Decoding the FDA’s Draft Guidance for HARPC

    Posted by Chelsey Davis on Oct 14, 2016 12:14:23 PM

    Decoding the FDA's Draft Guidance for HARPC

    The FDA published Draft Guidance on Preventive Controls for Human Food in the Federal Register on August 23, 2016. With over 200 pages thus far, the industry guidance represents the agency's current thinking on the development of food safety plans and hazard analysis as required by the Preventive Controls rule. 

    To help us better understand and dissect the information contained within the guidance, we enlisted the help of our tried and true friend, Marc Sanchez of FDA Atty.

    Before we dive into specifics, it’s really important to remember that this is only a draft guidance, which means it’s currently open for comments. Please note the deadline for comments is on February 21, 2017. Once the comment period has concluded, the FDA will review all comments to determine what revisions are necessary and reissue a final guidance document. 

    Additionally, it’s also important to remember that this is a guidance document. Think of it this way, if you were to place all of the information you get from the FDA into a hierarchy, the guidance documents in draft formand even in final formsit at the very bottom of that hierarchy.

    FDA is not changing the rules or the language of the rules with these guidances. The guidance is really only available as a recommendation on how you can follow the particular rule addressed. 

    In some cases, the guidance might be very applicable to your particular facility or product, but in many cases, it serves as a guidepost and is not meant to provide you with restrictions or requirements to follow. These restrictions and requirements will still come from the published rules, so you want to make sure you’re not following something in the guidance or interpreting the guidance in some way to be replacing parts of the rule.

    Draft Guidance on Human HARPC

    At the moment, there are only five chapters published and released, which also includes three appendices. Once the guidance document is completed, there will be 14 chapters total. There is already a good amount of information and detail listed in just the five chapters, so as you can imagine, there will be a substantial amount of material in 14 chapters.

    HARPC Draft Guidance: The Food Safety Plan 

    The main objective of the draft guidance is to provide industry with the FDA’s view regarding the Preventive Controls for Human Food rule, describe the structure of that rule, summarize those requirements, and provide a glossary of terms and definitions.

    In the first chapter, FDA focuses on the core requirements under the Preventive Controls for Human Food rule: the food safety plan. This part of the guidance is incredibly rich with detail. If you’ve already gone through a Preventive Controls Qualified Individual (PCQI) training, you’ll probably find that there is not nearly as much material as compared to what is covered in the class, but this is still a great resource for additional members on the food safety team. It provides enough information on the definition of a PCQI and the essential components needed for a complete food safety plan. 

    The guidance is also very cognizant of the fact that a lot of facilities are going to be following HACCP and trying to note the differences between HACCP and HARPC requirements. This is why you’ll see that some of the times, the guidance actually incorporates HACCP type activities.

    A concern Marc hears frequently regarding the food safety plan is folks want to know exactly what their food safety plan needs to contain. Is there a particular style, format, or structure it should be in? What kinds of sections should it include? 

    All of these questions are answered within this recommendation, but it’s also very clear that the FDA is not recommending one particular format or one particular style or section over another. It’s giving you—the facility—the flexibility to decide what works best within your organization.

    Hazard Analysis

    The next section within the guidance (Chapter 2) is very interesting because it gets into the weeds on the hazard analysis and really helps guide you through the different categories, which includes everything from chemical to biological to physical. This chapter, again, incorporates some of the elements you would see in a typical HACCP plan; items like the hazard analysis worksheet shown below.

    HACCP WorksheetAccording to the guidance itself, the hazard analysis must be written, regardless of the results of the analysis, and must include two elements: (1) a hazard identification and (2) a hazard evaluation. You conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are hazards requiring preventive controls. 

    An interesting takeaway with the recommendations you see in this section is the suggestion that you look at estimating the likelihood of occurrence as part of your hazard analysis for each operation or facility separately.

    There have been questions regarding how the hazard analysis works if you have multiple facilities, or domestic and foreign facilities. Perhaps you’re following the Foreign Supplier Verification Program (FSVP) rule for your foreign facilities and then also following the Preventive Controls rule for your domestic facilities. This recommendation really points to those questions to help illustrate that each of your operations needs to be treated separately.

    As the guidance points out, your estimates on the likelihood of occurrence should be derived from data regarding recalls and outbreaks, scientific literature, facility history, etc. This means that your hazard analyses and food safety plans will be a really rich source of information and will contain a lot of references to scientific literature, and numerous tables and appendices.

    FDA is not expecting to see an analysis during an inspection that simply glosses over the hazard or glosses over the likelihood of those hazards occurring. There really needs to be some strong scientific rationale for why the hazards are listed, what’s the associated likelihood of those hazards occurring, and what kind of preventive controls will need to be implemented to mitigate those hazards.

    The Rest of the Story…

    The last three chapters in the current version published are the densest. What’s really great about these chapters is if you have any question about a particular process you use, for example, if you use a wet process, a dry process, or if you use reduced oxygen packing, these types of details are captured within these last sections.

    Chapter three discusses the hazards, and chapter four includes all the information on preventive controls that are specific to those hazards identified in chapter three. There’s also a discussion as to how to implement those preventive controls and manage them throughout the lifecycle of the facility to ensure you’re preventing them or modifying/revising them as you discover more information. These chapters are really great for facilities that have specific questions related to their food products and operations. 

    There’s also a good discussion in the guidance on food and color additives, helping you understand what to do when those items aren’t approved or GRAS, or if you are unsure what their approval status is.

    Marc pointed out that this might be something you might not be thinking about necessarily, simply because you’re focused on microbial or physical/chemical hazards. It might not be top of mind to be thinking about what your suppliers are providing in terms of food additives, especially when relying on the GRAS determinations, but it is important to include.

    There’s a lot of information within this guidance, and as a resource for the industry, we try to provide as much help as we can when it comes to understanding exactly what the FDA expects. If you have any additional questions regarding this guidance, or FSMA in general, please drop us a line at

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    Tags: FSMA, Food Safety, HARPC


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