THE PRECAUTIONARY PRINCIPLE AND RISK MANAGEMENT DEFINED
Individuals, organizations and government departments define the terms "precautionary principle" and "risk management" in various ways, and there appears to be no standard definition of either term. The Committee supports the following definitions of these terms.
A. Precautionary Principle
In the absence of a generally accepted definition of the precautionary principle as it applies to health, the Committee supports the following definition, with appropriate modifications to focus on health rather than the environment. This definition is Principle 15 of the Rio Declaration 1992: "In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation." Moreover, as presented to the 1996 Women's Health Forum, the following understanding of the principle is supported by the Committee: "(The precautionary principle of environmental health) urges action prior to absolute proof of harm when there is strong indication from more than one scientific discipline and study that a substance is harmful, and when the consequences of not acting can be fatal."
B. Risk Management
Based on a November 1997 presentation by Health Canada to the House of Commons Standing Committee on Health, the risk management framework comprises the following elements:
- mission is accomplished through the continuous assessment of the risk and benefits of each product using a series of processes, including: policy development; product licensing submission review; post-market surveillance activities; and compliance and inspection;
- each process operates within a common six-step risk/benefit management framework that includes: analysis of risks and benefits; option identification and analysis; a decision; implementation of the decision; and monitoring;
- each process deals with specific aspects of safety, effectiveness and quality, at different stages of a product's life cycle;
- each process has different information available, uses different tools to analyze the information, and has different options available to address the issue;
- regulatory options correlate to the level of risk/benefit of the product; and
- some processes are client driven (such as a submission review), some are mandatory to review in accordance with the mandate (such as inspections), and some are driven by issues generated through other post-marketing processes (such as adverse drug reporting).
It should be noted that this is an adaptation of the framework, which was initially presented in the context of the Therapeutic Products Programme and therefore made specific mention of therapeutic products, rather than products more generally.
Moreover, a 1993 Health Canada publication entitled Health Risk Determination: The Challenge of Health Protection identifies a decision-making model for risk determination, and notes that the model's overall process of risk determination comprises the risk assessment phase and the risk management phase. The risk assessment phase comprises risk analysis, in which hazards are identified and their risks are estimated, and option evaluation, in which strategies for dealing with the risk are developed and analyzed. During the risk management phase, one or more options to control risk are selected and implemented. The decision is monitored and evaluated, and may be changed if needed.
THE CODEX ALIMENTARIUS COMMISSION AND THE JOINT EXPERT COMMITTEE ON FOOD ADDITIVES
The Joint Expert Committee on Food Additives (JECFA), which has existed since 1955, is the scientific advisory committee to the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations, and to Member Governments and the Codex Alimentarius Commission. The Committee's principal role is to assess the human health risks associated with the consumption of food additives, and to recommend acceptable daily intake levels, tolerable limits for environmental and industrial chemical contaminants in food, and maximum residue levels of agricultural chemical inputs in food, such as veterinary drug residues in meat and meat products. Membership on the Committee is not permanent; rather, members are appointed prior to each meeting.
The Codex Alimentarius Commission, which was established in 1962, is a subsidiary body of the FAO and the WHO that develops food standards and recommended international codes of hygienic and/or technological practices. Although Commission standards are voluntary, they become enforceable if they are accepted as national standards. As noted in the body of this report, these standards are increasingly used in disputes before the World Trade Organization.
Countries send delegations to meetings of the Codex Alimentarius Commission and its committees. From time to time, industry representatives serve on those delegations. Some Committee members are concerned about the potential conflict of interest. For this reason, the Committee urges that Canada's delegations include no representatives of companies whose products are under consideration at meetings of the Codex Alimentarius Commission or its committees.
Countries also influence the selection of JECFA panellists and advisors to those panels. Evidence was presented to the Committee that two JECFA panels on rBST contained members whose former associations with the manufacturer were well-known. The Committee also received evidence that the manufacturer proposed that Canada send an individual who subsequently served on the panel which met in February 1998. For these reasons, the Committee urges the Government to support only those Canadian scientists serving as JECFA advisors or panellists who are free of conflict of interest according to Health Canada's guidelines.
The Committee believes that public confidence in the Codex Alimentarius Commission and the JECFA, as well as in their decisions, will be enhanced when they operate in a transparent manner and when there is no possibility of allegations of conflict of interest or undue influence.
As noted in the body of this report, the Standing Senate Committee on Agriculture and Forestry experienced difficulties in receiving information from Health Canada. On 4 June 1998, Health Canada officials appeared before the Committee and made certain commitments with respect to documentation. In particular, Committee members had requested reports of the rBST internal review team. Officials indicated that the Committee would receive portions of the reports that did not reveal proprietary information or unsubstantiated personal attacks.
Ten weeks later, the Clerk of the Committee received a copy of the 21 April 1998 Gaps Analysis Report. Approximately one-third of its contents had been removed. Information was deleted in the same manner as information was removed from copies of the report released to individuals who had requested it under the Access to Information Act. Moreover, information was removed from the report which was contained in memoranda. Those memoranda had been released to individuals who requested them under the Access to Information Act, but only weeks later were provided to the Committee. Nine months after its initial request, the Committee has yet to receive from Health Canada all the documents it requested.
In the Committee's opinion, the department had removed information that need not have been removed under the Access to Information Act. In particular, it had deleted some information that had been in the public domain since 1990, and failed to provide to the Committee some information that had been made available to individuals outside the department.
Anyone using the Access to Information Act has the right to an independent review of a department's interpretation of what should be removed. The Office of the Information Commissioner can investigate and issue a non-binding finding, and the Federal Court of Canada can order the release of additional information. Since the Committee's request was not made under the Act, those review mechanisms were not available to the Committee.
The appropriate mechanism by which departments should provide information to Senate committees is found in Rule 90 of the Rules of the Senate and in the general principles governing Notices of Motions for Production of Papers tabled in the House of Commons in 1973. Powers of committees to "send for persons, papers and records" has been legally interpreted as giving virtually unlimited powers to compel the attendance of witnesses and to order the production of documents. In the opinion of the General Legal Counsel of the House of Commons, "it is inappropriate to use the access and privacy legislation in response to an attempt by a Parliamentary committee to exercise its powers to obtain production of such complete documents as are necessary in order to satisfy its terms of reference." In fact, according to Erskine May's Parliamentary Practice, which is reproduced in Beauchesne's Parliamentary Rules and Forms, witnesses appearing before committees must answer all questions put by members, and produce documents as required by the committee. If a witness refuses to provide a document which committee members feel is needed to assist their inquiry, the committee must adopt a motion ordering the production of the required information, or the attendance of the witness, and then to report the refusal to the respective House of Parliament. This avenue was not adopted by the Standing Senate Committee on Agriculture and Forestry, although the Committee does not support the manner in which documents were initially provided by Health Canada.
In view of these difficulties, and in addition to the recommendation made in the body of this report, the Committee urges the Clerk of the Senate, with the Clerk of the House of Commons, to review the issue of parliamentary committee access to documentation, both generally and with respect to departmental provision of the documentation needed for committees to do their work effectively and efficiently, and thereby best serve the Canadian public.
|17||June 4, 1998||From Monsanto:
Mr. Ray Mowling, Vice-President, Government and Public Affairs;
From Health Canada:
|20||October 22, 1998||From Professional Institute of the Public
Service of Canada:
Mr. Blair Stannard, Vice-President.
From Health Canada:
From Dairy Farmers of Canada:
From National Dairy Council of Canada:
|21||October 29, 1998||From Health Canada:
Mr. David A. Dodge, Deputy Minister;
* From the Council of Canadians:
From the National Farmers Union:
|23||November 17, 1998||From the Food Ethics Council (U.K.):
Mr. John Verrall.
|27||December 7, 1998||From Vermont Public Interest Research Group:
From Rural Vermont:
From Consumers Union, Consumer Policy Institute:
From Health Canada:
From Kooistra Farms (Illinois):
From Cave Creek Jerseys (Wisconsin):
From St. Marys Veterinary Clinic (Ontario):
From Canadian Animal Health Institute:
From Canadian Health Coalition:
From Toronto Food Policy Council:
As an Individual: