Tip of the Week: Hazard Analysis Support Documentation

Continuing to build on our FSMA tip of the week series, this week’s tip will be focusing on additional documentation that will provide guidance and support for your hazard analysis conclusions.  Remembering that the FDA will be taking a prescriptive seafood HACCP type approach to hazard analysis, one would expect that the FDA will be issuing guidance documents for the core aspects of the rules, including hazard analysis, preventive controls, environmental monitoring and food allergen control. 

To date, the FDA has been slow to issue these documents.  An open letter representing numerous food associations was sent in March of this year to the FDA requesting that their draft guidance documents be promptly issued so “companies do not run the risk of having to repeat their implementation efforts.”

So, while we wait for the FDA to issue draft guidance for the FSMA rules, where can we obtain additional support documents to help with hazard analysis?  

A good place to start would be determining if your product is considered “high risk”. Although the FDA has not issued draft guidance for how they will determine “high risk”, we do know that if you are in a food sector that has had a significant amount of recalls, such as bakery items with undeclared allergens, risk information would be readily available in the 4th annual Reportable Food Registry report.  This report lists the categories of food (commodities) broken down into individual food types and the hazards associated with those recalls.  

In addition, this report contains numerous links to industry and regulatory guidance documents to further research and support your conclusions for selecting appropriate preventive controls.  Some of these authoring food associations are listed below and could provide further guidance for FSMA:

From the Reportable Food Registry's 4th annual report

From the Reportable Food Registry's 4th annual report

  • American Baker’s Association
  • American Frozen Food Institute
  • American Spice Trade Association
  • Association for Dressings and Sauces
  • Flavor and Extract Manufacturers Association
  • Food Marketing Institute
  • Frozen Potato Products Institute
  • Grocery Manufacturers Association
  • Institute of Shortening and Edible Oils
  • International Bottled Water Association
  • Juice Products Association
  • National Association of Margarine Manufacturers
  • National Pasta Association
  • North American Millers’ Association
  • Peanut and Tree Nut Association 
  • Produce Marketing Association
  • Snack Food Association
  • Vinegar Institute

If your product is in a food category for which the FDA/USDA has issued guidance documents to control  specific hazards, then you will definitely want to review those documents and incorporate those recommendations into your food safety program.

If you are a risk assessment manager or a Preventive Control Qualified Individual you might spend the time to investigate the FDA-iRISK® 2.0 risk assessment tool.  This science-based public health tool analyzes various risk scenarios for your type of product and process, and gives you documented risk assessment for your chosen scenarios.

FOOD Tool outbreak map

FOOD Tool outbreak map

The Centers for Disease Control (CDC) offers the Foodborne Outbreak Online Database, that searches foodborne disease data by year, state, location of food preparation, food and ingredients, and cause. It provides information on numbers of illnesses, hospitalizations, deaths, the germ, and the confirmed or suspected cause.

Finally, let’s not forget colleges, universities, service industries, and training institutes that actively assist with compliance to food safety regulations.  All of the aforementioned resources can help you develop an effective food safety plan based on solid information to support your conclusions and comply with the preventive controls rule. 

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