Dairy Food Processing - Federal Regulations

Federal regulations for food processors encompass food safety, standards for manufacturing facilities, good manufacturing practices, and compositional standards.
Dairy Food Processing - Federal Regulations - Articles


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Dairy Food 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 that are more susceptible to illness, such as infants, small children, pregnant women, the elderly, people on some medications, undergoing treatments, or that may be otherwise immunocompromised.

Some food processing regulations are administered at the federal level and some at the state level or a more local 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.

It is the responsibility of each food processor to make themselves aware of, and meet, all of the regulations in their area.

Milk, and the delicious array of products made from it, are an excellent source of nutrition and have had a place at the human table for thousands of years. Milk and dairy products have long been associated with foodborne illnesses, which led the milk industry 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, and now they account for less than 1% of foodborne illness. As so nicely stated in the 2015 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."

Indeed, there is great innovation and growth occurring in all sectors of the dairy industry, and ongoing reports of illness and death from dairy product consumption. The versatility of milk allows the creation of products ranging from new artisanal cheeses sold at the local farmers market to specialty high-protein ingredients made using the latest in filtration and separation technologies that are sold on the global market. Whether a processor is making a traditional or an innovative dairy product, each product has its own manufacturing requirements, safety concerns, and regulatory requirements. Dairy innovators may need to go beyond the current regulations to provide scientific basis to show that their products are a low risk for causing illness.

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. 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.

Federal Regulations

Federal regulations for food processors encompass food safety, standards for manufacturing facilities, good manufacturing practices, and compositional standards.

The FDA website is a wealth of information for food processors, ranging from what you need to know for starting a food business, to guidance documents for following the latest regulations of the Food Safety Modernization Act. In addition to the general regulations for food processors, dairy processors need to follow the Pasteurized Milk Ordinance and any FDA and USDA standards that apply to the specific products they make.

Food Facility Registration

All facilities that manufacture, process, pack, or hold food are required to register with the FDA, per the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). Registration is free and can be done on the FDA website for Registration of Food Facilities or by contacting the FDA at furls@fda.gov, 800-216-7331.

Facilities registrations must be renewed every 2 year on even-numbered years.

For more information on the regulations and facility registration, see the FDA Guidance Document.

Good Manufacturing Practices

Good manufacturing practices (GMPs) are the foundation of producing high quality, safe food. GMPs are the practices, procedures, and policies we implement to ensure a safe and sanitary environment for food processing, packaging and holding. GMPs cover aspects of food processing from personnel practices to facility design.

All personnel that manufacture, process, pack or hold food must have training in basic food safety principles. The section of GMPs that applies to personnel serves as a good outline for training employees in practices such as disease control, hand washing, proper attire for food processing activities, and keeping personal items out of processing areas.

The current GMPs (cGMPs) have been part of the Code of Federal Regulations (21 CFR 110) since the mid-1980s. These regulations were updated in September 2015, with the new Food Safety Modernization Act Preventive Controls for Rule. Replacing Part 110, is Part 117 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food.

In addition to guidelines for personnel, the cGMPs provide guidance on the immediate food processing environment, and areas that do not come in direct contact with food but are important in keeping the entire food processing environment in a sanitary condition. Topics contained in the cGMPs are of interest to employees, management, plant manufacturing, sanitation, and maintenance personnel:

  • Personnel
  • Plants and grounds
  • Sanitary operations
  • Sanitary facilities and controls
  • Equipment and utensils
  • Processes and controls
  • Warehousing and distribution
  • Defect action levels

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