Web-based hazard-assessment tool for FDA’s FSMA animal food rule
The NGFA is making available exclusively to member companies a new web-based hazard-assessment tool to assist feed and pet food facilities in complying with the Food and Drug Administration’s final regulations implementing the Food Safety Modernization Act.
FDA’s final rule for current good manufacturing practice and hazard analysis and risk-based preventive controls for animal food requires covered animal food facilities (which encompasses facilities that manufacture, process, pack or hold feed, feed ingredients and pet food) to develop facility-specific animal food safety plans. The cornerstone of the required plan is that facilities conduct an analysis of hazards that are known to be, or have the potential to be, associated with the facility or its animal food. The hazard analysis is to evaluate the severity and probability of the occurrence of such hazards to determine whether one or more of the hazards requires a preventive control. FDA’s final rule requires that determinations made during the hazard analysis are to be based upon experience, illness data, scientific reports and other information.
To assist members in completing the required hazard analysis, the National Grain and Feed Foundation and the American Feed Industry Association’s foundation – the Institute for Feed Education & Research – contracted with the University of Minnesota’s Center for Food Safety and Animal Health to review scientific literature and published recall reports for hazards that have occurred in animal food. The resulting “Scientific Literature Database Tool” summarizes published information regarding the occurrence of hazards in animal food. In addition, the tool contains qualitative scoring to describe the severity of identified hazards for 16 animal species groups.
The Scientific Literature Database tool is a starting point for NGFA members when developing a facility-specific hazard analysis. Facilities also will need to incorporate experience and other information when evaluating the severity and probability of known or reasonably foreseeable hazards associated with their facility and the types of animal food being manufactured, processed, packed or held to determine whether the hazard requires a preventive control.
Please Note: This Scientific Literature Database Tool does not supply all the information for an animal food facility to complete the required hazard analysis. However, the tool does provide a robust review of the occurrence of animal food hazards documented in scientific literature and by FDA. It is suggested that facilities use this database tool as a starting point for their hazard analysis and supplement the information provided with additional illness data, scientific research or experience to complete the facility-specific hazard analysis required by the FDA animal food rule.
Significantly, during the hazard analysis, animal food facilities also may consider the effect of prerequisite programs or current good manufacturing practices when evaluating the severity and probability of known or reasonably foreseeable hazards. The use of prerequisite programs or current good manufacturing practices may mitigate the risks posed by hazards sufficiently so that there is no need for the use of preventive controls. Ultimately, the FDA final rule requires that determinations as to whether a given hazard requires a preventive control are to be made and justified by a “Preventive Controls Qualified Individual” who is qualified in the application of hazard analysis and risk-based preventive controls.
The Scientific Literature Database Tool is being provided exclusively to NGFA member companies as a member benefit, and is another example of the highly relevant research and education initiatives being conducted by the NGFA Foundation. The tool, user guide and videos that describe how to use the tool are accessible through the links provided below.
Questions on the tool should be emailed to David Fairfield at firstname.lastname@example.org
Resources and Tools
- Scientific Literature Database
- Scientific Literature Database User Guide
- Scientific Literature Database Bibliography
- Demonstration Video 1 (Sheets 1-3 in Database)
- Demonstration Video 2 (Sheets 4-6 in Database)
- Demonstration Video 3 (Sheets 7-12 in Database)
- Demonstration Video 4 (Sheets 13-17 in Database)
- NGFA Feed Site
- More information on projects undertaken by the NGFA Foundation and how you can contribute is available here.
- Contact Senior Vice President of Feed Services David Fairfield