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

Verification of CCPs

So, are you telling the truth?

Is your production team doing what it says?  Are you sure?

Wanna know how to be sure?  It's through verification!

First, an easy way to remember the difference between verification and validation.  Verification comes from the latin root vera meaning truth.  Ergo (ha! more latin) verification is the HACCP step where you determine if you are telling the truth about your HACCP plan.  Validation asks if what you are doing is useful to control hazards.

Verification has 3 components:

• your CCPs are being followed
• the whole HACCP is in place and being followed
• regulatory verification

Verifying can be done many ways.  In meat production, a pre-shipment review is a regulated verification step.  In other types of production, any step where you review your logs and sign off that you have reviewed them, is a verification.  Audits are another good way of verifying work.  Finally, having the regulators pay you a visit and give you their findings is a way of verifying.

Some good ways to verify:

• Review your monitoring records.  You are spending ages recording everything, take a look at it, make sure you are recording correctly.  Review at a frequency that makes sense.  Don't review your cleaning step once a quarter only to find out that your concentrations of cleaner is WAY off.  Imagine THAT recall.
• Calibrate!  Got a thermometer?  Is it working?  You sure?  Fill a container with ice water, stick the thermometer in.  Make sure the thermometer is reading 32F.  If you don't remember why this works, consult your high school chemistry notes.
• Grab your accountant, promise you will take her out to lunch if she'll spend some time looking at your workers work.  Put her in a lab coat and have her watch one part of your production process.  Don't worry, the workers will do it right for about 3 minutes, and then, they'll do it how they always have done it.  Over lunch, talk to your accountant and figure out what's working and what isn't.
• Get some lab samples done.  Finished product testing is ok, but non-specific and expensive.  Test something specific, like your injector, or swab a food contact surface in your processing room.  If it turns up positive...

Call me, I'll help.  Dirigo Quality Meats can help with straightening out all sorts of processing problems.  908-907-7798

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!

It's Coming: FSMA

President Obama took office during one of the largest food borne illness outbreaks in our history.  During his first administration, the Food Safety Modernization Act was passed and signed into law.  At the dawn of his second administration the regulations are coming about as to what FSMA is going to mean for producers and importers.

Most folks who are already covered by the FDA regs are going to remain so.  They are simply going to need to update their process controls and paperwork to comply with the new regulations.  Most institutions on the following list are also going to have to institute CGMPs (Current Good Manufacturing Practices) as part of the law as well.  Likely as not, GMPs are something you are already doing!

So, the question remains...Are They Talking About Me?  Do I have to comply?

Do you have a facility that manufactures, processes, or packs human food? Yes

Are you currently registered with the FDA under current regulations? Yes

Do you store fruits and vegetables in a warehouse that are destined for further processing or distribution? Yes

Are you a farm, and don’t create or warehouse products on the farm? No

Do you sell less than $500,000 in products from your farm? No

Are you a small establishment making a low risk product, such as jams and jellies, honey or syrup? No

Are you already regulated under Low Acid Canned Food Guidelines? No

Do you produce seafood or juice? No

Do you produce alcohol or dietary supplements? No

Do you have a sales income less than $1M (might change to $500K or $250K)? Modified rules apply

Do you have warehousing with refrigeration? Modified rules apply

Do you have warehousing without refrigeration? No

Do you run a grain elevator that doesn’t further process? No

See yourself on that list?  Email michele<at>dirigoqualitymeats<dot>com or leave some contact info in the comments section and I will send you a Road Map for Ensuring FSMA compliance!

So Just What Do We DO Here?

As a public health veterinarian and former Army officer, I was responsible for the food safety program in my area for suppliers to the Department of Defense.  Working closely with the managers of the on base grocery stores (the PX system), food manufacturers that supply the DoD, and soldiers under my command, I ensured safe wholesome food was available to those who relied on the DoD system.

Ensuring a safe and wholesome food program requires excellent communication skills, a deep understanding of regulations, and training everyone to create a culture of food safety.  As an independent contractor in food safety, I work with my clients to design systems and processes that will result in safe food.  Understanding HACCP and the method to arrive at the process flow is only one part of that.  Prerequisite programs are needed to ensure that all workers know and understand the safety system that they are implementing.  As GFSI standards are becoming more important, I work with clients to select a 3^rd party auditing system and work to implement it.  As the FSMA comes into fruition, I work with clients to understand the changes and work with them.  My work has brought me in direct contact with government agencies responsible for licensing and auditing.  I understand government regulations and how to work with the Health Department and the Agriculture Department. I immensely enjoy the opportunity to train.  I have worked with the Maine Beef Quality Assurance Program to train beef producers on food borne illness from beef as well as zoonotic diseases.  My training as a veterinarian has given me expertise and insight into all aspects of the food chain.