Health Products and Food Branch
Policy Id.: 2000-FD-01
Date Issued: July 21, 2000
Revised: Sept 14, 2000
This policy on domestic and imported unpasteurized fruit juice/cider was developed following a specific health risk assessment (Health Canada, 2000). It reflects the current scientific opinion that the contamination of these products originates from poor hygienic practices, and that the risk of transmission can bereduced to a minimum using Good Agricultural and Manufacturing Practices.
Unpasteurized fruit juice and cider products have been involved in several recent foodborne outbreaks of bacterial origin (Health Canada, 2000). The most likely means of contamination identified has been fruit and/or juice becoming contaminated through direct contact with animal/human faeces or through indirect contact by water, food handlers, or soiled equipment (Beauchat and Ryu, 1999; Farber, 1989).
Four million (4,000,000) litres of unpasteurized apple juice/cider are sold every year in Canada, representing 6% of the total apple juice production in Canada. In addition, an estimated 2% of the Canadian population consumes unpasteurized juice and cider. These products are usually sold to consumers at orchards, cider mills, farmers markets, roadside stands, country fairs and juice bars. Some unpasteurized fruit juices/cider is also sold in refrigerated display cases or produce sections of stores.
Traditionally, unpasteurized fruit juices/cider have been considered nonhazardous due to their relatively low pH level. However, as a result of several recent outbreaks of food poisoning in North America involving unpasteurized fruit juices, it has become clear that certain harmful bacteria can survive these acidic conditions.
This policy is intended to improve the safety of these products for all Canadian consumers, particularly those most at risk - young children, the elderly and people with weakened immune systems.
A risk assessment entitled "Qualitative Risk Assessment: Unpasteurized Fruit Juice/Cider" was prepared by Health Canada in collaboration with the Canadian Food Inspection Agency (CFIA) and was finalized on May 10, 2000. This risk assessment, which was qualitative rather than quantitative, was prepared using information from current publications and documents. The development of this document involved extensive literature and Internet searches, as well as consultation with industry, Provincial/Territorial agencies and CFIA. It was used as the basis for deriving appropriate risk management options that could minimize the contamination of unpasteurized juices.
The prominent pathogens involved in unpasteurized juice/cider outbreaks have been identified as Escherichia coli O157:H7 and Salmonella spp. The infectious dose for E. coli O157:H7 is not yet known. However, based on the relatively high attack rates during outbreaks, it appears that the number of bacteria required to cause illness is very low. E. coli O157:H7 can cause severe damage to the lining of the intestine resulting in a condition called haemorrhagic colitis, the symptoms of which can include stomach cramps, vomiting, fever, and bloody diarrhea. Patients are given fluids to prevent dehydration from diarrhea (Doyle and Padhye, 1989). In a small percentage of people, haemolytic uremic syndrome (HUS) can develop, which may require patients to undergo blood transfusions and kidney dialysis. The disease can lead to permanent loss of kidney function and can be fatal in some cases (Doyle and Cliver, 1990; Doyle and Padhye, 1989). Children, the elderly and persons with weakened immune systems are considered to be at the highest risk.
Salmonella spp. are commonly found in the intestinal tract of humans and animals. Environmental sources of the organism include but are not limited to contaminated water and soil. All known species of Salmonella spp. are pathogenic to humans (Doyle and Cliver, 1990). The Salmonella infection that has been most associated with juice outbreaks is the gastroenteritic syndrome that is caused by non-typhoid strains of Salmonella spp. The severity of nontyphoid salmonella infection (known as salmonellosis), varies with the number of bacteria ingested and the susceptibility of the individual. Incubation is 8 to 72 hours before symptoms occur (D'Aoust, 1989; D'Aoust, 1997). Principal symptoms are nausea, vomiting, abdominal pain, dehydration and non-bloody diarrhea that can appear suddenly. Duration of the illness is usually from 1- 4 days. Human infections resulting in enterocolitis from non-typhoid salmonellae is generally self-limiting. The successful treatment of uncomplicated cases of enterocolitis may require only supportive therapy such as fluid and electrolyte replacement (D'Aoust, 1997).
The percentage of the Canadian population that consumes these products is estimated to be 2%, but the actual incidence of illness as a result of consumption of juices in the Canadian population is unknown. In addition, the incidence of foodborne pathogens of concern in unpasteurized fruit juices, as well as data on infectious doses that will cause illness, are not yet available.
This risk assessment demonstrated that the risk of infection by food borne pathogens such as E. coliO157:H7 and Salmonella spp . as a result of drinking unpasteurized juices/cider, is considered to be low, but the potential health consequences of infection can be severe.
In order to determine the most suitable risk management option that would minimize the risk to consumers, a consultation document was circulated to interested and affected parties.
The consultation document was mailed to a wide array of national stakeholders that included the following: national Canadian health, food-service and consumer associations; the Federal Provincial Territorial Committee on Food Safety Policy; Canadian Food Inspection Agency (CFIA); individual producers of unpasteurized apple juice and cider across Canada (approximately 285); and, sectoral associations of the juice and fruit/ produce industry. A total of 41 comments were received from the following sectors: Apple pressers and/ or producers, national industry representatives, provincial agricultural ministries (ON, MB, BC, SK, QC), public health associations, district health units, provincial health ministries (ON, MB, BC, NS, NB, NWT), a provincial economic ministry and the pasteurized juice industry. The input received was given full consideration in the development of this policy.
The goal of this policy is to reduce the possibility of contamination in all unpasteurized fruit juice and cider, both domestic and imported, sold in Canada. The strategy consists of a firm, but non-regulatory, approach for the summer/fall season of 2000, which will then be evaluated to determine if the food safety objectives of the policy were met.
Three (3) components represent the policy approach: 1)Implementation and use of the Code of Practice for the Production and Distribution of Unpasteurized Apple and Other Fruit Juice/Cider in Canada; 2) Label declaration using the words "unpasteurized" and "non pasteurisÚ"; 3) Development and implementation of an education campaign by Health Canada in collaboration with both CFIA and the Provinces/Territories.
In order to achieve compliance with Sections 4 and 7 of the Food and Drugs Act, the manner of production of unpasteurized juices/cider must follow practices which reduce the potential for contamination of the final food product. In 1998, based on information from a preliminary risk assessment, a steering committee with representation from government, food industry and consumers cooperatively developed a Code of Practice for the Production and Distribution of Unpasteurized Apple and other Fruit Juice/Cider in Canada. This Code of Practice outlines the steps that should be implemented by producers, processors, distributors and retailers to reduce the possibility of contamination of unpasteurized juices. It also recommends that these products be labelled as "unpasteurized". This document was distributed widely by the CFIA to the apple industry, the apple processing industry and Provincial/Territorial governments.
The Code of Practiceisinterpreted to therefore represent the benchmark for good industry practices. This places the onus on industry to demonstrate its ability and willingness to reduce potential risks associated with unpasteurized fruit juice/cider products.
Labelling of unpasteurized juice/cider products is intended to allow consumers to be aware of the nature of the product. Labelling of all unpasteurized juice/cider will be voluntary for the 2000 season. The label declaration should use the following words: "unpasteurized" and "non pasteurisÚ" and should be of a size that is clear and legible to consumers. The label declaration should be all-capitalized letters and may be applied as a sticker in a highly visible region on the container that is close to the principal display panel.
Minimum print sizes are prescribed in the Consumer Packaging and Labelling Regulations, Section 14 and should be used as a guideline to determine the size of the wording in relation to the size of the principal display panel of the label. However, the minimum type height of the lettering should not be less than 6.4 millimeters or one quarter inch, for principal display panel sizes less than 258 square centimeters or 40 square inches in area.
Health Canada will undertake the development of a campaign focussed on objectively informing consumers of risks associated with the consumption of unpasteurized fruit juices/cider. In carrying out this work, Health Canada will seek the collaboration of both CFIA and the Provinces/Territories.
The objective is to inform consumers in general, and more specifically children (including parents and guardians), the elderly and people with weakened immune systems, so that they may make an informed choice. While some industry and consumer information has already been provided by various levels of government, a joint, comprehensive education campaign will ensure that consumers have the information to make an informed choice, and that industry clearly understands this policy.
Phase 2 will be undertaken over winter 2000-01 and will evaluate both the effectiveness of the industry's compliance with the Code of Practice, including the labelling requirements, and the success of the consumer education campaign in raising awareness levels concerning the possible risks of consuming unpasteurized juice/cider. Information from the CFIA in coordination with Provincial/Territorial agencies will form the basis of the evaluation.
Inspection data regarding the level of voluntary compliance with all elements of the Code of Practice by the industry, will contribute to policy performance measures. This would include inspection and sample testing results. Effectiveness of industry compliance with product labelling will be evaluated and summarized through CFIA compliance data, as well as through information by provincial/territorial inspection reports.
Focus group surveys and consumer outreach programs will be used to measure the effectiveness of the consumer education campaign and the extent to which consumers understand: (a) the meaning of the terms "unpasteurized" vs "pasteurized" on labels and, (b) the risks associated with these products.
The results of the evaluation will be used to make decisions regarding any requirements for revisions to the policy, including consideration of the necessity for more stringent or regulatory requirements to aid in achieving compliance.
Successful implementation of this policy depends on effective collaboration between Health Canada, the Canadian Food Inspection Agency, the provincial/territorial Ministries of Health and Agriculture and their Regional Units. CFIA, along with Provincial and Territorial governments can also consider supplementary strategies to address specific regional issues. Industry associations will clearly be vital partners in assisting governments to communicate this new policy within their sector.
A May 2000 report on a survey of 15 Ontario apple cider producers highlights the need for coordination of regular inspections among various levels of government, greater focus on inspecting smaller producers who are more likely to experience problems, and the importance of providing producers with specific information concerning areas for improvement. Provincial reports such as this will be essential to a complete and systematic evaluation of Phase 1 of the program.
Ongoing surveillance by the Laboratory Centre for Disease Control and Provincial/Territorial disease surveillance agencies will continue to provide details concerning any outbreaks linked to unpasteurized juices.
Beuchat L.R. and Ryu J.H., 1997. Produce handling and processing practices. Emerg. Infect. Dis. 3(4): 459-465.
Consumer Packaging and Labelling Regulations, Section 14
D'Aoust, J-Y., 1989. Salmonella pp 341 - 351. In M.P. Doyle (ed.) Food borne Bacterial Pathogens. Marcel Dekker Inc. New York, U.S.
D'Aoust, J-Y., 1997. Salmonella Species. pp. 138 - 139. In: M.P. Doyle, L.R. Beuchat and T.J. Montville (eds.) Food Microbiology: fundamentals and frontiers. American Society for Microbiology, Washington, D.C.
Doyle, M.P. and D.O. Cliver, 1990. Escherichia coli pp.213-214; Salmonella pp.186-190. InFoodborne Diseases. D.O. Cliver (ed.) Academic Press, San Diego, California.
Doyle, M.P. and V.V. Padhye. 1989. Escherichia coli pp. 236-270. In Foodborne Bacterial Pathogens. M.P. Doyle (ed.). Marcel Dekker, Inc.
Farber, J.M. 1989. Foodborne Pathogenic Microorganisms: Characteristics of the organisms and their associated diseases. I. Bacteria. Can. Inst. Food Sci. Technol. J. 22(4):311-321.
Health Canada. (2000). In: Health Risk Assessment: "Qualitative Risk Assessment Unpasteurized Fruit Juice/Cider". Food Directorate, Health Products and Food Branch.