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Food Safety and Environmental Health Blog

Published: Fri, 10 Nov 2017 20:32:09 -0500

Last Build Date: Fri, 10 Nov 2017 20:32:09 -0500

Copyright: Copyright 2017

The Role of the "FSVP Importer" in FSMA

Fri, 10 Nov 2017 11:26:26 -0500

The Foreign Supplier Verification Program (FSVP) under FDA, was enacted in 2015 to require that foreign suppliers of food provide the same level of food protection for their food as provided by our public health system. 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” for the purpose of the FSVP law, as explained below) must perform a verification that a foreign supplier of food has complied with at least two new major FDA-FSMA federal rules; Produce Safety, and the CGMP and Hazard Analysis and Risk-Based Preventive Controls for Human Food Rules. FDA will hold the importer legally liable to ensure compliance with their requirements. The importer must approve the foreign supplier before bringing food into the US. The level of scrutiny applied to the importer’s approval process is based on a risk assessment of the supplier’s performance and historical risk of the commodity, akin to a Hazard Analysis in a Hazard Analysis Critical Control Point (HACCP) plan. While the traditional HACPP risk assessment model is complex, the FSVP makes the risk assessment a straightforward process. What is required in the FSVP version of the Hazard Analysis is to determine the “reasonably foreseeable hazards” in the commodity, based on the history of safety of the commodity, the history of the supplier meeting their own nation’s regulations, and conformance with US buyer’s requirements. To make such approval decisions, the 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 the foreign supplier and customers in the US. They arrange for cross-border shipments by preparing the US Customs filings for each food item brought into the US. The Customs forms have been changed 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 importer’s new food safety role very significant for both 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 legal compliance by the supplier on the food importer may have some unique benefits and improve public health protection, but raises conflict of interest questions. Shifting the compliance role to the importer will change how importers, suppliers, food brokers, customs brokers, manufacturers and retailers operate. The entire supply chain must communicate, 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 the supplier’s performance in granting entry approval. To accomplish the verification that a food item is safe to import, importers look at the hazard analysis and Food Safety Plan prepared by the supplier, and evaluate it considering the importer’s own hazard analysis. They must also evaluate compliance with the supplier’s own food safety laws and rules in the country of origin and research the history of reports of contamination through The Reportable Food Registry. They should know about past and current compliance issues with the Preventive Controls or Produce Safety Rule. Perhaps most importantly an importer must stay informed[...]

Changing Dynamics in the Food Safety Industry

Sat, 04 Nov 2017 08:04:49 -0500

The food safety industry is diverse, encompassing everything from laboratories to auditors, trainers and consultants. The industry operators rely on such outsourced services for a variety of reasons, but having available expertise is key to the business relationships. 

Labs provide the needed information about microbial, chemical and physical properties of foods to enable a hazard analysis in the required federal food safety systems (FDA Food Safety Modernization Act). Lab findings are also a type of verification of sanitation and the effectiveness of Hazard Analysis Critical Control Point (HACCP) programs under federal regulations. Because of the emphasis put on tests, labs typically have accredited tests that they can run. The trend now is for laboratory certification under ISO 17025. The growth of the food testing laboratories has been phenomenal, The food testing industry alone is worth approximately 14 billion a year in annual sales worldwide. This sector will only increase as the new federal laws under the Food Safety Modernization Act (FSMA) become phased in, Those laws now require additional environmental monitoring in food production facilities where ready to eat foods are exposed to the environment.

Auditors play a key role in verification of food safety systems. The results of food safety audits are used by buyers to assess both management effectiveness and food safety compliance. As the result of FSMA,, auditors are now to be "qualified". The rules for Qualified Auditors are basic, and require education and training as core competencies. Audit firms are growing rapidly as the third party audit system is now well entrenched in the retail buyers procurement process. Auditing companies are conducting tens of thousands of these audits yearly and this number will increase, once again, as FSMA rules become incorporated in the third party standards.

Consultants are in demand to assist operators in developing and implementing food safety systems, and as a second line of defense in monitoring and verification of the effectiveness and implementation of programs. Consultants need diverse skills, and since the industry is so diverse, consultants need to be competent in several specialties in the supply chain and with several commodities  (growing, raising, processing, packing, shipping, meat, dairy products, produce, seafood,) and know how food safety will be applied there. This is one area of the industry where there is a blend of experts, researchers, educators at the university and college levels, retired government officials, sanitarians, and former industry QA types. Such specialties in the workforce will find rich opportunities in the area of consulting.

Training in the food industry has several levels. There is an enormous amount of food safety training opportunities, from classrooms, to online courses, to webinars. Trainers typically have to be in some way qualified to teach the required courses that managers and employees must take. Training in the food industry spans from the food service employee to the operators of safety and quality systems at major processing firms. The need for training has further expanded by the need for a "Qualified Individual" to develop and manage the required federal food safety systems as found in the FSMA regulations. Courses around the US and overseas are now underway to provide the basic training in satisfying those requirements. Training firms and independent trainers, website operators and webinar educators are expanding their reach into this market.

Professionals with backgrounds in public health, food science, environmental health, epidemiology, and biological sciences are finding opportunities in this rapidly growing and changing market.


FSMA Rules Being Phased In

Thu, 02 Nov 2017 19:02:33 -0500

In 2011 the Food Modernization Act or FSMA was passed into federal legislation. FDA The US Food and Drug Administration in response has published 7 rules that are destined to have significant impact on the food industry: Preventive Controls for Human Food This is perhaps the most talked-about FSMA rule because it represents a major shift in the approach to food safety from reactive to proactive. It applies to facilities both foreign and domestic that hold, pack or process human foods. Essentially if a facility has registered with FDA under the Bio Terrorism Act, they will likely be subject to this rule This rule has four core components. Hazard Analysis and Risk-Based Preventive Controls replaces the traditional Hazard Analysis and Critical Control Points (HACCP) system. The rule requires a written Food Safety Plan that includes the following elements: Hazard analysis, including hazard identification and hazard evaluation Preventive controls, Sanitation, Allergen, Process, Supply Chain Oversight and management of preventive controls, including monitoring, corrective actions, and verification There is a major emphasis on the Supply Chain requirements to control the risks of incoming ingredients into manufacturing processes. A new definition of “farm” The Produce Rule divides farms into two categories: Primary production farms are operations “devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities.” This is a traditional farming operation; the farm may also operate a packing operation without being subject to the preventive Control Rules Secondary activities farms are operations “devoted to harvesting, packing, and/or holding raw agricultural commodities.” If the farm owner owns the facility, the Produce Rule, not the Preventive Control Rule applies Mixed Activities Farm are manufacturing operations located off the farm such as packing or processing, that are subject to the Preventive Controls Rule The purpose of this new definition is to help clarify who is required to register with the FDA (in general, farms aren’t), and thus who’s subject to FSMA. Foreign Supplier Verification Programs (FSVP) This section identifies which entity in the supply chain is responsible for preventive controls for different food hazards in imported food, typically it is the Importer who must verify the compliance of overseas suppliers with federal rules. It is a complex rule, for example, importers don’t need to verify preventive controls for identified hazards that will be controlled downstream by other processors. This rule has a long list of exemptions and variances, so make sure you know what areas apply to you. FSVP is both a law and a program, and applies to anyone who imports food into the United States (minus a few exemptions). The goal is to ensure that foreign suppliers meet the same food safety standards as domestic suppliers. Under this rule, importers must develop a FSVP plan: Perform a hazard analysis, including hazard identification and evaluation Evaluate food risk and supplier performance, including the supplier’s food safety history and all processes and procedures related to food safety Conduct supplier verification activities, such as audits, sampling and testing, and reviewing food safety records Take corrective actions when things go wrong This rule laces a great emphasis on record keeping by the importer. FDA will inspect those records for compliance. FDA will identify those Importers with FSVP responsibilities on the custom’s filings through the use of a unique identifier (Duns Number) Current Good Manufacturing Practices (CGMP) updates The new rule contains a few updates to CGMPs some previously nonbinding standards are now binding. These are large[...]

Making Room for the Human Element in Food Safety Auditing

Thu, 18 Jun 2015 12:57:42 -0500

  In today’s world of food safety requirements, food producers large and small and at all levels of the supply chain are subject to increasingly rigorous industry-driven food safety standards and audits. Third party audit standards have been revitalized by the all too apparent ineffectiveness of the way external parties verify food safety programs as brought to light in several foodborne illness outbreaks. Following the Jensen Farms incident, auditing firms have tightened the process for certification, for example, by raising the minimum score required for certification from 85% to 90%. In addition, the administration bodies at the major third party audit firms are intensely scrutinizing audit results and the performance of auditors. The anticipation of the implementation of FDA’s FSMA, turns the pressure up even higher, and it is likely that the third party standards will incorporate large sections of the new federal rules. Change is good, and there is a need for better evaluations. The goal of course is to provide the industry with auditors that are qualified and capable of identifying unsafe operations so that operators can address them. It is also essential that buyers are made aware of potential problems and so they can make more informed choices about qualifying suppliers. Auditors now spend about 90% of their time in an audit looking at paperwork. The management systems documentation evaluation portion of the audit can take an entire day. Auditors require documentation to verify that an operator is carrying out a total quality management system based on a continuous improvement model. Even small companies must now dedicate personnel strictly to keep up with the increasing demands of more and more detailed documentation. Outbreaks of foodborne illness are caused by the contamination of foods by pathogens. Investigations of these events very often reveal major lapses in sanitation. It is therefore of great concern when a food safety auditor is spending 90% of their time looking at paperwork, when the real risks are in the plant or operating environments. There is also a risk that the industry will become so focused on record keeping that basic sanitation, and other key elements of a food safety program, such as employee hygiene, training and supervision will begin to falter. Another troubling aspect of the increasing demand for documentation is the effect this is having on smaller or family owned and operated food businesses. The premise for the food safety management system is a good one, but the practical aspects of applying the literally hundreds of management protocols, and all the while keeping up with the fundamental aspects of sanitation and hygiene, has become a major burden for small firms. While we say the third party system is a “voluntary system”, that is really not correct. There is simply no market for suppliers without a food safety system. Producers at all levels must implement elaborate managements systems and keep them constantly updated and verified, regardless of the nurture of the company, its size or complexity. To expect a firm operated by a husband and wife, for example, to document every conversation about food safety or have detailed job descriptions, is an unrealistic expectation and adds nothing to the safety of the products produced. In our zeal to perfect our auditing methods we can loose sight of reality. A tiered system is probably not possible given the way our third party standards are developed, but placing small operations- a major portion of the food industry- in an unfair situation is not acceptable. The inability of an auditor to deal with human elements in the audit process makes a fair determination of conformance with the standard impossible. Rigid, inflexible rules, when they exist just for the sake of rules are distasteful to everyone concerned and cheapen the value of our service to the industry.  [...]

Is the Food Industry Doing Enough to Control Allergen's?

Sun, 31 May 2015 18:20:45 -0500

Widespread allergen exposures and the extent of the problem A recent spat of food product recalls due to undeclared allergenic agents illustrates the problem the food industry has in preventing allergen exposures. 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 US 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 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 US population. Persons with allergies may develop sometimes-serious medical consequences, such as breathing difficulties or go into anaphylactic shock after exposure to a host of allergens in food. There are eight major allergens that cause 90% 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 saying 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 they are allergic to, to avoid it until and they check with their doctor. When foods contain an undeclared allergen, or when allowable levels of a food additive, such as sulfites, used as a preservative 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 wh[...]

In Response to Michael Taylor

Fri, 22 May 2015 09:53:02 -0500


In Response to: "Blue Bell and the Very Real Impact of the Food Safety Modernization Act" at Food Safety news

I appreciate Michael Taylor's comments in the above article posted on Food Safety News and also believe that FSMA is a step in the right direction. The fact, however, is that companies around the globe have already adopted food safety systems! This article makes it sound like preventative controls are something new and that such programs will be brought about by new federal law. The fact is in most major operations the preventative controls are in place right now. There are firms that have not adopted such in their operations, and FSMA may help to address this, but by and large, the large food borne illness outbreaks we have seen are not the result not having a prevention program, but the failure of the program to prevent the hazard from occurring.

Breaking a law, however, comes with a high cost for non-compliance, and that hammer is needed for some. But for most operators, this is not the answer to the microbial contamination control problem in their facilities. Our overarching goal in industry should be to be in compliance with FDA's new laws, however, we need effective food safety management systems and we do not always have them. This is illustrated by the findings of serious sanitation issues, after the fact, in the investigation of the Blue Bell ice cream plant outbreak and many others.

As a regulator, consultant, auditor and investigator for almost 40 years, I am painfully aware of the difficulties in the implementation of complicated quality assurance and safety programs. In light of this, I feel simply more or different "preventative controls" are not likely to improve the situation much, by themselves.

Still, we look to FDA to help us, and I am still wondering if we will get what we need from the agency. We need consistent application and enforcement of the rules, and FDA has to get agents into the field, but most importantly, firms must organize their companies around food safety. This means establishing active and effective committees, appointing dedicated food safety staff, and a planned approach to assuring the safety of products. Companies must also effectively train and educate everyone in the organization, and maybe most importantly, apply the available science and technology to the food safety problem.

A lack of commitment within companies is a root cause of much of the failures of the existing programs, along with a lack of resources. We waste tons of money on audits, manuals, record keeping etc, etc, when we should be investing in educating our employees, improving our  infrastructures and applying technology. These applications should include onsite laboratory capability, remote monitoring of critical processes, and sophisticated traceability and recall programs.

I totally support what FDA is doing with FSMA, but we should recognize that a new system of preventative controls is only a solution if our food safety management systems are working effectively.


Listeria monocytogenes Current Epidemic and Public Health Response

Tue, 05 May 2015 23:05:26 -0500

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. 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 [...]

Process and Substance in Third Party Food Safety Audits

Sun, 20 Jul 2014 22:27:18 -0500

  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 th[...]


Tue, 28 Jan 2014 18:25:53 -0500

                Environ Health Associates, Inc. ACCREDITED HACCP COURSE “APPLYING HACCP PRINCIPLES™ TO PRODUCE” ü LEARN THE ELEMENTS OF HACCP ü APPLY THEM IN YOUR OPERATION ü REDUCE RISK AND IMPROVE EFFICIENCY ü EARN RECOGNITION OF HACCP COMPETENCY 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).   COURSE INSTRUCTOR 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. [...]

FSMA Progresses but Confusion and Apprehension Build in the Produce Industry

Wed, 01 Jan 2014 14:33:42 -0500

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. See also: 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 [...]

The Produce Industry Still has a Long Way to Go to Ensure Food Safety

Thu, 28 Nov 2013 15:20:25 -0500

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. Antimicrobial Treatments 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, [...]


Mon, 26 Nov 2012 19:52:35 -0500



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Airline Food Safety and Industry Denial

Sun, 18 Nov 2012 05:22:28 -0500 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.  By GLENN RUPPEL, JIM AVILA (@JimAvilaABC) AND MARK GREENBLATT (@greenblattmark) Nov. 17, 2012 You're accustomed to airline food that's bland, tepid or otherwise unappetizing. You're probably not accustomed to hearing that it was prepared or stored in areas crawling with mice, ants and roaches. But that's what the Food and Drug Administration (FDA) saw when it inspected airlines and their outside caterers. Through a Freedom of Information Act request, "20/20" obtained lists of recent health violation records from the FDA, the agency in charge of inspecting airlines and their outside food caterers. Over almost four years, the industry counted more than 1,500 health violations. "Significant" problems were found a[...]

Today Show's Rehash of the Auditor Bash

Sun, 14 Oct 2012 19:49:45 -0500

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[...]

Who Was the Peanut Auditor?

Sat, 22 Sep 2012 17:27:24 -0500

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? 21.sep.12 barfblog Doug Powell 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 he[...]

Retailer Double Talk on Produce Safety

Sun, 16 Sep 2012 14:04:45 -0500

One of the hallmarks of protecting the fresh produce supply is a concept known as “buyer-driven” food safety controls. In the absence of regulations, the produce industry has been working under private standards drafted by the major buyers of produce, meaning the large retailers-the major supermarket chains. While the need to satisfy the retailer that foods supplied to them are safe, retailers themselves have been less than effective in ensuring that the people they commission to buy for them, their own “buyers”, only deal with operations with acceptable food safety systems. This means that many, if not most retailers, will buy produce from firms that have not been verified by competent third parties or by the retailers themselves (second party verification), when it is opportune for them to do so. For a revealing piece on this issue see The Perishable Pundit: The sad truth is that when buyers can get produce from a vendor at a cheaper price, the requirements for safety take second place. Even worse, buyers utilize the unapproved firm as a lever to get the operator with a food safety system, and subsequently higher production costs, to lower their price. Even small operations may invest hundreds of thousands of dollars in satisfying the strict rules of the Global Food Safety Initiative (GFSI). Often, firms must hire food safety personnel due to the overwhelming amount of self-inspection and paperwork involved. Laboratories and auditors must be paid for. Many times there are requirements for structural improvements and maintenance, chemicals to clean and treat water and many other similar costs to be borne day in and day out by suppliers. Thanks to the attitude of the major retailers, these suppliers cannot typically charge more for their products, and must absorb the costs as best they can while trying to stay competitive. It is unfair to say the least that buyers for the major retailers would use the lower priced unapproved supplier as leverage to keep down their costs. Instead of rewarding suppliers for diligent efforts that not only protect the retailer, but public health in general, they are causing animosity; many conscientious produce operators are indignant at the current double standard, but the fear of losing customers precludes most of them from expressing their exasperation. "Food safety culture" is a much used phrase and one preached to the supply chain by many of the world’s largest retailers. Retailers should be reminded that food safety culture begins at home, and such talk becomes a mockery in the eyes of the producer when retailers say one thing and do another. Not all produce firms have had an opportunity to be qualified by third party accreditation under any private scheme, but the population of certified firms is growing, Part of the reason for the shortfall is that the auditing firms performing such audits are themselves overwhelmed and lack the necessary manpower. In order to maintain pressure on the supply chain, the buyers for the major retailers have set deadlines for compliance, but then have to announce that another grace period or extension has been granted. Some relatively large producers of fruits and vegetables have just decided that the retail communities demands for conformance with third party food safety standards is a bluff and carry on business as usual; and they find most retailers are willing to buy their products anyway, on the basis of p[...]

FDA Finds Insanitary Conditions-Again

Sun, 16 Sep 2012 10:36:51 -0500

FDA once again on the basis of detecting a Listeria contaminated product, finds insanitary conditions at a producer, this time at Henrys Farm Inc. of Woodford, VA. It would be much better for everyone if FDA had found these conditions beforehand. These repeated exercises by FDA should be a warning to the produce industry, that sanitary conditions in produce operations need improving across the board. It also points to the tremendous job FDA will have in cleaning up the produce industry, if and when they are able. Until then, it appears reacting is the best they can do.
Here are the findings as published by Food Safety News:
- Rodent pellets in bags of mung beans, along with gnawing on 25 kg paper bags of soybeans located in the refrigerated seed storage section. and in a shed 200 feet West of this storage area. FDA reported "a foul odor consistent with rodent infestations associated with the shed."

- Gaps under the door to the refrigerated seed storage area and holes in the ceiling of a shed containing soybeans 

- A hand-washing sink draining used water onto the floor

- An accumulation of debris in the exit bin of the wash chute leading to the sprout air dryers and packaging machine and on the underside of a conveyor belt that transports soy beans.  

- Loose metal burns on the metal mesh conveyor belt in the sprout processing area measuring about a quarter of an inch around. 

FDA also charges Henrys with misbranding its product, saying the company's sprouts failed to bear a label including the name and place of business of the manufacturer or the net quantity. 
Who are the commercial buyers and distributers of these products? Do they have a clue what they are buying and selling? Food safety at this level of the produce supply has a long, long way to go.

Fear Mongering or Facts, Plaintiff Attorneys and Social Media in Food Safety

Fri, 14 Sep 2012 19:32:58 -0500

Fear Mongering or Facts, Plaintiff Attorneys and Social Media in Food Safety The tort system has become the fulcrum for food safety in the absence of a credible public health response to foodborne illness. Nobody goes to jail in the US for even the worst food safety breaches, even those that result from gross negligence, but they do get sued, big time. FDA especially, has lacked the power to levy any meaningful penalties against offending firms, even ones that have released contaminated foods knowingly into commerce. The Parnells and De Costers rest in their immunity from prosecution after they poison thousands and killed innocent consumers with their tainted products, but they cannot escape the long arm of the plaintiff attorney. The complacency that has developed due to the liaise-fare attitude of government, turned to fear of lawsuits, has now hardened into an attack on plaintiff lawyers, the last recourse for injured parties.   With that as a backdrop, the story below reeks of a reactionary mentality. The suggestions that social media be used to spin food safety information and deter consumers from getting the facts they need during an outbreak will not get very far. The public is not so easily fooled.   I believe that firms that practice food safety and are committed to the principles of public health protection should tout their message. But to play games with the access to factual information especially during an outbreak just reveals the shocking and desperate state the food industry is in.   Instead of manipulating social media, the food industry should be redoubling their efforts to stop the foodborne epidemic in this country and come clean with the American public.   US: Four ways plaintiffs’ lawyers leverage Google to stir food-safety fears 11.sep.12 Fast Company Richard S. Levick Despite the fact that America’s food safety infrastructure is the most efficient and effective in the world, the International Food Information Council Foundation’s 2012 Food and Health Survey found that only 20 percent of Americans are “very confident” in food supply safety. At the same time, one in six U.S. consumers has stopped buying a particular food or beverage brand because of safety concerns in the last twelve months. Given the rash of high-profile food recalls we’ve seen since 2007, the figure is understandable, even if it isn’t backed up by hard facts. Spinach, tomatoes, peanuts, lettuce, ground beef, and a host of other kitchen table staples all experienced significant incidence of contamination in the last five years. The resulting consumer anxiety got so bad in 2009 that Americans actually put their food safety fears on par with worries about the War on Terror. That’s a compelling statistic--and it ought to make farmers and food manufacturers wonder if there’s something else that is contributing to Americans’ fear of food. Even at the 2010 height of salmonella, listeria, and E. coli outbreaks, the U.S. Centers for Disease Control and Prevention released data showing that only one in every 125 million meals served in the U.S. had the potential to make a consumer fatally ill. Science supports a conclusion that the food we eat every day is, indeed, safe. So why don’t Americans feel that way? The answer lies in the fact that statistics can’t compete with emotion when it comes to assuaging anxiety. Numbers don’t move people the way that human drama does--and [...]

12 Steps for a Safe Produce Supply

Sun, 29 Jul 2012 23:36:47 -0500

Bill Marler, arguably the leading legal mind in food safety today, is not pulling any punches when he points out the deficiencies at Jensen Farms. The shocking truth is that the old ways of doing things in the produce industry must quickly come to an end. We cannot continue to hide from the truth. We should therefore be very worried about the future of the fresh produce industry, and do whatever we can to save it. The following is my take on what it will require to satisfy any future due diligence defense, in the event that the unthinkable happens, again. 1.       Equipment design All equipment that touches a produce item at any step of production must be stainless steel and NSF or UL approved, or equivalent, and otherwise meet the requirements for food contact surfaces as outlined by the USFDA Food Code. Any part of any piece of equipment that touches produce, whether the produce surface is part of the food, or is inedible, must be certified as safely designed. Existing equipment must meet the same requirements or must be dismantled and removed. This also applies to retail operations where produce is displayed handled and/or sold to the consumer. Non-food contact surface of equipment shall pass equivalent qualifications based on a risk assessment. 2.       Facility design Every facility that handles produce from the packing shed to the processor or cannery must be designed by a certified designer and pass a plan review process governed by a legal authority before construction. All such facilities must be inspected by a government entity and approved before operation. Existing designs must be brought up to standards immediately or cease operation. This also applies to the retailer. 3.       Potable water Only water that has met the chemical, biological and radiological standards for potability may contact produce at any stage of the growing, harvesting, packing and processing chain. This includes the retail level. All water supplies used anywhere in the produce industry must be approved prior to construction. Existing systems must be immediately resigned or abandoned if they cannot meet such requirements 4.       Personal Hygiene All persons handling produce at any step of the supply chain must be certified to be in good health on a frequent basis, and may not touch produce with bare hands. Adequate plumbed facilities that include approved waste disposal and hand washing must be provided anywhere produce is produced or handled. 5.       Food Safety Management Systems Food safety management system that includes a hazard analysis of each step of production must be in place at any produce operation, with the controls verified and validated for effectiveness by a competent authority having jurisdiction. This applies to the retail level. All produce must be treated to reduce pathogenic microorganisms to a safe level. Such treatments must be validated as safe and effective and included in an operations food safety management system. Such management systems must include a microbiological testing program for all water used, all surfaces touched by produce and the general environment, in process tests as well as end product tests to verify the effectiveness of controls, irregardless of the type of commodity. Such programs shall show the continuing absence of pathog[...]

Subway's Sick FSMS

Wed, 04 Jul 2012 11:44:14 -0500

The verification of supplier food safety has emerged as a critical component of a retail operation’s Food Safety Management System (FSMS), but we continue to see Subway stress supplier safety while poor management of its own operations results in outbreaks of foodborne illness.

See Bill Marler's Food Safety News to learn how a Subway contributed to a community wide outbreak of norovirus gastroenteritis.

In light of the costs borne by the supply chain to satisfy retail industries’ high standards for prevention, it is unfair for a firm as influential as Subway to have lax control over its own operations.  

It’s critical to have safe lettuce coming in the backdoor, but if an infected employee handles it, it negates all the costly prevention done upstream by suppliers. The revelation that this was allowed to happen creates animosity on the part of suppliers and undermines Subway’s own efforts at supplier control.

Subways’ food safety management system failed as the result of poor decision making; what we see here is the failure of food safety culture. Subway has an obligation to consumers who expect the company to be a supplier of safe wholesome food. Subway has an obligation to its suppliers to maintain the same vigilance over food safety they expect from them. By failing its obligations, Subway risks the reputation it has built, and the value of its brand.

As consumers, we should expect MUCH more of Subway. As food safety professionals, we should ask “what is the root cause of this failure” and “how best can Subway’s management solve the problem”.