Food Safety Standards Addressed in the Produce Safety Rule

This page is an abstract and is not intended to provide all requirements in detail. Please review the rule for a more complete description of the standards. 

The Produce Safety Rule describes good agricultural practice standards that covered farms must follow to comply with the rule.  Here is a summary of those procedures:

Training/Assignment for Responsibility (Subpart C of the Rule)

Both old tales and new misinformation on the internet can influence our perception of what causes foodborne illness.  Therefore, training is a key component of most regulations relating to food safety, the PSR included.  The rule says:

  • At least one responsible person must complete training equivalent to the standardized curriculum recognized by FDA (Produce Safety Alliance Grower training).
  • Assign at least one person the responsibility to ensure compliance with the rule—this person is in charge of your food safety program.
  • All workers (and those that supervise them) must be trained when hired and periodically after, at least yearly.  This includes temporary, part time, seasonal workers, family members, and volunteers (i.e. CSA members fulfilling a work requirement).

Worker Health and Hygiene (Subpart D of the Rule)

Training and Practice

People have a huge role in keeping our food safe.  They carry the pathogens that cause illness on their hands, skin, and in their gastrointestinal and respiratory tracts.  The rule says:

  • Handwashing, personal cleanliness, wearing clean clothes, not smoking or eating on the job, proper glove use, etc. are all practices and policies farm workers must know, understand, and follow.
  • The responsible person must train workers regarding health, hygiene, and food safety.
  • Training must go beyond specific health and hygiene practices.

Workers must know how they can impact the safety of the food they are handling. They must be trained regarding ANY tasks that relate to the safety of the food (i.e. how to clean and sanitize harvest bins; safe harvesting practices; preventing the contamination of food contact surfaces; how to mix sanitizer, etc.)

Employee Health

Sick workers or those with an infection can be the source of the pathogens that cause foodborne illness.  The rule says:

  • The supervisor must have policies, procedures and training in place to prevent ill or infected persons from contaminating produce.
  • You must exclude any person from working if they have an applicable health condition.  What are applicable health conditions?  Communicable illnesses that present a risk: infection, open lesion, vomiting, and diarrhea.
  • Personnel must be trained to tell their supervisor if they have, or if there is a reasonable possibility that they have these health conditions.
  • Restrooms and hand washing stations must be available to workers.  Workers need to be able to get to restrooms easily so they are not tempted to go on/near the field.

Visitors, including those attending a pick your own operation or working as a CSA member, need to be made aware of food safety practices and must have access to toilet and hand washing facilities.  There is flexibility regarding how you do this: training meetings or newsletters for CSA members; signage for pick your own operations; and “contracts” or “written agreements” with school tour groups are a few examples.

Agricultural Water (Subpart E of the Rule)

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

This part of the rule addresses water quality standards, inspection, maintenance, and testing requirements for water used in production, harvest, and post-harvest handling.

The definition of agricultural water is very important to this rule. It only applies to water that is intended to or likely to contact covered produce or food contact surfaces.  Direct water application could include overhead irrigation of tomatoes, but probably not drip irrigation of tomatoes (but maybe drip for carrots); any post-harvest application is considered agricultural water.

At the beginning of growing season or at least once annually, inspect your entire agricultural water system, including:

  • Water sources (ponds, streams, wells, municipal sources)
  • Distribution systems (irrigation systems, including drip systems; pesticide application; systems that bring water to packing facilities)
  • Facilities (presence of sewer/septic systems, wastewater disposal)
  • Equipment (consider cross connections in pesticide applicator systems, toilets, hoses, etc.)

During your inspection, identify any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces.

Pre-Harvest/Production Water

The FDA published a final rule that revised pre-harvest agricultural water provisions of Subpart E of the Produce Safety Rule.  Compliance dates, based on farm size are as follows:

  • The effective date for this Rule is July 5, 2024.
  • Large farms:  9 months after the effective date, April 7, 2023
  • Small farms:  1 year and 9 months after the effective date, April 6, 2026
  • Very small farms:  2 years and 9 months after the effective date, April 5, 2027

The rule replaces the previous pre-harvest water microbial quality criteria and testing requirements for covered produce (other than sprouts) with requirements for pre-harvest agricultural water assessments to help farmers identify hazards associated with their water systems and use and to address the management of those hazards.   In addition, if farms identify hazards, the Rule outlines corrective or mitigation measures that must be implemented to address them.

Farmers need to document that the inspection and assessment took place and any actions taken to address an inadequate water system or hazards that might introduce risks to your product.

Farmers must adequately maintain all water sources, to the extent they are under their control; and the water distribution system to the extent it is under their control.

Harvest and Post-Harvest Water

The new Rule regarding Pre-Harvest water has no bearing on the regulation of harvest and post-harvest water or water used in sprout production.  The original Rule requirements remain in effect.

For water used to irrigate sprouts, or to directly apply to produce during harvest or post-harvest; for food contact surfaces; or in hand-washing, the standard is no detectable generic E. coli per 100mL.  Municipal water sources and tested wells are acceptable for these uses. Test wells at least annually, prior the seasonal use for handwashing, produce washing or cooling or cleaning and sanitizing activities.  Keep water test records.  If using municipal water, annual water test results the supplier provides would meet the requirements.

Water used for washing produce must be monitored to ensure it is of safe and adequate quality.  If water treatments are used to maintain water quality/safety, these treatments must be monitored.  Records must be kept of monitoring activities and water treatment activities.

Biological Soil Amendments of Animal Origin (BSAAO) (Subpart F of the Rule)

Farmers must minimize the risk of contamination of fresh produce by holding, transporting, storing, treating, applying biological soil amendments of animal origin (BSAAOs) according to PSR standards.

  • Untreated BSAAOs can only be applied 120 days prior to harvest or in a way that does not come into contact with edible product  (no side dressing, for example).
  • If using raw manure you must keep records that show that the manure is not a source of contamination for covered produce, food contact surfaces, areas used for covered activity, water sources, water distribution systems and other soil amendments.
  • Farms can use BSAAOs treated to the most rigorous PSR standard directly on the edible (or soon to be edible) parts of produce.
  • There are two accepted methods for on farm treatment of manure that, if followed (and you have records to prove it), would not need to be tested for compliance.  You must keep records to show that you followed one of these methods. If you use a different method than those outlined in the rule, or, if you purchase treated manure, you must have documentation that it has been tested to prove it meets the microbial standards outlined in the rule.
  • If you are using treated manure, you must keep records to show that you are using treated manure and that you are handling the treated manure so that it does not become contaminated.

Wildlife, Domestic Animals, and Land Use (Subpart I of the Rule)

Both domesticated and wild animals can be sources of the microorganisms that can contaminate produce and cause foodborne illness.  We cannot eliminate wildlife from farms, but growers must regularly assess their growing areas and post-harvest facilities to determine if there is a potential food safety risk from wildlife, farm animals or pets and to have procedures in place to address identified risks.

  • The rule requires that you assess growing fields for potential animal intrusion and evidence of contamination, as needed during growing season and especially during harvest.  There is no requirement for documenting this, but you should still conduct these assessments. You must train workers that are harvesting to look for these risks and not to pick if there is concern for contamination.
  • If there is evidence of contamination (animal poop, damage to plants), you must evaluate risk and determine if you can harvest the product.
  • If packing areas are subject to wildlife intrusion (i.e. those that are not enclosed), the farmer must assess the risks and identify and implement procedures that would prevent contamination of covered produce and food contact surfaces, such as cleaning and sanitizing food contact surfaces prior to each use.
  • Assess the risks your domestic animals and pets may present.  Ensure that manure is stored in a way that reduces risks for contamination of covered produce.  Keep domestic animals out of the growing areas.  Manage working animals to minimize contamination.  Keep pets out of growing and packing areas.  Have procedures in place and train workers to minimize risk of contamination if they are working in both animal and produce areas.
  • Farms should consider the following risks when assessing their farmland: septic systems, nearby animal farms/facilities, residential and commercial land use.  Think about and implement ways to reduce risks identified during the assessment.

Growing, Harvesting, Packing, Holding (Subpart K of the Rule)

This section of the rule speaks to practices that reduce contamination of fresh produce during and after harvest.

  • If you grow both covered produce and produce that is not covered—you must keep them separate.  Wash, pack and handle them in a separate space or by handling the covered produce first thing in the day and the non-covered produce after that.  Be sure to adequately clean and sanitize food contact surfaces after handling non-covered produce, before using the surface for covered produce.  The best approach might be to treat all produce you grow as if it were covered produce.
  • Workers must use clean hands/utensils/tools for harvest.  Keep product off the ground during harvest, do not harvest dropped produce.
  • Ensure that you transport product to the packing facility using procedures that prevent contamination.
  • When handling produce in your facility, make sure that all food contact surfaces are clean and sanitary before contacting covered produce and use new or cleaned and sanitized packaging.

Equipment, Tools, Buildings (Subpart L of the Rule)

This section of the rule addresses food safety concerns of equipment used during all covered activities (including growing, harvest and post-harvest activities).

  • All tools, equipment, and buildings must be constructed of materials that can be cleaned and will not contribute to the contamination of produce.
  • All buildings used for covered activities and/or for storing equipment or packaging that might come into direct contact with covered produce are included; as are vehicles used for transportation of covered produce.
  • All tools or equipment that might come into contact with covered produce, including any that are used to measure (I.e. pH meters or thermometers), regulate or record conditions to control or prevent growth of pathogens must be used in a way that prevents contamination with pathogens.
  • This section addresses cleaning and sanitizing: when and how and which surfaces to clean and sanitize.  Farms must consider drainage, condensate and drip (from water pipes, compressors), and other characteristics of the post-harvest environment, including shielded light fixtures.

What the rule does NOT do is specify is that you must have a certain building, tools and equipment that is constructed in a certain way.  It doesn’t say you can’t use wood or that you must use stainless steel.  Only that surfaces should be cleanable and, if needed, you should be able to effectively sanitize in a way that prevents contamination.