Food Law

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Detailed Description

This law specifies requirements that farms must follow if they intend to produce agricultural commodities that will be sold to consumers without further processing.

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Standards for Produce Safety

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The statute is codified at 21 USC 350h

 

"[FDA] in coordination with [USDA] … shall … establish science-based minimum standards for the safe production and harvesting of … fruits and vegetables … that are raw agricultural commodities for which … such standards minimize the risk of serious adverse health consequences or death.

[Rule] shall --

(B) include, with respect to growing, harvesting, sorting, packing, and storage operations, science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water;

(C) consider hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced…"

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Once this regulation is finalized (and that may take a year), farms will be required to comply with these rules within 2 to 4 years.  Small farms and very small farms will have will have as long as six years to be in compliance.  But it is only a matter of time until these rules must be met.

Many of the details in this regulation reflect Good Agricultural Practices (GAP) that have been developed by other entities, including other food businesses.  Occasionally comparing the regulation to industry-based GAP may reveal extensive similarities between emerging industry expectations and this proposed regulation.

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A farm or farm mixed-type facility with an average annual monetary value of food sold during the previous 3-year period of more than $25,000 is subject to this requirement (proposed 21 CFR 112.4).

Several definitions:

  • A farm grows and harvests produce.
  • A mixed type facility is a farm that grows and harvest produces, but that also manufactures, processes, packs, or holds food.
  • Harvesting means activities traditionally performed by farms for the purpose of removing raw agricultural commodities from the place they were grown or raised ... Gathering, washing, trimming of outer leaves of, removing stems and husks from, sifting, filtering, threshing, shelling, and cooling raw agricultural commodities are examples of harvesting. 
    • Activities that transform a raw agricultural commodity into a processed food is NOT harvesting.  Restated, activities that transform raw agricultural commodities into a processed food are processing; such businesses must prepare and implement a food safety plan.
  • Holding means storage of food, including warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.
  • Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging.
  • Packing means placing food into a container, BUT ...

Farms (as defined above and are not exempt as defined subsequently) must take appropriate measures to minimize the risk of serious adverse health consequences or death from the use of, or exposure to, covered produce, including those measures reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into covered produce, and to provide reasonable assurances that the produce is not adulterated (proposed 21 CFR 112.11).

FDA offers a flowchart to determine the applicability of this regulation to farm businesses; see Proposed Standards for Produce Safety - Coverage and Exemptions/Exclusions for Proposed 21 PART 112.

In using this flowchart, be mindful of what it means if the produce safety rule does not apply.  For example in the first step, a farmer may answer "yes" because the farmer raises only food grains and no produce. That farmer is not subject either of the regulations proposed in January 2013 (produce safety or hazard analysis).  However at the fourth step, a farmer may say "yes" because the farmer processes produce that is NOT a raw agricultural commodity.  In that case, a "yes" relieves the farmer of complying with the produce safety regulation, but most likely subjects the farmer to the hazard analysis regulation.  Bottom line -- the outcome of reaching the right-hand column in this flowchart is NOT the same at each step of thought process.

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What is covered produce?

Food that is produce and that is a raw agricultural commodity (RAC) is covered (proposed 21 CFR 112.1).

Covered produce includes all of the following:
(1) 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).

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The following produce is not covered ...:
(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.

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(b) Covered produce is eligible for exemption ... 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 are processing 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; and
(2) The farmer documents the identity of the recipient of the covered produce that performs the commercial processing.

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Produce means any fruit or vegetable (including mixes of intact fruits and vegetables) and includes mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts and herbs.

  • A fruit is the edible reproductive body of a seed plant or tree nut (such as apple, orange and almond) such that fruit means the harvestable or harvested part of a plant developed from a flower.
  • A vegetable is the edible part of an herbaceous plant (such as cabbage or potato) or fleshy fruiting body of a fungus (such as white button or shiitake) grown for an edible part such that vegetable means the harvestable or harvested part of any plant or fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers, bulbs, stems, leaves, or flower parts are used as food and includes mushrooms, sprouts, and herbs (such as basil or cilantro).
  • Produce does not include food grains meaning the small, hard fruits or seeds of arable crops, or the crops bearing these fruits or seeds, that are grown and processed for use as meal, flour, baked goods, cereals and oils rather than for fresh consumption (including cereal grains, pseudo cereals, oilseeds and other plants used in the same fashion). Examples of food grains include barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, cotton seed, and soybeans.

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Personal opinion:  listing covered produced, produced not covered, produce eligible for exemption, etc may complicate (rather than simplify) the application of this regulation.  Producers who have reviewed these lists comment "many of the foods are consumed both raw or prepared, and we prepare these produce knowing the commodity may end up in one use or the other".  It may be better to offer definitions for each of these categories, provide examples, and then state that the regulation will be applied (or not applied) depending on how the food is ultimately consumed (fresh/raw or prepared).  To assume that a particular commodity will primarily be consumed in one manner and then to use that presumption to determine whether the crop (and farm) is subject to the "produce safety" regulation is NOT going to lead to the intended Congressional result.  These sections of these regulation will hopefully be reviewed and refined to more closely align with the issues Congress intended to address with this section of the FSMA.

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What standards must the farm meet?

  • Subpart C--Standards Directed to Personnel Qualifications and Training
  • Subpart D--Standards Directed to Health and Hygiene
  • Subpart E--Standards Directed to Agricultural Water
  • Subpart F--Standards Directed to Biological Soil Amendments of Animal Origin and Human Waste
  • Subpart I--Standards Directed to Domesticated and Wild Animals
  • Subpart K--Standards Directed to Growing, Harvesting, Packing, and Holding Activities
  • Subpart L--Standards Directed to Equipment, Tools, Buildings, and Sanitation
  • Subpart M--Standards Directed to Sprouts

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Training

Additional FDA information

All personnel who handle covered produce or food-contact surfaces, or who supervises such workers, must receive adequate training upon hiring, at the beginning of each growing season (if applicable), and periodically thereafter.

All personnel who handle covered produce or food-contact surfaces, or who supervises such workers, must have the training, in combination with education or experience to perform the person's assigned duties in a manner that ensures compliance ...

Training must be conducted in a manner that is easily understood by the personnel being trained.

Training must be repeated as necessary and appropriate in light of observations or information
indicating that personnel are not meeting standards established by the FDA.

Training must include:

  • Principles of food hygiene and food safety;
  • The importance of health and personal hygiene for all personnel and visitors, including recognizing symptoms of a health condition that is reasonably likely to result in contamination of covered produce or food-contact surfaces with microorganisms of public health significance; and
  • The standards established by FDA ... that are applicable to the employee's job responsibilities.

Persons who conduct harvest activities for covered produce also must receive training that includes:

  • Recognizing covered produce that should not be harvested, including covered produce that may be contaminated with known or reasonably foreseeable hazards;
  • Inspecting harvest containers and equipment to ensure that they are functioning properly, clean, and maintained so as not to become a source of contamination of covered produce with known or reasonably foreseeable hazards; and
  • Correcting problems with harvest containers or equipment, or reporting such problems to the supervisor (or other responsible party), as appropriate to the person's job responsibilities.

At least one supervisor or responsible party on the farm must have successfully completed food
safety training at least equivalent to that received under standardized curriculum recognized as adequate by the FDA.

The farm must assign or identify personnel to supervise (or otherwise be responsible for) operations to ensure compliance with the requirements.

The farm establish and keep records of training ... including the date of training, topics covered, and the persons(s) trained.

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Health and Hygiene

Additional FDA information

Take measures to prevent contamination of covered produce and food-contact surfaces by any person with an applicable health condition (such as a communicable illnesses that present a public health risk in the context of normal work duties, infection, open lesion, vomiting, or diarrhea).

Exclude any person from working in any operations that may result in contamination of covered produce or food-contact surfaces when the person (by medical examination, the person's acknowledgement, or observation) is shown to have or appears to have an applicable health condition, until the person's health condition no longer presents a risk to public health.

Instruct personnel to notify their supervisor(s) (or a responsible party) if they have, or if there is a reasonable possibility that they have an applicable health condition.

Personnel who work in an operation in which covered produce or food-contact surfaces are at risk of contamination must use hygienic practices while on duty to the extent necessary to protect against such contamination.

The hygienic practices must include

  • Maintaining adequate personal cleanliness to protect against contamination of covered produce and food-contact surfaces;
  • Avoiding contact with animals other than working animals, and taking appropriate steps to minimize the likelihood of contamination of covered produce when in direct contact with working animals;
  • Washing hands thoroughly, including scrubbing with soap and running water, and drying hands thoroughly using single-service towels, clean cloth towels, sanitary towel service or other adequate hand drying devices: (i) before starting work; (ii) before putting on gloves; (iii) after using the toilet; (iv) upon return to the work station after any break or other absence from the work station; (v) as soon as practical after touching animals (including livestock and working animals), or any waste of animal origin; and (vi) at any other time when the hands may have become contaminated in a manner that is reasonably likely to lead to contamination of produce.

If the farmer chooses to use gloves in handling covered produce or food-contact surfaces, maintaining gloves in an intact and sanitary condition and replacing such gloves when no longer able to do so.

Farmers must make visitors (any person (other than personnel) who enters the farm with the farmer's permission) aware of policies and procedures to protect the produce and food contact surfaces from contamination and take all steps reasonably necessary to ensure that visitors comply with such policies and procedures.  The farmer must make toilet and hand-washing facilities accessible to visitors.

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Agricultural Water

Additional FDA information

All agricultural water must be safe and of adequate sanitary quality for its intended use.

At the beginning of a growing season, the farmer must inspect the entire agricultural water system under the farmer's control (including water source, water distribution system, facilities, and equipment), to identify conditions that are reasonably likely to introduce foreseeable hazards into or onto produce or food-contact surfaces, including consideration of: 1) the source of the agricultural water; 2) the extent of the farmer's control over each agricultural water source; 3) the degree of protection of each agricultural water source; 4) use of adjacent or nearby land; and
5) the likelihood of hazards to agricultural water by another user of agricultural water before the water reaches the farm.

The farmer must maintain all agricultural water sources that are under the farmer's control by regularly inspecting each source and keeping the source free of debris, trash, domesticated animals, and other possible sources of contamination of produce to the extent practicable and appropriate.

The farmer must adequately maintain all agricultural water distribution systems as necessary and appropriate to prevent the water distribution system from being a source of contamination to produce, food-contact surfaces, areas used for a covered activity, or water sources, including regularly inspecting and adequately storing all equipment used in the system.

The farmer must immediately discontinue use of an agricultural water and/or its distribution system, and not use the water source and/or its distribution system when the farmer determines or has reason to believe that the agricultural water is not safe and of adequate sanitary quality for its intended use.  The water source cannot be reused until the farmer either: 1) re-inspects the entire agricultural water system, identify any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto produce or food-contact surfaces, make necessary changes, and test the water to determine whether the changes were effective and to ensure that the agricultural water is safe and of adequate sanitary quality for its intended use; or 2) treat the water in accordance with regulatory requirements.

As necessary and appropriate, the farmer must implement measures reasonably necessary to reduce the potential for contamination of produce as a result of pooling of water. For example, such measures may include using protective barriers or staking to keep covered produce from touching the ground or using an alternative irrigation method.

A farmer must treat any agricultural water (such as with an EPA-registered antimicrobial pesticide product) if the farmer knows the water is not safe and of adequate sanitary quality for its intended use.

The farmer must deliver any treatment of agricultural water in a manner to ensure that the treated water is consistently safe and of adequate sanitary quality for its intended use.  The farmer must monitor any treatment of agricultural water at a frequency adequate to ensure that the treated water is consistently safe and of adequate sanitary quality for its intended use.

The farmer must test the quality of agricultural water using a quantitative, or presence-absence method of analysis to ensure there is no detectable generic E. coli in the  agricultural water when it is: 1) used as sprout irrigation water; 2) applied in any manner that directly contacts produce during or after harvest activities, including when used to make ice that directly contacts produce; 3) used to make a treated agricultural tea; 4) used to contact food-contact surfaces, or to make ice that will contact food-contact surfaces; or 5) used for washing hands during and after harvest activities.

If a detectable generic E. coli is found, the farmer must immediately discontinue use of that agricultural water and/or its distribution system.  Before resuming use of the agricultural water, the farmer must either re-inspect the entire agricultural water system, identify any conditions that are reasonably likely to introduce hazards onto produce or food-contact surfaces, make necessary changes, and retest the water to determine whether the changes were effective and to ensure that the water meets the requirements.

When agricultural water is used during growing activities for produce (other than sprouts) using a direct water application method, the farmer must test the quality of water.  If found that there is generic E. coli, the farmer must immediately discontinue use of that agricultural water and/or its distribution system. Before the farmer may use the water source and/or distribution system again, the farmer must either re-inspect the entire agricultural water system, identify any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food-contact surfaces, make necessary changes, and retest the water to determine whether the changes were effective; or treat the water in accordance with the regulations.  The farmer may establish and use alternative standards provided that the farmer satisfy the regulations.

The farmer must test any agricultural water at the beginning of each growing season, and every three months thereafter during the growing season, except when:  1) the farmer receives water from a Public Water System that furnishes water that meets the microbial requirements under those regulations or under the regulations of a State approved to administer the SDWA public water supply program, and the farmer has Public Water System results or certificates of compliance that demonstrate that the water meets that requirement;  2) the farmer receives  water from a public water supply that furnishes water that meets the microbial regulatory requirement, and the farmer has  public water system results or certificates of compliance that demonstrate that the water meets that requirement; or 3) the farmer treats water in accordance with the regulatory requirements.

If the farmer uses untreated surface water for purposes that are subject to the regulation, the farmer must test the water as specified in the regulation.

The farmer must manage the water by establishing and following water-change schedules for re-circulated water, to maintain adequate sanitary quality and minimize the potential for contamination of covered produce and food-contact surfaces with known or reasonably foreseeable hazards (for example, hazards that may be introduced into the water from soil adhering to the covered produce).

The farmer must visually monitor the quality of water that the farmer uses during harvest, packing, and holding activities for covered produce (for example, water used for washing covered produce in dump tanks, flumes, or wash tanks, and water used for cooling covered produce in hydrocoolers) for build-up of organic material (such as soil and plant debris).

The farmer must maintain and monitor the temperature of water at a temperature that is appropriate for the commodity and operation (considering the time and depth of submersion) and is adequate to minimize the potential for infiltration of microorganisms into covered produce.

The farmer must establish and keep records of:  1) the findings of the inspection of the agricultural water system; 2) documentation of the results of any analytical tests conducted to determine whether agricultural water is safe and of adequate sanitary quality for its intended use; 3) scientific data or information you rely on to support the adequacy of a method used to satisfy the regulations; 4) documentation of the results of water treatment monitoring; 5) documentation of the results of water testing; 6) scientific data or information relied on to support any alternative to the requirements; and 7) annual documentation of the results or certificates of compliance from a public water system.

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Biological Soil Amendments

Additional FDA information

Biological soil amendment of animal origin means a biological soil amendment which consists of materials of animal origin, such as manure or non-fecal animal byproducts, or table waste.

A farmer must handle, convey and store any biological soil amendment of animal origin in a manner and location such that it does not become a potential source of contamination to produce, foodcontact surfaces, areas used for a covered activity, water sources, and water distribution systems.

A farmer must handle, convey and store any treated biological soil amendment of animal origin in a manner and location that minimizes the risk of it becoming contaminated by an untreated biological soil amendment of animal origin.

A farmer must handle, convey, and store any biological soil amendment of animal origin that has become contaminated as if it was untreated.

Treatment processes are acceptable for a biological soil amendment of animal origin that you apply in the growing of covered produce, provided that the resulting biological soil amendments are applied in accordance with the applicable requirements:
(a) A scientifically valid controlled physical process (for example, thermal), chemical process (for
example, high alkaline pH), or combination of scientifically valid controlled physical and chemical
processes that has been demonstrated to satisfy the microbial standard for Listeria
monocytogenes (L. monocytogenes), Salmonella species, and E. coli O157:H7;
(b) A scientifically valid controlled physical process, chemical process, or combination of scientifically valid controlled physical and chemical processes, that has been demonstrated to satisfy the microbial standard for Salmonella and fecal coliforms; or
(c) A scientifically valid controlled composting process that has been demonstrated to satisfy the
microbial standard for Salmonella and fecal coliforms.

For any biological soil amendment of animal origin that the farmer uses,  the farmer must establish and keep records...

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Domesticated and Wild Animals

Additional FDA information

If a farmer allows animals to graze or uses them as working animals in fields where covered
produce is grown, and under the circumstances there is a reasonable probability that grazing or working animals will contaminate covered produce, the farmer must:

(a) allow an adequate waiting period between grazing and harvesting for covered produce in any growing area that was grazed to ensure the safety of the harvested crop; and
(b) If working animals are used in a growing area where a crop has been planted, take measures to prevent the introduction of known or reasonably foreseeable hazards into or onto covered produce.

If under the circumstances there is a reasonable probability that animal intrusion will contaminate
covered produce, the farmer must monitor those areas that are used for a covered activity for evidence of animal intrusion:  (1) As needed during the growing season based on: (i) the covered produce; and (ii) farmer/worker observations and experience; and (2) Immediately prior to harvest.

If animal intrusion, as made evident by observation of significant quantities of animals, animal excreta or crop destruction via grazing, occurs, the farmer must evaluate whether the covered produce can be harvested in accordance with the requirements.

These requirements apply when a covered activity takes place in an outdoor area or a
partially-enclosed building and when, under the circumstances, there is a reasonable probability that animals will contaminate covered produce.  These requirements do not apply when a covered activity takes place in a fully enclosed building.

Bottom line with respect to wild animals:  train the workers to not harvest the crop if there is so much animal waste in the area that the commodity should not be used for food.  This regulation  does not intend the farmer to eradicate wild animals nor to fence them out.

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Growing, Harvesting, Packing, and Holding Activities

A farmer who grows, harvests, packs or holds both covered and excluded produce must a) keep covered produce separate from excluded produce; and b) adequately clean and sanitize, as necessary, any food-contact surfaces that contact excluded produce before using such food-contact surfaces for covered activities.

A farmer must take all measures reasonably necessary to identify, and not harvest, covered produce that is reasonably likely to be contaminated with a known or reasonably foreseeable hazard, including steps to identify and not harvest covered produce that is visibly contaminated with animal excreta.

A farmer must handle harvested covered produce in a manner that protects against contamination with known or reasonably foreseeable hazards--for example, by avoiding contact of cut surfaces of harvested produce with soil.

A farmer must not distribute covered produce that drops to the ground before harvest, unless it is exempt. Dropped covered produce does not include root crops (such as carrots) that grow underground or crops (such as cantaloupe) that grow on the ground.

A farmer must package covered produce in a manner that prevents the formation of Clostridium botulinum toxin if such toxin is a known or reasonably foreseeable hazard (such as for mushrooms).

A farmer must use food-packing material that is adequate for its intended use.

A farmer who reuses food-packing material must take steps to ensure that food-contact surfaces are clean, such as by cleaning and sanitizing, when necessary, food-packing containers or using a clean liner.

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Equipment, Tools, Buildings, and Sanitation

Additional FDA information

Equipment and tools likely to contact produce; and those instruments or controls used to measure, regulate, or record conditions to control or prevent the growth of undesirable microorganisms or other contamination are regulated, such as knives, implements, mechanical harvesters, waxing machinery, cooling equipment (including hydrocoolers), grading belts, sizing equipment, palletizing equipment, and equipment used to store or convey harvested covered produce (such as containers, bins, food-packing material, dump tanks, flumes, and vehicles or other equipment used for transport.

Buildings subject regulation include any fully- or partially-enclosed building used for covered activities, including minimal structures that have a roof but do not have any walls; and storage sheds, buildings, or other structures used to store food-contact surfaces (such as harvest containers and food-packing materials).

Equipment and tools must be designed, constructed, and workmanship to enable them to be adequately cleaned and properly maintained

Equipment and tools must be installed and maintained to facilitate cleaning of the equipment and adjacent spaces, and stored and maintained to protect covered produce from being contaminated and to prevent the equipment and tools from attracting and harboring pests.

Seams on food-contact surfaces of equipment and tools must be either smoothly bonded, or maintained to minimize accumulation of dirt, filth, food particles, and organic material and thus minimize the opportunity for harborage or growth of microorganisms.

The farmer must inspect, maintain, and clean and sanitize, when necessary and appropriate, all foodcontact surfaces of equipment and tools as frequently as reasonably necessary to protect against contamination of covered produce.

The farmer must maintain and clean all non-food-contact surfaces of equipment and tools used during harvesting, packing, and holding as frequently as reasonably necessary to protect against contamination.

Pallets, forklifts, tractors, and vehicles likely to contact produce must be used to minimize the potential for contamination of produce or food-contact surfaces with known or reasonably foreseeable hazards.

Instruments or controls used to measure, regulate, or record temperatures, hydrogen-ion concentration (pH), sanitizer efficacy or other conditions must be:
(a) Accurate and precise as necessary for their purpose;
(b) Adequately maintained; and
(c) Adequate in number for their designated uses.

Equipment used to transport produce must be:
(a) Adequately clean before use in transporting covered produce; and
(b) Adequate for use in transporting covered produce.

Buildings must be a suitable size, construction, and design to facilitate maintenance and sanitary
operations. Buildings must:

  • Provide sufficient space for placement of equipment and storage of materials;
  • Permit proper precautions to reduce the potential for contamination of produce, food-contact surfaces, or packing materials; the potential for contamination must be reduced by effective design including the separation of operations in which contamination is likely to occur by location, time, partition, enclosed systems, or other effective means
  • Be constructed in such a manner that floors, walls, ceilings, fixtures, ducts and pipes can be adequately cleaned and kept in good repair, and that drip or condensate does not contaminate covered produce, food-contact surfaces, or packing materials.

The farmer must provide adequate drainage in all areas where normal operations release or discharge water or other liquid waste on the ground or floor of the building.

The farmer must take reasonable precautions to prevent contamination of produce, food-contact
surfaces, and food-packing materials in fully-enclosed buildings with known or reasonably foreseeable hazards from domesticated animals by:

  • 1) Excluding domesticated animals from fully-enclosed buildings where covered produce, foodcontact surfaces, or food-packing material is exposed; or
  • (2) Separating domesticated animals in a fully enclosed building from an area where a covered activity is conducted on covered produce by location, time, or partition.

Guard or guide dogs may be allowed in some areas of a fully enclosed building if the presence of the dogs is unlikely to result in contamination of produce, food-contact surfaces, or food-packing materials.

The farmer must take measures reasonably necessary to protect produce, food-contact surfaces, and food-packing materials from contamination by pests in buildings, including routine
monitoring for pests as necessary and appropriate.

For fully-enclosed buildings, the farmer must take measures to exclude pests from buildings.  For partially-enclosed buildings, the farmer must take measures to prevent pests from becoming established in buildings.

The farmer must provide personnel with adequate, readily accessible toilet facilities, including toilet facilities readily accessible to growing areas during harvesting activities.  Toilet facilities must be designed, located, and maintained to 1) prevent contamination of produce, food-contact surfaces, areas used for a covered activity, water sources, and water distribution systems with human waste; 2) be directly accessible for servicing, be serviced and cleaned on a schedule sufficient to ensure suitability of use, and be kept supplied with toilet paper; and 3) provide for the sanitary disposal of waste and toilet paper.

During growing activities that take place in a fully-enclosed building, and during covered harvesting, packing, or holding activities, the farmer must provide a hand-washing station in sufficiently close proximity to toilet facilities to make it practical for persons who use the toilet facility to wash their hands.

The farmer must provide personnel with adequate, readily accessible hand-washing facilities during growing activities that take place in a fully-enclosed building, and during covered harvest, packing, or holding activities.  The hand-washing facilities must be furnished with (1) soap (or other effective surfactant); (2) running water top be used to wash hands; and (3) adequate drying devices (such as single service towels, clean cloth towels or sanitary towel service).

The farmer must provide for appropriate disposal of waste (for example, waste water and used singleservice towels) associated with a hand-washing facility and take appropriate measures to prevent waste water from a hand-washing facility from contaminating covered produce, food-contact surfaces, areas used for a covered activity, agricultural water sources, and agricultural water distribution systems with known or reasonably foreseeable hazards.

Hand antiseptic/sanitizer or wipes may NOT be used as a substitute for soap and water.

The farmer must 1) dispose of sewage into an adequate sewage or septic system or through other adequate means, 2) maintain sewage and septic systems in a manner that prevents contamination of produce, food-contact surfaces, areas used for a covered activity, agricultural water sources, and agricultural water distribution systems, 3) manage and dispose of leakages or spills of human waste in a manner that prevents contamination of produce, and prevents or minimizes contamination of food-contact surfaces, areas used for a covered activity, agricultural water sources, or agricultural water distribution systems.

After a significant event (such as flooding or an earthquake) that could negatively impact a sewage or septic system, the farmer must take appropriate steps to ensure that sewage and septic systems continue to operate in a manner that does not contaminate produce, food-contact surfaces, areas used for a covered activity, agricultural water sources, or agricultural water distribution systems.

The farmer must convey, store, and dispose of trash, litter and waste to: 1) minimize the potential for trash, litter, or waste to attract or harbor pests; and 2) protect against contamination of produce, food-contact surfaces, areas used for a covered activity, agricultural water sources, and agricultural water distribution systems with known or reasonably foreseeable hazards.

The farmer must adequately operate systems for waste treatment and disposal so that they do not constitute a potential source of contamination in areas used for a covered activity.

The plumbing must be of an adequate size and design and be adequately installed and maintained to: 1) distribute water under pressure as needed, in sufficient quantities, in all areas where used for covered activities, for sanitary operations, or for hand-washing and toilet facilities; 2) properly convey sewage and liquid disposable waste; 3) avoid being a source of contamination to produce, food-contact surfaces, areas used for a covered activity, or agricultural water sources; and 4) not allow backflow from, or cross connection between, piping systems that discharge waste water or sewage and piping systems that carry water used for a covered activity, for sanitary operations, or for use in hand-washing facilities.

If the farmer has domesticated animals, to prevent contamination of covered produce, food-contact surfaces, areas used for a covered activity, agricultural water sources, or agricultural water distribution systems with animal waste, the farmer must: 1) adequately control their excreta and litter; and 2) maintain a system for control of animal excreta and litter.

The farmer must establish and keep documentation of the date and method of cleaning and sanitizing of equipment used in 1) growing operations for sprouts; and 2) harvesting, packing, or holding activities.

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Sprouts

Additional FDA information

A farm that grows seeds or beans for use to grow sprouts must take measures to prevent the introduction of hazards into or onto such seeds or beans.

If the farmer knows or has reason to believe that a lot of seeds or beans have been associated with foodborne illness, the farmer must not use that lot of seeds or beans to produce sprouts.  The farmer must visually examine seeds and beans, and packaging used to ship seeds or beans, for signs of potential contamination with known or reasonably foreseeable hazards.

Farmers must grow, harvest, pack, and hold sprouts in a fully-enclosed building.  Any food-contact surfaces used to grow, harvest, pack, and hold sprouts must be cleaned and sanitized before contact with sprouts or seeds or beans.  The farmers must treat seeds or beans that will be used to grow sprouts using a scientifically valid method immediately before sprouting to reduce microorganisms.  Prior treatment conducted by a grower, handler, or distributor of seeds or beans does not eliminate the farmer's responsibility to treat seeds or beans immediately before sprouting.

The farmer must test the growing, harvesting, packing, and holding environment for Listeria species or L. monocytogenes.  The farmers must either: 1) test spent sprout irrigation water from each production batch of sprouts for E. coli O157:H7 and Salmonella species; or 2) if testing spent sprout irrigation water is not practicable, the farmer must test each production batch of sprouts at the in-process stage for E. coli O157:H7 and Salmonella species.

All of the following testing requirements apply for the growing, harvesting, packing, and holding
environment for Listeria species or L. monocytogenes.

  • The farmer must establish and implement a written environmental monitoring plan that is designed to identify L. monocytogenes if it is present in the growing, harvesting, packing, or holding environment.
  • The farmer's written environmental monitoring plan must be directed to sampling and testing for either Listeria species or L. monocytogenes.
  • The farmer's written environmental monitoring plan must include a sampling plan that specifies: 1) what collected samples will be tested for (i.e., Listeria species or L. monocytogenes); 2) the frequency the farmer will collect environmental samples, which must be no less than monthly; and 3) sample collection sites; the number and location of sampling sites must be sufficient todetermine whether measures are effective and must include appropriate food-contact surfacesand non-food-contact surfaces of equipment, and other surfaces within the growing, harvesting,packing, and holding environment.
  • The farmer must collect environmental samples and test them for Listeria species or L. monocytogenes.

The farmer must take the following actions if the farmer detects Listeria species or L. monocytogenes in the growing, harvesting, packing, or holding environment:

  • conduct additional testing of surfaces and areas surrounding the area where Listeria species or L.monocytogenes was detected to evaluate the extent of the problem, including the potential for Listeriaspecies or L. monocytogenes to have become established in a niche;
  • clean and sanitize the affected surfaces and surrounding areas;
  • conduct additional microbial sampling and testing to determine whether the Listeria species or L.monocytogenes has been eliminated;
  • conduct finished product testing when appropriate; and
  • perform any other actions necessary to prevent reoccurrence of the contamination.

All of the following requirements apply for collecting and testing samples of spent sprout irrigation water or sprouts:

  • The farmer must establish and implement a written sampling plan that identifies the number and location of samples (of spent sprout irrigation water or sprouts) to be collected for each production batch of sprouts to ensure that the collected samples are representative of the production batch when testing forcontamination.
  • In accordance with the written sampling plan required under regulations, the farmer must aseptically collect samples of spent sprout irrigation water or sprouts, and test the collected samples forE. coli O157:H7 and Salmonella species using a method that has been validated for its intended use(testing spent sprout irrigation water or sprouts) to ensure that the testing is accurate, precise, andsensitive in detecting these pathogens.

The farmer must establish and keep the following records:

  • Document treatment of seeds or beans at the farm to reduce microorganisms
  • The farmer's written environmental monitoring plan
  • The farmer's written sampling plan for each production batch of sprouts
  • The results of all testing conducted in accordance with the regulation
  • Any analytical methods used in lieu of the methods specified in the regulation
  • The testing method the farmer used in accordance with the regulation

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Exemption and Modified Requirement


A farm is eligible for a qualified exemption and modified requirements for a year if the farm 1) sold less than $500,000 of food and 2) sold at least half of the food directly to qualified end users.

Qualified end-user means (i) the consumer of the food; or (ii) a restaurant or retail food establishment that (I) is located (a) in the same State or (b) not more than 275 miles from such facility; and (II) is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.

A farm that qualifies for exemption must provide consumers the name and complete business address of the farm where the food was grown:
(1) If a food packaging label is required, the notification must appear prominently and conspicuously on the label of the food.
(2) If a food packaging label is not required, the notification must appear prominently and conspicuously, at the point of purchase, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or in an electronic notice, in the case of Internet sales.

FDA may withdraw the exemption for a qualified facility (a) in the event of an active investigation of a foodborne illness outbreak that is directly linked to the qualified facility; or (b) if the FDA determines that it is necessary to protect public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions at the qualified facility.

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Closing Thought

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Email David.Saxowsky@ndsu.edu

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