by Alan McConnell
Food Safety & Quality Management LLC

Cookies factoryThe Food Safety Modernization Act (FSMA) represents the first major overhaul of our nation’s food safety laws since the 1938 Food, Drug and Cosmetic Act. As such, it’s important that food processors begin work now to ensure full compliance by the implementation deadlines: September 10, 2016 for large businesses with greater than 500 employees; September 2017 for small businesses with less than 500 employees; and September 2018 for very small businesses averaging less than $1 million per year (adjusted for inflation) in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale.

Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. An effectively developed and implemented HACCP plan (Hazard Analysis and Critical Control Points plan) meets this requirement. The rule says that the food safety plan must include several components, all of which are found in a complete HACCP plan and supporting Prerequisite Programs (PRPs):

Hazard analysis: The first step is hazard identification, which must consider known or reasonably foreseeable biological, chemical, and physical hazards. These hazards could be present because they occur naturally, are unintentionally introduced, or are intentionally introduced for economic gain (if they affect the safety of the food).

Preventive controls: These measures are required to ensure that hazards requiring a preventive control will be minimized or prevented. They include process, food allergen, and sanitation controls, as well as supply-chain controls and a recall plan.

Monitoring: These procedures are designed to provide assurance that preventive controls are consistently performed. Monitoring is conducted as appropriate to the preventive control.

Corrective actions and corrections: Corrections are steps taken to timely identify and correct a minor, isolated problem that occurs during food production. Corrective actions include actions to identify a problem with preventive control implementation, to reduce the likelihood the problem will recur, evaluate affected food for safety, and prevent it from entering commerce. Corrective actions must be documented.

Verification: These activities are required to ensure that preventive controls are consistently implemented and effective. They include validating with scientific evidence that a preventive control is capable of effectively controlling an identified hazard; calibration (or accuracy checks) of process monitoring and verification instruments such as thermometers, and reviewing records to verify that monitoring and corrective actions (if necessary) are being conducted.

Product testing and environmental monitoring are possible verification activities but are only required as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system. Environmental monitoring generally would be required if contamination of a ready-to-eat food with an environmental pathogen is a hazard requiring a preventive control.


McConnell is the Technical Director and Principal Consultant with Food Safety & Quality Management LLC. He provides technical support to food processing companies across the U.S. and the world. He has over 22 years experience serving the food processing industry as a consultant, trainer, laboratory director, and quality control manager.

Special Note: Alan McConnell will be the instructor for a HACCP training course in Erie on March 22 & 23. Participants receive NSF International Certification for HACCP Training if they successfully complete the course exam. Click for more information and to register.