The Pennsylvania Department of Agriculture (PDA) Bureau of Food Safety and Laboratory Services is responsible for enforcing food regulations and inspecting food establishments.
The Pennsylvania Department of Agriculture (PDA) Bureau of Food Safety and Laboratory Services is responsible for enforcing food regulations and inspecting food establishments. It may be tempting to think of a government agency as a hindrance to your dreams of becoming a food entrepreneur, but PDA food inspectors are trained in food safety and sanitation and are knowledgeable about the food regulations with which you will have to comply. Working closely with a PDA food inspector as early as possible in your business development can save you time and money.
Your relationship begins with a telephone call to your nearest regional PDA office or the main office in Harrisburg. Ask to speak to a food inspector or a program specialist who can answer questions on food business startups. Be prepared to describe what is in your product, where you plan to make it, and how you intend to preserve and package it. The food inspector will tell you which regulations apply to your product, discuss registration or licensing requirements, offer advice on how to bring your facility up to standards, and perhaps stop by for a preliminary assessment of your operation (consultative non-regulatory inspections are subject to fees).
Here are some topics that are likely to come up the first time you discuss your food business with a PDA food inspector.
If you are thinking about using your home kitchen or any residential-style kitchen to process your product(s), PDA food inspectors can discuss applicable requirements for your situation. In general, you will need to register as a "limited food establishment." For more information, refer to the "Food for Profit: Home Food Processing" fact sheet. You can request the "Application Packet—Limited Food Establishment" form from the PDA Limited Food Establishments web site.
A commercial food establishment is a building, or place or portion thereof, or vehicle maintained, used, or operated for the purpose of commercially storing (warehousing), packaging, making, cooking, mixing, processing, bottling, baking, canning, freezing, packing, or otherwise preparing or transporting or handling food. If you intend to operate a food establishment, you must complete an "Application Packet—Food Establishment Registration" form from PDA prior to operation. The application can be found at the PDA Commercial Food Establishments web site.
In addition to your PDA Food Establishment registration and inspection, if you plan to sell your product directly to consumers (e.g., at your store or farm stand or by direct door or phone sales), you may be operating a retail food facility, which requires licensing by either PDA or a county/local health department. Not all retail food facilities in Pennsylvania are under the jurisdiction of PDA. There are six counties and many local municipalities, boroughs, townships, and cities that do their own inspection and licensing of retail food facilities. Check the local health departments listing at the PDA Retail Food web site section. If PDA has jurisdiction, obtain the appropriate Retail Food Facility Application form based on whether the facility is mobile, the event is temporary, and other criteria. Do this as early as possible to ensure no delay in opening your business.
You will need to obtain written verification that your local government (town, borough, city, or township) has approved the operation of food businesses at your location. Call your city or town hall and ask to speak to someone in the zoning office. If you get approval, ask for written verification. If your location is not zoned for food businesses, you'll have to find another place to make your product or apply for a variance—a process that will delay your start and involve additional costs.
Pennsylvania regulations require food processors to verify that their water comes from a safe source. If you plan to use municipal water, an annual water bill is adequate proof of its safety. If you are going to obtain water from a private well or cistern, you will first need to contact the Pennsylvania Department of Environmental Protection (PADEP) to determine if they have jurisdiction over your firm's water testing and monitoring. If they will not regulate your private water supply, obtain this in writing and have your water tested for coliform bacteria, nitrates, and nitrites at a state-approved water testing laboratory. In some instances, additional testing may be required. You are required to retest your water every year that your business is in operation or at a frequency determined by the agency regulating your water supply. Remember to keep a copy of your water bill or test results. You will need to show it to the food inspector during inspections.
Once you explain what your product is, how you will preserve it, and where you intend to make it, the food inspector can tell you if any laboratory testing is necessary. For example, if your product is not commonly known to be a shelf-stable non-TCS* food, the food inspector may ask you to test it for pH (acidity level) and water activity (aw). These two parameters may also be required to determine whether your product is an acidified food or a low-acid canned food (LACF), in which case additional regulatory requirements may apply. Jams and jellies will need to be tested for soluble solids (Brix) in order to meet truth-in-labeling requirements (standard of identity).
*TCS (time/temperature control for safety) foods—formerly referred to as a potentially hazardous foods (PHF)—are those foods that, because of their high moisture (aw > 0.85) and/or low acid content (pH > 4.6), may support growth of pathogenic microorganisms and become unsafe to eat if they are not kept refrigerated.
PDA enforces all federal food safety and sanitation regulations that pertain to the manufacturing of food products. This means you will have to make sure the place where you will be processing is in compliance with the Good Manufacturing Practice (GMP) regulation Sanitary Standards for the layout, condition of buildings and grounds, design and use of food equipment, processes and controls, storage and distribution, safe handling of ingredients, products and packaging materials, availability and maintenance of restroom and handwashing facilities, and food-handler qualification and hygienic practices.
The GMP regulation can be found in 21 CFR Part 117 Subpart B: Current Good Manufacturing Practice. Read the requirements carefully and conduct your own self-inspection before your first PDA inspection. A modernized GMP checklist is available on PDA's food safety website at "Current Good Manufacturing Practices (GMPs)—Food Establishment Checklist."
If your commercial wholesale operation includes any of the specialized processes related to seafood processing/warehousing, juice/cider processing, acidified foods (AF), or low-acid canned foods (LACF), you may be subject to certain specialized process regulations in addition to GMP requirements (HACCP, Process Filing, Training, etc.). For more details, check PDA's website in the "Food Manufacturing, Packing, Holding and Distribution" section.
All PDA-registered food establishments will have to comply with the applicable portions of the federal Food Safety Modernization Act (FSMA) rules unless specifically exempted in the rules (based on business size and type of operation). For information about PDA requirements under the FSMA rules, go to the "Food Safety Modernization Act (FSMA)" section of the PDA website. Information and training opportunities on FSMA are available from Penn State Extension at the "Food Safety Modernization Act (FSMA) page."
When all of the above tasks are complete and you feel your facility is in compliance with applicable regulations, make an appointment with the regional PDA office for your first official inspection.
The inspection process begins when the food inspector arrives at your facility. After reviewing verification of permission to operate at your location and proof that your water is safe, the food inspector will walk through your facility for a visual examination, process evaluation, and record review. Here is a list of suggestions that will help you get the most out of the experience.
You both have the same goal: to protect the public from harm. A visit from a food inspector provides an excellent opportunity to learn new sanitation techniques that can result in higher-quality, safer foods.
Walk along with the inspector. This gives you the chance to immediately correct simple problems as well as learn how to improve your own self-inspections. Take plenty of notes on any comments or violations so you can remember what problems were pointed out and more easily make corrections.
Do not offer food or other items to the inspector, as this could be misconstrued as an attempt to influence the inspector's findings. Do not lie, deceive, or attempt to hide anything—you could get in serious legal trouble and cost your company a lot of money.
Immediately after the inspection is over, ask the food inspector to explain their findings to you and offer suggestions on areas that need improvement. If you don't understand a violation, ask for an explanation. The food inspector will want to make sure you fully understand why you are being asked to make corrections to prevent repeat violations in the future. Make sure you address problem areas in your next self-inspection so they won't come up again during the next PDA inspection.
At the conclusion of your inspection, if satisfactory, the food inspector will give you a signed copy of the inspection report and collect
a small registration fee. If serious violations were found and you did not pass, don't panic. Make the necessary corrections immediately and arrange for another inspection so you can get your business up and running as soon as possible.
Contact information for the PDA Bureau of Food Safety main office in Harrisburg and the nine regional offices located throughout the state can be found at the PDA Food Safety website. You can also visit the Penn State Extension Food Safety and Quality website for additional resources on establishing and maintaining a food business.
Collaboration of Penn State Extension and the Penn State Department of Food Science.
