FEDERAL REG

SOR/2016-152: Cribs, Cradles and Bassinets Regulations

REGISTRATION OF FEDERAL REGULATION - VIA OIC DATABASE, PRIOR TO PART II OF THE GAZETTE

Registered
June 17, 2016


REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Executive summary Issues: Cribs, cradles and bassinets are the only products intended to provide unsupervised sleeping accommodation for infants and young children. To protect this vulnerable population, and provide a safe sleep environment, it is important that these products and their accessories be constructe... (Click for more)


House

1st Reading 2nd Reading 3rd Reading

Senate

1st Reading 2nd Reading 3rd Reading

Published on June 17, 2016

Bill Summary

SOR/2016-152: Cribs, Cradles and Bassinets Regulations

REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Executive summary Issues: Cribs, cradles and bassinets are the only products intended to provide unsupervised sleeping accommodation for infants and young children. To protect this vulnerable population, and provide a safe sleep environment, it is important that these products and their accessories be constructed in a manner that protects against known hazards that may result in injuries and deaths. The Cribs, Cradles and Bassinets Regulations (CCBR) had strict requirements for the construction and performance of these products. However, in collaboration with the ASTM International working groups for cribs, cradles and bassinets, Health Canada identified further hazards that were not addressed by the Regulations, such as those associated with the deformation and breakage of hardware on traditional crib drop sides, and is introducing new Regulations to address these hazards. These new CCBR (the Regulations) also further align the Canadian requirements for cribs, cradles and bassinets with the requirements established by the United States Consumer Product Safety Commission (U.S. CPSC), which adopt as law the voluntary ASTM standards for cribs, cradles and bassinets. Description: Under the Canada Consumer Product Safety Act (CCPSA), the Regulations are being introduced to make a number of major modifications to address identified hazards, including a prohibition on the sale, importation, manufacture and advertisement of traditional drop-side cribs, and the introduction of performance requirements and test methods for accessories for cribs, cradles and bassinets and stands for cribs, cradles and bassinets. The Regulations are intended to help improve the safety of these products to further safeguard against injuries and deaths, while bringing the majority of the Canadian regulatory requirements in line with those of the U.S. CPSC. Cost-benefit statement: The costs of these Regulations have a present value of $12.79 million over 20 years, discounted at a rate of 7%. The benefits have a present value of $34.37 million over 20 years, discounted at a rate of 7%. Therefore, these Regulations will deliver net benefits to Canadians in excess of $21.58 million. The net benefits have an annualized value of $2.04 million and a benefit/cost ratio of 2.69. Beyond this economic argument, some aspects of crib, cradle and bassinet designs were contributing to non-fatal and fatal incidents involving infants in Canada. The Regulations will help to better protect infants and young children. “One-for-One” Rule and small business lens: The “One-for-One” Rule does not apply to these Regulations, as they do not impose an administrative burden. The small business lens applies to these Regulations, but there are no expected substantial or disproportionate direct impacts on small businesses. The completed small business lens checklist follows the Regulatory Impact Analysis Statement (RIAS). Domestic and international coordination and cooperation: The Regulations align several aspects of the Canadian requirements with the U.S. requirements, where possible and appropriate. There are particular requirements in the U.S. specifications that were identified as adding further safety measures. Greater alignment of the Regulations with the requirements of the United States will facilitate industry compliance and trade between the two countries, as several manufacturers of these products sell in both Canada and the United States. Those few areas where these Regulations do not align with U.S. requirements were necessary to provide the same level of safety for all surfaces intended for unsupervised infant sleep. Background Cribs, cradles and bassinets are intended to be used by infants and young children for sleep without adult supervision. Young children constitute a particularly vulnerable segment of the population because they cannot recognize potentially dangerous conditions and therefore require a higher degree of protection than adults. The new Cribs, Cradles and Bassinets Regulations (CCBR) will improve the safety of these products by specifying the minimum safety requirements that these products need to meet in order to limit the risk of death and injury to users. Canada’s requirements for cribs, cradles and bassinets were among the most stringent in the world. However, Health Canada identified safety concerns associated with traditional crib drop-sides, which were allowed under the Regulations. In addition, crib, cradle and bassinet manufacturers requested greater alignment of the Canadian Regulations with other recognized international standards, specifically those of ASTM International. Since the CCBR were introduced in 2010, a number of substantial issues relating to crib, cradle and bassinet safety, including hazards associated with traditional crib drop-sides, crib mattress supports, and entrapment hazards from openings in fabric-sided products, resulted in reported incidents in Canada. Health Canada previously responded to these issues by negotiating voluntary recalls with industry, and identified the current improvements to the regulatory requirements to address these issues. Health Canada launched a public consultation on September 29, 2010, regarding the development of these new Regulations. On July 25, 2015, a formal consultation through publication in the Canada Gazette, Part I, was open for a comment period of 75 days. Issues Between January 1, 2010, and November 1, 2015, there were 38 recalls for cribs, cradles and bassinets, of which 14 were related to crib drop-sides, 5 to crib slat strength, 3 to crib mattress supports and 2 to instructions for assembly and proper use. The U.S. CPSC addressed these issues in regulations. Health Canada is aligning with that approach. Drop-side cribs generally have a tendency to be less structurally sound than cribs with fixed sides because of the additional stress caused by the repeated raising and lowering of the drop side. The hardware on these cribs has broken or deformed after routine use. When the drop side hardware breaks or deforms, the drop side can detach from the crib in one or more corners and create a space between the drop side and the crib mattress. The bodies of infants and toddlers have become entrapped in this space, which has led to suffocation. Complete detachment of the drop side from the crib has led to falls. Between January 2000 and November 2015, Health Canada received 104 complaints involving crib drop sides of all models sold in Canada, including those models that were ultimately recalled. The 104 reported drop-side complaints were associated with 94 non-injury-related incidents, 8 reports of bumps, scrapes and bruises, one report of a concussion, and one death. The death occurred in a crib where the original drop-side hardware had been replaced with parts that were not supplied by the manufacturer. The crib was also in a general state of disrepair. On December 28, 2010, the U.S. CPSC adopted revised mandatory requirements for cribs. This regulation requires that full-size cribs comply with the previously voluntary industry standard ASTM F1169-13. On October 23, 2013, the U.S. CPSC also adopted the previously voluntary industry standard for cradles and bassinets ASTM F2194-13a as law. The ASTM F1169-13 standard for full-size cribs included several new provisions, such as a restriction on crib sides that are not rigidly attached to the crib ends (the traditional style of crib drop-sides). Due to the revised U.S. CPSC requirement, which is based on the voluntary industry standard, many industry members no longer manufacture or sell traditional drop-side cribs in the United States and Canada. Objectives The objective of the Regulations is to improve the protection of the health and safety of young children with regard to the use of cribs, cradles and bassinets, including a specific focus on preventing injuries related to traditional drop-side cribs, and to further align Canada’s safety requirements with those of the United States. This ensures that all surfaces for unsupervised infant sleep provide the same level of protection. Description The Regulations of the CCPSA repeal and replace the CCBR, which were promulgated under the Hazardous Products Act. They enhance safety and better align Canada’s safety requirements with those adopted by the U.S. CPSC. This is accomplished by strengthening construction and performance requirements through the following: Prohibiting the sale, importation, manufacture and advertisement of cribs, cradles and bassinets with sides that are not rigidly attached to the crib, cradle or bassinet ends (i.e. traditional “drop sides”); Updating the structural integrity test method for the mattress support vertical impacting of cribs and cradles such that it is more repeatable; Adding an additional performance requirement and test method for crib slat strength; Including a performance requirement to further safeguard against incorrect assembly of key structural components of cribs, cradles, bassinets and accessories; Including performance requirements and test methods for accessories, such as sleep or change table accessories, that attach to cribs, cradles or bassinets; Including performance requirements for the maximum rest angle and maximum flatness angle of cribs, cradles, bassinets, sleep accessories and stands; Updating the completely bounded openings performance requirement and test method to clearly include cribs, cradles, bassinets and sleep accessories with sides made out of textile or other pliable materials, including removable textile or pliable material covers, under their scope; Changing the performance requirement for the maximum height of corner posts from 3 mm to 1.5 mm; Including a performance requirement and test method for the stability of cradles, bassinets and stands; Introducing performance requirements and test methods for stands that are designed or advertised for use with cribs, cradles and bassinets; Adding a performance requirement prohibiting the use of occupant restraints on cribs, cradles, bassinets and sleep accessories, and performance requirements and test methods limiting the length of cords and size of loops attached to cribs, cradles, bassinets, accessories and stands; Including minor administrative revisions to other sections to improve clarity and readability; and Providing a six-month transition period for the replacement of non-compliant cribs, cradles and bassinets available in the marketplace. A more detailed description of the new requirements can be found below. 1. Prohibition of the sale, import, manufacture and advertisement of traditional drop-side cribs, cradles, bassinets and sleep accessories In light of the safety concerns and alignment with the U.S. requirements for cribs, Health Canada is prohibiting the sale, importation, manufacture and advertisement of traditional drop-side cribs. This involves the introduction of a requirement that stipulates cribs with access sides having movable components intended to aid in access to the occupant must have those sides rigidly attached to the crib ends and contain no movable section less than 510 mm above the top of the mattress support in the lowest position. This also ensures that the movable portion of the crib access side does not create a toehold that could be used by the occupant to aid in climbing out of the crib. As traditional style drop sides on cradles, bassinets and sleep accessories pose the same hazard, the Regulations also limit the movement of sides on these products to the uppermost portion. This provision will provide a level playing field and prevent reintroduction of these products. 2. Mattress support vertical impact test method for cribs and cradles The current U.S. crib requirements feature a modified version of Health Canada’s mattress support vertical impact test for cribs. In order to best align requirements, Health Canada and the U.S. CPSC have agreed upon a common set of test requirements for both countries. These testing specifications closely resemble the former Canadian method, but involve changing certain parameters, such as the cycle frequency (to one impact for every four seconds from one impact per second) and the test mattress, to allow for greater repeatability of the test. The equipment and the test parameters are also aligned with the modified ASTM F1169-13 version of the mattress support vertical impact test. 3. Crib slat strength performance requirement and test method In Canada, the CCBR contained strict requirements relating to slats, where the slats must not turn, dislodge, deform or become damaged when tested. Despite those strict requirements, Health Canada continued to receive reports of crib slats breaking or disengaging. Cribs are intended to accommodate babies of an older age group than cradles and bassinets, and crib slats are subjected to greater wear and tear. As a result, Health Canada is also aligning its requirements with the more stringent performance requirements and testing parameters of the ASTM F1169-13 crib slat strength test, which involves applying a 356 N pull force to 25% of the crib’s slats. 4. Performance requirement for correct assembly of key structural components Health Canada has received reports of incidents associated with the incorrect assembly of cribs. The incorrect assembly of cribs, cradles or bassinets has the potential to result in serious injury or death. Consequently, Health Canada is aligning its requirements with the requirement in ASTM F1169-13 that stipulates crib designs must only allow for correct assembly of key structural components, such as side assemblies, end assemblies, mattress supports and stabilizing bars, or have permanent markings that indicate how to assemble the component. The Regulations require that these markings on cribs, cradles, bassinets, accessories and stands must be conspicuous in any misassembled state. 5. Accessory performance requirements and test methods Accessories, such as sleep and change table accessories are products that are designed or advertised for use with a crib, cradle or bassinet. They are designed to support the weight of a child and they can be placed on or fixed to the product with which they are used. Due to its structure, location, movement or failure, and the developmental capabilities of the child, a crib accessory may expose a product’s occupant to hazards, including openings that could lead to entrapment. Health Canada is aligning its requirements with the performance requirements and test parameters for openings, detachment and cord/strap length that assess entrapment in crib accessories from ASTM F1169-13. ASTM standards require that products must also meet other applicable ASTM standards, such as those for bassinets and change tables. The structural integrity requirements for sleep accessories and change table accessories are from the ASTM bassinet and change table standards respectively. These requirements apply to accessories that are designed or advertised for use with a crib, cradle or bassinet. Cradles and bassinets are designed to accommodate infants who are less developmentally capable than children who could be placed in a crib. Additionally, accessories to cradles and bassinets typically cover the entire surface area of the product to which they are attached, making it highly unlikely that a caregiver would place a child in the cradle or bassinet with an accessory covering the occupant retention area. The hazard of concern is not likely to occur for a cradle or a bassinet. As a result, the performance requirements and test parameters specifically associated with openings, detachment and cord/strap length are only being applied to cribs and not cradles and bassinets as was originally proposed. Currently, there is no requirement for cradles and bassinets, which are therefore in a position of status quo. The new requirements now align with the U.S. requirements and were made in response to persuasive comments received during the consultation period following publication in the Canada Gazette, Part I. More information on the comments received are available the “Consultation” section of this document. 6. Rest angle and flatness performance requirements The potential for serious injury or death is present when infants and young children are not placed to sleep on a firm and flat sleeping surface. To limit the potential for suffocation or entrapment, a maximum flatness and maximum rest angle are being introduced. The revised ASTM F2194-13a standard includes a maximum rest angle (for rocking or swinging bassinets and cradles) of 7° from the horizontal and, through a change to the standard’s scope, of 10° from the horizontal maximum allowable flatness angle for all bassinets and cradles. To align its requirements with the U.S. CPSC requirements, Health Canada is including a maximum rest angle of 7° from the horizontal, which, according to current science, should provide an adequate level of protection for rocking or swinging cribs, cradles, bassinets, sleep accessories and stands. Based on the current science and a Health Canada risk assessment, Health Canada is introducing a maximum flatness angle of 7° from the horizontal for cribs, cradles, bassinets, sleep accessories and stands. The rationale for this required angle, which is stricter than the U.S. requirement, is that 10° from the horizontal is an angle at which infants might not be able to keep their airways clear. Health Canada’s risk assessment was based on an examination of known incidents and deaths, internal development work and the results of a 1995 Australian study — the only known scientific study on infant sleep surface angles. The study’s infant test subjects were assessed at angles of 5, 7 and 10 degrees to determine what angle was the most protective in minimizing the risk of an infant rolling and getting trapped in a corner or other entrapment/asphyxiation scenario. All of the infants who were subjected to the 5 and 7 degree angles were able to keep their airways open since at those angles the infants still had the ability to pivot their head in order to maintain a free airway. Conversely, the infants tested at an angle of 10 degrees were unable to pivot their head, and their airways remained obstructed. This risk applies to any sleep surface. Health Canada, therefore, is adopting a 7 degrees maximum flatness angle in keeping with the view that all surfaces for unsupervised sleep should provide the same level of safety. The Canadian maximum flatness angle of 7 degrees should have no effect for the large majority of cribs, cradles, and bassinets, which already meet the requirement. Some niche products would not be able to be sold in Canada on the basis that flatness angles greater than 7 degrees are not protective of sleeping infants. These niche products represent a very small percentage of the Canadian crib, cradle and bassinet market. During the development of these Regulations by Health Canada, these niche products have resulted in incidents, so Canadians have already been cautioned against their use. 7. Completely bounded openings performance requirement and test method Some cradles and bassinets are sold with textile or pliable material sides or a textile or pliable material cover that fits over the product’s frame. These covers may include snaps or zippers that can be undone for ease of removal. Between January 2000 and November 2015, Health Canada received one report of an infant becoming entrapped between the bars of a bassinet’s metal frame and one report of an infant falling through the bars of a bassinet’s frame. Both of these incidents occurred when the frame was exposed as a result of the cover becoming unfastened. Although the CCBR included a requirement intended to ensure that the product did not have any hazardous openings in which a child could become entrapped or fall through, the U.S. CPSC adopted additional requirements that specify cradles and bassinets are to be tested with the textile or pliable material on the product, but without the snaps, zippers, etc., fastened. However, the U.S. CPSC does not address cribs with removable covers. In the future, it is possible that cribs with covers may arrive on the market. Therefore, Health Canada is clarifying the Regulations with respect to the requirements for completely bounded openings for cribs, cradles and bassinets with sides made of a textile or other pliable material. These Regulations include a requirement specifying that cribs, cradles, bassinets and sleep accessories with removable covers that can be taken off without the use of tools should be assessed for completely bounded openings without the snaps, zippers, etc., fastened. This testing assesses the foreseeable situation in which all of the removable cover’s fasteners have not been engaged after it has been removed for cleaning or replacement. This approach will help improve safety for real life situations by minimizing the potential for hazardous openings being present in the product’s frame. While the former Canadian test method for completely bounded openings assessed the same hazard related to completely bounded openings as the U.S. requirement, it differed in the manner in which the test was performed. Health Canada has simplified its approach by using the same test block that was already specified in the Regulations to assess completely bounded openings in cribs, cradles, bassinets and sleep accessories rather than introducing an additional block. 8. Maximum height of corner posts Corner posts on cribs, cradles, bassinets and sleep accessories may pose a strangulation hazard because a baby’s clothing could catch on the post. To improve safety and better align its requirements with those of the United States, Health Canada is limiting the height of corner posts on cribs, cradles, bassinets and sleep accessories from 3 mm to 1.5 mm. Bassinets and sleep accessories typically do not have corner posts. However, bassinets and cradles sold in the United States have to meet the corner post requirement under the U.S. CPSC rulemaking. Based on this situation with respect to cradles and bassinets and Health Canada’s recent cyclical enforcement testing of cribs, it is expected that the majority of cribs, cradles and bassinets on the Canadian market will already be compliant with this requirement and will therefore have little impact on industry. 9. Cradle and bassinet stability performance requirement and test method Health Canada is aligning its performance requirement and test method for cradle and bassinet stability with those the U.S. CPSC has adopted as law. This requirement is intended to make sure that the product does not tip over under a load of 10 kg, which represents the mean pull strength of a two-year-old male child. The inclusion of this requirement further safeguards the stability of cradles and bassinets and further aligns Canadian and U.S. requirements. 10. Stands In recent years, stands, in particular for bassinets, have become more popular on the Canadian market. Many sleep products are marketed for use both on and off a stand. Stands are supplied with the product, or sold separately and marketed for use with a specific product. Some stands are designed to accommodate a product that rests on it and others have latching or locking mechanisms that attach the product to the stand. Health Canada is aware of a death that resulted from a bassinet which was not attached to the stand on one side when the infant was put down for a nap. Similar incidents have been reported in the U.S., and the U.S. CPSC addressed the hazards related to these types of incidents through the introduction of the removable bassinet bed attachment requirement. Health Canada staff reviewed the U.S. CPSC removable bassinet bed attachment requirement and had concerns regarding its suitability. There are a number of options for compliance with the requirement. Two of these options (the stand shall not support the bassinet bed and the sleep surface of the bassinet bed shall be at least 20° off from the horizontal plane when the bassinet bed is in the unlocked position) involve designing the product in such a way to alert the caregiver that the bassinet bed is not appropriately attached to the stand (i.e. the product would appear unsafe when fasteners on the stand are unlatched or unlocked). Many removable bassinet beds incorporate handles such that they can be moved from room to room with the child in the product. It is reasonably foreseeable that some caregivers may attempt to attach the bassinet bed to its stand while the child is in the product. Product designs that cause the bassinet bed to collapse or tilt to a severe angle when unlatched or unlocked from the base may expose children to unnecessary hazardous conditions. Health Canada staff submitted a formal comment to this effect to the U.S. CPSC during its public consultation preceding the adoption of these new requirements. The U.S. CPSC has not expressed opposition to the Canadian approach. Due to these concerns, Health Canada is not aligning its requirements with this aspect of the U.S. CPSC requirements for cradles and bassinets. Rather, Health Canada is including a mandatory warning for stands to alert caregivers to the hazards associated with using a product when it is not appropriately secured to the stand. This warning, in addition to the new stability requirement and test method to which stands will be subjected, addresses the hazards related to stands. The overall safety of stands is also improved by the introduction of general safety provisions for stands. 11. Restraint system, attached cord length and loops The presence of cords and loops in an infant’s sleeping environment has the potential to lead to serious injury or death. Health Canada is aware of incidents and deaths that occurred when a child in a crib has gained access to a cord or loop. Therefore, Health Canada is including requirements related to attached cord length and loops in the infant’s sleep environment. The U.S. CPSC has regulated against restraint systems in the cradles and bassinets because restraints are unnecessary in cradles and bassinets and are, therefore, more likely to be unused. The U.S. CPSC is aware of incidents involving other products with restraints, such as swings, infant carriers and bouncers. (see footnote 2) Health Canada is aligning its requirements with those adopted by the U.S. CPSC for cribs, cradles and bassinets with respect to restraint systems in cradles and bassinets, attached cord length on cribs, and loops on accessories, and broadening the scope of these requirements to address restraint systems in cribs, attached cord length on cradles, bassinets, accessories and stands, as well as loops attached to cribs, cradles, bassinets and stands, in addition to accessories. 12. Minor revisions to improve clarity Minor adjustments to language and format have been made in order to increase the clarity, organization and readability of the Regulations. For example, the CCBR required that all cribs display the following warning: “Ensure that the sides of this crib are properly latched or locked in the appropriate position when a child is left unattended in it.” However, not all crib sides have movable components and, therefore, do not have multiple adjustment positions. The Regulations make it clear that certain warnings are only required for products with particular design characteristics. 13. Transition period The Regulations provide for a transition period of six months during which time the current CCBR would continue to apply to all cribs, cradles and bassinets sold, advertised, imported or manufactured in Canada. This provision would allow industry to modify or redesign its products to meet regulatory requirements, and verify the regulatory compliance of its products through product testing. This transition period is also in line with the transition time following revisions to the industry standards. Regulatory and non-regulatory options considered Status quo The option of maintaining the CCBR was rejected because it was determined that regulatory changes were required in order to provide an enhanced level of safety with respect to the use of cribs, cradles, bassinets and accessories. These changes address safety concerns, such as those specifically associated with traditional drop-side cribs that have been identified as causing serious injuries or deaths. If the Regulations were not adopted, the supply of potentially unsafe cribs, cradles and bassinets to Canadian consumers would not have been prohibited. Additionally, the Regulations would not have been further aligned with the U.S. law. Prohibition of the manufacturing, sale, advertisement and importation of all types of movable crib, cradle, bassinet or sleep accessory sides in Canada This option was rejected because it was determined that the Regulations could otherwise include a requirement to prohibit the supply of cribs, cradles, bassinets and sleep accessories with sides that are not rigidly attached to the crib, cradle, bassinet or sleep accessory ends, while allowing for the uppermost portion of the side to move. The safety issues, which were identified with traditional drop-sides, are addressed by ensuring that the lower part of the crib, cradle, bassinet or sleep accessory side is rigidly attached to the product’s ends. This eliminates the potential for the lower part of the side to separate from the ends, creating a gap between the side and the mattress in which a child could become entrapped. This still allows the upper portion of the crib, cradle, bassinet or sleep accessory side to move in order to allow for easier access to the child. A prohibition of all types of movable sides would have limited caregivers to the use of fixed-side cribs, cradles, bassinets and sleep accessories. This could have created difficulties for some caregivers who are small in stature or who have back problems. Additionally, the Regulations would not have been further aligned with the U.S. law. Adoption of the Regulations Adopting the Regulations was determined to be the preferred method of protecting the health and safety of young children using cribs, cradles, bassinets and accessories. The Regulations are intended to clarify certain aspects of the CCBR and put in place more stringent safety requirements concerning access sides, product assembly and crib slat strength. Additionally, this option addresses requests from stakeholders to further align Canadian and U.S. requirements for cribs, cradles, bassinets, accessories and stands. Benefits and costs The following table provides the results of the cost-benefit analysis. The annual results for a 20-year period are reported as the present value (see footnote 3) (PV) of cash flows. Over a 20-year period after the new CCBR become law, it is estimated that the changes could provide a net present value (see footnote 4) (NPV) of approximately $21.58 million. When annualized (see footnote 5) over the study period, the net present value amounts to $2.04 million per year. (see footnote 6) Cost-benefit statement This table presents the cost-benefit statement. Quantified impacts (in CAN$, in millions, October 2015 price level / constant dollars) Quantified impacts (in CAN$, in millions, October 2015 price level / constant dollars) Quantified impacts (in CAN$, in millions, October 2015 price level / constant dollars) Quantified impacts (in CAN$, in millions, October 2015 price level / constant dollars) Total PV Annualized Cost Benefits By stakeholder Avoided injuries (see footnote 7) Young children $17.87 $1.69 Avoided fatalities (see footnote 8) Young children $16.50 $1.56 Total benefits Total benefits $34.37 $3.25 Costs By stakeholder Higher product prices Consumer $3.59 $0.34 Lost resale income Consumer $4.23 $0.40 Government costs Health Canada $1.57 $0.15 Compliance costs Small business $2.83 $0.27 Compliance costs Medium–Large business $0.57 $0.05 Total costs Total costs $12.79 $1.21 Net benefits Net benefits $21.58 $2.04 Benefit-cost ratio Benefit-cost ratio 2.69 Qualitative impacts Qualitative impacts Qualitative impacts Qualitative impacts Consumer (positive) Consumers are expected to benefit from avoided injuries and fatalities relating to the new requirements for cradle vertical impacting, and for accessories to cribs, cradles and bassinets, but estimates of avoided cradle injuries and fatalities were not projected due to insufficient data. Consumers are expected to experience reduced health care costs and enhanced quality of life. Industry (positive) Industry may experience higher sales in export markets as Canadian products become increasingly recognized by foreign consumers for high standards of safety. Industry may face reduced claims for liability as a result of incidents involving their products. Industry may experience lower compliance costs due to improved alignment of U.S. and Canadian regulatory requirements. Consumer (positive) Consumers are expected to benefit from avoided injuries and fatalities relating to the new requirements for cradle vertical impacting, and for accessories to cribs, cradles and bassinets, but estimates of avoided cradle injuries and fatalities were not projected due to insufficient data. Consumers are expected to experience reduced health care costs and enhanced quality of life. Industry (positive) Industry may experience higher sales in export markets as Canadian products become increasingly recognized by foreign consumers for high standards of safety. Industry may face reduced claims for liability as a result of incidents involving their products. Industry may experience lower compliance costs due to improved alignment of U.S. and Canadian regulatory requirements. Consumer (positive) Consumers are expected to benefit from avoided injuries and fatalities relating to the new requirements for cradle vertical impacting, and for accessories to cribs, cradles and bassinets, but estimates of avoided cradle injuries and fatalities were not projected due to insufficient data. Consumers are expected to experience reduced health care costs and enhanced quality of life. Industry (positive) Industry may experience higher sales in export markets as Canadian products become increasingly recognized by foreign consumers for high standards of safety. Industry may face reduced claims for liability as a result of incidents involving their products. Industry may experience lower compliance costs due to improved alignment of U.S. and Canadian regulatory requirements. Consumer (positive) Consumers are expected to benefit from avoided injuries and fatalities relating to the new requirements for cradle vertical impacting, and for accessories to cribs, cradles and bassinets, but estimates of avoided cradle injuries and fatalities were not projected due to insufficient data. Consumers are expected to experience reduced health care costs and enhanced quality of life. Industry (positive) Industry may experience higher sales in export markets as Canadian products become increasingly recognized by foreign consumers for high standards of safety. Industry may face reduced claims for liability as a result of incidents involving their products. Industry may experience lower compliance costs due to improved alignment of U.S. and Canadian regulatory requirements. Child care centres (negative) Seven provinces and one territory (Manitoba, Ontario, Quebec, New Brunswick, Newfoundland and Labrador, Nova Scotia, Prince Edward Island and Yukon) have legislation that requires licensed child care operations to use cribs that meet federal requirements. Depending on the enforcement approach taken by the provincial and territorial governments, child care centres in affected regions may face costs associated with the replacement of equipment. There may be a rise in health care costs of child care workers due to increased back problems relating to repeated lifting and lowering of children into non-drop-side cribs. Child care centres (negative) Seven provinces and one territory (Manitoba, Ontario, Quebec, New Brunswick, Newfoundland and Labrador, Nova Scotia, Prince Edward Island and Yukon) have legislation that requires licensed child care operations to use cribs that meet federal requirements. Depending on the enforcement approach taken by the provincial and territorial governments, child care centres in affected regions may face costs associated with the replacement of equipment. There may be a rise in health care costs of child care workers due to increased back problems relating to repeated lifting and lowering of children into non-drop-side cribs. Child care centres (negative) Seven provinces and one territory (Manitoba, Ontario, Quebec, New Brunswick, Newfoundland and Labrador, Nova Scotia, Prince Edward Island and Yukon) have legislation that requires licensed child care operations to use cribs that meet federal requirements. Depending on the enforcement approach taken by the provincial and territorial governments, child care centres in affected regions may face costs associated with the replacement of equipment. There may be a rise in health care costs of child care workers due to increased back problems relating to repeated lifting and lowering of children into non-drop-side cribs. Child care centres (negative) Seven provinces and one territory (Manitoba, Ontario, Quebec, New Brunswick, Newfoundland and Labrador, Nova Scotia, Prince Edward Island and Yukon) have legislation that requires licensed child care operations to use cribs that meet federal requirements. Depending on the enforcement approach taken by the provincial and territorial governments, child care centres in affected regions may face costs associated with the replacement of equipment. There may be a rise in health care costs of child care workers due to increased back problems relating to repeated lifting and lowering of children into non-drop-side cribs. Results The cost-benefit analysis of the Regulations indicates that Health Canada has a strong economic basis for adopting the Regulations, as they deliver net benefits to Canadians in excess of $21 million. Costs will initially be borne by laboratories testing cribs, cradles and bassinets to determine whether the products meet the new requirements. These costs will be passed through to manufacturers having their products tested. Manufacturers will also face costs if their products do not meet the new requirements, thus needing modifications or redesigns. These costs will be passed through to product wholesalers, retailers and, ultimately, to Canadian consumers. In addition, the Government of Canada will experience economic costs through regulatory compliance promotion, monitoring, product testing and enforcement. These are opportunity costs involving the reallocation of existing resources; additional funding will not be requested and additional people will not be hired. Some child care operations may be impacted by provincial or territorial legislation that requires them to use cribs in their facilities that meet the federal requirements for cribs. It is important to note that it is these provincial and territorial requirements that directly impose the requirement on child care facilities to use a crib that is compliant with the federal regulations, and not the federal regulations themselves. The Regulations and the supporting CCPSA cover the manufacture, import, advertisement or sale of cribs, cradles and bassinets, but do not apply to the use of these products. Therefore, any costs to this group imposed by provincial and territorial legislation cannot be influenced by Health Canada. Health Canada intends to work with and support its provincial and territorial counterparts during the implementation of the Regulations. The cost-benefit analysis estimated the costs to Canadians that would be associated with higher prices for cribs, cradles and bassinets, and the inability to resell products that do not meet the requirements. The impact on Canadians of higher crib, cradle and bassinet prices of $1.05, $0.47 and $0.63, respectively, was estimated. The Regulations are intended to deliver benefits to Canadians in terms of avoided non-fatal and fatal injuries related to the use of cribs, cradles and bassinets. The Regulations will also increase the extent to which product requirements are aligned between Canada and the United States. For industry, alignment provides broader access to international markets by making it easier and more economically viable to market and compete in a global marketplace. Internationally aligned legislation is also more readily accepted by industry, which leads to higher compliance rates. Consumers Costs Canadian consumers may face costs as a result of the Regulations. These costs relate to higher product prices and prohibitions on the resale of non-compliant cribs, cradles and bassinets. With respect to higher product prices, the cost-benefit analysis indicated that the price of a typical crib, cradle or bassinet may increase on average by a maximum of $1.05 for cribs, $0.47 for cradles and $0.63 for bassinets. These price increases are expected to be maximum averages resulting from pass-through product testing, modification or redesign costs. The Regulations also result in an adjustment to the scope of which cribs, cradles and bassinets are prohibited from the sale, advertisement, manufacture or importation in Canada. Canadians holding used cribs, cradles and bassinets not meeting the new requirements will therefore not be able to advertise or sell (including giving away or donating) their used cribs, cradles and bassinets. A model of future product sales was made, based on estimates that about 225 000 cribs, 20 000 cradles and 100 000 bassinets are sold annually in Canada. These sales were estimated in the future based on birth projections by Statistics Canada. It was projected that a total of approximately 7.73 million cribs, cradles and bassinets would be sold over the 20-year period of analysis. In total, the 20-year present value of costs, discounted at a rate of 7%, is approximately $3.59 million. Estimates were made of the costs to Canadians for lost income from the resale of cribs, cradles and bassinets not meeting the new federal requirements. These lost incomes represent the receipts that Canadians would otherwise have received from the resale of products. The Regulations prohibit the sale of products held that do not meet the requirements. These estimates are made by combining estimates of the number of cribs, cradles and bassinets owned, expectations regarding the number of these products that would not meet the new requirements, resale rates and resale revenues. In total, the costs of lost product resale revenues were estimated at approximately $4.23 million over 20 years when discounted at a rate of 7%. Benefits Some aspects of former crib, cradle and bassinet designs are contributing to non-fatal and fatal incidents involving infants in Canada. Adoption of the new Regulations will reduce the social inequities by helping to protect children who otherwise do not have an option for avoiding consumer products that may pose health and safety hazards. Canadians will benefit from reduced numbers of non-fatal and fatal injuries resulting from the use of cribs, cradles and bassinets. The approach for valuing these benefits involved reviewing Canadian and U.S. data to develop estimates of the number of non-fatal and fatal incidents that will be avoided in Canada as a result of the Regulations. These data sources included Health Canada’s Product Safety Information System, the Public Health Agency of Canada Canadian Hospitals Injury Reporting and Prevention Program, and a number of databases and reports from the United States, including the U.S. CPSC In-Depth Investigation File and National Electronic Injury Surveillance System. A profile of non-fatal and fatal injuries avoided was projected into the future. These estimates were coupled with values per avoided non-fatal and fatal incident. Minor injuries were monetized at a value of $10,000, major injuries at $500,000, and fatalities (see footnote 9) at $6.8 million (all in 2010 dollars), considering the value of a statistical life. In total, $34.37 million in discounted benefits are anticipated over the 20-year time frame as a result of the forecasted reduction in injuries and fatalities. Child care centres Legislation in seven provinces and one territory (Manitoba, Ontario, Quebec, New Brunswick, Newfoundland and Labrador, Nova Scotia, Prince Edward Island and Yukon) requires that licensed child care operations use cribs that meet federal requirements. Therefore, when the changes introduced into the federal Regulations come into force, in order to meet provincial and territorial legislation, licensed child care operations in these jurisdictions may assume costs, resulting from the provincial and territorial legislation, to replace their inventory of cribs with models that are compliant with the new federal requirements. These costs are dependent upon the enforcement plans of the provincial and territorial governments. Enforcement activities with respect to the replacement of cribs used in child care facilities fall under the jurisdiction of the provincial and territorial governments. When the prohibition on the manufacture, sale, importation or advertisement of traditional drop-side cribs comes into force, the onus will be on the provincial and territorial governments to determine an appropriate period of time for the replacement of cribs with traditional drop sides used in child care facilities in provinces and territories with legislation requiring the use of cribs that are compliant with federal requirements. Health Canada will continue to provide guidance and support to its provincial and territorial counterparts in interpreting federal requirements to help ease any indirect regulatory burden. Industry Some costs may be assumed by product testing laboratories, product manufacturers, and product wholesalers and retailers. Information from these groups provided evidence that while costs may occur, they will be passed through the supply chain and ultimately be borne by Canadian consumers. A survey of product testing laboratories concluded that the incremental costs associated with the Regulations will be relatively small, are not expected to have any impacts on product testing laboratories, and will be passed through to product manufacturers. It is assumed that the maximum typical price increase will be 20% of existing costs (higher than indicated by the test facilities), or an average of $0.10 per crib. The results of a survey of North American product manufacturers indicated that the majority of manufacturers supplied products to Canadian and U.S. markets, and the models supplied to each country tended to be the same. Manufacturers also indicated that the Regulations will not result in significant cost impacts on crib, cradle and bassinet manufacturers and will not result in significant increases in product prices. To assess the net benefits of the Regulations, a maximum average cost increase per product was assumed and modelled. The maximum average cost increases modelled were $1.05 per crib, $0.47 per cradle and $0.63 per bassinet (including the effects of potential test cost increases and product modification cost increases). These increases represent less than 1% of product prices. Note that these increases are much higher than indicated in the survey and are used only in a precautionary assessment of the potential costs of the Regulations. A survey of product wholesalers and retailers indicated that any cost increases associated with the Regulations will be passed through to the consumer. Canadian consumers will therefore be expected to assume the costs of product testing, product redesign and product modification. The companies also indicated that a minimum of six months would be required to sell existing inventories of cribs, cradles and bassinets. Government The annual costs associated with the promotion, monitoring, testing and enforcement of the Regulations incurred by the Government of Canada were estimated at approximately $15,000. The total 20-year costs to the Government to conduct promotional, monitoring, testing and enforcement activities associated with the Regulations were estimated at approximately $1.57 million. These 20-year costs were discounted at a rate of 7%. These are opportunity costs involving the reallocation of existing resources; additional funding will not be requested and additional staff will not be hired. A copy of the complete cost-benefit analysis is available upon request. “One-for-One” Rule The “One-For-One” Rule does not apply to these Regulations, as they do not impose additional administrative costs. Small business lens The small business lens applies to these Regulations. The completed checklist follows the RIAS. During the cost-benefit analysis consultations, both large and small businesses were consulted. In terms of manufacturers, smaller businesses were found to have slightly higher costs for testing cribs than larger companies, since test fees from testing laboratories are applied “per model,” and those costs per product are smaller for models with higher sales. The number of firms (i.e. the number of firms involved in the manufacture and/or importation of cribs, cradles and bassinets) that will be affected by these regulatory changes was estimated at about 30 (see footnote 10) companies, based on the information from the cost-benefit analysis study that was conducted. This estimate was based on available information from the Juvenile Products Manufacturers Association and on contact information provided by Health Canada that was analyzed. Since traditional drop-side cribs have been effectively prohibited in the United States, the concentration of these products on the market has diminished greatly. A number of major industry members have indicated to Health Canada that they are no longer manufacturing, selling, importing or advertising traditional drop-side cribs in Canada. Therefore, the introduction of a Canadian prohibition on the sale, advertisement, import and manufacture of traditional drop-side cribs is projected to have a reduced impact on the costs faced by all businesses, regardless of their size. The majority of the new requirements align with specifications from U.S. legislation and voluntary standards with which the majority of North American cribs are already complying. A number of North American cradle and bassinet industry members indicate compliance, through the Juvenile Products Manufacturers Association certification program, with the voluntary industry standard that the U.S. CPSC has adopted into regulation. This table presents the inital and flexible options. Initial Option Initial Option Flexible Option Flexible Option Short description An immediate coming into force of the Regulations An immediate coming into force of the Regulations A coming-into-force period of six months A coming-into-force period of six months Maximum number of small businesses impacted 30 30 30 30 Annualized Average ($ October 2015) Present Value (see note *) ($ October 2015) Annualized Average ($ October 2015) Present Value (see note **) ($ October 2015) Total compliance costs $255,837 $1,796,923 $237,796 $1,670,184 Average cost per small business $8,525 $59,896 $7,927 $55,670 Note * Using a 10-year time horizon with a 7% discount rate. Note ** Using a 10-year time horizon with a 7% discount rate. The Regulations come into force six months after the day on which they are published in the Canada Gazette, Part II. This responds to stakeholder feedback, provides stakeholders with a flexible implementation option and respect the World Trade Organization Agreement on Technical Barriers to Trade requirement, which allows a reasonable interval between the publication of technical regulations and their entry into force in order to allow time for producers in exporting countries, particularly in developing countries, to adapt their products or methods of production to the requirements of the importing country. This is also consistent with the standard transition period of six months between versions of ASTM International standards. Consultation Consultation prior to the Canada Gazette, Part I, publication On September 29, 2010, Health Canada released a consultation document regarding the proposed changes to the CCBR. The following three options were proposed through the consultation: Maintain the status quo. Amend the Regulations to include several major changes that would align the Canadian requirements more directly with those of the U.S., including a prohibition of the sale, importation, manufacture and advertisement of cribs with sides that are not rigidly attached to the crib ends, while allowing for the uppermost portion of the crib side to fold, pivot or move with respect to the frame. (This option is reflected in the new Cribs, Cradles and Bassinets Regulations.) Prohibit the sale, importation, manufacture and advertisement of all types of movable crib sides in Canada. This consultation involved the publication of a news release by Health Canada, as well as the posting of the consultation document on Health Canada’s Web site. Health Canada also directly mailed the consultation document to a targeted group of approximately 2 000 stakeholders, which included public health organizations, provincial/territorial public health authorities, retailers, manufacturers, importers and product-testing laboratories. Notification of this consultation was also sent to interested parties via email through Health Canada’s Consumer Product Safety distribution list. Interested parties were invited to provide comments on the proposal within 75 days. A total of 25 submissions were received during the comment period. Fourteen of the respondents supported the option to further align Canadian and U.S. safety standards and to allow the uppermost portion of the crib side to move, nine respondents were not in support of the proposal to prohibit the sale, importation, manufacture and advertisement of the traditional style of crib drop-sides (option 3), and two respondents did not give a clear indication of their position with respect to the proposal. Responses were received from ten consumers, seven public health organizations, three retailers, one provincial coroner’s office, two importers, one inventor and one industry group. Six consumers opposed the prohibition of the sale, importation, manufacture and advertisement of traditional crib drop sides because they were concerned about the impact on caregivers who are of smaller stature or have back problems. Two retailers indicated that they did not feel that traditional crib drop sides were unsafe and expressed concerns regarding the impact on Canadian businesses. One importer was concerned that the proposal limiting the movement of crib sides to the uppermost portion would result in pinching and toehold hazards. The majority of public health organizations supported the second proposal, but some expressed concerns regarding the impact upon the second-hand market, daycares and families in the lower socio-economic group. The provincial coroner’s office was in support of the proposal to further align Canadian and U.S. safety standards and to allow the uppermost portion of the crib side to move. However, the coroner’s office stressed the need to ensure that regulatory actions are supported by incident data. The industry was in support of the changes for the most part, but urged Health Canada to consider reasonable implementation periods, such as 6 to 12 months, when implementing any regulations. A general response email was sent to the stakeholders that provided comments. As many of the comments received in response to the consultation mentioned the impact that the proposed changes to the CCBR would have on lower-income families, the second-hand market, daycares and Canadian businesses, it was necessary to commission a cost-benefit analysis to determine if the regulatory changes would have a benefit for Canadians. As previously stated, the cost-benefit analysis determined that the new CCBR would provide a net benefit to Canadians. Consultation with provincial and territorial governments regarding child care facilities In 2011, 2012 and 2014, Health Canada consulted with its provincial and territorial counterparts regarding the proposed changes to the CCBR. Those provincial and territorial government departments responsible for regulating child care facilities were contacted, by telephone and in writing, to inform them of the proposed changes to the CCBR and to solicit their input regarding the impact that these proposed changes may have on provincial and territorial legislation. It is important to note that the proposed changes to the CCBR do not prohibit the “use” of cribs with traditional drop sides, or other products that do not meet the new performance standards or follow the new test methods. The use of drop-side cribs in child care facilities varies greatly across Canada (approximately 90% to 1%). A number of provinces and territories were unable to comment on the level of use of drop-side cribs in their jurisdictions. In provinces with legislation requiring the use of either a crib or a playpen, child care facilities were more likely to make use of playpens (which are not impacted by these changes). Playpens were also predominantly used in provinces and territories with legislation that is not directly linked to the Hazardous Products Act (of which Part I and Schedule I have been repealed and replaced by the CCPSA), the CCPSA or the CCBR. The provinces and territories were unable to comment on what period of time would be afforded to child care facilities required to replace drop-side cribs. Some provinces and territories provide limited funding for the replacement of equipment or to cover administrative costs. In 2014, Health Canada sent a letter to the affected provinces and territories, soliciting feedback regarding the potential impact of the regulatory changes. Responses were received from Prince Edward Island, Ontario, Manitoba, Nova Scotia and Quebec. Prince Edward Island indicated that there may be costs associated with replacing drop-side cribs in daycares. Ontario would determine an appropriate period for the replacement of drop-side cribs, coupled with a knowledge-dissemination strategy regarding the impact of the regulatory changes on daycares. Manitoba stated that the province would need time to notify daycares of the changes and daycares would need time to make the necessary adjustments. Nova Scotia commented that the province did not anticipate that the regulatory changes for cribs would have a negative impact on child care legislation. Quebec indicated that consideration may be given to including a transition period for the replacement of drop-side cribs in the province’s child care legislation in order to reduce the financial impact on child care centres. Some public health organizations that provided responses during the 2010 consultation on the changes to the CCBR expressed concern regarding the financial impact of the proposal on child care facilities. There was also concern that the lack of access of drop-side cribs would make it difficult for many employees of child care facilities, who are usually female and of smaller stature, to access children in regular cribs. Canada Gazette, Part I, consultation On July 25, 2015, the proposed Cribs, Cradles and Bassinets Regulations were published in the Canada Gazette, Part I (CGI). A link to the CGI publication was posted on the Health Canada Web site. Direct emails were sent to stakeholders through the Consumer Product Safety distribution list. Health Canada also directly mailed a letter with a link to the consultation document to a targeted group of approximately 200 stakeholders, which included public health organizations, provincial/territorial public health authorities, retailers, manufacturers, importers and product-testing laboratories. Interested parties were invited to provide comments on the proposal within 75 days. Submissions were received from 17 stakeholders (with 2 providing comments twice). Comments were received from nine manufacturers, two industry associations (one manufacturer association and one retailer association), one testing laboratory, one communications firm, one retailer, one consultant, one distributor and one provincial government. Two stakeholders (one manufacturer and the provincial government) supported the proposed changes to the Regulations. Five stakeholders (four manufacturers and one retailer) expressed neutral positions. Five of the stakeholders (the communications firm, the distributor, the test laboratory, one industry association and one manufacturer) did not state a position with respect to the regulatory changes, but rather posed questions on the text. Five stakeholders (the consultant, one industry association and three manufacturers) did not support various aspects of the proposed changes. The comments and non-supportive responses fell under the following themes: Mattress flatness angle Comments were received from six stakeholders concerning the proposed maximum flatness angle requirement, two of which did not support the proposed changes. Questions were raised as to how the requirement would be applied and the rationale behind the misalignment between the Canadian proposal and the U.S. requirements. Further information regarding Health Canada’s rationale for the requirement was provided to stakeholders who commented on the proposal and incorporated into this document under the section entitled “Rest angle and flatness performance requirements.” The two that did not support this change wanted this requirement to align with the 10 degree requirement in the U.S. Health Canada maintains that any angle over 7 degrees is not protective of sleeping infants. Transition period Three stakeholders requested an extension of the coming-into-force period from six to twelve months. Consideration was given to this request, but it was ultimately decided that six months was an adequate transition period. Industry responses to the cost-benefit analysis survey indicated that six months was a reasonable coming-into-force period. A six month transition period is also consistent with World Trade Organization agreements and the transition time following the revision of an ASTM standard. Co-sleeping products Four comments related to co-sleeping products, such as bedside sleepers and in-bed co-sleepers. Stakeholders did not feel that these products were adequately addressed by the Regulations. The Regulations include requirements for all products with the primary function of providing sleeping accommodation for a child, with sides to confine the occupant. As a result, bedside sleepers and in-bed co-sleepers are already covered by the Regulations. Further information regarding the classification of products, including bedside sleepers and in-bed co-sleepers, can be found in the Industry Guide (http://www.hc-sc. gc.ca/cps-spc/pubs/indust/cribs-cradles-bassinets-lits-berceaux-moises/index-eng.php#a4-4d). Health Canada is of the position that all products intended to provide unsupervised sleeping accommodation for infants and young children should afford the same minimum level of safety as required by the Regulations. Health Canada has a well-established position of recommending against the use of bedside sleepers with their side lowered (http://www.hc-sc.gc.ca/cps-spc/pubs/cons/child-enfant/sleep-coucher-eng.php#a42). Additionally, Health Canada has recommended against bed sharing (http://www.hc- sc.gc.ca/cps-spc/pubs/cons/child-enfant/sleep-coucher-eng.php#a41). Instead, Health Canada and the Public Health Agency of Canada recommend room sharing for the first six months of a baby’s life (http://www.hc- sc.gc.ca/cps-spc/pubs/cons/child-enfant/sleep-coucher-eng.php#a31). Required information Two stakeholders commented that due to the small size of some products, it would be difficult to display all of the required instructions on the product. It is important to note, however, that the inclusion of assembly instructions on the bassinet is not a new requirement as it was a requirement under the Regulations. Section 52 provides an allowance for the required assembly instructions to be contained in or on a pouch that is permanently affixed to the bassinet provided that the relevant required warnings are also included. Therefore, Health Canada has already provided industry with an alternative to having the assembly instructions displayed on the product. Bassinet Stability Test Three stakeholders posed questions regarding aspects of the bassinet stability test. The level of alignment of the test method with the bassinets stability test found in the ASTM standard was questioned. It was also commented that the inclusion of diagrams might avoid confusion as to how the test is to be performed. The stability test in the ASTM bassinet standard instructs the analyst to conduct the testing on the product’s side. It does not specifically indicate which of the product’s four sides is to be tested. Therefore, it assumed that all four sides would have to pass the testing to fulfil the performance requirement. Health Canada’s new requirement is worded in such a way to reflect this. Diagrams can only depict certain product designs. Health Canada has taken the approach of describing the testing within the Regulations in order to address various product designs. Entanglement Two stakeholders posed questions regarding the entanglement requirement. This requirement was already included in the Regulations. In the Regulations, Health Canada has included the testing device used to assess entanglement into the text of the Regulations. This test device was previously only mentioned in the test method (M12.1, Test Method of Cribs) associated with the Regulations. This change was in response to stakeholder confusion as to how this hazard was assessed. Regulatory cooperation The Regulations further align Canadian requirements with those of the U.S. and provide additional clarity for industry. Health Canada has actively collaborated with the U.S. CPSC through its participation on ASTM crib, cradle and bassinet standard subcommittees and in discussions with U.S. CPSC staff. All of the major changes further align the Canadian Regulations with the requirements recently adopted for cribs, cradles and bassinets in the United States. Over the past few years, Health Canada and the U.S. CPSC have worked closely together to develop and accept a common set of test requirements for particular hazards. Minor differences between Canadian and U.S. requirements remain; however, they are not anticipated to have a significant impact on movement or trade of products between the two countries. These differences exist where Canadian requirements are more stringent and protective, where evidence has suggested the potential for increased safety benefits, or where differences were necessitated as a result of Canadian drafting conventions. Although these Regulations are not a commitment under the Joint Action Plan for the Canada–United States Regulatory Cooperation Council, it reflects the objectives of the Council by further aligning regulatory requirements between the United States and Canada, and helping to reduce regulatory barriers to cross-border trade. Rationale In the recent past, Health Canada has worked in collaboration with a number of companies for them to voluntarily recall various models of drop-side cribs when reported incidents have underlined potential health and safety hazards related to the use of these products. The Regulations further Health Canada’s objective of addressing emerging hazards in order to help protect the health and safety of young children using cribs, cradles and bassinets. Greater alignment of Canadian requirements, such as those for traditional drop-side cribs, crib impacting, crib slat strength and accessories to cribs, cradles and bassinets, with internationally recognized standards should ease the regulatory burden on industry. U.S. companies that are selling their products in Canada should benefit from the increased alignment between Canadian and U.S. requirements. Over the past few years, Health Canada has been actively participating in discussions with Canadian and U.S. manufacturers, safety advocates and government officials regarding the overall safety of cribs. Health Canada has identified the need for regulatory changes relating to traditional drop-side cribs in order to further safeguard the health of infants and young children. Additionally, the cost-benefit analysis demonstrates that there is a strong economic basis for adopting the Regulations. The costs of the regulatory proposal have a present value of $12.79 million over 20 years and discounted at a rate of 7%. The benefits have a present value of $34.37 million over 20 years and discounted at a rate of 7%. Therefore, the regulatory proposal would deliver net benefits to Canadians in excess of $21.58 million. There are positive qualitative benefits for consumers and industry, and indirect negative qualitative impacts for some provincial and territorial child care centres. Strategic environmental assessment These Regulations underwent a preliminary scan in accordance with the strategic environmental assessment (SEA) policy and a SEA form was completed. The SEA concluded that these Regulations are not expected to have any environmental impacts. Implementation, enforcement and service standards These Regulations will not result in any major changes to Health Canada’s enforcement activities. Compliance and enforcement will be facilitated by more clearly worded requirements laid out by the Regulations, as well as greater alignment between Canadian and U.S. requirements. Compliance and enforcement of the Regulations will follow established departmental approaches and procedures, including sampling and testing of products, inspection at retail and follow-up on complaints made by the Canadian public, public health organizations and trade. Non-compliant products will be subject to the actions available to Health Canada inspectors and other officials and will depend on the seriousness of the circumstances. These actions may include obtaining a voluntary commitment to product correction by industry, negotiation with industry for the voluntary removal of non-compliant products from the market, seizure, orders for recall or other measures, administrative monetary penalties and prosecution under the CCPSA. Health Canada will also seek to maximize compliance with the Regulations through ongoing industry and retailer education, and maximize crib, cradle and bassinet safety through consumer education. Contact Mr. Paul Chowhan Consumer Product Safety Directorate Healthy Environments and Consumer Safety Branch Health Canada Address Locator: 4908B 269 Laurier Avenue West Ottawa, Ontario K1A 0K9 Fax: 613-952-2551 Email: [email protected] Small Business Lens Checklist 1. Name of the sponsoring regulatory organization: Health Canada 2. Title of the regulatory proposal: Cribs, Cradles and Bassinets Regulations 3. Is the checklist submitted with a RIAS for the Canada Gazette, Part I or Part II? ☐ Canada Gazette, Part I ☑ Canada Gazette, Part II A. Small business regulatory design This table presents the Small business regulatory design. I Communication and transparency Yes No N/A 1. Are the proposed Regulations or requirements easily understandable in everyday language? ☑ ☐ ☐ These Regulations have been rewritten and reorganized to clarify requirements and language for industry, and to better reflect the wording of the requirements currently set out in the United States, with which many industry members are already familiar. These Regulations have been rewritten and reorganized to clarify requirements and language for industry, and to better reflect the wording of the requirements currently set out in the United States, with which many industry members are already familiar. These Regulations have been rewritten and reorganized to clarify requirements and language for industry, and to better reflect the wording of the requirements currently set out in the United States, with which many industry members are already familiar. These Regulations have been rewritten and reorganized to clarify requirements and language for industry, and to better reflect the wording of the requirements currently set out in the United States, with which many industry members are already familiar. These Regulations have been rewritten and reorganized to clarify requirements and language for industry, and to better reflect the wording of the requirements currently set out in the United States, with which many industry members are already familiar. 2. Is there a clear connection between the requirements and the purpose (or intent) of the proposed Regulations? ☑ ☐ ☐ The requirements directly address health and safety concerns with cribs, cradles and bassinets identified by Health Canada and the United States via reports of incidents and injuries. The requirements directly address health and safety concerns with cribs, cradles and bassinets identified by Health Canada and the United States via reports of incidents and injuries. The requirements directly address health and safety concerns with cribs, cradles and bassinets identified by Health Canada and the United States via reports of incidents and injuries. The requirements directly address health and safety concerns with cribs, cradles and bassinets identified by Health Canada and the United States via reports of incidents and injuries. The requirements directly address health and safety concerns with cribs, cradles and bassinets identified by Health Canada and the United States via reports of incidents and injuries. 3. Will there be an implementation plan that includes communications and compliance promotion activities, that informs small business of a regulatory change and guides them on how to comply with it (e.g. information sessions, sample assessments, toolkits, Web sites)? ☑ ☐ ☐ Health Canada is committed to working with small businesses to aid them in understanding and complying with the new requirements. Additional supporting information and industry guidance will be made available on Health Canada’s Web site, and regional product safety inspectors are available to assist businesses with any regulatory and compliance questions. Health Canada is committed to working with small businesses to aid them in understanding and complying with the new requirements. Additional supporting information and industry guidance will be made available on Health Canada’s Web site, and regional product safety inspectors are available to assist businesses with any regulatory and compliance questions. Health Canada is committed to working with small businesses to aid them in understanding and complying with the new requirements. Additional supporting information and industry guidance will be made available on Health Canada’s Web site, and regional product safety inspectors are available to assist businesses with any regulatory and compliance questions. Health Canada is committed to working with small businesses to aid them in understanding and complying with the new requirements. Additional supporting information and industry guidance will be made available on Health Canada’s Web site, and regional product safety inspectors are available to assist businesses with any regulatory and compliance questions. Health Canada is committed to working with small businesses to aid them in understanding and complying with the new requirements. Additional supporting information and industry guidance will be made available on Health Canada’s Web site, and regional product safety inspectors are available to assist businesses with any regulatory and compliance questions. 4. If new forms, reports or processes are introduced, are they consistent in appearance and format with other relevant government forms, reports or processes? ☐ ☐ ☑ No new forms, reports or processes are being introduced. No new forms, reports or processes are being introduced. No new forms, reports or processes are being introduced. No new forms, reports or processes are being introduced. No new forms, reports or processes are being introduced. II Simplification and streamlining Yes No N/A 1. Will streamlined processes be put in place (e.g. through BizPaL, Canada Border Services Agency single window) to collect information from small businesses where possible? ☐ ☐ ☑ Currently, relevant information is collected from industry on a case-by-case basis to verify compliance. No changes are occurring to the type of information that would be collected. Currently, relevant information is collected from industry on a case-by-case basis to verify compliance. No changes are occurring to the type of information that would be collected. Currently, relevant information is collected from industry on a case-by-case basis to verify compliance. No changes are occurring to the type of information that would be collected. Currently, relevant information is collected from industry on a case-by-case basis to verify compliance. No changes are occurring to the type of information that would be collected. Currently, relevant information is collected from industry on a case-by-case basis to verify compliance. No changes are occurring to the type of information that would be collected. 2. Have opportunities to align with other obligations imposed on business by federal, provincial, municipal or international or multinational regulatory bodies been assessed? ☐ ☐ ☑ No ongoing obligations are affected by these Regulations. No ongoing obligations are affected by these Regulations. No ongoing obligations are affected by these Regulations. No ongoing obligations are affected by these Regulations. No ongoing obligations are affected by these Regulations. 3. Has the impact of the proposed Regulations on international or interprovincial trade been assessed? ☑ ☐ ☐ The Regulations are not expected to have any impact on international or interprovincial trade, as they are moving towards improved alignment with our major trading partner, the United States. The Regulations are not expected to have any impact on international or interprovincial trade, as they are moving towards improved alignment with our major trading partner, the United States. The Regulations are not expected to have any impact on international or interprovincial trade, as they are moving towards improved alignment with our major trading partner, the United States. The Regulations are not expected to have any impact on international or interprovincial trade, as they are moving towards improved alignment with our major trading partner, the United States. The Regulations are not expected to have any impact on international or interprovincial trade, as they are moving towards improved alignment with our major trading partner, the United States. 4. If the data or information, other than personal information, required to comply with the proposed Regulations is already collected by another department or jurisdiction, will this information be obtained from that department or jurisdiction instead of requesting the same information from small businesses or other stakeholders? (The collection, retention, use, disclosure and disposal of personal information are all subject to the requirements of the Privacy Act. Any questions with respect to compliance with the Privacy Act should be referred to the department’s or agency’s ATIP office or legal services unit.) ☐ ☐ ☑ Any data that is required to be collected by these Regulations to verify compliance is not collected by any other department. Any data that is required to be collected by these Regulations to verify compliance is not collected by any other department. Any data that is required to be collected by these Regulations to verify compliance is not collected by any other department. Any data that is required to be collected by these Regulations to verify compliance is not collected by any other department. Any data that is required to be collected by these Regulations to verify compliance is not collected by any other department. 5. Will forms be pre-populated with information or data already available to the department to reduce the time and cost necessary to complete them? (Example: When a business completes an online application for a licence, upon entering an identifier or a name, the system pre-populates the application with the applicant’s personal particulars such as contact information, date, etc. when that information is already available to the department.) ☐ ☐ ☑ No forms are required for these Regulations. Health Canada provides flexibility to industry on how the information to verify compliance is completed. No forms are required for these Regulations. Health Canada provides flexibility to industry on how the information to verify compliance is completed. No forms are required for these Regulations. Health Canada provides flexibility to industry on how the information to verify compliance is completed. No forms are required for these Regulations. Health Canada provides flexibility to industry on how the information to verify compliance is completed. No forms are required for these Regulations. Health Canada provides flexibility to industry on how the information to verify compliance is completed. 6. Will electronic reporting and data collection be used, including electronic validation and confirmation of receipt of reports where appropriate? ☐ ☐ ☑ These Regulations do not include any reporting requirements. These Regulations do not include any reporting requirements. These Regulations do not include any reporting requirements. These Regulations do not include any reporting requirements. These Regulations do not include any reporting requirements. 7. Will reporting, if required by the proposed Regulations, be aligned with generally used business processes or international standards if possible? ☐ ☐ ☑ No reporting is required by these Regulations. No reporting is required by these Regulations. No reporting is required by these Regulations. No reporting is required by these Regulations. No reporting is required by these Regulations. 8. If additional forms are required, can they be streamlined with existing forms that must be completed for other government information requirements? ☐ ☐ ☑ No forms are required by these Regulations. No forms are required by these Regulations. No forms are required by these Regulations. No forms are required by these Regulations. No forms are required by these Regulations. III Implementation, compliance and service standards Yes No N/A 1. Has consideration been given to small businesses in remote areas, with special consideration to those that do not have access to high-speed (broadband) Internet? ☑ ☐ ☐ Health Canada regional product safety inspectors are available to small business in remote areas. The Consumer Product Safety Program has 12 regional offices across the country. There is a toll-free phone number that connects the caller to the closest regional office, along with a general email address. Health Canada regional product safety inspectors are available to small business in remote areas. The Consumer Product Safety Program has 12 regional offices across the country. There is a toll-free phone number that connects the caller to the closest regional office, along with a general email address. Health Canada regional product safety inspectors are available to small business in remote areas. The Consumer Product Safety Program has 12 regional offices across the country. There is a toll-free phone number that connects the caller to the closest regional office, along with a general email address. Health Canada regional product safety inspectors are available to small business in remote areas. The Consumer Product Safety Program has 12 regional offices across the country. There is a toll-free phone number that connects the caller to the closest regional office, along with a general email address. Health Canada regional product safety inspectors are available to small business in remote areas. The Consumer Product Safety Program has 12 regional offices across the country. There is a toll-free phone number that connects the caller to the closest regional office, along with a general email address. 2. If regulatory authorizations (e.g. licences, permits or certifications) are introduced, will service standards addressing timeliness of decision making be developed that are inclusive of complaints about poor service? ☐ ☐ ☑ No regulatory authorizations are introduced with these Regulations. No regulatory authorizations are introduced with these Regulations. No regulatory authorizations are introduced with these Regulations. No regulatory authorizations are introduced with these Regulations. No regulatory authorizations are introduced with these Regulations. 3. Is there a clearly identified contact point or help desk for small businesses and other stakeholders? ☑ ☐ ☐ Health Canada’s regional product safety inspectors are available to small businesses in any province. There is a toll-free telephone number that connects the caller to the closest regional office, along with a general email address. Health Canada’s regional product safety inspectors are available to small businesses in any province. There is a toll-free telephone number that connects the caller to the closest regional office, along with a general email address. Health Canada’s regional product safety inspectors are available to small businesses in any province. There is a toll-free telephone number that connects the caller to the closest regional office, along with a general email address. Health Canada’s regional product safety inspectors are available to small businesses in any province. There is a toll-free telephone number that connects the caller to the closest regional office, along with a general email address. Health Canada’s regional product safety inspectors are available to small businesses in any province. There is a toll-free telephone number that connects the caller to the closest regional office, along with a general email address. B. Regulatory flexibility analysis and reverse onus This table presents the Regulatory flexibility analysis and reverse onus. IV Regulatory flexibility analysis Yes No N/A 1. Does the RIAS identify at least one flexible option that has lower compliance or administrative costs for small businesses in the small business lens section? Examples of flexible options to minimize costs are as follows: longer time periods to comply with the requirements, longer transition periods or temporary exemptions; performance-based standards; partial or complete exemptions from compliance, especially for firms that have good track records (legal advice should be sought when considering such an option); reduced compliance costs; reduced fees or other charges or penalties; use of market incentives; a range of options to comply with requirements, including lower-cost options; simplified and less frequent reporting obligations and inspections; and licences granted on a permanent basis or renewed less frequently. ☑ ☐ ☐ A six-month coming-into-force period is established in these Regulations. This provides stakeholders with greater flexibility prior to implementation. A six-month coming-into-force period is established in these Regulations. This provides stakeholders with greater flexibility prior to implementation. A six-month coming-into-force period is established in these Regulations. This provides stakeholders with greater flexibility prior to implementation. A six-month coming-into-force period is established in these Regulations. This provides stakeholders with greater flexibility prior to implementation. A six-month coming-into-force period is established in these Regulations. This provides stakeholders with greater flexibility prior to implementation. 2. Does the RIAS include, as part of the Regulatory Flexibility Analysis Statement, quantified and monetized compliance and administrative costs for small businesses associated with the initial option assessed, as well as the flexible, lower-cost option? ☐ ☐ ☑ No flexible option has been provided, as no options were found to reduce costs for small businesses. No flexible option has been provided, as no options were found to reduce costs for small businesses. No flexible option has been provided, as no options were found to reduce costs for small businesses. No flexible option has been provided, as no options were found to reduce costs for small businesses. No flexible option has been provided, as no options were found to reduce costs for small businesses. 3. Does the RIAS include, as part of the Regulatory Flexibility Analysis Statement, a consideration of the risks associated with the flexible option? (Minimizing administrative or compliance costs for small business cannot be at the expense of greater health, security or safety or create environmental risks for Canadians.) ☑ ☐ ☐ Risks are minimal, as the majority of cribs, cradles and bassinets manufactured currently are expected to meet the requirements, as they have been in place in the United States since 2012. Therefore, the introduction of a similar Canadian prohibition on the sale, advertisement, import and manufacture of traditional drop-side cribs is projected to have a relatively smaller impact on the costs faced by all businesses, regardless of their size. Risks are minimal, as the majority of cribs, cradles and bassinets manufactured currently are expected to meet the requirements, as they have been in place in the United States since 2012. Therefore, the introduction of a similar Canadian prohibition on the sale, advertisement, import and manufacture of traditional drop-side cribs is projected to have a relatively smaller impact on the costs faced by all businesses, regardless of their size. Risks are minimal, as the majority of cribs, cradles and bassinets manufactured currently are expected to meet the requirements, as they have been in place in the United States since 2012. Therefore, the introduction of a similar Canadian prohibition on the sale, advertisement, import and manufacture of traditional drop-side cribs is projected to have a relatively smaller impact on the costs faced by all businesses, regardless of their size. Risks are minimal, as the majority of cribs, cradles and bassinets manufactured currently are expected to meet the requirements, as they have been in place in the United States since 2012. Therefore, the introduction of a similar Canadian prohibition on the sale, advertisement, import and manufacture of traditional drop-side cribs is projected to have a relatively smaller impact on the costs faced by all businesses, regardless of their size. Risks are minimal, as the majority of cribs, cradles and bassinets manufactured currently are expected to meet the requirements, as they have been in place in the United States since 2012. Therefore, the introduction of a similar Canadian prohibition on the sale, advertisement, import and manufacture of traditional drop-side cribs is projected to have a relatively smaller impact on the costs faced by all businesses, regardless of their size. 4. Does the RIAS include a summary of feedback provided by small business during consultations? ☑ ☐ ☐ Small businesses were consulted by Health Canada, and their input was taken into consideration. Small businesses were consulted by Health Canada, and their input was taken into consideration. Small businesses were consulted by Health Canada, and their input was taken into consideration. Small businesses were consulted by Health Canada, and their input was taken into consideration. Small businesses were consulted by Health Canada, and their input was taken into consideration. V Reverse onus Yes No N/A 1. If the recommended option is not the lower-cost option for small business in terms of administrative or compliance costs, is a reasonable justification provided in the RIAS? ☐ ☐ ☑ A six-month coming-into-force period will provide industry with time to redesign, test and supply new product models. A six-month coming-into-force period will provide industry with time to redesign, test and supply new product models. A six-month coming-into-force period will provide industry with time to redesign, test and supply new product models. A six-month coming-into-force period will provide industry with time to redesign, test and supply new product models. A six-month coming-into-force period will provide industry with time to redesign, test and supply new product models. Footnote a S.C. 2010, c. 21 Footnote 1 SOR/2010-261 Footnote 2 http://www.cpsc.gov/en/Regulations-Laws--Standards/Federal- Register-Notices/2013/Safety-Standard-for-Bassinets-and-Cradles/#h-11 Footnote 3 The present value of a dollar amount to be realized in the future may be expressed as of an earlier date (the present) by discounting it backward through time using a discount (interest) rate. For this study, a real discount rate of 7% was used as recommended by the Treasury Board Canadian Cost-Benefit Analysis Guide: Regulatory Proposals. Footnote 4 The net present value is equal to the present value of benefits minus the present value of costs. Footnote 5 Annualized NPV = [NPV * p] / [1-(1+p) ^-n], where p = discount rate (7%) and n = number of periods (20). This formula converts net benefits to constant annual values (i.e. it spreads net benefits smoothly through time). This approach allows for the comparison of net benefits that occur in different policy impact time periods on a consistent basis. Refer to the Canadian Cost-Benefit Analysis Guide: Regulatory Proposals. Footnote 6 The new requirements related to restraints, cords and loops, stands, the stability of cradles and bassinets and corner posts were not included in the consultation or the cost-benefit analysis. These requirements were added to address emerging issues and to further align with U.S. requirements. These changes are not expected to have a significant impact on the overall costs and benefits as they either affect a very small segment of the market or are aligning with requirements to which a large part of the industry is already complying. Footnote 7 Only the avoided injuries associated with the following new requirements could be quantified: prohibition of the sale, import, manufacture and advertisement of traditional drop-side cribs; structural integrity test method for mattress support vertical impacting of cribs and cradles; crib slat strength performance requirement and test method; performance requirement for correct assembly of key structural crib components; bassinet rest angle and flatness angle performance requirements and completely bounded openings performance requirement and test method. Footnote 8 Only the avoided fatalities associated with the following new requirements could be quantified: prohibition of the sale, import, manufacture and advertisement of traditional drop-side cribs; structural integrity test method for mattress support vertical impacting of cribs and cradles; crib slat strength performance requirement and test method; performance requirement for correct assembly of key structural crib components; bassinet rest angle and flatness angle performance requirements and completely bounded openings performance requirement and test method. Footnote 9 Cheminfo Services Inc., Cost-Benefit Analysis Regarding Proposed Regulatory Amendments for Cribs, Cradles and Bassinets, February 14, 2011, pages 73–74. Footnote 10 Cheminfo Services Inc., Cost-Benefit Analysis Regarding Proposed Regulatory Amendments for Cribs, Cradles and Bassinets, February 14, 2011, pages 35–36.

This Bill does not amend any statutes.

Sign up for alerts on this Bill

Receive emails tracking this Bill's progress.

See all your alerts in a dashboard.

Set an alert with one click and you're done!