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

Validation- Are Your Systems Aimed at the Right Spot?

It is really easy to confuse verification and validation.  Validation is a subset of verification, so when you are validating, you are verifying, though the converse is not true. Confused yet?

Verification= are you doing what you say you are doing?
Validation= is what you are doing protecting the public health?

Validation requires collecting and evaluating scientific and technical information to determine if the HACCP plan, when implemented correctly will effectively control the identified hazards (paraphrasing from a NACMCF definition).

Validating your HACCP means that you are assuring the plan is adequate for controlling food safety hazards.  If that seems like a big task, it is because it is.  You can't find a scientific paper that validates an individual HACCP  plan as a whole.  But, you can break it up and validate the CCPs.  Every CCP needs to be validated.  Taken together validated CCPs validate your HACCP.

So, start googling.  But not just anywhere.  Read up on your regulatory agency and validation

• USDA 
• FDA- dairy
• FDA- juice look in section F
• FDA- seafood (lumped into verification)

Start with those resources and look for scientific papers that pertain to the process you are working on.  Then start looking at the known physical, chemical, and microbiological hazards in your process.

Then, ask around to see if you are on track.  Ask your extension agent for help.  Shoot me an email, I'm always up for a conversation about food safety!

Once you have scientific papers to back up your CCPs, look at your actual process to see if it is delivering those critical limits.  Is your bacon being smoked at 144F?  Every single slab?  In all parts of the smoker?  Every single time?  Got records to prove it?  How about your cooler?  Is it supposed to be below 41F?  Is it?  In all parts, even right next to the door?  How are you going to test it?  Do you have records to prove it?

Validation can be hard, make sure you are doing it right.

Charcuterie For the Small Processor

DQM spent the weekend at the New England Meat Conference.  It was a fantastic gathering of entrepreneurs, producers, processors, chefs, meat cutters and just about anyone else working to create the New England market for local meats.

And if there was one over riding interest after "isn't this cool?  All the people I know and like are in one place!!" it was charcuterie.

From a food safety perspective, charcuterie is challenging.  But hey!  Let's break it down!  Food safety challenges are what we do here at DQM!  The following is by no means an exhaustive list, but, it is a good start.

First- figure out what you want to make.  And don't just say sausage.  Do you want to make Spanish sausage?  Mexican?  Polish? The more specific you define your product the easier it is going to be.  You need a recipe.  Even if it is your grandmother's that you used to make in the basement, you need to know what and how much is going into the product

Second- Understand what process steps are.  When you write a HACCP plan, you need to have a process flow diagram.  And your commercial charcuterie production needs to have one full of excruciating detail.  You are going to get inspected on how well you adhere to this flow, and if you don't, there can be huge consequences.  Make sure your process flow diagram starts with Receiving Meat.

Third- Once you understand what you are making and how, then start thinking about the whole food safety plan including pre-req programs, the HACCP plan itself, training, and what avenue of inspections are available.

Putting a delicious and safe charcuterie product in the marketplace is absolutely possible.  However, it takes attention to detail, and frankly, is tough to do without some help.  When you are ready to take that step, give DQM a call, and we will be right there with you to put your wonderful product into the marketplace!