The FSMA Produce Safety Rule establishes science-based, minimum food safety standards for growing, harvesting, packing, and holding fruits, vegetables, mushrooms, and sprouts intended for human consumption. The rule pertains to most produce growers, except for the smallest operations.

Learn more about the Produce Safety Rule and find training opportunities that address requirements, exemptions, and deadlines.

Video - Learn about the Produce Safety Rule

Learn more about the Produce Safety Rule and the specific requirements. It will help you determine whether your operation meets the definition of "farm" and is subject to the produce rule.

The Preventive Controls for Human Food Rule requires food processors and some produce packing operations to establish and implement a safety system that includes an analysis of potential hazards and establishment of preventive controls.

Learn more about the Preventive Controls for Human Food Rule and find training opportunities that address requirements, exemptions, and deadlines

Video - Who is Covered Under the Preventive Controls for Human Food Rule?

In this video, you will learn who is covered under the Preventive Controls for Human Food Rule. Learn if your operation is affected and what you need to do to comply.

The Preventive Controls for Animal Food Rule requires manufacturers and processors of food for animals to establish and implement a food safety system that includes an analysis of potential hazards and establishment of risk-based preventive controls.

Learn more about the Preventive Controls for Animal Food Rule and find training opportunities that address requirements, exemptions, and deadlines.

The Foreign Verification Program Rule (FSVP) requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.

Learn more about the Foreign Supplier Verification Program and find training opportunities that address requirements, exemptions, and deadlines.

Video - What is a FSVP?

In this video, the Foreign Supplier Verification Program (FSVP) is discussed. Learn about the activities and records that make up a FSVP, and if you are subject to the FSVP rule requirements.

The Food Defense rule applies to food companies registered with the FDA who are involved in the production, transport, storage, or distribution of food for sale to the public. The goal of this rule is for companies to establish control measures to prevent or minimize the risk that a person or group intentionally contaminates food with the intent of public harm.

Learn more about the Food Defense Rule and find training opportunities that address requirements, exemptions, and deadlines

The goal of the Sanitary Transportation of Human and Animal Food rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.

Learn more about Sanitary Transportation of Human and Animal Food Rule and find training opportunities that address requirements, exemptions, and deadlines.

The Produce Safety rule, usually shortened from its official name "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption," establishes, for the first time, science-based minimum food safety standards for growing, harvesting, packing, and holding fruits, vegetables, mushrooms, and sprouts intended for human consumption.

Learn more about the Produce Safety Rule

Fruits, vegetables, sprouts, and mushrooms that are covered under the regulation are only those:

1. Grown on commercial farms with average annual produce sales of at least $25,000 calculated over the previous three years of production and adjusted for inflation
2. Likely to be eaten raw (for example, lettuce, spinach, cucumbers, tomatoes, summer squash, and most fruits)

Read the fact sheet discussing farming activities and produce covered under the Produce Safety Rule

Produce rarely eaten raw (for example potatoes, corn, beets, beans, pumpkins, and winter squash) are not covered under the Produce Safety Rule. Retail establishments where produce is sold or served directly to consumers, such as farm stands, farmers markets, grocery stores, and restaurants, are not covered under this regulation, although they may be covered under other state or local regulations. Produce that is not sold commercially, such as grown only for personal consumption, is also not covered.

Key requirements that are intended to prevent contamination of produce during production, harvesting, and after harvesting are Worker Health, Hygiene, and Training; Agricultural Water for Pre- and Postharvest Uses; Biological Soil Amendments; Domesticated and Wild Animals; and Equipment, Tools, Buildings, and Sanitation.

Yes, farms with annual food sales lower than $500,000 over the previous three years (adjusted for inflation) may be eligible for a qualified exemption (QE) where only modified requirements are enforced. To be eligible for a qualified exemption, more than half of the average annual food sales must be to qualified end users (QEU). Qualified end users are consumers who purchase the food directly from the farmer and some local retail establishments.

Another exemption is the Processing Exemption. Covered produce that is processed to eliminate harmful microorganism is eligible for an exemption and only limited requirements apply. For example, a tomato crop destined for a commercial cannery would be eligible for this exemption. The rest of the crop would not be eligible, although it is possible that the qualified exemption could apply.

Use our Produce Safety Rule Coverage and Exemption tool to help you determine your regulatory status

If you have determined that your farm and the produce you grow are covered under the Produce Safety Rule, then there are certain training requirements. At least one supervisor or responsible person on a covered farm must have completed food safety training at least equivalent to that received under a standardized curriculum recognized by FDA.

The Produce Safety Alliance (PSA), in association with FDA, has created a seven-hour training curriculum. The course is offered around the country by certified educators. Penn State Extension offers training at multiple locations around the state.

Register for Penn State Extension's Produce Grower Certification Training

In addition, FDA requires that all personnel who harvest or handle fresh produce that is covered under the regulation, and those who supervise them, receive food safety training that is appropriate to their assigned duties. Training must be offered upon hiring and periodically thereafter, and it must be presented in a language that all workers can understand.

A written farm food safety plan provides a way for growers of fresh fruits and vegetables to get organized and focused on produce safety on their farm operations. A written farm food safety plan is not specifically required by FSMA, but it is nonetheless a useful tool in complying with FSMA. A written farm food safety plan is usually required for third party GAP audits. A written farm food safety plan becomes a central place for growers to assess risks, outline practices to reduce those risks, record policies and standard operating procedures (SOPs), and keep needed records.

Farm food safety plans can have many parts, but generally include the farm name, address, and description; the name and contact information for the farm food safety manager; a risk assessment of practices and conditions on the farm that can impact food safety; a description of practices that the farm undertakes to reduce risks; and records that document those practices. Other items that can be included are farm maps, policies and SOPs, training records, monitoring and risk assessment records, water test results, supplier and buyer information, input and equipment logs, cleaning logs, and self-audits.

Video - What is a Food Safety Plan?

Tools for Writing a Farm Food Safety Plan

The FSMA Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule, often shortened to the Preventive Controls for Human Food Rule, requires food manufacturers, processors, and some produce packing operations to establish and implement a food safety system to control potential hazards.

Learn more about the Preventive Controls for Human Food Rule

FDA-regulated commercial food operations that manufacture, process, pack, or hold human food for consumption in the United States. These operations are termed "food facilities" by FDA. Manufacturing/processing generally means making food from one or more ingredients or chemically or physically modifying food ingredients to create new products.

Examples include: Baking, boiling, bottling, canning, cooking, cooling, cutting, extracting juice, formulating, freezing, grinding, mixing, packing and packaging, pasteurizing, peeling, washing, and waxing. Manufacturing/processing does not include harvesting, packing, or holding on a farm.

The regulation does not apply to farms. However, processing activities that take place on a farm are covered under some aspects of the Rule. USDA regulated meat and poultry establishments, low acid canning operations, and seafood and juice process already under FDA regulation are also not covered. Because retail establishments and home-based businesses are not covered by FSMA, they are therefore not subject to the Preventive Controls for Human Food Rule. However, these activities may be covered under state or local regulations.

Facilities must establish and implement a food safety system that documents compliance with Good Manufacturing Practices (GMP). A written food safety plan is required that includes:

• Hazard analysis
• Risk-based process, allergen, and sanitation, supply chain preventive controls
• Monitoring, corrective actions and a recall plan
• Verification activities that document that the preventive controls are working

Yes, but first, it's important to understand that all food facilities are covered under the Preventive Controls Rule and all must comply with Current Good Manufacturing Practices (GMP). These are general company-wide food safety and sanitation standards that are designed to minimize food safety risks.

But not all facilities must have written preventive controls in place as part of a written food safety plan. There are 2 types of exemptions to the Preventive Controls for Human Food Rule: 1) the mixed type facility exemption and 2) the qualified facility exemption.

Mixed Type Facility Exemption: A mixed type facility is a farm where crops or animals are grown or raised and where processing and manufacturing activities occur. FDA exempts certain low-risk products and processing activities conducted on farms that have fewer than 500 full time employees or 3-year average annual food sales plus inventory less than $1,000,000. Lower-risk products and processes that take place on a mixed type facility include baked goods, candy, jams, jellies, maple syrup, vinegar, and other processed foods that do not require time/temperature controls for safety. Although not all parts of the Preventive Controls for Human Food apply, there are certain modified requirements that must be met.

Qualified Facility Exemption: Facilities with average annual food sales plus inventory less than $1,000,000 (taken over the previous 3 years and adjusted for inflation) or 2) less than $500,000 average annual sales provided that the average monetary value of all food sold directly to qualified end users is greater than that sold to other purchasers. Compliance with GMPs is the main requirement for qualified exempt facilities. A written food safety plan is not required if preventive procedures and policies are adequate to control potential food safety hazards or if other state or local regulations are followed.

Packing and holding activities conducted on a farm are only covered by the Produce Safety Rule. FDA has defined the term farm to mean either a:

1. Primary Production farm which is an operation under one management in one general physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities or
2. Secondary Activities Farm which is an operation, not located on a Primary Production Farm, where at least half of the produce that is packed and/or held is grown and harvested on a jointly owned Primary Production Farm.

Therefore, if packing and holding activities are not conducted on a primary farm and where half or less of the produce that is packed or held is grown on a farm under a different ownership than the packing house, then these activities are covered under the Preventive Controls for Human Food rule.

Compliance deadlines are phased in based on 3-year average annual produce sales.

• Deadline for larger growers with sales greater than $500,000 was January 26, 2018.
• Small businesses with sales between $250,000 and $500,000 had until January 28, 2019.
• Very small businesses with sales between $25,000 and $250,000 have until January 27, 2020.

For each category, an additional two years are given for compliance with the agricultural water standards issued in the regulation.

All workers must have food safety training that is appropriate for their job title and their level of responsibilities. Each facility must have at least one Preventive Controls Qualified Individual (PCQI) who will be responsible for writing and overall management of the food safety plan.

Although attending a formal training course is not specifically required in the Rule, it is highly recommended for those who self-designate as a PCQI. A standard 2½- day course developed by the Preventive Controls Alliance is offered by Penn State Extension certified instructors throughout the state and beyond.

Register for Penn State Extension's Preventive Controls for Human Foods Certification Workshop

A Preventive Controls Qualified Individual is an individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.

Video - What is a Preventive Controls Qualified Individual?

The Preventive Controls for Human Food regulation requires food manufacturers to develop and implement a written Preventive Controls Food Safety Plan. The focus of the Food Safety Plan is on managing higher risk foreseeable potential hazards and is analogous to managing "significant hazards" in a HACCP plan. The Food Safety Plan must include a hazard analysis, preventive controls and associated monitoring and corrective actions, and a recall plan. A designated Preventive Controls Qualified Individual must be responsible for oversight of the development and maintenance of the plan. Qualified Exempt facilities are not subject to the written plan requirement but must conduct a hazard analysis that shows they have adequate preventive controls in place.

Learn how to write a Preventive Controls Food Safety Plan

The FSMA Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation, often shortened to the Preventive Controls for Animal Food Rule, requires animal food businesses to comply with current good manufacturing practices (cGMP) and conduct a hazard analysis. Businesses that manufacture, process, pack, or hold animal food also may be required to establish and implement a food safety system to control potential hazards.

Learn more about the Preventive Controls for Animal Food Rule

Establishments that are regulated by the FDA that manufacture, process, pack, or hold food for consumption by animals in the United States are covered by this regulation. This includes feed mills, animal feed and pet food processors and manufacturers, as well as holding facilities.

Manufacturing/processing generally means making food from one or more ingredients or chemically or physically modifying food ingredients to create new products. Examples include: Baking, boiling, bottling, canning, cooking, cooling, cutting, dehydrating to create a distinct commodity, formulating, freezing, grinding, milling, mixing, packaging, pasteurizing, pelleting, and rendering.

Video - Is my Animal Feed Business Regulated Under the Food Safety Modernization Act?

Home based businesses where processing and manufacturing take place within a personal residence are not covered. With some exceptions, farms are not covered. Also, retail establishments that sell animal feed or pet food directly to consumers are not covered.

Additional exemptions apply to businesses that are solely engage in holding or transporting raw agricultural commodities, hulling, shelling, drying, packing, and holding nuts and hulls, or the ginning of cotton.

Facilities must comply with current Good Manufacturing Practices (cGMPs) which are baseline standards for keeping animal foods safe. cGMPs include personnel, water supply, sanitation, holding and distribution of animal food including human food by-products that are used for animal food, plant and grounds, and water supply.

Facilities also are responsible for conducting a hazard analysis to determine if preventive controls are needed for sanitation, process, and supply chain. Facilities requiring preventive controls will develop a written food safety plan to address these preventive controls along with monitoring, corrective actions, verification and recordkeeping activities, and a recall plan.

Yes, there are 3 types of exemptions to the Preventive Controls for Animal Food Rule where compliance with only some parts of the regulation is required:

1. The mixed type facility exemption
2. The qualified facility exemption
3. The holding facility exemption.

Mixed type facility exemption. A mixed type facility is a farm where crops or animals are grown or raised and where processing and manufacturing activities occur. These facilities are exempt if all the animals that consume all the feed are at the same location and under the same ownership or management or if some of the products that are processed at the farm are sold to another business. Additional considerations are based on the risk associated with the animal food being produced, the total sales, and the number of employees.

Qualified Facility Exemption: Facilities with average annual feed sales over the last 3 years plus the value of inventory totals less than $2,500,000 are eligible for this exemption.

Holding Facility Exemption: Facilities that only store raw agricultural commodities for use as animal food are eligible for this last exemption.

Am I required to attend a training course for the Preventive Controls for Animal Food Rule?

Animal food workers should have the appropriate education, training, and experience to perform their assigned job. Each facility must have at least one Preventive Controls Qualified Individual (PCQI) who will be responsible for writing and overall management of the food safety plan. Attending a formal training course is not specifically required in the Rule; however, it is strongly recommended and will provided documentation for anyone will be considered as a PCQI. A standard 2½- day course for animal food that was developed by the Preventive Controls Alliance is offered by Penn State Extension instructors.

Register for Penn State Extension's Preventive Controls for Animal Food Training

Both regulations have been enacted to further improve the safety of our food supply. The Veterinary Feed Directive (VFD) specifically seeks to provide oversight on the use of certain antibiotics in animal feeds. The Food and Drug Administration (FDA) will look to the VFD to guide producers to properly use these antibiotics in animal feeds by requiring more direct oversight by the herd veterinarian.

Learn how your dairy farm may be affected with FSMA and VFD

• Very small businesses with sales less than 2.5 million dollars must comply with preventive controls by September 17, 2019.
• Small businesses with less than 500 full time employees had to comply by September 17, 2018.
• All other larger businesses were required to comply by September 18, 2017.

Deadlines for implementing current Good Manufacturing Practices were 1 year before preventive controls dates.