A few weeks ago I had the opportunity to attend a Produce Safety Alliance train-the trainer training. This 2 day training was designed to provide those who work with producers a consistent foundation of produce safety and FSMA Produce Safety Rule information. I would like to dedicate this post to explaining the Produce Safety Rule.
What is the FSMA Produce Safety Rule?
The Produce Safety Rule is part of the FDA Food Safety Modernization Act (FSMA) that was passed by President Obama on January 4, 2011. This regulation focuses on setting the first-ever federal regulatory standards for the production, harvest, and handling of fruits and vegetables, in an effort to prevent microbial contamination and reduce food borne illnesses associated with fresh produce. The Produce Safety Rule was made available publicly on November 13, 2015 and was published in the Federal Register on November 27, 2015.
What does the FSMA Produce Safety Rule cover?
The Produce Safety Rule, outlined in Section 105 of FSMA, 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). The rule is divided into several parts, including standards for:
- Worker health, hygiene, and training
- Agricultural water, both for production and post-harvest uses
- Biological soil amendments (e.g., compost, manure)
- Domesticated and wild animals
- Equipment, tools, buildings, and sanitation
- Production of sprouts*
The FDA has a brief summary of the key requirements for the final Produce Safety Rule available on their website: https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472887.pdf
Will my farm be subject to the regulation?
If you grow, pack, process, or sell fresh produce, this regulation may apply to you. Review § 112.1—112.7 of the regulation to determine if your farm and the commodities you grow are subject to the regulation. A quick and easy way to help you determine whether you are subject to the regulation is by referring to the FDA’s fact sheet on coverage, exclusions, and exemptions. Just follow the flow chart by answering questions about your farm and it should aid you in figuring out if you are covered, not covered, or exempt from the produce safety rule. To see this chart use the following link: https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472499.pdf
Here are a few key exemptions and exclusions:
- 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.
Would you like more information on the Produce Safety Alliance (PSA) curriculum or the FSMA Produce Safety Rule?
- Sign up for the PSA general listserv. They send updates as they receive new information on the regulation, as well as educational opportunities and other produce safety information: Stay in Touch with PSA
- Attend a training. The PSA Grower Training Course is one way to satisfy the FSMA Produce Safety Rule requirement outlined in § 112.22(c)
- Sign up for the FDA’s e-mail updates
- Contact PSA: https://producesafetyalliance.cornell.edu/contact-us/
Lastly, do not forget that you can contact your local extension office. Feel free to reach me at the CCE Office in Rensselaer County: 518-272-4210 or kls342@cornell.edu
Sources: https://producesafetyalliance.cornell.edu/
