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Description

This is a decision-tree flow chart titled "Maryland Department of Agriculture, Produce Safety Rule, Eligibility and Exemption Flow Chart." A box labeled "Part I" sits near the top, indicating this is the first part of the chart, which ends by directing the reader to Part II. The flow begins at a green diamond labeled "Start." From Start, an arrow leads down to the first decision box: "Does your farm grow, harvest, pack, or hold produce? (fruits, vegetables, microgreens, mushrooms, sprouts, nuts, and herbs) Sections 112.1 and 112.3(c) Complete the Produce Safety Rule Registration Form." From this box there are two exits. A NO branch (red circle) leads right to a red octagon reading "STOP You are not covered by the Produce Safety Rule." A YES branch (green circle) leads down to the next decision box: "Is it for personal consumption only?" From "Is it for personal consumption only?" there are two exits. A YES branch (green circle) leads right and up to the same red "STOP You are not covered by the Produce Safety Rule" octagon. A NO branch (red circle) leads left to the next decision box: "Is any of the produce you grow and sell usually consumed raw?" From "Is any of the produce you grow and sell usually consumed raw?" there are two exits. A NO branch (red circle) leads right to a red octagon reading "Produce that is rarely consumed raw, as listed on the exhaustive list in Section 112.2 is not covered by the Produce Safety Rule (e.g., asparagus, beets, corn, eggplant, okra, potatoes, pumpkins, winter squash). Complete the Non-Covered Commodities Exemption if you are only growing produce that is on the exhaustive list. Reassess eligibility if new crops are grown." This octagon is an endpoint. A YES branch (green circle) leads down to the next decision box: "Is your three-year average of gross produce sales less than $33,297 (dagger) (dagger)Adjusted for inflation (Based on 2022, 2023, 2024)." From the sales-value decision box there are two exits. A YES branch (green circle) leads right to a red-outlined octagon reading "You are exempt from the Produce Safety Rule. Complete the Sales Value Exemption form annually as it applies." This octagon is an endpoint. A NO branch (red circle) leads down to a box reading "My three-year average of gross produce sales is greater than $33,297 (dagger)." From that box, a YES branch (green circle) leads left to the final endpoint in bold text: "Proceed to Part II." Outside the flow, in the lower right corner, is a funding acknowledgment note: "This publication is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U2FFD007444 totaling $1,280,384 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government." A Maryland Department of Agriculture logo appears in the title area, also outside the flow.

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Description

This is a decision tree titled "Part II Qualified Exemption Eligibility," produced by the Maryland Department of Agriculture (its logo appears in the top right corner). It helps a farm determine whether it is covered by the Produce Safety Rule or eligible for a Qualified Exemption. The flow begins at a green diamond labeled "Start." An arrow leads from Start down to the first decision box: "Does your farm on average (in the previous three years) as per Section 112.5, have more than $33,297 and less than $665,947 annual food sales? †Adjusted for inflation (Based on 2022, 2023, 2024)." The word "food" carries an asterisk pointing to a definition note described below. From this first box there are two exits. A "NO higher sales" branch (a red circle) leads down and left to the final coverage outcome. A "YES" branch (a green circle) leads down to the next decision box. Second decision box: "Do you sell to Qualified End Users? Qualified End Users include: Farm Stands, Farmers Markets, CSAs, Restaurants and/or Retailers in MD or not more than 275 miles from the farm." From this box, a "NO" branch (a red circle on the left) leads left and then down to the final coverage outcome. A "YES" branch (a green circle) leads down to the next decision box. Third decision box: "Do you sell to Non-Qualified End Users? Non-Qualified End Users include: Wholesale Distributors, Brokers, Produce Auctions, any sales (including Restaurants and/or Retailers) more than 275 miles from the farm." From this box, a "NO" branch (a red circle on the right) leads right and then down to the Qualified Exemption outcome. A "YES" branch (a green circle) leads down to the next decision box. Fourth decision box: "Are the majority (≥51%) of total food sales to Qualified End Users (QEU) or Non-Qualified End Users (NQEU)?" This box has two orange arrow outcomes pointing down and outward. The left arrow reads "More sales (≥51%) to NQEU" and leads to the coverage outcome. The right arrow reads "More sales (≥51%) to QEU" and leads to the Qualified Exemption outcome. Coverage outcome (a red octagon, lower left): "Your farm IS COVERED by the Produce Safety Rule and subject to the full requirements of 21 CFR Part 112." This outcome is reached by the "NO higher sales" branch of the first box, the "NO" branch of the second box, and the "More sales (≥51%) to NQEU" arrow of the fourth box. Qualified Exemption outcome (a yellow-bordered box, lower right): "You are eligible for a Qualified Exemption under Section 112.5 and must meet the requirements of Section 112.6. Complete the Qualified Exemption form annually as it applies. Documentation must be submitted each year to be eligible. Without documentation on file, it is assumed your operation is fully COVERED by the Produce Safety Rule." This outcome is reached by the "NO" branch of the third box and the "More sales (≥51%) to QEU" arrow of the fourth box. Outside the flow, next to the first decision box, sits a blue circle labeled "Define" pointing to a blue-bordered note that defines food: "*Food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act and includes seeds and beans used to grow sprouts. (f) The term 'food' means (1) articles used for food or drink for man or other animals. (E.g., produce, eggs, dairy, meat, honey, processed or homemade foods (jams, pickled items, baked goods…), beverages, foods/drinks purchased for resale (commercially produce and/or purchased from other farms…), sales of live food animals, and animal feed such as pet milk, hay, silage, grain…)" A small footnote at the bottom center, outside the flow, reads: "This publication is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U2FFD007444 totaling $1,280,384 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government."

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