FSMA Preventive Controls Rule: What Is It and What Does It Mean?

When the FSMA Preventive Controls Rules were released in 2011, confusion over the intricacies and information of the rules swept the food manufacturing industry. Here’s what you need to know to ensure success as the deadlines for compliance with the FSMA Rules approach.

What is the FSMA PC Rule?

At its core, the FSMA Preventive Controls Rule looks to regulate food manufacturing by presenting a proactive, preventive approach to food safety.¹ Rather than continue the reactive practices that many facilities have upheld in years past, the FSMA PC Rule is bringing forth a new methodology that encourages the implementation of preventive measures to catch issues before they become problematic.

The Details

One of the major factors that is being implemented to help achieve this is the introduction of a written food safety plan that is to be updated every three years.² This plan is required and should be uniquely tailored to each facility that is involved with the processing, packaging, or manufacturing of food. In the interest of underlining the emphasis on preemptive action, the Preventive Controls Rule requires that the written food safety plan address a HARPC-based approach.³ For more information on how the new HARPC and the more commonly known HACCP methods differ, read our article on Hazard Analysis and Risk-Based Preventive Controls.

While the task of creating an individualized safety plan for each of your facilities may sound daunting, you will be able to receive guidance by hiring a PCQI, a preventive controls qualified individual. A PCQI is required to oversee the preparation of nearly all facilities’ food safety plans (with a few exemptions) in order to ensure the effectiveness of the plan, as well as its compliance with the FSMA Preventive Controls Rules.² Learn more about the role of PCQIs in our article, To PCQI or Not To PCQI.

Although the pages upon pages of information defining the intricacies of the PC Rule and the food safety plan’s requirements may seem overwhelming at first, the essentials that you need to know can be boiled down to four key components.³ These include:

• Hazard Analysis
• Risk Based Preventive Controls
• Oversight and Management of Controls
• Verification

Hazard Analysis

The first step towards creating your very own efficient food safety plan, this component is a critical part of maintaining the quality of the food in your facility. When conducting hazard analysis, you should consider the naturally occurring sources of contamination as well as those introduced through human error or poor judgement. FSMA’s rule requires that you examine the possibility of any “reasonably foreseeable” biological, chemical, or physical hazard that could crop up, from employees neglecting to wash their hands to the storage of food at improper temperatures.⁴

Risk Based Preventive Controls

After identifying the potential hazards housed in your facility, you must take steps to ensure that each hazard is minimized or eliminated entirely. Included in this process are the actions decided upon that would be best at diminishing the hazard’s potential to compromise the safety of your facility’s food. This includes the implementation of thorough sanitation procedures, caution regarding food allergens, and cross contamination prevention.⁴ Some of these controls could be as simple as requiring employees to wash their hands or change gloves when handling certain foods, while others may be more elaborate. Regardless, all the preventive controls incorporated to your facility play an essential role in keeping your food and customers safe, making this a crucial component of your food safety plan.

Oversight and Management of Controls

To keep the preventive controls introduced above remain effectual, you must monitor the effects of the controls once they are implemented. Keep the controls in place adaptable and flexible so you can have an up-to-date food safety plan for your facility. Based on your observations, you should take action to ensure that the safety of your food is not compromised. If a recurring problem is identified, take corrective actions and adjust your preventive controls accordingly. Additionally, when issues are identified, any affected food should be examined and evaluated for contaminants, as well as kept from being sold to consumers. These types of processes and oversight should also be recorded for future reference and documentation.⁴

Verification

In order to confirm that the initial preventive controls are still applicable, verification activities are required “when appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system.” Examples of these activities include product testing and environmental monitoring for things like proper temperature, cleanliness of storage areas, and checks on the accuracy of facility equipment.⁴ By gathering and using empirical data about your preventive controls, it can be seen whether a specific control is actually controlling one of the identified hazards at the facility. This information will help you not only by confirming the standard of your facility but also when updating your food safety plan by showing which controls work and which don’t.

Compliance Dates

With all these requirements, the task of modifying your facility’s processes to be in compliance with the FSMA’s Preventive Controls rules may seem formidable. However, the FDA has recognized that the switch will not be instantaneous, and has allowed some leeway in terms of strict adherence to the new rules within a certain time period. This grace period comes to an end at the arrival of certain “compliance dates,” which are essentially just deadlines by which your business must be following the procedures outlined in the Preventive Controls rules. These dates differ depending on the kind of facility at which you are established, and can have multiple caveats depending on whether your business fits into the FDA’s definition of a certain facility type. We constructed a basic list of compliance dates, but if you are looking for more details, you can look further into the topic here.

Compliance Dates for Produce Safety

All Other Farms Not Small or Very Small – January 26, 2018

Small Businesses – January 26, 2019

Very Small Businesses – January 26, 2020

Compliance Dates for Manufacturers

Not Small or Very Small Businesses – September 19, 2016

Small Businesses – September 18, 2017

Very Small Business – September 17, 2018

Businesses Subject to the Pasteurized Milk Ordinance – September 17, 2018

Compliance Dates for Supply Chain Facilities or Receiving Facilities

Small Business (Supplier Not Subject to the Human Preventive Controls or Produce Safety Rules) – September 18, 2017

Small Business (Supplier Subject to the Human Preventive Controls or Produce Safety Rules) – September 18, 2017

Not a Small or Very Small Business (Supplier Not Subject to the Human Preventive Controls or Produce Safety Rules) – March 17, 2017

Not a Small or Very Small Business (Supplier Subject to the Human Preventive Controls and Produce Safety Rules) – six months after the supplier is required to comply

Exemptions

With all these rules, it’s no surprise that there are some tricky exceptions. Click here to read more about potential exemptions or modified requirements that your facility may be subject to.

 

¹ https://www.carolinafarmstewards.org/fsma-frequently-asked-questions/

² https://www.fda.gov/food/guidanceregulation/fsma/ucm247559.htm

³ https://cdn.orkin.com/downloads/commercial/orkin-university-resources/FSMA_Special_Report_Final.pdf

⁴ https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm