The food business is as competitive as ever. Food manufacturers are under tremendous pressure to formulate new products while meeting emerging regulatory requirements, reducing costs, and protecting their brands. Food manufacturing companies are increasing the attention paid to food fraud, which can greatly impact a brand if adulterated food ends up on customers’ plates. Food safety concerns stemming from food fraud are a risk to consumers in our globalized food system. Food companies are keenly aware of the consumer’s desire for safe, high-quality foods. The rise in consumer awareness drives companies to continually strengthen their food safety and quality programs.
Explore this issueAugust/September 2017
Food Fraud Yesterday and Today: Little (And A Lot) Has Changed
Food fraud issues are not new. Frederick Accum’s “A Treatise on Adulterations of Food and Culinary Poisons” from 1820 and Dr. Harvey W. Wiley’s Poison Squad of 1902 demonstrate the long-standing concern with adulterated foods and undeclared additives. What has changed is that the health risk due to food fraud (a.k.a. economically-motivated adulteration, or EMA) has become a widely-publicized issue with corresponding increases in regulatory and certification program requirements. What has also changed is the sophistication with which fraudsters adulterate food and the speed of evolution of analytical detection methods.
Food fraud is complex and includes the dilution or substitution of ingredients with an alternate ingredient (this could be an ingredient of lesser quality or even one that is not intended for use in food), the artificial enhancement of perceived quality (such as fraudulently increasing the apparent protein content and “improving” the color with undeclared color additives), the use of unapproved antibiotics and preservatives, misrepresentation of nutritional content, and fraudulent labeling claims (such as organic, cage-free, etc.).
New Requirements: Focus on FSMA and GFSI
Both the U.S. FDA and the Global Food Safety Initiative (GFSI) have recognized the threat of food fraud in the food supply. As a result, new FDA regulatory requirements and GFSI requirements have been established to ensure that food manufacturing and distribution facilities address food fraud vulnerabilities in their food safety and quality management systems.
The FDA’s focus is on EMA that can result in food safety issues, and it requires facilities to identify potential hazards (including those resulting from EMA) during their documented hazard analysis process. When raw materials with relevant potential hazards are identified, appropriate controls should be put in place. Given the nature of EMA, these will most likely be supply chain controls.
Facilities certified under GFSI programs such as British Retail Consortium (BRC), Food Safety System Certification (FSSC) 22000, and Safe Quality Food (SQF) must consider food fraud in terms of both food quality and safety. For companies that will be certified under SQF Edition 8 and FSSC 22000 Version 4—both of which will become effective in January 2018, food fraud vulnerability assessments and mitigation plans will be new requirements of those certification programs.
Risk Mitigation: Tools and Guidance
In contrast with unintended contamination with microbiological, viral, or other agents which may be present in animals or the food production environment, food fraud includes the added challenge of being both intentional and economically motivated. This makes risk assessment a more difficult task. Food fraud is generally addressed from the perspective of vulnerability—in other words, which ingredients in a portfolio may be more vulnerable to fraud due to various specific factors. These include things such as the strength of the supplier relationship, the audit strategy, the effectiveness of the analytical methods, and the known history of fraud for a given ingredient.
The U.S. Pharmacopeial Convention (USP) Food Fraud Mitigation Guidance (www.foodfraud.org) is a publicly-available framework that guides users through an evaluation of nine contributing factors to food fraud vulnerability. It also guides users through the process of considering potential impacts of food fraud, both economic- and health-related, and putting a mitigation plan in place to reduce vulnerabilities. Food fraud history is specifically cited as an important component of vulnerability assessments. USP has developed a tool, the Food Fraud Database, for quickly searching and identifying relevant historical records for food fraud along with published analytical detection methods. USP also publishes the Food Chemicals Codex that describes the form, function, and specifications for more than 1,200 food ingredients, along with analytical methods and corresponding reference materials that can be used to ensure their quality and purity and further establish the identity of food ingredients. Use of public standards can be an important component of a food fraud control plan in addition to being useful in an overall food quality control program.
Documenting Vulnerability Assessments and Control Strategies
There are three primary steps to effective food fraud prevention programs:
- Raw Material Vulnerability Assessment;
- Food Fraud Mitigation Plan; and
- Food Fraud Program Sustainment.
The first step in creating a food fraud prevention program is to conduct a vulnerability assessment of all raw materials or groups of raw materials. As part of this assessment, food producers must identify the source of their ingredients to determine whether they come from potentially high-risk geographic areas or suppliers. Other considerations include whether ingredients have a known history of adulteration and whether there are economic considerations that would increase the incentive for fraud. Raw materials can then be categorized as low, moderate, or high vulnerability.
The second step in creating a food fraud prevention program is developing a food fraud mitigation plan, which is required by GFSI-recognized certification program owners. Once the vulnerability assessment is complete, the food producer must determine what specific control measures are required. These will depend on the vulnerability level and may include laboratory testing, audits, and any additional measures determined by the facility. At a high level, the following are some general strategies for reducing food fraud vulnerability for sourced ingredients.
Understand your supply chain. This includes the geographic region where the raw material is sourced, the number of upstream suppliers, and what upstream controls are in place.
Know your suppliers and track their performance history. Effective supply chain management programs should include comprehensive supplier approval procedures and supplier evaluation processes. Supplier approval procedures must require potential vendors to submit all relevant information, such as product specifications and third-party audits. Once approved, the supplier evaluation procedures address supplier performance, including tracking of any non-conformities and ongoing evaluations of pricing, service, delivery, and third-party audits completed at least on an annual basis.
Determine necessary verification processes. This may include audit strategies and specification and testing requirements. Once accurate vulnerability levels have been assessed and determined, appropriate verification methods can be established in the written food fraud mitigation plan. These verification methods will likely differ among raw materials and suppliers based on the vulnerabilities. A trusted supplier of a low vulnerability ingredient may only be required to provide a third-party audit report. Moderate-risk raw materials may require a certificate of analysis (COA) in addition to the third-party audit. High-risk suppliers of high vulnerability ingredients may be required to perform periodic verification testing to validate the results of the COAs they provide.
The last step is to put in place a food fraud program sustainment system to ensure continued compliance and validation of food fraud management systems. These management systems must be kept up-to-date as companies develop products with new raw materials or source raw materials from different suppliers. Quarterly reviews are recommended, as well as an annual validation assessment to ensure the ongoing effectiveness of a company’s systems and to meet the annual review requirements of GFSI-recognized certification programs.
Training All Employees is the Best Line of Defense
Food fraud prevention must be an important aspect of every food safety and quality management system. All employees should be aware of the potential for food fraud and be empowered and encouraged to report any concerns of potential food fraud incidents. Food processors should provide relevant personnel with appropriate education related to recognizing and reducing food fraud risks.
This education may include Preventive Controls Qualified Individual training seminars for those responsible for conducting the FDA-required hazard analysis; specialized training for QA and receiving personnel responsible for verification of product specifications and COAs at time of receipt; and general awareness training for all employees.
Chilton, VP professional services at Alchemy Systems, has over 30 years of experience in the food industry, specializing in food safety, quality assurance, and plant management. Reach him at Jeff.email@example.com. Dr. Everstine, scientific liaison at USP, joined the organization in 2015 to advance the development of food fraud mitigation tools and resources, including serving as the technical lead for the re-design and expansion of USP’s Food Fraud Database.