Pet food and animal feed plants that must register with FDA follow 21 CFR 507, not the human food rule in Part 117. Part 507, published in September 2015, has a higher very small business line, names nutrient hazards and has no allergen control category.
This guide is for QA and feed safety managers at pet food plants and feed mills, including Gulf exporters, who sell into the US or supply a US buyer.
How does Part 507 differ from Part 117?
Part 507 requires a covered plant, unless exempt, to follow current good manufacturing practice (CGMP) and run a written food safety plan. Its main compliance dates ran from 2016 to 2019. The table compares the two rule texts.
| Point | Part 507 (animal food) | Part 117 (human food) |
|---|---|---|
| Food covered | Pet food, animal feed, raw materials and ingredients (507.3) | Human food |
| Who a hazard can harm | Humans or animals (507.3, 507.33(c)(1)) | Humans |
| Very small business line | Under $2,500,000 a year, adjusted for inflation | Under $1,000,000 a year, adjusted for inflation |
| Nutrient deficiency or toxicity | Named chemical hazard (507.33(b)(1)(ii)) | Not named |
| Food allergen controls | No such category (507.34(c)) | A preventive control category (117.135(c)) |
| Supply-chain program | Subpart E | Subpart G |
| Withdrawal of qualified facility exemption | Subpart D | Subpart E |
| Preventive control compliance dates | 2017 to 2019, one year after the CGMP dates | 2016 to 2018, the same as the CGMP dates |
| Qualified facility attestation | Form FDA 3942b | Form FDA 3942a |
The rule's own nutrient examples are too little thiamine in cat food, too much vitamin D in dog food and too much copper in food for sheep. An allergen programme on a pet food line is good practice, not a Part 507 control category.
A plant that makes both human and animal food may apply Part 117 subparts B and C to its animal food instead. Its food safety plan must then also address animal food hazards (507.1(d)).
What must the animal food safety plan contain?
A preventive controls qualified individual (PCQI) prepares or oversees a written plan with seven parts: hazard analysis, preventive controls, supply-chain program, recall plan, and procedures for monitoring, corrective action and verification (507.31). The hazard analysis is written for each type of animal food, even when it finds nothing to control.
If animal food is exposed to the environment before packaging and gets no later lethal step, the analysis must evaluate environmental pathogens such as Salmonella and Listeria monocytogenes (507.33(c)(2)).
A PCQI validates process controls before use or within 90 calendar days of starting production. Monitoring and corrective action records are reviewed within 7 working days, unless a PCQI writes a justification for longer (507.47, 507.49(a)(4)). The whole plan is reanalysed at least every 3 years, and sooner after a significant change or a control that failed (507.50).
What did FDA cite in its 2025 and 2026 warning letters?
Of six recent letters, three concern pet food and three concern feed mills where animals died.
Raw Bistro Inc., 17 February 2026: a retail sample of raw dog food tested positive for Salmonella. The hazard analysis for a complete dog food did not identify nutrient deficiency or toxicity (507.33(a)). Its ingredient wash, used as the pathogen control, did not prevent recontamination and was not validated (507.34(a)(1), 507.47(a)). FDA added that finished product testing is verification, not a control.
Best Buy Bones, Inc., 30 April 2026: FDA found Salmonella Uganda in bully bite chews. Oven time and temperature for chicken and duck feet were not met, and no PCQI reviewed those records (507.34(a)(1), 507.49(a)(4)(i)). A supplier control for a serious hazard had no annual onsite audit or written justification (507.130(b)).
Lystn LLC, trading as Answers Pet Food, 18 June 2025: four retail lots of raw pet food carried Salmonella or L. monocytogenes. FDA cited sanitation controls for environmental pathogens (507.34(c)(2)) and supplier verification (507.115(a)(2)).
On the feed side, King Farm (4 December 2025) had no way to check corn and wheat for mycotoxins (507.25(b)(2)) after at least 30 horse deaths linked to fumonisin. Livestock Nutrition Center (11 April 2025) and J.D. Heiskell Holdings (12 June 2025) were cited under 507.33(c)(1) after animal deaths linked to monensin. The Heiskell letter also cited the medicated feed labelling rule (21 CFR 225.180).
Is your plant exempt or a qualified facility?
A qualified facility skips subparts C and E and follows 507.7 instead (507.5(d)). One route is a very small business: under $2,500,000 a year in animal food sales plus the market value of animal food held without sale. The other needs sales to qualified end-users above all other sales, and total food sales under $500,000. Both use a 3-year average adjusted for inflation, and both count subsidiaries and affiliates.
FDA's current animal food cut-offs, averaged over 2023 to 2025, are $3,432,379 and $686,476. FDA intends to update them each April.
You determine your status each year by 1 July. Attestations on Form FDA 3942b are due every 2 years, in even-numbered years, between 1 October and 31 December, so 2026 and 2028 are submission years.
Part 507 does not apply to establishments, including farms, that need not register (507.5(a)). FDA says a feed mill that is part of a fully vertically integrated farm, feeding only that farm's animals, is not covered. A site that only stores unexposed packaged animal food is exempt from subparts C and E (507.10).
Canned pet food is processed under the low-acid canned food rule, Part 113. If the plant complies with Part 113, it is exempt from subparts C and E, but only for the microbiological hazards Part 113 regulates.
What is AAFCO's role, and does it bind your plant?
The Association of American Feed Control Officials (AAFCO) is a voluntary membership association of state and federal regulatory officials, plus officials from other countries. Its model laws and label rules bind only where a state adopts them. Part 507 is federal law that FDA enforces.
FDA requires pet food labels to show the product identity, net quantity, the manufacturer's or distributor's name and place of business, and ingredients in descending order by weight. Some states add their own labelling rules, many based on an AAFCO model.
Most states adopt AAFCO's ingredient definitions, but the FDA and AAFCO memorandum of understanding on those definitions expired on 1 October 2024. FDA's guidance #293 (October 2024) says it generally does not intend food additive enforcement for ingredients in chapter six of AAFCO's 2024 list. Guidance #294, final in July 2025, sets up an interim Animal Food Ingredient Consultation (AFIC) process with FDA.
What does a Gulf exporter need before shipping pet food or feed to the US?
Part 507 covers foreign facilities that must register, and for registration "food" includes animal feed and pet food. You renew registration in the October to December window of every even-numbered year, name a US agent and accept that FDA may inspect.
The Foreign Supplier Verification Programs (FSVP) rule is your US importer's duty, and you are its foreign supplier. For a serious hazard you control, such as Salmonella in raw pet food, expect an onsite audit before first import and at least yearly, unless the importer documents that another check is adequate.
An FDA inspection in the past year can replace that audit. An inspection by your own authority counts only if FDA has recognised your country's food safety system as comparable or equivalent, so do not assume a Gulf authority's inspection counts. Saudi feed registration with SFDA is a separate duty and does not replace Part 507.
A small exporter may be a qualified facility, and the sales tests count sales in every market, not only US sales. If you attest to compliance with your own country's food laws instead, your label must show the manufacturing facility's full address (507.7(e)). Buyers may also ask for FAMI-QS or a Codex HACCP system, but neither replaces Part 507.
How AGS can help
The U.S. Pet Food & Animal Feed Preventive Controls Management System (21 CFR 507) has 243 documents in editable Microsoft Word and Excel. It includes a 21 CFR Part 507 compliance matrix, a regulatory applicability assessment, an animal food hazard library, a recall plan and 35 illustrative pet food and feed models. It does not cover ruminant feed (cattle, sheep, goats), FSVP or FDA registration.
Frequently asked questions
Does an animal food PCQI need an FDA certificate?
No. There is no federal PCQI licence. A PCQI qualifies through training at least equivalent to an FDA-recognised standardised curriculum, or through job experience (507.53). FDA works with the Food Safety Preventive Controls Alliance on that training.
Do human food by-products sold as feed fall under Part 507?
Not fully, if a facility that complies with the Part 117 CGMPs only holds and distributes them. Then only the by-product holding rules apply (507.12(b)). Drying, pelleting or heat treatment brings in the CGMPs and, unless exempt, a Part 507 hazard analysis (507.12).
Which FDA guidance explains Part 507?
FDA has final guidance #235 on CGMP (October 2017) and #245 on hazard analysis and preventive controls (July 2022). Guidance #246 on the supply-chain program is still the June 2018 draft.
AGS provides independent documentation toolkits. This guide and the referenced kit are not affiliated with, endorsed by or approved by the US Food and Drug Administration or the Association of American Feed Control Officials. It is general information, not legal or veterinary advice. What applies depends on your facility's activities, size, the species you feed and the exemptions you qualify for.
Reviewed October 2026. Facts checked against the sources current at publication.
