Is it a Risk? Is it a Hazard? What's the Difference?

As I talk to people about FSMA and other food safety regulations, I am constantly asked the difference  between a risks and hazards.

As FSMA comes into effect there is going to be a lot more emphasis on systems that put in prevention programs..."

Under the proposal, each owner, operator or agent in charge of a facility (those required to register with FDA under Section 415 of the FD&C Act), with certain exceptions, would be required to comply with the hazard analysis and risk-based preventive controls. The preventive controls are science- and risk-based in that the rule would require controls only where necessary to prevent hazards to public health and exempt certain facilities from requirements or modify requirements for certain low-risk activities. Second, they are flexible in that firms could develop preventive controls that fit their products and operations, as long as they are adequate to significantly minimize or prevent all food safety hazards that are reasonably likely to occur."

Risks are the big picture.  From 3000 feet in the air, places like FSIS look at the public health impacts of various risks.  The FDA has also identified a lot of different risks in the food chain.

• Food from unsafe sources
• Inadequate cooking
• Improper holding time and temperature
• Poor personal hygiene

The FDA has identified 5 interventions, outlined in the Food Code, that inspectors look at during assessments of plants to ascertain the level of management control over those risks.

• Demonstration of Knowledge
• Implementation of Employee Health Policies
• Hands as a Vehicle of Contamination
• Time/Temperature Relationships
• Consumer Advisory

Essentially if a plant can show that the food safety systems use the interventions to mitigate risk, the FDA deems the food fit to eat. Many scientists over many years and with a lot of money investigated just where in plants food risks come from and came up with that list.


So using the FDA Food Code risks, we can identify some hazards.  For example

Risk: Food from unsafe sources (for example, leafy greens that are picked in unsanitary conditions) 
Hazard: E. coli
Intervention: Approved supplier program can make this not reasonably likely to occur (remember, critical control points control hazards, pre-req programs make hazards NRLTO).  This would be a knowledge based intervention

Risk: Inadequate cooking (let's take eggs) 

Hazard: Salmonella 
Intervention: Cooking shell eggs to 145F for 15 seconds, or to 160 if they are with other foods.  This is an example of a critical control point. There's going to be nothing else after the cooking step that would kill salmonella.  This would be a time/temperature intervention.  A consumer advisory intervention would be telling consumers that eating undercooked eggs can make them sick.

Risk: Improper holding time and temperature (for example, cooked veggies in a sauce in a buffet)
Hazard: Staph aureus intoxication
Intervention:  This one actually needs several.  First, a time/temperature intervention of keeping hot foods hot and out of the staph danger zone, this would be a critical control.  Second, employee health policies need to emphasize not handling food with open cuts, need a pre-req program that complies with GMPs here.  And third, understanding how hands are a vehicle for contamination and emphasizing hand washing, again a pre-req program on personal hygiene.

As FSMA comes into affect, FDA regulated entities are going to have to catch up to USDA regulated entities.  Written food safety plans that take scientifically developed risks and delineate the hazards that come out of those risks will be required.  DQM is set to help small growers and processors cope with the coming onslaught.  Call today for your free phone consultation and ask for Dr. P.  90-907-7798