FDA Pest Control Requirements for Food Plants Under 21 CFR 117

The FDA's pest control rule for human food facilities is short. Under 21 CFR 117.35(c), pests must not be allowed in any area of the plant, effective measures must be taken to keep them out of manufacturing, processing, packing and holding areas, and pesticides may only be used under precautions that protect food, food-contact surfaces and packaging. Everything else, from bait station maps to trend reports, is how a plant proves it is meeting that standard when an investigator walks in.

Where pest control sits in Part 117

Part 117 is the rule FDA finalized in 2015 under the Food Safety Modernization Act. Its full name is Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. Pest control shows up in three places.

Subpart B, the CGMPs. These are the baseline sanitation and facility rules that apply to most registered food facilities. Section 117.35 covers sanitary operations, and paragraph (c) is the pest control paragraph. Section 117.20 covers plant and grounds.

Subpart C, hazard analysis and preventive controls. If your hazard analysis identifies pest contamination as a hazard requiring a preventive control, pest control can become a sanitation control with its own monitoring, corrective action and verification records. Many plants treat it instead as a prerequisite program under the CGMPs, and document the reasoning in the food safety plan.

Subpart F, records. Any preventive control you do adopt needs records that meet the Subpart F requirements, including being kept as originals or true copies and being available for review.

What 117.35(c) actually asks for

Read it slowly and it breaks into four obligations.

1. No pests in any area of the plant. Not "low activity" or "under control." The standard is absence, which is why investigators treat a single live rodent or a fresh dropping trail near product as a finding.
2. Exclusion from food areas. The rule asks for effective measures to exclude pests from manufacturing, processing, packing and holding areas. Exclusion means physical work: door sweeps, dock seals, sealed utility penetrations, screened openings, closed gaps under roll-up doors.
3. Protection against contamination. Measures must protect against food on the premises being contaminated by pests. This covers stored ingredients, finished goods and packaging.
4. Restricted pesticide use. Pesticides are allowed only with precautions that protect food, food-contact surfaces and packaging materials. In plain terms: the right product, applied per its label, in the right place, by someone qualified, with a record of it.

The grounds rule people forget

Section 117.20(a) requires the grounds around a plant to be kept in a condition that protects against contamination. One of the listed duties is properly storing equipment, removing litter and waste, and cutting weeds or grass close to the plant that could act as an attractant, breeding place or harborage for pests.

That language matters in October. Pallet stacks against the back wall, tall grass along the fence line and an overflowing dumpster pad are the exact conditions that pull mice toward a heated building as temperatures drop.

Section 117.20(b) adds construction duties, including adequate screening or other protection against pests. Torn screens on make-up air units and propped-open dock doors fall here.

How inspectors tend to read it

An FDA investigator is not checking whether you have a contract with a pest company. They are checking whether the plant is free of pests and whether your controls are working. In a typical walk-through, expect attention on:

• Physical evidence. Droppings, gnaw marks, rub marks, insect activity at light fixtures, stored product insects in spilled ingredient.
• Gaps. Daylight under doors, open conduit, unsealed pipe chases between rooms.
• Device placement. Bait stations inside production rooms are a red flag. Interior rodent control in food areas is normally mechanical (traps, glue boards in protected stations), with toxic bait kept to the exterior perimeter.
• Pesticide storage. Chemicals stored away from ingredients and packaging, labelled, and secured.
• Records that match the floor. If the logbook says "no activity" and there are fresh droppings behind the mixer, the gap between paper and reality becomes its own problem.

Pest-related observations regularly appear on Form 483 inspection reports, and the real cost is the follow-up: extra customer audits, product holds and a rushed rebuild of the program.

Paperwork that supports the program

Part 117 does not hand you a list of pest control documents. Customer audits and GFSI schemes such as SQF and BRCGS are much more specific, and most US plants build to those. A file that holds up for both usually contains:

Our guide to what auditors look for in a pest control file goes deeper on how to organize this so it reads cleanly during an audit.

The pesticide side: FIFRA and state licensing

Federal law under FIFRA makes the pesticide label legally binding, so the label decides where a product can go in a food plant and what precautions apply. Many labels restrict use in food handling areas or require food to be removed or covered first.

Separately, each state runs its own certification program for commercial applicators, built on the federal standards in 40 CFR Part 171. The person treating your plant should hold the right category for the work in your state. Ask for it in writing; a valid certification is a record an auditor may want to see.

A practical program for a US food plant

For most processing and warehousing sites, a program that satisfies 117.35(c) looks like this:

• Exterior perimeter of tamper-resistant bait stations, spaced along the walls and fence line, serviced on a fixed schedule.
• Interior mechanical devices at doors, along walls and near entry points, with no rodenticide inside production or storage rooms.
• Insect light traps placed away from exposed product and away from doors where they would attract insects inside.
• Exclusion work after every inspection that finds a gap: door sweeps, dock seals, sealed penetrations.
• Service frequency set by risk, often every two weeks or monthly for food plants, with more frequent checks during fall rodent pressure.
• Quarterly trend review with the plant's food safety lead, so the program changes when the data does.

Facilities in Chicago and Dallas face very different seasonal pressure, Norway rats and cold-driven mice in one, cockroaches and stored product insects for more of the year in the other, so the device plan should not be a copy-paste from another site.

Frequently asked questions

Does 21 CFR 117 require a licensed pest control company?

The regulation does not say a plant must hire an outside company. It requires effective exclusion and safe pesticide use, and state law usually requires certification for anyone applying pesticides commercially. Most plants use a licensed provider because it covers both the applicator requirement and the documentation auditors expect.

Can bait stations go inside a food processing area?

Toxic rodenticide stations inside production, packing or ingredient storage areas create a contamination risk and draw attention from investigators and auditors. The usual approach is exterior bait only, with mechanical traps inside. Always follow the product label, which may restrict indoor use outright.

How often should a food plant have pest control service?

Part 117 does not set a frequency. Many food plants run service every two weeks or monthly, with the schedule driven by risk, past activity and what the customer audit standard requires. Fall and early winter often justify more frequent rodent checks.

Is pest control a preventive control under FSMA?

It can be. If your hazard analysis finds that pest contamination is a hazard requiring a preventive control, it becomes a sanitation control with monitoring, corrective actions and verification. Many plants instead manage it as a CGMP prerequisite program and record that decision in the food safety plan.

Get a written scope for your plant

If you run a food plant or warehouse in the US and want a pest program built around 21 CFR 117 and your audit standard, send us the details through the quote form. Include the square footage, the audit scheme you are certified to and any recent findings, and we will come back with a written scope and device plan.