FDA classifies each inspection report to reflect the compliance status of the firm. Fifty-two percent of the firms were classified as "No Action Indicated (NAI)." This classification is given when no objectionable conditions or minor insanitary conditions are found during the inspection. This classification was also assigned to 12% of the firms who were not in operation at the time of the inspection due to the seasonal nature of the industry and the limited hours of operation. Thirty-six percent of the inspections were assigned the designation, "Voluntary Action Indicated (VAI)," because objectionable conditions were observed but the significance did not warrant administrative or regulatory follow-up. There were no firms classified as Official Action Indicated (OAI) which is assigned when administrative or regulatory action is warranted. The distribution of classifications and designations assigned to the inspections is shown in Figure 10.
Figure 10. FDA Inspection Classifications and Designations
An assessment was made based on inspectional findings, and each firm was categorized as having good, marginal, or poor sanitation conditions. Good sanitation conditions indicates that the firm had no or minor insanitary conditions and that it applied basic sanitary controls to their operation, including washing the apples with water from a tested supply, culling bruised or rotten apples, and holding the apples under sanitary conditions. Marginal operations include situations where some insanitary conditions existed, or apples were not washed, untested water is used, or apples were not adequately culled. Poor operations included those situations where insanitary conditions were of the nature that could result in the likelihood of contamination.
On the basis of this assessment, 67% of the firms were categorized as having good sanitation, 27% were considered marginal, and 4% had poor sanitary conditions. Twenty-nine firms were not in operation and a comparative assessment of their sanitary conditions could not be made. The summary of sanitary conditions is shown in Figure 11.
Figure 11. Summary of Sanitary Conditions
FDA's inspections indicated that two-thirds of the firms inspected were operating under good sanitation conditions. A firm with good sanitary conditions exhibited the following.
- Apples are culled at harvesting so only wholesome apples are collected.
- If drops are used, they are carefully managed and washed.
- All wash water comes from a protected source that is tested for microbiological indicators at least yearly just before the season starts.
- The apples are sorted and culled prior to pressing to remove damaged apples, badly bruised apples, or apples with rot or worms.
- The apples are spray washed and wet-brushed prior to pressing with water treated with an antimicrobial agent.
- The conveyor system, chopper, and pressing equipment are of sanitary design and condition. The equipment is free of organic residues and any hardwoods have a smooth, easily cleanable surface.
- Once apples are pressed, the cider is kept in closed piping and vats, is promptly cooled, and is not exposed to cross-contamination.
- The processing area is enclosed, clean and uncluttered, and free from flying insects.
- The equipment is cleaned and sanitized, and the processing area is cleaned, after processing and/or before processing is resumed.
- Toilet facilities and hand washing facilities are available, and employees practice good hygiene with respect to hand washing, clothing and hair restraints, and eating and smoking behavior.
- The plastic, finished product containers are stored in a clean and protected area, are not reused, and are clean when filled.
FDA's inspections disclosed that nine firms or 4% were operating under poor sanitary conditions. A firm with poor sanitary conditions exhibited the following.
- No sanitation facilities are provided in the orchard during harvesting.
- Domestic animals are grazing adjacent to orchard, or stabled or penned adjacent to processing facility.
- Drops are used and mixed with tree picked or otherwise poorly managed.
- Apples are inadequately culled and badly bruised apples are used.
- The wash water is from a nonpublic water supply source that is not sampled and tested annually and as required by state water quality regulations.
- Apples are not washed or are inadequately washed prior to pressing, or flume water is not flowing or changed frequently.
- Equipment is in disrepair, especially wood surfaces, and is not easily cleanable.
- Food contact surfaces are not clean, or are not properly cleaned and sanitized between uses.
- Personal hygiene is poor and there are no hand washing facilities.
- There are open entry ways from the outside.
- There are flying insects in the processing area, on equipment, and in vats holding cider.
The operations at firms with good and poor sanitary controls provides a perspective on what is seen as "best practices" by processors to address the most likely sources of microbial contamination of the product. These practices are as follows.
- Culling --- Prompt and effective culling of apples after harvesting to remove cut, badly bruised, rotten, and insect or bird damaged apples that might have been contaminated with pathogens.
- Initial Washing --- Prompt washing of apples after harvesting and culling to clean the surface and reduce the transfer of organic material between apples that may be contaminated with pathogens.
- Prompt Processing or Refrigerated Holding --- Prompt processing of the apples after harvesting to reduce the potential for pathogen growth during extended holding, or refrigerated storage of apples if processing is delayed more than one day.
- Final Culling, Washing, and Brushing --- Effective culling, washing, and wet-brushing of apples with water containing an antimicrobial agent immediately prior to crushing/chopping to remove damaged apples that may have been contaminated with pathogens, and to provide a clean surface that will not introduce pathogens into the cider during processing.
- Closed Processing System --- Effective containment of the cider in a system of closed pipes and covered vats to the extent possible after pressing to reduce the risk of cross-contamination from environmental sources and employee handling.
- Equipment Sanitation --- Prompt and effective maintenance, cleaning, and sanitizing of all food contact surfaces on equipment including sprayer-brush units, conveyors, and any hardwood surfaces to avoid the build-up of organic residues that may harbor microorganisms as well as the proper cleaning, drying and storage of press cloths.
- Environmental Sanitation --- Maintenance of a sanitary environment by providing wall, ceiling and floor surfaces that are easily cleanable and clean; having screened or closed entry ways; eliminating flying insects; utilizing a safe water supply; promptly removing and properly storing pomice; maintaining adjacent grounds free of debris, trash, and pest harborages; and keeping domestic animals and animal pens well removed from the processing facility.
- Employee Hygiene --- Maintenance of clean and functional toilet facilities, hand washing facilities, and hand sanitizing stations in the production area; and enforcement of good hygienic practices involving hand washing, protective clothing, and no eating or smoking in the production area.