In my last series I discussed the main elements required by the Preventive Controls for Animal Food rule (21 CFR 507). At this point all animal feed manufacturers need to have a written plan in place. One criterion for re-evaluation of your plan is when “new Information” becomes available. That would include new FDA guidance.
In May of this year the FDA issued draft guidance on Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover. The introduction states that while the guidance does not significantly change the rules in place since the 1970’s (21 CFR 225) but it will result in the replacement of “prior guidance found in the Compliance Policy Guides Sec. 680.500 Unsafe Contamination of Animal Feed from Drug Carryover and 680.600 Sequencing as a Means to Prevent Unsafe Drug Contamination in the Production, Storage, and Distribution of Feeds, (both of which we intend to withdraw after this guidance is finalized), but includes updates and additional information.”.
Comments on this new guidance are due by 8/8/2022 and can be made at the website linked here.
This guidance identifies adherence to 21CFR 225, 507 and the Sanitary Transportation of Food as factors in preventing the unsafe contamination of food across the food chain. It addresses several methods for carry-over prevention, specifically: physical cleanout, flushing and sequencing. All these methods should be discussed in your feed safety plan. The guidance discusses in some detail the various life cycle and intended use considerations that must also be addressed in your plans.
This draft guidance document should be reviewed by all medicated feed manufacturers, licensed and unlicensed. Should it be approved by the FDA, this will require that all medicated feed manufacturers re-evaluate their feed safety plans to ensure compliance with the updated guidance and make changes to any identified deficiencies.