Food production is a challenging business, and every detail can contribute to staying competitive and profitable. Developing a food safety plan is a key element in improving the odds of success. Small businesses may not be required to have a food safety plan, but they should consider taking the time to develop and maintain a plan that is developed specifically for their product.

Who is Required to Have a Food Safety Plan?

In 2011, the Food Safety Modernization Act (FSMA) was signed into law, marking the most significant update to U.S. food safety laws in over 80 years. FSMA shifted the approach to food safety from reacting to problems to preventing them. However, it mainly focused on larger food companies.

Smaller businesses—those with under $1.2 million (adjusted for inflation) in average annual sales of human food over the previous three years—are exempt from FSMA's Preventive Controls for Human Food (PCHF) rule. According to the U.S. Food and Drug Administration (FDA), out of approximately 72,000 U.S. food manufacturers, about 46,685 must follow the PCHF rule.^1,2 That leaves roughly 25,315 manufacturers that are exempt and not required to have a written food safety plan.

Still, even if it is not required, having a food safety plan is highly recommended for small-scale producers. In fact, it can be argued that a food safety plan is the most critical element of a food manufacturing business. Even the very best food will not be well-received if it harbors pathogens and sickens customers. A food safety plan is developed to make sure that food products are consistently safe. Developing a plan includes examining every step of production for safety. Analysis starts with ordering ingredients, and then following those ingredients through receiving, storing, processing, shipping, and final use of the product.

Developing a food safety plan is especially important for entrepreneurs with limited food manufacturing experience and few resources. Without a clear understanding of food safety hazards, they risk causing harm to consumers—and to their business. A food safety plan helps minimize these risks and ensures the production of safe food. No matter the company size, having a food safety plan in place is just good business.

A Food Safety Plan is Part of a Food Safety System

A food safety system is a set of practices that work together to ensure that manufactured food is safe for consumption. An effective system should include:

• Current Good Manufacturing Practices (cGMPs): These cover basic hygiene, sanitation, and facility maintenance.
• Prerequisite programs: These include cleaning procedures, water quality, equipment upkeep, pest control, and training programs.
• Written food safety plan: FDA defines a food safety plan as "the primary documents in a preventive controls food safety system that provides a systematic approach to the identification of food safety hazards that must be controlled to prevent or minimize the likelihood of foodborne illness or injury."³ In short, it is a step-by-step guide to identify and manage food safety risks, including how to respond if something goes wrong.

Together, the system elements create the foundation for safe food production.

Why a Food Safety Plan Matters for Small Companies

While hard data on recalls by small companies is limited, most food recalls are caused by issues that a food safety plan can prevent—such as contamination or labeling errors.⁴ A study by DeBeer et al. (2023) found that 95 percent of recalls between 2020 and 2023 were due to biological, chemical, physical, or allergen-related hazards—exactly the issues that a hazard analysis in a food safety plan is designed to catch.⁴

By developing and using a food safety plan, small businesses can reduce the likelihood of a recall. If a recall is ever necessary, having a plan in place helps ensure a faster and more effective response.

"Extension agents are a great resource for finding research-based information and local regulatory requirements."

Getting Started

Small businesses can develop a food safety plan by:

• Having a team member complete the Preventive Controls Qualified Individual (PCQI) training course. This is an excellent training that delivers detailed information on all parts of building a food safety plan. Upon completion, participants receive a PCQI certificate and should have all the knowledge and tools needed to construct a food safety plan.
• Hiring a food safety consultant. Consultants can be helpful and may speed up the process, but they can be expensive.
• Seeking help from a land grant university's cooperative extension service. Extension agents are a great resource for finding research-based information and local regulatory requirements.

Step 1: Describe the Facility and Products

Start by documenting:

• A description of the facility and food safety team.
• A product description, including what is made, its final form, and the intended customer.
• A step-by-step overview of how the product is made—from receiving ingredients to shipping the final product.

It is helpful to create a flow diagram to visualize this process. Include all ingredients, packaging materials, and steps. Involve employees who work on the production floor, as they can help ensure that no steps are missed. Missing a step here could mean missing a critical hazard later.

This section can also convey useful information to customers, employees, suppliers, auditors, and inspectors. Including the history of the company, vision statements, and other items of interest can be a good marketing tool and help convey a culture that is built on safety and quality.

Step 2: Conduct a Hazard Analysis

This is the most time-consuming, but most important, part of the plan. Using a flow diagram, evaluate each step for potential biological, chemical, or physical hazards. For each identified hazard, determine whether:

• It is reasonably likely to occur. If so, it must be controlled using preventive controls.
• It is unlikely to occur. If so, it may be managed under cGMPs or other prerequisite programs.

A common pitfall is identifying too many preventive controls. This can lead to an overwhelming and impractical amount of monitoring and recordkeeping. While conducting a hazard analysis, there is one key question for each potential hazard: "Is this hazard reasonably likely to occur and cause illness or injury to the consumer?"

• If the answer is yes, then it should be managed with a preventive control.
• If the answer is no, then the hazard should still be addressed—but through cGMPs or another prerequisite program.

In practice, most food safety plans contain five or fewer preventive controls. Being selective and strategic ensures that the plan is both effective and manageable.

Step 3: Identify Preventive Controls

The most common types of preventive controls are:

1. Process preventive controls: Used when a hazard can occur during processing. Example: Cooking chicken to 165 °F to prevent Salmonella. The plan must define the critical limit (normally a numeric value), how to monitor it, what to do if something goes wrong, and how to verify it is working.
2. Allergen preventive controls: Ensures that allergens are declared on labels and that there are cleaning protocols in place to prevent allergen cross-contact. Example: Having procedures in place to cross-check for allergens if any ingredients must be substituted. Another example is to include a step to check labels, for each production run, to confirm that the allergen statement is declared and is legible.
3. Sanitation preventive controls: These controls go beyond standard cleaning (cGMPs) to control risks like environmental pathogens or allergen cross-contact. They must detail who is responsible, how and when to clean, and how to verify effectiveness. Example: Sanitation controls can be a preventive control when food contact surfaces have been identified as a potential source of biological contamination and require a sanitation step to reduce or eliminate a pathogen. In this case, the sanitation preventive control would include documenting the details of the sanitation step.
4. Supply chain preventive controls: Applied when a supplier is responsible for managing a hazard. Example: If a company depends on its supplier to pasteurize eggs to eliminate Salmonella, then the food safety hurdle is applied with the supplier. Companies must verify that the supplier is controlling the hazard through documentation and approved supplier programs.

"Every food safety plan must include a recall plan. This plan outlines how to identify affected products, notify customers, and quickly remove products from the market."

Step 4: Documentation and Record-Keeping

"If it isn't written down, it didn't happen." Documentation proves that a food safety system is being followed and working.⁵ This includes:

• Monitoring records
• Corrective actions
• Verification and validation activities
• Supply chain documentation
• Training records.

These records help spot breakdowns in the system—and may even prevent a recall.

Step 5: Develop a Recall Plan

Every food safety plan must include a recall plan. This plan outlines how to identify affected products, notify customers, and quickly remove products from the market. A well-constructed plan will help reduce chaos and stress, should a recall be necessary. This can help producers make smart decisions while maneuvering through the process. It is a best practice to conduct a mock recall annually to test the plan and make sure products can be traced both forward (to customers) and backward (to suppliers).

Example: A recent recall of cucumbers. An investigation implicated fresh, unprocessed cucumbers with more than 50 illnesses across numerous states.⁶ The cucumbers, which were found to be contaminated with Salmonella, were an ingredient used by multiple companies in prepared salads and other food products. This is a good reminder that while companies can do their very best to avoid a recall, it is not always in their control.

Does developing a food safety plan require more time and paperwork? Yes, but the payoff is worth it. By investing in a well-structured food safety plan, small-scale food companies can protect their customers, safeguard their brand, and strengthen their long-term success—even if they are not legally required to have a plan.

As you begin the process, keep in mind that many of the necessary practices and procedures may already be in place. Often, developing a food safety plan is simply a matter of documenting what you are already doing and identifying any missing pieces that need to be formalized.

Acknowledgment

The authors thank Janet Riley of Janet Riley Strategies, Andrew Clarke of Loblaw Companies Ltd., and Mark Beaumont of Danone for their insights shared at the “Food Safety Culture and Communication” session at the 2024 Food Safety Summit.

References

1. Smartscrapers. "List of Food Manufacturers in United States." May 5, 2025. https://rentechdigital.com/smartscraper/business-report-details/list-of-food-manufacturers-in-united-states.
2. King, H. and W. Bedale. Hazard Analysis and Risk-Based Preventive Controls: Improving Food Safety in Human Food Manufacturing for Food Businesses. Elsevier, Academic Press: 2018. https://books.google.com/books?hl=en&lr=&id=VYuZDgAAQBAJ&oi=fnd&pg=PP1&dq=how+many+very+small+food+businesses+are+exempt+from+the+preventive+control+for+human+food+rule&ots=D1SCLrTfvU&sig=lS682BsoirZxD0zPawxcWU5d0ek#v=onepage&q&f=false.
3. U.S. Food and Drug Administration (FDA). Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry. https://www.fda.gov/media/99547/download
4. eDeBeer, J., E.R. Blickem, Y.S. Rana, D.M. Baumgartel, and J.W. Bell. "An Analysis of  Food Recalls in the United States, 2002–2023." Journal of Food Protection 87, no. 12 (December 2024): 100387. https://doi.org/10.1016/j.jfp.2024.100378.
5. Food Safety Preventive Controls Alliance (FSPCA). Training Manual for the FSMA PCHF Training Course, Version 1.2. https://www.fspca.net/pc-human-food-preventive-controls-qualified-individual.
6. FDA. "Outbreak Investigation of Salmonella: Cucumbers (May 2025). Content current as of June 30, 2025. https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-cucumbers-may-2025.