| |||||||||||||||||||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||
 |
| ||||||||||||||||||||||||||||||||||||
 |
|||||||||||||||||||||||||||||||||||||
|
Vol. 137, No. 47 — November 22, 2003 Candles RegulationsStatutory Authority Hazardous Products Act Sponsoring Department Department of Health REGULATORY IMPACT Description The purpose of this regulatory initiative is to improve the protection of the health and safety of Canadians when exposed to candles. This is accomplished by introducing labelling, composition, and performance requirements for candles within a common Candles Regulations. The Candles Regulations restrict the lead content of candle wicks with metallic cores and set requirements for warning labels on candles or their packaging. To ensure that all legislative requirements for candles are easily accessible by manufacturers or importers, the existing prohibition of candles which may spontaneously relight when extinguished has been transferred to the Candles Regulations. The key components of this regulatory initiative are as follows: — mandatory bilingual warning labels and safe-use instructions on the candle or its packaging; — maximum allowable lead content limit of 600 mg/kg for the cores of metallic candle wicks; — continued prohibition on candles which may spontaneously re-light when extinguished; and — requirement for test methodologies that conform to good laboratory practices as set out by the Organization for Economic Co-operation and Development (OECD). The Hazardous Products Act prohibits or restricts the advertisement, sale or importation of products which are or are likely to be a danger to the health or safety of the public. The proposed Candles Regulations are consistent with Health Canada's commitment to eliminate unnecessary lead exposure in children through its proposed Lead Risk Reduction Strategy for Consumer Products, to protect Canadians against health risk factors over which they have little control, and to promote the safe use of products. Under the authority of the Hazardous Products Act, a prohibition on candles which may spontaneously relight when extinguished was introduced in May 1977 to protect the public from the fire hazard associated with their use. Consequential amendments to item 29, Part I, of Schedule I to the Hazardous Products Act reflect the transfer of the current prohibition to the proposed Candles Regulations. Labelling Requirements Most candle fire incidents occur as a result of human error, predominantly when burning candles are left unattended close to combustible materials or within the reach of children. Some fires occur when people fall asleep with candles still burning. Warning labels on candles or their packaging will help ensure that information on safe candle use is available to the public, thereby reducing the risk of property damage and injury or loss of life from candle misuse. The required warning will read as follows: WARNING: To prevent fire, do not leave burning candles unattended. Do not place burning candles on or near anything that can catch fire. Keep burning candles out of reach of children. Lead Content Limits for Metallic Candle Wick Cores Lead is a metal which has no useful function in the human body and is toxic even at very low levels of exposure. Lead accumulates in the body, so that exposure to even very low levels of lead may increase the body burden of lead to harmful levels. The adverse effects of lead on young children have been documented in hundreds of studies. Many of these effects are long-term or permanent. Until recently, scientists believed that blood lead levels in children of less than 10 µg/dL did not represent a health hazard, but a study published in 2000 indicates that even blood lead levels below 5 µg/dL may be associated with harmful effects on the intellectual development and behaviour of children. Since lead can pass through the placenta to the fetus, exposure to lead during pregnancy can result in miscarriages, premature births, and damage to the fetus. Lead also has a variety of severe adverse health effects on adults. While the wicks of most candles sold in Canada are made entirely of cotton, some candles, typically pillars, votives, tealights and other container candles, have wicks containing a metal core made of zinc, tin, or lead, or a mixture of these metals. An estimated 10 percent of candles on the Canadian marketplace contain lead-core wicks. The metal core supports the cotton or paper wick and is believed to make candles burn more slowly and evenly. These metals, having low melting points, melt as the cotton is being burned. Studies in 1999 and 2000 have shown that 20 to 35 percent of the lead in pure lead candle wicks is vaporized. Scientific trials have shown that lead-core wick candles may release up to 2200 µg of lead per hour when burned. The United States Consumer Product Safety Commission has determined that lead emissions of 430 µg/hour could result in hazardous lead exposure to children. A recent study indicates that one candle-burning episode per week may release enough lead to raise a child's blood lead level above 10 µg/dL, which is Health Canada's recommended intervention level for lead. Because the concentration of airborne lead produced by burning lead-core candles varies with factors such as core diameter, burning rate and duration, and room size and ventilation, it is difficult to predict when and where toxic levels of lead fumes may accumulate in a room. There are no visible emissions which would indicate that lead is being released into the air. The health risk is greatest for children under three, who are not only more susceptible to the effects of lead, but tend to spend most of their time indoors. Secondary exposure to lead through lead-core candles may occur when uninhaled lead fume particles emitted by the candles settle onto floors, furniture, and other surfaces and become part of household dust. This dust is a significant hazard for young children, who may crawl or play in it, handle objects on which dust is present or put them in their mouth, or lick dust-laden hands. Lead has a sweet taste, which makes ingestion of lead-containing dust attractive to children. Airborne lead will dissipate over time without a continuing source, but leaded dust can accumulate and remain a source of ongoing lead exposure. Alternative metal candle wick cores exist, such as zinc or tin, and the use of candles containing zinc or tin wicks is not believed to represent a human health hazard. The Consumer Product Safety Bureau of Health Canada has carried out two national surveys of leaded candles. The first survey was completed in December 1999, with testing completed in January 2000. Over 2 400 lines of candles were inspected and 65 samples of candles with metal core wicks were selected for laboratory analysis. Of the 65 candles, 28 (43.1 percent) were found to have wick cores containing more than 50 percent lead. Most of the lead-containing candles were imported. A follow-up survey carried out in May 2001 indicated that of 88 candles with metal core wicks sampled, 24 percent, or 21 out of 88 cores, contained more than 40 percent lead. Given the large numbers of candles sold and used each year in Canada, there is a significant possibility that young children and pregnant women will be exposed to toxic lead fumes through use of lead-core wick candles. Some of Canada's major trading partners have already taken action against lead-core candles. In 1974, the Candle Manufacturers Association of America trade group initiated a voluntary ban on lead-core candles. Under the United States' Federal Hazardous Substances Act, the Consumer Product Safety Commission has introduced a proposal to ban the manufacture, import or sale of candles with more than 600 mg/kg lead in the cores of their wicks. The ban is expected to come into force in the fall of 2003. Australia placed a temporary ban on the sale of lead-wick candles in September 1999, pending further study, and New Zealand followed suit in June 2000. European candle manufacturers do not use metal-core wicks. The proposed Regulations are required in Canada because currently, Health Canada must rely on persuasion and the good will and good sense of the retailers selling candles. However, the presence of lead in candle wicks is not obvious, and candle retailers may not even be aware of whether or not the candles they market contain lead in the wick cores. The Canadian Environmental Law Association, the Ontario College of Family Physicians and the Learning Disabilities Association have all urged that Health Canada take action to eliminate this source of lead exposure. The requirement that evaluations of lead content be based on test data of sufficient quality, rigour and reproducibility is a basic principle in these Regulations. The reference to OECD good laboratory practice ensures that departmental and manufacturer selected test methods satisfy the manner in which laboratory studies are planned, performed, monitored, recorded and reported. Alternatives Lead Content Limits for Metallic Candle Wick Cores 1. No Change to Current Management Practices Under this option, there would continue to be no legal restrictions on the advertisement, sale or import of candles or candle wicks containing significant amounts of lead in their cores. Continuing to allow the advertisement, sale or importation of candles with lead core wicks is not an acceptable option because, as explained above, the use of these candles creates a significant lead exposure risk to the health of Canadians, particularly young children. 2. Compulsory Labelling of Lead-core Wick Candles for Lead Content This option would require that all candles containing lead-core wicks which are offered for sale in Canada be accompanied by a label warning that hazardous quantities of lead fumes may be released when the candle is burned. Since lead is released into the air as soon as a lead core wick begins to burn, the only effective risk control message on lead-core wick candles would be a warning that the candles should not be lit; in other words, that they should not be used for their intended purpose. It would be unreasonable to expect that people would buy candles containing lead wicks and then refrain from burning them. 3. Voluntary Compliance with a Maximum Lead Content Standards by Manufacturers, Importers, Distributors, and Vendors Under this option, compliance with maximum lead content standards established by Health Canada for candle wicks would be voluntary. Health Canada has already requested retailers to voluntarily discontinue the sale of lead-core wick candles. As a follow-up to its nation-wide candle survey in late 1999, Health Canada issued a Candle Trader Information Bulletin on candle safety issues in January 2000. The Bulletin included a paragraph urging dealers to "immediately stop the use of lead core wicks in their products. Candle importers and distributors are asked to supply candles having non-lead core wicks." Over 550 copies were distributed at trade shows and mailed to candle distributors and manufacturers across Canada. A copy was provided to the U.S.-based National Candle Association. Results of Health Canada's second candle survey, in May 2001, indicated that significant numbers of lead-core candles were still being sold on the Canadian marketplace and that voluntary compliance had not been effective. Continuing to rely on voluntary compliance is not appropriate because of the health risks to small children and the difficulty for the retailer and the consumer of identifying candles containing lead core wicks. The American candle industry voluntarily agreed to discontinue use of lead in candle wicks in 1974. However, a small percentage of candles on the American market still contain lead. Importers and retailers themselves may not know whether or not the candles they sell have lead-core wicks. 4. Lead Risk Reduction Strategy Health Canada has been working for a number of years on a hazard-based Lead Risk Reduction Strategy for Consumer Products to which children are likely to be exposed. The Strategy proposes a lead content limit of 600 mg/kg for consumer products, including candles, which are designed to be burned or melted in enclosed spaces. However, the Strategy is a complex document which includes a wide range of consumer products. This being the case, it must be expected that development of one regulation based on the Strategy could not be implemented in the near future. Lead wick candles represent an immediate and significant health risk to consumers, and it would be inadvisable to wait a number of years before taking action against them to protect the health of Canadians. In addition, the United States Consumer Product Safety Commission recently voted to ban the manufacture, import, or sale of lead wicks and candles with lead wicks. This federal United States ban comes into effect in the fall of 2003. If Canada does not have a comparable regulation in place and if there are inventories of candles with leaded-core wicks in the distribution system at the time of the U.S. action, these candles may be directed to the Canadian market. Benefits and Costs Relight Candles Since the prohibition on candles which spontaneously relight has been in force since May 1977, there is no economic impact associated with the transfer of this existing prohibition to the proposed Candles Regulations. Labelling Requirements There are currently no federal labelling requirements for candles, other than those required for consumer commodities under the Consumer Packaging and Labelling Act and Regulations. However, members of the U.S.-based National Candle Association typically place safe-use instructions on their candles or on the candle packaging. In 2001, the American Society for Testing and Materials, in conjunction with the National Candle Association, developed a voluntary labelling standard for the candle industry. The safety messages required under the proposed Candles Regulations are similar to those recommended in the voluntary labelling standard. Costs to meet the labelling requirements are expected to be minimal for those industry members already complying with the voluntary labelling standard. Lead Content Limits for Metallic Candle Wick Cores An economic impact assessment was conducted in 2002. This study assessed the expected costs, benefits and distributional effects of limiting lead content in the cores of candle wicks to 600 mg/kg. The assessment was performed using a standard cost-benefit framework, which measures impacts in terms of their social values. Copies of this study may be obtained from the contact listed at the end of the RIAS. The assessment of cost only considers incremental costs. These are the costs that arise from the proposed regulatory action and do not include costs for pre-existing activities. The total cost of an enforced regulation is represented by compliance costs to industry and government regulatory costs. Cost data came from industry representatives (personal interviews) and government monitoring costs of other regulations. The incremental costs to society of the proposed Regulations can be represented by the following equation: Total Social Costs = Total Incremental Private Costs + Total Incremental Government Costs Benefits were assessed based on the identification and categorization of the adverse impacts that will be avoided through the proposed regulatory action. Social benefits can be assessed and measured in terms of avoided social losses. These are not limited to reductions in out-of-pocket expenses or increased earnings; non-monetary gains to society, such as the avoided pain and suffering from illness, can be evaluated in monetary terms. Costs Lead Content Limits for Metallic Candle Wick Cores An estimated 90 percent of candles sold in Canada do not contain lead-core wicks. Viable alternatives to lead, such as tin and zinc, are available and are currently used in metallic-core wicks. Although tin and zinc are often mined with lead and may contain small amounts of lead as a contaminant, these metals have not been shown to emit harmful levels of fumes. Paper and cotton wicks which remain erect during burning are also available. Therefore, any inconvenience or adverse economic impact resulting from a restriction on the lead content of candle wicks would be limited. Most of the candles with lead-core wicks gathered during Health Canada's surveys in 1999 and 2001 were imported. Therefore, importers may be more affected by this regulatory proposal than would Canadian manufacturers. Potential costs to industry and consumers of this regulatory proposal would include any costs to replace lead-core wicks with alternate wicks and any loss in product performance resulting from the replacement. Industry sources indicate that manufacturers who use lead-core wicks will not incur extra costs when switching from lead to tin or zinc as a core material, as prices are not greater for replacement metals. Through key informant discussions and the review of available literature sources, it has been determined that no loss in candle performance through the use of these alternative wicks would be expected. Since non-lead metallic wicks are available internationally, the regulatory proposal is expected to have negligible effects on the price and performance of imported candles with metallic-core wicks, although this has not been confirmed by importers. As a result, costs to Canadian industry and to consumers arising from the proposed Regulations on importation of candles would be negligible. Imported candles with non-lead metallic-core wicks are already available from exporting countries. The greatest proportion of lead-core candle samples obtained in Health Canada's 1999 and 2001 surveys originated from China. However, one 2001 candle sample originating from China was found to have a lead-free metallic core, indicating that the capacity to manufacture lead-free candles already exists in China. Health Canada's costs would include monitoring compliance costs, and costs of any related laboratory analysis. Studies of Canadian regulations have shown that monitoring costs by Health Canada inspectors and any related laboratory analysis or enforcement after a regulation is introduced are generally in the order of $30,000 in the first year. Monitoring of a new regulation tends to be integrated with other monitoring activities usually by transferring resources from other monitoring duties with no net increase in resources. However, the loss in the value of the displaced "other monitoring duties" remains a cost of the regulatory change. As experience is gained related to the effectiveness of the Regulations, monitoring costs tend to decline. Second- and third-year costs of monitoring may be in the order of $20,000 and $10,000. Thereafter, an average annual cost of $5,000 is assumed. Benefits Labelling Requirements Candle fire statistics are not available for all of Canada. However, between 1990 and 1999 in Alberta, the annual number of candle fires increased by 100 percent, causing 723 fire incidents, 10 fire deaths, 168 fire injuries and $12.4 million in property damage ($17,150 per fire incident, on average), and the share of fires started by candles tripled from 2 to 6 percent. Due to the increasing use of candles, these figures are increasing over time; in 2001 alone, candles accounted for 103 fire incidents and $3.3 million in property damage ($33,038 per fire incident, on average) in Alberta. Most of the candle fires were started because of human error. People need to know what to do to reduce the risk of fire and loss of life. Mandatory labelling requirements for candles, which include a warning statement and safe-use instructions, are aimed at reducing the incidence of fire, fire injuries and deaths, and property losses from candle misuse. Lead Content Limits for Metallic Candle Wick Cores The economic evaluation considered willingness to pay to avoid a condition, the cost of an illness, foregone lifetime earnings and compensatory spending. Benefit data, presented in Table 1 below, came primarily from values for cost of illness and medical costs found in the valuation literature. Table 1: Measures of Benefits for Lead Reduction
The data in this table indicates that the average cost of medical treatment for lead poisoning, combined with the cost for extra education, ranges between $6,000 and $10,000 per case. Given the health risk of burning candles with lead-core wicks, there are no public benefits to permitting the sale of such candles, especially since substitutes are readily available at similar cost. Restricting the lead content of candle wicks would also have a positive environmental impact, particularly on indoor environments, because of the reduction of lead fumes and lead-contaminated dust. Net benefit The proposed Candles Regulations are justified from a social perspective. The costs of this regulatory initiative would be minimal for Canadian industry, while lifetime costs to the government in terms of enforcement and control would have a present value of $90,000. Since data regarding benefits is limited, a true comparison of benefits and costs is not feasible. Costs over the lifetime of these Regulations have a present value of $90,000. Respecting the proposed restriction on the lead content of metal-core candle wicks, the partial benefits per case of avoided lead poisoning are in the range of $6,000 to $10,000. Therefore, these Regulations are efficient as long as, over its lifetime, 9 to 15 cases of lead poisoning are avoided. Respecting the proposed labelling requirements, the partial benefits of avoiding property loss from candle-related fires are in the range of $17,000 to $33,000 per fire. Costs will be recouped if 3 to 5 candle-related fires are avoided. In summary, the benefit-cost analysis has indicated, based on the available data, that the proposed Candles Regulations would be an efficient control measure if, over their lifetime, 9 to 15 cases of lead poisoning or 3 to 5 fires are avoided. As well, the distributional analysis has shown, based on certain assumptions of the user, that members of Canadian society would feel no significant adverse impacts. Consultation Most candles in Canada are sold in general merchandise stores. The number of retail outlets in Canada which sell candles is so large that it would not be feasible to contact them all individually. However, the Retail Council of Canada, which represents over 90 percent of retail merchants in Canada, the National Candle Association, and the Canadian Association of Importers and Exporters Inc. have been informed of Health Canada's intentions to regulate the lead content of candle wicks. In addition, a Candle Traders' Bulletin outlining the concerns with lead-core wick candles was distributed to over 550 trade members in January 2000. Health Canada did not receive any negative comments following these actions. The Retail Council of Canada, the National Candle Association, the Canadian Gift and Tableware Association, and the Canadian Association of Importers and Exporters Inc. will be notified of Health Canada's proposed Candles Regulations so that they may prepare comments as set out by the federal regulatory process. On January 8, 200l, Health Canada issued a consumer advisory telling consumers how to identify lead-core wick candles and advising that they not be used because of the health risks associated with lead fumes. This advisory is posted on Health Canada's Web site. Compliance and Enforcement Compliance and enforcement of the proposed Candles Regulations and consequential amendments to Schedule I to the Hazardous Products Act will follow departmental policy and procedures, including sampling and testing of candles, and follow-up of consumer and trade complaints. Actions taken on non-complying products will be based on the powers given under the Hazardous Products Act to Health Canada inspectors. These actions may range from negotiation with traders for the voluntary withdrawal of these products from the market to prosecution under the Hazardous Products Act. Health Canada will also maximize compliance with the proposed Regulations through industry and retailer education. Co-operation from the Canada Customs and Revenue Agency in the case of imported candles and wicks may be negotiated as required. Paul Chowhan, Manager, Chemistry and Flammability Division, Consumer Product Safety Bureau, Product Safety Programme, Healthy Environments and Consumer Safety Branch, Department of Health, Address Locator 3504D, MacDonald Building, 123 Slater Street, Ottawa, Ontario K1A 0K9, (613) 952-1994 (Facsimile), paul_chowhan@hc-sc.gc.ca (Electronic mail). Notice is hereby given that the Governor in Council, pursuant to section 5 (see footnote a) of the Hazardous Products Act, proposes to make the annexed Candles Regulations. Interested persons may make representations with respect to 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 Paul Chowhan, Manager, Chemistry and Flammability Division, Consumer Product Safety Bureau, Product Safety Programme, Healthy Environments and Consumer Safety Branch, Department of Health, Address Locator No. 3504D, MacDonald Building, 123 Slater Street, Ottawa, Ontario K1A 0K9 (fax: (613) 952-1994; e-mail: paul_chowhan@hc-sc.gc.ca). Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act. Ottawa, November 19, 2003
EILEEN BOYD
TABLE TO SUBSECTION 3(2) MINIMUM HEIGHT AND SIZE OF TYPE
R.S., c. 24 (3rd Supp.), s. 1 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
NOTICE:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
