Zero tolerance for contamination?

Who would want to be a risk manager in the food industry nowadays? The recent Cadbury’s million-bar product recall” shows that where public health is concerned a zero tolerance threshold may well be the best policy. However, in food, as in life, there is no such thing as zero risk.

Increased sensitivity in testing means that there may now be a whole host of undesirable and/or unsafe” contaminants newly identified in our foods, but in such tiny quantities that they may be unlikely to have any ill effect. Where does your company stand on the risk management issues involved?

The key decisive factor to consider in any risk management is the safety of human health

The main European Food Regulation 178/2002 sets out the law on when a Food Business must carry out a withdrawal and recall and when to notify the competent authorities. This is when a Food Business Operator considers or has reason to believe a food is in breach of the ‘Food Safety equirements’, namely, if the food is either “unsafe” meaning it may be injurious to health, or it is unfit for human consumption. In either scenario, on a literal reading of the Regulation, it must be withdrawn from supply and the relevant competent authorities notified. Recall, however, should be a last resort where other measures are not sufficient to achieve a high level of health protection.

In practice, much greater attention is given to hazards that may be injurious to health as compared to those that simply affect the fitness for consumption of a food such as mould or other quality efects.

Cadbury’s recall

In June 2006 Cadbury announced it was recalling seven brands in Britain. They were linked to a salmonella outbreak affecting 37 people. The company had earlier discovered some quantities of the montevideo strain of the bacteria in its products after a leaking pipe dripped contaminated water onto a production conveyor belt of chocolate crumb base.

There has been media outcry over Cadbury’s not notifying the authorities sooner than it did and having to take this recall action. The delay was reportedly caused by Cadbury’s risk assessment process. Prior to the reported outbreaks occurring Cadbury’s had looked carefully at the available data on the level of amounts of salmonella that had caused previous outbreaks. They then made a risk management decision that, based on the low amount of the salmonella bacteria detected, the risk of any adverse event from the contamination did not require any withdrawal or recall action.

After the Food Standards Agency (FSA) was informed of the situation this decision was scrutinised. Specialist Salmonella Contact Group of the independent Advisory Committee on the microbiological Safety of Food (ACMSF), with the benefit of hindsight, has since concluded there should be a “zero” tolerance level for salmonella in ready-to-eat foods.

This might be said to indicate an expectation by regulators and consumers of absolutely no naturally occurring bacteria that may cause ill health in ready-to-eat foods, even if they appear at levels that are (based on historical data) unlikely to have any physiological impact.

Other high profile food incidents

Recent incidents such as: the contamination by illegal colourings Para Red and Sudan 1 in early 2005, the ITX (Isopropylthioxanthone) contamination in baby food in November 2005, and contamination of US rice with an unauthorised GM variety reported in August 2006 illustrate that expectations of safety are not necessarily consistent, and there is still room for risk-based decision making in cases of food contamination.

Para Red and Sudan 1

The European Food Safety Authority (EFSA) was introduced to provide risk assessment information in a clear and transparent form to inform both the EU Parliament and the risk management of member states and food business operators. The EFSA supported the evidence that the illegal colours were possible genotoxic carcinogens but there was insufficient information to carry out a full risk assessment. Some Member States found that extremely small levels of contamination posed such a low risk that no recall or withdrawal was necessary. The UK FSA’s position was a blanket recall of all contaminated food, without a threshold de minimis level.

ITX in baby food

In November 2005 it was reported there was contamination at very low levels in some liquid infant formula products of the industrial chemical ITX, a component of printing inks used on some food packaging. In this instance, the EFSA considered the chemical in relation to the amounts found in the food product and concluded there was no immediate health risk. Based on this the FSA concluded no withdrawal or recall was necessary.

GM rice contamination

Most recently contamination has been found in long grain US rice by an unauthorised GM strain. Despite it being stated there was insufficient information available for the EFSA to produce a full risk assessment, it was found that the contamination was not likely to pose an imminent safety concern to humans or animals on the basis of toxicological, molecular and compositional data. Preliminary reports from US rice producers indicated the level of adventitious presence of the GM rice might be below the labelling threshold level of 0.1% (Riceland reported 0.06% i.e. 6 in 10,000 seeds). However exposure levels in the EU Members States could not be estimated accurately from the data provided. The FSA have considered no withdrawal or recall is necessary and that it would not be proportionate for retailers to track down and remove all products from sale that contained the genetically modified rice. The FSA then updated their advice reminding retailers that the GM material is illegal and that it was retailers' responsibility to ensure that the food they sell complies with the law. Any rice known to be contaminated with GM material was illegal and should be removed from sale. This seems to contradict the FSA's own initial position on proportionality and their response on ITX in baby food and goes further than the food safety requirements, possibly as a result of pressure from consumer and environmental organisations.

Conclusion

In the case of contamination a risk assessment should always look carefully at the potential hazard. If there are even the slightest safety concerns one needs to tread very carefully. The burden of proof, in practice, is on producers to establish that the risk of this hazard occurring is, if not non-existent, then so low as to be statistically insignificant. However, as the recent history has shown, evidence of risk is open to much interpretation. It must be anticipated that the “Precautionary Principle” could be asserted by regulators to justify action to err on the side of caution if there is any scientific uncertainty.

Risk assessment in the food industry should also take into account consumer confidence and brand reputation as well as hazard and the likelihood of the hazard occurring in this highly risk averse and sensitive industry.

This article first appeared in the Food & drink bulletin in November 2006. Please click here to view the pdf in a new window.