Tag Archives: intentional adulteration

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.

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.