Lead Risk Reduction Strategy

Appendix E. The Lead Strategy - Results of the Public Consultation Process

The Lead Strategy - Summary Report
Results of the Public Consultation Process

The Delphi Group & Health Canada
November 1998

I. National Feedback Objectives

The Product Safety Bureau of Health Canada has been working diligently with key stakeholder groups to develop a Strategy to reduce the lead content of consumer products, especially those products intended for use by children.

The Product Safety Bureau utilized stakeholder feedback sessions in three Canadian cities: Vancouver, Montreal and Toronto, to develop an outline for the national Lead Strategy. The objectives of the feedback sessions were as follows:

• To communicate to the session participants the regulatory and non-regulatory options available to the Product Safety Bureau for the purpose of reducing the lead content of consumer products,
• To determine which options are supported by the stakeholders and the rationale for their support,
• To document any additional issues that will assist with the formation of the final draft of the Lead Strategy.
• To communicate to the stakeholders the next steps that the Product Safety Bureau will take to deal with this issue.

II. Feedback Session Activities and Attendance

• The evaluations conducted at each National Feedback Session suggested that there was a high degree of agreement amongst participants that the session's objectives had been achieved. (please see Appendix A for evaluation results).
• Vancouver attendance was low (10) in comparison to the number of invitations that were mailed. The Montreal session had better attendance (15) but several of the manufacturing representatives commented that attendance from the business sector was surprisingly poor given the importance of the agenda. Toronto had the largest turnout (28) with a good balance of business and health stakeholders.
• In all three cities, the following agenda items took place: presentations by Health Canada staff, question and answer periods and group discussions. Evaluations suggested that the group discussions added clarity and also assisted with the achievement of the session's stated objectives.
• The sessions were facilitated by:
  
  Vancouver:

  Diana Cartwright & Bruce Dudley
  Montreal:

  Christopher Duschenes & Bruce Dudley
  Toronto:

  Diana Cartwright & Bruce Dudley
• All facilities were well equipped and arranged in accordance with the room layouts provided. However, in retrospect, the Toronto session would have been improved by the use of a larger room in addition to a breakout room for the purpose of group discussions. Food was also available for each session and was of high quality. In Toronto, there was a minor problem with the visual aids (high resolution overhead did not work) however, this technical difficulty was minimized by utilizing back-up color overheads which Health Canada staff had prepared in advance.
• The sessions provided valuable insights on various aspects of the Lead Strategy. In addition, individuals who completed the evaluation forms indicated that the process was beneficial.

III. Session Themes from Discussion

The following points were developed from discussions during both the question and answer periods and group discussions:

• Several discussions were held concerning the degree of threat (risk) that lead poses to both children and adults. These discussions were commenced by both health and business stakeholders. Is the Lead Strategy directing resources to a low priority item? -This will be addressed by a cost/benefit analysis.
• Rationale for selecting extractable versus total lead as the basis for the lead strategy .
• Discussion regarding focused regulation (as opposed to a shotgun approach) was a recurring theme. The concept described a targeted approach to reduce the impact to business in areas with little or no concern while focusing Health Canada on problem "hot-spot" areas., e.g. "adds value not cost", "results in a level playing field", "should not suppress business opportunities".
• Children need to be the focus of the effort as they are at greatest risk. Additionally, discussion supported the notion that regulation should be used to protect the vulnerable members of society. Voluntary mechanisms may be utilized to address other areas.
• The issue of lead dust surfaced in several discussions and it was agreed that this issue would be reviewed by the Product Safety Bureau of Health Canada.
• Representatives of business, health and consumers organizations raised concerns regarding voluntary mechanisms. It was suggested that limited knowledge of these mechanisms could cause problems.
• Defining a strategy that works (has the desired outcome) by the most efficient means possible was a goal that was stated by all participants.
  
  
• The issue of accountability surfaced across the country and was present regardless of the mechanism being discussed. All parties concerned should understand their role in addressing lead in consumer products. Additionally, all parties should be held accountable for that role.
• To ensure that benefits are being realized, the results of the Lead Strategy efforts must be monitored and made available.
• The Canadian Lead Strategy should interface with international efforts in other countries such as the US and Europe. Our efforts must complement these without creating trade barriers.
• Efforts are required to improve the Canadian response to situations wherein products are identified as a problem.
• Whether the approach is voluntary , regulated or a combination of both, clarity is essential to avoid confusion and to improve the effectiveness of the Lead Strategy -the "hot spots" need to be well defined.
• Efforts to address what may be "largely" an off-shore issue, must ensure that the Canadian strategy does not penalize domestic manufacturers.
• The issue of product review was discussed and on several occasions it was suggested that Health Canada should continue to act as a "watch-dog." This includes both product testing and inspection. It was also suggested that product bans would be an effective means of getting dangerous products off the shelf.
• The need for consumer education was identified through several related discussions. Additionally, consumers have a need for information so they may make informed choices. Product labelling was also discussed.
  
  
• Concern was expressed regarding older products such as antiques. Concern was also expressed regarding new products which are constantly being introduced into the market.
• Discussion also took place on the subject of lead being present in a product to serve a purpose, versus being present for no apparent reason. There was strong support for the elimination of lead that serves no practical purpose.
  
  
• Self declaration, by industry, was discussed as a component of the voluntary mechanisms. This prompted additional discussion on the need for tougher penalties for businesses which take advantage of voluntary components.
• A long lead time on the implementation of the strategy was discussed. This would give the manufacturing, retail and importer sectors time to adjust.

IV. Thrust of Session Themes

Key themes were generated in all three cities; however, there were subtle differences which have been reflected in the discussion items and again in the evaluation feedback. The following points were present in all three exercises:

• That a regulatory approach be used for products designed specifically for use by children. This approach should also deal with the issue of lead dust where product application and total lead warrants.
  
  
• That voluntary mechanisms be used to reduce levels of extractable lead for products designed specifically for use by both children and adults
• That Health Canada continue to develop the Lead Strategy utilizing stakeholder input to create an efficient yet effective mechanism for the control of lead in consumer products.

The results of the tally regarding preference of regulations or voluntary mechanisms were as follows:

	Regulatory	Voluntary	*Combination	No Opinion
Vancouver	0	0	10(100%)	0
Montreal	3(20%)	0	12(80.0%)	0
Toronto	8(28.6%)	0	15(53.6%)	5(17.9%)

*Support for the combination approach in Toronto was based on several modifications to the concept. This included the idea that problem areas or "product hot-spots" could be drawn into the regulation when deemed necessary. Additionally, efforts should be made to limit the impacts on products when little or no risk is identified.

V. Process Recommendations

The national feedback sessions have been a positive experience for many of the stakeholders. Health Canada should take action on the following general and specific recommendations. This will facilitate the continued development of the Lead Strategy:

General Recommendations

• Communicate the results of these sessions to the participants as soon as possible and encourage feedback. This will ensure that there is agreement on the summary of the sessions. (This is required to ensure the integrity of the process).
• Prepare a press release to communicate the action that Health Canada has taken and is taking to deal with the issue of lead. This release should describe specific actions. (See specific recommendations).
• Develop a communication mechanism in order to keep stakeholders and other interested parties up to date on the development of the Lead Strategy .e.g. a fax server utilizing a group fax function would be an ideal communication tool for an update that could be sent every 2-3 months.

Specific Recommendations

• Develop a smaller working group made up of key stakeholders. (e.g. The Learning Disabilities Association of Canada and the Retail Council of Canada. ) This working group may assist in the completion of the details of the Lead Strategy. Participants who are not paid by an employer should be paid a stipend to cover expenses and travel costs.
  
  
• Develop in-house expertise at the Product Safety Bureau regarding voluntary mechanisms.
• Finalize the Lead Strategy and proceed to implementation as soon as possible.
• Establish an evaluation group to not only review the results of the Lead Strategy efforts but also to discuss ongoing requirements. e.g. support/education.

Lead Strategy Framework Recommendations

The Lead Strategy's framework is of critical importance to the successful reduction of lead in Canadian consumer products. The Delphi Group recommends the following framework:

Regulatory

• The Product Safety Bureau will need to continue its role as monitor and enforcer . e.g. product testing and compliance monitoring. Health Canada should be seen visibly pursuing this role.
• Develop a "product banning mechanism" that may be used in extreme cases, where products are determined to pose imminent danger to Canadians.
• Regulations should target products intended for children (with a defined age range.) This encompasses products which are intended to be or likely to be mouthed by children.
• A mechanism to bring specific product lines within the purview of the regulations should also be defined and described for future "hot spot issues".

Voluntary

• develop a supportive policy framework for the voluntary component of the Lead Strategy. Voluntary mechanisms which lack a legislative or policy support often have a minimal effect.
• Develop and describe the various components of a voluntary mechanism. These components should define the following:
  • Voluntary Covenants/partnerships - self management
  • Supply Chain Management
  • Pollution Prevention (lead elimination or replacement)
  • Labelling/education
• Develop the content of the voluntary mechanisms. This should include, as a minimum, the following:
  • clearly defined targets and objectives
  • the free loader clause
  • positive and negative incentives (links to reg's)
  • monitoring effectiveness and accountability
  • Define support for the development of this innovative and proactive approach to dealing with lead in consumer products.

The National Feedback Sessions demonstrated that there exists support for an innovative approach to dealing with the issue of lead in consumer products, provided the risks to Canadians and their children are managed.

Appendix A
Evaluation Responses

Fifty-three participants attended the National Feedback Sessions, of which 38 (71.1% ) completed evaluation forms. The following is a sampling of the feedback received from the evaluations:

1. Do you feel the meeting accomplished its objectives
   • Poor
     0
   • Acceptable
     0
   • Good
     4
   • Very Good
     29
   • Excellent
     5
   • Average = 4.02
     
     
2. What did you like best about the session?
   • group discussion
   • well represented by a wide range of players
   • bilingual presentations
   • open discussion with the various interest groups
   • Health Canada officials much clearer and less defensive
   • good opportunity for discussion
   • frankness of information provided by presenters
   • approach on extractable lead
   • opportunity to be heard
   • facilitators and presenters did a great job
   • ample opportunity for input
   • the need to take a step back to consider the strategies
   • networking
   • exchange between different people from different disciplines
     
     
3. What did you like least about the session?
   • difficult to hear with 2 focus groups going on at once
   • cramped meeting room
   • too large a group
   • Health Canada representatives did not speak enough French
   • not enough time to ask questions
   • no clear pathway left for us by Health Canada
   • not enough background e.g. risk index
   • too much attention to regulatory/voluntary
   • not enough discussion about the benefits -how many children have been poisoned by lead
   • constant focus on blind issue -consensus should be based on products intended &
   • likely to be used by children
   • presentation
   • not enough technical discussions which I feel are relevant to the issue
   • not enough representation from industry
   • it was difficult to understand some of the English content
   • nothing negative
     
     
4. Were there any unanswered questions or concerns that you would like follow-up?
   • Is there any reason why Canada cannot be the leader in setting lower levels of lead for products?
   • Off -shore products should be monitored, regulated and if they don't comply, penalized.
   • timing of the final report from Health Canada?
   • opportunity for further input into "final report"
   • why didn't we go to the US TDI (15 mg/day) total for the risk assessment?
   • I would hope that Canadian manufacturers will be informed now that Health Canada is moving to regulate lead.
   • for persons without the background on the issue -needed more history
   • issue of limits on total lead (not just leachable needs to be addressed, since disposal of consumer products (i.e. incineration) could permit entry of lead into environment
   • Are there any plans to use research conducted by lead organizations such as ILMC & ILZRO in Europe?
   • unavailable data regarding injuries caused by lead poisoning
   • how will the data be gathered i.e. will physicians other than emergency and poison control be considered
   • in your feasibility study, please consider the number of unreported cases of lead poisoning
   • details on the assessment of risk: extractable lead and scenario of 8 mg
   • details of the actual rules and regulations in place
   • more information on disorders and symptoms caused by lead exposure
   • I would like to receive complimentary information on the technical aspects of the lead toxicity.
     
     
5. Do you have any additional comments you would like to make?
   • would like to continue to be involved
   • thanks for the opportunity to be involved
   • would like some Canadian and US data to indicate the need for a Lead Strategy
   • there appears to be a need for baseline data on lead poisoning
   • looking forward to follow-up
   • well conducted session
   • provide participants with proposal regarding all pathway/exposures to lead and how this will be incorporated into the lead strategy
   • be proactive from the start with respect to reducing or eliminating the overall risk
   • concerned primarily with regulations concerning imported products
   • does Europe/US use regulatory or combination method
   • all high risk products such as pacifiers should have lead component completely removed
   • As a consumer I feel that this meeting has shown me I should always buy Canadian.
   • re-emphasize harmonization with the N. American market, a regulatory approach that adds value not cost, looking at product groupings in terms of what other regulations apply to them e.g. Electrical Products and Electrical safety
   • definitions of child's toy -a child of 8-9 is not likely to mouth a toy
   • we need interim action
   • relieved to hear that lead dust is being considered in terms of children's exposure pathway
   • you provided the best hot, fresh scones I have ever had at a meeting
   • I am satisfied that my agency's concerns and interests have been fully addressed and will be reflected in the final decision.
   • I look forward to the receiving "summary", I will follow-up then if necessary .
   • a very enriching experience

Appendix B
Session Participants

Vancouver, 26 March 1996

Montreal, 25 mars 1998

Toronto, 26 March 1998