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Are you a qualified facility?

The FDA issued industry guidance today (9/14/2018) for very small companies manufacturing pet food. These are companies grossing less than $500,000 a year. As the guidance document is written in legalese, a simplified clarification follows:

All companies producing animal food are required to be registered.

  • If the companies gross >$500,000 a year, they are required to register as a food facility via this link. You must renew every two years, by December 31. (The renewal period opens October 1 of the renewal year – a great calendar item.)
  • If the companies gross <$500,000 a year, they can attest to being “qualified” (which means very small) every two years, by December 16. That can be done with this form.

“Qualified” means:

  • You do not need the same food safety plan (FSP) and HACCP (Hazard Analysis and Critical Control Points) plan required of the larger companies by FSMA. You can use written arrangements with suppliers in lieu of an FSP and HACCP.
  • However, if the FDA determines your product may need a recall, without the FSP and HACCP in place, the situation may be worse than if the company were registered as a food facility and had FSP and HACCP in place. Once the recall is completed, your facility will then be required to have these plans.

For these reasons, we recommend registering as a food facility from the very beginning and maintaining the appropriate FSP and HACCP; in the long-run, it will be worth doing the paperwork now.

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