Posted: 05 Feb 2018 06:33 PM PST
On Monday, January 21 (amid the government shutdown) the Center for Veterinary Medicine of the Food and Drug Administration (CVM) released a draft guidance document addressing Subpart C of the Agency’s regulation titled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (PC rule). Subpart C contains the requirements for facilities to use when developing a written animal food safety plan, conducting a hazard analysis and implementing risk-based preventive controls, if needed.
The draft guidance includes five chapters:
Similar to what FDA did in the draft guidance for human food preventive controls, CVM prepared a list of different animal food ingredients with specific references to hazards. Although this listing of hazards may seem helpful, it does have disadvantages and seems somewhat inconsistent with the PC rule. Inspectors can be expected to use the list to determine whether a company has included the listed hazards listed in it’s hazard evaluation. This appears inconsistent with the requirement that a company must conduct its own analysis based on the scientific literature, personal experience, illness data, etc. We also note that the list of hazards for various ingredients appears to be based on data going back to 1989 – almost thirty years ago. Query to what extent thirty year old data are relevant.
The timing of the draft guidance is somewhat unfortunate, because the compliance date for all businesses except those that are small or very small has already passed. FDA published final rules to implement the hazard analysis and risk-based preventive control (PC) provisions for human and animal food on September 17, 2015. Businesses that are not small or very small businesses under the rule were required to comply with the animal food preventive control provisions as of September 18, 2017. (Small businesses need to comply by no later than September 17, 2018, and very small businesses need to comply with limited provisions by September 17, 2019.) FDA announced last year in August that it planned to delay routine preventive controls inspections for large businesses until fall 2018. However, at that time the Agency made clear that this delay in inspections did not mean that companies should wait with the development of their food safety plan. In the absence of CVM guidance, those food safety plans may not include or have considered hazards that CVM now has identified. It remains to be seen how CVM will use its own guidance and whether it will rely on the hazards identified in this draft guidance.
Comments to the draft guidance are due by July 23, 2018.
The draft guidance includes five chapters:
- food safety plan requirements;
- recommendations for conducting a hazard analysis;
- hazards associated with the manufacturing, processing, packing and holding of animal food;
- examples of preventive controls that may be used to significantly minimize or prevent animal food hazards; and
- preventive control management components.
Similar to what FDA did in the draft guidance for human food preventive controls, CVM prepared a list of different animal food ingredients with specific references to hazards. Although this listing of hazards may seem helpful, it does have disadvantages and seems somewhat inconsistent with the PC rule. Inspectors can be expected to use the list to determine whether a company has included the listed hazards listed in it’s hazard evaluation. This appears inconsistent with the requirement that a company must conduct its own analysis based on the scientific literature, personal experience, illness data, etc. We also note that the list of hazards for various ingredients appears to be based on data going back to 1989 – almost thirty years ago. Query to what extent thirty year old data are relevant.
The timing of the draft guidance is somewhat unfortunate, because the compliance date for all businesses except those that are small or very small has already passed. FDA published final rules to implement the hazard analysis and risk-based preventive control (PC) provisions for human and animal food on September 17, 2015. Businesses that are not small or very small businesses under the rule were required to comply with the animal food preventive control provisions as of September 18, 2017. (Small businesses need to comply by no later than September 17, 2018, and very small businesses need to comply with limited provisions by September 17, 2019.) FDA announced last year in August that it planned to delay routine preventive controls inspections for large businesses until fall 2018. However, at that time the Agency made clear that this delay in inspections did not mean that companies should wait with the development of their food safety plan. In the absence of CVM guidance, those food safety plans may not include or have considered hazards that CVM now has identified. It remains to be seen how CVM will use its own guidance and whether it will rely on the hazards identified in this draft guidance.
Comments to the draft guidance are due by July 23, 2018.
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