The Role of the "FSVP Importer" in FSMA

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 about reported foodborne illness outbreaks associated with the commodity and/or supplier, product recalls, and withdrawals, and import refusals at the port of entry.

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

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

The FSVP rule requires that the FSVP importer be in the US. and register with Dunn and Bradstreet to obtain a unique facility identifier or “DUNS number”. The DUNS number is a key part of the customs filing. It cannot be overemphasized that The FSVP importer placed on the Customs record must be a Qualified Individual under the FSVP law, through education training and experience, and possess the depth of knowledge needed to perform somewhat complex risks assessments at several levels of the supply chain. Not all food importers will be comfortable in their new role as FSVP importer. Not all will have the technical and scientific knowledge and experience needed to successfully develop their own risk assessment, and assess a risk assessment done by others. Additionally, the FSVP importer must document this entire process for a variety of foods and facilities, including farms, packing houses, processors, manufacturers and distributors.


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

Changing Dynamics in the Food Safety Industry

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

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 largely related to training requirements and basic sanitation and hygiene. These rules were previously referenced in CFR 110, but now they have been migrated into the FSMA Preventive Controls Rule.

Preventive Controls for Food for Animals

This rule is the animal food version of the previous rule. The big thing here is that animal food processors are now — for the first time — required to comply with CGMP standards.

This rule also requires a Food Safety Plan, defines what’s considered a farm, and provides for more flexible supply chain programs. Note that feed mills associated with farms are not covered under this rule, but the FDA plans to issue rules in the future governing these organizations.

Standards for Produce Safety

This rule establishes “science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables” for human consumption.

The Produce Safety Rule has six core components, all related to reducing the risk of contamination of produce:

  • Agricultural water. Criteria for water quality and guidance for water testing.
  • Biological soil amendments. How to reduce the risk of contamination associated with raw manure and stabilized compost.
  • Sprouts. An entire section dedicated to mitigating risks associated with sprouts.
  • Domesticated and wild animals. Guidance for preventing contamination of produce by animal activities.
  • Worker training and health and hygiene. Health and hygiene requirements for farm workers who handle covered produce of food contact surfaces.
  • Equipment, tools, and buildings. Standards for cleaning and sanitation of physical structures and facilities.

Accredited Third-Party Certification

This rule establishes a voluntary program to accredit third-party auditors to conduct food safety audits and issue certifications for foreign facilities and the food they produce.

These certifications have two main purposes:

Sanitary Transportation

The Sanitary Transportation Rule establishes requirements for sanitary practices to reduce the risk of food becoming contaminated during transportation. This rule applies to “shippers, receivers, loaders, and carriers who transport food in the United States by motor or rail vehicle.”

The requirements fall into four categories:

  • Vehicles and transportation equipment
  • Transportation operations
  • Training
  • Records

Intentional Adulteration (Food Defense)

Finally, the Food Defense Rule aims to protect the food supply against intentional contamination. It primarily covers “large companies whose products reach many people.”

Under this rule, food facilities must prepare and implement a written food defense plan. The approach to these plans is similar to the HACCP system, and includes:

  • Vulnerability assessment. Evaluation of vulnerability for each type of food handled at the facility, including the potential impact on public health, the degree of physical access to the product, and the ability to successfully contaminate the product.
  • Mitigation strategies. Strategies to minimize or prevent vulnerabilities at each stage of the process.
  • Mitigation strategy management components. Steps to implement mitigation strategies, including monitoring, corrective actions, and verification.
  • Training and record-keeping. Like in the Preventive Controls Rules, all plans and activities must be documented.

Making Room for the Human Element in Food Safety Auditing


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?

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.

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 when out of control. We can classify them into 4 broad categories, such as chemical, physical, biological and radiological (thanks Fukashima). We develop controls for the particular hazards that are expected to occur, and critical controls for the likely ones with the most potential for harm. Food safety plans built on the principles of Hazard Analysis Critical Control Point (HACCP) must consider the likelihood of occurrence of these chemical hazards in most food manufacturing processes. While producers of commodities such as eggs, fresh meat or fresh produce do need to list allergens, most other foods require some type of allergen control and/or label.

Control starts with identifying the specific allergenic ingredients. Then, an operator must determine how they are handled and how they flow through a production system. Such studies often reveal points where cross contamination with allergens may occur. Controlling cross contamination between allergenic and non-allergenic ingredients on production lines is necessary when the line runs both allergenic and non-allergenic food, or when a variety of allergens are run. However, cross contamination controls begin at the time a firm receives an allergen-containing ingredient and continue during its storage, internal transport and during packing.

Proper cleaning between product runs is the most fundamental control. Visual inspection of the equipment to detect particles remaining post-cleaning is a useful effort, but unseen residues of allergens may linger and cross contaminate the next product run, as even the best cleaning may not result in 100% removal of particles. The cleaning process must also consider the forms, i.e., pastes or films, encountered and match that with the appropriate cleaner. Some plants must use dry cleaning methods when water in a production environment is detrimental, such as when manufacturing confectionaries, or in bakery environments. Such dry methods can be ineffective and can lead to cross contamination. Even when detergents and water can be applied to equipment, applications may be uneven, leaving traces behind. As better laboratory methods of detection have increased the specificity of tests, investigators looking for allergens can detect smaller and smaller amounts of them.

In-plant allergen testing of equipment, however, can provide verification that allergens are not present on a surface after cleaning. Some tests used in a plant environment are not allergen-specific, and utilize quick colorimetric tests for proteins, sugars or other markers of allergen contamination. Operators instead should use ELISA kits (enzyme-linked immunosorbent assay); while much more sophisticated and expensive they can be validated and possibly validate the protein or sugar swab methods. ELISA tests may be a better choice for in plant testing. Such testing can be qualitative as well as quantitative (a 5 ppm Level of Detection typically). Operators should also develop protocols to establish the baseline information needed to interpret results. Establishing baseline acceptance criteria requires establishing the levels of allergens in products when various levels of allergens are detected on surfaces of equipment. Off-site labs having more sophisticated methods usually conduct such validation studies. Such validation data may allow operators to accept some trace levels and avoid the pitfall of chasing molecules around a plant, when such levels are shown not to affect the final product.

Operators must designate cleaning tools for specific areas to avoid the tool as a form of cross contamination and Sanitation Standard Operating Procedures must be developed. Such SSOP should contain the designation of a cleaning crew and sanitation employees need ongoing training. The SSOP should contain the items requiring cleaning, the types of cleaners used, dilution values for detergents and degreasers, how to maintain effective levels, water temperature, tools used, how often the cleaning is carried out, and the timing of visual inspections and verification. As in all HACCP based-systems the results of the testing program are recorded and verified.

Cross contamination may occur during storage and internal transport

Storage of allergen containing materials together in the same area can also lead to cross contamination when the operation has not effectively designated the proper storage areas. Storage of allergenic foods above non-allergenic, or a mix up of ingredients or finished products can lead to cross contamination through the environment. Ideally a facility should store sensitive items in separate enclosed areas, but not all plants have the capacity for separate storage. In these situations, careful monitoring and a visual marking or signage is helpful.

Even forklifts and pallet jacks could play a role along with totes and other containers.

Labeling Failures

Because we have risks in allergen control, and our controls may not always be successful, the label should provide the at-risk consumer with enough information for making a decision. As mentioned earlier however, the use of language such as “may contain…” or “made in a plant that also processes…” make food choices more difficult and impacts the quality of life for such consumers.

Labels are applied to final unit packages by hand, or by a label machine, typically. Rolls of labels have to be run for each batch of product. The timing and staging often lead to the packing of several products at once and different label sets on the plant floor. When the products differ as to allergens it is easy to make an error in the application of labels. Errors can also occur in the printing of labels, and allergenic ingredients may be inadvertently left out if the operator has not done his due diligence and did not realize the product or ingredient contained an allergen. Highly refined oils are hidden ingredients in many products and may contain trace amounts of proteins, for example.

Foodservice allergen control

Patrons of restaurants are often highly at risk to be exposed to allergens. No such menu labeling requirements are required in the USFDA Food Code. Restaurants handle a complex variety of foods and it is nearly impossible to know for every recipe and every product, what allergens may or may not be there or to separate them. Furthermore, the operating conditions of restaurants are very different then processing plants and there is very little that can be done about preparing and storing various allergen sensitive foods together.

The last line of defense is the waiter or waitress who is often the only person except for the cook who can answer a question about whether a food contains a certain ingredient or not. Even then, it may be impossible to know in every case, every allergenic ingredient.

The effectiveness of industry allergen control programs

As illustrated by the recent spate of recalls, the food industry’s response to allergen control has been less than completely successful and more needs to be done. The industry needs better testing regimens and adherence to properly developed cleaning protocols. As in the case with preventing microbial contamination, a company must provide the resources necessary, and have the experience and technical ability to monitor and control a sometimes-complex array of policies, procedures and validation methods.

And for a variety of reasons, some unknown, the situation is getting worse:

  • According to a study released in 2013 by the Centers for Disease Control and Prevention, food allergies among children increased approximately 50% between 1997 and 2011.
  • Researchers are trying to discover why food allergies are on the rise in developed countries worldwide, and to learn more about the impact of the disease in developing nations. More than 17 million Europeans have a food allergy, and hospital admissions for severe reactions in children have risen seven-fold over the past decade, according to the European Academy of Allergy and Clinical Immunology (EAACI).

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

In Response to Michael Taylor


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

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 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.

Process and Substance in Third Party Food Safety Audits

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.











Environ Health Associates, Inc.







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.


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

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 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:

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Negativity comes not only from the ranks of government, but from so called “food freedom” groups.

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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.

See here:

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