Regulations

Food products are regulated to ensure that the food supply is safe for all people. Regulations provide minimum standards for all food processors, small and large alike, to ensure quality food that does not harm consumers. Microbial contamination of foods is of particular concern for consumers who are more susceptible to illness, such as infants, small children, pregnant women, the elderly, people on some medications, undergoing treatments, or who may be otherwise immunocompromised.

Milk and dairy products have long been associated with foodborne illnesses, which led dairy processing to become the first sector of the food industry to implement its own regulations to improve food safety. When the first Pasteurized Milk Ordinance (PMO) was passed in 1924, milk products accounted for approximately 25% of all foodborne illness. Currently, they account for less than 1% of foodborne illness. As stated in the PMO, "Despite the progress that has been made, occasional milkborne outbreaks still occur, emphasizing the need for continued vigilance at every stage of production, processing, pasteurization and distribution of milk and milk products. Problems associated with assuring the safety of milk and milk products have become extremely complex because of new products, new processes, new materials and new marketing patterns, which must be evaluated in terms of their public health significance."

Some food processing regulations are administered at the federal level and some at the state level. Some regulations apply to all food processors such as registering your facility with the FDA and following Good Manufacturing Practices (GMPs), while other regulations may only apply to certain food products, such as pasteurization conditions or yogurt standards. Federal regulations for dairy foods processors include food facility registrations, food safety requirements, and dairy product standards. The Pennsylvania Department of Agriculture is responsible for regulations at the state level including issuing manufacturing permits, facility approvals and inspections, and dairy processing regulations.

It is the responsibility of each food processor to make themselves aware of, and meet, all of the regulations that apply.

The processor has the responsibility to meet the current:

• federal, state, and local regulations that apply to all food processors,
• federal, state, and local regulations that apply to all dairy processors, and
• regulations that apply to the specific food they manufacture, such as yogurt, ice cream, or Gouda cheese.

Pennsylvania allows the sale of raw milk and the manufacture of aged raw milk cheeses, with the appropriate permits. It is recommended that manufacturers of raw milk products be familiar with state and federal regulations and resources for pasteurized products, as some of this information also applies to raw milk products.

It is critically important that all dairy food processors understand and follow the regulations that apply to their facilities, their product line, and state-specific regulations. Penn State Extension has a library of resources on dairy food manufacturing to help you stay in compliance. Find information on regulations for dairy food facilities, the Food Safety Modernization Act (FSMA), dairy product standards, and Good Manufacturing Practices (GMPs) included in our resources.

The Pasteurized Milk Ordinance

The Grade "A" Pasteurized Milk Ordinance (PMO) is the primary guidance document for all dairy processors. The PMO is a federal level document that can be adopted at the state level for enforcement. The PMO contains regulations for dairy farms and dairy processing plants, including facility requirements, equipment requirements, product and water testing requirements, food safety plants, and other pertinent topics for dairy processing. Even if your dairy facility is not making Grade A dairy products, the PMO is still the reference point for regulators. It contains information for approval and inspection of your facility and testing of raw milk for all dairy food processors.

Food Facility Registration

This federal regulation requires that food processors register their facilities with the FDA per the Bioterrorism Act of 2012. Registration is free and needs to be updated biannually. Some small-scale processors are exempt from this regulation.

Regulations for Pennsylvania Dairy Foods Processors

The Pennsylvania Department of Agriculture (PDA) Milk Sanitation Program is the regulatory body for dairy processors in Pennsylvania. PDA issues milk processing permits which must be renewed annually.

The main regulatory requirements for Pennsylvania dairy processors are found in Chapter 59a of the Pennsylvania Code. The sale of raw milk for drinking is legal in Pennsylvania and these regulations are found in Chapter 59a. Additional regulations for frozen dessert manufacturers are found in Chapter 57 of the Pennsylvania Code.

The Food Safety Modernization Act (FMSA)

The Food Safety Modernization Act (FMSA) is a comprehensive federal regulation passed in 2011 that contains 7 rules for food manufacturers, with different rules pertaining to various aspects of the food processing industry. The Preventive Controls for Human Foods rule applies to all food processors, with different requirements for processors of different sizes. All processors are required to have documented training of their employees and follow Good Manufacturing Practices (GMPs).

Food processors must assess the risk of hazards for the products that they make, and implement preventive controls appropriately to manage these risks. The depth of the food safety plan that a processor must develop, implement, and monitor will depend on the size of the company and the products made. Penn State Extension provides tools to help dairy processors and small-scale cheesemakers develop their food safety systems and plans.

Dairy Product Standards

Federal regulations for dairy products include Standards of Identity and Product Standards that define product composition, manufacturing procedures, and quality parameters. It is important for dairy processors to be familiar with the specific standards for the products they are making to comply with the legal requirements for products like yogurt, cheese, ice cream, and others.