As we enter the new year, we were asked by Food Safety Magazine to address the top food safety challenges facing the industry. We believe that the one overriding food industry concern is how to best manage food safety across the global supply chain while ensuring regulatory compliance.

This article is meant to provide the reader with background information as well as action steps that can be taken to mitigate the inherent risks of a global food supply chain.

Why Is This Our Major Concern?
It is no secret that there have been significant media exposure, public health impact and decrease in consumer confidence in recent years due to some significant food safety incidents. This has increased focus on food safety by consumers, the industry, lawmakers and regulatory agencies.

The increased awareness of some of these large-scale foodborne illness and contamination events has resulted from the following:

• Advances and improvements in public health signal detection (PulseNet)[1]

• New regulatory reporting requirements of contaminated food products in commerce (The Reportable Food Registry)[2]

• Improved communication streams and interconnectivity between regulatory agencies domestically and internationally

PulseNet is a system whereby state public health laboratories analyze strains of certain pathogenic bacteria from ill individuals and determine their genetic fingerprint. This is then shared nationally with the Centers for Disease Control and Prevention (CDC), allowing CDC to “connect the dots” when the same genetic fingerprint of an organism is isolated from clinical specimens from geographically dispersed regions.

Then an investigation can ensue to evaluate whether there is a common food or environmental source of this genetically matched strain that made people ill. Several multistate outbreaks have been detected due to PulseNet and this collaboration to improve signal detection.

The FDA Reportable Food Registry, launched in 2009, requires firms to report instances of product contamination, provided they meet certain criteria related to the possibility of serious adverse health consequences or death to humans or animals. Additionally, the upstream and downstream distribution-supply chain partners may need to submit their distribution and handling information as well. This has resulted in significant recalls related to, among others, hydrolyzed vegetable protein and allergens.

These systems, among others, have contributed to the rising number of food recalls in the past several years, and there is every indication that science and technology, improved signal detection, regulatory oversight and collaboration across borders will continue to expand, making more detection of adulteration and subsequent food recalls in the future a definite possibility.

In addition, an ever-increasing complex global food and ingredient supply has introduced further opportunities for contamination to be incorporated into food products.

What Do I Specifically Need to Be Concerned About?
Within the supply chain, adulteration is the key food safety issue. Adulterated food is food that is generally impure, unsafe or unwholesome. The main federal laws governing adulterated foods are the Federal Food, Drug and Cosmetic Act (FD&C Act), the Federal Meat Inspection Act and the Poultry Products Inspection Act. These laws contain separate language defining in very specific terms how the term “adulterated” will be applied to the foods each of these laws regulates. Products that are adulterated under these laws’ definitions cannot enter into commerce for human food use. Under U.S. law, using an ingredient not approved by the U.S. Food and Drug Administration (FDA) is one form of food adulteration. State statutes may also regulate adulterated food produced or sold in the state.

Adulteration can be unintentional or intentional. This includes biological, chemical or physical hazards. Intentional adulteration can be for economic or other reasons, such as food defense. Additionally, other issues such as consistency, quality, availability and price are of concern to all those in a company who are involved with the supply chain.

Further, the global food supply continues to grow in volume and complexity. Imports are expected to continue to grow because of cost concerns (need for lower costs and higher productivity), availability (includes seasonality) and consumer demand for diverse food products.

According to an FDA Report entitled “Pathway to Global Safety and Quality,”[3] between 10 and 15 percent of all food consumed in the U.S. is imported. According to the U.S. Government Accountability Office (GAO), imports account for nearly two-thirds of the fruits and vegetables and 80 percent of seafood eaten domestically. Seafood and spices are among the most imported food items.

Consumers in the U.S. are accustomed to a wide selection of food products from around the world. The growth of imported products is coming from locations such as Mexico, China, Asia, India and Africa. According to an analysis of food products refused by FDA at the port, conducted by the U.S. Department of Agriculture (USDA) Economic Research Service,[4] “The three food industry groups with the most violations were vegetables (20.6 % of total violations), fishery and seafood (20.1%) and fruits (11.7%). Violations observed over the entire time period include sanitary issues in seafood and fruit products, pesticides in vegetables and unregistered processes for canned food products in all three industries.”

FDA-regulated products come from more than 300,000 facilities in 150 countries. Projected growth rates of imported foods are 5–15 percent per year. Imports will continue to grow because of the rise of emerging markets, the scarcity of natural resources and the increased flow of capital, information and goods across borders. With this increase will come increased complexity for regulators, as the distinction between foreign and domestic products continues to blur and becomes ever more complex. With this complexity comes the challenge of being able to trace the products, ensure that all entities within the supply chain meet their responsibility for food safety and quality and address the ever-growing number and sophistication of those who wish to perpetrate economic fraud or food supply terrorism.

What Has Been or Is Being Done to Address Global Supply Chain Food Safety and Defense?
From a regulatory perspective, several new laws and regulations have been enacted in recent years to help address the safety of the global food supply chain, including the Bioterrorism Act of 2002[5] and the FDA Food Safety Modernization Act (FSMA).[6]

While most of those have been discussed elsewhere in this magazine, we felt that putting this information in one place would aid you in making decisions as well as being able to explain the need for these programs when requesting resources, whether for people, money or departmental cooperation. However, regulations are only as good as the resources to investigate and enforce them.

For example, in fiscal 2010, there were almost 10 million shipments of imported food to the U.S., but FDA was only able to physically examine 2.1 percent of those shipments. Within FSMA, mandatory inspections of food facilities will be based on risk. All high-risk domestic facilities must be inspected within 5 years of enactment and no less than 3 years thereafter. Within 1 year of enactment, FDA must inspect at least 600 foreign food facilities and double those inspections every year for the next 5 years. This would mean that in year six, FDA would have to conduct 19,200 inspections. Will the FDA have adequate resources of money and trained people to do this?

The responsibility for protecting your products, brand and supply chain partners can only rest on a more complete understanding of the following:

• All of the possible hazards across your supply chain

• Mitigation strategies you and your supply chain partners have in place

• Monitoring and verification across the supply chain to ensure the systems are working and are contemporary with the emerging food safety issues as they arise

The following describes the aforementioned acts.

The Bioterrorism Act of 2002 requires FDA to receive prior notice of food imported into the U.S. FDA uses this information in advance of the imported foods’ arrival to review, evaluate and assess the information, and determine whether to inspect the imported food.

The act also requires the registration of food facilities, which means that domestic and foreign facilities that manufacture/process, pack or hold food for human or animal consumption in the U.S. must register with FDA.

The following information must be submitted to FDA prior to product import:

• Identification of the submitter, including name, business address, telephone number and email address

• Identification of the transmitter (if different from the submitter), including name, business address, telephone number and email address

• Entry type and CBP (Bureau of Customs and Border Protection) identifier

• Identification of the article of food, including:

• FDA product code

• Common or usual name or market name

• Estimated quantity, described from the smallest package size to the largest container

• Lot, code number or other identifier (if applicable)

• For food that is no longer in its natural state, identification of the manufacturer: manufacturer’s name and either 1) the registration number, city and country of the manufacturer or 2) both the full address of the manufacturer and the reason the registration number is not provided (reasons listed in the Compliance Policy Guide for Prior Notice of Imported Food)

• For food that is in its natural state, identification of the grower and growing location address, if known

• FDA country of production

• Name and full address of the shipper, if different from the manufacturer

• Country from which the article of food is shipped or, if the food is imported by international mail, the anticipated date of mailing and country from which the food is mailed

• Anticipated arrival information (location, date and time) or, if the food is imported by international mail, the U.S. recipient (name and address)

• Identification of the importer, owner and ultimate consignee (except for food imported by international mail or transshipped through the U.S.) with name and full address

• Identification of the carrier and mode of transportation (except for food imported by international mail)

• Planned shipment information (except for food imported by international mail)

In response to increased globalization, FDA has expanded its capabilities and regulatory authority. The PREDICT systems,[7] for instance, use novel data analytics from the entire life cycle of a product to better identify and target high-risk products before they enter the country. It is believed that using this better intelligence, admissibility of safe products will be speeded and FDA can focus its investigations on the goods most likely to harm the public.

The FDA FSMA sections include the following:

• Preventive Control Plans. Food manufacturing facilities must develop and implement science-based written plans that evaluate hazards that could affect the safety of food.

• Mandatory Produce Safety Standards. FDA must establish science-based minimum standards for the safe production and harvesting of fruits and vegetables.

• Required Inspections. Mandatory inspections of food facilities are based on risk. All high-risk domestic facilities must be inspected within 5 years of enactment and no less than 3 years thereafter. Within 6 years of enactment, FDA would have to conduct 19,200 inspections of foreign food facilities annually.

• Product Tracing. FDA is required to establish a comprehensive product tracing system to track movement of food products from farm to point of sale or service. The goal being to identify sources of foodborne illnesses earlier and to contain outbreaks more quickly.

• Third-party Certification. Designated imported foods must be certified by a third party with expertise in food safety under the oversight of FDA.

• Certification for High-risk Food. FDA can require that high-risk imported foods be accompanied by a credible third-party certification or other assurance of compliance as a condition of entry into the U.S.

• Increased Inspection Authority. Inspect records of any entity (excluding farms and restaurants) that manufactures, processes, packs, distributes, holds, receives or imports food products.

• Mandatory Recall Authority. This requires a recall based on a “reasonable probability” that an article of food is adulterated, misbranded or will cause “serious adverse health consequences or death” to people or animals.

• Suspension of Registration. FDA can suspend registration of a facility if it is determined that the food poses a reasonable probability of serious adverse health consequences or death. A facility that is under suspension is prohibited from distributing food.

FDA’s new approach rests on four core building blocks:

1) FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.

2) With these coalitions, FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.

3) FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized information technology capabilities.

4) FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry and public- and private-sector third parties.

However, given all of FDA’s new initiatives and responsibilities, it appears the agency will be hard-pressed to meet the demands of the globalization of the food supply system because of lack of resources in both people and money.

Who Else Is Helping?
The Department of Homeland Security (DHS) Science & Technology Directorate Centers of Excellence (COE) network was developed.[8] The COE is an extended consortium of hundreds of universities that generates groundbreaking ideas for new technologies and critical knowledge, while also relying on each other’s capabilities to serve DHS’s many mission needs.

All COEs work closely with academia, industry, department components and first responders to develop customer-driven research solutions to “on the ground” challenges as well as provide essential training to the next generation of homeland security experts. The research portfolio is a mix of basic and applied research addressing both short- and long-term needs. The COE extended network is also available for rapid response efforts.

Managed through the Office of University Programs, the COEs organize leading experts and researchers to conduct multidisciplinary homeland security research and education. Each center is university- or co-led in collaboration with partners from other institutions, agencies, national laboratories, think tanks and the private sector.

There are currently 12 COEs across the country.

• The Center for Risk and Economic Analysis of Terrorism Events (CREATE), led by the University of Southern California, develops advanced tools to evaluate the risks, costs and consequences of terrorism.

• The Center for Advancing Microbial Risk Assessment (CAMRA), led by Michigan State University and Drexel University established jointly with the U.S. Environmental Protection Agency (EPA), fills critical gaps in risk assessments for mitigating microbial hazards.

• The Center of Excellence for Zoonotic and Animal Disease Defense (ZADD), led by Texas A&M University and Kansas State University, protects the nation’s agricultural and public health sectors against high-consequence foreign animal, emerging and zoonotic disease threats.

• The National Center for Food Protection and Defense (NCFPD), led by the University of Minnesota, defends the safety and security of the food system by conducting research to protect vulnerabilities in the nation’s food supply chain.

• The National Consortium for the Study of Terrorism and Responses to Terrorism (START), led by the University of Maryland, informs decisions on how to disrupt terrorists and terrorist groups through empirically grounded findings on the human element of the terrorist threat.

• The National Center for the Study of Preparedness and Catastrophic Event Response (PACER), led by Johns Hopkins University, optimizes our nation’s preparedness in the event of a high-consequence natural or man-made disaster.

• The Center of Excellence for Awareness & Location of Explosives-related Threats (ALERT), led by Northeastern University and the University of Rhode Island, will develop new means and methods to protect the nation from explosives-related threats.

• The National Center for Border Security and Immigration (NCBSI), led by the University of Arizona in Tucson (research co-lead) and the University of Texas at El Paso (education co-lead), is developing technologies, tools and advanced methods to balance immigration and commerce with effective border security.

• The Center for Maritime, Island and Remotes and Extreme Environment Security (MIREES), led by the University of Hawaii and Stevens Institute of Technology, focuses on developing robust research and education programs addressing maritime domain awareness to safeguard populations and properties in geographical areas that present significant security challenges.

• The Coastal Hazards Center of Excellence (CHC), led by the University of North Carolina at Chapel Hill and Jackson State University in Jackson, MS, performs research and develops education programs to enhance the nation’s ability to safeguard populations, properties and economies from catastrophic natural disaster.

• The National Transportation Security Center of Excellence (NTSCOE) was established in accordance with HR 1, implementing the recommendations of the 9/11 Commission Act of 2007 in August 2007. The NTSCOE will develop new technologies, tools and advanced methods to defend, protect and increase the resilience of the nation’s multimodal transportation. It comprises seven institutions.

• The Center of Excellence in Command, Control and Interoperability (C2I) led by Purdue University (visualization sciences co-lead) and Rutgers University (data sciences co-lead) will create the scientific basis and enduring technologies needed to analyze massive amounts of information to detect security threats.

In light of pending regulations stemming from the FSMA, food and beverage companies must be cognizant of the effectiveness of their suppliers’ food safety and food defense programs. This is especially important for imported products. Companies must develop close interactions with ingredient vendors, packaging providers, brokers, distributors and other partnerships. Preventing contaminated foods from reaching customers’ tables is primarily the responsibility of the vendor. Prior to the FSMA, food and beverage companies voluntarily addressed intentional adulteration of products. Now companies will be required to consider the potential for intentional adulteration as part of their hazard analysis.

Food and beverage companies are increasingly aware of such challenges as they continue to extend supply chains, both domestically and abroad. Having an effective food defense program complements a company’s food safety system and soon must be addressed to comply with the new regulations soon to be published by FDA as mandated by the FSMA. FSMA Section 805 will be added to the FD&C Act (21 U.S.C. § 385), requiring every U.S. importer to perform risk-based foreign supplier verification activities to verify that the food it imports is (a) produced in compliance with the requirements of Section 418 (hazard analysis and preventive controls) or Section 419 (produce standards); and (b) is not adulterated under Section 402 or misbranded under Section 403(w) (allergen labeling).

When it comes to food defense, according to the GAO, the federal government is not efficiently managing or utilizing resources in the defense of the nation’s food system. After the terrorist attacks in 2001, President George W. Bush and Congress initiated polices to protect the food supply. Billions have been spent, but according to Lisa Shames, GAO’s Director of Natural Resources and the Environment, in her testimony before Congress, “There is no centralized coordination to oversee the federal government’s overall progress implementing the nation’s food and agricultural defense policy.” According to this report, a lack of coordination means that “any natural or deliberate disruption of the agriculture or food production systems—including natural disasters, disease outbreaks and food contamination—can present a serious threat to the national economy and human health and can halt or slow trade.” As a result of this report, in part, improved coordination of all relevant federal agencies (FDA, CDC, DHS, EPA, Department of Defense and others), state and local agencies and industry is an overriding theme across the FSMA. A coordination platform already exists within the DHS for collaboration and response to agroterrorism and other disasters and the Food and Agriculture Coordinating Council, including a government component and an industry component with representatives of all stakeholders involved, who are able to share classified information and ongoing efforts by all members to prepare for and mitigate intentional contamination of the food supply.

In September 2009, the USDA Food Safety and Inspection Service (FSIS) published Notice 67-09,[9] which outlines what the agency expects responsible establishments to develop in the way of a food defense plan. Previous FSIS surveys revealed that a very low percentage of establishments had even minimal food defense procedures in place, and in fact, FSIS is conducting another survey in 2011 of amenable establishments.[10]

As a result, the agency is now moving forward with full expectation that every amenable establishment implements a food defense program commensurate with the guidance provided in “Food Defense Plan Security Measures for Food Defense.”[11]

What Is the Significance of Food Fraud, Otherwise Known as Economic Adulteration?
Examples of economic fraud are becoming more and more prevalent. In an article that will be published in the near future, Spink and Moyer[12] define food fraud as a collective term encompassing 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. Food fraud is a broader term than either the economically motivated adulteration defined by FDA or the more specific general concept of food counterfeiting. Food fraud may not include “adulteration” or “misbranding,” as defined in the FD&C Act, when it involves acts such as tax-avoidance and smuggling.

Recent examples of food fraud include imported vegetable protein that contained melamine and sickened or killed American pets; milk tainted with melamine in China that killed and injured many children; honey that was banned in Europe because of lead, illegal antibiotics or not being real honey used in the U.S.; incorrectly identified fish species; caviar; fruit juices; olive oil; spices, etc.

What Can I Do to Protect My Product and Brand across the Supply Chain?
While many programs and systems have been developed and implemented with varying degrees of success, we believe it is incumbent on all of the food segments within the U.S. to protect their customers and their companies through their own comprehensive programs. Every step along the food supply chain must be held accountable for what they supply or handle. It is essential to understand and have confidence that your immediate source of supply also has conducted a preventative controls assessment as characterized in the FSMA. Members of the supply chain must have a clear understanding of the production and processing controls necessary as well as have them functionally verified and validated to address the hazards that may be associated with the foods they handle both up and down the supply chain.

Experience has shown that you can’t simply rely on a certificate of analysis (COA), supplier specifications or someone else’s portrayed activities and knowledge. A minor ingredient with functionality in many varied food products, if adulterated, can cause devastating impact to the brand and ultimately public health. The Peanut Corporation of America peanut butter recall is a quintessential example of an ingredient that ended up in thousands of processed products over multiple brands that were recalled over a 6-month period.

What Are the Key Areas to Be Addressed?
The following are five areas that should be addressed in any company’s food safety program:

1. Development of updated, comprehensive specifications
Activities should start with the development of comprehensive specifications. Without well-thought-out specifications, comprehensive purchasing agreements and supplier review programs cannot be developed. Specifications must be developed with input from all applicable departments, including food safety, product development, purchasing, operations, logistics and risk management. Hazards should be identified and addressed. If a proven intervention, such as irradiation for spices, is available, use it.

2. Development of comprehensive purchasing agreements
This is one area that is often overlooked by the food safety professional who might not be involved with the development or review of the agreement. Input from the food safety professional is vital regarding what is required of the supplier to minimize risk. The first area must be that the products comply with all of the federal rules and regulations regarding food or ingredients imported into the U.S. Next, what are the requirements (i.e., frequency, reporting system, planned vs. surprise audits, time to complete corrective actions, etc.) for auditing both by a certified third party and by the purchasing company? Are there indemnification cla