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- FSMA and the Produce Safety Rule: Does the rule apply to me?
The Food Safety Modernization Act (FSMA) Produce Safety Ruleis federal food safety legislation for fruit and vegetable farms. This rule sets federal regulatory standards for the production, harvest and handling of fruits and vegetables in an effort to prevent microbial contamination and reduce foodborne illnesses. Standards are established in the following major areas:
Worker training and health and hygiene.
Agricultural water.
Biological soil amendments of animal origin (manure).
Domesticated and wild animals.
Equipment, tools and buildings.
Is my farm covered by the FSMA Produce Safety Rule?
While food safety is important for all farms, the FSMA Produce Safety Rule regulation only applies to some farms. Definitions play a key role in understanding if your farm is subject to the FSMA Produce Safety Rule or not, so you will have to think about your own operation, read the ruleand then determine if it applies to you.
There are several ways your farm or operation may be excluded or exempt from the FSMA Produce Safety Rule. Exclusions and exemptions are based on:
- The typeof food you grow.
- Total annual sales of the food you grow.
- Where you sell your food.
- Who you sell food to.
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Farms with total sales of produce less than $25,000are not covered by the FSMA Produce Safety Rule.
This amount is a three-year rolling average and it is adjusted for inflation. Check the Minnesota Department of AgricultureProduce Safety Rule Farm Status page for updated inflation adjusted sales cut-offs.
The following types of produce are not covered by the FSMA Produce Safety Rule (for definitions of the following, see § § 112.2 and § 112.3 of the Produce Safety Rule).
Produce for personal or on-farm consumption.
Produce that is not a raw agricultural commodity.
Produce destined for commercial processing where there is a kill step.
Produce that is rarely consumed raw.
See AlsoMushroom Food Safety - Penn State ExtensionInsight into the evolutionary and domesticated history of the most widely cultivated mushroom Agaricus bisporus via mitogenome sequences of 361 global strainsGrowing Morels: Tips and TechniquesMushrooms and Food Pathogen RiskThis is the complete FDA exempt list.
Produce not on this list is not exempt under the “rarely consumed raw” provision.
asparagus
beans, black, great Northern, kidney, lima, navy, 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
water chestnuts
Your farm is eligible for a qualified exemptionif you meet all of these categories:
Your average annual food sales (produce and all other crops and value-added products) over the previous three years are less than $500,000*; and
More than 50 percent of those food sales are to “qualified end-users,” such as restaurants, grocery stores and other retail food establishments (including direct-to-store sales) located in your same state or Indian reservation or within a 275 mile radius of your farm.
Consumers are qualified end users regardless of location (direct marketing through farmers markets, community supported agriculture, internet sales, etc.).
For more details on the criteria for meeting the conditions written above, see FDA Produce Safety Rule summary of exemptions and key provisions.
*This value is a three-year rolling average and it is adjusted for inflation. Check the Minnesota Department of AgricultureProduce Safety Rule Farm Status page for updated inflation adjusted sales cut-offs.
You will need to demonstrate that your farm is eligible for the qualified exemption. This means you must keep sales records and make them available upon request.
If your farm is eligible for the qualified exemption, you must also follow modified labeling requirements:
When a food packaging label is required, you must prominently and conspicuously display on the food packaging label the name and the complete business address of the farm where the produce was grown.
When a food packaging label is not required on food, you must prominently and conspicuously display,at the point of purchase (at the time of sale, like at the farmers market), the name and complete business address of the farm where the produce was grownon a printed label, poster, sign or placard. Forinternet sales include anotice on the sale web page.
The complete business must include the street address or post office box, city, state and zip code for domestic farms, and comparable full address information for foreign farms.
Commercial processing exemption note: If you rely on the commercial processing exemption, you must meet each of the criteria in 21 CFR 112.2(b), for all produce that you intend the exemption to cover. This includes requirements for providing a disclosure statement with each shipment, collecting annual assurance statements from your customers and maintaining certain records.
The regulation states that if your farm is covered by the rule, ‘at least one supervisor or responsible party from the farm’ must complete food safety training at least equivalent to the standardized curriculum recognized by the FDA. (§112.22(c)). The Produce Safety Alliance (PSA), a national group based at Cornell University, has developed a FSMA training course that is one way to fulfill the training requirement of the Rule.
At the training, you will learn the specifics of what a covered farm must to do to be in compliance with the Produce Safety Rule. Currently, it is the only training that meets the training requirement of the Produce Safety Rule.
UMN Extension is working closely with partners to host FSMA trainings in all areas of the state for produce farmers. All growers, including those that may be exempt from the full rule and any others interested in learning about produce safety and Good Agricultural Practices (GAPs) are encouraged to attend. View more information on upcoming FSMA trainings in Minnesota.
For more information
FSMA Facts: Does this rule apply to you?(FDA) - Decision tree to help you understand if the rule applies to your farm.
Minnesota Department of Agriculture Produce Safety Program
Author: Annalisa Hultberg, Extension educator
Funding for this information was made possible, in part, by the Food and Drug Administration through grant PAR-16-137. Additional support was provided by the Minnesota Department of Agriculture and the United States Department of Agriculture (USDA) Specialty Crop Block Grant Program.
Reviewed in 2021
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