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Frequently Asked Questions

Click on the questions below to see answers.

What is the Food Safety Modernization Act?

The Food Safety Modernization Act (FSMA) was passed in 2011 by President Obama and is the most sweeping reform of our food safety laws in more than 70+ years (since the Food Drug and Cosmetic Act of 1938). The act aims to ensure the US food supply is safe by shifting the focus from responding to contamination to preventing it. The Food and Drug Administration has developed seven different regulations that encompass FSMA including (1) Produce Safety Rule, (2) Preventive Controls for Food for Human Rule, (3) Preventive Controls for Food for Animals Rule, (4) Mitigation Strategies to Protect Food Against Intentional Adulteration Rule, (5) Sanitary Transportation of Human and Animal Food Rule, (6) Foreign Supplier Verification Programs Rule, and (7) Accredited Third-Party Certification Rule. Additionally, many of the FSMA rules require food safety training to fulfill compliance.

The Produce Safety Rule (PSR) is one of the seven food safety regulations that are part of the Food Safety Modernization Act (FSMA). The PSR sets a series of standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption: 21 Code of Federal Regulations Part 112 . Similar to the other FSMA rules, the PSR aims to be proactive rather than reactive by focusing on high risk practices and identification of hazards within individual operations.  For example, there are no requirements for uncontrollable factors, such as number of wildlife allowed in fields.  Instead, the PSR mandates covered produce not be harvested when contaminated by feces (e.g., bird dropping on a tomato intended for fresh market). Standards are set for: agricultural water; biological soil amendments; sprouts; wildlife and domesticated animals; worker health, hygiene, and training; equipment, tools, and buildings; among others.

This question is tricky and not easily answered in a simple FAQ.  There are some nice resources in the Producer Resources section that you can explore that will help to answer your questions:

All types of produce are covered by the rule except as provided by specific exemptions from the rule. Exemptions include produce that:

    • is grown for personal or on-farm consumption
    • is not a “raw agricultural commodity.” (A raw agricultural commodity is any food in its raw or natural state)
    • will receive commercial processing that adequately reduces microorganisms of public health concern (e.g., through use of a “kill step”) is eligible for exemption under certain conditions (including keeping certain documentation).
    • is on the “rarely consumed raw” list. The “rarely consumed raw” list is exhaustive and contains the following fruits and vegetables: asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts.  [The content of this list in the final rule is somewhat different from the proposed version. These changes were made in response to public comments and based on FDA’s analysis of available data. For example, Brussels sprouts and kale were removed from the proposed list, and pecans were added to the final list.]

As per the Produce Safety Alliance:

  • The rule does not apply to certain specified produce commodities that are rarely consumed raw. You can find the list of produce not covered by the regulation in § 112.2.
  • The rule does not apply to produce that is used for personal or on-farm consumption, or that is not a Raw Agricultural Commodity (RAC).
  • The rule provides an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance (e.g., via a “kill step”) as long as certain disclosures are made and written assurances are received, with appropriate documentation.
  • The rule does not cover produce farms that have an average annual value of produce sold during the previous 3-year period of $25,000* or less.
  • The rule provides a qualified exemption and modified requirements for farms that meet two requirements: (1) the farm must have food sales averaging less than $500,000* per year during the previous 3 years; and (2) the farm’s sales to qualified end-users must exceed sales to others.

A qualified end-user is either: (1) the consumer of the food or (2) a restaurant or retail food establishment that is located in the same State or the same Indian reservation as the farm or not more than 275 miles away.  Instead, these farms are required to include their name and complete business address either on the label of the produce that would otherwise be covered (if a label is required under the FD&C Act and its implementing regulations) or to display the same information at the point-of-purchase.  These farms are also required to establish and keep certain documentation (See § 112.7).

* See FSMA Inflation Adjusted Cut Offs for the value adjusted for inflation and averaged over three years.

The Produce Safety Rule (PSR) is regulation that establishes science-based minimum standards for safe production and harvesting of fresh fruits and vegetables. These standards are based on a foundation of Good Agricultural Practices (GAPs). However, while the PSR is based on a solid framework of understanding on-farm risks and GAPs, it is not the same as GAP certification.  Whereas the FSMA PSR is regulatory and mandatory for growers who are covered under the PSR, GAP certification is a voluntary program that verify that fruits and vegetables are produced, packed, handled, and stored as safely as possible to minimize risks of microbial food safety hazards.

Although a farm may already be GAP certified, If that farm is covered under the PSR, then it must still adhere to and comply with the requirements of the regulation.

The Produce Safety Alliance has provided information related to compliance dates on their website. For a PDF of the revised compliance dates click here.

The Virginia Department of Agriculture and Consumer Services received federal grant funding in 2016 to establish a Produce Safety Program within the Office of Dairy and Foods. This regulatory program works to address the growing, packing, holding and dissemination of produce grown on farms and encourages the safe production of fruits and vegetables and promotes understanding and compliance with the FDA Produce Safety Rule and state legislation.

Produce Safety Rule Coverage and Exemptions

Produce Safety Alliance
The Produce Safety Alliance (PSA) is a collaborative project between Cornell University, United States Department of Agriculture, and the Food and Drug Administration. The overarching objective of the Alliance is to provide the produce industry and associated groups with training and educational opportunities related to current best practices and guidance, and future regulatory requirements. This PSA website offers a wealth of resources, links, and future training opportunities.

Overview of the Food Safety Modernization Act Produce Safety Rule (FST-270NP)
This brief factsheet provides a nice overview of the PSR.

Visión General de la Ley de Modernización de la Inocuidad de los Alimentos; Norma de la Inocuidad de los Productos Agrícolas Frescos (FST-291NP)
This factsheet provides a nice overview of the PSR (Spanish version)

Rarely Consumed Raw Produce
This FDA factsheet details produce that is defined as “rarely consumed raw”, which is important for determining covered and exempt products.

Productos Agrícolas Frescos “Raramente Consumidos Crudos”
Spanish version of the “Rarely Consumed Raw Produce” factsheet

Coverage and Exemptions Flowchart for Produce Safety Rule (PSR)
This simple flowchart can help you determine if you are covered by the PSR.

Is my farm operation covered or exempt from the Produce Safety Rule?
Interactive flowchart tool (English version)

¿Mi huerta está cubierta o exenta de la Norma de Inocuidad de los Productos Agrícolas Frescos (PSA por sus siglas en Ingles)?
Interactive flowchart tool (Spanish version)

Produce Safety Rule Compliance

VDACS Produce Safety Program
See the May 2025 Newsletter for information from the Produce Safety Program.

Produce Safety Rule Compliance Dates and Timeline

Revised Compliance Dates
Simple chart showing compliance dates for the PSR

Required Records for the PSR

Workers

Food Safety Modernization Act Produce Safety Rule: Worker Health, Hygiene, and Training  (FST-278NP)
This factsheet provides a nice overview of this vital part of the regulation including key requirements and recordkeeping.

More Than Words Illustrations
Excellent PSA tools that can be downloaded, printed, and distributed for educational purposes such as training farm workers about on-farm food safety hazards and best practices.

Fruit and Vegetable Food Safety Training Video for Field Employees (PSA)

Agricultural Water

FDA Water Updates
FDA published a revision to Subpart E – Agricultural Water (pre-harvest)on May 6, 2024. The revised Subpart E moves from reliance on testing pre-harvest water for decision making to assessing the whole agricultural water system. The expectation is that each grower understands their water usage and quality and how water management practices can minimize risks to crops. Farms should be prepared to explain their assessment and rationale during the inspection process. Harvest and Post-Harvest Water Requirements have not changed.

PSA Resources Related to FSMA PSR Requirements for Agricultural Water
This link provides a lot of excellent materials to explore. Of particular note are:

Animals

Food Safety Modernization Act Produce Safety Rule: Wildlife and Domesticated Animals (FST-272NP)
This factsheet provides a look at the key standards related to wildlife and domesticated animals.

Soil Amendments

Biological Soil Amendments of Animal Origin (FDA Factsheet Jul 2018)
At a glance overview (English version).

Mejoradores Biológicos de Suelo de Origen Animal (FDA Factsheet Jul 2018)
At a glance overview (Spanish version).

Produce Safety Factor to Consider when Using Biological Soil Amendments of Animal Origin (BSAAO)

FSMA Produce Safety Rule: Documentation Requirements for Commercial Soil Amendment Suppliers
This factsheet provides guidance on the purchase of BSAAOs and requirements growers may be legally required or impact the ability to market fruits and vegetables.

Produce Safety Rule Inspections

NASDA About On-Farm Readiness Review

Preventive Controls for Human Food Rule

Final Rule on Preventive Controls of Human Foods At-a-Glance Factsheet
This four-page FDA factsheet provides an overview of the Preventive Controls for Human Food Rule (PCHF) and outlines key requirements and compliance dates.

VDACS Handbook for Small Food Businesses
This resource covers a wide of range of foods, what regulations producers must be compliant with to sell food in Virginia, and  food safety practices for food manufacturing and processing businesses.

Food Safety Preventive Controls Alliance
The Food Safety Preventive Controls Alliance (FSPCA) is composed of members of the food industry, academia, and state and federal regulatory agencies. This FDA-funded group is charged with supporting the food industry comply with the PCHF and Preventive Controls for Animal Food (PCAF) regulations by developing a nationwide core curriculum, training, and outreach materials. The FSPCA has also established a technical assistance network to answer questions related to complying with the regulation or the science behind food safety. The websites below have links to various related topics.

Food Producer Technical Assistance Network (FPTAN)
Formerly known as the Food Innovations Program, the FPTAN provides assistance for Virginia’s food entrepreneurs to produce high quality, safe, and innovative food products. The program is directed by Melissa Wright, who provides one-on-one support regarding food safety, product formulation, Virginia food regulations, and general concerns associated with starting a food business that may be inspected by Virginia Department of Agriculture and Consumer Services (VDACS) or Virginia Department of Health (VDH). The FPTAN also offers food testing services (e.g., pH, water activity, Brix) to help ensure food safety and regulatory compliance for new food products entering the market. In addition, this program can provide nutrition facts panels for your product’s label.  The website provides more information, including a link to request an evaluation of your product.

Other Links

Southern Center
As part of our efforts to provide education and outreach in the FSMA PSR and PCRHF, the FPSFT is part of the Southern Center.  The Southern Center includes participation from land-grant institutions in Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, and Virginia.  To learn more about the Southern Center, other regional centers in the US, or find information related to FSMA training in the southern US, visit the Southern Center website.

CONTACT Produce Safety Research
UF IFAS Extension produce safety site including webinars, training, social media, and publications. For instant notifications when Contact drops, you can subscribe to their YouTube channel.

Food Safety Resource Clearinghouse
This Clearinghouse is a curated source of Produce Safety and Preventive Controls for Human Food related resources.  Anyone can search and view the resources linked to the clearinghouse by using one or all of the search tools below (type, topic, state, and/or keywords).