Tanimura & Antle, Inc. is voluntarily recalling its packaged single head romaine lettuce, out of an abundance of caution, due to possible E. Coli 0157:H7 contamination. The product has a packaged date of 10/15/2020 or 10/16/2020, and the UPC number 0-27918-20314-9.
Although no illnesses have been reported, the recall is based on the test result of a random sample taken and analyzed by the Michigan Department of Agriculture and Rural Development. The company distributed 3,396 cartons to 20 states. Retailers and distributors can identify the affected products using the Product Traceability Initiative stickers (571280289SRS1 and 571280290SRS1) that are attached to the exterior of the case.
With the increasing globalization of the food industry, ensuring that products reaching consumers are safe has never been more important. Local, state and federal regulatory agencies are increasing their emphasis on the need for food and beverage laboratories to be accredited to ISO/IEC 17025 compliance. This complicated process can be simplified and streamlined through the adoption of LIMS, making accreditation an achievable goal for all food and beverage laboratories.
With a global marketplace and complex supply chain, the food industry continues to face increasing risks for both unintentional and intentional food contamination or adulteration.1 To mitigate the risk of contaminated products reaching consumers, the International Organization for Standardization (ISO), using a consensus-based approval process, developed the first global laboratory standard in 1999 (ISO/IEC 17025:1999). Since publication, the standard has been updated twice, once in 2005 and most recently in 2017, and provides general requirements for the competence of testing and calibration laboratories.2
In the recent revision, four key updates were identified:
A revision to the scope to include testing, calibration and sampling associated with subsequent calibration and testing performed by a laboratory.3
An emphasis on the results of a process instead of focusing on prescriptive procedures and policies.4
The introduction of the concept of a risk-based approach used in production quality management systems.2
A stronger focus on information technologies/management systems, specifically Laboratory Information Management System (LIMS).4
As modern-day laboratories reduce their reliance on hard copy documents and transition to electronic records, additional emphasis and guidance for ISO 17025 accreditation in food testing labs using LIMS was greatly needed. Food testing laboratories have increased reliance on LIMS to successfully meet the requirements of accreditation. Food and beverage LIMS has evolved to increase a laboratory’s ability to meet all aspects of ISO 17025.
Chain of Custody
A key element for ISO 17025 accredited laboratories is the traceability of samples from accession to disposal.5 Sometimes referred to as chain of custody, properly documented traceability allows a laboratory to tell the story of each sample from the time it arrives until the time it is disposed of.
LIMS software allows for seamless tracking of samples by employing unique sample accession numbers through barcoding processes. At each step of sample analysis, a laboratory technician updates data in a LIMS by scanning the sample barcode, establishing time and date signatures for the analysis. During an ISO 17025 audit, this information can be quickly obtained for review by the auditor.
Procurement and Laboratory Supplies
ISO 17025 requires the traceability of all supplies or inventory items from purchase to usage.6 This includes using approved vendors, documentation of receipt, traceability of supply usage to an associated sample, and for certain products, preparation of supply to working conditions within the laboratory. Supply traceability impacts multiple departments and coordinating this process can be overwhelming. A LIMS for food testing labs helps manage laboratory inventory, track usage of inventory items, and automatically alerts laboratory managers to restock inventory once the quantity falls below a threshold level.
A food LIMS can ensure that materials are ordered from approved vendors only, flagging items purchased outside this group. As supplies are inventoried into LIMS, the barcoding process can ensure accurate storage. A LIMS can track the supply through its usage and associate it with specific analytical tests for which inventory items are utilized. As products begin to expire, a LIMS can notify technicians to discard the obsolete products.
One unique advantage of a fully integrated LIMS software is the preparation and traceability of working laboratory standards. A software solution for food labs can assist a technician in preparing standards by determining the concentration of solvents needed based on the input weight from a balance. Once prepared, LIMS prints out a label with barcodes and begins the supply traceability process as previously discussed.
Quality Assurance of Test and Calibration Data
This section of ISO 17025 pertains to the validity of a laboratory’s quality system including demonstrating that appropriate tests were performed, testing was conducted on properly maintained and calibrated equipment by qualified personnel, and with appropriate quality control checks.
Laboratory Personnel Competency
Laboratory personnel are assigned to a specific scope of work based upon qualifications (education, training and experience) and with clearly defined duties.7 This process adds another layer to the validity of data generated during analysis by ensuring only appropriate personnel are performing the testing. However, training within a laboratory can be one of the most difficult components of the accreditation process to capture due to the rapid nature in which laboratories operate.
With a food LIMS, management can ensure employees meet requirements (qualifications, competency) as specified in job descriptions, have up-to-date training records (both onboarding and ongoing), and verify that only qualified, trained individuals are performing certain tests.
Calibration and Maintenance of Equipment
Within the scope of ISO 17025, food testing laboratories must ensure that data obtained from analytical instruments is reliable and valid.5 Facilities must maintain that instruments are in correct operating condition and that calibration data (whether performed daily, weekly, or monthly) is valid. As with laboratory personnel requirements, this element to the standard adds an additional layer of credibility that sample data is precise, accurate, and valid.
A fully integrated software solution for food labs sends a notification when instrument calibration is out of specification or expired and can keep track of both routine internal and external maintenance on instruments, ensuring that instruments are calibrated and maintained regularly. Auditors often ask for instrument maintenance and calibration records upon the initiation of an audit, and LIMS can swiftly provide this information with minimal effort.
Measurement of Uncertainty (UM)
Accredited food testing laboratories must measure and report the uncertainty associated with each test result.8 This is accomplished by using certified reference materials (CRM), or known spiked blanks. UM data is trended using control charts, which can be prepared using labor-intensive manual input or performed automatically using LIMS software. A fully integrated food LIMS can populate control data from the instrument into the control chart and determine if sample data analyzed in that batch can be approved for release.
Valid Test Methods and Results
Accurate test and calibration results can only be obtained with methods that are validated for the intended use.5 Accredited food laboratories should use test methods that are current and contain embedded quality control standards.
A LIMS for food testing labs can ensure correct method selection by technicians by comparing data from the sample accession input with the test method selected for analysis. Specific product identifiers can indicate if methods have been validated. As testing is performed, a LIMS can track time signatures to ensure protocols are properly performed. At the end of the analysis, results of the quality control samples are linked to the test samples to ensure only valid results are available for clients. Instilling checks at each step of the process allows a LIMS to auto-generate Certificates of Analysis (CoA) knowing that the testing was performed accurately.
The foundation of a laboratory’s reputation is based on its ability to provide reliable and accurate data. ISO 17025:2017 includes specific references to data protection and integrity.10 Laboratories often claim within their quality manuals that they ensure the integrity of their data but provide limited details on how it is accomplished making this a high priority review for auditors. Data integrity is easily captured in laboratories that have fully integrated their instrumentation into LIMS software. Through the integration process, data is automatically populated from analytical instruments into a LIMS. This eliminates unintentional transcription errors or potential intentional data manipulation. A LIMS for food testing labs restricts access to changing or modifying data, allowing only those with high-level access this ability. To control data manipulation even further, changes to data auto-populated in LIMS by integrated instrumentation are tracked with date, time, and user signatures. This allows an auditor to review any changes made to data within LIMS and determine if appropriate documentation was included on why the change was made.
ISO 17025:2017 requires all food testing laboratories to have a documented sampling plan for the preparation of test portions prior to analysis. Within the plan, the laboratory must determine if factors are addressed that will ensure the validity of the testing, ensure that the sampling plan is available to the laboratory (or the site where sampling is performed), and identify any preparation or pre-treatment of samples prior to analysis. This can include storage, homogenization (grinding/blending) or chemical treatments.9
As sample information is entered into LIMS, the software can specify the correct sampling method to be performed, indicate appropriate sample storage conditions, restrict the testing to approved personnel and provide electronic signatures for each step.
Monitoring and Maintenance of the Quality System
Organization within a laboratory’s quality system is a key indicator to assessors during the audit process that the facility is prepared to handle the rigors that come with accreditation.10 Assessors are keenly aware of the benefits that a food LIMS provides to operators as a single, well-organized source for quality and technical documents.
An ISO 17025 accredited laboratory must demonstrate document control throughout its facility.6 Only approved documents are available for use in the testing facility, and the access to these documents is restricted through quality control. This reduces the risk of document access or modification by unauthorized personnel.
LIMS software efficiently facilitates this process in several ways. A food LIMS can restrict access to controlled documents (both electronic and paper) and require electronic signatures each time approved personnel access, modify or print them. This digital signature provides a chain of custody to the document, ensuring that only approved controlled documents are used during analyses and that these documents are not modified.
Corrective Actions/Non-Conforming Work
A fundamental requirement for quality systems is the documentation of non-conforming work, and subsequent corrective action plans established to reduce their future occurrence.5
A software solution for food labs can automatically maintain electronic records of deviations in testing, flagging them for review by quality departments or management. After a corrective action plan has been established, LIMS software can monitor the effectiveness of the corrective action by identifying similar non-conforming work items.
Food and beverage testing laboratories are increasingly becoming accredited to ISO 17025. With recent changes to ISO 17025, the importance of LIMS for the food and beverage industry has only amplified. A software solution for food labs can integrate all parts of the accreditation process from personnel qualification, equipment calibration and maintenance, to testing and methodologies.11 Fully automated LIMS increases laboratory efficiency, productivity, and is an indispensable tool for achieving and maintaining ISO 17025 accreditation.
Remember the 2015 Listeria outbreak linked to Blue Bell Creameries? The outbreak led to three deaths and 10 illnesses between January 2010 and January 2015. On Thursday the Department of Justice ordered the company to pay $17.25 million in criminal penalties for shipping contaminated products linked to that outbreak. The sentence, enforced by U.S. District Judge Robert Pitman (Austin, Texas), is the largest fine and forfeiture ever imposed in a conviction involving a food safety case.
“American consumers must be able to trust that the foods they purchase are safe to eat,” stated – Acting Assistant Attorney General Jeffrey Bossert Clark, Justice Department’s Civil Division in an agency news release. “The sentence imposed today sends a clear message to food manufacturers that the Department of Justice will take appropriate actions when contaminated food products endanger consumers.”
In May 2020 Blue Bell pleaded guilty to two misdemeanor counts of distributing adulterated ice cream. The following is an excerpt from the Department of Justice news release:
“The plea agreement and criminal information filed against Blue Bell allege that the company distributed ice cream products that were manufactured under insanitary conditions and contaminated with Listeria monocytogenes, in violation of the Food, Drug and Cosmetic Act. According to the plea agreement, Texas state officials notified Blue Bell in February 2015 that samples of two ice cream products from the company’s Brenham, Texas factory tested positive for Listeria monocytogenes, a dangerous pathogen that can lead to serious illness or death in vulnerable populations such as pregnant women, newborns, the elderly, and those with compromised immune systems. Blue Bell directed its delivery route drivers to remove remaining stock of the two products from store shelves, but the company did not recall the products or issue any formal communication to inform customers about the potential Listeria contamination. Two weeks after receiving notification of the first positive Listeria tests, Texas state officials informed Blue Bell that additional state-led testing confirmed Listeria in a third product. Blue Bell again chose not to issue any formal notification to customers regarding the positive tests. Blue Bell’s customers included military installations.”
Food production managers have a critical role in ensuring that the products they make are safe and uncontaminated with dangerous pathogens. Health and wellness are in sharp focus for consumers in every aspect of their lives right now, and food safety is no exception. As food safety becomes a continually greater focus for consumers and regulators, the technologies used to monitor for and detect pathogens in a production plant have become more advanced.
It’s no secret that pathogen testing is performed for numerous reasons: To confirm the adequacy of processing control and to ensure foods and beverages have been properly stored or cooked, to name some. Accomplishing these objectives can be very different, and depending on their situations, processors rely on different tools to provide varying degrees of testing simplicity, speed, cost, efficiency and accuracy. It’s common today to leverage multiple pathogen diagnostics, ranging from traditional culture-based methods to molecular technologies.
And unfortunately, pathogen detection is more than just subjecting finished products to examination. It’s become increasingly clear to the industry that the environment in which food is processed can cross-contaminate products, requiring food manufacturers to be ever-vigilant in cleaning, sanitizing, sampling and testing their sites.
For these reasons and others, it’s important to have an understanding and appreciation for the newer tests and techniques used in the fight against deadly pathogens, and where and how they might be fit for purpose throughout the operation. This article sheds light on the key features of one fast-growing DNA-based technology that detects pathogens and explains how culture methods for index and indicator organisms continue to play crucial roles in executing broad-based pathogen management programs.
LAMP’s Emergence in Molecular Pathogen Detection
Molecular pathogen detection has been a staple technology for food producers since the adoption of polymerase chain reaction (PCR) tests decades ago. However, the USDA FSIS revised its Microbiology Laboratory Guidebook, the official guide to the preferred methods the agency uses when testing samples collected from audits and inspections, last year to include new technologies that utilize loop-mediated isothermal amplification (LAMP) methods for Salmonella and Listeria detection.
LAMP methods differ from traditional PCR-based testing methods in four noteworthy ways.
First, LAMP eliminates the need for thermal cycling. Fundamentally, PCR tests require thermocyclers with the ability to alter the temperature of a sample to facilitate the PCR. The thermocyclers used for real-time PCR tests that allow detection in closed tubes can be expensive and include multiple moving parts that require regular maintenance and calibration. For every food, beverage or environmental surface sample tested, PCR systems will undergo multiple cycles of heating up to 95oC to break open DNA strands and cooling down to 60oC to extend the new DNA chain in every cycle. All of these temperature variations generally require more run time and the enzyme, Taq polymerase, used in PCR can be subjected to interferences from other inhibiting substances that are native to a sample and co-extracted with the DNA.
LAMP amplifies DNA isothermally at a steady and stable temperature range—right around 60oC. The Bst polymerase allows continuous amplification and better tolerates the sample matrix inhibitors known to trip up PCR. The detection schemes used for LAMP detection frees LAMP’s instrumentation from the constraints of numerous moving pieces.
Secondly, it doubles the number of DNA primers. Traditional PCR tests recognize two separate regions of the target genetic material. They rely on two primers to anneal to the subject’s separated DNA strands and copy and amplify that target DNA.
By contrast, LAMP technology uses four to six primers, which can recognize six to eight distinct regions from the sample’s DNA. These primers and polymerase used not only cause the DNA strand to displace, they actually loop the end of the strands together before initiating amplification cycling. This unique looped structure both accelerates the reaction and increases test result sensitivity by allowing for an exponential accumulation of target DNA.
Third of all, it removes steps from the workflow. Before any genetic amplification can happen, technicians must enrich their samples to deliberately grow microorganisms to detectable levels. Technicians using PCR tests have to pre-dispense lysis buffers or reagent mixes and take other careful actions to extract and purify their DNA samples.
Commercialized LAMP assay kits, on the other hand, offer more of a ready-to-use approach as they offer ready to use lysis buffer and simplified workflow to prepare DNA samples. By only requiring two transfer steps, it can significantly reduces the risk of false negatives caused by erroneous laboratory preparation.
Finally, it simplifies multiple test protocols into one. Food safety lab professionals using PCR technology have historically been required to perform different test protocols for each individual pathogen, whether that be Salmonella, Listeria, E. coli O157:H7 or other. Not surprisingly, this can increase the chances of error. Oftentimes, labs are resource-challenged and pressure-packed environments. Having to keep multiple testing steps straight all of the time has proven to be a recipe for trouble.
LAMP brings the benefit of a single assay protocol for testing all pathogens, enabling technicians to use the same protocol for all pathogen tests. This streamlined workflow involving minimal steps simplifies the process and reduces risk of human-caused error.
Index and Indicator Testing
LAMP technology has streamlined and advanced pathogen detection, but it’s impractical and unfeasible for producers to molecularly test every single product they produce and every nook and cranny in their production environments. Here is where an increasing number of companies are utilizing index and indicator tests as part of more comprehensive pathogen environmental programs. Rather than testing for specific pathogenic organisms, these tools give a microbiological warning sign that conditions may be breeding undesirable food safety or quality outcomes.
Index tests are culture-based tests that detect microorganisms whose presence (or detection above a threshold) suggest an increased risk for the presence of an ecologically similar pathogen. Listeria spp. Is the best-known index organism, as its presence can also mark the presence of deadly pathogen Listeria monocytogenes. However, there is considerable skepticism among many in the research community if there are any organisms outside of Listeria spp. that can be given this classification.
Indicator tests, on the other hand, detect the presence of organisms reflecting the general microbiological condition of a food or the environment. The presence of indicator organisms can not provide any information on the potential presence or absence of a specific pathogen or an assessment of potential public health risk, but their levels above acceptable limits can indicate insufficient cleaning and sanitation or operating conditions.
Should indicator test results exceed the established control limits, facilities are expected to take appropriate corrective action and to document the actions taken and results obtained. Utilizing cost-effective, fast indicator tests as benchmark to catch and identify problem areas can suggest that more precise, molecular methods need to be used to verify that the products are uncontaminated.
As discussed, technology plays a large role in pathogen detection, and advances like LAMP molecular detection methods combined with strategic use of index and indicator tests can provide food producers with powerful tools to safeguard their consumers from foodborne illnesses. However, whether a producer is testing environmental samples, ingredients or finished product, a test is only as useful as the comprehensive pathogen management plan around it.
The entire food industry is striving to meet the highest safety standards and the best course of action is to adopt a solution that combines the best technologies available with best practices in terms of processes as well –from sample collection and preparation to monitoring and detection.
Yesterday the CDC reported that the E.coli outbreak linked to romaine lettucegrown in the Salinas, CA growing region is over. The contaminated lettuce should no longer be available, and FDA states that consumers do not need to avoid romaine lettuce from Salinas. The agency will continue its investigation into the potential factors and sources that led to the outbreak.
The FDA did identify a common grower link to the E.coli O157:H7 contamination as a result of its traceback investigation. However, a statement released yesterday by FDA Deputy Commissioner for Food Policy and Response Frank Yiannas points out that “this grower does not explain all of the illnesses seen in these outbreaks.”
To be specific, the FDA, CDC and other public health agencies were tracking three outbreaks involving three separate strains of E.coli O157:H7 linked to romaine lettuce. During the course of the investigation FDA, CDC, the California Department of Food and Agriculture and the California Department of Public Health conducted sampling of the water, soil and compost of several of the fields in the lower Salinas Valley that were connected to the outbreak. “So far, sample results have come back negative for all of the three outbreak strains of E. coli O157:H7. However, we did find a strain of E. coli that is unrelated to any illnesses in a soil sample taken near a run-off point in a buffer zone between a field where product was harvested and where cattle are known to occasionally graze,” Yiannas said in the agency statement. “This could be an important clue that will be further examined as our investigation continues. However, this clue does not explain the illnesses seen in these outbreaks.”
Finding the contamination source(s) is critical, as it will aid romaine growers in putting safeguards in place to help prevent future contamination.
As for the final case count (with last illness onset on December 21, 2019) of this outbreak, there were 167 total illnesses and 85 hospitalizations across the United States. No deaths were reported.
As of December 17, seven infections were reported, with four hospitalizations and one death across five states. The hard-boiled eggs were sold both in bulk pails to food processors, restaurants and retailers, as well as directly to consumers at the retail level, and have “Best If Used By Dates” through March 2, 2020.
FDA used whole genome sequencing to find a genetic match in the outbreak strain from samples collected at Almark’s facility during agency inspections in February and December of this year.
The report states that a sediment sample coming from an on-farm water reservoir in Santa Maria (Santa Barbara County, California) tested positive for the outbreak strain of E. coli O157:H7. Although this particular farm was identified in several legs of the Fall 2018 traceback investigations that occurred in the United States and Canada, as well as being a possible supplier of romaine lettuce in the 2017 traceback investigations, the FDA said that the farm is not the single source of the outbreak, as there is “insufficient evidence”. The traceback suggests that the contaminated lettuce could have come from several farms, because not all tracebacks led to the farm on which the contaminated sediment was found.
“The finding of the outbreak strain in the sediment of the water reservoir is significant, as studies have shown that generic E. coli can survive in sediments much longer than in the overlying water. It’s possible that the outbreak strain may have been present in the on-farm water reservoir for some months or even years before the investigation team collected the positive sample. It is also possible that the outbreak strain may have been repeatedly introduced into the reservoir from an unknown source,” stated FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas in a press announcement.
Although the exact route of contamination cannot be confirmed, the FDA hypothesizes that it could have occurred through the use of agricultural water from an open reservoir, which has increased potential for contamination.
The investigation teams also found evidence of “extensive” wild animal activity and animal burrows near the contaminated reservoir, as well as adjacent land use for animal grazing, all of which could have contributed to the contamination.
Considering the significant effect that the past two E.coli outbreaks involving romaine lettuce have had on both the public as well as the produce industry, FDA made several recommendations on preventive measures that leafy greens growers and industry can take to avoid such pathogenic contamination, including:
Assessing growing operations to ensure they are in line with compliance to FSMA and good agricultural practices
Making sure that any agricultural water that comes into direct contact with the harvestable portion of the crop, food contact surfaces and harvest equipment is safe and sanitary
Address and mitigate risks associated with agricultural water contamination that can occur as a result of intrusion by wild animals
Address and mitigate risks associated with the use of land near or adjacent to agricultural water sources that can lead to contamination
Conduct root cause analysis whenever a foodborne pathogen is identified in the growing environment, agricultural inputs like water or soil, raw agricultural commodities, or “fresh-cut” ready-to-eat produce
For the broader industry:
The development of real-time procedures that enable rapid examination of the potential scope, source and route of contamination
All leafy green products should have the ability to be traced back to the source in real time, and information include harvest date. In November, FDA requested voluntary labeling [https://foodsafetytech.com/news_article/cdc-alert-do-not-eat-romaine-lettuce-throw-it-out/] to help consumers identify products affected during an outbreak
The adoption of best practices in supply chain traceability
In an effort to determine the prevalence of Salmonella, Listeria and E. coli O157:H7 in sprouts, FDA conducted a large sampling study of sprouts, the results of which were released last week.
The agency collected 825 samples from 37 states, Puerto Rico and the District of Columbia and found 14 positive samples at eight of the 94 growers (10 samples came from four growers). Samples were collected from three production process points: Seeds, finished product and spent irrigation water, and tested for contamination. FDA found the following contamination:
Salmonella on 2.35% of seed samples, 0.21% in finished sprouts and 0.53% in spent irrigation water
Listeria monocytogenes on 1.28% of finished sprouts
No positive E. coli O157:H7 results in finished sprout or spent irrigation. Due to limitations of the test method, FDA didn’t test seed samples.
“Sprouts are especially vulnerable to pathogens given the warm, moist and nutrient-rich conditions needed to grow them. From 1996 to July 2016, there were 46 reported outbreaks of foodborne illness in the United States linked to sprouts. These outbreaks accounted for 2,474 illnesses, 187 hospitalizations, and three deaths.” – CFSAN
In the event that contaminated sprout samples were uncovered, FDA worked with the firms that own or released the affect sprouts to conduct voluntary recalls or destroy them. FDA inspections also followed.
In 2011 three U.S. government agencies, the CDC, the FDA and the USDA’s Food Safety Inspection Service (FSIS) created the Interagency Food Safety Analytics Collaboration (IFSAC). The development of IFSAC allowed these agencies to combine their federal food safety efforts. The initial focus was to identify those foods and prioritize pathogens that were the most important sources of foodborne illnesses.
The priority pathogens are Salmonella, E. coli O157:H7, Listeria monocytogenes and Campylobacter. To research the most important product sources, the three agencies collaborated on the development of better data collection and developed methods for estimating the sources of foodborne illnesses. Some of this research was to evaluate whether the regulatory requirements already in effect were reducing the foodborne pathogens in a specific product matrix. The collection, sharing and use of this data is an important part of the collaboration. For example, when the FDA is in a facility for routine audit or targeted enforcement, they will generally take environmental swabs and samples of air, water and materials, as appropriate, which are then tested for the targeted pathogens. If a pathogen is found, then serotyping and pulsed-field gel electrophoresis (PFGE) fingerprinting is performed, and this is compared to the information in the database concerning outbreaks and illnesses. This data collection enables the agencies to more quickly react to pinpoint the source of foodborne illnesses and thereby reduce the number of foodborne illnesses.
The IFSAC strategic plan for 2017 to 2021 will enhance the collection of data. The industry must be prepared for more environmental and material sampling. Enhancement of data collection by both agencies can be seen through the FSIS notices and directives, and through the guidance information being produced by the FDA for FSMA. Some examples are the raw pork products exploratory sampling project and the FDA draft guidance for the control of Listeria monocytogenes in ready-to-eat foods.
Starting May 1 2017, the next phase of the raw pork products exploratory sampling project will begin. Samples will be collected and tested for Salmonella, Shiga-toxin producing E. coli (STECs), aerobic plate count and generic E. coli. In the previous phase, the FSIS analyzed 1200 samples for Salmonella for which results are published in their quarterly reports. This is part of the USDA FSIS Salmonella action plan published December 4, 2013 in an effort to establish pathogen reduction standards. In order to achieve any objective, establishing baseline data is essential in any program. Once the baseline data is established and the objective is determined, which in this situation is the Health People 2020 goal of reducing human illness from Salmonella by 25%, one can determine by assessment of the programs and data what interventions will need to take place.
The FDA has revised its draft guidance for the control of Listeria monocytogenes in ready-to-eat food, as per the requirement in 21 CFR 117 Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Foods, which is one of the seven core FSMA regulations. Ready-to-eat foods that are exposed to the environment prior to packaging and have no Listeria monocytogenes control measure that significantly reduces the pathogen’s presence, will be required to perform testing of the environment and, if necessary, testing of the raw and finished materials. Implementing this guidance document helps the suppliers of these items to cover many sections of this FSMA regulation.
The purpose of any environmental program is to verify the effectiveness of control programs such as cleaning and sanitizing, and personnel hygiene, and to identify those locations in a facility where there are issues. Corrective actions to eliminate or reduce those problems can then be implemented. Environmental programs that never find any problems are poorly designed. The FDA has stated in its guidance that finding Listeria species is expected. They also recommend that instead of sampling after cleaning and/or sanitation, the sampling program be designed to look for contamination in the worst-case scenario by sampling several hours into production, and preferably, just before clean up. The suggestion on this type of sampling is to hold and test the product being produced and to perform some validated rapid test methodology in order to determine whether or not action must be taken. If the presence of a pathogen is confirmed, it is not always necessary to dispose of a product, as some materials can be further processed to eliminate it.
With this environmental and product/material testing data collected, it is possible to perform a trends analysis. This will help to improve sanitation conditions, the performance of both programs and personnel, and identity the need for corrective actions. The main points to this program are the data collection and then the use of this data to reduce the incidence of foodborne illness. Repeated problems require intervention and resolution. Changes in programs or training may be necessary, if they are shown to be the root cause of the problem. If a specific issue is discovered to be a supply source problem, then the determination of a suppliers’ program is the appropriate avenue to resolve that issue. Generally, this will mean performing an audit of the suppliers program or reviewing the audit, not just the certificate, and establishing whether they have a structured program to reduce or eliminate these pathogens.
Don’t miss the Plenary Mock Food Safety Trial: Sam I Am who made Green Eggs and Ham is represented by Shawn Stevens vs. Food Safety victims represented by Bill Marler. Judged by Steve Sklare | November 30 at the 2017 Food Safety Consortium | Learn moreWith FSMA regulations coming into effect, food companies must prepare for the arrival of FDA investigators, as the agency has made it a priority to inspect U.S. food facilities, and they won’t always show up announced. Prior to an investigator’s arrival, it’s important to iron out several details in order to be adequately prepared. The following are 10 questions that every company should add to its pre-inspection checklist and make sure they are addressed before the inspection.
Where will you meet? Pinpoint a place where you will host the FDA investigators. It should be a space that has enough room for them to review records, but it should not provide access to records (paper or digital) that could be viewed unsupervised.
Who are the Designated Individuals? Assign a primary and secondary Designated Individual (DI) for each facility. This person serves as the liaison with the FDA investigators and should coordinate vacation time to ensure that one DI will always be available if FDA arrives. Although not required, the DI should also complete Preventive Control Qualified Individual Training.
Has the written food safety plan been finalized? And, do the primary and secondary DIs know its components (i.e., GMPs, Sanitation Programs, Preventive Control Plan, Recall Plan, Environmental Monitoring Program, Foreign Supplier Verification Plan, Sanitary Transportation Plan, Food DefensePlan, and Produce Safety Plan)?
Are records readily accessible? The DI should be able to immediately access any supporting records from the past three months for FDA review (FDA requires that most records are maintained for at least two years, but investigators usually ask to review the preceding three months).
Have corrective actions been documented? When a deviation occurs, you must document all corrective actions. These actions should identify the deviation’s root cause and actions to prevent recurrence. If product safety is not affected, this should include a written conclusion that the deviation “does not create an immediate or direct food safety issue.”
Have you conducted environmental monitoring and environmental sampling? If your company processes ready- to-eat food products that are exposed to the environment prior to packaging, FDA will require you to have an environmental monitoring program. In addition, the agency will collect 100–200 microbiological samples from your facility, so you need to know exactly what FDA will find before it arrives. By conducting your own FDA-style facility swabbing, you’ll be able to identify and immediately correct any hidden problems. It’s also important to develop your swabbing and testing plan with the help of legal counsel so that the final testing results are confidential.
Do you have a “No Photographs” policy? If not, you should. FDA Investigators will often insist on taking photographs while inspecting the processing environment. If your corporate policy prohibits visitors from taking photographs, you may in some cases be able to prevent FDA from taking pictures as well.
Do you have a “Do Not Sign” policy? Sometimes, FDA Investigators will insist that a company representative sign a statement or affidavit during an inspection. You’re not legally obligated to do sign such a document. You should develop a policy stating you will neither sign nor acknowledge any written statements presented by FDA Investigators.
Have you identified a suitable “on call” food industry lawyer? Add a food industry lawyer familiar with the inspection process to the company’s emergency contact list. This lawyer should be notified and remain “on call” during the inspection and serve as a resource to help answer any regulatory or investigator-related questions that arise during the process.
Did you conduct a mock FDA inspection? One of the most effective ways to prepare for an FDA visit is to conduct a mock inspection. Food industry consultants and/or lawyers can visit your facility and play the role of the Investigator. Ask them to review your programs to identify possible regulatory shortfalls, and work with you to implement strategies that will strengthen your programs and reduce your regulatory exposure.
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Data generated from cookies and other behavioral tracking technology is not made available to any outside parties, and is only used in the aggregate to make editorial decisions for the websites. Most browsers are initially set up to accept cookies, but you can reset your browser to refuse all cookies or to indicate when a cookie is being sent by visiting this Cookies Policy page. If your cookies are disabled in the browser, neither the tracking cookie nor the preference cookie is set, and you are in effect opted-out.
In other cases, our advertisers request to use third-party tracking to verify our ad delivery, or to remarket their products and/or services to you on other websites. You may opt-out of these tracking pixels by adjusting the Do Not Track settings in your browser, or by visiting the Network Advertising Initiative Opt Out page.
You have control over whether, how, and when cookies and other tracking technologies are installed on your devices. Although each browser is different, most browsers enable their users to access and edit their cookie preferences in their browser settings. The rejection or disabling of some cookies may impact certain features of the site or to cause some of the website’s services not to function properly.
The use of online tracking mechanisms by third parties is subject to those third parties’ own privacy policies, and not this Policy. If you prefer to prevent third parties from setting and accessing cookies on your computer, you may set your browser to block all cookies. Additionally, you may remove yourself from the targeted advertising of companies within the Network Advertising Initiative by opting out here, or of companies participating in the Digital Advertising Alliance program by opting out here.