Food safety. What a changing landscape this has been over the past three years! Since the tragic events of Sept. 11, 2001, the stewardship of food safety has increased in both depth and breadth—far beyond what many of us could have ever envisioned. This is true for the food industry, in general, and for one of its more popular segments—beverages.

The product portfolios of beverage companies have been increasing over time, as companies innovate to address the changing needs of consumers, and to drive growth in maturing markets. The range of products has expanded well beyond “traditional” soft drinks (regular and diet versions of cola, lemon-lime, orange and other popular variations) to include a multitude of more creative formulae. Unusual and sometimes pungent flavors in novel packaging now abound.

According to the National Soft Drink Association (NSDA), in 2002 alone, the retail sale of carbonated soft drinks totaled more than $61 billion, and Americans consumed slightly less than 53 gallons of carbonated soft drinks per person per year. The soft drink industry in the United States employs more than 183,000 people nationwide, and pays more than $18 billion annually in state and local taxes.

In addition to the carbonated soft drink segments, the explosive opportunities for “non-carbonated beverages” (NCBs) are quickly being realized on a global basis by many beverage manufacturers. This group includes products known as non-carbonated beverages, functional beverages and new-age beverages. Their formulae, obviously, do not include carbon dioxide, which substantially changes the challenges involved with their manufacture. Vitamins, minerals, macro- and micro-nutrients, soy, dairy, fiber and a variety of other ingredients are added in response to the innovative needs of the global beverage consumer. In general, the consumer preferences drive the formulation and the packaging, while corporate image, trademark protection and regulatory requirements drive the safety of these products.

Is Being “Safe” Enough?
The concept of “safety” is worth addressing from two very different and important perspectives: the “perception” of safety and the “reality” of safety. Make no mistake, the mere “perception” that a product is unsafe—irrespective of peer-reviewed, credible scientific data to the contrary—can present a major challenge for a food or beverage company. One case study that illustrates this point is the recent widely-publicized allegations that carbonated beverages produced in India by two of the world’s largest multinational producers contained traces of pesticides.

Last year an environmental activist group in India tested samples of carbonated beverages from India and reported the presence of residues from several common pesticides. The group said similar tests of the companies’ products made in the United States did not detect any of the pesticides. And in a clear contravention of generally accepted scientific procedures, the group compared its data for the finished beverages to the European Union norms for drinking water. Based on its assessment, the group alleged in a public announcement that:

• Products sold by the multinational corporations (MNCs) in India are not safe;
• The MNCs apply lower quality standards in India than in the U.S.; and,
• India lacks the pesticide standards necessary to ensure the safety of consumers of soft drinks and other products.

The allegations generated news both inside and outside India. Resulting newspaper headlines described the products using such terms as “poison” and “toxic.” Consumers were confused, even scared. Though this was based entirely on the “perception” of safety—without any credible scientific basis—sales of the products suffered.

Now, the “reality.” Even if one assumes the data are correct (and significant questions remain about the methodology), the ultra-trace levels of the common pesticides reported by the activist group represent less than one-tenth of one percent (< 0.1%) of the Acceptable Daily Intake (ADI) established by the World Health Organization (WHO). The concept of Acceptable Daily Intake (ADI) is the cornerstone of health-based standard setting processes, and is used by the World Health Organization and countries worldwide to assure the protection of public health. The ADI is the amount of a substance that can be ingested safely every day over an entire lifetime. The WHO, which has evaluated pesticide residues for more than 40 years, establishes ADIs.

Perception: The beverages are toxic! Reality: The beverages have been—and remain—perfectly safe! Adding to the irony of this situation is the fact that many staples of the Indian diet—foods consumed much more frequently and in greater quantities than soft drinks—typically contain levels of pesticide residues thousands of times higher than the levels the group reported in soft drinks.

This is just one of many examples in which data-based attempts to demonstrate safety can fall short, or sometimes grossly mislead. As a result, food and beverage manufacturers must become increasingly vigilant in assuring not only the “reality” of product safety but also the consumer “perception” of product safety. Science-based food safety programs can do a lot to mitigate both the real and perceived risks to product safety, but cannot completely reduce them to zero.

Risk Management Using Science-based Food Safety Approaches
Standard programs like Hazard Analysis and Critical Control Points (HACCP), Good Manufacturing Practices (GMPs), Clean-in-Place (CIP)/Sanitize-in-Place (SIP) protocols, and a host of other food safety-related acronyms are useful—in fact, critical—to managing and minimizing food safety risks. One challenge, in particular, to these programs remains one of the most insidious legacies of September 11th—the threat of intentional sabotage with agents of chemical or biologic weaponry. Thankfully, the majority of our processes and systems are robust enough to guard against this threat, but again, knowledge and due diligence are key.

HACCP is a required approach in many segments of the food industry, but is not yet a global requirement for beverages. Some individual countries have required that beverage manufacturers adopt a formal HACCP program, while others accept the “spirit” of HACCP, which is adequately satisfied by many comparable internal risk management and quality programs. HACCP is, indeed, a valuable tool, and is perhaps even more valuable when it remains voluntary. Some suggest that when HACCP becomes a regulatory mandate, its value is diluted, since people’s focus then becomes satisfying the “letter” of the law, rather than embracing the overall “spirit” in which it was intended (which often affords a broader and more extensive scope).

In addition to risk identification and management through HAACP and a variety of other tools, food and beverage safety can be viewed as something conducted for fundamental protection through the formulation and the processing themselves. As we alluded to earlier, the carbon dioxide in a carbonated soft drink, coupled with the acidity and the natural bacteristatic properties of some of the flavor oils, provide a substantial margin of protection from microbial spoilage. So much so, in fact, that the risk of pathogenic bacteria in a traditional carbonated beverage is near zero. Even harmless spoilage organisms (mostly yeast) find it difficult to survive and thrive in a carbonated beverage matrix. So, carbonated beverages have been—and remain—among the most innately robust and safe liquid refreshments in this industry.

As our product portfolios expand, however, non-carbonated beverages present new and unique challenges. First, no carbonation means that the microbial protection afforded in carbonated soft drinks must be obtained by other means for NCBs. In the case of most non-carbonated beverages (with cold-filled, preserved systems being the exception), this microbial safety is achieved less from formulation and more from the process.

The evolution of NCB processing has increased momentum over the past five years, and the learning curve continues to develop. Certain processes, however, remain among the “bread and butter” of non-carbonated beverage manufacture on a global basis. These include tunnel pasteurization, hot-filling and cold-fill aseptic processing.

Tunnel Pasteurization. As the name implies, the finished beverage in its already filled and sealed package is passed through a heating tunnel. The time and temperature are carefully engineered to effect the desired “kill rate” using a particular target organism of interest. After the thermal inactivation step, the product passed through a network of cooling sprays, where its temperature is adjusted to near ambient in order to minimize any adverse thermal effects on the flavor or nutrient systems.

Hot-filling. Unlike tunnel pasteurization, where the product is filled cool or at ambient temperatures and then heated, hot-filled beverages are filled into their containers immediately after a thermal processing step. In fact, the temperature of the liquid product is utilized to also sanitize the package into which the NCB is filled. Once filled and sealed, the bottles are often inverted for a short time to ensure that the hot product contacts the neck area of the package and the inside surfaces of the closure. After a sufficient time period at the elevated temperatures, the filled package is then cooled to near ambient temperature. Compared to tunnel pasteurization, which takes approximately 20-40 minutes, hot-filling operations generally involve the use of higher temperatures and much shorter operational times (totally two to 10 minutes).

Cold-fill Aseptic Processing. Aseptic filling has been in existence for years, but has been primarily utilized in the food canning industry. In this model, canned foods and beverages are typically thermally processed to achieve a “12-D,” or 12–log reduction (99.9999999999%) in the organism of interest. For low-acid foods, the historical organism of interest has been the spores of the bacterium Clostridium botulinum. Cold-fill aseptic processing in the beverage industry is only now becoming a more routine application of this technology.

In this model, the liquid beverage is thermally processed (often at higher temperature and shorter times than hot fill), then rapidly returned to near ambient temperature, and the sterile beverage is then hermetically filled and sealed into a package that has been previously sterilized within a sterile environment. This is unique to the other processes in that the product and package are separately sterilized—the product, with heat, and the package with heat, sterilant chemicals, or a combination of both.

When aseptic filling into polyethylene terephthalate (PET) packages was introduced, it represented substantial savings over hot fill, since the more costly heat-set PET was no longer required. This opened the door for myriad innovative packaging designs in PET, while providing the consumer with a safe, flavor-robust, shelf-stable product.

The ultimate end objective of these processes is unilateral and inarguable—product safety. Thankfully, with proper design, engineering, validation and continued oversight of these systems, commercial product that meets this criterion of safety is relatively straightforward to provide. The difficulty—and where the “art” meets the “science”—is balancing the microbial protection afforded by the thermal process while maintaining an appealing flavor profile and retaining any nutritional claims that are desired.

Advances in Monitoring and Future Challenges
There have been marked improvements in the capability of the various monitoring instruments and kits available to the beverage processor over the years. These advances have been realized for both in-line and off-line plant measurement devices, as well as those test kits available for use in the laboratory. A philosopher was once credited with the phrase, “The definition of ‘purity’ is limited only by our ability to detect species.” As this ability continues to improve, the probability of finding things in places that were previously considered “immune” will become more the norm. A mere 50 years ago, many analytic measurements were expressed in percentages, since that was the capability at the time. Techniques have improved over time to allow measurement in parts-per-million and then parts-per-billion. Today, parts-per-trillion are becoming common units in which to express the concentrations of many analytes. Some contaminants, like the polychlorinated dibenzodioxins and furans, can now be measured in parts-per-quadrillion concentrations in water! Again, the more closely we look, the more frequently we will find. The challenge will be for the scientists in a corporate environment to use sound, credible, science-based arguments to assure their senior management counterparts that these ultra-trace levels, in most cases, are expected, ubiquitous and pose no risk to product safety.

One area in which opportunities will, sadly, continue to exist is intentional sabotage. Although this risk was always present prior to 9/11, it has now taken on a graver dimension. Food and beverage manufacturers must assure that their processes and products continue to protect the consumer, and a refined, extensive crisis management plan is key to reaching this end. Plant and product security-driven test kits are currently available to test for a variety of chemical and biologically-based toxins. In the summer of 2003, for example, the U.S. Environmental Protection Agency (EPA), as part of its Environmental Technology Verification Program (ETV), placed a high priority on the evaluation of eight commercially available rapid toxicity testing systems for drinking water. These systems were of Israeli, British, Finnish and American design. The systems were challenged with chemical poisons, as well as weaponry agents selected by a panel of experts, and included aldicarb, colchicine, cyanide, botulinum toxin, ricin, soman, VX, and others. EPA issued their final report on these technologies on Dec. 23, 2003. Each system had its own advantages and disadvantages, but this clearly underscores the evolution of rapid test kits in today’s business environment.

Another opportunity for monitoring beverage systems is in the area of food allergens. For traditional carbonated soft drinks, this was rarely, if ever, a concern, since the formulae were relatively simple and the risk of allergenic ingredients or cross-contamination was low to none. Now, as our range of beverage products increases to include a variety of more “functional” or “physiologically significant” fortificants, so should our due diligence with respect to allergens. Again, to meet this growing need, monitoring kits will be needed to accurately demonstrate the absence of any allergenic residues in our products.

Finally, the last challenge for beverage manufacturers—and one that also incorporates the “real” and “perceived” safety concepts introduced earlier in this article—is the topic of genetically modified organism (GMO) regulations. In the United States, the U.S. Food and Drug Administration (FDA) has not promulgated any extensive food laws regulating chemical residues from GMOs in beverages. This is in stark contrast to the European Union, where such directives have been in effect since April 18, 2004. According to EC Regulation 1829/2003 of Sept. 22, 2003, “GMO labelling will be required on final foods delivered to the consumer or to mass catering establishments in the case of foods consisting of or containing a GMO, and/or foods produced from, or containing ingredients produced from, a GMO. Further, a “GMO” is an [non-human] organism, the genetic material of which has been modified in a manner that does not occur naturally by reproduction and/or natural mutation. An “ingredient” is any substance used in the manufacture or preparation of a foodstuff and still present in the finished product, even if in altered form. Additives used as processing aids, carry-over additives, and solvents or media for additives and flavors are not “ingredients.”

In many ways the EU is pioneering the legislation of GMO, and other countries are expected to eventually follow suit. In many cases, we will not have the benefit of a globally-unified lexicon of GMO-related definitions, nor will we enjoy harmonization of laws across the world. The choice of test methodology with which to demonstrate compliance is also likely to vary from agency to agency, and from food matrix to food matrix. For the beverage industry, especially on a worldwide basis, the challenges will be to monitor and proactively assure compliance to these pending regulations.

Future Challenges Require Work-Smart Philosophy
Due to a confluence of factors, including economic and political trends, companies continue to “restructure” or “reorganize.” No matter what the euphemism, this nearly always translates into changing resources—human, financial and intellectual—which, in turn, leads to tremendous challenges in providing a sustainable environment for knowledge transfer. To be proactive with respect to regulatory challenges, one must be seasoned in the field, and must develop a long-term network of formal and informal influence. This cannot be accomplished overnight, or even within a year.

Similarly, this rationale remains valid for nearly all aspects of the beverage industry where a scientific “skills reservoir” is necessary and valued. The need for beverage manufacturers to “work smarter” and more productively will only increase in the next three to five years, which makes the establishment of a formal and sustainable training infrastructure critical.

Daniel W. Bena is currently Senior Fellow with PepsiCo International, and serves as a water subject matter expert for the International Beverage Division. Bena is recognized externally as a technical leader in the field as evidenced by his contribution to numerous texts, articles, and presentations on water and beverage-related topics, and his current Chair of the Water Quality Committee of the National Soft Drink Association in Washington, DC, the beverage industry’s political trade organization.

In addition, he was a contributing member of the NSDA’s Haloacetic Acid and Cryptosporidium Task Forces, where he worked with the EPA during their negotiated rulemaking process for these drinking water contaminants. He has critically reviewed monographs for the Codex Alimentarius Commission, and has authored several papers for submission to government bodies. Bena chairs the Emerging Scientific Interests Subcommittee of the International Society of Beverage Technologists, and serves as Editorial Advisor for Food Safety Magazine. He holds a B.S. in biochemistry, and an M.S. in industrial pharmacy.

Keith Gasser is currently Quality Systems Group Manager for PepsiCo International, with expertise in the manufacturing of high acid non-carbonated beverages. He has served on the Quality Council of the Florida Juice Processors Association, and on HACCP task forces with the National Food Processors Association. He has led facilities towards ISO 9000 certification and HACCP recognition and has contributed to articles and books on the subject. He holds a B.S. in chemical engineering and an M.S. in business.