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Beyond vulnerability assessments

How to verify a food defense plan

The USA FSMA Intentional Adulteration Rule deadline is fast approaching, with implementation required by 26th July.  Food defense plans are our most requested service this month, and not just for companies in the United States.  Businesses that export to the US are also affected.

The Intentional Adulteration (IA) rule

The Intentional Adulteration (IA) rule requires food businesses to identify vulnerable parts of their food manufacturing processes, implement strategies to reduce the vulnerabilities and monitor and verify that those strategies are working.  As part of the verification processes, some experts are recommending that food businesses challenge their food defense system on a regular basis.  Food safety management system standards, including SQF Edition 8, also require that manufacturing facilities challenge their food defense system.  What exactly does it mean to ‘challenge’ a food defense system, and how is that different to monitoring and verification of the system?

Monitoring vs verification vs challenge testing

Monitoring, verification and challenge testing are different, but the terminology can be confusing when used with food defense plans.  Some commentators and trainers are using the three words almost interchangeably; however, the three words actually refer to different elements of a food defense plan.

Monitoring means, at its most basic level, to check that procedures are being followed and that processes are happening as they should.  The checking process must be documented.  So, the act of monitoring is documenting in real time the actions taken to follow a given procedure or the measured outputs of a specific process.

Within a food safety plan, an example of monitoring would be checking the internal temperature of three pies from each batch after a cooling step and recording the temperature on a form.  Within a food defense system, a mitigation strategy might be the implementation of a procedure to lock all external doors, or to leave all external doors locked.  For this procedure, the monitoring activity could be a once-per-shift process of checking and recording the lock/unlock status of each door.

Verification is the process of making sure that monitoring has been done properly.  When cooling pies, for example, verification could include a once-per-shift check by a supervisor or manager that the cooled pie temperatures are being recorded AND that appropriate action has been taken if the temperature has exceeded critical limits.  Verification also includes internal audits; the internal auditor checks that the managers have been signing off the monitoring records, that the records are complete and available for all shifts and that corrective actions have been properly recorded.

In our food defense example, verification could include a check of the door lock monitoring records by a manager or supervisor.  The manager would review the records to see that they were completed on time, at the correct frequency and that any deviations, such as a broken lock, have been identified and actioned correctly.  Verification of door lock status could also be included in a weekly plant walk-through by a manager.  Internal audits would check that all these activities were being done and recorded properly.

Challenge testing is real-world scenario testing of a system’s efficacy.  A challenge test aims to validate whether procedures are effective when implemented as expected, as well as highlighting any failures in implementation.  A challenge test is different to a verification process because it would usually test the implementation and effectiveness of many food defense mitigation strategies rather than focussing on one element such as door locks.

What is the weakest link in your food defense plan?

 

How to conduct a food defense challenge

  1. Decide on a challenge action. For example, a common food defense challenge test is a penetration test, in which an unauthorised person attempts to gain access to a sensitive area.
  2. Create a food defense challenge report. In the report document exactly what you plan to do in the challenge test.  Include what, when, how, who and next steps.

For example: A person unknown to staff (Ms Jane Doe, of Acme Services) will attempt to get from the main reception area into ingredient weighing area A.  She will be wearing a business suit covered by a lab coat.  Once there, she will remain for up to twenty minutes unless challenged by an employee.  She will then leave.

If the intruder is challenged, she will claim to be a new food safety consultant/pest control account manager/new human resources manager and attempt to remain in the area.

  1. Include written contingency plans in case of escalation, for example, what will be done if police are called.
  2. Get approval for the plan from senior management.
  3. In the report record the following:
    • Name of Senior manager who has signed off on this plan.
    • Names of people who have been informed of the challenge test
    • Names of people who will be working in the affected areas at the time of the challenge, have they been trained in food defense?
    • A description of what staff are supposed to do in this scenario; what procedures should be followed.
  4. Define and document the criteria for failure and success; what will happen if the food defense procedures are working 100% correctly; what will happen if the food defense procedures are working only partially; and finally, how might the scenario progress if there is a complete fail of procedures and systems?

For example, if the ‘intruder’ is able to remain in the ingredient weighing area for 20 minutes without being challenged by an employee this could be considered a complete fail of the food defense system.  If the intruder is challenged but can convince the employee to allow them to remain in the area unattended, this could be considered a partial fail; if the employee chooses to remain with the intruder to ‘keep an eye on them’ this could be considered a better outcome than leaving the intruder unattended.

  1. Run the challenge. Have a trusted staff member observe from a discreet distance.
  2. Describe in the report what happened.
  3. Convene a meeting of the food defense team and analyse the results of the challenge test.
  4. Perform root cause analyses and raise corrective action/s for any failures in the system.
  5. Close out corrective action/s
  6. Take action to prevent a scenario like this from reoccurring, based on the root cause analyses.

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Raw Material Specifications

Raw material specifications are an important defence against food fraud for all food businesses.  Whether you are a restaurant, a specialty grocer, delicatessen, central kitchen, hotel or manufacturer, you are susceptible to food fraud.  Robust specifications can help to protect your food business from inadvertently purchasing, using or serving fraudulent ingredients and raw materials.  They can also help to protect your business from the financial fall-out if things go wrong.

Fraudulent materials include:

Modern Dairy food-processing industry Worker On A Milk Factory

Specifications for raw materials and ingredients should contain the following information:

  1. Name of the material
  2. A description of the material, including biological, chemical and physical characteristics
  3. Composition of the material, including additives and processing aids
  4. Country of origin
  5. Method of production
  6. Packaging format/s or unit of measure
  7. Delivery method/s
  8. A description of the labelling, lot ID and coding for traceability
  9. Storage conditions and shelf life
  10. Preparation and/or handling before use
  11. Acceptance and rejection criteria
  12. Requirements for certificates of analysis for high risk materials or vulnerable materials
  13. Special requirements such as allergen information, organic status, GMO status, fair-trade and ethical sourcing policies
  14. Information about compliance with statutory and regulatory requirements, where relevant
  15. A requirement for suppliers to notify of any authenticity issues with the product
  16. A requirement for suppliers to notify of any changes to the product
  17. Formal agreement between the supplier and purchaser
  18. Document control features, such as author, date and page numbers.

Download our excellent template today

How to develop a raw material specification:

  • Create a template that suits the needs of your business.  A tabular format is easy to work with.  Include all of the sections above, even if you don’t think you will use them now, or if they are not relevant to some of your materials.  You can always leave them blank.
  • You should create a separate specification for every unique material, do not create category-level specifications.
  • Obtain product specifications from your suppliers and use them to add key criteria to your specifications.
  • Add any extra criteria that will help you to control the quality, safety and authenticity of your products.  It is useful to imagine that you are receiving the material at your door or loading dock; what would you like to know about the material before you accept it? For example: Is it at the correct temperature?  Is it properly labelled?  Is the packaging undamaged with no evidence of tampering?  Is the material free of undeclared allergens?  Does it have the fat content you expect?  Has it been aged (meat) for as long as you expect?  Is it free from salmonella?  Use these questions to check that you have included all important criteria in your specification.
  • Don’t forget to include requirements for suppliers to have a food safety certificate, licence, approval or registration, where relevant.
  • If you are purchasing materials under fixed supplier contracts (as would be the case for  food manufacturers), the draft specifications will need to be approved by your purchasing department and by the suppliers themselves before they can be formally issued and implemented.
  • Review each specification at least annually and update the issue/review date.

Need help?

Contact Us Today

Our food safety and authenticity experts can develop your purchasing specifications. Click here for a free introductory consultation.

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Five things every food safety professional should know about food fraud

1. Food fraud is in the spotlight

Food fraud has been around for thousands of years but has become more prominent in the food safety and food certification industry in the last few years, following the European horse meat scandal of 2013.  Although no food safety problems arose during that incident, it was realised that similar incidences could have serious impacts on food safety.  For that reason, food fraud prevention requirements were introduced into all major food safety management system standards between 2017 and 2020.

2. New terminology

Definitions related to food fraud and food integrity have been refined in the last five years and there is now consensus on the four key terms below, although the term food security still causes confusion.

food fraud,defense,safety,security

  • Food safety relates to issues of unintentional contamination, with the aim of reducing exposure to naturally occurring hazards, errors and failures in food systems.
  • Food fraud was defined by  Spink and Moyer (2011) as “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.”  More recently that definition has been updated to capture all types of food crime: Food fraud is deception, using food, for economic gain (Food Fraud Initiative, Michigan State University).  Within food fraud there are types of fraud that involve tampering with the food by adulterating or diluting the food.  This type of fraud is sometimes called ‘economically motivated adulteration’ (EMA).  Other types of fraud that do not involve adulteration are also deemed to be ‘food fraud’.  These include black market and grey market sales, theft, illegal importing, avoidance of tax and counterfeiting.
  • Food defence is a term that has come to be defined as the effort to prevent acts of adulteration that are intended to cause harm to a food business or to consumers, such as acts of terrorism or attempted extortion.
  • Food security is unrelated to food fraud but is instead an issue of food supply and food access for populations who are under threat from food shortages.

Other terms to know:

  • Vulnerability assessments are assessments of vulnerability to food fraud, either at the raw material, product or facility level.  Within the USA the term vulnerability assessment can also refer to a food facility’s vulnerability to malicious tampering of product on its site, either by its own employees or external forces.   Learn more about vulnerability assessments.
  • Horizon scanning is the act of looking for and analysing threats and opportunities that will emerge in the medium to long term.  Within the food industry, horizon scanning means the act of collecting information about current trends and predicted incidences that could increase the likelihood of food fraud for a particular food material.  For example, climate change is likely to reduce coffee production which could drive up prices and increase fraudulent activity in that sector.
Coffee,authentic,fraud,horizon scanning
Coffee harvests are being affected by climate change

 

3. Food safety standards have become more rigorous

Food fraud prevention and mitigation measures are now a requirement of all major food safety management system standards.  The Global Food Safety Initiative (GFSI), a group of food companies whose mission is to harmonize, strengthen, and improve food safety management systems around the globe, sets guidance for food safety standards.  Well known GFSI standards include BRC, FSSC 22000 and SQF.  Between 2015 and 2017, all GFSI food safety standards were updated to include requirements for food companies to perform a food fraud vulnerability assessment and have a food fraud mitigation plan in place.   Click here for the GFSI Food Fraud Position Paper.

The new requirements for vulnerability assessments and mitigation plans require more resources for most food businesses, particularly those with large numbers of raw materials and suppliers.

4. There are new regulatory requirements for food businesses

The Food Safety Modernization Act (FSMA) in the USA has been implemented for most food businesses in the previous few years.  Within the FSMA rules, food businesses are required to address hazards from adulterants introduced for the purposes of economic gain.  These must be included in food safety hazard analyses and if hazards are found, preventive controls must be implemented.  This means that economically motivated adulteration (EMA), a subset of food fraud, must be addressed under the new FSMA rules.

The Food Safety Modernization Act (FSMA) also includes specific requirements for ‘food defense’ which are aimed at preventing malicious adulteration and tampering as well as fraudulent adulteration.  This is known as the Intentional Adulteration (IA) rule.  The IA rule is being progressively implemented in the USA.  FSMA rules for IA will also be enforced internationally for all food facilities that manufacture food for export to America.  Click here for US FDA’s food defense guidance

food defense,vulnerability assessment,FSMA,
All American food companies will be required to have a food defense plan

 

5.  Detection of food fraud remains a challenge, despite new lab techniques

Our ability to detect food fraud has improved over the last few years, but challenges remain.  There are many technologies available, from traditional ‘wet’ chemical tests to spectroscopy and chromatography to modern forensic DNA methods.   Protein isoelectrofocusing (a type of electrophoresis) is a conventional test that provides information about the source of various milk proteins in a cheese and can be used to detect cows milk in “buffalo milk” mozzarella, for example.  PCR (polymerase chain reaction) techniques, in which a cow milk-specific gene is amplified and detected are being developed for cheese testing and they are claimed to be more specific.

Coffee variety testing has traditionally been done using Fourier transform infrared spectroscopy, a method that exploits the different amounts of chlorogenic acid and caffeine in robusta and arabica varieties.  However, a new method that exploits the different mitochondrial genetic markers in the two varieties will soon be able to achieve the same results quickly and easily in the field with ‘lab on a chip’ technology.

Researchers looking for fraudulent aloe vera can exploit its distinctive NMR (nuclear magnetic resonance) profile, due to the position of acetate groups within a key polysaccharide in the plant.  The NMR profile represents a ‘fingerprint’ for aloe vera.

Another type of ‘fingerprinting’ is based on the spectra created by different ratios of stable isotopes.  For example, it is possible to tell the difference between corn-fed and wheat-fed chicken, using stable isotope ratio mass spectrometry by comparison with databases of reference samples.  This method has also been used to check provenance claims for meat and wine products.

Authentic beef mince
What meat is that?

 

Despite the surge in technology surrounding food fraud detection, it remains difficult to detect fraudulent adulteration unless you know what you are looking for.  As an example, DNA testing can be used to determine if beef mince has been made from a cow but can’t tell me whether it has been adulterated with undeclared beef offal.  Olive oil that is suspected of having been adulterated with other edible oil can easily be tested for such adulteration in a lab test, but verifying its country of origin is more difficult.  Adulteration of ‘arabica’ coffee with the cheaper robusta variety can be detected with a simple test but that same test will not disclose whether ground coffee has been adulterated with cheaper fillers such as corn, soybean or wheat, a practice which is common in some markets.  There are now a number of ‘fingerprinting’ techniques that are designed to ‘flag’ any sample that is not authentic, no matter what the adulterant, however they can only be used if there is already an extensive database of authentic samples with which to compare the suspect sample.  Australian honey brand owners who were caught with supposedly inauthentic honey in an NMR-based fingerprint test claimed that the database used in the testing, which was done in Germany, was not suitable for testing Australian honeys.  Read more about the Australian honey scandal.

We have a lot of tools in our arsenal to answer questions about fraudulent food but those tools are only useful if we ask the right questions.

Need to learn more?  Want practical advice from expert food scientists? Click here for a free introductory consultation.

 

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How to design a food fraud testing plan

Authenticity testing of ingredients and foods is an important tool in the fight against food fraud, but it’s not easy to get it right.  Here are our recommendations to help you design a food authenticity testing plan.

  1. First define the goals of the testing plan.  Because different materials have different food fraud risk profiles, you will need a different testing protocol for each material that you want to test.  For each material to be tested, choose a test type and laboratory and set accept-reject criteria for test results.  Use our testing checklist to help.
  2. Decide how samples will be collected, and define the sample size with the help of your chosen laboratory. For each lot or batch of material that needs to be tested, figure out how to obtain a sample that is properly representative of that batch. Sampling protocols will depend on the size of the lot, the form of the food (solid, liquid, bulk, etc.) and the practicalities of accessing materials within the batch.  Learn more about sampling protocols from the US FDA’s laboratory manual.
  3. Choose a frequency of testing for each material and document it in the plan.
  4. Write down your goals, test methods, accept/reject criteria, sampling procedures and approved laboratories.  This written information will be the foundation for your testing plan document. Add a description of what action you will take if you get results that confirm or imply authenticity problems with the sample. Who will you report the results to? Who is responsible for making decisions about actions to be taken?  Add document control features and file the plan within the food fraud section of your food safety management system.
  5. Implement your plan.  Be prepared to change your test frequencies or test methods as new information becomes available.  Review your test plan at least annually to make sure it aligns with your food fraud vulnerability assessment results.

Read this next: Food fraud testing frequency: how often should you test?

 

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Food testing checklist

Like many other food safety and quality professionals, perhaps you are thinking about implementing a testing program for food fraud detection.  Are there vulnerabilities in your supply chain? Maybe you are buying products or raw materials that are on our food fraud hot list, or perhaps your food fraud vulnerability assessments identified materials that might be affected by food fraud.

Food authenticity testing laboratory lab

Testing is an important tool in the fight against food fraud, but it’s not always easy to get it right. Are you prepared for testing? Before you begin to contact laboratories, make sure you can answer these questions:

  • Do you need a ‘snap-shot’ of a product at a single point in time or are you aiming to build a longer-term picture of authenticity?
  • Are you acting on any specific information, such as a tip-off or allegation from a competitor?
  • Is there a particular adulterant you need to look for?
  • Are you a brand owner checking possible counterfeits or diverted products to determine if they are legitimate?
  • Do you need the test results to stand up in a court of law or other legal scenario?
  • Is the test material a single agricultural product or a processed multi-component food?
  • Is the material shelf stable or will it need special sample storage/transport conditions between sampling and testing?
  • Is the testing needed to check on credence claims, for example, organic, free-range, country of origin?
  • Do you need qualitative or quantitative results? For example do you need to know if an adulterant is present or absent in the tested material or do you also need to know the amount of the adulterant that might be present?
  • What level of certainty do you require?
  • How much time have you got?
  • What’s your budget?

And finally…

  • Are you prepared for what you might find; do you have a plan of action to take if food fraud is detected?

There are many laboratories that perform some type of food authenticity testing, but few that perform many types. Expect to speak to a number of different laboratories before you find one that can meet your needs.

Read this next: How to design an authenticity testing program