What Makes a High-Risk Facility
High-risk facilities are picked out from the food industry by the FDA. These choices are determined through the evaluation of certain distinguishing factors that put a facility and its food in greater danger of having a food safety issue. The factors are each identified in section 421(a) of the Federal Food, Drug, and Cosmetic Act.1 For your convenience, we took the factors and listed them below so you can get a better idea of what may bump your facility into the high-risk category.
Risk Factors include:
- The known safety risks of the food manufactured, processed, packaged, or stored at the facility.
This criterion looks at the history of food safety issues that is tied to the products your facility deals with, rather than the safety procedures in place at your facility. For instance, items determined as high-risk foods through outbreak and recall data, such as leafy greens, sprouts, baked goods, spices, or eggs, will increase the level of risk associated with your facility.2
- The compliance history of a facility.
This is evaluated for the past two years, specifically in regards to concerns about food recalls, outbreaks of food-borne illnesses, and violations of safety standards
- The rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls.
Making your food safety plan too lenient can hurt your facility more than it can help it. Calculate your food safety plan with potency in mind. Read our Food Safety Checklist for Packing and Storage Facilities to create your plan with facility requirements in mind, or read the Safety Checklist for Worker Health and Hygiene to formulate a plan that combats issues that could be caused by your employees. Better yet, read both and be doubly prepared!
- Whether the food manufactured, processed, packed, or held at the facility meets the criteria for priority under Section 801(h) of the FD&C Act.
This relates to the preference given in order to detect intentional adulteration of food offered for import into the United States.
- Whether the food or the facility that manufactured, processed, packed or held such food has received a certification as described in Section 801(q) (which concerns any imported food) or 806 (the voluntary qualified importer program) of the FD&C Act as appropriate.
While this is more of an extension of number 4 on the list than a distinctly independent factor, it is just as important as each of the other factors listed.
- Any other criteria deemed necessary and appropriate by the secretary for the purpose of allocating inspection resources.
Although this may sound rather broad, this stipulation is paramount to ensure that any unforeseen factors that crop up can still be addressed. ‘Necessary and appropriate criteria’ can include the establishment type and the activity conducted at the facility, as well as the number of years since the facility’s last inspection.
List created based on information found on the FDA website3
This list has contributed to the creation of the FDA’s process of deciding what exactly defines a high-risk facility, so keep it in mind when working in your facility. So far, this categorization has been restricted to only dealing with domestic facilities that produce or process human foods.4
How to Avoid Being Labelled High-Risk
Being classed as a high-risk facility can be caused by one of two things: either there are inherent risk factors that occur at the industry wide level, such as certain products that are generally seen as high-risk, or there are risk factors at the company level, which include more specific issues that are created through negligence.5
On occasion, a facility is automatically put into the high-risk category based on one factor, rather than a consideration of the entire list, simply because that factor is so impactful that it cancels out the evaluations of the other components of the list.6
“The best way to prepare for tomorrow is to be ready today.”
To avoid being added to the list of high-risk facilities, equip your facility with the tools and procedures it may need to pass inspections with flying colors. Five years after the date that the FSMA bill was passed as a law, it is required that all domestic facilities undergo inspection. Following that five-year-mark, high-risk facilities must be inspected every three years, while non-high-risk facilities only need be inspected every five years.7 These assessments are crucial to the status of your facility, so it is wise to take them seriously. To have your facility’s analysis run smoothly, have the proper food safety plan and related standard operating procedures implemented and ready to present on the date of your inspection. In addition, be in compliance with any relevant food safety rules and possess a basic understanding of how to handle an FDA inspection. For further information, check out this list of FDA Inspection Dos and Don’ts.
What Does It Mean If I Am a High-Risk Facility?
Being high-risk is not necessarily a bad thing. As stated above, your facility may have been placed in this category without any infractions on your part, simply being labelled high-risk because of the nature of the food your facility produces. Even if you have been labelled high-risk for other reasons, this categorization merely puts your facility higher on the FDA’s priority list of facilities to inspect.7
However, if your facility has been marked as high-risk for other reasons, particularly those caused by oversight or a lack of adherence to your food safety plan, it is imperative that corrections are made, for the good of your facility and the safety of your consumers.