Romaine Calm: Breaking Down the Produce Safety Rule Coverage, Exemptions, and Exclusions
By Tucker Diego, VT Agency of Ag
This is the third article in our series “Breaking Down the Produce Safety Rule”. Citations in this article refer to specific sections in the Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR). These citations and additional subparts of the FSMA Produce Safety Rule can be accessed via the Electronic Code of Federal Regulations at https://go.usa.gov/xQjSt (case-sensitive).
The Food Safety Modernization Act Produce Safety Rule (21 CFR Part 112) is the first-ever federal food safety standard for farms that grow, harvest, pack, or hold produce. The PSR establishes minimum science-based standards to prevent microbial contamination of fresh produce and reduce foodborne illness outbreaks. With routine inspections beginning in 2019 for the largest businesses covered under the Produce Safety Rule, it is important to know whether your farm is covered, eligible for an exemption, or excluded from the PSR altogether. Continue reading to learn about the key exemptions and exclusions, and the appropriate next steps to take for your farm.
Tip: FDA provides a visual flowchart of the exemptions and exclusions discussed in this article, and it may be helpful to refer to it as you continue reading. Find this flowchart at https://go.usa.gov/xQjJm (case-sensitive).
The PSR is complex and many nuisances are communicated in some of the key definitions of this Rule. To truly understand your status under this rule, it is important to review and understand the following definitions.
The Produce Safety Rule applies to farms, defined as “primary production farms” or “secondary activities farms.”
A primary production farm is an operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, [and/or] the raising of animals ..." (112.3). The Rule also applies to secondary activities farms, defined as "an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm ..." (112.3).
Produce is defined as "any fruit or vegetable (including mixes of intact fruits and vegetables) and includes mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts, and herbs ..." (112.3).
The definition of food is important for determining eligibility for a qualified exemption (see below). Food is defined as (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
Produce That is "Rarely Consumed Raw"
Certain produce that is typically cooked before being eaten is considered "rarely consumed raw" and is not covered by the PSR. The FDA has published the following exhaustive list of rarely consumed raw produce: 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 (112.2(a)(1)).
Produce for Personal/On-Farm Consumption
Produce that is for personal consumption or for on-farm consumption is not covered by this Rule.
Produce That is Not a Raw Agricultural Commodity
The Rule only applies to produce in its raw, unprocessed state. Produce that undergoes manufacturing or processing, such as slicing, freezing, or canning, is not covered by this Rule.
Minimum Produce Sales Threshold
Farms with annual produce sales of less than $25,000* averaged over the previous three years, are not covered by this Rule (112.4(a)).
This is the most common exemption and may apply to many small and medium sized farms. A farm that is eligible for a qualified exemption from the Produce Safety Rule must comply with certain modified requirements and keep documentation as per sections 112.6 and 112.7 in the Rule. To be eligible for a qualified exemption a farm must:
- have annual total food sales of less than $500,000* averaged over the previous three years; AND
- the majority of all food sales are to qualified end-users, defined as
- the consumer of the food
- a restaurant or retail food establishment located in the same state or within 275 miles from the farm.
Examples of qualified end-users may include farm stand, farmers market, or community supported agriculture (CSA) customers as well as restaurants, grocery stores, and food cooperatives. The term qualified end-user does not include distributors and does not include restaurants or retail food establishments located more than 275 miles from the farm (unless within the same state).
Note: This exemption refers to total food sales which includes all human and animal food products sold. Examples include processed foods and animal feed such as hay, silage, or grain.
Commercial Processing Exemption
Produce sold to a buyer who will conduct further commercial processing with a "kill step" is eligible for an exemption from the Rule. For more information about this exemption refer to section 112.2(b) at https://go.usa.gov/xQDqg (case-sensitive).
What does it mean to be eligible for an exemption?
A qualified exempt farm is not required to undergo routine inspection, but must meet specific modified requirements under the Rule. If you think your farm meets one of the exemptions listed above, please reach out to the Produce Program at the Vermont Agency of Agriculture, Food, & Markets to confirm your eligibility and receive further guidance.
What does it mean to be covered by the Rule?
If you determine that your farm does not meet one of the above exemptions or exclusions and is covered by the Rule, contact the Produce Program team to receive guidance on the next steps to prepare for compliance with Produce Safety Rule. The Produce Program is committed to assisting Vermont farms with the educational and technical resources they need to comply with this regulation and are continually updating resources for growers.
Growing produce safety on your farm, (regardless of coverage), can lead to new market access, product development, increased efficiency, and will support your farm in becoming an all-around sustainable agricultural business.
Contact Our Team
Tucker Diego – Produce Safety Inspector
Dominique Giroux – Outreach and Education Coordinator
*All sales figures should be adjusted for inflation using 2011 as a baseline. Current inflation adjusted cut-offs can be accessed at https://go.usa.gov/xQDqZ (case-sensitive).
FSMA Produce Safety Rule Compliance Dates
(based on annual produce sales
averaged over previous 3 years)
Compliance Dates for Most Produce
All other businesses (>$500K)
January 26, 2018
Small businesses (>$250 – 500K)
January 28, 2019
Very small businesses (>$25 – 250K)
January 27, 2020
Stay informed on FSMA regulations, news, and funding opportunities by enrolling in the Produce Portal at www.Agriculture.Vermont.gov/ProducePortal