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Chapter 5: Food Safety Basics

Producing a product safely.

Consumers trust that the food they buy is safely processed and handled. They believe that food companies make food safety a priority. Food safety is critical for any food business. Food safety is a part of every aspect of production, including ingredient sourcing, processing, packing, shelf life, storage, delivery, and staff training and labor practices. Food safety starts at the beginning! Preparing a food safety plan for your product(s) helps to reduce risks for both your customers and business. 

To properly operate a food business, food manufacturers must understand the facets within food safety. Before production begins, you’ll need to know the food regulations that are specific to your product, secure any permits or certifications, and implement appropriate controls to manage any food safety hazards. Training resources are listed at the end of this chapter.

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General Food Handling

General Food Safety Table

Why is food safety important?

The most important thing to understand about food safety regulation is the multiple, overlapping jurisdictions. Depending on the food products produced and the manufacturing location, a producer may be subject to local regulation, state regulation, and federal (FDA or USDA) oversight. Farm to Institution New England has an excellent resource on this topic: “Food Safety Regulations, an Introduction for Entrepreneurs.”  

If foods are not processed or handled properly, a public health issue can result. Identifying major (biological, chemical, and physical) concerns and implementing monitoring activities will help to control these health concerns, ensuring the safety of our food supply. Table 4, below, outlines regulations by food category, to show what certifications are needed for juice versus seafood for example. 

Who federally regulates food production in the United States?
Within the United States, two different bodies regulate food: The United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA). When starting a new food business, you will need to determine which regulating body will oversee your production. 

The USDA covers meat and poultry (including egg products). The FDA monitors the remaining food products including dairy, seafood, produce, packaged foods, bottled water, food/color additives, and meat products with less than 2% cooked meat and whole eggs. This is important as food safety covers the entire spectrum of food. However, specific foods will require more rules due to their unique risks.

Overall, enforcing strict good manufacturing practices (GMP’s), standard operating procedures (SOP’s) and other food safety measures in your production and facility will protect consumers from risks of foodborne illnesses, allergies, and other hazards. By preventing these potential hazards, you will be able to produce a safe, quality food product. 

This chapter: 

  • Introduces the basics of current good manufacturing practices (cGMPs) and food safety concepts. 
  • Demonstrates the value of developing and managing a food safety plan.
  • Outlines a variety of food safety-related government regulations. 
  • Discusses the importance of record keeping. 

Understanding these big picture food safety concepts will be a foundation for your business’s growth. 

By reviewing the content below, we hope that you will understand that: 

  • Food safety is an important consideration when developing and producing a new food product. 
  • Food regulations and food safety risks vary by the type of food you are producing.
  • It is the food business’s responsibility to identify and manage the risks specific to their food and processing facility. 

FSMA: The Food Safety Modernization Act

The Food Safety Modernization Act (FSMA) was passed in 2011. This law gives the FDA additional regulatory authority over food production to help reduce the incidence of foodborne illness in the U.S. food supply. 

Within FSMA, there are seven newly added regulations to prevent contamination at every stage of production. These rules ensure that food safety is considered from beginning of the process to the end. They apply to both human and animal food products. 

While there are seven added regulations, the Preventive Controls for Human Food (21 CFR 117) (preventive controls rule) is the regulation that requires covered food facilities to develop and implement a food safety plan. Food facilities must comply with the standards outlined within the rule. 

cGMPs
Current Good Manufacturing Practices (cGMP) or Good Manufacturing Practices (GMP) are general practices that help ensure that the processing facility operates in a clean and safe working condition. The preventive controls rule requires that all food processing facilities operate under GMPs regardless of the type of food being processed. The preventive controls rule requires products to be safe and controlled, whether in storage, manufacturing, processing, or packing. CGMP covers the following areas of the facility. These rules (Preventive Controls for Hum Food CFR Title 21: Part 117, Subpart B) are standard and will keep your product safe.

  • General Personnel
  • Plant and ground
  • Sanitary Operations
  • Sanitary facilities and controls
  • Equipment and Utensils
  • Processes and Controls
  • Warehousing and Distribution
  • Holding and Distribution of human food by-products for use as animal food
  • Defect Action Levels

Whether you are in the initial phases of product development or already producing in a commercial food facility, implementing systems to manage GMPs is important. It ensures that products are consistently produced and controlled according to quality and food safety standards. Establishing an effective GMP program helps provide strong foundational support for the development of a food safety plan. If you are working with a co-packer or contract manufacturer, you may be able to operate within their established GMPs.

Food safety plans and food safety regulations

A food safety plan is a written document specific to your food product and the facility in which it’s being processed to manage food safety risks. The plan:

  • Identifies potential hazards, 
  • Establishes a control for managing each hazard,
  • Identifies the actions needed if there is an issue, and
  • Provides details about how to handle a problem that poses a threat to public health. 

Developing and implementing a food safety plan is a valuable systematic approach that helps your operations have Preventive Controls, in other words, controls in place that prevent a potential hazard. These controls will prevent or minimize the incidence of foodborne injury, illness, or death. 

The FDA rules include several food regulations specific to the type of food produced and/or processing method. As previously mentioned, due to the different nutritional compositions of food, each food product introduces a different set of food safety considerations.

How the food is regulated and what is required for regulatory compliance may vary depending on the regulation. As the owner of a food business, you have a responsibility to review food regulations and understand which ones pertain to your product. 

Table 4, below, summarizes that within the federal regulations, several food safety rules are housed within the USDA and the FDA. The Table also outlines regulations by food category.

Food Safety Table

General components within a food safety plan

The FDA requires a food safety plan for all food processors that must comply with a federal regulation (for example, HACCP vs. Preventive Control). However, the components within each plan vary depending on the type of food regulations. Find a general overview of the key components of the food safety development process below. It shows the type of information required in food safety plans. 

Suppose your business is small enough to be exempt from federal regulations. In that case, it is still valuable to identify the food safety risks associated with your particular food and food processing facility. Establishing a process for managing these hazards will help protect your customers and business. When contracting a food safety plan, a process flow diagram can help you layout your facility operation and map out your needed parameters and values at your preventive controls.

General elements of a food safety plan include:  

  • Hazard Analysis: The first part of the food safety plan consists of identifying any potential hazards. They include physical (e.g., metal or rocks), chemical (e.g., allergens or pesticides), or biological (e.g., bacteria and viruses) concerns that have the potential to cause a public health issue. Conducting a hazard analysis starts by identifying all the raw materials and processes used to produce the product. Then systematically ask: “is there a reasonable likelihood for a hazard to exist?” 

For example, let’s say we were assessing the hazards of a pasteurized fruit drink. It is reasonably likely that one of the starting raw materials, fruit juice, would have a biological hazard as pathogens may be present. So the cooking step, in this case, pasteurization, is a process that could help control this hazard.   

  • Controlling the hazard: If you identify a hazard in your operation, it is important to identify a control that will help manage this hazard. When implementing a control specific to a processing step, you must identify a scientifically validated method that can help manage the concern. For example, if you were pasteurizing a fruit drink, you would look to a peer-reviewed scientific journal that contains an article about that specific process. You would follow the time and temperature noted in the article that demonstrates significant microbial reduction (usually 4-6 logs) in the “pertinent microorganism.” 
  • Establish controls: Once you have identified the methods to control the identified hazard, you will need to determine the appropriate parameter, value, or control limit. These are the conditions that must be maintained to ensure the safety of your food product. An example could be using a specific time and temperature condition to process the fruit drink.
  • Monitoring the hazard: The next step is to implement a monitoring activity that routinely confirms the control is being met throughout production. This checkpoint demonstrates your operation is managing the food safety concern. For the fruit drink processing example, the monitoring activity could be the use of a calibrated thermometer and timer on each production batch. You would document the monitoring activities. This record provides evidence that your operation has control over the food safety hazards.
  • Oversight and management: In addition to the monitoring activity, it is important to have a system that verifies the plan is working. If there is an operational failure within your process, you will need to identify and record any corrections and/or corrective actions made. You need to demonstrate that you were able to safely return to producing a safe food product before any hazard could be released into the local food system. Some verification activities include record reviews, food test sampling, and/or third-party auditing.  
  • Recall plan: A recall plan is a systematic process that can efficiently identify and return (recall) food products from commerce. Recalls occur when there is reason to suspect that the implicated food product may cause a public health concern (illness, injury, or death). Some examples of why a product would be recalled include microbiological contamination (such as Salmonella or Listeria monocytogenes), the discovery of a physical contaminant (such as shards of glass), or a chemical contaminant (such as an undeclared allergen). The recall plan provides details that help the business quickly and efficiently retrieve all the food back to ensure consumer safety. 

Preparing and implementing a proper food safety plan requires a strong knowledge of what your food product is and how it is processed. New food entrepreneurs should understand the potential risks for their products early in the development process. This ensures that you identify the appropriate food safety controls to produce a safe product from the start. 

Validation vs. verification
Food safety plans often include the terms validation and verification. While these two terms sound similar, they are different, and both support your food safety plan. 

Validation is the scientific and technical information that determines that your food safety controls effectively control the hazards. 

Verification refers to the activities that help ensure that the food safety plan is operating as intended. 

Validation and verification are different in that; if your validation is invalid, then your verification will not be able to control the hazard because the Critical Control Point (CCP - described in the HACCP section) is not accurate to remove, reduce, or prevent the hazard. 

Preventive controls
Within the newly implemented FSMA regulation, Preventive Controls for Human Food is a regulation that requires a food safety plan for foods other than meat, poultry, seafood, or juice. The development of a new food product must be controlled to reduce and remove any hazards. You will develop, maintain, and oversee these control points in your facility. Preventive controls are organized into four categories:

  • Process preventive control: Process control is included in any process of your product that needs a value or critical limit to maintain the food’s quality. Some examples of values may include refrigerating, cooking, and possibly acidifying. A process control must have a scientifically validated method that helps demonstrate that the food safety control will manage the hazard. 
  • Food allergen preventive control: The nine most common allergens are: milk, eggs, fish shellfish, tree nuts, peanuts, wheat, and soybean, and sesame, which was added in April 2021. Producers need to be sure there is no cross-contamination within the operation. You also need to take all appropriate measures to ensure that allergens are accurately declared on the food product label. If selling outside the U.S., there may be additional allergens to consider. For example, the EU considers mustard and celery to be allergens.  
  • Sanitation preventive control: Some food operations may not have a known processing step that will remove or reduce a risk. Therefore, a significantly heightened activity may be needed to clean and sanitize certain facility areas and/or production equipment. This step helps minimize the hazards from surfaces and the environment. 
  • Sanitation controls include a written standardized procedure (SOP) with a monitoring activity to confirm that the cleaning and sanitizing were conducted appropriately and a record to demonstrate that the activity was completed.
  • Supply Chain preventive control: Some food product operations may have a hazard that they cannot control in their process. Therefore, more scrutiny from where they source their raw materials may be required. A supply chain preventive control means the processor uses supporting documentation from their supplier as the control. These supplier records demonstrate that the supplier properly managed the hazard.

Attestation and exemptions for “very small businesses”
Attestation is a written statement by the processor verifying that the contents are formally certified or witnessed. Issuing an attestation to the FDA for your facility means that your business is in compliance with non-federal food safety laws and regulations or is capable of integrating preventive controls to prevent any hazards with its foods (21 CFR part 117 subpart A, B, C, D, E, F, G and 21 CFR part 507 subpart A, B, F). 

To do so, you will need to attest to FDA’s Form 3942a (for human food as 3942b is for animal food) attesting to two claims. First, the facility must be defined as a “qualified facility,” meaning that your facility qualifies for modified requirements, rather than full requirements, of the preventive controls rule. Second, that your production adheres to the state/local/county non-federal food safety law based on licenses, inspections, permits, certifications; or that you have identified and prepared preventive controls that will be monitored to ensure control of effectiveness. 

We encourage you to develop and implement a food safety plan as a best practice. It is required for processors covered under the PC rule and those that process meat, poultry, seafood, or juice (HACCP plans). However, fully written food safety plan exemptions for preventive controls are allowed for a “very small business” instead of a “qualified facility.” If you are a “very small business,” you will still need to attest to FDA’s form (3942a/3942b). There will be a section for your exemption. 

Please note that being a “very small business” does NOT mean that you are exempt from the second section of complying with non-federal food safety laws and regulations. You are also required to integrate preventive controls to prevent any hazards. 

As defined in Title 21 CFR 117.3, “qualified facility” must require: “(1) During the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and

(2) The average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.”

As “very small business” is defined as (Title 21 CFR 117.3), ”a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (for example, held for a fee).”

HACCP
Hazard Analysis of Critical Control Points (HACCP) is a process that helps to identify, evaluate, and control any food safety hazards. It is required by law for seafood, juice, meat, and poultry manufacturers to systematically identify and control known food safety hazards. HACCP is broken down into seven principles at which your HACCP Plan would be identified to control process specific hazards. The seven principles are described below.

  1. Conduct a hazard analysis: All food has some form of hazard, whether they are physical, chemical, or biological. These hazards can occur at any point, from storage to processing to even packaging. With this, you will need to evaluate, identify, and determine the biological, chemical, and/or physical hazards that exist within your product and facility.
  2. Determine the critical control points (CCPs): After identifying the food safety hazards, you will need to establish a means to control these potential hazards at a specific point in the production process. 
  3. Establish critical limits: By setting up a “critical control point (CCP),” you establish the limit that deems the critical conditions needed to manage the hazard. CCP would be set up only for the “critical limit” to have a set maximum/minimum parameter to prevent, eliminate, or reduce the hazard to an acceptable level.
  4. Establish monitoring procedures: With critical control points and critical limits established, you will need to monitor these CCPs. It ensures that the food is being processed safely with controlled hazards. You will also need to record these monitoring actions for future use in verification.
  5. Establish corrective actions: Issues will arise. They may be human error, machinery malfunction, or something unexplainable. In these situations, you will need an appropriate procedure to either correct the issue or prevent the unsafe product from reaching the consumer whenever a deviation occurs.
  6. Establish verification procedures: With verification, you will need to review and/or check all activities and monitoring procedures to ensure that the food safety system is functioning as the HACCP plan states. 
  7. Establishing record-keeping and documentation procedures: Within every food-processing area of the facility, record-keeping and documentation are crucial. They help managers and business owners keep track and maintain records of safe food production and corrective actions implemented. This documentation can be crucial in the future for verification or in times of a recall. 

Preventive control vs. HACCP

Preventive controls and HACCP may seem like very similar food safety risk management systems, but there are distinct differences. 

 

HAACP and Preventive Controls Table

(Figure 5) Comparing HACCP & Preventive Controls. Image has been modified/re-organized from FSPCA’s Preventive Controls for Human Food Chapter 1.

Although the Hazard Analysis and monitoring activities are similar, one key difference is how the controls are established. Specifically, HACCP focuses only on processing-based controls that have quantifiable critical limits to control the hazards. 

PC calls for a wider scope of controls (process, allergen, sanitation, and supply chain) that establish parameters and values (both quantitative and qualitative) to control the hazards. Please note that certain foods, such as juice, seafood, meat, and poultry, require a HACCP-based plan and must abide by their respective HACCP regulations.

Since they are different regulations and have different structural components, they cannot be used interchangeably. They do not have the same requirements. Preventive Controls for Human Food covers many more categories compared to HACCP. Additionally, a processing facility may need to manage different types of food safety plans depending on the different types of foods being processed. Therefore, be sure to identify what your food is to determine what regulations you must abide by within FDA and USDA.

Legal and financial implications

Food safety is an important consideration to protect the health of consumers. The legal and financial implications for producing unsafe food can be detrimental to your business. Recalls can be attributed to something that occurred directly through your operation, or the business may be affected by others within your supply chain. Products are recalled for a variety of reasons, such as adulteration, misbranding, violative products from the market, or any other hazard. 

Regardless, if there is ever a need to recall a product, you MUST have a recall plan to quickly recall the product to maintain public health. The Massachusetts wholesale license requires a recall plan. The faster a business can retrieve the product, the lower the business and public safety risks. A recall plan lists the steps a company would take to handle certain situations such as a foreign object, undeclared allergen, etc. Business owners should address potential hazards as soon as possible as they make you directly liable, affect your reputation with customers and the local food system, and can be costly.

Record keeping
Recording and keeping any relevant food safety documentation is important for all aspects of production, including manufacturing, receiving, cleaning/sanitizing, cooking, and much more. To record and document any information on any critical limits, processes, dates/times, signatures, and other needed information will provide a reliable source of data in times of need for any recalls, legal and financial issues, as well as reviewing the performance of the facility workers

Key food safety points

Food safety is an important topic that helps to protect your business as well as the consumer purchasing your product. This chapter covered many categories regarding food safety that may have been overwhelming. Below are key points that you should take away from this chapter:

  • Understand your product
    Knowing every detail of the product you are making will prepare you to categorize which regulations you fall under. It will help you understand whether you will be regulated by USDA or FDA, as well as identify and control the hazards associated with the products being processed. 
  • Be very thorough with your food safety risk management system
    Whether your product falls under HACCP or Preventive controls, it is crucial to build a well-informed food safety plan. The food safety plan helps to establish control of the product you are producing specifically in the processing facility. Therefore, be sure that your plan is specific in recording the monitoring activities, defining the critical limit and/or parameters and corrective actions. Invest the time now to put together a thorough plan so that your future productions will run smoothly and issues will be resolved quickly.  


If it’s not written down, it never happened!
Record keeping helps to demonstrate controls and troubleshoot if issues arise. Detailed records showing production monitoring history, verification reviews, and corrective actions can significantly help manage a food safety concern. In particular, if you have established records in the event of a product recall, you are able to lessen the business impact.

Additional food safety resources

Including training/certifications on PCQi, HACCP, GMP

Food Safety Plan Development and Training

General Food Safety

Preventive Controls

HACCP

Record Keeping

Other

 

 

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