Produce Safety Rule (FSMA) in Maine

In 2011 the federal Food Safety Modernization Act (FSMA) created science-based food safety standards for previously unregulated produce farms. The Produce Safety Rule (PSR) is 1 of the 7 parts of FSMA and is the only part currently enforced by Maine Department of Agriculture, Conservation & Forestry (DACF) inspectors commissioned with the Food and Drug Administration (FDA). More information on FDA's FSMA website.

According to the 2017 US Ag Census, Maine has about 7,600 farms. Farms include those that offer food products (maple, livestock, animal feed, aquaculture, dairy, wild foraging, produce, etc.) and non-food products (Christmas trees, fiber, etc.). 

About 2254 of the 7,600 farms in Maine are produce farms. Through a Cooperative Agreement Program, Maine is building an inventory of active farms to identify produce farms and offer outreach, education, and technical assistance in addition to conducting inspections on produce farms subject to the federal rule. The national moto is “Educate before and while we regulate."

On this Page:

• What is the Produce Safety Rule?
• Is my Farm Subject to the Produce Safety Rule?
• How do Inspections Work?
• Technical Assistance
• Education
• Resources

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What is the Produce Safety Rule?

The Produce Safety Rule is a federal regulation intended to prevent human illness and death from pathogen contamination of fresh produce via people, water, soil amendments, animals, and equipment surfaces during growing, harvesting, packing, and holding fresh produce. 

More information: FDA’s Produce Safety Rule website / Produce Safety Rule (Full Text)

Is my Farm Subject to the Produce Safety Rule?

Your produce farm is subject to the Produce Safety Rule (Fully Covered) if you answer YES to 1-4:

1. My farm grows and/or harvests produce (including herbs, mushrooms, sprouts, tree nuts, and some pulses). Harvest includes wild foraging.
2. The produce my farm grows and/or harvests is commonly consumed raw (lettuce, etc.).
3. My farm’s gross annual produce sales are greater than $25,000.
4. My farm’s gross annual total food sales (all food for human or animal) are greater than $500,000. OR, if my farm’s gross annual total food sales are less than $500,000, the predominance of sales are to distributors rather than Qualified End Users (QEU). A QEU is a retail/restaurant within 275 miles of the farm and includes direct to consumer sales.

FDA Coverage and Exemptions/Exclusions Flow Chart

If you answered NO to question #2, the produce must be on the FDA Rarely Consumed Raw list to be exempt from the PSR.

If you answered NO to question #3, your farm is “Not Covered” by the Produce Safety Rule. The federal Food Drug & Cosmetic Act (FD&C Act) requires all food offered for consumption to be safe. This applies to farms that are not subject to the Produce Safety Rule.

If you answered NO to the second part of question #4, your farm is “Qualified Exempt” from inspection. You are required to maintain a record proving your status and label your packaged produce with your farm name/address. More Information at Produce Safety Alliance Resources For Recordkeeping.

There is an exemption from inspection for produce that is commercially processed because it is processed to adequately reduce the presence of microorganisms that make people sick.

The $25,000 and $500,000 values are adjusted for inflation every April. More information at FSMA Inflation Adjusted Cut-offs.

How do Inspections Work?

Initial inspections are educational in nature. Currently all inspections are scheduled in advance. The coverage status of the farm will be confirmed during scheduling.

On the day of the inspection the inspector will present their FDA pocket credentials, issue an FDA Form 482-Notice of Inspection, conduct a walk-through of the farm activities and review records all while openly discussing observations with the farm. 

At the close of inspection, an FDA Form 4056 will be issued. A narrative, “summary” report will be written by the inspector and reviewed by a co-worker as a double-check before being issued to the farm via email and snail mail. 

Observations of lesser significance will be captured on the summary report. Observations of greater significance will be captured in the FDA Form 4056. Any FDA Form 4056 with observations must be shared with FDA so they may determine if compliance & enforcement action is required. FDA compliance & enforcement action could consist of a regulatory letter/meeting and/or “follow-up” inspection that FDA may choose to join.

Maine has authority to detain/embargo and destroy adulterated food. Maine may elect to schedule a "for-cause" inspection which is the state-level version of a "follow-up" inspection resulting from FDA compliance & enforcement action.

More Information: FDA Produce Safety Rule Inspections Tip: Start with the Fact Sheets linked at the bottom of the page.

Technical Assistance

I have a question, who do I contact?

Maine DACF, Quality Assurance & Regulations, Produce Safety Program +

UMaine Cooperative Extension +

Food & Drug Administration +

Education

Produce Safety Alliance (PSA) Grower Training is offered in Maine by University of Maine Cooperative Extension. This training or equivalent is required for farms subject to the Produce Safety Rule. The course/manual also serves as a resource for farms that participate in the GAP audit program. Anyone interested in farm food safety best practices may take the course. UMCE PSA Grower Training

Resources

• DACF's Produce Safety Rule Resource Library
• Sign up for our listserv. A couple notifications are sent out monthly that cover program updates and educational opportunities.