Proposal for Legislative Action on Infant Bath Seats and Bath Rings

Pre-Consultation Disposition Report
July 2009

Table of Contents

• Executive Summary
  • Introduction
  • Consultation
  • Feedback and Response
  • Results of the Consultation
• Background
  • General
• Pre-consultation Process
  • References
  • Area of Consultation
  • Submissions
• Disposition of Comments
  • Overview of Comments
  • Option 1: The establishment a prohibition on the advertisement, sale and importation of all infant bath seats and bath rings in Canada.
    • Feedback in Favour of Option 1
    • Feedback Against Option 1
  • Option 2: The establishment a prohibition on the advertisement, sale and importation of all infant bath seats and bath rings in Canada that do not meet the requirements of a referenced technical standard.
    • Feedback in Favour of Option 2
    • Feedback Against Option 2
• Next Steps

Executive Summary

Introduction

In May 2007, Health Canada's Consumer Product Safety Bureau (CPSB) consulted with Canadians on a proposal to introduce legislation, under the Hazardous Products Act, regarding the advertisement, sale and importation of infant bath seats and bath rings in Canada.

The legislative options given consideration were:

• The establishment of a total prohibition on the advertisement, sale and importation into Canada of all infant bath seats and bath rings, and
• The establishment of a prohibition on the advertisement, sale and importation into Canada of all infant bath seats and bath rings that do not meet the requirements of a referenced technical standard.

Consultation

Over a 60-day period (May 25, 2007 to July 25, 2007), the CPSB consulted with more than 3,300 stakeholders, which included manufacturers, importers, first nation communities, head offices of retail chains, industry associations, consumer safety associations/groups, medical professionals and relevant community associations. The pre-consultation was conducted via a targeted mass mail-out, the Health Canada on-line consultation site and a general distribution to all subscribers of "Health Canada Consumer Product Safety News".

Feedback and Response

During the 60-day pre-consultation period, there were 79 written submissions received. During the same period, the pre-consultation posting on the Health Canada web site (http://www.hc-sc.gc.ca/cps-spc/advisories-avis/info-ind/infant_bath-bain_bebe-eng.php) was viewed 660 times and the document itself was downloaded 814 times.

Additionally, at the time of the pre-consultation, approximately 1,500 individuals were subscribed to the "Health Canada Consumer Product Safety News".

The majority of the written submissions came from consumers and community associations. The remaining submissions were received from public health, trade, medical professionals, provincial governments and non-governmental organizations (NGO). It is important to note that two submissions (one from a health unit and another from a NGO) were in the form of a package containing multiple letters of support and each letter was included in the overall count.

Results of the Consultation

Of the of 79 submissions received, there were 61 in support of the total prohibition, 6 opposing the prohibition and 6 in support of the adoption of a technical standard. Additionally, 3 submissions informed CPSB of a change of address, one shared their experience with bath seats, one requested additional information and another informed CPSB that they did not sell infant bath seats.

Background

General

Health Canada helps protect the Canadian public by researching, assessing and collaborating in the management of the health risks and safety hazards associated with the many consumer products that Canadians use everyday.

Health Canada is especially concerned with the health and safety of children, who represent a particularly vulnerable segment of the Canadian population. Health Canada's CPSB works with industry and the public to help prevent product-related injuries, and to promote safety and the safe use of consumer products.

One of the juvenile product categories of concern to the Department is infant bath seats and bath rings. The Department has been monitoring the safety of infant bath seats and bath rings for quite some time, and has recently focussed its attention on introducing legislation, under the Hazardous Products Act, regarding the advertisement, sale and importation of infant bath seats and bath rings in Canada. Infant bath seats and bath rings pose a risk of drowning for infants who are placed in these products. In Canada, since 1983, there have been at least 12 fatal infant drownings and 25 near-miss drownings associated with the use of these products. Currently, there are no legislated safety requirements for infant bath seats and bath rings in Canada.

Pre-consultation Process

Prior to the development of legislation, the Department must follow the regulatory process, which dictates that a pre-consultation be held and all affected parties be consulted. A pre-consultation period of 60 days (May 25, 2007 to July 25, 2007) for infant bath seats and bath rings took place and various stakeholders were consulted via a targeted mass mail-out, the Health Canada on-line consultation site (http://www.hc-sc.gc.ca/ahc-asc/public-consult/index-eng.php), and a general distribution to all subscribers of "Health Canada Consumer Product Safety News" (http://www.hc-sc.gc.ca/cps-spc/advisories-avis/_subscribe-abonnement/index-eng.php).

The stakeholders that were consulted included:

• Manufacturers/Importers of infant bath seats and bath rings
• Health authorities
• Head offices of retail chains
• First nation communities
• Industry associations
• Consumer safety associations/community groups
• Medical professionals
• General public
• Health units
• Public health groups
• Provincial governments

The legislative options included in the pre-consultation were:

• The establishment of a total prohibition on the advertisement, sale and importation of all infant bath seats and bath rings in Canada, and
• The establishment of a prohibition on the advertisement, sale and importation of all infant bath seats and bath rings in Canada that do not meet the requirements of a referenced technical standard.

The CPSB consulted with over 3,300 stakeholders through the mass mail-out and targeted another 1,500 subscribers of "Health Canada Consumer Product Safety News". During this same period, the pre-consultation posting on the Health Canada website (http://www.hc-sc.gc.ca/cps-spc/advisories-avis/info-ind/infant_bath-bain_bebe-eng.php) was viewed 660 times and the document itself was downloaded 814 times. Stakeholders had the opportunity to submit their comments in writing, by email or by fax.

References

The main document entitled Proposal for Legislative Action on Infant Bath Seats and Bath Rings, was made available for review in both official languages along with two Health Canada advisories on infant bath seats and bath rings (one published in 2005 and the other published in 2006), as well as a fact sheet on these products (published in 2007).

Area of Consultation

The pre-consultation document focussed on soliciting input regarding Health Canada's proposal to implement legally binding requirements concerning the advertising, sale and importation of infant bath seats and bath rings in Canada, as well as providing stakeholders with important safety information concerning these products.

The document contained a detailed product description of infant bath seats and bath rings along with images of the affected items, a summary of the drowning hazard associated with the use of these products, a summary of the drownings and near-miss drownings that have occurred in Canada and the United States, an overview of the safety standards and regulations outside Canada, and a description of the false sense of security that these products promote to parents and caregivers.

Submissions

A total of 79 submissions were received from stakeholders:

• 32 consumers (When they provided their submissions, certain medical professionals did not specifically represent their organization/Non Governmental Organization (NGO)/Health Unit, etc. Therefore, these submissions were included within the consumer category).
• 7 from public health groups
• 7 from health authorities (including two changes of address)
• 7 health units
• 1 First Nation community
• 5 NGOs
• 3 from trade (one requested additional information on the pre-consultation and another informed CPSB that they did not sell infant bath seats)
• 1 from a retail outlet
• 4 medical professionals
• 2 provincial governments

It is important to note that the two largest submissions (one from a public health unit and the other from a NGO) were identical, but contained separate letters of support of the NGO's position and each letter was considered as an individual submission and accordingly was included in the overall count.

A standard reply letter, which included a link (http://www.hc-sc.gc.ca/cps-spc/advisories-avis/info-ind/infant_bath-ltr-bain_bebe-eng.php) to the Consumer Product Safety section of the Health Canada web site for updates on the infant bath seat and bath ring initiative was sent to each respondent.

Disposition of Comments

Sixty-one submissions indicated a strong support for an overall prohibition of all bath seats and bath rings. Only six submissions supported a prohibition of all bath seats and bath rings not meeting a referenced technical standard. Six respondents indicated strong opposition to the prohibition of these products, but not necessarily support for the other option. Several submissions also included detailed rationales and attachments.

Overview of Comments

Below is a summary of the feedback received from the respondents for each option. Certain comments were combined to avoid repetitiveness and therefore, each point below does not necessarily represent a separate submission or respondent. It is also important to note that the submissions, that included numbers and statistics, were properly sourced in the documents, but these sources were omitted below for the purposes of keeping this report clear and concise. The intention of the overview is to state the main arguments supporting and opposing each option.

Option 1: The establishment a total prohibition on the advertisement, sale and importation of all infant bath seats and bath rings in Canada.

Feedback in Favour of Option 1

General comments:

• A ban is the most effective means of regulating infant bath seats and bath rings, and it also presents the fewest challenges compared to the other option.
• Bath seats and bath rings are unnecessary infant-care products and pose an unreasonable risk of bathtub drowning.
• The "precautionary approach" as set out by the Privy Council Office, recognizes that the absence of scientific certainty shall not be viewed as a justification to postpone decisions where there is a risk of serious or irreversible harm. This approach applies to bath seats since they represent "serious and irreversible harm" to infants.

Child Developmental Factors:

• By 7 months of age, infants are inclined to reach, but ultimately struggle to access objects that are out of reach. If a child sees an object floating in the tub, they may reach for it. This action, combined with the child being top-heavy, may cause the bath seat to fall over.
• Infants between the ages of 7-12 months of age may be capable of pulling themselves to a standing position. Infants in this age range may also notice their parents leave the room and have the desire and skill to attempt to follow them resulting in the child subsequently falling out of the bath seat and becoming submerged in the water.
• There is no developmental benefit to using bath seats and there is a risk of serious injuries similar to baby walkers.

Supervision Factors:

• Many studies of bathtub drownings showed that infants and young children were left unattended for a short period of time. An American study showed that common reasons for leaving a child unattended included making a phone call (24%), attending to other children (24%), retrieving something, such as a towel or clothes, for the child (17%) and attending to household chores (17%).
• Supervision by an older sibling can give parents a false sense of security, which can contribute to an increased risk of drowning for the younger child.
• Parents find it easier to use bath seats because they prop up the child and free the parents' hands and it also gives the child more freedom in the tub therefore, parents are more comfortable leaving children unattended in the bath seat if they are within viewing/hearing range or if an older child is present.

Design Flaws:

• Many bath seat designs lack restraints that would prevent an infant from climbing out of the seat and falling into the water, particularly when the infants are left alone.
• Bath seats promote a hands-free approach to bathing, which is contradictory to established safe infant bathing practices that state the caregiver must remain in constant physical contact with infant while bathing. Research shows that this inherent design flaw provides a false sense of security, which may lead parents and caregivers to leave infants unattended in a bath seat or fill the tub with more water than is needed to bathe an infant (since the bath seat appears to hold and support an infant in a higher, upright seated position).
• The performance of the suction cups located on the bottom of the bath seat/bath ring can be diminished by dirty tub surfaces, slip-resistant tub surface design, improper cup sealing throughout use during bathing and cup degradation due to regular use. These scenarios can result in tip-over scenarios where infants fall out of the product causing them to become submerged underwater.

Caregiver Education:

• Caregivers are not only parents. They may also be babysitters, relatives or friends who may not be familiar with the hazards associated with infant bath seats and bath rings.
• Behaviour studies should be conducted on the effectiveness of warning information on products. Warning labels have a limited effect when there is a lack of initial perceived risk. For example, parents believe that if a product is for sale in a major retail store, then it must be safe.

Financial Reasons:

• Drowning is the second leading cause of injury-related death to Canadian children. 58 children aged 14 years and under drown each year and 140 children are hospitalized for near miss drownings. The annual cost for drowning in Canada, according to the World Health Organization is 250 million Canadian dollars.
• Children with severe neurological impairment following a near-drowning incident often require ongoing specialized care. This may result in serious financial hardship for the family, as well as society in general.
• There is no margin of error when misuse occurs. A young child can drown quickly in as little as 5 cm of water. Research shows that bath seat-related injuries are more likely to result in death than other infant care products.

Feedback Against Option 1

• The infant bath seat and bath ring industry will lose revenue.
• The number of infants across Canada that are bathed in bath seats regularly and safely is unknown.
• The rates at which infants are left unattended with bath seats and the rates at which infants are left unattended without bath seats are unknown.
• A national coronial review should be conducted to better understand the circumstances and mechanisms involved in bathtub drowning (with and without infant bath seats). It is difficult to determine with certainty whether infant bath seats are increasing or reducing drowning rates.
• A multi-faceted information and education campaign regarding the safe use of infant bath seats and bath rings is recommended. The message should be sent out to caregivers who do not use bath seats as well as to key influencers such as doctors, who can then pass the message on to the general public.
• Bath seats can provide benefits to infants that have health or developmental issues.
• Banning bath seats and bath rings will not eliminate the problem, as consumers will access these products through other sources such as countries where legislation may be more lenient.

Option 2: The establishment a prohibition on the advertisement, sale and importation of all infant bath seats and bath rings in Canada that do not meet the requirements of a referenced technical standard.

Feedback in Favour of Option 2

• Legislative solutions alone are insufficient to change bathing behaviours. However, regulating the standard to which bath seats and rings are made could result in products that would be less likely to put infants at risk by malfunctioning or by impeding the rescue of infants when submerged. This, combined with a multi-faceted approach to communicate that constant physical contact is the safest way to bathe an infant, is recommended.
• A bath seat or bath rings designed to a higher standard could potentially save an infant's life.
• A referenced technical standard and continued education around the proper use of bath aids appears to be the most practical option.
• A certification program will encourage the design of safer infant bath seats and bath rings.

Feedback Against Option 2

• Canada should not adopt the US ASTM standard for infant bath seats since it will lead consumers to believe that the Government deems ASTM-compliant bath seats and bath rings safe. The fact that this standard has been revised four times over an eight-year span (in 2001, 2003, 2004 and 2007) suggests that this standard is ineffective.
• A referenced technical standard would be very resource intensive in terms of compliance and enforcement.
• A referenced technical standard does not address the false sense of security of infant bath seats and bath rings.
• There is no established certification body, such as the US Juvenile Product Manufacturer's Association (JPMA), to certify compliant juvenile products in Canada.

Next Steps

Based on the comprehensive feedback received by the respondents, and in particular, the NGOs and health units who submitted detailed reports, Health Canada will further investigate the impacts of both legislative options on the health and safety of Canadian children and on the economy. Health Canada must follow the regulatory process prior to implementing new mandatory requirements, which would include a formal consultation, which will be pre-published in the Canada Gazette Part I

Health Canada will also continue to provide information and education on infant bath seats and bath rings and will post project updates on the legislative process on the department's website (http://www.hc-sc.gc.ca/cps-spc/child-enfant/equip/bath-bain-eng.php).