Today I am continuing our overview of the FSMA with a more detailed look at the Produce Safety Rule (Produce Rule). Feel free to reference my first two posts here and here where I explain briefly what the FSMA is and give a detailed look at the Preventive Controls Rule.
The Produce Safety Rule
The Food and Drug Administration (FDA) released proposed revisions to the Produce Rule (Section 105) of FSMA on September 19, 2014 with a comment period that ended December 15, 2014. The overview of the Preventive Rule will reflect those proposed changes even though they are not yet final.
In short, the Produce Rule reflects FDA’s regulations which establish standards for produce safety. In its proposed Produce Rule, FDA described new standards for the growing, harvesting, packing, and holding of produce for human consumption. With that said, the Produce Rule sets standards for the following major areas:
1. Worker Training
a. This section requires training for supervisors and farm personnel who handle produce covered by the Produce Rule.
2. Health and Hygiene
a. This section would require farm employees to follow sanitary practices, including but not limited to hand washing, not working when sick, and maintaining personal cleanliness.
3. Agricultural Water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce
a. The Rule would require the use of a treatment method effective to make the water safe and of adequate sanitary quality for its intended uses (see § 112.43(b)). The proposed rule would also require delivery of the treatment in a manner to ensure that the treated water consistently meets that standard, and to monitor the treatment at a frequency adequate to ensure that the treated water consistently meets that standard (see § 112.43(c)).
4. Biological Soil Amendments of Animal Origin
a. The Rule specifies types of treatments, methods of application, and time intervals between applications of certain soil amendments. This includes manure, composted manure, and practices during crop harvest.
5. Domesticated and Wild Animals
a. For domesticated animals, the Rule requires certain standards, such as waiting periods between grazing and crop harvest. For wild animals, the Rule requires farmers to monitor wildlife intrusion and not harvest produce visibly contaminated with animal feces.
6. Equipment, Tools, and Buildings
a. The Rule sets standards for tools and equipment which come into contact with produce as well as for buildings and other faculties where raw fruits and vegetables will be held or packaged.
a. This section sets standards for sprout production, including treatment of the seeds before sprouting and testing of irrigation water for pathogens
Each of these sections also has certain standards for recordkeeping and document adherence.
To Whom Does the Produce Rule Apply?
The Produce Rule applies to farms which cultivate fruits and vegetables in their raw or natural (unprocessed) state and make more than $25,000 in annual produce sales. This is different than the Preventive Rule because the Produce Rule does not apply to manufacturers or processors. However, if you grow raw fruits and vegetables and also manufacture or further process the produce, you may be subject to both rules. The Produce Rule does not apply to raw agricultural commodities that are rarely consumed raw (such as squash), those produced for personal or on-farm consumption, and (with certain documentation) those destined for commercial processing such as canning, which will adequately reduce microorganisms of public health concern (FDA Guidance Document).
The proposed Produce Rule covers the following produce (remember, the Rule has not been finalized and this list may change):
Fruits and vegetables such as almonds, apples, apricots, aprium, asian pear, avocados, babaco, bamboo shoots, bananas, Belgian endive, blackberries, blueberries, broccoli, cabbage, cantaloupe, carambola, carrots, cauliflower, celery, cherries, citrus (such as clementine, grapefruit, lemons, limes, mandarin, oranges, tangerines, tangors, and uniq fruit), cucumbers, curly endive, garlic, grapes, green beans, guava, herbs (such as basil, chives, cilantro, mint, oregano, and parsley), honeydew, kiwifruit, lettuce, mangos, other melons (such as canary, crenshaw and persian), mushrooms, nectarine, onions, papaya, passion fruit, peaches, pears, peas, peppers (such as bell and hot), pineapple, plums, plumcot, radish, raspberries, red currant, scallions, snow peas, spinach, sprouts (such as alfalfa and mung bean), strawberries, summer squash (such as patty pan, yellow and zucchini), tomatoes, walnuts, watercress, and watermelon; and
(2) Mixes of intact fruits and vegetables (such as fruit baskets).
Compliance dates vary depending on what type of facility definition you fall under. Definitions under the Produce Rule are different than the definitions under the Preventive Rule so pay close attention to where your operation fits under each rule.
1. Very Small Business: A business that has an average annual monetary value of food sold during the previous three-year period of no more than $250,000 would have four years from the effective date to be in compliance. (see § 112.3(b)(1))
2. Small Business: A business that has an average annual monetary value of food sold during the previous three-year period of no more than $500,000 would have three years after the effective date to comply with most provisions. (see § 112.3(b)(2))
3. Other Businesses: A business that is not small or very small and does not qualify for an exemption would have two years after the effective date of the final rule to comply with most provisions.
4. The compliance dates for water quality standards and related testing would be an additional two years beyond compliance dates for the rest of the final rule.
For further information on the Produce Rule, visit the FDA website.
Stay tuned for another FSMA post next week!