Produce Safety Rule (FSMA) in Maine

In 2011 the federal Food Safety Modernization Act (FSMA) initiated science-based food safety standards for previously unregulated produce farms with the intention of preventing human food-borne illness and/or death from pathogen contamination of fresh produce from people, water, soil amendments, animals, equipment, tools, and buildings during growing, harvesting, packing, and/or holding fresh produce. The Produce Safety Rule (PSR), finalized in 2015, is 1 of the 7 parts of FSMA. Maine has a Cooperative Agreement Program with the Food and Drug Administration (FDA) to enforce the PSR on their behalf. More information on FDA's FSMA website.

Maine is building an inventory of active farms to identify produce farm, to determine their coverage status under the Produce Safety Rule, and offer food safety outreach, education, and technical assistance. Although not all farms selling produce are subject to the PSR, the federal Food Drug & Cosmetic Act (FD&C Act) requires all food offered for consumption to be safe. We encourage all Maine produce farms to reach out!

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Is my Farm Subject to the Produce Safety Rule?

Farms are subject to the Produce Safety Rule if you answer YES to 1-3. See FDA Coverage and Exemptions/Exclusions Flow Chart

1. My farm grows and/or harvests produce that is sold in its raw or natural state (including vegetables, fruits, herbs, mushrooms, sprouts, tree nuts, some pulses, and wild foraging).
2. My farm grows and/or harvests produce that is sold in its raw or natural state that is not exempt from the Produce Safety Rule. Exempted crops: Asparagus; beans, black; beans, great Northern; beans, kidney; beans, lima; beans, navy; beans, pinto; beets, garden (roots and tops); beets, sugar; cashews; cherries, sour; chickpeas; cocoa beans; coffee beans; collards; corn, sweet; cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; squash, winter; sweet potatoes; and water chestnuts.
3. My farm’s gross annual produce sales are greater than $25,000 when averaged for the last 3 years and adjusted for inflation. Current inflation adjusted values: FSMA Inflation Adjusted Cut-offs.

Qualified Exempt farms: Farms subject to the regulation may be exempt from inspection of farm activities if average gross annual total food sales (all food for human or animal) are less than $500,000 adjusted for inflation AND the predominance of total food sales are to Qualified End Users (QEU) rather than distributors. A QEU is a retail/restaurant within 275 miles of the farm and includes direct to consumer sales. Qualified Exempt farms are required to maintain a record proving financial qualification and label packaged produce with farm name/address. Produce Safety Alliance Qualified Exemption Review Template under Recordkeeping.”

How do Inspections Work?

FDA Fact Sheet Produce Safety Rule (21 CFR 112) “What to Expect of a Regulatory Inspection” Informational Handout for Farmers. More Information: FDA Produce Safety Rule Inspections. Potential enforcement action resulting from significant observations during an inspection is expedited reinspection. Repeat significant observations during an expedited reinspection could result in FDA action such as a regulatory meeting or letter. Maine has authority to detain/embargo and destroy adulterated food.

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, or equivalent, is required for farms subject to the Produce Safety Rule, but we encourage all farms selling produce to complete it. The course/manual also serves as a resource for farms that participate in third-party food safety audit programs. Upcoming Grower Training. Contact us if you want to be notified of trainings offered in Maine.

Resources

• DACF's Produce Safety Rule Resource Library
• Sign up for our listserv to receive tips, program updates, and educational opportunities.