TABLE OF CONTENTS
- APPLE CIDER INSPECTION ASSIGNMENT
- STATE CONTROLS
- INSPECTION FINDINGS
- ANALYSIS OF INSPECTIONAL FINDINGS
- MICROBIOLOGICAL QUALITY OF THE PRODUCT
- FUTURE NEEDS
- Attachment 1. Questionnaire Used in Apple Cider Assignment.
- Attachment 2. State Regulations, Programs and Activities — Summary of Information Provided
- Attachment 3. Summary of Good Manufacturing Practices Applied by Selected Apple Juice/Cider Producing States and Canada
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.
FDA's Intervention Strategy
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:
- while the risks associated with specific juices vary, there are safety concerns and the history of public health problems associated with fresh juices indicates a need for active safety interventions;
- juice manufacturers implement and strictly adhere to industry Current Good Manufacturing Practices (CGMPs);
- mandatory Hazard Analysis and Critical Control Point (HACCP) and safety performance criteria form the general conceptual framework needed to assure the safety of juices, and control measures should be based upon a thorough hazard analysis;
- safety performance criteria be used instead of mandating specific intervention technology, and that, for some fruits, interventions may be limited to surface treatment, but for others, additional interventions may be required; and
- a tolerable level of risk may be achieved by requiring an intervention(s) that has been validated to achieve a cumulative 5 log reduction in the target pathogen(s).
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.
APPLE CIDER INSPECTION ASSIGNMENT
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:
identify firms operating under insanitary conditions, document the conditions, and take appropriate regulatory action;
develop a profile of the sanitation control measures used in apple cider industry and of the safety of fresh cider based on inspection results and sample analysis of in-process and finished product samples; and
- determine the extent of voluntary implementation of FDA's labeling recommendations.
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.
Apple Cider-Specific GMPs
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.
- State A — In 1994 the Department of Public Health conducted a sampling survey of 61 apple cider producers along with the inspection of their facilities. None of the producers pasteurized their products. All samples were negative for E. coli O157:H7 as well as Salmonella sp. The median total coliform level was 93 MPN/ml with 14% of the results greater than 1,100 MPN/ml and the highest 11,000 MPN/ml. The median fecal coliform level was 4.3 MPN/ml and the highest 240 MPN/ml. In addition, 25 samples of cider were collected from retail markets. Total coliforms, generic E. coli, or E. coli O157:H7 bacteria were not detected in any sample. The standard plate counts on 84% of the samples were less than 100 cfu/ml and the highest 13,000 cfu/ml.
- State B — In 1993 the Department of Health sampled cider from 25 firms. All samples were negative for E. coli O157:H7 as well as generic E. coli. Three samples had total coliform levels in excess of 1,100 MPN/ml that suggests contamination of a non-fecal origin. In 1997 the Department of Health collected 32 samples of cider during inspections. No E. coli O157:H7 or Salmonella sp. was found. Two of the samples were positive for generic E. coli, with the highest result 11 MPN/ml. Seventy-five percent of the total coliform results were below the detection level of the test and the highest 93 MPN/ml. Four samples taken at the retail level showed similar low microbial levels.
State C — During the 1997-1998 cider season, the Department of Health studied the use of a variety of treatments in the production of apple cider. The state advised FDA that:
The cider operations used several different methods including pasteurization (18%), chemical sanitation of the apples (45%), hot dip of the apples (9%), (ultra violet) UV treatment of the cider (9%), and the exclusion of windfalls (82%), as well as a combination of these methods, to control the biological hazard. Laboratory analysis of in-line apple, pomace and cider, as well as finished bottled cider samples, did not find E. coli O157:H7, Salmonella, or Staphylococcus spp. Generic E. coli was not isolated in raw in-coming apples or apple pomace, but was found in 6 of 28 (21%) of "fresh" (unpasteurized) cider samples including three in-line samples. This suggests that E. coli is introduced during in-plant processing. To produce pathogen-free cider, operators, in addition to HACCP controls, must strictly conform to good manufacturing practices and sanitation procedures. The use of controls geared to the prevention or elimination of pathogens on the source apples is critical, but alone may not be sufficient for product safety.
State D — In November of 1996, the Department of Agriculture collected 114 samples of apple cider from operating cider mills and retail locations throughout the state. They reported that:
Results showed all samples negative for E. coli O157:H7. The pH of the samples ranged from 3.2 to 3.8 (mean=3.5). Mean plate counts were 4.2 x104 CFU/ml. While almost 60 samples did not exhibit the presence of coliforms, counts ranged as high as 1,100 MPN/ml resulting in a mean coliform count of 41 MPN/ml. Eight samples showed the presence of E. coli (generic) indicating fecal contamination. These results show that (the State"s) cider industry may be vulnerable to E. coli contamination.