Food Safety Modernization Act (FSMA) Compliance

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.

What is the Produce Safety Rule (PSR)?

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. Here, we describe the PSR standards wildlife and domesticated animals.

How do I know if I am covered or exempt?

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:

What produce is covered by this rule, and what produce is not covered?

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.]

What are special rules for Qualified Exempt farms?

Carolina Farm Stewardship Association: FSMA Frequently Asked Questions: What are the Special Rules for Qualified Exempt Farms?

Is the Produce Safety Rule the same as GAP certification?

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.

If I am already GAP certified, do I also need to comply with FSMA PSR?

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.

What are the compliance dates for the PSR?

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

Who regulates the PSR in Virginia?

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. Website.

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

Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds
FDA’s guidance for guidance related to these commodities (March 2019)

VDACS Produce Safety Program
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 is working 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. Visit this site to find out more.

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)

Does my Farm have to Comply with the Food Safety Modernization Act’s Produce Safety Rule? A Tool to Assist Producers (FST-294NP)
This factsheet provides a written format of the interactive flowchart tool immediately above

Carolina Farm Stewardship Association Interactive FSMA Produce Rule Flowchart
This tool leads you through a series of questions to help you figure out how your farm/food business may be affected by federal rules on the production and handling of produce under the Food Safety Modernization Act (FSMA).

FSMA’s Produce Safety Rule…Are you Covered or Exempt?
This excellent document from the Southern Center for Training, Extension, Outreach, and Technical Assistance to Enhance Produce Safety outlines everything you need to know about whether or not you are covered or exempt under the rule. While the document is lengthy, it is well worth the read to better understand the PSR.

Produce Safety Rule Compliance

Revised Compliance Dates
Simple chart showing compliance dates for the PSR

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.

Food Safety Modernization Act Produce Safety Rule: Agricultural water (FST-271NP)
This excellent factsheet provides details about how agricultural water is defined in the PSR, establishing a microbial water quality profile, what corrective measures are acceptable, and simple recordkeeping suggestions.

The Water Analysis Method Requirement in the FSMA Produce Safety Rule
Information about monitoring agricultural water quality as outlined in the PSR.

Metodología de Ensayos Equivalentes para Agua de Uso Agríciola
Equivalent Testing Methodology for Agricultural Water (Spanish)

Demystifying Agricultural Production Water Testing under the FSMA Produce Safety Rule (FST-350NP)
This document covers why, what, and how to sample and test your production water, and most importantly how to interpret your production water test result.

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.

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).

Raw Manure under the FSMA Final Rule on Produce Safety
Why FDA Wants Public Input on Assessing the Risk of Raw Manure as Fertilizer: A Q&A with Samir Assar

Composting and Compost Use
VCE’s site which includes training, websites, and resources links

Cyclosporiasis and Fresh Produce
Factsheet detailing this pathogen and requirements of the PSR

Cyclosporiasis y los Productos Agrícolas Frescos
Spanish version of factsheet about Cyclosporiasis

Produce Safety Rule Inspections

On-Farm Readiness Review (OFRR): The Next Step in Preparing for FSMA’s Produce Safety Rule
To help prepare for the regulation, operations can choose to have an On-Farm Readiness Review (OFRR). The OFRR is a program designed specifically to help produce operations align their food safety practices with the FSMA Produce Safety Rule, and be prepared for an inspection by VDACS. Learn more about the OFRR program.

NASDA About On-Farm Readiness Review

FDA Food Safety Modernization Act (FSMA) Portal

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.

https://www.ifsh.iit.edu/fspca
https://www.ifsh.iit.edu/fspca/resources

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.

Producers