Highlights of How FDA's Produce Rule Affects Diversity on the Farm and the Surrounding Landscape

With our encouragement, the Food Safety Modernization Act (FSMA) written by Congress sought to make sure that conservation mandates would be addressed in these regulations, and that no conflicts or duplication would occur with the National Organic Program.

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While we don't like everything in this Produce Rule (there was no attempt to rein in misguided buyer requirements), we feel FDA heard our concerns about conservation.  

The rules accommodate the co-management of food safety and conservation, most notably in the sections on domesticated and wild animals, agricultural water, and biological soil amendments. Below we highlight some of the practices that can still be done on the farm, what farmers can't do, and what new practices FDA requires.

Here are the highlights of the new FSMA Rule:

1) Animal and Plant Diversity (under FDA's Domesticated and Wild Animals; and Growing, Packing, Harvesting, and Holding standards)

What You Can Still Do on the Farm

  • Grow raw agricultural commodities (also known as covered produce) in diverse landscapes with native species without using fences to exclude animals from outdoor growing areas or destroying animal habitat or otherwise clearing farm borders around outdoor growing areas or drainages (§ 112.84). This rule allows you to still:
  • Use conservation practices that reduce pathogens in the soil (adding compost and planting cover crops), water and air (planting non-crop vegetation such as grasses and windbreaks to filter pathogens).
  • Plant conservation practices that benefit the farm (healthy soil, pollination, pest control, air purification, clean and abundant water, and flood control)

If you adhere to the monitoring requirement for animal contamination (see below and § 112.83), you can still:

  • Allow the presence of animals in production fields of raw agricultural commodities (covered produce). Animals, in and of themselves, are not a significant food safety risk (Preamble on Animal Intrusion).

  • Encourage beneficial organisms (natural enemy insects, insectivorous birds, rodent-eating raptors and mammals) to be on the farm.

  • Grow produce and raise livestock on the same farm.

  • Use working animals (horses, guard dogs, weeder geese) around the produce fields (§ 112.83).

  • Allow cats and dogs to be outside the farm (Preamble on Animal Intrusion).

  • Allow livestock to graze leftover crops.

What's New You Have to Do

  • Monitoring in an Outdoor Area or a Partially Enclosed Building - FDA requires monitoring raw agricultural commodities (covered produce) in an outdoor area or a partially enclosed building during the growing season for significant evidence of potential contamination by grazing animals, working animals, or wild or domesticated animal intrusion. Observation of significant numbers of animals, significant amounts of animal feces or significant crop destruction, determines how much of the crop can or can't be harvested. Measures should be used to help you later during harvest in identifying produce that is or may have been contaminated so you don't harvest it (§ 112.83).
  • FDA requires growers conduct a visual assessment in an outdoor area or a partially enclosed building for contamination immediately prior to and during harvest of raw agricultural commodities (covered produce) to identify and not harvest what is or may be contaminated (§ 112.112).
  • Protect Native Species and the Environment - Nothing in this regulation authorizes the "taking" of threatened or endangered species as that term is defined by the Endangered Species Act. As mentioned above, the regulation does not require covered farms to take measures to exclude animals from outdoor growing areas, or to destroy animal habitat or otherwise clear farm borders around outdoor growing areas or drainages (§ 112.84).
  • Using Precautions with Fully Enclosed Buildings - FDA requires that precautions be taken to prevent contamination when domestic animals are located in or around fully enclosed buildings. You must either:
  • Exclude domesticated animals from fully enclosed buildings where raw agricultural commodities (covered produce), food contact surfaces, or food packing material is exposed, or
  • Separate domesticated animals in a fully enclosed building by time, location, or partition.
  • Guide or guard dogs can be in some areas if they are unlikely to result in contamination (§ 112.127).

 2) Water (under FDA's Agricultural Water standard)

What You Can Still Do on the Farm

  • Use water for irrigation without complying with this section of the Produce Rule, if it is not intended to or is unlikely to contact raw agricultural commodities (covered produce) during its growth, such as using drip irrigation on tree fruit crops (Preamble in General Comments).
  • Use your agricultural water without testing if it is treated or is from a municipal water system (§ 112.46).
  • Use your agricultural water if it is of adequate sanitary quality for its intended use. One use is more strict and requires no generic E. coli be present in the water, and the other is less strict and requires your water meets acceptable levels of generic E. coli (§ 112.41).

What's New You Have to Do

  • Water system - FDA requires that you inspect and maintain your agricultural water system to the extent that it is under your control (including water sources, water distribution systems, facilities, and equipment), such as correcting any significant deficiencies (e.g., repairs to well cap, well casing, sanitary seals, piping tanks and treatment equipment, and control of cross-connections), keeping debris, trash, and domesticated animals out of water sources as much as possible, reducing hazards associated with pooled water that can be a source of contamination of raw agricultural commodities (covered produce), and being aware of potential neighboring contamination (§ 112.42).
  • Adequate Sanitary Water Quality for Intended Use- FDA has two levels of adequate water quality:
  • FDA doesn't allow the use of agricultural water with any generic E. coli per 100 mL of water to irrigate sprouts; to directly apply to raw agricultural commodities (covered produce) during harvest or post-harvest activities; for food contact surfaces, or in hand-washing during harvest/post-harvest handling (§ 112.44).
  • FDA requires that you determine if your agricultural water has an acceptable level of generic E. coli for use on raw agricultural commodities (covered produce) during the growing season; for example, you can't use it for overhead irrigation on tomatoes, but you probably could on tomatoes that are drip irrigated; and you can't use buried drip on carrots (Preamble in General Comments and § 112.3).
  • Testing Water for Acceptable Level of Generic E. coli Used During Growing Season - FDA requires the water is tested and the results are calculated in these two ways:
  1. A geometric mean (GM) of your agricultural water samples of 126 or less colony forming units (CFU) of generic E. coli per 100 mL of water; and

  2. A statistical threshold value (STV) of your agricultural water samples of 410 or less CFU of generic E. coli per 100 mL of water (§ 112.44).

If, based on test results, you satisfy the above water quality criteria, then you may use your water as planned. If, however, your water quality exceeds the threshold, then you can still use the water, provided you either:

  1. Stop using the water source until you re-inspect your water distribution system to see if you can determine what’s wrong, rectify it, and then verify that your action was effective to bring the water back under the threshold;

  2. Treat the water; or

  3. Apply a time interval (in days) between last irrigation and harvest that is based on a calculation that measures the die-off of microbes due to natural factors like exposure to wind or sun (NOTE: this is only an option for water used during growing, not for water used in harvest or post-harvest activities) (§ 112.45).

    • FDA's die-off rate of 0.5 log reduction per day is used to determine whether your agricultural water is not too contaminated to allow natural die-off in 4 days, or if it would take more than that time to reduce the pathogens in the water, and hence is too contaminated to use without treatment (§ 112.45).

  • When agricultural water testing is appropriate (water is not coming from a municipality or is not treated), FDA requires that water be tested annually, taking many samples in the first 2-4 years to develop a baseline water profile, then fewer samples annually after that. More tests are required for surface water (20 samples for the baseliine and five samples annually) than for groundwater (four samples for the baseliine and one sample annually) (§ 112.46).
  • FDA allows the use of alternative standards in place of: the microbial water quality standard for untreated irrigation water; the microbial die-off rate; and the testing frequency for untreated surface water. However, you must have “adequate scientific data or information” to prove its effectiveness (§ 112.49).
  • Treatment - If treatment is determined necessary, FDA requires that the treatment be effective, the treatment makes the water consistantly safe, and that you monitor the effectiveness of the treatment (§ 112.43).
  • During Harvest, Packing and Holding - FDA requries measures be taken for water used during harvest, packing, and holding activities. These include, for example, managing the water by establishing and following water-change schedules for recirculated water; visually monitoring the water quality; and maintaining and monitoring water temperature (§ 112.48).
  • Agricultural Water Records - FDA requires records be kept of inspection of agricultural water sources and systems, and pooling of water; generic E. coli test results, water treatment monitoring, microbial die-off, and municipal (annual) documentation (§ 112.50).
  • Compliance - FDA is requiring that farms come into compliance with the water standard four, five and six years from the effective date of the final rule, which is two extra years compared to the other parts of Rule. All farms already have two, three, or four years to come into compliance based on their status as a small or very small business (which is based on sales).

3) Raw Manure, Stabilized Compost and Agricultural Tea (under FDA's Biological Soil Amendments of Animal Origin and Human Waste standard)

What You Can Still Do on the Farm

  • Use manure and compost on raw agricultural commodities (covered produce) without a waiting period between application and harvest (§ 112.56), but with conditions. FDA predicts this will change after more research is done in the next 5-10 years.
  • When "curing" compost, insulation is not required (§ 112.3).
  • Use properly made agricultural tea (§ 112.51).

What's New You Have to Do

  • Handle, Convey and Store - FDA requires that you 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 raw agricultural commodities (covered produce), food contact surfaces, areas used for a covered activity (growing, harvesting, packing or holding), water sources, water distribution systems, and other soil amendments (§ 112.52).
  • Applications - FDA has different requirements for untreated and treated biological soil amendments:
  • Manure and other untreated biological soil amendments must be applied in a way that does not contact raw agricultural commodities (covered produce) , and minimizes the potential for contact after application (§ 112.56).
  • Compost and other treated biological soil amendments must be applied in a way that minimizes the potential to contact raw agricultural commodities (covered produce) during and after application (§ 112.56). A treated soil amendment must be processed to completion to adequately reduce microorganisms of public health significance (§ 112.51).
  • Agricultural Tea - FDA requires in the case of agricultural teas that the biological materials must be processed to adequately reduce microorganisms of public health significance. Untreated surface water cannot be used to make the tea, and the water must have no additives and no detectable generic E. coli per 100 mL (§ 112.51).
  • Treatment- FDA states that acceptable treatment processes include any scientifically valid controlled physical, chemical, or biological process – or a combination – that is validated to satisfy certain microbial standards (§ 112.55). Composting is considered a common biological process, and validated composting methods (§ 112.54) include:
  • Static composting that maintains aerobic (i.e., oxygenated) conditions at a minimum of 131 °F (55 °C) for 3 consecutive days and is followed by adequate curing; and
  • Turned composting that maintains aerobic conditions at a minimum of 131 °F (55 °C) for 15 days (which do not have to be consecutive), with a minimum of five turnings, and is followed by adequate curing.
  • Biological Soil Amendment Records - FDA requires that if you are making compost, you maintain records that document the validity of the treatment process (§ 112.60).
  • FDA requires that if you are using compost from a supplier, you must obtain annual records (§ 112.60) showing that
  • The treatment process used is scientifically valid and carried out with appropriate process monitoring, and
  • Has been handled, conveyed, and stored in a manner and location to minimize the risk of contamination by untreated or in process biological soil amendment of animal origin. 

Disclaimer:  This information provides guidelines and practical tools for use by growers. The information provided herein is offered by Wild Farm Alliance in good faith and believed to be reliable, but is made without warranty, express or implied, as to merchantability, fitness for a particular purpose, or any other matter. It is intended as an educational resource and not as technical advice tailored to a specific farming operation or as a substitute for actual regulations and guidance from FDA or other regulatory agencies. It is also not intended as legal advice. We will not be responsible or liable, directly or indirectly, for any consequences resulting from use of this document or any resources identified in this document.