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Food Safety in New Zealand: Application of a Risk Management Framework

Annexes

Annex 1: Risk Assessment

Risk assessment represents an evaluation of the probability of occurrence (likelihood) and severity (magnitude) of known or potential adverse health effects that result from human exposure to hazards in foods. Although the ideal goal is a quantitative estimate of risk, qualitative expressions of risk are common in many situations, eg ranking of levels of risk as high, medium or low.

To the extent practicable, NZFSA keeps the risk assessment process separate and distinct from the risk management so as to protect the integrity and objectivity of the risk assessment. NZFSA strives to ensure:

• each risk assessment is fit for its intended purpose and transparent in its documentation

• the scope is clearly stated

• there is an open exchange of ideas between risk assessors, risk managers and other stakeholders

• factors that impact on the risk assessment are identified, eg resource constraints and data gaps, and assumptions and uncertainties are explained

• the reporting style allows risk managers and other stakeholders to properly understand the risk assessment and an interpretive summary is provided for lay readers.

The risk assessment process

Food safety risk assessment is a scientifically based process consisting of four steps (shown in Figure 6). Steps 2 and 3 can be carried out in any order.

Hazard identification

Hazard identification concerns the possible presence of biological, chemical or physical agents capable of causing adverse health effects. This is a qualitative exercise that utilises a ‘weight-of-evidence’ approach and it may include ranking of different hazards in a food(s) in order of their likely importance. (As a consequence, low-ranking hazards may not be included in subsequent risk assessment because of resource implications.) In the case of chemicals in food, hazard identification may include quantitative evaluation of toxicological data from animal studies. In the case of biological hazards in food, epidemiological data on the possibility of foodborne illness is essential.

Hazard characterisation

Hazard characterisation determines the nature of the adverse health effects. In the ideal situation this will include a dose-response assessment. However, accurate dose-response data at the point of consumption are difficult to obtain for microbiological hazards and risk assessments will often rely on qualitative hazard characterisation. Dose-response studies for chemical hazards using animal models contain both quantitative and qualitative elements, especially in extrapolation of data from high-dose chemical toxicity studies in animals to low-dose exposures in humans.

Figure 6: The risk assessment process

Exposure assessment

Exposure assessment is the dietary intake of hazards that is likely to occur. Exposure of a defined consumer population to a specific hazard may have a qualitative or a quantitative base. Inadequate information on dietary intake and/or the distribution/level of hazards within the food at the point of consumption will limit the ability to conduct a risk assessment.

Risk characterisation

Risk characterisation is the integration of the above activities into an estimation of the probability and severity of adverse effects likely to occur in a given population. ‘What if’ scenarios can be used to evaluate the impact of different assumptions and different ranges of input data on model outcomes. The outcome for each new ‘what if’ scenario is compared to the baseline outcome to determine the degree of change.

Uncertainty

Uncertainty in a risk assessment (the quality of being unknown) should be clearly separated from variability (a characteristic of natural phenonema that differs from one observation to the next). When data is lacking, uncertainty can be represented in a risk assessment by use of a range of possible data values. Uncertainty also arises from various conceptualisations when modelling a system. Risk assessors must ensure that risk managers understand the sources and degree of uncertainty in the risk assessment and the impact it has on risk estimates.

Sensitivity analysis

Sensitivity analysis helps NZFSA risk assessors to select those control measures that best achieve risk management goals. Probabilistic software programmes can perform sensitivity analysis by producing graphs or rank correlation statistics between input parameters and output parameters. This allows risk assessors to systematically investigate which input variables have the greatest influence on the outputs of the risk assessment.

Annex 2: Risk Communication

Risk communication encompasses a continuous and interactive exchange of information between all parties involved in food safety. It describes the work done by NZFSA to bridge the gap between the evaluation of risk by experts and the views of other stakeholders, eg safety assessments of genetically modified organisms carried out by Food Standards Australia and New Zealand (FSANZ) have not revealed any evidence of adverse health effects, yet consumers continue to be concerned about transgenic plants in the food supply, especially in relation to possible long-term health and environmental effects. NZFSA takes into account knowledge, attitudes, values, practices and perceptions of stakeholders when communicating risk management options and decisions.

NZFSA risk communication strategy

NZFSA has a fully documented risk communication strategy and develops specific implementation plans that engage with internal (eg administrators, risk managers, risk assessors and risk communicators) and external stakeholders on food safety issues. Stakeholder interests may be significantly affected by regulatory risk management decisions and participation and involvement of stakeholders throughout all phases of the RMF process is essential.

The nature and urgency of the risk information to be conveyed will drive each implementation plan. This can range from predominantly one-way communication to the public to urgently advise or warn about a particular risk, to full two-way engagement with a number of stakeholder groups over a reasonable period of time. Risk communication must also service international reporting obligations.

A variety of methodologies are used to communicate with the public. Active methods such as media-based information campaigns, websites, email alerts and 0800 telephone information services are employed in risk events that are of high interest to the public and/or industry. Scheduled meetings with stakeholder representatives (eg quarterly meetings with consumer advocates) are a good means of proactively engaging on upcoming issues. Routine publication of periodicals, pamphlets and technical reports by risk communicators are other vehicles by which NZFSA improves public awareness and knowledge.

Emergency situations

Risk communication in an emergency situation requires a tailor-made implementation plan and NZFSA has developed an Emergency Communication Programme and supporting manual to enable the organisation to move quickly into response mode when necessary. The programme is shared with the Ministry of Agriculture and Forestry (MAF) and Biosecurity New Zealand (BNZ) and can accommodate a range of responses.

Where risk communication needs span multiple sectors, the joint NZFSA/MAF/BNZ approach clearly differentiates the likelihood of animal health impacts versus the likelihood of human health impacts when there is an epidemic of exotic disease, eg ‘highly pathogenic’ avian influenza. Even so, public reactions are unpredictable. In the recent outbreak of avian influenza in Southeast Asia, the Japanese government clearly informed their public that foodborne risks from imported poultry products were negligible but consumers still markedly reduced their purchase of chicken meat and eggs.

Risk communication messages

Before formulating risk communication messages, it is necessary to identify the various stakeholder groups that will be predominantly affected by a food safety issue or emergency and properly understand their motivations and opinions. Risk communicators, risk managers and risk assessors should all contribute to this task.

When communicating on risk issues, NZFSA strives to fully understand risk perception factors. Humans tend to fear similar things for similar reasons and the study of risk perception identifies the psychological factors by which we subconsciously ‘decide’ what to be afraid of – and how afraid to be. Public perception of risks often differs from expert analysis and the public’s judgement of benefits and risks is significantly affected by information flows. Thus it is necessary to identify the most appropriate media to disseminate information to, and communicate with, different types of stakeholders. Key messages must take into account distributional issues, eg who benefits and in what way, and the importance of the benefit. Key messages must effectively communicate the degree and significance of uncertainty in the risk assessment.

Stringent risk communication efforts are made by NZFSA to nurture public trust and credibility. Above all, information is disseminated as soon as possible in an unfolding food safety situation, with frequent updates, so that stakeholders do not become focused on a perceived suppression of facts rather than management of the risk itself.

The clarity and impact of key messages for each stakeholder group is monitored by NZFSA to the extent practicable. Public opinion research can be used to gauge whether all relevant target groups were reached and if their level of understanding of key messages was adequate. Behaviour change as a result of risk communication is also evaluated if appropriate. Reasoned involvement with stakeholders throughout a risk analysis process helps with acceptance of a final risk management decision, even if stakeholders are not in agreement.