Legal Considerations for Microgreens Production

Introduction To Regulatory Obligations

The production of raw agricultural commodities for human consumption and the conduct of direct sales or value-added processing is subject to a framework of federal and state statutes and regulations, and even local ordinances, which can contain production, handling, processing, and other regulatory food standards and licensing requirements.

Compliance is necessary, or the risk of regulatory liability arises. A business can incur regulatory liabilities to state, federal, or local government agencies, which can result in monetary fines and orders to cease certain practices or even stop operations entirely. 

This article is designed to educate and help protect specialty crop producers from incurring these liabilities. A producer can be found negligent, or its product found defective, and owe monetary damages in the event of a food-borne illness claim, if the failure to comply with a government requirement caused an injury to a person or property.

A few clarifications about this article are in order at the outset.

• This article primarily focuses on the principal regulatory obligations arising from a handful of Pennsylvania laws most likely to impact specialty crop producers. More specifically, it will concentrate upon the obligations applicable to operating a "retail food facility" or a "food establishment" under Pennsylvania law, or both. Those are the key terms for purposes of this article and will be explained and defined below.
• The so-called "Model Food Code," a federal regulation that becomes applicable to retail food facilities and food establishments in Pennsylvania by its adoption via regulations of the Pennsylvania Department of Agriculture, regulates food handling, processing, and storage activities conducted while engaging in direct sales of specialty crops. The finer details of the Model Food Code are beyond the scope of this article. Its existence and role in Pennsylvania's regulatory framework are the necessary takeaways for readers of this article.
• This article will not address the regulation of commodities other than specialty crops, such as meat, poultry, dairy, and eggs.
• The federal Food Safety Modernization Act (FSMA) will be explained generally, but it is an extremely broad subject that commands its own educational curricula well beyond the scope of this article. FSMA regulations and compliance are in the process of being phased in over time, a process that has consumed many years to date and will continue to progress in the coming years. More information about FSMA is in the Resources below.

At the federal level, the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) work cooperatively to address food safety in the United States. These two federal agencies promulgate regulations pursuant to laws enacted by the U.S. Congress to regulate food safety and other matters related to the security of the nation's food supply nationally. Specifically, the USDA has regulatory authority, among other things, over meat, poultry, and egg products, while the FDA regulates all other food products in the U.S., along with dietary supplements, veterinary and human drugs, and many other biological products.

At the Pennsylvania state level, food safety laws are administered by, and regulations to enforce those laws are promulgated by, the Pennsylvania Department of Agriculture (PDA) pursuant to several laws enacted by the Pennsylvania General Assembly dealing with food safety. Additionally, under Pennsylvania law, county and municipal governments have the option to choose to become involved in food safety regulation by forming and operating a local health department. If so, the local health department supplants the Pennsylvania Department of Agriculture as the licensor and inspector of retail food facilities, but not food establishments.

The determination of the licensor depends upon the exact location of a retail food facility. For a particular location, it must first be determined who the licensor is and what regulations are adopted and in effect for that jurisdiction. Pennsylvania has a contingent of county and municipal health departments that could have jurisdiction. More information about the local health departments existing in Pennsylvania is in the Resources below.

This article will first outline federal statutes and regulations generally, before proceeding to address Pennsylvania state statutes, regulations, and licensing.

Federal Law and Regulations

1.  FSMA's Produce Safety Rule

The Food Safety Modernization Act (FSMA) was enacted as federal law in 2011 with the aim of minimizing the significant annual public health burden imposed by foodborne illness or disease in the United States. FSMA marks a shift away from the federal government's historic sole focus on detecting, compiling data on, and responding to foodborne illness outbreaks, toward a preventative objective that reaches all the way to the farm.

Approximately nine major sets of federal regulations, and seven more subsets of those nine, all referred to as "Rules," have been finalized by the FDA in its implementation of FSMA. However, not all, or the entirety of all, have become effective as of 2025. For the purposes of this article, just one of these rules will be discussed, the Produce Safety Rule. To gain a larger understanding of FSMA, see the Resources at the conclusion of this article.

The "Produce Safety Rule" is important for specialty crop producers engaged in direct sales. Many other FSMA regulations, or parts of regulations, issued under FSMA can apply to a specialty crop producer's activities, and producers are best served by seeking out FSMA education and training specifically for their operation’s scope.  

The Produce Safety Rule establishes farm-level minimum standards for the safe growing, harvesting, packing, and holding of produce for human consumption, marking the first time that minimum standards have been established for these processes and functions at a farm.

The focus of the rule is "raw agricultural commodity" production. A raw agricultural commodity is defined in the rule as "any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing." Covered produce includes fruits and vegetables that are regularly consumed in their raw form. The rule provides a list of such produce. Generally, farms subject to the rule's requirements include farms whose average annual monetary value of produce sold, averaged over the past three years, exceeds $25,000.

The Produce Safety Rule requires that covered producers comply with its requirements to minimize the risk of illness or disease caused by a consumer’s use of, or exposure to, produce covered under the Act.

Covered producers must follow requirements relating to personnel qualifications and training, health and hygiene, agricultural water, animal access and contact, activities related to growing, harvesting, packing, and holding covered produce, as well as equipment, tools, buildings, and sanitation. These requirements also include specific analytical methods and record-keeping. The rule also provides provisions for variances from the rule’s requirements, compliance and enforcement provisions, and the withdrawals of qualified exemptions.

For specialty crop producers, the threshold question is whether their farm or produce items offered for sale are subject to the Produce Safety Rule, or whether they fall into one of the rule’s exemption categories. The following provides a list of exemptions under the Rule:

• Produce that is rarely consumed raw. Examples include beans, corn, peanuts, and sweet potatoes. The rule provides an exhaustive list of such produce.
• Produce produced for personal consumption or for consumption on the farm or a farm under the same management.
• Produce that is not a raw agricultural commodity (RAC).
• Produce going to processing that has a kill step, meaning that the produce is commercially processed in a way that "adequately reduces the presence of microorganisms of public health significance." This exemption requires annual written assurance of the processes used.
• Producers with less than $500,000 annual food sales and whose majority of food sales (by value) is directly to a qualified end user (not to consumers).
• Farms with less than $25,000 annually in produce sales averaged over the past 3 years.

2.  Model Food Code

The FDA publishes and adopts an updated Model Food Code every four years. This model code is designed to assist state and local governments by providing a model to help in developing their own food codes and to strive for a jurisdiction-to-jurisdiction uniformity that also aligns with federal government policy. Pennsylvania has formally adopted the current version of the FDA's Model Food Code through incorporation by reference into the PDA's food safety regulations. The Model Food Code was most recently updated via a 2022 edition published in January 2023 and supplemented in 2024. A completely new edition of the Model Food Code is expected in 2026.  Details about Pennsylvania's incorporation of the Model Food Code will be discussed below.

Pennsylvania Law and Regulations

1.  Act 106 of 2010 – Recodification of Pennsylvania's Food Safety Laws

In 2010, Pennsylvania repealed and reenacted, in a substantially revised version, its set of laws addressing food safety in the processing, manufacturing, storage, handling, transport, and retail sale of food and food ingredients, and prepared or made-to-eat foods sold, served, or delivered in any manner. This includes all food stores, restaurants or operations of any kind providing food for human consumption, on or off premises.

The legal term for what was done in 2010 is a "recodification." This was done to: (a) address outdated and inadequate provisions that had not kept up with changing circumstances; (b) provide more uniform administration by government; and (c) provide clarity and an "easier to read and understand" compilation of food safety requirements for the regulated community and the general public.

The act of the Pennsylvania General Assembly accomplishing this recodification is called Act 106 of 2010. The act is divided into two separate laws with similar names, which work together to include within their scope every conceivable situation that is deemed to need food safety regulation, and how the requirements are enforced.  Both laws will be summarized below and are titled:

(a) Retail Food Facility Safety Act; and

(b) Food Safety Act

For specialty crop producers, this means that as of the Act's effective date in 2011, the operation of a farm market, a stand or space at a farmers' market, and potentially any areas on a farm or other premise where food is stored, handled, processed, or packaged is regulated by PDA—if meeting the definition of a "retail food facility" or a "food establishment."

More details will be provided below, but the term "retail food facility" generally refers to a sales location, and the term "food establishment" refers to a processing or storage location. Regarding the former term, if a local health department is in existence for the county or municipality involved, and a facility meets the definition of a retail food facility, then PDA's jurisdiction is supplanted, and the local health department is the licensor.

2.  Retail Food Facility Safety Act

The Retail Food Facility Safety Act (Act) sets out the licensing and food safety requirements with which retail food facilities in the Commonwealth of Pennsylvania must legally comply. Generally stated, the Act requires retail food facilities to obtain a license and submit to inspections on a regular basis and authorizes the Pennsylvania Department of Agriculture to promulgate regulations carrying the force of law which establish food handling and storage requirements, and cleanliness requirements for equipment and personnel within a retail food facility.

The Model Food Code serves as most of those regulations and is adopted in Pennsylvania in substantially the same form as it appears in federal FDA regulations. The most critical portions of the law for specialty crop producers in the business of direct sales are outlined below. More information can be found under Resources below.

a. License Requirement

Section 5703 of the Act requires that all retail food facilities obtain a license, except for those facilities that are explicitly exempted. Section 5703(a) states that it is "unlawful for any proprietor to conduct or operate a retail food facility without first obtaining a license," and Article 5703(b) outlines retail food facilities exempt from licensing. Among other things, licensure makes known to governmental authorities most of the potential sources in the event of a foodborne illness or disease and allows the state or local government to "traceback" (find the source), track (determine who may have been exposed), and hopefully control sources of foodborne illness.

There are two critical questions to answer to determine if a specialty crop producer may be operating in such a way as to require a retail food facility license:

(1) Whether any portion of the farm meets the definition of a "retail food facility?

(2) If yes, whether that portion qualifies for a license exemption?

To answer the first inquiry, a "retail food facility" is defined as "A public eating or drinking place or a retail food establishment." The operative terminology is "retail food establishment," defined in the Act as follows:

An establishment which stores, prepares, packages, vends, offers for sale, or otherwise provides food for human consumption and which relinquishes possession of food to a consumer directly, or indirectly through a delivery service such as home delivery of grocery orders or delivery service provided by common carriers. The term does not include dining cars operated by a railroad company in interstate commerce or a bed and breakfast homestead or inn.

Note: The term "public eating or drinking place" is an obsolete term appearing in Pennsylvania's previous law, repealed by Act 106 of 2010. It continued to appear in PDA's regulations for several years thereafter, but has now been completely stricken and can be disregarded.

As a result of the Act's definitions, any specialty crop producer selling their products directly to a consumer is operating a retail food facility. This includes every on-farm market, farmers' market stand, or community-supported agriculture (CSA) arrangement. If more than one of these activities is being conducted on the same premise, only one retail food facility license is needed for that premise. If such activities are conducted at more than one location, separate licenses are needed for each location where those activities are being conducted.

b. Exemptions from Licensing

The Act outlines two categories of exemptions from the retail food facility license requirement. One category is mandatory and applies state-wide, while the other category may be formally adopted at the discretion of the "licensor," i.e., either PDA or a county or local health department, as applicable.

• Mandatory State-Wide Exemptions:
  • sells only raw agricultural commodities.
  • sells only prepackaged, non-potentially hazardous food or beverages.
  • sells only honey produced on site and compliant with Honey Sale and Labeling Act.
• Discretionary Exemptions:
  • operates three days or less per calendar year.
  • all foods and beverages sold only through a vending machine.
• owned by a charitable nonprofit entity and is a:
  • a food bank operated for charitable or religious purposes.
  • a soup kitchen operated for charitable or religious purposes.
  • promotes extracurricular recreation for K-12 public/private/parochial schools and offers only non-potentially hazardous foods or beverages.
• school cafeterias.
• owned by a church/religious order or institution (plus some additional criteria, see the Act’s text).

For all portions of the state where PDA is the licensor because no county or local health department exists, PDA has adopted all the discretionary exemptions except: (a) school cafeterias; and (b) facilities owned by a church/religious order or institution.

Within the jurisdiction of a county or local health department, consultation with the licensor is necessary to determine what discretionary exemptions, if any, have been adopted there.

To fully understand the exemptions, it is necessary to understand the terminology "potentially hazardous food or beverage." Potentially hazardous food is defined by the FDA as any food that requires time or temperature controls for safety (TCS) to limit pathogenic microorganism growth or toxin formation. Common examples include foods containing any meat, eggs, or dairy products.

Oddly enough, gas stations provide an illustration of a simple dividing line between exempt and non-exempt retail food facilities. If a gas station sells only packaged snack foods and bottled soft drinks, it can operate with no retail food facility license. As soon as hot dogs on a roller, fountain drinks or milk are offered, it is required to possess a retail food facility license. Based upon that simple illustration, the sheer number of facilities that must be licensed and inspected by either PDA or a local health department pursuant to the Retail Food Facility Safety Act is quite staggering.

Lastly, and very significantly, the Act states that an exempt facility "shall remain subject to inspection and all other provisions of this subchapter." This means that, although the existence, location, and operational details of an exempt retail food facility are not required to be on file with or made known to a licensor, if a foodborne illness should occur or another matter arises that brings the facility's existence and operation to the attention of the applicable licensor, the facility can be inspected. In addition, during any such inspection, the license-exempt facility may be found in violation of the food handling or operational requirements (excepting the license requirement) of the Retail Food Facility Safety Act and its authorized regulations, i.e., the Model Food Code as adopted in Pennsylvania.

The Retail Food Facility Safety Act also establishes penalties for violations of any provision of the Act. First and second violations are summary offenses, the equivalent of a traffic ticket, and the operator is fined between $100 and $300. After the second offense, a violation may be considered a misdemeanor of the third degree. In addition, the violator may also be assessed a civil penalty not to exceed $10,000 for each offense committed. The civil penalty amount is to be determined based upon the "gravity of the violation," and a warning may be issued in lieu of a monetary civil penalty if the violation "did not cause harm to human health."

3. The Food Safety Act

The Food Safety Act serves two purposes.

• Firstly, a portion of it is Pennsylvania's framework for registering and regulating "food establishments" which manufacture, process, transport, or store food but do not engage in retails sales or any other form of delivery to the consumer at that location. Otherwise, it would be required to be licensed as a retail food facility.
• Unlike retail food facilities, the regulation of food establishments does not involve county or local health departments in any way. The Pennsylvania Department of Agriculture (PDA) is the sole regulatory entity in the state for food establishments. In jurisdictions where a local health department exists, PDA has agreements with many of those jurisdictions to avoid duplicative inspections by having PDA assume all regulatory duties if a location houses both a retail food facility and a food establishment.
• Secondly, the Food Safety Act provides general purpose provisions which apply to both retail food facilities and food establishments on several topics, including defining when food is "misbranded" or "adulterated" and authorizing enforcement action by the Pennsylvania Department of Agriculture to remove and exclude it from commerce.

a. Registration of Food Establishments

Food Establishment is defined as:

A room, building, or place or portion thereof or vehicle maintained, used, or operated for the purpose of commercially storing, packaging, making, cooking, mixing, processing, baking, canning, freezing, packing, or otherwise preparing, transporting, or handling food. The term excludes retail food facilities, retail food establishments, and public eating or drinking places, and those portions of establishments operating exclusively under milk or milk products permits.

This definition is extremely broad and specialty crop producers should recognize that portions of a farm homestead, barns, and outbuildings on a farm, in whole or in part, can certainly be considered "food establishments" under Pennsylvania state law. 

If a licensed retail food facility, i.e., farm market, is being operated on the premises, then all portions of the property devoted to the listed activities will generally be considered simply work areas already encompassed by the retail food facility license.

However, for any otherwise unlicensed premise devoted to the listed activities where the food is transported off-site for a retail delivery or sale at another location, a food establishment registration will be necessary.

The requirement for a food establishment is registration, not a license. The terminology has a technical difference in legal enforcement matters, but suffice it to say that most food establishment registrants do not experience any functional difference between a license and a registration. The establishment remains subject to inspection by PDA and essentially the same penalties for non-compliance.

b. Regulations Applicable to Food Establishments

The Act also includes a provision that adopts wholesale by incorporation all federal food manufacturing, processing, and related regulations. Pennsylvania's Food Safety Act states,

All regulations and supplements thereto or revisions thereof adopted under the Federal acts which relate to food on, before or after the effective date of this subchapter are adopted as regulations in this Commonwealth and shall remain in effect unless subsequently modified or superseded by regulations promulgated by the secretary.

These federal food-related regulations can be those authored and issued by the United States Department of Agriculture (USDA) or the Food & Drug Administration (FDA). They are found in the Code of Federal Regulations, called the "CFR."  This encompasses more than just the Model Food Code.

These FDA regulations prescribe the manufacturing, processing, and packaging methods that apply to hundreds of foods. The objective is to reduce risk in foods that have the potential to harbor or produce pathogenic microorganisms or toxins if the regulations are not followed. This is particularly important in foods manufactured to be eaten without cooking or other "kill step" which destroys bacteria and pathogens.

The breadth of these regulations incorporated into Pennsylvania law are well beyond the scope of this article. The important takeaway is that a party wishing to produce, store, pack, process,  transport or handle a particular food in Pennsylvania must register as a food establishment, or be otherwise licensed as a retail food facility, and must comply with all the applicable federal regulations that concern that food, and, when applicable, including its ingredients. The Pennsylvania Department of Agriculture, Bureau of Food Safety, is the best resource for learning what applies to a particular food, preparation method, or packaging method. Many private food safety consultants are also available to address those issues.

Other federal regulations on food manufacturing incorporated into Pennsylvania state law define exactly what attributes a food must possess to be labeled with a particular common name. These are called "standards of identity." A simple example is the standard of identity for "butter." It defines what and how butter must be made in order to be called butter, rather than something else like margarine or oleo. Standards of identity serve an important function in giving consumers assurance that a food "is what it says it is" and is not misleading consumers or misrepresenting the product in its labeling.

c. Provisions Applicable to Retail Food Facilities and Food Establishments

The Food Safety Act contains a laundry list of fourteen prohibited acts which apply to all Retail Food Facilities and Food Establishments. Some are simple prohibitions, such as not keeping food at the safe temperatures (hot or cold) set by regulation.  Some are potentially complex and lengthy prohibitions with explanatory and definitional terms that must be understood.  The two most important deal with prohibited:

(1) "misbranded" foods; and
(2) "adulterated" foods.

Under the Pennsylvania Food Safety Act's regulation of Retail Food Facilities and Food Establishments, the following acts, among others, are prohibited:

• Adulterating or misbranding any food; the "manufacture, sale, delivery, consignment, bailment, holding or offering for sale" of any adulterated or misbranded food.
• "Knowingly receiving in commerce" and "the delivery or proffered delivery thereof for pay or otherwise" of misbranded or adulterated food.
• Adding a "poisonous or deleterious substance" to food, which can include pesticides and food additives used in violation of federal law.

Misbranded food is defined, in part, to include the following:

• Its labeling is false or misleading in any way; it is offered for sale under the name of another food; it is an imitation of another food without the word "imitation" immediately followed by the name of the food simulated; its container is so made, formed, or filled as to be misleading.
• It is represented as a food for which a standard of identity exists, and it fails to conform to the standard of identity.
• Its package does not bear a label containing the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity, weight, measure, or number.
• Its label does not bear the common or usual name of the food, if any.
• If made from two or more ingredients, the common or usual name of each ingredient is not listed in descending order of predominance by weight (except spices, flavorings, and colorings, which may be designated as "spices, flavorings, and colorings" without naming each).
• If it contains any artificial flavoring, artificial coloring, or chemical preservative, unless the label states that fact ("[C]hemical preservatives shall not apply to a pesticide chemical when used in or on a raw agricultural commodity which is the produce of the soil.").
• If it is a raw agricultural commodity containing a pesticide chemical applied after harvest (unless the container's label so states "the chemical used and the common name and function of the chemical.")
• If any sign, placard or other graphic at a retail display of the food is false or misleading in any particular.

An important note on misbranding:

An exception to many of the acts of misbranding are granted for the following: "Bakery goods sold at retail by the bakery directly to the consumer in a store or market stand operated by the bakery" and "Bakery goods sold to the operators of retail food facilities when the required information is available to the public on the premises of the retail food facility."

Another very significant exception exists for food which is not offered for sale in packaged form. That is the exception that would apply to loose microgreens sold in an unpackaged form. This exception requires that the food "shall be accompanied by a sign, placard or notice listing the ingredients in descending order of predominance by weight." A single word designating the variety of raw vegetables or fruits for sale is usually sufficient; however, mixed, loose microgreens are required to be sold with a sign, placard, or notice that states the varieties included in the mix.

Specialty crop producers should also be aware that the Model Food Code and the other federal food regulations incorporated into Pennsylvania law, contain more and different requirements to avoid misbranding claims. The above is simply provided as an example of how foods can be considered misbranded in retail sale. Reviewing the types of things considered by Pennsylvania law to be misbranding and applying that information to foods potentially made and sold, producers can begin to understand what issues need to be fully investigated and planned for in venturing into direct or wholesale sale of their products. Consultation with PDA, other licensor personnel if applicable, Penn State Extension, or private food safety consultants, about particular foods and particular wholesale or retail plans and packaging is highly recommended and virtually essential to avoid missteps.

Adulterated food is defined, in part, to include the following:

• It contains "any poisonous or deleterious substance" which may render it injurious to health.
  • However, this does not include "a pesticide chemical in or on a raw agricultural commodity, a food additive or a color additive."
• It is a raw agricultural commodity and contains a pesticide chemical used in a manner out of compliance with federal law.
  • However, if the pesticide is still existing in an amount not greater than the tolerance prescribed for the raw agricultural commodity after processing "through canning, cooking, freezing, dehydrating or milling," and the residue "has been removed to the extent possible in good manufacturing practice," it will not be considered adulterated.
• It contains a color additive which is used in a manner out of compliance with federal law.
• It consists, in whole or in part, of any "diseased, contaminated, filthy, putrid or decomposed substance or is otherwise unfit for food."
• It has been produced, prepared, packed or held under unsanitary conditions such that "it is contaminated with filth," rendered diseased, unwholesome, or injurious to health.
• Its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health, unless the container is fabricated or manufactured with good manufacturing practices according to federal law.
• Food concerning which:
• any valuable constituent has been, in whole or in part, omitted or abstracted therefrom;
• any substance has been substituted wholly or in part;
• damage or inferiority has been concealed in any manner; or
• any substance has been added thereto or mixed or packed so as to increase its bulk or weight or reduce its quality or strength or make it appear better or of greater value than it is.

This is a complex but only partial list of potential conditions of food that can be considered adulteration. Many producers may justifiably feel that the scenarios described as adulterated food are unlikely to occur and may even be far-fetched under normal circumstances.

Nevertheless, it is important to understand that cases of foodborne illness from salmonella, e-coli, listeria, and other sources, do arise quite frequently from contamination scenarios that are not particularly far-fetched or relegated to only poorly maintained farms. These pathogens can arise in a manner which can be perceived as "out of the blue" and seemingly without obvious fault. Once again, this fact reinforces the necessity of product liability insurance coverage. 

Be aware that the FSMA rule known as “Preventative Controls for Human Food” is the federal regulation that sets standards for all food establishments in preventing adulteration by the existence of pathogens in food handling practices. Information on that rule, and all other aspects of FSMA, should always be sought separate from this article in order to assure compliance.

d. Pennsylvania's Limited Food Establishments

Lastly, although it is not something specifically provided for in the Model Food Code and federal food production regulatory scheme, Pennsylvania and many other states provide an additional compliance method for specialty crop producers who engage in processing or packaging of food pursuant to a set of less expensive production/processing facility requirements that still serve food safety concerns but allow smaller operations with less resources to participate in direct sales. Some jurisdictions use the terms "cottage food business," or "home-based kitchen." This can also include the relatively newer concept of more than one producer sharing a common kitchen/processing facility location. 

PDA describes the limited food establishment allowance as follows:

• The Department will allow some 'limited' types of food processing to occur in a 'residential style kitchen ' that may not meet the full regulatory code requirements, with the intent of the producer to offer these products for sale to the public. . . Generally, the types of production that can occur in 'limited food establishments' (whether an actual home-use kitchen or a kitchen designed in a residential fashion) are limited to foods that are not 'time and temperature controlled for safety' (TCS) foods (i.e., potentially hazardous foods, 'PHF'). TCS foods are foods that will support the growth of pathogenic microorganisms and require temperature controls (kept hot or cold).  TCS foods can only be produced in a licensed / registered 'commercial' food establishment kitchen that meets the full regulatory code requirements, including separation from residential-use areas, and adequate plumbing fixtures.

The best way to familiarize oneself with the regulatory process for obtaining and operating under a limited food establishment in Pennsylvania is to read the PDA Bureau of Food Safety's Limited Food Establishment Registration Packet. See Resources below for more information. It is very detailed and contains extensive explanations of the requirements and process for approval. 

Limited food establishments under Pennsylvania law remain solely under PDA's jurisdiction, with no involvement of county or local health departments. All retail sales still must occur through a duly licensed retail food facility, which are subject to county and local health department regulation where such entities exist. Various FSMA rules also may apply equally to limited food establishments.

Lastly, limited food establishments should not be confused with mobile and temporary retail selling operations, such as food trucks, trailers, and event vendors. Mobile and temporary retailing of prepared foods is simply another form of retail food facility license and is regulated as such by county or local health departments or PDA, as applicable. PDA maintains a dedicated webpage with multiple articles and resources specifically addressing mobile and temporary retail food facilities. See Resources below for more information.

Resources

FDA

FDA's Food Homepage – FDA's food regulation homepage. To see how FDA’s food regulation resources are organized, see "Navigate the Food Article" and "Industry Guidance & Regulation" menus at the bottom of this page.

Food Safety Modernization Act (FSMA)

• Full Text of the Food Safety Modernization Act (FSMA)
• Frequently Asked Questions on FSMA
• FSMA Rules & Guidance for Industry
• What's New in FSMA
• FSMA Training
• FSMA Technical Assistance Network (TAN)

FSMA Compliance Dates

PDA

Retail Food Facility Safety Act & Food Safety Act

Food Manufacturing, Packing, Holding and Distribution

PDA Regional Food Safety Offices

County and Local Health Departments

Application Packet – Retail Food Facilities and Restaurants

Farmers Market Application Packet

Farmers Market General Articlelines

Farmers Market Article to Licensing and Sales Tax

Mobile Food Facilities, Fairs and Temporary Homepage

Foods with Standards of Identity

Application Packet Food Establishment Registration: Food Establishment

Application Packet Food Establishment Registration: Limited Food Establishment

Shared Facility Agreement

Other

State and Federal Regulations for Food Processors, Luke LaBorde, Penn State Extension (2023)

"Cottage Food" Laws, National Agricultural Law Center

Cottage Foods and Home Cooking, Harvard Law School, Food Law and Policy Clinic (2021)

This work is supported by the Northeast Extension Risk Management project award no. 2023-70027-40447, from the U.S. Department of Agriculture's National Institute of Food and Agriculture.