Tag Archives: intentional adulteration

Food Fraud

Mitigating Food Fraud Is Complex, But Not Impossible

By Maria Fontanazza
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Food Fraud

Nearly 10% of the food supply is affected by food fraud, yet many food companies are not well equipped to deal with the problem, according to a survey cited by SSAFE at USP’s recent Food Fraud Mitigation Hands-on Workshop. Nearly 40% of companies said it is easy for fraudsters to fake their food products and about one-third named gaps in supply chain transparency as a fraud vulnerability problem. In addition, about one third of respondents were unaware of whether their suppliers have been part of a criminal offense.

How secure is your supply chain? Learn how to mitigate these risks at the Food Safety Supply Chain conference | June 5-6, 2017

Food fraud is defined as the intentional misrepresentation of the true identity or contents of a food ingredient or product for economic gain, said Janet Balson, senior food safety consultant at USP. In many cases, adulteration cannot be detected by visual inspection alone. Companies must look at the susceptibility of certain ingredients and products (common targets include olive oil, honey, milk, chicken, tea, spices and fish), potential economic gain, and vulnerabilities in the supply chain. Since only a small amount of fraud cases are detected, it is important to conduct a thorough vulnerability assessment that examines the supply chain, QA methods, testing frequency, audits, supplier history, and historical, geo-political and economic factors, and from there, a multi-disciplinary team can develop an appropriate control plan based on the level of risk.

Food companies can leverage several tools (they also work in a complementary fashion) to identify and assess potential hazards in ingredients and products, including EMAlert, USP’s Food Fraud Database 2.0 and SSAFE’s Food Fraud Vulnerability Assessment tool. Arcchana Patil, senior manager of food safety & defense, QRC at The Hershey Company and Samantha Cooper, manager of food safety & quality assurance at GMA compared several of these platforms, offering a few tips on their capabilities and how companies can make the best use of the tools.

  • USP Food Fraud Database 2.0: Contains almost 7,000 food fraud records and allows searching of records by ingredient. Helps in the process of evaluating food fraud vulnerability. Its customizable dashboard and search function update users on new records. The platform also provides automated analytics tools. The tool is best used by subject matter experts, a group or by food fraud and food defense teams.
  • EMAlert: A real-time predictive model for economically motivated adulteration that quantitatively analyzes vulnerability for a group of ingredients based on weights given by users. Commodity data for each attribute is continuously updated. It provides a good platform for commodity scanning for sourcing and procurement teams. The tool is best used by subject matter experts, a group or by food fraud and food defense teams.
  • SSAFE Food Fraud Vulnerability Assessment: Available in 10 languages, it provides a good starting point for companies to assess their vulnerability at an ingredient, product, brand, facility, country or company-wide level. It identifies vulnerabilities to enable mitigation, but it does not offer mitigation techniques. The tool can be applied throughout the supply chain, from feed and primary production to manufacturing and catering. It can be used by different segments of the supply chain, along with corporate, but it is best used by cross-functional teams in quality, lab, procurement, legal and manufacturing.
  • World Factbook of Food: With more than 130 foods and 75 country profiles, the Factbook data is curated from a variety of sources to assist in risk assessment. The repository of food and country profile contains product uses, consumption, production and trade information, along with population, economy, climate and governance.
  • Food Adulteration Incidents Registry: Containing more than 550 unique incidents of food fraud and intentional adulteration, the registry provides verified event information to support vulnerability assessments. The platform uses a repository of open data records.

The shortage of food due to climate, environmental and political changes will put further pressure on the availability of certain ingredients and is likely to cause an uptick in food fraud. However, there are more tools than ever before to help companies deal with this problem, but the key is to try to stay one step ahead. As the speakers and attendees at the USP workshop reflected on the issue, they shared their predictions on where they see food fraud headed in the near term:

  • Companies will need to use technology to push further into their supply chains (i.e., tier two or three) where there is a higher risk.
  • The implementation of blockchain technology will make it more difficult for fraudsters to fake data, especially with processed foods.
  • The food industry will be able to learn from other industries that have counterfeiting issues, such as the pharmaceutical industry.
  • Use of smarter complementary tools that fight food fraud will help companies better mitigate risks and intervene more swiftly.
Vulnerability assessment

Protecting Food Against Intentional Adulteration: The Vulnerability Assessment (Part One)

By Debby L. Newslow
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Vulnerability assessment

FDA, as part of FSMA, released its rule titled “Protecting Food Against Intentional Adulteration” on May 27, 2016. This rule was proposed in 2013. FDA received and responded to 200+ comments prior to its final release.

FDA states that this rule “is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, [and] economic disruption of the food supply absent mitigation strategies.”1

The rule requires a documented “Food Defense Plan” that at a minimum includes the following:

  • Vulnerability assessment
  • Mitigation strategies
  • Procedures for food defense monitoring
  • Food defense corrective action procedures
  • Food defense verification procedures
  • Records confirming implementation, maintenance and conformance to the defined requirements
  • Evidence of effective training

As a food safety professional with more than 30 years in the industry, reviewing this rule brought back many memories. These memories combined with information gained from a recently completed Food Defense/ Crisis Management workshop presented by Rod Wheeler really set my brain into motion.2

Years ago, industry focused on crisis management and product recall. Requirements included having a crisis management team that was led by associates representing both upper and middle management. In addition, most programs included the following:

  • Posted identification of the crisis management team (i.e., pictures, phone numbers, etc.)
  • Specific training for receptionist and guards
  • Mock crisis exercises (i.e., fire drills)
  • Planned crisis calls to the operation’s direct incoming phone numbers (i.e., receptionist and guards)
  • Mock recalls (from supplier through finished product and distribution)
  • Security inspections which may now be considered the pre-cursor to today’s “Vulnerability Assessment”

With the introduction of the GFSI approved schemes (FSSC 22000, BRC, SQF, GlobalG.A.P., Primus, etc.), requirements for crisis management, emergency preparedness, security programs, food defense training and continuity planning gained an increase focus. Do any or all of these programs meet the requirement for a “vulnerability assessment”?

In the 2013 publication, Food Safety Management Programs, this subject-matter chapter was titled “Security, Food Defense, Biovigilance, and Bioterrorism (chapter 14)”.3 An organization must identify the focus/requirements that are necessary for its operation. This decision may relate to many different parameters, including the organization’s size, design, location, food sectors represented, basic GMPs, contractor and visitor communication/access, traceability, receiving, and any other PRP programs related to ensuring the safety of your product and your facility. Requirements must be defined and associates educated to ensure that everyone has a strong and effective understanding of the requirements and what to do if a situation or event happens.

Confirming the security of a facility has always been a critical operational requirement. Many audits have been performed that included the following management statement: “Yes, of course, all the doors are locked. Security is achieved through key cards or limited distribution of door keys, thus no unwanted intruder can access our building.” This statement reminds me of a preliminary assessment that I did not too long after the shootings at a Pennsylvania manufacturer in September of 2010. The organization’s representor and myself were walking the external parameter of a food manufacturer at approximately 7:30 PM (still daylight). We found two doors (one in shipping and one accessing the main office), with the inside door latch taped so that the doors were not secure. The tape was not readily evident. The doorknob itself was locked, but a simple pull on knob opened the door. Our investigation found that a shipping office associate was waiting for his significant other to bring his dinner and was afraid that he would not be at his desk when she arrived. An office associate admitted that that door had been fixed to pull open without requiring a key several months earlier because associates frequently forgot their keys and could not gain access to start work.

Debby Newslow Debby Newslow will present ” Sanitary Transportation for Human & Animal Food – Meeting the new FDA Requirements” at the Food Safety Supply Chain Conference  | June 5–6, 2017 | Attend in Rockville, MD or via webcast | LEARN MORE

We also observed a large overhead door adjacent to the boiler room along the street side of the facility open, allowing direct access to the processing area by passing through the boiler room and then the maintenance shop. It was stated that the door had been opened earlier in the day waiting for the delivery of new equipment. No one at the time knew the status of the shipment or why the door was still open.

Finding open access to facilities is becoming more and more common. A formal vulnerability assessment is not necessary to identify unsecured doors (24/7) in our facilities. Education and due diligence are excellent tools for this purpose.

Another frequently identified weakness is with organization’s visitor and contractor sign-in prerequisite programs. What type of “vulnerability” are we creating for ourselves (false confidence) with these programs? Frequently these programs provide more questions than answers:

  • Does everyone really sign in?
  • What does signing the visitor log mean?
  • Are visitors required to show identification?
  • Are the IDs actually reviewed and if so, what does this review include?
  • Who is monitoring visitors and contractors and are they trained?
  • Do all contractors have to sign the log or are they allowed to access the building at different locations?
  • Do those contractors who make frequent or regular trips have their own badges and/or keys (keycards) so they don’t have to take the time to sign-in (i.e., pest control, uniform supplier vending services)?
  • How are contractor badges controlled?
  • Are visitors required to be accompanied during the visit or does it depend on the visitor and whom they are visiting?
  • Are visitors and contractors trained in company requirements?
  • Do visitors and contractors have an identifying item to alert your associates of their status (i.e., visitor badge, visitor name badge, specifically colored bump cap, colored smock, etc.)?
  • How are truck drivers monitored? Do they have a secured room for them or do they have complete access to the facility to access the restrooms and breakroom?
  • How are terminated associates or associates that have voluntarily left the company controlled?
    • Can these associates continue to access the facility with keys, access cards, or just through other associates (i.e., friends or associates that did not know that they were no longer an employee)?
  • How many more questions can there be?

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Food Fraud

Using Data to Prevent Food Fraud

By Maria Fontanazza
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Food Fraud

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates for some businesses began in September 2016.  Economically Motivated Adulteration (EMA) or food fraud is a component in the Preventive Controls Rule.  As the global supply chain becomes more complex, preventing EMA and compliance to Preventive Controls for Human Food rule can be a challenging task.

A food company’s supply chain can be the weakest link in their food safety program. Learn strategies and how to mitigate risks at the Food Safety Supply Chain Conference | June 4–5, 2017 | Rockville, MD, LEARN MORELast year GMA and Battelle released EMAlert, a tool that enables quantitative evaluation of a company’s supply chain to economically motivated adulteration. USP also provides a platform to help companies with food fraud mitigation strategies. In a Q&A with Food Safety Tech, experts from the USP Food Program, Jeff Moore, Ph.D., science director and Karen Everstine, Ph.D., scientific liaison explain how the Food Fraud Database 2.0 works and how it can help companies with FSMA compliance.

Food Safety Tech:  How does the Food Fraud Database 2.0 assist food companies in identifying hazards and vulnerabilities?

Jeff Moore, Ph.D.: We reengineered the database [previously Food Fraud Database 1.0] from the ground up, including the structure of the data. Users wanted not just a source of high quality data to inform of risks and vulnerabilities that were related to food fraud but also some ability to analyze the information and get alerts and real-time information to figure out what to do in real time.

Karen Everstine, USP Food Program
Karen Everstine, Ph.D., USP Food Program

Karen Everstine, Ph.D.: Since it was reengineered, we’ve been able to include a lot of fields that allow food companies to tailor their results to information that is most applicable to them (i.e., geographic location). Automated analytics give a visual of what’s happening to see trends more quickly.

Moore: We have a team of dedicated analysts that are constantly scouting the public domain and looking for information globally to add to the database to make sure it’s the most comprehensive, up-to-date global database of food fraud information.

FST: What tools within FFD 2.0 can help companies with FSMA compliance?

Everstine: One of the things in the FSMA PC rule is the fact that food companies now have to identify potential hazards, whether they are intentional or unintentional, which includes food fraud-related hazards. One of the tools we built into the database is an EMA (Economically-Motivated Adulteration) hazard identification report. It allows users to input a list of their ingredients (those sourced and brought into the facility to create a finished food product), and then the report output identifies which ingredients are associated with potential hazards (i.e., adulterants that might pose a health threat to consumers). That’s the main tool we’ve built to target FSMA compliance.

Moore: One of the key parts of the PC rule as related to EMA is a question of whether the ingredient has a history of association with potentially hazardous adulterants. We put together an expert panel at USP and Karen [Everstine] was responsible for working with the panel to develop a classification system to identify adulterants that are potentially hazardous.

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John Ryan, Ryan Systems, Inc.
FST Soapbox

Substituted Ingredients Are Only the Tip of the Iceberg

By John M. Ryan, Ph.D.
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John Ryan, Ryan Systems, Inc.

While the United States has no legal definition of food fraud, current thinking tends to be focused primarily on companies and products involved in the illegal substitution of one ingredient for another in a product. Such substitution generally involves substituting a cheap filler in the place of the labeled ingredient. In recent news, Parmesan and Romano cheeses have captured news headlines because of illegal “misbranding” of foods meaning that the label on shredded cheeses from companies like the Castle Cheese, Inc. company in Slippery Rock, PA include ingredients found through FDA testing that are included in percentages beyond allowable levels. In the case of shredded cheeses, so called “imitation” cheese better is known as wood pulp. The labels stated that the ingredients were 100% cheese.

Perhaps Slippery Rock is an apt name for the Castle Cheese operation where the inclusion of wood pulp was cheaper than the inclusion of real parmesan cheese. Such activities are becoming increasingly known as “economically motivated” and the practice is one of economically motivated adulteration. The FSMA final rule, Focused Mitigation Strategies to Protect Food Against Intentional Adulteration, will make these practices illegal.

Such intentional cheating has a long record in the history of food. No one really knows the extent of such food fraud activities, when they started (perhaps at the beginning of time?), or who could claim to be the first person to win an international award for creativity.

There are so many ways to commit food fraud that it boggles the mind and creates an almost complete inability on the part of governments, testing laboratories, food processors, retailers and the public to identify, let alone fully prevent and capture the guilty every single time.

Think about a few things. Is it fraudulent to leave the identification of GMO ingredients off of labels? If a packer knowingly packs a product in dirty packaging, is that practice fraudulent? If the food safety part of the government knows how high the levels of fecal coliform are on most of the produce we eat but does not acknowledge the problems or inform the public, is this practice fraudulent? How about the idea that a retail outlet replaces an “expired” label on hamburger with a new unexpired label? Or how about the time Sysco was shipping perishable foods in refrigerated trucks and storing eggs, milk, meat, chicken and other products in the same storage sheds where you might keep leftover junk from your garage? Do “Good Things Come From Sysco”?

But none of those examples have anything to do with intentionally substituting a cheaper ingredient for an ingredient on the label. Honey, olive oil, coffee, juices, fish, alcohol, milk and dairy products, fish, vitamins, meat, spices, organic foods, maple syrup, peanut product, flavorings, preserves, cereals, colorings, wines, vinegar, purees, sweeteners ,and other ingredients are involved. And food fraud occurs in manufacturing, processing, packing and food holding operations. Such large opportunities for all foods in all operations means the entire food chain is—at one time or another, in one place or another—suspect.

Ryan_foodfraud_packaging

The Grocery Manufacturers Association (GMA) estimates that food fraud may cost the global food industry between $10 billion and $15 billion annually with lost sales between 2% and 15%. They estimate that approximately 10% of all commercial food products are impacted.

Considering the fact that the food industry claims their profit margins are only a few percent, it would seem that if they wanted to reduce food costs, food fraud would surely be a prime business improvement target. And GMA, unfortunately, is also focused on economically motivated adulteration such as unapproved additives, mislabeling, counterfeit ingredients, transshipment (shipping from one country to another to repackage and relabel in order to avoid taxes), and dilution.

When a consumer enters a supermarket in search of fresh meat, poultry or fish to cook for dinner, he or she knows little about how those products were packaged. Adding water to the pad that is often inserted under the meat to soak up blood, adds weight to the scale and money to the price. Packing the meat using carbon monoxide is common in order to “preserve” the product color. Red meat should look red, right? While the FDA considers this practice generally recognized as safe (GRAS), studies regarding how carbon monoxide interacts with the foam packaging and the clear plastic wrap covering the package are nonexistent. What makes the practice deceptive is the lack of information on the label that tells consumers carbon monoxide is used to preserve color. Of equal importance are recent studies that clearly show that many of the plastics used in today’s food packaging operations contain toxic chemicals shown to be dangerous to humans.

Interestingly enough, the European Union has a definition of food fraud:

‘Food fraud is a collective term used to encompass the deliberate and intentional substitution, addition, tampering, or misrepresentation of food, food ingredients, or food packaging; or false or misleading statements made about a product for economic gain’.

After the monster European horsemeat scandal (remember that one?) in which horse meat was substituted for beef to the embarrassment of many companies, such as Burger King and Ikea, the United Kingdom promised proactive solutions from food laboratories and improving supply chain audits in an effort to slow and diminish the number of incidents reported annually.

In the United States, we frequently point to the melamine (milk substitution) in baby formula or the pet food problems that came out of China as evidence that foreign companies are primarily to blame for food fraud. Coupled with governmental trade agreements and the attitude that other countries are dumping substandard product on American consumers, it seems easy to blame others for food fraud –except for the fact that we in America are dealing with so many incidents.

The problem with our inability to tackle food fraud in part comes from the gap between our ability to identify and develop appropriate and targeted food ingredient testing capabilities. So many types of food, so many types of tests, so many types of ingredients, and so many types of ways to intentionally or accidentally cheat the system all combine to confuse and confound our efforts to quickly and economically establish detection systems.

In most food distribution arenas, food traceability systems are slowly being agreed upon and implemented. However, the FDA does not seem to be able to help with establishing data and other standards that would help establish traceability requirements designed to quickly and accurately get to the source suppliers in food fraud events. Other industries under FDA medical device and drug laws have worked to establish solid chain of custody systems. Chain of custody implies that the suppliers and handlers are legally responsible and clearly identified. Leadership in this area is clearly needed.

While there are many good resources evolving both within and outside of the United States, those resources are scarce and relatively immature. It seems that without some basics, such as legal definitions, standardized testing practices, and an agreement that food fraud is much more than substitution of one ingredient for another, we have a very long way to go if we expect to get the food fraud system under control.

Specific Training Required Under FSMA: A Look at Each Rule

By James Cook
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All seven core rules of FSMA require general training of individuals or employees and qualified individuals requiring education, training or experience to perform specific tasks. By including training in these regulations, the FDA has made specific training mandatory.

Training Required by FSMA Final Rules

In the current Good Manufacturing Practices (cGMP) and preventive control rules, as per 21 CFR 117.4 and 507.4, all individuals engaged in the manufacturing, processing, packing and holding of food must have the education, training or experience to perform assigned duties and must be trained in the principles of food hygiene and food safety. However, the preventive controls qualified individual (PCQI) and qualified auditor, to rules 21 CFR 117.180 and 507.53, can be an individual who has successfully completed a class equivalent in curriculum to that recognized by the FDA, or have the necessary job experience. In both cases, the training must be documented, including the date of training, type of training and those personnel trained.

This means that all employees are to be trained in food hygiene and food safety to at least the standard presented in the regulations and more specifically as per the cGMP requirements. Additionally, individuals who are responsible for a specific critical control point will still need to be trained in HACCP. However, this will probably not be sufficient for an employee responsible for preventive control, as he or she may require training in Hazard Analysis Risk-Based Preventive Control (HARPC), or training specific to the area in which the employee is involved (e.g., allergens, sanitation, supply chain or recall programs, or preventive controls).

For the preventive control qualified individual and qualified auditor, the training needed may be that of the approved FDA curriculum, as developed by the Food Safety Preventive Control Alliance (FSPCA). Although this training course is not a regulatory requirement, FDA inspectors and other regulatory personnel who are auditing facilities will have completed this training, meaning qualified auditors will be expected to have this training, and eventually preventive controls qualified individuals (PCQIs) will be expected to do so too. The qualified auditor and a PCQI will still require the education, experience and other training to perform the specific job duties as listed in the regulations. Unfortunately, it is likely that neither the industry nor the government will have enough lead instructors ready to train everyone who would want or need to be trained before the compliance dates become effective. Additionally, this training course is not yet available for animal food, and the industry has been informed by FSPCA that a Foreign Supplier Verification Program (FSVP) training module will be added to the training course. The FSVP is discussed in the Supply-Chain Preventive Control module, and the fact that there are some similarities between these regulations helps individuals involved in the FSVP program, or in auditing it.

In the produce safety rule, training requirements are listed in subpart C 21 CFR 112.21, 112.22, 112.23 and 112.30. Personnel who require training are those handling covered produce and their supervisors. As with the cGMP and preventive control rules, the principles of food hygiene and food safety must be taught to these personnel. More specifically they must learn how to identify an ill or infected person, and be taught about microorganisms of public health significance, such as Salmonella, Listeria and E. coli O157 on food contact surfaces. Additionally, personnel who harvest covered produce must be trained in recognizing produce that is contaminated with known or reasonably foreseeable hazards to ensure it isn’t harvested. These personnel must be trained in the use of harvest containers and equipment to ensure that they are functioning properly, clean and maintained, and to identify when they are not. At the same time, employees must be trained in correcting any issues or in reporting them to a supervisor in order to have them corrected. All this training must be documented in the same way as the cGMP and preventive control programs.

Unlike the cGMP and preventive control rules, the produce safety rule’s requirement to have a qualified individual, supervisor or responsible party on each farm that has completed a recognized FDA course, or equivalent, is not optional. This course will be available through the Produce Safety Alliance and is anticipated to start in September 2016. The grower food safety course required for supervisors will include an introduction to produce safety, worker health and hygiene training, soil amendments, wildlife, domestic animals and land use, agricultural water, post-harvest handling and sanitation, as well as how to develop a food safety plan.

The training for produce, conducted by the Produce Safety Alliance and/or trained trainers, does not cover training for sprouts; training for sprouts is being developed by the Sprout Safety Alliance and will include topics specifically for sprouts, such as antimicrobial treatment of sprouting seeds.

In the FSVP, the qualified individuals must have the education, training or experience necessary to perform activities as per 21 CFR 1.503. These qualified individuals will develop the FSVP and those activities such as hazard analysis, supplier approval, determining verification activities and frequency, corrective actions and other activities for the FSVP. These personnel must be able to read and understand the records to be reviewed for this program. This means they must know English and may also need to know the local language at point of product manufacture or farming. 

At this time there is no structured training program for these individuals, but the FSPCA training program, alongside education and experience can provide the training necessary for these people to perform the job activities. A PCQI would be qualified for the role of a FSVP qualified individual, but the FSVP probably would not be qualified for the PCQI role. This is because the activities in the FSVP are not as complicated as those required by the cGMP and preventive controls rules, and therefore the FSVP qualifications would not need to be as stringent.

Training Under Proposed Rules

In the proposal for Sanitary Transportation of Human and Animal Foods, 21 CFR 1.910, the FDA requires carriers of these products to train personnel who are engaged in transportation operations. This should include awareness of potential food safety problems that may occur to food during transport, basic sanitary practices that would address those problems and the responsibilities of the carriers in the regulation. As with all training in these regulations, the type of training, who was trained and when they were trained must be documented.

Since this is a proposal, the training for teaching the carrier’s responsibility is not yet finalized but will require nothing more than explaining that section of the regulation. The training of potential food safety issues and the problems that might occur during transport are handled during standard cGMP and food safety training.

For the proposed Intentional Adulteration rule, per 21 CFR 121.160, the personnel and supervisors assigned to the actionable process steps must receive training in food defense awareness and their responsibilities in implementing the migration strategies. Also, as per 21 CFR 121.130, the vulnerability assessment is to be performed by a qualified individual, and this individual is to be qualified through experience and/or appropriate training.

For basic food defense, the FDA offers various courses and information, such as Food Defense 101, on their food defense webpage. An online course is offered in English and Spanish and covers the awareness training and the regulations for employees. Upon course completion, a certificate is provided. The agency also has a downloadable food defense plan builder that can be used to develop a food defense program. The agency also provides vulnerability assessment software, but additional training in PAS 96 or ISO/TS 22000 food defense would aid qualified personnel in making sure that this vulnerability assessment is correct and that the strategies to reduce risks are appropriate and not excessive.

There is an abundance of training courses and materials available from the FDA, USDA FSIS, associations and industry. FSMA employee training requires having personnel with the proscribed education and experience to perform specific tasks, and that they be trained as soon as possible in order for them to develop the programs. Additionally, all personnel should be trained at least annually in food hygiene, food safety and food defense.