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 establishes science-based, minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables to prevent microbial contamination and reduce foodborne illnesses associated with fresh produce. These standards apply to fruits and vegetables usually consumed raw, such as cantaloupes, lettuce, cucumbers, and tomatoes. The standards do not apply to rarely consumed raw commodities such as potatoes and pumpkins.
Any produce farm conducting over $25,000 in average annual produce sales of fresh fruits and vegetables may potentially be covered under the Produce Safety Rule. In Delaware, it is mandatory for all produce farms (regardless of Produce Safety Rule Coverage) to register with the Delaware Department of Agriculture.
More information on the Produce Safety Rule, educational opportunities, and the registration process can be found below.
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.
Refer here for a video from the Produce Safety Alliance on what exempt farmers 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 at least one individual from every covered farm to receive training under an FDA-recognized curriculum. The Produce Safety Alliance (PSA) Grower Training course currently 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.
In Delaware, the Delaware Department of Agriculture collaborates with the University of Delaware Cooperative Extension hosts training a few times a year. Scheduled training will be listed below. If one is not listed and you need to attend a training (as soon as possible), some online and self-paced training is available through the Produce Safety Alliance’s Website. Remember, this course is required to be in compliance with the Produce Safety Rule.
Click here for online/self-paced training options.
The Delaware Department of Agriculture, in partnership with the University of Delaware Cooperative Extension, is 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 before an inspection. All notes that are taken during these reviews remain on the farm. More information about these reviews can be found below.
If you are interested in an On-Farm Readiness Review, please email: DE.ProduceSafety@delaware.gov
What to Expect During an On-Farm Readiness Review in Delaware
Launched in early 2022, the Delaware Produce Safety Portal will become the preferred way for new and existing farms to submit their mandatory annual registration information and apply for exemptions.
As of 2019, the Delaware Department of Agriculture has made it mandatory through State regulations (Produce Safety Regulations 302 Del. Code. § 3.0) that all farms within Delaware that grow, harvest, pack, or hold produce intended for human consumption and for sale, register with the Delaware Department of Agriculture by April 30, annually.
This mandatory registration process is intended to verify who is and who is not covered under the Food Safety Modernization Act (FSMA): Produce Safety Rule (21 CFR 112). This process allows us to provide valuable education, technical assistance, and compliance information to regulated farms and businesses, excluding farms that are not required to comply with the rule, and prioritize inspections.
Due to the various exemptions available, Delaware is awarding exemption certificates by exemption type as outlined in the Produce Safety Rule. Since farm information changes from year to year, we are asking farms to return their exemption applications simultaneously as their mandatory registration (on an annual basis). The exemptions will expire on April 30 of the following year the exemption was granted regardless of the awarded date.
A link to an interactive exemption decision-making tool is available from within the portal to assist farms in determining their exemption status.
To register your business, claim an existing business or update your information, please utilize our online Grower Registration Portal. Paper applications are available to download on the portal’s home page.
All produce farms with over $25,000 in gross average annual produce sales are potentially subject to a regulatory Inspection. The Delaware Department of Agriculture conducts these inspections on behalf of the FDA.
Since this is the first-time produce farms have been subject to regulatory food safety inspection, first inspections are being treated as educational. 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 better understand what to expect.
To assist the grower in implementing 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.
Related Topics: Delaware, education, FDA, Food and Drug Administration, food safety, Food Safety Modernization Act, FSMA, on-farm readiness reviews, produce, Produce Safety Rule