ARCHIVED — Vol. 146, No. 45 — November 10, 2012
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Regulations Amending Schedule 2 to the Canada Consumer Product Safety Act (TCEP)
Canada Consumer Product Safety Act
Department of Health
(This statement is not part of the Regulations.)
Issues: Children’s polyurethane foam (PUF) products that contain tris (2-chloroethyl) phosphate (TCEP) [Chemical Abstracts Service No. 115-96-8] have the potential to cause harmful effects in children under three years of age. Migration of TCEP from PUF products as a result of young children’s mouthing behaviour may contribute to oral exposure to this substance. TCEP is considered a carcinogen for which there may be a probability of harm at any level of exposure and it may cause impaired fertility in males. Children are more susceptible to the harmful effects as a result of their physiological status. For this reason, the Government of Canada is taking proactive measures to protect the health and safety of children under three years of age.
On August 22, 2009, a notice containing a summary of the final Government of Canada Screening Assessment Report for TCEP and the Proposed Risk Management Approach were published in the Canada Gazette, Part Ⅰ. The screening assessment concluded that TCEP may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health. The Proposed Risk Management Approach outlined actions as part of a Government of Canada-wide initiative to control this substance which included a proposal to prohibit the use of TCEP in certain household products and materials.
Description: A prohibition of products made, in whole or in part, of PUF that contains TCEP and intended for children under three years of age is proposed under Schedule 2 to the Canada Consumer Product Safety Act (CCPSA). The prohibition would include both products that a child uses, such as toys, and products that an adult uses to care for a child, such as sleep positioners and nursing pillows. As TCEP has been identified in children’s products that have been imported into Canada, the proposed prohibition would be the most effective measure for ensuring that these products are no longer manufactured, advertised, sold or imported in Canada. The CCPSA provides the authority to enact such a prohibition.
Cost-benefit statement: The benefits of the proposal, a reduction in potential adverse health effects in young children due to exposure to TCEP, outweigh the costs of implementation. Industry has already moved away from the use of TCEP as a flame retardant in PUF and has replaced it with alternatives; therefore, the impact of the prohibition on industry is expected to be limited. Economic burden on consumers is also expected to be limited as the majority of children’s PUF products currently on the market are not treated with TCEP.
Business and consumer impacts: It is expected that the proposed prohibition will have a minor overall impact on industry, while consumers will have the benefit of purchasing and using safer children’s products made with PUF at little or no additional cost, and that present less risk to children under three years of age.
Domestic and international coordination and cooperation: The prohibition is not anticipated to pose any adverse trade impacts. Other jurisdictions, including the United States and the European Union, are considering or have taken similar action.
Under the Government of Canada’s Chemicals Management Plan, which was announced in December 2006, TCEP was identified as a high priority substance for assessment because it was considered to pose an intermediate potential for exposure to individuals in Canada and to be a substance that causes concern for humans owing to possible carcinogenic effects. The European Chemicals Bureau has classified TCEP as a Category 3 carcinogen, which is a substance that causes concern for humans owing to possible carcinogenic effects, and as a Category 2 reproductive toxicant, as it may impair fertility.
On August 22, 2009, a notice containing a summary of the final Government of Canada Screening Assessment Report for TCEP and the Proposed Risk Management Approach were publish in the Canada Gazette, Part Ⅰ (www.gazette.gc.ca/rp-pr/p1/2009/ 2009-08-22/pdf/g1-14334.pdf). The Screening Assessment Report concluded that TCEP may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health. This conclusion was based on the carcinogenicity of TCEP for which there may be a probability of harm at any level of exposure and the potential to cause impaired fertility in males. The Proposed Risk Management Approach at that time indicated the intention of the Government of Canada to prohibit the use of TCEP in PUF in furniture, electronic products (e.g. televisions and computers), adhesives, non-apparel textiles, upholstery, the back-coating of carpets, rubber and plastics, and paints and varnishes, and to determine the final extent of the prohibition based upon consultation and discussion with stakeholders.
On March 2, 2011, the Order adding TCEP to Schedule I to the Canadian Environmental Protection Act, 1999 (CEPA 1999) was published in the Canada Gazette, Part Ⅱ (www.gazette.gc.ca/rp-pr/p2/2011/2011-03-02/pdf/g2-14505.pdf).
The substance TCEP is an industrial chemical with flame retardant properties. It is commonly used as a plasticizer and viscosity regulator with flame retardant properties in polyurethanes, polyester resins, polyacrylates and other polymers. The general population of Canada is potentially exposed to TCEP from consumer products that contain PUF, such as furniture or mattresses and from electronic equipment. Emissions from upholstered furniture and from television sets may contribute to TCEP levels in indoor air. However, some of these products may also be sources of oral or dermal exposures to TCEP. Estimates of exposure to TCEP from children mouthing foam cushioning were derived in the Screening Assessment Report. The highest consumer product exposure estimates were for infants aged 0–6 months old mouthing PUF cushioning containing TCEP.
The major health impacts from exposure to TCEP are the potential for carcinogenicity and impaired fertility. The Government of Canada Screening Assessment Report indicated that carcinogenic effects included kidney tumours in rats and mice; thyroid tumours in rats; and liver, forestomach and Harderian gland tumours and leukemia in mice. Mixed results were obtained in the limited in vivo and in vitro genotoxicity assays in mammalian cells. However, based on the range of tumours observed in multiple species of experimental animals for which the modes of induction have not been made clear, it cannot be discounted that TCEP may induce tumours via a mode of action involving direct interaction with genetic material. TCEP is, therefore, considered a carcinogen for which there is a probability of harm at any level of exposure.
No significant increase in tumours was observed in carcinogenicity studies in mice dermally administered TCEP. Long-term inhalation studies using TCEP were not identified.
Reproductive toxicity has also been observed in several oral studies in rats and mice. In 2005, the European Union classification and labelling working group for human health classified TCEP as a reproductive toxicant Category 2, indicating that it may impair fertility. This conclusion was based on the reproductive toxicity studies in mice, including crossover mating trials and evaluation of reproductive organs and sperm parameters in sub-chronic studies.
In an oral reproductive study in mice using the continuous breeding protocol, decreased numbers of live pups per litter and decreased numbers of litters per pair were observed when they were administered a daily dose of TCEP. This study included crossover mating trials; the results showed adverse effects on sperm in males (decreased sperm counts and motility, increased number of abnormal sperm). In 18-week studies on rats and mice, testicular toxicity was observed in both species (decreased relative testes weight and increased number of abnormal sperm in mice; decreased sperm motility in rats).
Health Canada considers children under three years of age to be at the greatest risk of adverse health effects from exposure to TCEP. It is well understood that frequent mouthing and sucking activity among infants and young children under three years of age is a common and necessary part of their behaviour and development. It is also known that TCEP can migrate out of foam toys and foam children’s products in response to sucking or chewing. Therefore, young children rather than older children are considered to be at a greater risk of oral exposure to TCEP. Additionally, due to their low body weight and rapid rate of physical growth and development, young children are also considered to be more vulnerable to the possible adverse health effects of the substance.
The objective of this regulatory proposal is to enhance the safety of infants and toddlers from the possible harmful effects that may be caused by unnecessary exposure to TCEP in the target consumer products. This would be accomplished by amending Schedule 2 to the CCPSA, thus prohibiting the manufacture, import, advertising or sale of consumer products intended for children under three years of age that are made, in whole or in part, of PUF that contains TCEP. This prohibition could include consumer products such as toys, sleep positioners, and nursing pillows made of PUF that contains TCEP. There are currently no express requirements under the CCPSA for consumer products that contain TCEP.
At the time of the publication of the Screening Assessment Report and the Proposed Risk Management Approach, it was unknown whether TCEP was used in PUF products intended for children under three years of age in Canada; therefore, risk management measures under federal consumer product safety legislation aimed at these products were not considered at that time. However, subsequent to results obtained from Health Canada Product Safety Laboratory (PSL) testing, the risk management approach for TCEP was expanded to include actions under the CCPSA.
The Government of Canada’s Screening Assessment Report indicates that the Danish Environmental Protection Agency of the Danish Ministry of the Environment had published four studies containing information on concentrations of TCEP in consumer products, including foam children’s products. TCEP was measured in one of the studies on toys and children’s products. Four out of the five products sampled did not contain TCEP at levels above the detection limit (not specified). It was detected in a soft cube toy for children made of textile, plastic and foam rubber at levels ranging from 4 900 to 6 500 mg/kg.
To gain a better understanding on the use of TCEP in consumer products on the Canadian market, Health Canada’s PSL conducted two rounds of sampling and testing for TCEP in a variety of consumer products made of PUF. During the first round of testing in 2009, 14 sofas, 4 mattresses, 10 children’s products including toys, 4 acoustical panels and the seat from a car were tested to determine the presence of TCEP. The results of this testing confirmed the presence of TCEP in 4 of the sofas, the seat from the car and 2 children’s products. The 2 children’s products were a PUF book and a sleep positioner and they contained 13 000 mg/kg and 21 000 mg/kg of TCEP, respectively. Further sampling and testing was conducted in 2010 with the focus on a broader range of children’s products containing PUF, including toys. Of the 30 children’s products tested, a sleep positioner and a book contained TCEP at 34 mg/kg and 3 800 mg/kg, respectively. TCEP was detected in 3 other products (a sleep positioner, coloured blocks and a sun visor); however, in amounts lower than was possible to accurately quantify.
Since Health Canada’s PSL testing, a study was published in Environmental Science and Technology (http://pubs.acs.org/ doi/full/10.1021/es2007462) in May 2011 in which TCEP was identified in 17 out of 101 PUF children’s products tested. The products identified as containing TCEP included sleep positioners, nursing pillows, portable mattresses and baby carriers. The concentration range of TCEP was 1 080–5 940 mg/kg with a mean concentration of 5 910 mg/kg.
In addition to the prohibition under the CCPSA, another Government of Canada measure being considered is the application of the Significant New Activity provisions under the Canadian Environmental Protection Act, 1999. The provisions would require the notification to the Government of Canada of any new activity involving, in any one calendar year, more than 100 kg of the substance TCEP. The Notice of intent to amend the Domestic Substances List to apply the provisions of CEPA 1999, and to start a 60-day public comment period, was published in the Canada Gazette, Part Ⅰ, on July 30, 2011.
Other jurisdictions have begun to look at risk management measures with respect to TCEP in children’s products. In June 2011, the State of New York proposed a bill in which the sale of child care products containing TCEP intended for use by a child three years of age or younger would be prohibited in that state. The prohibition will apply to consumer products intended for use by children under three years of age such as baby products, toys, car seats, nursing pillows, crib mattresses, and strollers. The bill is expected to come into force on December 1, 2013. Products will be prohibited if they contain more than one-tenth of one per centum of TCEP.
Additionally, in the European Union, the Toy Safety Directive currently limits the presence of TCEP in toys to ≤0.5% by weight. In December 2010, the Enterprise Directorate General of the European Commission requested an opinion of its Scientific Committee on Health and Environmental Risks (SCHER) on the expected risks of TCEP when it is used in toys or part of the toys intended for use by children younger than 36 months of age or in other toys intended to be placed in the mouth in concentration limits below those set out under the classification and labelling legislation and on whether lower concentration limits should be set for TCEP. On March 22, 2012, the SCHER concluded that exposure to TCEP from toys cannot be considered safe, and the use of TCEP should be avoided in all toys, not just those for children under 36 months of age. The opinion is available on the European Commission’s Public Health Web site (http://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_0_158.pdf).
Health Canada has carefully reviewed the SCHER opinion. Having considered all the scientific evidence, Canada’s proposed regulatory action targets a specific age group identified as being at the greatest risk from exposure to TCEP. This regulatory proposal takes into consideration the voluntary reductions in TCEP use undertaken by industry and complements other instruments available to the Government to identify and control risks, such as the Significant New Activity provisions under CEPA 1999.
Regulatory and non-regulatory options considered
The continued manufacture, advertisement, sale and importation of products intended for children under three years of age that are made, in whole or in part, of PUF that contains TCEP is not considered a viable option.
In Canada, there are a large number of companies that either manufacture PUF or that manufacture products with PUF as a component. However, current information indicates that these companies no longer use TCEP in their products and have ceased doing so in the last five years. Some PUF products either do not require a flame retardant or applications that require a flame retardant have a variety of alternatives to TCEP.
This information, however, conflicts with the results of testing performed by Health Canada’s PSL during 2009–2010, which identified that 7 out of the 40 children’s products tested, and available on the Canadian market, contained varying amounts of TCEP. The reason for this discrepancy is unknown; however, it could potentially be either from products that were imported from countries where TCEP is still used or as a result of Canadian manufacturers using industrial PUF scrap or post-consumer PUF scrap. However, the Polyurethane Foam Association has indicated that 99% or more of recycled foam is used in re-bonded carpet cushion. It is unlikely that children’s product manufacturers would use recycled foam as a supply chain is not in place for this purpose and recycled foam may not be clean. PUF recyclers receive bales of recovered PUF from different manufacturing and post-consumer sources. Each bale can contain a variety of PUF by density, colour, and past uses; some of the varieties of PUF may contain TCEP.
The status quo would allow importers of children’s products and Canadian children’s product manufacturers to continue using PUF for their products without ensuring that the PUF they are using does not contain TCEP. Under this option there would continue to be no federal regulatory restrictions on the manufacture, advertisement, sale or importation in Canada of children’s PUF products containing TCEP. For this reason, it is considered that this option does not best protect infants and toddlers up to three years of age from these sources of TCEP exposure.
Mandatory labelling to identify the use of TCEP in children’s products cannot achieve the same level of protection as a prohibition, which is considered necessary to protect infants and toddlers under three years of age.
The main purpose of precautionary labelling on a consumer product is to bring an issue to the attention of the user, and to help them use the product safely. Mandatory labelling to identify an inherent health hazard from the reasonably foreseeable use of a product would allow the product to be sold without significantly reducing the health risk.
It cannot be assumed that a label on children’s products identifying TCEP content would be sufficient to prevent young children from mouthing these products. It is therefore prudent to introduce a prohibition that would provide greater health and safety protection to this susceptible subgroup.
Regulatory limit option
Under this option, a regulatory limit would specify an allowable level of total TCEP in children’s products made, in whole or in part, of PUF. Products found to contain TCEP in a quantity equal to or greater than the specified allowable limit would be prohibited.
Since TCEP is considered a non-threshold carcinogen with the possibility of harm at any level, it is not possible to determine a safe level of TCEP exposure for infants and toddlers up to three years of age. Therefore, restricting TCEP content to a specified level would not adequately reduce the levels of exposure to newborns and children under three years of age; thus, this is not considered a viable option.
Under this option, products made, in whole or in part, of PUF that contains TCEP and intended for children under three years of age would be prohibited from manufacture, advertisement, and sale in and importation into Canada. Children under the age of three are the focus of this proposed prohibition as a result of the Screening Assessment Report identifying this subgroup as the most highly exposed population. The frequent mouthing behaviour children in this age range are known to exhibit increases the likelihood they would be exposed to TCEP and its potentially harmful effects. The same level of risk as a result of dermal and inhalation exposure to TCEP was not identified in the Screening Assessment Report.
The prohibition would include both products that a child under three years of age uses, such as toys, and products that an adult uses to care for a child under three years of age, such as sleep positioners and nursing pillows. The prohibition would not apply to PUF products for children three years of age and older.
This option would provide the greatest protection to Canadian infants and toddlers and would eliminate one source of TCEP exposure to this susceptible group, thus reducing their overall exposure to this substance.
Benefits and costs
A cost-benefit analysis report entitled Cost-Benefit Analysis to Support Using the Hazardous Products Act to Prohibit Products Intended for Children Made from Polyurethane Foam Containing Tris (2-chloroethyl) Phosphate (TCEP) [May 2011] was prepared for Health Canada. An electronic copy is available, upon request. The report describes the costs that government, industry and consumers would incur as a result of the proposed prohibition. Information was obtained through an extensive review of existing information sources and a widespread survey of approximately 60 individuals, businesses, and organizations.
Stakeholders that were contacted for feedback included toy associations from several countries; flame retardant manufacturers, distributors and associations; Canadian foam manufacturers; children’s product manufacturers, retailers and safety associations; health and environmental organizations; and product testing laboratories.
Profile of industry
Global production and use of TCEP has been in decline since the late 1980s as its historic use in rigid and flexible PUF has been substituted by other phosphate ester flame retardants. Global consumption of TCEP peaked at over 9 000 tonnes in 1989 and declined to below 4 000 tonnes by 1997. Global consumption was estimated at less than 1 000 tonnes by 2005. This steady decline suggests that global consumption was in the range of 150 tonnes in 2010. This declining global trend is supported by estimates from the European Union that show a significant reduction of consumption between 1998 and 2002 from 2 040 tonnes to 1 010 tonnes.
Production of TCEP has been dramatically reduced; therefore, so has the use of TCEP as a flame retardant or plasticizer. On a global basis, and based on the available data and simple forecast, consumption of TCEP in 2010 was less than 2% of what it was 20 years ago.
The only North American manufacturer of TCEP ceased production in 2009, and the only European producer stopped production in November 2010. However, there are indications that TCEP may continue to be manufactured in Asia.
Current state of TCEP in Canada
TCEP use by industry in Canada is considered to be negligible. Consultations with international flame retardant manufacturers and major Canadian foam manufacturers did not identify any Canadian manufacturers that use TCEP in their products.
A survey of 14 PUF manufacturers and PUF product manufacturers did not identify any stakeholders that continue to use TCEP in their products. Many indicated that they did use the substance in the past, but ceased doing so over the past five years. In light of this information, and given the phase-out of TCEP by flame retardant manufacturers, it is expected that there is limited, if any, use of TCEP by PUF product manufacturers in Canada.
Despite this reduction in TCEP use, TCEP may be present in existing consumer products produced over the past 20 years. These items may continue to be in children’s products and in the homes of Canadians. Additionally, this reduction in TCEP use does not preclude the continued use of TCEP in children’s products available for sale in Canada that are imported from countries around the world.
In 2008, 98% of toys sold in Canada were imported. Actual imports were $3,133 million (of which $481 million were subsequently re-exported). For all imports of toys and related products, 81% originated in China in 2008. The next largest country that exported these products to Canada was the United States, accounting for 10% of Canada’s imports. Canadian toy and related products manufacturers supplied only 2% of the Canadian market.
No trade data is available that corresponds to children’s products containing PUF. However, one category — HS Code 950341, “Stuffed Toys Representing Animals or Non-Human Creatures” — encompasses some types of stuffed toys and some of these are expected to contain flexible PUF. Similar to the previous trade data that covered a broader category of toys, the vast majority (96%) of these stuffed toys were imported from China in 2006.
Table: Trade in certain stuffed toys (2006)
Source: Industry Canada, Trade Data Online, Trade by Product, HS Code 950341.
Note: This data series was terminated in 2006.
Health Canada testing of PUF children’s products identified the presence of TCEP in 7 out of 40 products, all 7 of which were imported from China.
Costs to industry
No costs are expected to be borne by Canadian flame retardant manufacturers or distributors, PUF manufacturers, or PUF recyclers. Some costs may be borne by Canadian children’s product manufacturers, importers, distributors and retailers for ensuring that their PUF children’s products do not contain TCEP. Additionally, there may be an increase in costs for PUF distributors for certifying the PUF they are supplying does not contain TCEP.
Children’s product manufacturers and importers may face increased costs as a result of providing assurance to children’s product distributors and retailers that their products do not contain TCEP. This could be accomplished by providing a certification indicating the source of the PUF and its absence of TCEP or having the products tested. Information from Health Canada’s PSL indicates that testing costs would be approximately $750 to $1,000 per sample.
Canadian distributors and retailers would require assurances from the manufacturers or importers that products made, in whole or in part, of PUF do not contain TCEP. In the event the assurance cannot be provided or the products are determined to contain TCEP, there may be a cost involving the replacement of products that contain TCEP.
As a result of the global reduction in the consumption of TCEP and the movement of industry to alternative flame retardants, the costs to Canadian children’s product manufacturers, distributors, importers and retailers is anticipated to be minimal.
Costs to consumers
Consumers may face increased costs when buying children’s products containing PUF that do not contain TCEP, although these are anticipated to be minimal, if any. Potential costs could arise from the costs to children’s product manufacturers, importers, distributors and retailers ensuring that their PUF products do not contain TCEP. These costs may depend on the number of children’s products made, in whole or in part, of PUF and the average costs of providing assurances that these products do not contain TCEP.
Of the 40 products tested by Health Canada, pricing was available for 31 of the children’s products — 5 child care products and 26 toys. The average price of the child care products was $13.47 and the average price of the toys was $7.45. The overall average price for all products was $8.42.
Given that global consumption of TCEP has decreased significantly and other countries are imposing similar restrictions for this substance, particularly in regards to products intended for children, it is expected that manufacturers of these types of products already use materials that do not contain TCEP. Therefore, it is anticipated that PUF children’s products would continue to be available at comparable cost with no reduced availability.
Costs to Government
Annual costs for Health Canada’s Consumer Product Safety Directorate will include implementation, monitoring, sampling, testing and enforcement. Health Canada estimates that the cost of implementation would be approximately $128,250 and monitoring, sampling, testing and enforcement costs would be $67,750 in the year immediately after the prohibition is introduced. These costs would decline over time as non-compliant products are removed from the marketplace. For subsequent years, the estimated average cost is $7,500 per year. The present value cost of administering the prohibition over a 20-year period, at a discount rate of 8%, is approximately $240,000.
Benefit to Canadians
The main source of TCEP exposure for infants from 0–6 months old as identified in the Screening Assessment Report results from mouthing PUF foam cushioning. The benefits of this proposal in a particular year would be estimated by a comparison of the number of children facing an adverse impact from exposure to TCEP in children’s products with the benefits of avoiding that adverse impact.
While economic values reflecting the value of an avoided impact, such as a fatality, incidence of cancer, or impaired fertility, are available, no means are known to estimate the number of children experiencing adverse impacts from mouthing products containing TCEP.
An estimate of the number of children with access to children’s products containing TCEP levels above 20 mg/kg can be made. For example, there were 1.1 million children under the age of three in Canada in 2010. (see footnote 1) It could be assumed that each child has access to at least one product containing PUF. It could further be assumed that about 10% of these have levels of TCEP in excess of 20 mg/kg (based on Health Canada’s testing). This gross estimate suggests that 110 000 children have access to at least one children’s product made, in whole or in part, of PUF with levels of TCEP above 20 mg/kg.
However, no method is known to estimate the number of children that will mouth products to the extent that a critical effect level would be reached. Making such an estimate would require information on the distribution of daily TCEP uptake based on mouthing behaviour and product TCEP content. It would also require a more reliable estimate of the level at which a negative health impact may occur.
Despite the impacts not being quantifiable, Canadian children may be experiencing adverse impacts from some children’s PUF products that contain TCEP. Thus, there is a justification for moving forward with a prohibition of TCEP in these products. Such a prohibition would help prevent adverse impacts arising from TCEP in children’s PUF products by eliminating one source of TCEP exposure for children under three years of age.
Given the global reduction in the consumption of TCEP and the movement of industry toward alternative flame retardants, the costs to Canadian children’s products manufacturers, distributors, importers and retailers is anticipated to be minimal.
Costs are expected to be minimal since most production of PUF products uses material not treated with TCEP.
Health Canada estimates that the cost of implementation would be approximately $128,250 and testing and enforcement costs would be $67,750 in the year after the legislation is introduced. These costs would decline over time as non-compliant products are removed from the marketplace. For subsequent years, the estimated average cost is $7,500 per year. The present value cost of administering the prohibition over a 20-year period, at a discount rate of 8%, is approximately $240,000.
Reduced exposure to products made, in whole or in part, of PUF that contains TCEP.
Small business lens
The proposed prohibition is expected to have only negligible impact on small business, as no new administrative requirements are being introduced beyond those that industry must currently meet. Under the CCPSA, there is a requirement for industry to prepare and maintain documents that indicate, in the case of a retailer, the name and address of the person from whom they obtained the consumer products, where they sold the consumer products, and the period during which they sold the consumer products, and, in the case of any other person, the name and address of the person from whom they obtained the product or to whom they sold it, or both, as applicable.
This requirement enables Health Canada to protect the public by addressing or preventing dangers to human health or safety that are posed by consumer products by quickly tracking products of concern through the supply chain up to the highest level of trade. This allows for an easier determination of where and when the product was distributed; thus, it allows for recalls to be administered more efficiently and effectively.
Additionally, the impact on Canadian children’s products manufacturers, distributors, importers and retailers is anticipated to be minimal. As small businesses tend to source their products from larger businesses, it is anticipated that these larger businesses will undertake any burden of seeking assurances from product manufacturers and distributors that the PUF children’s products do not contain TCEP.
Therefore, regulatory flexibility options in the form of partial or complete exemptions from compliance or simplified and less frequent record-keeping obligations were not considered.
It is being proposed that the Regulations come into force six months after the day on which they are published in the Canada Gazette, Part Ⅱ. This is a 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. Domestic small businesses will also benefit from this period prior to the proposed Regulations coming into force.
On September 13, 2010, a pre-consultation on the proposal to prohibit TCEP in PUF children’s products intended for children under three years of age was posted on the Health Canada Web site. Additionally, the pre-consultation was emailed to 59 select interested stakeholders, and over 7 000 consumer product safety news subscribers were notified. The interested stakeholders included testing laboratories, standards associations, children’s product and toy associations (whose members include retailers and importers), flame retardant associations, PUF associations, public health associations and non-governmental organizations. Associations from numerous countries were contacted. The countries included Australia, Brazil, China, Italy, Japan, Korea and Thailand. The pre-consultation was subject to a 60-day comment period with a closing date of November 11, 2010.
As a result of this pre-consultation, nine comments were received from stakeholders that included five industry members and four individuals. No stakeholders were opposed to the prohibition and three specifically indicated support.
Three industry members did not specifically comment on the proposed prohibition, but had inquiries related either to Health Canada’s PSL test method or to whether their product was one that tested positive for TCEP. Of the two industry members that commented on the proposed prohibition, one was a manufacturer of PUF products that indicated that it did not currently use TCEP in any of its products, nor had it used TCEP in any of its products for more than 10 years. Furthermore, this industry member indicated it had not used TCEP in routine bedding, furniture, or consumer product items for more than 20 years. The industry member also supported Health Canada’s commitment to consumer safety.
The other industry member to respond was a toy retailer and it indicated that it was in favour of the prohibition. The member’s comments were twofold, firstly, that the scope of the prohibition should be expanded to include all children’s toys and products with which children may come into contact, such as mattresses and pillows, not just those for children under three years of age, and secondly, that mandatory labelling should be required on all products that contain TCEP.
The highest consumer product exposure estimates as determined in the Government of Canada Screening Assessment Report were for infants and toddlers as a result of mouthing PUF cushioning. Studies have shown that mouthing behaviour is most prominent in children under three years of age. These products represent a reduced health hazard if they are not put into the mouth and would, therefore, not pose the same hazard to children over three years of age. The proposed prohibition of TCEP in children’s PUF products under the CCPSA will protect children under three years of age from exposure to TCEP containing PUF in products intended for a child under three years of age.
The main purpose of precautionary labelling on a consumer product is to bring an issue to the attention of the users, and to help them use the product safely. Mandatory labelling to identify an inherent health hazard from the reasonably foreseeable use of a product would still allow the product to be sold without significantly reducing the health risk.
Two of the individuals who responded likewise indicated they were in favour of the prohibition and that the scope of the prohibition be expanded to include more products. One individual inquired about how to identify products that may contain TCEP in order to dispose of them.
The fourth individual who responded did not specifically indicate whether or not they supported the prohibition but commented that fumes from PUF may cause adverse health effects in some individuals.
Off-gassing from PUF products is a different issue entirely than the mouthing by children under three years of age of TCEP in PUF products, with different potential health effects. PUF is a chemical product with a wide range of applications. When properly produced, cured and adequately ventilated prior to product assembly, PUF should not off-gas chemicals. However, if time is not allowed for complete curing or adequate ventilation after curing, products can off-gas chemicals from the PUF for a period of time. This temporary off-gassing may cause some people to experience temporary health effects, especially those with chemical sensitivities. Off-gassing of a particular product typically dissipates over time, as do any health effects.
Health Canada is proposing to proceed with the prohibition of the manufacture, import, advertising or sale of products, intended for children under three years of age, that are made, in whole or in part, of PUF that contains TCEP, as it is considered the most effective option to reduce the exposure to TCEP of children under three years of age. Total benefits of this proposal outweigh the costs, as industry has for the most part shifted away from the use of TCEP and replaced it with alternative flame retardants; however, a certain percentage of children’s PUF products that contain TCEP remain available in Canada and there are negative health effects of exposure to this substance.
Implementation, enforcement and service standards
Compliance and enforcement of the prohibition under the CCPSA of products made, in whole or in part, of PUF that contains TCEP and intended for children under three years of age will follow established departmental approaches and procedures, including sampling and testing of products and follow-up of both consumer and industry complaints. 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 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 prohibition through ongoing industry and retailer education.
Risk Management Strategies Division
Risk Management Bureau
Consumer Product Safety Directorate
Healthy Environments and Consumer Safety Branch
269 Laurier Avenue W
Address Locator 4908B
PROPOSED REGULATORY TEXT
Notice is hereby given that the Governor in Council, pursuant to subsection 37(1) of the Canada Consumer Product Safety Act (see footnote a), proposes to make the annexed Regulations Amending Schedule 2 to the Canada Consumer Product Safety Act (TCEP).
Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part Ⅰ, and the date of publication of this notice, and be addressed to Sheila Davidson, Project Officer, Risk Management Bureau, Consumer Product Safety Directorate, Healthy Environments and Consumer Safety Branch, Department of Health, MacDonald Building, Address Locator 4908B, 269 Laurier Avenue West, Ottawa, Ontario K1A 0K9 (fax: 613-952-2551; email: firstname.lastname@example.org).
Ottawa, November 1, 2012
Assistant Clerk of the Privy Council
REGULATIONS AMENDING SCHEDULE 2 TO THE CANADA
CONSUMER PRODUCT SAFETY ACT (TCEP)
1. Schedule 2 to the Canada Consumer Product Safety Act (see footnote 2) is amended by adding the following after item 15:
16. Products that are made, in whole or in part, of polyurethane foam that contains tris (2-chloroethyl) phosphate and that are intended for a child under three years of age.
COMING INTO FORCE
2. These Regulations come into force six months after the day on which they are published in the Canada Gazette, Part Ⅱ.
Statistics Canada, CANSIM Table 051-0001, Estimates of Population, by Age Group and Sex for July 1, Canada, Provinces and Territories.
S.C. 2010, c. 21
S.C. 2010, c. 21
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