Revolutionary Changes to Food Safety Regulations – A look into the FDA’s Preventive Controls Rule

In 2011, a revolutionary piece of regulation landed on the President’s desk. The framework of the regulation would modernize the food industry and food safety. The Food Safety Modernization Act or FSMA shifted the industry from a reactive approach to food safety to a proactive one. Of the Food Safety Modernization Act came seven rules.

1.?????? Preventive Controls for Human Food

2.?????? Preventive Controls for Animal Food

3.?????? The Produce Safety Rule

4.?????? Sanitary Transportation

5.?????? Accredited 3rd Party Certification

6.?????? Foreign Supplier Verification

7.?????? The Intentional Adulteration Rule or Food Defense

RESOURCES: https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma

The Current Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive Controls for Human Food Rule, or the Preventive Controls Rule was established September 17, 2015 and required virtually all food companies involved in manufacturing, processing, packing or storing food to conduct a hazard analysis, and where necessary, establish preventive controls. Hazard Analysis and Risk-Based Preventive Controls or HARPC, serves as the framework for constructing sound Food Safety Plans. Global Food Safety Consultants or GFSC examines the preventive controls rule to provide insight for the food safety professional and the public.

Hazard Analysis

Food comes with many desirable characteristics. The texture, the taste and wonderful aromas all contribute to our specific personal preferences. However, our foods may also contain threats to our well-being. Hazards in our food can be defined as substances or materials that may cause illness or injury. Understanding that hazards exist in our food is critical. Generally, in food safety, there are three types of hazards:

Biological - Bacteria, Parasite, Virus

Chemical (including radiological) - Pesticide, Sanitizer, Lubricant, Allergens

Physical - Glass, Metal, Foreign Objects

RESOURCE: https://haccpalliance.org/

The Preventive Controls Rule builds upon this by requiring food companies to conduct a hazard analysis. Hazard analysis is the process of identifying hazards related to each step in a process. Once hazards are identified, food facilities must determine if they are significant and require a preventive control. It can be difficult to understand which hazards are associated with the products being produced. To complicate this even more, the operating environment may create additional hazards that need to be considered. Luckily, resources are abundant. Using scientific papers, historical data, trade associations and regulations, a food safety professional can assemble a sound hazard analysis that accurately presents the risks associated with the products and operating environment.

All this information needs to be compiled into a document or hazard analysis. Generally, this takes in the form of a table or chart, but there are not any specific requirements on the layout of this document. Whatever system is used to document the hazard analysis, it is important to assure all hazards are accounted for in each step in the process. Along with the identification of hazards is a well-written justification as to why you think hazards are significant or not.

Hazard analysis is critical to food safety success. It is a systematic approach that grants food companies the ability to foresee hazards relevant to their products and processes. Companies can then establish preventive controls to prevent the production of hazardous food.

Establishing Preventive Controls

A well-written hazard analysis will serve as a guidepost for integrating preventive controls, where necessary, into your process. The FDA defines a preventive control as steps taken to reduce or eliminate food safety hazards. Preventive controls are paramount for food safety success and to assure they do just that, we reflect on the term validation. Validation is the process of assuring a preventive control is effective in reducing or eliminating food hazards. It is the process of developing effective parameters or measurements to assure the step or process you are controlling will, in fact, perform as expected. Validation differs from verification, and this causes confusion in food safety. Validation is the process of developing a plan for control and verification is assuring the plan is being followed.

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