“Gluten-free diets becoming more common even if celiac disease isn’t.” “California adds glyphosate to list of cancer-causing chemicals.” “Flour recalled over possible link to E. coli outbreak.” “Huge recall of frozen fruits and vegetables after Listeria outbreak.” “Brazil’s largest food companies raided in tainted meat scandal.” “Recalls of organic food on the rise.” “Sally the salad robot is aimed at reducing the risk of foodborne illness by assembling salads out of precut vegetables stored in refrigerated canisters.” “Hurricane Harvey brings food safety challenges to millions.” As these headline news items attest, there are growing challenges in food safety that companies must address to remain innovative and grow their businesses.

Despite significant advances in detection tools, regulations, monitoring and consumer education on food safety, reports of foodborne illness outbreaks are expected to increase. More sensitive testing methods, changing consumer behaviors, climate change, modes of transportation and increasing complexity and globalization of the supply chain all contribute to this increase. The U.S. Centers for Disease Control and Prevention reports that foodborne diseases cause an estimated 48 million illnesses each year in the United States, including 9.4 million caused by known pathogens.

Food safety challenges exist along each step of the supply chain from concept to commercialization. The very name “supply chain” assumes that this is a linear relationship.  However, as we all know, the complexity of the current supply chain from farm to fork makes it difficult to accurately manage the challenges facing us today, so organizations must reduce the complexities within the supply chain to enable accurate control of the process. This will involve the proactive identification of potential risks and their mitigation, resulting in brand protection and meeting ever-changing consumer needs. Addressing these food safety challenges will require investments in information technology (IT), end-to-end management of the supply chain and building food safety capability from the CEO down to the line operators. The following key areas must be managed to address the new food safety challenges facing the food industry.

Information Technology
Capturing digital information across the supply chain is difficult. Most organizations are still using spreadsheets or have multiple stand-alone systems. The capability to harvest these data and gain insights is becoming more of a necessity than a luxury. A company cannot afford to not have these systems in place to mine vast amounts of data to identify and prevent risks.

Moreover, these IT tools can impact productivity as well as food safety and quality. An excellent example is the potential use of Blockchain technology to monitor performance and behaviors of supply chain partners. Blockchain has also been shown to be an effective tool in the management of food fraud and food defense issues. Leading multinational food companies have begun to take notice and invest in Blockchain technology. Yet, with these advances, we also encounter new vulnerabilities for the enterprise. Hacking, identity theft and other modes of internet-mediated fraud are major challenges. It is easy to imagine the possibility of having the company’s operations be brought to a grinding halt due to internet intruders gaining access to a company’s critical information and processes. This is most assuredly a new and evolving threat. The ramifications of these illicit internet activities for food safety must be given priority consideration in the company’s business plans and risk assessment activities. 

Supply Chain Management
A chain is only as strong as its weakest link: Manufacturers need to maintain a strong perimeter defense. For many in the industry, the safety of the ingredients, packaging and equipment coming into our facilities is the weakest link. After all, the complexities of managing what comes into our buildings can be vast and overwhelming. The global food supply depends on highly efficient and well-regulated supply chains. Under the best conditions and with state-of-the-art controls, supply chains represent a monumental source of risk for food safety and also for an enterprise’s financial well-being. Shareholder performance correlates well with supply chain management.

The Food Safety Modernization Act (FSMA) recognizes the vulnerability of suppliers and heavily regulates minimum standards that every U.S. Food and Drug Administration (FDA)-regulated food facility must follow. For those overwhelmed by the prospect of building a supplier management system, FSMA is a good (and required) place to start. But is it enough? Does compliance with the regulations protect you against the unexpected, the “known unknowns”?   

The following are among FDA’s key new import authorities and mandates relating to the control of inbound supply chain management.

•    Importer accountability: For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe.

•    Third-party certification: FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports.

•    Certification for high-risk foods: FDA has the authority to 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.

•    Voluntary Qualified Importer Program: FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities.

•    Authority to deny entry: FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located.

Food Safety Leadership
Management commitment is essential to ensure that food safety challenges are adequately controlled to maximize business performance and to minimize disruption resulting from failures to protect the consumer. To ensure that food safety is an enabler of business growth, company leadership must provide adequate and necessary resources and demonstrate behaviors that support the importance of food safety in limiting or mitigating enterprise risk.

Food safety professionals must move from a compliance function to the role of business partner who infuses food safety into the company strategy. They must become great storytellers when communicating or selling food safety initiatives to show both the ability to produce safe food and enable business growth. Food safety professionals must be able to show the benefits and return on investment of these key food safety initiatives. Food safety professionals must also build food safety knowledge with frontline operators to help change behaviors and ensure food safety plays a critical role in getting product out the door.

If we accept and understand that modern food processing can be traced to 1810 with the opening of a canning plant in France and that food safety as a subject was first codified in 1906 with the advent of the Pure Food and Drug Act, then we understand that food safety as a discipline is not really a new topic, but only in 2011 was the most comprehensive food safety legislation, FSMA, finally enacted. Food companies large and small are still grappling with the concept of food safety and how or where it fits into their corporate culture. CEOs and CFOs and their corporate boards are standing up and taking notice. Food safety is a critical business process that demands the highest level of visibility in the corporate structure and strategic plan. Leading food companies have made this calculation and understand the importance of ensuring that the products they manufacture and market will not cause irrevocable harm to the consumer or to the enterprise.

Discussions of “food safety culture” are very topical. The best food safety culture will only be a subset of a much broader corporate culture. Defining a corporate culture is the CEO’s prerogative. When food safety executives are effective in causing the organization to consider food safety proactively instead of as an afterthought, and when food safety is a part of every transactional conversation, it is then part of the company’s culture. Food safety is about risk and risk tolerance. A CEO’s propensity for risk will impact both corporate and food safety culture.

Other Important Challenges to Consider
Infrastructure
Government officials have noted that the U.S. needs increased infrastructure investment to strengthen our economy, enhance our competitiveness in world trade, create jobs and increase wages for our workers and reduce the costs of goods and services for our families. It is further noted that the poor condition of the U.S. infrastructure has been estimated to cost a typical American household thousands of dollars each year.

Experts in the field report that infrastructure projects, like roads and bridges, should be designed to survive rising sea levels and other consequences of climate change (see below). They report that this approach to infrastructure enhancement would protect taxpayer dollars spent on projects in areas prone to flooding and also improve “climate resilience” across the U.S.—that is, a community’s ability to cope with the consequences of global warming.

Since 2011, the ongoing water crisis in Flint, Michigan, is compelling proof that the water distribution systems across the country are at risk and so too are the populations that they service. We have a very old water infrastructure in our nation, with many areas still maintaining Civil War-era cast-iron pipes, with an estimated useful life of 150 years (at the time of installation). “A major symptom of the aging water infrastructure includes 300,000 water main breaks in North America as a result of widespread corrosion problems, adding up to a $50.7 billion annual drain on our economy. Leaking pipes are also losing an estimated 2.6 trillion gallons of treated drinking water annually, representing $4.1 billion in wasted electricity every year.”[1]

From personal experience, a ruptured main in a 150-year-old distribution system in a northern Kentucky town took several weeks for public health authorities and FDA to pronounce it free of contaminants and its water safe for consumption and use in food processing operations. Moreover, affected food companies were required to destroy significant quantities of food that had been manufactured after a sustained pressure drop had been confirmed within the distribution system. Additionally, the impacted municipality did not have the laboratory capacity to monitor the microbiological safety of its water supply during and after the failure. Recovery and testing were aided by the labs of a large ice cream producer and food processor based in the town.

The inundation of water treatment facilities with floodwater, during some natural disasters, as described below, is an immense public health challenge. With such a catastrophic occurrence, it would be reasonable to conclude that the entire water distribution system has also been compromised. In older systems where potable waterlines and raw sewage lines are contained in a common subterranean vault, there is the real threat of dangerous microbes being introduced into the water distribution system. In this situation, the safety of the water supply depends on pipe integrity and on the pressure differential between the potable waterline and the raw sewage line. That is, the higher pressure on the waterline would preclude the entry of materials leaking from the sewage line in the event of a failure.

Natural Disasters
Between August 25 and September 11, 2017, the U.S. mainland was inundated by hurricanes Harvey (August 25) and Irma (September 11). Within weeks of those catastrophic storms, hurricanes Jose and Maria (September 20, 2017) ravaged the U.S. Virgin Islands, Puerto Rico and other islands of the Atlantic basin. The damage to the infrastructure in the affected communities varied. The preliminary cost of storm-related damage from Hurricane Harvey alone was estimated between $70 and $200 billion. Damage estimates from Puerto Rico, where the infrastructure was all but obliterated by hurricanes Jose and Maria, are currently beyond speculation. One month after September 20, only 45% of the island’s population has access to clean water; more than 80% of the island is without electrification; 50% of the main highways remain closed due to damage or debris; and 25% of the country’s ports remain inoperable.

The relevance to food safety management is that with the advent of global warming, new strategies are needed for control over supply chains and protection of public health. Imagine a food processing operation in Houston, post-Hurricane Harvey and what it will take to bring that facility back on line. Most assuredly, the water supply and sewer systems were heavily damaged. Owing to the density of the petrochemical industry in that area and damage to its infrastructure, an assortment of exotic chemicals could find their way into groundwater and water treatment facilities. It is inconceivable that absent federal intervention from the Federal Emergency Management Agency and the U.S. Environmental Protection Agency, these infrastructure challenges can be resolved. So, not only is the manufacture of food suspended, but there will also be questions about the public health status of previously processed food and food ingredients in the manufacturing supply chains. Raw materials and ingredients that may have been held up in transit due to failed roads, railways and ports will demand a comprehensive food safety assessment. One might also imagine a cold storage distribution center that has flooded and lost power. In this case, the food safety assessment would probably involve representatives of the U.S. Department of Agriculture Food Safety and Inspection Service, local public health officials as well as company food safety personnel. In this example, the disposition would most likely be straightforward and predicated on maintaining proper cold-chain integrity. If the cold chain were preserved and objective data available to document this, then the food might likely be judged safe. But in the absence of objective data, one could only conclude that the materials are unfit for human consumption. In the last several years, cloud-based monitoring technologies have emerged that may be helpful in the acquisition and preservation of critical storage temperature data.

In contrast, food safety assessments where packaged or canned foods are involved might not be so straightforward. A company taking a very conservative approach in managing the disposition of affected materials could encounter difficulty with FDA. That is, the agency would probably be inclined to conclude that the canned and packaged foods may have been held under insanitary conditions where they may have become adulterated and are not fit for human consumption. There is no one-size-fits-all solution for these sorts of disasters. It is understood that all concerned parties, the marketing and manufacturing company and the regulatory agency staff, are trying to do their best to protect public health. Planning and guidance for managing adverse weather or infrastructure failure events should be included in the company’s crisis management and special events procedures.

Another scenario might involve raw material and ingredients delayed in transit. It is easy to envisage railcars, over-the-road transport vehicles or ships containing sensitive food ingredients that are unable to deliver because of infrastructure compromised by a natural disaster. In most cases, these items are to be delivered for a just-in-time production schedule, and shipments might include highly perishable materials. Imagine the predicament of a juice processor with a sea tanker load of orange juice, intended for further processing, stuck in port for a week or more without the ability to unload its cargo. This vast quantity of juice would most likely spoil before it could be offloaded and processed. There are many less dramatic but equally challenging examples involving shipment of mixed loads of food and other nonfood materials that should be considered. This situation represents a potentially insidious threat, depending on the nature of the products involved. These scenarios must be evaluated on a case-by-case basis to establish the threat and risk to food safety.

Weather- and infrastructure-related events are increasingly a challenge for food safety management. These threats must be considered in the company’s crisis management program. The food safety team, in conjunction with legal, logistics and others, should conduct a failure modes and effects analysis and consider storm events and infrastructure failures as part of the exercise. From experience working with clients in hurricane-prone areas, for example, where the risk assessment leads to the development of plans for the removal and relocation of the plant’s critical manufacturing assets, retorts, kettles, heaters and packaging line equipment were on the relocation list. This sounds extreme, but in fact, the company preserved its property and probably ensured a speedy recovery of its plant operations.

Validation
Among the myriad challenges facing the food industry is the new FSMA requirement for the validation of preventive controls. Validation seeks to confirm, with a high degree of confidence, that a preventive control measure of a food safety plan is effective at mitigating or reducing the identified food safety hazard to an acceptable level. Validation is a relative new concept for the food industry and is causing concern and confusion for both regulatory operatives and food safety specialists. The process validation scheme in Figure 1[2] depicts the steps involved in the validation process. Also superimposed beneath the validation scheme is the formula used for the food safety objectives. You will see when proceeding left to right that [H°] (risk characterization) is associated with the input to the process being validated. The sum of the reduction plus the sum of any increase of the hazard (–ΣR + ΣI) corresponds to the preventive control, and the output of the process is the performance objective (FSO/PO) for achieving safe food.[2]
 
Summary
The brave new world of food science and technology has been a boon for mankind. Today, we can produce food and foodstuffs more efficiently than ever before. The power of science and technology has transformed food processing. We have capabilities today that we dared not dream about a mere 20 years ago. Whole-genome sequencing, gluten-free grains, metagenomics, nonallergenic peanuts and high-pressure thermal sterilization are all prime examples. More and more often, the regulatory agencies are demanding that companies prospectively validate the safety of novel and emerging technologies. Innovation is disruptive and often involves a high level of risk taking. For this reason, food companies are often reluctant to lead innovation. The prevailing attitude, among industry-leading companies, toward innovation is “me too” or “we’d prefer not to be first.”

It was absolutely revolutionary 225 years ago (circa 1790) when Nicolas Appert was able to stuff food into glass bottles and immerse them in boiling water to preserve them for ambient storage. It is interesting to contemplate the potential harm that this breakthrough technology harbored. Neither Appert nor other scientists of his day had any understanding of anaerobic bacteria and most assuredly had no concept of the consequences of exposure to the deadly neurotoxin produced by Clostridium botulinum. The reader will recall that germ theory (by Louis Pasteur, Joseph Lister and Robert H. Koch) was not fully elucidated until about 1880. Yet, the canning industry has thrived and, in a very real way, changed the world and the world’s economic development. Perhaps the only other technological advancement in food to surpass the societal impact of the canning industry has been the development of mechanical refrigeration. In developed countries, the demand for food in the cold chain is rapidly expanding, so much so that the modern supermarket has been reengineered to accommodate more and more refrigerated and frozen products.

In addition to advancements in preservation technologies, we can now manipulate crops and select for specific plant attributes that would have caused Gregor Mendel to pause and ponder. The ability to genetically manipulate food and food crops is controversial. George Washington Carver, the great American food scientist of last century, reported that “farmers had every right to encourage the abundance of their crops including the use of genetic modification.” Carver studied, among other scientific disciplines at Iowa State College (1896), the genetic modification of cacti.[3] In fact, the food industry has been on the genetic modification journey for many years and with good outcomes for mankind. The truth is that man has been modifying food crops since we transitioned from hunter-gatherers to an agrarian society. Risk is an element of innovation. The food industry and its regulatory companions must be vigilant to safeguard the public from potential harm arising from the use of novel processing and preservation technologies. But at the same time, we should discourage the hunt for phantom risks that will probably impede innovation.

There is also increasingly risk to the food supply associated with natural disasters: Floods, hurricanes and wildfires are prime examples. These disasters can devastate and disrupt supply chains, which may cause great harm to the stability of society. The food industry is at great risk and the foods they manufacture susceptible to the devastation caused by flooding, fires and storms. In fact, these climate-related natural disasters may be the biggest contemporary issue facing the food industry. Climate change, an extrinsic risk, is causing the food industry, and especially food safety leaders, to rethink business plans and strategies to cope with this new reality.  

In food processing operations, there are myriad risks, both intrinsic and extrinsic. It is also understood that there is, during the mass production of human food, no such thing as zero risk. Yes, we can make exquisite measurements to a precision level of 6–7 × 10-⁹, but this is still not zero. There is always a residual risk, and it is the responsibility of those who manufacture and market food products to manage that risk to a level that will do no harm. It is only with this mindset that the industry together can meet these and other future challenges in food safety.   

Larry Keener, CFS, PCQI, is president and CEO of International Product Safety Consultants. He is a member of the Editorial Advisory Board of Food Safety Magazine.

References
1. triecker.wordpress.com/2014/05/20/critical-infrastructure-vulnerability-water-delivery-systems/.
2. Anderson, NM et al. 2011. “Food Safety Objective Approach for Controlling Clostridium botulinum Growth and Toxin Production in Commercially Sterile Foods.” J Food Prot 74(11):1956–1989. doi:10.4315/0362-028X.JFP-11-082.
3. Hersey, MD. My Work Is That of Conservation: An Environmental Biography of George Washington Carver (Athens, GA: University of Georgia Press, 2011).
 
Resources
1. www.food-safety.com/magazine-archive1/junejuly-2017/the-supply-chain-and-food-safety-culture-distribution/.
2. www.provisioneronline.com/articles/104300-dont-save-bad-pennies-with-older-meat-and-poultry-plants-equipment.
3. www.labmanager.com/insights/2015/12/insights-on-food-safety#.WfjHRltSwdU.
4. www.food-safety.com/magazine-archive1/augustseptember-2013/the-squeaky-wheel-is-transporation-the-watershed-for-food-safety-and-food-defense/.
5. www.food-safety.com/magazine-archive1/junejuly-2011/ex-ante-or-ex-post-food-safety-strategies-process-validation-versus-inspection-and-testing/.
6. www.food-safety.com/magazine-archive1/februarymarch-2006/hurdling-new-technology-challenges-investing-in-process-validation-of-novel-technologies/.     
7. www.food-safety.com/magazine-archive1/octobernovember-2003/transportation-the-squeaky-wheel-of-the-food-safety-system/.     
8. www.food-safety.com/magazine-archive1/octobernovember-2001/water-ensuring-its-safety-for-use-in-food-processing-operations/.     
9. Keener, L. 1999. “Mechanistics of Selling Food Safety,” Food Testing & Analysis 5(4).
10. Keener, L et al. 2014. “Harmonization of Legislation and Regulations to Achieve Food Safety: U.S. and Canada Perspective.” J Sci Food Agric 94(10):1947–1953.