Are you Subject to Produce Safety Rule Under FSMA?


The following are the basic criteria that will determine whether an operation that meets the definition “farm” is subject to the produce rule:

First, Does your farm grow, harvest, pack or hold produce? If your answer is yes, you are covered by this rule.

List of produce that are covered under section 112.1
(1) Fruits and vegetables:

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, kiwi fruit, 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).

List of produce that is not covered by this part (section 112.2)

(1) Produce that is rarely consumed raw, specifically the produce on the following exhaustive list – arrowhead, arrowroot, artichokes, asparagus, beets, black-eyed peas, bok choy, brussels sprouts, chick-peas, collard greens, crabapples, cranberries, eggplant, figs, ginger root, kale, kidney beans, lentils, lima beans, okra, parsnips, peanuts, pinto beans, plantains, potatoes, pumpkin, rhubarb, rutabaga, sugarbeet, sweet corn, sweet potatoes, taro, turnips, water chestnuts,winter squash (acorn and butternut squash), and yams;

(2) Produce that is produced by an individual for personal consumption or produced for consumption on the farm or another farm under the same ownership; and

(3) Produce that is not a raw agricultural commodity.

(b) Covered produce is eligible for exemption from the requirements of this part (except as noted in paragraphs (b)(1), (b)(2), and (b)(3) of this section) under the following conditions:

(1) The covered produce receives commercial processing that adequately reduces the presence of microorganisms of public health significance.

Examples of commercial processing that adequately reduces the presence of microorganisms of public health significance are processing in accordance with the requirements of parts 113, 114, or 120 of this chapter, treating with a validated process to eliminate spore -forming microorganisms (such as processing to produce tomato paste or shelf-stable tomatoes), and processing such as refining or distilling produce into products such as sugar, oil, spirits, or similar products; (2) You must establish and keep documentation in accordance with the requirements of subpart O of this part, of the identity of the recipient of the covered produce that performs the commercial processing described in paragraph (b)(1) of this section; and (3) The requirements of this subpart and subpart Q of this part apply to such produce.

For complete list, please go to 21 CFR 112

http://www.fda.gov/Food/GuidanceRegulation

Second, if your farm on average in the last three years have $25k or less in annual produce sales, you are not covered by this rule.

Third, the produce is eligible for exemption from the rule if the following criteria has been met:

If your farm on average (in the previous three years) as per Section 112.5: have < $500k annual food sales,  AND a majority of the food (by value) sold directly to “qualified end-users”?

Section 112.3(c) “Qualified End-User”

  • The consumer of the food  OR
  • a restaurant or retail food establishment that is located— (i) in the same State or the same Indian reservation as the farm that produced the food; OR (ii) not more than 275 miles from such farm. (The term “consumer” does not include a business.

Fourth, Below are the key requirements under the Produce Safety Rule. There is a general approach in each criteria that must be met and you can check more detailed information at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm :

  1. Agricultural Water : Water Quality and Testing.
  2. Biological Soil Amendments: Raw Manure and Stabilized Compost.
  3. Sprouts: Preventive Measures, Pathogen Testing, Listeria Testing
  4. Domesticated and Wild Animals: Farmers are required to take all measures reasonably necessary to identify and not harvest produce that is likely to be contaminated. The rule addresses the concerns on feasibility of compliance for farms that rely on grazing animals (such as livestock) or working animals for various purposes. It establishes the same standards for these animals as it does for intrusion by wild animals (such as deer or feral swine)
  5. Worker Training and Health and Hygiene
  6. Equipment, Tools and Buildings: Sanitation for contaminating produce.

Compliance Dates

Compliance dates for covered activities, except for those involving sprouts, after the effective date of the final rule are:

  • Very small businesses, those with more than $25,000 but no more than $250,000 in average annual produce sales during the previous three year period : four years
  • Small businesses, those with more than $250,000 but no more than $500,000 in average annual produce sales during the previous three year period: three years
  •     All other farms: two years

The compliance dates for certain aspects of the water quality standards, and related testing and recordkeeping provisions, allow an additional two years beyond each of thes compliance dates for the rest of the final rule.

Compliance dates for modified requirements for farms eligible for a qualified exemption are:

  • For labeling requirement (if applicable): January 1, 2020
  • For retention of records supporting eligibility for a qualified exemption: Effective date of the final rule.

For all other modified requirements:

  • Very small businesses, four years after the effective date of the final rule
  • Small businesses, three years after the effective date of the final rule

Compliance dates for covered activities involving sprouts after the effective date of the final rule are:

  • Very small businesses: three years
  • Small businesses: two years
  • All other farms: one year

 

To read the complete Final Rule on Produce Safety:

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm#exemptions

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