Food Safety Modernization Act

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Introduction
Summary
Must Read Articles
Resources and Support
Disclaimers
References

Key Take Aways

If you grow, harvest, pack or hold produce typically eaten raw, you must follow the rules set forth by the Food Safety Modernization Act (FSMA) and the Michigan Food Law.

The FSMA Produce Safety Rule established minimum regulatory requirements and inspection rules for on-farm produce safety practices.

Farms that grow, harvest, pack or hold produce and have average annual produce sales of more than $25,000 are “covered” by the Rule and must be inspected. There is an initial assessment and thereafter, routine assessments every 3 to 5 years.

Farms that grow $25,000 or less are exempt, although they may still receive a phone call to confirm that they still are exempt from inspection.

Many farms may qualify for an exemption if their farm has average annual food sales of less than $500,000 and the majority of food sales are made directly to qualified end users.

The Michigan On-Farm Produce Safety (MIOFPS) Team was established to make sure growers have the information needed to implement the FSMA rules. The MIOFPS website provides a wealth of information about the resources available.

You may also need to obtain state and local licenses for products that you sell at your farm.

INTRODUCTION

Food safety is an essential aspect of running a business that involves growing, selling or processing food and it is the law. Agritourism businesses, regardless of the size, must make this a priority for the safety of their visitors. Take the time to inform yourself of the law and the necessary requirements and take advantage of the recourses and support that are available to help you along the way.

Food Safety Modernization Act (FSMA)
In 2011, The FDA Food Safety Modernization Act (FSMA) was enacted to ensure the safety of our food system and to prioritize prevention of food-borne illness. Rules were developed detailing the specific actions that must be taken by businesses to prevent food contamination and keep the public safe.

In 2018, Michigan adopted the FSMA federal regulations into the Michigan Food Law (P.A. 92 of 2000, as amended) and Michigan Feed Law (P.A. 120 of 1975, as amended) through House Bill 4811 and House Bill 4812).

Please read the information from the Michigan Department of Agriculture and Rural Development about FSMA: https://www.michigan.gov/mdard/food-dairy/food-safety/food-safety-modernization-act

FSMA Produce Safety Rule
Produce Safety Rule
In 2016, the Produce Safety Rule (PSR) went into effect to establish standards for the growing, harvesting, packing and holding of produce for human consumption. The PSR includes mandatory regulations for farms that grow, harvest, pack, or hold produce typically eaten raw and establishes minimum regulatory requirements you must follow and that will be inspected regarding on-farm produce safety practices.

Farms Covered by the Rule
Basically, if you grow, harvest, pack or hold produce that may typically be eaten raw and have average annual produce sales more than $25,000, you are covered under this rule and are eligible for a food safety inspection from MDARD. You will receive an initial inspection and then afterward, will receive routine inspections every 3-5 years. You are exempt from a food safety inspection if your sales are $25,000 or less, but you may be contacted by phone or email every few years to verify that you are still exempt.

To know if the PSR applies to your farm and to receive important information about the rule, you can complete the MDARD Produce Safety Tool.

Also, be sure to review the U.S. Food and Drug Administration’s Standards for Produce Safety and FDA Fact Sheet Produce Safety Rule (21 CFR 112) – Rarely Consumed Raw Produce, because the $25,000 sales threshold is not the only factor used to determine compliance. Many farms may qualify for a Qualified Exemption under 21 CFR 112.5 if their farm has average annual food sales of less than $500,000 and the majority of food sales are made directly to qualified end users.

If a farm qualifies for this exemption, it is not exempt from all requirements. Instead, it must comply with the modified requirements in 21 CFR 112.6 and maintain records required by 21 CFR 112.7. These requirements generally include:

Displaying the farm name and complete business address on labels, packaging, or at the point of sale.
Maintaining records demonstrating eligibility for the qualified exemption.
Keeping documentation supporting annual sales and qualified end-user sales.

FSMA Food Safety Inspections
Initial inspections will observe your farm in action to identify and reduce any produce safety risks. You will receive a report of areas that need to be addressed. It’s important to address any findings from the initial inspection before you have a routine inspection.

Routine inspections will document any violations of farm food safety practices that are not in compliance with the PSR. There are two categories of violation: A core violation/observation is a practice that does not pose an imminent health risk but must be corrected as soon as possible. A priority observation poses a serious imminent health risk

Please review the helpful information on inspections from the Michigan On-Farm Food Safety website: https://www.miofps.org/post/routine-inspections-are-beginning-here-s-what-you-need-to-know

Resources for Michigan Produce Growers
Michigan created the Michigan On-Farm Produce Safety (MIOFPS) Team, which is a collaboration of MDARD staff, Michigan State University Extension Educators and Conservation District Product Safety Technicians who work together to make sure that producers have the information and resources they need in order to implement the food safety rules.

Visit MIOFPS website for information about the free resources available to Michigan growers, including a list of Produce Safety Technicians, a Produce Safety Risk Assessment Tool, information on Produce Safety Alliance (PSA) Grower Training, and On Farm Readiness Reviews.

Watch this video created by MDARD about Produce Safety Risk Assessments: https://www.youtube.com/watch?v=6CD0OIEpNWs&t=190s

Additional Questions?
Contact the MDARD Customer Service Center at 800-292-3939 or see the map below for information on your regional produce safety inspector.
Michigan Produce Safety Program Inspector Coverage Map

Do I Also Need a Food License?
You may need to obtain state and local licenses for products you are selling at your farm. Rules are based on whether the foods are of your own production or not. There are additional exemptions if you produce the food yourself and are selling it at your farm.

Please see MDARD’s Food Establishment Licensing Details, FAQ and Step-by-Step Guide for information about licenses you may need. Or contact MDARD at 800-292-3939. Also, please review Module 41: Farm Market GAAMPs and Other Regulations for a summary of the licenses which may apply to your operation.

SUMMARY

Following food safety practices are a necessary part of running an agritourism operation. Although it may seem overwhelming, there is support available to help you through the process. The Michigan On-Farm Produce Safety (MIOFPS) Team has developed informative resources and videos and are also available by phone or in person to help you navigate the FSMA rules.

MUST READ ARTICLES

FSMA Produce Safety Inspections: What to Expect and Where to Find Resources
https://www.michiganfarmnews.com/fsma-produce-safety-inspections-what-to-expect-where-to-find-resources

MDARD Produce Safety Assessments Resume
Farm News 5 Video: https://www.youtube.com/watch?v=BlKYARSx2cw

Produce Safety Inspections: Clearing up the Who, When and How Often of On-Farm Produce Safety Inspections
https://www.canr.msu.edu/agrifood_safety/Newsletter-Articles/produce-safety-inspections

Routine Inspections are Beginning: Here’s What You Need to Know: https://www.miofps.org/post/routine-inspections-are-beginning-here-s-what-you-need-to-know

RESOURCES AND SUPPORT

Act No. 92, State of Michigan, Effective March 26, 2018
https://www.legislature.mi.gov/documents/2017-2018/publicact/htm/2018-PA-0092.htm

Act No. 93, State of Michigan, Effective March 26, 2018
https://www.legislature.mi.gov/documents/2017-2018/publicact/htm/2018-PA-0093.htm

Food Safety and Modernization Act
https://www.michigan.gov/mdard/food-dairy/food-safety/food-safety-modernization-act

Food Safety Modernization Act and Produce Safety Rule
https://www.michigan.gov/mdard/food-dairy/food-safety/food-safety-modernization-act/fsma-produce-safety

MDARD Produce Safety Tool
https://www.michigan.gov/mdard/food-dairy/food-safety/food-safety-modernization-act/fsma-produce-safety

Michigan On-Farm Food Safety Website
https://www.miofps.org

Michigan Produce Safety Program Inspector Coverage Map

Michigan State University Extension Produce Safety Alliance Trainings: https://www.canr.msu.edu/produce_safety_rule_training_and_cer/index

DISCLAIMERS

The information provided in this online module is for informational and educational purposes only. It is not intended as professional advice and should not be relied upon as such. While efforts have been made to ensure accurate and up-to-date information, we cannot guarantee its reliability or completeness. Readers are encouraged to do their own research and consult with qualified professionals before making any decisions based on the content presented.

References to commercial products, trade names, or suppliers are made with the understanding that no endorsement is implied and that no discrimination against other products or suppliers is intended.

The opinions and advice expressed are solely those of the authors and may not reflect those of the Michigan Agritourism Association, its board of directors, or members. Michigan Agritourism and the authors are not liable for any direct or indirect damage resulting from the use of the information shared with you. Your use of this toolkit indicates your acceptance of these terms.

REFERENCES

Anderson, M. (2025, October 6). Routine Inspections are beginning! Here’s what you need to know. MIOFPS. https://www.miofps.org/post/routine-inspections-are-beginning-here-s-what-you-need-to-know

FSMA Produce Safety Inspections: What to expect, where to find resources. (2026, August 13). An Official Publication of Michigan Farm Bureau. https://www.michiganfarmnews.com/fsma-produce-safety-inspections-what-to-expect-where-to-find-resources

Michigan Department of Agriculture & Rural Development. (2020, June 17). Produce Safety Inspection for farm owners (Subtitle Optional) [Video]. YouTube. https://www.youtube.com/watch?v=6CD0OIEpNWs

Michigan Farm Bureau. (2020, June 29). FN5 Daily: MDARD produce farm inspections resume [Video]. YouTube. https://www.youtube.com/watch?v=BlKYARSx2cw

MSU Extension, Agrifood Safety, Produce Safety Inspections (n.d.) https://www.canr.msu.edu/agrifood_safety/Newsletter-Articles/produce-safety-inspections