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                "alt": "Decision tree for Produce Safety Rule Qualified Exemption eligibility (Maryland Dept of Agriculture)",
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                    "text": "201 (f)",
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                    "text": "Qualified End Users?",
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                    "text": "Complete the Qualified Exemption form",
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                    "text": "21 CFR Part 11 2",
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            "text": "This is a decision tree titled \"Part II Qualified Exemption Eligibility,\" published by the Maryland Department of Agriculture. It helps a farm determine whether it is covered by the Produce Safety Rule or eligible for a Qualified Exemption.\n\nThe flow begins at a green diamond labeled \"Start.\" An arrow leads 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).\"\n\nFrom this first decision box there are two paths. A \"NO higher sales\" branch (red circle) leaves to the left and down and leads to the final red stop-sign outcome. A \"YES\" branch (green circle) leaves downward to the next decision box.\n\nThe next decision box reads: \"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 (red circle) leaves to the left and leads to the final red stop-sign outcome. A \"YES\" branch (green circle) leaves downward to the next decision box.\n\nThe next decision box reads: \"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 (red circle) leaves to the right and leads down to the yellow-bordered Qualified Exemption outcome box on the lower right. A \"YES\" branch (green circle) leaves downward to the final decision box.\n\nThe final decision box reads: \"Are the majority (≥51%) of total food sales to Qualified End Users (QEU) or Non-Qualified End Users (NQEU)?\" This has two outcomes shown as orange arrows pointing left and right. The left orange arrow is labeled \"More sales (≥51%) to NQEU\" and leads to the red stop-sign outcome. The right orange arrow is labeled \"More sales (≥51%) to QEU\" and leads to the yellow-bordered Qualified Exemption outcome box.\n\nThe red stop-sign outcome (bottom left) reads: \"Your farm IS COVERED by the Produce Safety Rule and subject to the full requirements of 21 CFR Part 112.\" This terminus is reached by the \"NO higher sales\" branch of the first box, the \"NO\" branch of the second box (do you sell to Qualified End Users), and the \"More sales (≥51%) to NQEU\" arrow.\n\nThe yellow-bordered outcome box (bottom right) reads: \"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 terminus is reached by the \"NO\" branch of the third box (do you sell to Non-Qualified End Users) and the \"More sales (≥51%) to QEU\" arrow.\n\nOutside the flow, a blue \"Define\" circle connects to a blue-bordered note reading: \"*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...).\"\n\nA footnote at the bottom, outside the flow, states this publication is supported by the 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, and that the contents do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.",
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