Preventive Controls for Animal Food

The Preventive Controls for Animal Food rule, 21 CFR part 507, gave animal food its first current good manufacturing practice regulation and applied the same food safety plan structure as the human food rule to feed mills, pet food plants and the human food facilities that sell their by-products as feed.

What it is
FSMA final rule
Where it lives
21 CFR part 507
Final rule
September 2015
Docket
FDA-2011-N-0922
Published by
U.S. Food and Drug Administration

Who it covers

Facilities that manufacture, process, pack or hold animal food and are required to register with the FDA, which reaches feed mills, pet food manufacturers, rendering plants and ingredient suppliers. Farms are outside it, and so, for most purposes, are human food facilities that merely hold a by-product for sale as animal food.

That last group is the one the rule spends most effort on. A brewery selling spent grain, a juice plant selling peel or a dairy selling liquid whey is covered only to the extent of not contaminating the by-product, unless it processes the by-product further, for example by drying or pelleting it, at which point it becomes an animal food manufacturer.

What it requires

Before this rule there was no good manufacturing practice regulation for animal food at all. Subpart B of part 507 supplies one, written for the diversity of the sector rather than copied from the human food practices, and a human food facility further processing a by-product can choose to follow either set.

Subpart C mirrors the human food rule: a written food safety plan with a hazard analysis, preventive controls for the hazards that need them, monitoring, corrective actions, verification and records. The controls named are process controls, sanitation controls, a supply-chain program and other controls; there is no allergen control, because the hazard does not exist for animals in the same way.

A facility whose hazard analysis finds no hazard requiring a preventive control documents that finding and stops there. The rule is explicit that the analysis is the requirement and the controls follow from it, not the other way round.

In the FDA’s words

Processors already implementing human food safety requirements and who are just holding by-product for use as animal food, do not need to implement additional preventive controls or CGMP regulations when supplying a by-product (e.g., wet spent grains, fruit or vegetable peels, liquid whey) for animal food, except to prevent contamination.

U.S. Food and Drug Administration, FSMA Final Rule for Preventive Controls for Animal Food, updated 2023-07-13. Read 2026-09-16.

The by-product question is the one most human food facilities have about this rule, and this is the FDA's answer to it.

A facility that appropriately determines through its hazard analysis that there are no hazards requiring a preventive control would document such a determination in its hazard analysis but would not need to establish preventive controls.

U.S. Food and Drug Administration, FSMA Final Rule for Preventive Controls for Animal Food, updated 2023-07-13. Read 2026-09-16.

The hazard analysis is the requirement; the controls follow from what it finds.

Compliance dates

WhoDate
Businesses other than small and very small: good manufacturing practicesSeptember 19, 2016
Businesses other than small and very small: preventive controlsSeptember 18, 2017
Small businesses, fewer than 500 full-time equivalent employees: good manufacturing practicesSeptember 18, 2017
Small businesses: preventive controlsSeptember 17, 2018
Very small businesses, under $2,500,000 a year adjusted for inflation: good manufacturing practicesSeptember 17, 2018
Very small businesses: preventive controlsSeptember 17, 2019

The FDA staggered the practices and the controls a year apart at every size, and the records a very small business needs to prove its size were due from January 1, 2017. Some dates were later extended; every one has now passed.

The dates are the FDA’s, as stated on FSMA Final Rule for Preventive Controls for Animal Food, updated 2023-07-13, read 2026-09-16. Compliance dates have been extended before; check that page before planning against any of them.

Exemptions

Section 507.5 carries the exemptions. A qualified facility is subject to the modified requirements of section 507.7. A facility solely storing unexposed packaged animal food is outside subparts C and E. Human food facilities holding by-products for animal food without further processing are covered only by the limited provisions of section 507.12, provided they already comply with the human food practices.

Where it is in 21 CFR

The rule is codified at 21 CFR part 507, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals. Title 21 is a work of the United States government and in the public domain, so the regulation is reproduced in full on this site. These are the sections a reader of this page most often needs.

What goes wrong in practice

A rule describes the controls; the FDA’s recall records are what happened where a control was missing. These are the hazards and the kinds of food whose records this rule is most often written against.

Questions

Does the FSMA animal food rule apply to a brewery selling spent grain?
Only in a limited way. A human food facility that follows the human food good manufacturing practices and merely holds a by-product such as spent grain, peel or liquid whey for use as animal food needs no additional preventive controls or animal food practices beyond not contaminating it, for example with cleaning chemicals or refuse. If it further processes the by-product, by drying or pelleting it, the animal food rule applies in full.
What is the difference between 21 CFR part 507 and part 117?
Part 507 is the animal food rule and part 117 the human food rule. Both require a written food safety plan built on a hazard analysis with preventive controls, monitoring, corrective actions, verification and records. Part 507 has its own good manufacturing practices written for feed and pet food, and it has no allergen control, since allergen labelling is a human food hazard.

The other FSMA rules

FSMA is enforced as 10 rules, and a single business frequently sits under several. The Act itself, and how the rules fit together.

An inspection under this rule asks for the records behind each requirement, and finding them is the work. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.