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.
County, city or other local departments of health may have regulations that apply to food manufactures in their jurisdiction.
Contact your county, city or other local health department to see if there are local regulations that apply to your business. A listing of local health departments is maintained by the Pennsylvania Department of Agriculture.
The dairy industry in Pennsylvania is regulated by the Milk Sanitation Program of the Department of Agriculture.
The Milk Sanitation Program
The Bureau of Food Safety and Laboratory Services, of the Pennsylvania Department of Agriculture (PDA), has responsibility to oversee the manufacture and sale of dairy products. The Milk Sanitation Program issues permits for the manufacture and sale of dairy products, conducts inspections and enforces regulations for all raw milk and pasteurized dairy processing plants and permit holders, and assists manufacturers with operational and regulatory questions.
The PDA regional milk sanitarian is the day-to-day contact for dairy manufacturers, and should be the first point of contact for people looking to start a new dairy processing operation or make significant changes to an existing one. Pennsylvania is divided into 7 agricultural regions, and your local sanitarian can be found by contacting the regional Bureau of Food Safety Offices or the Milk Sanitation Program (Paul Hoge, firstname.lastname@example.org, 724-443-1585, or Steve Kurtz, email@example.com, 717-836-3257).
Pennsylvania regulations, forms, and resources for dairy processors are found on the PDA web pages that support the dairy foods industry:
- The Milk Sanitation Program page contains the application for a permit to sell milk products, regulatory guidelines, and forms related to dairy processing. Contact: Steve Kurtz, Program Specialist, 717-836-3257, firstname.lastname@example.org or Paul Hoge, Program Specialist, 724-443-1585, email@example.com
- The Frozen Dessert Regulations page contains regulations for the manufacture and testing of frozen desserts, including retail operations. Wholesale manufacturers are also subject to Chapter 59a requirements of the Milk Sanitation Program. Contact: Sherri Morris, Program Manager, 717-787-5289, firstname.lastname@example.org
- The Food Safety Laboratory Division page contains information on required compositional, microbial, and antibiotic testing for milk and dairy products, official test procedures and laboratory certification, and a list of contract laboratories. Contact: Mike Hydock, Chief of Lab Division, 717-772-3236, email@example.com
Obtaining a Permit to Sell Milk or Milk Products
All permits to sell milk or milk products are issued and regulated by the Milk Sanitation Program, Bureau of Food Safety and Laboratory Services, PDA. The permit application can be obtained by contacting the Milk Sanitation Program.
There is no cost for the permit, but the manufacturer is responsible for following all appropriate Pennsylvania and Federal regulations, and is financially responsible for any testing required to meet regulations.
Milk and Dairy Product Regulations
The regulations for milk and dairy products are covered in Chapters 39, 57, and 59a of the Pennsylvania Code, under Title 7 - Agriculture. Regulations for raw milk permits and products are outlined the Raw Milk Guidance document of Milk Sanitation Program. Manufacturers of raw milk products should be aware that some state and federal regulations and resources for pasteurized products, such as the PMO, also apply to raw milk products, and, therefore, manufacturers should also be familiar with these regulations and documents.
Chapter 59a - Milk Sanitation
Chapter 59a contains the basic regulatory framework for the Milk Sanitation Program that all applies to all Pennsylvania dairy processors. Key provisions include permit requirements, farm and milk plant facility requirements and inspections, laboratory testing, and adoption of the PMO and USDA standards for manufacturing milk products.
Chapter 59a contains regulations pertaining to
- The production, transportation, processing, handling, sampling, examination, labeling and sale of milk, raw milk, milk products and manufactured dairy products.
- The inspection of dairy farms, milk plants, receiving stations, transfer stations, milk tank truck cleaning facilities, milk tank trucks and bulk milk haulers/samplers.
- The issuing, suspension and revocation of permits to milk plants, receiving stations, transfer stations, milk tank truck cleaning facilities anddistributors.
Chapter 59a was passed on May 21, 2011 and replaced Chapter 59 as the most current rule on Milk Sanitation. This rule provides guidance on the basic sanitation and safe production practices for the dairy industry to protect the health and safety of consumers. These regulations helped bring the Commonwealth's standards into alignment with other federal milk product standards, the current Grade ''A'' Pasteurized Milk Ordinance (Grade ''A'' PMO), and the current state-of-the-science.
The full text of Chapter 59a is sometimes difficult to retrieve from the Milk Sanitation Program page and can also be accessed from Title 7 of the Pennsylvania Code.
Chapter 57 - Milk and Dairy Product Standards
Many dairy products in the U.S. and Pennsylvania have defined compositional or other manufacturing characteristics. Chapter 57 contains the Pennsylvania definitions and compositional standards for dairy products, and often defers to the Federal standards in the Code of Federal Regulations (CFR).
Chapter 57 includes standards, or the CFR reference, for almost 100 dairy products like milk, lowfat milk, buttermilk, yogurt, butter, and dry products, and cheeses. Standards for frozen dairy desserts are found in Chapter 39.
In the case of standardized products, it is important that dairy processors meet these definitions and requirements to ensure the consistent manufacture of high quality dairy products throughout the industry. In the case of non-standardized products, the manufacturer has a responsibility to produce safe dairy products that taste good.
Chapter 39 - Frozen Dessert Standards
Chapter 39 contains standards and requirements for frozen desserts, including retail operations. Manufacturers and retailers of frozen desserts must have a frozen dessert permit. Wholesale manufacturers of frozen desserts must also comply with Chapter 59a.
Chapter 39 has compositional standards for over 20 frozen desserts and includes label requirements, sanitation, facility requirements, and laboratory testing requirements for mix manufacturers, wholesalers of frozen products, retail operations, and mobile operations.
Raw Milk Guidance Document
The Raw Milk Guidance Document was issued on November 21, 2011 to describe the requirements for obtaining and maintaining a permit to produce raw milk for human consumption. This document contains practices and requirements for raw milk microbial standards, sanitation, animal health, facilities, water supplies, packaging, and enforcement.
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 firstname.lastname@example.org, 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:
- Plants and grounds
- Sanitary operations
- Sanitary facilities and controls
- Equipment and utensils
- Processes and controls
- Warehousing and distribution
- Defect action levels