In April of 2013, Nicholas Kluge wrote an article titled: Government Liability for an Unnecessary Product Recall This article analyzed the recent decision of Los Angeles Salad Co. v. Canadian Food Inspection Agency, 2013 BCCA 34, which is a British Columbia Court of Appeals case. In this…
As reported by The Packer (and announced by the FDA), “the FDA is reopening the comment period for a draft risk assessment for certain food facilities that include farm packing operations for fresh fruits and vegetables.” See FDA Reopens Comment Period on Food Facilities.
My phone rings the other day and I look at the number… I did not recognize it. Of course, I answer the phone with a friendly, “Good morning, this is Jason.” Just that quickly I am connected to a conference room filled with concerned produce company executives with little time for pleasantries. I quickly discover that the company is involved in a foodborne illness outbreak and has several concurrent fires to put out. Against this back drop, the questions start flying:
- Do I have to give the government copies of my customer list?
- Do I have to allow the government to take pictures of my product, operation, etc.?
- Do I have any rights when it comes to a government inspection?
- What do I need to say or not say to my customers?
- Is there something we should be doing that we are not?
- Does my insurance policy cover this?
- Do I have enough insurance?
- Does it matter that the contaminated product was not ours?
- Do we have any exposure here?
- What should we be doing right now to mitigate our exposure to any type of litigation?
- What should we be doing to protect our brand identify and the company name?
Grappling with any one of these questions while you are watching a foodborne illness outbreak unfold in real-time is both difficult and time sensitive. In an ideal world, you would have a crisis management plan ready to be pulled off the shelf and executed upon. Moreover, the company’s employees would be similarly prepared as they would have received re-occurring training on the company’s crisis management policies and procedures.
The reality for most produce companies is much different… Under a sales driven business model, it is far to common for produce companies to rely on the food safety promises of third parties (many of which are not readily capable of verification) and for product testing to be too heavily focused on good arrival standards, which are governed by the relevant sales contracts. Against this back drop, even successful produce companies find themselves in uncharted waters when they are thrust into the middle of a foodborne illness outbreak and forced to handle all the related media exposure, demands from government investigators and other unanticipated events.
So What Should You Do? (Top 10)
- Seek the advice of an experienced food law attorney of your chosing!
- Through either your attorney or your company, have strategic partners identified and available for you to call upon for assistance. This will help ensure that the crisis management activities of your company does not preclude the company from continuing its “normal” business operations.
- Don’t write anything or say anything that you do not want to see in the media.
- Know your rights and proactively manage any and all government inspections or requests for information.
- Prepare and implement a public relations plan designed to address at least two main target audiences: (i) your customers and (ii) the public.
- Initiate the audits necessary to both identify the source of the problem (contaminated product) and to trace all of the contaminated product that flowed through your company or which may still be in your company.
- Be aware of cross contamination issues…
- Know how to properly document all of the processes mentioned above.
- Know how to properly destroy contaminated food.
- Conduct a review of all relevant insurance policies, supply contracts and other documents that may contain contractual obligations the company must comply with during the crisis. (i.e. are you obligated to notify your insurance carrier of the problem within a certain period of time?)
As you can see from the foregoing list, there are many things a produce company needs to know and do in order to protect itself (as best it can) from the fall out associated with a foodborne illness outbreak. Many of these things can and should be prepared in anticipation of a foodborne illness incident that we all hope never occurs, but there are also many things that can be done and should be done as the event unfolds.
Again, if you find yourself in the middle of a foodborne illness outbreak or related recall you would be well advised to seek the advice of an experienced food law attorney of your choosing. As we know from witnessing the Jensen Farms outbreak, few companies are adequately prepared to deal with these types of situations and that could lead to the demise of your company. Of course, time is always of the essence in these types of cases.
Wrongful death cases related to foodborne illnesses cost the food industry billions of dollars each year and very few, if any, companies responsible for the problem live to tell the story. Why? Frankly this is the way juries like it when it comes to food safety and public health. Accordingly, these types of cases are often won or lost before a civil action is ever filed.
According to a recent FDA guidance document, the FDA’s risk-based model for prioritizing inspections of food establishments utilizes technology to analyze traditionally available information and to set the agency’s priorities for allocating domestic inspection resources.
What does this mean in layman’s terms?
It means the FDA is going to analyze the data it already collects, tracks and monitors to determine the agency’s priorities when it comes to identifying food facilities to inspect.
How does the FDA identify a high-risk facility?
The answer to this question is two fold. First, the FDA looks at inherent risk factors at the industry wide level. The industry wide risk factors include, but are not limited to:
- foodborne illness outbreaks
- reports of adverse events associated with a specific industry of category of food (i.e. cantalope, sprouts, etc.)
Secondly, (and most importantly) the FDA looks at inherent risk factors at the firm or company level. The firm or company level risk factors include, but are not limited to:
- the known safety risks of the food manufactured, processed, packed or held at the facility. (i.e. if your facility handles high-risk food(s) your facility will be deemed a high-risk facility based on that fact alone)
- compliance history of the firm or company (i.e. food recalls, outbreaks of foodborne illnesses and prior violations of food safety standards)
- the rigor and effectiveness of your hazard analysis and risk-based preventative controls.
- whether the food manufactured, processed, packed or held at the facility meets the criteria for priority under section 801(h)(1) of the FD&C Act, which relates to the prioritization to detect intentional adulteration in food offered for import into the U.S. (applies only to foreign food facilities)
- whether the food or the facility the manufactured, processed, packed or held such food has received a certification from the FDA under the foreign supplier verification program or the voluntary qualified importer program.
- anything else the FDA deems necessary and appropriate. Two known examples include the establishment type / type of activity conducted at the facility (i.e. manufacturer/processor, repacker/packer, etc.) and the number of years since last inspection.
How is the information used to determine inspection priority?
The FDA’s decision-making process is based primarily on the first two bullets and the last. The balance of the risk factors will be incorporated into the FDA’s decision-making process as they continue to develop their data collection and testing tools and will be laid out in the forthcoming Preventative Controls regulation.
In addition, the FDA may inspect facilities more often than the frequency mandate as a result of emerging public health information, follow-up to violative inspections and/or samples, etc.
From a technical position, the FDA is utilizing “a software program that assesses the characteristics of each facility in the agency’s inventory.” This “software provides data access, analysis and reporting from the agency’s internal data systems.” See Domestic Facility Risk Categorization
What does all of this mean to my business?
The FDA estimates that there are approximately 22,325 domestic high-risk (HR) food facilities and about 60,000 non high-risk (NHR) domestic food facilities. FSMA calls for all HR domestic food facilities to be inspected within five years of the date the bill was signed into law. Thereafter, all HR food facilities will be inspected once every three years and all NHR food facilities will be inspected once every five years. Importantly, FSMA limits its inspection of food facilities to only those required to register under the Section 415 of the FD&C Act, which is the Bioterrorisim Act.
Food companies would be well advised to start preparing for inspections NOW before the USDA comes knocking. A company may proactively mitigate many of the FDA’s risk factors through preparation. For example, there should be no excuse for a food company not to:
- be properly registered under the Bioterrorism Act.
- have the proper food safety plans and related standard operating procedures prepared and ready for inspection.
- be in compliance with many of the already known food safety rules.
- possess a solid understanding of how to manage a FDA inspection
- and more…