1. How do I conduct a Hazard Analysis?

A hazard analysis is the first step in the process of writing your feed safety plan. In the FSPCA Hazard Analysis and Preventive Controls course Chapter 3 discusses common animal feed safety concerns. But the hazard analysis process outlined in Chapter 5 requires a deeper dive. The hazard analysis required in your feed safety plan must be specific to your facility. The rule states:

21 CFR 507.33 (a)(1) You must 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 animal food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control;

Back in 2015 AFIA recognized that the industry needed help with this process. They worked with the University of Minnesota over a two-year period to publish the “Scientific Literature Database Food for Animals” (version 1.2 April 2017). This database identifies hazards in 16 animal species found in ingredients and finished animal foods. The database scope and inclusion criteria are literature written in English; published in the United States and Canada; and found in FDA recalls over the last 10 years; and other factors. 

CFD used the AFIA database and worked in collaboration with four member livestock feed mills to narrow the scope of the data to six species common to a livestock feed mill in our membership. The CFD Hazard Analysis Tool or “CFD HAT” was completed in 2018.

The rule requires that your hazard analysis evaluate 10 things:

  1. Formulation of the animal food
  2. Condition, function, and design of facility and equipment
  3. Raw materials and other ingredients
  4. Transportation practices
  5. Manufacturing/processing procedures
  6. Packaging and labeling activities
  7. Storage and distribution
  8. Intended or reasonably foreseeable use
  9. Sanitation, including employee hygiene
  10. Other relevant factors, such as temporal (weather-related) nature of some hazards

The CFD HAT begins your analysis of Raw Materials and Other Ingredients and the Intended or reasonably foreseeable use of the feed you manufacture. By evaluating hazards found in finished animal feeds, it also provides a window into the hazards that could originate from the manufacturing process. Use your process flow diagram to complete the process of hazard analysis.

The rule further requires:

21 CFR 507.33 (2) The hazard analysis must be written regardless of its outcome

It also requires that you document hazards that are known to our industry (Chapter 3) but do not rise to the level of a known and reasonably foreseeable hazard that is addressed in your feed safety plan.

For example, Bovine Spongiform Encephalopathy (BSE) is not prevalent in the United States and BSE is not cited in the source database for this analysis. It should still be documented as a hazard that was considered but not found to be Known and Reasonably foreseeable. A paragraph in your feed safety plan and copies of you last FDA Inspection reports (demonstrating compliance with 21 CFR Part 589.2000 and 21 CFR 589.2001) would fully demonstrate the mitigation of the hazard. Reference to the World Organization Resolution No. 26 (85th General Session of the World Assembly, May 2017) indicating the United States has a negligible risk of Bovine Spongiform Encephalopathy would also be appropriate. Therefore, it is not a Known or Reasonably Foreseeable Hazard. If your facilities BSE inspection was not successful, the hazard may be elevated to a Known or Reasonably Foreseeable Hazard and be addressed in your feed safety plan.

Pesticide Contamination is also a hazard that has not risen to the level of a known and reasonably foreseeable hazard. This week the FDA issued the FY 2019 Pesticide Report, Noting that it is “Consistent with Trends Over the Past 8 Years, Pesticide Residue Levels Remain Low“. The report can be found here: Pesticide Residue Monitoring Program Report for FY 2019. In your next update to your Feed Safety Plan a reference to this report would be appropriate.

If you would like more information on the CFD Hazard Analysis Tool (CFD HAT). Email [email protected].