Session 7: Population Health Risk Management

EPI 5181 Dr. Daniel Krewski

Regulatory and Non-Regulatory Options for Population Health Risk Management • Regulatory Options – Direct Regulation – Self Regulation – Permits/Approvals • Economic Options – Insurance and Other Compensatory Schemes – Levies and Other Cost Structure – Fiscal Support McLaughlin Centre for Population Health Risk Assessment Session 7 – 2/37

Regulatory and Non-Regulatory Options for Population Health Risk Management • Advisory Options – Consultative Approach – Administrative Approach – Disclosure and Adverse Publicity – Worker Information – Public Awareness • Technological Options • Community Action McLaughlin Centre for Population Health Risk Assessment Session 7 – 3/37

Precautionary Principle

• ‘Better safe than sorry’ principle • A tool to aid decision-making in the face of uncertainty • Origins in European environmental regulation • Fast becoming a fundamental principle of international environmental law – Present in over 20 international laws, treaties, protocols and declarations • Application to health risk management?

– Currently unclear – Widespread debate regarding the definition, scope and implementation of the principle – 14 different interpretations currently in use worldwide McLaughlin Centre for Population Health Risk Assessment Session 7 – 4/37

Rio Declaration

“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.”

Rio Declaration on Environment and Development, 1992 (Principle 15) McLaughlin Centre for Population Health Risk Assessment Session 7 – 5/37

high Scientific Uncertainty

Applicable Issues

Climate Change Biodiversity Loss Particular Matter Ozone Depletion BSE & vCJD GMOs low less serious reversible Harm McLaughlin Centre for Population Health Risk Assessment serious irreversible Session 7 – 6/37

The Debate

Interest groups say… Industry says… – – – – Creates presumption in favour of health and safety Prevention of harm is preferable to abatement of harm

after

it has occurred Scientific risk assessment is not perfect Focus on solutions instead of establishing tolerable levels of problems – Is vulnerable to abuse due to lack of uniform interpretation • e.g. trade protectionism – Impedes technological / economic development – Threat to sound science – Limits consumer choice – There’s no such thing as zero risk!!!

McLaughlin Centre for Population Health Risk Assessment Session 7 – 7/37

Moving Forward

• Implementation of Precaution in Canadian Policy will require the resolution of a number of important issues: • What is the scope of the principle?

− Specific toxic chemicals? All toxics? All environmental contaminants? All health policy? All public policy ??? • Does the principle impose a duty to act with precaution, or simply a duty to consider precautious alternatives?

• Who holds the burden of proof – the regulators, or industry?

• What is the required standard of evidence (of harm, safety)?

• To what extent should the costs and benefits of a technology be considered? • What level of risk is acceptable in order to benefit from a technology?

McLaughlin Centre for Population Health Risk Assessment Session 7 – 8/37

Precautionary Principle Proceed with Caution

McLaughlin Centre for Population Health Risk Assessment Session 7 – 9/37

Risk-Based Decision Making

• Expend risk management resources in proportion with the amount of risk anticipated

In contrast to the precautionary principle, risk-based decision making requires evidence of risk before intervention. Unlike the precautionary principle, the level of effort expended to control risk is related to the level of demonstrated risk.

McLaughlin Centre for Population Health Risk Assessment Session 7 – 10/37

Health and the Environment CEPA: Power and Responsibilities of the Minister of Health • Part I (Guidelines) – Formulate health-based objectives, guidelines and codes of practice • Part II (Toxic Substances) – Collect data and conduct investigations for assessment purposes – Priority Substances Program – New Substances Program – Strategic Options • Part V (International Air Pollution) – Assess health impact of Canadian sources or air pollution outside Canada McLaughlin Centre for Population Health Risk Assessment Session 7 – 11/37

Health and the Environment Health Assessments Under CEPA • To determine whether a substance “…is entering or may enter the environment in a quantity…that may constitute a danger in Canada to human life or health.” McLaughlin Centre for Population Health Risk Assessment Session 7 – 12/37

Health and the Environment CEPA Assessment of Priority Substances • A substance is deemed “toxic” under CEPA if it enters or is present in the environment in concentrations: a) having or that may have an immediate or long term harmful effect of the environment; b) constituting or that may constitute a dancer to the environment on which human life depends; or c) constituting or that may constitute a dancer in Canada to human life or health McLaughlin Centre for Population Health Risk Assessment Session 7 – 13/37

Health and the Environment Outcome of PSL 1 Assessments • 25 of the 44 PSL 1 substances have been designated as CEPA “toxic”, many on the basis of concern for human health • Strategic options process (SOP): control options for toxic substances are developed through multistakeholder consultations McLaughlin Centre for Population Health Risk Assessment Session 7 – 14/37

Health and the Environment

Evaluation •Population health Problem/Context •Identify issue & hazard •Population health approach •Surveillance •Targeted risk assessment & health research Risks •Data from: surveillance, approach •Broad problem context •Surveillance •Targeted risk assessment •Targeted health research •Consultation with experts Engage Stake-holders •Communication •Stakeholder participation •Review Actions •Develop plan •Identify roles & responsibilities •Commit resources •Identify monitoring & evaluation needs Emergency Response Trigger Decisions •Select risk management strategy epidemiology, toxicology, exposure and statistical analyses Options •Review regulatory/ non regulatory options •Risks, costs, benefits, legislative, jurisdictional, sociocultural factors McLaughlin Centre for Population Health Risk Assessment Session 7 – 15/37

Health and the Environment

Air Pollution Health Effects Pyramid Severity of Effect Mortality Hospitalizations

Emergency Room Visits

Medication Use Respiratory Symptoms Lung Function Impairment Subclinical Effects Population Affected McLaughlin Centre for Population Health Risk Assessment Session 7 – 16/37

Overall Process – Sulphur in Gasoline

Task A Process Setup Environment Canada, Health Canada, CPPI, Provinces Review Process Data Task B Basic Data & Information on Atmosphere, Health Effects, Env. Effects, Costs and Competitive Impacts Task C Fact Finding Steering Committee Stakeholder Advisors (Other Provinces, Federal Departments, NGOs, etc.) Manager Secretariat Atmospheric Science Panel Health & Env.

Impacts Assessment Panel Expert Panels Cost and Competitiveness Assessment Panel Options and Recommendations Governmental Working Group Broad Consultation with all stakeholders Ministers/ Cabinet Deputy Ministers McLaughlin Centre for Population Health Risk Assessment Session 7 – 17/37

Federal-Provincial Subcommittee on Drinking Water

• Guidelines for Canadian Drinking Water Quality • Subcommittee Organization – Federal-Provincial Committee on Environmental and Occupational Health (CEOH) – Federal, provincial and territorial representation – Secretariat – Health Canada • Publications – Sixth edition of guideline booklet (1996) – Supporting documentation McLaughlin Centre for Population Health Risk Assessment Session 7 – 18/37

Drinking Water Guidelines Development Process

McLaughlin Centre for Population Health Risk Assessment Session 7 – 19/37

Drinking Water Quality Guidelines:

Physical/Chemical and Radiological Parameters

100 80 60 40 20 0 45 0 1968 52 5 1978 79 5 1987 82 5 1989 82 5 1993 64 80 1996 Radiological Physical/Chemical

McLaughlin Centre for Population Health Risk Assessment Session 7 – 20/37

Microbiological Contaminants in Drinking Water: Micro-organisms and Human Health • Drinking water that is contaminated with human or animal faecal material may contain a wide range of pathogen micro-organisms. These pathogens can be divided into: – Viruses – Hepatitis A – Bacteria – E. Coli 0157 – Protozoa - Giardia McLaughlin Centre for Population Health Risk Assessment Session 7 – 21/37

Factors Influencing Human Health Risk from Water-Borne Pathogens

• Concentration of pathogen • Minimum dose capable of producing infection • Virulence of the pathogen and immune status of the host • Volume of water ingested McLaughlin Centre for Population Health Risk Assessment Session 7 – 22/37

Disease Outbreaks: Boil Water Advisories in British Columbia, 1986-1996

250 200 150 100 50 0 1986 1988 1990 1992 Year 1994 1996

McLaughlin Centre for Population Health Risk Assessment Session 7 – 23/37

International Drinking Water Quality Guidelines: World Health Organization • 40 countries participated in the preparing of second edition guidelines, 1993 • Develop guide for individual countries • No tolerable lower limit guidelines for pathogens • Guidelines for microbiological parameters: bacterial, virological and parasitological quality • Guidelines for chemical parameters: threshold effects, non-threshold effects and potential carcinogens (respect IARC classifications) • Guidelines for radioactive parameters McLaughlin Centre for Population Health Risk Assessment Session 7 – 24/37

Framework for Management of Drinking Water Quality: A Preventative Strategy from Catchment to Consumer McLaughlin Centre for Population Health Risk Assessment Session 7 – 25/37

Recommendations from Walkerton Inquiry

• Enhanced population health surveillance • Scientific methods for characterizing microbiological risks • Source water protection • Total water quality management • Minimization of risk McLaughlin Centre for Population Health Risk Assessment Session 7 – 26/37

Great Lakes Basin Cancer Risk Assessment Study

• Case-control study: relationship between various drinking water parameters and cancers of the bladder, colon and rectum • Dr. L. Merret, W.King (University of Toronto and Ontario Cancer Treatment and Research Foundation) • Dr. Y. Mao (LCDC – Health Canada) • 5 000 residents of Ontario counties south of Sudbury and Timiskaming (60% served by water from Great Lakes) • Cases identified from directories

Ontario Cancer Registry

and matched controls identified at random from telephone McLaughlin Centre for Population Health Risk Assessment Session 7 – 27/37

Trihalomethanes in Great Lakes Study

Cancer risks associated with years using water with TMH levels greater than 50 ppb

Bladder Cancer Colon Cancer Rectal Cancer

SR SR

10 to 19 years 20 to 34 years 35 years or more 0 0.5

1 Relative Risk 1.5

2

The above risks are relative to the risk associated with the use of water with THM levels greater than 50 ppb for 0-9 years in the last 40 years SR = Increased risk; not likely due to chance McLaughlin Centre for Population Health Risk Assessment Session 7 – 28/37

Trihalomethanes in Great Lakes Study

Distribution of study population according to estimated THM levels in their water supply in 1990

20% 18% 45% Less than 25 ppb Between 25 and 49 ppb Between 50 and 74 ppb Greater than 75 ppb 17%

McLaughlin Centre for Population Health Risk Assessment Session 7 – 29/37

Scope of Proposed DWMSA

McLaughlin Centre for Population Health Risk Assessment Session 7 – 30/37

Risk

• The risk of a medical device is determined by the

adverse health outcomes

that may be sustained by the patient or provider, as a result of using the device, and the

likelihood

of such adverse effects occurring.

McLaughlin Centre for Population Health Risk Assessment Session 7 – 31/37

An Improved Medical Devices Regulatory Program New Directions Revised Policies New Bureau Improved Medical Devices Program Improved Communications International Harmonization Improved Safety Collaborative Approach McLaughlin Centre for Population Health Risk Assessment Session 7 – 32/37

Community Action

• International Endorsement – WHO Constitution (1946) “Informed consent and active cooperation are of utmost importance in the improvement of the health of the people.” – National Policies on Health Education and Promotion: Call for greater citizen participation in prevention planning.

– Ottawa Charter for Health Promotion: Incorporates “Strengthen Community Action” McLaughlin Centre for Population Health Risk Assessment Session 7 – 33/37

Community Action

• Successful community programs evolve from a high degree of community involvement and sense of ownership • Community participation involves people in: – Defining their own needs – Setting their own priorities – Controlling their own solutions – Evaluating their own progress L.Green, 1986 McLaughlin Centre for Population Health Risk Assessment Session 7 – 34/37

Community Development

• A process to establish partnerships with community members to build strength (social and economic), self-reliance and well-being • A process for planned change that helps build healthy communities McLaughlin Centre for Population Health Risk Assessment Session 7 – 35/37

Goals of Community Development

• Task Goals: – Concrete outcomes – Tangible results produced – Improve quality of life • Process Goals: – Group development goals – Strengthen community confidence and self-esteem – Transfer skills – Attain community ownership/control McLaughlin Centre for Population Health Risk Assessment Session 7 – 36/37

Comparison

• Traditional Health Services Approach – Health professional is the expert – “Top down” – Expert retains control • Community Development Approach – Health professional is helper, facilitator, a partner – Community is the expert – Locally developed solutions to problems “Bottom Up” – Community retains control McLaughlin Centre for Population Health Risk Assessment Session 7 – 37/37