Lead Risk Reduction Strategy

6.0. Proposed Regulations under the Lead Risk Reduction Strategy (LRRS) for Consumer Products

The LRRS takes a precautionary stance by using a hazard-based rather than a product-based approach to regulating lead content in consumer products. This hazard based concept is analogous to the approach used by the Consumer Product Safety Bureau in developing the recently promulgated Consumer Chemicals and Containers Regulations amendments. Since the proposed measures are hazard-based rather than product-based, they will provide an effective means of controlling lead exposure from a wide range of consumer products rather than a few specific products. The advantage of a hazard-based approach is the broader regulatory coverage which it gives, addressing hazards which are common to many products. This approach places the responsibility of controlling the hazard on the manufacturer by limiting the lead content in regulated product categories.

6.1. General Considerations

The LRRS recognizes risk-based management by proposing regulations for five product categories. The groups are based on product description and use, and on the relative risk of lead exposure to children.

The risk was evaluated on the basis of two factors:

1. the probability that product/child interaction would occur and would result in exposure to lead. The probability of interaction depends on accessibility of the product as a whole to children, and on accessibility of lead-containing components of the product to children. For example, some toys contain batteries or electronic components which contain lead, but the toy is designed in such as way that these components are not accessible (taking into account the foreseeable actions of a child.)
2. the expected level of exposure, which depends on factors such as the proportion of lead in the product which is migratable and the frequency of exposure to the product. Exposure to lead is affected by the form of lead, solubility of the lead, the chemical and mechanical properties of the substrate in which the lead is present, and how aging and/or wear and tear of the product will affect accessibility to lead.

The greatest risk was assigned to products for which both factors had a high magnitude. See Appendix F for a summary of the five Product Groups.

A total prohibition of lead in any form in all consumer products would be unrealistic since consumers, especially children, are constantly being exposed to very low baseline levels of lead in the environment.

To fairly reflect the reality of these low background lead levels as they affect Canadian and other industrial processes and to maintain a wide choice of consumer products on the Canadian marketplace, specific lead content standards and performance standards in the proposed regulations are in harmony with international standards and those of Canada's trading partners.

There are three groups of products which may contain lead and to which children may potentially be exposed which are not included in the current Strategy. These groups are:

• 1. Household Furnishings and Fittings with which Children are Likely to Interact, such as furniture and furniture and coverings, vent coverings, railings, windows and window covering products, carpeting, rugs, and other floor coverings, wall paper, doors and door trim, gift-wrapping paper, ribbons, bows and other gift-wrap items, Christmas tree ornaments, garlands, and other holiday trim.
• 2. Products Intended to be Used in Public Spaces, such as tools, nails, screws and other fasteners, scuba dive weights, exercise weights, caulking lead and casketing, and leaded greases.

These two categories contain a very broad range of products. Regulatory controls on the lead content of these products would affect a large number of industry sectors, and require extensive consultations. Since the risk of lead exposure to children is not as great for these products as for Groups 1-5, Health Canada has decided to develop a separate strategy at a later date to address the risks of lead exposure associated with these categories of product. This will allow Health Canada to proceed more quickly to control the greater risks of lead exposure associated with product groups 1-5.

• 3. Products used for Hunting, Target Shooting or Fishing, such as shot used for hunting or target shooting, and sinkers and jigs (weighted hooks) used for fishing and angling. A number of potential adverse effects for both the environment and for human health are associated with these products (see Appendix G for a fuller discussion of the environmental and health impacts of leaded hunting and fishing products). However, it is unclear whether or not Health Canada has the authority under the Hazardous Products Act to regulate the sale of these products. A legal opinion on this issue is being sought. Jurisdiction over the use of lead shot and lead sinkers and jigs is shared by a number of federal and provincial agencies, including Environment Canada and Parks Canada. Because of this jurisdictional complexity, it is considered that a separate Strategy should be developed for fishing and hunting products, with substantial input from all stakeholder agencies.

6.2 Proposed Regulations

The consumer products included in the proposed lead reduction regulations under this Strategy have been divided into five categories as follows:

The proposed regulations for each product category are outlined below:

6.2.1. Group 1: Products Likely to be Ingested in Significant Quantities

Examples of Group 1 Products

• children's crayons
• children's modelling clays
• children's paints, including finger paints and make-up paints
• chalk

Lead Limits:
For each individual component of Group 1 products which is likely to be ingested, total lead must not exceed 75 mg/kg. Migratable lead therefore can not exceed 75 mg/kg.

Intent:
The intent of the Group 1 lead content restrictions is to protect consumers, especially young children, from exposure to lead through ingestion of a Group 1 product.

Rationale:
Group 1 products are not only mouthed, but often ingested by young children. Most young children have ready access to these products, especially crayons, and over a period of time could ingest sufficient quantities to create a risk of exposure to harmful levels of lead. A 1994 risk assessment carried out by Health Canada demonstrated that levels of lead in crayons greater than 75 ppm would be sufficient to raise children's blood lead to harmful levels if it is assumed that one 14 g crayon is consumed per year.

The following exemptions apply to Group 1 products:

• food, beverages, medicines, or other products which are intended for human consumption (Lead contamination of these products is regulated under the federal Food & Drug Act.)

6.2.2 Group 2: Products Intended to be or Likely to be Placed in or near the Mouth (Excludes Products in Group 1)

Examples of Group 2 Products:

• plastic beverage straws (lead migration from straws is more likely to occur through contact with the saliva than with the beverage)
• mouthpieces used in sports such as snorkels, SCUBA mouthpieces, breath deflectors and mouthguards
• musical instruments with mouthpieces, such as tin or penny whistles, kazoos, flutes and recorders
• pacifiers, baby bottle nipples, teethers, rattles
• crib toys
• toys labelled by manufacturers as being suitable for children less than three years of age, or which are likely to be used by a child of less than three years of age

Lead Limits:
For each and every individual component of Group 2 products which is intended to be or likely to be mouthed, total lead must not exceed 90 mg/kg. By definition, therefore, migratable lead cannot exceed 90 mg/kg.

Intent:
The intent of the Group 2 lead content restrictions is to protect consumers from exposure to lead through use of products or product parts which are normally placed in or in close proximity to the mouth. The restrictions also protect children under 36 months of age, whose normal behaviour entails mouthing objects in the course of exploring the world about them, by ensuring that the lead content of consumer products which they are most likely to mouth is reduced to the extent practicable.

Rationale:
Mouthing of objects containing lead results in lead-contaminated saliva which is absorbed from the digestive system into the body. In view of lead's deleterious effects on young children even at very low concentrations, it is essential to ensure that the risk of lead exposure associated with this group of products is negligible. This is achieved by limiting the total allowable lead content for each individual component of a Group 1 product to 90 mg lead per kg of product component. The 90 mg/kg standard is based on the European Committee for Standardization's European Standard EN-3, entitled "Safety of toys - Part 3: Migration of certain elements", issued in December 1994 (27) which limits leachable lead content in toys intended for children under six to 90 mg/kg.

There are two reasons for choosing this standard:

1. There is no known correlation between total and migratable lead that can be used to predict migratable lead from the total lead content of a specific product.
2. Mouthing new products which have protective coverings or coatings over the lead may not produce significant leaching of lead. However, mouthing may result in high exposure to lead when aging and wear have damaged the covering or coating, exposing the lead beneath. Mouthing itself has a wearing effect on coverings and coatings. As a result of a 1998 consumer complaint, Health Canada tested the two pendants of a child's necklace for migratable lead content. Both pendants had a core composed of approximately 75% lead, and both were covered with a decorative coating, When new, one pendant was found to contain non-detectable levels of migratable lead and the other contained 0.69 mg/kg migratable lead. However, when identical pendants that had been chewed by the complainant's child were tested, the migratable lead level of one was 251.6 mg/kg and of the other, 104.0 mg/kg. These levels considerably exceed the 90 mg/kg leachable lead limit set by the EN-3 standard. Once the thin protective coating was partially removed through the reasonable and foreseeable actions of a child, unacceptable levels of lead were released.

Restricting the total allowable lead to 90 mg/kg ensures that the maximum migratable lead limit will never be exceeded with time or use. It is intended to ensure that there will be no intentional use of lead in the manufacture of Group 2 products. While there should be no intentional use of lead in Group 1 products, it is impractical to establish a lead content limit at or near zero, because of the occurrence of trace amounts of lead everywhere in the natural and human environment.