Environmental Monitoring Program

Food Safety

lthough we enjoy one of the Environmental safest food supplies in the world, foodborne illness remains Acommon in the United States Monitoring Program: where foodborne illness outbreaks affect millions and kill thousands of people. These outbreaks also undermine consumer conﬁdence in affected products, result in An Early Warning System for large recalls, and diminish market demand. A substantial number of foodborne illness outbreaks result from poor hygiene Microbiological Hazards practices. Microorganisms can survive in food processing and handling environments. They are generally introduced into the food environment through raw materials, pests, by Lakshmikantha Channaiah air, water, and employees. Usually, the rou- tine applications of good sanitation practices are able to control these microorganisms inside the food processing and handling

environments. However, if contamination Photo: © Kativ | istockphoto.com

8 NOVEMBER/DECEMBER 2013 AIB UPDATE Food Safety

levels are high or sanitation procedures are indicator organisms, spoilage organisms, and crobiological hazards in both the produc- inadequate, microorganisms may establish pathogens of concern in a timely manner. tion and post-production environment and can contaminate food products leading To reduce the risk of microbial product when well-developed and effectively to foodborne illness outbreak. contamination, one must have insight into implemented as an integral component Various pathogenic microorganisms implementing an effective EMP in a food of prerequisite programs. such as E. coli, Listeria monocytogenes, and facility and properly interpreting the data • Helps to identify harborage niches and hot Salmonella spp. have well-established his- to initiate appropriate corrective actions. spots in a plant that may act as a source tories of being potential contaminants in of contamination. food-handling environments. Hence, it is EMP BENEFITS • Is a critical aspect of documenting the critical to monitor the hygienic environment Some of the key beneﬁts of EMP are that it: overall sanitary state of the facility. in the food manufacturing facility for the • Measures the overall effectiveness of • Validates the sanitation program and helps production of high quality and safe food sanitary design, personnel practices, and in determining the frequency required for products. An environmental monitoring operational methods. cleaning and sanitation. program (EMP) will assess the effectiveness • Provides information (source and con- of the overall hygienic practices in a facil- centration) about indicator organisms, EMP is not designed to validate the ity and provide necessary information to spoilage organisms, and/or pathogens of effectiveness of cleaning and sanitizing prevent possible microbial contamination concern in a timely manner, so that ap- methods, but is more focused on validating of food products. Keep in mind that EMP propriate corrective actions can be initiated cleaning and sanitizing frequencies, and all does not make food safe. Rather, it provides to prevent potential microbial outbreaks. the programs of the Good Manufacturing valuable data (source and concentration) on • Acts as an early warning system for mi- Practices (21 CFR).

AIB UPDATE NOVEMBER/DECEMBER 2013 9 Food Safety

Table 1: Environmental sampling zones

All direct food contact surfaces in the plant (e.g., blenders, conveyors, Zone 1 utensils, work tables, etc.).

Nonfood contact areas in the plant that are closely adjacent to product Zone 2 contact surfaces. In general, this is the area where environmental contamination is most likely to affect the safety of the product (e.g., equipment framework, maintenance tools, drip shields, housings, etc.).

Nonfood contact surfaces that are not Zone 3 close to zone 1. If zone 3 is contami- nated with a pathogen, it could lead to contamination of zone 2 through employees’ actions or movement of machinery (e.g., walls, ﬂoor, drains, etc.).

Areas remote from the product processing areas. If zone 4 is not maintained in Zone 4 a good sanitary condition, it can lead to cross contamination of zones 1, 2, and 3 (e.g., ofﬁce areas, locker rooms, maintenance room, etc.).

10 NOVEMBER/DECEMBER 2013 AIB UPDATE Food Safety

AN EFFECTIVE EMP indicate the potential presence of pathogens It is important to compare the envi- The first task in the implementation of an that may cause significant health risks to ronmental sampling results against a target EMP is to bring together individuals familiar consumers. Zone 1 is tested for indicator level or a baseline. Any increase in micro- with the operation to help identify potential organisms, and zones 2 to 4 are tested for organisms or pathogen number should be areas of risk and concern in a facility. This indicators and pathogens. monitored. These results signal a possible group will be the EMP team and may in- The following reasons explain some of deviation in the sanitary conditions. An clude the plant quality manager, the plant the advantages of using indicator organisms appropriate corrective action (e.g., change or corporate microbiologist, line supervisors in an EMP: of sanitizers, change in sanitizing frequen- or operators, and sanitation supervisors or • They are less expensive and save time cies, etc.) should be initiated to bring the workers. If the facility does not have a food compared to pathogens. values close to or below the target/baseline. safety microbiology expert experienced in • Low prevalence of pathogenic microor- Further, it requires monitoring to check the the development and implementation of ganisms limits the practical significance indicator or pathogenic microorganism level an EMP, it is strongly recommended that of direct pathogen testing. in the plant. the facility contact an experienced outside • Indicator microorganisms are high in expert for guidance. numbers and can be easily enumerated. TYPICAL CORRECTIVE ACTIONS An EMP should be carefully designed • Indicator microorganisms are a valid FOR PATHOGEN POSITIVES after evaluating the facility and its products. representative of pathogens of concern Scenario I: Positive zone 1 Different food plants (e.g., plant vs. animal since indicators use nearly the same pH, 1. Stop production in the affected line. products, dry vs. wet processing facility) nutrients, temperature, water, etc. as that 2. Stop product. with various food products may require of pathogens. 3. Thoroughly examine the area, both visu- different EMPs. An EMP is specific to a • They are non-pathogenic, so there is not ally and through vector swabbing. facility and to the individual operations a need for sophisticated containment 4. Breakdown production lines for inspec- within a facility. A tailored environmental facilities/labs (e.g., Bio Safety Level-2) for tion and take appropriate corrective ac- monitoring program with a baseline/target sample analysis. tions (e.g., leakage, employee traffic, etc.). will be more specific as well as more effective 5. Thoroughly clean affected site (50-foot in assessing the overall sanitary conditions Indicator organisms are not a substitute radius) and swab site and adjacent areas of the facility. for testing for pathogens. A positive result (zones 2 and 3). It is critical for the EMP team to define indicates possible contamination and a risk 6. Increase sampling frequency (e.g., from what constitutes highest risk areas (zone 1) of foodborne disease. Examples of some of weekly to daily) until you get three con- to lowest risk areas (zone 4) for product con- the indicator microorganisms that can be secutive negative results. tamination in a facility. Also, it is important used to monitor hygienic conditions are total to choose the right testing tools and methods aerobic plate count, total coliforms, fecal Zone 1 is normally tested for indicator before beginning to collect samples. coliforms, and Enterococcus spp. of fecal ori- microorganisms. Testing zone 1 for patho- It also is critical for food manufacturers gin. Table 2 (on page 12) provides a general gens such as Salmonella is normally done to develop a science-based environmental overview of EMP in a food manufacturing only for special situations. If zone 1 tests testing and verification program that effec- facility with details of probable indicator positive for a pathogen, then the product tively monitors the overall hygiene quality microorganims and sampling frequencies. made on that line must be held until further of the facility. Table 1 (on page 10) provides confirmative test results are available, and a general overview of environmental zones ESTABLISHING A BASELINE it will most likely initiate a recall situa- in a food manufacturing plant. In general, AND CORRECTIVE ACTIONS tion. Therefore, it is important to have a most environmental swab samples should Historical data, such as the previous six to predetermined action plan that would be be taken from zones 2 to 3, and fewer 12 months of consecutive data, is needed implemented in case of a Salmonella (or samples should be taken from zone 4. to establish a baseline/target. For example, any pathogen) positive zone 1. The response However, the frequency and number of if a site tests <50 cfu for a year with two or team and appropriate management should samples per zone should be modified after three spike readings, then 50 cfu would be make a careful decision on disposition of reviewing the results and effectiveness of set as the baseline. finished product, which is put on hold as corrective actions. The environmental monitoring program a result of zone 1 positive. If possible, the and the target/baseline are unique for each product should be reworked or condemned INDICATOR MICROORGANISMS plant and for each type of products. Also, according to all legal and regulatory pro- Indicators are non-pathogenic microorgan- it is different for different zones (1 to 4). cedures. isms that may be naturally present in food or Since the reasons for a positive finding are the environment. These indicator organisms likely to be plant specific, the corrective Scenario II: Positive zone 2 are used to assess the overall sanitation or action will differ from plant to plant based 1. Breakdown production lines for inspec- environmental condition that may signal or on final food products. tion.

AIB UPDATE NOVEMBER/DECEMBER 2013 11 Food Safety

2. Restrict traffic flow in these areas to the Scenario IV: Positive zones 2 and 3 quencies or modify method. extent possible. 1. Break down production lines for inspec- • Reexamine employee traffic patterns 3. Thoroughly examine the area, both visu- tion. and redirect, if feasible. ally and through vector swabbing. 2. Restrict traffic flow in these areas to the • Make repairs (e.g., leaks, cracks etc.). 4. Take appropriate corrective actions (e.g., extent possible. • Audit production handling practices leakage, employee traffic, etc.). 3. Thoroughly examine the area both visu- (e.g., product and material handling, 5. Collect swabs after thorough cleaning ally and through vector swabbing. etc.). (zones 2 and 3) in a 50-foot radius 4. Take appropriate corrective actions (e.g., • Redesign and/or perform equipment 6. Increase sampling frequency (e.g., from leakage, employee traffic, etc.). maintenance as needed to eliminate weekly to daily) until you get three con- 5. Collect swabs after thorough cleaning harborage niches that may act as a secutive negative results. (zones 2 and 3) in a 50-foot radius. source of contamination or facilitate 7. Zone 1 swabbing and/or finished prod- 6. Increase sampling frequency (e.g., from cleaning access. uct testing may need to be initiated or weekly to daily) until you get three con- • Conduct indirect cleaning such as floor intensified in the event of persistent zone secutive negative results in zones 2 and 3. scrubbing and sanitation or cleaning of 2 positives. 7. Zone 1 swabbing and/or finished prod- overhead equipment, A/C ducts and uct testing may need to be initiated or pipes, etc. Scenario III: Positive zone 3 and nega- intensified in the event of persistent zone • Increase the swab frequencies. tive zone 2 2 positives. • Verify the effectiveness. This is an early indication that the cleaning • Monitor and document. and sanitation programs need to be more POSITIVE RESULTS— robust or redesigned. ACTION PLAN PROCEDURES In a rare and extreme situation, where a 1. Restrict traffic flow in these areas to the 1. Reassemble your team. “hot zone” cannot be eliminated, the area extent possible. 2. Initiate root-cause investigation. (What should be physically quarantined from the 2. Thoroughly examine the area. happened?) rest of the plant until a permanent solution 3. Collect swabs after thorough cleaning 3. Use the team’s findings to improve opera- can be found. (zone 3) in a 50-foot radius. tions, such as: 4. Increase sampling frequency (e.g., from • Thoroughly examine the area, both MAPPING weekly to daily) until you get three con- visually and through vector swabbing. A map of all sampling locations on a facility secutive negative results. • Increase cleaning and sanitation fre- design diagram is an effective way of identify-

ENVIRONMENTAL MONITORING PROGRAM AND SAMPLING PLAN

Sampling sites Where to sample? Frequency of testing What to look for

Blenders, conveyors, utensils, Total plate count, coliforms, yeast and Weekly Zone 1 work tables, etc. molds, enterobacteriaceae. Equipment framework, mainte- Total plate count, coliforms, yeast Zone 2 nance tools, drip shields, hous- Weekly and molds, enterobacteriaceae, Listeria ings, etc. spp., and Salmonella spp. Total plate count, coliforms, yeast Walls, ﬂoor, drains, air handling Weekly and molds, Listeria spp., and Salmo- Zone 3 units, etc. nella spp. Total plate count, coliforms, yeast Ofﬁce areas, locker rooms, Monthly and molds, enterobacteriaceae, Listeria Zone 4 maintenance room, etc. spp., and Salmonella spp.

Table 2: Example of an environmental monitoring program and sampling plan. It is recommended that food manufacturing facilities customize their EMPs after careful evaluation of microbial risks associated with their products and in compliance with the regulatory guidance/standards. The sampling frequency, type of indicator microorganism, and number of samples per zone can be modiﬁed after reviewing the results and assessing the effectiveness of corrective actions.

12 NOVEMBER/DECEMBER 2013 AIB UPDATE ing hot spots to take appropriate corrective actions. Map the locations of any negative (green color flag), increasing trend (yellow color flag), and positive samples/results (red color flag) on a facility design diagram to help define the scope of the problem. Map- ping helps in identifying harborage niches and hot spots that may act as a source of R contamination. AIB International’s SUMMARY In recent years, it has become increasingly Microbiological critical for food industries to implement effective hazard control programs as both Food Safety USDA and FDA have become far more { aggressive in implementing risk-based Consulting Services preventive control procedures even before FSMA is fully implemented. A properly established environmental monitoring program will act as an early warning system for potential microbial MICROBIOLOGICAL RISK ASSESSMENT hazards in a food manufacturing plant and confirm that sanitary designs, personnel 3$7+2*(1(19,5210(17$/ practices, and operational methods already 021,725,1*DQG6$03/,1* in place are, in fact, effective. Apart from the food contact surfaces and .,//67(39$/,'$7,21 nonfood contact surfaces discussed above, 6+(/)/,)(678',(6 the air, water, and even plant employees also can act as potential sources of contamina- 7528%/(6+227,1* tion. Periodic air, water, and plant employee 6285&(75$&.,1* hand swab samples should be monitored for indicators as well as pathogens. )22'6$)(7<('8&$7,21DQG75$,1,1* If you find a high level of microorganisms, then appropriate corrective actions Many foodborne illness outbreaks result from lack of food (including employee hygienic training) safety knowledge, lack of testing and monitoring, poor should be implemented to avoid product hygiene practices, and lack of kill step validation. contamination. Concerns about microbial issues in the food industry Although FSMA’s proposed preventive continue to become more challenging from a scientific and controls rule did not include requirements a regulatory standpoint. The Food Safety Modernization Act for environmental monitoring or finished includes microbiological requirements related to hazard product testing, it is understood that the analysis, product testing, water testing, and environmental food manufacturer needs to develop and monitoring. implement an effective EMP that is capable of detecting signs of microbial contaminants AIB International provides customized services to help our as early as possible and initiate appropriate clients in their commitment to produce the safest food possible corrective actions, thus eliminating or re- in every step of manufacturing. Our microbiological food ducing the potential microbial hazard and safety consulting services are tailored to the specific needs of assuring safety of the product. AIB our customers.

The author is Director of Microbiology and To schedule food safety microbiology consultation or Food Safety Education, AIB International. training at your facility, contact AIB’s Food Safety Education Department at 800-633-5137 or [email protected].

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