle a baby during bathing, but dozens of infants have drowned using them. In many cases, the parent’s back was turned momentarily. . . Needless to say, a baby or toddler should never be left alone in a tub.(8)
An earlier Baby Products Guide includes yet another a stern warning, illustrating a typical scenario that makes these products so dangerous:
Avoid Suctioned Bath Seats: Babies and toddlers can drown in only one inch of water. Bath seats do not protect-45 babies died while using them. Most had suction cups to hold them in place.
A typical scenario: A baby is left playing the seat when someone comes to the front door or the telephone rings. The mother believes the seat will protect her baby. She walks away and is gone for a few minutes. The baby reaches over to retrieve a toy or tries to stand up. The suction on the bottom pops loose. The baby falls forward or slips. The parent finds her baby face down in the tub. But by then, it’s too late.
Our advice: Just don’t buy one. And never leave a baby or toddler unattended in water, in a regular tub or a baby bathtub, for even a minute. The risks are too great(9).
While this CU Guide warns parents never to leave a child alone, it also acknowledges reality: a parent can become distracted, and a child should not have to pay with her or his life as a result.
There are other factors at work, as well. Professor Clay Mann, of the Intermountain Injury Control Research Center at the University of Utah Medical school, studied drownings with bath seats and drownings in bath tubs. He found two significant differences between the groups: caregivers filled the bath tub higher when they used a bath seat and they were more likely to make a willful decision to leave a child unattended in a tub when a bath seat was being used. (10)
Opponents of the ban, including CPSC staff, argue that consumers may be deprived of a useful product with a ban. Others may argue that while 96 children have died, millions of parents use bath seats successfully and safely. To that argument we offer this:
Congress is considering ordering the FDA to ban Ephedra, the weight loss herb that has been linked to more than 100 deaths. The state of Illinois banned the product in May. They are doing so in spite of the fact that millions of people use the herbal supplement without incident. The same is true for a number of other products that pose danger to some but are used successfully by many. If the hazards presented by the are severe enough and the product presents an unreasonable risk of danger, the product should be banned or regulated so as to minimize the hazards.
Consumers Union believes that the only appropriate regulatory action for the CPSC is to institute a ban of this product. Bath seats present an inherent problem: despite warnings on the product to the contrary, they appear stable and foster in too many caregivers the mistaken sense that a baby will be safe if left alone for a brief time. Bathtubs alone, to be sure, are also involved in baby drownings, but they don’t compound the hazards of water with a product that appears to provide safety and protection from the water, but ultimately does not.
CPSC Staff Recommendations and Options for the Commissioners
We turn our attention to the staff briefing materials and recommendations for Commission action. CU appreciates the staff’s careful analysis and its thorough weighing of pros and cons of each option, all arrived at after testing. The Briefing Paper notes, “CPSC staff believes that ASTM F 1967-03 does not adequately address the drowning risks presented by baby bath seats. As currently revised, the ASTM standard addresses hazards associated with entrapment and submersion, but there are not adequate provisions to address hazards associated with tip-over or children coming out.”
CPSC staff is recommending three Medicare Modernization Act proposed requirements for the proposed rule to help address the hazards associated with bath seats: 1) stability performance requirement to address the tip-over hazard, 2) a leg opening performance requirement to address the entrapment and submersion hazard, and 3) a labeling requirement to help address incidents of children coming out of the bath seat. CPSC staff believes that to adequately address the hazards, bath seats should conform to the requirements.
Staff points out that the Commission has the option of accepting these recommendations, which is highlighted in Option 4 listed below, or choosing a course of action from the other choices listed:
1) Defer Action
2) Terminate Rulemaking
3) Initiate NPR for a Ban of Baby Bath Seats
4) Initiate NPR with all Three Requirements for a Proposed Mandatory Rule
5) Initiate NPR with Two Requirements for a Proposed Mandatory Rule
Taking each in order,
1) Defer Action: CPSC staff rejects deferring action because past ASTM subcommittee actions simply take too long. “If the Commission decides to defer action or terminate rulemaking, bath seats that are potentially hazardous will continue to be manufactured or sold in the US”
CU agrees that deferring action would mean hazards from bath seats continue to threaten the safety of children and is the wrong policy.
2) Terminate Rulemaking: CPSC staff rejects for the same reasons they reject deferring action. CU agrees.
3) Initiate NPR for a Ban of Baby Bath Seats: CPSC staff does not support a ban because of a belief in the proposed performance requirements that address the tip-over and entrapment/submersions. Staff also supports a forceful warning label to draw attention to the hazards that result when children are left unattended. Staff also argues that there is no means to predict the effect that ban of seats would have on the fatality rate associated with infant drownings.
CU disagrees for reasons stated above.
4) Initiate NPR with all Three Requirements for a Proposed Mandatory Rule – this is the option CPSC staff recommends
5) Initiate NPR with Two Requirements for a Proposed Mandatory Rule – CPSC staff suggests this as an alternative to option 4 above since ASTM has already adopted the leg opening testing rule.
CU’s Comments on CPSC Staff Recommended Changes to the Voluntary Standard
1. Tip Up Hazard/Stability Performance Requirement
CPSC’s data indicates that more children die from bath seats tipping over than other causes. The tip-overs were involved in a total of 110 incidents, 30 deaths and 80 non-fatal incidents. Bath seats rely on suction cups to hold the seat in place and tip up represent the failure of those suction cups to do the job. Of course, children don’t remain still, they move around, they play, they kick, they grab, they splash.
In making its recommendations, staff tested larger bath suction cups than those currently in use and found that they “held a seal for 20 minutes.” However, the Briefing Paper does not instill confidence: “A performance requirement that requires all products to remain stable on slip-resistant bathing surfaces should reduce the likelihood of tip over incidents due to surface adhesion failure.”(Italics added).
We know the staff means to improve the product and make it safer for children. However, CU believes the time for experimentation with bath seats has long passed. The baby seat manufacturers have known since the 1980s that children were drowning or experiencing near-drownings using these bath seats and yet it resisted CPSC and consumer group efforts to making design changes.
Children should not be treated as guinea pigs. CU simply does not believe that a baby product can ever be secure when it relies on the strength of suction cups on the bottom of a tub, especially since so many are treated with slip-resistant material. 96 children dying using this product is too many. We should stop experimenting with the lives of children and eliminate this product from the marketplace. A satisfactory standard is not feasible.
Of course, if the commissioners choose not to support a ban of this product, and instead adopt the staff recommendation on suction cups, CU can only hope that the staff is correct in believing that the larger and more durable suction cups will reduce injuries and deaths. We would support this change in the standard as preferable to no change at all.
2. Entrapment & Submersion Hazard/Leg Opening Performance Requirement
Though we support banning the product altogether, if bath seats are to remain on the market, we would certainly support a leg opening performance requirement. CPSC data indicate that one of the three scenarios in which babies die in bath seats comes about when they slide through side or leg openings in the bath seat or rotate around and slipping through those openings. Under the staff recommendations, all leg and side openings must withstand testing from both a torso and a shoulder probe designed to simulate the size of a baby. The probes must not be able to pass through these openings.
The ASTM task group has developed and approved a leg opening performance requirement and it will be published this summer.
3. Coming out Hazard/Performance Requirement vs. Labeling Requirement
One of the three fatality scenarios involves the bath seat remaining upright, with the child found out of the seat. CPSC staff does not support a restraint system to address this problem with the bath seat because it might “make it impractical for its intended purpose in aiding caregivers when bathing children.” The Briefing Paper argues that it would be too hard to work around the restraint in bathing a child, and children are hard to restrain in bath seats because they are “naked and wet.”
Because “a restraint system does not appear to be a practical approach for preventing children from coming out of a bath seat, staff recommends a force warning label to warn about the need for constant caregiver attendance.”
Staff argues for strengthening the label from its current message:
“Warning, Prevent Drowning, ALWAYS keep baby within arm’s reach”
to this:
“Warning, Children have drowned while using bath seats. ALWAYS keep baby within arm’s reach. This bathing aid is NOT a safety device. Stop using when child is able to pull up to a standing position.”
Once again, we understand that staff hopes to reduce the hazards posed by this product and is well meaning in its recommendations. But we believe staff’s conclusion that a warning is all that can be done to prevent children from crawling out of baby bath seats simply reinforces the fundamental truth: these products are inherently dangerous and an adequate safety standard is not feasible.
Consumers Union does not accept the notion that we can sticker over a safety problem. If the Commission accepts this recommendation, then certainly the warning sticker should be as strong as possible. In this regard, staff’s suggested language is preferable to the status quo. We can only hope that more caregivers and parents will take notice when they read children have died using these products – but hoping it will be effective is not good enough.
If CPSC adopts staff recommendations, it should also recall bath seats currently in circulation
If the Commission opts for the action recommended by staff and imposes mandatory regulations on bath seats, it should recall the bath seats currently in circulation. The Briefing Package makes clear that the current bath seat design is faulty – the suction cups are too small to secure the seat and the leg openings are too wide, allowing children to slip through them into the water. Sadly, it is likely that more deaths and injuries will occur unless the remaining bath seats are recalled.
Conclusion
With 96 children dead and countless others injured, CU has stated throughout these proceedings that we believe this product to be inherently dangerous and should be taken off the market. We are gravely disappointed by the failure of this commission over the past decade to either impose strong mandatory standards on the product or ban it altogether. And we find the actions of the baby bath seat makers to be equally disappointing. As they watched the number of deaths and injuries mount, they consistently resisted efforts to make the product safer and instead played the blame game, pointing the finger at parents whose children died using the product. In an era of greater corporate scrutiny, we would hope for better conduct from makers of these products.
The commission is now in a new era. Chairman Harold Stratton and his fellow commissioners have an opportunity to bring a fresh perspective to these issues. We urge the commission to show strong leadership in making the safety of children paramount.
July 28, 2003
Respectfully submitted,
Sally J. Greenberg
Senior Product Safety Counsel
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Notes:
(1) ASTM official minutes of meetings, February 24, 1999 and August 30, 1999.
(2) ASTM F 1967-99 “Standard Consumer Safety Specification for Infant Bath Seats,” published June 1999.
(3) ASTM F 1967-01, June 2001
(4) Plaintiff v Safety 1st, Inc., Deposition of Paul Alan Ware, Jones, Fritz & Sheehan, Boston, MA, June 1, 1999, pp. 13-19.
(5) “Lack of safety rules for bath seats irks some,” USA Today, January 14, 2003
(6) Id.
(8) Consumer Reports Guide to Baby Products, July 2001.
(9) Consumer Reports Guide to Baby Products, February 2000.
(10) See Petition of Consumer Federation of America To Ban Baby Bath Seats, July 25, 2000.