A safe food supply is essential to health and consumer confidence. In order to prevent food borne illnesses, which impact nearly 50 million people in the US annually, regulatory standards are required of most food production operations. However, compliance with current and future safety rules and documentation regulations is becoming increasingly streamlined and simpler through the use of technology. As the baking industry settles into the era of the Food Safety Modernization Act (FSMA) and implements measurement and reporting protocols, positive results are starting to emerge.

FSMA, the 2011 Food Safety  Modernization Act, modified the FDA dynamics to be more proactive, concentrating on prevention of food safety issues rather than reacting after the fact.

What does FSMA include?⁷

FSMA has seven different rules designating specific actions to take at various points to ensure food safety.

1. Produce safety rule: Mandatory rules for producing/growing, harvesting, packing, and storing edible products.
2. Preventive control for human food: Under this category, good manufacturing practices, hazard analysis, and risk-based preventive management are the focus. To identify and minimize hazards, food facilities must have a food safety plan with hazard analysis and risk-based preventive control.
3. Preventive controls for animal food: This segment centers on animal food with the same goal of good manufacturing practices as discussed in rule #2.
4. Foreign supplier verification programs(FSVP): FSVP requires that importers conduct regular risk-based activities to verify that the food shipped in the US meets US food safety standards.
5. Accreditation of third-party auditors/certification body: This authenticates a voluntary program for accreditation of third-party certification organizations, also known as third-party auditors. These examiners conduct food safety inspections and issue certification of foreign entities and foods they produce.
6. Sanitary transportation of human and animal food: This section covers defending food transport from farm to table by keeping it safe from contamination during transportation.
7. Prevention of intentional adulteration: The rule for mitigation strategies aims to prevent deliberate adulteration. It encompasses acts intended to cause broad-scale harm to public health and acts of terrorism targeting the food supply.

The first task is to determine which rule(s) apply to your entity and start working on a specific program. Once developed, following the below protocols will help maintain a robust food safety program.

• Recognizing hazards
• Identifying preventive controls
• Building a supply chain endorsement program
• Establishing a recall plan

FSMA and the Bakery Industry

Over the last decade, bakeries have had time to prepare for key compliance dates, based on the size of the operation.  There are exemptions to the laws with exceptions for commodity, risk, size of the facility, and other factors.¹ Most bakery-related compliance deadlines fell between 2016 and 2018, with some deadlines as late as 2020 for small businesses.

With all compliance dates now reached, the  positive impact of the rollout is starting to show. So far, the international supply chain’s adherence to  FSMA rules is yielding good outcomes. When comparing countries compliant to the original GFSI rules (on which FSMA was based), the United States is leading in compliance. There have been over 10,762 compliance actions in the United States, which is higher than anywhere else in the world.⁹

Research on the impact of FSMA concludes that the highest food-borne illness cases arise from companies with less than 100 employees. Improving food safety in this particular segment can help FSMA achieve its stated purpose (US FDA, 2018, January 30).⁴ Although FSMA rules were published in 2011, the dynamics of the food industry and food processing means staying abreast of the latest developments, regulations and changes to previous methodologies.

The Future of Food Safety

While adherence to regulations has been widely embraced, the FDA aims to improve the ease of compliance by  making food safety smarter.  In July 2020, the latest blueprint was announced. Among its objectives, the new guidance seeks to integrate:

1. Tech-enabled traceability
2. Smarter tools and approaches for prevention and outbreak response
3. New business models and retail modernization
4. Food safety culture

Some expect that the FDA will propose that the guidelines become law as early as  2022, so getting your technology house in order sooner rather than later will ensure a smooth transition.

Technology Already Making Compliance Easier for Bakeries

The HACCP (Hazard Analysis and Critical Control Point) in FSMA’s second rule requires eliminating Salmonella pathogens to an acceptable level. Validating and tracking this elimination, or “kill step,” is a crucial requirement for baked product sales in the US.

To address this requirement, AIB International collaborated with the Kansas State University, University of Georgia, and American Bakers Association Food Technical and Regulatory Affairs Committee to develop scientific validation procedures for safety of bakery products. Following a series of experiments, AIB published articles discussing the validation step for controlling Salmonella in different bakery products such as hamburger buns,⁷ breads, cakes, and other baked goods in April 2016.⁸  The kill step calculator utilizes the product’s internal temperature and time of baking to determine the process lethality for Salmonella in log values.

By using the kill step calculator with a thermal profiler, bakers can automatically calculate and provide acceptable lethality based on an extensive scientific program. Furthermore, the program also filters the data through three-way validation and generates the report. These records are compliance proof for FDA auditors.

There are many elements to FSMA compliance, but automating the kill step reporting will help save time, reduce reliance on third-party consultancies and ensure excellent record keeping with a tool and platform that serves many other functions within the baking operation.
 

References

1. https://www.fda.gov/food/food-safety-modernization-act-fsma/compliance-date-extensions-and-clarifications-fsma-final-rules
2. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food
3. Vega, D. (2021). Food Safety Interventions in the Bakery Industry: Microbial Safety from Wheat Milling to Finished Baked Products (Doctoral dissertation).
4. Suprin, M. (2021). Was Food Safety Modernized? The Impact of the Food Safety Modernization Act (Doctoral dissertation, Northeastern University).
5. Grover, A. K., Chopra, S., & Mosher, G. A. (2016). Food safety modernization act: A quality management approach to identify and prioritize factors affecting adoption of preventive controls among small food facilities. Food Control, 66, 241-249.
6. https://www.fda.gov/media/108775/download
7. Channaiah, L. H., Holmgren, E. S., Michael, M., Sevart, N. J., Milke, D., Schwan, C. L., … & Milliken, G. (2016). Validation of baking to control Salmonella serovars in hamburger bun manufacturing, and evaluation of Enterococcus faecium ATCC 8459 and Saccharomyces cerevisiae as nonpathogenic surrogate indicators. Journal of food protection, 79(4), 544-552.
8. https://www.aibinternational.com/inspections-consulting/baking/kill-step-validation/
9. https://datadashboard.fda.gov/ora/cd/complianceactions.htm