The Shanghai FDA has been using @RISK for monitoring contaminants as well as food safety risk assessment, focusing on food service and the circulation of foodstuffs within the city. As a part of the civil administration, analyzing and regulating potential risks, especially in the food supply, are top concerns that could potentially affect over 20 million residents.
The Shanghai Food and Drug Administration is the department responsible for monitoring the safety of the production, circulation and consumption of food, drugs, health supplements and cosmetics for the City of Shanghai. As a part of the civil administration, analyzing and regulating potential risks, especially in the food supply, are top concerns that could potentially affect over 20 million residents.
The Shanghai FDA has been using Palisade’s @RISK software for risk and decision analysis since 2007 for monitoring contaminants as well as food safety risk assessment, focusing on food service and the circulation of foodstuffs within the city. Tian Mingsheng, Inspector and Chief Physician of the Shanghai FDA, explains how @RISK has benefited Shanghai’s food supply.
Working to Keep Shanghai Safe
When the Shanghai FDA needs to carry out testing and analyses of poisonous or otherwise dangerous biological and chemical contaminants, exposure assessments must be carried out for both chemical and biological contamination. The large amounts of complex data generated in the process must undergo quantitative scientific analyses and comparisons using specialized software.
The Administration also uses dietary surveys to gather data on residents’ expenditure on various foods, which requires the use of powerful, specialized analysis software – such as @RISK. Since officially beginning the use of @RISK in 2007, the software has played an indispensible role in the efficient development of food safety monitoring at the Administration, helping guarantee the safety of the food Shanghai residents consume.
Accurate Assessments for Different Groups
Before @RISK, the main challenge for the Shanghai FDA was its inability to carry out probability simulations in the monitoring and evaluation of food safety risks. The Administration relied on mean averages to calculate average risk exposure, a method that does not allow for accurate, quantitative exposure assessments for sensitive groups or highly exposed populations, leaving no way to describe the formation and development trends behind a risk. As a result, formulating effective countermeasures and strategies was difficult, as some highly exposed groups and people with high sensitivity to particular substances or pollutants were left out. It was difficult for the Administration to gain accurate information about how the health of these populations was affected or what the effects were, and effective supervision measures could not be formulated.
The Shanghai FDA took steps to counter the issue, but were unable to gain precise, broad data and conclusions. Thus, there was an urgent need for an effective risk evaluation and assessment software suite to carry out precise, broad probability assessments, produce accurate exposure assessment results and create complete late-stage modeling collections for use in scientific decision analysis.
Applying Monte Carlo with @RISK
The Monte Carlo method and probability assessments have been used by the Administration since the 90s. In 2005, use of the Monte Carlo method in China was still in the early stages. When the Shanghai FDA began risk monitoring in 2005, the first problem it faced was how to handle the large amounts of data being generated, match contaminants with real food contamination data and carry out probability assessments. In 2007, the WHO and FAO used @RISK software for constructing risk models in a number of risk assessment reports.
Consequentially, in 2007, the Shanghai FDA decided to take the lead in becoming the first organization in Mainland China to purchase @RISK 5.0, gaining excellent results with a nitrite contamination risk assessment for cooked meats, cadmium contamination exposure assessments, a vomitoxin risk assessment for wheat products and a risk assessment for bacillus cereus contamination in rice, completely overcoming previous setbacks.
After many achievements with @RISK, the Shanghai FDA decided to upgrade to DecisionTools Suite 5.7 after its release by Palisade in 2012, gaining more powerful functionality to continue moving forward with risk and decision analyses for microbial contamination. The Administration also carried out analyses on vibrio parahaemolyticus contamination in seafood and listeria contamination in refrigerated ready-to-eat meals with excellent results to make effective, needed risk management recommendations.
Using @RISK to Understand Potential Health Risks of Nitrate
In 2008, the Shanghai Food and Drug Administration used @RISK to carry out exposure analysis on nitrite in cooked meat, a classic example of how @RISK can be used in risk and decision analysis. All eyes were on Shanghai as it prepared to host the 41st World Expo in May 2010, and the government was very concerned about maintaining food safety during the event. In 2008, the Shanghai FDA began carrying out data monitoring and quantitative analysis of nitrite contamination in cooked meat, making random checks on 370 meat products and finding 16 products that exceeded standards, a rate of approximately 4%. Researchers carried out curve fitting on the data, and found an exponential distribution for the contamination.
They then held a dietary survey to find the amounts of cooked meat products Shanghai residents ate per day and found a left-truncated normal distribution. On the basis of this initial data, they then used a beta distribution to show the probability of consuming nitrites in excess of standards in normal consumption habits. After that, the researchers used @RISK software to simulate the sample 10,000 times, multiplying the three variables to fit possible real-life situations, and thus gained an exposure dose of nitrite that could be ingested by a regular Shanghai resident by eating cooked meats.
The Shanghai FDA discovered that there was a possibility of passing the 0.3g/dose threshold for acute nitrite poisoning, as well as a possibility for exceeding the allowable daily intake (ADI). With the results of these exposure assessments, the Shanghai FDA was able to provide appropriate management countermeasures based on the conclusions by, for example, proposing that businesses in the food service industry be forbidden from using nitrite to avoid quantities exceeding standards in cooked meats due to improper use or other factors and high residual risk, thereby completely eliminating the possibility of nitrite poisoning at its root.
Eliminating Old-Fashioned Methods
The Shanghai Food and Drug Administration is very satisfied with its collaboration with Palisade’s @RISK software for risk and decision analysis, finding its powerful, scientific risk analysis functionality, and especially the DecisionTools Suite, extremely valuable. You could say that, while risk assessment and problem-solving used to rely solely on the senses and subjective experiences, with @RISK, the Shanghai FDA has been able to eliminate its old-fashioned, backward risk assessment and evaluation methods, and find patterns even at the micro level, finding, for example, patterns and risks in chemical and biological contamination, with important implications for maintaining food safety for Shanghai residents.