Making Some Sense on the “Final” Rule on Food Safety

2016 Summer
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Printable PDF (1.2M)

The produce safety rule(s) on food safety are now finalized.  These rules are part of the much larger Food Safety Modernization Act (FSMA).  They affect everyone who grows, ships, processes, packages, and sells food and food products.  While many smaller growers are exempt from compliance with these rules, that does not remove these same growers from following proper practices to reduce the chance of food-borne illnesses.  Much of this article is summarized from the FDA food Safety article: Key Requirements: Final Rule on Produce Safety.  Every produce grower should read this 7-page article.

Water Quality

The water quality standards are based heavily on an active water testing program and the presence of generic E. coli bacteria.  No detectable (zero level by water testing at an accredited laboratory) is allowed in agricultural water used for: hand washing, cleaning food contact surfaces, water that contacts food, water to make ice, and water used to irrigate sprouts. If any E. coli is detected in sources used for any of these purposes, then proper treatment or a change of water source is immediately required.

For water that is used for irrigation and pesticide spray applications, the levels have been set at two interrelated levels; the GM (geometric mean) and STV (statistical threshold value).  Think of the GM as the average E. coli level in a given water source.  That level is 126 colony forming units (CFU) in a 100 ml water sample.  The STV level was created due to the high variability in water sources during the growing season in response to weather evens and shifts in water levels in aquifers.  That level is 410 CFU.  These levels were set to provide growers, consultants and regulators measurable values to use in managing water sources.

If your water source test above the levels described in the paragraph above, then there are 3 methods to reduce E. coli levels in order to safely sell your produce: Water treatment, washing produce with water that meets the current standard, and allowing time for dangerous microbes to die off after the last application of water that exceeds current levels.

Water Testing

This is probably going to be the heaviest burden on produce growers as the water testing protocols are fairly intensive.

  • For farms that are using untreated surface water, the requirement is a survey of 20 samples collected near harvest over 2 to 4 years. These samples will be used to develop a given farms GM and STV.  Then, 5 samples must be collected every year to update those calculations.
  • For untreated ground water sources, they call for an initial survey of 4 samples collected in one year near harvest, then one sample per year to update those calculations.
  • Untreated groundwater that is used for handwashing on food handling surfaces, for making ice and in other places where zero E. coli is allowed must be tested 4 times in the first year, then once annually unless that annual test indicates any E. coli.
  • Public water and water that is treated per these “rules treatment requirements” are not required to be tested so long as those sources meet relevant requirements.

Raw Manure Use

Farmers must apply raw manure to fields at least 120 days before that crop is harvested for crops that are not in contact with the soil.  So, crops such as greens and herbs fall under this 120 day requirement.

The second part of this rule covers crops such as: trellised tomatoes, peppers, eggplant, and sweet corn where the edible portion does not come into ground contact.  Here the interval between application and harvest is 90 days.

Stabilized Compost

Microbial Standards have been set for biological soil amendments and manure that has been composted completely.  Those making such stabilized amendments need to follow those guidelines.  Any application of such materials must be done in such a way as to minimize the chance for contact with produce at all times.


Simply put, sprouts are considered to be dangerous under this rule.  There is just no other way to interpret these new regulations.  Sprout seeds must be tested, water used to irrigate sprouts must be tested and the final product (sprouts) must be tested.  All must be found free of dangerous microbes.

Due to the intensive testing regimen and time requirements to grow and safely sell sprouts while they are still in saleable condition, it is hard to see how to produce sprouts for sale without an on-site laboratory.  It is very hard to see how small sprout producers can survive and still comply.

Domesticated and Wild Animals

This area of the rule has been much discussed, and it looks like commonsense has prevailed.  If animals are used in the production of produce such as horses or mules used to spray cultivate and pull harvest wagons, farmers are required to take all measures reasonable to prevent contamination of produce by livestock.  If contamination is noticed, and farmers are required to inspect their fields, then those areas should be marked.  Farmers are not required to exclude wild animals from production areas, destroy habitat, clear borders or drainage areas.

Worker Training, Health & Hygiene

Requirements include:

  • Keeping ill or infected workers from handling food or coming into contact with food contact surfaces.
  • Having all food handling workers trained and in compliance with proper hand washing practice.
  • Preventing farm visitors from contaminating food and food contact surfaces.
  • All farm workers and their supervisors that handle food, apply pesticides, and the like must be trained in health and hygiene.

Equipment, Tools and Buildings

Standards are now in place for equipment, tools and structures that relate to food production and handling.  Greenhouse germination chambers, packing areas, toilets, and handwashing facilities is part of these specifications.


  • The current rule does not apply to processed produce, only to raw produce. Your local health department of Department of Agriculture can provide you with the rules for processed produce products.
  • Commodities that are rarely consumed raw such as asparagus, black beans, kidney beans, lima beans, navy beans and similar beans, garden beets, eggplant, sweet corn, okra, potatoes, pumpkins, winter squash, sweet potatoes and peanuts are exempted as proper cooking should kill any pathogens.
  • – Food grains for the same reason as above.
  • Produce for personal or on-farm consumption.
  • Economic exemptions: 1) Farms with produce sales of less than an average of $25,00 over the past 3 years. 2) Farms with total food sales of less than $500,000 per year over the prior 3 years. And, 3) Farms that sell produce to be processed in such a way to reduce or eliminate any pathogens (such as squash for pumpkin pie).

Even though you may be exempt, being exempt from these regulations does not free growers from their responsibility to grow and sell only safe produce.  Not only can the FDA remove an exemption due to food safety investigations and their responsibility to protect public health, but farmers are not protected from liability in the case of food-borne illnesses if they are exempt.

It is highly recommended that every farm practice good food safety throughout their operation.

  • Know your water sources and test regularly for the presence of E. coli. Treat if necessary to reduce the potential for contamination from these sources.
  • Everyone that handles produce in any way should receive training in proper practices, health and personal hygiene.
  • When renovating or rebuilding packing, production and storage areas be sure to build them in compliance with the latest standards as it is always easier and less expensive to do this right the first time.
  • Regularly attend food safety trainings to stay current. There is ongoing research into manure and manure handling that will impact future regulations.


These new rules are complex, but compliance is not an insurmountable hurdle.  Learning about them and implementing them into your regular production practice will not only make you a safer grower, but will also help to avoid food safety related legal entanglements.

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