Pasteurized Milk Ordinance: Requirements, Testing, and Inspections

The Pasteurized Milk Ordinance is the FDA’s model code for Grade A milk safety, and all 50 states, Washington D.C., and Puerto Rico have adopted it into their own laws.¹ The FDA writes and updates the document, but enforcement belongs to the states. The current version is the 2023 revision, and it governs everything from how dairy cows are housed to what has to be written on the side of a milk tanker.

What the Ordinance Covers

The rules apply to products classified as Grade A. That’s virtually all fluid milk sold in retail stores, plus yogurt, cottage cheese, dry curd cottage cheese, and cultured products like sour cream. In technical terms, it covers products with a standard of identity under 21 CFR Part 131, together with cottage cheese under 21 CFR Part 133.² Butter, most cheeses other than cottage cheese, and puddings are excluded and fall under separate manufacturing-grade regulations.

Anyone who manufactures, hauls, receives, or sells Grade A milk in an adopting jurisdiction must hold a permit from the local regulatory agency. Operating without one is a violation.

One boundary worth stating up front: the ordinance sits alongside a separate federal rule, 21 CFR 1240.61, that prohibits shipping raw (unpasteurized) milk across state lines in final package form for people to drink.³ Some states allow raw milk sales inside their borders under their own rules; crossing state lines with it for retail sale is a federal violation.

Farm-Level Requirements

A Grade A permit starts at the farm. Dairy herds must be enrolled in tuberculosis and brucellosis eradication programs with regular testing. Milking barns and housing areas have to drain properly, resist pests, and be cleanable. Manure disposal protocols are mandatory.

Cooling is where many producers get tripped up. Raw milk must reach 50°F or below within four hours of the start of milking, then drop to 45°F or below within two additional hours. That six-hour window from milking to full chill is the outer limit, not a target.²

Water supplies must come from a protected source, and individual farm wells require bacteriological testing at least once every three years.

Animal Drug Storage

Drug contamination is one of the fastest ways to lose a permit, and the ordinance is unusually detailed about how farms store medications. Drugs for lactating animals must be kept physically separate from drugs for non-lactating animals like dry cows, calves, and bulls. Separate shelves in the same cabinet can satisfy this, but the segregation has to be clear.

Every drug label must show the prescribing veterinarian’s name and address, the active ingredient by its generic or chemical name (brand names alone won’t pass inspection), dosage and administration instructions, and the milk discard time, even when that time is zero. Drugs not approved by the FDA for use in dairy animals, or those the FDA has banned from extra-label use, cannot be stored in the milkhouse, milking barn, or parlor. That prohibition extends to homeopathic and “all-natural” products that don’t meet federal labeling rules.² Drug administration equipment cannot be cleaned in vats used for milking equipment.

Processing and Pasteurization

At the plant, all surfaces that contact milk must be smooth, non-absorbent, non-toxic, and corrosion-resistant. AISI 300-series stainless steel is the benchmark, though equally corrosion-resistant alternatives are accepted.⁴ Equipment must be built for disassembly or cleaning in place.

The ordinance recognizes multiple pasteurization time-temperature combinations. The two most common are batch (vat) pasteurization at 145°F for 30 minutes and continuous-flow high-temperature short-time (HTST) pasteurization at 161°F for 15 seconds.² Products with 10 percent or more fat, 18 percent or more total solids, or added sweeteners must be heated an additional 5°F above these minimums.

Continuous-flow systems must include mechanisms that stop under-heated milk from advancing through the line. The forward-flow pumps shut down when product temperature drops below the pasteurization threshold and the diversion valve hasn’t fully diverted. The phosphatase test acts as a chemical check on pasteurization: a phosphatase-positive sample means the process must be investigated and corrected, and the milk cannot be sold.⁵

Every container of Grade A milk must be labeled with the identity of the plant where pasteurization occurred and must comply with federal food labeling laws, including the Nutrition Labeling and Education Act. The label must show pasteurization status and any added vitamins.

HACCP as an Alternative

The ordinance offers a voluntary Hazard Analysis and Critical Control Point program in place of traditional inspection. Under HACCP, the plant and its regulatory agency jointly develop a hazard-based food safety system. Regulatory personnel conduct HACCP audits rather than conventional inspections, at least every six months, and auditors must have specialized HACCP training. Participation is voluntary on both sides.²

Bacterial and Somatic Cell Limits

The ordinance sets numeric limits at multiple points in the supply chain. Repeated violations trigger permit suspension.²

Individual producer raw milk: no more than 100,000 bacteria per milliliter before it is mixed with other producers’ milk.
Commingled raw milk: no more than 300,000 bacteria per milliliter after pooling but before pasteurization.
Pasteurized milk: no more than 20,000 bacteria per milliliter in the finished product.
Somatic cell count: no more than 750,000 per milliliter for individual producer milk, an indicator of udder health.

The gap between the 100,000 individual limit and the 300,000 commingled limit gives a practical buffer, so good milk from one farm can offset slightly elevated counts from another. The 20,000 cap on finished pasteurized product still has to be met.¹

Drug Residue Testing

Every bulk milk tanker must be screened for drug residues before it can be unloaded at a plant. When a tanker screens positive, the plant must immediately notify the regulatory agency, isolate the milk, and identify which producer samples on the truck caused the result. Confirmation testing is performed by an official or officially designated laboratory to trace the contamination to the farm.

Once identified, the producer’s Grade A permit is immediately suspended and further pickups stop until subsequent tests come back clean.⁶ The contaminated milk must be disposed of in a way that keeps it out of both human and animal food chains. The violating producer bears the cost: the value of all the milk on the contaminated load plus disposal expenses. Because a bulk tanker can hold milk from several farms, the responsible producer pays for all of it.

Inspections, Suspensions, and Fines

Dairy farms must be inspected at least once every six months. Processing plants, receiving stations, and transfer stations face inspections at least once every three months.² Inspectors check equipment maintenance, sanitation logs, and compliance with every applicable provision.

When violations are found, the regulatory agency can suspend a facility’s permit. Reinstatement depends on the cause. For bacterial, coliform, or cooling temperature violations, the agency must inspect within one week of receiving a reinstatement application and issue a temporary permit once the problem is confirmed corrected. Accelerated sampling then follows, up to two samples per week on separate days over three weeks, before full reinstatement.⁷ Somatic cell violations follow a similar path once resampling shows the herd’s milk is back within limits. Drug residue suspensions are handled under Appendix N and require clean results before pickups resume.

Because the PMO is a model code, the specific fine amount is left blank for each adopting jurisdiction to fill in. The text states that violators “shall be punished by a fine of not more than $_____” and each day a violation continues can count as a separate offense. Adulterated or misbranded product can be seized and disposed of under applicable law.

Bulk Milk Transport

Milk tank trucks and their associated equipment must be inspected by the regulatory agency at least once every 24 months. During transport, milk must stay at 45°F or below, and any product left in external transfer equipment like hoses or pumps that exceeds that temperature must be discarded.

Tank interiors must be smooth, non-toxic, and cleanable, and must be cleaned and sanitized before first use. If more than 96 hours pass between cleaning and the next use, the tank must be re-sanitized. A cleaning tag on the outlet valve must identify the truck, the date and time of cleaning, the location, and who did the work. Shipping documents for every load must include the shipper’s name, permit number, product identity, weight, temperature at loading, date, grade, and seal numbers.² A copy of the current inspection report must travel with the truck, or the tank must display a label identifying the regulatory agency and the month and year of its last inspection.

The Interstate Milk Shippers List

Operations that ship across state lines need to be on the Interstate Milk Shippers List, maintained by the FDA. Processing plants, receiving stations, and transfer stations need a sanitation compliance rating of 90 or higher to qualify. Manufacturers of single-service containers and closures for milk products need at least 80.⁸

Ratings are conducted by certified Milk Sanitation Rating Officers and must be renewed at least once every 24 months. The evaluation covers producing farms, receiving and transfer stations, the processing plant, and the enforcement performance of the supervising regulatory agency. A facility that drops off the list loses the ability to sell Grade A products into interstate commerce.

How the Ordinance Gets Updated

Changes to the PMO come through the National Conference on Interstate Milk Shipments, which brings together state regulatory officials, industry representatives, and federal personnel under a memorandum of understanding with the FDA.² At biennial conferences, participants propose amendments addressing new technologies, emerging safety concerns, and issues regulators encounter in the field. Approved changes are incorporated into subsequent PMO revisions published by the FDA.

1
Food and Drug Administration. Grade A Pasteurized Milk Ordinance
2
National Conference on Interstate Milk Shipments. Grade A Pasteurized Milk Ordinance – 2023 Revision
3
eCFR. 21 CFR 1240.61 – Mandatory Pasteurization for All Milk and Milk Products in Final Package Form Intended for Direct Human Consumption
4
Food and Drug Administration. Pasteurized Milk Ordinance – Section: Item 9r Utensils and Equipment Construction
5
U.S. Department of Agriculture. Grade A Pasteurized Milk Ordinance – Section: Electronic Phosphatase Tests
6
Food and Drug Administration. Pasteurized Milk Ordinance – Appendix N
7
Food and Drug Administration. Grade A Pasteurized Milk Ordinance – Section: Reinstatement of Permits
8
U.S. Food and Drug Administration. Interstate Milk Shippers List