Proposed Group 2 Regulations Under the Lead Risk Reduction Strategy for Consumer Products (LRRS)

Stakeholder Consultation - November 2011

1. Purpose

Health Canada's objective in distributing this consultation document is to provide stakeholders with an opportunity to comment on proposed new lead content restrictions under the Lead Risk Reduction Strategy for Consumer Products (LRRS) before the formal regulatory process is initiated. Identifying and resolving stakeholder concerns through early consultation is expected to facilitate the development of effective and workable lead content regulations for affected products.

2. Background

Lead is an inexpensive heavy metal which has many potential uses in children's products, but the substance is very toxic, especially to children, even at low doses. Lead builds up in the body so ongoing exposure, even to relatively low levels of lead, can eventually result in accumulation of harmful levels in the body. Lead has been shown to have subtle effects on children's development even at very low blood lead levels. No safe level of lead in the blood has been identified by the international scientific community. However, since lead occurs naturally in the earth, and has been used industrially for centuries, it is found in trace amounts everywhere. It would be impractical for regulators to set limits of zero lead in products, since testing will always show detectable amounts of lead.

Children are especially at risk of exposure to lead in consumer products, since exposure occurs mainly when lead-containing products are chewed, sucked, or swallowed. Lead is a soft metal and some exposure can also occur when objects with surfaces containing high amounts of lead, such as lead figurines, are handled and the hands are then put to the mouth.

The  Canada Consumer Product Safety Act (CCPSA), which replaced Part I and Schedule I of the Hazardous Products Act, came into force on June 20, 2011. The Act includes prohibitions on the manufacture, import, advertisement or sale in Canada of consumer products which pose an unreasonable hazard to human health or safety.  The CCPSA also prohibits the supply of products that do not meet the requirements set out in the regulations. There are various regulatory limits on the lead content of children's products under the CCPSA. However, current regulations do not address all children's products or product components which may create a risk of chronic exposure to lead.

The LRRS proposes lead content limits for four categories of consumer products to which children are most likely to be exposed.  Group 1 Regulations have been enacted as the Consumer Products Containing Lead (Contact with Mouth) Regulations. These Regulations, which are under the CCPSA, can be viewed at the  Justice Canada site.

3. Regulatory Proposal

This regulatory proposal would extend the scope of the  Consumer Products Containing Lead (Contact with Mouth) Regulations to additional product groups. The proposed changes are indicated below. This is not an official regulatory draft.

Definitions:

The definition of "consumer product containing lead" would be expanded to include:

1. products intended for use in play or learning by children aged 3-13
2. child care articles intended for use in caring for children under the age of 4 years
3. clothing or clothing accessories intended for children under the age of 14 years

The following definition would be added: 

"child care article" means a product that is intended to facilitate the carrying, transport, relaxation, sleep, or hygiene of a child under four years of age

Regulated Activities

To align with the provisions of the  Canada Consumer Product Safety Act, the scope of the regulations will be adjusted to include the manufacture of affected products, as well as the import, advertisement or sale.

4. Specific Questions for Stakeholders

Some questions which stakeholders may wish to comment on are outlined below.  However, Health Canada welcomes stakeholder input on all areas which directly relate to the above regulatory proposal. 

4a. Clarity

• 1. Is the meaning of the proposed text, including the definitions, clear? If not, what clarification is needed?

4b. Scope of the Regulations

• 2. Is the scope of the regulatory proposal clear? If not, what clarification is needed?

If you are unsure whether specific types of products would be affected by this proposed regulatory initiative, please identify these product types.

• 3. Is the scope of the regulatory proposal sufficient to adequately protect children against lead exposure from children's products?

4c. Technical Feasibility

• 4. Is the 90 mg/kg total lead limit technically feasible for accessible parts of affected products?
• 5. If not, for which types of products, or product parts, is the proposed limit of 90 mg/kg total lead not technically feasible? If possible, indicate why the limit is not feasible for each part identified.
• 6. For each part identified in Question 4, indicate whether the proposed conditions of exemption for parts that cannot feasibly meet the total lead limit are workable.

4d. Economic Impact (for industry stakeholders)

• 7. Do you anticipate that the proposed regulations will have an economic impact on your company or your business sector?
• 8. If yes, what kind of impact?  (A quantitative estimate would be appreciated.)

4e. Coming into force

Unless otherwise specified, federal regulations come into force on the date they are registered. To allow for a transition period, the regulations may indicate that they come into force a specified period of time after the day on which they are registered.

• 9. Would you recommend a transition period to allow industry more time to comply with the proposed regulatory change? 
• 10. If yes, please indicate why you would recommend a transition period.
• 11. Is a transition period recommended for some affected products, or product parts, and not for others?  If yes, please identify these products/parts and indicate why a transition period is recommended for these products/parts.
• 12. What length of transition period would be appropriate? 

4f. Testing and Certification

The  Consumer Products Containing Lead (Contact with Mouth) Regulations do not require the use of any specific test methodology for determining total lead content. However, parts exempted from the total lead limit of 90 mg/kg must be tested for compliance with the 90 mg/kg migratable lead limit using the EN71-3 methodology specified in the Regulations.

While companies are advised to test products they market in Canada to ensure that they are compliant with all applicable health and safety requirements, this regulatory proposal does not include mandatory requirements for testing and certification of affected products and product parts.

• 13. Please identify any concerns related to this regulatory proposal regarding testing of affected products or product parts.

4g. Other Issues

Please identify any issues of concern which do not fall into the areas listed above.

5. Further Consultation

Health Canada will review and respond to stakeholder comments received on this consultation document by providing a written summary of the comments and Health Canada's responses. Further consultation activities may be undertaken, if appropriate, between completion of this consultation and initiation of the formal regulatory process. The formal regulatory process includes an additional opportunity for stakeholder to provide input, generally in the form of a 75-day comment period following pre-publication in  Canada Gazette, Part I.

6. Submission of Comments

Stakeholders may submit comments in any written form, by regular mail to the address below or by e-mail to CPS-SPC@hc-sc.gc.ca. Respondents may wish to respond directly to the questions above.

The closing date for submission of comments on this proposal is February 17, 2012.

Consultation on proposed Group 2 Regulations under the Lead Risk Reduction Strategy for Consumer Products
Risk Management Bureau
Consumer Product Safety Directorate
Health Canada
123 Slater Street, 4^th floor, Address locator 3504D
Ottawa, Ontario
K1A 0K9