Aligning hazards with risk: a “prudent” activity

The passage of the Food Safety Modernization Act (FSMA) brought with it some sweeping changes and requirements for nearly every facility that grows, processes, transports or distribute foods. And produce growers — field or greenhouse — are no exception. In fact, it may be the produce growers who have faced the greatest adjustment, since the rule marked the first time that science-based minimum standards were established for this segment of the food industry.

As specifically stated in the Summary of FSMA’s Produce Safety Rule: “The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards.” But because no two facilities are identical — growing the exact same produce under the exact same conditions — individual operations need to consider their circumstances to address relevant hazards and assess the risk.

Thus, FDA goes on to say in the rule that “one way to do this is through the voluntary use of farm-specific operational assessments and food safety plans.” These assessments, it says, “can help farms identify and take measures that may be prudent for their individual operations to prevent the introduction of known or reasonably foreseeable hazards, including any non-biological hazards.”

As a foundational element of FSMA’s Preventive Controls rule, the food safety plan is essentially the written documentation of a food facility’s identification of hazards and development of preventive controls based on the assessment of their risk. So while produce growers need not go to the extent of developing a full food safety plan with all its requirements and intricacies, the application of its hazard identification and risk analysis may be — to apply the words of FDA — “prudent.”

Chart courtesy of FDA

So how does one go about applying this prudence? A good start would be to follow the example of FDA itself, which used a four-step process to inform the development of the standards of the Produce Safety Rule in its qualitative risk assessment on produce contamination. The process focuses on the application of a hazard analysis, which, as used by FDA, is defined as “the process of collecting and evaluating information on hazards and the conditions leading to their presence to determine which hazards are significant for food safety and therefore should be addressed.”

Hazard identification and risk analysis. While FDA’s process included hazard identification, hazard characterization, exposure assessment and risk characterization, produce growers can use a somewhat simpler version combing two of these and adding the management step, as follows:

1. Identify the hazard. Identify any potential biological, chemical and physical hazards, such as those directly related to each specific produce item and process, any biological amendments used and hazards that could be introduced from the environment are ascertained. These should include any “known or reasonably foreseeable hazards” capable of causing adverse health effects and can be determined through a brainstorming session, facility historical data, as well as research into relevant sources (scientific literature, outbreak data, government or industry food safety guidance documents, historical data for similar products, etc.). Some additional considerations should include:
• Intended use and distribution (e.g. direct to retail, or will it undergo further processing?)
• Past experience with the produce, such as product testing results and consumer complaints
• Pathogens known to be associated with specific produce or biological amendments used
• The condition, function and design of the greenhouse that could cause contamination
• Processing activities and equipment used to make the product (e.g., ease of cleaning, potential for damage, cross contamination of allergens, etc.)
• Sanitary conditions of the greenhouse and employee hygiene
2. Characterize the hazard and assess exposure. The hazard characterization is essentially a dose-response assessment. That is, it is the probability of a microbiological hazard occurring to the level (dose) that it could cause an adverse health effect (response). It provides a qualitative description of the adverse effects of hazards that may result from consumption of contaminated produce. Similarly, exposure is the level of contamination in the food related to the quantity of the food consumed. A variety of factors should be considered in evaluating exposure, such as the likelihood of produce contamination from water, soil amendments, animals, workers, equipment and buildings. For example, the table on page 30 shows FDA’s evaluation of the relative likelihood of produce becoming contaminated with pathogens of public health concern from soil amendments.
3. Manage the risk. With the hazards identified, assessed and prioritized, produce growers can more efficiently and effectively manage the associated risk. It is important to remember, though, that risk management is not a one-time activity. Rather, potential hazards should be regularly re-assessed and the management plan re-worked and updated as needed for control.

The Produce Safety and Prevent Controls rules of FSMA are separate and distinct, but there are aspects that overlap as recommendations, if not requirements. As FDA states, in full, “Although we are not requiring that covered farms conduct operational assessments or develop food safety plans, we continue to believe that such assessment can help farms identify and take measures that may be prudent for their individual operations to prevent the introduction of known or reasonably foreseeable hazards.”

Lisa is the editor of Quality Assurance & Food Safety (QA) magazine. llupo@gie.net