Center for Food Safety & Applied Nutrition
Report of 1997 Inspections of |
Historical records indicate that apple cider consumption dates back several thousand years. They show that Julius Caesar drank cider during his invasion of England in 55 BC.(1) Apple trees were introduced in America from England by the early settlers and were planted widely by the settlers and Indians. Cider became a common drink by the mid-nineteenth century when it reached its peak consumption in the U.S. Today most apple juice is bottled and pasteurized although fresh unpasteurized cider continues to be very popular in regions of the country where mills press apple cider for local consumption during the fall months. Cider is usually distinguished from apple juice in that it is not filtered. Consumers are often willing to pay a premium for unpasteurized cider because of its fresh tastes.
During the past few years there have been several reported foodborne illness outbreaks attributed to the consumption of unpasteurized apple juice and cider. These outbreaks have raised the concerns of public health officials and fresh apple cider producers. Fruit juice beverages had historically been shown to be associated with illnesses only on isolated occasions. The recent outbreaks were attributed to three different pathogenic microorganisms with the most serious being Escherichia coli O157:H7. Other pathogens that were involved were Salmonella Typhimurium and Cryptosporidium parvum. A review of the literature and FDA and state enforcement reports show that illnesses have also occurred from non-microbial hazards in other fruit and vegetable juices. Although fruit juice is acidic and thus inhibitory to the growth of most microorganisms, recent studies have shown that E. coli O157:H7 and Salmonella sp. can tolerate acid conditions and survive. It is speculated that outbreaks have occurred because, in part, fruit juices are frequently consumed by persons at greatest risk of life-threatening illness; that is, children, the elderly and persons with compromised immune systems.
In December 1996 FDA convened a Public Meeting on the safety of juice. This was followed-up with a meeting of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF). These meetings were in response to the concerns of the public health community stemming from the illness outbreaks. NACMCF recommended to FDA that:
FDA believed there was an urgency in advising the apple cider industry and the public of the potential risks associated with unpasteurized cider before the 1997 fall apple cider season. On August 28, 1997 FDA published a Federal Register Notice titled "Fruit and Vegetable Juice Beverages: Notice of Intent to Develop a HACCP Program, Interim Warning Statement, and Educational Program" (Vol. 62, No, 167, p 45593–45596). The notice announced measures to reduce the risk of illness from disease-causing microorganisms in unpasteurized fruit and vegetable juices. The new strategy includes food-safety control programs for the industry, new labeling for products, and education programs for consumers and manufacturers. On April 24, 1998 FDA published a proposed HACCP regulation for the juice industry (Federal Register, Vol. 63, No. 79, p 20450-20486). Public comments on the proposal were being reviewed by FDA at the time of the issuance of this report.
The Agency believes that the benefits of a mandatory HACCP program will be enhanced with educational programs aimed at industry and consumers. Consistent with the recommendations of NACMCF, the Agency believes that industry education programs should address basic food microbiology, principles of cleaning and sanitizing equipment, other good sanitation practices, and processing controls that enhance food safety. Such educational programs will greatly assist juice processors in developing and implementing an effective HACCP program. In addition, consumers should be educated about the risks to certain populations associated with the consumption of untreated juice and the potential for the presence of pathogens and other hazardous substances.
Sources of Contamination of Apple Cider
Understanding the hazards involved and best practices for control are important in developing an improved food safety control program for the apple cider industry. The most likely source of contamination is apples that come in contact with pathogenic microorganisms from fecal material. Cattle, deer, and sheep are the most common reservoirs of pathogens, although these animals may be asymptomatic themselves. Birds, rodents, insects, and poor worker-hygiene may also be sources of contamination. Contamination is more likely to be introduced on to apples during the growing and harvesting phases of the cider production process. Animal feces can contaminate apples either directly by contaminating apples dropped on the ground or indirectly by contaminating workers, crates used to haul apples, water used for spraying and irrigating orchards, and possibly by being carried in the air. The use of untreated or improperly treated manure also increases the potential for contamination. Surface water is more susceptible to contamination than water from a properly protected well or a public supply. Washing apples may reduce surface contamination unless the water itself is contaminated which can happen if it is from an unprotected and untested private source or it is not changed frequently when tubs or flumes are used for washing the apples.
Studies reported in the scientific literature have demonstrated that microbial pathogens that are introduced onto the surface of an apple can migrate into the tissue of the apple through breaks in the skin and through the flower end. In addition, the infectious dose of pathogens required to cause illness is very low. One contaminated piece of fruit could affect an entire batch of cider. The current practice of washing and brushing fresh apples before pressing is not considered a reliable method for eliminating pathogens.
The primary goal of food safety controls is to reduce the likelihood that the outside surface of an apple becomes contaminated. It is also the goal to prevent fecal material on one apple from contaminating other apples, as can happen if the wash water becomes contaminated. Once pathogens are inside the apple, it is highly unlikely that sanitation-control measures will be effective in eliminating such pathogens without some type of heat treatment of the cider. Sorting and discarding apples with broken skins and apples that are badly bruised or worm damaged are important control measures.
While sanitation controls can help prevent hazards from being introduced into the finished product, they can not reduce pathogens that might be present to acceptable levels. NACMCF recommended to FDA that the juice industry apply the more effective HACCP requirements. They also recommended that a 5 log reduction in the pertinent pathogen be used as the criteria for an acceptable level of reduction. FDA decided that other steps should include labeling any product that has not been processed to achieve a 5 log reduction in order to better alert children, the elderly, and persons with weakened immune systems who are considered to be at higher risk.
In August 1997 FDA issued an assignment to its field offices to inspect fresh, unpasteurized apple cider operations and to collect samples of in-line and finished product. The field assignment was integral to FDA's intervention strategy in two respects. First, inspections and appropriate follow-up regulatory actions addressed the immediate concern expressed by some at the 1996 public meeting that a processed food is being produced under insanitary conditions. Second, the juice industry must have a strong foundation of sanitation programs in order for HACCP to be successfully implemented
The objectives of the assignment were to:
The field offices in cooperation with state officials developed an inventory of firms that manufactured unpasteurized apple cider. Each field office was assigned a target number of firms to inspect in each state in order to meet the national goal of 250 inspections. Firms were selected from the inventory on the basis of whether they sold interstate or intrastate, and whether they had been recently inspected by the state.
Checklist of Specific Apple Cider Processing GMP Controls
There are several CGMP-based controls that a producer can apply which will reduce the likelihood of a hazard being introduced into the finished product. A checklist was developed for the inspections that identified possible controls that were specific to apple cider operations. This checklist is provided in Attachment 1. It was intended to supplement basic CGMP requirements that are common to all processors, such as employee hygiene, equipment and facility construction, rodent control, cleaning, etc. The checklist was not intended to imply that processors should be applying all of the controls, or that the lack of any particular control was evidence of insanitary operations.
The checklist covered a wide range of harvesting, handling, and processing controls. Some controls are likely to be more critical than others in that if not properly applied, there is a greater likelihood that a hazard could be introduced. The practices that have a greater likelihood for allowing a hazard to be introduced or not controlled are: (1) application of untreated or improperly treated manure in the orchards; (2) use of non-potable water for washing and processing, (3) unmanaged use of apples picked off the ground (drops), (4) use of badly bruised and rotten apples, (5) poor worker hygiene, and (6) failure to apply good sanitation practices to prevent contamination of the cider during and after pressing.
Primary responsibility for the regulatory control of the fresh apple cider industry is with the states. The majority of fresh cider producers are intrastate operations with most selling seasonally at on-site market-type outlets. Several states have recognized the potential food safety hazards associated with apple cider and have instituted special measures to address these hazards. These include promulgation of specific CGMPs for cider operations, food sanitation workshops for cider operators, HACCP training courses, inspection and sampling initiatives directed at the cider industry, and research into the effectiveness of different control measures.
FDA obtained information about state initiatives from two sources. First, the U.S. Apple Association provided FDA with a report of results of a survey they conducted in the spring of 1997 of state trade associations and horticultural societies about state activities. The information received provided an industry perspective of actions being taken. Although some changes in state programs and additional activities have occurred in the past year, this information provides a baseline summary of state activities at the time FDA began its apple cider initiative.
Second, FDA sent a request to state Departments of Health and Agriculture for information that would help in designing and planning the inspection assignment. The information request was for: (1) an inventory of fresh apple cider operations, (2) any regulations specific for apple cider operations, (3) state inspection plans for cider operations, (4) any state requirements regarding labeling of cider, and (5) any state education programs for the cider industry. Many states responded to this request, and the information provided, in combination with the U.S. Apple Association information, provides a good overview of state activities. A summary of responses is provided in Attachment 2.
Five states and Canada provided FDA with copies of their CGMPs or recommended guidelines for apple cider operations. The CGMPs contain information that these health and agriculture agencies believe affect the levels of occurrence and/or introduction of pathogens during the production of unpasteurized cider. The CGMPs cover growing, harvesting, transporting, storing, processing, and packaging. A summary of these practices is provided in Attachment 3 Collectively, the summary provides a comprehensive listing of practices that can serve to reduce the possibility of contamination.
State Inspection and Microbiological Sampling Initiatives
The CGMPs developed by the states and Canada are based on existing knowledge of factors that influence contamination of unpasteurized apple cider. Much of the information on these factors is provided in the scientific literature, as well as from several universities with agriculture extension service programs.
Several states have also conducted comprehensive inspections of their cider industry, collected samples for microbiological analysis, and studied factors that affect the safety of unpasteurized cider. The study results that were provided to FDA are summarized below. Since the purpose is to report but not compare results, the specific States are not identified. FDA and the States consider foods that contain any detectable E. coli O157:H7 or Salmonella, or levels of Staphylococcus aureus of 104 cfu/ml or more, to be adulterated. Total and fecal coliforms, and generic E. coli are quality parameters for which there are no food safety regulatory action levels although they may indicate fecal contamination.