When addressing EMA, the time to act is now. A concept I’ve heard those “in the know” say is “If not now, then when; if not us, then who.”[1] It is my perspective, as an academic, that FDA’s FDECS clearly is taking a leadership role in expanding the umbrella of food defense from counterterrorism to all intentional contamination. EMA of food and food ingredients—which includes intentional contamination, intentional adulteration and the broader concept of food fraud[2]—is a public health threat of concern for FDA. Overall, EMA covers all product regulated by FDA, and an FDA-wide work group has been in existence since just after the landmark FDA Open Meeting on EMA in May 2009. FDECS—as well as other components of FDA, the U.S. government (USG) and international partners—has been working on several projects and initiatives addressing EMA of food even before the passage of the Food Safety Modernization Act (FSMA). Actually, the focus began even before the 2011 U.S. Government Accountability Office report “Better Coordination Could Enhance Efforts to Address Economic Adulteration and Protect the Public Health.”[3] This article will review the FDECS EMA actions, direction and the support for industry.

A Federal Register Notice of a 2009 FDA Open Meeting defines EMA as:

The fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain. EMA includes dilution of products with increased quantities of an already-present substance (e.g., increasing inactive ingredients of a drug with a resulting reduction in strength of the finished product, or watering down of juice) to the extent that such dilution poses a known or possible health risk to consumers, as well as the addition or substitution of substances in order to mask dilution.[4]

The History of Food Defense
In the years since September 11, 2001, FDA’s FDECS has sought ways to develop, create and make available tools and resources for industry to help decrease the likelihood of intentional contamination of FDA-regulated products within their control. After 9/11, the initial focus was on national security-related critical infrastructure protection. The early food defense actions for USG agencies were directed by Homeland Security Presidential Directives (HSPDs) 7 and 9 to focus on counterterrorism.[5, 6] These directives addressed critical infrastructure identification, prioritization and protection and defense of U.S. agriculture and food. The FDA food defense focus has broadened to all types of intentional contamination, including EMA.

EMA incidents are not new. Most of the early food laws focused on adulterants used fraudulently for economic gain.[7] The U.S. Pure Food and Drug Act of 1906 was reportedly intended to address “fraud jokers.”[8] Congress passed the 1938 U.S. Food, Drug & Cosmetics Act (FD&C Act) around the time of a deadly food adulteration with diethylene glycol.[9] While the type of fraud and the adulterants used have changed as perpetrators have learned ways to cheat the system, some of the same threats often persist. Unfortunately, diethylene glycol is still a problem and recently was identified as an adulterant in toothpaste seized in the U.S.

The fraudster’s goal in an EMA incident is economic gain. The perpetrators are stealthy and actively seek to avoid detection.[10] Once the legal system has evaluated an incident and due course has been followed, the food is determined to be illegal since it is “adulterated food” as defined by the FD&C Act.[11] While the incident may be economically motivated, the public’s health is always at risk.[12] Beyond the actual public health threat, EMA incidents are a major concern for undermining consumer confidence in a particular food company if not the entire food system. While the vast majority of these incidents don’t create a public health threat, there is sometimes a lack of clarity on how the product was handled, which itself is a vulnerability. And some of these incidents have a very broad impact, potentially exposing public health to considerable risk.

Many other types of fraud may even go unnoticed, such as diluted product, country-of-origin labeling fraud or genuine but stolen goods reintroduced to the supply chain. Some well-known recent examples include melamine in infant formula, species substitution in fish and horsemeat in beef products. Although the regulatory and enforcement focus is on the broad array of possible food-related EMA incidents, the opportunity for fraud covers all FDA-regulated product categories.

EMA Activities and Initiatives across FDA
EMA is not limited just to food risks. The term covers all FDA products, including dietary supplements, drugs, medical devices, radiological products, animal and veterinary products, cosmetics and others. Shortly after the 2009 Open Meeting on EMA, FDA created a Workgroup on Economically Motivated Adulteration (WEMA). Neil Stiber, WEMA chair, stated at the 2012 Food Safety Summit that, “The WEMA goal is not to just identify vulnerabilities but to help provide safe food.”

WEMA facilitates and encourages the sharing of EMA information across FDA. This communication is important because the commodities that FDA regulates share common ingredients and supply chains. Hence, an EMA threat to one product group should be recognized as a risk to others. Furthermore, Stiber stated, “For example, because protein substitutes are a concern for multiple product types, the WEMA has shared information about methods and approaches to test for protein substitutes. Additionally, because glycerin is used across all FDA commodities, the WEMA helped to develop a ‘FDA Notification to Industry’ to raise awareness about a potential threat to the glycerin supply chain.”[13]

EMA and FSMA
Continuing regulatory attention to food fraud, FSMA addresses EMA prominently. FSMA includes 11 mentions of “intentional adulteration,” which includes EMA incidents. Beyond just mentioning EMA, there is a proactive emphasis in FSMA that includes over 70 mentions of “prevent” or “prevention.” This focus is aligned with FDECS activities that focus on protecting the food supply from intentional contamination. As FDA’s Jason Bashura stated in his August/September 2013 Food Safety Magazine article, “A food defense plan will help businesses maintain a safe working environment for their employees, provide a quality product to their customers and protect their bottom line.”[14] This applies to EMA as well, because any food protection countermeasures reduce the vulnerability of the system to any type of attack.

That article also mentioned several concepts specifically related to EMA. While the creation of food defense plans is currently voluntary, FDA food defense activities can help industry begin building prevention programs. This is where the “culture of food defense” is being built—from the foundational elements of planning and preparedness to aid in prevention. These activities are supported by outreach and engagement with a broad range of stakeholders across the farm-to-fork spectrum, including academia, industry, nongovernment organizations and other federal agencies.

Industry and International Interests
At the 2013 Institute of Food Technologists (IFT) conference, Joe Scimeca (a food safety vice president at Cargill), speaking for the Grocery Manufacturer Association (GMA) Workgroup on Economic Adulteration, stated that “intentional adulteration is a game changer” due to the nontraditional threats that have been negatively impacting the industry. At the Global Food Safety annual meeting held in March, Vice Chair Frank Yiannas (the vice president of food safety at Walmart) identified food fraud/EMA as one of the top five “critical areas that GFSI [the Global Food Safety Initiative] should focus on over the next 3 years” and also one of the top five “food safety issues within your business.” Also at the conference, board member Hugo Byrnes (the vice president of product integrity at Royal Ahold, a retailer in The Netherlands) stated that food fraud was one of six top challenges for GFSI. EMA definitely is a focus and concern for industry—both domestically and globally.
 
FDA Food Defense Outreach and Activities
FDA’s FDECS has broad outreach and support activities that support public health and industry needs. Some of these activities include internally developing products such as the new Food Defense Plan Builder Tool, supporting nationwide FSMA outreach meetings, collaborating on articles and publications, providing domestic outreach to train/educate industry stakeholders on the use of the Food Defense Plan Builder Tool and funding projects and developing/refining easy-to-use tools such as the online Food Defense 101 training and the Food-Related Emergency Exercise Bundle (FREE-B).

A wide range of partners is collaborating with FDA on EMA activities, including industry, trade organizations and academia. Their activities span FDA and the USG, and encompass engaging with academia, outreach to industry through trade shows and conferences and service provider participation in a wide range of projects.

Highlights include the following:

Interactions across FDA: The agency’s internal engagement on EMA began even before the first public meeting on the issue. The Center for Food Safety and Nutrition (CFSAN) has been collaborating with the Office of Regulatory Affairs, Center for Veterinary Medicine and others.

WEMA: This internal group has monthly meetings, comprising staff from all FDA product centers, the Office of Regulatory Affairs and the Office of the Commissioner. WEMA includes risk managers, economists, regulatory counsel, policy analysts and scientists. This is a multidisciplinary, collaborative approach to capitalize on commonalities between FDA’s product centers.

FDA WEMA in Action:
FDA Notification to Industry: Products using oils, glycerin or protein that were derived from the Jatropha plant may have toxic effects (July 6, 2012)

Communication Portal: Established an email address to solicit relevant information from suppliers and manufacturers about the glycerin supply chain or other suspected adulteration, using IntentionalAdulteration@fda.hhs.gov

International Outreach Engagements:
•    FDA-China FDA (CFDA) Bilateral Workgroup on EMA: Jan. 2013

•    FDA-CFDA Annual Bilateral Meeting: April 2013

•    India — Food Safety and Standards Authority of India (FSSAI): Published a two-part booklet, Quick Test for Some Adulterants in Food

•    The Seafood Authenticity Project: Led by CFSAN and co-led by the Office of Regulatory Affairs Division of Field Science. Key external collaborators were the Smithsonian Institution and the Canadian Center of DNA Barcoding. The main issues were “misbranding” within the meaning of Section 403 [21 U.S.C. 343(b)] of the FD&C Act, which pertains to food “offered for sale under the name of another food,” and “adulteration” within the meaning of Section 402 [21 U.S.C. 342(b)] of the FD&C Act, for food that “has been substituted wholly or in part.” The study focused on identifying those main issues, what occurs, why it occurs and what are the implications. Some of the implications were food safety incidents and economic adulteration. The project then published a method in January 2011, conducted a proficiency test in October 2011 and posted the Standard Operating Procedures on the FDA website in February 2012. In March 2012, FDA issued the first field sampling assignment, published as “Species Substitution in Wholesale Seafood.”

There are other FDA and USG activities that provide insight into the market and import-related factors that contribute to EMA prevention. These include the Operational and Administrative System for Import Support (OASIS) program, which is an automated FDA system for processing and making admissibility determinations for shipments of foreign origin, FDA-regulated products seeking to enter domestic commerce. Another is the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) program, which assists entry reviewers in targeting higher-risk shipments for examination. The FDA Food Defense Targeting Center also coordinates a broad range of activities that focus on protecting the food supply. A current activity mentioned above is the Food Defense Plan Builder Tool, which is designed to assist operators of food facilities with food defense plan development.

There are also activities that span the USG, including collaboration between FDA and the Food Safety Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA). For example, the President’s Food Safety Working Group (FSWG) was created in March 2009. It is chaired by the secretary of Health and Human Services and the secretary of agriculture. The three core principles of the FSWG are prioritizing prevention, strengthening surveillance and enforcement and improving response and recovery. The FSWG Group Task 42 addresses EMA and is led by USDA/FSIS, together with FDA and the Department of Homeland Security (DHS).

Other collaborations include the food defense national security-related activity, created under HSPD 7, which established critical infrastructure sector partnerships. The Food and Agriculture Sector Coordinating Council is the principal entity for industry coordinating with the government on a wide range of critical infrastructure protection activities and issues. A Sector Coordinating Council (SCC) is comprised of industry representatives and companies. A Government Coordinating Council is formed as the government counterpart for each SCC to enable interagency and cross-jurisdictional coordination. Since food products cross the borders into the U.S., the DHS U.S. Customs and Border Protection is a key partner in most of these activities. Other agencies such as the Federal Bureau of Investigation are also often key partners in many activities.

FDA food defense activities also extend to academia. The National Center for Food Protection and Defense (NCFPD) was created at the University of Minnesota by an original DHS grant to focus on food-related national security issues and has broadened to food defense, including EMA. Michigan State University (MSU) has created a Food Fraud Initiative that has received funding through the NCFPD and has just finished work on an FDA Innovative Food Defense Program Grant, in partnership with the Michigan Department of Agriculture. New Mexico State University has the Center for Animal Health, Food Safety and Bio-Security, which has been working across FDA beyond food products. NCFPD Director Dr. Amy Kircher stated, “EMA is a considerable public health threat and a significant economic issue that requires our research attention. It is imperative to find solutions to mitigate the consequences of EMA to minimize animal and human health concerns.”

A key activity for FDA is conducting outreach and education. An efficient venue for this is trade shows, conferences and the committees of professional associations. FDECS has been invited to and has presented at a range of events, including the Food Safety Summit, the IFT annual meeting, meetings and committees for GMA, Association of Food and Drug Officials events and activities with the International Association for Food Protection. Another unique type of program supported by FDA is a partnership with the National Environmental Health Association (NEHA), which leads an Industry–Foodborne Illness Investigation Training and Recall Response (I-FIIT-RR) program.[15] The workshops are hosted by NEHA with FDA funding. Programs like this assemble a wide range of stakeholders for an introduction to and discussion of EMA concepts. Recent improvements to the I-FIIT program have included integration with the “Wilted Woes”[16] FREE-B exercise, and continued collaborations are underway to further refine and improve the existing scenario to focus the objectives and streamline the question sets contained within the scenario. The secondary use of the FREE-B tool shows its adaptability, but, moreover, an important step in how the tool is helping, through a nongovernment organization (NEHA), to assist industry in developing a food defense culture.

Other EMA-related activities include coordinating activities across the FDA food groups. Other important related FDA publications include FDA’s International Food Safety Capacity-Building Plan, February 2013[17] and FDA’s Global Pathways to Food Safety and Quality, January 2011.[18]

There are many examples of how FDA food defense activities have led to a greater understanding of the topic and the development of novel products. The FREE-B workshop grants are especially impactful with a wide range of recipients.[19]

EMA FREE-B Grant Development
The FREE-B program has spurred numerous new projects and has assisted in developing new food defense resources and products. For example, the 2013 Innovative Food Defense Program awarded a project to the Michigan Department of Agriculture and Rural Development and the Food Fraud Initiative at MSU. This project created an EMA-themed tabletop exercise that will be publicly available at www.fda.gov/fooddefense.

Jason Bashura, FDA’s project officer for the FREE-B program, stated on a recent conference call, “In general, the FREE-B program has been a very efficient and effective way for FDA to engage leading researchers and provide tools for our stakeholders. We’ve truly been able to help to ‘connect the dots’ in food emergency response planning and preparedness.”

The pilot EMA tabletop exercise was conducted in June and featured over 70 attendees from a range of organizations such as industry, regulatory agencies, academia, trade organizations and consumer groups. The insight from the pilot was incorporated into the final FREE-B content. Brad Deacon, the principle investigator and a Michigan Department of Agriculture official, stated, “The tabletop exercise was a great way to bring together our key stakeholders. The director of our agency led the program and demonstrated the importance of food fraud prevention.”

This project met the goals of addressing the traditional counterterrorism and emerging intentional contamination objectives. By identifying and reducing the vulnerabilities inherent in economically motivated incidents, the fraud opportunity is reduced, and so is the opportunity to penetrate the legitimate supply chain for a terrorist act.

I believe that through the Innovative Food Defense Program award, and being able to help bolster the FREE-B program with an EMA scenario, we can make an impact in raising awareness and help to identify prevention countermeasures. Having this content posted free on the FDA website lets us reach a very broad audience. Co-principal investigator Doug Moyer, a researcher for MSU’s Food Fraud Initiative and the lead instructor for MSU’s Counterfeit Medicines graduate course, stated, “It’s important to note that this exercise improved the protection of the food supply chain but did not give the bad guys a road map of how to attack. We took a holistic and all-encompassing approach to reduce the fraud opportunity.”

MSU is working to expand the impact of this FREE-B project by connecting with current and future exercise participants and facilitators. MSU has created content and a way for experts and interested parties to continue to network (visit www.FoodFraud.msu.edu to engage). Brad Deacon commented that “participating in this exercise, with so many stakeholders from across industry and agencies, led us to identify important focus areas for the state of Michigan.”

Call to Action
All of FDA—food, drugs and other products—is evolving to a global perspective and a focus on prevention. The process has been spurred on by FSMA and is still a work in progress. Industry, consumer and international stakeholders have been encouraged to communicate their thoughts and suggestions to FDA through many venues. Comments or presentations can be made at open meetings and to the Federal Register through official requests for comments, and FDA solicits direct feedback from interested parties.

FDA’s FDECS supports the protection of the food supply and provides food defense tools and resources for industry to utilize in support of development of a culture of food defense. Through all of these efforts, FDA continues to protect, preserve and promote the public’s health and well-being. This article provided an overview of the history of EMA defense, food system vulnerabilities, ongoing FDA food defense-related activities and other products and services that can not only help with compliance but also can meet the broader FDA mission of prevention. 

John Spink, Ph.D., is the director of the Food Fraud Initiative, an assistant professor within the College of Veterinary Medicine at MSU and a principle investigator on the FDA FREE-B tabletop exercise for EMA/food fraud.

References
1. www.FoodFraud.msu.edu.
2. Spink, J. and D.C. Moyer. 2011. Defining the Public Health Threat of Food Fraud. J Food Sci 76(9):R157–162.
3. www.gao.gov/products/GAO-12-46.
4. FDA. 2009. Economically motivated adulteration; Public meeting; Request for comment, Docket No. FDA-2009-N-0166. Federal Register 15497.
5. U.S. Department of Homeland Security. 2003. Homeland Security Presidential Directive 7: Critical infrastructure identification, prioritization and protection.
6. U.S. Department of Homeland Security. 2004. Homeland Security Presidential Directive 9: Defense of United States agriculture and food.
7. Fortin, N.D. 2009. Food regulation: Law, science, policy and practice. Hoboken, NJ: Wiley.
8. Tousley, R.D. 1941. The Federal Food, Drug and Cosmetic Act of 1938. J Market 5(3):259–269.
9. World Health Organization. 2006. The safety of medicines in public health programmes: Pharmacovigilance, an essential tool. WHO Library Cataloguing-in-Publication Data. World Health Organization.
10. Spink, J. 2011. The challenge of intellectual property enforcement for agriculture technology transfers, additives, raw materials and finished goods against product fraud and counterfeiters. J Intellectual Prop Rights 16(2):183–193.
11. 21 U.S.C. 321. 2004. The Federal Food, Drug, and Cosmetic Act, Chapter II—Definitions. Food and Drug Administration.
12. Spink, J. and D.C. Moyer. 2013. Understanding and combating food fraud. Food Technol 67(1):6.
13. www.fda.gov/downloads/ForIndustry/GuidanceDocuments/UCM310867.pdf.
14. Bashura, J.P. 2013. The expanding umbrella of food defense. Food Safety Magazine 19(4):70–77.
15. www.neha.org/ifiit/index.html.
16. www.fda.gov/Food/FoodDefense/ToolsEducationalMaterials/ucm295902.htm.
17. www.fda.gov/downloads/Food/GuidanceRegulation/UCM341440.pdf%E2%80%8E.
18. www.fda.gov/downloads/AboutFDA/CentersOffices/OC/GlobalProductPathway/UCM259845.pdf.
19. www.ift.org/knowledge-center/read-ift-publications/science-reports/contract-reports/
freeb-workshops.aspx.