FDA Food Safety Modernization Act Produce Safety Rule (FSMA)
What is FSMA?
The FDA Food Safety Modernization Act (FSMA), which was signed into law on January 4, 2011, is the most comprehensive reform of the nation's food safety laws since 1938. Its goal is to better protect public health by shifting US food supply safety efforts from a response to a prevention approach. FSMA is comprised of seven rules that span the entire food supply chain. Of these rules, the one most likely to impact produce growers is the Produce Safety Rule.
*Funding for website, materials and video was made possible, in part, by the Food and Drug Administration through grant PAR-16-137. The views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.*
Produce Safety Rule
The Produce Safety Rule establishes a minimum set of food safety standards for farms to follow in order to reduce the risk of microbial contamination during the growing, harvesting, packing, and holding of fresh fruits and vegetables for human consumption.
The Produce Safety Rule is divided into seven parts:
Training: Establishes training requirements for farm supervisors and personnel who handle produce.
Health and Hygiene: Growers, and their employees, must abide by certain hygienic practices, such as regular hand washing, to reduce the spread of contamination.
Agricultural Water: Under the rule, growers must take steps, such as routine water testing, to ensure agricultural water is safe for its intended use.
Biological Soil Amendments of Animal Origin: The rule addresses the classification, treatment, and application of certain soil amendments, such as raw and composted manure.
Domesticated and Wild Animals: Requirements include taking measures to reduce risks associated with animals in and around produce fields.
Equipment, tools, and buildings: The rule sets standards for the maintenance of equipment, tools, and other food contact surfaces that come into contact with produce.
Sprouts: The rule establishes a separate set of standards for sprout producers. For more information, visit the Sprout Safety Alliance website.
In addition to these standards, there are requirements to maintain records of certain activities to verify compliance with the rule. Click for more information on record keeping requirements and a set of printable example templates:
ODA Produce Safety YouTube Video
FSMA Produce Safety Rule in Ohio - https://youtu.be/OR6giFrAspE. A 2 ½ minute overview of the Produce Safety Rule implementation in Ohio.
What is ODA Division of Food Safety’s role?
The Ohio Department of Agriculture, Division of Food Safety, through a cooperative agreement with the FDA, is responsible for enforcing the Produce Safety Rule in Ohio. We have been working to identify and address the needs of produce growers in Ohio who are covered by the Produce Safety Rule.
We will begin farm inspections according to the compliance dates outlined below, but prior to inspections, we’ll be providing free farm consultations. These voluntary consultation visits will help growers identify what steps they may need to take to comply with the Produce Safety rule before a regulatory inspection. We are also providing Produce Safety Alliance Grower Training courses across the state free of charge to Ohio farms. If you are interested in participating in a free farm consultation visit or want to know more about the Produce Safety Alliance Grower training, contact Matt Fout at (614) 600-4272 or email@example.com.
Is my farm covered?
Under the Produce Safety Rule in Ohio, farms will fall into one of four categories:
1) Farms that are excluded from the rule
2) Farms that are eligible for a qualified exemption
3) Farms that are covered by the rule
4) Farms that request a voluntary inspection under the rule
If a farm does not qualify for any of the exemptions listed in the flow chart, then it is considered a farm covered under the rule, and must comply with the full requirements of the Produce Safety Rule. Farms can also request to have their farm voluntary inspected under the FSMA Produce Safety Rule.
If you are uncertain how your farm will be classified, you can contact us at (614) 600-4272 or email firstname.lastname@example.org. and we’ll walk you through the exemptions.
A farm may request a voluntary inspection under the FSMA Produce Safety Rule. A voluntary inspection under the FSMA Produce Safety Rule may help farms that are excluded or exempt from the rule show they are following a set of produce safety standards in order to reduce the risk of microbial contamination during the growing, harvesting, packing, and holding of fresh fruits and vegetables on their farm. There is no charge for a voluntary inspection under the FSMA Produce Safety Rule. A produce farm that requests a voluntary inspection would be provided a yearly inspection and documentation from the ODA to show they are inspected under the FSMA Produce Safety Rule.
If you are interested in a voluntary inspection under the FMSA Produce Safety Rule contact us at (614) 600-4272 or email email@example.com.
The Produce Safety Rule came into effect on January 26, 2016, and compliance dates for some parts of the rule have already taken effect. For covered farms, there is a staggered schedule of compliance dates. The chart below shows the current compliance dates for the Produce Safety Rule.
*Chart provided by the Cornell Produce Safety Alliance
1. According to the Proposed Rule issued on 9/13/17, Compliance dates for Subpart E, Agricultural Water, allow an additional four years.
2. A farm eligible for a qualified exemption must notify consumers as to the complete business address of the farm where the food is grown, harvested, packed, and held.
3. A farm is a small business if, on a rolling basis, the average annual monetary value of produce sold during the previous 3-year period is no more than $500,000.
4. A farm is a very small business if, on a rolling basis, the average annual monetary value of produce sold during the previous 3-year period is no more than $250,000.
What should produce growers do to prepare?
Farms can request a free farm consultation visit to determine specific requirements to their farm. This service is offered as a one-on-one training in which ODA staff will visit farms and walk growers through what will be expected with new federal regulations on their farm. Farms will also receive resource materials that will help aid in compliance. Farms that are exempt from the rule are also welcome to schedule consultation visits. To schedule a free farm consultation visit, call Matt Fout at (614) 600-4272 or email firstname.lastname@example.org.
Produce Safety Alliance Grower Trainings
The Produce Safety Rule requires at least one supervisor or responsible party from every farm covered under the rule to receive training under an FDA recognized curriculum. The Produce Safety Alliance Grower Training is the only standardized national training program currently approved by FDA to satisfy this requirement.
Since 2017, trained and certified staff from the Ohio Department of Agriculture have conducted more than 50 Produce Safety Alliance Grower Training courses regionally throughout the state and have trained over 900 produce growers. If you have a location that would like to host the one-day training please contact Matt Fout at (614) 600-4272 or email email@example.com. There is no fee for the training for any Ohio produce grower. The cost for out of state growers is $85.
We will be offering more courses starting in January 2022. Check our website in December 2021 for more information on 2022 course offerings or call Matt Fout (614) 600-4272 for more information.
Ohio farms inspected under the FSMA Produce Safety Rule
Farms included on this list fall under the FSMA Produce Safety Rule and have been inspected by the Ohio Department of Agriculture. The Produce Safety Rule established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption. The rule requires covered farms to take appropriate measures to minimize the risk of serious adverse health consequences or death from the use of, or exposure to, produce, including those measures reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into produce that falls under the regulation, and to provide reasonable assurances that the produce is not adulterated. This list will be updated frequently to reflect ODA inspected produce farms that are going the extra step to produce safer produce.