Posted on May 22, 2015 by Roy Costa
Tags: Farm to Fork
Listeria monocytogenes bacteria are very hardy infectious bacteria and widely distributed in nature, and very difficult to control. Listeria monocytogenes previously known to veterinary science as a pathogen of sheep, first came to light as a major foodborne agent when the largest and most deadly outbreaks in US history occurred in queso fresco cheese manufactured in Los Angeles, California. http://en.wikipedia.org/wiki/List_of_foodborne_illness_outbreaks_by_death_toll
The deadliest foodborne illness outbreak in US history, it claimed the lives of approximately 50 persons and infected 86 known victims. From this time forward the public health response has been to actively track cases identify outbreaks and to put into place initiatives to reduce incidence. USDA was instrumental in developing protocols for the meat industry to follow to control the organism in USDA regulated products. Listeria monocytogenes is considered to be so pathogenic that in the US there is no tolerance for its presence in food. There has been some success in controlling Listeria monocytogenes in USDA commodities, but recently, over the last 3 years or so we have seen this agent get thorough the public health safety net an alarming number of times.
In a just few years, in the US we have seen Listeria monocytogenes in cantaloupe (2011) kill 30 people, and infect 146 known cases, and outbreaks and or recalls involving several brands of ice cream, sliced apples, candy apples and pasta salad.
The Chain of Infection and Controls
Listeria monocytogenes is a uniquely challenging pathogen with novel characteristics. It is psychrotropic, growing at temperatures below 32°F. This important ability gives the bacteria a competitive advantage, as the less hardy spoilage organisms and other competitors are not able to grow, or grow as quickly. Long periods in the cold chain during distribution of a product coupled with a long shelf life are important factors that increase the risk of growth.
Once the organism enters a food production environment, it can create environmental niches that allow for propagation on surfaces such as floors, drains, walls, and equipment. Bio-films are complex substrates of adherent cells frequently embedded within a self-produced matrix of an extracellular polymeric substance. Listeria monocytogenes can establish itself in such substrates further reducing the ability for normal cleaning and sanitizing to remove it. The colonization by Listeria monocytogenes of food processing equipment is an associated factor in many outbreaks. In the cantaloupe outbreak of 2011, investigators found the packinghouse’s packing line to be contaminated, in the 2015 ice cream outbreak in involving the Blue Bell Ice Cream Company; the bacteria were also found in the company’s equipment.
After a food is processed, the bacteria can remain for extended periods in the food and survive to a customer. Ready to eat prepared foods then become the vehicle for one of the most hazardous of all bacteria, with a mortality of around 30%; especially at risk are the elderly, and those with underlying medical conditions. Pregnant women are often included in the victims of outbreaks along with the their unborn, a very tragic consequence. The foods implicated in outbreaks are varied, and include hot dogs, luncheon meat, meat spreads, smoked fish, cantaloupe, and ice cream and candy apples. Attempting to warn at risk persons is made almost impossible, as almost all processed foods and many fruits and vegetables are prone to infection.
Given the growing magnitude of this public health challenge, we need a strong public health response targeted specifically to deal with Listeria monocytogenes. The following recommendations are offered:
A multidisciplinary committee is needed to create a coordinated national response. This group should advise the food processing industry and other at risk points of the food supply chain about controls such as environmental sanitation and verification.
The medical profession must play an increased role in coordinated efforts to better inform consumers and at-risk persons about the prevention of Listeriosis.
A unilateral requirement is needed to require all food processors to perform effective and ongoing testing of equipment and environments. This should be coupled with encouraging the application of in-plant micro-assay methods of detection using QT-PCR and other rapid techniques.
The eventual implementation of the FDA Food Safety Modernization Act and Preventive Controls rules will provide the needed support to strengthen the current public health response.
As the result of numerous national and international outbreaks of foodborne illness, food industries worldwide have come under increasing pressure to ensure that their products are safe, wholesome, and meet government standards. FDA and USDA have the primary authority for our food supply nationally, while individual states typically regulate local food operations through state and county departments of agriculture and health.
The public health burden of foodborne illness in the US is significant, with many thousands hospitalized. The Centers for Disease Control and Prevention reports these agents are responsible for 5,000 deaths a year.
Outbreaks of foodborne illness cost the US food industry untold millions in claims and legal fees yearly, as well as cause crises and business disruptions. (One law firm alone has recovered over 500 million dollars in damages for clients affected by foodborne illness).
In response, the world’s major retailers now require that their suppliers, growers, packers, processors, and manufactures of food prove their adherence to their standards for safety and quality. Auditing companies, hired by the suppliers themselves, now inspect many thousands of food operations a year, globally. Such inspection numbers may actually rival or even surpass what government is able to do, making the private regulation of food safety both big business and an important public health issue.
Auditors follow a set of standards and guidelines developed by the auditing firms who employ them. The process for creating a “third party standard” is in itself regulated by the International Standards Organization, better known as ISO. Certification bodies use these private standards and pay a percentage of the proceeds from auditing back to the standard holder or owner. The standard is developed through an open and transparent consensus process that involves the buyers and sellers of products, government, the scientific community, and other interested parties. Many standards can be found on the websites of the organizations providing such services. In addition, there are guidelines produced that help to guide the auditing process and set policies and procedures in place for the execution of the audit.
Ultimately, audits provide the buyer with assurance that suppliers meet the standards they adopt. The expectation is that of limiting liability by demonstrating due diligence in sourcing raw materials. However, such findings do not necessarily protect the exposure of a seller or buyer if there is an outbreak or if a consumer is made ill or injured. Even when firms have satisfactory audit findings, they may be sued under the doctrine of “strict liability”. In such legal cases, the plaintiff does not have to prove negligence, only that “they were injured by a product”, and the product was in some way “defective”, i.e., was adulterated.
The goal of any food safety program then should be to prevent food borne illness or injury. The independent third party food safety audit can be a tool to further this goal, but such audits are not currently particularly capable of protecting public health, as they are more focused on limiting the buyer’s legal liability. However, when third party standards are followed, they undoubtedly reduce the potential for illnesses to occur. Adherence to them is likely leading to better food safety, but recent events have revealed significant flaws in the third party audit model.
Much has been written about the 2011 Listeria monocytogenes outbreak in cantaloupe that claimed the lives of 33 victims in one of the most devastating foodborne illness outbreaks of recent years. In the trial of the grower/packer, Eric Jensen, FDA opined that the auditor employed by Mr. Jensen was seriously deficient in his findings. The basis for FDA’s criticism is that the audit firm found the operation to be at a 96% conformance rate with the standard (Superior) just days before the outbreak was identified, and allegedly did not find many of the violations later reported by FDA. While FDA takes the position the audit was flawed, the audit firm publicly supports the findings of the auditor. The auditing company in spite of this criticism stands behind the auditor and states, “he did his job with great care”.
This was not the first serious outbreak of foodborne illness where an auditor was criticized for giving a superior rating to a facility that was later shown to be unsanitary. In 2007, the Peanut Corporation of America knowingly distributed salmonella contaminated peanut products and caused a recall of over 4000 different foods, as well as taking the lives of 7 persons and injuring many more. Although the facility was very poorly maintained and had a serious rodent problem, the auditor had several months before given the firm a superior rating.
Third party audits clearly suffer from some serious drawbacks as regards public health protection. Private auditors have no authority to stop production or to embargo or condemn food products; this can only be done by regulatory agencies that have legal authority. In fact, auditors have no legal authority, at all. Under the contract, the “auditee” can restrict the scope of the audit, stop an audit, or simply cancel it. The true power in the third party model is the buyer. If the buyer is unhappy with the audit results, the buyer can cancel orders or put the supplier on some provisional status. The buyer can also chose not to do business with a supplier that opts out of being audited. Buyers however, rarely exercise these powers, as typically, buyers need to have products and need to have as many sources of products as possible. Limiting competition over time puts the buyer in a poor position; therefore price, availability, and quality issues may outrank safety scores. It is well known in the industry that produce buyers especially can and do go outside the approved supply chain whenever they feel they need to.
If an auditor finds the potential for product adulteration, the best he/she can do to protect public health is down-score the item in the audit question, reducing the audit score (for example, failure to properly validate the sanitary quality of re-circulated water in a produce washing operation would result in a 10 point loss out of more than 1000 available points). Less frequently, an auditor may actually see an actual contamination issue, such as broken glass in contact with food or fecal contamination. In these cases, the auditor can strike against the relevant question and if that question results in the failure of the audit (and very few questions do), the audit can stop, but only at the auditee’s request; the auditor has no ability to stop the audit.
Although an auditor may advise the auditing firm immediately of such hazardous findings, the findings may take several days to get to the buyer requesting the report. In the meantime, although it would be illegal to do so, the auditee might ignore the findings and continue selling and distributing contaminated products.
To summarize, auditors have no authority to stop production and very limited power to protect public health when they find adulterated products or the conditions that lead to that.
As an alternative, auditors cannot report such findings to authorities. Whistleblower rules under FDA do not afford protection to auditors who are under contract to keep audit findings confidential. Such contractual agreements preclude an auditor from reporting adulterated food or grossly insanitary conditions to local public health officials, FDA or USDA, although this may change under proposed FDA rules (FSMA).
Currently, auditors announce their visits, sometimes months in advance. The conditions an auditor might find on the day of the audit may be very different from the conditions otherwise maintained, making the audit findings highly biased. Experienced auditors will find telltale signs of neglect in a facility, but other gross problems may be temporarily covered up. The provision for unannounced audits is in the protocols of some certification bodies, but unannounced audits rarely occur.
Especially in the auditing of fresh produce operations, much more scientific information is needed to strengthen the audit criteria. In the Jensen Farms case for example, the court found that chlorine should have been used to sanitize the cantaloupe. However, the scientific literature does not support a significant reduction in Listeria with a chlorine wash, once the organism has attached to a fruit. The FDA guidance at the time of this outbreak did not specifically require the use of chlorine in single-use potable water used to wash and cool the cantaloupe. The audit template used by the audit firm also did not specifically require the use of a sanitizer like chlorine to sanitize single use water. Uncertainty in the scientific basis for critical sanitation rules and changing perspectives in this very volatile industry is counter-productive to an effective audit.
Equipment used in most food processing environments (operations that cut produce, or otherwise alter the form of raw products) must meet well-understood design standards for cleanliness and sanitation. Independent standard setting bodies such as UL and NSF typically set design criteria for food processing equipment in regulated industries, but such certifications are lacking in operations packing whole fresh fruits and vegetables. At Jensen Farms; the packing equipment used did not have to meet pre-approval by any recognized body, yet FDA found that the condition of the packing line conveyor was a substantial contributing factor to the outbreak. An auditor is in a difficult position to make a determination about the acceptability of a variety of equipment under a wide variety of usage conditions without the aid of such certifications or agency pre-approvals.
Produce facilities currently do not need to meet a pre-approval process for their physical construction, either. In the Jensen Farms outbreak, the failure to properly discharge and control wastewater was found to be significant by FDA, as were the condition of the floors, yet we have no published guidelines for construction of the facility itself. Given the wide variation in locations and variety of produce operations in general, the lack of a formal building code is a major hindrance to an effective audit.
The review of laboratory findings greatly strengthens the validity of audits, but only when the findings are verifiable and accurate and the sampling methods and results are free of bias. Unfortunately, the way the standard that was used by the Jensen Farms auditor was written, microbial tests of environment and equipment were optional. One of the hallmarks of outbreaks is that identification of that outbreak usually involved the detection of the causative agent in products. If investigators can find the agent after the fact in food, it only makes sense that product and environmental testing results are critical to an evaluation of a firm’s true level of safety. This is another area that needs significant strengthening.
While audit companies are rightly focused on the process their auditors follow in executing an audit, it is clear that audit results, however true to the standard and inspection protocol they might be, often lack substance. It is also clear that auditors are not entirely capable of detecting unsafe operations, and totally ineffective at stopping such operations, even when they observe gross contamination of products.
Because the court in the Jensen Farms case has found that auditors have a legal and moral responsibility to protect public health, auditing companies and the food industry as a whole must address these basic weaknesses and solve the problem of auditors being responsible to protect public health without the authority to do so.
ü LEARN THE ELEMENTS OF HACCP
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Class held Feb 13th and 14th 2014. THIS IS A 2 DAY *ADVANCED HACCP COURSE.
Persons taking this course include:
Facility managers, production supervisors, quality assurance staff, trainers, food safety consultants, regulators and auditors responsible for food inspection.
On Day 1, learn and apply methods to develop effective GAP and GMP programs and 1. Conduct a hazard analysis, 2. Identify critical control points, 3. Set limits, 4. Monitor the system, 5. Initiate corrective actions in your operation, 6. Verify and, 7. Document the system. On Day 2, learn the required features of the GFSI HACCP audit process, with a focus on verification and validation.
The HACCP Alliance Certification seal on the “Applying HACCP Principles™” course means it is the most recognized HACCP certified course offered to the food industry.
We designed Advanced Applying HACCP Principles™ for those seeking a higher level of HACCP competence:
(*A basic understanding of food safety management, GMP, GAP, and SOP is desirable before taking this course).
Roy E. Costa, RS, MS (MBA) Registered Sanitarian and President of Environ Health Associates, Inc. He is a retired Sanitation and Safety Supervisor and Education and Training Specialist with the Department of Business Regulation and the State of Florida Department of Health. Mr. Costa is a highly qualified food safety auditor, trainer, consultant, author and international presenter on the topics of food safety and HACCP.
COURSE SCHEDULE AND LOCATION
This 2-DAY course will be presented on FEBRUARY 13TH AND 14THat the *Clarion Hotel, Deland, Florida. Day 1: Registration and reception at 7:30 AM, class 8 am to 5 pm. Day 2: Class from 8 am to 12 pm. Complimentary lunch from 12-1 on Day 1. Continental breakfast served each morning at 7:30 am.
*See attached hotel map, ask for special rate.
Class Registration Form: Call Katherine Jones at: 386-316-7266 or send message to
Payment method: Bring company check to class; check made payable to Environ Health Associates, Inc.
Cost: $699.00 per person includes 2 continental breakfast and lunch.
I suppose anytime one enacts a sweeping new law that affects an entire industry we can expect an outcry from the newly regulated. When it comes to the US Food and Drug Administration’s Food Safety Modernization Act, this is no exception.
FSMA has been plodding along to its final conclusion in 2015, with FDA laying the ground work for what will be a long and difficult process of implementation of the rules.
While there has been progress in rulemaking with the release of two critical rules, preventive controls for human food, and produce safety, and five more, we have still have only a murky idea of the impact this legislation will have..
The produce rule is difficult to interpret. For example, the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption contains provisions that apply to farms, but also exempts farms based on a number of factors, such as type of crop, size, ownership of growing areas and production facilities, as well as commercial vs noncommercial operations. With all the exemptions, it is a roll of the dice whether a farmer will need to comply with any, all, or part of the proposed rules.
Naturally, with the present uncertainty there is concern. Publically, the produce industry seems to begrudgingly accept FDA’s powers, but in private, produce industry professionals express doubt about FDA’s abilities to effectively carry out the regulation in such a vast industry, and few operators have actually read the rules, even though two key ones have been out for comments since Jan. 2013.
Some of the apathy is due to the major produce operators in large part having already applied most of the required food safety initiatives outlined in the rule. The larger firms in the industry adopted the main tenants of Good Agricultural Practices and Good Manufacturing Practices in the form of industry guidance and third party audit standards years ago. The problem now seems to be, as it was from the beginning, the so called small farmers and producers. Most of these minor suppliers have not been brought under the same requirements as those imposed upon major suppliers to the large retail stores. These are the produce suppliers who grow and handle products at the end of the supply chain. It includes facilities that store, re work and deliver products weeks after harvest directly to food service and small groceries. Currently, our third party system of food safety controls has not affected these operators, and thus the fear.
Some amount of fear may not be bad thing, however. In my experience, many of these operations are in poor condition and lack hygienic standards. I recently visited a wholesale distribution and cold storage facility in Miami. The operation handled flowers, plants and produce, commingling them! Re-packing was going on throughout this poorly kept operation on the tops of old boxes and wooden pallets. The dirty hands of the cloth gloved workers touching previously washed products while they graded out decayed and non conforming product, with no hand wash sinks available.
This is the kind of operation I occasionally find in the backwater of the produce industry. It’s not my role to fix these issues, I was there to bid on a consulting project, which I did, and I was glad when I walked away from this mess. But I am left with the question of whose responsibility is this?
With that thought in mind, it was with some annoyance that I read the comments of the State of Georgia Commissioner of Agriculture, Gary Black on FSMA.
Black said in late December “new food safety rules proposed by the federal government could prove cumbersome and costly for Georgia farmers”. That cost is probably not as high as Mr. Black might make out, but I agree it can be expensive to hire a consultant to develop a program of food safety controls in operations where they never existed before, perhaps $2,500.00 to $5,000.00 or more for the consultant in a business doing $500,000. Add to this, the costs to upgrade operations such as refrigeration, acquire equipment, and make structural improvements to meet inspection requirements. FDA suggests that about $30,000 might be needed in large operations. My own experience is that currently, a medium sized produce packing facility can spend up to $250,000 a year to comply with the third party food safety standards already imposed by the major buyers.
One could argue, however, that such expenditures for safe facilities and hygienic operations are simply the cost of doing business and it is unfair for only parts of the industry to shoulder the obligation.
Dr. Michael Doyle, director of the University of Georgia's Center For Food Safety gave some balance to the discussion. “From my perspective, it's all about public health," Doyle said. "We've had so many of these outbreaks." According to FDA there have been 131 outbreaks attributed to produce between 1996 and 2010, and that list has obviously grown.
Read more here:
Read more here:
Negativity comes not only from the ranks of government, but from so called “food freedom” groups.
Read more here:
Due to the push back from all sides, the end of the year saw FDA express reservations about some of its new FSMA requirements, especially those proposed for agricultural water testing, and is reevaluating the impacts of the regulation on farms, generally.
Read more here:
What this means is a setback for consumers who will wait even longer for the safety of produce, and in the meantime, the produce industry is still very vulnerable to large outbreaks of foodborne illness, as we saw in 2013 with Hepatitis A in imported pomegranate seeds,
and the parasite Cyclospora in imported greens used in salad mix.
Another Jenson Farms type of outbreak is not out of the question, either.
While there is quite a bit of controversy concerning what happened at Jenson Farms, there is no denying that the fresh produce industry has been forced to reevaluate its food safety efforts.
The Buyer Driven Food Safety Model
Third party food safety audits are still what they have always been, an industry led method to determine conformance with a set of voluntary standards. As third party auditors, we have no control over the operations we audit. The only real control lies with the customers of the operation. The customer can choose not to purchase from a supplier, work with the supplier to correct problems uncovered in the audit processes, or ignore the audit findings. Increasingly however, customers are becoming more selective and looking much more closely at audits before making buying decisions. Unfortunately, the dictates of supply and demand still apply, and if a customer needs product and the price is right, buyers will purchase from suppliers with questionable records, or even those without any oversight at all. In the end, audit findings are still just one of the criteria that a prospective customer uses to make a buying decision.
Traceability and Recall
Traceability is improving, with some firms investing considerable resources in advanced electronic record keeping and coding of unit packaging. Still, recent outbreaks show that traceability is a difficult matter. The recent outbreak of cyclosporiasis in leafy greens this year illustrates the difficulty with traceability. Even with over 600 cases of illness affecting numerous states, investigators did not conclusively link the outbreak cases to a supplier. The final report by CDC indicated that both cilantro and bagged salad items were involved, without pointing to a single source of the contamination of both products. Products might be coded when they are packaged, but processors do not always maintain the needed batch coding records to tie inputs to outputs, and there is plenty of comingling going on throughout the supply chain. While traceability systems such as PTI, Harvest Mark and ScoringAg are available, the industry has not come to a consensus as to what it wants, leaving suppliers with uncertainty as to what system to choose.
Packers and processors are using a variety of antimicrobial treatments such as ozone, chlorine dioxide, chlorine and peracetic acid; however, we lack clear scientific evidence for the sanitizing effect of these treatments on fresh produce. Treating the water used to wash produce is a wise idea, especially if the wash water is reused (recycled), and we can reliably determine the effectiveness of that type of treatment. The problem with sanitizing produce is that each product has its own world of microbial issues, such as surface area characteristics and vulnerability to microbial colonization, and each antimicrobial treatment process has its own set of variables, e.g., concentration, contact time, and coverage. Determining the precise methods needed to inactivate a wide range of microbes in such diverse products and processes remains elusive. Currently, the USDA does not recognize any microbial treatment for whole fruits and vegetables as capable of sanitizing and therefore no antimicrobial product has a registration for reduction of human pathogens on whole fruits and vegetables. Much more research is needed in this particular area of produce safety.
The Food Safety Knowledge Gap
The produce industry is moving forward with the education and training of its personnel, but currently there is no approved or recognized program of instruction in food safety in the produce industry. Unlike training programs at the restaurant level, very little has been done to identify the core curriculum needs of the produce industry. For example, operators of complicated antimicrobial addition systems are usually recruited from existing production staff having no training in chemistry or microbiology. Such operators often do not fully appreciate the complexities of sanitizing processes and concepts such as free chlorine, oxidation-reduction-potential (ORP), and pH. While microbial treatment of process water and surfaces are becoming standard operating procedures, the industry lacks the expertise to perform tests or interpret results. Findings often get filed without an evaluation by a knowledgeable person. The use of ATP as a verification tool is required by most third party standards (and FSMA), yet few firms have the skills needed to effectively establish such programs and/or benefit from this type of monitoring.
While a HACCP program is often required (by buyers) the understanding of the concept by the produce industry is marginal. Without a grasp of epidemiology, microbiology and science in general, this concept is nothing more than window dressing in many firms.
Equipment Design and Construction Standards
There is no formal registration process for equipment used in the produce industry. Unlike the dairy industry where processors have very successfully applied the 3-A standards, there is no set of criteria for the finish of surfaces, or even the types of equipment used to pack or process fruits and vegetables. We see everything from cast iron to stainless steel construction of various grades, with rubber, plastics and even cloth and wood used as food contact surfaces.
Control of Wastewater
There are several commodities that are not typically washed before packing, such as berries and watermelons, but many produce items are washed, generating a substantial amount of wastewater. The systems for collection and discharge of wastewater from washing- flumes dump tanks and spray bars are often poorly designed, resulting in water flooding production areas. Wherever there is water collecting, these is a substantial risk of microbial contamination; workers splash through wastewater pooling on floors, and forklifts splash such water onto packaging and products . Poorly designed and located floor drains and floors that are not properly sloped to drain are common problems throughout the industry.
Facility Construction and Design
Just as there are no recognized industry standards for equipment, there is no national industry standard for design of produce facilities. Facilities can be open sheds with no walls and bare concrete floors while other are enclosed production facilities with a variety of layouts and construction types. Facilities in the produce industry are often viewed as part of farming operations and resemble farm buildings (pole barns), as opposed to the processing facilities one might find in fisheries or meatpacking. Attempting to control contamination, (physical, chemical and microbiological) in such facilities can be frustrating to those tasked with sanitation.
Probably the best deterrent to an outbreak in high risk commodities is a robust microbial sampling program for products and surfaces. There is some controversy as what constitutes a high risk commodity, but those fresh produce commodities with an edible peel and those that are in a ready to eat form (no cooking required) might be targeted, along with those produce items with a history of causing outbreaks. It is reasonable that since outbreak investigations can often isolate the pathogen on incriminated produce that such contamination could be spotted ahead of time before such products cause harm. The problems remain as to what to sample, what analysis methods to use, what microbial indicator organism to use, or pathogen to look for, and how much and how often to sample; and then there are the problems of how to interpret the results, and when to initiate a recall. The produce industry is by and large poorly prepared to employ microbial testing to its advantage.
FDA rules under FSMA are still not clear. After years of waiting, the produce industry is still uncertain as to what the impact of the new requirements will be, and FDA itself appears to be groping for answers. It will be years before the FDA can effectively enforce its rules, and the industry must move forward on its own, now.
While the produce industry is frightened by what happened to the Jensen brothers, the industry remains perplexed as to what to do, and the reality is this same scenario could play itself out again at any number of firms. What is clear is that in spite of the progress that has been made in food safety, the fresh produce industry has a long way to go to prevent another Jensen Farms type of incident.
HACCP CLASS FORMING
Many produce firms have adopted Hazard Analysis Critical Control Point systems, only to find that when they are audited, there are major deficiencies and non-conformances.
We are offering a HACCP class that addresses the major issues in developing and implementing produce HACCP plans. This course will provide you with the following:
· A solid overview of the 5 preliminary steps and 7 HACCP principles as outlined by the USFDA and CODEX Alimentarius.
· A step by step process for building your HACCP plan
· They key elements of HACCP audits under GFSI and Standard Primus and how to comply
· A certification that is recognized throughout the world
This is a workshop format and most of the class work is done by teams, so there is a great degree of interaction.
Please plan on joining us, and if you have already been certified under this program, pass this information along. This class is offered a few times a year so please take advantage of this opportunity if you need it. If you have a HACCP plan we will show you how to tighten it up, if not, its best to come prepared at least with an idea about your process and flow and we will walk you through the process.
Thanks and we look forward to hearing from you. Click link below for registration form.
I had the opportunity to help develop the above report, and review the findings of FDA inspections over the last few years at the nation's top air carrier caterers. The findings, as reported by ABC 20-20 are clearly indicative of lack of control over production environments, people and production processes, the very things food safety management systems are supposed to address.
The comments by industry are predictable. The "we didn't do it" philosophy, "head in the sand" approach is apparent, in spite of spin doctor statements. When you get caught with these types of issues, the public is not going to listen to the rhetoric about how great your food safety programs are, quite the contrary. Not one of these spokespersons would admit that their company had a problem or offer solutions, its all about denial. We see this again and again, especially after outbreaks.
The heads of these companies apparently are so disconnected from reality that they feel they can boast about how great their food safety programs are, even in the face of 1,500 FDA violations and many instances of gross sanitation conditions. Again, this is the same mantra we hear after an outbreak in FDA regulated facilities.
I lay much of the blame at the feet of FDA. This agency has the authority to stop such conditions and they opt time and again to walk away from problems and not take the tough stand that as consumers we expect, except in the most egregious of cases.
All we have to do is look at the poor record on FDA in the pharmaceutical compounding business or at Sunland (peanuts), or in the myriad of other outbreaks where the agency had performed inspections. No one is accepting responsibility, we get the same pathetic answers from FDA as from industry.
Taking a tough stand by inspectors is personally costly, it means confrontation, its perilous to careers and even to ones personal safety. I know this only too well, so I am very grateful to have an opportunity to again stand some ground against the food industry representatives who want to claim all is well in the face of mounting sanitation and health code violations and deceive themselves and the public.
This type of public confrontation is what we need to dispel the false sense of security the food industry and FDA has created for itself.
I applaud ABC 20-20 and all the other media who go to bat for the nation's consumers. This type of work is actually a preventive approach, as it pushes the issues in a way that compels both FDA and industry to respond, unlike third party audits and FDA inspections that occur behind closed doors.
I hope I have more opportunity to tell it like it is, and I hope the airline food industry is listening. I know they are hearing, but are they listening? Time will tell, but from the sound of their statements, I don't think so.Continue Reading...
Despite that all of this has been said before, Bloomberg and the Today Show still think there is something to say about third party food safety audits, but they say nothing new. Of course, there are going to be outbreaks in facilities that have third party inspections. Just like there are outbreaks in facilities regulated by USDA, FDA and every county health department across the US. Why is that a surprise? Third party auditors are in almost every facility that should be inspected by FDA. Where is FDA? Do the agency and its inability to police the food industry share the blame for the situation? What about the thousands of facilities that do not have outbreaks THAT ARE AUDITED? It’s impossible to measure prevention…let’s see…show me the data on how many outbreaks didn’t happen? Hmmm.
All of these stories expose the weakness in the third party system, which I admit there is. As an auditor, I do not carry a badge, cannot stop production, and cannot close an establishment. I can even be constrained from taking pictures, samples and can be denied access to records and documents at the discretion of management. I can only evaluate the questions on the audit template and only those that are in the so called scope of the audit.
Doug Powell asks for the data, and well he should, but he is not likely to get it since this data is proprietary. Audit companies are not going to publish the scores of auditees, and why should they? These audits are simply tools for the buying community to make purchasing decisions, not public health protection documents. If there is weakness in the system, it is that retailers will buy from anyone, and simply hide behind a smoke screen of due diligence, putting the burden of food safety on the supplier, while the buyers themselves are free to scour the markets for the best price and ignore food safety.
And forget the scores, there are so many questions that the points do not always indicate the real level of risk, but buyers and retailers do not read the reports, they simply go by scores. In my opinion, the buyers need to be educated because few if any of them really know how to interpret the findings from third party audits.
Left to its own devices, due to the inability of our public health agencies to afford us food protection, the food industry has created a system it can live with. Such is the case with third party audits. No retailer is going to make the system so strict that it constricts the supply, or God forbid causes a shortage and prices rise. And there is the profit motive, as this article brings out, and not just at AIB. Remember, FMI the billion dollar voice of the food industry owns the most recognized GFSI scheme called SQF, and they are not alone- all auditing companies work for the industry and adjust themselves to the prevailing powers that be- to make money, that is business and just what you would expect from an industry driven concept. It is so naïve to think any other way.
If you want independent auditors who are not beholden to someone, then we better fund a righteous FDA and keep the political honchos in Washington away from the inspectors. It can’t be done either-so there.
So now what?
More outbreaks, more tragic deaths and more of the blame game; this nightmare is not going away just because the Today Show runs a story. The problem is that the microbes have become firmly entrenched in our environment and attack our food supply at will, and we seem to lack the ability to detect them or eradicate them. Our best hope is a huge infusion of scientists, science and technology into the food industry, but we are a generation away from seeing the beneficial effects, even if we start now.
So on we go with incompetent people running our food safety programs, basic hourly workers with no knowledge of chemistry or microbiology in charge of food safety in too many plants, coopted auditors, and poor little old FDA limping to the scene after some tragic event to tell us what went wrong. Pathetic.
Read on and try not to barf.
Show us the data, forget the faith; food sickens millions as company-paid checks find it safe
William Beach loved cantaloupe -- so much so that starting in June last year he ate it almost every day. By August, the 87-year-old retired tractor mechanic from Mustang, Oklahoma, was complaining to his family that he was fatigued, with pain everywhere in his body.
On Sept. 1, 2011, Beach got out of bed in the middle of the night, put his clothes on and walked into the living room. His wife, Monette, found him collapsed on the floor in the morning. At the hospital, blood poured from his mouth and nose, splattering sheets, bed rails and physicians.
He died that night, a victim of Listeria monocytogenes. Beach was one of 33 people killed by listeria that was later traced by the U.S. Food and Drug Administration and state officials to contaminated cantaloupes from one Colorado farm. It was the deadliest outbreak of foodborne disease in the U.S. in almost 100 years.
“He died in terror and pain,” says his daughter Debbie Frederick.
That’s how Stephanie Armour, John Lippert and Michael Smith begin their food safety and aduits and inspections opus for Bloomberg. The Today Show may run a version this morning, because I taped a bit for it at Brisbane’s Channel 7 studios last week.
About seven weeks after Beach started eating cantaloupes, a private, for-profit inspection company awarded a top safety rating to Jensen Farms, the Granada, Colorado, grower of his toxic fruit. The approval meant retailers such as Wal-Mart Stores Inc. (WMT) and Wegmans Food Markets Inc. could sell Jensen melons.
The FDA, a federal agency nominally responsible for overseeing most food safety, had never inspected Jensen.
During the past two decades, the food industry has taken over much of the FDA’s role in ensuring that what Americans eat is safe. The agency can’t come close to vetting its jurisdiction of $1.2 trillion in annual food sales.
In 2011, the FDA inspected 6 percent of domestic food producers and just 0.4 percent of importers. The FDA has had no rules for how often food producers must be inspected.
The food industry hires for-profit inspection companies -- known as third-party auditors -- who aren’t required by law to meet any federal standards and have no government supervision. Some of these monitors choose to follow guidelines from trade groups that include ConAgra Foods Inc. (CAG), Kraft Foods Inc. and Wal-Mart.
The private inspectors that companies select often check only those areas their clients ask them to review. That means they can miss deadly pathogens lurking in places they never examined.
What for-hire auditors do is cloaked in secrecy; they don’t have to make their findings public. Bloomberg Markets obtained four audit reports and three audit certificates through court cases, congressional investigations and company websites.
Six audits gave sterling marks to the cantaloupe farm, an egg producer, a peanut processor and a ground-turkey plant -- either before or right after they supplied toxic food.
Collectively, these growers and processors were responsible for tainted food that sickened 2,936 people and killed 43 in 50 states.
“The outbreaks we’re seeing are endless,” says Doug Powell, lead author of an Aug. 30, 2012, study on third-party monitors called “Audits and Inspections Are Never Enough.” Powell, a professor of food safety at Kansas State University, says Americans are at risk whenever they go to a supermarket.
“You need to be in a culture that takes food safety seriously,” Powell says. “Right now, what we have is hidden. The third-party auditor stickers and certificates are meaningless.”
In some cases, for-hire auditors have financial ties to executives at companies they’re reviewing. AIB International Inc., a Manhattan, Kansas, auditor that awarded top marks to producers that sold toxic food, has had board members who are top managers at companies that are clients.
Executives of Flowers Foods Inc. (FLO), which makes Tastykake, and Grupo Bimbo SAB in Mexico City, which makes Entenmann’s pastries, Sara Lee baked goods and Wonder Bread, serve or have served on AIB’s board.
“There’s a fundamental conflict,” says David Kessler, a lawyer and physician who was FDA commissioner from 1990 to 1997. “We all know about third-party audit conflicts. We’ve seen it play out in the financial world. You can’t be tied to your auditors. There has to be independence.”
As flawed as the inspection system is in the U.S., it’s more problematic with imported food, especially coming from countries with lower sanitary standards, says Michael Doyle, director of the University of Georgia’s Center for Food Safety. In some emerging markets, farms growing food for export to the U.S. aren’t inspected at all.
The U.S. will import half of its food by 2030, up from 20 percent today, Doyle says. Bloomberg Markets visited growers in China, Mexico and Vietnam and found unsanitary conditions for produce, fruit and fish exported to the U.S.
Auditors evaluate their clients using standards selected by the companies that pay them, says Mansour Samadpour, owner of IEH Laboratories & Consulting Group in Lake Forest Park, Washington, which does testing for the FDA. The auditors sometimes follow a checklist that the company they’re inspecting has helped write.
“If you have a program for adding rat poison to a food, the auditor will ask, ‘Did you add as much as you intended?”’ Samadpour says. “Most won’t ask, ‘Why the hell are we adding poison?”’
Not only has the government outsourced auditing to the food industry; the auditors themselves often outsource their vetting to independent contractors -- people over whom they don’t have direct management control.
While Primus Labs declined to comment directly for this story, it did supply a response from its law firm, Kaufman Borgeest & Ryan LLP in New York. Auditors, the statement says, serve at the pleasure of their clients and cannot go beyond what they are asked to do.
“Third-party auditing will continue to be as effective as those requiring the audits (buyers/suppliers) and the audited suppliers make them,” the law firm writes. James Markus, a lawyer representing Jensen, didn’t return calls seeking comment.
From the outset, the FDA lacked the resources to inspect all of the country’s food producers.
The food industry moved to fill that vacuum with private auditors in the 1990s. Danone SA (BN), Kraft, Wal-Mart and other companies created the Paris-based Global Food Safety Initiative in 2000 to write guidelines for third-party auditors.
The program, whose vice chairman is Frank Yiannas, Wal- Mart’s vice president for safety, requires companies to be audited once a year. It doesn’t mandate testing for pathogens. In 60 manufacturing plants, Wal-Mart suppliers reported a third fewer recalls in the two years after adopting GFSI standards, Yiannas says.
In some cases, companies use their own auditors to check suppliers. In 2002 and 2006, Nestle USA, a subsidiary of Vevey, Switzerland-based Nestle SA (NESN), refused to use Peanut Corp. of America as a supplier. Nestle inspectors found rodent carcasses and pigeons in Peanut Corp.’s Plainview, Texas, plant.
Nestle’s rejection didn’t stop Lynchburg, Virginia-based Peanut Corp. from doing business with other customers or seeking approval from third-party auditors. In 2008, AIB International auditor Eugene Hatfield gave Peanut Corp.’s Blakely, Georgia, plant a “superior” rating.
And there’s a whole lot more. Our take on all this is below:
D.A. Powell, S. Erdozain, C. Dodd, R. Costa, K. Morley, B.J. Chapman
Internal and external food safety audits are conducted to assess the safety and quality of food including on-farm production, manufacturing practices, sanitation, and hygiene. Some auditors are direct stakeholders that are employed by food establishments to conduct internal audits, while other auditors may represent the interests of a second-party purchaser or a third-party auditing agency. Some buyers conduct their own audits or additional testing, while some buyers trust the results of third-party audits or inspections. Third-party auditors, however, use various food safety audit standards and most do not have a vested interest in the products being sold. Audits are conducted under a proprietary standard, while food safety inspections are generally conducted within a legal framework. There have been many foodborne illness outbreaks linked to food processors that have passed third-party audits and inspections, raising questions about the utility of both. Supporters argue third-party audits are a way to ensure food safety in an era of dwindling economic resources. Critics contend that while external audits and inspections can be a valuable tool to help ensure safe food, such activities represent only a snapshot in time. This paper identifies limitations of food safety inspections and audits and provides recommendations for strengthening the system, based on developing a strong food safety culture, including risk-based verification steps, throughout the food safety system.
Whilst I value the commentary of my friend and colleague, Doug Powell and agree almost 99% with his theory and thought, I have to question this aside at the conclusion of the story below.
Do we ask "who was the inspector" every time we have an outbreak in a regulated restaurant or meat plant? How is that relevant?
The auditor or inspector is not in charge of food safety. As a profession, we are there to evaluate either conformance with a prescribed set of rules written by a buyer (in the case of an auditor) or compliance with laws written and enacted by government.
The findings are useful for improving an operation, and the findings may point to risks inherent in a process or product or facility, but the inspection or audit process may not necessarily uncover every defect, hidden hazards or those of such a nature that they cannot be readily discerned through visual observation or records review. In any case, breakthrough events do not invalidate either inspections or audits, nor do they undermine their value or negate the need to continue such.
On the other hand, we have seen obvious defects and unsafe conditions left unchecked by an auditor or an inspector, and then a subsequent outbreak occur. We have to ask why that happens, and I believe that reporting and observational biases are a challenge for both inspectors and auditors. The biggest prejudices that such an expert has are lack of knowledge, time constraints, failure to see the entire operation, pressure from the operator, invalid audit or inspection protocol, faulty inspection report or method used to evaluate risks, politics, business concerns and self interest.
These flaws potentially exists in every inspection or audit process and the extent of which they manifest will invalidate the outcome.
Therefore, it is important to ask more than just who an inspector was; it is much more important to look at the whole auditing and inspection process. I believe these failures are not so much the result of "who was the auditor" but how well the audit process was able to uncover issues, and of course how well the operation cooperated with the auditor and responded to concerns.
29 sick with Salmonella linked to Trader Joe’s peanut butter; why is Penn. going public and others aren’t?
Now would be the usual time for some consumer education group to issue yet another jackass advisory, this time about how consumers should cook their peanut butter, or choose it with care, or something else they have no control over.
It is food safety education month, don’t ya know.
The Pennsylvania Department of Health today advised consumers that Trader Joe's Valencia Creamy Salted Peanut Butter made with sea salt may be related to a multi-state outbreak of salmonella.
The department is working with the Centers for Disease Control and Prevention and public health officials in several states to investigate the outbreak. Nationally, there have been 29 cases of illness with two cases reported in Pennsylvania.
Trader Joe's has voluntarily removed the product for sale from its stores; however, consumers who have the product in their homes should discard it and should also be aware that this product is sold online through other retail outlets.
Additionally, the department advises anyone who recently consumed Trader Joe's Valencia Creamy Salted Peanut Butter made with sea salt and then became ill to consult their healthcare provider, local health department, or call the Department of Health at 1-877-PA-HEALTH.
Where did this peanut butter originate? Does hipster fave Trader Joe’s audit their suppliers? Who was the auditor?
Nothing yet on the Trader Joe’s website.