It is clear that many people and many businesses are sympathetic to protecting public health, and also understand the risks they face trying to conduct business as usual during the COVID-19 pandemic. However, there are too many people not practicing social distancing, and not wearing face coverings in the community. The lack of compliance by some of our businesses and citizens is now driving the surge of cases in Florida, and we should ask why this is happening. 

The simple answer is that poor compliance with COVID-19 precautions in restaurants, retail stores, bars, and other places of transmission in our community happens because businesses and patrons think they can get away with not following the rules and guidance from our authorities.

But its more complicated than that. In addition to the wrong messages from some of our leaders, and disrespect by some for the rules, our agencies are partly to blame for non-compliance. Given that there is little transparency with state agencies in Tallahassee, there appears to be a lack of coordination between the agencies that technically have the ability to hold businesses accountable to follow the accepted guidance and rules.

Lack of political support for the Florida Department of Health, and poor leadership at the agency over many years, has silenced what should be the most effective agency with the means of controlling COVID-19 in Florida’s communities. In recent years, the DOH has lost jurisdiction over food services, childcare and institutions-including healthcare facilities. Those responsibilities have been divided between the Florida Department of Business and Professional Regulation- FLDBPR, The Florida Department of Agriculture and Consumer Services-FLDACS, and the Agency for Health Care Administration-AHCA There is poor coordination between these agencies in regards COVID-19 control, and no discernable central command, so to speak. Therefore, there appears to be no expedient way to bring the varied rules these agencies operate under into a cohesive enforcement effort. Currently, Florida has a disconnected patchwork of rules and agencies, with the remarkable result that ACHA and DBPR are now tasked with protecting public health during a deadly pandemic! 

The problem is, neither AHCA nor DBPR are public health agencies. While they do have the capacity to take action against a licensed establishment, the problem is with the agencies themselves. DBPR suffers from having to maintain the political support of the Florida Restaurant and Lodging Association lobby, for one thing. Another is that some field staff in these agencies do not have science backgrounds, or even college degrees, and yet they make sometimes complex public health decisions, i.e., identifying and managing an outbreak, or who stays open and who gets closed. 

I am not aware of a formal mechanism for DBPR, AHCA and DOH to work together to investigate COVID-19 compliance issues. When a cluster of cases is suspected in a facility, our agencies should be coordinating together to investigate the cluster, apply their respective expertise and take the corrective actions as necessary to protect the public. The DOH has limited jurisdictional powers and cannot even enter a nursing home without being invited in by the licensing agency, much less enforce a rule. That is even more troubling, considering the terrible loss of life in Florida’s nursing homes.

Another observation is that there is little visible evidence of effective public health promotion at the DOH, even though the disciplines of Public Health Promotion and Education can be effective functions when communication channels are properly utilized. In order to change negative public opinion, messages must reach the community explaining to them the “why’s” of social distancing, and face coverings. 

Enforcement of COVID-19 rules is now a policing issue in a growing number of Florida municipalities. Sending a police officer to deliver a citation, or levy a fine may deter some violations, but this method of dealing with COVID compliance is a scattershot approach, and may not be sustainable. 

The root-cause of the present dysfunction in enforcement is the politicizing of the existing agencies tasked with protecting public health and safety. Little by little, DOH’s jurisdiction has been taken apart, piece by piece by Florida’s legislators.

Now that we have a crisis, where is the strong and effective public health agency, the one agency whose mission it is to protect public health? It sits on the sidelines. We barely hear anything from DOH outside of telling us about the gruesome statistics.

It seems ironic, but it is the public that must support public health. The public must understand that undercutting health protections for political purposes has put them at risk. Our citizens should demand that our legislature reverse the gutting of DOH programs and provide DOH with political support, sufficient manpower, and funding. We should not let lobbyists in Tallahassee dictate public health policy as they continue to do. 

What has happened to the Department of Health is an insult to our citizens and should be remembered in November. Voters need to send a strong message: Public Health, Safety and Welfare are the Overriding Goals of ALL Regulatory Agencies! We need emergency legislation to amend the Florida statutes and administrative codes, and give back to the Florida DOH its rightful jurisdictional power, allowing them to do the professional public health work they have the responsibility for. 

While Florida’s governor has recently come out in favor of enforcement, there must be other initiatives. Alone, measures such as shutting down bars and pulling a few alcohol licenses do not address the long-term compliance and transmission problems we are surely facing. 

The reluctance of businesses to enforce the required COVID 19 controls is now backfiring, and injured persons are filing lawsuits and seeking damages. The public’s disrespect for social distancing and face coverings is also backfiring, with the state of Florida now considered a nationwide COVID-19 transmission hot spot. 

It is obviously in the best interest of everyone to comply with best practices. Education, the application of science, and enforcement, when necessary, will get us out of this dilemma- but we need to get on with it. 

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The foodservice industry is remarkable for many reasons, the hard work, the long hours, the fierce competition, and the sheer number of operations. Making a go of a restaurant has many challenges; around 60 percent of new restaurants fail within the first year. And nearly 80 percent shutter before their fifth anniversary. This is unfortunately the result of the difficulties in managing labor, controlling food costs, and low profit margins, and it seems you have to be just plain lucky — or have incredible food, a very solid business model, excellent management and effective marketing.

Consider also that foodservice is a high-risk enterprise, and those that get in trouble with foodborne illness, sanitation issues, or a customer injury, face liability, as well as the loss of reputation and the confidence of customers.

With these problems as a backdrop, COVID-19 might just be the last straw for many operations, which is tragic, given that so many workers depend on the industry for a livelihood, and consumers may no longer be able to enjoy the convenience and the wide variety of choices they have come to expect.

The FDA has recently published “Best Practices for Re-Opening Retail Food Establishments During the COVID-19 Pandemic.” This is helpful, and the industry has been expecting to receive such guidance. Now it falls on the local and state health departments to promulgate these standards into regulations and start enforcement.

The USFDA Food Code, adopted by most health departments, already has numerous provisions for communicable disease controls, and the provisions for exclusion or restriction of ill workers, sanitation and personal hygiene should be familiar concepts.

The challenge will be to translate what is known to be effective against the foodborne microorganisms in the “back of the house” into COVID-19 preventive measures in the “front of the house.” Customers and their habits cannot be controlled by the operator in the same way as worker practices, so a paradigm shift needs to take place.

I do not believe anyone has at this time a perfect answer to airborne transmission of COVID-19 in a restaurant, and therefore it is likely that we are going to see localized outbreaks with restaurants as a common exposure. With that will come exposure of the business to legal liability.

There is proposed federal legislation at this time to address the potential business risk that will come from lawsuits and COVID-19; but at the same time, we have FDA informing us of the best practices to reopen a restaurant. It is very likely that the local health departments will soon be tasked with regulation, inspection and investigation of restaurant related COVID-19 clusters. The public can be expected to file complaints, especially if they have observed a breakdown in protocols; if an outbreak occurs, the results could be devastating for an entire brand. 

In light of the public health and business risks, restaurant and bar operators must establish due diligence and implement the guidance we now have. The following check list is adapted from the afore mentioned FDA best practices guidance, with some additional recommendations:    

1. Inform employees that if they have tested positive for COVID-19, or have been in contact with a known positive case, that they must disclose this information immediately to management.
2. Exclude all employees exhibiting any symptom of communicable disease while on the job.
3. Remind employees not come to work when ill for any reason, but specifically if they have coughing, shortness of breath, and/or fever, and report such symptoms in themselves, family members, and close contacts.
4. Maintain a sick-log and watch for an uptick in employees calling in ill. Contact the health department if you suspect an outbreak is occurring.
5. Provide a written policy describing return to work procedures following the FDA guidance.
6. Post the following statement at the guest entrance “DO NOT ENTER if you are known to be positive for COVID-19 or have a cough, shortness of breath or fever.
7. Maintain a 6-foot distance between guests in seating areas, waiting areas, check out areas, or between guests on lines awaiting entry.
8. Place hand sanitizer stations at the guest entrances and at bathrooms, monitor guest behavior and ensure the sanitizers are being used.
9. Remove all common items from tables, including condiments and menus. 
10. Discontinue salad bars and buffet type self-service.
11. Maintain ware-washing equipment, proper wash temperatures and sanitizer concentrations.
12. All employees in contact with guests should wear a mask or other facial covering.
13. Bussers and others handling or cleaning used utensils or guest tables should be wearing sanitary gloves. The gloves need to changed frequently, but especially between handling soiled items and serving food.
14. Perform daily temperature checks of employees at the start of each meal period. Any employees with elevated temperatures should be excluded.
15. Observe guests for excessive coughing or sneezing, it may be necessary to ask such guests to leave the premises.
16. Maintain a high level of sanitation in restrooms, with hourly cleaning and sanitizing of fixtures and common touch points.
17. Ensure bathroom hand sinks are stocked with soap, warm water, paper towels or other approved hand drying method.
18. Use approved hard surface sanitizers following label directions, and clean and sanitize guests’ tables, chairs, and cushions between guests.
19. Clean and sanitize guest area floors nightly. 

We should recognize that especially in the beginning, implementing all of the preventive measures for COVID-19 may be difficult, or even impossible for some establishments; however, survival chances are better for those that are able restore public confidence in dining at their establishment. The public is expecting to see an obvious commitment by restaurants to their health and safety, and the best of the industry will step up to the plate. 

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If anything should restore the confidence of the American people in our governmental agencies and institutions, it is the leadership of our medical and public health professionals in this time of crisis. We should all appreciate the diligent response to the COVID-19 pandemic coming from our public health agencies and medical communities. We should also recognize the remarkable willingness of our businesses to close, and for workers to sacrifice their jobs to prevent the loss of life. These magnanimous efforts of goodwill on the part of one and all are particularly comforting in light of the political divides that separate us. 

While there has been a heroic effort on the part of many, I want to emphasize my admiration for the steadfast determination of the Centers for Disease Control and Prevention and state and local public agencies, as they have exercised their power to protect us in the face of political backlash and protests. It is therefore reassuring that in spite of the hardships we face, we have pulled together, and the public has respected the disease mitigation efforts recommended by the experts. The last few weeks have made me proud to be a public health professional. 

It’s still a long way to full recovery, but as the result of the heightened public awareness about communicable disease generated by the pandemic, I predict there will be some positive benefits that will eventually result.

The average person now clearly realizes that personal hygiene and sanitation can play vital roles in preventing disease transmission. This is true, even for those diseases like COVID-19 that are primarily respiratory in nature, as respiratory droplets contaminate hands and environmental surfaces and then spread through cross-contact. This transmission pathway is well known; however, this current pandemic has brought the risks into sharp focus for everyone. 

There are several positive outcomes that should result from the public’s renewed respect for more frequent and effective hand washing, and improved environmental sanitation. Those who have tested positive for COVID-19 are a lot more likely to be washing their hands and sanitizing their schools, workplaces and living environments than they were in the past — we are reaching close to 1 million positive COVID-19 cases in the US at the time of this writing — and those who were fortunate enough to avoid exposure now feel the pressure to follow suit.

In addition to flattening the COVID-19 epidemic curve, improved hygienic practices on a national scale will also likely reduce the burdens of influenza, colds, and viral gastrointestinal disease agents such as norovirus, and can also act to limit the spread of some bacterial agents, such as Shigella.

Public health agents at the federal, state and local levels have demonstrated their tremendous value to society, and as a result, there should be increased support for public health programs and the enforcement of public health rules. Programs that should benefit at the local level include public health nursing, environmental epidemiology, and the regulation of schools, childcare centers, nursing homes, food service, and retail food establishments. For all public health agencies, it may mean better funding, an increase in manpower, and an increase in political support.

When good hygiene practices become institutionalized, they become part of the culture. These beneficial behaviors are then passed along to our children and pay dividends in better health and longer life for generations to come. These practices, if they are sustained, will also help to control the next round of emerging pathogens that will surely come.

As mechanisms of communicable disease transmission change, our survival depends on a vigorous response, and on continuous advancements in research and medical science. It was just a few hundred years ago when plagues went unchecked and killed much of the population. To avoid this, we must have prompt notification of an emerging danger, receive scientifically sound advice, act quickly to mitigate the risks, and have access to effective medical treatments. 

COVID-19 has taught us that worldwide pandemics develop very quickly and know no national, cultural or ideological boundaries. We must therefore foster in all nations an increased appreciation for improving communicable disease surveillance, and the value of taking a proactive response to emerging disease threats.

Our survival increasingly depends on sharing information, teamwork, communication and coordination across borders; for in the eyes of the pathogens, we are indeed one people. 

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The food industry and our public health agencies have long recognized that they share the same responsibility to protect consumers from unsafe food.  The modern food industry is, however, growing more diverse, dynamic, and complex. making the application of food protection throughout the broad spectrum of operations a challenge for industry and regulators alike.

As these food production systems become more complicated, they become riskier, so it is not surprising that meeting our shared goal of reducing the incidence of foodborne illness is a moving target. The persistence of bacterial, viral and parasitic foodborne agents of disease in the food supply, coupled with the many risks inherent in modern production, processing and distribution, result in interactions that increase the threat of contamination.

Consolidation of production into larger and larger plants, long supply chains, a transient, undervalued workforce, consumer demands for convenience, and more fresh processed fruits and vegetables are just a few factors driving negative trends. To protect public health in this time of increasing risk, what is needed is the scientific and systematic application of preventive measures at all stages of production, and then the coordination and cooperation of industry and public health agencies working together to solve problems before they result in a crisis for consumers.

Unfortunately, we are not there yet with the concept of prevention. FDA has seen an increase in the number of foodborne ill investigations it conducted in the last two reporting periods. In 2018 and 2019 there were a total of 32 of these investigations, up from seven nationwide outbreaks in 2017. While there may be other factors influencing these statistics, such as the better detection and investigation of outbreaks, this trend may also mean our preventive controls are not yet working as intended. 

The Food Safety Modernization Act and “Risk Based Preventive Controls” has been in effect since 2017, and the industry is responding, recognizing that food safety is in their hands, but it will probably take many more years for the positive effects of this legislation to be realized. Our controls will improve, however, the more we can foster a culture of prevention within our industry and in the regulatory agencies overseeing compliance with safe practices. While this makes total sense, this concept must start with our public health professionals who should lead by example. 

Unfortunately, serious issues known to regulators are allowed to persist in too many USDA and FDA operations. An FDA inspector’s response to poor sanitation and safety in their facilities seems to be primarily to issue a form 483a Inspectional Observations or a Warning Letter (meaning likely violations) only to return years later and find the same issues again. Repeat violations include finding pathogens in the production environment and insanitary conditions whereby food should be considered adulterated, with none, or ineffective corrections taken.

FDA seems to be stuck in the old “command and control” model that was supposed to be replaced by the FSMA prevention concept. The old model is where a failing operation only fixes a problem after they have been officially notified or when forced to. FDA is right in wanting to change this situation and foster a culture of prevention within the industry, and industry gets it, but a culture of prevention has to begin with the agency itself. FDA apparently has the legal muscle to take action against repeat violators, but does so typically only after an outbreak has occurred. 

The toxic political environment that our public health agencies find themselves in does not help, so given the current state of affairs, we should not be surprised if things get worse before they get better. 

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I have a bias toward sanitation, which is the maintenance of healthful conditions, as a primary, if not the most fundamental disease control practice. As an environmental health professional, I am focused on preventing routes of disease transmission through the environment. To do this, we must understand that the routes are complex and involve three fundamental interactive epidemiological principles. Those are agent, host and environment.

In my foodborne-communicable disease investigation work over the past 40 years, it’s notable that in almost all cases, gross contamination involving the food is evident. Most often, the disease agent is passed either directly from an infected source, such as a human or other animal, or indirectly via cross contamination through an environmental exposure to contaminated air, water, humans, surfaces or foods.

The nature of the 2018 Rose Acre Farms outbreak and recall is not typical in that we have vertical transmission of Salmonella from the ovary of the chicken to the egg. In this case the factors of agent and host are working somewhat independently from the environmental source, but there must always be an environmental source somewhere in the chain of infection. Recognizing the potential sources of contamination is problematic of course, as the environmental conditions in poultry operations are highly conducive to the propagation of bacteria.

We know from the FDA investigations of both the 2018 Rose Acre and the Quality Egg outbreak 10 years ago, and my own personal observations, that there were poor environmental sanitation conditions, especially the rodent vector problem that cannot be ignored. Some industry experts at Egg-News have publicly claimed that no matter how many rodents or flies are breeding in the manure beneath the cages, that if the chickens are not infected to begin with, they will not become infected.

However, it cannot be denied that transmission to the layer-hens happened through some exposure of the chicken to salmonella in the layer-house. The potential sources there are water and chicken feed. Depending on the situation, rodents could spread the bacteria around an entire operation and contaminate feed storage areas and water sources, especially when the infestation is severe, as it was at Rose Acres. Flies are also capable of becoming vectors.

There was also processing happening at both operations where eggs were washed and further handled, so we might have a situation where the shell is contaminated, leading to problems in further handling. The sanitation at Rose Acres is suspect based on FDA finding poor cleaning methods of the equipment, and I personally observed the same or similar problems at Quality Egg. Pardon me, but  I don’t believe all of this is coincidence.

Salmonella Braenderup is not a typical egg-associated Salmonellae strain, the same industry experts have also publicly claimed that a possible environmental route might exist, such as a structural defect. In this case I agree with that, based on FDA findings.

Why I believe there is a bigger problem in the egg industry is that Quality Egg and Rose Acre farms, the bad actors I am referring to, are some of the biggest producers in the United States, so it cannot be said that the issues are isolated to a small segment of the industry. It is simply not enough for industry spokespeople to claim most egg producers are safe when we have massive contamination of the food supply and untold numbers of human infections through eggs.

Foodborne illness surveillance systems like CDC’s Foodnet show Salmonella infections in the population are still almost at baseline after almost 20 years of hard work by the food industry as whole to put into place best management practices. So, it’s aggravating when we see major food operators flaunt the rules.

I know Rose Acre said, “we have to do better.” That is a healthy response and a good starting place, if they have the capacity and the commitment to follow through. The Netherlands eliminated Salmonella from their egg supply many years ago through meticulous hygiene in the entire operation.

The deeper problem I am alluding to is that while these egg industry bad actors are known to the buying community, the supply chain seems unwilling to make buying decisions based on food safety. That is also egregious, since we now have laws in place through FSMA that are supposed to curb that mentality.

And what about Food and Drug Administration and the U.S. Department of Agriculture in all of this? They seem to be just standing by until something bad happens then they go into reactive mode. This should not be. In fact, disease transmission is preventable, so why are we not doing it?

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While a high degree of cleanliness may be impractical in an industrial egg production facility, Salmonella in eggs is a major public health threat and sanitation is needed to improve the effectiveness of several other Salmonella interventions.

Egg production in the United States is estimated at 75 billion eggs per year. This enormous volume of production requires a mechanized process, and through many innovations, the industry has been able to maintain an abundant supply of eggs at a relatively low price.

This is good news for consumers, but it comes at a cost to society. There is an environmental impact from these operations which confine vast numbers of birds in a relatively small, enclosed area, and there are important humanitarian issues concerning the care of the animals which has sparked public debate and consumer concerns.

While more Eco-friendly egg-production methods exist and may be an answer to some of the problems of industrial egg production, “factory farming”  is the norm and is unlikely to change. The “cage-free” concept sits well with consumers, but those layer hens are still subject to similar inhumane conditions found in the “battery cage” method, and there does not seem to be a correlation between these methods and lower Salmonella incidence.

As a sanitarian, I became familiar with sanitation issues in egg production during a private investigation of the Quality Egg Salmonella Enteritidis outbreak of 2010 with Marler-Clark law firm. That outbreak affected thousands of victims and involved a total breakdown of best industry practices at a facility under the so-called control of the now notorious DeCoster family.

In the Rose Acre Farms Salmonella Braenderup outbreak of 2018, it’s not surprising that the observations by FDA at the facility in North Carolina (Hyde County Egg-Pantego NC) note one of the main issues found at Quality Egg eight years earlier-an uncontrolled rodent infestation.

(For the FDA From 483)

www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm604794.pdf

It is not that food safety professionals haven’t learned how to control Salmonella in egg production. In 2009 the USDA through its APHIS branch released a report citing a European study that provided a method for the Prevention, Detection, and Control of Salmonella in Poultry. The methods are believed to have gained acceptance in the U.S. egg industry, but as we see once again outbreaks occur where management fails to ensure that operations follow the required protocols for control.

(For the APHIS report)

www.aphis.usda.gov/import_export/animals/oie/downloads/tahc_sep09/tahc_prev_detec_cont_salm_poul_78_sep09.pdf

Perhaps the most effective way to prevent the transmission of Salmonella through eggs is early detection of Salmonella in egg production. It should be pointed out that Salmonella in whole eggs is the result of trans-ovarian transmission, where the bacteria are deposited in the egg before the shell is formed. This transmission route has important considerations for controls, (i.e., to prevent deposition of Salmonella in the egg we must first and foremost prevent the infection of the laying hen).

As a primary control, breeder stocks must be tested and found free of Salmonella. An infected breeding hen which provides eggs that are hatched into chicks then raised into laying hens could infect a flock.  A second important control s the testing of chicken feed; the contaminated feed would provide an ongoing source of infection in a flock.

But even if layers and feed are not infected, the threat of Salmonella in an egg production house might still originate from rodents and flies infesting the chicken litter and manure as it collects under the cages. Vectors and filth can then contaminate feed, mechanized equipment, processing equipment, people, water and environments causing massive cross contamination throughout the operations and thereby perpetuate the infection of many more eggs

Effective rodent and insect control in a layer house take a coordinated effort between plant management and pest control operators. Pest pressure will be greatest when the plant and grounds are not maintained, sanitation is poor, and outer openings are not protected. Certainly, a rodent-free environment would be ideal, but this is practically impossible in a layer house. The goal of the rodent control program should be therefore to reduce the breeding population of rodents to an acceptable number by relying on properly placed and maintained rodent devices to both trap and poison rodents. The vast number of rodent traps and bait stations needed requires a systematic rodent device monitoring program which is well executed and documented. When analyzed, the trends in data from such monitoring can identify an increase in catches and sightings allowing effective intervention to thwart an infestation.

Early detection of Salmonella in a layer house through tests of the wastes that are building up under cages also allows an effective intervention which could include a temporary halt in production. The facility could then remove infected materials and trigger further surveillance, If the infection has spread to the flock, culling would be necessary, and perhaps a product recall could be initiated as a precaution.

Eggs are typically processed by washing them to remove organic material then treating them with antimicrobial treated water. If problems with antimicrobial levels, equipment, environmental sanitation, or water quality are occurring, environmental niches will spread contamination throughout a plant creating a continuous source of exposure.

Maintaining control over the facility environment, the animals, people, equipment, feed, and water are formidable tasks faced by managers of industrial egg production facilities; however, when outbreaks occur, they are widespread and sometimes deadly. Outbreaks result in a significant public health impact, not to mention potential criminal, regulatory or civil action (recall that Quality Egg owners served prison time for their failures). The failure of management to perform due diligence is a troublesome but common theme in many past foodborne illness outbreaks and will likely surface again as a causation factor at Rose Acre Farms.

While Rose Acre Farms and the former Quality Egg operations may be bad actors in the egg industry, the underlying challenge for the industry is to be proactive in identifying and isolating egg suppliers who have an ongoing history of noncompliance. Certainly, these firms are known to the major retail buyers- and to FDA. It may be FDA faces major political or administrative challenges in regulating the egg industry, but this current failure of the food safety system is yet another indication that further change is needed in our food safety programs and that we are still a long way from the risk-based model FDA is hoping the food industry will embrace.

Editor’s note: Bill Marler is managing partner of the food safety law firm of Marler Clark, and he is also the publisher of Food Safety News.   Roy Costa has served as an expert witness for Marler Clark in some of the most important food safety cases in the last 25 years.

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This is needed as outbreaks of foodborne illness continue to occur both in foreign and domestically sourced foods. Under this law, importers, also known as FSVP importers, must perform a verification step to ensure that foreign suppliers of food destined for sale in the United States have complied with at least two major rules of the Food Safety Modernization Act (FSMA)— the Produce Safety Rule and the Current Good Manufacturing Processes (CGMPs) and Hazard Analysis and Risk-Based Preventive Controls Rule for Human Food.

FDA will hold importers legally liable for ensuring compliance among their foreign suppliers. Importers must approve foreign suppliers before bringing food into the United States. The level of scrutiny applied to the importer approval process is based on a risk assessment of any given supplier’s performance and the historical risk of the commodity, akin to a Hazard Analysis in a Hazard Analysis Critical Control Point (HACCP) plan.

While the traditional HACPP (Hazard Analysis and Critical Control Points) risk assessment model is complex, the FSVP makes risk assessment a straightforward process. What is required in the FSVP version of hazard analysis, which focuses on prevention, is to determine the “reasonably foreseeable hazards” based on the history of safety of the commodity, the history of the supplier meeting their own nation’s regulations, and conformance with U.S. buyers’ requirements.

To make such determinations, an importer must be a “Qualified Individual” as well as an “FSVP Importer” and must be able to read and understand food safety documents such as audits, monitoring, training records, and microbial test results. Qualifications for the person designated as the FSVP Importer are not explicitly spelled out in the rules, however, education, training and experience are mentioned.

Importers of food act as the intermediary between foreign suppliers and U.S. customers. They arrange for cross-border shipments by preparing U.S. customs filings for each food item brought into the US. The customs forms have been updated by FDA to include an entry for the “FSVP Importer” for each line item of food.

It is estimated that 15 percent of the U.S. food supply is imported, including 50 percent of fresh fruits, 20 percent of fresh vegetables and 80 percent of seafood, making the importers’ new food safety role very significant for foreign and domestic trade. For example, an importer may have to disapprove a supplier and discontinue using them, thereby preventing the supplier’s food from entry.

Placing the burden of verification of foreign suppliers’ compliance on U.S. food importers may have some unique benefits and improve public health protection, but it raises conflict of interest questions. Shifting the compliance role to importers will change how importers, suppliers, food brokers, customs brokers, manufacturers and retailers operate. The entire supply chain must communicate now, and make buying decisions considering the new FSVP regulations. How everyone in the supply chain will comply with these new laws, while protecting their business interests and maintaining transparency, remains to be seen.

Importers must be competent to make sometimes challenging decisions about their suppliers’ performance when granting entry approval.

To verify that a food item is safe to import, importers look at the hazard analysis and Food Safety Plan prepared by the supplier. The importer evaluates the plan, considering the importer’s own hazard analysis. Importers also must evaluate the supplier’s compliance with food safety laws in a food’s country of origin and research the history of reports of contamination through The Reportable Food Registry. Importers should know about past and current compliance issues with the Preventive Controls or Produce Safety rules. Perhaps most importantly, an importer must stay informed about reported foodborne illness outbreaks associated with every commodity and/or supplier, product recalls, market withdrawals, and import refusals at ports of entry.

The FSVP is both a law, and a program that importers must have in place, with policies and procedures for foreign supplier approval, evaluation, verification, and corrective actions, all of which require extensive recordkeeping.

Records are the key to compliance, and FDA will often inspect records by sending staff to the office of the registered FSVP Importer. Or, FDA can request the records be sent to them in electronic form or as paper copies.

The FSVP rule requires that the FSVP Importer be in the United States and register with Dunn and Bradstreet to obtain a unique facility identifier or “DUNS number.” The DUNS number key for filing customs forms.

It cannot be overemphasized that the FSVP Importer named on the customs record must be a “Qualified Individual” under the FSVP law, through education, training and experience, and possess the depth of knowledge needed to perform somewhat complex risk assessments at several levels of the supply chain.

Not all food importers will be comfortable in their new role as FSVP importer. Not all will have the technical and scientific knowledge and experience needed to successfully develop their own risk assessment, and assess risk assessments done by others. Additionally, the FSVP Importer must document this entire process for a variety of foods and facilities, including farms, packing houses, processors, manufacturers and distributors.

Therefore, there is a growing need for many “FSVP Qualified Individuals.” All in the food supply chain should become more familiar with the FSVP rule so they can improve compliance throughout the food industry, minimize the potential for unsafe food and protect our nation’s interests in foreign food trade.

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Neither the Food and Drug Administration nor the Centers for Disease Control have disclosed potential root cause in the latest outbreak, however, the factors that lead to contamination of produce are well known.

Just as in an operation with previous sanitation or food safety failures, food industries as a whole with unsafe track records need to collectively correct deficiencies on an industry-wide basis. The tomato industry in Florida has adopted the Tomato GAP — Florida T-GAP — rule in response to tomato-borne Salmonella outbreaks. This example of an industry-wide program has proven to be successful. There have been no nationwide outbreaks of Salmonella in Florida grown tomatoes during the past few years.

For the papaya industry to take similar effective corrective actions, the root cause of microbial contamination of papaya must be determined.

We can examine three categories of risk:

1. Animal intrusion, or animal fecal matter;
2. Human to food transmission through fecal matter and sewage; and
3. Unsafe applications of water aka the three W’s — workers, water, and wildlife.

Papaya is a tree fruit that grows on a palm-like tree, about 10-15 feet off the ground. Irrigation water is usually applied by the drip method, where only the shallow roots receive water. Water also is sometimes used to dilute and apply crop protection chemicals such as a pesticide.

While water from unsafe sources is a known Salmonella risk, trees provide a convenient location for birds, and avian activity is a logical assumption as the root source of papaya contamination.

The recent report by FDA that three separate outbreak strains of Salmonella have been detected in papaya from one farm, is somewhat confounding and makes developing a theory difficult. Salmonella is carried by birds, and sometimes entire flocks or populations can be infected. However, avian infections involving several strains simultaneously might mean separate exposures of Salmonella in the environment, which conceivably may occur in a region with notoriously poor environmental sanitation.

Humans can be infected with Salmonella and spread the infection to papaya during harvesting. Subsequently, tools, containers, vehicles, and facilities used to handle and pack the fruit can become contaminated, furthering the spread of the pathogen. Again, three separate strains at work simultaneously in the harvester workforce is hard to comprehend.

Outbreaks with multiple strains of pathogens occur, but this is not typical of foodborne illness outbreaks, which are often traced to a common source of a single agent. When multiple agents are involved, the vehicle is often sewage. Human sewage is highly infectious and could contain not just several strains of a pathogen, but multiple pathogens, such as Enterohemorrhagic E. coli and Salmonella.

Exposure to sewage can occur when septic systems or treatment plants fail. Flooding or excessive rainfall can increase the risk of environmental transmission of pathogens to fruit. Soil can be carried to harvested fruit by multiple vehicles in the harvest operations, so a soil-borne or surface water exposure route is not out of the question.

Packing operations that receive and pack contaminated papaya can serve as a means of cross-contamination. If packing equipment or a facility’s environment become soiled, Salmonella can spread over time and establish environmental niches with the production environment then serving as the reservoir of the agent. Being a consolidation point, contaminated packinghouse work surfaces can contaminate large amounts of otherwise safe fruit.

We expect and hope that FDA and CDC will get to the bottom of what happened, and make the information public so the papaya industry can prevent future occurrences.

While the problem of microbial contamination of fresh fruits and vegetables is a difficult problem — fresh produce is the leading category of commodities involved in foodborne illness outbreaks — a properly developed risk-based food safety plan should minimize the risk of large-scale and ongoing outbreaks. A coordinated effort to adopt Good Agricultural Practices, specific to the papaya industry, is needed.

In the meantime, there is a risk assessment document available to tree fruit producers. The standards in it are based on the reasonably foreseeable and known risks related to growing and harvesting tree crops. The Produce Safety Alliance (PSA) at Cornell University recommends that growers of fresh produce develop a food safety plan. Completing a risk assessment is a good starting point, but the implementation of a plan’s policies and procedures takes management commitment and work.

Given the diverse risks in fresh produce, the details needed to ensure the adequate safety of these commodities are elaborate and as diverse as the risks themselves. Education is essential to carry out the implementation of a food safety plan. The PSA Produce Safety Course is available in English and Spanish through a variety of entities, including Environ Health Associates Inc. of Florida. Produce growers, harvesters and packers are encouraged to complete the PSA course or schedule an in-house training session.

For a complimentary copy of the risk assessment document for tree fruit, contact Katherine Jones, administration manager at Environ Health Associates by calling 386-316-7266 or sending email to [email protected].

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• 1993 Milwaukee, WI, Cryptosporidium parvum parasites in the public water supply sickened 400,000 people, killing more than 100;
• 2000 Walkerton, Ontario, E. coli O157:H7 contamination of the municipal water system sickened 5,000 people and killed five;
• 2015 Flint, MI, it is confirmed that switching the source for the public water supply from Lake Huron to the Flint River, known to include high levels of corrosives, caused lead contamination because the river water eroded pipes and solder joints. The entire population was exposed to high levels of lead for many months before it was confirmed. The lead was at toxic levels for 12,000 or more children. The number of related deaths is unknown. Many of the children face learning disabilities and life-long health problems.
• 2016 El Paso County, CO, more than 200 toxic industrial compounds called perfluoroalkyls (PFAs) were found in 106 samples from drinking water systems that serve 70,000 customers. These compounds, even in small quantities, are believed to be mutagenic and disrupters of the bodies’ endocrine system.

Given the real possibility that water systems may contain microbial and/or chemical contaminates, it is part and parcel of any food safety inspection to require that operators prove the potability of any source of water used in a food plant. Potable is a somewhat archaic term, from the Late Latin potabilis, meaning “drinkable.” Inspectors often ask food facility operators to conduct annual microbial tests, even on municipal water systems. This is an important parameter and inspectors should not overlook this requirement. Inspectors may also require samples to be taken from a facility’s plumbing to ensure that cross-connections have not contaminated the facility’s distribution system. Most utilities are able to maintain the minimum 0.2 ppm Free Active Chlorine concentration needed to ensure the microbial safety of water, however, dead-end lines may lack sufficient circulation and old pipes or loose joints may allow ground water intrusion, compromising the water system. Typically, water plant operators rely on the coliform test to determine the success of water disinfection. While these microorganisms are not pathogenic, their presence in a water system indicates ineffective chlorination, and thus the potential for the presence of pathogens. When found, the usual response is to conduct a second test for so-called generic E. coli bacteria. If E. coli bacteria are found, the facility may not use that water system and must provide mitigation, such as hyper-chlorination, and they must re-test such water before putting the system back into use. The Food Safety Modernization Act of 2011 (FSMA), in its Produce Rule, has a zero-tolerance approach for generic E. coli in agricultural water, including that used on post-harvest produce. This is an appropriate test, because it is common for produce facilities to use wells for water processes such as washing and cooling, without disinfection. The coliform test would not be an appropriate test for such systems, as coliform bacteria are likely to be present in non-chlorinated systems, and in themselves cause no harm. The regulation of agricultural water supplies is very spotty. County health departments often enforce the EPA’s Safe Drinking Water Act, but stop short at the regulation of water used in agriculture. Consequently, regulations have not required chemical, microbial or radiological tests for such water supplies, even though they are used directly on produce for human consumption. Currently, food safety auditors ask for microbial tests of these water supplies as part of a third-party food safety audit, but construction criteria and pre-approval of these systems, and the all important chemical tests, in most cases, are missing from the standards. This is a gap in our food safety controls, and FSMA and its Produce Rule have not addressed this problem. The FDA is apparently leaving it up to local public health agencies to decide whether to regulate a farm or packinghouse’s water supply. Given the poor state of funding for most local public health departments, a new initiative to identify and regulate the water supplies for hundreds of thousands agricultural water systems is highly unlikely. In this event, it is very important the third-party auditing firms, the last line of defense for food safety, revisit the standards for the safety of these systems and become more aware of potential chemical and radiological hazards, and not just the microbial aspects of water used in food production.   (To sign up for a free subscription to Food Safety News, click here.)

Cyclospora is a protozoan parasite that forms an oocyst. These hardy survival forms of this parasite allow it to remain infective for an extended period of time and protect it from treatments with sanitizers. The current outbreak in imported cilantro supplied by Mexico’s Pueblo region could not have been prevented anywhere else than on the farm. FDA reports that operations in this region of Mexico lack safe water supplies and have grossly inadequate sanitary facilities. Undoubtedly, these areas have had third-party oversight. We don’t have a clear picture of what types of controls were in place and why they failed, but it again raises some very serious questions about the competency and capacity of our current supplier control and food safety auditing efforts.

While progress has been made in the facilities that handle produce, more needs to be done at the farm level. Growers are faced with formidable challenges when implementing GAP programs. Farms are non-sterile environments subject to all sorts of foodborne illness hazards, mainly from animals, domestic and wild, contaminated irrigation sources, and, as recently revealed in the FDA investigation of the current Cyclospora outbreak, chronically poor or non-existent hygienic standards.

Policing vast expanses of crops is quite challenging. It is very easy to lose control over harvesting operations when hundreds of workers are spread out over large territories. In addition to the logistical problem of locating and maintaining sanitary portable hygiene facilities in these remote areas, farmers must cope with poorly educated workers, language barriers and cultural issues. However, there can be no tolerance for fecal matter in a human food crop.

Once again we see operations that are failing to provide the most basic of all sanitation practices. We may never know all of the facts surrounding the current Cyclospora problem, but after all the industry has done to improve sanitation, it is disheartening and frustrating to all of us trying to make a difference to see a complete breakdown of basic sanitation in a major foreign supplier. It is also pathetic that buyers in the U.S. would purchase products grown under these conditions. The people responsible need to provide some answers, but, as history has shown, the produce industry does not have all the answers.

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• Paleteria La Jalpita Issues Allergy Alert On Undeclared Milk And Sulfite In Ice Cream Bars And Popsicles
• The Popcorn Factory, Inc. Issues Allergy Alert on Undeclared Milk in Product
• Bedessee Imports Inc., Voluntarily Recalls Brown Betty Coconut Milk Powder Due to Presence of Undeclared Milk
• Euro Import Distributions Inc Issues an Alert on Undeclared Sulfites in Dried Apricots

While food manufacturers usually have allergen controls in place, protecting those in the population with food allergies can be particularly challenging. Undeclared allergens are considered a significant chemical hazard in food and thus a critical control in many processes, yet most product recalls are due to undeclared allergens. The U.S. Food and Drug Administration (FDA) requires manufacturers to list on the food label the eight most common ingredients that trigger food allergies. At-risk consumers rely on the labels on foods to guide them in making healthy choices and to protect themselves from allergens. Therefore, the failure to properly label foods when they contain allergenic ingredients, or when they have the potential to contain an allergenic compound, is a massive failure of a company’s food safety system. Allergens are proteins and other substances known to react with a susceptible person’s immune system to precipitate an allergic reaction. There are approximately 15 million at-risk consumers in the U.S. population. Persons with allergies may develop sometimes serious medical consequences, such as breathing difficulties, or may go into anaphylactic shock after exposure to a host of allergens in food. There are eight major allergens that cause 90 percent of allergic reactions:

• Milk
• Eggs
• Peanuts
• Tree nuts (such as almonds, cashews, walnuts)
• Fish (such as bass, cod, flounder)
• Shellfish (such as crab, lobster, shrimp)
• Soy
• Wheat

Food labeling laws require food allergens to be identified even in very small amounts — but only when they’re contained as an ingredient. Manufacturers aren’t required to include warnings about food allergens accidentally introduced during manufacturing or packaging (cross-contamination). The label lists the type of allergen — for example, the type of tree nut (almond, walnut) or the type of crustacean shellfish (crab, shrimp) — as well as any ingredient that contains a protein from the eight major food allergens. The labels also include any allergens found in flavorings, colorings, or other additives. Many manufacturers voluntarily include warnings, but these advisory labels aren’t always clear. Manufacturers have different ways of stating that a food allergen may be present. For example, labels may say, “manufactured in a factory that also processes wheat” or “may contain soy.” Work is needed to make the format of these advisory labels more consistent so that it’s easier to identify which products contain allergens. Medical authorities advise consumers in doubt about whether a product contains something to which they are allergic to avoid it until they check with their doctor. When foods contain an undeclared allergen, or when allowable levels of a food additive used as a preservative, such as sulfites, are exceeded, such foods are deemed adulterated and a recall is initiated. A product recall is a crisis for a company; it results in serious economic loss and legal entanglements and can be a major challenge to the viability of a brand. Hazard Analysis Critical Control Point (HACCP) controls during manufacturing Product contamination and adulteration can take several forms. We classify substances as foodborne hazards if they are reasonably likely to cause illness or injury when out of control. We can classify them into four broad categories, such as chemical, physical, biological and radiological (thanks to Fukushima). We develop controls for the particular hazards that are expected to occur and critical controls for the likely ones with the most potential for harm. Food safety plans built on the principles of Hazard Analysis Critical Control Point (HACCP) must consider the likelihood of occurrence of these chemical hazards in most food manufacturing processes. While producers of commodities such as eggs, fresh meat or fresh produce do need to list allergens, most other foods require some type of allergen control and/or label. Control starts with identifying the specific allergenic ingredients. Then, an operator must determine how these ingredients are handled and how they flow through a production system. Such studies often reveal points where cross-contamination with allergens may occur. Controlling cross-contamination between allergenic and non-allergenic ingredients on production lines is necessary when the line runs both allergenic and non-allergenic food, or when a variety of allergens are run. However, cross-contamination controls begin at the time a firm receives an allergen-containing ingredient and continue during its storage, internal transport, and during packing. Proper cleaning between product runs is the most fundamental control. Visual inspection of the equipment to detect particles remaining post-cleaning is a useful effort, but unseen residues of allergens may linger and cross-contaminate the next product run since even the best cleaning may not result in 100-percent removal of particles. The cleaning process must also consider the forms (e.g., pastes or films) encountered and match that with the appropriate cleaner. Some plants must use drycleaning methods when water in a production environment is detrimental, such as when manufacturing confectionaries, or in bakery environments. Such dry methods can be ineffective and can lead to cross-contamination. Even when detergents and water can be applied to equipment, applications may be uneven, leaving traces behind. As better laboratory methods of detection have increased the specificity of tests, investigators looking for allergens can detect smaller and smaller amounts of them. In-plant allergen testing of equipment, however, can provide verification that allergens are not present on a surface after cleaning. Some tests used in a plant environment are not allergen-specific and utilize quick colorimetric tests for proteins, sugars, or other markers of allergen contamination. Operators instead should use ELISA kits (enzyme-linked immunosorbent assay). While much more sophisticated and expensive, they can be validated and possibly validate the protein or sugar swab methods. ELISA tests may be a better choice for in-plant testing. Such testing can be qualitative as well as quantitative (a 5 ppm Level of Detection typically). Operators should also develop protocols to establish the baseline information needed to interpret results. Establishing baseline acceptance criteria requires establishing the levels of allergens in products when various levels of allergens are detected on surfaces of equipment. Off-site labs having more sophisticated methods usually conduct such validation studies. Such validation data may allow operators to accept some trace levels and avoid the pitfall of chasing molecules around a plant when such levels are shown not to affect the final product. Operators must designate cleaning tools for specific areas to avoid the tool as a form of cross- contamination, and Sanitation Standard Operating Procedures must be developed. Such SSOP should contain the designation of a cleaning crew, and sanitation employees need ongoing training. The SSOP should contain the items requiring cleaning, the types of cleaners used, dilution values for detergents and degreasers, how to maintain effective levels, water temperature, tools used, how often the cleaning is carried out, and the timing of visual inspections and verification. As in all HACCP-based systems, the results of the testing program are recorded and verified. Cross-contamination may occur during storage and internal transport Storage of allergen-containing materials together in the same area can also lead to cross-contamination when the operation has not effectively designated the proper storage areas. Storage of allergenic foods above non-allergenic, or a mix-up of ingredients or finished products can lead to cross-contamination through the environment. Ideally a facility should store sensitive items in separate enclosed areas, but not all plants have the capacity for separate storage. In these situations, careful monitoring and a visual marking or signage is helpful. Even forklifts and pallet jacks could play a role, along with totes and other containers. Labeling failures Because we have risks in allergen control and our controls may not always be successful, the label should provide the at-risk consumer with enough information for making a decision. As mentioned earlier, however, the use of language such as “may contain …” or “made in a plant that also processes …” make food choices more difficult and impacts the quality of life for such consumers. Labels are applied to final unit packages by hand, or typically by a label machine. Rolls of labels have to be run for each batch of product. The timing and staging often lead to the packing of several products at once and different label sets on the plant floor. When the products differ as to allergens, it is easy to make an error in the application of labels. Errors can also occur in the printing of labels, and allergenic ingredients may be inadvertently left out if the operator has not done due diligence and did not realize the product or ingredient contained an allergen. Highly refined oils are hidden ingredients in many products and may contain trace amounts of proteins, for example. Foodservice allergen control Patrons of restaurants are often at high risk of exposure to allergens. No such menu labeling requirements are required in the USFDA Food Code. Restaurants handle a complex variety of foods, and it is nearly impossible to know for every recipe and every product what allergens may or may not be there or to separate them. Furthermore, the operating conditions of restaurants are very different than processing plants, and there is very little that can be done about preparing and storing various allergen sensitive foods together. The last line of defense is the waiter or waitress who is often the only person, except for the cook, who can answer a question about whether a food contains a certain ingredient or not. Even then, it may be impossible to know in every case every allergenic ingredient. The effectiveness of industry allergen control programs As illustrated by the recent spate of recalls, the food industry’s response to allergen control has been less than completely successful and more needs to be done. The industry needs better testing regimens and adherence to properly developed cleaning protocols. As in the case with preventing microbial contamination, a company must provide the resources necessary and have the experience and technical ability to monitor and control a sometimes complex array of policies, procedures, and validation methods. And, for a variety of reasons (some unknown), the situation is getting worse:

• According to a study released in 2013 by the Centers for Disease Control and Prevention, food allergies among children increased approximately 50 percent between 1997 and 2011.

• Researchers are trying to discover why food allergies are on the rise in developed countries worldwide and to learn more about the impact in developing nations. More than 17 million Europeans have a food allergy, and hospital admissions for severe reactions in children have risen seven-fold during the past decade, according to the European Academy of Allergy and Clinical Immunology.

As with all things food, the hopeful implementation of FDA’s FSMA will strengthen the backbone of allergen control efforts in the future, but the industry should recognize that more is needed now.

The Development of Food Safety Systems in Agriculture

The organized practice of growing fruits (the seed-bearing portion of a plant) and vegetables (the edible portions of plants) for human and domesticated animal consumption emerged at the dawn of recorded history. Evidence of agricultural endeavors date back at least 12,000 years. The altering of communities of fruits and vegetables for man’s own benefit resulted in significant changes in once formerly hunter-gatherer communities, and mankind’s success in agriculture paved the way for the birth of our modern civilized society.

There is nothing more iconic than the image of the farmer plowing his field, and anyone rubbing shoulders with these hard-working individuals enters a world of timeless traditions.

The application of food safety in the growing and harvesting of produce is, however, a new development. Only in the past 20 years or so have experts formulated agricultural food safety principles borrowed mainly from food manufacturing, and these rapidly evolving systems of safety and hygiene rules are impacting farming in many ways. One must thoroughly appreciate the history of agriculture as we impose these new concepts on farming operations and realize that they are mostly foreign to traditional farming methods.

Food safety in any application may seem quite simple, and so it appears to be in agriculture, at least on the surface. If the growing area is free of contamination and workers are in good health, and the environment, water and overall growing conditions do not negatively impact operations, consumption of fresh fruits and vegetables should be considered a low risk for causing foodborne illness.

The evidence, however, points strongly in the other direction. Produce-borne outbreaks caused by bacteria, parasites and viruses are all-too-common events and, in many instances, investigation reveals unsanitary conditions in the growing area as the initial source of the pathogenic agent.

In 2006, spinach produced by Earthbound Farms caused a disastrous E. coli O157:H7 outbreak that seriously affected public health and sent shockwaves through the entire produce industry. The protracted outbreak investigation was confounded by poorly documented supply chain record-keeping, but, eventually, the trail led to a small farm in San Benito, CA, nestled in the foothills of central California’s Sierra Nevada. In the meantime, consumers nationwide stopped purchasing spinach, which, in turn, caused a serious market crash.

This outbreak illustrated several important factors that would play out again and again in future produce-linked outbreaks. Most important, from the point of view of the safety of the growing area, it was found that feral pigs frequented the farming area; fecal specimens from one herd collected close by revealed E. coli O157:H7, but, interestingly, not the outbreak strain.

The source of the spinach only came to light many weeks after the first case of E. coli, and, in the meantime, the fields had been harvested and product shipped to the Earthbound Farms processing plant for processing, packaging and distribution. Investigators obtained environmental samples from the facility that revealed the causative agent, and, in order to eradicate the bacteria from its processing equipment and environment, the facility ultimately had to close temporarily. In total, more than 200 people were sickened and three of them died. Following that outbreak, the company redesigned its food safety practices to become an industry leader in growing safe produce.

The ensuing crisis of consumer confidence at the time created a powerful driver for change, and the years that followed saw wide-scale adoption by farmers of industry-led Good Agricultural Practices (GAP). The application of control measures based on FDA guidance documents with significant enhancements continues until this day.

Challenges in Agricultural Food Safety

The U.S. Food and Drug Administration (FDA) tells us to consider the following pre-harvest risks when growing fruits and vegetables, and this paper will evaluate the relative importance of the most significant ones and further explore current public health concerns:

• Feces contamination of growing and harvesting areas by humans and wild and domestic animals
• Unsafe irrigation water
• Runoff
• Flooding
• Growing area land use
• Adjacent land use (septic systems, leach fields, biosolids, industrial operations, intense livestock operations)
• Infected workers harvesting and handling produce, or poor hygiene
• Improper cleaning and sanitizing of harvest equipment and utensils
• Cross-contamination in recycled irrigation water
• Inadequate pest control
• Contaminated containers
• Contaminated seed and sprouting
• Contaminated soil
• Green, or inadequately composted, manure
• Air (dust)
• Water for other uses (for example, pesticides, foliar treatments, growth hormones)
• Manure and soil amendments

Feces contamination of growing and harvesting areas by humans, and wild and domestic animals:

Wild Animals:

Intrusion by wild animals is a serious issue from a crop-loss standpoint and can have severe economic consequences. Farmers have traditionally attempted to control significant grazing by deer and the uprooting of plants by feral pigs, as well as the damage caused by birds and ground animals, such as rodents, rabbits and raccoons. Efforts to control wild animal populations, however, are only marginally effective, and, in some regions, crop losses of 20-30 percent can be expected from deer, while a large flock of birds can completely destroy a crop in a day or two.

Barriers, such as fences, are only effective for larger herbivores, such as deer or pigs (and very sturdy fences are required), but there is virtually no completely effective barrier for birds or small ground animals (short of enclosure in a greenhouse).

Bird control has taken several forms, such as gas cannons and other acoustical repellents, visual repellents, physical exclusion and biochemical repellents, but the persistence of birds is remarkable, especially Canadian geese and certain migratory birds (cedar waxwing), starlings, sparrows and crows. Virtually all birds can be vectors for Salmonella and Campylobacter, as well as parasites, such as Cryptosporidium and Cyclospora cayetanensis, while Salmonella and E. coli are the major concerns with herbivores.

Wild animals and agriculture have existed side by side for millennia, so it is not reasonable that we can solve the animal intrusion problem in just a few years. Furthermore, there is a competing side of the argument that says such wild populations of animals should be nourished rather than exterminated!

Striking a balance between allowing some natural populations of animals in farming areas and restricting or eliminating them is not easily accomplished. Probably the best defense against contamination by animals is diligence by farmers and especially immediately before harvest. Knowing when and where such intrusion and potential contamination is occurring is critical to any type of mitigation. Areas favored by animals may include the portions of crops nearest to natural cover and riparian areas; birds especially like to drink water when feeding. Often the marginal areas set back away from roads or human activity will be the most impacted by deer, although raccoons and pigs can range widely in a field. Most of the deer and wild pig activity occurs during nocturnal hours, early morning and at dusk, while bird activity may reflect migratory patterns, with the availability of roosting and nesting locations favoring feeding sites.

Animals may favor the growing area depending on the level of maturity of the crop; the closer to harvest, often the more attractive the crop becomes. Therefore, the period just before harvesting is likely the best time to intervene. Interventions include scouting areas at night, lights and netting (in berry crops and grapes) and trapping, but probably the best intervention is for the producer to recognize where animal intrusion has taken place and not harvesting those zones with the contamination. Adverse findings include feces, tracks, gnawing and pecking, as well as rooting by pigs. Harvesters need a degree of experience to recognize the signs of animals and a thorough scouting of the blocks before harvesting must take place. When evidence is found, the affected areas require marking, flagging, or otherwise cordoning off. This must be coupled with supervision to ensure that these zones are not harvested. Such crops can be “placed on hold” and tested before harvest, but it is best not to harvest the crop and to plow it under. Traps may be useful to control pigs and raccoons, but, once caught, disposal or relocation of the animal is a problem, and trapping usually requires a licensed entity and can be costly and time-consuming.

Domestic Animals:

Domestic animal production coexists with produce farming, and the produce farmer may also rear cattle or other domestic animals. Growers benefit in this arrangement by having a means to dispose of silage, and, at the same time, benefit from the use of manure for crop nutrition. Domestic animal production produces wastes, which can easily find their way to produce fields with equipment, people, wind, dust and rain. While field fencing is usually adequate to control small herds of cattle, fences must be kept repaired and in the proper place. The setbacks between domestic animals and crops are poorly defined in the third-party standards, and there is controversy and a lack of reliable scientific data to guide the farmer as to how far to separate operations. The many variables, such as topography, soils, drainage and the type of crop, all affect the ability of pathogens in adjacent animal waste to contaminate a crop. Animal wastes may also affect irrigation water sources, especially surface water sources, although poorly constructed or shallow wells may also be impacted. These setbacks are best determined on a case-by-case basis through a risk assessment that studies the topography, slope of the land, drainage and water-holding characteristics of soils, and takes into consideration the magnitude of the adjacent animal population.

FDA’s Food Safety Modernization Act (FSMA) is expected to address the setback issue, but, as with everything in this Act, only time will tell if a final rule will actually be enforced.

Human Waste:

Human contamination of growing areas is still a potential problem in spite of the advances made in the availability of portable toilets and hand-washing facilities in produce operations. A farm needs at least one portable toilet for every 20 workers, and separate facilities are required when women are present. Constant oversight and maintenance is required to ensure there is always a sufficient amount of water, soap, and hand-drying devices. But compliance with personal hygiene requirements, as basic as they are, is often problematic, with cultural, language issues and time constraints all impeding effectiveness.

Currently, most third-party standards call for a sufficient number of portable toilets to be within 5 minutes walking distance, or a quarter-mile of workers at all times. This requires numerous freestanding portable toilets in specific locations throughout the farm, or for the units to be on wheels. Even then, suitable places to locate the units may be difficult to find. A half-mile walk through rugged terrain in 90-degree heat may encourage workers to take shortcuts, and a diligent inspector all too often uncovers human fecal remains and signs of toilet waste in, or immediately adjacent, to growing areas. Furthermore, the portable toilets themselves are potential sources of contamination, with each containing a holding tank of at least 10 gallons of raw sewage that must be pumped out safely at least two to three times a week when at capacity. Servicing and otherwise maintaining these units is an ongoing, labor-intensive and expensive undertaking, and violations of rules regarding the accessibility, care and upkeep of these facilities is still quite common in spite of the industry’s newfound emphasis on personal hygiene. Some very sensitive operations, such as in tomato harvesting, find it necessary to dedicate a “monitor” for the portable toilets. The sole function of this employee is to make sure employees use the facilities properly and that they wash their hands afterward.

The sinks provided with these portable toilets are barely adequate, producing a small amount of unheated water. The efficacy of hand-washing under these conditions is debatable.

Unsafe Irrigation Water:

Although some farmers do not irrigate crops (“dryland” farming techniques), the norm is to utilize available sources of water to supplement rainfall. In some areas, the availability of water sources (“water rights”) has become a volatile political issue, and experts warn of impending water shortages. Most states have water authorities that manage the use of water, placing restrictions on the amount of water allowed. Due to these pressures, farmers are often forced to use water with marginal qualities, use treated municipal wastewater, and to recycle irrigation water.

Water sources may include groundwater, with wells tapping both shallow and deep aquifers, and surface water, e.g., ponds, lakes, rivers and streams, as well as canals and ditches. All of these sources are subject to varying degrees of potential contamination, but surface water sources are very vulnerable. Rivers, streams, canals and ditches are open, flowing bodies of water, and contaminants that may be found in the watershed are easily distributed to downstream locations. Sources of pollution include point sources, such as industrial operations that may release heavy metals and toxic discharges, sewage treatment plants, storm water drains and myriad non-point sources found in developed areas. Cattle and Concentrated Animal Feeding Operations (CAFOS) are significant risks and have been suspected as a source of pathogens in rural environments. The lack of land use planning often brings produce areas in close proximity to cattle, pigs, and poultry houses.

The problems of land use are at the root of many of the contamination issues in farming, but there is just so much available land and remedies are difficult to find. Political considerations prevail, rather than a planned approach to decisions as to where to locate competing industries.

Ground water sources, while somewhat safer, are also subject to contamination depending on their depth, construction, and characteristics of the water table. One of the missing links in our safety programs is the lack of standards for the construction of irrigation wells. While the EPA Safe Drinking Water Act proscribes the construction of potable water wells and distribution systems, most regulatory authorities have exempted agricultural wells from their rules.

Irrigation systems can use methods, such as overhead irrigation using what are known as pivots, sub-irrigation methods such as seepage, and micro-drip irrigation. While direct foliar application of water probably carries the highest risk, all methods can contaminate crops and soil.

The development of standards for pre-harvest application of irrigation water continues to be controversial, and FSMA rules are much anticipated. The key microbiological standard in use now is based on the level of generic E. coli. When an operation has only one sample result, the total bacterial count cannot exceed 125 CFU (colony forming units). As the sample data pool increases over time, a 5 sample rolling mean can be calculated; in this scenario, the average colony count cannot exceed 235 CFU in a 100mL sample. While these limits appear to be protective, scientific validity for these limits is somewhat lacking, and the standards themselves have been derived from EPA’s Recreational Bathing Rule. In places such as Florida, which is blessed with an exceptionally pure, deep aquifer (the Floridan Aquifer), ground water rarely, if ever, fails to meet the requirements, while in intensively farmed areas, such as the San Joaquin Valley in California, it is likely to find excessive concentrations of E. coli.

For many with impaired water quality, growers must treat the water with an antimicrobial to bring it into compliance, mostly using chlorine either as hypochlorite or gaseous chlorine.

But treatment and regular testing is not enough; farmers must have a validated sampling plan that is based on a risk assessment. This requires studying the characteristics of the irrigation system, mapping, selecting representative sample points, a systematic approach, effective sampling methods, and the accurate interpretation of results. If undesirable results of irrigation testing are obtained, procedures must be in place to verify the safety of the products under production since the last water test and to confirm findings with a second test. Mitigation of contamination in well casings may be accomplished through the super-chlorination or shocking of the well; however, in worst-case scenarios, undesirable water sources must be abandoned and secondary sources utilized.

While farmers are very knowledgeable about the physical operations of wells, they may lack the basic understanding of microbiological standards and tests and how to interpret results, and they may also lack expert knowledge about the safe and effective use of antimicrobial agents.

The data collected often reveal associations in time, place, person, and illness in the population. Such can lead an investigator to valuable information to stop outbreaks from continuing, but only if the data is accurate, properly understood, and acted upon.

Outbreaks usually have a defined course and chain of events, and when data are plotted, they will reveal onset dates, peaks and the tailing away of cases. The data may also reveal the immediate source of a contaminated food, allowing consumers to protect themselves if the information is made public. The epidemiologist is in a critical situation when they have data that supports a hypothesis that an outbreak of disease is occurring.

As surveillance improves, thanks to better diagnostics and more effective reporting, we now see a marked increase in foodborne illness outbreaks that come to light through an epidemiological approach.

Historically, the most fundamental finding in a foodborne outbreak investigation is the isolation of the causative organism from both victims and foods. When this detail is at hand, they provide strong associations between victims and likely causes. In such cases, the epidemiologist has traditionally made that information public. This allows the public to make a choice, helps in further case finding, and allows the removal of affected products.

But the gold standard is difficult to obtain, and only a fraction of the actual foodborne outbreaks known to occur have a confirmed cause; this success being dependent on the shelf life of the food items, the ability to isolate the pathogens from food, and other factors.

The Peanut Corporation of America (PCA) caused a deadly and long-lasting outbreak with its peanut butter products in 2007-2008. Cases continued over several weeks before the CDC — in tandem with Team Diarrhea — made the associations with King Nut, and eventually PCA.  The question was repeatedly asked, “Why did it take so long for the outbreak to be recognized?” The delay drew the attention of some notables in epidemiology and led to criticism in CDC’s epidemiological approach.

On the other hand, recently a state health investigator pointed to a Salmonella outbreak in Cantaloupe without the causative agent being isolated. A detailed trace-back of cases led to strong associations between the importer and those made ill. The importer, who was named in the press, sued the epidemiologist, but later dropped the suit.

These shots across the bow of epidemiology are still apparently resounding.

Now we learn CDC and health departments in 10 states investigated an outbreak of 70 cases of Salmonella, but kept the process secret, and now will not reveal the name of the implicated restaurant. While it is clear that epidemiology as a science has limitations, the data can also be convincing, especially when there are clusters of cases that point to a common immediate source. Withholding the name of the immediate source, even when specific foods cannot be identified, does little to protect the public from immediate hazards or to find solutions to future occurrences.

While epidemiology is a powerful tool, it is one that can also backfire. In the international outbreak of E coli in sprouts last year, we saw the quandary epidemiologists faced. European officials jumped the gun several times. In good faith, they implicated a wide variety of possible vehicles and sources before finally identifying the source of contamination in a totally different country, and in a totally different product than was first thought (sprouts not cucumbers).

In the nationwide US outbreak of peppers/tomatoes in 2008, associations between tomatoes and cases became less and less likely as more cases of salmonellosis in persons eating peppers came to light. The effect on the tomato industry was dramatic, with losses in the untold millions.

When public health officials make mistakes in foodborne outbreaks, the industry suffers and the political fallout is extreme. To the extent that they do not act to protect the public, they fail their mission. We should not forget that local officials are closely tied to their communities in many ways. Local health departments rely on revenue generated from the local food service industry. After many years, bonds form between local public health agencies and industry, naturally, and out of necessity. When a regulator is compelled by the evidence and must take on the health protection role, he can find it painful. The wrong word — “strawberries instead of blueberries” can cost one their position. Therefore, it is not unreasonable for the regulator to be stuck in a “damned if you do, and damned if you don’t” situation, especially if he is a local.

In the end, honesty is the best policy during any outbreak of disease. When the investigator is guided by a careful analysis of data, an honest presentation of the facts and truthful explanation is all we can ask for.  Consumers demand no less from CDC.  Perhaps there needs to be “whistleblower protections” for CDC from lawsuits (ironically, this protection is afforded now by the FSMA-but only to workers in FDA-regulated facilities).

It’s in the best interest of everyone to work together in crisis times like these in food safety. The public understands and forgives a mistake when it occurs out an abundance of caution to protect them, but there is no forgiveness for a failure to inform them and they suffer as a result. The failure of CDC to name names is preventing the redress that victims rightfully have for damages and also reflects the power industry has to keep our investigators silent.

___
Roy Costa is the founder and owner of the consulting firm Environ Health Associates, Inc. Mr. Costa is a registered professional sanitarian with 30 years of environmental heath practice in the academic, government and private sectors. Mr. Costa is an educator and food safety trainer with International experience in a number of countries.

Countless tons of foods travel through interstate commerce and internationally daily. The complicated route that most foods take from farm to plate is remarkable and catching the random contaminates as they filter through is challenging. Keeping up with food safety requires a broad background, not just in the microbiological, chemical and physical hazards ever present, but a firm understanding of the supply chain and the risk passed from step to step.

The first duty of a food safety auditor is to detect non-conformances with standards. The standards are themselves complex, reflecting the industry, and its wide risk of exposures. Not to mention that the standards can be imperfect by themselves; it takes a knowledgeable person to interpret them in every situation. Scientific justification exists for most standards, but standards may vary dependent on the scope of the audit, the operation, commodity, regulation and many other factors.

Technical skill is needed, along with the ability to think on one’s feet, focus and determination. A sense of where trouble might be hidden sometimes comes with experience. In addition to the skills needed, an auditor must constantly stay tuned-in to the latest developments; for example, a food safety auditor not realizing we have gaps in knowledge of produce safety would be truly in the dark.

What the Jensen-Frontera Salmonella outbreak showed me, as an auditor, was that my thinking has to change, while I am still left with some unanswered questions.

If a failing score instead of a superior score was issued, would this have stopped the Jensen brothers from selling their products and prevented the outbreak? Does industry expect the audit process to provide a high number to satisfy some buyer, a low number to rule out a supplier, or is the expectation to find problems and to make diligent corrections?  (I believe auditors providing high numbers are a bit more popular, but the ones finding problems much more effective!)

And now the really tough questions: are the Jensens guilty of not knowing that conditions in their plant could poison the nation? And is the auditor who didn’t “see the Listeria problem coming” someone aiding and abetting … an accomplice?

Unfortunately, I don’t have good answers to these questions. Maybe the legal process will sort it out, but what a terrible way to learn.

The audit is a risk assessment whereby perspectives change with the methods used. Seeing the facility or operation through the lens of the audit template questions gives one type of perspective, performing a risk assessment based on conditions and their interrelationship might be another (of course, somehow they should coincide).

In retrospect, we can see now that the melon-packing-process hazards were connected in time, temperature and moisture, and further connected with the growth of Listeria on cantaloupes. Audits, the way they are currently conducted, are not likely to detect subtle relationships like these.

Business relations as well as practicality affect the scope of the audit. The audit scope is very important to determine, for the auditor is more or less bound by the constraints.

Food safety auditing is a big business and growing rapidly. We should accept that in the business world relationships will develop. The human element will always be with us, but food safety auditors these days are carrying a lot of weight and need to use their growing power wisely … not to penalize companies, but to improve the situation. It is not our role to police the industry, but we can feel like a soldier on patrol sometimes in our work and sometimes feel like we have come under fire.

Protecting the food people eat is a shared responsibility, one way too big for even an army of auditors.

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Roy Costa, a registered professional sanitarian with 30 years of environmental heath practice in the academic, government and private sectors, is the founder and owner of the consulting firm Environ Health Associates and author of the Food Safety & Environmental Health Blog.

Jim Prevor, produce industry analyst, says changes are needed, while the law firm Marler-Clark is suing a food safety auditor and a third-party auditing firm.

The lingering question remains, “how can we improve this system”?

Third-party audits are best implemented when there are regulatory controls over the audited operations, thus underpinning them.

In their absence, third-party audits are flawed by a lack of standard government requirements such as the preapproval of equipment, structures, layout and design, waste disposal methods and potable water sources.

Third-party food safety audits are currently conducted as part of a firm’s overall quality assurance program. The audits are simultaneously  environmental risk assessments, regulatory compliance assessments, evaluations of production processes and analyses of management controls.

Food safety auditors, auditing companies, standard setting and certification bodies, and all players in the produce supply chain share a common interest. These partners should work together through a logical and cooperative approach guided by the best available science, to protect public health, and in so doing, their own interests.

Suggestions for improving the third party food safety auditing processes include:

Changing the roles of the audit company, buyer, and customer:

Currently, buyers (retailers, middlemen, brokers, marketing groups) require that suppliers schedule and pay for an audit with an auditor or auditing company. Since the auditees make such arrangements, they are the customers of the audit firm. The auditor is beholden to the “customer” to establish the time and location of the audit in advance. The auditee also negotiates the price, and can even request a particular auditor, although the final decision as to which auditor to assign in generally left to the auditing firm.

If roles are reversed, and the “buyer” becomes the “customer,” then the buyer would schedule the audit, and the buyer would pay for the auditing firm for the audit. The buyer would then receive the audit report directly and have control over its dissemination.  Most importantly, this process would allow for an unannounced audit to occur. Auditing firms know that scores of announced audits are often much lower that announced ones, suggesting observational bias that this method might filter out.

The buyer, as the customer, would become the driving force behind audits, their timing, stringency, frequency and interpretation.

Fee arrangements and the practical aspects of doing business may pose hurdles to this approach, but the resulting value to buyers may make this method attractive enough to induce changes in the current business models.

Roles of government and auditing firm:

The Food Safety Modernization Act (FSMA) currently addresses the need for auditor competency when working in post-harvest operations under federal jurisdiction and as part of FDA’s “Foreign Supplier Verification Program.” Auditing companies should require that auditors become fully familiar with existing FDA produce safety guidance and the new requirements of the FSMA, especially the requirements for a hazard analysis and science-based controls.

The FDA should begin an effort to meet with buyers and auditing company executives to discuss partnerships, and establish liaison with them to coordinate their activities around meeting the goals of the FSMA.

The FDA should protect auditors under whistle blower protection provisions and require that the buyers (as the drivers of the model) provide to them all third-party documents related to food safety within 10 days. The third-party risk assessment findings should drive the need for FDA to conduct its own rapid response risk assessment within 30 days, if and when necessary to protect public health.

Auditing companies should report “automatic failures” resulting from adulteration to FDA  within 24 hours.

Transparent communications should happen between the FDA, auditing firms and buyers. FDA should make known its own compliance records in a timely fashion. Third parties should not audit any facility operating under FDA sanctions until such firms are in substantial compliance.

When third-party audit criteria are less stringent than federal rules, their value as a risk assessment tool is negated.  Risk assessments, especially newly adopted ones such as Global GAP- should be scrutinized. Currently, the failure to have toilets available to field workers in Global GAP would not trigger an automatic failure, this standard also allows hand gel to replace hand washing, such unsanitary practices are not acceptable under the FSMA.

Reassessments by buyers and auditing firms

A buyer should be required to perform a reassessment either through a third-party auditing firm or through its own (2nd party) audit, in any operation where corrective actions must be verified.

The following should trigger a reassessment audit;

– A Critical Control Point failure in a Hazard Analysis Critical Control Point (HACCP) based system

– An automatic failure of the audit 

– Laboratory or others test indicating a microbial, chemical or physical hazard exists in a facility, product or process 

– Significant noncompliance with FDA rules (when published)

– Significant repeated failures of the food safety management system

– Expanded role of microanalysis

Because auditors have access to a supplier’s micro-testing results, they can base risk assessments on the findings. Expanded micro-testing will allow auditors to make better judgments concerning the microbiological quality of products, equipment, and water used in a wide variety of processes and environments.

The government and science community, including researchers, academicians, and practitioners should work together to enable a more accurate microbial risk assessment.

The future of third party audits

In the short term, there is no viable substitute for third-party risk assessments in fresh produce operations. Buyers are not prepared to audit the many suppliers they have by themsleves, and government bodies are not adequately funded to begin the process of regulating the full multitude of suppliers, domestic and international.

In the long term, an effective FDA would reduce the need for constant oversight by third parties, but this does not appear to be a certainty given the political and economic picture as it appears today.

Self-audits (internal audits or first-party audits) are much underutilized. Supplier “self reporting” directly to buyers could provide data so that audit frequencies could be adjusted using a risk-based approach.

The best alternatives to improve produce safety through third-party audits may include:

– Buyer financing and coordination of the audit

– Unannounced audits

– FDA involvement in the third-party audit process including determining auditor competency, training  and oversight

– Risk-based fre
quencies for audits based on
self-reporting

– Transparency of all audit and inspection findings by all concerned

– Validated physical, chemical and microbial standards

–  Expanded use of first- and second-party audits

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“Improving the Effectiveness of Third Party Food Safety Audits” was first posted on Roy Costa’s Food Safety & Environmental Health Blog on Nov. 24, 2011. Reposted with permission.

That all involved maintain some degree of responsibility for this disaster is without question. When a disaster like this occurs, one must ask who is responsible, but also why did it occur and how can it be prevented in the future.

The produce industry is unregulated and has been since the founding of this country, and this is the primary problem. In the recent past, we have become painfully aware of the inadequacies of our industry-led prevention efforts at the farm level. In defense of the effort, while much has been done, it has been a short time to change the nature of agriculture. This is what we are doing by implementing food safety strategies in open air and on-farm environments. We must also change the culture; animals on farms, for example, have been a given for centuries.

Food safety auditors executing a buyer-driven auditing model rely upon the certification body to develop and manage the standard that guides their work in the field. The standard is not a public health law and it is not developed like one. The auditor has no legal authority to demand records, embargo products, or close an operation, for example.

Enforcement, if you will, has been in the hands of the “buyers.” They rely on third-party audits, their own second-party audits, letters of guarantee and the like, before make buying decisions. Buying decisions should take into account food safety, but supply and demand pressures might induce buyers to purchase from sources without a clear safety margin. However wrong this is, there is nothing illegal about this practice.

Auditors currently are not required to inform FDA of violations, but auditors are currently required to know what regulatory violations have been cited in the records of the firm, and if they were corrected. Auditors are also expected to follow the guidelines of the audit and make an accurate assessment of findings. When this is not done we must ask why.

So there is a connection between the two independent systems of food safety “regulation,” but a relationship that is way underutilized.

Auditors conduct prearranged audits to evaluate the conditions of the environment, equipment, water supply, personnel, waste removal, use of chemicals, vector control, general sanitation, equipment hygiene, and structure maintenance, within a sometimes narrow scope of the audit.

Regulators should be approving plants and operations in advance, then making frequent unannounced visits to determine compliance with laws and rules. They also have free range to demand any required document and inspect any licensed area. While both touch on the same items, the perspectives and powers are vastly different. The legal process should occur in cases where violations are not corrected or immediate threat to the public is found, and buyers should not purchase from unsafe sources.

Auditors cannot perform these vital public health functions, nor can they directly affect buying decisions.

Generally, FDA guidance and the available research form the basis for the audit criteria. However, issues like severity can be difficult to interpret. For example, in cantaloupes the commodity has not had the type of industry oversight we have in leafy greens or tomatoes (under market orders). But FDA has provided guidance to the melon industry. We should mention this reference below: 

— Using single pass (or one use) cooling water of sufficient quality for this intended purpose also may be used to cool product.

This is the source of info that indicates single pass water of sufficient quality may be used for washing melons. There is no mention of antimicrobial in this application. For dump tank or flume water, or where direct melon-to-melon contact occurs in common water, then treatment is indicated. Standards vary greatly as to disinfection of water, and for sanitizing various fruits and vegetables.

The risk assessments are still developing (and so are the politics involved with any industry-led effort.) It is telling that, according to “commodity thinking,” cantaloupes fall into the class of fruits and vegetables with “inedible peels.” This narrow definition ignores the other routes of disease transmission with this product. Microbial testing of products and the production environments is not a given. This is telling because in other Listeria-susceptible products FDA and USDA demand stringent testing programs for the environment.

Water used in packing operations is required by the third parties to be potable. FDA has not published specifics about how to determine potability in a packinghouse environment, the references simply being for the use of potable water at the start of a washing process. Potability has come to mean that coliform bacteria are not present in a 100 ml sample. There are no guidelines for chemical parameters for safety in the potable supply and no requirements for the wells themselves to be treated or permitted before construction. No FDA requirement I know of demands that the local health departments permit, inspect, and require a certified operator to maintain the water quality.

At Jensen Farms, wash water for cantaloupes was apparently not reused, being simply a single pass wash of cantaloupe without treatment. There is nothing prohibiting washing cantaloupes or any produce in this fashion in the standard as long as the source is potable. This is room for improvement in the third-party standard, but until the industry as a whole agrees on water treatment standards for these melons it is unclear how to develop them. This is now apparently a glaring deficiency, and just one amongst myriad things not addressed in food safety at the packinghouse level by FDA.

In light of these problems in our food safety systems, auditors and auditing companies have stood in the gap for regulators. I appreciate FDA and its remarks concerning the training of auditors and any classes they could offer would be much appreciated. To date, however, I know of know such training program for industry auditors sponsored by the FDA that is available today. One day that might change.

We also have to thank the FDA for such a well-developed theory on causation and it is perfectly clear that the focus should be on the packing environment.

Problems that existed in this plant in this situation are accurately described by FDA in its report. The evidence is clear for the propagation and spread of Listeria monocytogenes through water and surfaces, and “improper cooling” of cantaloupe. Pre-cooling to remove field heat as a route of causation makes perfect sense, but pre-cooling is by no means a standard practice on farms or packinghouses in general, as pointed out by FDA in its guidance.

The nature of equipment in packinghouses is subject to contamination and often hard to clean; moving heavy crates of products will deteriorate floors; draining is often a problem especially where washing flumes and spray systems are used. Some structures and waste disposal systems are better developed than others for this type of “dirty” packing work; however, there are no standards for construction of a packinghouse.

Currently, there are no regulations for the construction and maintenance of packing equipment; its design, layout or even fundamental function have no legal basis. Regulatory agencies normally have the functions of approving the designs, equipment and plumbing schedules, lighting, finish of walls and floors in a plant. Auditors rate these items according to the dictates of
the standard within the scop
e of the audit. Of course, FDA has the authority over such, and it would be best to have regulations of these items, but FDA has not exercised that authority and has only written guidance for general requirements. I appreciate what FDA has done in ferreting out the causation at Jensen/ Frontera, but it would have been much better for them to have published packinghouse rules, and been there before the outbreak to enforce the requirements they address as violations now.

Therefore, in light of these ongoing and serious gaps in food safety, the industry itself has required what it finds to be the best practices to protect itself to the extent it can. That these industry requirements are suited to the needs of the buyer is self-evident and expected. More importantly, things need to change as we understand risks better; but what a tragic way to learn.

It’s sad that the farmer in this case did not recognize the difference between his potato line and a “cantaloupe line,” nor the distinction between a potentially hazardous product like cantaloupes and a non-potentially hazardous raw potato. In crops like potatoes, bulb onions, carrots, beets, there is dirt, the distinctions between risks of different crops do not generally drive standards. However, with melons the risks should have been identified, and the best practices possible followed, and they were not.

In a risk assessment we develop such preventive measures for a variety of crop types and information like this often comes out if properly done. But then, HACCP is not “required” in produce; but training in risk assessments should be mandatory for operators of high risk facilities and especially for auditors.

About the future of third-party audits, I think we need the FDA to be conducting their own risk assessments and allow us third parties to simply be the eyes and ears of industry, and not the enforcers of public health protection in this nation.

This is not the role of the third-party auditor.

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“The Role of the Third Party Food Safety Auditor” was first posted on Roy Costa’s Food Safety & Environmental Health Blog on Oct. 22, 2011. Reposted with permission.

Investigators have known about the melon’s food safety problem since at least the early 90s, when numerous nationwide outbreaks of Salmonella occurred with melons; tens of thousands of cases were reported in these outbreaks. Cantaloupes (musk melons) are most the most frequently identified melons in outbreaks, although watermelon and honeydew (rarely) have also caused outbreaks.

While other pathogens such as E. coli O157:H7 and Listeria can find their way into many crops, Salmonella seems to be the bacterial pathogen of greatest concern with melons. Salmonellosis can be a severe illness and the infection leads to complications with reactive arthritis and other chronic diseases in about 15 percent of cases. It is therefore of utmost importance for public health that only Salmonella-free agricultural products reach the consumer.

Fresh Produce Contamination Sources

The melon supply chain has numerous hazardous points beginning with growing and harvesting and continuing through packing, storage, transport, distribution, processing and final consumption.

Cantaloupe can be contaminated any time the crop is in the ground, but the contamination problem is likely to start when the fruit is ripe and ready to be picked. Animals such as deer, coyotes, raccoons, rodents, feral pigs, and birds are attracted to the crop at this stage. Animal vectors in the growing environment may also include amphibians, reptiles and domestic animals.

Animals can affect the crop directly or through contamination of the water supply used for irrigation and crop protection. Manure may contain animal wastes, and fertilizers pose their own unique threat.

Infected humans are also a risk anywhere in this chain. Fecal matter, especially human waste in the growing or harvesting area, is a very significant risk factor and farmers must strictly control this potential.

Fresh Produce Food Safety Efforts

Current food safety efforts by the produce industry rely upon guidance documents from the U.S. Food and Drug Administration (FDA) on safe growing and handling of fresh fruits and vegetables; but until recently, industry compliance has been voluntary.

In the absence of government mandates, the private sector has developed its own standards for the safe production of many types of fresh fruits and vegetables. Determining an operation’s conformance with the industry prescribed rules is primarily the task of industry auditors who are contracted by the major retailers around the world. Without regulation, there is no legal basis for compliance with food safety requirements. The buyer-driven rules can be circumvented when the supply is low and no alternative source exists. There is little oversight when local producers sell directly to the public or to restaurants. Foreign producers are not necessarily held to the same production standards as those in the U.S., and several U.S. melon outbreaks have involved Mexico and Honduras.

With the passage of the Food Safety Modernization Act in 2011, we can soon expect better regulation and better compliance on the part of producers, both foreign and domestic.  However, the problem of contaminated melons will likely remain, due to the nature of the agricultural methods used and the nature of the plant itself.

Produce Contamination and the Supply Chain

Once contaminated, a cantaloupe will likely remain contaminated until reaching the consumer. Melons travel through a complex series of supply chain distribution steps involving farmers, growers, harvesters, packers, distributers, wholesalers, retailers, processors and food service operations.

Cantaloupes are not typically washed before packing. If they are packed in a packinghouse, they go through a grading process to remove damaged and diseased fruit; they are then loaded either in bins for further distribution or in retail size boxes. Netted bags bay be used, and packers may also individually wrap melons. Like cantaloupes, watermelon and honey dew may also be packed without a wash step, or even packed for final shipment directly to retailers from the field.

Cantaloupe is protected to an extent by an “inedible” peel and rind. Therefore, one would reason that if contamination occurred on the outside of the fruit, the edible portion would be safe until exposed. Until recently, experts assumed little or no growth of bacteria could occur on the hard outer surfaces of a cantaloupe, but recognized that the netted exterior provided an excellent site for the attachment of bacteria. Thanks to new research, we now know that Salmonella can actually penetrate the exterior of the melon, even when no bruising occurs, and Salmonella may also multiply on the outer portions of a melon after attachment. This means that any spot in the supply chain with extended ambient storage conditions will amplify the Salmonella problem, if it is there.

An explosive situation occurs when the internal portions of the melon are exposed to Salmonella from the external surfaces. Melons provide a rich source of nutrients for bacteria, along with more than adequate moisture. If conditions of temperature are hazardous (above 41° F and below 135° F), bacterial multiplication will occur, and this can be very rapid in the range of 70° F to 120° F. Ingestion of just a few Salmonella may be tolerable to some healthy adults, but many strains are able to infect persons in low numbers. When numbers are high, consumers with underlying medical conditions will experience life-threatening effects, and all exposed persons can become ill to varying degrees if infected.

The Role of the Consumer in Produce Safety

All of us have a role in food safety — it is often said that “food safety is a shared responsibility.” While the fresh produce industry works to control problems in the supply chain, the end user, meaning the final consumer, carries much of the burden. This is unfortunate, as reliance upon the food safety efforts of consumers to protect themselves has many pitfalls.

The exposures begin when consumers physically handle melons at the retail level. In fact, touching, knocking and squeezing melons are the standard methods used by consumers to select a ripe melon. While this seems like an innocent activity, it may be another means by which melons can be cross contaminated. Such handling at the point of sale may even allow Salmonella to infect the consumer directly!

Purchasing criteria at the market:

1. Be aware of product recalls and outbreaks. It’s hard to know in a developing crisis what produce in your local store may be affected. This is why it is so important that the fresh produce industry maintains effective traceability systems and recall procedures. You might elect not to purchase any suspected items during an outbreak period.

2. Do not purchase damaged, diseased, or decayed melons.

3. Select
melons carefully, avoid excessive handling or use hand cleansing arrangements, or gloves if provided.  We cannot expect every retail market to provide gloves for consumers, but many do, and some provide hand gel and other hand cleansing aides.

4. Look for a label on the melon. It will be difficult at first to tell if you are looking at the label used at the register for inventory and pricing (Universal Pricing Code-UPC-barcode) or traceability information. The country of origin must be clearly identified. If the market does not have labels on the melons or you cannot understand them, speak to the manager, but consider shopping where you can identify as much as you can about the individual unit you are buying.

5. Place these products into an individual plastic bag (which should be provided). Do not store them unprotected in a cart or in a cloth shopping bag. Go home as soon as possible; do not leave melons in a warm car.

Once you arrive home, you must take other steps:

1. Before storage at home, wash the melon in water just a little warmer than the fruit. The melon will likely warm up on its way home, so it is best to use warm water, not cold. Colder water will increase the absorption of water into the melon and drive bacteria further into the fruit.

2. You can use a moderately stiff- bristle brush to assist in cleaning.

3. A commercial vegetable wash may be used, or you may soak the whole melon in a dilute household bleach and water solution (7 drops per gallon) for a minute or so. But in reality, if the melon has been exposed to Salmonella, you will likely not be able to remove it completely, whatever the cleaning method.

4. After washing, store the whole melon in the refrigerator in a new plastic bag or wrapper. Discard the old wrapper, but maintain traceability information along with your receipt of purchase. The refrigerator thermostat should be set to maintain the melon at 41° F. Provide a refrigerator thermometer independent of the thermostat and adjust the units cooling settings accordingly.

5. Wash your hands and clean the sink and counter and all utensils after handling the melons. You can use a dilute solution of bleach and water or other household disinfectants designed for the kitchen, as a final step.

Melon prep:

1. When preparing the melon, wash your hands before beginning, use a clean cutting board, and use clean utensils, containers and equipment.  Wash all of these items thoroughly after prep.

2. Consider any peels or rind remaining on product, or materials removed, to be inedible, and dispose so as not contaminate the finished item.

3. After processing, slicing, cubing, etc., place in a clean covered container in the refrigerator.

4. Store at 41° F for up to 7 days and then dispose of the remaining items (some bacteria that cause illness can actually grow in a prepared refrigerated product if you give them enough time).

5. Maintain the cut melons at 41° F during extended periods of service. This may require ice, a cooler or other method when away from home. If melons and dishes containing them are stored at room temperature, dispose the item after four hours. These measures imply you have a clock handy and know when products were removed from refrigeration; you must also have an accurate metal-stem pocket thermometer, calibrated to +/- 2° F, using the ice melt- point method.

Consumers as a group are not well-equipped or knowledgeable enough to handle contaminated foods, especially when they will not cook the food. It is clear that while the consumer is the last line of defense for the safety of foods they prepare, the burden of contamination in ready- to-eat agricultural products falls too heavily on consumers. 

The enlightened consumer with effective tools, equipment and know-how may be better able to control risks with melons (and other problematic foods), but the fresh produce industry must continue to find ways to reduce contamination to levels most consumers are prepared to deal with.

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Roy Costa writes about food safety in his Food Safety & Environmental Health Blog. See www.haccpprinciples.com for more information on Costa’s work and food safety education programs.

1. Most outbreaks that result in lawsuits have evidence of multiple major sanitation deficiencies

2. Most have pest problems as part of the documentation

3. Many have serious time and temperature issues

4. Many have personal hygiene issues

It seems like to have an outbreak that results in a lawsuit requires a lot of negligence. It is usually not some failure at a Critical Control Point (CCP), or an invalid Hazard Analysis Critical Control Point (HACCP) plan due to some error in thinking.

It’s gross sanitation issues that put people in this spot more often than not.

Those that have at least a semi-scientific program with oversight of any type and are managing basic sanitation adequately seem less likely to get into deep trouble with litigation, and if they do, there is less likely to be a smoking gun.

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Roy Costa’s “Reflections on Outbreaks” first appeared Feb. 16, 2011 on his Food Safety & Environmental Health Blog.   See www.haccpprinciples.com for more information on Costa’s work and food safety education programs.