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. Contact Matt Fout at 614-600-4272 or mfout@agri.ohio.gov for more information on record requirements and 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 began produce farm inspections in 2019 according to the Produce Safety Rule compliance dates.  We provide farm produce safety consultations and provide Produce Safety Alliance Grower Training courses across the state upon request to any Ohio produce farm.  If you are interested in participating in a farm consultation visit or want to know more about the Produce Safety Alliance Grower training, contact Matt Fout at (614) 600-4272 or mfout@agri.ohio.gov.

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 mfout@agri.ohio.gov. and we’ll walk you through the exemptions. 

Voluntary inspection 

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 mfout@agri.ohio.gov.

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 mfout@agri.ohio.gov.

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 70 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 mfout@agri.ohio.gov.  There is no fee for the training for any Ohio produce grower. The cost for out of state growers is $85.

Trainings:

Trainings for 2024 will be announced in December.
                      

Contact Matt Fout at (614) 600-4272 or email mfout@agri.ohio.gov to register for a course or to schedule one in your area.