Summary of the Risk Decision Making - Assessment/Management Discussion Group, Nov 14, 2003

Participants:

Franca Ursitti, Toronto Public Health - Health Promotion & Env. Protection & OPHA Environmental Health Workgroup
Louise Aubin, Peel Region Health & OPHA Environmental Health Workgroup
Helen Doyle, York Region Health & OPHA Environmental Health Workgroup
Annette Collins, Toronto Public Health - Injury Prevention
Angela Li-Muller, Toronto Public Health - Health Promotion & Env. Protection

A2.3 - Making Decisions Regarding Risk

Concerns

1. A2.3.1 The proposed Act states that: "The assessment of risk shall be based solely on science and objective observation." The group had difficulty accepting "solely" as a limiting factor on what risk assessment is based on.

The goal of a risk assessment is to obtain a realistic estimate of the risk of a product or activity so as to inform appropriate or (optimal) risk management decisions and actions. The risk assessment process requires making various assumptions, which ideally must be based on solid scientific evidence. However, there are different degrees of scientific evidence. Therefore, there is a need to err on the side of caution in cases where there is not much information (or when there is a large degree of uncertainty? ). This kind of precautionary measure must be written into the risk assessment process. While the proposal indicates that the notion of precaution will be inserted into the risk management process, the group felt that there is a need to insert the precautionary principle into the risk assessment process as well.

Specific Recommendations

1. The precautionary principle needs to be explicitly written into the Act regarding both Risk Assessment & Risk Management.

2. Risk Assessment needs to be precautionary and realistic in order to serve overall objective which is to give a sense of the risk associated with a product or activity. The notion of realistic needs to defined by setting criteria/triggers/standards and which, in turn, need to be subject to public consultation.

3. The processes of Risk Assessment and Risk Management need to reflect ongoing changes in knowledge upon which the assessment was conducted. A regular review process should be incorporated in the Act.

4. Vulnerable/susceptible groups need to be considered in the process.
   Note: The Pest Control Products Act was mentioned as an example of a new regulation that had, to some degree, incorporated the above noted issues.

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Public Involvement in Risk Assessment & Risk Management

Specific Recommendations

1. Actively solicit public involvement in risk assessment/management.

   Process for Public Involvement

   1. Canada Gazette - the group recognized that this doesn't reach many people. It reached the group/individual already engaged in the issues. It needs to be improved made more user- friendly.

   2. The Ontario Environmental Bill of Right process/system seems to have greater reach and was seen as a better mechanism for public engagement. The electronic interface (website) is difficult to navigate. Health Canada could use this as an example, to refine and expand.

   3. Health Canada needs to work with local authorities that have extensive community networks (e.g. Tobacco Network).

   Content

   1. Risk assessment, in particular, is very technical and it can be very difficult to engage the public on very technical issues. However, the group felt that the process needed to include public consultation/notice, in particular, for anything that is being fast-tracked.

   2. The public consultation needs to be an open and active process.

2. The relationship between Health Canada and the Canadian Standards Association is unclear. For example, if Health Canada refers/adopts any CSA standards then Health Canada needs to have an active role in developing/reviewing the standards. The group felt that currently this was the case in some instances but not others. The group also felt that any standard/guideline that was developed by Health Canada alone and/ or CSA required a meaningful public consultation process. This process needs to be more open/transparent than it currently is.

3. Some existing regulations need to be rolled over into the new scheme as regulations or incorporated into the Act (group to identify some of these).

4. Create a prohibited Substance/Products List: link to CEPA toxic list/HPA part 1 of Schedule 1 (banned items list) / Consumer Chemical Containers Regulations - Part 2 of Schedule 1.

5. The group felt strongly that chronic/acute toxicity need to be considered in risk assessment. Currently the proposal bases toxicity on acute affects only.

Questions Raised

1. How are the voluntary standards going to be included in the new Act? Will they be incorporated into regulations?

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Lifecycle of Products

Specific Recommendations

1. Section H of the proposal indicates that anyone along the line (i.e. the whole lifecycle) will be responsible for the product and any potential undue risk it may cause to health. However, the proposal is not clear where this Act would apply. This needs to be further detailed by Health Canada.

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Implementation of the Act

Q19: Will supplier have difficulty complying with General Safety Requirement?

1. Complying with GSR will be difficult particularly as it relates to enforcing end user reselling (eg. Selling recalled products at garage sales)

2. Given the Internet trade market there is a need for clear and comprehensive Customs screening requirements

3. The group saw strong labeling requirements on the product/at points of purchase as being an important way to comply with the General Safety Requirement and to minimize contravention later along the supply chain. Manufacturers instructions need to be included/affixed to the product for and included instructions for proper use and disposal.

Specific Recommendations

1. Health Canada needs to commit resources to implement the Act (in particular the General Safety Requirement) which includes a) the characterization of undue risk b) enforcement. Health Canada will need to invest in research activities to support a) and b).

Questions Raised

1. Will the new Act allow for more stringent provincial regulations/local by-laws to take precedence over the federal Act/regulations?

2. Is any product(s) going to be grand-fathered with respect to the General Safety Requirement e.g. lead in crystal

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