Hurdle Technology

Many food safety professionals are familiar with the term “hurdle technology”¹. The concept refers to the fact that, in many cases, multiple, low-level mitigations used sequentially or concurrently are more effective at reducing and eliminating microbes than the sum of the individual “hurdles.” The term was coined before “technology” was as omni-present as it is today, with vendors offering technologies that address all aspects of food safety: from the generation of HACCP plans to document control and management, rapid testing, traceability systems, new processing technologies, and many more discussed in this issue of QA. Sorting through all these technologies—and how they fit into your business—can be quite a hurdle.

One common question is how technology might be used to help meet the requirements of the Food Safety Modernization Act (FSMA). The answer, however, generally requires an individual focus on the needs of the company: How can you improve your business and the safety and quality of your products, and thereby protect your brand? Pursuing robust food safety and food quality standards, that include strong preventive controls, will get you to the point of being compliant with what we expect to be in the FSMA regulations.

Many technologies can, however, be related to FSMA, and here we categorize them and discuss how technology can help you overcome some FSMA (and business) hurdles.

Prerequisite Programs. While the preventive control rules are still behind the doors of the Office of Management and Budget (OMB) as of this writing, FSMA specifies that preventive controls include prerequisite programs such as sanitation, training, environmental monitoring, food allergen control programs, recall plans, GMPs, and supplier-verification activities. There are a number of technological innovations that can help firms achieve GMPs and other components of prerequisite programs.

For example, FSMA requires firms to evaluate their sanitation programs, including “sanitation procedures for food-contact surfaces and utensils and food-contact surfaces of equipment.” Given the expectations of environmental testing and concern about allergen cross contamination, there are opportunities both for the providers of cleaning and sanitation chemicals and products as well as manufacturers of equipment to innovate to help food producers better manage sanitation in their facilities, consequently assuring compliance with FSMA.

Preventive Controls.

• Processes. USDA-regulated and a few FDA-regulated products are already required to have HACCP plans. Realistically, many firms have already gone through the process of identifying potential hazards and their critical control points (CCPs) and limits. Gone are the days when thermal processing, pH, salt content, and metal detection are the only CCP options. Researchers continue to identify novel ways to treat foods to reduce or detect potential hazards. Given USDA FSIS’ recent emphasis on verification and validation, firms who choose to use new technologies will want to use processes that have been validated. More conventional technologies benefit from volumes of published data (which in some cases has been used to develop models). Newer processes will need to be thoroughly explored to ensure that the “validation” aspect is covered. Determining and designing appropriate validation studies will require some effort. Firms will need to consider whether studies can be conducted in research environments or if they must be validated in a production center, and whether or not results obtained in one facility using one piece of equipment can be extrapolated to other locations or other equipment. Still, technologies such as irradiation (not new but still limited in use), high pressure processing, cold plasma, and others offer product-dependent benefits that can help firms satisfy consumer, customer, and regulatory expectations for safety and quality.
   
• Testing. Testing helps ensure that the food safety system is working, and includes that of finished products as part of verification activities as well as environmental testing as part of prerequisite programs. Given the short shelf life and/or just-in-time production that exists in many operations, firms are often faced with needing to decide if they should hold product while waiting for test results. Thus, there is a need for tests that are more rapid and more reliable. University researchers and diagnostic firms continue to find new ways to identify problematic food products more rapidly and with greater sensitivity at a reasonable cost. Tests are based on DNA, RNA, proteins, or other molecules, and they vary in the amount of sample preparation, sample volume, detection technology, and specificity. As testing becomes more prevalent, food companies will need to ensure that they are able to properly interpret and analyze results, ensure that appropriate sampling strategies are being used, trends are being determined, and preemptive action is taken when needed. Thus, data management is another area where technology goes hand in hand with FSMA.
   
• Recordkeeping. Of increasing importance, and apparent in FSMA, is a need to manage many different types of records. These include food safety plans that outline the prerequisite programs, HACCP plans, and food defense plans. Data generated as a result of these plans also need to be maintained, as well as documentation of the corrective actions implemented. While the recordkeeping regulations stemming from the Bioterrorism Act of 2002 already require one-up/one-back supply chain information, FSMA authorizes FDA to require additional records related to high-risk foods. And as we’ve seen in many outbreaks, although one-up/back records exist, piecing them together through the supply chain presents some challenges.

Conclusion. Technology should be seen as an enabler, not only to meet regulatory requirements, but more importantly, to protect your products and brands. As and when the FSMA proposed rules emerge, it will be possible to look at the new proposed requirements and provide more concrete suggestions around the use of technology. But as we all wait, it is well worth considering how some of the new technology solutions can be applied to food production that will place food firms in an optimal place to both protect their brands and be compliant with what will likely be in the new requirements.

 

¹Leistner L (1995) “Principles and applications of hurdle technology.” In Gould GW (Ed.) New Methods of Food Preservation, Springer, pp. 1–21.