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The Produce Safety Rule under the Food and Drug Administration Food Safety Modernization Act (FSMA), signed into law in 2011, is now in effect. The rule focuses on regulatory standards for the safe growing, harvesting, packing and holding of fruits and vegetables, in an effort to prevent microbial contamination and reduce foodborne illnesses associated with fresh produce.
Refer to the Food and Drug Administration’s Standards for Produce Safety Exemptions/Inclusions worksheet to figure out if your farm/operation is covered under the rule.
Use our exemption decision tool below to assist in figuring out if your farm/operation is eligible for total exemption or qualified exemptions. Please be aware that if you are eligible for qualified exemptions, you still need to maintain the appropriate paperwork that is required under an exemption status.
Refer here for a video from the Produce Safety Alliance on what exempt farmer’s should know about the Produce Safety Rule.
“Education before and while Regulation” is the motto that the FDA and cooperating states have adopted. The Produce Safety Rule requires that at least one individual from every covered farm receive training under a FDA recognized curriculum. Currently, the Produce Safety Alliance (PSA) Grower Training course satisfies that requirement. Any farm which produces over $25,000 in average annual produce sales of fresh fruits and vegetables may be potentially covered under the Produce Safety Rule: making this course mandatory per 21 CFR Section 112.22(c). This course is a collaboration between Cornell University, FDA and USDA to assist produce growers in meeting the regulatory requirements of the Produce Safety Rule under FSMA. This training is divided into several parts:
The Produce Safety Alliance Grower training course is a one-time, all-day course tailored to the Produce Safety Rule. This course is not to be mistaken with the half day Good Agricultural Practices / Good Handling Practices Course. You will receive a nationally recognized certificate upon successful completion.
**At this time, every farm covered under the Produce Safety Rule (those with over $25,000 in average annual produce sales) is required to be in compliance with the federal regulations. If you fall within the previously mentioned sales category and have not taken the training course, you are currently out of compliance.
The Delaware Department of Agriculture, in partnership with University of Delaware Extension, are performing On-Farm Readiness Reviews. On-Farm Readiness Reviews are voluntary, confidential, free, non-regulatory, on-farm risk-assessments designed to help the grower gauge their readiness for the Produce Safety Rule prior to an inspection. All notes that are taken during these reviews are left on farm. More information about these reviews can be found below. If you are interested in an On-Farm Readiness Review please contact: DE.ProduceSafety@delaware.gov
As of June 11, 2019; new State Produce Safety regulations (Produce Safety Regulations 302 Del. Code. § 3.0) went into effect which requires that all farms within Delaware that grow produce, must register with the Delaware Department of Agriculture to verify compliance with the Produce Safety Rule. In order to verify compliance; fill out the below confidential “Grower Registration”, and return to the Delaware Department of Agriculture, via the options provided on the form. Once we receive your registration, we will contact you to verify if your facility is covered or exempt from the Produce Safety Rule, and discuss any next steps.
In 2020, the Delaware Department of Agriculture will continue to perform regulatory inspections; on behalf of FDA, of produce farms with over $250,000 in gross annual produce sales. Refer to the compliance date chart to determine when your farm will become subject to a regulatory inspection. Since this is the first time farms have been subject to regulatory inspections, these inspections will be treated highly educational at first. In addition, all inspections will be scheduled, unless there is an outstanding condition. Refer to the “What to Expect during an Inspection” document below to gain a better understanding of what to expect.
Compliance Dates (2018-2020):
In an effort to assist the grower in implementation of the Produce Safety Rule on their farm, the Produce Safety Alliance has put together a Records Required by the FSMA Produce Safety Rule: Fact Sheet. Click here to download the FSMA Produce Safety Rule: Templates for PSR records.
If you are interested in Produce Safety Alliance training or and On-Farm Readiness Review, please contact the Produce Safety Rule program at (302) 698-4500 or via email at DE.ProduceSafety@delaware.gov.