Disclaimer: Regulations change frequently and vary by jurisdiction, so always confirm current requirements with your state and local authorities. This article is for general information only and is not a substitute for official regulatory guidance or legal advice.

Milk is a “High Risk Food” Item. Because it can support the rapid growth of bacteria when mishandled, the FDA is serious about how it is processed and has classified it as a “High Risk Food”.

This classification means that certain regulations exist at the federal and state levels to help prevent foodborne illness and create consumer trust.

Our clients are small farmers and co-ops, looking to sell directly to consumers.

At Micro Dairy Masters, we understand milk handling at scale and build safe, automated systems that handle these concerns for you.

Understanding these basics and then abiding by them doesn’t just give your brand a positive reputation from the start; it also prevents costly repairs, makes inspections go smoothly, and keeps approvals from being delayed.

The more consistent you can make your processes, the more intentional each gallon of milk becomes, and the better your micro dairy will do.

Who Oversees a Micro Dairy

Unfortunately, starting and running a micro dairy isn’t as simple as bottling and selling milk. There are rules you need to follow, people you need to consult with, and organizations that you need to appease.

Typically, micro dairies will interact most with their state’s Department of Agriculture or their Department of Health. The departments use FDA models, which keep things streamlined. They will also conduct inspections and handle normal paperwork such as licensing and enforcement. Local authorities are also typically involved in conversations about zoning, wastewater, and building codes.

On the federal level, you will consult with the FDA for guidance on inspection models and oversight authority for cross-state dealings. Federal understanding also becomes crucial when your products fall outside Grade A programs, which are handled at the state level.
It’s important that you, your state, and the federal government work as a team so that you can make the most out of your dairy and put the best products forward that you possibly can.

Understanding the Pasteurized Milk Ordinance

The first thing you should know is that the 2023 Pasteurized Milk Ordinance (usually referred to as the “PMO”) is a federal model regulation that’s handled by the FDA. It is what creates the uniform standards you see in the industry for producing, pasteurizing, and selling anything labeled as Grade A milk or milk product.

You cannot simply abide by the PMO and call it good, since states have something to say about it, as well. Almost every state abides by the PMO, but almost all of them have some minor, state-specific modifications that you will need to understand and put into practice.

The benefits of the PMO are that it supports consistency across states, it encourages employee hygiene and health standards, and the required testing and documentation mean that the facility, equipment, and construction are all safe and proper for milk handling, storage, and transport.

The PMO mostly applies to Grade A milk and related products, but some products fall under different regulations, such as certain aged cheeses. It’s important to know how your products are affected.

Get Grade A Raw Milk Ready for Pasteurization

To get your raw milk ready to become a Grade A, ready-for-the-shelves product, you need to get a few things handled according to general PMO guidelines (remember to check your state laws, as they could be stricter than the PMO!).

• Cool to 50°F (10°C) or less within 4 hours from the start of the first milking
• Cool to 45°F (7°C) or less within 2 hours after completion of milking
• Blend temperature after first and subsequent milkings must not exceed 50°F (10°C)
• Bacterial limits (Standard Plate Count): Individual producer milk: ≤ 100,000 CFU/mL prior to commingling
• Commingled milk prior to pasteurization: ≤ 300,000 CFU/mL
• Somatic Cell Count (SCC): Individual producer milk: ≤ 750,000 cells/mL
• Drug residues – No positive drug residue/inhibitory substance results

Finished Grade A Pasteurized Milk and Milk Products

To get a finished, Grade A product, you need to meet some additional PMO requirements about pasteurization.

• Cooled to 45°F (7°C) or less and maintained there
• Bacterial limits (Standard Plate Count) ≤ 20,000 CFU/mL (or per gram where applicable)
• Coliform ≤ 10 CFU/mL (special allowance noted for certain bulk shipments)
• Phosphatase (verification of pasteurization) < 350 mU/L by an approved electronic phosphatase procedure
• Drug residues – No positive results on approved drug residue detection methods

Pasteurization Temperature Requirements

In order to assure consistent, safe products, the PMO requires that you meet certain minimums when it comes to how hot and how long you’re pasteurizing your milk. Usually, you will be directed to use a phosphatase test to verify proper pasteurization by confirming that all ALP is destroyed, and therefore any pathogens.

Here are common minimums:

• 63°C (145°F) for 30 minutes (vat/LTLT)
• 72°C (161°F) for 15 seconds (HTST)

Facility, Equipment, and Sanitation Expectations

As you’ve seen already, you have to hit the correct numbers to qualify for Grade A compliance. However, you also have to have the right systems. This includes sanitary designs, cleaning processes, and documentation of all control factors. It all starts with:

Permits and Inspections

In order to get a permit and/or a license for your dairy farm/milk plant, you need to undergo certain inspections that include a review of your farm, practices, and equipment. The inspector will be looking for strict adherence to the PMO framework for Grade A production.

Cleanable design and hygienic practices

Every piece of equipment you have that comes into contact with milk must be non-absorbent, smooth, corrosion-resistant, and cleanable. Additionally, you must follow written cleaning and sanitizing procedures (CIP setup, wash cycles, chemical concentrations, verification, etc). Just saying you do it isn’t enough. It needs to be documented every single time, down to the smallest detail.

Water Quality

Any water used in the milk production process must be fit for human consumption and managed well enough that it prevents contamination. If you visit the FDA’s website, you’ll see that they go into great detail about the requirements around water systems and testing procedures.

Common Misconceptions That Slow New Micro Dairies Down

Micro dairies tend to think that, because they’re small, they’re not subject to regulatory obligations at either the federal or the state level.

However, PMO standards are non-optional when it comes to producing Grade A milk in most states. Additionally, FDA guidance doesn’t cover state-specific licensing and approval requirements, which means you’ll be in contact with a lot of different people before this is done.

Misconceptions can often lead to underdesigned facilities or underprepared farmers. It’s best to have a firm understanding of your goals, your means, and what’s required of you before you take the first step. Clarifying all this early means you have to fix fewer mistakes, and you can get rolling with less stress, time, money, and effort.

Setting Yourself Up for Success Before You Begin

Knowing isn’t enough. You need to take action.

Before you start processing products, it’s important to take a few steps to ensure your success and a smooth launch.

Firstly, contact your state dairy regulator while you’re still planning. Confirm which license category applies to the products you want to create, and request a facility plan review before you break ground or buy equipment.

Secondly, design your recordkeeping and sanitation systems before you have your first inspection, not after. In fact, the earlier you get these sorted, the easier it will be to create a routine that makes everyone happy and puts out high-quality milk products every time.

Lastly, know that you are not alone in this. There are lots of micro dairies across the states, and many of them are on the exact same path that you are on. Knowing what you want before you get started is an exceptional way to start strong on the journey to success.