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

What does the OIG report mean?

Well, as the wheels of governance turn, the OIG has audited how FSIS tests beef trim for grinding.

BLUF: "The Office of Inspector General (OIG) found that the Food Safety 
Inspection Service (FSIS) needs to re-evaluate its E. coli testing 
methodology, as it relates to the downstream processing of boxed beef 
products. FSIS tests product designated as ground beef or likely to 
become ground beef, but they do not sample all boxed beef product. 
Some downstream processors grind such boxes of unsampled cuts of 
beef without sampling it for E. coli prior to grinding. Similarly, 
“retail exempt establishments”—grocery stores, butcher shops, etc.—
potentially grind their own ground beef; but unlike Federally 
inspected plants, FSIS does not sample and test bench trim at these 
establishments for E. coli. FSIS does have a program for periodically 
testing the final ground beef products at downstream processors and 
retail exempt establishments before it enters commerce. Also, FSIS is 
not testing tenderized meat products for E. coli despite several recent 
recalls."

So, there are a few gaps.  FSIS tests the beef trim that's obviously going for grinding, but it doesn't always test boxed beef that can end up being ground.

Raise your hand if you work at an establishment that grinds boxed beef.  Yep, that's a lot of you.

Directive 10010.1 sounds like it was a big target of this audit.

Which means, small USDA inspected producers, get ready for more testing.  Make sure your supplier program is pristine.  Are you keeping track of where that boxed beef is coming from?  Do you have a really good lotting system? If you get the boxed beef from a broker, it is going to behoove you to trace that beef trim back to the original source.

And for heavens sake, if you are tenderizing beef test your needles, test the tubing and keep really good records.  Because FSIS is probably going to be taking a really close look at what you are doing.  Nobody wants and OIG report out there, even on a Friday afternoon, that says you aren't fulfilling your primary mission.

PS- BLUF is Army speak for Bottom Line Up Front.

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!

Hazards and FSMA

The regulations that are part of the FSMA, are becoming clear.  The FDA is clearly working hard on making sure the marketplace has adequate information.  They've re-organized the website and added a Small Business Page.

But here's the short and dirty version.  Processors that need to register:

• Dietary supplements and dietary ingredients
• Infant formula
• Beverages (including alcoholic beverages and bottled water)
• Fruits and vegetables
• Fish and seafood
• Dairy products and shell eggs
• Raw agricultural commodities for use as food or components of food
• Canned and frozen foods
• Bakery goods, snack food, and candy (including chewing gum)
• Live food animals
• Food for animals (e.g., pet food, pet treats and chews, animal feed)

Farms don't have to register IF all the food  "is grown, raised, or consumed on that farm or another farm under the same ownership, as well as facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership."

FDA compliant businesses will need to address the following hazards:

•  Biological
• Chemical
• Physical
• Radiological hazards
• Natural toxins
• Pesticides
• Drug residues
• Decomposition
• Parasites
• Allergens
• Unapproved food and color additives
• Hazards that occur naturally
• Hazards that may be unintentionally introduced
• Identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism

That is no short list!  

Fortunately, help is at hand  I will teaching a Risk Analysis/HACCP 101 course on April 24 at the Androscoggin Chamber of Commerce.  The Course wil cover the risk analysis and HACCP that the FDA requires.  Registration is on the website.  We look forward to seeing you!

Risk Analysis

As I have posted on the Dirigo Quality Meats FaceBook page, I am going to start offering Risk Analysis and HACCP training. As I go about the process of writing this one day course, I am learning a great deal.

1. I probably should have stuck math in college out through linear algebra
   
2. There is practically no one bridging the gap between rigorous mathematical approach to risk analysis and a more bottom up organic approach that is common in food safety discussions.
   
3. The preferred method of teaching about risk analysis starts with a definition.  I was taught in high school English class this was a pretty weak way to start an essay.  I think the same is true of a Power Point deck.
   
4. I am trying to come up with some interesting risk analysis activities and it is HARD.