While I think everyone would agree that Russian roulette is a risky endeavor, not everyone would concede that zip lining, rock climbing or skydiving are risky activities. The ambiguity of “risk” can be extended to the Food Safety Modernization Act (FSMA) regulations, particularly the designation of “high-risk” foods and the mitigation of the intentional adulteration of foods.

In contrast to a subjective definition of risk, the Food and Drug Administration (FDA) is actively developing an objective definition of risk pertaining to food safety hazards.

Since the enactment of the comprehensive food safety law more than eight years ago, the FDA has gradually developed the core FSMA regulatory requirements and has begun a staggered approach to enforcement.  However, the slow pace of the FSMA regulatory progress has triggered several lawsuits by consumer advocacy groups and others. Due to a spike in foodborne illness outbreaks last year, several groups demanded the complete implementation and enforcement of the FSMA regulations.

In October 2018, the Center for Food Safety (CFS) and the Center for Environmental Health (CEH) filed suit against the FDA for its failure to comply with the FSMA deadline for issuing a list of high-risk foods.

The lawsuit was reminiscent of a 2012 lawsuit filed against the FDA by several consumer groups due to missed FSMA deadlines for core regulations, including the final rule to prevent the intentional adulteration of food.  

The advancement of the new FSMA regulations might challenge the food industry. How will the upcoming implementation of the intentional adulteration rule and a final list of “high-risk” foods impact food companies? Will an FDA list of “high-risk” foods taint consumer perceptions of the safety of such products?

Defining “High-Risk” Foods

Under FSMA, the designation of “high-risk” foods refers to potential food safety hazards, but the definition of a “high-risk” food facility is more closely related to historical facility inspections. The process for the identification of high-risk food facilities for increased inspections is based on two risk factors: 1) poor compliance history or 2) the known safety risks of food manufactured, processed, packed or held at the facility.

The food safety law mandated the establishment of a list of “high-risk” foods as well as additional recordkeeping requirements to improve traceability of such foods during a foodborne illness outbreak. Currently, the proposed criteria for defining high-risk foods emphasizes historical food safety data. A few industry comments on the draft criteria questioned how the FDA might modify the list in response to the emergence of new food safety issues in a previously “safe” product. For example, peanut butter was previously considered to be a “safe” product, but the risk of Salmonella in the product was clearly established by foodborne illness outbreaks.

In light of recent outbreaks linked to leafy greens, several consumer groups recently petitioned the FDA to designate leafy greens as “high-risk” foods and to impose more stringent recordkeeping requirements for all fresh produce.

The FDA draft approach for defining “high-risk” foods suggested the following criteria should be considered: (1) outbreak frequency and illness occurrence, (2) severity of illness, (3) likelihood of microbial or chemical contamination, (4) microbial growth potential/shelf life, (5) the probability of contamination and steps taken during manufacturing to reduce contamination, (6) food consumption patterns, and (7) economic impact.

An evaluation of both microbial and chemical hazards will be considered to determine the risk of a specific food. The total risk score for a food or food category would be determined by an assessment of various factors, including the number of foodborne illness outbreaks, recalls and other food safety issues reported annually. The chemical hazards to consider include: allergens, mycotoxins, pesticides, heavy metals, industrial chemicals and other chemicals formed during processing.

To date, the FDA has coordinated pilot programs of the traceability of high-risk foods and solicited public comments on its draft approach for the review and evaluation of data to designate foods as high-risk. The Institute of Food Technologists (IFT) conducted pilot programs for processed foods and fresh produce under the FDA’s direction in response to the FSMA mandate for evaluating the traceability of high-risk foods. Within the IFT final report  (2013), the organization suggested that the FDA should establish a uniform set of recordkeeping requirements for all foods regardless of risk classification.

The ramifications of the high-risk designation for the food industry may include implementation of separate recordkeeping protocols, mandatory tracing procedures, and increased FDA inspections of facilities producing high-risk foods. In addition, the FDA will likely increase inspections of the records for non-high-risk foods manufactured within a facility producing high-risk foods.

Defending Against IA Risks

In May 2016, the FDA issued the final rule for Mitigation Strategies to Protect Food Against Intentional Adulteration (IA), which is commonly referred to as the “food defense” rule. Under the final rule, each covered facility would be required to prepare and implement a written food defense plan addressing vulnerabilities and actionable process steps, mitigation strategies, monitoring procedures, corrective actions and verification activities.

The food defense rule represents a shift in focus from other FSMA rules. While several core FSMA rules are focused on specific foods or hazards, the food defense rule is focused on strategies to reduce risks for vulnerable processes.

To support industry compliance with the rule, the FDA has issued a revised draft guidance for the industry (March 2019), posted a fact sheet, and held a public meeting this year to discuss the requirements.  

In general, the FDA follows an “educate before, and while we regulate” approach to FSMA inspections.  The general industry compliance date for the IA rule is July 26, 2019, and the agency will begin enforcement of the rule in March 2020. Small businesses and very small businesses must comply by July 2020 and July 2021, respectively.   

Understanding Your Risks

Due to the significance of a high-risk designation, the food industry should closely monitor the development of the final FDA list of high-risk foods. Moreover, anyone responsible for complying with the various FSMA regulations should understand the potential risks associated with their products.

Food industry professionals can obtain a wealth of food safety information from the scientific literature, food recall data, public records of facility inspections, warning letters and outbreak investigation reports. A scientific literature review can provide foundational information regarding the potential microbial, chemical and physical hazards associated with a specific food matrix, technology, process or environment.

Mérieux NutriSciences‘ experts also offer consultation services to ensure your facility is following food safety best practices and meeting requirements set forth by FSMA. Our experts can perform an FDA readiness gap assessment, build your plant’s food safety plans and perform a comprehensive hazard analysis on your ingredients to make sure your final product is safe for consumers.


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