NEWS from CPSC

Today I am voting to proceed with a Notice of Proposed Rulemaking (NPR) for baby bath seats. Rulemaking is appropriate in this case because the voluntary standard currently in place, and even the proposed revisions, will not adequately reduce the risk of injury associated with these products. A ban is not, however, justified because there is little credible evidence that the use of baby bath seats increases the risk of infants drowning because parents or caregivers left them unattended.

Background

In 1994, the Staff presented the Commission with a request to ban baby bath seats. Because there was no credible evidence before the Commission suggesting that infants bathed in bath seats were at a greater risk of drowning than infants bathed without bath seats, I voted against a ban on bath seats. The 1994 staff briefing package presented little data on the feasibility of a performance standard for bath seats; the only issue before the Commission was a complete ban of the product.

By 2001, the evidence before the Commission painted a very different picture. This evidence included 78 deaths and 110 non-fatal incidents and complaints involving baby bath seats and rings. Forty-one of the 110 non-fatal incidents or complaints occurred in the presence of a parent or caregiver. These incidents involved one of three hazard scenarios: 1) a tipover of the bath seat due to the failure of suction cups to adhere to the tub's surface; 2) a child "submarining" or becoming entrapped in the leg openings of the bath seat; and 3) a child coming out of the bath seat while the bath seat remained upright. The data, however, continued to show that children bathed with bath seats were at no greater risk of drowning than children bathed without them; a ban remained unsupported by the evidence.

The Record before the Commission

Banning

The briefing package supporting the recommendation to issue an NPR demonstrates that the relative risk of bathing infants with the assistance of baby bath seats is the same as bathing them without such bathing aids. Sadly and tragically, parents and caregivers leave infants in bathtubs with or without bath seats; but there is no credible evidence that the presence of a bath seat induces parents or caregivers to leave infants unattended in tubs when they would not have otherwise done so. There is, therefore, no support for a ban of these products.

Ineffectiveness of Voluntary Standard

While the voluntary standard in place in 2001 did seek to address the hazard scenarios of tipover, submarining and getting out of the bath seat, it failed to do so effectively. This voluntary standard sought to remedy the tipover hazard caused by the failure of suction cups to adhere to non-skid bath surfaces through the use of a warning that the product should not be used on such surfaces. The standard was ineffective. The warning was on the package of the product, which is easily overlooked and generally disposed of by the consumer once the product is used. In addition, it is difficult for a consumer to determine whether or not a given tub has a slip-resistant surface. Although a task group of the voluntary standards subcommittee was considering the leg hole entrapment issue, I believed that it would prove advantageous for the Commission to look into the leg hole entrapment issue as well. Consequently, I voted for an Advance Notice of Proposed Rulemaking.

Staff's Recommendation of Performance Standards and Labeling

The record today shows incidents involving tipover, submarining, or coming out of a bath seat continue. I believe the staff ‘s recommended performance requirement and labeling will address these bath seat hazards. The proposed stability standard, which requires that a bath seat remain stable whether or not it is on a slip-resistant surface, should reduce the likelihood of tip-over incidents due to surface adhesion failure. This will end the reliance on suction cups made with present technology as a means of ensuring stability. The staff's performance standard for the appropriate size of the leg hole openings, also included in the proposed voluntary standard, should address entrapment and submarining problems by ensuring that the leg hole openings are small enough to prevent an infant's limbs or torso from sliding through, or "submarining." This may also reduce the number of incidents where the child comes out of the bath seat, although they are not intended to remedy this hazard. Finally, the revised labeling requirement the staff has proposed is a stronger label that should instill in parents and caregivers the importance of being with the infant at all times when the infant is in a bath seat. Proposals to add a water level indicator, however well intentioned, may simply contribute to a belief that there is a safe level of water in which to bathe a baby, which is not the case.

Conclusion

The issue of baby bath seats is one of the most emotionally distressing of the issues faced by the Commission during my service, because virtually all of these drownings could be prevented by the simple presence of a responsible parent or caregiver. There is never any valid reason to leave an infant unattended in a tub. No consumer product safety standard can substitute for an attentive parent or caregiver. The proposed standard will, however, assist consumers in dealing with some of the hazards presently associated with the use of baby bath seats. I believe the voluntary standard for bath seats has not adequately reduced the risk of injury associated with baby bath seats, so I am voting today to proceed with a NPR for this product.

We have been petitioned by the Consumer Federation of America and nine other organizations to ban the sale of baby bath seats. A number of the petitioners also subsequently asked the Commission to recall bath seats made prior to the effective date of any ban. Let me first address what is before us today in the rulemaking proceeding.

At the ANPR stage of this proceeding, our staff believed there could be certain mechanical hazards with bath seats that needed to be addressed. At that stage, based on the staff's briefing package, I also believed that the use of suction cups to attach bath seats to a tub bottom was a bad idea. We are now at the NPR stage and it has become increasing clear that the use of suction cups as the primary means of stabilizing bath seats was a design error. A caregiver was present in 51 of the 115 tipovers (both fatal and non-fatal). These incidents cannot be blamed on a lack of supervision. There is a product problem. The suction cups are central to the use of the product. Suction cups are only viable on clean, level, smooth tub surfaces. And the suction cups themselves need to be kept clean and intact. Suction cups cannot be relied upon to adhere to new non-skid tubs or tubs with decals or tubs that may have soap residue or other dirt or debris on them. While the products' packaging and instructional literature indicate they should not be used on non-skid tubs, our staff has determined that non-skid tubs can be hard for a consumer to identify and I agree. Staff has also found that in certain circumstances suction cups may initially appear to be securely attached to the tub, only to detach some time later. Thus, no amount of carton labeling or instructions inside the box (both of which will likely be discarded by the time any second users get the product) can be relied upon to ensure these products are used only in the limited, rather pristine environment in which they work best.

For all of these reasons staff is proposing what is, in effect, a ban on the old and current design of baby bath seats. Staff does not believe that any bath seat that uses suction cups as its primary means of keeping the seat stable and secure will be able to meet the proposed stability test. And this would be true regardless of the number or size of the suctions cups used.

In over half of the 21-entrapment/submersion incidents (fatal and non-fatal) a caregiver was present. Again, a lack of supervision is not the problem. The size of the side and leg holes in bath seats manufactured up to this time appears to be another design error. In addition to addressing the entrapment/submersion problem, reducing the size of the leg holes may also make it more difficult for some infants to get out of the seat or make it impossible for larger infants to use the seat. Since we have seen a number of deaths and non-fatal incidents involving children who were older than the recommended age (or developmentally more advanced than the average child) and who were able to climb out of the seat on their own, this would be a design plus, rather than a drawback.

Together the two design issues discussed above have contributed to 34 infant deaths. We know of another 98 incidents that did not result in death, although some of those children needed medical treatment and their condition may have been quite serious. This is not to say that in every case these flaws were the sole factors leading to the infants' deaths or injuries. However, staff believes that eliminating these flaws would have eliminated almost all of the deaths. The Commission's findings in 1994, based on the limited data it had at that time, no longer hold. Sadly, we have more incidents to review, partly because we have more thorough reporting of them due to the visibility this issue has gotten through the work of the petitioners and others. Many of these new incidents are non-fatal and they have helped to complete the picture of how this product, as currently designed, has failed in its intended use. I support the staff proposal to address these two design issues.

The third problem the staff addresses is children who come completely out of the bath seat in one way or another. This is a difficult issue as it can encompass a number of factors: age or physical ability of the child; the amount of water in the tub; as well as product design features that may aid children in climbing out. Nevertheless, given the innovative way that industry tackled the baby walker dilemma, I find it hard to believe that manufacturers cannot come up with some design solutions to reduce this hazard. Our Human Factors staff was able to envision a possible passive restraint system and a test methodology, although they acknowledged that such an unobtrusive, automatic self-adjusting restraint system would be a challenge to make. Whether there are design solutions to this particular issue or not, I think there are additional things that could be done in this area. While I agree that a stronger product warning label is necessary, I wonder if the proposed label is strong enough. We also have a number of users for whom English is not their primary language. A pictogram of the drowning hazard (if one could be developed) would be a graphic reminder that might be more readily acknowledged by a caregiver during each bath than printed language. If we have to rely on language on the label, then I am inclined to agree with one of the commenters who felt language should be added along the lines of: "NEVER leave a child alone in a bath seat." I think it is more direct than "ALWAYS keep baby within arm's reach." And, in the midst of Hispanic Heritage Month, I wonder if requiring the warning label to also be in Spanish would not be appropriate. I remember one investigation of a bath seat fatality where the caregiver stated that the warnings were only in English and French and as she spoke only Spanish, she could not read them.

Other labeling issues raised by commenters included requiring a label on the product that would indicate that it meets the CPSC standard (assuming one is adopted) and putting the warning labels on both the front and the back of the packaging. Both of these proposals seem fine, although if bath seats look dramatically different, as we think they will without suction cups, the former requirement would not be necessary in order to distinguish new seats from pre-standard ones.

While I support strengthening the warning label on the product, I believe we should consider making the language even stronger and look at other things we can do to decrease the number of deaths from babies "coming out" of bath seats. In that regard, one of the issues I keep coming back to is the amount of water being used in bath tubs to bathe babies. While I realize there is no safe level of water for an infant, as a practical matter water is a necessary component in bathing. In looking at the in-depth investigations, it is clear that too many caregivers are putting too much water in the tub. The minimum recorded water depth for the 27 fatalities described in the briefing package was 3 inches and the median depth was 7 inches. Anything we can do to reduce the amount of water used in bathing a child is a step in the right direction. The language the 2003 ASTM standard requires in the instructions accompanying the product is one such step, but as we know, instructions often get discarded. Additionally, I am not sure that telling a caregiver to use as little water as necessary gives them much guidance, even though that language follows the information that babies can drown in as little as one inch of water.

Having the bottom 3/4 of an inch (for example) of bath seats in a contrasting color (or some other visual cue), to indicate that the water in the tub should not be higher, would imprint on many caregivers' minds that only enough water is needed to wet and rinse a wash cloth. While this might not eliminate all deaths related to excessive water, it should reduce the "slumping over" deaths and the cases where children's escapes from the seat were aided by the buoyancy created by too much water in the tub. And perhaps the message about using very little water will begin to filter down to caregivers who do not use bath seats, which would go a long way to reduce bath tub drownings, whatever the bathing scenario might be. It is true, as staff notes, that a water mark is not going to get at the overflow incidents or the incidents where a sibling turns on the water. But there are relatively few incidents in those categories. Short of recommending that caregivers not use water to bathe infants at all, we need to use every means at our disposal to encourage caregivers to reduce the amount of water they use to bathe their infants.

Another factor that affects the ability of infants to come out of bath seats, and one raised by a number of the commenters, is the age range during which infants should be bathed in bath seats. The 2003 ASTM standard requirements on labeling and instructional literature use 5 months to 10 months and developmental stages—the ability to sit up unassisted and the ability to pull up to a standing position—as the parameters for the use of this product. Several commenters feel that the use of the 5- and 10- month figures could result in the least developed 5-month old child being put in the seat too soon and the most developed 10-month old being allowed to stay in too long (assuming the caregivers' pay more attention to the age recommendation than to developmental actualities). They feel our standard should be geared to protecting the most vulnerable children--the least mobile children at the youngest end of the age range and the most mobile at the upper end of the age range. I think there is merit to that argument. If no 5-month olds were in bath seats, we would eliminate the age group most at risk from drowning in a bath seat versus drowning in a tub without a bath seat. At the other end of the age spectrum we begin to see more fatalities where children are found in the water or have gotten out of the seat. Some manufacturers have encouraged the longer-term use of their product, beyond the 10-month age recommendation. One manufacturer's literature states the age limit for use of their bath seat as 18 months or 25 lbs. That language will have to change under the 2003 ASTM standard, but I think we should reconsider the appropriateness of the current age range recommendation that is coupled with the developmental guidelines.

Nearly all commenters stated the need for an information and education campaign about the hazards of bathtub drownings (with or without bath seats). Our new Strategic Plan includes a goal to reduce child drownings, including those that occur in the home. Since most of the in-home drownings are in bathtubs, the agency will be expending resources to get the message out, in conjunction with other partners, that young children and water are a very dangerous combination. To all of those who expressed interest in working with us to accomplish our goal to reduce tub drownings, I thank you. And thanks to those who have already partnered with us in the past in this area. Whether we end up with a mandatory standard or a voluntary one, we should, at the appropriate time, add the old style baby bath seats to our "Most Wanted" list on our Recall Roundups and Thrift Store sweeps.

I know many commenters wanted an outright ban of bath seats. If it were clear that babies were always safer being bathed in a tub without a bath seat than being bathed in a tub with a bath seat, that would be an easy call. But our data, to date, does not show that. It does show that we can make significant reductions in the number of deaths by making changes in bath seat design. And there are a number of consumers, especially those with certain types of disabilities, for whom the bath seat is indispensable—it is the only way they can bathe their babies.

I think the Commission should go forward with the Proposed Rule despite the changes that have already been made, and purportedly will be made, to the ASTM voluntary standard. Until a final standard covering all of our requirements, as finally determined by the Commission, is in place and being complied with, we should go forward with our proposed mandatory rule. At this point, we do not even know what the new bath seats will look like. As with baby walkers, once new products are on the market, we would need to monitor the marketplace and test new products to any new standard before we could determine substantial conformance.

Several commenters also want the Commission to use its enforcement powers to recall bath seats that do not conform to the staff proposal. Rulemaking is prospective only. As far as I have been able to ascertain, once the Commission has embarked on a rulemaking remedy it has never gone back and done a retroactive recall of the same product for the same defect. Indeed, there may be procedural barriers to doing so as our statutes contemplate manufacturers having an opportunity to bring their products into compliance after a rule has been promulgated. Nevertheless, assuming the Commission does go forward with a mandatory rule or defers to a voluntary one, I am sympathetic to the need to switch over to safer seats as soon as possible. That would entail working to get the old ones out of consumers' homes. While recalls are one way to raise public awareness of the deficiencies of the old seats, there are also other ways to do that.

This is not the forum to decide the recall issue. I will ask that the Commission hold further discussions, in an appropriate forum, on how best to remove from the hands of consumers bath seats that do not comply with any future standard that may be adopted.